Community Regional Medical Center

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to ensure patient’s right to be informed for one of two patients, Patient (Pt 12), when Pt 12 was admitted to the hospital with complex diagnoses including sepsis and was assessed to require interpreter services and the electronic medical record did not accurately reflect whether nursing staff utilized interpretive services in accordance with professional standards of care and the hospital’s policy and procedure. These failures had the potential for patients with non-English language preferences to inadequately receive or understand medical procedures and educational information provided to them which could result in negative health outcomes Findings: During a review of Pt 12’s Patient Demographics (PD) (document providing demographic information about the patient to include name, date of birth, admission date, emergency contact and more), dated 8/20/25, the PD indicated Pt 12 was a 65-year-old female arrived to the emergency Department (ED) on 8/16/25 at 8:28 a.m., was admitted to the ED on 8/16/25 at 8:34 a.m., and admitted as inpatient on 8/16/25 at 4:14 p.m. with admission reason as Sepsis (a life-threatening emergency caused by the body’s extreme, uncontrolled response to an infection, leading to widespread inflammation, tissue damage, organ failure, and potentially death). The PD indicated Pt 12 “ ... preferred spoken language: Spanish, Interpreter Needed? Yes ...” During a concurrent interview and record review with 8/20/24, at 1:30 p.m., with the Manager of the Emergency Department (MED) 1, Electronic Medical Record (EMR) for Pt 12 were reviewed. The document titled, “Emergency Department Patient Care Timeline” (EDTL) indicated Pt 12 arrived at the Emergency Department (ED) on 8/16/25 at 8:28 a.m. and was admitted as an inpatient on 8/16/25 at 4:14 p.m. the EDTL indicated Pt 12 was Spanish Speaking and needed interpreter services. The document titled, “History and Physical” (H&P) dated 8/16/25 at 8:47 a.m. indicated Pt 12 “ ... is a 65 y.o. (year old) female with cirrhosis, history of hepatic encephalopathy (a serious, potentially reversible neurological condition caused by a buildup of toxins in the blood due to advanced liver disease or liver failure, which prevents the liver from filtering them properly) ...” The document titled, “Interpreter Flowsheet” (IFS) dated 8/16/25 to 8/20/25 was reviewed, the IFS indicated on 8/16/25 Interpreter was used with name as “start”, location as “start”. The IFS indicated on 8/17/25 interpreter was used with no documentation of the interpreter ’ s name, interpreter session type, interpretation provided to, and interpretation location. The IFS indicated that from 8/18/25 to 8/20/25 there was no documentation if an interpreter was needed, the interpreter type, interpretation method, interpreter name, interpreter session type, interpretation provided to, and interpretation location. MED 1 stated that while family members may assist with basic communication such as bathroom requests, they should not be used as interpreters for medical situations. MED 1 stated the Licensed Nurse (LN)s are expected to document the interpreter ’ s name in the Pt 12 ’ s medical records as part of standard protocol. MED 1 stated Pt 12 required professional interpreter services to ensure comprehensive understanding of her treatment plan and care instructions. MED 1 stated failing to provide proper interpreter services could result in Pt 12 or family members giving uninformed consent or experiencing confusion about medical procedures and treatments they do not fully understand. During an interview on 8/21/25 at 1:08 p.m., with the Manager Interpreter Services (MINTS), the MINTS stated the hospital provides 24/7 interpreter services, which include iPad (portable electronic device where the interpreter was called from) devices for remote interpreter access and bilingual tiered (certified medical interpreters trained professionals who can translate health information correctly) staff. The MINTS stated the hospital uses a two-Tiered process, Tier 1 staff for conversational communication only and Tier II staff for medical communication and complex healthcare discussions. The MINTS stated that any nurse or physician without a tier badge must utilize professional interpreter services when treating patients with language barriers. The MINTS stated nurses utilizing interpreter services should document in the IFS. During a concurrent interview and record review on 8/21/25 at 1:18 p.m., with RN 5 and MED 1, the document titled IFS dated 8/18/25 to 8/20/25 was reviewed, the IFS indicated that from 8/18/25 to 8/20/25 there was no documentation whether an interpreter was needed, interpreter type, the interpreter ’ s name, the interpreter ’ s session type, interpretation provided to, and interpretation location. RN 5 stated, interpreter services should be used when a non-English speaking patient is seen for medical screening. RN 5 stated when an interpreter is used, it should be documented. RN 5 stated the importance of having an interpreter present was to ensure clear communication with the patient. RN 5 stated “we need to be on the same page when sharing information”. RN 5 stated, without proper interpretation, there was the significant risk of miscommunication, potentially leaving the patient unclear about their condition, treatment plan, or care instructions. MED 1 stated the physician ’ s documentation contained no record of interpreter services being utilized for Pt 12 while in Provider at Triage (PAT) 1 on 8/16/25 at 8:47 a.m. MED 1 stated the interpreter usage should have been documented during each nursing shift, but the documentation was not completed. MED 1 stated the LNs failed to record the interpreter ’ s names and Identification number in Pt 12 ’ s medical records. During a concurrent interview and record review on 8/21/25 at 1:25 p.m., with the MINTS, the document titled, “Flowsheet History” (FH) dated 7/22/25 to 8/21/25 indicated RN 10 documented on 8/17/25 at 7:30 a.m. “interpreter Type- Bilingual CMC Staff, Interpretation Method- In person/ direct Contact”. The MINT stated when “In person/ direct Contact” is documented, it means the person that documented was the Interpreter. The document titled H & P dated 8/16/25 at 8:47 a.m. was reviewed, the H & P indicated Medical Director (MD) 1 saw Pt 12 on 8/16/25 at 8:47 a.m. The H & P indicated there was no documentation of interpreter service used during MD1 ’ s visit. The MINTS stated RN 10 and MD 1 were not tiered staff and therefore were required to use interpreter services. The MINTS stated that all interpreter services usage must be documented in the IFS and the patients ’ medical record as per the policy titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired “. The MINTS stated the importance of proper interpretation services is to ensure informed decision-making in patient care. The MINTS stated that failure to provide adequate interpretation could result in adverse patients ’ outcomes. During a concurrent interview and record review on 8/21/25 at 2:37 p.m., with the Director Critical Care Services (DCC) and the Manager of Intensive Care Unit (MICU), the document titled, EDTL was reviewed, the EDTL indicated Pt 12 was transferred to the Intensive Care Unit (ICU) on 8/19/25 at 12:25 p.m. The document titled IFS dated 8/19/25 to 8/21/25 was reviewed, the IFS indicated there was no documentation by the nurses that interpreter services were used in communication with Pt 12 or family members. The DCC stated Pt 12 was admitted to the Intensive Care Unit (ICU) on 8/19/25 at 12:25 p.m. The DCC stated Pt 12 was Spanish speaking and required Interpreter services to ensure comprehension of the plan of care. The DCC stated LNs are expected to utilize interpreter services when caring for patients with language barrier. The DCC stated the nursing documentation lacked any record of interpreter services usage. The DCC stated the LNs failed to document their use of interpreter services in the Pt 12 ’ s medical record. The MICU stated Pt 12 was in the ICU for encephalopathy (any disorder affecting brain function, causing symptoms like confusion, personality changes, memory loss, and in severe cases, coma), sepsis, increasing oxygen (O2) requirements. The MICU stated the expectation was that LNs should communicate with patients in a manner they can understand and properly document all the interpreter services used. The MICU stated the importance of providing interpretation services was that patients had the right to receive medical information in their preferred language and to be fully informed about their care. The MICU stated that without proper interpretation services patients may experience adverse outcomes due to lack of understanding about their condition and treatments. The MICU stated communication barriers could potentially lead to a decline in patient status and overall condition. During an interview on 8/25/25 at 1:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated, staff should validate the translator ’ s status and level of training for language interpretation as per the policy. The CNO stated, otherwise, the staff should use the computer interpreter services that are contracted by the hospital. During a review of the hospital policy and procedure (P&P) titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired “, dated 6/14/24, the P&P indicated, “PURPOSE: A. To define the communication system that is used for patients who have Limited English Proficiency (LEP) ... B. To provide guidelines for coordinating timely response in meeting the assessed special language needs of individual patients ... C. To comply with Americans with Disabilities (ADA), Title VI of the Civil Rights Act of 1964 and Health and Safety Code of California ... 1. Health and Safety Code of California requires licensed general acute care hospitals to provide language assistance services to patients with language or communication barriers ... Community Medical Centers (CMC) has contractual agreements that define expectations and response time, and those vendors are the only language contract services that must be used E .... Upon testing and training, such a staff member is assigned a one or two badge buddy, depending on their scope of competency in the given targeted language F. Language Service Line: Language services are available via phone 24 hours a day, 7 days a week ... G. Non-English or LEP: Those individuals whose native language is other than English and who cannot speak, read, write or understand the English language at a level that permits them to interact effectively with health care providers ... VI. DOCUMENTATION: B. Requesting staff members document in the patient’s EHR if an interpreter or device is/ was used for the following 1. a) Name of the interpreter, including i. interpreter used (first and last name) ii. Interpreter agency, as appropriate iii. Time iv. Date ...2. If the requesting staff member is a tiered bilingual staff, can document in their notes or the interpreter flow sheet that they themselves interpreted. A review of professional reference, “American Journal of Medicine- Interpreters in Health Care: A Concise Review for Clinicians”, found at “https://pubmed.ncbi.nlm.nih.gov/31935351/“, dated Jan 11 2020, the reference indicated, “ ...Conclusion: It is our duty, both ethically and legally, to provide an environment where our patients can feel comfortable knowing they will be listened to and offered information in a language they can understand. The use of a well-trained health care interpreter is often the most important step in fulfilling this duty ...” During a review of a professional reference titled, “Interpreter services and effect on healthcare - a systematic review of the impact of different types of interpreters on patient outcome.” Found at “Journal of migration and health, 7, 100162. https://doi.org/10.1016/j.jmh.2023.100162”, dated 24 Jan 2023, the reference indicated “ ... Utilization of interpreters to facilitate communication between health care providers and non-native speaking patients is essential to provide the best possible quality of care .... Results were indicative of in-person professional interpreter resulting in highest satisfaction and communication, ... In-person Professional interpreter is the interpreter type resulting in greatest satisfaction and best communication outcome for the patients .... In conclusion, professional interpreter is the interpreter type resulting in greatest satisfaction and best communication for the patients, when compared to other types of interpretation or none, and should be used in the ER, in- and out-patient clinics or hospitals, when available ....” During a review of a professional reference titled, “Safety first: The importance of interpreters & translated documents in preventing patient harm”, found at “https://wmc.wa.gov/safety-first-importance-interpreters-translated-documents-preventing-patient-harm”, dated October 7, 2020 the reference indicated, “ ... When used effectively, interpreters and translated documents not only enable providers to communicate with their LEP [limited English proficiency] and NEP [non-English proficiency] patients, but also help promote patient safety by preventing medical errors and patient harm, which will minimize health disparities within this population ... open communication channels with their provider allows these patients to truly be in the center of their care ...””

“PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION CFR(s): 482.13(b)(4) The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital. This Standard is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to promptly notify Patient (Pt) 1’s family/Responsible Party (RP, a person designated by the patient who can make medical decisions on behalf of the patient) of his admission to the hospital on 5/25/25 at 2:53 a.m. and did not notify the family/RP until nearly three hours later after Pt 1 died. This failure resulted in Pt 1’s family and Responsible Party’s inability to participate in medical decisions for Pt 1. Findings: During a review of Pt 1 ’ s “Emergency Medical System (EMS) Run Sheet (RS, a document describing the assessment and treatment of a patient in route to the hospital)”, dated 5/24/25, the RS indicated EMS was called to a Skilled Nursing Facility (SNF) where Pt 1 resided, due to Pt 1 experiencing abdomen pain, nausea and vomiting for 24 to 36 hours. The RS indicated Pt 1 was found to be hypotensive (low blood pressure) and two electrocardiograms (EKG, a test that records the heart ’ s electrical activity) which each revealed a STEMI (ST-Segment Elevation Myocardial Infarction, a severe heart attack caused by a complete blockage of a heart artery, leading to a lack of oxygen and damage to the heart muscle). The RS indicated Pt 1 was transported to the hospital. During a review of Pt 1 ’ s “Emergency Department Timeline (EDTL)”, dated 5/24/25 - 5/25/25, the EDTL indicated Pt 1 arrived in the ED by ambulance at 7:35 p.m. on 5/24/25. The EDTL indicated Pt 1 was treated for hypertension (high blood pressure) and sepsis (a life-threatening emergency that occurs when the immune system overreacts to an infection causing organ dysfunction and potentially death). The EDTL indicated Pt 1 continued to experience a high heart rate, low oxygen levels, and respiratory distress and was eventually intubated (a breathing tube inserted through the mouth and down into the windpipe for air to get through) at 11:29 p.m. The EDTL indicated Orders for Pt 1 to be admitted to the inpatient intensive care unit (ICU) on 5/25/25 at 2:53 a.m. The EDTL indicated Pt 1 had an arterial line (art line, a tube inserted into a large artery for fluids and medication administration and measuring arterial pressure) placed at 4:40 a.m. The EDTL indicated while nursing staff were attempting to get a reading from the art line, Pt 1 ’ s telemetry monitor (recording of patient ’ s heart rhythm) reading was noted to be asystole (no heart rate) and a code blue (cardiac and respiratory resuscitation) was started at 4:51 a.m. During a review of Pt 1 ’ s “Code Timeline (CTL)”, dated 5/25/25, the CTL indicated despite resuscitation efforts Pt 1 died at 5:09 a.m. During an interview on 8/21/25 at 2:18 p.m. with Pt 1 ’ s daughter (Complainant, CO 1), CO 1 stated her husband was Pt 1 ’ s RP. CO 1 stated she and RP 1 did not know Pt 1 was at the hospital. CO 1 stated they first received a call from the hospital from a social worker on 5/25/25 at 5:45 a.m., who asked if RP 1 was coming to the hospital. The second call was from a doctor on 5/25/25 at 5:55 a.m. to tell RP 1 Pt 1 had died. During an interview on 8/25/25 at 1:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated a patient ’ s family member or Responsible Party should be notified of a patient ’ s admission as soon as possible so they are aware and can make decisions regarding the care of the patient. During a review of the hospital ’ s policy & procedure (P&P) titled, “Patient ’ s rights and Responsibilities”, dated 3/14/25, the P&P indicated, “ ... PATIENT RIGHTS ... A. Patients are applicable to all [name of hospital ’ s parent company] patients ... the hospital shall provide processes to support the following patient rights ... 3. To have a family member (or representative of choice) ... notified promptly of admission to the hospital as soon as possible ...8. To be informed and, when appropriate, for their families to be informed about the outcomes of care, including unanticipated outcomes ... ...”.”

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 49884 Based on observation, interview, and record review, the hospital failed to securely store medications, when one of two sampled anesthesia (temporary loss of feeling or awareness to prevent pain) medication cabinets containing inhalation (breathe in) anesthetics (medicine to cause deep sleep) were left unlocked in OR 2 on Campus 2. This violated the hospital’s “Medications - Orders, Administration, Storage, Documentation” policy. This failure had the potential for unauthorized staff to access anesthetic medications with the possibility of diversion (when a medication is taken for use by someone other than whom it is prescribed or for a reason other than what it is prescribed). Findings: During a concurrent observation and interview on 8/19/25 at 2 p.m., with Registered Nurse (RN) 6, and Nurse Manager (NM) 2 in OR 2, a cabinet labeled “Inhalation anesthetic agents stored inside” was unlocked. RN 6 explained that the medications were gases used in the anesthesia machine to put patients to sleep during surgical procedures. The cabinet contained six unopened containers of anesthetic agents: two 250 milliliter (mL-a unit of volume measurement) metal bottles of sevoflurane (an inhaled, medication used to start and maintain deep sleep for surgical procedures), two 100 mL dark brown glass bottles of isoflurane (another inhaled medicine used to start and maintain deep sleep for surgical procedures), and two 240 mL metal bottles of desflurane (another inhaled medication to start and maintain sleep for surgical procedures) RN 6 stated that the cabinets were “monitored” but not locked (no nursing staff were in the OR, or in the hallway around the OR prior to our entry monitoring the room). RN 6 added that anesthesiologists (physicians who specialize in administering anesthesia during medical procedures) were often in a “hurry”, so they left the cabinet open in the morning, and they relied on the closing technologists to lock it overnight. When asked whether the anesthetic agents were always emergent-justifying the anesthesiologist’s need to hurry and the cabinet remaining unlocked between cases-RN 6 responded, no. RN 6 clarified that anesthesia technologists were responsible for locking and unlocking the cabinets, but a key was also available in the automated medication dispensing system, allowing nursing staff to access it. Nurse Manager (NM) 2 stated that staff should lock the cabinet when no surgical cases were in progress. NM 2 emphasized that locking the cabinet was important to prevent unauthorized access, as only anesthesia staff should handle these medications. During an interview on 8/25/25 at 1:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated medications used for anesthesia should be in a locked area. The CNO stated when medications were not in a locked area there was a chance for someone other than the anesthesiologist to get ahold of the medication and have a bad outcome (harm). During a review of the hospital P&P tiled, “Medications - Orders, Administration, Storage, Documentation,” dated 6/30/25, indicated, “ ...Medication Storage ...Medication storage areas are to be locked when not in use. ...Only authorized personnel will have access to medication storage areas. ...Authorized personnel include i. Registered Nurse ii. Licensed Vocational Nurse iii. Pharmacy personnel iv. Providers v. Respiratory Care Practitioner ...And other personnel who are authorized to administer medications ...Medications will be securely stored at all times and at the appropriate temperature ...” During a review of the professional reference titled, “Statement on Security of Medications in the Operating Room,” dated 10/18/23, the professional reference indicated, “ ...A secure environment of care is necessary for medication safety. Medication safety includes the security of oral, sublingual [under tongue], parenteral [typically by injection (needle) or infusion (plastic line into vein)], and inhaled pharmaceutical agents used for elective and emergency patient care. A secure physical area ensures the integrity of anesthesia machines as well as other equipment and materials. Security of medications, while maintaining rapid accessibility, in a secure anesthetizing location is essential for patient safety. ...CMS has provided specific guidance on security in the OR environment in the Federal Register on November 27, 2006, Vol. 71, No. 227. The document states the following: “An area in which staff are actively providing patient care or preparing to receive patients, that is, setting up for procedures before the arrival of a patient, would generally be considered a ’’secure area.’’ For example, the operating room suite would be considered secure when the suite is staffed and staff are actively providing patient care. When the entire suite is not operational or otherwise not in use, for example, weekends, holidays, and after hours, the suite would not be considered secure. When the suite is closed or otherwise not in use, we would expect all drugs and biologicals to be locked ...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital failed to have an effective Governing Body (GB) legally responsible for the conduct of the hospital when: 1. Resources and oversight were not provided to ensure the hospital provided care in a safe setting and ensured the patient’s right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety for eight of 11 sampled patients (Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services in the Emergency Department (ED) after obtaining physician order for inpatient care instead of moving them into an appropriate inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units (Refer A115, Finding 1 and A-0144). 2. Resources and oversight were not provided to ensure two patients were free from all forms of abuse or harassment when a Patient Care Technician (PCT) slapped Pt 92 and a Doctor of Osteopathy (DO, licensed physician with a unique focus on the muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8’s hospital room and conducted an inappropriate physical exam that included touching without gloves her breasts, back, buttocks and genitals on 5/6/25 at 5:11 a.m. (Refer to A115, Finding 2 and A-0145, Finding 1 and 2). 3. Resources and oversight were not provided to ensure the hospital maintained an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program when the program did not implement effective actions to address the ongoing concerns of inpatients in the ED receiving all or most of their care in the ED instead of having the care provided in the appropriate inpatient unit. (Refer to A263, Finding 1, A309 and A115, Finding 1) 4. Resources and oversight were not provided to ensure the hospital nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients’ (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions. (Refer to A-396) 5. Resources and oversight were not provided to ensure an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of hospital acquired infections (infection one gets while receiving treatment in a healthcare facility) and other infectious diseases. (Refer to A747 and A749, all Findings). 6. Resources and oversight were not provided to ensure an organized food and nutrition service when the Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital’s organizational chart; and The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital’s organizational chart and job description were not aligned at Surgical Campus 2. (Refer to A0618, Finding 1 and A-0619) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner for all patients.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45929 Based on observation, interview and record review, the hospital failed to protect and promote each patient’s rights when: 1. The hospital failed to ensure care was provided in a safe setting and failed to ensure the patient’s right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety and quality care for eight of 11 sampled patients (Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services in the Emergency Department (ED) after physician’s order to provide inpatient care instead of moving them into an appropriate inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units (Refer to A-0144). 2. The hospital failed to ensure two patients were free from all forms of abuse or harassment when a Patient Care Technician (PCT) slapped Pt 92 and a Doctor of Osteopathy (DO, licensed physician with a unique focus on the muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8’s hospital room and inappropriately conducted a physical exam touching breasts, back, buttocks and genitals without gloves and without consent of Pt 8 on 5/6/25 at 5:11 a.m. (Refer to A-0145, Finding 1 and 2). 3. The hospital failed to follow their policy and procedure on grievances for one patient, Patient (Pt) 6, when hospital staff were made aware of Pt 6’s request to file a grievance related to his care in the Emergency Department and no grievance or follow up was made of Pt 6’s concerns (Refer to A-0118). The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe and quality setting.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 47205 Based on observation, interview and record review, the hospital failed to ensure an active, effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program had been developed, implemented, and adjusted in order that the hospital could achieve sustainable regulatory compliance, quality care and safe standards of care when: 1. The hospital failed to ensure 2 of twenty-four (24) patients were free from surgical procedure errors when Pt 19 experienced a wrong-side procedure (nerve block) and Pt 30 experienced a retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure) that went unreported to the California Department of Public Health (CDPH). (Refer to A-0951). 2. The hospital failed to have a QAPI program that effectively tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care), and implement preventive measures when the hospital did not conduct a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) to determine the cause, and implement measures to ensure future incidences would not occur. (Refer to A-0286) 3. The hospital failed to preserve the patient’s right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety for seven of 11 sampled patients (Pt) (Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) by holding them in the Emergency Department (ED) instead of moving them into an inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units. (Refer to A-0144) The cumulative effect of these systemic deficiencies resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe environment and professional manner that promotes reporting and investigating adverse patient events and to analyze their causes, and to implement preventive actions and mechanisms that include feedback and learning throughout the hospital to maintain patient safety.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the facility failed to have a well-organized and effective nursing service when: 1. The hospital failed to ensure nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients’ (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions. (Refer to A-396) 2. External supplies on the Triage Labor and Delivery Unit (unit where women in labor are assessed) crash cart (mobile medical cart equipped with essential supplies and equipment to manage life-threatening emergencies) were not checked for their presence or expiration in accordance with the P&P titled, “ Code Blue - Medications & Crash Carts (CB)” for four of six days on 5/6/25. (Refer to A 398) 3. Licensed nurses did not create a wound Lines, Drains and Assessment (LDA) in Patient (Pt) 92’s electronic medical record (EMR) when a coccyx (tailbone) wound was identified, in accordance with the hospital policy titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24. (Refer to A 398) 4. Licensed nurses did not place a pressure redistribution waffle mattress (an overlay placed over hospital mattress to evenly distribute weight and keep patients cool and dry) for one of 3 sampled patients (Pt 2) in the Emergency Department (ED) according to hospital P&P titled,” Pressure Injury Risk Assessment, Prevention, Staging, and Treatment”. (Refer to A 398) 5. Licensed Nurses (LNs) failed to ensure critical laboratory values for one (1) of twelve (12) sampled patients (Pt 27) was repeated after intravenous (IV-into a vein) fluid resuscitation (the medical practice of replacing fluids lost by the body, usually through IV administration) was ordered to stabilize Pt 27’s critically elevated lactic acid level (LA- a buildup of lactic acid in your bloodstream) in accordance with hospital P&P titled “Provider Notification Regarding Patient Status” dated 11/14/23 and professional practice standards. (Refer to A 398) 6. Hospital staff failed to document the indication (reason) for the order and administration of Quetiapine (an antipsychotic medication that treats several kinds of mental health conditions by balancing the levels of hormones (chemicals that coordinate different functions in your body) that help regulate your mood, behaviors and thoughts) for 1 of 12 sampled Pts (Pt 22) per hospital P&P titled “Medications - Orders, Administration, Storage, Documentation”, dated 12/19/23, and P&P titled “Documentation in the Health Record”, dated 6/14/18. (Refer to A 398) 7. LNs did not take actions according to hospital P&P titled “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24, prevent the development of a hospital acquired injury from a skin tear. (Refer to A 398) 8. Pt 98 was administered the incorrect amount of high-risk/high-alert medication (Medications that have a heightened risk of causing significant patient harm when they are used in error). (Refer to A 398) 9. The dose of Patient 78’s propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 78’s Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). (Refer to A 405) 10. The dose of Patient 63’s insulin (a medication used to lower blood sugar level) was not adjusted as prescribed according to Patient 63’s insulin order. (Refer to A 405) The cumulative effect of these system problems resulted in the hospital’s inability to provide nursing services in a safe setting.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital failed to ensure an organized food and nutrition services when: 1. The Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital’s organizational chart; and The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital’s organizational chart and job description were not aligned at Surgical Campus 2. (Refer to A-0619) 2. One of five cooks (Cook 1) was not competent in the day-to-day duties of meal preparation and the competencies completed for Cook 1 did not reflect the depth and scope of the position at one of three campuses (Surgical Campus 2). (Refer to A-0622) 3. Nutritional needs were not met in accordance with recognized dietary practices for three of ten patients who were provided care in the Emergency Department (ED) at Campus 1 as inpatients, Patient (Pt) 2, Pt 17 and Pt 44 when hospital staff failed to follow physician diet orders ensuring patients received meals. Pt 2 and Pt 44 were diagnosed and admitted as inpatients related to complications of cancer and were not provided meals on multiple occasions and meal intake was not documented; each stayed in the ED for multiple days. Pt 44 was admitted to the ED for complications of developmental delay and mental health and did not have documented evidence of meal intake. The ED did not have a system in place to ensure timely delivery of meals, meals were provided per physician order, and a monitoring system to ensure meals and/or snacks were offered. (Refer to A-0629) 4. Therapeutic diet orders were not followed when nutrition supplements initiated by the Registered Dietitians lacked clear parameters within the prescribed diet order in the hospital’s approved diet manual. (Refer to A-0630) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 45977 Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of hospital acquired infections (infection one gets while receiving treatment in a healthcare facility) and other infectious diseases, when: 1. The hospital failed to ensure food preparation equipment and storage for food preparation equipment were in sanitary condition for one of two kitchens located in the main hospital (Refer to A750 finding 1). 2. An ice machine located in the main kitchen of the main campus was not clean in accordance with professional standards (Refer to A750 finding 2). 3. One of one Neonatal intensive care unit (NICU) nurses at the main hospital campus did not perform hand hygiene between glove changes during NICU milk preparation and one of five cooks on campus B of the hospital did not perform hand hygiene between glove changes during food preparation in accordance with the hospital’s policy on hand hygiene (Refer to A750 finding 3). 4. The physical environment in the NICU of the main hospital did not support the preparation of milk and the addition of modulars (nutritional supplementation) to minimize cross contamination in accordance with professional standards. Nursing staff did not don personal protective equipment (PPE) and did not adhere to infection control standards in the preparation of milk for newborns (Refer to A750 finding 4). 5. Nursing staff in the Emergency Department (ED) did not keep the door closed in the isolation room for Patient (Pt) 39 in accordance with recommendations for the CDC (spell out) for transmission-based droplet precautions. Pt 39 was diagnosed with Rhinovirus and worsening respiratory symptoms and had a physician order for respiratory droplet precautions on 5/4/25 (Refer to A750 finding 5). 6. Registered Nurse (RN) 20 did not wear a mask during a bedside procedure for Pt 100. Pt 100 was admitted to Neurology ICU (Intensive Care Unit) on 5/6/2025 and required a ventricular drain and central venous line and RN 20 did not wear a mask while assisting providers during the procedures in accordance with infection control standards (Refer to A750 finding 6). 7. Two placenta specimens were stored in clear plastic containers in an open untied bag in the Labor & Delivery Unit’s soiled utility room and not stored in a sealed biohazard container in accordance accepted professional standards (Refer to A750 finding 7). 8. An unlabeled and undated container with half a sandwich was stored in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit and should have either been thrown away or labeled and dated in accordance with the hospital’s policy on safe food storage titled, “Storage” (Refer to A750 finding 8). 9. Soiled adhesive from labels was left on communication boards in patient rooms on 5West, supply bins and cupboards in the clean utility room, nutrition room and medication rooms of the Rehabilitation Unit and should have been discarded in accordance with the with infection control standards (Refer to A750 finding 9). 10. two of ten patients, Pt 17 and Pt 98, the intravenous tubing was not labeled and dated in accordance with hospital policy and procedure (P&P) titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites” (Refer to A750 finding 10). 11. Outpatient clinic staff did not flush weekly an eye wash station in the outpatient clinic as per P&P titled, “Emergency Shower and Eye Wash Station Policy” (Refer to A750 finding 11). 12. Three of six hospital supply rooms in outpatient clinics stored patient care supplies on dirty, contaminated floor and were not stored in accordance with infection control standards (Refer to A750 finding 12). 13. Staff of on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties did not clean and sanitize a glucometer (a medical device used to test blood for the levels of glucose or sugar) in accordance with the hospital’s policy titled, “BRAND NAME] Glucose Meter,” and was visibly dirty with a dark, reddish brown spot at the entrance where the blood is sampled (Refer to A750 finding 13). 14. Clean supplies were stored under the sink in four of 50 cabinets and not in accordance with hospital policy titled, “Environmental Cleaning and Disinfection Policy”, and infection control standards in the following areas: auxiliary pathology lab, outside the entrance to the Operating Room (OR), Campus B; second floor, East Plaza of the outpatient clinic, Neuro Rehab Center; second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties (Refer to A750 finding 14). 15. One of one sampled endoscopic (a thin flexible tube with a camera and light at the tip, used to visualize the internal parts of the body) storage cabinets were observed with four endoscopes touching each other and allowing for possible damage and cross contamination and not stored in accordance with the manufacturer’s guidelines titled, “[BRAND NAME] Reprocessing Manual” (Refer to A750 finding 15). 16. Garlic aioli was not monitored and part of the temperature cooling process in the bistro café kitchen and did not follow Food Code requirements (Refer to A750 finding 16). 17. Scrambled eggs that were previously cooked were above 41 degrees Fahrenheit (F) and were not monitored for temperature cooling process in the café kitchen in the main hospital in accordance with Food Code (Refer to A750 finding 17). 18. Previously cooked food items stored in the refrigerator in the bistro café kitchen were above 41 degrees F. and did not follow Food Code requirements (Refer to A750 finding 18). 19. Staff failed to ensure biohazardous waste containers (a regulated container storing needles, glass, medication, and sharp objects) were closed between operating room (OR) cases in accordance with national guidelines for two of four sampled biohazardous waste containers (Surgical Services 1, OR T-9) (Refer to A750 finding 19). 20. Staff failed to ensure clean and dirty equipment in the high-level disinfection (HLD - the process used for the destruction of all germs except for low levels of bacterial spores) cardiology (relating to the heart) decontamination (to remove dangerous germs from objects) workroom was separated in a manner to prevent cross-contamination according to national standards (Refer to A750 finding 20). 21. Hand hygiene was not performed after donning and doffing gloves for three of three sampled glove removals in accordance with hospital’s P&P titled, “Hand Hygiene” and nationally accepted standards (Refer to A750 finding 21). 22. Employees did not have access to a handwashing sink that was separated from the decontamination sink in accordance with the CDC and OSHA regulatory regulations in the cardiology decontamination workroom (Refer to A750 finding 22). 23. There was no documented evidence that the hospital followed the manufacturer’s instructions for use (IFU) for daily cleaning of 1 of 1 sampled transesophageal echocardiogram (TEE - a heart test using a camera, a flexible tube) machine, located in the Cardiology Outpatient Department, second floor of the main hospital (Refer to A750 finding 23). 24. Terminal cleaning was not done in accordance with the hospital’s P&P, titled, “Procedural Area Terminal Cleaning,” and nationally accepted standards and yellow spots were scattered throughout a wall vent for one of two sampled wall vents. (Surgical Services 2, OR 3) (Refer to A750 finding 24). 25. The heart-lung machine (Extracorporeal -- a machine that takes over the functions of the heart and lungs during surgery) was observed with brown and orange substances streaking down the side of the machine, (Surgical Services 2, OR 3) and not cleaned as per the hospital’s P&P, titled “Medical Extracorporeal Life Support Guidelines” (Refer to A750 finding 25). 26. A fluid warmer in OR 3 had a brownish ring round the bottom of the basin and the basin case had several areas of chipped paint and rough brownish discoloration (Surgical Services 2) and not cleaned according to the hospital’s P&P titled, “Procedural Area Terminal Cleaning,” and nationally accepted standards (Refer to A750 finding 26). 27. 18 of 21 sampled surgical instrument case carts did not have clean/biohazardous (a biological substance that poses a threat to the health of living organisms) labels in accordance with the hospital’s P&P titled, “Instrument Transport” and nationally accepted standards (Refer to A750 finding 27). 28. two of two sampled instrument loading carts (specialized heat-resistant cart used for steam sterilization) and two of two sampled autoclaves (machines used to sterilize patient reusable surgical instruments) (SPD 2nd floor) in accordance with the manufacturer’s IFUs and nationally accepted standards for cleaning were followed (Refer to A750 finding 28). The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe setting.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to provide surgical services in accordance with acceptable standards of practice and did not ensure prevention of surgical errors for two (2) of twenty-four (24) patients sampled (Patient (Pt) 19 and Pt 30) when: 1. Pt 19 was consented for a right arm fistula creation [a connection between two parts of your body that do not normally connect. It often takes the form of a tunnel or passageway] by Medical Doctor 1 (MD1) and MD1 ordered a right arm nerve block (a procedure that numbs the nerves in the shoulder and arm area, providing pain relief) and did not verify the correct surgical site in accordance with the hospital’s policy and procedure (P&P) titled “Universal Protocol - Procedural Areas” before performing a left shoulder nerve block. (Refer to A-0951, 3) 2. Pt 30 experienced a retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure) after a vaginal delivery surgical repair and during which the provider lost the suture needle used to repair a tear made during the birthing process. (Refer to A-0951, 1) These failures led to Pt 19 receiving the wrong-side nerve block to the left shoulder and avoidable pain and suffering and temporary non-use of the left shoulder and Pt 30 experiencing a RFO, resulting in an imbedded surgical needle to Pt 30’s right-sided vulva (the external (outer) female genital organs) causing pain and suffering, delayed healing, and repeated surgical procedures to remove the surgical needle. The cumulative effect of these systemic deficiencies resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“COMPLIANCE WITH LAWS CFR(s): 482.11(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. This Standard is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to promptly report a stage 3 pressure ulcer (a skin injury resulting from prolonged pressure, friction, or shear, leading to tissue damage) on Patient 92 in accordance with reporting requirements for CCR Title 22, Division 5, Chapter 1, Article 11. This failure had the potential to result in skin and tissue injuries to not be reported timely. Findings: During a review of Patient (Pt) 92’s “History & Physical (H&P)”, dated 3/26/25, the “H&P” indicated Pt 92 was admitted on 3/26/25 for cellulitis (a common bacterial infection of the underlying tissues) of the right arm. During a review of Pt 92’s electronic medical record (EMR), the EMR indicated Pt 92 was placed in two-point (both wrists) Non-Violent restraints (devices that limit a person’s freedom of movement) to prevent the patient from pulling on medical equipment on 3/27/25 at 4:30 a.m. until 3/29/25 at 12:54 p.m.; on 3/29/25 at 1:30 p.m. until 4/3/25 at 10:00 a.m.; and on 4/3/25 at 7:30 p.m. until 4/10/25 at 6:09 a.m. The EMR indicated Pt 92 was placed in four-point (both wrists and both ankles) Violent restraints (used to manage violent or self-destructive behavior) due to agitation on 4/10/25 at 10:15 p.m. until 4/11/25 at 10:23 a.m. The EMR indicated Pt 92 was placed in two-point restraints on 4/17/25 at 4:58 p.m. until 4/18/25 at 7:02 a.m. The EMR indicated Pt 92 was placed on four- point restraints on 4/23/25 at 9:00 p.m. until 4/24/25 at 10:48 a.m.; and on 4/24/25 at 11:55 p.m. until 4/28/25 at 4:17 p.m. The EMR indicated Pt 92 was placed in two-point restraints on 4/30/25 at 5:25 a.m. until 5/6/25 at 10:32 a.m. and on 5/6/25 at 5:25 p.m. until 5/9/25 at 12:40 a.m. During a review of Pt 92’s “Wound Specialist Note (WSN)”, dated 5/3/25 at 10:12 a.m., the “WSN” indicated, “ ...Wound consult received for ‘left knee skin tear, pressure injury to coccyx’ ... The buttock wound has skin breakdown ... It is important to note that any moisture associated concerns place this tissue is at higher risk for pressure injury ...Sacral/buttocks [coccyx area] denuded, partial and full thickness wound ...”. During a concurrent interview and record review on 5/14/25 at 8:48 a.m. with the Director of Critical Care (DCC) and the Wound Specialist Nurse Educator (WSNE), Pt 92’s “Wound Line Drains and Assessment (LDA)” was reviewed. The WSNE stated the first time Pt 92’s coccyx was noted on the “LDA” was on 5/3/25 at 5:17 p.m. (more than seven hours after the “WSN”) and noted to be a stage 2 pressure injury (a partial-thickness loss of skin that extends into the first two layers of skin but not to the muscle). The DCC stated nursing staff should create an LDA for any skin injury as soon as it is identified even if they don’t know what type of injury to call it. The DCC stated Pt 92’s coccyx injury was moisture related and not a pressure injury, and thus not reportable. The DCC stated Pt 92’s coccyx injury was both a partial and full-thickness injury. During an interview on 5/15/25 at 12:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated if Pt 92’s coccyx injury was a full-thickness skin loss, then it is a stage 3 pressure injury (into the fat tissue). During a review of the hospital’s policy and procedure (P&P) titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24, the P&P indicated, “ ... POLICY ... Upon identification of a suspected pressure injury, whether present on admission or hospital-acquired, the RN [Registered Nurse] shall photograph, describe and document the injury location on the appropriate section of the electronic health record (EHR) ... Staging/Treatment ... Stage 3 Pressure Injury - Full-thickness skin and loss with exposed muscle ...”. During a review of the hospital policy and procedure (P&P) titled, “Adverse Event Reporting to the California Department of Health Services”, dated 1/3/22, the P&P indicated, “ ... PURPOSE ... to comply with the mandated reporting requirements of Health and Safety Code §1279>1(b) ... Adverse event includes any of the following ... A stage 3 or 4 ulcer, acquired after admission ...”. During the review of a professional reference titled, “Prevention and Treatment of Pressure Ulcers/Injuries (P&T)”, dated 2025, the “P&T” indicated, “ ... individuals at risk of pressure injuries, especially when moisture and heat at the skin-surface interface are contributing factors ...”. During a review of a professional reference titled, “Classification of Pressure Injuries (CPI)”, dated 10/2020, “ ...Over the decades, PIs [Pressure Injuries] have had alternate naming conventions such as decubitus ulcers, pressure sores, and pressure ulcers. In 2016, the National Pressure Injury Advisory Panel (NPIAP), formerly the National Pressure Ulcer Advisory Panel, updated the definition of PI and the staging system to classify each PI type.1 The updated definition of PI reads ‘A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities an condition of the soft tissue’ ...”. During a review of a professional reference, California Code of Regulations (CCR), the CCR indicated, “ ... Stage 3 pressure ulcer” means a full-thickness loss of skin ...”.”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to follow their policy and procedure on grievances for one Patient (Pt) 6, when hospital staff were made aware of Pt 6’s request to file a grievance related to his care in the Emergency Department and no grievance or follow up was made of Pt 6’s concerns. This failure resulted in not esuring Pt 6’s request and right to have his grievance filed, addressed, and promptly resolved and the potential for other patients’ grievances not to be filed, addressed and resolved. Findings: During a review of Pt 6’s “Face sheet (FS)”, dated 4/20/25, the “FS” indicated Pt 6 was Spanish speaking. During a review of Pt 6’s “Emergency Patient Timeline (EDTL)”, dated 4/20/25 to 4/22/25, the “EDTL” indicated Pt 6 was brought in by ambulance on 4/20/25 for issues with his urinary catheter (a flexible tube used to drain urine from the bladder). The “EDTL” indicated Pt 6 had a history of congestive heart failure (CHF, a condition where the heart’s pumping ability is impaired) and his oxygen saturation (percentage of oxygen in the circulating blood) was low. The “EDTL” indicated Pt 6 had blood drawn on 4/20/25 at 9:05 p.m., on 4/21/25 at 10:08 a.m. and 4:04 p.m. The “EDTL” indicated Pt 6 refused a blood draw on 4/22/25 at 4:01 a.m. and had blood drawn at 9:11 a.m. During a review of “Intake Information (II, an online complaint for to the California Department of Public Health [CDPH])” dated 4/23/25, the “II” indicated Complainant (CO) 1 was a representative for the Program of All-Inclusive Care for the Elderly (PACE) of which Pt 6 was his client. “II” indicated on 4/22/25 at approximately 2:44 p.m., Pt 6 reported to him that he was currently in the hospital and stated on 4/21/25 in the afternoon medical staff wanted to draw blood a third time from him causing him concern. The “II” indicated, “ ... My client [Pt 6] further reported that he clearly told the medical staff that he didn’t feel comfortable with them drawing more blood a 3rd time, in such a short amount of time, so he panicked and resisted, and noted that medical staff still physically forced him to comply, to where he felt they were almost going to break one of his arms and were really hurting him during the process. My client, [Pt 6] reported that while medical staff were trying to restrain him, out of frustration, one of the medical staff stated ‘Stupid, we’re just trying to help you’. However, my client, Mr. [Pt 6] noted he already told medical staff “no”, and that he did not feel comfortable with them drawing more blood from him, but that they didn’t care to listen to him, and proceeded to draw his blood by force. My client, [Pt 6] reported that the medical staff there did not explain things clearly to him, and he was afraid to get more blood drawn as noted. My client, [Pt 6] also reported that medical staff advised him that he needed to fast today, but he noted he was very hungry, and that medical staff did not clarify to him for how long he needed to fast for. My client, [Pt 6] also reported that the medical staff there tending to him have and continue to be very unprofessional and rude, so he voiced wanting to file a grievance against the medical staff who treated him poorly ... I explained ... he would need to file a grievance there at the hospital, but that he can ask to speak to the Medical Social Worker [MSW] there to further assist him. My client, [Pt 6] then stated to me that he had already asked the medical staff at different times, that he wanted to speak to the Medical Social Worker there, but no one has came by to speak to him yet, and so he expressed that he felt medical staff are not taking him seriously and are ignoring his requests. I noted to my client, [Pt 6] that as soon as I ended the call, I would notify my client’s assigned Primary Care Doctor and assigned RN [Registered Nurse] at my agency called [name of city] PACE on what my client shared with him, and will also call [name of hospital], and ask to speak to a Medical Social Worker for follow up, and will advocate for my client as needed. My agency medical staff and I have reached out to to [sic] the Medical Social Worker and Case Manager there at [name of hospital] and asked that they tend to our client’s concerns and needs, and assisting him in filing a grievance against the medical staff who he reported mistreated him by using physical force ...”. During an interview on 5/8/25 at 1:39 p.m. with the Manager of Licensing and Accreditation (MLA), the MLA stated Risk Management was unable to locate a grievance for Pt 6. During the review of “PACE Email Trail (Email)”, dated 5/22/25, the “Email” indicated PACE RN Laison (RNL) wrote, “ ... I called CM [CM 1] and informed her of all of his concerns/grievances and requested Spanish speaking staff. I also informed her to have a SW see him to address concerns as well and that he has been waiting ...”. The “Email” indicated CO 1 wrote, “ ... I just got off the phone with assigned SW [LCSW 1], to introduce myself, and to advocate for our [Pt 6’s] need and his concerns regarding his treatment from medical staff ...”. During a review of Pt 6’s “Case Manager Note (CMN)”, dated 4/22/25, the “CMN” indicated, “ ... Received a call from [RNL] @ [name of city] PACE. States patient is [sic] called there [sic] SW. States patient is upset regarding multiple lab draws and requesting to speak to SW. secure messages sent via [electronic message system name] to [RN 28] to follow up regarding above. Secure message sent via [electronic message system name] to [LCSW 1] requesting to follow up regarding above ...”. During a review of Pt 6’s Social worker note (SWN), dated 4/22/25, the “SWN” indicated LCSW 1 wrote, “ ... Received secure message from case manager requesting follow up with patient due to patient calling PACE upset about multiple lab draws ... Writer also received call from [CO 1] ... He stated that called their office with complaints of not being fed and having too many lab draws. He asked for someone to follow up with him. Writer reviewed chart and noted that patient has been nothing by mouth since midnight for possible procedure. Also noted that he has been refusing lab draws. Writer went by patient’s room. He was eating and did not appear to be in any distress. Social worker will follow up with patient tomorrow morning due to time constraints today ... Addendum: Patient moved to 8th floor. Handoff sent to unit social worker via secure chat ... [Revision History 4/23/25] ...”. During a concurrent interview and record review on 5/13/25 at 11:09 with LCSW 1 and the Social Work Supervisor (SWS), Pt 6’s SWN and CMN were reviewed. LCSW 1 stated she was not aware Pt 6 wanted to file a grievance. LCSW 1 stated she went by Pt 6’s isolation room (a specialized hospital room designed to isolate patients with contagious disease or to protect those with weakened immune systems, preventing spread of infection) at the end of her shift, saw that he was eating, and did not make contact with Pt 6. LCSW 1 stated she intended to come back in the morning to see Pt 6. LCSW 1 stated in the morning Pt 6 had been moved to a new floor and she sent a message to LCSW 2 who covers the new unit. SWS stated LCSW 2 never wrote a note in pt 6’s medical record and therefore, did not make contact with Pt 6. The SWS stated there was a discharge note by Discharge Navigator on the day of discharge, 4/28/25 and it did not address food, lab draws or staff behavior. The SWS stated if case management/social work do not follow up on patient concerns, it can be detrimental to their health and this incident was an opportunity to improve communication. During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated if patient concerns are not dealt with there could be, “ ... a bad experience overall ...”. During a concurrent interview and record review on 5/22/25 at 9:55 a.m. with CO 1, “II” was reviewed. Referring to his notes, CO 1 stated he spoke to Licensed Clinical Social Worker (LCSW) 1, expressed concerns, asked for assistance to Pt 6 in filing a grievance and later spoke to LCSW 1 again who stated Pt 6 was then assigned to LCSW 2. CO 1 stated Case Manager (CM) 1 was also aware of the complaint. During a review of the hospital’s policy and procedure (P&P) titled, “Patient and Patient’s Representative complaint & Grievance”, dated 10/30/24, the P&P indicated, “ ... PURPOSE ... To meet patients’ reasonable expectations of care and service in a timely, reasonable and consistent manner ... DEFINITIONS ... Complaint: Any concern expressed by the patient or patient’s representative concerning care or service that can be resolved as soon as possible by the staff or managers present while hospitalized. A complaint is considered resolved when the patient or patient’s representative is satisfied with the actions taken on their behalf ... POLICY ... Issues that qualify as grievances include ... Complaints that involve allegations of abuse or neglect ... Situations where the patient or patient’s representative requests the complaint be handled as a formal complaint or grievance ... PROCEDURE ... If the concern cannot be resolved by the person receiving the complaint, the chain of command is followed until the complaint can be addressed. The supervisor on duty for the point of service (POS) is contacted. If the supervisor is not available, contact the manager; if the manager is not available contact the director ... If the situation endangers or potentially endangers the patient, such as neglect or abuse, Risk Management is to be contacted immediately ... DOCUMENTATION ...All complaint and grievances will be reported and documented in the IRIS [Incident Reporting Intranet System, the hospital’s secure incident reporting system] system ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to ensure care was provided in a safe setting for seven of 11 sampled Emergency Department (ED) patients (Patient (Pt) Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) when: The hospital failed to ensure the patient’s right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety and quality of care for seven of 11 sampled patients (Pt) (Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services to them in the Emergency Department (ED) instead of appropriately moving them into an inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units. Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44 and Pt 45 each were assessed and treated in the ED, determined to require inpatient care and were provided all or most of their care in the ED, rather than the appropriate inpatient unit. These failures resulted in a violation of Pts Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) (hallway patients) rights to privacy and dignity when they remained in a hallway bed (a gurney/stretcher), out in plain view of other patients, staff, and visitors in a very busy and crowded ED while they waited for many hours up to several days for an inpatient admission bed. Pt 2 was admitted and held in the ED in a room. The wait time (or TT) required both hall and room patients to share access to a limited number of available ED restrooms (no showers available). Pts in ED hallway beds did not have access to call bells to request staff assistance, they did not have privacy while eating, or toileting (if incontinent (unable to voluntarily control retention of urine or feces in the body), etc.). Pts admitted and held in the ED hallway beds, or room beds were not provided with hygiene care, meals, did not benefit from a quiet healing space, the use of a telephone, and television available to Pts on the inpatient units. Findings: During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member, Pt 2, was admitted to the hospital as an inpatient on 4/24/25 but remained in the ED for 110 hours before being moved to an inpatient room. CO 3 stated Pt 2 endured the discomfort of a gurney during her long stay in the ED. CO 3 stated she requested a regular hospital bed for Pt 2, and staff informed CO 3 only bariatric (wider and longer for larger bodies) beds were allowed for the ED, but none were available. CO 3 stated Pt 2 did not receive her meal on several occasions throughout the time she was held in the ED. CO 3 stated Pt 2’s hospital gown, underclothes, sheets, or pillowcases where not changed and new items were not provided for the entire length of the ED stay. CO 3 stated Pt 2 was moved to the Medical Oncology Unit (a specialized hospital unit where patients with cancer receive treatment and care) on 4/29/25 in the afternoon. CO 3 stated Pt 2 did not receive the same level of care in the ED as in the inpatient unit. CO 3 stated on the inpatient unit Pt 2’s care included hygiene, meals, and a wound nurse consultation. CO 3 stated on the inpatient unit Pt 2 had a bathroom in the room, had a quiet and restful environment, and had a much more comfortable bed. During a concurrent observation and interview on 5/6/25 at 10:30 a.m., with the Director of the Emergency Department (DED), and the ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the unit. The ED was observed to be very busy, with many patients of all ages on gurneys or hallway beds as well as in rooms. MED 1 stated there were 205 patients in the ED with a total of 128 patients admitted and held in the ED waiting for an inpatient bed assignment. During the tour, patients were observed to be waiting, eating, sitting on gurneys interacting with the one visitor allowed at bedside or receiving infusions of IV medications, throughout the three zones in the ED, Red, Yellow, Green, and in the overflow East Hall/South Hall areas. The DED stated patients were provided with privacy screens upon request. Privacy screens observed, while providing patient privacy, contributed to the already cluttered state of the hallways and made visualization of patients without a means to alert staff for help (there are no call bells available to hallway bed patients) was difficult. The DED stated nursing staff were in the hallways to watch and listen to patients calling out for assistance, because no call bells were available for any hallway patients. During a concurrent observation and interview on 5/6/25 at 10:40 a.m. with Pt 45 in the ED East Hall Overflow area, Pt 45 was observed lying in a hallway gurney in a hospital gown, with disheveled (untidy) hair, and noticeable body odor. Pt 45 did not have a call light, a television, or a telephone near him. Pt 45 stated he had been at the hospital for three days. Pt 45 stated he had not been “cleaned up (shower, clean gown, or sheets)” or brushed his teeth since he had been in the hospital. Pt 45 stated he would like to clean up and he would like to hurry the process along so he can go home. During a concurrent observation and interview on 5/6/25 at 1:31 p.m. with the Director of Critical Care (DCC), Pt 2, and CO 3 in Pt 2’s inpatient hospital room, Pt 2 was observed in a clean hospital gown, with neatly combed hair, sitting upright in a wheelchair, next to her hospital bed, with family member (CO 3) at bedside. Pt 2 had healing wounds with scabbing on both hands. Pt 2 had a type of medical boot on both feet with toes exposed, and scabbing was observed on the toes. Pt 2’s lips were observed with healing wounds. Pt 2 stated she did not like the care she received in the ED. Pt 2 stated she believed the nurses in the ED could not give the kind of care they do on the inpatient unit, because they seemed too busy. Pt 2 stated she did not have her gown or bed sheets changed while in the ED. Pt 2 stated she was not given a bath, or oral care, and no one cleaned her hands prior to eating. Pt 2 stated the inpatient unit was restful, she was bathed, the bed was more comfortable, and she felt more cared for than when she was in the ED. During an interview on 5/6/25 at 1:40 p.m., with the Manager (M) of the Cardiac Progressive Care Unit (CPCU- a specialized hospital unit that provides care for patients with heart conditions who require more intensive monitoring and treatment than a regular medical ward), on the CPCU, the MCPCU stated they were staffed for 58 beds, total capacity [on the unit] was 64 beds. The MCPCU stated she was not aware of how many ED holds were waiting for a bed assignment and transfer to the CPCU, since she last checked earlier “this morning.” The MCPCU explained the unit was divided into 2 sections- East and Central each assigned a Clinical Supervisor (CS). The MCPCU stated both CSs were free of a patient assignment. During an observation and interview on 5/6/25 at 2:31 p.m. with Pt 44 and RN 11 in Pt 44’s ED hospital room in the Green Zone, Pt 44 stated he was agreeable to an interview. Pt 44 was a frail elderly patient with disheveled hair, in a hospital gown, lying flat on a gurney. Pt 44 stated he came to the hospital five days ago and was first placed in the hallway by an elevator. Pt 44 stated it was noisy, and he didn’t sleep. Pt 44 stated he was in the hall for two nights and was in a room for three days. Pt 44 stated he had not showered since arriving at the hospital. Pt 44 stated he also had no gown change, linen (bed sheets, pillowcases, and blankets) change, or toothbrush provided. Pt 44 stated he was going to ask today, because no one had offered any hygiene supplies. RN 11 stated she would provide the hygiene supplies he needed. Pt 44 stated meals were on time in the room, but in the hall sometimes food did not come at all. During an interview on 5/6/25 at 2:36 p.m. with RN 11, in the ED Green Zone, RN 11 stated, Patients should have hygiene supplies, clean gowns, linens... to feel human while they were in the hospital.” RN 11 stated patients should be asked about hygiene and should be cleaned up every day, and the hygiene should be documented in the medical record. During an interview on 5/6/25 at 2:51 p.m. with RN 12, in the ED Yellow Zone, RN 12 stated the difference in care from admitted ED patients versus ED patients were skin assessments were more through, completing medication reconciliation, and providing an air mattress to prevent skin breakdown. RN 12 stated ensuring the patient and linen were clean was important because it helped to prevent skin breakdown and reduced infection risks. RN 12 stated the hospital used to have call bells in the hall, but “I don’t know where they are now”. RN 12 stated, patients called out when they needed help. RN 12 stated, patients were at a higher risk for falls without a call bell, because they could try to get up without help if they needed to go to the bathroom or if they were confused. During a concurrent observation and interview on 5/6/25 at 3:40 p.m. with the Director of Capacity Operations (DCO) and Pt 42 in the Discharge Lounge (an area in the hospital where patients can wait while the final steps of their discharge processes are being completed.), Pt 42 was observed in street clothes, sitting in a recliner chair, with intravenous (IV- medical technique that administers fluids, medications and nutrients directly into a person’s vein) antibiotics (medication to destroy germs) infusing into the right wrist. Pt 42 stated he wanted to talk about his experiences in the ED. Pt 42 stated he arrived at the ED on 5/1/25 at around 8 p.m. and the ED was very busy. Pt 42 stated he was on a gurney in the hallway for the first few days, then moved to an area in the green zone with curtains around the gurney. Pt 42 stated he had never been admitted to the hospital before and he did not know what to expect, but he expected basic human care and did not receive that. Pt 42 became tearful and stated he was not offered hygiene supplies, a shower, a clean gown or his linens changed while he was held in the ED. Pt 42 stated he had to ask for a toothbrush and some bath wipes (pre-moistened cloths used for bathing patients without water) to clean himself a few days after admission, but he did not feel clean without a shower. Pt 42 stated cleanliness was important to him. Pt 42 stated he had to request socks from the staff. Pt 42 stated he got one pair but was expected to walk across the dirty ED floor to go to the bathroom. Pt 42 stated the bathroom was filthy and was shared with all the patients in the zone he was in so it was often occupied. Pt 42 stated he felt dehumanized and did not feel taken care of while in the ED. The DCO stated patients should feel cared for when in the hospital no matter what unit they were in. The DCO stated the level of care for admitted patients should be the same for ED and inpatient units. During a concurrent observation and interview on 5/6/25 at 3:55 p.m. with the DCO and Pt 43 in the Discharge Lounge, Pt 43 was sitting in a recliner chair, dressed in street clothes, with a family member at the chairside. Pt 43 stated she was agreeable to an interview. Pt 43 stated she was in the ED for two days. Pt 43 stated she was admitted as an inpatient and discharged from the ED. Pt 43 never moved to an inpatient unit. Pt 43 stated no one changed her sheets or her gown during her admission, and she had to get her bath wipes from a cart because no one offered them to her. Pt 43 stated the bathroom in the green zone was filthy, so she would go down to the yellow zone because it wasn’t as dirty. During an interview on 5/7/25 at 9:25 a.m. with Nurse Supervisor (NS) 1 on the 7th floor Medical Oncology (dedicated area within the hospital that focuses on the diagnosis, treatment, and care of patients with cancer) and Progressive Care Unit (PCU- offer a higher level of monitoring and intervention than standard medical-surgical floors). NS 1stated staff on the inpatient unit used the bath wipes to clean patients after a bowel movement (BM) but used wash cloths with water and soap to clean the patients every day. NS 1 stated patients were wiped with chlorhexidine (CHG-antiseptic [a chemical agent to prevent the growth of germs]) wipes everyday as well. NS 1 stated patients received a clean gown and clean bedding every day. NS 1 stated ensuring the patients were clean and on clean linens helped to prevent infection. During a concurrent observation and interview on 5/7/25 at 11:30 a.m. with the DED in the main ED Green, and Yellow Zones, the ED was observed to be busy with patients of all ages in the halls on gurneys. The ED census was 102 admitted patients. There was very little room to move through the hall between patients, staff, and visitors. No call bells were again observed with the patients in the hallways. The DED stated the patients in the halls do not have call bells, and to “think of the environment”. The DED stated the bells would be very loud and distracting to other patients in the area. The DED stated the nurses could see the patients and the patients could call out for help. When asked about hospital beds for comfort for the admitted and held patients, the DED stated hospital beds did not work in the ED halls because there was no room for them due to the size of the bed (too large). The DED stated the ED rooms could house the bed, but the patients were moved in and out of the rooms frequently and the beds were cumbersome (large, heavy difficult to move). The DED stated the hall patients obviously did not get the same level of care as the patients moved to the inpatient units, and there was no private bathroom for any of the patients. The DED stated he believed the hospital care was the same because the patients received consultations, case management and discharge planning as the patient would on the inpatient unit. The DED stated his expectation was for the patients to get daily care and for nursing staff to respond to patient needs when doing patient rounding. The DED stated oral care, and changing gowns was a part of daily care. The DED stated his expectation was nursing staff would ensure patient hygiene was taken care of. During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the DED, Pt 2’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 4/24/25, Admission Transfer Discharge (ADT), and “Daily Care Flowsheet (DCF)”, dated 4/24/25 to 4/29/25, were reviewed. The DED stated Pt 2 arrived at the ED on 4/24/25 at 5:10 p.m. The “H&P” indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body’s immune system to target and destroy cancer cells). The “H&P” indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The “ADT” indicated Pt 2 was admitted to the hospital on 4/24/25 at 8:39 p.m. The DED stated Pt 2’s admitting diagnosis was an allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25. Pt 2 was moved to the inpatient Medical Oncology Unit on 4/29/25 at 11:06 a.m. Pt 2’s total time spent in the ED was 138 hours. The “DCF” indicated on 4/25/25 at 9:59 a.m. Pt 2 ate “25%” of the meal. The “DCF” indicated, on 4/25/25 no lunch, dinner or snacks were provided, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The “DCF” indicated, on 4/29/25 at 6:56 p.m. “0%” diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented. The “DCF” indicated, Pt 2 did not have any hygiene care (bath, linen change, hair wash), or oral care provided from 4/24/25 to 4/29/25 at 2 p.m. The DED stated if the nursing staff provided daily care, it should be documented. The DED stated, daily care interventions such as hygiene, and oral care were a part of all patient’s plan of care. The DED stated that all patients had a right to cleanliness and hygiene. The DED stated, assuring patients’ hygiene needs were met decreased the risk of infections. During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2’s “Daily Care Flowsheet (DCF)”, dated 4/24/25 to 4/29/25 and “Physician Orders (PO),” dated 4/25/25 to 4/29/25, were reviewed. The “PO” dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. The “DCF” indicated on 4/25/25 at 9:59 a.m. Pt 2 ate “25%” of the meal. The “DCF” indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The “DCF” indicated, on 4/29/25 at 6:56 p.m. “0%” diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented. During an interview on 5/8/25 at 11:38 a.m. with MED 1, MED 1 stated, the mattresses in the ED were the same as the inpatient beds, just smaller to fit in the ED. MED 1 stated, the inpatient hospital beds electronic adjustable movements, for the knees and feet were “just for comfort”. During an interview on 5/8/25 at 11:02 a.m. with the DED and MED 1 Pt 45’s “ED Pt Care Timeline (EDCT)”, and “DCF” dated 5/4/25 to 5/6/25, were reviewed. The “EDCT” indicated, “ ...Arrival ...5/4/25 at 1:48 p.m. ...TT [time spent in the ED before being moved to the inpatient bed] 54:58 [hours:minutes] ... 1:52 p.m. Start Triage Initiated ...2:02 p.m. ED Notes Addendum Chief Complaint Patient presents with Pain Chest x [for] 2 days ... brought in by ambulance from home for CP [chest pain], on right side radiates [spread] with stomach ... Wheelchair Bound [confined to a wheelchair] ... 2:05 p.m. Patient roomed in ED To room EAST H [number] [hallway gurney] ... 5/5/25 11:44 a.m. Admission Information ... Patient Admit Service: Medicine ... Requested Bed Type ... CPCU Tele [Cardiac Progressive Care Unit a telemetry unit is a floor in a hospital where patients undergo continuous cardiac (heart) monitoring], ... Precautions ... Aspiration Precautions ... Fall precautions ... Nursing - Cardiac monitoring, progress mobility as tolerated ...”. Care was provided to Pt 45 in the ED in an overflow hallway bed from 5/4/25 through 5/6/25 at 8:46 p.m. when he was moved to an inpatient CPCU Pt 45’s “DCF” indicated no hygiene, or nutrition were provided to Pt 45 for 5/4/25 and 5/5/25. The DED stated the patient should have his daily care and meals documented. During an interview on 5/8/25 at 11:18 a.m. with the DED Pt 44’s “H&P”, “ADT” and, and “DCF” dated 5/4/25 to 5/7/25, were reviewed. The H&P indicated Pt 44 was an 85-year-old male who arrived in the ED on 5/4/25 by ambulance for fever and chills. The DED stated Pt 44 was admitted as an inpatient on 5/4/25 at 12:48 p.m. The DED stated Pt 44 was admitted as an inpatient for Systemic Inflammatory Response Syndrome (SIRS- widespread pain, swelling, throughout the body). The “ADT” indicated Pt 44 was held in the ED as an inpatient from 5/4/25 to 5/6/25. Pt 44 was held in the ED for 52 hours and 35 minutes. The “ADT” indicated Pt 44 was in a hallway bed as an inpatient for 25 hours and 35 minutes, Pt 44 was in an ED room for 27 hours. Pt 44 was transferred to an inpatient hospital room on 5/7/25 at in the ED observation unit for 18 hours and 2 minutes and was transferred to a progressive care unit (PCU) on 5/7/25 at 9:07 p.m. The “DCF” indicated Pt 44 had no hygiene care documented from 5/4/25 to 5/6/25. The DED stated Pt 44 had no meal documentation on 5/4/25 or 5/6/25. The DED stated Pt 44 should have all daily care activities and all meals documented in the medical record. During a concurrent interview and record review on 5/8/25 at 2:05 p.m. with the DED and MED 1, Pt 43’s “EDCT”, and “DCF” dated 5/4/25 to 5/6/25 were reviewed. The “EDCT” indicated, “ ...Arrival 5/4/25 at 10:02 a.m. Depart 5/6/25 2:47 p.m. TT 52:45 ...” The DED stated Pt 43 was never moved to an inpatient unit, Pt 43 was admitted as an inpatient, held, and was discharged from the ED. The “EDCT” indicated, “ ... 5/4/25 10:05 a.m. ...To room R-04 [room Red Zone] ...5/4/25 10:06 a.m. Chief Complaints Updated difficulty breathing ... 5/4/25 12:33 p.m. Decision to Admit ... 5/4/25 Admission Information Patient Admit Service: Medicine ... Bed Requested ... Medicine ... 5/4/25 Patient Transferred from room R-04 to YH [Yellow Zone Hall] ...5/5/25 3:48 a.m. Transfer to Green [Green Zone] ...5/6/25 at 2:47 p.m. To department DC [discharge] Lounge ...”. The DED stated the “DCF” had no documentation indicating nursing staff provided Pt 43 with daily care (hygiene, bathing, oral care, gown or linen changes from 5/4/25 to 5/6/25. The DED stated daily care should have been provided to and documented for Pt 43 during her ED admission. During a concurrent interview and record review on 5/8/25 at 2:18 p.m. with the DED and MED 1, Pt 42’s “EDCT”, and “DCF” dated 5/1/25 to 5/3/25 were reviewed. The “EDCT” indicated, “ ...Arrival 5/1/25 at 8:27 p.m. Depart 5/3/25 8:56 p.m. TT 48:29 ...” The DED stated Pt 43 was moved to an inpatient unit on 5/3/25. The “EDCT” indicated, “ ... 5/1/25 8:28 p.m. Triage Started ...5/1/25 8:30 p.m. Chief Complaints Updated Jaundice [a yellow discoloration of eyes and skin] (Pt presented to [other hospital] for abdominal pain and yellow eyes for 3 days ...) ...5/1/25 10:48 p.m. decision to admit for observation ...5/2/25 12:21 a.m. ...Admit to Inpatient ...Bed Requested ... Medicine ...5/3/25 8:53 p.m. Transport to: 4C CPCU ...”. The DED stated the “DCF” had no documentation indicating nursing staff provided Pt 42 with daily care from 5/1/25 to 5/3/25. The DED stated nursing notes indicated on 5/3/25 at 4:52 Pt 42 received toiletries. During an interview on 5/9/25 at 10:53 a.m. with MED 1 and the DED, MED 1 stated ED leadership want to make sure the patients in the ED were comfortable. MED 1 stated he recognized the patients may not be as comfortable as on the inpatient units, but he believed the care was equitable (fair). The DED stated ED staff were able to give comparable care at the level “we are able to” (since the unit does not have all things the inpatient units have). The DED stated the ED staff were providing the standard of care by the policy. When asked about a patient’s right to hygiene, the DED stated he did not know if they were providing the standard of comfort the inpatient departments had, but the ED staff were attempting to provide what they could knowing the environment they work with. The DED stated he believed the ED was meeting the standard of care. During a review of hospital Policy and Procedure (P&P) titled, “Standard of Practice for Emergency Department”, dated 9/23/24, indicated, “ ...Maintain and/or improve skin integrity during hospitalization through appropriate nursing interventions. Promote patient comfort, cleanliness, and sense of well being by assisting with activities of daily living (ADL’s) ...”. According to hospital P&P the ED nursing staff were not following the Standard of Practice. During a concurrent observation and interview on 5/9/25 at 1:39 p.m. with the DED and MED 1 in the main ED, staring in the Green Zone, the area was loud and busy with patients lining the walls in gurneys. MED 1 stated the census was 200 ED patients and 107 admitted patients. The DED stated bed control determined which patients went up first to the inpatient units. The DED stated the ED did not have a specific area for admitted patients and the ED nurses adapted to the patients coming into the ED. The DED stated nursing staff were assigned to a geographic area and were assigned to the patient in the area. The DED stated the charge nurse gave patient assignments. The Yellow Zone was busy with patients lining the halls and was comparable to the noise and congestion of the Green Zone. The Red Zone was calm, and quiet, without nurses rushing around, and with only one patient in a hall bed. During an interview on 5/9/25 at 1:47 with LVN1, RN 2 (charge nurse) and the DED, LVN 1 stated she was assigned to the Green Zone areas Q, R, S, T for the day. LVN 1 stated she had four patients assigned to her and all four patients were admitted inpatients. LVN 1 stated one of her duties was to help patients with their meals. LVN 1 stated when the patient had a special diet, she would call the kitchen to get the meal. LVN 1 stated hot foods were microwaved for the patients in the ED, because they came from the kitchen cold the night before. LVN 1 stated the patients usually had two choices of a heated meal or a cold sandwich. LVN 1 stated some of the inpatient units had a menu the patients could choose from but not in the ED. LVN 1 stated the Green Zone had one microwave, and the yellow zone had two microwaves to heat the meals. The DED stated the Red Zone did not have a microwave. The DED stated the ED had one shower and patients were not taken upstairs to any inpatient units to shower. When asked if the patients were able to get out of bed and stretch their legs or walk, especially the hallway patients. RN 2 stated the staff tried to limit circulatory ambulation (patients walking around the unit) around the unit to prevent the patients from engaging in other patient’s care. RN 2 stated, “We do our best create privacy”. When asked if there was a place for patients to go to receive sensitive medical news or treatments, RN 2 stated the staff could utilize the treatment rooms for privacy if the patient was in a hall bed. RN 2 stated, in his experience staff utilizing the treatment rooms was infrequent. LVN 1 stated, she never witnessed staff utilizing the treatment rooms for privacy to speak with patients. During an interview on 5/9/25 at 2:13 with the DED, RN 2, and Patient Care Technician (PCT) 1, PCT 1 stated she liked the “fast pace” of the ED. PCT 1 stated, if the patient was “just ED” the patient came in and received care right away. PCT 1 stated “just ED” meant the patient would be in and out of the ED quickly. PCT 1 stated her role was to assist patients with activities of daily living (ADLs-feeding, bathing, toileting, drinking, oral care, mobility). PCT 1 stated her role was about the same for admitted patients as ED patients. PCT 1 stated she worked 12-hour shifts and worked from 7 a.m. to 7:30 p.m. When asked if she could speak to one of her patients and ask if surveyors could speak with them for a moment, PCT 1 stated she did not really know any of them. PCT 1 stated she had not spoken to them today and stated they had been “calm” today. PCT 1 stated it was typical (usual) not to talk to the patients. During an interview and record review on 5/9/25 at 3:10 p.m., with RN 27, on the CPCU RN 27 stated “Daily Cares (Toileting, bathing/showering, hand cleansing, assisting with drinking and eating, etc.)” are offered daily as a routine on the unit. During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2’s “DCF”, dated 4/24/25 to 4/29/25, was reviewed. The DCC stated Pt 2’s first hygiene documentation began on 4/29/25 at 2 p.m. The DCC stated Pt 2 was moved to the inpatient unit on 4/29/25 at 11:06 a.m. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort. The DCC stated gurneys were not the same as the inpatient hospital beds. The DCC stated gurneys were not as comfortable as inpatient hospital beds. During an observation and interview on 5/9/25 at 3:35 p.m., with Registered Nurse (RN) 1 and Pt 25, in Pt 25’s room, Pt 25 was observed to be lying on his left side, head on his left shoulder. Pt 25 was wearing a hospital gown hair disheveled, with eyes closed. Pt 25 consented to be interviewed about his admission. Pt 25 stated he was not helped in toileting/shower or bed bath, “was down there [in ED] three (3) days, bed was not comfortable, was in a hallway, stated he requested a shower and was not provided one.” During an interview on 5/9/25 at 3:42 p.m., with PCT 3, on the CPCU, PCT 3 stated, with a new patient, she makes sure to get the room ready by placing toiletries and other patient care items (soap, toothbrush, etc.) so when the patient comes to the unit, they are ready to offer toileting if needed. PCT 3 stated on the new admission patient arrival she checks Vital Signs (VS- Blood pressure, Heart Rate, etc.) and reports any abnormal VS to the primary nurse. PCT 3 stated she has only floated to the ED as a sitter (1:1 observation for safety), stated completed PCT daily cares as needed only for the patient she is sitting with. During a review of hospital document titled, “History and Physical (H&P-define)” dated 5/2/25, the document indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person’s ability to communicate, interact socially, and understand the world around them), schizophrenia (a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 and was discharged on 5/6/25. During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17’s chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, “Flow Sheet” was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate “50%” of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, “he may have been refusing meals, but if he was, they didn’t document it.” M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, “Care Plan Details,” dated 5/6/25 indicated, “ ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures available. Provide verbal encouragement ...” The document titled, “Physician Orders” dated 5/2/25 indicated, “Diet: Regular.” M1E stated, “He didn’t receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn’t eating. During a review of the hospital document titled, “Diet Manual & Enteral Nutrition Formulary 2025,” the manual indicated, “ ...Patients who refuse the foods served will be offered substitutes of equal nutritional value. This may include oral nutrition supplements ...” During an interview on 5/15/25 at 11:25 a.m., with the Chief Nursing Officer (CNO), the CNO stated, “this should never happen. If the patient was eating, it should be documented. If the patient wasn’t eating, that should be documented as well, and the doctor should be notified. A hard reset is needed. These things should never happen.” The CNO stated his expectation was for nursing staff to provide patients with daily care activities (hygiene, oral care, meals, linen changes, etc.) regardless of the patient being admitted, in the ED, or a patient on the inpatient units. During a review of the hospital’s P&P titled, “Patient’s Rights and Responsibilities”, dated, 3/14/25, indicated, “ ...the hospital shall provide processes to support the following patient rights: 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting ...” During a review of the hospital’s P&P titled, “Oral Care”, dated 2/15/22, indicated, “ ...PURPOSE To provide standardized oral care for the hospitalized patient. To provide evidence based guidelines for oral care in order to prevent hospital acquired infections. ...Oral care should be encouraged for every patient in the hospital as it effectively decreases the risk of infection. ...Oral assessments and care should be done at least every shift and more frequently if indicated ...Document oral care in the electronic health record (EHR) ...”. During a review of the hospital’s P&P titled, “Documentation in the Health Record”, dated 6/14/18, indicated, “ ...PURPOSE A. To provide a complete record of patient care and patient progress. B. To facilitate communication among care providers and enhance continuity of care. ...All patient care and activities are to be documented at the time care is provided.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 49884 Based on interview and record review the hospital failed to ensure two of eight sampled patients (Patient [Pt] 8 and Pt 92) were free from all forms of abuse and harassment when: 1. Doctor of Osteopathy (DO, licensed physician with a unique focus on the Muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8’s hospital room and sexually assaulted Pt 8, including fondling her breasts and genitals without gloves on 5/6/25 at 5:11 a.m. Doctor of Osteopathy (DO) 1 entered a restricted area of the Emergency Department, and was not assigned to any patient in the area, entered Pt 8’s hospital room without turning on the lights and without introducing himself to Pt 8 as a physician and did not obtain permission from Pt 8 and examined Pt 8’s back, breasts, buttocks and genitals in a manner where she “felt completely violated [fail to respect (someone’s peace, privacy, or rights)] by the way he was touching me”. DO 1 was not assigned as a physician for Pt 8 and after examining Pt 8 left the room without turning on the light or documenting in Pt 8’s electronic medical record. These failures resulted in Pt 8 feeling afraid, anxious, angry and feeling as if she was sexually assaulted. These failures resulted in Pt 8’s right to be free from abuse and her right to have care in a safe setting. All patients cared for by DO 1 were and are at risk of harm as a result of these failures. 2. Staff were aware of Pt 92’s aggressive and combative behavior and history of confusion and alcohol withdrawal, Pt 92 kicked Patient care Technician (PCT) 2 and PCT 2 immediately and inappropriately responded by slapping Pt 92. Pt 92’s physical abuse was not self-reported by the hospital and should have been. This failure resulted in a probable avoidable physical abuse of Pt 92. Findings: 1. During a concurrent interview and record review on 5/8/25 at 3:28 p.m. with the Director of the Emergency Department (DED) and Manager of the Emergency Department (MED) 1, Pt 8’s “Emergency Department Patient Care Timeline (EDCT),” “Nursing Notes (NN)”, “Provider Notes (PN)”, “Social Work Notes (SWN)”, dated 5/3/25 to 5/6/25, and “Discharge Summary”, dated 5/6/25 were reviewed. The “EDCT” indicated, Pt 8 arrived in the ED on 5/3/25 at 10:56 p.m., and the chief complaint was all-terrain vehicle (ATV) accident, with pain and deformity to left arm and elbow. Pt 8 reported wearing no helmet and driving 20 miles per hour. The “EDCT” indicated, Pt 8 was admitted to ED observation (a specific area within an ED where patients requiring extended monitoring and evaluation are cared for) on 5/4/25 at 8:18 a.m. and was transferred to the ED Observation Unit at 9:17 a.m. The “EDCT” indicated, Pt 8 transferred to the surgery department on 5/4/25 at 2:29 p.m., and transferred back to the ED Observation Unit after an open reduction internal fixation of the left elbow surgery (ORIF- procedure to repair a severe broken bone by realigning the broken bone and using screws, plates, or rods to secure the bone while it heals) at 7:40 p.m. The “PN” dated 5/5/25 at 7:19 a.m. written by the Orthopedic (physician that specializes in the diagnosis, treatment, and prevention of injuries and diseases of the bones, muscles, joints, ligaments, and tendons) physician indicated, “ ... Seen and examined ...complaining of severe left elbow pain about the left elbow ... Patient has poorly controlled postoperative pain ...” The “EDCT” indicated, Pt 8 remained in the ED Observation Unit on 5/5/25, and received pain medications. The “EDCT” indicated on 5/6/25 at 5 a.m. Pt 8’s primary nurse, Registered Nurse (RN) 15 documented “Hourly Observation Status: Observation Continues” The “EDCT” indicated, RN 15 administered two medications to Pt 8 on 5/6/25 at 5:20 a.m. The “NN” created on 5/5/25 at 8:39 p.m. by RN 15 had an addendum was added on 5/6/25 at 5:30 a.m. “ ...Patient states that one male wearing green scrub with badge came to her room without introducing himself in the dark without turning light on. He started to listen to her heart touching her inappropriately. He also asked [her] to lay flat and started to examine her private area touching her inappropriately. He stayed 5-10 min and left per patient ...”. The “EDCT” indicated, Pt 8’s attending physician documented a “Significant Event Addendum” on 5/6/25 at 6:47 a.m., “ ...I was alerted by nursing staff that the patient states someone came into her room and touched her chest inappropriately without consent. Appropriate notifications made to hospital security and supervisors. Social work consulted for APS [Adult Protective Services] report ...”. The “NN” from 5/6/25 at 7:02 a.m. written by Nursing Supervisor (NS) 3 indicated, “ ...0620 [6:20 a.m.] Risk Management Notified at this time ... patient’s complaints this morning of being inappropriately touched by a [physical description] male, dressed in mint-colored scrubs ...”. The “PN” indicated, Pt 8 was evaluated by the orthopedic physician on 5/6/25 at 7:35 a.m. with no mention of the incident. The “EDCT” indicated, Social Worker (SW) 1 documented on 5/6/25 at 8:42 a.m., “ ... 0800 (8a.m.) Informed by OBS (Observation Unit) RN Supervisor - Patient sexually assaulted by medical staff member this morning at 0530 (5:30 a.m.) ... SW placed a call to [city] PD (police department) ...will come to bedside unknown ETA (estimated time of arrival) ...”. The “EDCT” indicated the PD did not come to the hospital to speak with Pt 8, Pt 8 wanted to be discharged and have the police go to her home. The “EDCT” indicated Pt 8 was discharged from the hospital on 5/6/25 at 5:55 p.m. The “Discharge Summary” indicated, Pt 8 was “OK to d/c [discharge] per ortho [orthopedic physician]”. The “Discharge Summary” indicated, Pt 8 remained in ED Observation pending PD report but wished to “d/c to f/u [follow up] with PD at a later date”. The DED stated, there were “a lot of people consulting” (meaning the patient had other specialties besides orthopedic physicians advising and recommending treatments to her primary physician), and you can see “someone” going into the patient’s room on the surveillance video, the “person” came out, but the “person” has a mask on, so they did not know who the “person” was. The Patient came out as soon as the “person” left the room and reported someone inappropriately touched her. The DED stated Risk Management, and Social Workers were involved. The DED stated leadership and Risk Management interviewed staff and pieced the information together. The DED stated there were no interactions between the nursing staff and “person” wearing a “mask, badge and some scrubs”, who went into the room then right back out. The DED stated the “person” was in the room “less than five or 10 minutes”. The DED stated the hospital still had one more staff member to interview, and stated the Surveyor would need to speak to Risk Management for the results of investigation. Pt 8’s record review indicated no documented entries from anyone during the time of the incident, 5/6/25 between 5:11 a.m. and 5:17 a.m. the time the alleged perpetrator was in the room with the alleged victim. Pt 8’s record had no documented entries on 5/6/25 from any consulting physicians. Pt 8’s record had one assessment documented by her Orthopedic physician at 7:35 a.m. and a discharge summary written by her attending physician at 5:17 p.m. During a telephone interview on 5/12/25 at 9:27 a.m. with Pt 8 at home, Pt 8 stated, she arrived at the ED on Saturday for an accident she was in. Pt 8 stated she had surgery on her elbow on Sunday, and the plan was to go home the following day, Monday (5/5/25), but she was in so much pain the physicians decided for her to stay one additional day and discharge her Tuesday (5/6/25) morning. Pt 8 stated her parents went to the hospital to eat dinner with her on Monday night, because she was no longer in pain. Pt 8 stated she told her mother she did not have to stay the night with her because she “was in good hands”, and “she’s not a baby”. Pt 8 stated on Monday morning 5/6/25 around 5 a.m.-5:10 a.m. a man came into her room, and she was just coming out of her sleep. Pt 8 stated she twisted over and looked up at him. Pt 8 stated she thought the man was a doctor coming to do an exam. Pt 8 stated the man said to her, “oh I am going to do an exam”. Pt 8 stated, the man explained to her he was going to check her heart, and he put the stethoscope against her chest, then he began touching her breast in “weird ways”. Pt 8 stated the man put his hands on both sides of her breasts, pushed them together and said, “oh this is nice”, then released them. Pt 8 stated the man checked her arms and then asked her to roll to her left to check her back, Pt 8 stated she told him she could not turn to the left due to the surgery on the left elbow, so he told her to turn to the right. Pt 8 stated the man began checking her back and spine. Pt 8 stated she was unaware what he was doing, then he pulled her pants down from behind lifted her bottom and separated her buttocks. Pt 8 stated she felt something from behind and squirmed, flinched and made a noise, and the man said, “oh you are fine”, then went behind her head. Pt 8 stated the man began snapping his fingers and asked if she could hear, and she responded yes, he asked her to open her mouth and stick out her tongue, then went around to the front of the bed. Pt 8 stated, the man asked her if she was on her mensural cycle (Menstrual cycle is the regular discharge of blood and mucosal tissue from the inner lining of the womb) and she said no, her knees were bent up on the bed and he tried to push her knees apart then pulled down the front of her pants exposing her genitals (private parts). Pt 8 stated the man then said she was going to be discharged that day, and left the room, closing the curtain behind him. Pt 8 stated the man was whispering, and did not turn on the lights, the only light was the dim light from the hall. Pt 8 stated the man did not introduce himself, or wear gloves. Pt 8 stated the man did not have a mask on in the room. Pt 8 thought it was weird because everyone else had introduced themselves. Pt 8 stated “right when he left” she (Pt 8) went out of the room and asked staff sitting near her room who the person was, because she felt something was wrong by the way he was touching her. Pt 8 stated her nurse RN 15 said take your meds, just calm down. Pt 8 gave a detailed description of the man who came into her room, Pt 8 stated the room was too dark to read the name badge. Pt 8 stated the man was not anyone she had seen during her stay. During a concurrent observation and interview on 5/12/25 at 10:27 a.m. with MED 1 in the ED Observation Unit, security badge access was required for entry. The unit was calm and quiet, shaped like a horseshoe with the nursing station at the front of the horseshoe’s closed end. The patient areas were off the unit’s hall and hospital staff called the area’s “pods”, there were four pods in each area with a bathroom in the pod area at the back wall center location. The unit had four pods with four beds each for a total of 16 beds. The beds were separated by a curtain that hung from the ceiling and surrounded the hospital bed. The area where Pt 8’s room was located was directly to the right of the nurse’s station (when facing the nurses’ station from the front) and against the wall nearest the building’s windows. A monitor technician was seated on the far right of the nursing station. There were computers at the nursing station and a nurse, and a nursing supervisor were seated at the station typing on the computer. Pt 8’s room was approximately 10 to 12 feet away from the nurse’s station, directly in the line of sight from the nurse’s station. MED 1 stated the RNs were often in and out of the rooms, but the monitor tech and the nursing supervisor sit at the desk. During an interview on 5/12/25 at 10:32 with Monitor Technician (MT) 3 on the ED Observation Unit, MT 3 stated, only people with badge access could enter the unit, and visitors had to call into the unit for staff to let them in. MT 3 stated the unit only allowed two visitors per patient at a time, so she watched to make sure people did not have too many because there was not a lot of room in the pods. MT 3 stated she would feel comfortable asking someone if they needed help or what they were doing on the unit if they looked lost. MT 3 stated, she would probably not stop someone who looked like a physician, because she would assume they know where they are going and what they were doing. During an interview on 5/12/25 at 10:39 a.m. with NS 2 on the ED Observation Unit, NS 2 stated, if she saw someone coming to the floor in scrubs with a badge and a stethoscope, she was likely to follow them. NS 2 stated, “I am kinda nosy about that stuff”, and NS 2 stated she preferred to listen to physicians for a while to update the patient notes. NS 2 was not aware of allegations submitted by Pt 8. During an interview on 5/12/25 at 10:43 a.m. with RN 14 on the ED Observation Unit, RN 14 stated, if a patient came out of their room and reported someone assessed them but they did not know who or why, he would first look through the patient’s medical record to see if the patient had any consultations pending. RN 14 stated he would notify his supervisor. RN 14 stated he felt comfortable asking people to identify themselves. RN 14 was not aware of the allegations submitted by Pt 8. During a concurrent surveillance video review and interview on 5/12/25 at 2:48 p.m. with the Interim Security Director (ISD), Pt 8’s surveillance video from 5/6/25 beginning at 5:11 a.m. to 5:17 a.m. was reviewed. The ISD agreed with the following sequence of events. The video began on 5/6/25 at 5:11 a.m. with a west facing view of the hallway of the ED Observation Unit. At 5:11 a.m. a male (DO 1) of medium height in mint green jogger scrubs with greenish yellow tennis shoes with a stethoscope around his neck was walking up the hall, away from the camera. DO 1’s face could not be seen. DO 1 was walking at a normal pace. A female staff member (RN 15) was sitting at a computer workstation on wheels at the top of the camera frame, the computer was located near the far wall at the end of the unit, about four feet from where Pt 8’s pod was located. RN 15 was looking at the computer screen. DO 1 crossed in front of RN 15 and turned left into a pod area, out of the camera frame. DO 1’s face was not visible. The ISD stated the area DO 1 entered was the area of Pt 8’s room. Shadows indicating movement could be seen on the floor to the right of the screen, directly across from where the man turned left. The ISD stated the nurse’s station was on the right of the screen. At 5:14 a.m. a different female staff member (RN16) was observed walking in the hall with a computer workstation on wheels. RN 16 crossed the frame of the video into the pod area pushing the computer workstation on wheels, at 5:16 a.m. RN 16 walked out of Pt 8’s pod area with the workstation on wheels and stood by the nursing station looking at the computer screen. At 5:17 a.m. DO 1 walked out of Pt 8’s pod area. DO 1 turned to the right and walked up the hall, toward the camera, at a noticeable faster pace than when he walked onto the unit. RN 16 was standing at the workstation on wheels near the nurses’ station when DO 1 left Pt 8’s pod area. RN 16 could be seen turning her head quickly to the left to look towards DO 1. DO 1 did not speak with any of the staff on the unit and no staff stopped DO 1. DO 1’s face was seen on the camera; DO 1 was wearing a surgical mask. DO 1 had a badge on the left side of his scrub top. The surveillance video ended prior to Pt 8 alerting staff of her concerns. The ISD stated he believed Pt 8 reported her concerns shortly after DO 1 walked down the hall and out of the ED Observation Unit. DO 1 entered Pt 8’s Pod at 5:11 a.m. and exited at 5:17 a.m. During an interview on 5/12/25 at 2:56 p.m. with the RMD, the RMD stated the Risk Management Department was notified of the incident with Pt 8 on 5/6/25, the same day as the allegation. Nursing notes indicated Risk Management was notified on 5/6/25 at 6:20 a.m. The RMD stated the hospital initiated immediate investigation including staff interviews, requesting surveillance video, chart reviews, and security badge access reports. The RMD stated the hospital did identify someone who met the description of the person Pt 8 said examined her, a physician at the hospital (DO 1). The RMD stated someone who matched DO 1’s description went into Pt 8’s hospital room. The RMD stated DO 1 used his security badge in different areas and security was able to follow him on the cameras and through the security badge report. The RMD stated DO 1 was not Pt 8’s physician, or part of Pt 8’s care team (a group of healthcare members who work together to provide care for a patient). The RMD stated DO 1 was not assigned other patients on the unit on 5/6/25 and was not assigned to examine any patient on the unit at the request of another physician. The RMD stated DO 1 was a [specialty] hospitalist. The RMD stated, DO 1 did not document anything in Pt 8’s medical record. The RMD stated there was no need for this physician to examine Pt 8 because he was not a part of her care team. The RMD stated on 5/6/25 the date Pt 8 reported the incident with DO 1, nursing staff notified the clinical supervisor (NS 3), primary physician, house supervisor, and risk management. The RMD stated, risk management called the on-call administrator. The RMD stated the social worker notified the PD, and Adult Protective Services (APS). The RMD stated all notifications were on 5/6/25.The RMD stated no other complaints were reported to the Risk Management Department to indicate DO 1 had any other allegations like Pt 8 at the hospital. The RMD stated Risk Management then notified their leadership and the Peer Review (physician experts in a specific field who evaluate physician conduct) Committee. The RMD stated on 5/6/25 DO 1 was summarily (immediately) placed on administrative leave. The RMD stated the Risk Management Department’s investigation was completed and turned over to Medical Staff for peer review (further investigation). When asked about DO 1 allegedly performing breast, buttock and a genital exam on Pt 8 the RMD stated physicians could have a chaperone with them during assessments, especially if there was a private area to be assessed, but the hospital had no current policy indicating a chaperone was needed for exams. The RMD stated a policy was in progress but was not yet approved for implementation. The RMD stated that a chaperone during an exam was good for both the patient and the care provider. The RMD stated nurses did not stop DO 1because they did not know if he was coming in to examine her, and if he was a consultant physician. RMD stated a root cause analysis (RCA-a systematic process used to identify the underlying causes of a problem, rather than just addressing the surface symptoms) had not yet been decided or discussed. During a hospital document review titled, “Badge Access Audit (BAA)”, dated 5/6/25, the “BAA” indicated, 5/6/25 at 5:06 a.m. DO 1 entered the parking lot. The “BAA” indicated, at total of five different badge “card admitted” uses. The “BAA” indicated at 5/6/25 at 5:09 a.m. DO 1 entered the hallway to the ED Observation unit. The “BAA” indicated on 5/6/25 at 5:17 a.m. leaving the ED observation unit. During a telephone interview on 5/13/25 at 9:11 a.m. with RN 15, RN 15 stated she was the primary nurse for Pt 8 the morning of the incident on 5/6/25, and she recalled the incident between Pt 8 and DO 1. RN 15 stated she works the night shift from 7 p.m. to 7:30 a.m. RN 15 worked the night of 5/5/25 and the morning of 5/6/25, with her shift ending at 7:30 a.m. RN 15 stated Pt 8 reported to her on the morning of 5/6/25 after 5 a.m. someone with a stethoscope, went to Pt 8’s room without turning on the light, or introducing themselves and listened to Pt 8’s chest area, then inappropriately touched her chest and breasts, was told to lay on her side, and the man touched Pt 8’s buttocks, then Pt 8 was told to lay flat, and the man touched her “private area”. RN 15 stated Pt 8 also reported the man snapped his fingers around Pt 8’s ears, and said can you hear. RN 15 stated she did not remember seeing the man on the unit. RN 15 stated she did not recall the last time she saw Pt 8 before the incident, but it was at least thirty minutes or more, because she administered pain medications to Pt 8. RN 15 stated physicians generally came and left the ED Observation Unit without telling nursing staff. RN 15 stated the physician would only inform nursing staff if the nurse was needed for something. RN 15 stated only the orthopedic physicians would round (assess the patients) in the morning. RN 15 stated usually one or two physicians went and checked on the surgery site (cut area from surgery) and then left. RN 15 stated she did not have any means to check on physicians to determine if they were licensed or credentialed. RN 15 stated Pt 8 was very frightened and was crying when she reported the incident. RN 15 stated Pt 8 wanted the security footage to be checked right away. RN 15 stated she told her supervisor right away, and the primary physician was notified. RN 15 stated the primary physician said “ok”. RN 15 stated she had “no idea” of any way to prevent something like this incident from re-occurring. RN 15 stated she should keep an eye on the physicians going into the patients’ rooms, but it would be difficult because the nursing staff are in many different rooms. During an interview on 5/13/25 at 9:47 a.m. with the DED, the DED stated he was aware of Pt 8’s experience and the alleged conduct of DO 1 and stated several risk mitigation measures (the process of planning for and lessening the negative impact of potential risks) proved problematic (difficult). In the ED the security logs were reviewed to ensure only active personnel had access and the hospital removed access for people who should not have it. The ED Observation Unit had access granted to most physicians due to consulting services. The DED stated nurses should have some awareness about who was entering the patient’s rooms. The DED stated in the ED Observation Unit, there may be Orthopedic physicians, or Surgeons getting consents signed, or physicians rounding on patients. The DED stated DO 1 should not have been on the ED Observation Unit in Pt 8’s room. The DED stated the PD had to authorize a sexual assault examination of a patient, and the patient was not interviewed by the PD until Pt 8 was discharged. The DED stated the ED Observation Unit was a closed unit and required a security badge for entry. During an interview on 5/13/25 at 2:53 p.m. with the RMD, the RMD stated DO 1 had no patient complaints at any other hospitals he previously worked to her knowledge. The RMD stated, information about DO 1’s background check was completed through the Medical Staff Office. The RMD stated DO 1’s security badge access was removed on 5/6/25, the same day DO 1 was placed on administrative leave. The RMD stated Risk Management did not interview DO 1. DO 1 was not interviewed by hospital staff. During an interview on 5/14/25 at 7:38 a.m. with the DED and Patient Care Technician (PCT) 4, PCT 4 stated she recalled the incident with Pt 8 from the morning of 5/6/25. PCT 4 stated she worked the night shift on 5/5/25 and was working the morning of 5/6/25 when Pt 8’s incident occurred. PCT 4 stated the morning of the incident she was sitting at the computer in the pod where Pt 8’s bed was located. PCT 4 stated she heard someone walk past her, turned her head and saw a tall man wearing scrubs peeking through the curtain into Pt 8’s bed area. PCT 4 stated she turned back to the computer to finish her work and did not see the man go in, but PCT 4 stated she saw the man pull apart the curtain. PCT 4 stated, the next thing she saw was him leaving. PCT 4 stated minutes after he left, the patient walked out of her room and asked who the man was in her room and told PCT 4 she was uncomfortable with him. PCT 4 stated RN 15 went into the pod, and the patient came out of the curtain and spoke to RN 15. PCT 4 stated security came to the unit. PCT 4 stated the patient was upset, became emotional and began crying. PCT 4 stated the incident made her feel uncomfortable, that something like this could have happened. PCT 4 stated she did not realize DO 1 was there, and wished she could have helped Pt 8 more. During an interview on 5/14/25 at 7:52 a.m. with NS 3, NS 3 stated, he recalled the incident with Pt 8 from the morning of 5/6/25. NS 3 stated he was the Nursing Supervisor for the night of 5/5/25 and morning of 5/6/25. NS 3 stated RN 15 approached him and told him Pt 8 was distraught, because a man wearing mint green scrubs, came into her room never turned on the light, never introduced himself, inappropriately touched her and she felt violated. NS 3 reported the incident to leadership and got orders from the physician for the SW consult. NS 3 was at the nurse’s station and did not see the man come on the unit. NS 3 stated Pt 8 went out of her room and spoke to RN 15, but RN 15 was speaking faintly so NS 3 did not hear the conversation. NS 3 stated he (NS 3) did not speak to the patient at all, but RN 15 described in detail what Pt 8 reported. NS 3 stated he felt devastated, Pt 8 came to the hospital to get better and something like this happened. During an interview on 5/14/25 at 7:58 a.m. with RN 16, RN 16 stated she recalled the incident with Pt 8 from the morning of 5/6/25. RN 16 stated she was working the night shift from 5/5/25 to 5/6/25. RN 16 stated while passing medications for a patient directly across from Pt 8’s bed in the same four bed pod, RN 16 heard a man’s voice with Pt 8. RN 16 stated, a male walked out of Pt 8’s room area, but she was focused on the computer. RN 16 stated, the gentleman passed by and walked to the side of her. RN 16 stated she did not look at his face and RN 16 stated the man walked quickly causing RN 16 to see movement, so RN 16 turned around. RN 16 stated the thought was, “who is walking by so fast?” RN 16 stated the man was bald and in scrubs, so she figured the man was a doctor or something. RN 16 stated shortly after the man walked down the hall Pt 8 walked out of her room and spoke to PCT 4. RN 16 stated Pt 8 said the man did not introduce himself and asked her about her last menstrual cycle RN 16 stated Pt 8 seemed upset, and RN 16 knew “something was not right”. RN 16 stated physicians should document patient assessments. RN 16 stated she never had an experience where a physician examined a patient and did not document the exam. During an interview on 5/14/25 at 11:49 a.m. with the Director of the Neurological Hospitalist Department (DNH), the DNH stated he (the DNH) was DO 1’s Supervisor. The DNH stated, his (DNH) role was to provide a safe environment for patients and physicians, and he set clear expectations for his physicians. The DNH stated he was now aware of the allegations Pt 8 made against DO 1. The DNH stated he was not involved in the investigation. The DNH stated he received a phone call on 5/6/25 at 6 p.m. from the hospital’s Medical Executive Committee (oversee the peer review process to ensure the quality of medical care provided by the medical staff) President and was informed about the action taken with DO 1 not the details for the action. The DNH stated DO 1 was removed from the schedule. The DNH stated on 5/13/25 Pt 8’s medical record was given to him to review. The DNH stated after a chart review, he determined no physicians from his service, including DO1, were involved in Pt 8’s care, so the DNH closed Pt 8’s medical record, concluding his investigation as to whether DO 1 was part of Pt 8’s care team. DO 1 was not part of Pt 8’s care team. The DNH stated the team of physicians he directs provides care for neurological cases (brain, spinal cord, nerves). The DNH stated Pt 8 was an orthopedic case. The DNH stated a neurological assessment would include an assessment of the head area and cognition (how well someone is able to think, learn, remember, and use judgment and language). The DNH stated the physicians he supervised had a template to document in the patient’s record and all assessments were supposed to be documented. The DNH stated, as far as he was aware DO 1 had no other complaints against him. The DNH stated Pt 8 was not one of the neuro group’s patients and was not a neuro case. The DNH stated DO 1 was not scheduled to work on Tuesday 5/6/25. The DNH stated the transition of teams’ assignment change was on Wednesday’s at 7 am. The DNH stated the transition would have occurred on 5/7/25. The DNH stated Pt 8’s allegations would indicate moral and ethical behaviors not in line with that of a physician. During a review of hospital document titled “Call Schedule”, dated 5/1/25 to 5/31/25, the “Call Schedule” indicated DO 1 was not scheduled to work from 5/1/25 to 5/7/25. During a concurrent interview and record review on 5/14/25 with Director of Medical Staff Department (DMS), DO 1’s credentialing (process that establishes the qualifications of licensed professionals and assesses their background and legitimacy to provide services) documents, “Reappointment Approval Form” dated 10/31/24, “Peer References”, dated 6/14/24, and “Background Screening Report”, dated 6/14/24. The DMS stated DO 1 had active status as a member of Medical Staff at the hospital. The DMS stated DO 1 had no restrictions (no limitations or conditions) on his medical license. The “Background Screening Report” indicated, “County Court Search”, “Nationwide Criminal Search”, and “State Sex Offender” results were complete and clear of any negative reports. The two “Peer Review” documents indicated DO 1’s peers rated him “above standard” for “Ethical Practice [acting in a manner that is morally right and fair, adhering to principles of honesty, integrity, and respect for others]”, “Responsibility toward patients”, “Responsibility toward their profession”, and “Responsibility toward society”. The “Reappointment Approval Form” indicated, on 10/10/24 the Credentials Committee agreed with department recommendation and DO 1 was reappointed with Medical Staff status. The DMS was aware of allegations by Pt 8 against DO 1 and stated DO 1 was “summarily suspended- decision made by the MEC or president of the MEC.” The DMS stated DO 1’s EMR access, badge access, any access to all campuses where DO 1 might have privileges were suspended on 5/6/25. During an interview on 5/14/25 at 3:14 p.m. with the Director of Medical Staff Department (DMS) the DMS stated, DO 1 was suspended on 5/6/25 by Medical Staff. The DMS stated on 5/8/25 the Medical Staff Department contacted an outside investigation firm. The DMS stated on 5/12/25 the firm was approved. The DMS stated she did not know if anyone investigated DO 1’s electronic medical record usage to determine which patients were accessed by DO 1 and not assigned to him. During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO) the CNO stated, he was aware of the incident involving Pt 8 and the sequence of events that led to the report of alleged misconduct by DO 1. The CNO stated, the facility identified a medical staff member as the male person Pt 8 identified entering her room and allegedly touching her inappropriately. The CNO stated, the medical staff member was suspended, and a third-party vendor would be completing the investigation. The CNO stated nursing staff should have some awareness of who was seeing the patient (physicians). The CNO stated nursing and medical staff should slow down and be engaged in the patient’s care, to communicate. The CNO stated when physicians assess patients the documentation should be in the patient’s medical record. During an interview on 5/15/25 at 2:42 p.m. with Risk Management Analyst (RMA) 1, RMA 1 stated DO 1 had remote access (ability to access electronic medical records off site) prior to 5/6/25. RMA 1 stated on 5/6/25 DO 1’s remote access, and security badge access were removed at the time administrative leave started. RMA 1 brought in the contact number for DO 1’s legal counsel when the surveyor requested DO 1’s telephone number and the information of the third-party investigation company. During a review of the hospital’s policy and procedure (P&P) titled, “Standard of Practice for Emergency Department”, dated 9/23/24, indicated, “ ... Intervene appropriately to correct unsafe situations ...”. During a review of the hospital’s P&P titled, “Documentation in the Health Record”, dated 6/14/18, indicated, “ ...All care providers caring for the patient are to document within their scope of practice/job description. All patient care and activities are to be documented at the time care is provided ...”. During a review of the hospital’s P&P titled, “Patient’s Rights and Responsibilities”, dated 3/14/25, indicated, “ ... Patient rights are applicable to all [name of hospital] patients and parents/guardians of patients who are minors. ...the hospital shall provide processes to support the following patient rights: ...To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment. ...To know the name of the provider who has primary responsibility for coordinating the care and the names and professional relationships of other providers and non-providers who will see the patient...”. During a review of the hospital P&P titled, “Professional Behavior”, dated 12/12/24, indicated, “ ... A high standard of professional behavior, ethics and integrity are expected of each individual member of the Medical Staff of [name of hospital] ...This policy is a statement of the ideals and guidelines for professional behavior in all dealings with patients, families, other health professionals, employees, students, vendors, government agencies, and others, aiming for the highest levels of patient care, trust, integrity and honesty ... Egregious Conduct: Conduct that presents imminent danger to the health of any individual or as determined by the Department Chair ... based on the specifics of the incident in question. For example, an incident of Harassment, Sexual Harassment, and Inappropriate Sexual Conduct ... may be determined to be egregious ...”. During a review the hospital’s P&P from the Medical Staff Policy Manual titled, “Corporate [hospital name] Rules & Regulations”, dated 12/12/24, indicated, “ ...Professional Conduct Harassment of patients, hospital employees, fellow practitioners, visitors, or family members, in any form, including verbal, physical, and visual harassment, for any reason or because of a person’s race, color, national origin, ancestry, sex, gender, pregnancy, religious creed, age, physical disability or handicap, medical condition or marital status, or because of a person’s relationship or association with members of a protected group or association with organizations established for the preservation of rights protected under the law, or for any other reason prohibited by law or regulations, is prohibited ...”. 2. During a review of the hospital’s “Entity and Reporting Tool (ERT)”, dated 5/11/25, the “ERT” indicated the hospital reported to the California Department of Public Health (CDPH) a adverse event (any harmful or unfavorable outcome for a patient or staff member occurring while medical care is provided) on 5/6/25 involving Pt 92, a 75-year-old who was admitted for cellulitis ( tissue infection) in his arm. The “ERT” indicated Pt 92 had a history of alcohol abuse, and had a Clinical Institute Withdrawal Assessment (CIWA, a numerical assessment used to evaluate the severity of alcohol withdrawal symptoms, where a score of 0 to 7 indicated low risk) score of 7, was agitated and becoming aggressive toward staff. The “ERT” indicated Pt 92 had daily episodes of agitation requiring medication and restraints (devices or methods used to limit a person’s movement or freedom, often for safety reasons, in medical settings, or when dealing with potentially dangerous situations). The “ERT” indicated Pt 92 was given haloperidol (an antipsychotic medication used to treat hallucinations (perceptions of something not present), delusions (false beliefs), and disorganized thinking at 4:50 p.m., reassessed at 5:40 p.m. at which time Pt 92 kicked a Patient Care Technician (PCT) in the face. During an interview on 5/13/25 at 11:09 a.m. with the Manager of Licensing and Accreditation (MLA), the MLA stated PCT 2 (the PCT kicked in the face) was on leave and not available for interview. During a phone interview on 5/14/25 at 1:36 p.m. with RN 26, RN 26 stated she was caring for Pt 92 on 5/6/25 when PCT 2 was kicked by Pt 92. RN 26 stated Pt 92 had an order for restraints, and she asked PCT 2 to assist her in placing them on Pt 92, as PCT 2 was already in Pt 92’s room. RN 26 stated Pt 29 was confused and combative. RN 26 stated Pt 92 kicked PCT 2 in the face and PCT 2 immediately slapped Pt 92 in the face. RN 26 stated she had PCT 2 call their supervisor who sent PCT 2 out of Pt 92’s room. During an interview on 4/15/25 at 2:45 p.m. with the RMD, the RMD stated she was unaware of the slapping of Pt 92, when reporting Pt 92 kicking the PCT to the California Department of Public Health (CDPH). During a review of the hospital’s policy and procedure titled, “Patient’s Rights and Responsibilities (PR)””, dated 3/14/25, the “PR” indicated, “ ... Purpose ... To define rights and responsibilities of patients who receive services ... Patient Rights ... To be free from neglect; exploitation or harassment; and verbal, mental, physical, physical, sexual abuse and corporal punishment [the use of physical force to discipline or punish someone] ...”. During the review of a professional reference titled, “Elder abuse and dementia: A review of the research and health policy (EA)”, the “EA” indicated, “ ... Older adults with dementia often have psychological or behavioral symptoms such as agitation and aggression, which may intensify caregiver-recipient conflicts and results in elder abuse. Lower levels of cognitive function were associated with increased risk for elder abuse ...”. During a review of a professional reference titled, “What to do with a violent dementia patient” (undated), the reference indicated, “ ... Employing effective de-escalation techniques can help manage aggressive behavior and prevent escalation. These techniques are instrumental in maintaining a calm and supportive environment ... Remain Calm and Composed ... Demonstrating patience and avoiding reactive behavior ... Use Gentle, Reassuring Language ... Offer Choices and Control ... Redirect Attention ...”.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to have an effective Quality Assurance and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program that tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care) and implement preventive measures when: 1. The QAPI committee failed to monitor and track the use of the “Universal Protocol” in the pre-operative area where nerve blocks are sometimes performed. Patient (Pt) 19 was consented for a right arm fistula creation [a connection between two parts of your body that don’t normally connect. It often takes the form of a tunnel or passageway] by Medical Doctor 1 (MD1) and MD1 ordered a right arm nerve block (a procedure that numbs the nerves in the shoulder and arm area, providing pain relief) and did not verify the correct surgical site in accordance with the hospital’s policy and procedure (P&P) titled “Universal Protocol - Procedural Areas” before performing a left shoulder nerve block. Pt 19’s nerve block was performed in the pre-operative area. (cross reference A-0951,3). This failure resulted in no time-out being performed, which was part of the hospital Universal Protocol, which may have prevented the wrong side nerve block in Pt 19. 2. Hospital staff failed to submit an adverse event report (IRIS-Incident Reporting Intranet System) at the time of Pt 30’s “lost” suture needle event, in accordance with hospital P&P titled “Adverse Event Reporting” dated 1/3/22 and within 45 days. This failure resulted in the QAPI committee not investigating the incident and not performing a root cause analysis (RCA-is a method used to identify the main cause of an issue), for 77 days, the RFO (suture needle) after vaginal delivery on 2/21/25, to determine the cause and implement measures to ensure future incidences would not occur. (Refer to A-0951, 2). Findings: 1. During an interview on 5/14/25 at 2:45 p.m. with the DRM, the DRM explained how the hospital responded after they learned of the wrong side nerve block. The DRM stated they did a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) and found that the education regarding timeouts before nerve blocks may not have reached the providers. DRM stated they have now completed education with the anesthesia group and with the surgeons. Anesthesia Leadership reinforced “Universal Protocol - Procedural Areas” to make sure that anesthesia providers (medical doctors who specialize in anesthesia and CRNAs) know that a separate timeout is required for regional blocks (such as nerve blocks on arms or legs), spinals (Spinal blocks are injected directly into the spinal fluid through a needle in the patient’s back, providing immediate and complete pain relief) , or epidurals (epidurals are injected into the space outside the spinal fluid sac, allowing for continuous pain relief and greater control of pain levels without taking away all feeling.) DRM stated they also trained all staff that a nurse must be present for the timeout, and the timeout must be documented in the procedure record. During an interview on 5/15/25 at 11:00 a.m. with the Chief Nursing Officer (CNO) the CNO stated the root cause of the wrong side nerve block was the failure to do a timeout before the nerve block. The CNO described a timeout as. “A period to validate everything in the room. Everything before you cut.” During a review of hospital Policy and Procedure (P&P) titled, Universal Protocol - Procedural Areas” dated 12/19/22, the P&P indicated, “ ... I. PURPOSE: A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors. II. DEFINITION: A. Provider: A person who is authorized to provide care as determined by privilege or competency through the Medical Staff and the Board of Trustees - including the following: 1. Medical Staff Member: Physicians and others granted membership on the Medical Staff and, for purposes of this policy, includes individuals with temporary clinical privileges. 2. Advanced Practice Professional (APP): Physician assistants and advance practice nurses including nurse practitioners, certified nurse midwives, certified registered nurse anesthetists and other non-physician providers who provide direct patient care services under a defined degree of supervision by a physician Medical Staff Member. 3. Learner: A student, resident or fellow who does not have privileges or credentials on the Medical Staff of [name of health system] for their academic program ... III POLICY: A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or noninvasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), lnterventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: Pre-Procedure verification; Marking the site, when applicable; Procedural Briefing; Time Out; Debriefing ....D. Timeout: 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning. A. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped ...All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process ... D. Time Out addresses and verbally confirms among all team members the following elements: ... Correct procedure and laterality (when applicable) as consented. Ill. Site marked (when applicable). 2. During an interview on 5/9/25 at 10:54 a.m., with DWC, DWC stated her preliminary investigative findings in the matter of Pt 30’s RFO event, were that staff failed to submit an IRIS report on the day the RFO was detected (2/21/25). DWC stated to her knowledge, the only IRIS report submission was the report submitted by the DRM on 5/9/25. DWC stated her expectation was for staff to submit an IRIS report per hospital P&P, and as soon as possible once the adverse event occurs. During an interview on 5/16/25 at 11:02 a.m. with CNO, the CNO stated his expectation was for staff to report events such as the RFO incident on Pt 30 and that “what goes in should come out pre and post [areas] should be preparing the patient and all counts are done/accounted for and appropriately tracked to prevent RFO events. During a review of the facility’s policy and procedure (P&P) titled, “Adverse Event Reporting to the California Department of Health Services,” dated 1/3/22, the P&P indicated, “To comply with the mandated reporting requirements of Health and Safety Code 1279.1 (b). To support the improvement of patient safety and quality improvement initiatives ... Adverse event includes any of the following: Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient ... It shall be the policy of [hospital name] to report an adverse event, as define within Health Safety Code 1279.1, to the CDPH no later than five days after the event has been detected; or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients ... not later than twenty-four (24) hours after the adverse event has been detected ... In addition, the regulations specify the hospital is subject to an onsite investigation when CDPH determines that an adverse event or complaint is an ongoing threat of imminent danger of death or serious bodily harm. It is also our policy to investigate the source of the event, initiate any mitigation actions that may be indicated and cooperate fully with the CDPH throughout the process. All adverse events which may be considered reportable as defined by this policy shall be reported to the Supervisor/Manager immediately by involved staff and an Incident Reporting Intranet System (IRIS) completed within 24 hours ...It will be the responsibility of the Risk Manager to develop and submit the initial report to the CDPH...””

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 47205 Based on observation, interview and record review, the governing body (GB), medical staff and administrative officials failed to implement effective actions to address the known problem of a high number of inpatients provided care in the Emergency Department (ED). The hospital and Quality Assurance and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) Committee submitted an acceptable Plan of Correction (POC) in response to a Centers for Medicare and Medicaid Services (CMS- a federal agency that administers the Medicare, Medicaid, and other health insurance programs) authorized federal survey findings in August 2024 related to patients seen in the ED, admitted to an inpatient unit and remained in the ED for their entire inpatient stay; patients did not experience the benefits of inpatient unit care. The current survey found seven of eleven sampled patients (Pt [Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45]) were brought into the ED, determined to require admission to an inpatient unit and remained in the ED. The QAPI actions were not sufficient to address the high number of inpatients in the ED. (cross reference A144, finding 1) These failures resulted in not evaluating on an ongoing basis the effectiveness of improvement actions and denied patients the benefit and services that inpatient unit can provide and the ED does not provide. From January 2025 to May 2025 these failures resulted 2,206 total number of patients denied the benefit of services of inpatient units. Findings During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17’s chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, “Flow Sheet” was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate “50%” of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, “he may have been refusing meals, but if he was, they didn’t document it.” M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, “Care Plan Details,” dated 5/6/25 indicated, “ ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures available. Provide verbal encouragement ...” The document titled, “Physician Orders” dated 5/2/25 indicated, “Diet: Regular.” M1E stated, “He didn’t receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn’t eating.” During a review of hospital document titled, “History and Physical (H&P- an assessment from physician including medical history and exam)” dated 5/2/25, the H&P indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person’s ability to communicate, interact socially, and understand the world around them), schizophrenia (a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 and was discharged on 5/6/25. During a concurrent observation and interview on 5/6/25 at 3:55 p.m. with the Director of Capacity Operations (DCO) and Pt 43 in the Discharge Lounge, Pt 43 was sitting in a recliner chair, dressed in street clothes, with a family member at the chairside. Pt 43 stated she was agreeable to an interview. Pt 43 stated she was in the ED for two days. Pt 43 stated she was admitted as an inpatient and discharged from the ED. Pt 43 never moved to an inpatient unit. Pt 43 stated no one changed her sheets or her gown during her admission, and she had to get her bath wipes from a cart because no one offered them to her. Pt 43 stated the bathroom in the green zone was filthy, so she would go down to the yellow zone because it wasn’t as dirty. During an interview on 5/8/25 at 11:18 a.m. with the DED Pt 44’s “H&P”, “ADT” and, and “DCF” dated 5/4/25 to 5/7/25, were reviewed. The H&P indicated Pt 44 was an 85-year-old male who arrived in the ED on 5/4/25 by ambulance for fever and chills. The DED stated Pt 44 was admitted as an inpatient on 5/4/25 at 12:48 p.m. The DED stated Pt 44 was admitted as an inpatient for Systemic Inflammatory Response Syndrome (SIRS- widespread pain, swelling, throughout the body). The “ADT” indicated Pt 44 was held in the ED as an inpatient from 5/4/25 to 5/6/25. Pt 44 was held in the ED for 52 hours and 35 minutes. The “ADT” indicated Pt 44 was in a hallway bed as an inpatient for 25 hours and 35 minutes, Pt 44 was in an ED room for 27 hours. Pt 44 was transferred to an inpatient hospital room on 5/7/25 at in the ED observation unit for 18 hours and 2 minutes and was transferred to a progressive care unit (PCU) on 5/7/25 at 9:07 p.m. The “DCF” indicated Pt 44 had no hygiene care documented from 5/4/25 to 5/6/25. The DED stated Pt 44 had no meal documentation on 5/4/25 or 5/6/25. The DED stated Pt 44 should have all daily care activities and all meals documented in the medical record. During a concurrent interview and record review on 5/8/25 at 2:05 p.m. with the Director of the ED (DED) and the Manager of the ED (MED) 1, Pt 43’s “ED Pt Care Timeline (EDCT),” and “Daily Care Flowsheet (DCF)”, dated 5/4/25 to 5/6/25 were reviewed. The “EDCT” indicated, “ ...Arrival 5/4/25 at 10:02 a.m. Depart 5/6/25 2:47 p.m. TT 52:45 ...” The DED stated Pt 43 was never moved to an inpatient unit, Pt 43 was admitted as an inpatient, held, and was discharged from the ED. The “EDCT” indicated, “ ... 5/4/25 10:05 a.m. ...To room R-04 [room Red Zone] ...5/4/25 10:06 a.m. Chief Complaints Updated difficulty breathing ... 5/4/25 12:33 p.m. Decision to Admit ... 5/4/25 Admission Information Patient Admit Service: Medicine ... Bed Requested ... Medicine ... 5/4/25 Patient Transferred from room R-04 to YH [Yellow Zone Hall] ...5/5/25 3:48 a.m. Transfer to Green [Green Zone] ...5/6/25 at 2:47 p.m. To department DC [discharge] Lounge ...”. The DED stated the “DCF” had no documentation indicating nursing staff provided Pt 43 with daily care (hygiene, bathing, oral care, gown or linen changes from 5/4/25 to 5/6/25. The DED stated daily care should have been provided to and documented for Pt 43 during her ED admission. During an interview on 5/13/25 at 9:32 a.m., with hospital Vice President of Quality and Senior Vice President (DRQ) and Chief Financial Officer (CFO) and Senior Vice President Community Health Systems, CFO stated hospital clinical leaders are aware of the bed capacity challenges. Leadership’s focus has been on throughput. CFO stated he would have to defer to hospital leaders with a clinical background/focus on some of the patient care issues that have risen to his level of attention. CFO stated he is an active part of discussions at the governance level with daily reports reviewed by several levels of management. CFO stated the Board (BOD- are responsible for making strategic decisions, overseeing operations, and ensuring the hospital’s financial health and compliance with regulations. Essentially, they act as the hospital’s stewards, entrusted with its overall well-being)) is well aware of situation [inpatients boarding in the ED) and they are focused on initiatives to alleviate the volumes [in the ED]. CFO stated the hospital is actively renovating and looking to reopen a SNF location to move pts to that unit to help free up beds to reduce volumes hospital wide. CFO stated leaders acknowledge the ED volumes are increased over this last few years. Challenge with addressing it with anticipated addition of 154 licensed beds slated to open at end of calendar year 2025. CFO stated departmental quality reviews are occurring. CFO stated the ED “scorecard- Scorecards provide a high-level, one-page overview of a health system’s long-term, strategic outcomes improvement goals)” reviewed with the Chief Executive Officer (CEO) and that the facility BOD sees a general view not the actual ED score card. CFO stated the BOD has been provided the ED capacity and the inpatient boarding data is shared with them. CFO stated the hospital is always trying to get better. CFO stated the hospital has conducted a cost benefit study with a goal to staff all of the [licensed] beds. CFO stated the hospital made a compensation adjustment in July 2024. CFO stated ED care and ED inpatient care reimbursement is different in that outpatient is at a different reimbursement than inpatient reimbursement. During an interview on 5/13/25 at 12:30 p.m. with Vice-Chair Integrated Medical Staff and Interim CMO (DR1), and VPQ, DR1 stated [patient clinical] as a physician, he “hasn’t noted any outcomes concerns” however, as an administrator he is aware of the differences in the care in ED vs in-patient unit. DR1 stated some of the concerns he is aware of are ED RNs were having adaptation issue to pts with inpatient needs i.e.: intake and output monitoring/documentation. DR1 stated this resulted in educating the RNs in the ED on how to care for the inpatient they were caring for in the ED. DR1 stated he has seen better care as a result of the education. DR1 stated the Hospitalist was expected to come to the ED and drive the care of the inpatient. The Hospitalist is the point person for the inpatient care team. During an interview on 5/6/25 at 2:36 p.m. with RN 11, in the ED Green Zone, RN 11 stated, Patients should have hygiene supplies, clean gowns, linens... to feel human while they were in the hospital.” RN 11 stated patients should be asked about hygiene and should be cleaned up every day, and the hygiene should be documented in the medical record. During an interview on 5/6/25 at 2:51 p.m. with RN 12, in the ED Yellow Zone, RN 12 stated the difference in care from admitted ED patients versus ED patients were skin assessments were more thorough, completing medication reconciliation, and providing an air mattress to prevent skin breakdown. RN 12 stated ensuring the patient and linen were clean was important because it helped to prevent skin breakdown and reduced infection risks. RN 12 stated the hospital used to have call bells in the hall, but “I don’t know where they are now”. RN 12 stated, patients called out when they needed help. RN 12 stated, patients were at a higher risk for falls without a call bell, because they could try to get up without help if they needed to go to the bathroom or if they were confused. During an interview and record review on 5/9/25 at 2:05 p.m., with the Manager (M) of the (CPCU and RN 27 indicated that while Pt 25 was in the ED, the care plan should be focused on the problem of altered mental status and was not. During an interview on 5/15/25 at 11:02 a.m. with the Chief Nursing Officer (CNO), CNO stated it is his expectation that [Pt 25’s] CP include the chief complaint. CNO stated syncope/AMS should have been addressed in [Pt 25’s] CP. During a review of the hospital’s P&P titled “Interdisciplinary Plan of Care” dated 10/12/23, the P&P indicated, “... initiate the Plan of Care based on the patient’s comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders.” During a concurrent observation and interview on 5/7/25 at 11:30 a.m. with the DED in the main ED Green, and Yellow Zones, the ED was observed to be busy with patients of all ages in the halls on gurneys. The ED census was 102 admitted patients. There was very little room to move through the hall between patients, staff, and visitors. No call bells were again observed with the patients in the hallways. The DED stated the patients in the halls do not have call bells. The DED stated the bells would be very loud and distracting to other patients in the area. The DED stated the nurses could see the patients and the patients could call out for help. When asked about hospital beds for comfort for the admitted and held patients, the DED stated hospital beds did not work in the ED halls because there was no room for them due to the size of the bed (too large). The DED stated the ED rooms could house the bed, but the patients were moved in and out of the rooms frequently and the beds were cumbersome (large, heavy difficult to move). The DED stated the hall patients obviously did not get the same level of care as the patients moved to the inpatient units, and there was no private bathroom for any of the patients. The DED stated he believed the hospital care was the same because the patients received consultations, case management and discharge planning as the patient would on the inpatient unit. The DED stated his expectation was for the patients to get daily care and for nursing staff to respond to patient needs when doing patient rounding. The DED stated oral care, and changing gowns was a part of daily care. The DED stated his expectation was nursing staff would ensure patient hygiene was taken care of. During an interview on 5/9/25 at 10:53 a.m. with MED 1 and the DED, MED 1 stated ED leadership want to make sure the patients in the ED were comfortable. MED 1 stated he recognized the patients may not be as comfortable as on the inpatient units, but he believed the care was equitable (fair). The DED stated ED staff were able to give comparable care at the level “we are able to” (since the unit does not have all things the inpatient units have). The DED stated the ED staff were providing the standard of care by the policy. When asked about a patient’s right to hygiene, the DED stated he did not know if they were providing the standard of comfort the inpatient departments had, but the ED staff were attempting to provide what they could knowing the environment they work with. The DED stated he believed the ED was meeting the standard of care. During an interview on 5/8/25 at 11:38 a.m. with MED 1, MED 1 stated, the mattresses in the ED were the same as the inpatient beds, just smaller to fit in the ED. MED 1 stated, the inpatient hospital beds electronic adjustable movements, for the knees and feet were “just for comfort”. During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2’s “Daily Care Flowsheet (DCF)”, dated 4/24/25 to 4/29/25 and “Physician Orders (PO),” dated 4/25/25 to 4/29/25, were reviewed. The “PO” dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. the DCF indicated Pt 2 ate “25%” of the meal. The DCF indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The DCF indicated, on 4/29/25 at 6:56 p.m. “0%” diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented. During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2’s DCF, dated 4/24/25 to 4/29/25, were reviewed. The DCC validated in Pt 2’s DCF no documentation for diet eaten on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no diet eaten documentation for any meal, and 4/29/25 the only documentation was “0%” at 6:56 p.m. The DCC stated there should be some form of documentation for meals. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort. During an interview on 5/14/25 at 11:08 a.m. with two members of the Governing Body, Governing Body Member 2 (GBM2) stated he has been to the ED to do tours a few times, and he encounters people who have been patients or who have friends and family members who have been patients in the ED in the community. He stated patients do not want to be kept in the ED when they are admitted, “they want a bed.” GBM2 stated he understands that the hospital is receiving payment for patients to be on nursing units, but they are being kept in the ED because there are no beds available. GBM2 stated the Governing Body has been told that the patients in the ED are receiving care that is comparable to what they would receive if they were on an inpatient nursing unit. The Joint Commission Journal on Quality and Patient Safety article titled, titled “No More Useless Band-aids that Fail to Solve America’s Emergency Department Boarding Crisis,” dated 12/2023 retrieved 2/19/25 from https://www.jointcommissionjournal.com/article/S1553-7250(23)00234-9/fulltext indicated, “The causes of boarding as well as many proposed solutions have been well described. However, the suggestions are band-aid solutions such as changing ED workflow, surgical schedule smoothing, and alternate care sites, and none of them will alleviate boarding and its harms. Boarding is the manifestation of a dysfunctional health care system with misaligned financial incentives. It is a direct consequence of the United States’ patchwork, profit-driven health care system, not attributable to any single hospital or health care organization. While daily admissions from the ED will vary somewhat, the typical number can be easily determined from the ED’s historical records. Beds could easily be reserved for these anticipated admissions, and remaining beds could be allocated to elective admissions. Predicting the daily admission needs for the ED to function and serve the community is not a difficult task. We lack the will to do this, not the ability to make it happen. The lack of will arises from hospital administrators having no incentive to reserve space for ED admissions when they can allocate beds to elective admissions that generate higher profit. In both for-profit and not-for-profit ...” hospitals-which account for the overwhelming majority of annual acute inpatient admissions in the United States-the C-suite is tasked with remaining fiscally solvent. To do so, they favor patients with the kinds of insurance and the kinds of medical conditions that provide lucrative reimbursement for short lengths of stay. In following this strategy, admitted ED patients are queued up in the ED, occupying rooms and halls that need to be available to the patients in the ED waiting room. Consequently, our healthcare system caters better to a regional patient in need of advanced oncology therapy, organ transplant, or complex surgery than a local community member who presents to the ED with pneumonia or congestive heart failure who may find that emergency medical services cannot take them to their preferred hospital because its ED is diverting due to saturation. Boarding is a driver of ambulance diversion and leads to further inequities and disparities.15-21 Our healthcare system does not value care of the most vulnerable.22 While many factors contribute to the lack of acute inpatient psychiatric stabilization beds, a reimbursement system that undervalues such care is a major factor.23 Individuals suffering a mental health crisis experience some of the most egregious prolonged boarding in EDs awaiting acute inpatient psychiatric beds.24-27 The American College of Emergency Physicians policy statement titled, “Boarding of Admitted and Intensive Care Patients in the Emergency Department,” revised February 2023, retrieved 2/19/25 from https://www.acep.org/siteassets/new-pdfs/policy-statements/boarding-of-admitted-and-intensive-care-patients-in-the-emergency-department.pdf, indicated, “ ... Optimal utilization of the emergency department (ED) includes the timely evaluation, management, and stabilization of all patients. Once admitted, patient care is most effectively and safely delivered on inpatient units. Boarding of admitted patients in the ED represents a hospital-wide failure and contributes to lower quality of care, decreased patient safety, reduced timeliness of care, reduced patient satisfaction, an increased number of patients leaving without being seen, and increased mortality. Additionally, it directly contributes to ED crowding due to the resultant loss of bed and resource capacity. ED crowding and its negative impacts on patients are due to misaligned health care economics and financial pressures on hospitals ...” The Journal of Academic Emergency Medicine article titled, “The Association Between Length of Emergency Department Boarding and Mortality” retrieved 2/19/25 from https://onlinelibrary.wiley.com/doi/full/10.1111/j.1553-2712.2011.01236.x, indicated, “ ...ED boarding occurs when insufficient hospital capacity is available for admitted patients to be transferred to inpatient beds. The result is that admitted patients remain in the ED, sometimes for long periods. The concern is that due to competing demands by other patients and general system overload, boarders do not receive the same level of care that they would in inpatient beds. Several recent articles have identified safety issues with boarding, including adverse events, higher rates of ventilator-associated pneumonia, higher mortality rates for intensive care unit (ICU) patients per se, and for admissions overall. There are also higher rates of medication errors and preventable adverse events ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 45929 Based on observation, interview and record review, the hospital failed to ensure nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients’ (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions. These failures had the potential for inconsistent care delivery for patients (Pt 11, Pt 12, Pt 14, Pt 25, and Pt 49) and the potential for not receiving nursing care to reflect their individual needs and goals which could negatively affect patient well-being. Findings: During a concurrent observation and interview, on 5/6/25 at 10:50 a.m., Pt 11 was lying in bed on a medical unit, finger wrapped in gauze. Pt 11 was alert and able to discuss his injury. Pt 11 stated he cut his finger “about a month ago” and it got infected, and he had to have a surgical procedure to drain it. Pt 11 stated he was in a lot of pain the first few days after he was admitted, but the pain in his finger was better now, but his back was hurting now from lying in bed for so long. During a concurrent interview and record review with the Manager of 1 East Medical Unit (M1E), M1E reviewed the Electronic Medical Record (EMR) for Pt 11. The hospital document titled, “History and Physical” dated 4/27/25 indicated, “ ... History of Present Illness: [Pt 11] is a 37-year-old man with h/o HLD (history of high cholesterol), who presents for worsening L (left) index finger pain and swelling after accidentally cutting himself with brass ammunition casing on 4/7(2025). He went to urgent care on 4/14 (2025) and was prescribed prednisone (a medication to reduce swelling) and Amoxicillin/Clavulanate Potassium(an antibiotic) which he completed on 4/24 (2025). He underwent I&D (incision and drainage - opening the wound to allow pus to come out) at urgent care on 4/17 (2025). He has noticed worsening pain, swelling, redness and purulent discharge (pus) from the finger. Reports the tip of the finger is numb ...”. Reviewed hospital document titled, “Care Plan” which listed one of Pt 11’s needs as pain control. The Care Plan titled “Pain” was not individualized to indicate where Pt 11 was experiencing pain. The only notations were that the patient was “progressing.” M1E stated, “ ... the care plan should be more specific. They [the nurses] could have included what interventions seemed to help, whether that was elevating the arm, applying ice, etc. ...”. M1E stated that Pt 11 could possibly been having pain other than just his finger. During a concurrent interview and record review with M1E, M1E reviewed the EMR for Pt 12. The hospital document titled, “History and Physical” dated 3/26/25 indicated Pt 12 “ ... is a 63 y.o. (year old) female With past medical history of stage IV (4) colon cancer with liver mets (metastasis - spreading to other organs, in this case, the liver).” The document titled, “Progress note” dated 5/9/25 indicated patient’s health was “worsening”. On 5/06/25 a meeting was held with Pt 12’s family, and the family agreed to pursue hospice care (specialized form of healthcare that provides comfort and support to individuals who are terminally ill). The clinical record indicated Pt 12 had an order for “do not resuscitate.” The hospital document titled, “Care Plan” was reviewed which listed one of Pt 12’s needs as “Adapt to Life Changes.” The Care Plan “Adapt to life changes” had no further detail listed and was not individualized to indicate what kind of life changes Pt 12 was experiencing, and did not include her adjustment to her end-of-life diagnosis or going home with hospice care. M1E stated, “ ... the care plan should be more specific. I would expect to see something related to how she was adjusting to the fact that she was dying and going home with hospice care ...”. During a concurrent interview and record review of the EMR for Pt 14 with M1E the hospital document titled, “History and Physical” dated 4/5/25 indicated Pt 14 came to the emergency department on 4/5/25, brought in by ambulance after being found near a canal with no clothes on and was severely dehydrated. He was a 61-year-old male with past medical history of diabetes, hypertension (high blood pressure), hyperlipidemia (high cholesterol), coronary artery disease (heart disease), urinary tract infection, and other long-term illnesses, and brought to the hospital for altered mental status (confused and dazed.) A CT (computed tomography, a test that uses X-rays and a computer to see what’s happening inside of the body) was done of his chest, which showed a “left lateral 6 rib fracture with overriding of the fracture fragments” (one of his ribs was broken, and half of the rib was pushed down below the other half.) Review of the document titled, “Pain Monitoring” indicated Pt 14 was having pain on 4/8/25 at 4 a.m. at a pain level of 7 (pain scale of 1-10, with 1-3 being mild pain, 4-6 being moderate pain, and 7-10 being severe pain) and Pt 14 described the pain as hip pain in both hips. At 8:00 a.m. the same day, he described his pain as level 8, and the location was his left hip. At 9:00 p.m. on 4/8/25 he described his pain level as level 8, in his back at that time. Pt 14 continued to report pain throughout his stay, and on 5/1/25 at 2:00 p.m., Pt 14 described his pain level as level 4, in his lower back. M1E reviewed the document titled, “Care Plan” which included a care plan for “Pain” started on 4/8/25 at 9:13 a.m. The plan included “Control of acute pain,” and “Reduced pain sensation.” The plans were not individualized and did not indicate the locations of the pain or what interventions were helpful in reducing pain for Pt 14. M1E stated the care plan was incomplete, and it needed to be individualized to address Pt 14’s specific needs. During a review of Pt 25’s record review on 5/9/25 at 2:05 p.m., of Pt 25s “Face Sheet” the document indicated Pt 25 is a 68-year-old admitted to the hospital as an inpatient on 5/1/25 after coming to the Emergency Department (ED) for “Syncope.” (a temporary loss of consciousness) During a review of Pt 25’s EMR on 5/9/25 at 2:05 p.m., the “History and Physical (H&P)” indicated Pt 25 “ ... presented to the ED via EMS (Emergency Response) for AMS (altered mental status) and two witnessed episodes of syncope ... Assessment & Plan ... A. ... was very hypotensive (low blood pressure) with EMS...suspect the cause possible dehydration vs other ... P. ... keep on tele (Telemetry- Telemetry is used as an observation tool to monitor cardiac rhythm and rate, respiratory rate and oxygen level) ... BP (blood pressure) improved after fluids, will continue ... Past Medical History: Diagnosis Arthritis, Back pain, Back problem...Dizziness frequently - uses cane...Heart abnormality ...”. During a review of Pt 25’s EMR the “Plan of Care” dated 5/2/25 indicated, “ ... Problem: Risk of Impaired Skin Integrity ... Problem: Pain ... Problem High Risk for Skin Integrity Impairment ... Problem: Falls, Risk of ...”. During a concurrent interview and record review of Pt 25’s EMR with the Manager of the Cardiovascular Progressive Care Unit (MCPCU) and RN 27, the MCPCU and RN 27 stated the EMR did not include a Care Plan for Pt 25’s admission diagnosis. MCPCU stated it was her expectation that CPs are initiated, updated once per shift and completed per hospital policy. MCPCU stated CPs should be patient-specific and that Pt 25’s CP did not include a focus or plan for the management of the patient’s AMS. RN 27 stated she is assigned to care for Pt 25 today. RN 27 stated [for nurse care planning] depending on the [patient’s] chief complaint she does an assessment for care plan and her goals are to remove any barriers to progressing to a safe discharge. RN 27 reviewed Pt 25’s care plans and stated she did not find an active CP for AMS or syncope, but after her assessment of the patient, she agreed this focus should have been active and she would be adding AMS to her CP by the completion of her shift. During a concurrent interview and record review on 5/9/25 at 10:10 a.m. with the Nurse Manager of Behavioral Health (NMBH) and the Nurse Supervisor of Behavioral Health (NSBH), Pt 49’s “History & Physical (H&P)”, dated 4/30/25, was reviewed. The “H&P” indicated Pt 49 had a history of substance induced (substance abuse causing) psychosis (a mental disorder where an individual experiences a loss of touch with reality) and schizophrenia (a chronic brain disorder that affects a person’s ability to think clearly, manage emotions, and relate to others) and methamphetamine (a psychostimulant) use disorder (abuse). The “H&P” indicated Pt 49 uses methamphetamines seven times per week. During a concurrent interview and record review on 5/9/25 at 10:25 a.m. with the NMBH and the NSBH, Pt 49’s “Care Plan (CP)” dated 4/30/25 to 5/1/25, was reviewed. CP indicated, active problems of “ ... Risk for violence/aggression towards others ...suicide, Risk of ... Potential for injury related to falls ...”. When asked why there were no problems addressing Pt 49’s diagnosis of psychosis and substance abuse in the CP, the NMBH stated, “ ... good question ... should probably be some in there ...”. The NMBH stated when diagnoses are not addressed in the CP there was a potential for not treating the patient appropriately. During an interview on 5/15/25 at 11:15 a.m. with the Chief Nursing Officer (CNO), the CNO stated a patient’s major diagnoses and chief complaints should be addressed in each patient’s care plan and the care plans for Pt 11, Pt 12, Pt 14, Pt 25, and Pt 49 were not individualized. The CNO stated care plans should have had interventions that were individualized to meet the needs of the patients. During a review of the hospital’s Policy and Procedure (P&P) titled, “Interdisciplinary Plan of Care”, dated 10/12/23, the “P&P indicated, “ ... PURPOSE ... C. To promote interdisciplinary collaboration in order to develop a Plan of Care that is individualized, age and developmentally appropriate, and takes into consideration the physical, psychosocial, spiritual, and cultural needs of the patient and their family ... PROCEDURE ... 3. Initiate the Plan of Care based on the patient’s comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders ...”. During a review of a professional reference titled, “Integrating Personalized Care Planning into Primary Care (IPC)”, dated 10/24/19, the “IPC” indicated, “ ... Personalized [individualized] care planning, a process to collaboratively develop care plans tailored to patient priorities and social contexts, is increasingly important to providing high-quality, patient-centered care ... Often used with medically complex patients, personalized care plans have been effective in improving outcomes when integrated into the routine care and are now mandated by the Centers for Medicare and Medicaid Services for chronic care management reimbursement ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47205 Based on observation, interview and record review, the hospital failed to ensure all licensed nurses adhered to the hospital’s policies and procedures (P&P) and followed physician’s orders when: 1. Licensed Nurses did not check for the presence or expiration of external supplies on the Triage Labor and Delivery Unit (unit where women in labor are assessed) crash cart (mobile medical cart equipped with essential supplies and equipment to manage life-threatening emergencies) in accordance with the P&P titled, “ Code Blue - Medications & Crash Carts (CB)” for four of six days in May 2025. These failures placed potential patients on the unit (10) at risk for inadequate resuscitation. 2. Licensed nurses failed to document Pt 92’s coccyx skin wound when first identified in accordance with the hospital policy titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24. This failure resulted in potential delay in addressing and providing care to Pt 92’s full-thickness skin loss on his coccyx. 3. Licensed nurses did not place a pressure redistribution waffle mattress (an overlay placed over hospital mattress to evenly distribute weight and keep patients cool and dry) for one of three sampled patients (Pt 2) in the Emergency Department (ED) according to hospital P&P titled,” Pressure Injury Risk Assessment, Prevention, Staging, and Treatment”. This failure had the potential to result in harm to Pt 2 by increasing the risk for skin breakdown leading to pressure injuries (PI -damage to the skin and underlying tissue caused by prolonged pressure) and had the potential to worsen Pt 2’s wounds. 4. Licensed Nurses (LNs) failed to ensure critical laboratory values for one of twelve sampled patients (Pt 27) was repeated after intravenous (IV-into a vein) fluid resuscitation (the medical practice of replacing fluids lost by the body, usually through IV administration) was ordered to stabilize Pt 27’s critically elevated lactic acid level (LA- a buildup of lactic acid in your bloodstream) in accordance with hospital P&P titled “Provider Notification Regarding Patient Status” dated 11/14/23 and professional practice standards. This failure had the potential to result in Pt 27’s continued and unresolved lactic acidosis with the potential to result in decline in medical condition up to and including death. 5. Hospital staff failed to document the indication (reason) for the order and administration of Quetiapine (an antipsychotic medication that treats several kinds of mental health conditions by balancing the levels of hormones (chemicals that coordinate different functions in your body) that help regulate your mood, behaviors and thoughts) for one of twelve sampled Pts (Pt 22) per hospital P&P titled “Medications - Orders, Administration, Storage, Documentation”, dated 12/19/23, and P&P titled “Documentation in the Health Record”, dated 6/14/18. This failure had the risk for Pt 22 to be administered an unnecessary psychotropic medication leading to unwanted and/or adverse side effects of unnecessary medication(s). 6. LNs did not take actions on Pt 21’s skin tear in accordance with hospital P&P titled “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24, to prevent the development of a hospital acquired injury from a skin tear. This failure delayed identification and treatment of the pressure ulcer and had the potential for infection, pain, and prolonged recovery. 7. Pt 98 was administered the incorrect amount of high-risk/high-alert medication for sedation (Medications that have a heightened risk of causing significant patient harm when they are used in error). These failures placed Patient 98 at risk for not receiving the desired patient therapeutic medication goals (meaningful outcome for patients). Findings: 1. During a concurrent interview and record review on 5/6/25 at 11:06 a.m. with Registered Nurse (RN) 6 in the Labor and Delivery Triage Unit, the “Crash Cart Check Sheet (CCC)”, date 5/2025, was reviewed. “CCC” indicated the check list column titled, “ ... External Supplies Stocked Per List ... Clovis Only - Rad 97 [unknown equipment] present & operational ...” had a line drawn down the center of the column forming two columns. The left column indicated check marks on 5/4/25 and 5/6/25 and no check marks on 5/1/25, 5/2/25, 5/3/25 and 5/5/25. The right column indicated no check marks 5/1/25 through 5/6/25. RN 6 stated she was unsure what the split column indicated. RN 6 stated the combined columns had no checks on 5/1/25, 5/2/25, 5/3/25 and 5/5/25. During a concurrent interview and record review on 5/6/25 at 11:10 a.m. with Licensed Vocational Nurse (LVN) 2 in the Labor and Delivery Triage Unit, LVN 2 reviewed the “CCC”, date 5/2025. LVN 2 stated she along with other unit nurses performed crash cart checks on the unit. LVN 2 stated the “CCC” divided column, “ ... External Supplies Stocked Per List ... Clovis Only - Rad 97 present & operational ...” indicated the left side was for checking the external supplies on the unit crash cart while the right column indicated checking a particular piece of equipment at another sister hospital site and not applicable to this hospital. LVN 2 stated the “CC” indicated the external supplies on the cart for this hospital were not checked on 5/1/25, 5/2/25, 5/3/25 and 5/5/25. LVN 2 stated if external supplies on the cart, such as the resuscitation bag (a bag/mask device used to force air into the lungs of a patient) were not checked for their presence daily, a patient’s emergent resuscitation could be at stake. During an interview on 5/15/25 at 11:25 a.m. with the Chief Nursing Officer (CNO), the CNO stated crash cart equipment should have been checked for presence and expiration because it is needed to resuscitate patients. During a review of the hospital policy and procedure titled, “Code Blue - Medications & Crash Carts (CB)”, dated 3/14/25, “CB” indicated, “ ... Purpose ... To set the standard for appropriate supplies, medications and equipment necessary to initiate advance life support measures and to ensure uniformity of crash cart contents ... outline the process for securing and checking Code Blue Crash Carts ... Policy ... External crash cart checks ... are to be completed at least every 24 hours ... Document crash cart checks on the Crash Cart Check Sheet ...”. 2. During a review of Pt 92’s “History & Physical (H&P, an assessment from physician including medical history and exam)”, dated 3/26/25, the “H&P” indicated Pt 92 was admitted on 3/26/25 for cellulitis (a common bacterial infection of the underlying tissues) of the right arm. During a review of Pt 92’s “Wound Specialist Note (WSN)”, dated 5/3/25 at 10:12 a.m., the “WSN” indicated, “ ...Wound consult received for ‘left knee skin tear, pressure injury to coccyx’ ... The buttock wound has skin breakdown ... It is important to note that any moisture associated concerns place this tissue is at higher risk for pressure injury ...Sacral/buttocks [coccyx area] denuded, partial and full thickness wound ...”. During a concurrent interview and record review on 5/14/25 at 8:48 a.m. with the Director of Critical Care (DCC) and the Wound Specialist Nurse Educator (WSNE), P 92’s “Wound Line Drains and Assessment (LDA)” was reviewed. The WSNE stated the first time Pt 92’s coccyx was noted on the “LDA” was on 5/3/25 at 5:17 p.m. (more than seven hours after the “WSN”) and noted to be a stage 2 pressure injury (a partial-thickness loss of skin that extends into the first two layers of skin but not to the muscle). The DCC stated nursing staff should create an LDA for any skin injury as soon as it is identified even if they don’t know what type of injury to call it. The DCC stated Pt 92’s coccyx injury was moisture related and not a pressure injury, and thus not reportable. The DCC stated Pt 92’s coccyx injury was both partial and full-thickness injury. During an interview on 5/15/25 at 12:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated if Pt 92’s coccyx injury is a full-thickness skin loss, then it is a stage 3 pressure injury (into the fat tissue). During a review of the hospital’s policy and procedure (P&P) titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24, the P&P indicated, “ ... POLICY ... Upon identification of a suspected pressure injury, whether present on admission or hospital-acquired, the RN [Registered Nurse] shall photograph, describe and document the injury location on the appropriate section of the electronic health record (EHR) ... Staging/Treatment ... Stage 3 Pressure Injury - Full-thickness skin and loss with exposed muscle ...”. During the review of a professional reference titled, “Prevention and Treatment of Pressure Ulcers/Injuries (P&T)”, dated 2025, the “P&T” indicated, “ ... individuals at risk of pressure injuries, especially when moisture and heat at the skin-surface interface are contributing factors ...”. 3. During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member, Pt 2, was admitted to the hospital as an inpatient on 4/24/25 but remained in the ED for 110 hours before being moved to an inpatient room. CO 3 stated Pt 2 was forced to endure the discomfort of a gurney during her long stay in the ED. CO 3 stated she requested a regular hospital bed for Pt 2, and staff informed CO 3 only bariatric (wider and longer for larger bodies) beds were allowed for the ED, but none were available. CO 3 stated Pt 2 did not receive a waffle mattress for the first 30 hours on the gurney. During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of the Emergency Department (DED) and Manger of Emergency Department (MED) 1, Pt 2’s “H&P”, dated 4/24/25, “Admission Transfer Discharge (ADT)”, and “Daily Care Flowsheet (DCF)”, dated 4/24/25 to 4/29/25, were reviewed. The DED stated Pt 2 arrived at the ED on 4/24/25 at 5:10 p.m. The “H&P” indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body’s immune system to target and destroy cancer cells). The “H&P” indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The “ADT” indicated Pt 2 was admitted to the hospital on 4/24/25 at 8:39 p.m. The DED stated Pt 2’s admitting diagnosis was an allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25. Pt 2 was moved to the inpatient Medical Oncology Unit on 4/29/25 at 11:06 a.m. Pt 2’s total time spent in the ED was 138 hours. The “DCF” indicated, no special mattress was documented on the “DCF” until 5/2/25 at 7:55 p.m. The DED stated if the nursing staff provided daily care, and placed a special mattress, it should be documented. MED 1 stated a pressure reduction mattress overlay helped to prevent skin breakdown and reduce the risk of pressure injuries. During a review of the hospital’s P&P titled, “Pressure Injury Risk Assessment, Prevention, Staging, and Treatment”, dated 9/13/24, indicated, “ ...Use the Braden Scale Risk Assessment tool to identify patients at risk for pressure injury as part of the initial admission patient assessment. Subsequent Braden Risk assessments are completed each shift. The initial skin assessment upon admission and/or transfer from another unit will be conducted by an RN and a secondary licensed staff member. .... if the risk stems from immobility, address turning, positioning, and the support surface. If the risk is from malnutrition, address this problem, etc.”. During a review of the hospital’s P&P titled, “Documentation in the Health Record”, dated 6/14/18, indicated, “ ...PURPOSE A. To provide a complete record of patient care and patient progress. B. To facilitate communication among care providers and enhance continuity of care. ...All patient care and activities are to be documented at the time care is provided. 4. During a concurrent interview and record review of Pt 27’s Face Sheet (FS) dated 5/8/25, the FS indicated, Pt 27’s “... Admit Reason(s): Newborn/C/S [Cesarian Section- used to deliver a baby through surgical incisions {cut made in skin} to the abdomen {stomach} and uterus {womb}] ... Delivery [at] 15:09 [3:09 p.m.]...Admit Source Newborn [born inside this hospital]...”. During a review of a document provided by the hospital indicated, Pt 27’s “EPOC Lactate ... 5/7/25 [at] 15:29 [3:29 p.m.] [of] 2.4 [in red] ... Latest Reference Ranges & Units 0.5 - 2.2 mmol/L [millimoles per liter- a unit of measurement used to measure the concentration of a substance in a fluid] ...”. No further lactic acid results documentation was provided by the hospital. During a review of Pt 27’s “Neonatal Resuscitation” note dated 5/7/25 16:04 (4:04 p.m.), the note indicated, “... Indication: Requested to be present...for 33-week twin preterm delivery ... Brief Description: ... Placed on bubble CPAP [bCPAP, bubble continuous positive airway pressure, a noninvasive respiratory support modality used to manage newborns with respiratory distress] and transferred to NICU [Neonatal Intensive Care Unit-a specialized hospital unit that provides critical care for premature, sick, or critically ill newborn infants] ... Disposition: Transferred to NICU in critical condition ...”. During a review of Pt 27’s H&P dated 5/9/25, the H&P indicated, “... Current Diagnoses: Preterm (28.0-33.6 wks [weeks]), Gestational Age: 33w3d week female infant ... METABOLIC/RENAL [body system]: 1-Lactic acidosis [physiologic-of or relating to normal healthful functioning] resolved. There was an initial lactate level of 2.4 mmol/L which is likely physiologic for a fetus [a young human being or animal before birth) where metabolism is anaerobic with low oxygen saturation tensions]. Clinically, perfusion appears excellent with brisk capillary refill (the amount of time it takes for the capillaries [tiny blood vessels] in the skin to refill with blood after pressure is applied) on exam on 5/9/25 ...”. During a concurrent interview and record review on 5/9/25 at 10:00 a.m., of Pt 27’s Electronic Health Record (EHR- is an electronic version of a patient’s medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider) with the Manager of Neonatal Intensive Care Unit (MNICU) the EHR indicated Pt 27’s lactic acid level was elevated, with no documentation present of a discussion between the LN and attending (primary physician) of repeating a lactic acid level after IV Fluid resuscitation. MNICU stated the expectation is that staff follow the hospital P&P and at minimum a repeat LA level should have been completed to ensure the IV Fluid resuscitation ordered corrected the lactic acidosis. During an interview on 5/15/25 at 11:02 a.m., with the hospital Chief Nursing Officer (CNO), the CNO stated his staff had made him aware of the failure to repeat a LA for a neonate (a newborn child). The CNO stated appropriate follow up and a repeat LA laboratory test is expected and should have been done. During a review of the hospital “Provider Notification Regarding Patient Status” P&P dated 11/14/23, the P&P indicated, “...I. PURPOSE To provide staff with guidelines for keeping the resident, attending physician, consulting physician and/or advanced Practice Professional (APP) informed of the patient’s status. ... III. POLICY...B. The attending physician/APP is to be notified by the RN: ...3. Regarding abnormal laboratory results or critical values... VI. DOCUMENTATION A. Document in the EHR each time there is a discussion with and/or a call placed to a physician/APP concerning a patient, even if only the exchange is reached documentation should include the name of the physician/APP, the time, the reason, and the outcome of each discussion or call. B. Document the patient’s condition change, physician notification, actions taken, and the patient’s response in the EHR...”. During a review of the hospital “Critical Results Communication and Documentation” P&P dated 12/12/24, the P&P indicated, “... I. PURPOSE To ensure immediate reporting of the critical results of tests and diagnostic procedures to the appropriate care providers to enable provision of timely and appropriate treatment of patients...II. DEFINITIONS A. Critical Results: Results that require rapid clinical attention to aver significant patient morbidity or mortality [M&M-Morbidity is the state of being unhealthy for a particular disease or situation, whereas mortality is the number of deaths that occur in a population] ... All critical results must be communicated within defined time frames to the nurse caring for the patient or the provider. Documentation of the call including date, time and who received the critical result(s) must be made as a permanent part of the patient’s electronic health record [EHR] ...”. According to the National Library of Medicine “StatPearls” electronically retrieved on 5/20/25, from https://www.ncbi.nlm.nih.gov/books/NBK470202/#article-24002.s9, StatPearls indicated, “... Lactic acidosis is a common cause of metabolic acidosis [here is too much acid in the body fluids] in hospitalized and critically ill patients, serving as both a clinical marker of disease severity and a contributor to multiple organ dysfunction and mortality ... Diagnosis involves measuring serum lactate, ... and analyzing arterial blood gases. Prompt recognition and treatment-focused on the underlying cause-are essential. Management strategies include fluid resuscitation ... Serum lactate serves as both a marker of risk and a therapeutic target; the higher the level and the longer it remains elevated, the greater the risk of mortality [death] ...”. 5. During a concurrent interview and record review on 5/8/25 at 2:11 p.m., of Pt 22’s EMR, with the Director of Critical Care Services (DCC), the EMR indicated an order for quetiapine to be administered to Pt 22. DCC stated, after record review, Pt 22’s EMR did not indicate a reason for why the Quetiapine was ordered. DCC stated expects that staff and providers document the reason for the medication in the patient’s EMR. During a concurrent interview and record review of Pt 22’s FS, dated 5/12/25, indicated, Pt 22 was a “... 55-year-old [y.o.] ...Admit Reason(s): Mvc [Motor Vehicle Collision] ... Admit Event Date/Time: 4/22/25 ...”. During a review of Pt 22’s H&P, dated 4/23/25, the H&P indicated, “... 66 y.o. ... Trauma activation @ 2009 [8:00 p.m.] ... Chief Complaint ... Found pinned in truck, traveling at highway speeds, +seatbelt, flail chest [happens when three or more ribs located next to each other are fractured in two or more places] on left side, Glasgow coma scale [a neurological assessment tool used to measure a patient’s level of consciousness after a brain injury or other neurological insult] 3 [indicates the lowest possible level of consciousness, signifying deep unconsciousness or coma] upon arrival ... chest needled [a needle used in medical procedures to access the pleural space {the space between the lung and the chest wall}] with positive blood and air with EMS ... no reported medical history brought in by [third party air ambulance] ... intubated by [EMS] ... was initially stable, but became hypotensive with a positive FAST [stands for Focused Assessment with Sonography in Trauma, and it’s a rapid, bedside ultrasound examination] and was taken emergently to the operating room...Service to Admit: TICU [Trauma ICU], Inpatient Admission ...”. During a review of Pt 27’s order for Quetiapine dated 5/15/25, the order indicated, “... Ordered Dose: 25 mg [milligrams- unit of measurement] ... Route: Oral [by mouth] ... Frequency: 2 times daily...Scheduled Start Date/Time: 5/4/25 1200 [12:00 p.m.] ...”. During a review of Pt 22’s “Medication Administration Record (MAR)”, dated 5/8/25, indicated Pt 22 was given a dose of Quetiapine 25 mg at 8:33 a.m. on 5/8/25. During an interview on 5/15/25 at 11:02 a.m., with hospital CNO, CNO stated the indication for the medication should be documented in the order and with documentation in the EMR to indicate why the provider considered starting the medication [Quetiapine]. During a review of hospital P&P titled “Documentation in the Health Record”, dated 6/14/18, the P&P indicated, “... PURPOSE A. To provide a complete record of patient care and patient progress. B. To facilitate communication among care providers and enhance continuity of care. C. To provide a legal record of patient care... II. POLICY A. All care providers caring for the patient are to document within their scope of practice/job description. B. All patient care and activities are to be documented at the time care is provided ... 1. Documentation of assessments, completion of notes from interviews and history taking, medication administration ...”. The California Code of Regulations, Title 22, Section 70215 stated “ ... a registered nurse shall directly provide: ongoing patient assessment as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed and the findings documented in the patient’s medical record, for each shift, and upon receipt of the patient when he/she is transferred to another patient care area ...”. The California Nursing Practice Act, Business and Professions Code Chapter 6, Section 2725(d), defined an assessment as an observation of signs and symptoms of illness, reactions to treatment, general behavior, or general physical condition, and determination of whether the signs, symptoms, reactions, behavior, or general appearance exhibit abnormal characteristics, and implementation, based on observed abnormalities, of appropriate reporting, or referral, or standardized procedures, or changes in treatment regimen in accordance with standardized procedures, or the initiation of emergency procedures. 6. During a concurrent interview and record review on 5/8/25 at 1:26 p.m. with DCCS of Pt 21’s EMR, the EMR indicated Pt 21 developed a wound (also known as HAPI- hospital acquired pressure injury) to his buttocks. DCCS stated the nurse’s documentation in Pt 21’s EMR indicates Pt 21 developed a “skin tear” discovered on 5/5/25, in the setting of moisture-associated skin damage (MASD-caused by prolonged exposure to moisture sources like urine, stool, and/or sweat, causing the skin to soften and become more susceptible to damage. Moisture lesions and pressure injuries are skin conditions that can lead to damage or breakdown). DCCS stated the EMR indicated Pt 21’s Braden Scale Score (BSS- is a tool used to assess and categorize a person’s risk for developing pressure ulcers, with lower scores indicating a greater likelihood of developing a pressure injury) on 5/8/25 was 12 (High Risk: Total score of 10-12). DCCS stated was unable to locate nursing documentation was not present DCCS stated MASD is not recognized as a pressure injury (pressure injuries, or pressure ulcers, are caused by prolonged pressure on the skin, often over bony prominences, leading to reduced blood flow and tissue damage) by hospital P&P. DCCS stated as Director assigned oversight of the Wound nurses, she believes hospital P&P is in alignment with the position of the professional references [NDNQI, Journal of Wound, Ostomy and Continence Nursing (JWOCN), National Pressure Injury Advisory Panel (NPIAP)] used when developing wound care policy/ies. DCCS stated the monitoring and tracking of MASD wounds differs from the HAPI monitoring and tracking process. DCCS explained that because MASD skin injuries are not pressure injuries, they do not meet hospital policy criteria for reporting to state and other regulatory agencies as a HAPI or an adverse outcome/event. During a concurrent interview and record review of Pt 21’s FS dated 5/12/25, indicated, Pt 21 “... 47-year-old [y.o.] ... Admit Reason(s): Burn (Any Degree) Involving 20-29% of body surface ... Admit Event Date/Time: 4/16/25 ...”. During a review of Pt 21’s H&P dated 4/16/25, the “Burn Surgery” H&P indicated, “... 50 y.o. ... with no known medical history who presented as a burn activation [anticipated critical burn patient arrival]. Pt in significant distress and had difficulty answering any questions ... SUBJECTIVE: Unable to gather history given patient was severely agitated, in pain, and subsequently intubated [the process of inserting a tube called an endotracheal tube {ET} into the mouth or nose and then into the airway {trachea} to hold it open] ... Patient admitted to Burn ICU ...”. During a review of Pt 21’s “Wound Care Order” dated 5/9/25, the order indicated “... Order Date/Time 5/9/25 ... Frequency Every shift ... Comments To gluteal cleft wound [a wound that occurs in the intergluteal cleft, which is the space between the buttocks. It is a common site for skin breakdown due to factors like moisture, friction, and pressure], apply foam daily ...”. During an interview on 5/15/25 at 11:02 a.m., with hospital CNO, CNO stated HAPIs continued to be a process improvement focus with nurse leaders working on the deep tissue injuries (DTIs, a type of PI that involves damage to underlying tissues, but the skin may not be broken) and how moisture affects skin breakdown. CNO stated he expects LNs to go into “preventive mode” by making sure interventions to control moisture, (cleansing after stool, urine), applying lotions and creams as indicated to reduce moisture, friction, and sheer and ongoing assessments are done daily, incorporating the wound team. CNO stated it is his expectation that LNs document moisture, not as a HAPI but expect that it is being tracked, treated, and prevented as it can lead to a HAPI especially if over a bony prominence. The facility policy and procedure titled “Pressure Injury Risk Assessment, Prevention, Staging and Treatment” dated 9/13/24 indicated, “ ... I. PURPOSE...D. To implement wound management strategies to optimize the healing potential and prevent deterioration of existing pressure injuries... III. POLICY .... C. Patients with a subscale identified as a score of 1 or 2 are considered at risk for developing pressure injuries. The nurse will identify and implement an individualized plan of care that addresses the interventions appropriate to reduce the risk factors ... IV. PROCEDURE ... B. Prevention ...1. Skin Care ... e. Cleanse the skin promptly after an episode of incontinence (inability to control the flow of urine from the bladder (urinary incontinence) or the escape of stool from the rectum (fecal incontinence)) f. Use skin cleansers that are pH balanced for the skin...3. Moisture Control a. Control incontinence and minimize skin exposure by using under-pads, and barrier creams ... 4. Pressure Reduction-Positioning... e. Consider the level of immobility, exposure to shear, skin moisture... g. Use breathable incontinent pad when using microclimate management surfaces...k. If the patient cannot be moved or is positioned with the head of the bed elevated over 30 degrees, place a sacral border dressing on the sacrum (coccyx/buttocks) ... 5. Friction and Sheering Reduction a. Minimize friction injury with creams, skin sealants, or protective padding...C. Prevention by Risk Levels ... 3. If the patient scores a 1 or 2 in the moisture subscale, implement the following interventions as appropriate: a. Cleanse with incontinent wipes with each episode and pat dry. b. Apply appropriate skin protectant cream. c. Use briefs only for ambulating/sitting in chair. d. Apply incontinent pad on surface as appropriate. e. Offer toileting assistance every 2 hours. f. Consider fecal collection device. g. Consider low air loss mattress/overlay per protocol ... 7. If the patient scores a 1 or 2 in the friction and shear subscale, implement the following interventions as appropriate: a. Use a lift sheet to move patient. Consider trapeze on bed frame. b. Apply moisturizers to affected area(s) to reduce friction. c. Head of bed up 30 degrees or less except for meals/care/feeding. d. Avoid massaging bony prominences ... VI. DOCUMENTATION ... B. Document the following as appropriate with every reassessment in the EHR: 1. Braden Scale score. 2. Assessment, interventions and patient response. 3. Location of any changes in skin condition and erythema (redness of the skin). 4. Pain assessment and interventions. 5. provider notification of any changes. 6. Patient/family education. 7. Nutrition consumed ...”. According to Friction and Shear Considerations in Pressure Ulcer Development, Hanson, Darlene RN, MS; Langemo, Diane K. PhD, RN, FAAN; Anderson, Julie PhD, RN, CCRC; Thompson, Patricia RN, MS; Hunter, Susan RN, MSN, Author Information, Advances in Skin & Wound Care 23(1):p 21-24, January 2010. | DOI: 10.1097/01.ASW.0000363489.38996.13 electronically retrieved from https://journals.lww.com/aswcjournal/citation/2010/01000/friction_and_shear_considerations_in_pressure.11.aspx on 5/22/25, “... the National Pressure Ulcer Advisory Panel (NPUAP) indicated Friction abrades (to rub or wear away especially by friction) the skin of the epidermis (he outermost layer of skin) and dermis (the middle layer of skin), thereby decreasing the amount of pressure needed to create a pressure ulcer. A successful ulcer prevention program will address contributing factors such as pressure, shear forces, friction and moisture ...”. According to Lumbers M. Moisture-associated skin damage: cause, risk and management. Br J Nurs. 2018 Jun 27;27(Sup12):S6-S14. doi: 10.12968/bjon.2018.27.Sup12.S6. PMID: 29944429 electronically retrieved from https://pubmed.ncbi.nlm.nih.gov/29944429/ on 5/22/25, indicated “...Understanding the differential diagnosis (process is used to help make a final diagnosis when you have symptoms that don’t have one clear cause.) between moisture-associated skin damage (MASD) and pressure ulcers (PU) ensures appropriate management and interventions are instigated at the earliest opportunity. Most damage occurring to the buttocks or sacrum is attributed to pressure, shear, excessive moisture or a combination of these factors. MASD caused by excessive moisture to the sacrum/buttock area is recognized as incontinence-associated dermatitis (IAD); its occurrence is an identified risk factor in the development of PUs. Treatment for IAD should therefore focus on both IAD management and pressure ulcer prevention. ...”. According to Nora Warshawsky, Ph.D., R.N., NEA-BC, CNE, FAAN in the “The value of nursing preventative strategies in reducing hospital-acquired pressure injuries” dated 20 October 2023 electronically retrieved from https://info.pressganey.com/patient-workforce-safety/the-value-of-nursing-preventative-strategies-in-reducing-hospital-acquired-pressure-injuries on 5/22/25, “...Several evidence-based nursing interventions currently exist to prevent HAPIs from developing and to reduce the severity of the pressure injury stage. The first step in HAPI prevention is to routinely assess patients, beginning with admission, to identify those likely to develop pressure injuries. Preventative strategies-like routine repositioning, nutritional support, moisture management, and pressure redistribution-should be initiated as soon as at-risk patients are identified ...”. According to Yusuf S, Okuwa M, Shigeta Y, Dai M, Iuchi T, Rahman S, Usman A, Kasim S, Sugama J, Nakatani T, Sanada H. Microclimate and development of pressure ulcers and superficial skin changes. Int Wound J. 2015 Feb;12(1):40-6. doi: 10.1111/iwj.12048. Epub 2013 Mar 12. PMID: 23490303; PMCID: PMC7950852...electronically retrieved on 5/20/25, “ ... In conclusion, difference in skin temperature seems to be a predictor for pressure ulcer development and superficial skin changes, while synthetic fiber sheets are able to maintain a beneficial microclimate (refers to the heat and humidity at the intersection of the patient’s skin/body and the surface on which the patient is laying) ...”. 7. During a concurrent interview and record review, on 5/12/25, at 1:00 p.m., with the Manager of Neurology Intensive Care Unit (MN ICU), and Nurse Educator for Neurology ICU (NE 1), Pt 98’s EMR was reviewed. Pt 98’s H&P, dated 4/28/25, “MAR”, dated 5/9/25, and “Flow Sheet”, dated 5/9/25, were reviewed. Pt 98’s H&P indicated Pt 98 was a 41-year-old male, admitted on 4/28/25 with a history of hemorrhagic (a blood vessel in the brain ruptures and bleeds, causing damage to brain tissue) stroke. NE 1 stated Pt 98 had had a decompressive hemicraniectomy (surgery to the brain to relieve the pressure in the brain and prevent further brain damage). NE 1 stated, Pt 98 was recovering in the Intensive Care Unit (ICU- a specialized hospital unit that provides critical care and life support to patients who are very ill or injured). NE 1 stated, Pt 98 was intubated (a process where a healthcare provider inserts a tube through a person’s mouth or nose that delivers air or oxygen into a person’s lungs). NE 1 stated, Pt 98 had an order for dexomedeTOMIDdine (a medication for sedation of patients -used to decrease agitation/anxiety) to titrate (adjust a medication in small amounts based on the patient’s response) to a RASS (Richmond Agitation-Sedation Scale is used to assess and guide the depth of sedation for patients in a variety of settings, including those who are mechanically ventilated, receiving sedative medications, or have fluctuating levels of consciousness. The goal is to have a score of 0 or ?1.) of 0 (Alert and Calm). NE stated, for 5/8/25, Pt 98 was consistently on a dose of 0.3 mcg/kg/min [micrograms/kilogram/hour] and the RASS was -2 from 5/8/25 at 7:00 a.m. to 3:00 p.m. with no change in the dosage. NE 1 stated, the medication should have been adjusted to achieve a RASS of 0 or the doctor should have been called to clarify what should be done. NE 1 stated the expectation is that nurses follow the orders of the providers. NM ICU stated, she expected the nurses to follow the policies for sedation medications in the ICU and in this case, the nurse should call the doctor to clarify the order. During a review of Pt 98’s “Order Sheet (OS)”, dated 5/8/25, the OS indicated, “ ... dexomedeTOMIDdine ... Ordered dose: 0.2-1.2 mcg/kg/hr ... Route: Intravenous ... Admin Dose: 16.76-100.56 mcg/hr ... Start at 0.2 mcg/kg/hr and titrate to RASS of 0 (Alert and Calm); Titrate no more than 0.1 mcg/kg/hr every 30 minutes ... Most Recent Administration ... 5/8/25 0503 [a.m.] ... Dose 0.3.mcg/kg/hr ... “. During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated, staff should follow physician orders and call the provider if the order needs to be clarified. The CNO stated, he expected the nurses to follow the policies about the use of sedation in ICU. During a review of the facility’s policy and procedure (P&P) titled, “Analgesia and Sedation: Adult Critical Care”, dated 8/1/25, was reviewed. The P&P indicated, “ ... PURPOSE ... To provide guidelines for consistent, safe, effective management, and documentation of pain and sedation for adult patients in Critical Care areas ... Sedation of agitated critically ill patient will be started only after providing adequate analgesia and treating reversible physiological causes of agitation such as hypoxemia [lack of oxygen to the brain], hypoglycemia [low blood sugar levels], hypotension [low blood pressure], or withdrawal from alcohol or narcotics. G. Sedation level is to be monitored using the Richmond Agitation Sedation Scale (RASS). The sedation goal level will be a RASS score of 0 to -1, unless ordered differently by the physician/Advanced Practice Professional, and will be assessed daily by the physician/Advanced Practice Professional. ... D. Management/Titration of Sedation: ... 6. Inform the physician/Advanced Practice Professional if neurologic changes occur which warrant a need for increasing, decreasing, or discontinuing the medication....”. Review of Registered Nursing.org Professional Reference titled, “Does a Nurse Always Have to follow a Doctor’s Orders?” dated 1/30/23, (found at https://www.registerednursing.org/does-nurse-always-follow-doctors-orders/) indicated, “ ... nurses cannot just randomly decide which order to follow and which not to follow. Unless there is a safety concern (I.E., medication not indicated for patient and/or task conflicts with facility policy/protocol) or an order that conflicts with personal or religious beliefs, failing to carry out orders can be grounds for discipline by the employer as well as the board of nursing, as it could be deemed ‘neglect’.””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 41600 Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the Physician Orders, facility policies, and accepted standards of practice when: 1. The dose of Patient 78’s propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 78’s Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). This failure resulted in Patient 78 experiencing excessive sedation. 2. The dose of Patient 63’s insulin (a medication used to lower blood sugar level) was not adjusted as prescribed according to Patient 63’s insulin order. This failure resulted in Patient 63 experiencing excessive sugar levels in the blood. Findings: 1. A review of Patient 78’s clinical record showed that Patient 78 was a 72-year-old patient admitted to the facility for traumatic aortic dissection (serious condition where the aorta, the body’s main artery, tears or ruptures due to trauma). A review of Patient 78’s Physician Orders dated 4/14/25, indicated, an order for propofol intravenous (IV) drip with starting dose of 10 mcg/kg/min (microgram per kilogram per minute, unit of measure) or current infusing dose ...increase infusion by 5 mcg/kg/min every 5 minutes to goal ...once patient is stable at goal RASS, may decrease infusion by 5 mcg/kg/min every 5 minutes. Goal sedation: RASS -1 to 0 (The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with “awakens to voice” and ending with “unarousable.” Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is “alert and calm”). During a concurrent interview and clinical record review on 5/7/25 at 3:40 p.m. with the Director of Critical Care/Burn/Wound Services (DOCC), the DOCC stated, according to Patient 78’s Medication Administration Records (MAR), Patient 78’s propofol was administered with a dose of 15 mcg/kg/min at 10:42 a.m. on 4/14/25. The dose of 15 mcg/kg/min was kept the same at 7:41 p.m. on 4/14/25. The dose was increased to 20 mcg/kg/min at 12:39 a.m. on 4/15/25. The dose of 20 mcg/kg/min was kept the same at 5:34 a.m. and 8:20 a.m. and ended at 12:16 p.m. on 4/15/25. Patient 78’s RASS score was measured and documented thirty-seven times from 10:42 a.m. on 4/14/25 to 12:15 p.m. on 4/14/25. The RASS documentation indicated that Patient 78’s RASS score was at -5 (no response to voice or physical stimulation) with every RASS documentation when the propofol dose was kept the same or increased instead of lowering the dose as ordered by the physician. During a continued interview on 5/7/25 at 3:45 p.m. with the DOCC, the DOCC stated, the RASS goal of -1 to 0 should have been followed while Patient 78’s RASS was at -5. The nursing notes say ventilation compliance, but RASS was kept at -5. If the RASS needed to be at -5, the order should have been changed to be aligned with how the patient was doing. During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the nurses did not follow propofol’s Physician Orders. If there was a question or concern, the physician should have been contacted for clarification and adjustments accordingly. During a review of the facility’s policy and procedure (P&P) titled, “Medications - Orders, Administration, Storage, Documentation,” dated of 12/19/23, the P&P indicated, “It is the responsibility of the person administering the medication to verify the following ...The right dose ...The patient’s response to medication will be monitored for effectiveness and side effects. Information such as vital signs, laboratory values, clinical signs and symptoms, as well as the patient’s perception, will be evaluated ...A medication order must be clear, legible and include the following ...Dosage ...Frequency ...Orders to titrate medications must indicate starting rate, titration parameters and maximum rate. These orders may include ...sedation scale.” 2. A review of Patient 63’s clinical record showed that Patient 63 was a 61-year-old patient admitted to the facility for cardiogenic shock (a life-threatening condition where the heart can’t pump enough blood to meet the body’s needs, leading to inadequate blood flow to vital organs). A review of Patient 63’s Physician Orders dated 4/13/25, indicated an order for insulin regular in 0.9% (percent, unit of measure) NaCl (a type of IV fluid) 100 u/100 ml (units per milliliter, unit of measure), start infusion at 0.1 u/kg/hr (units per kilogram per hour, unit of measure), target Blood Glucose (BG): 150-250 mg/dL (milligram per deciliter, unit of measure) until resolution of DKA/HHS (diabetic ketoacidosis and hyperosmolar hyperglycemic state are both serious complications of diabetes). The Physician Order further stated for BG greater than 250 mg/dL: - if BG increased from previous value: increase insulin infusion by multiplying by 1.5; - if BG decreased by less than 50 mg/dL from previous value: increase insulin infusion by multiplying by 1.5; - if BG decreased by 50-75 mg/dL from previous value: continue same infusion rate. No change; - if BG decreased by 76-100 mg/dL from previous value: decrease insulin infusion by multiplying by 0.75; - if BG decreased by more than 100 mg/dL from previous value: decrease insulin infusion by multiplying by 0.5 During a concurrent interview and clinical record review on 5/7/25 at 3:21 p.m. with the DOCC, the DOCC stated, according to Patient 63’s MAR, Patient 63’s insulin dose on 4/14/25 was increased to 0.15 u/kg/hr at 1:31 a.m., and increased to 0.225 u/kg/hr at 3:54 a.m., increased to 0.34 u/kg/hr at 7:53 a.m., decreased to 0.255 u/kg/hr at 10:03 a.m., decreased to 0.13 u/kg/hr at 11:04 a.m., increased to 0.2 u/kg/hr at 12:08 p.m., and increased again to 0.3 u/kg/hr at 2:03 p.m. During a continued interview on 5/7/25 at 3:21 p.m. with the DOCC, the DOCC stated, on 4/14/25, Patient 63’s BG levels were recorded at 590 mg/dL at 8:25 a.m., increased to over 600 mg/dL at 8:55 a.m., and again measured at 624 mg/dL at 9:08 a.m., but the dose of insulin was not adjusted. BG reduction from 624 mg/dL at 9:08 a.m. to 580 mg/dL at 10 a.m., 44 mg/dL reduction from previous value, should have increased insulin infusion by multiplying by 1.5, but the nurses reduced the infusion rate to 0.255 at 10:03 a.m. on 4/14/25. Furthermore, the DOCC stated, “we should not have decreased the insulin dose and we were unable to find any notes regarding the dose decrease.” During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the nurses did not follow propofol’s, Physician Order. If there was a question or concern, the physician should have been contacted for clarification and adjustments accordingly. During a review of the facility’s P&P titled, “Medications - Orders, Administration, Storage, Documentation,” dated of 12/19/23, the P&P indicated, “It is the responsibility of the person administering the medication to verify the following ...The right dose ...The patient’s response to medication will be monitored for effectiveness and side effects. Information such as vital signs, laboratory values, clinical signs and symptoms, as well as the patient’s perception, will be evaluated ...A medication order must be clear, legible and include the following ...Dosage ...Frequency ...Orders to titrate medications must indicate starting rate, titration parameters and maximum rate.””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 41600 Based on observation, interview, and record review, the facility failed to ensure pharmaceutical products were stored and monitored properly according to the facility’s policies and procedures or manufactures’ specifications and requirements for a census of 810 patients, when: 1. Seventeen injectable vials of ceftazidime, a medication to treat bacterial infection, were not protected from light in accordance with the manufacturer’s storage requirements. 2. The room temperature was not monitored and recorded in five medication storage areas These failures had the potential for medication degradation and administration of potentially ineffective or expired medications. Findings: 1. During an inspection of the Neonatal Intensive Care Unit (NICU), satellite pharmacy on 5/6/25 at 3:30 p.m., seventeen injectable vials of ceftazidime 1g per vial (gram, unit of measure) were observed outside of manufacture’s box in a clear bag in a bin on the shelf in the pharmacy room. The storage bin did not have any “protect from light” labels on the outside and the seventeen vials were exposed to light. During an interview on 5/6/25 at 3:34 p.m. with the Pharmacist in Charge (PIC) 1, the PIC 1 stated, “drug efficacy could be decreased over time ...the ceftazidime vials should be protected from light.” During an inspection of the ceftazidime manufacturer’s label in the pharmacy on 5/6/25 at 3:35 p.m. with the PIC 1, the manufacture label on the vial indicated, “Protect from light.” During an interview on 5/9/25 at 10:30 a.m. with the Director of Pharmacy (DOP), the DOP stated, medications need to be stored according to the manufacture requirements to ensure ongoing potency and effectiveness. During a review of the facility’s policy and procedure (P&P) titled, “ Guidelines for Procurement of Pharmaceuticals,” dated of 4/2025, the P&P indicated, “All medications shall be stored at appropriate conditions that follow the manufacturer’s guidelines and is directed by pharmacy.” 2. During an inspection of an Emergency Department, ED, medication storage area (Pat1) on 5/6/25 at 11:10 a.m., with the ED Manager (MED), the medication room was observed to not have a thermometer or any room temperature logs. During an interview on 5/6/25 at 11:20 a.m. with the Registered Pharmacist (RPh) 1, the RPh 1 stated that there was no thermometer in the room to record the room temperature. During an inspection of another ED medication storage area (Yellow) on 5/6/25 at 11:40 a.m. with the MED, the medication room was observed to not have a thermometer or any room temperature logs. During an interview on 5/6/25 at 11:45 a.m. with the PIC 1, the PIC 1 stated, there was no thermometer/temperature logs in the medication room. During an inspection of a medication storage area (Oxygen/medication storage) in the radiology department on 5/6/25 at 3:15 p.m., with the director of imaging, the medication room was observed to not have a thermometer or any room temperature logs. During an interview on 5/6/25 at 3:15 p.m. with the PIC 1, the PIC 1 stated, there was no thermometer in the room to record the room temperature. During an inspection of a medication storage area in the dialysis unit on 5/7/25 at 9:25 a.m., with the RPH 2, the medication room was observed to not have a thermometer or any room temperature logs. During an interview on 5/7/25 at 9:25 a.m. with the RPH 2, the RPH 2 stated, the medication room temperature was not monitored and there was no thermometer in the room. During an inspection of a pharmacy in the Community Behavioral Health Center on 5/7/25 at 10:25 a.m., with the PIC 2, the pharmacy was observed to not have any temperature logs. During an interview on 5/7/25 at 10:25 a.m. with the PIC 2, the PIC 2 stated, that there was no temperature logs in the pharmacy. During an interview on 5/8/25 at 1:18 p.m. with the Director of Facilities (DOF), the DOF stated, facility and pharmacy teams are responsible for maintaining temperature in the medication storage areas. The DOF acknowledged that the temperature was not monitored in some of the medication storage areas. During an interview on 5/8/25 at 1:20 p.m. with the PIC 1, the PIC stated, if medications are stored out of temperature range required by the manufacture, it can affect the integrity of the medications stored in the medication room. During an interview on 5/9/25 at 10:30 a.m. with the Director of Pharmacy (DOP), the DOP stated, medications need to be stored according to the manufacture requirements to ensure ongoing potency and effectiveness. During a review of the facility’s policy and procedure (P&P) titled, “ Guidelines for Procurement of Pharmaceuticals,” dated 4/2025, the P&P indicated, “All medications shall be stored at appropriate conditions that follow the manufacturer’s guidelines and is directed by pharmacy...All medications shall be stored under appropriate temperatures ...room temperature shall be between 59°F to 86°F.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the hospital failed to ensure medications were kept in a secured area when intravenous bags (a liquid solution to allow medications to go through the vein) fentanyl (a potent synthetic opioid drug used for pain relief) and propofol (a medication used to put patients asleep and keep them unconscious during medical procedures) were observed unattended and unsecure in an empty patient room of the Neurology Intensive Care Unit (Neuro ICU) in accordance with the hospital’s policies and procedures (P&P) titled, “Medications - Orders, Administration, Storage, Documentation” and “Controlled Substances [a drug that has been classified by a government agency as having potential for abuse and addiction] ...”. These failures had the potential to result for medications to be diverted by unauthorized patients, staff and visitors. Findings: During a concurrent observation and interview on 5/6/25, at 11:04 a.m., with Manager of Neurology ICU (MN ICU), Director of Neuroscience (DN), Registered Nurse (RN) 18, and RN 19, while touring Neuro ICU, in empty room 1009, two medications of intravenous (IV) liquids were observed hanging from the IV pole. One bag was labeled fentanyl 250 ml (milliliter - unit of measurement) and the other medication was a full bottle, labeled propofol 100 ml vial. RN 19 stated, he was responsible for the medications and a patient had left to go to surgery. RN 19 stated, he had thought the staff had taken the medications with him to surgery. RN 19 stated, the medications should not be left unattended, should be in a secure room or drawer or discard. MN ICU stated, both medications are considered controlled substances and should be handled as per policy and not be hanging unattended in an empty patient room. MN ICU stated, she expected nurses who are working with controlled substances follow the policies associated with the handling of controlled substances. During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the medications should not have been left in an empty room and should have been discarded. The CNO stated, nurses should not leave controlled substance medication unattended and follow the policies associated with securing the medications. During a review of the hospital’s facility’s P&P titled, “Medications - Orders, Administration, Storage, Documentation”, dated 12/19/23, the policy indicated, “PURPOSE ... To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage and documentation of medications. ... C. Medication Storage ... 9. Medications will be securely stored at all times and at the appropriate temperature. ...” During a review of the hospital’s facility’s P&P titled, “Controlled Substances - Storage”, dated 12/6/24, the policy indicated, “PURPOSE ... To ensure that all Drug Enforcement Administration (DEA) defined controlled substances are managed in compliance with State and Federal laws pertaining to proper storage of controlled substances within the hospital. ... B. General Storage ... 4. In patient care areas of [BRAND] hospitals. medication storage is primarily maintained in a medication room. ADC [Automated Dispensing Cabinet] equipment are located in the medication room and are under video surveillance. ... 5. Controlled substances requiring refrigeration will be kept in a locked drawer secured to the refrigerator. ... 6. Those ADS [Automated Dispensing System] not in designated medication rooms are located in full view of licensed personnel and under video surveillance. C. Restricted Access ... C. Medication rooms are under security lock that requires badge access ... D. Only personnel authorized by hospital policy and applicable state laws have access to the ADS ...””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 41600 Based on observation, interview, and record review, the facility failed to ensure unwrapped and undated IV bags were not available for patient use according to the facility’s policies and procedures. This failure had the potential for patients to receive unsafe or ineffective IV fluids. Findings: During an inspection of an Emergency Department (ED) medication storage area (green) on 5/6/25 at 11:39 a.m. with the ED Manager (MED), four 1000 ml (milliliter, unit of measure) intravenous (IV) bags, were found unwrapped and undated among other IV bags on the shelf. During an interview on 5/6/25 at 11:40 a.m. with the Pharmacist in Charge (PIC) 1, the PIC 1 stated, the four IV bags should not have been there without a date ...when the IV bags were unwrapped, they needed to be dated and used within 30 days. During an interview on 5/6/25 at 11:42 a.m. with the MED, the MED stated, there was risk of infection if the IV bags were unwrapped with no date. During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the IV bags needed to have their outer wrap. During an interview on 5/9/25 at 10:36 a.m. with PIC 1, the PIC 1 stated, “we have posted laminated signs in medication room to stress the importance of removing from overwrap and discarding it if not used.” During a review of the facility’s policy and procedure (P&P) titled, “ Guidelines for Procurement of Pharmaceuticals,” dated 4/2025, the P&P indicated, “All medications shall be stored at appropriate conditions that follow the manufacturer’s guidelines and is directed by pharmacy... All pharmaceutical products Pharmacy procures shall meet the following criteria: 1. Meet or exceed USP, NF or FDA requirements for potency and labeling.””

“SAFETY FOR PATIENTS AND PERSONNEL CFR(s): 482.26(b)(1) Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use and disposal of radioactive materials. This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the facility failed to ensure proper safety precautions in accordance with the manufacturer’s instructions when one of three sampled lead aprons was observed folded and hanging. This failure had the potential to compromise the integrity of the lead apron which increases the risk of exposing patients, staff and visitors to unnecessary radiation. Findings During a concurrent observation and interview, on 5/9/25 at 11:15 a.m., with Outpatient Manager (OP M) 2, and Registered Nurse (RN) 25, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, one lead apron of three aprons was observed folded and hanging over the hanger. RN 25 stated, the apron was not hanging correctly and should be hanging using the straps on the apron. RN 25 unfolded the apron and correctly hung the apron. RN 25 stated, if the lead apron is not hung correctly, it can compromise the safety of the apron. The OP M 2 observed and did not state anything. During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated, he expects the nurse leaders of the different areas to own their areas and ensure they are in compliance during the rounds. The CNO stated, he expected the nurses to follow the policies about the use lead aprons. During a review of the manufacturer’s guidelines provided by the hospital titled, “[BRAND NAME] Safety, Cleaning & Storage Tips,” date 2025, indicated, “ ... ONGOING INSPECTIONS ... Buckles, Velcro, and straps position the garments for proper coverage. ... Garments with broken or damaged features that prohibit correct positioning should be removed from service and repaired or replaced ... STORING YOUR APRON AND PROTECTIVE APPAREL ... Radiation protection aprons should be hung by the shoulders or straps on an apron hanger. ... X-ray aprons should be rolled, not folded, when traveling. ... Avoid folding, stacking, or sitting while wearing aprons. ... Proper use, cleaning, and storage of radiation protection garments directly affect their integrity. ... “. During a professional reference review retrieved from https://research.columbia.edu/lead-aprons titled, “Columbia Research --Lead Aprons,” no date, the professional reference indicated, “ ... After using a lead apron, make sure to hang the apron so that it is not creased to avoid damage to the lead. Do not store the aprons folded or crinkled on a counter or table. This can cause cracks in the lead and can compromise the effectiveness of the apron. ...””

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 28773 Based on observation, staff interviews and review of hospital documents, the hospital failed to ensure the Food and Nutrition Services (FANS) department was effectively organized and managed effectively when: 1. The Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital’s organizational chart; and 2. The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital’s organizational chart and job description were not aligned at the Surgical Campus 2. The lack of organization, supervision, and oversight of the food and dietetic services department resulted in deficient practices in multiple areas related to safe food practice, sanitation, storage, and staff competency (Cross-reference A-0622 and A-0750). Findings: 1a. During a review of the hospital document titled Amendment to No. 1 to Food Services Management Agreement, dated 5/31/19 and effective date 1/16/20 between the Vendor and the hospital. The agreement listed a section “Compliance with law” that stated the Vendor shall comply with any and all applicable laws of governmental authorities concerning the provision of services contemplated herein, including without limitation, sanitation, safety and health related laws, and shall procure and maintain all necessary licenses and permits. The agreement also listed a section “Quality Assurance” the vendor agrees to perform the services in compliance with all applicable governmental laws and regulations and in accordance with all applicable standards and comply with all accrediting organizations’ standards, including state and federal laws and regulations. During the survey from 5/6/25 to 5/13/25, the survey team identified one cook (Cook 1) was not competent in the day-to-day duties of meal preparation and the competencies completed for Cook 1 did not reflect the depth and scope of the position at one of three campuses (FHSH). Cross Reference A-0622 and A-0750. During a review of the hospital’s untitled document of the Organizational Structure for FANS for Surgical Campus 2, dated 3/31/25, showed FSD 2 was above the Retail and Patient Sous Chefs and RD 1. During an interview with SFSD on 5/8/25 at 4:11 p.m., the SFSD stated that she was the RD with oversight to the FSD 2 and they had provided an updated FANS org chart that showed her position. During a review of the hospital document, untitled, FANS organizational structure, the document was not dated and not on hospital letterhead, showed SFSD with a solid line to the FSD 2. The FSD 2 had a solid line to the VP and a dotted line from SFSD to the VP. During an interview with SFSD, FSD 1, and Executive Chef on 5/9/25 at 9:07 a.m., SFSD stated she does a standards audit twice a year, and that audit consists of looking at the cleanliness, temperature logs, looking at uniform policy, hygiene, menus. SFSD stated weekly manager walk throughs are done by FSD 2 and the patient and retail chefs. SFSD confirmed she did not do those at the hospital. SFSD stated the infection control preventionist does rounds quarterly. 1b. During an interview with FSD 1 on 5/7/25 at 11:11 a.m., FSD 1 stated all the FSD job descriptions were the same for each hospital location. During a review of the FSD 2 job description, undated, indicated FSD 2 reports to the SFSD. It showed FSD 2 overall responsibility for the direction and guidance for FANS in collaboration with Clinical Nutrition Manager. FSD 2 is granted authority and delegated responsibility by the hospital’s governing body and medical staff for the operation of FANS. Surgical Campus 2 where FSD 2 worked did not have a Clinical Nutrition Manager position. During a review of SFSD job description, indicated “job summary” the SFSD in conjunction with the district manager provides oversight and is responsible for the contractual relationship and executive of the Vendor services in healthcare facilities ... attaining full regulatory compliance, adhering to ...applicable laws and regulations.” The SFSD job description indicated under primary duties and responsibilities the leadership and supervision are to supervise district team and hold regular in-person or virtual touch bases with unit leadership teams and conduct two-unit visits per year. During an interview with SFSD, FSD 1, FSD 2 on 5/13/25 at 11:13 a.m., SFSD stated she did the standard audit twice a year at all campuses, which consisted of observing Trayline and food production on the day she would complete the audit. SFSD stated that she would observe kitchen and retail while doing the audit and after she would meet with the FSD 2 about it. SFSD stated that she also did quarterly hospital visits in addition to the twice a year audits. SFSD stated that she does meet with FSD 2 more often however there is no formal documentation to validate the regular oversight and guidance. 2. During an interview with RD 1 on 5/8/25 at 3:15 p.m., RD 1 stated she had worked under the hospital and in August it will be two years. RD 1 stated she will collaborate with the FSD 2 and provide in-services to the kitchen staff. RD 1 stated she does not do any audits or oversight in the kitchen and she only works clinical. During a review of the hospital’s untitled document of the Organizational Structure for FANS at Surgical Campus 2, dated 3/31/25, showed FSD 2 was above the Retail and Patient Sous Chefs and RD 1. The RD 1 position had a straight line to the Retail and Patient Sous Chefs. The RD 1 position had a dotted line up to the VP of Nursing. During a review of RD 1 job description, dated last review 11/19/21, indicated the reporting to Manager or Supervisor. It did not state what Manager or Supervisor was the report, just listed the titles more generally. Review of the hospital document, titled “FY24 Annual Appraisal” for RD 1, performance review period dated 8/23/23-8/27/24, indicated the Supervisor title was Manager of the Bariatric Program (BPM). The evaluation indicated under “Essential Accountabilities”, that RD 1 consistently exceeded expectations for “conducts a nutrition assessment for patients within required time frames. Including screening for malnutrition, formulating a nutrition diagnosis based on collected data while utilizing evidence-based standards, and collaborating with the multidisciplinary team”. During an interview with SFSD, FSD 2 and RD 1 on 5/8/25 at 4:16 p.m., RD 1 stated since she has been a hospital employee there has not been any chart reviews or competencies done on her by a RD. SFSD stated since RD 1 was not part of the contracted service they do not do those on her but do them on all other RDs on all the other campuses. RD 1 stated her supervisor is over the bariatric program. During an interview with the Bariatric Program Manager (BPM) on 5/13/25 at 10:41 a.m., BPM stated that he has worked for three years at Bariatric Program. He stated his background is project management with recruiting. BPM stated he has a law degree, Master of Business Administration, was a medic in the past and had a biology degree. The BPM stated he is the person that does the evaluation on RD 1. The BPM stated he collaborates with nursing from the hospital to complete her evaluation. BPM acknowledged he does not have the skill set to evaluate RD 1 for clinical nutrition competency.”

“COMPETENT DIETARY STAFF CFR(s): 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties. This Standard is not met as evidenced by: 28773 Based on observation, interview and record review, the hospital failed to ensure one of five cooks (Cook 1) at one of three hospital campuses (Surgical Campus 2) was competent in the day-to-day duties of meal preparation. One of 51 patients, Patient (Pt) 90, had physician ordered pureed diet and Cook 1 did not prepare the puree chicken in accordance with the recipe specifications and was not knowledgeable of the correct temperature for the puree chicken. Cook 1 did not follow hand hygiene requirements in accordance with the hospital’s policy and procedure on hand hygiene. These failures had the potential to result in serving undercooked chicken to inpatients and visitors which could result in foodborne illness for a highly susceptible population, not following recipes for puree food items can result in food not being nutritious and palatable leading to decreased nutritional status and not having proper hand hygiene can result in the growth of microorganisms and leading to food borne illness. The Surgical campus 2 census was 51. Findings: During a review of the hospital document titled Entrée, Pureed Grilled Chicken Breast dated 2025 showed, three ounces Boneless Herbed Chicken Breast, two ounces U.H. Sauce, Chicken Stock - Low Sodium Fortified, .14-ounce thickener. Method: 1 Removed entrée from the oven when an internal temperature of 165 degrees Fahrenheit (F) is reached, rough chop and add to blender. 2. Bring stock to a boil, add to blender. 3. Puree for 1 ½ minutes or until entrée is smooth in consistency. 4. Place pureed entrée in a stainless-steel bowl and mix while added thickener a little at a time until fully incorporated. 5. Using a #8 scoop place puree entrée evenly into mold. 6. Place mold on to a sheet pan and place into freezer for a minimum of two hours. 7. Remove puree from freezer and remove puree from mold and place into a freezer bag, label and date and store in freezer. 8. To reheat- pull puree from freezer, place onto a plate, wrap plate with plastic wrap, microwave for three minutes or place in a steamer for 15 minutes until puree has reached 165 degrees F. During a review of the hospital document titled U.H. Sauce, Chicken Stock - Low Sodium Fortified dated 2025 showed, ingredients included low sodium chicken base, water, onion, celery, carrot, garlic, parsnip, turnip, bay leaf, parsley, rosemary and thyme. During a review of the medical record for Patient 90, showed Patient 90 was admitted to the hospital on 4/24/25 with diagnosis of coronary artery disease. A pureed low sodium, low fat diet was ordered by the Physician on 5/3/25. During an observation of the lunch meal of Cook 1 on 5/8/25 at 12:00 PM, Cook 1 placed one 5-ounce cooked chicken breast and an unmeasured quantity of water into a blender and blended the product. The product was a thin runny consistency. Cook 1 added an unmeasured amount of thickener to the chicken mixture. Cook 1 tested the temperature of the blended chicken with a dial thermometer. The temperature of the chicken was 152 degrees Fahrenheit (F). When asked if the temperature of the chicken was ok, Cook 1 stated as long as the food was above 135 degrees F it was fine. The Patient Sous Chef (PSC) intervened and stated the chicken would be reheated to reach 165 degrees F for meal service. During an interview with the Senior Food Service Director (SFSD), Food Service Director (FSD 1) and FSD 2 On 5/12/25 at 11:15 AM, the SFSD agreed Cook 1 did not follow the puree chicken recipe when he added an unmeasured quantity of water in place of two ounces U.H. Sauce, Chicken Stock- Low Sodium and did not measure the thickener per the recipe. The SFSD added it was her expectation that cooks follow all recipes. The SFSD also confirmed all cooks should be knowledgeable of proper cooking temperatures for foods. During a review of the hospital document titled Cook Job Description undated showed the cook was responsible to follow standard recipes and ensure safety of food prepared by following safe sanitary food handling practices- hot food hot and cold food cold. During a review of Cook 1’s personnel file, the competency evaluation signed and dated by Cook 1 on 6/24/19 showed Cook 1 was competent in reading and understanding recipes and food temperature control. Competency evaluations for Cook 1 did not include reading and understanding recipes and food temperature control. During a review of the hospital Policy and Procedure titled, Hand Hygiene dated 4/12/2025 showed, Purpose: to establish clear guidelines and procedures for proper hand washing, aiming to prevent the spread of germs and infections by ensuring healthcare workers and individuals consistently clean their hands at critical moments, ultimately protecting patients and staff from healthcare-associated infections. D. Glove Use: 2. Perform hand hygiene before donning after doffing gloves. During an observation of the lunch meal preparation on 5/8/25 at 12:00 PM, Cook 1 was observed to use gloved hands to place cooked chicken into a blender. Cook 1 then changed his gloves but failed to wash his hands then returned to food preparation. Cook 1 was observed to change his gloves a second time without washing his hands. During an interview with SFSD on 5/8/25 at 12:15 PM, SFSD confirmed hands should be washed between glove changes. During a review of the hospital document titled Cook Job Description, undated, showed the cook was responsible for handling food and equipment in accordance with sanitation and safety practices. Cross Reference to A-0750, Finding 3a. During a review of the Cook 1 competency evaluation signed and dated by Cook 1 on 8/27/24, showed Cook 1 was competent in proper glove use. During an interview with SFSD, FSD 1 and FSD 2 on 5/13/25 at 10:12 a.m., FSD 2 stated on an annual basis they do three to five competencies on the employees that pertain to their position duties. FSD 2 confirmed he did not do competencies of all of the different specific responsibilities for the position. During a review of the hospital policy and procedure titled “Competency Assessment Validation Program”, dated 12/1/22, indicated “Each employee is to achieve and maintain competence according to his/her role and responsibilities as outlined in the Job Description/Performance Evaluation and unit specific skills checklist.””

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital failed to ensure nutritional needs were met in accordance with recognized dietary practices for three of ten patients who were provided care in the Emergency Department (ED) as inpatients, Patient (Pt) 2, Pt 17 and Pt 44 when hospital staff failed to follow physician diet orders ensuring patients received meals. Pt 2 and Pt 44 were diagnosed and admitted as inpatients related to complications of cancer and were not provided meals on multiple occasions and meal intake was not documented; each stayed in the ED for multiple days. Pt 44 was admitted to the ED for complications of developmental delay and mental health and did not have documented evidence of meal intake. The ED did not have a system in place to ensure timely delivery of meals, meals were provided per physician order, and a monitoring system to ensure meals and/or snacks were offered. These failures had the potential to result in weight loss, reduced immune system (body’s ability to fight infection) function, leading to higher risk of infections, poor wound healing, and a worsening of medical conditions. Findings: During a review of the hospital documents titled “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 4/24/25, and Admission Transfer Discharge (ADT), dated 4/24/25 to 4/29/25, the H&P indicated, Pt 2 arrived in the ED on 4/24/25. The H&P indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body’s immune system to target and destroy cancer cells), and chronic kidney disease (CKD- kidneys are damaged and cannot filter blood properly). The H&P indicated Pt 2 was advised to go to the ED by her primary cancer treatment physician, for diffuse (widespread) dermatitis (inflammation on skin) suspected to be from the immunotherapy. The H&P indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The “ADT” indicated, Pt 2 arrived at the hospital’s ED on 4/24/25 and was admitted to the hospital on 4/24/25 at 8:39 p.m. for allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25, about 4.5 days. Pt 2 was moved to the inpatient Medical Oncology Unit (dedicated area within the hospital that focuses on the diagnosis, treatment, and care of patients with cancer) on 4/29/25 at 11:06 a.m. During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member Patient (Pt) 2 was admitted to the hospital as an inpatient on 4/24/25 and was held in the Emergency Department (ED) for 110 hours (4.5 days) before being moved to an inpatient room. CO 3 stated Pt 2 did not receive her meal on several occasions throughout the time she was held in the ED. During a concurrent observation and interview on 5/6/25 at 1:32 p.m. with Pt 2, CO 3, and the Director of Critical Care, in Pt 2’s hospital room on the Medical Oncology Unit, Pt 2 was sitting in a wheelchair at the side of her hospital bed talking with CO 3 and was agreeable to an interview. Pt 2 had scabbing on both hands, Pt 2 had a type of boot on both feet, but the toes were exposed, and scabbing was observed on the toes of both feet. Pt 2’s lips were observed with healing wounds. Pt 2 stated she did not like the care she received in the ED. Pt 2 stated she remembered in the ED she did not get a meal a few times. CO 3 stated she visited Pt 2 on one occasion in the late afternoon and asked Pt 2 what she had for lunch, and Pt 2 said no one ever brought lunch. CO 3 stated she then asked the nurse for food. Pt 2 stated she believed the nurses in the ED could not give the kind of care they do on the inpatient unit, because they seemed too busy. During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2’s “Daily Care Flowsheet (DCF)”, dated 4/24/25 to 4/29/25 and “Physician Orders (PO),” dated 4/25/25 to 4/29/25, were reviewed. The “PO” dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. the DCF indicated Pt 2 ate “25%” of the meal. The DCF indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The DCF indicated, on 4/29/25 at 6:56 p.m. “0%” diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented. During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2’s DCF, dated 4/24/25 to 4/29/25, were reviewed. The DCC validated in Pt 2’s DCF no documentation for diet eaten on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no diet eaten documentation for any meal, and 4/29/25 the only documentation was “0%” at 6:56 p.m. The DCC stated there should be some form of documentation for meals. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort. During a review of hospital document titled “History and Physical” dated 5/2/25, the document indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person’s ability to communicate, interact socially, and understand the world around them), schizophrenia a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 at 6:51 p.m. and was admitted as an inpatient to a medical/surgical unit (an inpatient unit where patients with medical conditions that are not considered life threatening are admitted) on 5/2/25 at 10:44 p.m., but stayed in a bed in the ED. For 4 days after the admission order was written. During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17’s chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, “Flow Sheet” was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate “50%” of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, “he may have been refusing meals, but if he was, they didn’t document it.” M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, “Care Plan Details,” dated 5/6/25 indicated, “ ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures are available. Provide verbal encouragement ...” The document titled, “Physician Orders” dated 5/2/25 indicated, “Diet: Regular.” M1E stated, “He didn’t receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn’t eating.” During a review of the hospital document titled, “Diet Manual & Enteral Nutrition Formulary 2025,” the manual indicated, “ ...Patients who refuse the foods served will be offered substitutes of equal nutritional value. This may include oral nutrition supplements ...” During an interview on 5/15/25 at 11:15 a.m., the Chief Nursing Officer stated, “this should never happen. If the patient was eating, it should be documented. If the patient wasn’t eating, that should be documented as well, and the doctor should be notified. A hard reset is needed. These things should never happen.” During a review of the hospital documents titled H&P, dated 5/4/25, and Admission Transfer Discharge (ATD), dated 5/4/25 to 5/7/25, the H&P indicated, Pt 44 arrived by ambulance in the ED on 5/4/25. The H&P indicated, Pt 44 was 85-years old with a PMH of metastatic (cancer that spread from the original location) adenocarcinoma (type of cancer starting in the glands lining the body’s internal organs) of the sigmoid (part of intestines closest to rectum) colon, with lung metastasis (cancer spread to lungs). Pt 44 presented to the ED with fever and chills. Pt 44 was admitted to the hospital as an inpatient on 5/4/25 at 4:32 p.m. for systemic inflammatory response syndrome (SIRS-a serious condition in which there is inflammation [redness, swelling, heat, pain and loss of function] throughout the whole body), sigmoid colon cancer. Pt 44was moved to the Progressive Care Unit (PCU- inpatient unit for Pts too ill for general medical surgical but not critically ill) 5/7/25 at 9:07 p.m. During a concurrent observation and interview on 5/6/25 at 2:31 p.m. with Registered Nurse (RN) 11 and Pt 44 in Pt 44’s ED hospital room in the Green Zone, Pt 44 was frail and lying on his back in his hospital gurney with the lights off in his room, and Pt 44 stated he was agreeable to an interview. Pt 44 stated, first he was placed in the hallway by an elevator, and it was noisy, and he didn’t sleep. Pt 44 stated, he spent two nights outside in the hallway and three nights in a room. Pt 44 stated, the food was on time when he was in the room, but when his bed was in the hall sometimes food did not come at all. Pt 44 stated, his complaints about care in the ED were, no sleep, no food, and no help with hygiene. During a concurrent interview and record review on 5/8/25 at 11:18 a.m. with the DED and the Manager of Emergency Department (MED) 1, Pt 44’s DCF dated 5/4/25 to 5/9/25 and “PO”, dated 5/4/25 was reviewed. The “PO” dated 5/4/25 at 4:26 p.m. indicated, Diet Gastrointestinal (GI-stomach and intestines) Bland/low fiber. The DCF indicated Pt 44 was not provided meals or snacks on 5/4/25. The DCF indicated, Pt 44 was not provided meals or snacks on 5/5/25 after 4 p.m. The DED stated nutrition should be documented. The DCF indicated Pt 44 was not provided meals or snacks on 5/6/25. The DED stated all meals and snacks should be documented. During an interview on 5/14/25 at 8:18 a.m. with the Director of Emergency Department (DED), the DED stated, heating meals in the ED was a huge undertaking and required a lot of staff time. The DED stated that the ED has three microwaves to heat meals and could probably use more. The DED stated his expectation was for staff to document meals. The DED stated ED staff were doing a better job documenting, but there was room for improvement. The DED stated staff documenting patient’s eating their meals was important to ensure the patients were getting the nutrition they require. The DED stated documenting patient’s intake, and output was a way to ensure the patients were meeting their basic needs, including nutrition and hydration.. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated, patient’s food should be warm and delivered, for all the ED patients not just the admitted and held patients. The CNO stated, documentation should be in the medical record for both intake and output. During a review of facility Policy and Procedure (P&P) titled, “Documentation in the Health Record,” dated 6/14/18, indicated, “ ... All care providers caring for the patient are to document within their scope of practice/job description. ...Electronic Health Record (EHR) 1. Documentation of assessments, completion of notes from interviews and history taking, medication administration (bar coding), vital signs, intake and output collection are recorded at the patient’s bedside ...”.”

“DIETS CFR(s): 482.28(b)(2) All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals. This Standard is not met as evidenced by: 47205 Based on observation, interview and record review, the hospital failed to ensure therapeutic diet orders were followed when nutrition supplements initiated by the Registered Dietitians lacked clear parameters within the prescribed diet order in the hospital’s approved diet manual. This failure can result in patients having an increase in adverse clinical status. Findings: During a clinical record review of Patient 109, the patient was admitted to the hospital on 4/3/25 with a past medical history that included diagnoses of Diabetes Mellitus (DM - a disorder characterized by difficulty in blood sugar control and wound healing), follicular lymphoma stage IV (cancer has spread to multiple sites outside of the lymph nodes, such as the liver, lungs, or bone marrow) with an admitting diagnosis of Neutropenic fever (fever in a patient with reduced neutrophil counts -neutropenia, which can be a complication of cancer treatments). The Nutrition Assessment dated 4/10/25, initiated after a consult ordered on 4/9/25 relating to poor oral intake and a new diagnosis of AML (Acute Myeloid Leukemia- a type of blood cancer that affects the bone marrow and blood, causing an overproduction of abnormal white blood cells). Diet order was a Diabetic Diet and po intakes were documented to be 44%. The Registered Dietitian documented 52% of the calorie needs were being met and 68% of the protein needs. The intervention documented was to add Glucerna shake (nutrition supplement designed for people with DM) twice daily. Review of the physician’s orders dated 4/10/25, Glucerna shake, 8 ounces, two times daily. The Nutrition Follow-Up note dated 4/14/25, the RD documented Patient 109 has had no oral intakes since 4/11/25 and has an appetite but dislikes the food and likes the oral nutrition supplement. The RD documented to continue diabetic diet and increase Glucerna shake to three times a day, and add Ensure Max protein once daily, and may have outside food to promote food intake. The next Nutrition Follow-Up note dated 4/22/25, which was 8 days after the last note. During a clinical record review of Patient 109 with a concurrent interview with Registered Dietitian (RD 2) on 5/7/25 at 9:30 a.m., RD 2 stated the hospital’s nutrition assessment policy. RD 2 stated nutrition supplements are part of a protocol within the current diet order. RD 2 stated the RD may individualize the dietary treatment plan within the parameters of the prescribed diet order as outlined in the diet manual. The diet order has an option that the physician must answer yes or no and can modify snacks, preferences, portion sizes or oral nutrition supplements. RD 2 stated they follow up on high risk in two to four days for ICU patients, patients who are not eating, malnourished, wounds, unstable tube feeding or feeding by vein. RD 2 stated for moderate risk they follow up in five to seven days when patient is eating okay, stable tube feeding, low RD needs and low risk they see patients in eight to 10 days when patient is stable. During a review of the hospital document titled Diet Manual and Enteral Nutrition Formulary 2025, revision dated 11/24, indicated “All Diet orders include the option of an Oral Nutrition Supplement (ONS). A Registered Dietitian, upon further assessment, may add, change, or discontinue an ONS based on the guidelines set forth in the facility diet manual. All diet orders may be individualized by modifying the distribution, type, and quantity of food and nutrients to meet the patient’s individual healthcare needs based on the parameters defined in the diet manual. If a physician does not want the dietitian to make changes to the patient’s nutrition care utilizing one or more of the outlined order entry modes, the physician indicates within the diet order a nutrition communication that expressly states the dietitian’s restrictions to ordering per protocol.” The ONS protocol in the diet manual showed all the diets that can be ordered at the hospital and what types of oral nutrition supplements were allowed for each diet type. During a review of hospital policy and procedures titled Patient Diet Orders and Menus, dated 10/7/24, indicated diet orders will be ordered and produced in accordance with the guidelines referenced in the diet manual and RDs may make dietary alterations, modifications and/or substitutions, within the diet order parameters, to achieve desired patient outcomes. During an interview with the Senior Food Services Director (SFSD) and Food Services Director (FSD 1) on 5/13/25 at 12:28 p.m., FSD 1 stated the Registered Dietitians (RDs) initiate a physician’s order in the electronic medical record for a nutrition supplement when the patient is not eating well. FSD 1 stated the menu for diabetic diet provides 4-5 carbohydrates per meal. FSD 1 acknowledged that adding nutrition supplements even though for diabetic patients would be in addition to the amount of carbohydrates allowed in the physician ordered diabetic diet. FSD 1 acknowledged that at times, the RDs may not follow up for reassessment or to see how the patient is tolerating the nutritional supplement for a few days depending on how they determined their risk level. SFSD and FSD 1 acknowledged there were no specific parameters within the table that indicated the circumstances/criteria, quantity, frequency and duration for the supplements within the therapeutic diet order.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the hospital’s infection prevention and control program (IPCP) failed to ensure a clean and sanitary environment in accordance with hospital policies and procedures and national standards of practice for infection control to prevent and control infections among patients, personnel, and visitors when: 1. The hospital failed to ensure food preparation equipment and storage for food preparation equipment were in sanitary condition for one of two kitchens located in the main hospital. 2. An ice machine located in the main kitchen of the main campus was not clean in accordance with professional standards 3. One of one Neonatal intensive care unit (NICU) nurses at the main hospital campus did not perform hand hygiene between glove changes during NICU milk preparation and one of five cooks on campus B of the hospital did not perform hand hygiene between glove changes during food preparation in accordance with the hospital’s policy on hand hygiene. 4. The physical environment in the NICU of the main hospital did not support the preparation of milk and the addition of modulars (nutritional supplementation) to minimize cross contamination in accordance with professional standards. Nursing staff did not don personal protective equipment (PPE) and did not adhere to infection control standards in the preparation of milk for newborns. 5. Nursing staff in the Emergency Department (ED) did not keep the door closed in the isolation room for Patient (Pt) 39 in accordance with recommendations for the CDC (spell out) for transmission-based droplet precautions. Pt 39 was diagnosed with Rhinovirus and worsening respiratory symptoms and had a physician order for respiratory droplet precautions on 5/4/25. 6. Registered Nurse (RN) 20 did not wear a mask during a bedside procedure for Pt 100. Pt 100 was admitted to Neurology ICU (Intensive Care Unit) on 5/6/2025 and required a ventricular drain and central venous line and RN 20 did not wear a mask while assisting providers during the procedures in accordance with infection control standards. 7. Two placenta specimens were stored in clear plastic containers in an open untied bag in the Labor & Delivery Unit’s soiled utility room and not stored in a sealed biohazard container in accordance accepted professional standards. 8. An unlabeled and undated container with half a sandwich was stored in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit and should have either been thrown away or labeled and dated in accordance with the hospital’s policy on safe food storage titled, “Storage”. 9. Soiled adhesive from labels was left on communication boards in patient rooms on 5West, supply bins and cupboards in the clean utility room, nutrition room and medication rooms of the Rehabilitation Unit and should have been discarded in accordance with the with infection control standards. 10. Two of ten patients, (Pt 17 and Pt 98) Intravenous tubing was not labeled and dated in accordance with hospital policy and procedure (P&P) titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites,” 11. Outpatient clinic staff did not flush weekly an eye wash station in the outpatient clinic as per P&P titled, “Emergency Shower and Eye Wash Station Policy”. 12. Three of six hospital supply rooms in outpatient clinics stored patient care supplies on dirty, contaminated floor and were not stored in accordance with infection control standards. 13. Staff of on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties did not clean and sanitize a glucometer (a medical device used to test blood for the levels of glucose or sugar) in accordance with the hospital’s policy titled, “BRAND NAME] Glucose Meter,” and was visibly dirty with a dark, reddish brown spot at the entrance where the blood is sampled. 14. Clean supplies were stored under the sink in four of 50 cabinets and not in accordance with hospital policy titled, “Environmental Cleaning and Disinfection Policy”, and infection control standards in the following areas: auxiliary pathology lab, outside the entrance to the Operating Room (OR), Campus B; second floor, East Plaza of the outpatient clinic, Neuro Rehab Center; second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties. 15. One of one sampled endoscopic (a thin flexible tube with a camera and light at the tip, used to visualize the internal parts of the body) storage cabinets were observed with four endoscopes touching each other and allowing for possible damage and cross contamination and not stored in accordance with the manufacturer’s guidelines titled, “[BRAND NAME] Reprocessing Manual”, 16. Garlic aioli was not monitored and part of the temperature cooling process in the bistro café kitchen and did not follow Food Code requirements. 17. Scrambled eggs that were previously cooked were above 41 degrees Fahrenheit (F) and were not monitored for temperature cooling process in the café kitchen in the main hospital in accordance with Food Code. 18. Previously cooked food items stored in the refrigerator in the bistro café kitchen were above 41 degrees F. and did not follow Food Code requirements. 19. Staff failed to ensure biohazardous waste containers (a regulated container storing needles, glass, medication, and sharp objects) were closed between operating room (OR) cases in accordance with national guidelines for two of four sampled biohazardous waste containers (Surgical Services 1, OR T-9). 20. Staff failed to ensure clean and dirty equipment in the high-level disinfection (HLD - the process used for the destruction of all germs except for low levels of bacterial spores) cardiology (relating to the heart) decontamination (to remove dangerous germs from objects) workroom was separated in a manner to prevent cross-contamination according to national standards. 21. Hand hygiene was not performed after donning and doffing gloves for three of three sampled glove removals in accordance with hospital’s P&P titled, “Hand Hygiene” and nationally accepted standards. 22. Employees did not have access to a handwashing sink that was separated from the decontamination sink in accordance with the CDC and OSHA regulatory regulations in the cardiology decontamination workroom. 23. There was no documented evidence that the hospital followed the manufacturer’s instructions for use (IFU) for daily cleaning of 1 of 1 sampled transesophageal echocardiogram (TEE - a heart test using a camera, a flexible tube) machine, located in the Cardiology Outpatient Department, second floor of the main hospital. 24. Terminal cleaning was not done in accordance with the hospital’s P&P, titled, “Procedural Area Terminal Cleaning,” and nationally accepted standards and yellow spots were scattered throughout a wall vent for one of two sampled wall vents. (Surgical Services 2, OR 3). 25. The heart-lung machine (Extracorporeal -- a machine that takes over the functions of the heart and lungs during surgery) was observed with brown and orange substances streaking down the side of the machine, (Surgical Services 2, OR 3) and not cleaned as per the hospital’s P&P, titled “Medical Extracorporeal Life Support Guidelines”. 26. A fluid warmer in OR 3 had a brownish ring round the bottom of the basin and the basin case had several areas of chipped paint and rough brownish discoloration (Surgical Services 2) and not cleaned according to the hospital’s P&P titled, “Procedural Area Terminal Cleaning,” and nationally accepted standards. 27. 18 of 21 sampled surgical instrument case carts did not have clean/biohazardous (a biological substance that poses a threat to the health of living organisms) labels in accordance with the hospital’s P&P titled, “Instrument Transport” and nationally accepted standards. 28. Two of two sampled instrument loading carts (specialized heat-resistant cart used for steam sterilization) and two of two sampled autoclaves (machines used to sterilize patient reusable surgical instruments) (SPD 2nd floor) in accordance with the manufacturer’s IFUs and nationally accepted standards for cleaning were followed. As a result of these failures all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Findings: 1. According to the United States Department of Agriculture (USDA) Food Code 2022 Section 4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces and Utensils A. Equipment, food-contact surfaces and utensils shall be clean to sight and touch, C. Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris. On 5/6/25 at 12:30 PM an observation of the food preparation area of the cafe kitchen was conducted with the Executive Chef of Food Services (Ex Chef) and the Senior Food Service Director (SFSD). Multiple bins located on shelves in various areas of the kitchen were observed to hold dry food, food service utensils and equipment. The shelves and bins were not clean with noticeable and excessive food debris, and a sticky brown substance. The can opener was observed with excessive sticky debris on the blade. The Ex Chef and SFSD confirmed the findings and agreed food preparation areas that were not clean could attract pests. The Ex Chef confirmed the can opener was not clean and would have it cleaned. 2. According to the USDA Food Code 2022 Section 4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces and Utensils A. Equipment, food-contact surfaces and utensils shall be clean to the sight and touch. On 5/6/25 at 3:12 PM, an observation of the ice machine located in the main kitchen of the main hospital and concurrent interview was conducted with the Plant Operations Supervisor (POS). The ice chute, the part of the ice machine that directed ice to the ice storage bin was observed with a gray residue. The POS confirmed the finding and stated the ice machine chutes were cleaned monthly. Review of the hospital document titled Engineering Order # 110520 showed the ice machine located in the main kitchen was last cleaned on April 5, 2025. 3. On 5/7/25 at 1:37 PM an observation of RN 3 performing NICU milk preparation in the critical care NICU was conducted with the Clinical Nutrition Manager (CNM) present. RN 3 was adding a fortifier (a nutritional additive) to a NICU infant’s bottles. RN 3 dropped the bottle top on the ground. RN 3 used her gloved hand to pick up the bottle top then discarded the bottle top in the trash. RN 3 changed her gloves but failed to wash her hands then proceeded with the milk preparation process. On 5/8/25 at 9:34 AM, an interview was conducted with the Director of NICU (DNICU) and the Director of Pediatrics (DPEDs). Both the DNICU and DPEDs confirmed hands should be washed between glove changes. a. During the lunch meal preparation on 5/8/25 at 12:00 PM, Cook 1 used gloved hands to place cooked chicken into a blender. Cook 1 then changed his gloves but failed to wash his hands then returned to food preparation. Cook 1 was observed to change his gloves a second time without washing his hands. On 5/8/25 at 1215 PM, an interview was conducted with SDFS (Senior Director of Food Service). The SDFS confirmed hands should be washed between glove changes. Review of the hospital Policy and Procedure titled, Hand Hygiene dated 4/12/2025 showed, Purpose: to establish clear guidelines and procedures for proper hand washing, aiming to prevent the spread of germs and infections by ensuring healthcare workers and individuals consistently clean their hands at critical moments, ultimately protecting patients and staff from healthcare-associated infections. D. Glove Use: 2. Perform hand hygiene before donning after doffing gloves. 4. A review of the professional reference titled Infant and Pediatric Feedings, Third Edition, Academy of Nutrition and Dietetics, 2019 showed, “Providing a separate designated space for the preparation and handling of human milk (HM) and formula is recommended. This space should have physical separation from direct patient care areas; be divided from the storage and anteroom areas and be used solely for the purpose of preparing HM and formulas by aseptic technique. The purpose of an anteroom is to serve as a buffer zone between the HM and formula preparation room and the rest of the health care hospital. The anteroom provides an area where personnel can practice appropriate hand hygiene and put on gowns and bonnets or hairnets before entering the preparation area. A sink used exclusively for hand hygiene is imperative in the anteroom or the identified buffer zone to the preparation area. The sink should have controls for water that do not require the use of hands. “Office space is necessary for the operation of the preparation room. If space does not allow for a separate anteroom or office, a designated buffer zone within the preparation room that is away from feeding preparation is necessary for hand hygiene and clerical duties to ensure aseptic technique. “A covered laundry hamper should be placed in the anteroom, office area or designated area away from feeding preparations may be used for depositing reusable gowns after they have been worn. “The handling of HM and feeding containers should be carried out using aseptic technique and in a location where there is little risk of contamination with pathogenic microorganisms or undesirable environmental substances. Feeding should not be prepared at bedside or in any patient care areas. Preparation requires a clean room with restricted access and healthy personnel. During the time designated for feeding preparation, only authorized personnel should enter the preparation room, and no other activity should be permitted in the room. “All work surfaces must be cleaned with an antimicrobial sanitizing solution that is appropriate for food contact surfaces. “The uniform worn into the feeding preparation area should not be street clothing that is worn regularly outside the health care hospital. Ideally a clean uniform should be donned in a locker room inside the health care hospital. “Personal protective equipment should be donned for feeding preparation, including a bonnet or hairnet, gloves and gowns as well as a beard cover if needed. “Modulars are most appropriately added in the feeding preparation room at the time of milk preparation. It is of vital importance to consider clinical indications when choosing modulars and additives. Proper handling and storage are imperative to ensure patient safety, as any manipulation of feedings increases the risk of contamination. Facilities should implement policies and procedures outlining the handling and distribution of modulars and additives. On 5/7/25 at 1:20 PM an interview was conducted in the critical care NICU with RN 4. RN 4 stated each NICU nurse was responsible for preparing feedings for their patients. RN 4 stated liquid fortifiers or modulars were added to the feeding bottles. Powdered formulas were mixed with sterile water in the kitchen by trained kitchen staff. On 5/7/25 at 1:37 PM, an observation of milk preparation located in the critical care NICU was conducted with RN 3 and the CNM present. RN 3 was preparing critical care NICU feedings on a counter that was located in the middle of the critical care NICU unit. There was no designated separate space for the milk preparation; visitors and staff were free to walk through the area where the milk preparation was performed. The counter had approximately six inches of space to prepare the feedings. On the preparation counter was a plastic bin, a container of sanitizing wipes labeled “Sani-Cloth” germicidal disposable wipes and 12 bottle warmers. On one side of the preparation counter was a covered trash bag used for soiled laundry. The preparation counter was approximately six feet across from a large hand sink that was accessible to visitors and staff. As RN 3 prepared the milk by adding a modular, she wore street clothes and a large vest-type jacket. RN 3 wore gloves but had no hair covering. During the milk preparation, two visitors washed their hands in the hand sink directly across from the milk preparation area. The CNM was asked if the sanitizing wipes were appropriate for food contact surfaces. The CNM confirmed the sanitizing wipes were not appropriate for food contact surfaces. The CNM stated the sanitizing wipes were only used to wipe the milk preparation counters. On 5/7/25 at 1:50 PM, an observation of the milk preparation area for the 3rd floor NICU and concurrent interview was conducted with RN 5. RN 5 stated each NICU room held between four to eight NICU beds. The milk preparation area was a small counter on top of a refrigerator approximately three feet by one foot. On the milk preparation counter were four bottle warmers and a plastic basket which contained pens and labels. Approximately two feet from the milk preparation counter was a hand sink. The hand sink did not have a splash guard, a barrier to prevent cross contamination from the spread of infection and maintaining a safe environment for patients. The milk preparation counter had a container of sanitizing wipes labeled “Sani-Cloth” germicidal disposable wipes which were attached to the side of the milk preparation counter. RN 5 stated the milk preparation counter was sanitized using the “Sani-Cloth” wipes and allowed to air dry. On 5/8/25 at 9:34 AM, an interview was conducted with the Director of NICU (DNICU) and the Director of Pediatrics (DPEDs). When asked what professional standards of practice were followed for the NICUs, neither the DNICU nor DPEDs were sure which professional standards of practice were followed. The DNICU and DPEDs were not aware of the professional standards of practice referred to in professional reference specifically for infant and pediatric feedings published by the Academy of Nutrition and Dietetics. The competency of the NICU nurses in regard to milk preparation was discussed with the DNICU and DPEDs. The DNICU and DPEDs confirmed NICU nurses were trained on hire but did not receive annual training on NICU milk preparation. The DNICU and DPEDs stated the hospital was only adding modulars to milk. The DPEDs agreed that the present set up in the critical NICU and NICU for milk preparation was a contamination risk being that anyone could enter the milk preparation area. The DPEDs agreed the hand sink accessible by visitors and staff directly across from the milk preparation counter in the critical NICU, the hand sink in the NICU without a splash guard, the dirty linen bin next to the milk preparation counter in the critical NICU, and office supplies on the milk preparation counter in the NICU were a concern. On 5/12/25 at 1:00 PM, a phone interview was conducted with NICU Infection Preventionist (NICUIP) and the Director of Accreditation, Licensing, Infection Preventionist. The NICUIP confirmed she did rounds in the NICU but did not have a specific schedule or audit for the milk preparation in NICU units. If she had a concern, she would address it at the time she noticed the problem. The NICUIP confirmed aseptic technique should be followed during milk preparation in the NICUs such as a clean space, PPE (protective personal equipment) and hand hygiene in a specific space. The NICUIP stated breast milk is fortified at bedside. When asked about the milk preparation areas located in the infant rooms and the fact that anyone is allowed in those rooms, the NICUIP stated it was fine because the milk was fortified breast milk and was not sterile. When asked if the sanitizing wipes used in the milk preparation areas should be food safe, the NICUIP stated the sanitizing wipes were a level 4 meaning the least toxic and she would expect that to be food safe. The NICUIP added once the sanitizing solution was dry it was ok to use with food. When asked about the soiled linen container next to the milk preparation counter in the critical NICU, the NICUIP stated it was fine since the soiled linen container was closed. The NICUIP stated the milk preparation space may be splashed with the hand sink location so close in the NICU rooms but that was ok since the nurses would wipe the milk preparation counter with the sanitizing wipe. Review of the hospital document titled Week 2 Expectations and Evaluation signed by RN 3 on 5/15/2023 showed RN 3 met standards for correctly demonstrates labeling, thawing, fortification and storage of breast milk. Correctly verifies and administers breast milk. Review of the P/P titled Breast Milk Management effective 1/13/2023 showed aseptic technique must be used in breast milk preparation and handling. 5. During a concurrent observation and interview on 5/6/25 at 2:02 p.m. with Manager of the Emergency Department (MED)1, and the Director of the Emergency Department (DED) in the ED’s Yellow Zone, Pt 39’s transmission-based droplet precautions room door was left open, and the patient was in the room without a mask. The DED stated doors to isolation rooms should remain closed to prevent the spread of infection. MED 1 closed the patient’s ED room door. During a concurrent interview and record review on 5/6/25 at 2:14 p.m. with Registered Nurse 10, Patient (Pt) 39’s “History & Physical (H&P- an assessment from physician including medical history and exam),” dated 5/4/25, “Microbiology Results,” dated 5/4/25, and “Isolation and Infection Instructions”, dated 5/4/25, were reviewed. RN 10 stated he was the primary nurse for Pt 39. The “H&P” indicated Pt 39 was a 77-year-old with worsening of shortness of breath over the last week, with difficulty breathing with exertion. The “H&P” indicated Pt 39 had an oxygen saturation (percentage of oxygen in blood) of 76% (normal 95%-100%) on room air. RN 10 stated Pt 10 went to the ED by ambulance and was admitted for acute respiratory failure with hypoxia on 5/4/25 at 7:26 a.m. The “Isolation and Infection Instructions” indicated, droplet precautions were ordered on 5/4/25. RN 10 stated Pt 39 was on droplet precautions for Rhinovirus (respiratory virus) and has pneumonia (an infection of the air sacks in the lungs). RN 10 stated, he did not know the door was left open to Pt 39’s hospital room. RN 10 stated the door to the isolation room should remain closed to prevent the spread of the virus to other patients, visitors and staff. During an interview on 5/14/25 at 2:30 p.m. with the Director of Infection Prevention (DIP) and the Infection Prevention Registered Nurse (IPRN), the DIP stated, his expectations from an infection control standpoint for isolation rooms was to ensure the right signage was up, and the personal protective equipment (PPE- Specialized clothing or equipment worn by an individual to protect them from various hazards in the workplace or other environments) matched the type of isolation. The DIP stated his expectation was everyone who entered the isolation room wore the correct PPE. The DIP stated his expectation was to limit the number of people in isolation rooms to reduce the risk of introducing additional microorganisms to the patient. During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the door to droplet precaution isolation room should be closed, and appropriate PPE should be worn in the room. During a review of professional reference titled, “Infection Control Summary of Recommendations” (retrieved from https://www.cdc.gov/infection-control/hcp/isolation-precautions/summary-recommendations.html), dated 11/27/2023, indicated “ ...in acute care hospitals, place patients who require Droplet Precautions in a single-patient room when available ... Ensure that patients are physically separated ...”. 6. During a concurrent observation and interview on 5/6/25 at 11:49 a.m., with Manager of Neurology ICU (MN ICU), Director of Neuroscience (DN), and RN 18 in the Neurology ICU, RN 20 was observed assisting Physician Assistant (PA) 1 inserting an External Ventricular drain (EVD) (a tube inserted into the brain to reduce excess fluids and/or monitor pressures in the brain) in Pt 100’s head and simultaneously, Nurse Practitioner (NP) 1 was inserting a central venous line (a large IV tube usually put into the vein in the groin or neck for fluids and/or monitoring) into the right groin. NP 1 and PA 1 were observed in gown, sterile gloves, cap, and eye protection during the procedure. RN 20 was observed documenting care, following the orders given by PA 1 and NP 1, monitoring Pt 100’s vital signs/response to the procedures and administering medications to Pt 100. RN 20 was observed wearing a cap, and no mask. MN ICU stated, RN 20 should be wearing a mask during the procedure to protect the patient from possible infection. During a review of Pt 94’s,”History & Physical [H&P],” dated 5/6/25, the “H&P” indicated, Pt 100 was admitted on 5/4/25, she was an 80-year-old female who complained of Headache at home and called Emergency Transport Services. In route, Pt 100 lost consciousness and had seizures. Pt 94 had a history of high blood pressure, heart disease and atrial fibrillation (an irregular heart beat). Pt 94 was found to more than likely have a hemorrhagic (a blood vessel in the brain ruptures and bleeds, causing damage to brain tissue) stroke due to brain aneurysm (a weakness in a blood vessel wall. During an interview record review, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), the IPRN stated, standard precautions face/eye shield, mask, gloves, gown are expected for anyone doing the procedure or are ready to help during the procedure. The IPRN stated, the staff should limit the number of people in the room to reduce the risk of introducing additional microorganisms to the patient. During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the staff should have had masks during the procedure as it is important to prevent infection. The CNO stated, the staff should work as a team and everyone should check each other. According to the CDC (Centers for Diseases Control and Prevention - an agency that works to protect people from health threats) reference titled “CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” (https://www.cdc.gov/infection-control/hcp/core-practices/index.html) dated 4/12/24, “ ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection ...risk assessment with use of appropriate personal protective equipment (e.g., gloves, gowns, face masks) based on activities being performed ...” 7. During a concurrent observation and interview on 5/6/25 at 10:50 a.m. in the Labor & Delivery Unit’s soiled utility room with Obstetric (OB, the field of study concentrated in pregnancy, childbirth and post birth period) Technician (OBT) 1, two placenta specimens in liquid were stored in clear plastic tubs inside unsealed clear plastic bags. OBT 1 stated the specimen bags should have been sealed to avoid spillage and the risk of transmission of infection. During an interview on 5/15/25 at 11:10 a.m. with the Chief Nursing Officer (CNO), the CNO stated laboratory specimens should be sealed in a plastic biohazard (marked as a potential disease producing pathogens) bag to avoid cross-contamination both to and from the specimen and the handler of the specimen. During the review of a professional reference titled, “A Comprehensive Guide to Biohazard Specimen Bags (CG)”, dated 2/2/24, the “CG” indicated, “ ... Biohazard specimen bags are also known as biohazard bags or specimen transport bags. They are specifically designed containers for the safe and secure transportation of biological materials posing a threat to human health. These materials include blood samples, tissues, cultures, and other potentially infectious substances ... Closure Mechanism: Secure closure mechanisms, such as zip-lock seals or adhesive strips, prevent exposure to the contents ... reducing the risk of contamination ...”. 8. During a concurrent observation and interview on 5/6/25 at 2:10 p.m. in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit with Registered Nurse (RN) 7, an unlabeled container contained half a sandwich. RN 7 stated the sandwich was sent up for a patient and was held but should have been thrown out if not eaten. RN 7 stated the sandwich should not have been saved as they had dated sandwiches in the refrigerator. During an interview on 5/15/25 at 11:30 a.m. with the CNO, the CNO stated patient food should be labeled with an expiration date because expired food could make a patient ill. During a review of facility’s P&P for Nutrition/Dining Services titled, “Storage,” dated 11/13/24, the policy indicated, “ ... PURPOSE ... Proper storage of food is essential to preserve its quality, prevent contamination and deter bacterial growth. Maintenance of proper storage procedures is a responsibility shared by receiving, store room, ingredient room, preparation and service personnel. ... All opened foods will be kept in containers that prevent contamination. Such containers will be clearly labeled with the common name of the food and dated with date food was opened and expiration date. ... “ 9. During a concurrent observation and interview on 5/6/25 at 1:27 p.m. on the Rehabilitation Unit with the Manager of the Rehabilitation Unit (MRU) in the clean utility room, nutrition room, and medication room, labels on the supply bins and cupboards were peeling off, exposing dirty adhesive. MRU stated peeling labels are an infection risk because the adhesive can trap organisms, and the labels can’t be properly cleaned. During a concurrent observation and interview on 5/6/25 at 2:01 p.m. on 5 West Unit with M1E in the clean utility room, labels on the edges of shelves were peeling off, exposing dirty adhesive. M1E stated the labels needed to be replaced because they can cause the spread of infection. During a concurrent observation and interview on 5/6/25 at 2:31 p.m. on 5 West Unit with the Supervisor (S5W) in room 587, surveyor noted “Contact Isolation” sign outside door of room. S5W stated this patient (Pt 15) is in isolation for VRE (Bacteria known as vancomycin-resistant enterococci (VRE) are resistant to some powerful antibiotics), CRE (Carbapenem-resistant Enterobacter (CREs) are certain kinds of bacteria that carbapenems (commonly used antibiotics) aren’t effective against.), and C.diff (Clostridium difficile (C. diff) is a bacterium that can cause inflammation of the colon (colitis). It is a common cause of antibiotic-associated diarrhea.) Surveyor and S5W, put on gowns and gloves and entered Pt. 15’s room. The communication board (a white board that provides information about the patient and the names of nurses caring for the patient) had been altered with a patch to change the name of the unit, using a piece of material approximately 1/8” thick, which was stuck on top of the old unit name, creating a raised edge around the patch. The same type of patch was used to change the room number on the communication board. On the edges of the patches, black residue was stuck around all sides. S5W stated the dirt around the edges is concerning, especially since Pt. 15 was in isolation for very resistant organisms, and the whiteboard could not be cleaned properly to protect staff and the next patient who is admitted to this room. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO reviewed a photograph that had been taken of the dirt around the patch and stated, “That is unacceptable. It is an infection control risk for everybody who goes in the room, and it is unacceptable.” During a review of facility’s policy titled, “Infection Prevention Plan,” effective date 2/27/25, the policy indicated, “ ... HAZARD SURVEILLANCE TOURS/ENVIRONMENTAL ROUNDS ... A multidisciplinary team with representation from Infection Prevention Department, Plant Services, Environmental Services/Housekeeping, Security, Safety Specialist, Clinical Engineering and unit leadership will document Hazard Surveillance Tours conducted a minimum of two times a year in call clinical areas ... and once per year in all non-clinical areas. ... The multidisciplinary team performs Hazard Surveillance Tours as part of a continuous proactive risk assessment. ... Hazard Surveillance Tour inspections are unannounced tours. ... All members of the team work collaboratively to complete a thorough inspection of the unit/area. ... It is the responsibility of the unit/area staff as a part of ... ongoing commitment of Hazard Surveillance to ensure that any items utilized are visually inspected for cleanliness, functionality, and/or damage immediately prior to use. ... “ According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, “ Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)” 10. During a concurrent observation and interview on 5/6/25 at 11:04 p.m., with MN ICU, DN, RN 18, and RN 19 in Pt 98’s hospital room, a bag of intravenous (IV) liquid was observed hanging from the IV pole, with tubing disconnected as Pt 98’s had left to surgery. There was no label on the tubing to indicate the date and time that the tubing was placed or when it should be changed. RN 19 stated, the IV tubing should have a label to indicate when tubing should be changed. MN ICU stated, it is not acceptable to have tubing not labeled and the tubing should be labeled. During an observation and interview on 5/6/25 at 2:30 p.m. with S5W in Pt 17’s hospital room, a bag of IV liquid was hanging from the IV pole, with tubing connected to Pt 17’s arm. There was no label on the tubing to indicate the date and time that the tubing was placed or when it should be changed. S5W stated, “All IV lines should be labeled. I can’t say when it was hung or when the tubing needs to be changed, so the nurse will have to change it now.” During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated IV tubing should be changed according to policy. During a review of the hospital’s policy and procedure (P&P) titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites,” dated 6/14/24, indicated, “ ... Purpose ... To establish the standard for maintaining asepsis by preventing the use of potentially contaminated intravenous (IV) tubing. ... Tubing changes of the following IV set, IV piggybacks and intermittent infusions are to be done every 7 days ... PROCEDURE ... C. Label new IV tubing with date to be changed. ...”. 11. During a concurrent observation, interview and record review on 5/9/25 at 10:35 a.m., with Outpatient Manager (OP M) 1, RN 21 and RN 22, on the third floor of the outpatient clinic, North Plaza, Pediatric Specialty, an eye wash station was observed in the lab draw area. The “Emergency Eyewash Station Weekly Activation Log” for the week checks indicated the last time the eye wash station had been checked and flushed was April 18, 2025 (See picture). OPM stated, lab personnel typically check the station but as the manager, she should ensure it is done weekly. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated he expected the eye wash station should be checked and flushed weekly according to policy. During a review of the hospital’s P&P titled, “Emergency Shower and Eye Wash Station Policy,” dated 10/3/23, indicated, “ ... Purpose ... To ensure the proper use and function of emergency eyewash stations. ... Weekly testing and flushing of Eye Wash & Emergency Shower stations will be the responsibility of the individual department in which they are located. ... 1. Each plumbed station shall be flushed for a minimum of 15 seconds to rid the system of any potential sediment and/or bacteria. ... 2. Each flushing shall be documented by the individual department utilizing the Eyewash Station Activation ... Log. Records are to be retained by said department. ...”. 12. During a concurrent observation, interview and record review on 5/9/25 at 10:35 a.m., with Outpatient Manager (OP M) 2, and RN 25, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, three clean utility rooms were observed. Two of the clean utility rooms in the halls next to the exam rooms had miscellaneous supplies on the floor under the wire shelving. RN 25 stated, supplies on the floor should be picked up and discarded as they could be contaminated. The OP M 2 picked up the supplies and discarded them. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated he expected rooms to be clean of debris and kept clean. The CNO stated, he expects managers to ensure this is being done. During an interview, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), The DIP stated, he expects the Environment of Care (EOC) rounds include: team rounding looking for hand hygiene, unit cleanliness, countertops, paint, looking for chips, demarcation lines between clean and dirty, cleaning solutions, expirations, hand gel, looking high looking low, clean/soiled utility, and any working space. The DIP stated he expects that units the infection control staff round routinely and ideally in patient areas daily but usually 2-3 times a week. The IPRN stated, nursing staff and infection control staff are rounding on the units and we check clean and soiled utility rooms. The IPRN stated, the expectation is that the rooms are debris free. During a review of the facility record titled, “Clinical Nurse 2 -- Job Description”, dated 4/1/2025, the record indicated, “ ... The role of the clinical nurse is to deliver patient care through assessment, planning, implementation, and evaluation of patient needs with the highest professional standard while promoting nursing excellence through continued education and research ... Demonstrates an ongoing evaluation of the patient condition and environment and initiates strategies to optimize patient safety and reduce risk ... “ During a review of facility’s policy titled, “Infection Prevention Plan,” effective date 2/27/25, the policy indicated, “ ... HAZARD SURVEILLANCE TOURS/ENVIRONMENTAL ROUNDS ... A multidisciplinary team with representation from Infection Prevention Department, Plant Services, Environmental Services/Housekeeping, Security, Safety Specialist, Clinical Engineering and unit leadership will document Hazard Surveillance Tours conducted a minimum of two times a year in call clinical areas ... and once per year in all non-clinical areas. ... The multidisciplinary team performs Hazard Surveillance Tours as part of a continuous proactive risk assessment. ... Hazard Surveillance Tour inspections are unannounced tours. ... All members of the team work collaboratively to complete a thorough inspection of the unit/area. ... It is the responsibility of the unit/area staff as a part of ... ongoing commitment of Hazard Surveillance to ensure that any items utilized are visually inspected for cleanliness, functionality, and/or damage immediately prior to use. ... “ According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, “ Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)” 13. During a concurrent observation, interview and record review on 5/9/25 at 10:35 a.m., with Outpatient Manager (OP M) 2, and RN 25, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, a glucometer (a medical device used to test blood for the levels of glucose or sugar) was observed with a dark, reddish brown spot at the entrance where the blood is sampled. RN 25 stated, the glucometer machine appears to have not been cleaned from the previous use. RN 25 stated, the glucometer needs to be cleaned after use with a patient. RN 25 immediately started cleaning the machine with a germicidal wipe. OP M 2 was asked about the machine and did not respond. During an interview, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), The DIP stated, he expects the Environment of Care (EOC) rounds include: team rounding looking for hand hygiene, unit cleanliness, countertops, paint, looking for chips, demarcation lines between clean and dirty, cleaning solutions, expirations, hand gel, looking high looking low, clean/soiled utility, and any working space. The DIP stated he expects that units the infection control staff round routinely and ideally in patient areas daily but usually 2-3 times a week. The IPRN stated, if a patient is in isolation, the glucometer stays in the room. The IPRN stated, if it is a shared glucometer, the expectation is that it is cleaned before and after each use with the hospital approved germicidal wipes, and if the patient is in isolation for c-diff, it is the orange wipes c-diff. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated he expected the glucometer machine to be cleaned as it could be in infection control issue. During a review of the hospital’s P&P titled, “[BRAND NAME] Glucose Meter,” dated 5/16/23, indicated, “ ... X. INSTRUMENT CLEANING AND DISINFECTING ... Clean and disinfect after each patient use. The [BRAND NAME] Glucose Hospital Meter should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and healthcare professionals. ... Cleaning is not the same as disinfecting. ... Disinfecting means to kill or prevent growth of disease carrying microorganisms. ... 1. Clean the Meter: Remove a fresh germicidal wipe from the canister. Wipe the external surface of the meter thoroughly with a fresh germicidal wipe. Discard the used wipe into an appropriate biohazard container. ... 2. Disinfect the Meter: Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally followed by 3 times vertically avoiding the bar code scanner and electrical connector. Gently wipe the surface area of the test strip port making sure that no fluid enters the port. ...”. 14. During a concurrent observation and interview on 5/8/25 at 11:40 a.m. with the Operating Room Nurse Manager, (NMOR) 1, RN 23 and RN 24, in the auxiliary pathology lab, outside the entrance to the Operating Room (OR), in the heart hospital, the cabinet under the sink was observed with a gallon plastic bottle of detergent. NMOR 1 stated, the cabinet should be locked and nothing should be stored under the sink. NMOR 1 stated, the bottle should not be stored under the sink. During an interview on 5/8/25 at 11:28 a.m. with the Chief Nursing Officer of Surgical Heart (CNO FS), the CNO FS stated she expected the staff not to store anything under the sink. CNO FS stated, she expected all the sinks to be locked. During a concurrent observation, interview and record review on 5/9/25 at 11:20 a.m., with Outpatient Manager (OP M) 2, RN 25 and Dental Assistant (DA) 1, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, two cabinets under sinks were observed in the sterile processing room. The cabinet under the sink closest to the exit of the room had a box of clean supplies and paper sign. The other cabinet under the sink had a metal piece of equipment used to clean instruments. RN 25 stated, the cabinets should be locked and nothing should be stored under the sinks. RN 25 stated, anything under the sink are considered dirty. OP M 2 observed the sinks and did not comment. During a concurrent observation, interview and record review on 5/9/25 at 10:35 a.m., with OP M 3, on the second floor, East Plaza of the outpatient clinic, Neuro Rehab Center, Exam Room # 2, the cabinet under the sink was observed with equipment used for caring for patients with neurological deficits. OP M 3 stated, the cabinet should be locked and nothing should be stored under the sink. OP M 3 stated, equipment should not be stored under sinks as cross contamination could occur. During an interview, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), The DIP stated, he expects the Environment of Care (EOC) rounds include: team rounding looking for hand hygiene, unit cleanliness, countertops, paint, looking for chips, demarcation lines between clean and dirty, cleaning solutions, expirations, hand gel, looking high looking low, clean/soiled utility, and any working space. The DIP stated he expects that units the infection control staff round routinely and ideally in patient areas daily but usually 2-3 times a week. The IPRN stated, during rounding it is an expectation that nothing is under the sink and under the sink is frequently checked for leaks and water damage because moisture could lead to an infection. IPRN stated, it is an expectation that staff follow all infection control practices. IPRN stated, it is an expectation that each unit maintain their equipment and round to make sure everything is functioning properly. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated he expected nothing to be stored under the sinks as it is an infection control issue and nursing staff should follow the policy. During a review of the facility record titled, “Clinical Nurse 2 -- Job Description”, dated 4/1/2025, the record indicated, “ ... The role of the clinical nurse is to deliver patient care through assessment, planning, implementation, and evaluation of patient needs with the highest professional standard while promoting nursing excellence through continued education and research ... Demonstrates an ongoing evaluation of the patient condition and environment and initiates strategies to optimize patient safety and reduce risk ... “ During a review of the facility policy and Procedure (P&P) titled, “Environmental Cleaning and Disinfection Policy”, dated 10/31/23, the record indicated, “ ... To reduce the risk of healthcare-associated infections (HAIs) by defining the general requirements for cleaning and disinfection performed by the environmental services department. ... Tasks sheets have been developed that detail the cleaning and disinfection requirements for designated areas. Tasks sheets also include general reminders about cleaning and disinfection, as wells as, a room checklist ... Department leadership will perform regular service quality checks ... “ During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, “Guidelines for Environmental Infection Control in Health-Care Facilities,” dated 7/2019, the professional reference indicated, “ ... Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations...” 15. During a concurrent observation, interview and record review on 5/9/25 at 11:40 a.m., with OP M 2, RN 25 and SPT, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, in the clean utility room across from the central nurses’ station, an endoscopic (a think flexible tube with a camera and light at the tip, used to visual the internal parts of the body) storage cabinet with four endoscopes were observed. The four endoscopes were hanging in the cabinet but the tubes were touching each other. SPT stated, the scopes should not be touching each other when being stored. SPT stated, scopes could potentially contaminate each other and does not follow the instructions manual. SPT stated, maybe if three scopes were stored instead of four, then they would not touch each other and she would correct it. OP M 2 did not respond to what was found. During an interview, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), The DIP stated, he expects the Environment of Care (EOC) rounds include: team rounding looking for hand hygiene, unit cleanliness, countertops, paint, looking for chips, demarcation lines between clean and dirty, cleaning solutions, expirations, hand gel, looking high looking low, clean/soiled utility, and any working space. The DIP stated he expects that units the infection control staff round routinely and ideally in patient areas daily but usually 2-3 times a week. During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated he expected the scopes to be stored in the cabinet to be according to the manufacture’s guidelines and policies. The CNO stated, the scopes should be stored correctly in order to prevent any infection issues. During a review of the manufacturers guidelines for reprocessing for the [BRAND NAME] Rhino-laryngo (nose and throat) videoscope titled, “[BRAND NAME] Reprocessing Manuel”, dated 3/31/23, the manual indicated, “ ... 7.1 Precautions of storage and disposal ... After reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscope or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them. Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated. All equipment must be thoroughly dried prior to storage. Microorganisms proliferate in wet/moist environments. Keep the cabinet doors closed to protect the equipment from environmental contaminants and accidental contact. ... “ During a professional reference review retrieved from https://www.infectioncontroltoday.com/view/best-practices-flexible-endoscopes-storage titled, “Best Practices for Flexible Endoscopes Storage,” dated 6/6/2023, the professional reference indicated, “ ... While not in use, endoscopes should be stored in a closed, clean cabinet. Endoscope cabinets can also be used for drying. Storage cabinets should be made of a material that can be disinfected. Store all endoscopes in a vertical position; this position is used to ensure complete drying. Review each endoscope’s instructions for use (IFU) and recommendations from AORN (Association for periOperative Registered Nurses) and The Joint Commission for the optimal storage recommendations. Some cabinet designs include provisions for horizontal storage, though most endoscope manufacturers will recommend vertical storage. While in storage cabinets, scopes should hang freely and avoid touching one another to prevent damage. The scope should also avoid touching the walls of the cabinet...” 16. During the tour of the café bistro kitchen at the main hospital (Campus 1) and observation, in the presence of the Executive Sous Chef (Ex Sous Chef) on 5/6/25 at 12:45 p.m., located in the reach-in refrigerator there was a large container (approximately four quarts) labeled garlic aioli that was 50 degrees F. An interview was conducted at the time with the Ex Sous Chef, he stated this was made recently and they do not monitor the cooling process of this type of product. During a review of the hospital policy and procedures titled, Food Cooling, dated 12/8/24, indicated, the purpose of the policy is to ensure proper time and temperature when cooling food. It indicated that cooked potential hazardous food (PHF) shall be cooled from 140 to 70 degrees F or less within 2 hours and to 41 degrees F or less within the total of 6 hours. The policy did not indicate cooling of foods that were not cooked but were potentially hazardous foods. During an interview with the Food Service Director (FSD 1) and Executive Chef on 5/9/25 starting at 9:07 a.m., the Executive Chef acknowledged that the garlic ailoi needed to be monitored for cooling and they have started that process now. During a review of the 2022 Food and Drug Administration (FDA) food code, it indicated that Time/Temperature Control for Safety Food (formerly “potentially hazardous food” (PHF)), means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation. It indicated these foods include garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation. According to the Food and Drug Administration (FDA) Food Code 2022, Section 3-501.14 Cooling, “Time/Temperature control for Safety Food shall be cooled within 4 hours to 5oC (41oF) or less if prepared from ingredients at ambient temperature.” 17. During the tour of the café kitchen at Campus 1 on 5/6/25 at 12:20 p.m., an observation of the walk-in refrigerator in the presence of the Ex Sous Chef, there was a hotel pan (approximately 12 by 20 inches) containing previously cooked scrambled eggs that were 49.8 degrees F. During an interview with the Ex Sous Chef at 12:25 p.m., stated all previously cooked foods are cooled down in the blast chiller before being placed in the walk-in refrigerator. Ex Sous Chef then went to go look at the cooling log and stated, it was not on the cooling log and they would need to throw it out. During a review of the hospital policy and procedures titled, Food Cooling, dated 12/8/24, indicated cooked potential hazardous food (PHF) shall be cooled from 140 to 70 degrees F or less within 2 hours and to 41 degrees F of less within the total of 6 hours. 18. During the tour of the café bistro kitchen at Campus 1 an observation, in the presence of the Executive Sous Chef and Retail Supervisor on 5/6/25 at 12:35 p.m., the under-counter reach-in refrigerator was 41 degrees F. There were multiple food containers. The quinoa dated 5/5/25 was 42.6 degrees F, Cooked eggs dated 5/4/25 were 42.8 degrees F, bacon bits dated 5/5/25 were 42.6 degrees F. Egg whites were undated and 41 degrees F. An interview was conducted at the same, the Retail Supervisor stated they check temperatures every two hours when these food items are on the line during the breakfast service. Once they are done with breakfast they move them to this refrigerator. The Retail Supervisor stated the egg whites were made this morning, were good for five days but needed a date. The Retail Supervisor showed a document titled Bistro Cold Top, dated 5/6/25. Review of the document at that time showed the egg white patty, cracked eggs, and quinoa and the last time a temperature check was taken was at 8:00 a.m. The rest of the log for those items was blacked out from the times 10:00 a.m. until 10:00 p.m. to indicate no temperature level was allowed to be written. The bacon bits showed a temperature checked was 38 degrees F at 10:00 a.m. and no temperature for 12:00 p.m. was documented at this time. There were multiple containers of some of these food items and it was unclear what container of food was checked for the temperature. During the review of the hospital policy and procedures titled Storage dated 11/13/24, indicated, under the refrigerator storage, the prevailing air temperature of refrigeration units containing potentially hazardous foods must be cold enough to maintain the temperature of food stored therein at 41degrees F or below. It further stated, all opened foods will be kept in containers that will be clearly labeled with the common name of the food and dated with date food was opened and expiration date. 19. During a tour and concurrent interview on 05/06/25 at 11:30 a.m., an interview was conducted with the Director of Accreditation and Infection Prevention (DA/DIP), and the Manager of Infection Prevention (MIP) in the basement sterile processing department (SPD-performs sterilization and other actions on medical devices and equipment). The DIP and MIP stated the hospital followed nationally recognized guidelines: a. APIC - Association for Professionals in Infection Control b. AORN - Association of Perioperative Registered Nurses c. AAMI - Association for the Advancement of Medical Instrumentation d. ASHRAE - American Society of Heating, Refrigerating, and Air-Conditioning Engineers e. CDC - Center for Disease Control f. OSHA - Occupational Safety and Health Administration During an observation and concurrent interview on 5/6/25 at 1:18 p.m., in the surgical services department (Surgical Services 1), with the DA/DIP, infection prevention registered nurse (IPRN) 1, the Director of Surgical Services (DSS) 2, the Manager of Operating Room (MOR) 1, and MOR 2, OR T-9 had two of four sampled biohazardous waste containers, a red biohazardous waste container and a blue pharmaceutical waste container, with lids open while the room was not in use. MOR 1 validated lids were open and stated “lids should be closed” in between cases. The DA/DIP stated open lids were “not ideal’ and an infection risk. MOR 1 and MOR 2 stated the OR followed AORN national guidelines. During an interview on 5/13/25 at 9:45 a.m., with IPRN 1 and the DA/DIP, in an office, IPRN 1 stated open sharps containers were “an infection control issue”, from potential cross contamination (unintentional transfer of harmful germs from one person, object, or surface to another) and/or diversion of medication (unauthorized rerouting of prescription drugs from the person who they were prescribed to another individual) and vector of transmission (any living thing that carries infectious germs from one person to another) causing an infection. IPRN 1 stated open containers allowed access to contaminated needles and vials, for someone wanting to divert medication. During a review of the hospital’s P&P titled, “Medical Waste Management”, dated 4/27/27, the P&P indicated “I. PURPOSE A. To prevent the contamination of patients, staff, equipment, and environment with medical waste ...V. PROCEDURE A. Waste Segregation ...3. Deposit Sharps into leak resistant, puncture resistant, rigid container which are taped or have tight lids ...” During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...”. A review of OSHA’s regulatory requirement indicated the following, “...29 CFR 1910.1030(d)(4)(iii)(B)(1)(i), dated 08/09/2007 (August 9, 2007), requires that...Regulated waste shall be placed in containers which are...Closable...”. 20. During a tour of the cardiology outpatient clinic on 5/7/25 at 1:15 p.m., with the DA/DIP, IPRN 1, the Director of Outpatient Vascular Services (DOVS), an observation and concurrent interview with Advanced Cardiac Sonographer (ACS) 1 occurred in the HLD decontamination workroom. ACS 1 was observed reprocessing a transesophageal echocardiography (TEE - a test that produces pictures of the heart) probe. ACS 1 stated TEE procedures were performed through the hospital and after completion of the procedure, cardiac sonographers (CS) transported contaminated TEE probes to the decontamination workroom for HLD reprocessing. ACS 1 placed the contaminated transportation container on the counter next to the decontamination sink and began processing the TEE probe. A sign above the counter indicated “dirty”, there was no designated clean area sign. ACS 1 cleaned the transportation container and placed it on the contaminated counter. ACS 1 stated there was no designated clean area. ACS 1 stated once the transportation container dried, it was stored above the ‘dirty” counter. ACS 1 validated the transportation container was placed on the contaminated counter after it had been cleaned. During an interview on 5/7/25 at 2:06 p.m., with the DA/DIP and IPRN 1, in the cardiology clinic hallway, IPRN 1 validated the ASC placed the clean TEE transport case back on the contaminated counter. IPRN 1 stated there was no way to ensure the TEE transport case was clean when it was placed on the counter without clear separation between clean and “dirty”. IPRN stated the lack of designated clean and dirty areas in the decontamination created potential for cross-contamination and the spread infection to patients and staff. During an interview on 5/13/25 at 9:45 a.m., the DA/DIP stated clean and dirty areas in a decontamination workroom must be separated and clearly marked to decrease the risk of cross-contamination and the potential for infection. During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...”. The review of AAMI ST 79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities” dated 2017, indicated “ ...3.2.2 Functional workflow patterns ... In ambulatory surgery and office-based surgical facilities where separate rooms might not be possible, the decontamination sink should be separated from the clean work area by either a 4-foot distance from the edge of the sink or a separating wall or screen ... Rationale: Separating “clean” and “dirty” areas limits environmental contamination and, therefore, the amount of bioburden on devices to be sterilized ...”. 21. During a concurrent observation and interview on 5/7/25 at 1:17 p.m., with ACS 1 and IPRN 1, in the cardiology HLD decontamination room, ACS 1 was observed cleaning a contaminated TEE probe. ACS 1 placed the probe in the sink, stated her “hands were sweaty”, removed her gloves and did not wash her hands before putting on a new pair of gloves. ACS 1 resumed cleaning the probe, then removed the probe from the sink, and carried it to the TEE reprocessor machine. ACS 1 held the probe in her right hand and put her left hand through the head opening of the protective gown, pulled her name badge with a contaminated glove, and swiped the TEE reprocessor machine to open it, and returned her badge under the gown. ACS1 validated that she used a contaminated glove, touched her name badge and that was not how she was trained. ACS 1 placed the probe in the reprocessor, removed contaminated gloves, and did not wash her hands before putting on a new pair of gloves. ACS 1 cleaned the contaminated transportation container, removed the contaminated gloves, and did not wash her hands. ACS 1 stated she should have washed her hands. During an interview on 5/7/25 at 2:06 p.m., with the DA/DIP and IPRN 1, in the cardiology clinic hallway, IPRN 1 shared what was observed with DA/DIP. IPRN 1stated there was an issue with hand hygiene, there was no hand gel, no handwashing sink, and no way to wash hands after HLD. IPRN 1 validated ASC 1 removed contaminated gloves three times without hand hygiene and reached under the protective gown and touched her name badge with contaminated gloves and then touched the doorknob with unwashed hands. The DA/DIP stated the hospitals’ P&P indicated hands are washed after glove removal. IPRN 1 stated ASC 1’s practice had the potential for “cross contamination”, and potential of infection for patients. During a concurrent interview and document review on 5/13/25 at 9:45 a.m., with the DA/DIP, the hospital’s hand hygiene plan and audits were reviewed. The DA/DIP stated the hand hygiene numbers continue to be a hospital concern. The hand hygiene audits indicated a threshold of 80%. The DA/DIP validated the audit numbers “were not there yet”. The DA/DIP stated there was a large variance between secret shoppers’ audits and monthly unit-based audits. The DA/DIP stated there was still work to do to reach an 80% threshold for hand hygiene goals and optimally they would be at 100% threshold. During a review of the hospital’s P&P titled, “Hand Hygiene” dated 4/12/25, the P&P indicated “ ...I. PURPOSE: To establish clear guidelines and procedures for proper hand washing, aiming to prevent the spread of germs and infections by ensuring healthcare workers and individuals consistently clean their hands at critical moments, ultimately protecting patient and staff from healthcare-associated infections (HAI) ...”III. POLICY ... B. At [Name of Hospital System] the expectation is that all staff perform hand hygiene following the World Health Organization’s (WHO) 5 Moments of Hand Hygiene when indicated .... PROCEDURE: D. Glove use 1. Gloves should be used during all patient-care activities that may involve exposure to blood and all other body fluids ...2. Perform hand hygiene before donning (putting on) and after doffing (removing) gloves ...7. The use of gloves does not replace the need for hand hygiene by either hand rubbing or handwashing ...F. Hand Hygiene Compliance ...3. Unit leaderships are responsible for enforcing compliance with all elements of this policy in their departments ...” During a review of the hospital’s P&P titled, “Instrument Transport” dated 9/7/22, the P&P indicated “I. PURPOSE: To provide guidelines for cleaning, transporting instruments and medical devices to Sterile Processing or other designated location for sterilization or disinfection to maintain infection prevention principles, safety, and facilitate optimal patient outcomes ...III. Policy ...F. Hand hygiene will be performed before and after removing Personal Protective Equipment (PPE) and at appropriate intervals. During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens 3. Limiting the transmission of infections associated with procedures 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” 22. During a concurrent observation and interview on 5/7/25 at 1:35 p.m., in the with ASC 1 and IPRN 1 in the cardiology HLD decontamination room, no handwashing sink was observed. There was a sink labeled “TEE probe cleaning station. Not for hand washing”, and a hopper (a deep sink used for the disposable of human waste and dirty materials). ASC 1 validated there was no handwashing sink in the decontamination room and stated the closest handwashing sink was through the door around the corner. During an interview on 5/7/25 at 2:06 p.m., with the DA/DIP and IPRN 1, in the cardiology clinic hallway, the IPRN validated there was no handwashing sink, and no hand gel in the decontamination workroom, the DA/DIP stated a HLD decontamination room must have a way to wash hands after decontaminating instruments minimally hand gel. The DA/DIP the ability to wash hands in a decontamination workroom was a national standard. The DA/DIP stated the hospitals’ P&P indicated hands are washed after decontamination. IPRN 1 stated ASC 1’s practice had the potential for “cross contamination”, and potential of infection for patients. During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” A review of CDC guidelines (2017), indicated, “ ...Staff should have access to a handwashing sink separate from the reprocessing sink ....” A review of the AORN’s guidelines for Perioperative Practice (2020), Guideline for Instrument Cleaning indicated the following, “...Regulatory Requirement: 2.4 Sterile Processing Area...The decontamination area must contain ...a dedicated hand hygiene sink...” Rationale: “The Occupational Safety and Health Administration... Hand hygiene facilities are required by OSHA for use after removal of PPE (personal protective equipment, protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer’s body from injury or infection) ...” 23. During a concurrent interview and document review on 5/7/25 at 1:32 p.m., in the decontamination room with ACS 1, the Astra-Tee Operator’s Manual was reviewed. The IFU indicated daily cleaning and disinfection before using the TEE reprocessor. ACS 1 validated the document and stated there was a process for cleaning but she was unsure who cleaned the processor. During an interview on 5/7/25 at 2:04 p.m., with the DOVS, and the manager of outpatient vascular services (MOVS), both the DOVS and MOVS stated they were unsure of the process or requirement for cleaning the reprocessing machine. The DOVS and MOVS both stated they were unsure if the machine was being cleaned daily according to the IFU, and the employee responsible for cleaning the machine was off for the day. Requested daily cleaning log and the MOVS stated “no log was kept”. During an interview on 5/8/25 at 2:50 p.m., with the Manager of Environmental Services (MEVS)1, and the DOVS, in the east conference room, MEVS 1 stated HLD areas were terminal cleaned daily, and HLD equipment and machines are each department’s responsibility. The DOVS confirmed there were no daily cleaning logs for the reprocessing machine and stated they needed to create a system. The DOVS stated cardiology staff were responsible for cleaning the TEE reprocessor and it cannot be only one employees responsibility. During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” During a review of the Astra TEE Operators Manual provided by the hospital, dated 2023, the manual indicated “ ...SECTION 3: ...Schedule for Routine & Preventative Maintenance ...Daily: Daily Wipe of Astra Unit *See Operator’s Manual Section 38: “DAILY CHECK/PRIOR TO OPERATION ...”. 24. During an observation and concurrent interview on 5/9/25 at 8:50 a.m., in the surgical services department (Surgical Services 2) OR 3, with the Manager of Peri-Op Services (MPS), the OR Supervisor (SOR), and the DA/DIP, the MPS stated OR 3 had been cleaned following the “terminal cleaning” policy the night before and was ready for use. One of two wall vents was observed scattered with yellow spots throughout the wall vent. The DA/DIP validated the scattered yellow spots on the wall vent and stated they should not be there. The MPS stated she was unsure what the yellow spots were and needed to be cleaned. During an interview on 5/9/25 at 3:00 p.m., with MEVS 2, in the first-floor conference room MEVS 2 validated the ORs were terminal cleaned nightly and terminal cleaning included “floors, tables, shelves, walls and sinks.” During an interview on 5/13/25 at 9:45 a.m., with IPRN 1, in an office, IPRN 1 stated she was the EVS liaison and EVS staff were trained to escalate a concern if something was unable to be cleaned. During an interview on 5/13/25 at 12:55 p.m., with MEVS 2 in the east conference room, MEVS 2 stated environmental service (EVS) staff were trained to clean the OR in between cases, and to terminal clean at the end of the day. MEVS 2 stated for uncleanable surfaces was EVS staff were expected to elevate to MEVS 2. MEVS 2 stated she was not aware the vents were splattered with yellow stains. During an interview on 5/13/25 at 1:06 p.m., with IPRN 1 in the east conference room, IPRN 1 stated “obviously splatter is not good”, clinical staff and EVS staff shared the responsibility for ensuring the OR suites were ready for the next patient. IPRN 1 stated cleaning misses in the OR “have the potential to spread pathogens (a bacteria, virus, or other microorganism that can cause disease) to other patients. During a review of the hospital’s P&P titled, “Procedural Area Terminal Cleaning”, dated 1/25/24, the P&P indicated “III. POLICY A. Terminal cleaning of procedural areas is completed daily by Environmental Services (EVS) staff ...V. PROCEDURE A. clean up any remaining body fluids/contamination ...D. Examine walls for visible soil and disinfect as needed ...” During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” A review of AORN “Guidelines for Environmental Cleaning”, dated January 2020 indicated “ ...terminal cleaning and disinfection of operating or procedure rooms be performed daily when these areas are in use. This process involves thorough cleaning of all surfaces and equipment to reduce the risk of infection ...” A review of OSHA requirements for bloodborne pathogens dated 8/9/2007, indicated the following: “...29 CFR 1910.1030(d)(4)(I),” requires that ...General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the hospital, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. 29 CFR 1910.1030(d)(4)(ii): All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. 29 CFR 1910.1030(d)(4)(ii)(A): Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning ...” 25. During an observation and concurrent interview on 5/9/25 at 8:50 a.m., in the surgical services department (Surgical Services 2) OR 3, with the MPS, the SOR, and the DA/DIP, the MPS stated OR 3 had been cleaned following the “terminal cleaning” policy the night before and was ready for use. There were several brown and orange stains streaked down the side of the heart-lung machine. The DA/DIP stated equipment in a clean, ready to use OR should not have streaks. The MPS stated the heart-lung machine was cleaned by the perfusionists (a person who operates the heart-lung machine during open-heart surgery) but it was everyone’s responsibility to make sure the OR’s were clean. During an interview on 5/12/25 at 1:05 p.m., with the DSS 2, in the east conference room, and the Supervisor of Perfusion (SP) 1 via speaker phone, SP 1 stated perfusionists were responsible to check the heart-lung machine before use and clean it with a “Sani-Cloth (a brand of disposable disinfectant wipes used to clean and disinfect) after use, for every surgery. SP 1 stated the perfusionists used a post-procedure check list but cleaning the machine was not on the list. A photo of the stained heart-lung machine was shared with DSS 2, and he described what he saw to SP 1. DSS 2 stated, “there was a pretty significant drip down the side of the machine it looked splattered on the side”. SP 1 stated “we can do better”; I want it to be cleaner between patients. SP 1 stated ultimate responsibility for a clean heart-lung machine was his and the other 3 perfusionists in the organization. During a review of the hospital’s P&P titled, “Procedural Area Terminal Cleaning”, dated 1/25/24, the P&P indicated “III. POLICY A. Terminal cleaning of procedural areas is completed daily by Environmental Services (EVS) staff ...V. PROCEDURE A. clean up any remaining body fluids/contamination ...G. Disinfect all horizontal surfaces, except anesthesia equipment, perfusion equipment, and bovies [a surgical instrument used to cut tissue and stop bleeding]) This equipment shall not be unplugged and is cleaned by OR staff ...” During a review of the hospital’s P&P titled, “Medical Extracorporeal Life Support Guidelines - [name of hospital]” indicated “ ...V. PROCEDURE ...D. Discontinuation ...2. Disassemble and clean all equipment, discarding all disposable materials in a hazardous waste container ...” During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” During a review of OSHA requirements for bloodborne pathogens dated 8/9/2007, indicated, “...29 CFR 1910.1030(d)(4)(I),” requires that ...General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the hospital, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. 29 CFR 1910.1030(d)(4)(ii): All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. 29 CFR 1910.1030(d)(4)(ii)(A): Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning ...” 26. During an observation and concurrent interview on 5/9/25 at 9:05 a.m., in the surgical services department (Surgical Services 2) OR 3, with the MPS, the SOR, and the DA/DIP, a fluid warmer was observed with brownish orange ring around the metal bowl of the warmer, and the case around the fluid warmer had several areas with chipped paint and a brown, rough to touch surface under the paint. The DA/DIP validated the observation and state it “looks like rust” and would be difficult to clean. During an interview on 5/9/25 at 9:35 a.m., with IP 1, on the second floor SPD, IP 1 stated rust cannot be cleaned, rust potentially harbored infectious microorganisms (tiny germs that can cause infection and disease) that increased risk of infection. During a follow-up interview on 5/13/25 at 9:45 a.m., with the DA/DIP, in an office, the DA/DIP acknowledged the rusted fluid warmer was an infection risk and the fluid warmer had been removed from OR 3. During an interview on 5/14/25 at 12:55 p.m., with MEVS 2, in the east conference room, MEVS 2 stated the OR cleaning process is shared between EVS and OR staff. MEVS 2 stated the process for broken, stained or uncleanable surfaces was to escalate to leadership. MEVS 2 stated she had not been notified about the rusted fluid warmer. During a review of the hospital’s P&P titled, “Procedural Area Terminal Cleaning”, dated 1/25/24, the P&P indicated, “III POLICY ...H. damaged surfaces cannot be disinfected properly. When found, this should be reported to the procedural area leadership team and will be removed from the procedural area ...V. PROCEDURE ...A. Clean up any remaining body fluids/contamination ...G. Disinfect all horizontal surfaces ...” During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” 27. During an observation and concurrent interview on 5/9/25 at 9:11 a.m., in the surgical services department (Surgical Services 2) sterile supply area, with the Manager of Peri-Op Services (MPS), the SOR, and the DA/DIP, 18 of 21 sampled case carts observed did not have labels indicated clean or biohazardous. The SOR stated they did not have enough signs to label the case carts biohazardous after use. During an interview on 5/13/25 at 9:25 a.m., with the DA/DIP, in an office, the DA/DIP validated there was a discrepancy in case cart identification between Surgical Services 1 and Surgical Services 2. DA/DIP stated both surgical services function under the same P&P, and national guidelines and the practical application should be the same. The DA/DIP stated clearly identified clean and dirty equipment is crucial to decrease cross-contamination. During a review of the hospital’s P&P titled, “Instrument Transport” dated 9/7/22, the P&P indicated “I. PURPOSE: To provide guidelines for cleaning, transporting instruments and medical devices to Sterile Processing or other designated location for sterilization or disinfection to maintain infection prevention principles, safety, and facilitate optimal patient outcomes ...H. Transport instrument to the decontamination area in SPD in enclosed box that is ...a, labeled with an indicator that indicates the contents are contaminated and biohazardous ...” A review of AAMI ST79, dated 2017 indicated “6.4 Containment: Contaminated items should be contained during transport from the point of use to the decontamination area ...OSHA requires that a) all containers, devices, or carts used for containing contaminated items be marked with a biohazard label, red bag, or other means of identifying contaminated contents ...6.5 Transport 6.5.1 Segregation of clean/sterile items. During transport, clean/sterile items should be contained and segregated from contaminated items, trash, and food ...” 28. During a concurrent observation and interview on 5/9/25 at 9:35 a.m., with the Supervisor of Sterile Processing (SSPD), the MPS, IP 1 and the DA/DVP in the second floor SPD, two of two sampled autoclave instrument loading carts (Loading Cart 1 and Loading Cart 2) observed had brown and orange discoloration throughout the loading cart and the loading rail track. Two of two sampled autoclaves (Autoclave 1 and Autoclave 2) observed had brown and orange discoloration along both sides of cart rack rails. The manufacturer instruction for use (IFU) was requested. The SSPD validated the brown and orange discoloration and stated it was rust. IP 1 stated there should be no rust on the loading rack or in the autoclave. IP 1 stated rust created a potential risk for infection. During a concurrent interview and record review on 5/9/25 at 3:37 p.m., with the SSPD, in the conference room the autoclaves’ manufacturer’s IFU was reviewed. The indicated weekly drain flushing was required for preventative maintenance (PM). The SSPD stated he was not aware of the weekly cleaning requirements and was not flushing the drain. The SSPD stated there were no cleaning logs for the autoclaves and loading carts. During an interview on 5/12/25 at 9:50 a.m., with the DA/DIP, walking to the clinics, the DA/DIP stated the infection preventionists were very focused and sometimes needed to ‘take a step back’ to look at the big picture so the simple things like the rust in the autoclaves were not missed, During an interview on 5/13/25 at 2:55 p.m., with the MPS, in the west conference room, the MPS stated she had oversight of the Second floor SPD and validated there were no cleaning tracking logs that defined IFU cleaning expectations daily, weekly, monthly for the SPD equipment. During a review of the hospital’s P&P titled, “High Temperature Sterilization”, dated 5/6/24, indicated “I. PURPOSE A. To provide guidance on the preparation, loading/unloading, operation, validation of high temperature sterilization equipment ...B. Loading the Autoclave 1. Before loading, inspect autoclave chamber and drain for debris, 2 Observe specific manufacturer’s instructions for use recommendations ...” During a review of the hospital’s P&P titled, “Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated “III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...” A review of “Steris AMSCO Evolution Series Steam Sterilizers Operating Manual” dated 2024, indicated “ ...8.3 weekly Maintenance ...Flush Chamber Drain as follows once a week ...2. Remove chamber drain strainer. Clean strainer ...3. Pour a solution of 60 mL of Liqui-Jet 2 Instrument Detergent and 500 mL of hot water into the drain ...8.9 Loading Equipment Cleaning Procedure 1. Spray the loading car and transfer carriage with diluted Prolustica HP Neutral Manual Cleaner cleaning solution and remove any soil with a damp cloth ... “”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to implement interventions meant to support the effectiveness of hospital policies and procedures (P&Ps) to assure the achievement and maintenance of high standards of medical practice and care when: 1. On 5/8/25, the hospital self-reported to the California Department of Public Health (CDPH), a suture needle had been “lost” during a laceration repair procedure on a Labor and Delivery (L&D) patient (Patient (Pt) 30), after a vaginal delivery, on 2/21/25. This failure resulted in Pt 30 suffering unnecessary pain, delayed healing, and an additional procedure to retrieve the retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure). 2. Hospital staff failed to submit an adverse event report (IRIS-Incident Reporting Intranet System) at the time of Pt 30’s “lost” suture needle event, in accordance with hospital P&P titled “Adverse Event Reporting” dated 1/3/22. This failure had the potential to place future L&D patients at risk of a RFO event and to experience unnecessary effects of a RFO such as pain, injury, and additional surgery/procedures. 3. On 3/28/25, the hospital self-reported to CDPH, staff failed to follow hospital P&P titled “Universal Protocol” dated 12/19/23 and performed a surgical procedure (nerve block) on Pt 19’s left arm (instead Pt 19’s right arm (correct arm). This failure resulted in Pt 19 suffering unnecessary pain, delayed healing, and an additional procedure. Findings: 1. During a concurrent interview and record review on 5/9/25 at 10:54 a.m., with the Director of Women and Children’s Services (DWC), DWC stated Doctor of Obstetrics/Gynecologist (OB/GYN) 1, approached her on the unit on the morning of 5/7/25 to report a RFO event. DWC stated OB/GYN 1 reported his colleague, OB/GYN 2, notified him Pt 30 presented to their private practice with a complaint of vaginal pain. OB/GYN reported he discovered and removed a retained suture needle after a physical exam was performed. DWC stated a preliminary investigation indicated Pt 30 delivered vaginally on 2/21/25 by a Certified Nurse Midwife (CNMW- an Advanced Practice Registered Nurse who specializes in the care of women’s reproductive health and childbirth) while Pt 30’s OB/GYN (OB/GYN 1) was in the Labor and Delivery (L&D) Operating Room (OR) with another patient. DWC stated an IRIS report was submitted by the Director of Risk Management and Pt Relations (DRM) on 5/9/25. During a telephone interview on 5/12/25 at 10:53 a.m., with Pt 30, Pt 30 stated she “tore- refers to perineal tearing, a common injury that occurs when the skin and tissues between the vaginal opening and anus (the perineum) stretch and tear during delivery) during delivery and the hospital midwife was doing the sewing. Pt 30 stated “lost needle” was announced in the room, but cannot recall who stated it. Pt 30 stated staff and CNMW searched and searched to locate the needle without success. Pt 30 stated CNMW “stated she was 95% sure it was not left” in the patient. Pt 30 stated her support persons, mother and significant other were the support persons in the room. Pt 30 stated there were two (2) nurses and an Emergency Medical Technician student present during the announcement and helped search for the missing suture needle. Pt 30 statedher mother told the staff that she wanted an x-ray to see if the needle could be found. Pt 30 stated an X-ray was done but results were not given to her, she asked for a follow up for a better view and another x-ray was done. Pt 30 stated she had discomfort, but since she had never given birth before, she did not know if the discomfort was normal or not. Pt 30 stated the discomfort and pain in the area was concerning and when she touched the area she felt a sharp surface. Pt 30 stated she had no other signs or symptoms of infection. Pt 30 stated she made an appointment with her doctor who completed a physical examination on 5/2/25 with a follow up appointment scheduled for 5/5/25 to remove the needle in the doctor’s office. Pt 30 stated the OB/GYN 2 numbed the area, removed it [the needle], with a small incision (cut) and added one (1) stitch. Pt 30 stated she was given a prescription for pain medication and reports is still uncomfortable, with stitch to be removed on 5/13/25. During a review of Pt 30’s “Delivery Note (DN)” dated 2/21/25, the DN indicated “...Delivery done for [OB/GYN])...he is involved with a c/s (c/s- Cesarian Section- the surgical delivery of a baby through a cut (incision) made in the birth parent’s abdomen and uterus) at present...[Pt 30] is a 21 y.o. (year old) G1P0 (describes a woman who is pregnant for the first time and has not yet delivered a baby) at 40w3d [40 weeks and 3 days] admitted for Labor...Laceration: 2nd...Repair: with edges well approximated and hemostatis achieved using 3-0 vicryl...Final instrument and lap count correct. NOTE: 3-0 Vicryl used to suture laceration- needle popped off spontaneously when re-grasping for next stitch, unable to account for needle. All drapes and bags searched. Pt tissue examined manually and not identified. [OB/GYN 1] aware and will manage follow up...” During a review of Pt 30’s “Office Visit” progress note dated 5/5/25, the note indicated “...Reason for Visit: Follow-up Visit... Comments Removal of the needle... Comments: 1 cm (centimeter-a unit of measurement) incision...of right vulva (the external (outer) female genital organs). Mass was grasped and bluntly removed intact. Appears to be a curved needle. Skin reapproximated with 2-0 vicryl...” 2. During an interview on 5/9/25 at 10:54 a.m., with DWC, DWC stated her preliminary investigative findings in the matter of Pt 30’s RFO event, were that staff failed to submit an IRIS report on the day the RFO was detected (2/21/25). DWC stated to her knowledge, the only IRIS report submission was the report submitted by the DRM on 5/9/25. DWC stated her expectation was for staff to submit an IRIS report per hospital P&P, and as soon as possible once the adverse event occurs. During an interview on 5/16/25 at 11:02 a.m. with CNO, the CNO stated his expectation was for staff to report events such as the RFO incident on Pt 30 and that “what goes in should come out pre and post [areas] should be preparing the patient and all counts are done/accounted for and appropriately tracked to prevent RFO events. During a review of hospital Policy and Procedure (P&P) titled, “Adverse Event Reporting to the California Department of Health Services” dated 1/3/22, the P&P indicated, “ ...I. PURPOSE A. To comply with the mandated reporting requirements of Health and Safety Code §1279.1(b). B. To support the improvement of patient safety and quality improvement initiatives... II. DEFINITIONS A. Adverse event includes any of the following: 1. Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient. A reportable event does not include a situation requiring prompt action that occurs in the course of surgery or a situation that is so urgent as to preclude obtaining informed consent. 2. Surgery performed on the wrong patient. 3. The wrong surgical procedure performed on a patient that is inconsistent with the documented informed consent for that patient. A reportable event does not include a situation requiring prompt action that occurs in the course of surgery, or a situation that is so urgent as to preclude the obtaining of informed consent. 4. Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained. ... III. POLICY A. It shall be the policy of Community Medical Centers (CMC) to report an adverse event, as defined within Health and Safety Code §1279.1, to the California Department of Public Health (CDPH) no later than five days after the event has been detected; or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than twenty-four (24) hours after the adverse event has been detected. ... IV. PROCEDURE A. Investigation 1. All adverse events which may be considered reportable as defined by this policy shall be reported to the Supervisor/Manager immediately by involved staff and an Incident Reporting Intranet System (IRIS) completed within 24 hours...” During a review of hospital P&P “Universal Protocol (UP- a set of guidelines for healthcare professionals that aims to prevent surgical errors) - Procedural Areas” dated 12/19/23, the P&P indicated “ ...I. PURPOSE: A. To provide guidance to [hospital] personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures ... B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors ... III. POLICY: B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR) ...Interventional Radiology (IR) ...etc.) ... D. The UP is composed of the following elements: 1. Pre-Procedure verification. 2. Marking the site, when applicable ... V. PROCEDURE: ... B: Site Marking... 7. For procedures on a lateralized internal organ via a minimally invasive approach (a surgical technique that uses smaller incisions and specialized equipment to perform procedures), whether percutaneous (a medical procedure or method that involves accessing tissue or inner organs by puncturing the skin with a needle, instead of making a large incision) or through a natural orifice (an opening in the body that can be used to access the abdominal cavity for surgery), mark the intended side at or near the insertion site that will remain visible after completion of the skin prep[aration] and sterile draping... C. Procedural Briefing...b. Correct procedure and laterality as consented. c. Site marked... D. Time Out 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out... 2. ... b. ... i. The written consent will be utilized as a guide for the patient’s identification and procedure... d. Time Out addresses and verbally confirms among all team members the following elements:... II. Correct procedure and laterality (when applicable) as consented... VI. DOCUMENTATION... C. If provider cannot mark a site that requires marking, ensure that a verification of the site/side with patient/substitute decisionmaker is documented in the EHR (Electronic Health Record)...” 3. A report dated 3/28/25 sent to CDPH from the hospital indicated, “On 3/26/25, a 70-year-old male patient with past medical history of end-stage renal disease [ESRD - kidneys were failing] presented to [name of hospital] for a right arm fistula creation [a connection between two parts of your body that don’t normally connect. It often takes the form of a tunnel or passageway]. Prior to surgery, the patient was to undergo a right (correct) arm peripheral nerve block for anesthesia. Informed consent (got written permission from the patient) performed for right (correct) arm peripheral nerve block. Positioning was interrupted prior to nerve block placement as RN briefly left room to gather medications. CRNA (Certified Registered Nurse Anesthetist - an RN trained to do anesthesia) and resident physician entered room and completed the nerve block on left (incorrect) arm without a timeout per universal protocol. The surgeon [Medical Doctor - MD1] entered [operating]room and immediately noticed the nerve block had been placed on the left (incorrect) arm. Local anesthetic injection was then performed on right (correct) arm and a right fistula creation was performed without further complications. The patient was transferred to PACU [post-anesthesia care unit]. Disclosure was done [patient was told what happened.] Patient was discharged [sent home] the same day ...” During a concurrent interview and record review on 5/12/25 at 3:30 p.m. with the Manager of Inpatient Surgery (MIS), MIS accessed the Electronic Medical Record (EMR) for Pt 19. The document titled History and Physical dated 3/26/25 indicated Pt 19 had end-stage renal disease (his kidneys were failing) and needed hemodialysis (a medical treatment that replaces the function of the kidneys when they are no longer working properly.) The reason for the surgery was for a procedure to “create a right brachial artery to upper arm basilic vein transposition fistula” (a surgical procedure to create a route for hemodialysis treatments.) The MIS reviewed the EMR and stated there is no documentation of a timeout for a nerve block in the patient’s chart. The document titled “H&P” dated 3/26/25 at 9:05 a.m. signed by MD 1 indicated, “COMPLICATIONS: Inadvertent anesthesia wrong site block (left instead of right) During an interview on 5/8/25 at 10:20 a.m. with the Vice-Chair of Integrated Medical Staff physician (DRI), the DRI stated he was familiar with the case because he had been part of the quality review process that investigated the event after it occurred. The DRI stated, “There should have been a timeout (a surgical timeout is a brief pause in the surgical procedure to verify critical information before the procedure starts to ensure patient safety), but the hospital didn’t do a timeout. The anesthesia provider (CRNA 1) proceeded with the nerve block without doing a timeout.” DRI stated that nerve blocks are “not without risks. Complications could include nerve injury, infection, and bleeding.” The patient received a nerve block that wasn’t needed, because they used another form of anesthesia to do the surgery on the correct side. During an interview on 5/9/25 at 11:00 a.m. with the Registered Nurse (RN 17) who was in the room at the time of the nerve block incident, RN 17 stated, “I went to short-stay (an area where patients are held while waiting for surgery) and brought him (Pt 19) back to the [operating] room. During that time, I had started to position the patient, but anesthesia needed to put on leads (wires to monitor heart rate) so I took that opportunity to leave the room and get the medications that would be needed. While I was out of the room, he (CRNA1) started on the nerve block. I usually initiate the timeout, but I wasn’t ready for that yet. I finished what I was working on, and MD1 came in and immediately saw what was happening. He said, “Which arm did you block?” RN 17 stated she hadn’t finished positioning the patient when the nerve block was started by CRNA1. RN 17 stated, “Anyone can call for a timeout. If he (CRNA 1) called for a timeout, I didn’t hear him and I didn’t participate. We do at least two timeouts, one before the nerve block and one before the surgical incision. I always do a timeout, but I wasn’t in the room and wasn’t ready to do the timeout.” RN 17 stated that when she oriented to her role as a surgical nurse, “Universal Protocol” was taught, which includes a timeout is done before every procedure and everyone has to stop and participate in the timeout. RN 17 stated, “The RN in the operating room calls for the timeout and makes sure everyone in the room is involved.” RN 17 stated MD1 had met with Pt 19 in the pre-operative area and had made a mark on the right arm to indicate on which side of the body they would be doing the procedure. RN 17 stated they also put a pink wrist band on the arm that they will be working on to show which side. The right arm had the surgeon’s mark indicating he would be doing the procedure on the right arm, and the right arm also had the pink wristband. RN 17 stated they were not short-staffed that day. During an interview on 5/9/25 at 11:30 a.m. with CRNA 1, he described the incident and stated that when he came into the operating room , Pt 19 was already in the room on the surgical table. The nurse was “in and out of the room” and she had a nurse with her that she was training. CRNA 1 stated, “I did the nerve block on the left side [wrong side], then MD 1 walked in and saw that it was the wrong side. Ultimately we did a MAC (Monitored Anesthesia Care is used for uncomfortable procedures or minor surgeries that do not usually require general anesthesia) with nerve block on the wrong side.” CRNA 1 stated a nerve block can last for up to 24 hours, so they didn’t do a nerve block on the right side because Pt 19 would not have been able to use either arm, so they did the MAC instead. CRNA 1 stated a pink arm band was placed on Pt 19’s right arm in the pre-op area, and the right arm had been marked in ink by the surgeon (MD 1) prior to the patient going into the operating room to indicate “laterality” (laterality refers to the side of the body where a specific condition or procedure is located.) CRNA 1 stated, “I didn’t look for the mark. I don’t always look for the mark on the arm.” CRNA 1 stated his normal pre-anesthesia evaluation included asking the patient questions, doing a physical assessment, reviewing the history and physical report, making sure the correct procedure as stated by the patient, and confirming laterality. CRNA stated, “In the computer there is a note from the surgeon showing what the surgery will be. The order was for the right side.” CRNA 1 stated the bed wasn’t in the orientation that he would expect for a right arm fistula. “We have standard timeouts that are done before incision, we have room verification process, and procedural timeouts before nerve blocks. At least two people participate, at least me and the nurse. We check the consent, verify it’s the right person, etc. In this case, we didn’t do that. The nerve block was done before the surgeon saw the patient in the room.” CRNA 1 stated nerve blocks, “have complications and risks, including infection risk and nerve damage.” CRNA stated he has reviewed the policy and now does a timeout 100% of the time. CRNA 1 stated, “I should have checked to see which arm the doctor had marked for laterality. I will do that every time in the future, for sure.” During an interview on 5/14/25 at 2:45 p.m. with the DRM, the DRM explained how the hospital responded after they learned of the wrong side nerve block. The DRM stated they did a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) and found that the education regarding timeouts before nerve blocks may not have reached the providers. DRM stated they have now done education with the anesthesia group and with the surgeons. Anesthesia Leadership reinforced “Universal Protocol - Procedural Areas” to make sure that anesthesia providers (medical doctors who specialize in anesthesia and CRNAs) know that a separate timeout is required for regional blocks (such as nerve blocks on arms or legs), spinals (Spinal blocks are injected directly into the spinal fluid through a needle in the patient’s back, providing immediate and complete pain relief) , or epidurals (epidurals are injected into the space outside the spinal fluid sac, allowing for continuous pain relief and greater control of pain levels without taking away all feeling.) DRM stated they also trained all staff that a nurse must be present for the timeout, and the timeout must be documented in the procedure record. During an interview on 5/15/25 at 12:30 p.m. with the surgeon (MD 1) who performed the surgery on Pt 19, MD 1 stated he remembered the surgery well. MD 1 stated that before any surgery is done, he evaluates the patient in the pre-operative area, does an interval H&P (talks to the patient to make sure nothing has changed since the patient was last examined) and then he marks the site by using an ink pen to show which side the surgery will be done. MD 1 stated he is the supervisor over the CRNAs, and “They are supposed to do a timeout before their procedure.” MD 1 stated that on the day of the surgery for Pt 19, “I walked in and immediately noticed it was the wrong arm. I positioned the patient as we normally would. I was trying to prevent harm to the patient, I didn’t want to have to reschedule. A fistula can be done under local anesthesia, so that’s what we did instead of doing a block on the right arm, which would have left him without the use of both arms for up to a day. MD 1 stated the anesthesia timeout is mandatory, and this was not a new process. During an interview on 5/15/25 at 11:00 a.m. with the Chief Nursing Officer (CNO) the CNO stated the root cause of the wrong side nerve block was the failure to do a timeout before the nerve block. The CNO described a timeout as. “A period to validate everything in the room. Everything before you cut.” During a review of hospital Policy and Procedure (P&P) titled, Universal Protocol - Procedural Areas” dated 12/19/22, the P&P indicated, “ ... I. PURPOSE: A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors. II. DEFINITION: A. Provider: A person who is authorized to provide care as determined by privilege or competency through the Medical Staff and the Board of Trustees - including the following: 1. Medical Staff Member: Physicians and others granted membership on the Medical Staff and, for purposes of this policy, includes individuals with temporary clinical privileges. 2. Advanced Practice Professional (APP): Physician assistants and advance practice nurses including nurse practitioners, certified nurse midwives, certified registered nurse anesthetists and other non-physician providers who provide direct patient care services under a defined degree of supervision by a physician Medical Staff Member. 3. Learner: A student, resident or fellow who does not have privileges or credentials on the Medical Staff of [name of health system] for their academic program ... III POLICY: A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or non¿invasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), lnterventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: Pre-Procedure verification; Marking the site, when applicable; Procedural Briefing; Time Out; Debriefing ....D. Timeout: 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning. A. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped ...All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process ... D. Time Out addresses and verbally confirms among all team members the following elements: ... Correct procedure and laterality (when applicable) as consented. Ill. Site marked (when applicable). The Anesthesia Patient Safety Foundation Newsletter article titled “Safety Considerations in Peripheral Nerve Blocks,” dated 2/2025, retrieved 5/27/25 from https://www.apsf.org/article/safety-considerations-in-peripheral-nerve-blocks/ indicated, “ ...Prevention of Wrong-Sided Blocks ... Wrong-sided procedures are considered “Never Events” ... The term “Never Event” was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to egregious medical errors that should never happen. There are certain characteristics identified in most wrong-sided blocks... Prior to starting the nerve block, visual confirmation of the correct procedure location is performed by both the patient and nurse using institution-specific standards, which can include placing a wristband marked with the word “yes” on the side corresponding to the surgery or marked clearly by the surgeon or provider performing the procedure. Involving the patient in the process prior to receiving sedation or anesthesia leads to decreased error and may enhance patient satisfaction as patients may feel they are active participants in the process and gain confidence in their providers ...””

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to protect and promote each patient’s rights when: 1. Signed consents were not obtained in a language the patient (Pt) could understand for Pt 13, Pt 17 and Pt 29 according to hospital policy and procedure (P&P) titled “Consents” and “Conditions of Admissions & Consent to Outpatient Care.” This failure denied Pt 13, Pt 17 and Pt 29 of their right to make informed consent about their care. (Refer to A-0131, item 1). 2. Pt 29 and Pt 40 received patient care and services that were not communicated in the preferred language, and interpreter services (help people communicate with each other when they speak different languages) were not used, in accordance with the hospital policies and procedures (P&P) titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired” (Refer to A-0131, item 2). These failures denied Pt 29 and Pt 40 to participate in their daily care and had the potential to affect all non-English speaking patients treated at the hospital. (Refer to A-0131, item 2). The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45929 Based on observation, interview and record review, the hospital failed to have an organized nursing service for nine of 52 sampled patients (Patient [Pt] 14, Pt 19, Pt 23, Pt 27, Pt 28, Pt 30, Pt 40, Pt 53 and Pt 56) when: 1. Licensed Nurses (LNs) did not follow the hospital’s Policies and Procedures (P&P) titled, “Pain Assessment and Management -Patients 14 and Older”, dated 1/15/25, and “Provider Orders”, dated 8/25/23, for five of 52 patients (Pt 19, Pt 23, Pt 28, Pt 40, and Pt 53) (Refer to A-0398, item 1). 2. LNs failed to follow the hospital’s P&P titled, “Medications - Orders, Administration, Storage, Documentation”, dated 12/19/23 for one of 11 patients (Pt 14) (Refer to A-0398, item 2). 3. Licensed Vocational Nurses (LVNs) and Patient Care Technicians (PCTs) failed to document an incident involving skin tears (traumatic wound when skin separates) to the chest caused by the removal of electrode stickers (small sticky patches that attach to the skin), for one of 56 patients (Pt 56) in accordance with the hospital P&P titled, “Documentation in the Health Record”, dated 6/14/18, (Refer to A-0398, item 3). 4. LVNs and PCTs failed to report an incident of patient harm through the hospital’s incident reporting system for one of 56 patients (Pt 56), after causing a skin tear wound to Pt 56’s chest when removing the telemetry (remote monitoring of heart rate and rhythm) electrodes, in accordance with the hospital’s P&P titled, “Incident Reporting Intranet System (IRIS)”, dated 1/13/22, (Refer to A-0398, item 4). 5. LNs and PCTs failed to follow the hospital’s policies and procedures titled, “Documentation in the Health Record”, and “Interdisciplinary Plan of Care”, dated 10/12/23, for two of five sampled patients (Pt 27 and Pt 30), and “Pressure Injury Risk Assessment, Prevention, Staging and Treatment”, dated 9/13/24, for one of five sampled patients (Pt 30) (Refer to A-0398, item 5). The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality health care by the nursing staff.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 41166 Based on observation, interview and record review, the hospital failed to ensure that safe pharmaceutical services had been provided to meet the needs of each patient as evidenced by: 1. For two of two patients (PT 5, PT 49), staff pharmacist did not clarify benzocaine 20% oral solution (medication used to relieve mouth pain) medication order when instructions for use were not clear; staff pharmacist did not provide accurate medication-related information to Registered Nurse (RN) 5 who administered benzocaine 20% solution to PT 5. As a result, PT 5 experienced dizziness, tachycardia (increased heart rate), tachypnea (abnormal rapid breathing), cyanosis (bluish-purple discoloration of skin due to lack of oxygen), was diagnosed with methemoglobinemia (rare condition where red blood cells cannot carry oxygen and can result in death), which required hospitalization in the Intensive Care Unit (ICU), and treatment with methylene blue (medicine used to treat methemoglobinemia) and hemodialysis (medical procedure that filters waste products and excess fluid from the blood when the kidneys are no longer functioning properly). (Refer to A 500) 2. The hospital failed to ensure unusable medications were not available for patient use when an intravenous (IV, in the vein) fluid bag was out of its protective overwrap against professional standards in the medication room (a room where medications are stored and prepared) on 2nd floor East. (Refer to A 505) The cumulative effect of this systemic problem resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure patients (Pts) were informed of their rights to make decisions about care for four of 13 patients (Pt 13, 17, 29 and 40) when: 1.Signed consents were not obtained in a language the patient could understand for Pt 13, Pt 17 and Pt 29 according to hospital P&P titled “Consents” and “Conditions of Admissions & Consent to Outpatient Care.” This failure denied Pt 13, Pt 17 and Pt 29 of their right to make informed consent about their care. 2. Pt 29 and Pt 40 received patient care and services that were not communicated in the preferred language, and interpreter services (help people communicate with each other when they speak different languages) were not used, in accordance with the hospital policies and procedures (P&P) titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired” These failures denied Pt 29 and Pt 40 to participate in their daily care and had the potential to affect all non-English speaking patients treated at the hospital. Findings: 1. During an interview on 2/25/25 at 10:02 a.m. with Pt 13, at bedside in the short stay pre-operative unit (the area or department in a hospital or clinic where patients receive care and preparation before undergoing a surgical procedure) , Pt 13 explained she did not speak English. Pt 13 stated Spanish is her primary language. Pt 13 stated she was at the short stay (where simple procedures or day surgery happens) unit today for a revision of her malfunctioning AV fistula (a connection that’s made between an artery and a vein for dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) access. Pt 13 voiced no concerns with her care at time of interview. During a concurrent interview and record review on 2/26/25 at 9:29 a.m. with Clinical Supervisor (CS) 3, and Imaging Manager (IM) 1, Pt 13’s Electronic Health Record (EHR- digital version of the medical record) was reviewed. Pt 13’s Face Sheet (FS-a document that contains a summary of a patient’s personal and demographic (all the non-clinical data about a patient (name, date of birth , address, etc.) information), the FS indicated, “...P[t 13], a 66-year-old...Admit Source: Home, work...Admit Event Date/Time: 2/25/25, 08:53 (a.m.)...” During a review of Pt 13’s EHR on 2/26/25 at 9:29 a.m. with CS 3 and IM 1, Pt 13’s “Short Form History and Physical (H&P- a formal assessment of a patient’s health that includes a medical history and physical exam)” dated 2/25/25, was reviewed. The H&P indicated Pt 13 “... Reason for visit: Poorly functional hemodialysis access...history of anemia (when there is not enough healthy red blood cells), dialysis, End-Stage Renal Disease (ESRD - It refers to a severe and irreversible loss of kidney function that requires ongoing treatment to maintain life), and hypertension (high blood pressure)...” During a review of Pt 13’s EHR on 2/26/25 at 9:39 a.m. with CS 3 and IM 1 , Pt 13’s “Authorization for and Verification of Consent to Surgery, Administration of anesthetics and Rendering of Other Medical Services (Informed Consent Form- permission granted in the knowledge of the possible consequences, given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits)” dated 2/25/25, was reviewed. The Informed Consent form reviewed was in English, with Pt 13’s signature affixed to page 1 of 2 authorizing the provider to perform “...Right upper extremity fistula gram (an X-ray procedure that examines a fistula, which is an abnormal passage between two parts of the body), possible intervention, possible dialysis catheter placement with procedural sedation...” CS 3 stated the witness signature affixed to the Informed Consent form was that of an Interventional Radiology department’s “tiered” Registered Nurse (RN). CS 3 explained the tiered language staff process included testing and certification of the level of ability to interpret in a language other than English. CS 3 stated RN 13, who obtained and witnessed the patient signature is a “Tier 2” level Spanish interpreter. CS 3 stated as a Tier 2 interpreter, RN 13 was not certified to read or write in Spanish, so the process used in the IR is that an English form is used to ensure RN 13 understands the form they are using to provide verbal interpretation to the patient. During a review of a document, undated, certifying RN 13’s level of interpreting proficiency...the Document indicated RN 13 “...has tested proficient to serve as a Tier 2 Bilingual Patient Care Communicator Using the language of: Spanish as of this date: 03/20/2021...In this role, clinical information can be provided to patients and families to enhance care and conversation...” During record review on 2/27/25 at 10:00 a.m. with the Director of Emergency Department (DED) , Pt 17’s “Electronic Health Record [EHR], “FS,” dated 2/23/25, Pt 17’s “H&P” dated 2/23/25, and the “Emergency Department Patient Care Timeline Interpreter Services Flowsheet [EDPCT]”, dated 2/23/25 to 2/26/25 were reviewed. The “FS” indicated Pt 17 arrived at the ED on 2/23/25 at 12:21 a.m. for hypoglycemia (is a condition where the blood glucose level drops below normal) and Pt 17’s preferred spoken language was Spanish, and an interpreter was needed. The “EDPCT” indicated, Pt 17 presented to the ED on2/23/25 at 12:21 am and stayed in the ED to 2/26/25 at 7:49 p.m. The “EDPCT” indicated Pt 17 was transported to Interventional Radiology (medical specialty that uses minimally invasive procedures to diagnose and treat conditions) on 2/24/25 at 3:05 p.m. and returned at 4:26 p.m. The “EHR” indicated Pt 17’s “Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services [AVCSAAROMS-legal document that signifies a patient’s informed agreement to undergo a surgical procedure, including the administration of anesthesia and any related medical interventions, after fully understanding the risks, benefits, and alternatives involved]” was in English and signed. The “AVCSAAROMS” did not include the second page where staff document if an interpreter was used. During a concurrent interview and record review on 2/28/25 at 9:34 a.m. with Clinical Supervisor (CS) 3 and Registered Nurse (RN) 10, Pt 17’s AVCSAAROMS, dated 2/24/25 was reviewed. RN 10 stated her signature was on the AVCSAAROMS and she witnessed the patient consent the form. RN 10 stated she does not remember if interpreter services was used, or a tiered (facility approved interpreter) interpreter was used with Pt 17. RN 10 stated she uses an English document instead of Spanish document for a Spanish speaking patient because, “We always do this”. During an interview on 2/28/25 at 10:30 a.m. with Nurse Practitioner (NP) 1, NP1 stated she was the provider who performed the procedure on 2/24/25 on Pt 17. NP 1 stated she does not remember if Pt 17 consented the AVCSAAROMS using interpreter services or a tiered interpreter. NP 1 stated when a tiered interpreter is used, she speaks in English and the tiered interpreter translates into the native language, then the tiered interpreter signs the consent form as does the patient. NP 1 states she does not document anything regarding consent forms. NP 1 stated she has not seen a Spanish consent form, only English. During a record review on 2/28/25 at 1:30 p.m. with CS 3, Pt 17’s AVCSAAROMS, dated 2/24/25 was reviewed. CS 3 stated they have Spanish Consent forms but don’t use them very often. CS 3 stated they use the Spanish Consent forms for Spanish Reading patients and if are unsure if the patients read Spanish, they use the English consent forms. CS 3 stated, “Our practice to Spanish speaking patients is to interpret in Spanish and sign the consent form in English”. CS 3 stated this practice has been in place before he was the supervisor which has been 5 years. During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29’s “Face Sheet [FS- a document that contains a summary of a patients’ personal information],” dated 2/11/25, Pt 29’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 2/11/25, and the “Interpreter Services Flowsheet [ISF]”, dated 2/11/25 and 2/12/25 were reviewed. The “FS” indicated Pt 29 was admitted on 2/11/25 at 4:52 a.m. for osteosarcoma (a type of bone cancer) Pt 29’s preferred spoken language was Panjabi (Punjabi), and an interpreter was needed. The “H&P” indicated, Pt 29 presented to the surgical department on 2/11/25 for scheduled right maxillectomy (surgical procedure to remove part or all the upper jaw) with reconstruction of right fibula free flap (using part of the smaller of the two leg bones to rebuild the upper jaw). During a concurrent interview and record review on 2/26/25 at 11:15 a.m. with ND 1 Pt 29’s “Conditions of Admission [COA- consent to the general terms and condition for receiving care from hospital. Authorizes general medical and nursing to be provided and financial responsibility for payment of hospital charges for services rendered],” dated 2/11/25 at 4:55 a.m. was reviewed. Pt 29’s “COA” was signed on 2/11/25 at 4:55 a.m. and witnessed by hospital staff. ND 1 stated the Interpreter Statement area, and the Interpreter signature area on Pt 29’s “COA” were blank. ND 1 stated an interpreter should have been provided to Pt 29 to interpret the “COA”. ND 1 stated the interpreter would then sign the form. ND 1 stated no family member signed the form indicating a family member interpreted the “COA”. During a concurrent interview and record review on 2/27/25 at 3:38 p.m. with the Director of Patient Access (DPA) and the Manager of Registration and Admitting (MRA), Pt 29’s “COA,” dated 2/11/25 and “FS” were reviewed. The DPA and MRA verified Pt 29’s “FS” indicated a preferred language of Punjabi. The DPA and the MRA verified Pt 29 signed the “COA” on 2/11/25 at 4:55 a.m. and a registration staff member signed the form as a witness on 2/11/25 at 4:55 a.m. The DPA stated a patient’s preferred language needed to be the language used to communicate with patients during the “COA” process. The DPA and the MRA verified the interpreter area on Pt 29’s “COA” was blank. The MRA stated, patient registration staff should have used an interpreter for Pt 29 to communicate the “COA” information, to ensure understanding of the form. The DPA stated, when an interpreter was used the interpreter services area was completed on the “COA”. The DPA stated, when a staff member was tiered and interpreted the “COA”, the staff would complete the interpreter area on the “COA” and enter the tier number on the “COA”. The DPA stated registration staff should have contacted interpreter services for Pt 29 and interpreter services should have signed the “COA”. During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English and consents are needed, it should be in the patient’s preferred language, otherwise the patient doesn’t know what they are signing. The CNO stated it is hospital policy to have non-English-speaking patients sign documents their native language and be attested by an interpreter. During a review of the hospital’s P&P titled, “Conditions of Admissions & Consent to Outpatient Care [COPC],” dated 12/1/20, indicated, “ ...All [Hospital Name] patients have the right to self-determination over his or her body and property ... A signed verification of the COA/COPC provides legal authorization for treatment or services. ...If a patient or the patient’s representative cannot communicate with the [Hospital Name] personnel because of language or communication barriers, [Hospital Name] personnel shall arrange for interpreter services ... If available, a copy of the COA or COPC should be provided to the patient or patient’s representative in their preferred language. ...If the COA or COPC is not available in the patient’s primary language the interpreter should orally translate the form for the patient and ask the patient to sign the English form if the patient agrees to the terms and conditions that the interpreter orally stated. If the patient or the legal representative agrees, the interpreter should be signing the “Interpreter Signature is Applicable” section on the COA or COPC. ...When an interpreter is used, it must be documented in the “Interpreter Signature if Applicable” section on the COA or COPC. ...Family member /friends of the patient can interpret for the patient; however, the family member/friend should not sign the COA or COPC for the patient. ...The person who interpreted the COA or COPC to the patient must sign and state their relationship to patient under the “Interpreter Signature if Applicable” section of the COA or COPC. ...If [Hospital Name] personnel registering the patient is a tiered interpreter (at least level 1) in the same language as the patient preferred language, he/she may translate the document, provide the document in the patient’s preferred language and fills out the “Interpreter Signature if Applicable” section of the COA or COPC...”. During a review of hospital P&P titled “Consents,” dated 4/13/23, the P&P indicated “...I. PURPOSE: A. To describe the principles of consent, protect the rights of patients, ...B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent...III. POLICY: A. the [hospital] patient has the right of self-determination over his or her body and property...B. A signed verification of consent provides legal authorization for treatment or services... [the hospital’ is responsible for obtaining the patient’s or legal representative’s consent for hospital services or activities...IV. PROCEDURE: A. Determine who is authorized to sign the consent form...6. Obtaining Consent a. Consent to hospital services should be obtained in writing on appropriate consent forms and in appropriate language as applicable, by appropriate personnel as follows...ii. Surgical procedures, blood transfusion, special invasive and non-invasive, such as a radiologic test using dye procedure that put the patient at risk and require consent...b. Informed Consent is to be given for all invasive, complex, medical procedures such as the following...ii. All non-emergency invasive procedures requiring procedural sedation... e. Verification of consent takes place once the physician has ordered the appropriate medical treatment. It is the responsibility of licensed personnel to verbally verify with the patient or the patient’s legal representative that a discussion has taken place between the physician/Advanced Practice Provider (APP) about the procedure including the risks, benefits and alternatives. If the patient or representative still has significant questions about the nature of the procedure or did not understand the information, hospital personnel must contact the patient’s physician to allow him or her to answer the patient’s questions. If the patient or legal representative does not verify that they provided informed consent to the physician, the procedure shall not begin (refer to the Informed Consent Flow Process document). Once the verification is complete, the patient will be asked to read and sign one of the following forms, as applicable: ... NOTE: If an interpreter is used to assist with the informed consent process, he/she will document on the consent form, if it includes the interpreter’s attestation or on the Interpreter Attestation During Informed Consent form per the Interpreters - Use for Limited English (LEP) and Deaf /Hard Of Hearing Patients policy....” According to the “Safety First: The Importance of Interpreters & Translated Documents in Preventing Patient Harm” column electronically retrieved on 3/5/25 from https://wmc.wa.gov/sites/default/files/public/Newsletter/4.SafetyFirst.pdf the column indicated “...Ensure Translation of Patient Education and Vital Clinical Documents Written communication with patients is just as important as verbal communication. Providers should make sure patient education materials, after visit or discharge summaries, and legal forms, such as informed consent, are translated in the top three or five languages in their service area. It is critical that... patients understand all the information necessary to make informed decisions about their care and know how to care for themselves when they return home to reduce the chances of hospital or ED (Emergency Department) readmissions and poor health outcomes...” 2. 2. During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29’s “Interpreter Services Flowsheet [ISF]”, dated 2/11/25 and 2/12/25 was reviewed. ND 1 stated Pt 29’s “ISF” indicated, an interpreter was used on 2/26/25 two times and on 2/27/25 one times while Pt 29 was in the Surgical Services Department. ND 1 stated no other “ISF” entries were entered into Pt 29’s Electronic Health Record (EHR). ND 1 stated Pt 29 was still admitted to the hospital as of 2/26/25. ND 1 stated, RNs should have used an interpreter to communicate with Pt 29, and the information should have been documented in the “ISF”. ND 1 stated RNs should be using an interpreter to interpret Pt 29’s POC, assessments, pain, medications, and general communication. ND 1 stated speaking to Pt 29 in his preferred language was important for him to understand what was happening to him. ND 1 stated RNs should document interpreter use in the “ISF.” During a concurrent interview and record review on 2/27/25 with Clinical Supervisor (CS) 1 and Registered Nurse (RN) 8, Pt 29’s “Admission Preferred Language [APL]”, dated 2/11/25 and the “ISF” dated 2/11/25 through 2/27/25 were reviewed. RN 8 stated Pt 29 spoke English and Punjabi. RN 8 verified in the “APL” Pt 29’s preferred language was Punjabi and needs interpreter was indicated. RN 8 stated, RNs must use certified language interpreters if the patient’s preferred language was other than English. RN 8 verified in the “ISF” only three entries were documented, and all were from surgical services from Pt 29’s day of admission. RN 8 stated, she communicated with Pt 29 in English and Punjabi. RN 8 stated she did not document in the nurses note or in the interpreter flowsheet speaking to Pt 29 in Punjabi, and she should have. RN 8 stated she had been tiered (tested-to interpret) but had not received the sticker for her badge yet. RN 8 stated, she should use an interpreter to communicate with Pt 29 since she did not have the tier sticker. RN 8 stated documenting interpreter use in the EHR was important, so the entire care team knew what Pt 29 had been educated about and Pt 29’s understanding of the POC. CS 1 stated, RNs should use an interpreter to communicate with patients in their preferred language, when the language is other than English. CS 1 stated, RNs should document in the EMR when using an interpreter. CS 1 stated, if the RN was a tiered interpreter they should still document the information interpreted in the nursing note or in the “ISF”. CS 1 stated, interpreting in the preferred language was important for patient understanding. During a concurrent interview and record review on 2/7/25 at 12:00 p.m. with the Director of Emergency Department (DED), Pt 40’s “EHR”, “FS”, dated 2/23/25, Pt 40’s “H&P,” undated, and the “EDPCT”, dated 2/22/25 through 2/25/25 were reviewed. The “FS” indicated Pt 40 arrived at the ED on 2/22/25 at 11:08 a.m. for fall from tree. Pt 40’s “FS” indicated his preferred spoken language was Spanish, and an interpreter was needed. The “EDPCT” indicated, Pt 40 presented to the ED on 2/22/25 at 11:08 a.m. and stayed in the ED to 2/25/25 at 2:08 p.m. The “EDPCT” indicated during Pt 40’s stay in the ED, hospital staff documented interpreter services/tiered interpreter use was five times, on 2/23/25 at 7:45 a.m., 2/23/25 at 3:57 p.m., 2/25/25 at 4:30 a.m., 8:40 a.m. and at 12:00 p.m. The DED stated every time staff touch a patient, they should be using an interpreter service or a tiered interpreter. The DED stated not only should staff be using some sort of interpreter services, but the staff should also be documenting it in the EHR. The DED stated staff did not follow policy for interpreter services. During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English, hospital staff should be using an interpreter to communicate with the patient. The CNO stated, hospital staff should be documenting in the EMR communication with the patient in their preferred language using one of the approved methods per policy. During a review of the hospital’s P&P titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired,” dated 6/14/24, indicated, “ ...Purpose ...To define the communication system that is used for patients who have Limited English Proficiency (LEP) ... Definitions ...Any staff member who communicates in languages other than English when caring for patients is referred to as a Care and Conversation Communicator ... Upon testing and training, such a staff member is assigned a Tier 1 or 2 badge buddy [a small card attached to the identification badge], depending on their scope of competency in the given targeted language. ...Courtesy Language Resources/In-house Language Resources (Tier 1).: Such a bilingual staff member is fluent in English and in the necessary second language. The staff member can speak and readily interpret general patient communication in the necessary second language. ( ...excluding medical information). ...Professionals (Tier 2): ...Such an individual has knowledge of anatomy, symptom description, common diseases/ailments, etc. and wishes to provide service to non-English speaking patients/clients/customers without the aid of an interpreter; he/she wishes to communicate directly with the patient. ...Certified Healthcare Interpreter (Tier 3): A certified professional whose exclusive job description is “INTERPRETER - 1, 2 or 3 - Health care” and who is fluent in both English and another language. Certified Healthcare Interpreters communicate critical medical information, such as informed consents, goals of care, end of life discussions, etc. ...Policy ...A certified health care interpreter (Tier 3) or badged bilingual staff (Tier 2) shall be used - telephonically, videoconferencing or in-person, as required - in any situation were clear and effective communication of medical information is necessary. ...presence of an interpreter for deaf, hearing impaired, or limited English-speaking patients is necessary to ensure thorough and accurate communication including “critical medical information” ...but are not limited to: 1. Explaining a medical procedure or intervention(s). 2. When Informed Consent is required for treatment. 3. When explaining and describing medical conditions, tests, treatment options, medications, surgery and other procedures. 4. When providing a diagnosis, prognosis, and recommendation for treatment during treatment and testing procedures. 5. When providing instructions for medications, post-treatment activities, and follow-up treatments. ...In the event that the patient prefers to use a friend or a family member to interpret on their behalf, one of the following waivers must be signed and scanned into the patient’s EHR. ...Documentation ...Staff member documents in the patient’s EHR if an interpreter or device(s) is/was used ...Name of the interpreter, including i. Interpreter used (first and last name) ii. Interpreter agency, as appropriate iii. Time iv. Date ...The staff member documents the following information in the EHR upon concluding the interpreter session including when interpretation was provided by a family member: 1. Start date 2. Start time 3. End time 4. Language Spoken 5. Interpreter Session type ...”. During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama assn.org/article/clinicians obligations use qualified medical interpreters when caring patients limited English/2017 03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP)... In the United States, patients with LEP have a legal right to access health care in their preferred language ...”.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 49769 Based on interview and record review, the hospital failed to ensure patients (Pts) were informed of their rights to make decisions about care for four of 13 patients (Pt 13, 17, 29 and 40) when: 1.Signed consents were not obtained in a language the patient could understand for Pt 13, Pt 17 and Pt 29 according to hospital P&P titled “Consents” and “Conditions of Admissions & Consent to Outpatient Care.” This failure denied Pt 13, Pt 17 and Pt 29 of their right to make informed consent about their care. 2. Pt 29 and Pt 40 received patient care and services that were not communicated in the preferred language, and interpreter services (help people communicate with each other when they speak different languages) were not used, in accordance with the hospital policies and procedures (P&P) titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired” These failures denied Pt 29 and Pt 40 to participate in their daily care and had the potential to affect all non-English speaking patients treated at the hospital. Findings: 1. During an interview on 2/25/25 at 10:02 a.m. with Pt 13, at bedside in the short stay pre-operative unit (the area or department in a hospital or clinic where patients receive care and preparation before undergoing a surgical procedure) , Pt 13 explained she did not speak English. Pt 13 stated Spanish is her primary language. Pt 13 stated she was at the short stay (where simple procedures or day surgery happens) unit today for a revision of her malfunctioning AV fistula (a connection that’s made between an artery and a vein for dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) access. Pt 13 voiced no concerns with her care at time of interview. During a concurrent interview and record review on 2/26/25 at 9:29 a.m. with Clinical Supervisor (CS) 3, and Imaging Manager (IM) 1, Pt 13’s Electronic Health Record (EHR- digital version of the medical record) was reviewed. Pt 13’s Face Sheet (FS-a document that contains a summary of a patient’s personal and demographic (all the non-clinical data about a patient (name, date of birth , address, etc.) information), the FS indicated, “...P[t 13], a 66-year-old...Admit Source: Home, work...Admit Event Date/Time: 2/25/25, 08:53 (a.m.)...” During a review of Pt 13’s EHR on 2/26/25 at 9:29 a.m. with CS 3 and IM 1, Pt 13’s “Short Form History and Physical (H&P- a formal assessment of a patient’s health that includes a medical history and physical exam)” dated 2/25/25, was reviewed. The H&P indicated Pt 13 “... Reason for visit: Poorly functional hemodialysis access...history of anemia (when there is not enough healthy red blood cells), dialysis, End-Stage Renal Disease (ESRD - It refers to a severe and irreversible loss of kidney function that requires ongoing treatment to maintain life), and hypertension (high blood pressure)...” During a review of Pt 13’s EHR on 2/26/25 at 9:39 a.m. with CS 3 and IM 1 , Pt 13’s “Authorization for and Verification of Consent to Surgery, Administration of anesthetics and Rendering of Other Medical Services (Informed Consent Form- permission granted in the knowledge of the possible consequences, given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits)” dated 2/25/25, was reviewed. The Informed Consent form reviewed was in English, with Pt 13’s signature affixed to page 1 of 2 authorizing the provider to perform “...Right upper extremity fistula gram (an X-ray procedure that examines a fistula, which is an abnormal passage between two parts of the body), possible intervention, possible dialysis catheter placement with procedural sedation...” CS 3 stated the witness signature affixed to the Informed Consent form was that of an Interventional Radiology department’s “tiered” Registered Nurse (RN). CS 3 explained the tiered language staff process included testing and certification of the level of ability to interpret in a language other than English. CS 3 stated RN 13, who obtained and witnessed the patient signature is a “Tier 2” level Spanish interpreter. CS 3 stated as a Tier 2 interpreter, RN 13 was not certified to read or write in Spanish, so the process used in the IR is that an English form is used to ensure RN 13 understands the form they are using to provide verbal interpretation to the patient. During a review of a document, undated, certifying RN 13’s level of interpreting proficiency...the Document indicated RN 13 “...has tested proficient to serve as a Tier 2 Bilingual Patient Care Communicator Using the language of: Spanish as of this date: 03/20/2021...In this role, clinical information can be provided to patients and families to enhance care and conversation...” During record review on 2/27/25 at 10:00 a.m. with the Director of Emergency Department (DED) , Pt 17’s “Electronic Health Record [EHR], “FS,” dated 2/23/25, Pt 17’s “H&P” dated 2/23/25, and the “Emergency Department Patient Care Timeline Interpreter Services Flowsheet [EDPCT]”, dated 2/23/25 to 2/26/25 were reviewed. The “FS” indicated Pt 17 arrived at the ED on 2/23/25 at 12:21 a.m. for hypoglycemia (is a condition where the blood glucose level drops below normal) and Pt 17’s preferred spoken language was Spanish, and an interpreter was needed. The “EDPCT” indicated, Pt 17 presented to the ED on2/23/25 at 12:21 am and stayed in the ED to 2/26/25 at 7:49 p.m. The “EDPCT” indicated Pt 17 was transported to Interventional Radiology (medical specialty that uses minimally invasive procedures to diagnose and treat conditions) on 2/24/25 at 3:05 p.m. and returned at 4:26 p.m. The “EHR” indicated Pt 17’s “Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services [AVCSAAROMS-legal document that signifies a patient’s informed agreement to undergo a surgical procedure, including the administration of anesthesia and any related medical interventions, after fully understanding the risks, benefits, and alternatives involved]” was in English and signed. The “AVCSAAROMS” did not include the second page where staff document if an interpreter was used. During a concurrent interview and record review on 2/28/25 at 9:34 a.m. with Clinical Supervisor (CS) 3 and Registered Nurse (RN) 10, Pt 17’s AVCSAAROMS, dated 2/24/25 was reviewed. RN 10 stated her signature was on the AVCSAAROMS and she witnessed the patient consent the form. RN 10 stated she does not remember if interpreter services was used, or a tiered (facility approved interpreter) interpreter was used with Pt 17. RN 10 stated she uses an English document instead of Spanish document for a Spanish speaking patient because, “We always do this”. During an interview on 2/28/25 at 10:30 a.m. with Nurse Practitioner (NP) 1, NP1 stated she was the provider who performed the procedure on 2/24/25 on Pt 17. NP 1 stated she does not remember if Pt 17 consented the AVCSAAROMS using interpreter services or a tiered interpreter. NP 1 stated when a tiered interpreter is used, she speaks in English and the tiered interpreter translates into the native language, then the tiered interpreter signs the consent form as does the patient. NP 1 states she does not document anything regarding consent forms. NP 1 stated she has not seen a Spanish consent form, only English. During a record review on 2/28/25 at 1:30 p.m. with CS 3, Pt 17’s AVCSAAROMS, dated 2/24/25 was reviewed. CS 3 stated they have Spanish Consent forms but don’t use them very often. CS 3 stated they use the Spanish Consent forms for Spanish Reading patients and if are unsure if the patients read Spanish, they use the English consent forms. CS 3 stated, “Our practice to Spanish speaking patients is to interpret in Spanish and sign the consent form in English”. CS 3 stated this practice has been in place before he was the supervisor which has been 5 years. During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29’s “Face Sheet [FS- a document that contains a summary of a patients’ personal information],” dated 2/11/25, Pt 29’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 2/11/25, and the “Interpreter Services Flowsheet [ISF]”, dated 2/11/25 and 2/12/25 were reviewed. The “FS” indicated Pt 29 was admitted on 2/11/25 at 4:52 a.m. for osteosarcoma (a type of bone cancer) Pt 29’s preferred spoken language was Panjabi (Punjabi), and an interpreter was needed. The “H&P” indicated, Pt 29 presented to the surgical department on 2/11/25 for scheduled right maxillectomy (surgical procedure to remove part or all the upper jaw) with reconstruction of right fibula free flap (using part of the smaller of the two leg bones to rebuild the upper jaw). During a concurrent interview and record review on 2/26/25 at 11:15 a.m. with ND 1 Pt 29’s “Conditions of Admission [COA- consent to the general terms and condition for receiving care from hospital. Authorizes general medical and nursing to be provided and financial responsibility for payment of hospital charges for services rendered],” dated 2/11/25 at 4:55 a.m. was reviewed. Pt 29’s “COA” was signed on 2/11/25 at 4:55 a.m. and witnessed by hospital staff. ND 1 stated the Interpreter Statement area, and the Interpreter signature area on Pt 29’s “COA” were blank. ND 1 stated an interpreter should have been provided to Pt 29 to interpret the “COA”. ND 1 stated the interpreter would then sign the form. ND 1 stated no family member signed the form indicating a family member interpreted the “COA”. During a concurrent interview and record review on 2/27/25 at 3:38 p.m. with the Director of Patient Access (DPA) and the Manager of Registration and Admitting (MRA), Pt 29’s “COA,” dated 2/11/25 and “FS” were reviewed. The DPA and MRA verified Pt 29’s “FS” indicated a preferred language of Punjabi. The DPA and the MRA verified Pt 29 signed the “COA” on 2/11/25 at 4:55 a.m. and a registration staff member signed the form as a witness on 2/11/25 at 4:55 a.m. The DPA stated a patient’s preferred language needed to be the language used to communicate with patients during the “COA” process. The DPA and the MRA verified the interpreter area on Pt 29’s “COA” was blank. The MRA stated, patient registration staff should have used an interpreter for Pt 29 to communicate the “COA” information, to ensure understanding of the form. The DPA stated, when an interpreter was used the interpreter services area was completed on the “COA”. The DPA stated, when a staff member was tiered and interpreted the “COA”, the staff would complete the interpreter area on the “COA” and enter the tier number on the “COA”. The DPA stated registration staff should have contacted interpreter services for Pt 29 and interpreter services should have signed the “COA”. During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English and consents are needed, it should be in the patient’s preferred language, otherwise the patient doesn’t know what they are signing. The CNO stated it is hospital policy to have non-English-speaking patients sign documents their native language and be attested by an interpreter. During a review of the hospital’s P&P titled, “Conditions of Admissions & Consent to Outpatient Care [COPC],” dated 12/1/20, indicated, “ ...All [Hospital Name] patients have the right to self-determination over his or her body and property ... A signed verification of the COA/COPC provides legal authorization for treatment or services. ...If a patient or the patient’s representative cannot communicate with the [Hospital Name] personnel because of language or communication barriers, [Hospital Name] personnel shall arrange for interpreter services ... If available, a copy of the COA or COPC should be provided to the patient or patient’s representative in their preferred language. ...If the COA or COPC is not available in the patient’s primary language the interpreter should orally translate the form for the patient and ask the patient to sign the English form if the patient agrees to the terms and conditions that the interpreter orally stated. If the patient or the legal representative agrees, the interpreter should be signing the “Interpreter Signature is Applicable” section on the COA or COPC. ...When an interpreter is used, it must be documented in the “Interpreter Signature if Applicable” section on the COA or COPC. ...Family member /friends of the patient can interpret for the patient; however, the family member/friend should not sign the COA or COPC for the patient. ...The person who interpreted the COA or COPC to the patient must sign and state their relationship to patient under the “Interpreter Signature if Applicable” section of the COA or COPC. ...If [Hospital Name] personnel registering the patient is a tiered interpreter (at least level 1) in the same language as the patient preferred language, he/she may translate the document, provide the document in the patient’s preferred language and fills out the “Interpreter Signature if Applicable” section of the COA or COPC...”. During a review of hospital P&P titled “Consents,” dated 4/13/23, the P&P indicated “...I. PURPOSE: A. To describe the principles of consent, protect the rights of patients, ...B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent...III. POLICY: A. the [hospital] patient has the right of self-determination over his or her body and property...B. A signed verification of consent provides legal authorization for treatment or services... [the hospital’ is responsible for obtaining the patient’s or legal representative’s consent for hospital services or activities...IV. PROCEDURE: A. Determine who is authorized to sign the consent form...6. Obtaining Consent a. Consent to hospital services should be obtained in writing on appropriate consent forms and in appropriate language as applicable, by appropriate personnel as follows...ii. Surgical procedures, blood transfusion, special invasive and non-invasive, such as a radiologic test using dye procedure that put the patient at risk and require consent...b. Informed Consent is to be given for all invasive, complex, medical procedures such as the following...ii. All non-emergency invasive procedures requiring procedural sedation... e. Verification of consent takes place once the physician has ordered the appropriate medical treatment. It is the responsibility of licensed personnel to verbally verify with the patient or the patient’s legal representative that a discussion has taken place between the physician/Advanced Practice Provider (APP) about the procedure including the risks, benefits and alternatives. If the patient or representative still has significant questions about the nature of the procedure or did not understand the information, hospital personnel must contact the patient’s physician to allow him or her to answer the patient’s questions. If the patient or legal representative does not verify that they provided informed consent to the physician, the procedure shall not begin (refer to the Informed Consent Flow Process document). Once the verification is complete, the patient will be asked to read and sign one of the following forms, as applicable: ... NOTE: If an interpreter is used to assist with the informed consent process, he/she will document on the consent form, if it includes the interpreter’s attestation or on the Interpreter Attestation During Informed Consent form per the Interpreters - Use for Limited English (LEP) and Deaf /Hard Of Hearing Patients policy....” According to the “Safety First: The Importance of Interpreters & Translated Documents in Preventing Patient Harm” column electronically retrieved on 3/5/25 from https://wmc.wa.gov/sites/default/files/public/Newsletter/4.SafetyFirst.pdf the column indicated “...Ensure Translation of Patient Education and Vital Clinical Documents Written communication with patients is just as important as verbal communication. Providers should make sure patient education materials, after visit or discharge summaries, and legal forms, such as informed consent, are translated in the top three or five languages in their service area. It is critical that... patients understand all the information necessary to make informed decisions about their care and know how to care for themselves when they return home to reduce the chances of hospital or ED (Emergency Department) readmissions and poor health outcomes...” 2. 2. During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29’s “Interpreter Services Flowsheet [ISF]”, dated 2/11/25 and 2/12/25 was reviewed. ND 1 stated Pt 29’s “ISF” indicated, an interpreter was used on 2/26/25 two times and on 2/27/25 one times while Pt 29 was in the Surgical Services Department. ND 1 stated no other “ISF” entries were entered into Pt 29’s Electronic Health Record (EHR). ND 1 stated Pt 29 was still admitted to the hospital as of 2/26/25. ND 1 stated, RNs should have used an interpreter to communicate with Pt 29, and the information should have been documented in the “ISF”. ND 1 stated RNs should be using an interpreter to interpret Pt 29’s POC, assessments, pain, medications, and general communication. ND 1 stated speaking to Pt 29 in his preferred language was important for him to understand what was happening to him. ND 1 stated RNs should document interpreter use in the “ISF.” During a concurrent interview and record review on 2/27/25 with Clinical Supervisor (CS) 1 and Registered Nurse (RN) 8, Pt 29’s “Admission Preferred Language [APL]”, dated 2/11/25 and the “ISF” dated 2/11/25 through 2/27/25 were reviewed. RN 8 stated Pt 29 spoke English and Punjabi. RN 8 verified in the “APL” Pt 29’s preferred language was Punjabi and needs interpreter was indicated. RN 8 stated, RNs must use certified language interpreters if the patient’s preferred language was other than English. RN 8 verified in the “ISF” only three entries were documented, and all were from surgical services from Pt 29’s day of admission. RN 8 stated, she communicated with Pt 29 in English and Punjabi. RN 8 stated she did not document in the nurses note or in the interpreter flowsheet speaking to Pt 29 in Punjabi, and she should have. RN 8 stated she had been tiered (tested-to interpret) but had not received the sticker for her badge yet. RN 8 stated, she should use an interpreter to communicate with Pt 29 since she did not have the tier sticker. RN 8 stated documenting interpreter use in the EHR was important, so the entire care team knew what Pt 29 had been educated about and Pt 29’s understanding of the POC. CS 1 stated, RNs should use an interpreter to communicate with patients in their preferred language, when the language is other than English. CS 1 stated, RNs should document in the EMR when using an interpreter. CS 1 stated, if the RN was a tiered interpreter they should still document the information interpreted in the nursing note or in the “ISF”. CS 1 stated, interpreting in the preferred language was important for patient understanding. During a concurrent interview and record review on 2/7/25 at 12:00 p.m. with the Director of Emergency Department (DED), Pt 40’s “EHR”, “FS”, dated 2/23/25, Pt 40’s “H&P,” undated, and the “EDPCT”, dated 2/22/25 through 2/25/25 were reviewed. The “FS” indicated Pt 40 arrived at the ED on 2/22/25 at 11:08 a.m. for fall from tree. Pt 40’s “FS” indicated his preferred spoken language was Spanish, and an interpreter was needed. The “EDPCT” indicated, Pt 40 presented to the ED on 2/22/25 at 11:08 a.m. and stayed in the ED to 2/25/25 at 2:08 p.m. The “EDPCT” indicated during Pt 40’s stay in the ED, hospital staff documented interpreter services/tiered interpreter use was five times, on 2/23/25 at 7:45 a.m., 2/23/25 at 3:57 p.m., 2/25/25 at 4:30 a.m., 8:40 a.m. and at 12:00 p.m. The DED stated every time staff touch a patient, they should be using an interpreter service or a tiered interpreter. The DED stated not only should staff be using some sort of interpreter services, but the staff should also be documenting it in the EHR. The DED stated staff did not follow policy for interpreter services. During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English, hospital staff should be using an interpreter to communicate with the patient. The CNO stated, hospital staff should be documenting in the EMR communication with the patient in their preferred language using one of the approved methods per policy. During a review of the hospital’s P&P titled, “Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired,” dated 6/14/24, indicated, “ ...Purpose ...To define the communication system that is used for patients who have Limited English Proficiency (LEP) ... Definitions ...Any staff member who communicates in languages other than English when caring for patients is referred to as a Care and Conversation Communicator ... Upon testing and training, such a staff member is assigned a Tier 1 or 2 badge buddy [a small card attached to the identification badge], depending on their scope of competency in the given targeted language. ...Courtesy Language Resources/In-house Language Resources (Tier 1).: Such a bilingual staff member is fluent in English and in the necessary second language. The staff member can speak and readily interpret general patient communication in the necessary second language. ( ...excluding medical information). ...Professionals (Tier 2): ...Such an individual has knowledge of anatomy, symptom description, common diseases/ailments, etc. and wishes to provide service to non-English speaking patients/clients/customers without the aid of an interpreter; he/she wishes to communicate directly with the patient. ...Certified Healthcare Interpreter (Tier 3): A certified professional whose exclusive job description is “INTERPRETER - 1, 2 or 3 - Health care” and who is fluent in both English and another language. Certified Healthcare Interpreters communicate critical medical information, such as informed consents, goals of care, end of life discussions, etc. ...Policy ...A certified health care interpreter (Tier 3) or badged bilingual staff (Tier 2) shall be used - telephonically, videoconferencing or in-person, as required - in any situation were clear and effective communication of medical information is necessary. ...presence of an interpreter for deaf, hearing impaired, or limited English-speaking patients is necessary to ensure thorough and accurate communication including “critical medical information” ...but are not limited to: 1. Explaining a medical procedure or intervention(s). 2. When Informed Consent is required for treatment. 3. When explaining and describing medical conditions, tests, treatment options, medications, surgery and other procedures. 4. When providing a diagnosis, prognosis, and recommendation for treatment during treatment and testing procedures. 5. When providing instructions for medications, post-treatment activities, and follow-up treatments. ...In the event that the patient prefers to use a friend or a family member to interpret on their behalf, one of the following waivers must be signed and scanned into the patient’s EHR. ...Documentation ...Staff member documents in the patient’s EHR if an interpreter or device(s) is/was used ...Name of the interpreter, including i. Interpreter used (first and last name) ii. Interpreter agency, as appropriate iii. Time iv. Date ...The staff member documents the following information in the EHR upon concluding the interpreter session including when interpretation was provided by a family member: 1. Start date 2. Start time 3. End time 4. Language Spoken 5. Interpreter Session type ...”. During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama assn.org/article/clinicians obligations use qualified medical interpreters when caring patients limited English/2017 03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP)... In the United States, patients with LEP have a legal right to access health care in their preferred language ...”.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47205 Based on observation, interview, surveillance video review and record review, the hospital failed to ensure nurses followed policies and procedures (P & P) when: 1. Licensed Nurses (LNs) did not follow the hospital’s P&P titled, “Pain Assessment and Management -Patients 14 and Older”, and “Provider Orders,” for five of 52 patients (Pt 19, Pt 23, Pt 28, Pt 40, and Pt 53). For four of 52 Pts licensed nurses did not complete a pain assessment (Pt 19, Pt 23, Pt 40, and Pt 53). For three of 52 Pts (Pt 19, Pt 28, and Pt 40) licensed nurses did not reassess pain after administration of pain medications within the expected timeframe. For two of 52 Patients (Pt 28, and Pt 53) licensed nurses did not administer adequate pain medications to address or re-address severe pain in accordance with physician orders and hospital P&P. These failures placed patients at risk to receive inadequate pain management and had the potential for LNs to not recognize a change in condition timely. 2. LNs failed to clarify an incomplete physician’s order (missing goal parameter -must state what the medication is for and specifically when, how much and how often the medication may be administered) for propofol (an intravenous (IV- administered into a vein) anesthetic medication used to help you relax or sleep before and during surgery or other medical procedures) for one (1) of eleven (11) patients sampled, Patient (Pt) 14, in accordance with hospital policy and procedure (P&P) titled “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23. This failure had the potential to result in a medication administration error, and avoidable harm to Pt 14 from over or under sedation (administering of a drug to produce a state of calm or sleep). 3. Licensed Vocational Nurses (LVNs) and Patient Care Technicians (PCTs) failed to document an incident involving skin tears (traumatic wound when skin separates) to the chest caused by the removal of electrode stickers (small sticky patches that attach to the skin), for one of 56 patients (Pt 56). Pt 56’s Electronic Medical Record (EMR) did not include an entry documenting a skin assessment after the skin tear was discovered, or documentation about applying a dressing (bandage) to the skin tear. Pt 56’s EMR also did not have documentation about reporting the incident to Pt 56’s family or reporting the incident to Pt 56’s physician prior to Pt 56’s discharge on 1/19/25 according to the LVN and PCT “Job Descriptions” and the hospital P&P titled “Documentation in the Health Record”. This failure resulted in Pt 56 sustaining a skin tear to the chest and was discharged without a plan of care for treatment to the skin tear wound which could lead to an infection of the wound. 4. LVNs and PCTs failed to report an incident of patient harm through the hospital’s incident reporting system for one of 56 patients (Pt 56), after causing a skin tear wound to Pt 56’s chest when removing the telemetry (remote monitoring of heart rate and rhythm) electrodes, in accordance with the hospital’s P&P titled, “Incident Reporting Intranet System (IRIS)”. This failure prevented hospital investigation into the incident from occurring timely, potentially preventing a reoccurrence of the incident in other areas of the hospital. 5. Nurses and PCTs failed to follow hospital P&P regarding nutrition for two of five sampled patients (Pt 27 and Pt 30) by not documenting and tracking the nutritional intake in the medical record for patients who had a care plan in place for a nutrition deficit according to hospital P&Ps titled, Documentation in the Health Record”, and “Interdisciplinary Plan of Care [IPOC-interdisciplinary care plans are detailed plans of care created by representatives from several medical disciplines or specialties, each focused on a specific patient’s condition, treatment goals, and methods for improving outcomes].” Nurses also failed to obtain a dietary consult for Pt 30 when she was eating an average of 25% of her meals and had significant weight loss of 10.68%, according to hospital P&P titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment” (involves identifying individuals at risk, implementing preventative measures, classifying injury severity, and providing appropriate care to promote healing). These failures resulted in Pt 30 to experience a significant weight loss due to not tracking/addressing her nutritional intake and deficiency, a dietary consult was not obtained and placed Pt 30 at an increased risk for skin breakdown, slow wound healing and a longer hospital admission. Findings: 1. During an observation and interview on 2/24/25 at 11:35 with Pt 23 in her hospital room on the Post Partum Unit, (a hospital ward where mothers and their newborns receive care and support immediately after childbirth, focusing on the mother’s recovery and the baby’s initial needs). Pt 23 was observed lying in her hospital bed with her eyes opened. Pt 23 stated she had a baby three weeks ago by Cesarean Section (C/S - a surgical procedure used to deliver a baby through a cut in the mother’s stomach and womb (a simple, everyday term for the uterus, the hollow, pear-shaped organ in a woman’s pelvis where a fetus develops before birth) and was readmitted because of an infection to the incision (surgical cut) from the C/S. Pt 23 stated she had a lot of pain around her incision area when she was first admitted to the hospital. Pt 23 stated, her pain was getting better with the medications she was receiving. During a review of Pt 23’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 2/23/25, and “Admission Discharge Transfer Events [ADT],” dated 2/23/25 to 2/24/25, the “H&P” indicated, Pt 23 presented to the Emergency Department (ED) for an infection of her cesarean section incision. The “H&P” indicated, Pt 23 reported the pain over the incision started worsening, and the incision started leaking fluid. The “H&P” indicated; Pt 23 was admitted to the hospital as an inpatient for intravenous (IV- medical technique that administers fluids, medications and nutrients directly into a person’s vein through a thin flexible tube) antibiotics (medications used to treat bacterial infections). The “ADT” indicated, Pt 23 arrived in the ED on 2/23/25 at 9:48 a.m., and was admitted as an inpatient on 2/23/25 at 2:33 p.m. Pt 23 was moved to the Postpartum (PP -a dedicated area within a hospital where new mothers stay after giving birth) Unit on 2/23/25 at 6:15 p.m. During a concurrent interview and record review on 2/25/25 at 2:55 p.m. with Nurse Director (ND) 4, Pt 23’s “Physician Medication Order [PMO] 1,” dated 2/23/25 at 10:10 a.m. was reviewed. “PMO 1” indicated, “ ...acetaminophen [mild pain medication] ... tablet 1,000 mg [milligram - a unit of measurement] ...Oral ... Once...”. During a concurrent interview and record review on 2/25/25 at 2:58 p.m. with Nurse Director (ND) 4, Pt 23’s “Physician Medication Order [PMO] 2,” dated 2/23/25 at 1:54 p.m. was reviewed. “PMO 2” indicated,” ...fentanyl [strong pain medication] ... Injection 50 mcg [micrograms - a unit of measurement] ...intravenous [IV]... EVERY 2 HOURS PRN [as needed] for SEVERE pain...”. During a concurrent interview and record review on 2/25/25 at 3 p.m. with Nurse Director (ND) 4, Pt 23’s “Pain Monitoring Flowsheet [PMF],” dated 2/23/25 to 2/24/25, was reviewed. The “PMF” indicated, on 2/23/25 at 10:14 a.m. Pt 23 was administered 1,000 mg acetaminophen. ND 4 stated, Pt 23’s “PMF” pain documentation was blank at the date and time of medication administration and no earlier pain assessment was in the “PMF”. ND 4 stated, Pt 23’s nurse should have assessed for pain prior to administering the medication, to ensure the administered medication was appropriate to the patient’s stated level of pain. The “PMF” indicated on 2/23/25 at 11:14 a.m. a reassessment pain score of 8 (severe). ND 4 stated, Pt 23’s nurse should have contacted the physician if Pt 23 was still in pain after pain medication reassessment if Pt 23 had no other pain medication orders. ND 4 stated, no additional pain medications were administered until 2:08 p.m. on 2/23/25. The “PMF” indicated, on 2/23/25 at 2:08 p.m. Pt 23’s nurse administered 50 mcg fentanyl through the IV. ND 4 stated, Pt 23’s “PMF” pain documentation was blank during the associated medication administration time. ND 4 stated, Pt 23’s nurse should have assessed Pt 23’s pain prior to administering fentanyl, because the previous pain score was three hours before. During a review of Pt 28’s “Face Sheet [FS - a document that contains a summary of a patients’ personal information],” dated 2/21/25, Pt 28 was admitted on 2/21/25 at 5:26 p.m. The “FS” indicated; Pt 28 was a transfer from one distinct unit of the hospital to a different distinct unit. The “FS” indicated Pt 28’s admit reason was, STEMI (ST Elevation Myocardial Infarction- [a life-threatening heart attack that occurs when a coronary artery (the blood vessels that supply the heart muscle with oxygen and nutrients) is completely blocked], and Acute Hypoxic Respiratory Failure (lungs cannot get enough oxygen for the body to survive). During a review of Pt 28’s “H&P,” dated 2/21/25, the “H&P” indicated, Pt 28 was brought in by ambulance to the ED on 1/14/25 for shortness of breath for four to five days. The “H&P” indicated; Pt 28 was admitted to the hospital as an inpatient on 1/14/25 for acute hypoxic respiratory failure. The “H&P” indicated Pt 28 had a coronary artery bypass graft [CABG - also called heart bypass surgery, is a medical procedure to improve blood flow to the heart) and tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) placement during the hospital admission of 1/14/25 to 2/21/25. The “H&P” indicated Pt 28 was moved to the hospital’s inpatient Rehabilitation (Rehab-a specialized area where patients receive intensive therapy to regain physical, cognitive [thinking], or functional abilities lost due to an injury, illness, or surgery) Unit on 2/21/25. During a concurrent interview and record review on 2/26/25 at 10:38 a.m. with ND 1, Pt 28’s “PMO,” dated 2/21/25 at 5:38 p.m. was reviewed. The “PMO” indicated, “ ...acetaminophen... tablet 650 mg... Oral ... Every 6 Hours PRN for MILD Pain...”. During a concurrent interview and record review on 2/26/25 at 10:40 a.m. with ND 1, Pt 28’s “PMF,” dated 2/25/25 to 2/26/25, was reviewed. The “PMF” indicated, on 2/25/25 at 8:37 p.m. a pain score of 10 (the worst pain) in Pt 28’s shoulder. The “PMF” indicated 650 mg acetaminophen was administered. ND 1 stated RNs administered a mild pain (1-3) medication for a severe pain (7-10) score. ND 1 stated, RNs should have contacted the physician for a pain medication for severe pain. ND 1 stated, if Pt 28 preferred mild pain medication for severe pain, RNs should have documented the refusal of stronger pain medication on the “PMF” and reported to the physician so the order could be updated. ND 1 stated, the “PMF” did not have another pain score documented until 2/26/25 at 9 a.m., 11 hours after medication administration. ND 1 stated Pt 28’s RN should have reassessed Pt 28’s pain within an hour of medication administration to make sure Pt 28’s pain was adequately controlled. ND 1 stated reassessment of pain was important to ensure adequate pain control for patients. During a review of Pt 53’s “H&P,” dated 1/20/25, the “H&P” indicated, Pt 53 presented to the ED with a complaint of abdominal pain, nausea, vomiting and constipation for two days. Pt 53 was admitted to the hospital as an inpatient on 1/20/25 at 3:27 p.m. for a small bowel obstruction (SBO-a blockage in the digestive system preventing normal passage of food, fluids, and gas), hydronephrosis (urine builds in kidney causing swelling), and adenocarcinoma (type of cancer that originates in cells that produce secreting substances-hormones, enzymes (help speed up chemical reactions in the body), mucus) of the rectum (part of large intestine between colon and anus) that had spread to the liver. Pt 53 was transferred to the Oncology (special unit where patients diagnosed with cancer receive treatment) Unit on 1/22/25 at 6:44 p.m. During a concurrent interview and record review on 2/28/25 at 9:05 a.m. with ND 1, Pt 53’s “PMO 1,” dated 1/20/25 at 2:17 p.m. was reviewed. “PMO 1” indicated, “ ... oxycodone immediate release tablet [strong pain medication] 5 mg ... Oral ... ONCE...”. During a concurrent interview and record review on 2/28/25 at 9:08 a.m. with ND 1, Pt 53’s “PMO 2,” dated 1/20/25 at 3:40 p.m. was reviewed. “PMO 2” indicated, “ ... oxycodone immediate release tablet 5 mg ... Oral ... Every 6 HOURS PRN for Moderate pain (pain score 4-6) ...”. During a concurrent interview and record review on 2/28/25 at 9:11 a.m. with ND 1, Pt 53’s “PMO 3,” dated 1/20/25 at 3:40 p.m. was reviewed. “PMO 2” indicated, “ ... oxycodone immediate release tablet 10 mg ... Oral ... Every 6 HOURS PRN for SEVERE pain ... (pain score 7-10) ...”. During a concurrent interview and record review on 2/28/25 at 9:15 a.m. with ND 1, Pt 53’s “PMF,” dated 1/20/25 to 1/22/25 was reviewed. The “PMF” indicated, on 1/20/25 at 3:52 p.m. Pt 53 was administered a 5 mg tablet of oxycodone, no pain score was associated with the medication administration. The “PMF” indicated, on 1/20/25 at 4:52 a pain reassessment of 9 (severe), no additional medications were administered at the time of reassessment. The “PMF” indicated, on 1/22/25 at 4:19 a.m. a pain reassessment of 8 (severe), no additional medications were administered at the time of reassessment. ND 1 stated, on 1/22/25 at 9:36 a.m. Pt 53 was administered a 10 mg tablet of oxycodone with no associated pain score. Pt 53 did not have a pain assessment or pain medication for six hours after scoring her pain 8 at 4:19 a.m. ND 1 stated nursing staff should have assessed Pt 53’s pain prior to administering medication and a pain assessment should be completed again after administration to assure the patient had pain relief. ND 1 stated, nurses should have assessed Pt 53 prior to medication administration to know if the appropriate level of pain medications were given according to reported pain and physician order, or if the patient even needed pain medication. ND 1 stated, nurses should document declination of pain medications in the EMR if Pt declines. ND 1 stated when a Pt did not have adequate pain control nurses should report to the physician for a different pain medication order. During an interview on 2/28/25 at 3:44 p.m. with the Chief Nursing Officer (CNO), the CNO stated pain should be assessed before and after pain medications were administered, to ensure patients were getting effective pain control. During a review of Pt 19’s “History and Physical (H&P-patient’s medical history and a physical examination. It is a comprehensive assessment that provides a detailed overview of the patient’s health status),” dated 2/22/25, the “H&P” indicated, Pt 19 chief complaint (primary reason for coming to the emergency department) for chest pain, shortness of breath (SOB) for days. Pt 19 was discharged on 2/15/25 but returned to the ER (emergency Room) on 2/16/25 for uncontrolled pain. During a review of Pt 19’s “Medication Administration Record (MAR- an electronic record of medications that were given),” dated 2/21/25-2/27/27, the “MAR” indicated, “... fentanyl (opioid pain medication to treat severe pain) injection 50 mcg [microgram-unit of measure], Dose: 50 mcg, Freq: ONCE, Route: IV (intravenous). Start: 2/24/25 10:50 p.m., End: 2/24/25 11:10 p.m. ...”. During a review of Pt 19’s “MAR,” dated 2/21/25-2/27/27, the “MAR” indicated, “... Hydromorphone (narcotic to treat moderate to severe pain. injection 0.25 mg [milligram-unit of measure], Dose: 0.25mg, Freq: Every 4 hours PRN [as needed], Route: IV, PRN Reason: Severe Pain, Start: 2/25/24 12:52 a.m., End: 2/25/25 7:55 a.m. ...”. During a concurrent interview and record review on 2/26/25 at 10:00 a.m. with the Director of Emergency Department (DED), Pt 19’s “MAR” and “Pain Monitoring Flowsheet (PMF-documentation for charting specific pain interventions and pain levels)” dated 2/21/25 to 2/27/25 was reviewed. The “MAR” on 2/24/25 indicated, Pt 19 was administered fentanyl 50 mcg at 11:10 p.m. on 2/24/25 and hydromorphone 0.25 mg at 1:56 a.m. on 2/25/25. The “PMF” indicates no pain assessment was charted prior to administration of both medications. The DED stated Pt 19’s pain assessment was not complete prior to administration of medications. The DED states Pt 19’s pain should have been assessed prior to administration of pain medication. During a review of Pt 40’s “History and Physical (H&P),” dated 2/22/25, the “H&P” indicated, “... Pt 40’s Chief Complaint was a fall approximately 50 feet from a tree, and Pt 40 does not remember if he lost consciousness. The “H&P” indicated the plan was to admit Pt 40 to the TICU (Trauma Intensive Care Unit) and control his pain using multimodal pain control (multiple interventions to achieve effective pain relief) During a review of Pt 40’s “Medication Order,” dated 2/22/25, the “MO” indicated, “ ... fentanyl injection 50 mcg, Ordered Dose: 50 mcg, Route: Intravenous, Frequency: Once, Admin Dose: 50 mcg ...”. acetaminophen 325 mg Tab ... 650 mg 2 tab ... Oral, [every four hours as needed for] PAIN ...” During a review of Pt 40’s “MO”, dated 2/22/25, the “MO” indicated, “ ... fentanyl injection 25 mcg, Ordered Dose: 25 mcg, Route: Intravenous, Frequency: Once, Admin Dose: 25 mcg, Scheduled Start Date/Time: 2/22/25 3:50 p.m., End Date/Time: 2/23/25 11:05 a.m. ...” During a review of Pt 40’s “MO”, dated 2/22/25, the “MO” indicated, “ ... oxycodone (narcotic pain medication used to treat moderate to severe pain) immediate release tablet 5 mg, Ordered Dose: 5 mg, Route: Oral, Frequency: Ever 4 hours PRN for MODERATE Pain, Admin Dose: 5 mg, Scheduled Start Date/Time: 2/22/25 3:49 p.m., End Date/Time: 2/23/25 11:05 a.m. ...”. During a review of Pt 40’s “MO”, dated 2/22/25, the “MO” indicated, “ ... oxycodone immediate release tablet 5 mg, Ordered Dose: 5 mg, Route: Oral, Frequency: Ever 4 hours, Admin Dose: 5 mg, Scheduled Start Date/Time: 2/22/25 3: 49 p.m. (Original Order) Start Date/Time (After Last Modification) 2/23/25 11:21 a.m., End Date/Time: 2/25/25 7:22 a.m. ...”. During a review of Pt 40’s “MO”, dated 2/23/25, the “MO” indicated, “ ... acetaminophen (pain medication used to treat minor pain and fever reduction) tablet 1,000 mg, Ordered Dose: 1,000 mg, Route: Oral, Frequency: Every 6 hours, Admin Dose: 1,000 mg, Scheduled Start Date/Time: 2/23/25 1:00 p.m., End Date/Time: 2/23/25 -- ...”. During a concurrent interview and record review on 2/25/25 at 2:00 p.m. with the (DED), Pt 40’s “MAR” and “PMF” dated 2/22/25 to 2/26/25 was reviewed. The “MAR” indicated, Pt 40 was administered fentanyl 50 mcg at 12:34 p.m., administered fentanyl 25 mcg at 4:49 p.m. on 2/22/25 and at 5:43 a.m. on 2/2/3/23, administered oxycodone 5 mg at 3:36 a.m. on 2/23/25 and at 11:48 a.m. on 2/23/25, and administered acetaminophen 1,000 mg at 1:22 p.m. on 2/23/25, 1:49 a.m. on 2/24/25, 2:38 a.m. and 7:05 p.m. on 2/26/25. The “PMF” indicates no pain assessment was charted prior and/or after administration of these medications. The DED stated Pt 40’s pain assessment was incomplete, Pt 40 did not have pain assessments prior and/or after administration of pain medications. The DED stated the LNs did not follow hospitals pain policy. During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated pain assessments prior to medication administration and after administration are mandatory and should always occur. The CNO stated without a pain assessment prior to or after administration of medication, nurses would not know if the pain medication was effective. During a review of the hospital’s P&P titled, “Pain Assessment and Management -Patients 14 and Older,” dated 1/15/25, indicated, “ ... Pain screen is used to determine if pain is present or absent by utilizing verbal acknowledgment of pain by a patient/family/caregiver or utilizing a pain measurement tool. ...Comprehensive pain assessment may include information from the patient/family about provoking factors, quality/characteristics, region/radiation, relieving factors, associated symptoms, timing, and pain intensity scores obtained with a pain measurement tool. ...analgesic (a drug that reduces pain) history, medical diagnosis, physical assessment ... Data Collection and Assessment ... Assess and reassess pain using one of the following scales as appropriate. a. 0-10 pain intensity scale (adolescents to adults who do not have cognitive (relating to the mental process involved in knowing, learning, and understanding things) disorders). The appropriate pain rating scale is used to determine an appropriate pain management modality ... Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain. Patients’ denial of pain will be interpreted as 0. ...Pain Management Plan ... Once a pain management plan is established, in agreement with the patient/family/caregiver and the health care team, the pain management care plan is administered as prescribed to achieve desired comfort level. ...Implementation 1. Medications will be administered based on the patient’s pain scale level identified and as ordered by the provider. ...Monitor - Assessment/Reassessment of Pain Management and Adverse Effects 1. Assessment for pain is to be completed using the appropriate pain assessment tools during routine unit assessment times, prior to pain medication administration and as needed. 2. Reassessment for pain intensity and presence of adverse effects is to be completed following administration of pharmacological pain management. Reassessment parameters are based on route and typical timeframes needed to reach peak effect. a. IV Administration - within 30 minutes. b. Oral (by mouth)/Intramuscular (into a muscle)/Subcutaneous (beneath the skin) - within 60 minutes. c. This reassessment will be documented in the EHR using the appropriate pain and sedation scale as indicated. ... If the patient appears to be sleeping, the nurse will document objective observations in the EHR, and a pain intensity level will not be documented. ... Document the following in the appropriate section of the EHR: 1. If pain is identified as an issue, the initial assessment will include pain intensity (0-10), verbal pain descriptors, or the behavioral pain score and the patient’s acceptable level of pain, location, quality, duration, and any associated symptoms. ...Subsequent reassessments should include the following: intensity, location, response to treatment modalities, and type of pain assessment scale used. ...Any interventions for pain management, such as analgesics on the Medication Administration Record according to policy. ...Any communication with the provider. ...The patient’s care plan reflecting an active plan for the treatment of pain ...”. During a review of the hospital’s P&P titled, “Provider Orders,” dated 8/25/23, indicated, “ ...The RN acknowledgment of orders indicates they assume responsibility for ensuring implementation of the order within the prescribed period. ... Questions and concerns regarding carrying out physician’s orders. ... The RN, LVN and Licensed Psychiatric Technician (LPT) are health practitioners and must act prudently to deliver optimal patient care. Each licensed person is responsible for a knowledge base in his or her health care area. It is their responsibility to question inexact, illegible or potentially inappropriate physician’s orders. This includes, but is not limited to, medication dosages and administration. ... The RN is to call the physician to clarify the order ...”. During a review of the professional reference titled, “Acute Pain Management Pearls: A Focused Review for the Hospital Clinician [health care professional],” dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, “ ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade [a series of coordinated responses where hormones produced by neurons [make up brain and nervous system] that are released in succession to body responses] that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and institutional [facility] priority as a key driver of patient outcomes ...”. 2. During a concurrent observation and interview with the ICU Nurse Director, (ND) 6 on 2/24/25 at 1:05 p.m., during a tour of the Burn Intensive Care Unit (ICU- a department of a hospital in which patients who are dangerously ill are kept under constant observation) Pt 14 was on a continuous IV administration of propofol. During a review of Pt 14’s Electronic Health Record (EHR- a digital version of a patient’s medical history) on 2/26/25 at 2:31 p.m., with ND 6, Pt 14’s Face Sheet (FS-a document that contains a summary of a patient’s personal and demographic (all of the non-clinical data about a patient (name, date of birth , address, etc.) information), the FS indicated, “...Admit Reason (s): 2nd And 3rd Degree Burns to Abdomen, Legs And Genitals...ED Arrival Date/Time: 2/23/253 16:30 (4:30 p.m.)...Admit Source: Transfer from another acute care hospital...Date/Time First Inpatient: 2/23/25, 16:34 (4:34 p.m.)...” During record review of Pt 14’s EHR, on 2/6/25 at 2:31 p.m., with ND 6, Pt 14’s “History and Physical (H&P- a formal assessment of a patient’s health that includes a medical history and physical exam)” dated 2/23/25, was reviewed. The H&P indicated Pt 14 was an “...87-year-old...patient with a history of hypertension (high blood pressure) and pacemaker (a device used to control an irregular heart rhythm (heart beat(s)) ...transferred from a [local general acute care hospital (GACH)] for burns over bilateral lower extremities (both legs), genitals and buttocks...injury... [while] using a welding torch when his pants caught fire...” During a concurrent interview and record review of Pt 14’s EHR, on 2/28/25 at 9:00 a.m., with ND 6 and RN 12, Pt 14’s “Propofol Order” dated 2/25/25, was reviewed. The order indicated “... propofol infusion 10 mg/ml (milligrams per milliliter- the amount of one substance dissolved in a specific volume of a liquid)... Admin Instructions: Goal sedation: Ventilator compliance/synchrony (a patient’s breathing efforts are perfectly aligned with the breaths delivered by a mechanical ventilator (a type of therapy that helps you breathe or breathes for you when you can’t breathe on your own)...” RN 12 stated she did not believe the order was incomplete and therefore did not seek to clarify the order with the ordering provider. RN 12 stated has administered this medication to other patients, under the same goal sedation instructions in the past. RN 12 explained that she titrated (the medication dose is either progressively increased or decreased in response to the patient’s status) the propofol to ensure that Pt 14 was tolerating, but not fighting against the mechanical ventilator settings. ND 6 stated this goal sedation is used in a special population of patients, such as Pt 14, who require special administration considerations and are more difficult to sedate. ND 6 stated she agreed with RN 12’s actions in administering the propofol as ordered and therefore, did not believe a clarification was needed. During an interview on 2/28/25 at 3:38 p.m. with the Chief Nursing Officer (CNO) the CNO stated, nurses were expected to follow hospital P&Ps. CNO stated any incomplete order [such as Pt 14’s propofol order] should be clarified with the provider. CNO stated the “ventilator compliance/synchrony” sedation goal is incomplete as it does not provide a specific goal for the nurse to follow. During a review of hospital P&P) titled, “Medications - Orders, Administration, Storage, Documentation” dated 12/19/23, the “P&P” indicated “ ...I. PURPOSE To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage and documentation of medications...III. POLICY... 3. A medication order must be clear, legible and include the following...g. For infusions, orders to titrate medications must indicate starting rate, titration parameters and maximum rate. These orders may include, but not limited to systolic blood pressure (the pressure in your arteries when your heart beats, pushing blood out to the body), respiratory rate, ...sedation scale, and pain scale...4. Any orders for medications that are illegible, incomplete, and/or unclear will require clarification. a. ...RN will contact the ordering prescriber and clarify using the telephone/verbal order process... V. PROCEDURE A. Acknowledge and verify that all orders are valid and contain all elements required in related [hospital] policies...” According to the Joint Commission (JC- is the nation’s oldest and largest standards-setting and accrediting body in health care) electronically retrieved on 3/5/25 from: https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/medication-management-mm/000002114/?p=1 the JC defines the “Required elements for medication titration orders: Medication name, Medication route, Initial or starting rate of infusion (dose/min), Incremental units the rate can be increased or decreased, Frequency for incremental doses (how often does(rate) can be increased or decreased, Maximum rate (dose) of infusion, Objective clinical endpoint (RASS score (a medical scale used to measure the agitation or sedation level of a person), CAM score (a tool used by healthcare professionals to quickly and accurately identify delirium, a state of confusion), etc.... Goals when developing requirements for safe administration:...Nursing not placed in a position of making dosing/administration decisions that may conflict with their scope of practice...” 3. During a review of Pt 54’s “H&P,” dated 1/15/25, and “ADT,” dated 1/15/25 to 1/19/25, the “H&P” indicated Pt 54 was a 78-year-old who was brought to the ED by family with a complaint of (C/O) dizziness, nausea and vomiting, slurred speech and difficulty walking. Pt 54 was admitted to the hospital as an inpatient on 1/15/25 at 5:59 p.m. for hypoglycemia (low blood sugar), near syncope (almost fainting), acute kidney injury (AKI- a sudden and often reversible decline in kidney function), abnormal ECG (heart test), and cirrhosis (disease where healthy liver tissue is replaced by scar tissue). The “ADT” indicated Pt 54 was discharged from the hospital on 1/19/25 at 2:56 p.m. During a telephone interview on 2/27/25 at 1:50 p.m. with Family Member (FM) 1, FM 1 stated when Pt 54 was discharged from the hospital on 1/19/25 family members observed the staff “hurrying” to get Pt 54 out of the hospital room. FM 1 stated, his brother, and cousin watched the “nurse” pull the lines (IV lines) and “roughly” pull off all the chest electrode stickers. FM 1 stated, when Pt 54 got home, and family helped change Pt 54’s clothing, gauze and tape were discovered on her chest over a skin tear where one of the electrodes was removed. FM 1 stated the wound was bleeding and family members bandaged the wound again. FM 1 stated nursing staff did not inform the family of the skin tear at the time of discharge. FM 1 stated, Pt 54’s family did not see the skin tear at the hospital, or the bandaging of the wound, they just saw the “nurse” pulling off medical equipment quickly. FM 1 stated, his brother called the hospital and made a complaint about the incident on 1/20/25. FM 1 stated, if Pt 54’s family did not see the wound when changing Pt 54, they would not have known, and it may have gotten infected. FM 1 stated, the “nurse” should have told the family when the incident occurred. During a concurrent interview and record review on 2/28/25 at 9:39 a.m. with ND 1, Pt 54’s “Wound Care Flowsheet [WFS],” dated 1/15/25 to 1/19/25 was reviewed. The “WFS” indicated from 1/15/25 to 1/19/25 Pt 54’s skin was documented as intact during assessments. ND 1 stated, the last skin assessment documented was on 1/19/25 at 9:45 a.m. ND 1 stated, nurses were required to document a skin assessment every shift and anytime a change in skin integrity (skin being free from damage) occurred. ND 1 stated no documentation was in the “WFS” indicating skin tear prior to discharge. ND 1 stated, nurses should have documented the skin tear, and dressing application. During a concurrent interview and record review on 2/28/25 at 9:45 a.m. with ND 1 Pt 54’s “Discharge Summary [DS-a clinical report at the end of a hospital stay outlining details],” dated 1/19/25 at 12:49 and “Discharge Note,” dated 1/19/25 at 2:57 p.m. were reviewed. The “DS” indicated, Pt 54’s skin was warm. ND 1 stated the “DS” did not indicate any skin tear, or treatment for a skin tear in the physician’s “DS”. The “Discharge Note” indicated, “ ... Patient discharged. Alert and oriented x4 ... No complaint of pain or discomfort expressed. Discharge instructions and follow up provided, patient verbalized understanding. Discontinued PIV [peripheral IV]. Last set of vitals taken at 1407 [2:07 p.m.]. All patient belongings were taken with the patient. Medications sent to preferred pharmacy. Patient left via private vehicle.” ND 1 stated Pt 54’s skin tear, or any treatment for a skin tear was not documented in the nursing discharge notes. ND 1 stated, nursing staff should have documented the skin tear in Pt 54’s EMR. During an interview on 2/28/25 at 3:06 p.m. with ND 1, ND 1 stated, after the complaint was received from Pt 54’s family about a skin tear during discharge an investigation began. ND 1 stated, Pt 54 was discharged by an LVN and a PCT from the Discharge Lounge (area where patients can wait while awaiting discharge). ND 1 stated when a patient was discharged, they were held in the discharge lounge until all discharge activities were completed. ND 1 stated, the investigation discovered the LVN and the PCT were “rushing” to get the patient ready to leave, and the PCT removed the telemetry electrodes, causing a skin tear. ND 1 stated, the PCT told the investigator she reported the skin tear to the LVN. ND 1 stated, no skin tear information was documented in Pt 54’s EMR. ND 1 stated both the LVN and the PCT should have documented the skin tear, and subsequent treatment in the EMR. ND 1 stated, the LVN should have reported the incident to Pt 54’s physician, and to Pt 54’s family. ND 1 stated, the LVN was re-educated about documenting changes in condition and the PCT was re-educated about “slowing down” and “not rushing” During an interview on 2/28/25 at 3:45 p.m. with the CNO, the CNO stated, regardless of being admitting or discharged the patient/patient’s family should be informed when a skin tear was caused by a staff member, because the patient may need additional interventions. The CNO stated Pt 54’s physician should have been informed, to ensure no additional medications or orders needed to be added to the discharge plan. The CNO stated, LVNs and PCTs should have documented the incident in the EMR, under progress notes, or under skin assessments. The CNO stated Pt 54 should have been educated about the skin tear and any suggested care and treatment of the wound. During a review of the hospital document titled, “LVN Job Description,” dated 6/19/24, the LVN Job description indicated, “ ...Job Summary ...The Licensed Vocation Nurse (LVN) identifies patient needs, maintains quality standards, and provides basic patient care. The LVN also partners with the Registered Nurse (RN) to perform skills, procedures, and other tasks that are outside their clinical scope of practice. ... Essential Accountabilities ...Recognize, communicate and document changes in patient’s condition either emergent or in response to patient care. ... Assure completeness of patient record ...”. During a review of the hospital document titled, “Patient Care Tech [PCT] 1 Job Description,” dated11/13/24, the PCT 1 Job description indicated, “ ... Job Summary ...Under the direction of a licensed clinical staff member [RN, LVN], the Patient Care Tech 1 (PCT1) provides both basic patient care and clerical support using defined procedures and standards in accordance with the goals of the unit ... Essential Accountabilities ...Records vital signs, height, weight and I/O. Collects and records data as assigned and reports information to RN. Recognizes, communicates and documents changes in patient’s condition either emergent or in response to patient care ...”. During a review of the hospital document titled,” Documentation in the Health Record,” dated 6/14/18, indicated, “ ...All patient care and activities are to be documented at the time care is provided ...”. During a review of a professional reference titled, “Health professionals’ routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study,” dated 2/16/23, the professional article indicated, “ ... Documentation is a standard way of keeping ongoing patient care information. It is the relevant facts of routine health information and patient care plans, such as professionals’ evaluation and judgement about the patients, evaluation charts, tests, reports, subjective notes or professionals’ reflections ... Documenting routine practices is essential for the continuity of patient care, ... communication among healthcare professionals and better patient diagnoses and treatments ... it should be patient-focused, accurate, relevant, clear, permanent, confidential and timely ... Poor documentation practice affects patient management, continuity of patient care and medicolegal (relating to both medicine and law, encompassing areas like medical jurisprudence (using medical knowledge in legal cases) and medical law (the legal aspects of healthcare) issues, which arise from incomplete and inadequate documentation, lack of accuracy and poor quality. It leads to adverse patient outcomes, medication errors and patient deaths. Distorted health information may influence health professionals’ decision-making capabilities due to inappropriate and misleading documentation practices ...”. 4. During a review of Pt 54’s “H&P,” dated 1/15/25, and “ADT,” dated 1/15/25 to 1/19/25, the “H&P” indicated Pt 54 was a 78-year-old who was brought to the ED by family with a complaint of (C/O) dizziness, nausea and vomiting, slurred speech and difficulty walking. Pt 54 was admitted to the hospital as an inpatient on 1/15/25 at 5:59 p.m. for hypoglycemia (low blood sugar), near syncope (almost fainting), acute kidney injury (AKI- a sudden and often reversible decline in kidney function), abnormal ECG (heart test), and cirrhosis (disease where healthy liver tissue is replaced by scar tissue). The “ADT” indicated Pt 54 was discharged from the hospital on 1/19/25 at 2:56 p.m. During a telephone interview on 2/27/25 at 1:50 p.m. with Family Member (FM) 1, FM 1 stated when Pt 54 was discharged from the hospital on 1/19/25 family members observed the staff hurrying to get Pt 54 out of the hospital room. FM 1 stated, his brother, and cousin watched the “nurse” pull the lines (IV lines) and “roughly” pull off all the chest electrode stickers. FM 1 stated, when Pt 54 got home, and family helped change Pt 54’s clothing, gauze and tape were discovered on her chest over a skin tear where one of the electrodes was removed. FM 1 stated the wound was bleeding and family members bandaged the wound again. FM 1 stated nursing staff did not inform the family of the skin tear at the time of discharge. FM 1 stated, Pt 54’s family did not see the skin tear at the hospital, or the bandaging of the wound, they just saw the “nurse” pulling off medical equipment quickly. FM 1 stated, his brother called the hospital and made a complaint about the incident on 1/20/25. FM 1 stated, if Pt 54’s family did not see the wound when changing Pt 54, they would not have known, and it may have gotten infected. FM 1 stated, the “nurse” should have told the family when the incident occurred. During a review of the hospital’s “Adverse Event Log [AEL],” dated 12/1/24 to 2/24/25, the “AEL” had no reported incidents from 1/19/25 to 1/21/25 for skin/tissue for Pt 54. During an interview on 2/28/25 at 3:10 p.m. with ND 1, ND 1 stated, an incident report was not entered into the IRIS system after the incident occurred. ND 1 stated the PCT should have entered an incident report regarding a skin tear to Pt 54. During an interview on 2/28/25 at 3:45 p.m. with the CNO, the CNO stated, an incident should have been entered into the reporting system. During a review of the facility’s policy and procedure titled, “Incident Reporting Intranet System (IRIS),” dated 1/13/22, indicated, “ ... To provide a mechanism for reporting and tracking unusual incidents related to the care of patients. ... Incident: An unusual situation or occurrence at a [name of hospital] owned or managed facility, or on [name of hospital] property, which is inconsistent with a desired patient outcome or with the routine operation of the facility. Incidents reported at [name of hospital] range from “no harm” to Sentinel Events [a serious, unexpected adverse event that results in death, permanent harm, or severe temporary harm to a patient]. ...IRIS (Incident Reporting Intranet System): Network application utilized to document unusual incidents. IRIS is accessible through the corporate intranet website and directly from selected workstation desktop icons. ... Only facts and objective information are to be documented in the incident report. Nurses’ narrative notes and multidisciplinary notes are to document, when pertinent, visible injuries, vital signs, and physician notification. ...Any [name of hospital] employee, medical staff member, ...Minor Harm An event or reaction that resulted in the need for minor intervention such as increased patient assessments, repeat specimen collection, or first aid. ...Temporary Significant Harm An event or reaction occurred that resulted in significant intervention such as initial or prolonged hospitalization, or increased level of care. ...Responsibility ... Patient Safety/Risk ... Review and follow up documentation for incidents involving assigned areas of accountability ...”. 5. During a review of Pt 27’s “H&P,” dated 2/20/25, the “H&P” indicated Pt 27 presented to the ED for generalized weakness for two weeks on 2/19/25 at 4:20 p.m. The “H&P” indicated, Pt 27 had a medical history of Systemic Lupus Erythematosus (SLE-autoimmune disease in which the body’s immune system attacks its own tissues, causing inflammation and damage in various organs). Pt 27 was admitted for elevated troponin (a protein found in heart muscle, when heart is injured, it is released), exacerbation (sudden worsening of symptoms) of chronic heart failure (heart not pumping blood effectively), and anemia (low levels of healthy red blood cells to carry oxygen) on 2/20/25 at 2:32 a.m. and was moved to the Oncology Unit on 2/20/25 at 6:55 p.m. During a concurrent interview and record review on 2/26/25 at 10:23 a.m. with ND 1 Pt 27’s “Care Plans [CP]”, dated 2/22/25 to 2/26/25, were reviewed. The “CP” indicated, “Problem: Nutrition Deficit”, started on 2/22/25. The “CP” indicated, “Goal: Adequate nutritional intake”, with interventions of education, for prescribed diet, food-medication interaction, and oral supplementation. ND 1 stated, determining if a patient was meeting the adequate nutritional intake goal was tracked and monitored by looking at the information documented on the intake flowsheet. During a review of Pt 27’s EMR document titled, “Weight Flowsheet [WF],” dated 2/19/25 to 2/25/25, the “WF” indicated, on 2/19/25 at 4:19 Pt 27 stated his weight was 230 pounds (lbs-a unit of mass measurement). The “WF” indicated, on 2/23/25 at 11:30 p.m. Pt 27 weighed 230 lb 6.1 ounces (oz-a unit of mass measurement), and was weighed by bed scale. The “WF” indicated on 2/24/25 at 5:49 p.m. Pt 27 weighed 225 lb 15.5 oz and was weighed by bed scale. The “WF” indicated on 2/25/25 at 10:44 p.m. Pt 27 weighed 227 lb and 11.8 oz and was weighed by bed scale. From 2/23/25 to 2/25/25 Pt 27 had 1.15% weight loss. During a review of Pt 27’s “Physician Diet Order [PDO],” dated 2/24/25 at 8:41 a.m., the “PDO” indicated, “ ... Diet hemodialysis [Special diet for people who use a machine to clean the blood] ... Start Date/Time 02/24/25 08:45 [8:45 a.m.] ...End Date/Time Until Specified ... Order Details ...Frequency ... Diet Effective Now ...”. During a concurrent interview and record review on 2/26/25 at 10:27 a.m. with ND 1 Pt 27’s “Intake Flowsheet,” dated 2/19/2025 to - 2/26/2025, was reviewed. The “Intake Flowsheet” indicated; Pt 27 did not have the percentage of diet entered for every meal. The “Intake Flowsheet” indicated, on 2/24/25 the only diet entry was 75% diet eaten at 9:26 p.m., no documentation was entered for breakfast or dinner. The “Intake Flowsheet” indicated, on 2/25/25 the only diet entry was 50% diet eaten at 8:45 p.m., no documentation was entered for breakfast or dinner. ND 1 stated, the percentage of diet eaten, and amount of diet supplements a patient was drinking was supposed to be documented on the flowsheet, for every meal. ND 1 stated, PCT’s were supposed to document in the “Intake Flowsheet” flowsheet when the food tray was picked up, and the PCT was supposed to report to the RN if the patient was not eating or eating very little. ND 1 stated, when patients continued to have inadequate nutrition and low percentages of intake less than 50% the RN should contact the physician for a dietary consult order, or a nutritional supplement. ND 1 stated Pt 27 did not have dietary consult order. During an interview on 2/27/25 at 11:14 a.m. with PCT 1, PCT 1 stated, she had been caring for Pt 27 since he was transferred to the unit on 2/26/25. PCT 1 stated her role in Pt 27’s nutrition was to pick up trays and deliver trays when a patient was on isolation (State of being separated from others). Pt 27 stated her role was to document the intake of food and fluids into the EMR on the “Intake Flowsheet”, and if patients were not eating to report to the patient’s RN. PCT 1 stated, encouraging Pts to eat was one of the duties assigned to PCTs. PCT 1 stated documentation of nutrition into the EMR was important to ensure proper nutrition, and if the Pt was not eating enough, the physician could then make changes to the Pt’s diet and could add supplements if necessary. During an interview on 2/27/25 at 11:17 a.m. with RN 9, RN 9 stated she is caring for Pt 27 for the day. RN 9 stated, Pt 27 had a “CP” for Nutrition Deficit due to a Cancer Diagnosis and Pt 27 got chemotherapy (a type of cancer treatment that uses drugs to kill or slow down growth of cancer cells) every week. RN 9 stated Pt 27 could get nutritional supplements as an intervention for nutrition deficit if ordered. RN 9 stated the way to progress the CP intervention would be to track and trend intake. RN 9 stated, the intake must be entered on the “Intake Flowsheet” to track the information. RN 9 stated RNs were supposed to contact the physician when patients were not eating and ask the physician for a nutrition consult for additional calories. RN 9 stated another way to ensure adequate nutrition could be to track and trend weights. RN 9 stated RNs were supposed to ensure PCTs document in the “Intake flowsheet”. During a review of Pt 30’s “H&P,” dated 2/20/25, the “H&P” indicated Pt 30 was an 85-year-old who was brought in by ambulance to the ED for body aches, generalized weakness, fevers, chills, and a cough, for 10 days. The “H&P” indicated, Pt 27 Pt 30 had a medical history of seizure disorder (chronic condition of recurring temporary episode of abnormal electrical activity in the brain that causes sudden change of behavior, movement, or consciousness), and Diabetes (disorder characterized by difficulty in blood sugar control and poor wound healing). The “H&P” indicated Pt 27 was admitted on 2/20/25 for sepsis (a life-threatening blood infection), community acquired pneumonia (CAP-an infection of the lungs that occurs outside the hospital setting), and depression (persistent low mood, loss of interest in activities). During an observation on 2/24/25 at 1:45 p.m. in Pt 30’s hospital room, Pt 30 was observed lying in bed at a 45-degree angle with her eyes closed, her respirations were even and unlabored. Pt 30 was observed with bilateral wrist restraints on, attached to the bed. Pt 30’s body looked frail. Pt 30 was not interviewable at the time of observation; Pt 30 was confused. During a review of Pt 30’s EMR document titled, “Weight Flowsheet [WF],” dated 2/19/25 to 2/25/25, the “WF” indicated, on 2/19/25 at 9:39 Pt 30’s weight was 130 lbs. The “WF” indicated, on 2/23/25 at 3 a.m. Pt 30 weighed 129lbs and 13.6 oz. The “WF” indicated on 2/24/25 at 4:32 a.m. Pt 30 weighed 116lb and 10oz. The “WF” indicated on 2/25/25 at 3:28 a.m. Pt 30 weighed 116ln and 2.9oz. From 2/23/25 to 2/25/25 Pt 30 had 10.68% weight loss. During a concurrent interview and record review on 2/26/25 at 11:25 a.m. with ND 1 Pt 30’s “IF,” and “Nursing Notes” and “PDO”, dated 2/21/2025 to - 2/25/2025, was reviewed. The “IF” indicated; Pt 30 did not have the percentage of diet entered for every meal. The “IF” indicated, on 2/22/25 the percentage of Pt 30’s diet eaten at 10 a.m. was 25%, at 2 p.m. was 0% and at 9:05 p.m. was 0% with a note Pt 30 refused dinner and nurse was aware. The “IF” indicated, on 2/23/25 the percentage of Pt 30’s diet eaten was 25% at 10:59 a.m. and 25% at 9:47 p.m. no entry was documented for lunch. ND 1 stated Pt 30’s average intake from 2/21/25 to 2/25/25 was 25%. ND 1 stated, the nursing notes do not indicate the physician was contacted to request a dietary consult. ND 1 stated Pt 30 was on a diabetic diet and Pt 30’s physician ordered a nutrition supplement on 2/22/25, but no documentation was in the “IF” for supplement intake. ND 1 stated, RNs should contact the physician when patients were not eating, to obtain an order for a dietary consultation, or supplement. ND 1 stated, Patient’s intake should be documented to collect data, RNs would need to see if the patient was progressing toward the goal of adequate nutrition or would need to change CP interventions. During a concurrent interview and record review on 2/26/25 at 11:20 a.m. with ND 1 Pt 30’s “Care Plans [CP]”, dated 2/22/25 to 2/26/25, were reviewed. ND 1 stated Pt 30 had a “CP” that was started on 2/20/25 for high risk of skin integrity impairment. The “CP” indicated, a goal of “Adequate Nutrition Intake”. ND 1 stated, the interventions were, consulting dietary, nutritional supplementation, and monitor weight as ordered or per unit standard of care. ND 1 stated Nursing staff did not follow the care plan by weighing the patient daily or consulting with dietary. ND 1 stated, a second “CP” of risk of impaired skin integrity, was started on 2/20/25. ND 1 stated the goal was absence of skin injury, and the interventions were to assess Pt 30 for a risk for skin impairment using the Braden Tool (a tool used to predict the risk of pressure ulcers in patients), assessing the patient’s usual food intake pattern. ND 1 stated, determining if a patient was meeting the adequate nutritional intake goal was tracked and monitored by looking at the information documented on the intake flowsheet. During an interview on 2/27/25 at 9:48 a.m. with Registered Nurse (RN) 7, RN 7 stated, when patients had a care plan for nutrition deficit RNs should ensure documentation of how much the patient was eating, voiding, and mobility. RN 7 stated nutrition was important to prevent skin breakdown and promote healing. RN 7 stated documentation was important to help the medical team determine what was causing the nutrition deficit. RN 7 stated, a nutrition deficit could be caused by a cognitive (thinking) issue, altered mental status (change in a person’s mental function, including their level of consciousness, awareness, cognition, or behavior), or many other issues. RN 7 stated, the physician should be notified when a patient was not eating and get an order for a dietary consult. RN 7 stated the Registered Dietician would give recommendations for increasing the caloric intake for the patient. During an interview on 2/28/25 at 3:44 p.m. with the CNO, the CNO stated, staff should be documenting intake and output in patient’s medical record to track if a patient’s nutrition was getting worse or improving. The CNO stated if patients were scoring low (1-very poor, or 2 probably inadequate) in the nutrition category upon RN shift assessment, the RN needed to contact the physician for an order. The CNO stated the physician could write an order for a nutritional supplement, medications, or a dietary consult, to assist with nutrition. The CNO stated RNs should monitor nutrition upon admission and throughout the hospital stay. During a review of the hospital’s P&P titled, “Interdisciplinary Plan of Care [IPOC]”, dated 10/12/23, indicated, “ ...The Plan of Care is to be used for all patients admitted to [hospital name] with time measurable goals evaluated daily and at discharge. ... Initiate the Plan of Care based on the patient’s comprehensive assessment and medical care of the provider responsible for the patient. ... Complete the documentation of goals at the end of each shift. Review and revise the interventions as appropriate. ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders ...” During a review of the hospital’s P&P titled,” Documentation in the Health Record,” dated 6/14/18, indicated, “ ...All patient care and activities are to be documented at the time care is provided ... Documentation of assessments, completion of notes from interviews and history taking, ...intake and output collection are recorded at the patient’s bedside. ...Documentation of care planning, completion of bedside educational modules, and result reviewing and graphing may be recorded outside the patient’s room ...”. During a review of the hospital’s P&P titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment,” dated 9/13/24, indicated “ ...Patients with a subscale (a specific section or component within a larger measurement tool or assessment) identified as a score of 1 or 2 are considered at risk for developing pressure injuries. The nurse will identify and implement an individualized plan of care that addresses the interventions appropriate to reduce the risk factors. ... Use the Braden Scale Risk Assessment tool to identify patients at risk for pressure injury as part of the initial admission patient assessment. Subsequent Braden Risk assessments are completed each shift. ... Develop a plan of care based on the areas (of risks, rather than on the total risk assessment score. For example, ...If the risk is from malnutrition, address this problem, etc. ... Nutrition a. Nurse completes the admission nutrition screening on all patients within 24 hours of admission to the hospital. The LVN reports abnormal findings to the RN and collaborates with the plan of care. Based on the nutrition screen results, all patients identified as at risk for malnutrition ... be referred to the Registered Dietitian (RD). ...Assess the adequacy and tolerance of oral nutrition, enteral [delivering nutrients directly to the stomach through a tube] nutrition, and/or parenteral [providing nutrients directly into bloodstream through a plastic tube into a vein] nutrition intake. List and record milliliters (ml [a unit of volume measurement]) of all liquids consumed including oral nutrition supplements on Intake and Output flowsheet (I&O) ...”. During a review of the hospital’s referenced document, “Braden Scale for Predicting Pressure Sore Risk”, in the P&P titled, “Pressure Injury Risk Assessment, Prevention, Staging and Treatment,” dated 9/13/24, indicated, “ ... Nutrition usual food intake Pattern ...1. Very Poor 2. Probably Inadequate 3. Adequate 4. Excellent ...”. During a review of the hospital’s document titled, “Standards of Practice Grid,” undated, the document indicated, Document intake and output every eight hours as needed, unless otherwise ordered on General Medical/Surgical Floors ...” During a review of the hospital document titled, “Patient Care Tech [PCT] 1 Job Description,” dated11/13/24, the PCT 1 Job description indicated, “ ... Job Summary ...Under the direction of a licensed clinical staff member [RN, LVN], the Patient Care Tech 1 (PCT1) provides both basic patient care and clerical support using defined procedures and standards in accordance with the goals of the unit ... Essential Accountabilities ...Records vital signs, height, weight and I/O. Collects and records data as assigned and reports information to RN. Recognizes, communicates and documents changes in patient’s condition either emergent or in response to patient care ...”. During a review of a professional reference titled, “Health professionals’ routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study,” dated 2/16/23, the professional article indicated, “ ... Documentation is a standard way of keeping ongoing patient care information. It is the relevant facts of routine health information and patient care plans, such as professionals’ evaluation and judgement about the patients, evaluation charts, tests, reports, subjective notes or professionals’ reflections ... Documenting routine practices is essential for the continuity of patient care, ... communication among healthcare professionals and better patient diagnoses and treatments ... it should be patient-focused, accurate, relevant, clear, permanent, confidential and timely ... Poor documentation practice affects patient management, continuity of patient care and medicolegal issues, which arise from incomplete and inadequate documentation, lack of accuracy and poor quality. It leads to adverse patient outcomes, medication errors and patient deaths. Distorted health information may influence health professionals’ decision-making capabilities due to inappropriate and misleading documentation practices ...”. During a review of a professional reference titled, “Nutritional Assessment,” dated 4/10/23, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK580496/) indicated, “ ... Evaluation of nutritional status is critical, either to identify if an individual has nutritional imbalance due to an underlying condition or to assess if an individual is likely to develop a pathological [condition related to disease or illness] condition due to nutritional imbalance. ...Nutritional assessment and intervention together break the vicious cycle between malnutrition and various diseases or conditions, in which malnutrition aggravates a disease/condition, and the disease/condition, in turn, precipitates malnutrition. Breaking this cycle helps in improving clinical outcomes. Nutritional and clinical management based on comprehensive nutritional assessment results in positive healthcare outcomes by reducing the recovery period, hospital length of stay, risk of complications, susceptibility to infections, and mortality (a term also used for death rate, or the number of deaths in a certain group of people in a certain period of time) associated with clinical and surgical illnesses. The use of standardized, systematic nutrition risk screening and assessment in the clinical setting also helps in reducing overall healthcare costs ...Nurses also help with early nutritional screening to identify nutrition risk factors and monitor the patient’s condition to maintain timely documentation records of clinical status...””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 41166 Based on interview and record review, the hospital failed to ensure medication was distributed from pharmacy in accordance with standards of practice and hospital policy and procedures when for two of two patients (PT 5, PT 49): 1. For PT 5, staff pharmacist did not clarify benzocaine 20% oral solution (medication used to relieve mouth pain) medication order when instructions for use were not clear, and staff pharmacist did not verify benzocaine 20% oral solution medication order or product for PT 5 and provided inaccurate medication-related information to Registered Nurse (RN) 5. 2. For PT 49, staff pharmacist did not clarify benzocaine 20% oral solution medication order when instructions for use were not clear. These failures resulted in RN 5 to incorrectly administer 30 milliliters (ml- unit of measure) of benzocaine 20% oral solution to Patient (PT) 5, and instructed PT 5 to swallow 30 ml of benzocaine 20% oral solution on 1/30/25. As a result, PT 5 experienced dizziness, tachycardia (increased heart rate), tachypnea (abnormal rapid breathing), cyanosis (bluish-purple discoloration of skin due to lack of oxygen), was transferred to Intensive Care Unit (ICU) , diagnosed with methemoglobinemia (rare condition where red blood cells cannot carry oxygen and can result in death), and treated with the antidote (medication taken to counteract poison) methylene blue (medicine used to treat methemoglobinemia) and hemodialysis (medical procedure that filters waste products and excess fluid from the blood when the kidneys are no longer functioning properly). PT 5 was discharged on 2/4/25. Findings: 1. During a concurrent interview and record review on 2/24/25 at 1:16 p.m., with Medication Safety Coordinator (MSC) and Nurse Director of Pediatric Unit (ND) 3, PT 5’s “History and Physical Exam (H&P)” dated 1/23/25 and “Medication Orders” dated 1/30/25 were reviewed. PT 5’s H&P indicated PT 5, age 25, presented to the Emergency Department for a ruptured gangrenous (tissue that has died) appendix (a tube-shaped structure like a pouch, attached to and opening into the lower end of the large intestine in humans), and was eventually admitted to the pediatric unit after operation. MSC stated, a medication order for benzocaine 20% oral mouth solution was verified by RPH 2 on 1/30/25 at 3:13 pm. MSC stated Pharmacy Technician (PhT) printed a label for the benzocaine 20% oral solution medication order after nursing staff requested the medication on 1/30/25 at 3:17 p.m. and packaged the medication. MSC stated the medication was verified and signed by RPH 2, after which the medication was delivered to the pediatric unit. MSC acknowledged RN 5 administered 30 ml of benzocaine 20% oral solution to PT 5 on 1/30/25 at 4:49 p.m. and the order was discontinued by a medical doctor on 1/30/25 at 7:16 p.m. ND 3 stated PT 5 was admitted to a side of the pediatric unit where pediatric nursing staff provided care for small adults. During a concurrent interview and record review on 2/24/25 at 2:23 p.m., with PhT and RPH 2, PT 5’s “Medication Orders” dated 1/30/25 were reviewed. PT 5’s medication order for benzocaine 20% oral solution ordered 1/30/25 at 3:05 p.m. indicated, benzocaine 20% oral solution, mouth/throat four times daily as needed for pain. PhT stated once a label was dispensed, a pharmacy technician would find medication, scan medication and label, put any auxiliary labels (provide extra information to ensure that medicine administration, use, and storage are done in the proper way) if needed and give to the pharmacist. PhT stated the label would usually indicate what auxiliary label was needed. RPH 2 acknowledged his pharmacist initials for checking PT 5’s 20% benzocaine oral solution. RPH 2 stated when doing final check of a medication product, a pharmacist was expected to check the right product, right size, right dose, expiration date, make sure auxiliary labels are correct and that it has been prepped by a pharmacy technician. RPH 2 stated mouth/throat was a topical route where a nurse should dip an applicator into the bottle and apply to mouth sores, and for topical product, doses cannot be quantified easily. RPH 2 acknowledged that PT 5’s benzocaine 20% oral solution medication label did not have any instructions. RPH stated mouth/throat meant topical administration to mucous membrane in the mouth, and orally meant swallowing. During an interview on 2/24/25 at 2:41 p.m., with Director of Pharmacy (DOP) and MSC, DOP stated she did not know if the hospital had a policy that defined mouth/throat as a route of administration and could not answer as to why mouth/through was used in the hospital’s order entry system. MSC stated there was a topical route in the hospital’s medication order entry system. MSC stated topical could apply to the body, mouth and throat, and would hope end user would clarify if confused about the route. MSC acknowledged PT 5’s benzocaine 20% oral solution medication label did not have administration instructions and stated there were opportunities to improve the instructions which had been done, including adding administration instructions for “do not swallow”, “swish and spit”, and removal of benzocaine 20% oral solution from the pharmacy inventory and hospital’s medication order entry system. MSC acknowledge it was the responsibility of the pharmacist to clarify medication orders for clear directions or instructions to help prevent medication errors. During an interview on 2/24/25 at 2:52 p.m., with ND 3, ND 3 stated she spoke with RN 5, and RN 5 did not recognize the form of benzocaine that was sent from pharmacy, so she called RPH 3 to ask how to administer the medication. RPH 3 directed RN 5 to instruct PT 5 to swish and swallow benzocaine 20% oral solution since PT 5 was having throat pain. ND 3 stated, as a result, RN 5 administered 30 ml of benzocaine 20% oral solution to PT 5, and instructed PT 5 to swish and swallow the medication. ND 5 stated if RN 5 would have had administration instructions that would have clarified what mouth/throat meant, instead of having just mouth/throat. ND 5 stated she had not seen mouth/throat as directions before. During an interview on 2/24/25 at 2:57 p.m., with DOP and MSC, DOP stated she spoke with RPH 3 and his recollection was that he did not look at the medication product or medication order in the hospital’s medication order system, and misinterpreted the medication RN 5 called about. MSC stated when a pharmacist receives a call, the expectation was to look at the medication order, check references, clarify medication order with provider if needed and give consultation. DOP stated pharmacists did not follow expectations on how to clarify medication orders. DOP acknowledge PT 5’s benzocaine 20% oral solution medication label did not have sufficient information on how to use the product, and the expectation was to contact provider, get clarifying information, and make adjustment to the order accordingly. DOP acknowledged mouth/throat route was not defined in the hospital’s medication administration policy and stated it was important for pharmacists, nursing staff and providers to know how route was to be used to reduce risk of incorrect medication administration. During a concurrent interview and record review on 2/26/25 at 1:11 p.m., with DOP and RPH 2, PT 5’s order for benzocaine 20% oral solution ordered 1/30/25 at 3:05 p.m., was reviewed. RPH 2 acknowledged she was the pharmacist who reviewed the order on 1/30/25 at 3:13 p.m. RPH 2 stated the expectation when reviewing a medication order was to review the key elements including dose, route, frequency, and sometimes end dated, and seek clarification if needed, with the doctor. RPH 2 stated, to her, mouth/throat meant topical, so swish and spit, gargle and spit, not swallow. RPH 2 acknowledged, the hospital did not have a definition for mouth/throat and stated her definition was based on her clinical judgement. RPH 5 acknowledged the benzocaine 20% oral solution medication order did not have cautionary instructions in the direction, and at the time thought it was clear that the medication should not be swallowed. RPH 2 stated she did not see any cautionary instructions printed on the label and acknowledged if cautionary instructions for benzocaine 20% oral solution were entered fin hospital medication order system, they would have printed on the medication label. During a concurrent interview and record review on 2/26/25 at 1:34 p.m., with RPH 2, PT 50’s medication order for lidocaine 2% mucosal oral solution (medication to relieve pain) was reviewed. PT 50’s order for lidocaine 2% mucosal oral solution ordered on 2/21/25 at 1:30 p.m., indicated 15 ml every 15 minutes, mouth/throat, swish and swallow. RPH 2 acknowledged mouth/throat could also mean “swish and swallow” and was not only indicated for “swish and spit”. RPH 2 stated if benzocaine 20% oral solution was swallowed, a patient could experience adverse effects including methemoglobinemia. During an interview on 2/26/25 at 1:47 p.m. with RN 5 and RPH 3, RN 5 stated she received PT 5’s benzocaine 20% oral solution bottle with a clear seal around the top, with a printed label on the bottle in a clear plastic zipped bag. RN 5 stated since she was unfamiliar with the medication, she asked her charge nurse about the medication, and the charge nurse directed her to ask RN 5 to consult RPH 3. RN 5 stated when she asked RPH 3 if PT 5 should “swish and swallow” or “swish and spit” the benzocaine 20% oral solution, RPH 3 told her PT 5 should “swish and swallow” the medication since PT 5 was experiencing pain in the throat. RN 5 stated she looked at the hospital’s drug reference and scanned the bottle’s manufacturer code for dosage information but was unable to find dosage information. RN 5 stated 30 ml was printed on PT 5’s benzocaine 20% oral solution label so she administered 30 ml to PT 5 on 1/30/25 at 4:52 p.m. During an interview on 2/26/25 at 2 p.m., with RPH 3, RPH 3 stated he did not review the medication order when RN 5 called to clarify directions for PT 5’s medication and thought the medication was lidocaine viscous oral solution. RPH 3 stated RN 5 told him it was for throat pain, so he instructed RN 5 to administer as “swish and swallow” because the medication needed to touch the throat to be effective. RPH 3 stated that ideally a pharmacist is expected to pull the information for the specific patient, and it was important to ensure the five rights of the patient to make sure the information was accurate. During a continued interview on 2/26/25 at 2:10 p.m., with RN 5, RN 5 stated PT 5 had already had surgery for his ruptured appendix and on 1/30/25, PT 5 was stable and medical staff was looking at his wound to make sure it wasn’t infected. RN 5 stated after approximately 45 minutes after administering PT 5 30 ml of benzocaine 20% oral solution, RN 5 was notified that PT 5 was asking for a nurse. RN 5 stated she observed PT 5 sitting at the edge of bed, saying that he was feeling dizzy. PT 5 stated he was sitting on a chair eating dinner and had a sudden urge to have a bowel movement. PT 5 stated he had a bowel movement, started feeling dizzy and called for RN 5. RN 5 stated she immediately took a reading of PT 5’s blood pressure, which was elevated and PT 5’s oxygen saturation (measurement of oxygen in the blood, normal range is between 95 to 100%), which was 77%. RN 5 stated she grabbed and put on a nasal cannula (flexible tube that delivers oxygen through the nose) on PT 5, called the charge nurse and informed her about PT 5. RN 5 stated after putting on PT 5’s nasal cannula, PT 5’s oxygen saturation improved to 80% so she changed his oxygen delivery to a nonrebreather mask (a type of oxygen mask that is used to deliver high concentrations of oxygen to patients who can breathe on their own but need supplemental oxygen, preventing them from rebreathing their exhaled carbon dioxide). RN 5 stated charge nurse called the physician, house supervisor and other medical staff. RN 5 stated the physician assessed PT 5 and PT 5 was transferred to the ICU on 1/30/135 at 7:26 p.m. During a concurrent interview and record review on 2/26/25 at 2:24 p.m., with RN 5, RN 5 stated PT 5’s 30 ml bottle of benzocaine 20% oral solution bottle did not have instructions for use. A review of two photographs of PT 5’s benzocaine 20% solution bottle provided by the hospital indicated the bottle did not contain instructions for use. During a record review on 2/26/25, PT 5’s “Physician Progress Note (PPN)”, signed on 1/30/25 at 8:24 p.m., the PPN indicated, “Paged by RN at 5:56 RN that patient had sudden drop in oxygen to 75% with minimal improvement even on nonrebreather fac mask at 100%. Immediately wend to bedside and patient was pale, on nonrebreather, but had no increased work of breathing on the facemask. O2 [oxygen] hovering at 80% and heart rate was elevated at 120s-130s and blood pressure 150s/80s, afebrile [not having a fever]. [PT 5] states that just before he was having a bowel movement and suddenly felt dizzy and weak and short of breath. RN called to room and he was able to walk back to bed. [PT 5] had clear lung sounds, and did not appear to be struggling to breath. His fingertips and toes appeared pale/dusky and cold. .. further review of MAR [medication administration record] found [PT 5] given benzocaine mouth spray as an oral solution approximately 1 hr [hour] prior to this episode. This raised suspicion for methemoglobinemia. Given ongoing poor oxygen saturation patient transferred emergently to ICU for further work up and management.” During an interview on 2/27/25 at 9:04 a.m., with RN 6, RN 6 acknowledged he was one of the nursing staff who provided care for PT 5 in the ICU. RN 6 stated he started his shift on 1/30/25 at 7pm, and PT 5 was transferred to ICU under his care on 1/30/25 at 7:26 p.m. RN 6 stated once PT 5 arrived in ICU, he was assessed, toxicology was consulted and recommended methylene blue, PT 5 was intubated for safety, a vascular catheter (vascath- flexible plastic tube that is inserted into a vein located either in the neck or in the groin and used for exchange transfusion) was inserted and PT 5 was dialyzed (a medical treatment that removes waste products and excess fluid from the blood when the kidneys are not functioning properly) around 2 to 3 a.m. in the morning. RN 6 stated when he returned the next day on 1/31/25 at 7 p.m., PT 5 was alert, walking and had returned to baseline. RN 6 stated when PT 5 arrived in the ICU, PT 5 was experiencing labored breathing, elevated heart rate (HR) in the 130’s, his extremities were more on the darker side and not the usual pale cooler, PT 5 was cool to touch. During a concurrent interview and record review on 2/27/25 at 10:14 a.m., PT 5’s “Flowsheet History (FH)” dated 1/30/25 to 1/31/25, the FH indicated PT 5 readings for 1/30/25 at 1 a.m., heart rate (HR) 99 and blood pressure (BP) 132/80; 1/30/25 at 11:48 a.m., HR 96 and BP 144/83; 1/30/25 at 5:55 p.m., HR 129 and BP 158/87; 1/30/25 at 6:25 p.m., HR 125 and BP 153/90; 1/30/25 at 7:45 p.m., HR 136 and BP 153/86; 1/30/25 at 10 p.m., HR 144 and BP 181/125; 1/30/25 at 10:20 p.m., HR 140 and BP 175/107; 1/30/25 at 11 p.m., HR 108 and BP 149/86; 1/31/25 at 1 a.m., HR 84 and BP 112/70; 1/31/25 at 4 a.m., HR 69 and BP 103/59; 1/31/25 at 7 a.m., HR 86 and BP 129/86; 1/31/25 at 4 p.m., HR 88 and BP 123/72; 1/31/25 at 10 p.m., HR 85 and BP 129/71; 1/31/25 at 11:31 p.m., HR 86 and BP 119/65. During a record review on 2/27/25 at 10:14 am, PT 5’s FH dated 1/30/25 to 1/31/25 indicated PT 5’s oxygen saturation readings on 1/30/25 at 8:10 a.m., 96%; 1/30/25 at 11:48 a.m., 97%; 1/30/25 at 5:55 p.m., 77%; 1/30/25 at 6:29 p.m., 82%; 1/30/25 at 7:45 p.m., 73%; 1/30/25 10 p.m., 87%; 1/30/25 at 11 p.m., 87%; 1/31/25 12 a.m., 88%; 1/31/25 at 1 a.m., 89%; 1/31/25 at 4 a.m., 95%; 1/31/25 at 6 a.m., 93%; 1/31/25 at 8 a.m., 90%; 1/31/25 at 12 p.m., 93%; 1/31/25 at 4 p.m., 95%; 1/31/25 at 7 p.m., 96%; 1/31/25 at 10 p.m., 96%; 1/31/25 at 11:31 p.m., 97% During a continued interview and record review on 2/27/25 at 10:40 a.m., with RN 6 and Nurse Manager (NM) 4, PT 5’s “Laboratory Results” dated 1/30/25, MAR dated 1/29/25 through 2/4/25, and “Nursing Note” dated 1/31/25 at 3:43 a.m., were reviewed. RN 6 stated methemoglobinemia was a rare reaction from ingesting benzocaine solution where the blood cannot bind oxygen and worst-case scenario, a patient needed to be dialyzed. NM 4 stated a diagnosis for methemoglobinemia was confirmed on 1/30/25 at 7:55 p.m., with a positive laboratory result value of 50.9 for methemoglobin. RN 6 stated PT 5 was administered 4 doses of methylene blue on 1/30/25 at 7:37 p.m., 7:57 p.m., 8:11 p.m., and 8:33 p.m., to treat methemoglobinemia. RN 6 stated PT 5 received dialysis treatment during the early morning of 1/31/25 for 82 minutes. NM 4 acknowledged PT 5’s signs and symptoms experienced was likely due to benzocaine intoxication, and if not caught in time, there was risk for death, cardiac arrest ( medical emergency where the heart suddenly stops beating, preventing blood from being pumped to the body), and loss of life and limb. During a record review on 2/26/25, PT 5’s PPN, signed on 1 /30/25 at 10:59 p.m., the PPN indicated, “discussed concerns for possible methemoglobinemia with on call toxicologist [name]. [MD 6] recommended STAT [immediate] dosing of methylene blue [dose] and may repeat this up to 3 total doses at 10-minute intervals if no response to first dose ... First dose finished at 1944. Saturations remained in 70’s. Second dose finished at 2002. Saturations remained in 70s-80s. Third dose began and discussed with Dr. [name] again at 1015 to let him know the third dose is being administered ... Discussed with hematology [study of blood diseases] @ [at] 2029, who will plan for exchange transfusion [a medical procedure where a patient’s blood or blood components are removed and replaced] tonight. Vascath consent obtained, see separate note. [MD 6] recommending endotracheal intubation [medical procedure that involves inserting a flexible tube into the windpipe to keep the airway open], consent obtained; see separate note.” 2. During a concurrent interview and record review on 2/26/25 at 9:33 a.m. with Nursing Manager (NM) 4 and RN 4, PT 49’s H&P dated 1/16/25 and “Medication Orders” dated 1/19/25 were reviewed. PT 49’s H&P indicated, PT 49, age 24, presented to the Emergency Department on 1/16/25 for altered mental status (a change in how well the brain is working), combative, and with a positive laboratory result for methamphetamines (powerful addictive drug that can cause depression, hallucinations, and violent rages), and was admitted to the ICU. PT 49’s order for benzocaine 20% oral solution, ordered 1/19/25 at 5:33 a.m., indicated benzocaine 20% solution, mouth/throat, four times daily as needed for pain. RN 4 stated PT 49 needed medication to soothe his throat so benzocaine 20% oral solution was ordered by the physician. RN 4 acknowledged the medication label for benzocaine 20% oral solution did not have administration instructions, and stated he had previous experience administering benzocaine 20% oral solution. RN 4 stated he knew the medication should not be swallowed, so he poured some of benzocaine 20% oral solution in a medication cut and instructed PT 49 to gargle and spit out the medication. During an interview on 2/26/25 at 1:11 p.m. with DOP, DOP stated staff pharmacists who verified PT 49’s benzocaine 20% oral solution order were unavailable because pharmacist who verified PT 49’s benzocaine 20% oral solution medication order was no longer employed at the hospital and pharmacist who verified packaging of Pt 49’s benzocaine 20% oral solution was not scheduled to work during survey period. During an interview on 2/27/25 at 2:21 p.m., with DOP, DOP stated mouth/throat was an ambiguous indication for a route of administration. DOP stated the expectation was for pharmacists clarify how the mediation was intended to be used, and for any medication, clear instructions to prevent medication error are important. DOP acknowledged mouth/throat route of administration was ambiguous and need to be clarified because it could be “swish and swallow” or “swish and spit”. DOP stated RPH 2 who received medication order should have identified the instructions for use were unclear and need to clarify directions with prescriber. DOP stated for medications that are given orally not swallowed, or swish and spit, instructions would be in the administration instructions of the medication order. DOP acknowledged PT 5’s benzocaine 20% oral solution bottle did not have instructions and was delivered to RN 5 with the manufacturer box containing instructions. DOP acknowledged a pharmacist role is to serve as a drug subject matter expert and provide accurate drug information to nurses and healthcare providers. DOP stated before providing drug information, the expectation was for a pharmacist to look at medication order and/or product directly to confirm that they are talking about the correct product or order. DOP stated this was important to ensure there was no miscommunication about the question or order to prevent medication error or potential patient harm. DOP stated methemoglobinemia was a known potential adverse event to benzocaine ingestion and even in small doses. DOP stated this was a serious adverse event because it prevents proper oxygen carrying by the red blood cell and could potentially lead to patient death. DOP stated PT 49’s benzocaine 20% oral solution medication order should have been verified by a pharmacist. During a continued interview on 2/27/25 at 2:36 p.m., with DOP and PM, DOP stated that on the day pharmacy leadership was made aware of PT 5’s benzocaine 20% oral solution medication incident, pharmacy leadership reviewed all benzocaine products in the hospital’s medication order entry system and removed all benzocaine products except single dose benzocaine applicator spray, and pharmacy staff was notified. DOP stated education was also provided to pharmacy staff for expectation that orders needing doses or instructions for administration be clarified before verification and dispensing, and when asked about questions regarding a medication order or product, to look at medication order and product before answering the question. PM stated an in-service presentation on the methemoglobinemia was also provided to all pharmacists. During a review of the hospital’s Policy and Procedures (P&P), titled, “Medications- Orders, Administration, Storage, Documentation”, dated 12/19/23, the P&P indicated, “A medication order must be clear, legible and include the following ... d. dosage and method of administration ... Any orders for medication that are illegible, incomplete, and/or unclear will require clarification .... If an illegible, incomplete, and/or unclear order is received in the pharmacy, the pharmacist will contact the ordering prescriber and will clarify using the telephone/verbal order process ...Pharmacy will communicate the changes to the patient’s RN ...” During a review of the hospital’s P&P, titled “Provider Orders”, dated 8/25/23, the P&P indicated, “If an RN or LVN [licensed vocational nurse]/LPT [licensed psychiatric technician] receives a physician’s order and believes it should not be carried out because of the above-mentioned reasons, the following actions are to be taken: a. If it is a medication order, utilized the Hospital Formulary, Physician Desk Reference (PDR), Care Notes PDR, or pharmacist to confirm correct dosage, administration route, and side effect.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 45929 Based on observation, interviews, and record review, the facility failed to ensure unusable medications were not available for patient use when an intravenous (IV, in the vein) fluid bag was out of its protective overwrap against professional standards in the medication room (a room where medications are stored and prepared) on 2nd floor East. This failure had the potential for patients to receive altered, ineffective, and contaminated medications. Findings: During a concurrent observation and interview on 2/24/25 at 11:35 a.m. in 2nd floor East medication room with Registered Nurse (RN) 1, an IV fluid bag missing its protective overwrap was in the stock of IV fluids available for patient use. RN 1 stated an IV fluid bag that did not have a protective overwrap could not be used for a patient. RN 1 stated the IV fluid bag could have been tampered with and should have had a date and time on the bag once the overwrap had been removed. RN 1 stated the exposed IV bag needed to be disposed of. During a review of a professional reference titled, “Working up a sweat (WUS)”, dated 10/2002, the “WUS” indicated, “ ... The purpose of the overwrap [for IV bags] is to improve shelf life and to stabilize the drug concentration. What happens then if a bag is removed from its overwrap and remains unused for days or weeks? Over time, the fluid volume inside the bag decreases and the drug concentration per milliliter [ml, a unit of measure] increases ... Don’t remove the overwrap from any I.V. bag stored in your unit until you’re ready to use the solution ...”. During a review of a professional reference titled, “Expiration dates and removal of i.v. bag overwrap (EDR)”, dated 9/1/95, the “EDR” indicated, “ ... The overwrap protects against evaporation of the solution, desiccation [removal of moisture] of the container, drug oxidation [common way of degrading a drug], and photochemical [with light] inactivation of the drug. Without a barrier, substantial moisture loss may occur, increasing the drug concentration ... Manufacturers of these products recommend ... removing the overwrap just before the drug or solution is administered ...”.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45929 Based on observations, interviews and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures and clinical standards of practice for infection control when: 1. Ice was found in six open plastic cups in the patient nutrition freezer in the 2nd floor patient nutrition room and six plastic pitchers in 4th floor patient nutrition room. 2. One package of self-adherent wrap bandage (a stretchy, tape-like bandage that sticks to itself, not to skin or clothing) was observed on the floor of the clean supply room on the 8th floor Cardiovascular (heart) Medical Surgical (MS) Unit. One new unused electrocardiogram (ECG) (a record or display of a person’s heartbeat) electrode (sticker) was observed on the floor of the clean supply room on the 7th floor MS Oncology (cancer treatment) Unit. Four packages containing individual 18-guage (G-inner diameter of needle opening measurement) hypodermic needles (thin sharp hollow needle) were observed on the floor of the clean supply room on the 4 South Unit at the Surgery Center. Two packages containing needleless cannulas (a medical device designed to access intravenous (into the vein) systems without the use of a traditional needle), and one unused blood collection tube were observed on the floor of the clean supply room on the 2nd floor Cardiovascular Intensive Care Unit (CVICU-specialized heart care) at the Surgery Center. 3. Intravenous line (IV) infusing medication did not have alcohol-impregnated caps (caps disinfect and protect IV access points, reducing the risk of infection) for one of ten patients (Patient 40). These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the spread of infection. Findings: 1. During a concurrent observation and interview on 2/24/25 at 11:20 a.m. on the 2nd floor patient nutrition room with Registered Nurse (RN) 1, six uncovered plastic cups were filled with ice in the freezer and the ice pieces were fused together. RN 1 stated the ice was probably placed in the freezer when the ice machine was out of order several days ago. RN 1 stated she did not recall the date the ice machine was out of order. During a concurrent observation and interview on 2/24/25 at 1:15 p.m. on the 4th floor patient nutrition room with RN 11, six plastic ice pitchers were filled with ice in the freezer. RN 11 stated the ice was placed in the freezer when the ice machine’s filter was replaced on 2/21/25. During an interview with the Infection Prevention Director (IPD) on 2/28/25 at 2:30 p.m., the IPD stated it was not the hospital’s practice to store ice in the patient’s nutrition freezer. During a professional reference tiled, “Why the ice cubes in my ice container stick together? (WIC)”, dated 3/22/18, the “WIC” indicated, “ ... If ice cubes have not been used for a long period of time, the cubes melt into each other during the defrost cycles and stick together ...”. During a professional reference titled, “Preventing Ice contamination with Safe Practices (PIC)”, dated 4/15/20, the “PIC” indicated, “ ... The FDA [Food and Drug Administration] defines ice as food ... Since ice contamination starts with the user, you need to make sure your employees are handling the ice properly ... never throw unused ice back into the ice bin. If a server accidently fills an extra glass with ice, they should toss that ice into a sink ...”. 2. During a concurrent observation and interview on 2/24/25 at 1:25 p.m. with Nurse Manager (NM 5), on the 8th floor MS Cardiovascular Progressive Care Unit, in the Clean Supply Room, one package of self-adherent wrap bandage was observed on the on the floor. NM 7 stated, supplies should not be used on patients after being on the floor, due to cross contamination. NM 5 stated if supplies fall on the floor, they should be thrown away. NM 5 discarded the package into the trash. During a concurrent observation and interview on 2/24/25 at 1:49 p.m. with Clinical Supervisor (CS) 2, on the 7th floor MS Oncology Unit, in the Clean Supply Room, one new unused ECG electrode was observed on the floor. CS 2 stated, the electrode should not be on the floor and should not be used on patients after being on the floor. CS 2 stated supplies should not be used on patients after being on the floor due to cause cross contamination. CS 2 stated the electrode should be thrown away. CS 2 discarded the electrode in the trash. During a concurrent observation and interview on 2/25/25 at 10:44 a.m. with Nurse Director (ND) 5, on the Surgery Center’s 4 South Unit, in the Clean Supply Room, four packages containing individual 18-G hypodermic needles were observed on the floor. ND 5 stated using the needles on a patient would be an infection control concern, due to cross contamination. ND 5 stated, the floor was considered dirty, and patient supplies should not be on the floor. ND 5 stated supplies on the floor should be discarded. ND 5 discarded the needles into the container for sharps disposal. During a concurrent observation and interview on 2/25/25 at 10:58 a.m. with ND 5, on the Surgery Center’s 2nd floor CVICU, in the Clean Supply Room, two packages containing needleless cannulas, and one unused blood collection tube were observed on the floor of the clean supply room. ND 5 stated, the supplies should not be on the floor due to infection control. ND 5 discarded the supplies into the trash. During an interview on 2/28/25 at 2:36 p.m. with the IPD, the IPD stated, anything on the floor needed to be thrown away. The IPD stated, the standard of practice was to use clean patient supplies, and not use patient supplies dropped on the floor, because the floor was dirty. During an interview on 2/28/25 at 3:42 p.m. with the Chief Nursing Officer (CNO), the CNO stated, supplies for patients should not be on the floor in the clean supply room. The CNO stated when supplies were found on the floor they should not be used on patients and should go back to the central supply department, or in the trash. During a review of the professional reference titled, “The role of the surface environment in healthcare-associated infections”, dated August 2013, the professional reference indicated, “ ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider’s hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ...”. During a review of the professional reference titled, “Good Storage and Distribution Practices for Medical Products”, (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, “ ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ...”. During a review of the professional reference titled, “Keeping it Sterile: Fundamentals of Sterile Storage,” (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, “ ... Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ...”. 3. During a concurrent observation and interview on 2/24/25 at 11:37 a.m. with the Director of Emergency Department (DED), NM 6 and NM 7 in the Green zone in the Emergency Department, Pt 40 had an antibiotic (medications used to treat and prevent bacterial infections) infusing (method of putting fluids, including drugs, into the bloodstream) via IV tubing (flexible plastic tube that delivers fluids and medications into a patient’s bloodstream) without alcohol-impregnated caps (is a cap or cover that is infused with alcohol, designed to be placed on the implanted port of IV tubing to disinfect the access point and prevent contamination) on the IV tubing port (NM 6 stated since the IV tubing was a one-time use for an antibiotic he was unsure if it needed any alcohol-impregnated caps on it. NM 6 stated he was not sure if the facility had a policy for one-time (designed to be used once and then thrown away) or multi-use (designed to be used repeatedly) IV tubing. The DED stated all IV tubing ports should have alcohol-impregnated caps on them. The DED stated the nurse should have put the alcohol-impregnated caps on the IV tubing port. The DED stated the alcohol-impregnated caps help prevent infection. During an interview on 2/28/25 at 2:30 p.m. with the IPD, the IPD stated that the expectation is for all nurses to put alcohol-impregnated caps on all IV tubing, regardless of single use or multi-use. The IPD stated it is common practice to have caps on IV tubing’s. The IPD stated the caps help mitigate infections and are to be used on all IV tubing’s to help protect the patient from possible infections. During an interview on 2/28 at 3:36 with the CNO, the CNO stated it is the facility policy to have an alcohol-impregnated cap on every IV tubing both single and multi-use IV. The CNO stated the caps help with infection prevention and keeps the patients from getting sicker than they already are. During a review of the hospital’s P&P titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites,” dated 6/14/24, the P&P indicated, “I. PURPOSE. To establish the standard for maintaining asepsis by preventing the use of potentially contaminated intravenous (IV) tubing. II. DEFINITIONS. A. Disinfecting Port Protector (brand name): A single use passive disinfection device that luer-locks securely onto needless IV ports and provides a physical barrier to contamination between accesses. Disinfects in 1 minute ...Policy ... D. Aseptic technique and standard precautions are to be followed when performing this procedure. 1. A disinfecting port protector should be aseptically attached to each needleless accessible port (brand name) and at the end of the IV tubing (brand name) after each intermittent use ...V. Procedure ...I. Remove disinfecting port protector and scrub the needless connector with alcohol swab for at least 15 seconds ...”.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to ensure staff adhered to interventions meant to support the effectiveness of the policy and procedure (P&P) titled “Universal Protocol - Procedural Areas” for one (1) of eleven (11) sampled patients when on 2/18/25, the hospital self-reported to the California Department of Public Health (CDPH), a wrong side orthopedic (branch of medicine dealing with the treatment of bones, joints and muscles) procedure after surgery on Patient (Pt) 2 on 2/13/25. This failure resulted in an unnecessary procedure for Pt 2, and had the potential for Pt 2 and future patients to suffer, needlessly, from the effects of wrong side surgery such as pain, injury, and additional surgery. Findings: During record review on 2/26/25 at 8:45 a.m., with Nurse Director (ND) 6, Pt 2’s Electronic Health Record Electronic Health Record (EHR- a digital version of a patient’s medical history) was reviewed. During record review of Pt 2’s History and Physical (H&P- a formal assessment of a patient’s health that includes a medical history and physical exam) dated 12/13/25, indicated “...CHIEF COMPLAINT: ... Pedestrian vs Vehicle...reportedly struck by vehicle traveling approximately 45 miles per hour (mph)...42 y.o. (year old)...GCS 13 (Glasgow Coma Scale score- is a number that describes how responsive a patient is. It’s used to assess a patient’s level of consciousness and the severity of brain injuries. A score of 13 to 15 indicates mild traumatic brain injury (TBI), also known as a concussion). trauma (injury) noted to face, open deformity of left lower leg (a bone in the leg has broken through the skin, leading to an open wound and potential infection, and a possible need for surgery to fix the fracture and any accompanying damage), and closed deformity of left wrist (a deformity that doesn’t involve an open wound or fracture), obvious open left tib-fib (tibia-fibula- a fracture of both the tibia (shinbone) and fibula (calf bone) where the bone has pierced through the skin, requiring immediate medical attention and potentially surgery) and appears to have right acetabulum (a break in the socket-shaped bone (acetabulum) on the right side of the hip joint) fracture on pelvis (bones between the lower abdomen and upper thighs that connect the spine to the legs) x-ray. Initially hemodynamically (how your blood flows through your arteries and veins and the forces that affect your blood flow) stable (enough to go to CT where Pt 2 was found to have fluid around the liver and possibly down to the pelvis. Patient BP (blood pressure) began to drop after CT down into the 80’s, MTP (rapid administration of large amounts of blood products) activated and patient taken emergently to the OR (operating room)...... Patient reports taking a blood thinner, but doesn’t know what...No past medical history on file...unable to assess history at this time...Assessment & Plan...to OR, Plan films and orthopedic consult for orthopedic injuries after OR...” During record review of Pt 2’s “ADT Events” undated, the record indicated Pt 2 was taken to the OR on “...2/13/25 at 0705 (7:05 a.m.)...” then to the Post-Anesthesia Care Unit (PACU)- a specialized recovery room in a hospital or surgery center where patients are closely monitored after undergoing surgery or procedures that require anesthesia (use of medicines to prevent pain during surgery and other procedures) on “...2/13/25 at 1121 (11:21 a.m.)...” remaining in the PACU Overflow area from “...2/13/25 at 1319 (1:19 p.m.) to 1629 (4:29 p.m.)...” During record review of Pt 2’s “Treatment Plan (TP)” dated 2/13/25 at 4:22 p.m., the TR indicated, “...Patient’s acetabulum (s a cup-shaped socket in the pelvis that forms the hip joint.) fracture requires femoral traction (a technique using devices and weights to gently pull and realign a fractured or dislocated leg (or thighbone, or femur) to restore proper alignment and stabilize the fracture for healing, either as a standalone treatment or before surgery). Will proceed under implied consent as below. Implied Consent: Patient unable to provide informed consent; unable to contact family or next of kin. It is believed that the benefits from the procedure(s) would outweigh the associated risks of the procedure(s). Furthermore, it is inferred that the patient or patient’s surrogate would consent to the procedure if the patient was not incapacitated or patient’s surrogate was available. Procedure: right femoral skeletal traction pin (a medical procedure where a pin is surgically inserted into the femur bone, typically at the distal end, to facilitate skeletal traction for fracture management or temporary stabilization)...” During an interview on 2/27/25 at 9:05 a.m., with Director Peri-Operative, Surgery Scheduling and Revenue (DOR), DOR stated did not witness event, reported event via [hospital event reporting system]. DOR stated a preliminary investigative indicated Pt 2 was hemodynamically unstable with the RN at head of bed monitoring Pt 2 (who just arrived from the OR to PACU). DOR stated there were 3 teams [of surgeons] OMFS (Oral Maxillofacial Surgery- a dental specialist, surgically trained in a hospital-based residency, who specializes in the diagnosis and surgical treatment of diseases, injuries, and defects involving the face, mouth, and jaw), Trauma Team, at the head of bed near the center of Pt 2’s bedside, Ortho closer to foot of the bed. DOR stated a time out (a short, planned pause before an invasive procedure or surgery to ensure the right patient, procedure, and site are being addressed, promoting patient safety and preventing errors) was not performed prior to the orthopedic surgery. DOR stated the Residents (a medical school graduate who is undergoing postgraduate training in a specific medical specialty) determined the left leg had been pinned (an orthopedic surgeon (bone doctor) pushes a metal pin or wire through the skin and into the bone) at time of completion of the procedure, but prior to traction initiation. DOR stated the orthopedic surgeons (Residents) performed the procedure under implied consent (implied consent allows healthcare providers to act in the best interest of the patient’s well-being when time-sensitive decisions are necessary) due to their determining the injury to be of an urgent nature. DOR stated her understanding of implied consent is when there is danger to life or limb, don’t delay care to get consent from next of kin (refers to the closest living relative of a patient who is authorized to make medical decisions on their behalf if they are unable to do so themselves). DOR stated once the event was detected, a huddle (a brief, informal meeting among healthcare team members to discuss patient care, safety, and operational issues) was conducted with MD 3. DOR stated a debrief with the involved parties was on 2/18/25. With a root cause analysis (RCA- is a tool to help healthcare organizations retrospectively study events where patient harm or undesired outcomes occurred to identify and address the root causes) initiated by Risk Management on 2/21/25. During an interview on 2/27/25 at 1:08 p.m., with Director of Risk Management and Patient Relations (DRM), DRM stated the event was first detected Event occurred on 2/13 approx. 7:44 p.m. and was reported to CDPH on 2/18/25. DRM stated the RCA had been started with an RCA meeting held on 2/21 including the event staff. DRM stated since then, the DOR began conducting huddles with PACU staff on expectation regarding timeouts. DOR stated an outcome and any related recommendations will be provided to CDPH when it is available. DRM stated hospital has initiated immediate education to all residents and attending faculty as of 2/27. DRM stated this education included review of informed consent policy, highlighting the differences between simple and complex procedures and then universal protocol and time-out steps, and reviewed Universal Protocol policy with close attention to specific procedures done in procedural areas, which should be done the same as it is done in the OR suite. DRM stated the preliminary contributing factors were multiple procedures performed in tandem with many disciplines involved . DRM stated hospital has required signed attestations from residents, and attending faculty. DRM stated they are still working on other gaps identified and how to manage those. During an interview on 2/27/25 at 3:42 p.m., via telephone, with Medical Doctor (MD) 4 and MD 2, MD 4 stated a consult for [Pt 2], a trauma patient, was requested while Pt 2 was in Emergency Department. MD 4 stated Pt 2 had been taken to the OR emergently. MD 4 stated he saw PT 2 in the PACU, after reviewing a CT angiogram images showed “run-off.” MD 4 stated this is an exam that looks at vessels (a tube or canal that carries body fluids, such as blood or lymph, throughout the body) in lower extremity (leg) under contrast (A dye or other substance that helps show abnormal areas inside the body). MD 4 stated radiology images were reviewed in the team room with MD 2 and another Resident. MD 4 stated images reviewed. MD 4 stated during this review a hypothetical scenario (a situation that is imagined or proposed but may or may not be real) as it would require a different approach. MD 4 stated on his arrival to the PACU there were two (2) other teams present [MOFS and General (Trauma)] along with an X-ray Technologist (uses specialized equipment to take x-rays and other medical images to help doctors diagnose and treat illnesses and injuries) performing x-ray exams ordered before Pt 2 was taken to the OR emergently. MD 4 stated he approached Pt 2 at bedside. MD 4 stated he asked neighboring staff (RNs) to help with gathering supplies. MD 4 stated he irrigated and closed the wounds with nylon suture. MD 4 stated short leg splint (LT) traction supplies were prepared, the area marked and they proceeded w/application to L. MD 4 stated MD 2 (supervising faculty - a physician with a faculty appointment within a medical school who oversees the clinical activities and/or research projects of medical students, residents, or fellows to ensure patient safety, appropriate supervision, and professional development) presented to the PACU. MD 4 stated MD 2 notified them that the procedure should have been on right leg. MD 4 proceeded to prepare the right side. MD 4 stated the procedure was performed under “implied consent” Pt 2 was intubated and sedated and had been a trauma activation admitted under a trauma name (Doe), with no contact information to reach out to anyone to get consent. MD 4 stated general surgery were present overseeing x-ray procedure, OMFS was repairing laceration. MD 4 stated RN 14 was located at bottom left side of Pt 2’s bedside. MD 4 stated he briefly interacted with RN 14, “she was one of the nurses to grab supplies” for the procedure and a neighboring RN also helped him gather the needed supplies for the procedure. MD 4 stated Lifesaving,” probably not lifesaving, no.” Recommended traction pin due to unstable acetabular.... concern for further subluxation or potential dislocation. MD 4 stated given Pt 2’s instability, on (blood) pressure medications, telemetry monitoring, unstable vital signs (VS-measurements of the body’s most basic functions) with labile (blood) pressures in the low 100’s, it is usual to have the teams at the bedside in PACU. MD 4 stated he discussed with General Surgery (Resident), asked one of those residents asked for a bolus (a single dose of a drug or other medicinal preparation given all at once) of propofol [to sedate Pt 2]. MD 4 stated the general surgeon stated Pt 2 was likely able to tolerate the bolus and the procedure was started. MD 4 stated his understanding of implied consent is necessary for the betterment for the patient who is not able to consent/advocate for themselves and without an identified health care representative. MD 4 stated he received education about the consent process at the beginning of residency group in a lecture format in June 2024. MD 4 stated a time out had not been performed before starting the procedure which resulted in the incorrect side procedure. MD 4 stated a time out was done on the second procedure (to the correct leg). During an interview on 2/28/25 at 8:30 a.m., with Registered Nurse (RN) 14, RN 14 stated she recalled the event involving Pt 2. RN 14 stated she had been relieved for a break by a resource (a registered nurse who supports other nurses by providing extra assistance with patient care tasks, such as admissions, discharges, and other nursing responsibilities, often helping to ensure the timely completion of tasks and improve overall patient care) RN, who reported Pt 2 was hemodynamically stable after leaving the OR for the IR intervention for possible pancreatic bleed. RN 14 stated upon assuming care of Pt 2, blood pressure had stabilized. RN 14 stated the surgical teams OMFS and Trauma/General were at Pt 2’s bedside in the PACU. OMFS was concerned with facial laceration repair, Trauma/General Surgery team concerned with Pt 2’s hemodynamic stability after multiple blood products, and exploratory laparotomy with closure of Pt 2’s abdomen with an “brand name” (device used as -(a temporary abdominal closure system, designed to remove fluids from the abdominal cavity and draw wound edges together) and a trip to the Interventional Radiology (IR- the minimally invasive, image-guided treatment of medical conditions that once required open surgery). RN 14 described Pt 2’s bedside as very busy with her actively monitoring vital signs, initiating vasopressor support along with managing pain and sedation medication drips. Added to this activity was the x-ray technologist moving about the patient positioning and shooting numerous x-rays ordered by the surgical teams. RN 14 stated she did not assist the orthopedic residents during their procedure. RN 14 stated she did not realize that the orthopedic residents had initiated a procedure until she overheard statements made, by whom she did not recall, that the wrong side had been pinned. MD 5 stated he recalled the event. MD 5 stated shortly before he went to PACU MD 4 and MD 2 (Supervising Faculty) were in the team room MD 4 was going through the imaging with MD 2. MD 5 stated they reviewed Pt 2’s CT images, which showed “runoff.” MD 5 stated an x-ray of the pelvis, single view was pulled up with the CT scan pelvic imaging only around the right hip joint. Both saw the RT pelvis fracture with previous pelvic hardware located on Pt 2’s left side. MD 5 stated it was easy to see where the facture was based on LT previous hardware. MD 5 stated he had received report that Pt 2 had been in general surgery to the abdomen, was unstable, intubated and sedated. MD 5 stated given the extent of the injuries Pt 2 suffered, when there is a fracture, where they would not be doing in a definitive surgery (a more permanent procedure), they could wash it out (clean), close [the wound(s)] and apply a supplemental immobilization device. MD 5 stated because of Pt 2s unstable condition, the pelvic fracture could not be addressed right away. MD 5 stated it was decided to place the leg in traction after reviewing the imaging which showed a right transverse acetabulum and LT tib fib. MD 5 stated it was agreed that a long leg splint foot to mid-thigh, to stabilize the fracture to take pressure off the acetabulum. MD 5 stated he did not participate in the theoretical/educational discussion had by MD 4 and MD 2. MD 4 stated MD 4 went to gather supplies needed for the washout and splinting. MD 5 stated he met up with MD 4 in the PACU where all needed supplies were already at Pt 2’s bedside. MD 5 stated x-rays were being done, with general surgery residents supervising and working on the patient hemodynamics, MD 5 stated he and MD 4 spoke with a general surgeon about plan to apply a long leg splint for the tib fib and the traction. MD 5 stated a time out was not done for the first procedure. MD 5 stated they started with prepping washing and then splinted. MD 5 stated a time out was not necessary for the washing out and splint application. MD 5 stated a time out should have been done for application of a traction device. MD 5 explained shortly after placing the splint, MD 2 arrived and recognized the error. MD 5 stated weight had not been applied to the left leg. MD 2 ordered an immediate removal of the traction pin (one pin) to the left side- distal thigh/femur. MD 5 stated the left sided pin was removed and immediately irrigated and closed. MD 4 stated they then moved on to the right after getting new supplies. MD 5 stated he wrote the implied consent note after assessing the Pt 2’s medical status (intubated, sedated, etc.). MD 5 stated the decision to treat by placing the right lower extremity was due to concern with prevention of morbidity [rate] (the state of being symptomatic or unhealthy for a disease or condition) with this type of fracture pattern. MD 5 stated putting in the pin was not emergent but had the potential to evolve (become more complicated). During an interview on 2/28/25 at 3:38 p.m., with Chief Nursing Officer (CNO), the CNO stated, expectation is that this type of event, wrong side surgery, should not happen. CNO stated procedure should be with consent, procedure to be done with confirmation of which side is to be operated on and any x-rays/imaging reviewed before conducting a time out to ensure the correct site is agreed upon by the staff. During a review of hospital P&P titled “Universal Protocol - Procedural Areas,” dated 12/19/23, on 3/6/25, the P&P indicated, “...I. PURPOSE A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors... III. POLICY A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or non-invasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), Interventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: 1. Pre-Procedure verification. 2. Marking the site, when applicable 3. Procedural Briefing. 4. Time Out...E. The Universal Protocol is to be integrated with all other elements of patient safety, identification and preparation for a procedure as detailed in the following Patient Care policies: 1. Patient Identification. 2. Pre-Procedure & Post-Procedure Care 3. Procedural Sedation and Analgesia by Non-Anesthesia Professionals. F. Site marking is done by the provider who is credentialed and privileged by Community Medical Centers (CMC) Medical Staff to perform the intended invasive procedure and who will be present and directly involved in the procedure. Resident providers directly involved in the procedure and under the supervision of the faculty/attending provider may perform site marking. Site marking is done with the input of the patient, if possible, and should occur before the patient is moved to the procedural setting unless the pre-procedure and procedure areas are one and the same. G. The Universal Protocol verifications, pre-procedure/briefing, site marking, Time Out, and debriefings are to be documented in the electronic health record (EHR) when applicable. H. All staff whose role requires that they schedule or prepare patients for surgery or other procedures that require an informed consent, or who work as part of the procedural team, are to demonstrate competency in Universal Protocol... V. PROCEDURE ...A... 3. Verify and document all elements of the Universal Protocol beginning in the pre-procedure area and continuing into the procedural area for verification of all safety elements...b... iii. Pre-procedure verification must be completed prior to the start of the procedure, except in justifiably emergent situations... c. Time Out: Immediately before start of the procedure, verify and document all elements of the Time Out... D. 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning....a. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped. i. EXCEPTION: For both elective and STAT craniotomies, timeouts will occur after the patient marking and positioning, but before the drapes are applied. b. The provider (e.g., Surgeon) verbally initiates the verification process. For areas performing invasive procedures that do not require nursing support (e.g., Mammography, Nuclear Medicine, Ultrasound, etc.) the licensed technologist will initiate the verification process. i. The written consent will be utilized as a guide for the patient’s identification and procedure. c. All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process. d. Time Out addresses and verbally confirms among all team members the following elements: i. Correct patient I. Confirmed with two identifiers (per Patient Identification policy). II. Correct procedure and laterality (when applicable) as consented. III. Site marked (when applicable). IV. Fire risk assessment score. A. Alcohol-based preps are dry prior to use of cautery (see also policy OR-Skin Prep of Surgical Patient) V. Ask question “are there any concerns identified in the procedural briefing/time out process”. e. If there is a concern by any team member, or differences of opinion on any element of the Time Out, clarification is to be made by the primary Surgeon or provider before the procedure is allowed to begin. All members of the team must accept and be in agreement to continue. VI. DOCUMENTATION A. Document on the Universal Protocol in the EHR. 1. Begin with the Pre-Procedure Checklist, if patient’s procedure is surgical. 2. Document Pre-Procedure Verification as prompted. Document if site marking is required. 3. Document the Time Out as prompted. Note the time the Time Out was performed...” According to the Joint Commission’s (JC- the nation’s oldest and largest standards-setting and accrediting body in health care) website: Universal Protocol (UC) is one of nine (9), 2025 Critical Access Hospital National Patient Safety Goals concerned with preventing mistakes in surgery, electronically retrieved on 3/7/25 from: https://www.jointcommission.org/standards/national-patient-safety-goals/critical-access-hospital-national-patient-safety-goals/ , the Simplified version or the standards indicated “...Make sure that the correct surgery is done on the correct patient and at the correct place on the patient’s body... Mark the correct place on the patient’s body where the surgery is to be done... Pause before the surgery to make sure that a mistake is not being made...””

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42321 Based on video surveillance review, interview, and document review the hospital failed toprotect and promote four of four patient’s (Pt 3, Pt 6, Pt 8, and Pt 4) rights when: 1. Pt 3 was admitted to the Emergency Department (ED) as a 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) /danger to others for aggressive behavior and nursing staff witnessed an Emergency Medical Technician (EMT) (not a hospital employee) physically restrain Pt 3 and policies and procedures were not followed to protect Pt 3’s right to be free from physical abuse. (Refer to A 0145, #1) 2. Pt 6 was admitted for 9/2/24 to the psychiatric (Psych) unit (area where patients who have mental health issues are kept for safe care) of the hospital for suicidal ideation (thoughts of wanting to end one’s life) and aggressive behavior and on 9/3/24 the hospital security personnel used a taser on Pt 6 against their policy for taser use and against the recommendations of The Centers for Medicare and Medicaid Services (CMS). (Refer to A 0145, #2) 3. Pt 7 was admitted on 9/23/24 to the Psych unit of Hospital A for psychosis (a group of symptoms that involve a loss of touch with reality) and history of aggression and hearing voices. A plan of care was created for Pt 7’s Psychosis and aggression, but the interventions were not effective and resulted in the facilities inability to prevent Pt 7 from physically attacking Pt 8. (Refer to A 0145, #3) 4. Pt 4 was marked as “eloped (when a patient leaves a hospital without authorization or supervision, and it could pose a threat to the patient’s safety or health)” while still in ED and did not get results of physician ordered computed tomography (CT medical imaging procedure that uses X rays to create detailed cross sectional images of the body) or medications to alleviate pain. (Refer to A 0144). The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe and effective manner in accordance with the statutory mandated Condition of Participation for Patient Rights.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47205 Based on observation, interview and record review, the hospital failed to ensure an organized nursing service that provides 24 hour nursing when: 1. The hospital failed to ensure Licensed Nurses (LNs) developed and/or updated individualized care plans ( CP-a written document that outlines the care a patient will receive, based on their specific needs and goals) related to infection, sepsis (a severe infection in the blood) and chest pain for four of 73 sampled patients (Patients (Pt) 2, 14, 16, and 17). (Refer to A0396). 2. The hospital failed to ensure LNs assessed and reassessed pain levels for three of 73 patients (Pt 15, Pt 18, and Pt 73) in accordance with hospital policies and procedures (P&P) and acceptable standards of practice (Refer to A0398). 3. The hospital failed to ensure Licensed Nurses (LNs) administered medications in accordance with the hospital’s policy and procedure (P&P) titled “Medications Orders, Administration, Storage, Documentation” and acceptable standards of practice for medication administration safety, when one of one sampled patients (Pt) 74 was administered Fentanyl and Versed from incompletely labeled syringes (without required “ new label on the transfer container or syringe contains the following information: i. Name of solution or medication ... ii. Strength and amount ... iii. Volume ... vi. Date prepared ...,”) intravenously (IV into the vein) bolused (single dose of a drug or other substance given over a short period of time) medication(s) by Registered Nurse (RN) 9 which had been prepared by another LN (RN 10). (Refer to A0405). The cumulative effect of these system problems resulted in the hospital’s inability to provide care in a safe and quality setting.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 41166 Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient as evidenced by: The hospital failed to maintain drug storage areas in accordance with acceptable standards of practice. in one of three inspected Emergency Department (ED) medication rooms; in one of one ED Trauma Equipment Rooms, and cart in one of two inspected Operating Rooms (OR). Refer to A 491 The hospital failed to ensure an effective system to accurately reconcile controlled drugs (medications with high probability of addiction and are controlled by the federal government) losses for two of five sampled patients (Patients 54, 57). Refer to A 494 The hospital failed to develop and implement a policy and procedure that addressed the use of auto verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not have a system for monitoring the appropriate use of the auto verification process to ensure that medications dispensed by the use of auto verification process were distributed in accordance with applicable standards of practice. The hospital auto verified approximately 60,000 medication orders from 10/1/24 to 10/31/24. Refer to A 500 The hospital failed to ensure all sterile (germ free) compounding (a process of making sterile medications administered into the vein) and the administration of chemotherapy (toxic cancer treatment that uses drug to kill or stop the growth of cancer cells) drugs was performed consistent with national standards of practice. Refer to A 501 The hospital failed to ensure Controlled Substance (CS, those with high potential for abuse and addiction) medications were stored according to facility policy and procedures (P&P) for one of four randomly sampled patients (Patient 47); and Patient’s medication brought from home was reconciled and accounted for one of four randomly sampled patients (Patient 48). Refer to A 503 The hospital failed to ensure unusable medications were not available for use when two opened and used medication vials, intended for single use, were not discarded according to manufacturer’s instructions in one of two inspected Operating Rooms (OR); and IV (intravenous, into the vein) bags removed from the manufacturer’s protective overwrap were labeled with an expiration date in one of two inspected ORs. Refer to A 505 The cumulative effect of this systemic problem resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49769 Based on observation, interview, and record review, the hospital failed to ensure one of four sampled patients (Pt) 4 received complete and ordered treatment in the Emergency Department (ED) when Pt 4 was marked as “eloped (when a patient leaves a hospital without authorization or supervision, and it could pose a threat to the patient’s safety or health)” while still in ED and did not get results of physician ordered computed tomography (CT-medical imaging procedure that uses X-rays to create detailed cross-sectional images of the body) or medications to alleviate pain. This failure resulted in Pt 4 having pain that was not treated and had the potential to delay treatment for possible injuries that may have been found on the CT scan. Findings: During a concurrent observation and interview on 10/31/24 at 11:30 a.m., with Manager of Emergency Department (MED) 3 in the Provider at Triage (PAT -waiting area for patients) 2 area, three staff members called out patient names for continued care. Staff members did not walk the entire lobby calling patient names. Staff stood outside the door to the lobby and called patients’ names. Staff called a patient’s name two times and then went back into the PAT 3 (where provider assess patients and confidential information is discussed) area. During this observation one patient approached MED 3 and asked if his name was called and stated he “couldn’t hear because it was loud.” MED 3 stated staff will attempt to call patient three separate times and if no response, they are marked as eloped and taken out of the Emergency Tracking Board (ETB - a computerized log used to monitor the progress and location of a person while being treated during their stay in the ED.) MED 3 stated the patient must re-register and start the process again from the beginning if they are marked as “eloped” , as if they were a new patient. MED 3 stated hospital policy and procedure (P&P) was to enter a note in the patient’s EMR (Electronic Medical Record) after a third and final attempt at calling for patient is made to indicate the patient did not respond after being called three times and is considered to be eloped. MED 3 stated staff do not chart every time they have called the patient. During an interview on 11/6/24 at 9:45 a.m., with Pt 4, Pt 4 stated he arrived at the hospital on 10/11/24 around 5:30 p.m., by ambulance, due to a Motor Vehicle Accident (MVA). Pt 4 stated he was sent to the PAT 1 area and then met with a provider (doctor or other medical professional) who ordered pain medication for his back pain and a CT. Pt 4 stated he then went to the PAT 2B (area where medications are administered) area to receive his pain medicine and was told to return to the PAT 1 area to wait for his CT results, which he was told would take approximately one hour. Pt 4 stated he returned from CT to PAT 1 and waited for approximately 2 hours for his name to be called for CT results. Pt 4 stated he did not leave the PAT 1 or use the restroom while waiting for his name to be called. Pt 4 stated he saw a provider walk by and inquired about CT results and continued pain. Pt 4 stated the provider stated they would prescribe more pain meds and inquire about CT results which take roughly 2 hours to return. Pt 4 stated he waited about one more hour and inquired about results from PAT 2 area staff who informed him that he had been taken out of the system as eloped. Pt 4 informed staff that he was present the entire time and had not heard his name at any time and no staff walked over to where he was sitting calling out patient names. Staff informed Pt 4 that he had to re-register and start the process over from the beginning. Pt 4 stated he left because he could no longer sit in pain. Pt 4 stated he went to urgent care about 5 days later, due to continued pain where he was diagnosed with “severe whiplash.” During an interview on 11/6/24 at 11:10 a.m., with Director of Emergency Department (DED), the DED stated there is no policy if a patient elopes to be checked back into system at the same point in the ED process . The patient must begin the entire process over from the beginning. The DED stated that is the expectation. The DED stated that if there is a situation where a patient was intentionally or accidently discharged as eloped, then it should be elevated to a supervisor to discuss. During an interview on 11/6/24 at 2:30 p.m., with Certified Nursing Assistant (CNA) 1, CNA 1 stated she waits about 15 minutes between calling the same patients and after the third call, she notifies the nurse and provider to let them know that the patient did not answer three calls. CNA 1 stated she believed overhead call/paging system is only used after third attempt at calling the patient. CNA 1 stated that she puts the number of attempted calls on the ETB. Once the patient is taken out the system, all notes are automatically deleted from the ETB and cannot be retrieved. CNA 1 stated she should be charting the third attempt to call a patient in the patient chart, not just the ETB. During an interview on 11/6/24 at 2:45 p.m., with MED 2, MED 2 stated that the expectation is that all staff document all attempts to call patients in the patient’s chart so all staff can see if attempts were made. MED 2 stated education to staff began approximately June, 2024 . MED 2 stated the problem with the ETB is that it deletes all notes once a patient is taken out of the system and staff cannot see what notes were put in. During an interview on 11/7/24 at 9:45 a.m., with Registered Nurse (RN) 25, RN 25 stated the ETB is where notes and updates are documented to communicate what needs to be done for a patient, especially if they go from one area to another. RN 25 stated the notes on the ETB do not transfer to the patient’s chart and notes should be documented in the patient’s chart. RN 25 stated staff should be documenting on a nurses note or flow sheet in the patient’s chart when a patient does not answer three times. RN 25 stated the overhead call/paging system is used every time staff call a patient. RN 25 stated if a patient is taken out of the system already, it is up to the provider to put them back into the system if it is an emergent situation. If it is not an emergent situation then the process starts from the beginning. During an interview on 11/7/24 at 1:45 p.m., with Licensed Vocation Nurse (LVN) 3, LVN 3 stated staff sometimes use overhead call/paging system, and he doesn’t know specifics on criteria as to when they should be using overhead call/paging system. LVN 3 stated staff should be calling out patient names in all PAT areas. LVN 3 stated staff should be writing a nurse’s note in the patient’s chart to let all staff know that an attempt was made to call the patient when there was no response. LVN 3 stated he thinks staff use the ETB to track the first and second attempt just because it is easier and faster. LVN 3 stated if patient has been taken out of the system, such as an elopement, and the patient wants to continue care, then it just depends on how long they have been gone. LVN 3 stated if it has been 30-40 minutes then patient can resume care and the elopement can be undone and care can continue from when they left. LVN 3 stated if it is longer than 40 minutes the patient needs to re-register and start the process all over again. During a record review of Pt 3’s “Emergency Department Timeline (EDTL),” dated 10/11/24, the EDTL indicated, “ ... 2209 [10:09 p.m.], After MSE (Medical Screening Exam)-No Response, After Medical Screen Call-No Response: 1st Call, (CNA 1 Name) ... 2306 [11:06], ED Notes, Pt is NAx3 (No Answer three times), will remove from [name brand computerized application] ... 2307 [11:07 p.m.], AMA/Eloped (Against Medical Advice) Disposition (the final destination for a patient after receiving care, or the decision made about a patient’s care in an ED) Selected, ED Disposition set to Eloped ...””

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 47205 Based on video surveillance review, interview, and document review, the hospital failed to keep three of three patients (Pt 3, Pt 6, and Pt 8) free from all forms of abuse or harassment when: 1. Pt 3 was admitted to the Emergency Department as a 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) /danger to others for aggressive behavior and nursing staff witnessedan Emergency Medical Technician (EMT) (not a hospital employee) physically restrain Pt 3 and policies and procedures were not followed to protect Pt 3’s right to be free from physical abuse. (Refer to A 0145, #1) 2. Pt 6 was admitted for 9/2/24 to the psychiatric (Psych) unit (area where patients who have mental health issues are kept for safe care) of the hospital for suicidal ideation (thoughts of wanting to end one’s life) and aggressive behavior and on 9/3/24 the hospital security personnel used a taser on Pt 6 against their policy for taser use and against the recommendations of The Centers for Medicare and Medicaid Services (CMS). (Refer to A 0145, #2) 3. Pt 7 was admitted on 9/23/24 to the Psych unit of Hospital A for psychosis (a group of symptoms that involve a loss of touch with reality) and history of aggression and hearing voices. A plan of care was created for Pt 7’s Psychosis and aggression, but the interventions were not effective and resulted in the facilities inability to prevent Pt 7 from physically attacking Pt 8. (Refer to A 0145, #3) These failures resulted in physical and psychosocial (e.g. harm to one’s mental health) harm to Pt 3, Pt 6, and Pt 8. Findings: 1. During a review of Pt 3’s “Patient Care Report (PCR a document that records the care given to a patient by Emergency Medical Service (EMS) while transporting them to a medical facility),” dated 9/30/24, the “PCR” indicated, EMS was called for a patient with chief complaint of violent behavior. Upon arrival, [City Name] Police Department advised EMS that Pt 3 spit on law enforcement faces ... Pt 3 was found in police car with handcuffs behind her back. Pt 3 was assisted to EMS gurney and placed in wrist restraints for aggressive behavior. Pt 3 continued to be aggressive so restraints were applied to ankles as well. According to the PCR, on the way to Hospital A, Pt 3 was cooperative and apologetic. Pt 3 was brought to the hospital and handed off to ED staff. During a review of Pt 3’s “History and Physical (H&P a formal assessment of a patient’s condition by a Medical Doctor),” dated 10/1/24, the “H&P” indicated, Pt 3 presented to the ED under 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) for danger to others. Pt 3 was initially aggressive and uncooperative requiring medications but became cooperative after medications were given. Patient 3 was medically cleared (medical professional evaluated Pt 3 and determined there are no underlying medical illness) and was evaluated by the psychiatric liaison (mental health professional who specializes in the connection between mind and body and how it affects physical and mental health) and Pt 3 was cleared to discharge to police custody. During an interview on 11/5/24 at 8:45 a.m. with Registered Nurse (RN) 23, RN 23 stated he witnessed an EMS worker walking by Pt 3’s gurney while in the ED hallway and Pt 3 spit on the EMS worker. RN 23 stated he witnessed the EMS worker lunge at Pt 3 after being spit on. RN 23 stated he witnessed the EMS worker leaning against the hospital gurney with one foot hanging over the rail which was in the up position on the gurney. RN 23 stated it appeared the EMS worker had his arm pressing down on Pt 3’s head and shoulder area and away from EMS workers face. RN 23 stated the EMS worker was pulled off Pt 3 by law enforcement. Pt 3 was handcuffed by law enforcement to gurney along with having hospital restraints on her wrists. RN 23 stated he did not inform the ED Medical Doctor (MD) about the incident and did not write a note about the incident. RN 23 stated he should have informed the MD and written a note in the electronic health record. During an interview on 11/5/24 at 2:25 p.m. with Security Officer (SO) 1, SO 1 stated he witnessed Pt 3 spit on the EMS worker and then the EMS worker “aggressively threw himself” at Pt 3. SO 1 stated the EMS worker was using his elbow and forearm to the patient’s head area to hold Pt 3 down. SO 1 stated the EMS worker used his elbow to push down and away from Pt 3’s jaw. SO 1 stated the EMS worker was almost laying on Pt 3 with his body and was “dangling off the gurney”. SO 1 stated this lasted about 3 seconds and then a law enforcement officer pulled the EMS worker “over the rails” to get him off Pt 3. SO 1 stated he did not see the EMS worker again and an EMS Supervisor arrived about an hour later and talked with law enforcement. During an interview on 11/6/24 at 7:30 a.m. with SO 2, SO 2 stated security was made aware of a 5150 patient who was on the way to Hospital A on 9/30/24 around 10:30 p.m. SO 2 stated he witnessed law enforcement and hospital security assisting Pt 3 into hospital restraints which included both wrists and ankles along with handcuffs to each wrist in hospital gurney in the hallway. SO 2 stated he asked law enforcement to remove handcuffs to better position the patient and restrict movement, but law enforcement refused to remove handcuffs due to Pt 3’s aggressive nature. SO 2 stated he witnessed an EMS worker walk by Pt 3’s gurney and Pt 3 spit on the EMS worker. The EMS worker then lunged at Pt 3 where both his feet left the ground, and he was on his toes with side rails up laying on Pt 3. SO 2 stated it appeared the EMS worker had his forearm in Pt 3’s neck and shoulder area, and it looked like his forearm was pressing down into Pt 3. SO 2 stated law enforcement then pulled the EMS worker off Pt 3. 3. SO 2 stated at this point, law enforcement agreed to reposition Pt 3. SO 2 stated Pt 3 was positioned on her back with right arm upward to right side of head in a wrist restraint as well as handcuff. The left arm was down by her left hip in a wrist restraint and handcuffed as well. SO 2 stated both ankles were in restraints also at this time. SO 2 stated this was when a spit hood (cloth/mesh device placed of the head of a patient designed to stop them from spitting/biting) was reapplied because Pt 3 could no longer take it off due to being repositioned. SO 2 stated Pt 3 was calm after this repositioning and reapplying of the spit hood. SO 2 stated report was filed and followed chain of command (to an authoritative structure established to resolve administrative, clinical, or other patient safety issues by allowing healthcare clinicians to present an issue of concern through the lines of authority until a resolution is reached) when he reported to security and medical personnel. During an interview on 11/4/24 at 10:30 a.m. with Medical Doctor Resident (MDR) 2, MDR 2 stated he was assigned to care for Pt 3 and was not made aware that Pt 3 was assaulted by EMS worker. MDR 3 stated if he had been made aware of any assault, he would have done a physical and mental evaluation of Pt 3 and reported the incident. During an interview on 11/4/24 at 11:15 a.m. with the Director of Emergency Department (DED), the DED stated he was aware of the incident that occurred with Pt 3 and stated the expectation is for all nurses to inform Medical Doctors when there is an assault in the facility. The DED stated this is not negotiable. The DED stated the expectation is for all patients to be free from any form of abuse. During an interview on 11/7/24 at 2:20 p.m. with Risk Manager (RM) 1, RM 1 stated that after the incident involving an EMS worker and Pt 3, there was no Root Cause Analysis (RCA Used for events with serious harm or death where the goal is to identify the root causes of an issue and develop a plan to prevent it from happening again) review or an Apparent Cause Analysis (ACA Used for near misses or events with minimal to no harm with where the goal to identify an action plan to address the immediate situation and prevent recurrence) review. RM 1 stated there was a regular investigation. RM 1 stated this incident was found to be unavoidable. RM 1 stated the investigation did not discover that Pt 3 had about 12 inch wiggle room which allowed her to take the spit hood off while in handcuffs. RM 1 stated there needs to be an update with law enforcement to better determine who has authority for patients in handcuffs. RM 1 stated at this time there is no plan to prohibit the involved EMS worker to return to the hospital and there is no plan to ensure similar incidents do not occur. During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...” Attempts were made to contact Pt 3 and the EMS provider between 11/4/24-11/7/24 but neither have responded. 2. During a review of Pt 6’s face sheet (FS document that has the patient’s demographic information to include name, date of birth, contact information, insurance, chief complaint etc..), dated 9/18/24, the FS indicated Pt 6 was admitted on 9/2/24 at 3:42 p.m. for Suicidal Ideation (SI thinking about or planning suicide) and psychosis (a group of symptoms that involve a loss of touch with reality) not specified (NOS) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 9/4/24 at 11:32 a.m. disposition written as homeless or homeless shelter. During a review of Pt 6’s “ED Pt Care timeline,” dated 11/1/24, the ED (emergency department) timeline indicated Pt 6 had a Mental Status Exam (MS) on 9/2/24 at 10:47 a.m. with a chief complaint of Psychiatric Suicidal. The MS indicated, “ ... Patient presented Alert and oriented times 3 (patient is alert to person, place, and time) patient respond to name. Patient confirmed name and date of birth. GCS 15 (Glasgow Coma Scale clinical scale used to reliably measure a person’s level of consciousness; scoring 3 15; 15 best score). Patient is observed ambulating in the unit without difficulties. Patient appears anxious. Rapid speech inconsistent and demanding. Patient hesitate in engaging in assessment process. Writer. Inquired regarding event leading to ED encounter. Patient states just let me out of here right now. “I was drinking I do not have to tell you anything.” Writer advises patient of 1799 hold (medical hold allows licensed healthcare providers to detain a patient for up to 24 hours) in ED and patient endorses suicidal ideation with plan (approves the plan to keep him safe). Patient noted increased agitation and refused to listen and demanded to leave. Patient report relocating to [name of city] recently, patient again demanded. I just want my car so I can drive off right now. Patient refused to acknowledge Suicidal ideation and plan. Patient refused to disclose where he lives, mental health history, substance use, psychotropic (affects a patient’s mental state) medications, and history treatment. Patient appears guarded and insists on discharge. Patient refused to give collateral. Patient reports he is receiving mental health services via telehealth. Patient denies any VH (visual hallucinations - seeing things that are not there), AH (auditory hallucinations- hearing things that are not real), HI (homicidal ideations- thoughts about killing someone). Patient offered and encouraged to follow up with Fresno County Behavioral Health. Patient declined resources. Patient present poor insight and judgment on mental health and current status. Patient presents symptomatic (showing signs of disease or injury) and unstable. Psychiatrically for discharge at this time, patient presents highly impulsive and at risk for further decompensation (decline in mental stability) due to poor insight, judgment, and thoughts of harm to self behaviors... Refuses or feels unable to agree to safety plan... Recommendation/ plan of care. Recommendation is to place patient on a 5150 hold (a legal term for a 72 hour psychiatric hospitalization for someone experiencing a mental health crisis) for danger to self and refer a patient to inpatient psychiatric treatment. Continue to endorse suicidal ideation. Patient continues to be symptomatic for psychiatric illness and recommendation is to refer to inpatient psychiatric hospital for stabilization ...” During a review of Pt 6’s History and Physical (H&P) dated 9/3/24, at 7:50 a.m., the H&P indicated, “History of Present Illness: 42 year old male patient with past medical history of type 2 diabetes (body doesn’t produce enough insulin (a hormone that lowers the level of glucose (a type of sugar) in the blood) or your cells don’t respond properly to insulin), hyperlipidemia (abnormally high levels of lipids or fats in the blood), seizures (a sudden change in behavior, movement, or consciousness caused by abnormal electrical activity in the brain), migraines (a severe headache that causes throbbing, pulsing head pain on one side of your head), substance abuse (excessive use of alcohol, pain medication, or illegal drugs), bipolar disorder (a mental illness that causes unusual shifts in a person’s mood, energy, activity levels, and concentration) admitted on 5150 due to danger to self. It is reported the patient presented to ED with symptoms of worsening depression with suicidal thoughts with plan to jump off into a freeway. Patient reported that he was not feeling right. Patient reported that his medications were not helping him ... Upon admission patient was agitated and aggressive towards staff he received Zyprexa (antipsychotic (treat symptoms of psychosis) medication can treat several mental health conditions) 10 mg (milligram unit of measurement) IM (inter muscular) emergency medication. Patient refused vitals yesterday. Today, patient refused to participate in H&P exam versus being sleepy ... Past Medical History: ... PTSD (post traumatic stress disorder a mental health condition that can develop after someone experiences or witnesses a traumatic event) ... TBI (traumatic brain injury a brain injury that is caused by an outside force) ... Plan ... Therapy per Psychiatry ...” During a review of Pt 6’s document titled, “Significant Event Note,” dated 9/3/24, at 12:07 p.m., indicated, at “11:25 (a.m.) Pt (patient Pt 6) asking to speak to social worker with reason, “I don’t want to be here”. Reassured patient that SW will talk to him today but is not available right now. Patient went back to room. At 11:49, Pt barricaded himself in room blocking the doors with his body. Explained to pt that he is able to stay in his room with the door closed but cannot barricade door due to safety concerns. Pt refusing to move. Security was called to room for assistance. After continued refusal, pt opened door, raised fist, was screaming profanities, and threatened to hit staff. Code grey (a call overhead requesting assistance for a combative patient) called overhead. Medication orders placed Zyprexa 10 milligrams IM injection given to pt’s arm per pt preference. Pt provided with 2 cups of water and snacks per request. Explained to patient that he needs to stay in his room until he remains calm, Pt refused to stay in his room stating, “I will go wherever I want, if I want water I will get water.” Due to this response, ptmoved to Quiet Room (QR- safe room with no objects to hurt themselves or others) for safety reasons. In route to QR, patient attacked security officer. Pt safely brought down to ground by security and staff, pt tased in the LLE (left lower extremity) and abdomen, brought into QR and placed on violent locked restraints (physical restraints that fully immobilize a patient- all four limps restrained (4-point restraint) -used as an emergency measure to keep a patient or others safe when there is a risk of physical harm). Redness noted to abdomen. LLQ (Left lower quadrant- location left lower abdomen), oozing blood to L upper lip. Sitter at bedside, will continue to monitor. 12:40 (p.m.) Pt continues to shout profanities and demand release. MD updated; new orders placed for additional medication. Linen and gown change due to urination. Thorazine (medication used to treat mental health conditions) 100 milligrams IM medicated, will continue to monitor.” During an interview on 10/30/24, at 1:25 p.m., with Charge Nurse (CN 1), CN 1 stated she worked on 9/3/24 and was assigned to the unit 4 where Pt 6 resided. CN 1 stated she had just come back from break when she noticed security was down the hallway and she was updated that Pt 6 had barricaded himself in his room. CN 1 stated she pushed the code button when she heard commotion and the staff had gotten Pt 6’s door open, she informed his nurse (Registered Nurse (RN 1)) to contact the doctor and get orders for medication. CN 1 stated the Code team arrived and attempted to deescalate the situation by talking with Pt 6, but Pt 6 was very agitated, unpredictable, and unstable, “we tried to offer him juice and therapy, then [RN 1] brought the medication, all [Pt 6] stated was that he wanted to leave”. CN 1 stated Pt 6 accepted the medication and was asked to stay in his room until the medication started to help, he had promised to stay in his room but no more than 5 10 minutes later he was yelling and screaming wanting to leave his room, so security was called to help escort him to the quiet room. CN 1 stated she walked in front, and they had 3 4 security officers on the sides and behind Pt 6 while they walked him to the quiet room. CN 1 stated Pt 6 has a history of a TBI, and he lunged at and attacked the security officer to his right side, he started to swing and hit with his fists. CN 1 stated the security and staff tried to contain him and Pt 6 was resistant and would not stop fighting, he was told multiple times to stop, and he would not. CN 1 stated Security told him that they would tase him if he didn’t calm down and he didn’t so security tased him in his right lower abdomen. CN 1 stated he was still yelling and fighting after he was tased and then Pt 6 froze and was calm enough to move him to the quiet room. CN 1 stated she attempted to talk with Pt 6 once he was put in the 4 point violent restraints, but Pt 6 was erratic, and “we were waiting for his medication to take effect”. CN 1 stated even in restraints he was verbally abusive and threatening staff by saying he would cut her head off and statements that he wanted a gun to shoot himself. During an interview on 10/30/24, at 1:53 p.m., with Mental Health Worker (MHW 1), MHW 1 stated she worked on 9/3/24 and was doing room checks and noticed Pt 6 was getting agitated and barricaded himself in his room, at that time she informed the nurse of what Pt 6 was doing. MHW 1 stated the nurse went to try and deescalate the patient and security helped to try to get the patient to open his door. MHW 1 stated she did not see Pt 6 get tased; she was busy watching the other patients in this unit. During an interview on 10/30/24, at 2:05 p.m., with MHW 2, MHW 2 stated part of her job was to round on patients every 15 minutes and when she attempted to open Pt 6’s door to do her visual check of the patient he had barricaded himself in there and would not let her in. MHW 2 stated she told the nurse and the nurse attempted to talk to Pt 6 to get him to open the door and security joined him in his attempts. MHW 2 stated “I don’t know if he [Pt 6] tried to hit [nurses name]” but security had to intervene. MHW 2 stated the therapist, and the house supervisor were also there attempting to deescalate the patient. MHW 2 stated Pt 6 was agitated, and she thinks he attacked the security guard and “they took him down” and a couple of minutes later they tased him. MHW 2 stated once Pt 2 was calm enough they took him to the quiet room, and he was placed in 4 point restraints. During an interview on 10/30/24, at 2:15 p.m., with the Security Team Lead (STL), the STL stated he was working downtown at Hospital A when he heard on the radio that there was an agitated patient pacing back and forth and his staff were not able to deescalate him. STL stated he left Hospital A and headed to the off campus psychiatric unit, once their Pt 6 was in his room and “we heard banging on his wall”, and Pt 6 had shut the door hard. STL stated, “medical staff came, and we opened the door, and I observed Pt 6 punching the wall” at this medical staff had gotten orders for restraints, so “we needed to move him to the quiet room.” STL stated Pt 6 initially refused to go to the quiet room saying he “was going to kill us but after several attempts we convinced him to exit the room and walk with us to the quiet room”. STL stated out of nowhere while in the hallway “Pt 6 attacked one of our officers by pushing her which caused her to hit her head on the wall and we went hands on with Pt 6. Once on the floor, one of our officers was pinned underneath Pt 6.” STL stated, “we were having a hard time getting ahold of Pt 6’s arms and legs, we could not get him [his officer] out from under Pt 6 because Pt 6 was punching and kicking”. STL stated, “I undid my taser, removed the cartridge to give him a dry stun to gain control of him, it kind of worked. As soon as the cycle was over, he [Pt 6] started again. I then gave him a couple of more stuns with the taser, after the fourth one we got control, placed him in the taco (hard plastic device used to lift patients off the floor) and moved him to the room where we restrained him even during that he was cussing and spitting at us.” STL stated he has done the initial taser training upon hire and does continued education on taser use annually. During a review of the video footage of the incident on 9/3/24, Pt 6 was observed having multiple staff attempt to talk with him while he barricaded himself in his room. Pt 6 emerged from his room at 12:14 p.m., a total of four security guards were standing around him, one in front, one to each side and one behind him, nursing staff and mental health workers were also walking with the patient to the quiet room when Pt 6 pushed the female officer to his right hard and she hits the wall behind her, at that point a second officer jumps in and takes Pt 6 to the ground, the two other officers are attempting to restrain Pt 6 but Pt 6 was hitting and kicking out his legs. The security officer who initially took Pt 6 down to the floor was under the patient and one of the security officers, the team lead was seen pulling out his taser and tasing Pt 6, multiple staff surround Pt 6, so it is difficult to see the patient and where he got tased, nursing staff bring medication and give it in the patient’s arm. Pt 6 was seen still fighting then goes still and security was able to restrain him and put him in the taco face down. At 12:20 p.m. Pt 6 was seen transported into the quiet room in the taco and being moved onto the bed where four point restraints were being placed on him, Pt 6 was still fighting but was secured and nursing staff was now doing an assessment. During a review of the hospital’s policy titled, “Taser Usage,” dated 2/17/21, indicated, “I. PURPOSE the purpose of this policy is to establish guidelines for the deployment and use of the taser by Security Services Staff. II. POLICY This policy is established to control the deployment and use of the taser to maximize the safety of the facility and staff while limiting potential injuries and corporate liability. A taser may only be possessed and deployed by an authorized, designated, certified, and properly trained security officer or supervisor of this department. III DEFINITIONS ... c. Taser the taser is a less than deadly device used to incapacitate subject (s) by discharging an electronic current into the subject via two wired probes. The taser may also be use in a touch stun capacity with a discharged cartridge in the device or when the taser is not equipped with a cartridge ... VII. A. the following procedure shall be adhered to while deploying a taser in an authorized manner and circumstances. 1. The taser shall not be deployed or displayed at any time unless the officer has specific information that reasonably indicates the use of a taser is warranted. The circumstances of each incident shall dictate the reasonableness for the deployment of the taser. The officer must reasonably believe that a credible threat to the safety of the officer or others exists. 2. The taser should not be used to simply overcome resistance when adequate assistance is available. 3. The taser shall not be used as an intimidation tool to gain compliance where the reasonable deployment is not justified. The taser shall not be deployed against passive demonstrators ... X. MULTIPLE APPLICATIONS If after the first application of the taser, an office is unable to gain compliance and circumstances allow, the officer should consider whether or not the taser device is operating properly and if other options or tactics may be more appropriate. However, multiple, and reasonable applications on the subject may be warranted and are not precluded. XI. AFTER DISCHARGE RESPONISBILITIES ... B. The taser officer shall prepare a detailed incident report which thoroughly covers the circumstances and justification for deployment. The identification of the utilized taser shall be identified in the documentation. Each officer involved in the taser incident shall complete a supplemental report detailing their actions and observations. All documentation shall be done promptly without delay ... XIII. TASER USE REVIEW BOARD After each taser deployment, the shift supervisor and manager shall review all documentation to evaluate the appropriateness for the deployment. All taser deployment reviews shall be completed by the Use of Force Review Board as defined by the Use of Force policy.” During a review of the hospital’s policy titled, “Use of Force,” dated 8/22/23, indicated, “I. PURPOSE the purpose of this policy is to provide security officers with guidelines for the legal and proper use of physical force where required to protect the safety of patient’s staff, visitors, others, and property. II. POLICY It is the policy of [name of hospital] Security Department that security officers are permitted to use reasonable force when: A. the security officer reasonably believes that he/she is in imminent danger of suffering bodily injury or being touched unlawfully (“self defense”), someone is in imminent danger of suffering bodily injury (“defense of another”), or to protect [name of hospital] property from immediate harm (“defense of property”). B. The security officer reasonably believes that the use of reasonable force is necessary to defend against that danger. The security officer shall use the minimum amount of force necessary to accomplish lawful objectives and immediately cease once an individual is under control. The security officer shall use no more force than is reasonably necessary to defend against the danger ... IV. USE OF FORCE CONTINUUM The use of force continuum is a system used by this department to determine the reasonable force is a given situation ... The possible security officer response levels are as follows: A. Level 1: Officer presence (examples: physical appearance, professional bearing) B. Level 2: Verbal commands (example: clear and deliberate) C. Level 3: Soft techniques (examples: physical control tactics/wrist locks (grabbing the opponent’s hand and twisting and/or bending it in a non-natural direction) D. Level 4: Hard techniques (examples: Taser/strike points/impact weapons/ OC Spray). All levels identified above in the use of force continuum shall be documented and investigated pursuant to this department’s policy. During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...” During a review of the State Operations Manual (SOM) Appendix A Survey Protocol, Regulations and Interpretive Guidelines for Hospitals,dated 4/19/2024, the SOM indicated, “ ... CMS does not consider the use of weapons in the application of restraint or seclusion as a safe, appropriate health care intervention. For the purposes of this regulation, the term “weapon” includes, but is not limited to, pepper spray, mace,nightsticks, tasers, cattle prods, stun guns, and pistols. Security staff may carry weapons as allowed by hospital policy, and State and Federal law. However, the use of weapons by security staff is considered a law enforcement action, not a health care intervention. CMS does not support the use of weapons by any hospital staff as a means of subduing a patient in order to place that patient in restraint or seclusion. If a weapon is used by security or law enforcement personnel on a person in a hospital (patient, staff, or visitor) to protect people or hospital property from harm, we would expect the situation to be handled as a criminal activity and the perpetrator be placed in the custody of local law enforcement ...” 3. During a review of Pt 7’s face sheet (FS) dated 10/10/24, the FS indicated Pt 7 was a 30 year old male admitted on 9/23/24 at 10:22 p.m. for Psychosis (a collection of symptoms that affect the mind, where there has been some loss of contact with reality) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 10/7/24 at 2 p.m. During a review of Pt 7’s History and Physical (H&P) date 9/22/24 at 9:12 a.m., the H&P indicated, “ ... chief complaint Patient presents with Psych Bizarre Behavior. EMS went on scene, pt refusing to answer questions. Refusing treatment. Making odd comments about being 13 year old ... History of Present Illness: [name of Pt 7] is a 30 y.o. male patient with reported history of schizophrenia (a chronic mental disorder that affects a person’s ability to think, perceive reality, and interact socially), marijuana abuse who was brought in by ambulance to ED on 1799 for SI (suicidal ideation thoughts of killing himself) ... On asking about SI, he nods yes but says “I don’t remember why”. Denies ETOH (ethanol- type of alcohol) abuse. Smokes marijuana off and on. Reports hearing voices in his head but does not remember what the voices state ...” During a review of Pt 7’s document titled, “Plan of Care,” dated 10/3/24 at 12:12 p.m., the plan of care indicated, “Problem: Risk for violence/aggression towards others Goal: Refrain from acts of violence/aggression during length of stay, and demonstrate improved impulse controls at the time of discharge LTG [long term goal] Outcome: Not Progressing Goal: Verbalize thoughts and feelings associated with harming others STG [short term goal] Outcome: Progressing Goal: Refrain from harming others STG Outcome: Not Progressing Goal: Refrain from destructive acts on the environment or property STG Outcome: Progressing Goal: Control angry outbursts STG Outcome: Not progressing ... Goal: Identify appropriate positive anger management techniques LTG Outcome: Not Progressing ... Problem: Cognitive Perceptual Pattern Impaired Goal: Able to refrain from responding to false sensory perceptions (hallucinations, are the experience of perceiving objects or events through the senses when they are not present) STG Outcome: Not Progressing Goal: Refrain from acting on delusional thinking (a fixed false belief that a person holds onto, even when there is evidence that it is not real)/internal stimuli (changes, experiences, or feelings that occur within someone) STG Outcome: Not Progressing Goal: Demonstration of accurate environmental perceptions LTG Outcome: Not Progressing ... Problem: Coping Ineffective Goal: Able to identify one positive coping skill STG Outcome: Not progressing Goal: Effective coping LTG Outcome: Not Progressing ... Problem: Mood Altered Lability Goal: Demonstrates control over impulsivity with assistance STG Outcome: Not Progressing Goal: Utilizes positive coping mechanisms STG Outcome: Not progressing Goal: Demonstrates appropriate boundaries LTG Outcome: Not Progressing Goal: Mood stable LTG Outcome: Not progressing Problem: Social Interaction - Impaired Goal: Able to identify behaviors that impede relationships STG Outcome: Not Progressing... Goal: Able to achieve maximum level of psychosocial functioning Outcome: Not Progressing ... Problem: Violence, Self/Others Directed, Risk of Goal: Absence of self harm LTG Outcome: Progressing Goal: Communicates desires to harm self/others STG Outcome: Progressing Goal: Identifies triggers to aggressive behavior STG Outcome: Not Progressing Goal: Absence of harm to others LTG Outcome: Not Progressing Goal: Absence of violence LTG Outcome: Not progressing ...” During a review of Pt 8’s FS dated 10/10/24, the FS indicated Pt 8 was a 25 year old male admitted on 9/25/24 at 2:21 p.m. for Psychosis and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 10/5/24 at 11:30 a.m. During a review of Pt 8’s Psychiatric H&P dated 9/25/24 at 12:36 p.m., the H&P indicated, “ ... 25 year old male with previously diagnosed schizophrenia and methamphetamine (powerful, highly addictive stimulant that affects the central nervous system) use who presented to [Hospital D] on 9/17 on a 5150 for GD [gravely disabled- a condition in which a person, as a result of a mental disorder, is unable to provide for his or her basic personal needs for food, clothing, or shelter] after being found psychotic and unable to care for himself ... During admission at [Hospital D], patient was initially agitated, non-cooperative, refusing meals and medications ... Patient was eventually transferred to [the off-campus psychiatric unit] on 9/25 ... Contacted patient’s cousin ... she stated that the patient was diagnosed with bipolar disorder (a serious mental illness that causes extreme mood shifts, including periods of mania and depression) two years ago, however, during recent hospitalizations, providers expressed that the patient likely has schizophrenia instead ...” During a review of the Investigative Summary (IS) (not dated), the IS indicated, “Aggressor/Patient: [Pt 7] Victim/Patient: [Pt 8] ... Summary: 25 y/o victim patient was receiving shower supplies from staff in the hallway of unit 3, when aggressor patient approached and hit victim multiple times in the head, face, back and ankle without provocation. Victim reportedly fell to the floor after these patients were separated. Victim c/o pain 10/10. American Ambulance transported the victim to the [Hospital A] ED. He was evaluated, medically cleared, and returned to [off campus psychiatric unit] on a different unit. Victim: 10/3 0810: pt was receiving shower supplies in the hallway from staff, when male peer approached pt, unprovoked, and hit pt multiple times to head, face, back and right ankle resulting in pt falling on the floor. Pt complained of 10/10 pain to head and right ankle at this time.0906: Pt arrived in ED, Pain assessment: 0/10. 1030: XR (x-ray- images that create pictures of the inside of the body) L (left) Ankle: Negative exam. 1039: XR L Forearm: No definite fracture is seen. 1615: Pt DC (discharged) from ED (emergency department) and returned to [off campus psychiatric unit] Unit 1. 1653: Skin Check: Pt has c/o (complaint of) stomach pain and left arm pain both 5/10. Skin check was done by RN and MHW performed the skin check and there was no contraband and pt had a contusion to left forearm. Aggressor: 10/3 0815: approached peer in the hallway, unprovoked, and punched peer multiple times. Separated pt and peer, security, code team, house supervisor and [doctors name] was notified. Benadryl (antihistamine that helps with pain and itching, side effect drowsiness) 50 mg (milligrams- unit of measurement); Haldol (treatment for schizophrenia) 5 mg and Ativan (sedative can help with anxiety and seizure activity) 2 mg IM (intramuscular- in the muscle) given. 1451: LCSW (licensed care social worker) note: explored how Pt is feeling, and he replied, “This feels like hell.” Pt stated his anger has been building for some time, and that the other Pt whom he assaulted disrespected him. 1534: Pt seen/heard on the phone with his mother. Pt appeared agitated, glaring at staff walking by, clutching his bracelet. Asking mom why she didn’t want him to go home. Pt later seen pacing the hall, standing in one place, and glaring at everyone walking by, and clutching his fists. Pt offered medication for anxiety/agitation. Pt agreed. [doctors name] called and order was placed for 100 mg Thorazine (treats mental health conditions, regulates mood) by mouth. 1852: pt heard punching the wall a few times in the quiet room. Ativan by mouth was given with no complications ...” During an interview on 10/31/24, at 2 p.m. with MHW 3, MHW 3 stated she was handing out shower supplies on 10/3/24, she had just given Pt 8 shower supplies when she heard her coworker yell and she saw Pt 7 hitting Pt 8 on the ground. MHW 3 stated it was just the beginning of their shift and she did not see any prior interaction between Pt 7 and Pt 8, “this was unprovoked”. MHW 3 stated, “I tried to separate them [Pt 7] stepped back and then he came back to attack [Pt 8],” code grey was called. MHW 3 stated they were able to get Pt 7 to stop and keep him from Pt 8, the nurse came and assessed Pt 8 and security stayed with Pt 7. During an interview on 10/31/24, at 2:06 p.m., with MHW 4, MHW 4 stated she worked on 10/3/24 and was in the process of doing vital signs on patients when she saw Pt 7 punching Pt 8 who was standing there to get bath stuff. MHW 4 stated she pushed the patient with the wheelchair out of the way and called for help, RN 2 called the code. MHW 4 stated we tried to separate them but “I could not hold him (Pt 7), he (Pt 7) was too fast. It was unprovoked.” MHW 4 stated we did get them apart and Pt 8 was moved to the TV room and was checked out and ended up getting sent to the hospital while Pt 7 was kept away from him. During an interview on 10/31/24, at 2:15 p.m., with RN 2, RN 2 stated she was the Charge nurse on 10/3/24 on unit 4 when the incident occurred between Pt 7 and Pt 8. RN 2 stated she had assigned these two patients to RN 3 at the beginning of the day shift. RN 2 state she was at the nursing station when she heard a noise in the hallway, she investigated the hallway and immediately yelled to call the code grey and pushed the button for code grey because Pt 7 was hitting Pt 8. RN 2 stated she came around the nurse’s station and attempted to pull Pt 7 away from the Pt 8. RN 2 stated she then was trying to keep the Pt 8 away from Pt 7 telling him to go to his room and eventually he did when security came and escorted him. During an interview on 11/4/24, at 1:30 p.m. with RN 3, RN 3 stated she worked on 10/3/24 and was the nurse for both Pt 7 and Pt 8. RN 3 stated, “I remember talking with [Pt 8] and I had just sat him down in the day room and brought him his breakfast. I told him we were going to have a good day ... My other patient was sleeping, breakfast had just arrived. Another patient came and asked for her medications, and it (the medication) was on another unit, so I let them know (other staff on the unit) I had to grab it from another unit and at that time everything was fine and safe.” RN 3 stated, “When I was coming back to the unit I heard the code grey. It was already over, and people were responding to the code 9by the time she got back to the unit).” RN 3 stated she was less than two minutes off the unit to get the medication and that left three employees on the unit. RN 3 stated she did not know how this could have been prevented it was “completely unprovoked. He [Pt 7] had no history of violence”. RN 3 stated she assessed Pt 8 and helped him off the ground and made sure he was okay. RN 3 stated Pt 8 had complaints of head, face, and ankle pain so she reached out to the doctor, and he ordered for Pt 8 to go to the hospital to get checked out. RN 3 sated when Pt 8 came back from the hospital he was moved to a different unit for his safety. During the review of the video footage for the incident dated 10/3/24, at 8:10 a.m. Pt 7 was seen walking up behind Pt 8 who was receiving shower supplies from MHW. Pt 7 punches Pt 8 and Pt 8 goes to the ground and Pt 7 continues punching him, staff was attempting to get Pt 7 to stop and get him off Pt 8. Pt 8 was blocking his head trying to protect himself. Note there was another patient between the scene who was pushing his wheelchair in front of him that was blocking one of the MHW from getting to Pt 7 and Pt 8 to help. It took a minute to get this patient out of the way. Code gray must have been called because within that minute security was there and Pt 7 was already pulled off Pt 8, but Pt 7 did try to come towards Pt 8 again, but staff was between them and prevented this. Security walked Pt 7 to his room while staff helped Pt 8 off the ground. During a review of Pt 7’s Progress Note dated 10/3/24 at 2:50 p.m., the Progress Note indicated, “ ... This morning, patient had a significant event where he punched another patient multiple times, seemingly unprovoked ... He was able to state that he does have a mental illness (diagnosed with schizophrenia/schizoaffective disorder) and he was able to name the medications he is currently being prescribed ... When asked about the events of this morning, he said he beat up the other patient because “this place makes me sick.” He stated that “there is only so much you can take before you snap.”” During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...””

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 42321 Based on video surveillance review, interview, and document review, the hospital failed to keep three of three patients (Pt 3, Pt 6, and Pt 8) free from all forms of abuse or harassment when: 1. Pt 3 was admitted to the Emergency Department as a 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) /danger to others for aggressive behavior and nursing staff witnessedan Emergency Medical Technician (EMT) (not a hospital employee) physically restrain Pt 3 and policies and procedures were not followed to protect Pt 3’s right to be free from physical abuse. (Refer to A 0145, #1) 2. Pt 6 was admitted for 9/2/24 to the psychiatric (Psych) unit (area where patients who have mental health issues are kept for safe care) of the hospital for suicidal ideation (thoughts of wanting to end one’s life) and aggressive behavior and on 9/3/24 the hospital security personnel used a taser on Pt 6 against their policy for taser use and against the recommendations of The Centers for Medicare and Medicaid Services (CMS). (Refer to A 0145, #2) 3. Pt 7 was admitted on 9/23/24 to the Psych unit of Hospital A for psychosis (a group of symptoms that involve a loss of touch with reality) and history of aggression and hearing voices. A plan of care was created for Pt 7’s Psychosis and aggression, but the interventions were not effective and resulted in the facilities inability to prevent Pt 7 from physically attacking Pt 8. (Refer to A 0145, #3) These failures resulted in physical and psychosocial (e.g. harm to one’s mental health) harm to Pt 3, Pt 6, and Pt 8. Findings: 1. During a review of Pt 3’s “Patient Care Report (PCR a document that records the care given to a patient by Emergency Medical Service (EMS) while transporting them to a medical facility),” dated 9/30/24, the “PCR” indicated, EMS was called for a patient with chief complaint of violent behavior. Upon arrival, [City Name] Police Department advised EMS that Pt 3 spit on law enforcement faces ... Pt 3 was found in police car with handcuffs behind her back. Pt 3 was assisted to EMS gurney and placed in wrist restraints for aggressive behavior. Pt 3 continued to be aggressive so restraints were applied to ankles as well. According to the PCR, on the way to Hospital A, Pt 3 was cooperative and apologetic. Pt 3 was brought to the hospital and handed off to ED staff. During a review of Pt 3’s “History and Physical (H&P a formal assessment of a patient’s condition by a Medical Doctor),” dated 10/1/24, the “H&P” indicated, Pt 3 presented to the ED under 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) for danger to others. Pt 3 was initially aggressive and uncooperative requiring medications but became cooperative after medications were given. Patient 3 was medically cleared (medical professional evaluated Pt 3 and determined there are no underlying medical illness) and was evaluated by the psychiatric liaison (mental health professional who specializes in the connection between mind and body and how it affects physical and mental health) and Pt 3 was cleared to discharge to police custody. During an interview on 11/5/24 at 8:45 a.m. with Registered Nurse (RN) 23, RN 23 stated he witnessed an EMS worker walking by Pt 3’s gurney while in the ED hallway and Pt 3 spit on the EMS worker. RN 23 stated he witnessed the EMS worker lunge at Pt 3 after being spit on. RN 23 stated he witnessed the EMS worker leaning against the hospital gurney with one foot hanging over the rail which was in the up position on the gurney. RN 23 stated it appeared the EMS worker had his arm pressing down on Pt 3’s head and shoulder area and away from EMS workers face. RN 23 stated the EMS worker was pulled off Pt 3 by law enforcement. Pt 3 was handcuffed by law enforcement to gurney along with having hospital restraints on her wrists. RN 23 stated he did not inform the ED Medical Doctor (MD) about the incident and did not write a note about the incident. RN 23 stated he should have informed the MD and written a note in the electronic health record. During an interview on 11/5/24 at 2:25 p.m. with Security Officer (SO) 1, SO 1 stated he witnessed Pt 3 spit on the EMS worker and then the EMS worker “aggressively threw himself” at Pt 3. SO 1 stated the EMS worker was using his elbow and forearm to the patient’s head area to hold Pt 3 down. SO 1 stated the EMS worker used his elbow to push down and away from Pt 3’s jaw. SO 1 stated the EMS worker was almost laying on Pt 3 with his body and was “dangling off the gurney”. SO 1 stated this lasted about 3 seconds and then a law enforcement officer pulled the EMS worker “over the rails” to get him off Pt 3. SO 1 stated he did not see the EMS worker again and an EMS Supervisor arrived about an hour later and talked with law enforcement. During an interview on 11/6/24 at 7:30 a.m. with SO 2, SO 2 stated security was made aware of a 5150 patient who was on the way to Hospital A on 9/30/24 around 10:30 p.m. SO 2 stated he witnessed law enforcement and hospital security assisting Pt 3 into hospital restraints which included both wrists and ankles along with handcuffs to each wrist in hospital gurney in the hallway. SO 2 stated he asked law enforcement to remove handcuffs to better position the patient and restrict movement, but law enforcement refused to remove handcuffs due to Pt 3’s aggressive nature. SO 2 stated he witnessed an EMS worker walk by Pt 3’s gurney and Pt 3 spit on the EMS worker. The EMS worker then lunged at Pt 3 where both his feet left the ground, and he was on his toes with side rails up laying on Pt 3. SO 2 stated it appeared the EMS worker had his forearm in Pt 3’s neck and shoulder area, and it looked like his forearm was pressing down into Pt 3. SO 2 stated law enforcement then pulled the EMS worker off Pt 3. 3. SO 2 stated at this point, law enforcement agreed to reposition Pt 3. SO 2 stated Pt 3 was positioned on her back with right arm upward to right side of head in a wrist restraint as well as handcuff. The left arm was down by her left hip in a wrist restraint and handcuffed as well. SO 2 stated both ankles were in restraints also at this time. SO 2 stated this was when a spit hood (cloth/mesh device placed of the head of a patient designed to stop them from spitting/biting) was reapplied because Pt 3 could no longer take it off due to being repositioned. SO 2 stated Pt 3 was calm after this repositioning and reapplying of the spit hood. SO 2 stated report was filed and followed chain of command (to an authoritative structure established to resolve administrative, clinical, or other patient safety issues by allowing healthcare clinicians to present an issue of concern through the lines of authority until a resolution is reached) when he reported to security and medical personnel. During an interview on 11/4/24 at 10:30 a.m. with Medical Doctor Resident (MDR) 2, MDR 2 stated he was assigned to care for Pt 3 and was not made aware that Pt 3 was assaulted by EMS worker. MDR 3 stated if he had been made aware of any assault, he would have done a physical and mental evaluation of Pt 3 and reported the incident. During an interview on 11/4/24 at 11:15 a.m. with the Director of Emergency Department (DED), the DED stated he was aware of the incident that occurred with Pt 3 and stated the expectation is for all nurses to inform Medical Doctors when there is an assault in the facility. The DED stated this is not negotiable. The DED stated the expectation is for all patients to be free from any form of abuse. During an interview on 11/7/24 at 2:20 p.m. with Risk Manager (RM) 1, RM 1 stated that after the incident involving an EMS worker and Pt 3, there was no Root Cause Analysis (RCA Used for events with serious harm or death where the goal is to identify the root causes of an issue and develop a plan to prevent it from happening again) review or an Apparent Cause Analysis (ACA Used for near misses or events with minimal to no harm with where the goal to identify an action plan to address the immediate situation and prevent recurrence) review. RM 1 stated there was a regular investigation. RM 1 stated this incident was found to be unavoidable. RM 1 stated the investigation did not discover that Pt 3 had about 12 inch wiggle room which allowed her to take the spit hood off while in handcuffs. RM 1 stated there needs to be an update with law enforcement to better determine who has authority for patients in handcuffs. RM 1 stated at this time there is no plan to prohibit the involved EMS worker to return to the hospital and there is no plan to ensure similar incidents do not occur. During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...” Attempts were made to contact Pt 3 and the EMS provider between 11/4/24-11/7/24 but neither have responded. 2. During a review of Pt 6’s face sheet (FS document that has the patient’s demographic information to include name, date of birth, contact information, insurance, chief complaint etc..), dated 9/18/24, the FS indicated Pt 6 was admitted on 9/2/24 at 3:42 p.m. for Suicidal Ideation (SI thinking about or planning suicide) and psychosis (a group of symptoms that involve a loss of touch with reality) not specified (NOS) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 9/4/24 at 11:32 a.m. disposition written as homeless or homeless shelter. During a review of Pt 6’s “ED Pt Care timeline,” dated 11/1/24, the ED (emergency department) timeline indicated Pt 6 had a Mental Status Exam (MS) on 9/2/24 at 10:47 a.m. with a chief complaint of Psychiatric Suicidal. The MS indicated, “ ... Patient presented Alert and oriented times 3 (patient is alert to person, place, and time) patient respond to name. Patient confirmed name and date of birth. GCS 15 (Glasgow Coma Scale clinical scale used to reliably measure a person’s level of consciousness; scoring 3 15; 15 best score). Patient is observed ambulating in the unit without difficulties. Patient appears anxious. Rapid speech inconsistent and demanding. Patient hesitate in engaging in assessment process. Writer. Inquired regarding event leading to ED encounter. Patient states just let me out of here right now. “I was drinking I do not have to tell you anything.” Writer advises patient of 1799 hold (medical hold allows licensed healthcare providers to detain a patient for up to 24 hours) in ED and patient endorses suicidal ideation with plan (approves the plan to keep him safe). Patient noted increased agitation and refused to listen and demanded to leave. Patient report relocating to [name of city] recently, patient again demanded. I just want my car so I can drive off right now. Patient refused to acknowledge Suicidal ideation and plan. Patient refused to disclose where he lives, mental health history, substance use, psychotropic (affects a patient’s mental state) medications, and history treatment. Patient appears guarded and insists on discharge. Patient refused to give collateral. Patient reports he is receiving mental health services via telehealth. Patient denies any VH (visual hallucinations - seeing things that are not there), AH (auditory hallucinations- hearing things that are not real), HI (homicidal ideations- thoughts about killing someone). Patient offered and encouraged to follow up with Fresno County Behavioral Health. Patient declined resources. Patient present poor insight and judgment on mental health and current status. Patient presents symptomatic (showing signs of disease or injury) and unstable. Psychiatrically for discharge at this time, patient presents highly impulsive and at risk for further decompensation (decline in mental stability) due to poor insight, judgment, and thoughts of harm to self behaviors... Refuses or feels unable to agree to safety plan... Recommendation/ plan of care. Recommendation is to place patient on a 5150 hold (a legal term for a 72 hour psychiatric hospitalization for someone experiencing a mental health crisis) for danger to self and refer a patient to inpatient psychiatric treatment. Continue to endorse suicidal ideation. Patient continues to be symptomatic for psychiatric illness and recommendation is to refer to inpatient psychiatric hospital for stabilization ...” During a review of Pt 6’s History and Physical (H&P) dated 9/3/24, at 7:50 a.m., the H&P indicated, “History of Present Illness: 42 year old male patient with past medical history of type 2 diabetes (body doesn’t produce enough insulin (a hormone that lowers the level of glucose (a type of sugar) in the blood) or your cells don’t respond properly to insulin), hyperlipidemia (abnormally high levels of lipids or fats in the blood), seizures (a sudden change in behavior, movement, or consciousness caused by abnormal electrical activity in the brain), migraines (a severe headache that causes throbbing, pulsing head pain on one side of your head), substance abuse (excessive use of alcohol, pain medication, or illegal drugs), bipolar disorder (a mental illness that causes unusual shifts in a person’s mood, energy, activity levels, and concentration) admitted on 5150 due to danger to self. It is reported the patient presented to ED with symptoms of worsening depression with suicidal thoughts with plan to jump off into a freeway. Patient reported that he was not feeling right. Patient reported that his medications were not helping him ... Upon admission patient was agitated and aggressive towards staff he received Zyprexa (antipsychotic (treat symptoms of psychosis) medication can treat several mental health conditions) 10 mg (milligram unit of measurement) IM (inter muscular) emergency medication. Patient refused vitals yesterday. Today, patient refused to participate in H&P exam versus being sleepy ... Past Medical History: ... PTSD (post traumatic stress disorder a mental health condition that can develop after someone experiences or witnesses a traumatic event) ... TBI (traumatic brain injury a brain injury that is caused by an outside force) ... Plan ... Therapy per Psychiatry ...” During a review of Pt 6’s document titled, “Significant Event Note,” dated 9/3/24, at 12:07 p.m., indicated, at “11:25 (a.m.) Pt (patient Pt 6) asking to speak to social worker with reason, “I don’t want to be here”. Reassured patient that SW will talk to him today but is not available right now. Patient went back to room. At 11:49, Pt barricaded himself in room blocking the doors with his body. Explained to pt that he is able to stay in his room with the door closed but cannot barricade door due to safety concerns. Pt refusing to move. Security was called to room for assistance. After continued refusal, pt opened door, raised fist, was screaming profanities, and threatened to hit staff. Code grey (a call overhead requesting assistance for a combative patient) called overhead. Medication orders placed Zyprexa 10 milligrams IM injection given to pt’s arm per pt preference. Pt provided with 2 cups of water and snacks per request. Explained to patient that he needs to stay in his room until he remains calm, Pt refused to stay in his room stating, “I will go wherever I want, if I want water I will get water.” Due to this response, ptmoved to Quiet Room (QR- safe room with no objects to hurt themselves or others) for safety reasons. In route to QR, patient attacked security officer. Pt safely brought down to ground by security and staff, pt tased in the LLE (left lower extremity) and abdomen, brought into QR and placed on violent locked restraints (physical restraints that fully immobilize a patient- all four limps restrained (4-point restraint) -used as an emergency measure to keep a patient or others safe when there is a risk of physical harm). Redness noted to abdomen. LLQ (Left lower quadrant- location left lower abdomen), oozing blood to L upper lip. Sitter at bedside, will continue to monitor. 12:40 (p.m.) Pt continues to shout profanities and demand release. MD updated; new orders placed for additional medication. Linen and gown change due to urination. Thorazine (medication used to treat mental health conditions) 100 milligrams IM medicated, will continue to monitor.” During an interview on 10/30/24, at 1:25 p.m., with Charge Nurse (CN 1), CN 1 stated she worked on 9/3/24 and was assigned to the unit 4 where Pt 6 resided. CN 1 stated she had just come back from break when she noticed security was down the hallway and she was updated that Pt 6 had barricaded himself in his room. CN 1 stated she pushed the code button when she heard commotion and the staff had gotten Pt 6’s door open, she informed his nurse (Registered Nurse (RN 1)) to contact the doctor and get orders for medication. CN 1 stated the Code team arrived and attempted to deescalate the situation by talking with Pt 6, but Pt 6 was very agitated, unpredictable, and unstable, “we tried to offer him juice and therapy, then [RN 1] brought the medication, all [Pt 6] stated was that he wanted to leave”. CN 1 stated Pt 6 accepted the medication and was asked to stay in his room until the medication started to help, he had promised to stay in his room but no more than 5 10 minutes later he was yelling and screaming wanting to leave his room, so security was called to help escort him to the quiet room. CN 1 stated she walked in front, and they had 3 4 security officers on the sides and behind Pt 6 while they walked him to the quiet room. CN 1 stated Pt 6 has a history of a TBI, and he lunged at and attacked the security officer to his right side, he started to swing and hit with his fists. CN 1 stated the security and staff tried to contain him and Pt 6 was resistant and would not stop fighting, he was told multiple times to stop, and he would not. CN 1 stated Security told him that they would tase him if he didn’t calm down and he didn’t so security tased him in his right lower abdomen. CN 1 stated he was still yelling and fighting after he was tased and then Pt 6 froze and was calm enough to move him to the quiet room. CN 1 stated she attempted to talk with Pt 6 once he was put in the 4 point violent restraints, but Pt 6 was erratic, and “we were waiting for his medication to take effect”. CN 1 stated even in restraints he was verbally abusive and threatening staff by saying he would cut her head off and statements that he wanted a gun to shoot himself. During an interview on 10/30/24, at 1:53 p.m., with Mental Health Worker (MHW 1), MHW 1 stated she worked on 9/3/24 and was doing room checks and noticed Pt 6 was getting agitated and barricaded himself in his room, at that time she informed the nurse of what Pt 6 was doing. MHW 1 stated the nurse went to try and deescalate the patient and security helped to try to get the patient to open his door. MHW 1 stated she did not see Pt 6 get tased; she was busy watching the other patients in this unit. During an interview on 10/30/24, at 2:05 p.m., with MHW 2, MHW 2 stated part of her job was to round on patients every 15 minutes and when she attempted to open Pt 6’s door to do her visual check of the patient he had barricaded himself in there and would not let her in. MHW 2 stated she told the nurse and the nurse attempted to talk to Pt 6 to get him to open the door and security joined him in his attempts. MHW 2 stated “I don’t know if he [Pt 6] tried to hit [nurses name]” but security had to intervene. MHW 2 stated the therapist, and the house supervisor were also there attempting to deescalate the patient. MHW 2 stated Pt 6 was agitated, and she thinks he attacked the security guard and “they took him down” and a couple of minutes later they tased him. MHW 2 stated once Pt 2 was calm enough they took him to the quiet room, and he was placed in 4 point restraints. During an interview on 10/30/24, at 2:15 p.m., with the Security Team Lead (STL), the STL stated he was working downtown at Hospital A when he heard on the radio that there was an agitated patient pacing back and forth and his staff were not able to deescalate him. STL stated he left Hospital A and headed to the off campus psychiatric unit, once their Pt 6 was in his room and “we heard banging on his wall”, and Pt 6 had shut the door hard. STL stated, “medical staff came, and we opened the door, and I observed Pt 6 punching the wall” at this medical staff had gotten orders for restraints, so “we needed to move him to the quiet room.” STL stated Pt 6 initially refused to go to the quiet room saying he “was going to kill us but after several attempts we convinced him to exit the room and walk with us to the quiet room”. STL stated out of nowhere while in the hallway “Pt 6 attacked one of our officers by pushing her which caused her to hit her head on the wall and we went hands on with Pt 6. Once on the floor, one of our officers was pinned underneath Pt 6.” STL stated, “we were having a hard time getting ahold of Pt 6’s arms and legs, we could not get him [his officer] out from under Pt 6 because Pt 6 was punching and kicking”. STL stated, “I undid my taser, removed the cartridge to give him a dry stun to gain control of him, it kind of worked. As soon as the cycle was over, he [Pt 6] started again. I then gave him a couple of more stuns with the taser, after the fourth one we got control, placed him in the taco (hard plastic device used to lift patients off the floor) and moved him to the room where we restrained him even during that he was cussing and spitting at us.” STL stated he has done the initial taser training upon hire and does continued education on taser use annually. During a review of the video footage of the incident on 9/3/24, Pt 6 was observed having multiple staff attempt to talk with him while he barricaded himself in his room. Pt 6 emerged from his room at 12:14 p.m., a total of four security guards were standing around him, one in front, one to each side and one behind him, nursing staff and mental health workers were also walking with the patient to the quiet room when Pt 6 pushed the female officer to his right hard and she hits the wall behind her, at that point a second officer jumps in and takes Pt 6 to the ground, the two other officers are attempting to restrain Pt 6 but Pt 6 was hitting and kicking out his legs. The security officer who initially took Pt 6 down to the floor was under the patient and one of the security officers, the team lead was seen pulling out his taser and tasing Pt 6, multiple staff surround Pt 6, so it is difficult to see the patient and where he got tased, nursing staff bring medication and give it in the patient’s arm. Pt 6 was seen still fighting then goes still and security was able to restrain him and put him in the taco face down. At 12:20 p.m. Pt 6 was seen transported into the quiet room in the taco and being moved onto the bed where four point restraints were being placed on him, Pt 6 was still fighting but was secured and nursing staff was now doing an assessment. During a review of the hospital’s policy titled, “Taser Usage,” dated 2/17/21, indicated, “I. PURPOSE the purpose of this policy is to establish guidelines for the deployment and use of the taser by Security Services Staff. II. POLICY This policy is established to control the deployment and use of the taser to maximize the safety of the facility and staff while limiting potential injuries and corporate liability. A taser may only be possessed and deployed by an authorized, designated, certified, and properly trained security officer or supervisor of this department. III DEFINITIONS ... c. Taser the taser is a less than deadly device used to incapacitate subject (s) by discharging an electronic current into the subject via two wired probes. The taser may also be use in a touch stun capacity with a discharged cartridge in the device or when the taser is not equipped with a cartridge ... VII. A. the following procedure shall be adhered to while deploying a taser in an authorized manner and circumstances. 1. The taser shall not be deployed or displayed at any time unless the officer has specific information that reasonably indicates the use of a taser is warranted. The circumstances of each incident shall dictate the reasonableness for the deployment of the taser. The officer must reasonably believe that a credible threat to the safety of the officer or others exists. 2. The taser should not be used to simply overcome resistance when adequate assistance is available. 3. The taser shall not be used as an intimidation tool to gain compliance where the reasonable deployment is not justified. The taser shall not be deployed against passive demonstrators ... X. MULTIPLE APPLICATIONS If after the first application of the taser, an office is unable to gain compliance and circumstances allow, the officer should consider whether or not the taser device is operating properly and if other options or tactics may be more appropriate. However, multiple, and reasonable applications on the subject may be warranted and are not precluded. XI. AFTER DISCHARGE RESPONISBILITIES ... B. The taser officer shall prepare a detailed incident report which thoroughly covers the circumstances and justification for deployment. The identification of the utilized taser shall be identified in the documentation. Each officer involved in the taser incident shall complete a supplemental report detailing their actions and observations. All documentation shall be done promptly without delay ... XIII. TASER USE REVIEW BOARD After each taser deployment, the shift supervisor and manager shall review all documentation to evaluate the appropriateness for the deployment. All taser deployment reviews shall be completed by the Use of Force Review Board as defined by the Use of Force policy.” During a review of the hospital’s policy titled, “Use of Force,” dated 8/22/23, indicated, “I. PURPOSE the purpose of this policy is to provide security officers with guidelines for the legal and proper use of physical force where required to protect the safety of patient’s staff, visitors, others, and property. II. POLICY It is the policy of [name of hospital] Security Department that security officers are permitted to use reasonable force when: A. the security officer reasonably believes that he/she is in imminent danger of suffering bodily injury or being touched unlawfully (“self defense”), someone is in imminent danger of suffering bodily injury (“defense of another”), or to protect [name of hospital] property from immediate harm (“defense of property”). B. The security officer reasonably believes that the use of reasonable force is necessary to defend against that danger. The security officer shall use the minimum amount of force necessary to accomplish lawful objectives and immediately cease once an individual is under control. The security officer shall use no more force than is reasonably necessary to defend against the danger ... IV. USE OF FORCE CONTINUUM The use of force continuum is a system used by this department to determine the reasonable force is a given situation ... The possible security officer response levels are as follows: A. Level 1: Officer presence (examples: physical appearance, professional bearing) B. Level 2: Verbal commands (example: clear and deliberate) C. Level 3: Soft techniques (examples: physical control tactics/wrist locks (grabbing the opponent’s hand and twisting and/or bending it in a non-natural direction) D. Level 4: Hard techniques (examples: Taser/strike points/impact weapons/ OC Spray). All levels identified above in the use of force continuum shall be documented and investigated pursuant to this department’s policy. During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...” During a review of the State Operations Manual (SOM) Appendix A Survey Protocol, Regulations and Interpretive Guidelines for Hospitals,dated 4/19/2024, the SOM indicated, “ ... CMS does not consider the use of weapons in the application of restraint or seclusion as a safe, appropriate health care intervention. For the purposes of this regulation, the term “weapon” includes, but is not limited to, pepper spray, mace,nightsticks, tasers, cattle prods, stun guns, and pistols. Security staff may carry weapons as allowed by hospital policy, and State and Federal law. However, the use of weapons by security staff is considered a law enforcement action, not a health care intervention. CMS does not support the use of weapons by any hospital staff as a means of subduing a patient in order to place that patient in restraint or seclusion. If a weapon is used by security or law enforcement personnel on a person in a hospital (patient, staff, or visitor) to protect people or hospital property from harm, we would expect the situation to be handled as a criminal activity and the perpetrator be placed in the custody of local law enforcement ...” 3. During a review of Pt 7’s face sheet (FS) dated 10/10/24, the FS indicated Pt 7 was a 30 year old male admitted on 9/23/24 at 10:22 p.m. for Psychosis (a collection of symptoms that affect the mind, where there has been some loss of contact with reality) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 10/7/24 at 2 p.m. During a review of Pt 7’s History and Physical (H&P) date 9/22/24 at 9:12 a.m., the H&P indicated, “ ... chief complaint Patient presents with Psych Bizarre Behavior. EMS went on scene, pt refusing to answer questions. Refusing treatment. Making odd comments about being 13 year old ... History of Present Illness: [name of Pt 7] is a 30 y.o. male patient with reported history of schizophrenia (a chronic mental disorder that affects a person’s ability to think, perceive reality, and interact socially), marijuana abuse who was brought in by ambulance to ED on 1799 for SI (suicidal ideation thoughts of killing himself) ... On asking about SI, he nods yes but says “I don’t remember why”. Denies ETOH (ethanol- type of alcohol) abuse. Smokes marijuana off and on. Reports hearing voices in his head but does not remember what the voices state ...” During a review of Pt 7’s document titled, “Plan of Care,” dated 10/3/24 at 12:12 p.m., the plan of care indicated, “Problem: Risk for violence/aggression towards others Goal: Refrain from acts of violence/aggression during length of stay, and demonstrate improved impulse controls at the time of discharge LTG [long term goal] Outcome: Not Progressing Goal: Verbalize thoughts and feelings associated with harming others STG [short term goal] Outcome: Progressing Goal: Refrain from harming others STG Outcome: Not Progressing Goal: Refrain from destructive acts on the environment or property STG Outcome: Progressing Goal: Control angry outbursts STG Outcome: Not progressing ... Goal: Identify appropriate positive anger management techniques LTG Outcome: Not Progressing ... Problem: Cognitive Perceptual Pattern Impaired Goal: Able to refrain from responding to false sensory perceptions (hallucinations, are the experience of perceiving objects or events through the senses when they are not present) STG Outcome: Not Progressing Goal: Refrain from acting on delusional thinking (a fixed false belief that a person holds onto, even when there is evidence that it is not real)/internal stimuli (changes, experiences, or feelings that occur within someone) STG Outcome: Not Progressing Goal: Demonstration of accurate environmental perceptions LTG Outcome: Not Progressing ... Problem: Coping Ineffective Goal: Able to identify one positive coping skill STG Outcome: Not progressing Goal: Effective coping LTG Outcome: Not Progressing ... Problem: Mood Altered Lability Goal: Demonstrates control over impulsivity with assistance STG Outcome: Not Progressing Goal: Utilizes positive coping mechanisms STG Outcome: Not progressing Goal: Demonstrates appropriate boundaries LTG Outcome: Not Progressing Goal: Mood stable LTG Outcome: Not progressing Problem: Social Interaction - Impaired Goal: Able to identify behaviors that impede relationships STG Outcome: Not Progressing... Goal: Able to achieve maximum level of psychosocial functioning Outcome: Not Progressing ... Problem: Violence, Self/Others Directed, Risk of Goal: Absence of self harm LTG Outcome: Progressing Goal: Communicates desires to harm self/others STG Outcome: Progressing Goal: Identifies triggers to aggressive behavior STG Outcome: Not Progressing Goal: Absence of harm to others LTG Outcome: Not Progressing Goal: Absence of violence LTG Outcome: Not progressing ...” During a review of Pt 8’s FS dated 10/10/24, the FS indicated Pt 8 was a 25 year old male admitted on 9/25/24 at 2:21 p.m. for Psychosis and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 10/5/24 at 11:30 a.m. During a review of Pt 8’s Psychiatric H&P dated 9/25/24 at 12:36 p.m., the H&P indicated, “ ... 25 year old male with previously diagnosed schizophrenia and methamphetamine (powerful, highly addictive stimulant that affects the central nervous system) use who presented to [Hospital D] on 9/17 on a 5150 for GD [gravely disabled- a condition in which a person, as a result of a mental disorder, is unable to provide for his or her basic personal needs for food, clothing, or shelter] after being found psychotic and unable to care for himself ... During admission at [Hospital D], patient was initially agitated, non-cooperative, refusing meals and medications ... Patient was eventually transferred to [the off-campus psychiatric unit] on 9/25 ... Contacted patient’s cousin ... she stated that the patient was diagnosed with bipolar disorder (a serious mental illness that causes extreme mood shifts, including periods of mania and depression) two years ago, however, during recent hospitalizations, providers expressed that the patient likely has schizophrenia instead ...” During a review of the Investigative Summary (IS) (not dated), the IS indicated, “Aggressor/Patient: [Pt 7] Victim/Patient: [Pt 8] ... Summary: 25 y/o victim patient was receiving shower supplies from staff in the hallway of unit 3, when aggressor patient approached and hit victim multiple times in the head, face, back and ankle without provocation. Victim reportedly fell to the floor after these patients were separated. Victim c/o pain 10/10. American Ambulance transported the victim to the [Hospital A] ED. He was evaluated, medically cleared, and returned to [off campus psychiatric unit] on a different unit. Victim: 10/3 0810: pt was receiving shower supplies in the hallway from staff, when male peer approached pt, unprovoked, and hit pt multiple times to head, face, back and right ankle resulting in pt falling on the floor. Pt complained of 10/10 pain to head and right ankle at this time.0906: Pt arrived in ED, Pain assessment: 0/10. 1030: XR (x-ray- images that create pictures of the inside of the body) L (left) Ankle: Negative exam. 1039: XR L Forearm: No definite fracture is seen. 1615: Pt DC (discharged) from ED (emergency department) and returned to [off campus psychiatric unit] Unit 1. 1653: Skin Check: Pt has c/o (complaint of) stomach pain and left arm pain both 5/10. Skin check was done by RN and MHW performed the skin check and there was no contraband and pt had a contusion to left forearm. Aggressor: 10/3 0815: approached peer in the hallway, unprovoked, and punched peer multiple times. Separated pt and peer, security, code team, house supervisor and [doctors name] was notified. Benadryl (antihistamine that helps with pain and itching, side effect drowsiness) 50 mg (milligrams- unit of measurement); Haldol (treatment for schizophrenia) 5 mg and Ativan (sedative can help with anxiety and seizure activity) 2 mg IM (intramuscular- in the muscle) given. 1451: LCSW (licensed care social worker) note: explored how Pt is feeling, and he replied, “This feels like hell.” Pt stated his anger has been building for some time, and that the other Pt whom he assaulted disrespected him. 1534: Pt seen/heard on the phone with his mother. Pt appeared agitated, glaring at staff walking by, clutching his bracelet. Asking mom why she didn’t want him to go home. Pt later seen pacing the hall, standing in one place, and glaring at everyone walking by, and clutching his fists. Pt offered medication for anxiety/agitation. Pt agreed. [doctors name] called and order was placed for 100 mg Thorazine (treats mental health conditions, regulates mood) by mouth. 1852: pt heard punching the wall a few times in the quiet room. Ativan by mouth was given with no complications ...” During an interview on 10/31/24, at 2 p.m. with MHW 3, MHW 3 stated she was handing out shower supplies on 10/3/24, she had just given Pt 8 shower supplies when she heard her coworker yell and she saw Pt 7 hitting Pt 8 on the ground. MHW 3 stated it was just the beginning of their shift and she did not see any prior interaction between Pt 7 and Pt 8, “this was unprovoked”. MHW 3 stated, “I tried to separate them [Pt 7] stepped back and then he came back to attack [Pt 8],” code grey was called. MHW 3 stated they were able to get Pt 7 to stop and keep him from Pt 8, the nurse came and assessed Pt 8 and security stayed with Pt 7. During an interview on 10/31/24, at 2:06 p.m., with MHW 4, MHW 4 stated she worked on 10/3/24 and was in the process of doing vital signs on patients when she saw Pt 7 punching Pt 8 who was standing there to get bath stuff. MHW 4 stated she pushed the patient with the wheelchair out of the way and called for help, RN 2 called the code. MHW 4 stated we tried to separate them but “I could not hold him (Pt 7), he (Pt 7) was too fast. It was unprovoked.” MHW 4 stated we did get them apart and Pt 8 was moved to the TV room and was checked out and ended up getting sent to the hospital while Pt 7 was kept away from him. During an interview on 10/31/24, at 2:15 p.m., with RN 2, RN 2 stated she was the Charge nurse on 10/3/24 on unit 4 when the incident occurred between Pt 7 and Pt 8. RN 2 stated she had assigned these two patients to RN 3 at the beginning of the day shift. RN 2 state she was at the nursing station when she heard a noise in the hallway, she investigated the hallway and immediately yelled to call the code grey and pushed the button for code grey because Pt 7 was hitting Pt 8. RN 2 stated she came around the nurse’s station and attempted to pull Pt 7 away from the Pt 8. RN 2 stated she then was trying to keep the Pt 8 away from Pt 7 telling him to go to his room and eventually he did when security came and escorted him. During an interview on 11/4/24, at 1:30 p.m. with RN 3, RN 3 stated she worked on 10/3/24 and was the nurse for both Pt 7 and Pt 8. RN 3 stated, “I remember talking with [Pt 8] and I had just sat him down in the day room and brought him his breakfast. I told him we were going to have a good day ... My other patient was sleeping, breakfast had just arrived. Another patient came and asked for her medications, and it (the medication) was on another unit, so I let them know (other staff on the unit) I had to grab it from another unit and at that time everything was fine and safe.” RN 3 stated, “When I was coming back to the unit I heard the code grey. It was already over, and people were responding to the code 9by the time she got back to the unit).” RN 3 stated she was less than two minutes off the unit to get the medication and that left three employees on the unit. RN 3 stated she did not know how this could have been prevented it was “completely unprovoked. He [Pt 7] had no history of violence”. RN 3 stated she assessed Pt 8 and helped him off the ground and made sure he was okay. RN 3 stated Pt 8 had complaints of head, face, and ankle pain so she reached out to the doctor, and he ordered for Pt 8 to go to the hospital to get checked out. RN 3 sated when Pt 8 came back from the hospital he was moved to a different unit for his safety. During the review of the video footage for the incident dated 10/3/24, at 8:10 a.m. Pt 7 was seen walking up behind Pt 8 who was receiving shower supplies from MHW. Pt 7 punches Pt 8 and Pt 8 goes to the ground and Pt 7 continues punching him, staff was attempting to get Pt 7 to stop and get him off Pt 8. Pt 8 was blocking his head trying to protect himself. Note there was another patient between the scene who was pushing his wheelchair in front of him that was blocking one of the MHW from getting to Pt 7 and Pt 8 to help. It took a minute to get this patient out of the way. Code gray must have been called because within that minute security was there and Pt 7 was already pulled off Pt 8, but Pt 7 did try to come towards Pt 8 again, but staff was between them and prevented this. Security walked Pt 7 to his room while staff helped Pt 8 off the ground. During a review of Pt 7’s Progress Note dated 10/3/24 at 2:50 p.m., the Progress Note indicated, “ ... This morning, patient had a significant event where he punched another patient multiple times, seemingly unprovoked ... He was able to state that he does have a mental illness (diagnosed with schizophrenia/schizoaffective disorder) and he was able to name the medications he is currently being prescribed ... When asked about the events of this morning, he said he beat up the other patient because “this place makes me sick.” He stated that “there is only so much you can take before you snap.”” During a review of the facility’s policy and procedure (P&P) titled, “Patient’s Rights and Responsibilities,” dated 2/10/2022, the P&P indicated, “I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, the hospital failed to ensure nursing staff updated and developed individualized care plans (required documents to help guide care for patients) related to infection (Pt (patient) 2 and Pt 14), sepsis (a severe infection in the blood) (Pt 14 ) and chest pain (Pt 17) for four of 73 sampled patients (Pts 2, 14, 16, and 17) when: 1. Nurses did not develop an individualized care plan for Pt 2’s infection when his admitting diagnosis (the reason he was admitted to the hospital) was for a disease caused by the human immunodeficiency virus (HIV) that severely damages the body’s immune system and makes it difficult for the body to fight off infections. 2. Nurses did not develop an individualized care plan for Pt 14’s potential for infection when he had a broken femur (thigh bone) from a motorcycle accident and the bone tore through the skin (an open fracture) and was sticking out, causing a risk for infection. 3. Nurses did not develop an individualized care plan for Pt 16’s sepsis (a severe and often deadly infection) when his admitting diagnosis was cholangitis (condition that is usually caused by a bacterial infection or blockage in the bile duct near the gallbladder) and was diagnosed with sepsis after admission. 4. Nurses did not develop an individualized care plan for Pt 17’s chest pain when the primary reason he was transferred to Hospital B was for a NSTEMI (non-ST elevated myocardial infarction - a type of heart attack that occurs when the heart doesn’t get enough oxygen.) These failures had the potential to cause inconsistent delivery of care, which can result in the decline or lack of improvement for Pts 2, 14, 16, and 17’s health conditions. Findings: 1. During a concurrent observation and interview on 11/1/24 at 1:10 p.m. with the Director of Inpatient Cardiovascular Services (DICS) and Registered Nurse (RN) 24, observed Pt 2 in his bed in room Pt 2’s hospital room. RN 24 stated Pt 2 was in isolation (in a private room to) because he has an infection, and we were required to wear an isolation gown (a disposable gown worn over clothing while in the patient’s room and discarded when leaving the room to prevent the spread of infection) to enter the room. During a concurrent interview and record review 11/1/24 at 2:38 p.m. with the Director of Intensive Care Services (DICS) and the Manager of the Intensive Care Unit (MICU), the MICU opened the Electronic Medical Record (EMR) for Pt 2. The document titled, “Consults,” dated 10/9/24 by MDF (Medical Doctor Fellow (a doctor who is continuing their education) 3 indicated Pt 2 was a man with a history of an immune deficiency disease which makes it difficult for the body to fight off infections, illnesses, and certain cancers. He was admitted to the hospital on 9/21/24. The consult indicated Pt 2 had a previous admission from 8/5/24 - 9/5/24 for meningitis (an infection in the brain or spinal fluid) and an immune deficiency disease. During a review of document titled “Progress Notes” dated 10/31/24 by MD (Medical Doctor) 5, the document indicated a chest x-ray on 10/19/24 showed, “worsening consolidation (when the air in the small airways of the lungs is replaced with a fluid, solid, or other material such as pus, blood, water, stomach contents) in the right mid and upper lung with cavitation (a gas-filled area in the lung) near complete opacity (areas in the normally dark-appearing lung that appear denser, hazy, or cloudy) of the right lower and middle lobes (sections of the lung.)” During a review of the hospital document titled, “Plan of Care” the MICU and DICU searched for a care plan related to infection and were unable to find one. The MICU stated Pt 2 has infections currently and is at high risk of infection because of his diagnosis of immune deficiency which makes it harder for his body to fight infection. When asked if a care plan for infection management and prevention should have been included in the Care Plan, the DICU stated, “I would have liked there to be one.” 2. During a concurrent interview and record review on 11/4/24 at 1:00 p.m. with the Director of Pediatrics (DPED) and the Clinical Educator for Pediatrics (CE1,) CE 1 opened the EMR for Pt 14. The document titled, “H&P (History and Physical) dated 10/29/24 at 4:52 p.m. indicated Pt 14 was a male who was riding a motorcycle on 10/29/24 when he was hit by a car. The note indicated Pt 14 was “found to have a left femur fracture (broken thigh bone) and left pulmonary contusion (a bruise on the lung from a chest injury) ... Assessment & Plan ...A. left open femur fracture (the long bone in the thigh was broken and immune deficiency) ... placed in traction with orthopedics. Given Ancef in the ED (Emergency Department).” The hospital document titled “Orthopedic Surgery Progress Note,” dated 11/1/24 at 9:43 a.m. indicated Pt 14 went to surgery on 10/30/24 for a “ ...midshaft femur fx (fracture) 2/2 MCC (a fracture that is considered to have a major complication (MCC) due to its severity, typically indicating a displaced or complex fracture that might require extensive surgical intervention and could lead to significant complications like infection, blood loss, or impaired function.) During a review of the hospital document titled “Plan of Care” DPED and CE 1 searched the document for a care plan related to infection and they were unable to find one. DPED stated, “I don’t see a care plan for infection, and all surgical patients are at risk of infection.” CE 1 stated nurses should have created a care plan for infection prevention, especially since Pt 14 had an open fracture. 3. During a concurrent interview and record review on 10/31/24 at 2:45 p.m. with the DICS, the opened the EMR for Pt 16. The document titled, “Progress Notes,” dated 10/31/24 at 12:01 p.m. indicated, “ ...[Pt 16] is a ... male with a medical history significant for recurrent cholangitis (condition that is usually caused by a bacterial infection or blockage in the bile duct near the gallbladder) metastatic cholangiocarcinoma (a rare and aggressive cancer that occurs when bile duct cancer cells spread beyond the bile ducts to other parts of the body, GERD (gastroesophageal reflux disease - A digestive disease in which stomach acid or bile irritates the food pipe lining ...Assessment & Plan ... A: Sepsis ... with most probably intraabdominal (inside the abdomen) source ...” The DICS then opened the document titled, “Plan of Care” and searched for a care plan related to sepsis or active infection and was unable to find one. The DICS stated nurses should have created a care plan for sepsis. 4. During a concurrent observation and interview on 10/30/24 at 3:25 p.m. with RN 26, we entered a hospital room at Hospital B and observed Pt 17 lying on his back in a hospital bed. Pt 17 appeared to be uncomfortable, and stated he had a “heart problem” and was probably going in for heart surgery. During a concurrent interview and record review on 10/31/24 at 2:45 p.m. with the DICS, the DICS opened the EMR for Pt 17. The document titled, “Progress Notes,” dated 10/31/24 at 7:27 a.m. indicated Pt 17 was a man who went to a nearby hospital with chest pain which started 4-5 days before he went to the hospital. He was transferred to Hospital B for a higher level of cardiac (heart) care. Progress note indicated, “Daily plan: CAD (coronary (heart) artery disease - planned for CABG (Coronary artery bypass grafting (CABG) is a surgical procedure that improves blood flow to the heart by bypassing blocked or narrowed coronary arteries) on 10/31/24 ... Assessment & Plan: NSTEMI (non-ST elevated myocardial infarction - a type of heart attack that occurs when the heart doesn’t get enough oxygen.) The DICS then opened the document titled, “Plan of Care” and searched for a care plan related to cardiac care and was unable to find one. The DICS stated nurses should have developed a care plan for cardiac care because that is the main reason Pt 17 came to the hospital and the reason he was having surgery. During a review of the hospital’s policy and procedure (P&P) titled “Interdisciplinary (involves nursing and other health providers) Plan of Care” dated 10/12/23, the P&P indicated, “... initiate the Plan of Care based on the patient’s comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 51223 All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). Based on interview, clinical record review, and hospital policy review, the hospital failed to ensure three out of 73 Patients (Pt) had their pain levels assessed and reassessed in accordance with hospital policy and procedure when: 1. Pt 15 was administered intravenous (IV in the vein) opioid(a class of pain relieving drugs used for moderate to severe pain) for severe pain and did not receive a post intervention pain assessment within 30 minutes. 2. Pt 18 was administered oral (by mouth) medication for moderate pain and did not receive a post intervention pain assessment within 60 minutes. 3. Pt 73 was administered IV medication for severe pain and did not receive a post intervention pain assessment within 30 minutes. These failures had the potential to delay care and treatment decisions to achieve an acceptable pain level to facilitate timely discharge for Pts 15, 18, and 73. Findings: 1. During a record review on 10/31/24 2:38pm in the Directors office of Hospital B with the Director of In Patient Cardiovascular Service (DICS), the DICS opened the Electronic Medical Record (EMR) for Pt 15. The document titled, “History and Physical (H&P a formal assessment of a Pt’s medical history and current condition),” dated 10/28/24 at 8:07 p.m., the “H&P” indicated, Pt with a “diagnosis of subcutaneous abscess (a pus filled cavity within the skin caused by a local bacterial infection). Pt 15 had two surgical procedures on 9/6/24 to explore and clean the abscess and on 10/29/24 an incision and drainage (“I&D” a cut made to reach the abscess and release pus from the body). Pt 15’s “Pain Monitoring Summary” indicated on 10/29/24 at 4:24 p.m., Pt 15 complained of severe pain 10/10 (Pain scale 0 10 descriptors, 0 no pain, 1 3 mild pain, 4 6 moderate pain, and 7 10 severe pain) with pain goal (an acceptable level of pain intensity) of 4/10. Pt 15 was administered IV hydromorphone (an opioid pain medicine to relieve severe pain given in the vein). The “Pain Monitoring Summary” record indicated a post intervention pain reassessment was not documented after receiving an IV opioid. During an interview on 11/6/24 at 9:20 a.m. at Hospital B with the Manager of Emergency Department (MED1), the MED1 stated he expects Licensed Nurses (LN) to reassess Pt’s pain for intervention effectiveness once pain is identified and after medications are administered. During an interview on 11/6/24 at 11:00 a.m., in the Directors office of Hospital A with the Manager of 1E (M1E), the M1E stated the pain reassessment was expected to occur within 30 minutes after giving an IV pain medication or one hour after giving an oral pain medication to ensure pain has resolved or to implement another intervention if the pain has not been relieved. 2. During a record review of Pt 18’s “Hospitalist Daily Progress Note”, dated 10/31/24, the progress note indicated, this was previously admitted to Hospital A on 9/15/24 and discharged 9/19/24 subsequently re admitted to Hospital A on 10/28/24. Pt 18 had swelling on the lower right leg, a chronic wound over the right lower leg, right mid and lower femoral deep vein thrombosis (“DVT” a blood clot formed in a deep vein, usually in the legs) and thrombophlebitis (an inflammatory process that causes a blood clot to form and block one or more veins, usually in the legs). During a record review and concurrent interview on 11/5/24 2:10 p.m., in the Director’s office at Hospital B with Director of In Patient Cardiovascular Service (DICS), the DICS opened the EMR for Pt 18. The document titled; “Pain Monitoring Summary” dated 10/30/24 at 5:22 p.m. indicated Pt 18 complained of inner ankle pain 6/10 (moderate pain) with a pain goal of 5/10. Pt 18 was administered an oral (by mouth) dose of 650 milligrams (a unit of measurement of weight ) acetaminophen. (pain reliver or feverreducer) The “Pain Monitoring Summary” record indicated a pain reassessment was not documented after receiving oral pain medication. The DICS stated there was no post intervention pain reassessment done after Pt 18 was administered medication at 5:22 p.m. During an interview on 11/6/24 at 9:20 a.m., at Hospital B with the Manager of Emergency Department (MED1), MED1 stated, he expects LNs to reassess Pt’s pain for intervention effectiveness once pain is identified and after medications are administered. During an interview on 11/6/24 at 11:00 a.m., in the Directors office of Hospital A with the Manager of 1E (M1E), M1E stated, pain reassessment was expected to occur within 30 minutes after giving an IV pain medication or 1 hour after giving oral pain medication to ensure pain has resolved or to implement another intervention if the pain has not been relieved. 3. During a concurrent interview and record on 11/7/24 with the Director of Emergency Department (DED) the DED opened the Electronic Medical Record (EMR) for Pt 73. The document titled, “History and Physical” (H&P a formal assessment of a Pt’s medical history and current condition by a medical provider) dated 10/30/24, indicated Pt 73 arrived at Hospital A on 10/30/24 at 9:16 a.m. with chief complaint low back pain. The “H&P” indicated, “ ... who presents to the Emergency Department (ED) with headache and lower back pain ... notes she has peed herself due to having to walk slow from her back pain and did not make it to the toilet ...” During a concurrent interview and record review on 11/7/24 at 2:45 p.m., with the DED, Pt 73’s “Emergency Department Timeline (EDTL)”, dated 10/30/24 was reviewed. The “EDTL” indicated, “ ... 10:01 [a.m.] Medication Given: acetaminophen (Tylenol) table 1,000 mg [milligram, a unit of measure] Dose 1,000 mg; Route: Oral ...”. The “EDTL” indicated no other pain assessment was conducted until 12:37 p.m. on 10/30/24. The “EDTL” indicated, “ ...12:38 [p.m.] Medication Given: Ketorolac (pain medication) injection15 mg Dose 15 mg; Route: Intravenous (administered into a vein) ...” The “EDTL” indicated no other pain assessment was conducted until 14:00 (2:00 p.m.). The DED stated oral pain medications should be reassessed in 45 minutes to an hour and IV (intravenous) medications should be reassessed in 15 minutes to 30 minutes. The DED stated if pain is not reassessed, then there is no way of knowing if the medication was effective. The DED stated reassessments were not completed on Pt 73 and should have been. During a review of facility’s policy and procedure titled, “Pain Assessment & Management Patients 14 and Older” Policy and Procedure dated 9/13/24, indicated, “...E. Evaluation/Reassessment of Pain Management ...2. Reassessment: pain intensity, level of sedation, respiratory rate, and pattern, if receiving opioids, and presence of adverse effects (an unwanted undesirable effect that is possibly related to a drug) will be reassessed after each unscheduled pharmacological (using medication to treat a patient’s condition) pain management intervention (the act of interfering to prevent harm or improve function) once a sufficient time has lapsed for the treatment to reach peak effect. A. Generally, IV medication is effective within 30 minutes and PO (by mouth) medication is effective within 60 minutes. This re assessment will be documented in the EHR (electronic health record) using the appropriate pain and sedation scale ...4. Compare post intervention pain level to acceptable pain level to determine intervention effectiveness and/or additional interventions for Pts able to provide a self report ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 47205 Based on observation , interview, and record review, the hospital failed to ensure Licensed Nurses (LNs) administered medications in accordance with the hospital’s policy and procedure (P&P) titled “Medications Orders, Administration, Storage, Documentation” and acceptable standards of practice for medication administration safety, when one of one sampled patients, (Pt) 74 was administered fentanyl and versed from incompletely labeled syringes (without required “ new label on the transfer container or syringe contains the following information: i. Name of solution or medication ... ii. Strength and amount ... iii. Volume ... vi. Date prepared ...,”) intravenously (IV into the vein) bolused (single dose of a drug or other substance given over a short period of time) medication(s) by Registered Nurse (RN) 9 which had been prepared by another LN (RN 10). This failure resulted in a medication administration error for Patient (Pt) 74. Pt 74 received IV medication without administering LN verification of the “Five (5) Rights of Medication Use (the “five rights” are emphasized for the preparation of medication administration: right patient, right drug, right dose, right site, and right timing. It is essential to explain to patients how the medication will be administered, obtain consent for procedures when indicated (e.g., central venous catheter (a thin, flexible tube that’s inserted into a vein). The site of application of the drug should be chosen based on its adequacy and indications. The label on the medication should be checked for its name, dose, and approved usage route...)” prior to use, which had the potential to result in Pt 74’s harm, up to and including death. Findings: During an observation of Pt 74’s procedure on 11/6/24 at 8:48 a.m. in the Interventional Radiology (IR-a medical specialty that uses minimally invasive image-guided procedures to diagnose and treat conditions in the body) department, room one (1), RN 9 was observed at the bedside speaking with Pt 74. RN 10 was observed to be drawing up medication from two vials into separate syringes at the medication cart located in room 1. RN 10 recapped the syringes and placed the empty vials onto the left, lower area on the surface of the medication cart. RN 10 handed the 2 pre filled syringes to RN 9. RN 9 administered the ordered IV medication during the procedure. During a review of Pt 74’s “Short Form History and Physical (H&P)” dated 11/6/24, the H&P indicated, “..History of Present Illness: Renal (kidney) failure, ascites (a buildup of fluid in your abdomen (belly) often due to liver disease), poor function to perm cath (a flexible tube that’s inserted into a blood vessel in the neck or upper chest to provide long term access to the bloodstream) ... Past Medical History ...Congestive Heart Failure (CHF when your heart can’t pump blood well enough to give your body a normal supply), Chronic kidney disease, (CKD- is a long-term condition that occurs when the kidneys are damaged and can’t filter blood properly) dialysis (a treatment that replicates the kidney’s function and cleans the waste from blood for individuals with kidney disease or kidney failure) patient ...” During a review of Pt 74’s “Authorization for and Verification of Consent to Surgery, Administration of Anesthetics [a drug or other substance that causes a loss of feeling or awareness] and Rendering of Other Medical Services (Consent)” dated 11/6/24, the Consent indicated Pt 74 was to have a “ ...Tunneled dialysis (a flexible catheter (thin tube) that goes into a vein in your chest) catheter exchange with procedural sedation (the techniques of managing a patient’s pain and anxiety to facilitate appropriate medical care) and paracentesis (a procedure in which a thin needle or tube is put into the abdomen to remove fluid from the peritoneal cavity (the space within the abdomen that contains the intestines, the stomach, and the liver).” During an interview on 11/6/24 at 9:25 a.m. with RN 9 and RN 10 immediately after Pt 74’s procedure in the IR procedure room, RN 10 stated he obtained and drew up the sedation medications (Fentanyl and Midazolam) ordered by the IRMD and transferred them into the syringes for use during the procedure. RN 9 stated she had and pre-labeled the syringes with medication name labels. RN 9 stated this practice allows for the RN to know which medication should be transferred into them. RN 9 and RN 10 explained they have worked as a team for some time and have developed a workflow in which like the situation with Pt 74, one nurse drew up the medication and the other administered it. RN 9 stated she did not watch RN 10 transfer medications from vials to the pre-labeled syringe(s). RN 9 referred to the syringes used in Pt 74’s procedure and each syringe was observed to have a only a medication name label on the each syringe. RN 10 stated he did not prepare the medication in the presence of RN 9, she was “with the patient, trying to calm him down.” RN 10 stated he was not aware of a policy against this practice. RN 9 stated she was not able to ensure the right medication had been drawn up in the right syringe(s) because she did not witness RN 10 prepare the medications. RN 9 stated the potential harm to the patient, as a result of this practice is that the patient could receive the wrong medication. During an interview on 11/6/24 at 9:38 a.m. with the Clinical Supervisor (CS) 1 and the Interim Director of Imaging Services (IDIS), they stated their expectation was for LNs to follow the hospital’s P&P on medication administration. During a review of the hospital P&P titled “Medications Orders, Administration, Storage, Documentation” dated 12/19/23, the P&P indicated “ ... I. PURPOSE: To provide guidelines for the safe and accurate ....administration ... of medications ... III. POLICY: ... B. Medication Administration ... 17. It is the responsibility of the person administering the medication to verify the following ... a. Drug allergies, b. The right drug, c. The right patient, d. The right dose, e. The right time, f. The right route ... V. PROCEDURE: ... F. Before administering any medications, verify that no contraindications to the medication exist and check drug allergies ...G. ... verify the medication label matches the Medication Administration Record (MAR) or prescriber’s order ... J. ... 3 ... a. ... I. Containers used to transfer medication and solutions from the original packaging include such things as syringes ... II. An immediately administered medication is one that an authorized staff member prepares or obtains, and administers directly to the patient without any break in the process, such as laying the syringe or container down for later use ... NOTE: Pre labeled empty syringes or containers are not acceptable ... b. The new label on the transfer container or syringe contains the following information: i. Name of solution or medication ... ii. Strength and amount ... iii. Volume ... vi. Date prepared ... c. If the person preparing the medication or solution is not the person administering it, verify the information on the new label, both verbally and visually, between two individuals qualified to participate in the procedure. Verify information on the label against the original medication or solution container ... d. Immediately discard any medication or solution that is found unlabeled ...” According to the National Institutes of Health (NIH)’s National Library of Medicine, “Nursing Rights of Medication Administration” by Hanson A, Haddad LM. Nursing Rights of Medication Administration. [Updated 2023 Sep 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan . Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK560654/ on 11/13/24 the article indicated “ ...Nurses have a unique role and responsibility in medication administration, in that they are frequently the final person to check to see that the medication is correctly prescribed and dispensed before administration ... According to the Joint Commission’s “National Patient Safety Goals® Effective January 2024 for the Hospital Program” dated 10/4/24, electronically obtained from https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2024/npsg_chapter_hap_jan2024.pdf on 11/15/24, the article indicated “...Goal 3. Improve the safety of using medications. NPSG.03.04.01 Label all medications, medication containers, and other solutions on and off the sterile field in perioperative (the time around a surgical operation, typically from when a patient enters the hospital or doctor’s office until they return home) and other procedural settings (a room in a hospital where procedures are performed that may require sterile (free from germs) instruments or supplies, but don’t require an aseptic (medically clean or without infection). Note: Medication containers include syringes, medicine cups, and basins...Rationale for NPSG.03.04.01 Medications or other solutions in unlabeled containers are unidentifiable. Errors, sometimes tragic, have resulted from medications and other solutions removed from their original containers and placed into unlabeled containers. This unsafe practice neglects basic principles of safe medication management, yet it is routine in many organizations. The labeling of all medications, medication containers, and other solutions is a risk reduction activity consistent with safe medication management. This practice addresses a recognized risk point in the administration of medications in perioperative and other procedural settings...” According to the National Institutes of Health (NIH)’s National Library of Medicine, “Medication Routes of Administration” by Kim J, De Jesus O. Medication Routes of Administration. [Updated 2023 Aug 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan . Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK568677/on 11/14/24 the article indicated “Five (5) Rights of Medication Use (the “five rights” are emphasized for the preparation of medication administration: right patient, right drug, right dose, right site, and right timing. It is essential to explain to patients how the medication will be administered, obtain consent for procedures when ndicated (e.g., central venous catheter), and help prepare patients before they receive their medication. The site of application of the drug should be chosen based on its adequacy and indications. The label on the medication should be checked for its name, dose, and approved usage route.” According to the National Institutes of Health (NIH)’s National Library of Medicine “Medication Administration Safety and Quality: An Evidence Based Handbook for Nurses” Hughes RG, Blegen MA. Medication Administration Safety. In: Hughes RG, editor. Patient Safety and Quality: An Evidence Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 37. Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK2656/ on 11/15/24 the article indicated “Medication errors occur in all settings and may or may not cause an adverse drug event (ADE). Medications with complex dosing regimens and those given in specialty areas (e.g., intensive care units, emergency departments, and diagnostic and interventional areas) are associated with increased risk of ADEs.6 Phillips and colleagues found that deaths (the most severe ADE) associated with medication errors involved central nervous system agents, antineoplastics, and cardiovascular drugs. Most of the common types of errors resulting in patient death involved the wrong dose (40.9 percent), the wrong drug (16 percent), and the wrong route of administration (9.5 percent). The causes of these deaths were categorized as oral and written miscommunication, name confusion (e.g., names that look or sound alike), similar or misleading container labeling, performance or knowledge deficits, and inappropriate packaging or device design.””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 46393 Based on observation, review of hospital policies and procedures (P&P) and interview with staff, it was determined that the hospital failed to maintain drug storage areas in accordance with acceptable standards of practice when: 1a. Six different types of IV (intravenous, into the vein) solution bags were identified stored in one plastic bin labeled for normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 L (liter, unit of measurement) IV bags in one of three inspected Emergency Department (ED) medication rooms (ED Yellow); and 1b. Nine NS 500 ml (milliliter, unit of measurement) IV solution bags were identified stored in a bin labeled for NS 500 ml irrigation solution (used for cleansing, washing, or rinsing) bags one of three inspected ED medication rooms (ED Red). 2. Three different types of IV solution bags were identified stored in one of one ED Trauma Equipment Rooms that was not monitored for temperature or humidity. 3. Four IV medications and an anesthesia medication tray (tray containing multiple medications used during surgery) were identified inside a supply cart in one of two inspected Operating Rooms (Trauma OR). These failures had the potential to result in administration of incorrect or unusable medications to patients in the hospital. Findings: 1a. During a tour of the hospital’s ED Yellow Medication Room on 10/30/24 at 11:10 a.m. with the Pharmacy Manager (PM), the following IV bags were identified in a bin labeled for NS 0.9% IV 1 L IV bags: - One dextrose 5% (D5W, a mixture of sugar and water) / 0.45% sodium chloride (1/2 NS, half-normal saline solution, a mixture of salt and water) with 20 mEq (milliequivalent, unit of measurement) potassium chloride (to treat low potassium) 1 L IV bag; - Two dextrose 10% (D10W, a mixture of sugar and water) 1 L IV bags; - One NS 500 ml IV bag; - One D5W 1 L IV bag; and - One 1/2 NS 1 L IV bag. During an interview on 10/30/24 at 11:15 a.m. with the PM, the PM acknowledged the IV bags listed above were not stored in the correct bin. The PM stated IV bags were stocked by Materials Management staff and Pharmacists checked medication rooms during monthly unit inspections. 1b. During a tour of the hospital’s ED Red Medication Room on 10/30/24 at 11:19 a.m. with the PM, nine NS 500 ml IV bags were identified stored in a bin labeled for NS 500 ml irrigation solution bags. During an interview on 10/30/24 at 11:21 a.m. with the PM, the PM acknowledged the NS 500 ml IV bags were not stored in the correct bin. During a follow-up interview on 10/31/24 at 9:16 a.m. with the PM, the PM stated the expectation was for the bins to be filled with what was labeled on the bin. The PM added, if the wrong product had been given to a patient, it could have led to negative patient safety. During an interview on 11/1/24 at 11:05 a.m. with the Director of Pharmacy (DOP), the DOP stated the IV bags inside the bin should have matched the label on the bin to prevent errors. During a review of the hospital’s policy and procedure (P&P) titled, “Patient Labeling/Storage/Rotation of Inventory,” dated 11/2/22, the P&P indicated, “After verification of labeling requirements, identify bin location to shelve inventory...Verify Lawson number, manufacture product number, and location of each item prior to shelving inventory.” 2. During a tour of the hospital’s ED Trauma Equipment Room on 10/30/24 at 11:29 a.m. with the PM, a shelf with three large plastic bins were observed. Each plastic bin contained the following IV bags: - NS 1 L; - NS 500 ml; and - Lactated Ringer (LR, a mixture of water, sodium chloride, sodium lactate, potassium chloride, and calcium chloride) 1 L. The ED Trauma Equipment Room was not observed to have been monitored for temperature and humidity. During an interview on 10/30/24 at 11:34 a.m. with the PM, the PM said he would need to check if temperature and humidity was monitored in the ED Trauma Equipment Room. During a follow-up interview on 10/31/24 at 9:12 a.m. with the PM, the PM stated that the ED Trauma Equipment Room was not monitored for temperature or humidity. The PM stated IV bags were considered medications and needed to be stored according to manufacturer’s specifications. The PM added, if not stored according to manufacturer’s specifications, the efficacy of the IV bags could have been compromised. During a concurrent interview and record review on 11/1/24 at 2:49 p.m. with the Manager of Plant Operations and Maintenance (MPOM), the hospital’s ED Trauma Rooms’ temperature, humidity, and pressure logs dated May, June, July, September, and October 2024 were reviewed. The ED Trauma Rooms’ temperature, humidity, and pressure logs indicated Trauma Rooms 1 through 3 were monitored but did not indicate that the ED Trauma Equipment Room was monitored. The MPOM stated staff had not monitored temperature, humidity, or pressure inside the ED Trauma Equipment Room. During an interview on 11/1/24 at 3 p.m. with the DOP, the DOP stated IV bags are considered medications and the expectation was for the IV bags to have been stored according to manufacturer instructions to ensure potency was maintained. The DOP acknowledged the temperature and humidity of the ED Trauma Equipment Room was not monitored. Review of the manufacturer instructions on the NS 1 L, NS 500 ml, and LR 1 L IV bags’ outer packaging indicated, “Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit])...” During a review of the hospital’s P&P titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, the P&P indicated, “Medications will be securely stored at all times and at the appropriate temperature.” 3. During a tour of the hospital’s Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following medications were observed stored inside an anesthesia supply cart: - One anesthesia medication tray (contained multiple medications for surgery); - One phenylephrine (to treat very low blood pressure or heart problems during surgery) 1000 micrograms (mcg, unit of measurement)/10 ml in NS, 10 ml injection syringe; - Two Cefazolin (an antibiotic used for infection) 1 gram (g, unit of measurement) powder for injection vials; - One Rocuronium (a powerful muscle relaxer for use during surgery) 50 milligram (mg, unit of measurement)/5 ml, 5 ml injection vial; and - One hydralazine (to treat high blood pressure) 20mg/1 ml, 1 ml injection vial. During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart. During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated, the expectation was for medications to be stored secured in the proper location according to the hospital’s P&P. Further review of the hospital’s P&P titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, indicated, “All medications removed from a medication storage area (e.g., floor stock, Pyxis) must only be removed for one patient at a time. If medication dispensed is not administered or used, the medication should be returned to the original storage area as soon as possible, but no later than the end of the shift.””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 46393 Based on observation, review of hospital policies and procedures (P&P) and interview with staff, it was determined that the hospital failed to maintain drug storage areas in accordance with acceptable standards of practice when: 1a. Six different types of IV (intravenous, into the vein) solution bags were identified stored in one plastic bin labeled for normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 L (liter, unit of measurement) IV bags in one of three inspected Emergency Department (ED) medication rooms (ED Yellow); and 1b. Nine NS 500 ml (milliliter, unit of measurement) IV solution bags were identified stored in a bin labeled for NS 500 ml irrigation solution (used for cleansing, washing, or rinsing) bags one of three inspected ED medication rooms (ED Red). 2. Three different types of IV solution bags were identified stored in one of one ED Trauma Equipment Rooms that was not monitored for temperature or humidity. 3. Four IV medications and an anesthesia medication tray (tray containing multiple medications used during surgery) were identified inside a supply cart in one of two inspected Operating Rooms (Trauma OR). These failures had the potential to result in administration of incorrect or unusable medications to patients in the hospital. Findings: 1a. During a tour of the hospital’s ED Yellow Medication Room on 10/30/24 at 11:10 a.m. with the Pharmacy Manager (PM), the following IV bags were identified in a bin labeled for NS 0.9% IV 1 L IV bags: - One dextrose 5% (D5W, a mixture of sugar and water) / 0.45% sodium chloride (1/2 NS, half-normal saline solution, a mixture of salt and water) with 20 mEq (milliequivalent, unit of measurement) potassium chloride (to treat low potassium) 1 L IV bag; - Two dextrose 10% (D10W, a mixture of sugar and water) 1 L IV bags; - One NS 500 ml IV bag; - One D5W 1 L IV bag; and - One 1/2 NS 1 L IV bag. During an interview on 10/30/24 at 11:15 a.m. with the PM, the PM acknowledged the IV bags listed above were not stored in the correct bin. The PM stated IV bags were stocked by Materials Management staff and Pharmacists checked medication rooms during monthly unit inspections. 1b. During a tour of the hospital’s ED Red Medication Room on 10/30/24 at 11:19 a.m. with the PM, nine NS 500 ml IV bags were identified stored in a bin labeled for NS 500 ml irrigation solution bags. During an interview on 10/30/24 at 11:21 a.m. with the PM, the PM acknowledged the NS 500 ml IV bags were not stored in the correct bin. During a follow-up interview on 10/31/24 at 9:16 a.m. with the PM, the PM stated the expectation was for the bins to be filled with what was labeled on the bin. The PM added, if the wrong product had been given to a patient, it could have led to negative patient safety. During an interview on 11/1/24 at 11:05 a.m. with the Director of Pharmacy (DOP), the DOP stated the IV bags inside the bin should have matched the label on the bin to prevent errors. During a review of the hospital’s policy and procedure (P&P) titled, “Patient Labeling/Storage/Rotation of Inventory,” dated 11/2/22, the P&P indicated, “After verification of labeling requirements, identify bin location to shelve inventory...Verify Lawson number, manufacture product number, and location of each item prior to shelving inventory.” 2. During a tour of the hospital’s ED Trauma Equipment Room on 10/30/24 at 11:29 a.m. with the PM, a shelf with three large plastic bins were observed. Each plastic bin contained the following IV bags: - NS 1 L; - NS 500 ml; and - Lactated Ringer (LR, a mixture of water, sodium chloride, sodium lactate, potassium chloride, and calcium chloride) 1 L. The ED Trauma Equipment Room was not observed to have been monitored for temperature and humidity. During an interview on 10/30/24 at 11:34 a.m. with the PM, the PM said he would need to check if temperature and humidity was monitored in the ED Trauma Equipment Room. During a follow-up interview on 10/31/24 at 9:12 a.m. with the PM, the PM stated that the ED Trauma Equipment Room was not monitored for temperature or humidity. The PM stated IV bags were considered medications and needed to be stored according to manufacturer’s specifications. The PM added, if not stored according to manufacturer’s specifications, the efficacy of the IV bags could have been compromised. During a concurrent interview and record review on 11/1/24 at 2:49 p.m. with the Manager of Plant Operations and Maintenance (MPOM), the hospital’s ED Trauma Rooms’ temperature, humidity, and pressure logs dated May, June, July, September, and October 2024 were reviewed. The ED Trauma Rooms’ temperature, humidity, and pressure logs indicated Trauma Rooms 1 through 3 were monitored but did not indicate that the ED Trauma Equipment Room was monitored. The MPOM stated staff had not monitored temperature, humidity, or pressure inside the ED Trauma Equipment Room. During an interview on 11/1/24 at 3 p.m. with the DOP, the DOP stated IV bags are considered medications and the expectation was for the IV bags to have been stored according to manufacturer instructions to ensure potency was maintained. The DOP acknowledged the temperature and humidity of the ED Trauma Equipment Room was not monitored. Review of the manufacturer instructions on the NS 1 L, NS 500 ml, and LR 1 L IV bags’ outer packaging indicated, “Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit])...” During a review of the hospital’s P&P titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, the P&P indicated, “Medications will be securely stored at all times and at the appropriate temperature.” 3. During a tour of the hospital’s Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following medications were observed stored inside an anesthesia supply cart: - One anesthesia medication tray (contained multiple medications for surgery); - One phenylephrine (to treat very low blood pressure or heart problems during surgery) 1000 micrograms (mcg, unit of measurement)/10 ml in NS, 10 ml injection syringe; - Two Cefazolin (an antibiotic used for infection) 1 gram (g, unit of measurement) powder for injection vials; - One Rocuronium (a powerful muscle relaxer for use during surgery) 50 milligram (mg, unit of measurement)/5 ml, 5 ml injection vial; and - One hydralazine (to treat high blood pressure) 20mg/1 ml, 1 ml injection vial. During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart. During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated, the expectation was for medications to be stored secured in the proper location according to the hospital’s P&P. Further review of the hospital’s P&P titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, indicated, “All medications removed from a medication storage area (e.g., floor stock, Pyxis) must only be removed for one patient at a time. If medication dispensed is not administered or used, the medication should be returned to the original storage area as soon as possible, but no later than the end of the shift.””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 41166 Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. Based on interview and record review, the hospital failed to ensure an effective system to monitor high usages of controlled drug (medications with high probability of addiction and are controlled by the federal government) by providers and accurately reconcile controlled drugs losses for two of five sampled patients (Patients 54, 57). This failure increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could put Patients 54 and 57 at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs. Findings: During an interview on 10/31/24 at 11:28 a.m., with Pharmacy Manager (PM), when asked about reconciliation of controlled drug losses, PM stated the Control Substance Coordinator (CSC) was responsible for reconciling control drug discrepancies (records of drugs taken out of an automated dispensing cabinet [ADC machine containing controlled drugs] by nurses or providers but are not accounted for by administration or waste records) in the hospital. PM stated CSC reviewed reports and patient records on weekdays and worked closely with the hospital’s drug diversion committee. During a concurrent interview and record review on 11/1/24 at 1:17 p.m., with CSC and Pharmacy Manager Education and Clinical (PMEC), a report titled, “Providers Reconciled Discrepancy Report (PRDR),” dated 10/1/24 to 10/31/24, were reviewed. The PRDR indicated the following: On 10/8/24, an anesthesiologist (doctor who administers drugs to cause a loss of feeling or awareness [anesthesia] in a patient), withdrew Ketamine (medication that doctors use as an anesthetic to induce loss of consciousness) 100 mg (milligrams unit of measurement) from an ADC and administered 40 mg to Patient (PT) 54. The PRDR indicated Ketamine 60 mg was unaccounted for, when asked, CSC was unable to locate documentation of Ketamine 60 mg administration or waste for PT 54 on 10/8/24. A review of PT 54’s Anesthesia Record, dated 10/8/24, indicated the same anesthesiologist that administered Ketamine 60 mg to PT 54 on 10/8/24 had documented the administration 13 days later, on 10/21/24. On 10/15/24, an anesthesiologist withdrew Fentanyl (medication used for pain management) 100 mcg (microgram unit of measurement) from an ADC for PT 57. The PRDR indicated Fentanyl 100 mcg was unaccounted for, CSC was unable to locate documentation of Fentanyl 100 mcg administration or waste for PT 57 on 10/15/24. A review of PT 57’s Anesthesia Record dated 10/15/24, indicated the same anesthesiologist that administered Fentanyl 100 mcg to PT 57 on 10/15/24 had documented the administration 6 days later, on 10/21/24. During a continued concurrent interview and record review on 11/1/24 at 1:17 p.m. with CSC and PMEC, CSC acknowledged the anesthesiologists’ common practice was to resolve the control drug discrepancies by documenting late administration entries for the unaccounted controlled drug administrations on patients’ anesthesia records. PMEC stated providers could make corrections on patients’ medication administration record and document the administration was given on a specific day. When asked if there was a surveillance report to track and trend how many providers were documenting late administration entries for control drug administrations, PMEC stated no. When asked how pharmacy was able to determine whether the late entries were accurate or potential diversions, PMEC was unable to provide an answer. During an interview on 11/1/24 at 2:21 p.m., with CSC and Director of Pharmacy (DOP), CSC stated unresolved discrepancy reports and high user (providers and staff with high number of control drug dispense) reports were emailed to nursing management. CSC acknowledged providers including anesthesiologists and CRNAs (Certified Registered Nurse Anesthetist a nurse who administers anesthesia and other medications, and provide care before, during, and after medical procedures) also accessed control drugs out of the ADC . When asked if high user reports for providers were shared with the anesthesiologists, CSC stated no. The CSC said high user reports were given to nursing management to share with the anesthesiologists. DOP acknowledged nursing management did not have oversight over the anesthesiologists and did not monitor anesthesia practice. During an interview on 11/4/24 at 1:13 p.m., with PM and DOP, PM stated the purpose of the high user trend report was for pharmacy to collaborate with nursing and anesthesia to identify trends and intervene if it could potentially lead to diversion. DOP stated there were opportunities for additional oversight for anesthesia providers and control substance handling practices. DOP acknowledged pharmacy was expected to have oversight of controlled drug handling. During an interview on 11/4/24 at 3 p.m., with Chief Nursing Officer (CNO) and DOP, CNO stated the CNO was part of the controlled substances diversion prevention committee. CNO acknowledged the committee would not be able identify potential controlled drug diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) with the current practice used by anesthesiologists to resolve control drug discrepancies. DOP acknowledged the expectation was for anesthesia providers to have documented their review of the high user report. DOP was unable to provide documentation that the high user report for providers was being reviewed. During a review of the hospital’s Policy and Procedure (P&P) titled, “Controlled Substance Surveillance System”, dated 6/27/24, the P&P indicated, “Monthly Review of Anomalous Usage Report. Pharmacy generates an ADC report that identifies ADC end users with high activity of controlled substance withdrawals in comparison to a similar cohort. This report is reviewed by the pharmacy leadership and unit nursing and anesthesia leadership to ensure appropriate use of controlled substances. Nursing and anesthesia leadership attests compliance on a monthly basis.” During a review of the hospital’s P&P titled, “Controlled Substances Diversion Prevention Steering Committee Charter”, dated 3/12/4, the P&P indicated, “Reviews and analyzes organizational data from controlled substances surveillance reports on a regular basis to identify trends and opportunities for improvement.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 41166 §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. Based on interview and record review, the hospital failed to develop and implement a policy and procedure that addressed the use of auto verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not have a system for monitoring the appropriate use of the auto verification process to ensure that medications dispensed by the use of auto verification process was distributed in accordance with applicable standards of practice. The hospital auto verified approximately 60,000 medication orders from 10/1/24 to 10/31/24. This failure had the potential for the dispensing and administration of inappropriate medications auto-verified for all patients in the Emergency Department (ED), resulting in patent harm. Findings: During an interview on 10/30/24 at 9:57 a.m., with Director of Pharmacy (DOP) and Pharmacy Manager (PM), DOP and PM were asked about the medication order verification process. DOP stated ED providers were able to enter certain medication orders without verification by a pharmacist. DOP stated the auto verified orders entered by the ED providers were made available to licensed nursing staff to administer to patients from the automated dispensing machine (medication distribution system that provides computer controlled storage, dispensing, and tracking of drugs at the point of care in patient care units). During an interview on 10/30/24 at 1:48 p.m., with PM, when asked about the hospital’s Auto verification Policy and Procedures (P&P), PM stated the hospital did not have an auto verification P&P. PM stated management had decided to turnoff auto verification process in the ED. During an interview on 11/1/24 at 11:11 a.m., with Medication Safety Coordinator (MSC) and DOP, MSC stated he was unsure when auto verification process was initiated or who initiated it. DOP stated it was initiated in 2011 due to concerns for potential delay and turn around time for medications in the ED. DOP stated the medication order had to be placed by an ED physician for an ED patient for a medication that was available in the automated dispensing machine and not on the hospital’s “Never Auto verify” list. During an interview on 11/1/24 at 11:16 a.m., with MSC and DOP, when asked about the importance of having a hospital P&P for auto verification, MSC stated an auto verification P&P would have provided additional guideline and transparency. DOP stated an auto verification P&P would have had periodic review and evaluation of the process. DOP stated medications were periodically added to the “Never Auto verify” list. DOP acknowledged she was a member of the Pharmacy & Therapeutics (P&T) committee, and stated its role was to have oversight in pharmaceutical service (processes involved in the preparation, distribution, and administration of drugs) to ensure medications were available and used appropriately. The DOP added, it would have been useful to have a standardized policy. MSC stated having auto verified medications that have undergone medication safety review would add another layer of oversight to have ensured appropriate use of auto verified medications. During an interview on 11/1/24 at 11:23 a.m., with DOP, DOP stated the decision to have auto verification happened before her leadership. DOP acknowledged since she had been in the position of DOP, no guidelines were established for the use of auto verification in the hospital. DOP stated it was important to establish clear criteria for selection of medications that can or cannot be auto verified for associated risk, as well as have periodic review of process and patient outcome. When asked about retrospective review (looking back at auto verified medication orders that have been processed for appropriateness and outcomes to improve process) of auto verified medication orders, DOP stated no retrospective review of auto verified medication orders had been conducted since the auto verification process was initiated in 2011. DOP acknowledged that by bypassing a pharmacist’s first review, a patient could potentially have been administered an inappropriate dose of a medication. DOP acknowledged auto verified medication orders were not restricted to one time orders, and could have been ongoing orders in ED, where a patient could have received multiple doses of an auto verified medication. During a review of the hospital’s “Never Auto verify” list, undated, the following medications were not observed to be on the list: fentanyl (controlled substance drug with a high potential for abuse and addiction, used to treat pain) IV (intravenous into the vein), propofol IV (powerful drug used to help patients relax or sleep), and Vancomycin IV (drug used to treat infections). DOP acknowledged the medications were not listed on the hospital’s “Never Auto verify” list and stated fentanyl IV could have been ordered by a provider as an ongoing order without review by a pharmacist, which could have potentially put a patient at risk for adverse effects such as respiratory depression or sedation if inappropriate doses were administered. DOP stated propofol IV and vancomycin IV could have also been ordered by a provider as ongoing orders without review by a pharmacist, which could have also potentially put a patient at risk for adverse effects. During a record review on 11/4/24 at 11:18 a.m., with DOP and PM, the hospital’s “Auto verified Medication Order List”, dated 10/1/24 to 10/30/24 was reviewed. The hospital’s “Auto verified Medication Order List” indicated orders for Patients (PT) 52 and 53. During a review of PT 52’s “Medication Administration Record (MAR),” dated 10/5/24, the MAR indicated fentanyl (medication for pain) 75 mcg (micrograms unit of measurement) IV every 2 hours as needed for severe pain, ordered 10/5/24 at 7:54 p.m., and discontinued on 10/6/24 at 5:18 p.m.; lidocaine patch (medication for pain), apply 1 patch to right lower back, and 1 patch to left lower back every 24 hours, administered over 12 hours, ordered 10/5/24 at 9:18 a.m., and discontinued on 10/6/24 at 5:18 p.m. During a concurrent interview and record review with DOP on 11/4/24 at 11:29 a.m., PT 52’s MAR was reviewed. DOP acknowledged PT 52’s fentanyl and lidocaine patch orders were continuous orders and not one time orders and were processed via auto verification. DOP acknowledged lidocaine patch was not considered an emergency medication and stated the rules were for ED providers to write medication orders that were on not on the “Never Auto verify” list, however some of the medications auto verified included routine medications and non emergency medications. During a review of PT 53’s MAR, dated 10/5/24, the MAR indicated hydromorphone (pain medication) 0.5 mg (milligrams) IV every 2 hours as needed for severe pain, ordered 10/5/24 at 9:06 a.m., and discontinued on 10/7/24 at 12:40 a.m. During a concurrent interview and record review with DOP on 11/4/24 at 11:38 a.m., PT 53’s MAR was reviewed. DOP acknowledged PT 53’s hydromorphone order was not a one time order. During an interview on 11/4/24 at 2:41 p.m., with Chief Nursing Officer (CNO), and Director of Nursing Operations (DNO), when asked about auto verification, CNO stated it was established to keep up with patient flow during emergencies, to prevent delay in patient care. CNO acknowledged the hospital did not have an auto verification policy and procedure, and stated the importance of a policy and procedure was to enable review by all disciplines, including physicians and nursing staff to make sure everyone agreed, conduct risk assessment, and ensure the practice was safe. CNO acknowledged PT 52’s lidocaine patch order was not an emergency order and stated non emergency medication orders were included for auto verification. CNO acknowledged if a medication was not ordered as one time but as needed, then the medication order was be considered a maintenance order. CNO stated it was important for pharmacist, professionals who were specialized with medications, to assist physicians and nursing to check the effect of an ordered medication on the patient’s diseases, allergies, kidney function, or anything that would change the effect of a medication. DNO acknowledged the hospital did not conduct a retrospective review of auto verification medication orders and stated, it should be happening. CNO stated it was important to look for safety concerns around anytime of dosing. When asked how many medication orders were being auto verified, DNO stated approximately 2,000 orders per day. During a review of the hospital’s P&P titled, “Pharmacy and Therapeutics Committee Charter,” dated 2/9/23, the P&P indicated, “To review and recommend to the MEC [Medical Executive Committee committee of medical staff who is responsible for making decisions related to patient care, clinical policies, and physician performance] relevant policy, procedures, and protocols that may be necessary for the operation of medication usage and nutrition care.” During a review of American Journal Health System Pharmacy article titled, “ASHP [American Society of Health System Pharmacists] Guidelines: Minimum Standard for Pharmacies in Hospitals,” dated 2013, the article stated, “All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. There shall be a procedure for retrospective review of these orders.” During a review of American Journal Health System Pharmacy article titled, “ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System,” dated 5/15/21, the article stated, “The formulary system should review and approve all policies related to the medication use process; all medication use policies, regardless of their origination, should flow through the P&T committee.” During a review of ASHP article titled, “Autoverification Toolkit,” dated 2024, the article stated, “3. Define scope for autoverification ... 5. Draft policy changes to support autoverification within the organization. a. Medication use policies b. Downtime policies .... 6. Seek appropriate committee approval for policy changes. a. Pharmacy and Therapeutics b. Relevant clinical leadership/medical staff committees ... 8. Develop process for continued assessment and optimization/new requests for autoverification. Monitoring may include but is not limited to: a. Patient safety events b. Technical event c. Retrospective analysis of auto verified orders d. Autoverification utilization ... 9. Develop education plan for all appropriate stakeholders. a. Initial roll out education b. Ongoing educational needs ...””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 41166 §482.25(b)(1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. Based on interview and record review, the hospital failed to ensure all sterile (germ free) compounding (a process of making sterile medications administered into the vein) and the administration of chemotherapy (toxic cancer treatment that uses drug to kill or stop the growth of cancer cells) drugs was performed consistent with national standards of practice when: 1. For one out of one sampled patient, Patient (PT) 51, chemotherapy medication Gemcitabine was dispensed from pharmacy and administered without the use of a closed system transfer device (CSTD drug transfer device that prevents the transfer of contamination from environment into the drug containing system and the escape of hazardous drug or vapor concentrations outside the drug containing system). 2.One of one Environmental Services Staff (EVS) (EVS 1), cleaned the sterile compounding area without completion of the pharmacy competency assessment. These failures increased the potential for patients to be administered contaminated medications leading to severe infections and exposure of hazardous drugs to patients and staff leading to adverse effects, including skin irritation, and severe effects, pregnancy complications, and cancer. ]Findings: 1. During an interview on 10/30/24 at 10:20 a.m. with the Sterile Compounding Coordinator (SCC) in the pharmacy sterile compounding room, SCC stated all compounded chemotherapy drugs were sent with CSTD, unless the provider who ordering the medication requested not to have one. SCC stated in most instances chemotherapy medication prepared in a syringe was dispensed with a CSTD and chemotherapy medication dispensed in an IV (intravenous into the vein) bag was dispensed with tubing (connects IV bag to patient’s access site) containing normal saline (solution of salt and water),in most instances. During an interview on 10/31/24 at 2:02 p.m., with Registered Nurse Educator for Surgery (RNES), when asked about chemotherapy medication administration into a patient’s bladder, RNES stated pharmacy delivered the chemotherapy medication in a syringe to the operating suite (section of hospital that includes multiple operating rooms, as well as other rooms and spaces). During surgery, a licensed nurse would hand the syringe containing chemotherapy medication to the surgeon, and the surgeon would administer the chemotherapy. When asked how the surgeon administered the chemotherapy medication into the patient’s bladder, RNES stated the surgeon would attach a bigger syringe to the patient’s foley catheter (flexible tube that drain urine from the bladder) then removed the cap off the smaller syringe with chemotherapy medication, administered chemotherapy medication into larger syringe, and used gravity for instillation (medical procedure to slowly introduce a liquid medication into the body) into bladder through the foley catheter. During an interview on 10/31/24 at 2:11 p.m., with Nursing Manager for the operating room (NM) 11, NM 11 stated that administering administration of chemotherapy medication from smaller syringe into larger syringe using gravity was not a closed system if the smaller syringe containing the chemotherapy medication did not attach directly to the foley catheter. NM 11 stated when by not using a CSTD was not used, the chemotherapy medication was exposed to the air, potentially exposing staff, and patient to chemotherapy medication. During an interview on 10/31/24 at 2:14 p.m., with Pharmacy Manager (PM), PM stated that Gemcitabine (chemotherapy medication that can be used to treat bladder cancer) had a CSTD, what pharmacy was missing was the CSTD connector that attached to the foley. PM stated pharmacy would make sure to send the CSTD connector with any hazardous drug which had to be administered using an intra catheter (tube inserted into the bladder to deliver drugs directly into the bladder). During a concurrent interview and record review on 10/31/24 at 2:25 p.m., with PM, PT 51’s “Medication Administration Record (MAR),” dated 7/18/24, was reviewed. The MAR indicated Gemcitabine 2000 mg (milligrams unit of measurement) in Normal Saline (solution of salt and water) 0.9% (concentration) ml (milliliter unit of measurement) intravesical (within the bladder) syringe, with administration instructions, “must be administered by MD [physician]. NOT FOR IV USE. Chemotherapy drug, use double ASTM [develops standard for chemotherapy gloves] gloves, chemo gown, eye/face protection (if liquid that could splash), and CSTD for administration. Dispose of properly,”, was ordered on 7/18/24 at 11:18 a.m. and administered on 7/18/24 at 2:56 p.m. The PM acknowledged Gemcitabine was dispensed from pharmacy in a CSTD. During a telephone interview on 11/4/24 at 12:38 p.m., with Medical Doctor (MD) 1, MD 1 stated he was one of two urologists (doctor who specializes in conditions that affect the urinary tract and reproductive system in people) who performed bladder instillation with chemotherapy medications at the hospital. MD 1 stated that during a bladder instillation surgery, immediately following the procedure after a foley catheter with a catheter syringe was placed in the patient’s bladder, he would inject the chemotherapy medication from the smaller syringe into the catheter syringe and allowed it to drain by gravity. MD 1 stated he was aware of using a CSTD and used one at the infusion center. MD 1 stated using an CSTD in the operating room will required pressure, which would not have been safe for a patient who had just undergone surgery, so it was considered safer to have been administered by using gravity. MD 1 acknowledged he did not use a CSTD. MD 1 acknowledged by injecting the chemotherapy medication from the smaller syringe into the catheter syringe, the medication was no longer sterile and stated it was done at the end, after the sterile part of the procedure. During an interview on 11/4/24 at 4:26 p.m., with Director of Pharmacy (DOP) and Vice President of Regulatory, Risk, Medical Affairs (VPR), when asked about compounding and dispensing Gemcitabine with CSTD, DOP stated pharmacy was able to compound Gemcitabine in IV solution bags with primed tubing or syringes with CSTD, based on provider preference. VPR stated providers had tried it with a bag once and it leaked into the surgical field. When asked, VPR was unable to provide literature regarding the inability to use CSTD during administration of the chemotherapy medication in an operating room due to positive pressure not safe for patients who had just undergone surgery. During a review of the “CSTD Manufacturer Information Leaflet (MIL)” provided by the hospital, the MIL indicated, “[brand] closed male luer [type of connector attached to syringe to make it leak free connections between two parts] for use with [brand] needle free valve and open female luer connectors only ... Achieving a Closed System. Proper use of [brand] closed male luer and [brand] needle free valve will ensure a closed system. A closed system may also be achieved with an open female luer connector if handled as follows: do not disconnect the system once it is connected. Discard the entire system as one after use.” During a review of an article provided by the hospital, titled, “Intravesical Administration of Therapeutic Medication for the Treatment of Bladder Cancer,”, dated 6/2020, the article indicated, “Reconstitute 1000 mg/50 ml normal saline or 2000 mg/50 100 ml normal saline, or use premixed Gemcitabine with closed system administration set ... Procedure: Insert a catheter tip syringe containing the treatment with an adaptor at the tip of the syringe to prevent spillage or splash during insertion. Or, insert the primed tubing attached to medication vial into the catheter. Instill ... Gemcitabine per gravity flow or by gentle push instillation.” During a review of United States Pharmacopeia (USP a nationally recognized reference for hazardous drug) publication titled, “USP 800 Hazardous Drugs Handling in Healthcare Settings” printed 10/9/23, the publication indicated, “A CSTD must be used when administering antineoplastic HDs [hazardous drugs] when the dosage form allows.” During a review of Pharmacy Times (a nationally recognized reference) article, titled “Closed System Transfer Devices Reduce Exposure to Contaminants,”, dated 3/2023, the article indicated, “Closed system transfer devices (CSTDs) are used during the preparation of hazardous drugs (HDs) as a mechanism to reduce the transfer of drugs or vapors into the environment ... Antineoplastic [cancer treating] drugs are generally nonselective in their mechanism of action [how they work], affecting both cancerous and noncancerous cells; this leads to adverse effects, including skin irritation, and severe effects, such as pregnancy complications and some forms of congenital [condition present at birth] disabilities. Exposure is even linked to some forms of cancer.1 Therefore, nurses, pharmacists, and pharmacy technicians handling these medicines face exposure to aerosols, droplets, and vapors of dangerous chemotherapy drugs, which can easily escape standard syringes and contaminate the workplace. Furthermore, because of the adhesive properties of chemotherapy drugs, these contaminants can leave the designated workspace.4 Traces of chemotherapy drugs have been found on unlikely places, such as doorknobs, keyboards, and other surfaces, placing other hospital staff members, patients, and their families at risk.” 2. During a concurrent interview and record review on 11/1/24 at 3:40 p.m., with Sterile Compounding Coordinator (SCC), the “EVS Cleaning Log (CL),”, dated September 2024 was reviewed. The CL indicated EVS 1 independently entered and cleaned the hazardous and non hazardous IV sterile compounding areas on 9/7/24 and 9/8/24. SCC acknowledged EVS 1 independently entered and cleaned the hazardous and non hazardous IV sterile compounding areas but was unable to provide documentation for EVS 1’s completion and passing of the EVS competency administered by pharmacy. SCC stated EVS is expected to notify pharmacy of any new EVS staff so they can complete the cleaning competency. SCC stated EVS 1 should not have cleaned the IV sterile compounding areas by herself if she was not signed off for competency because it could potentially lead to microbial (organisms that are too small to see with the naked eye and can cause disease) growth in the IV sterile compounding rooms. During an interview on 11/1/24 at 3:51 p.m. with EVS Supervisor (EVSS), EVSS stated EVS staff was expected to pass the EVS competency administered by pharmacy before EVS staff was allowed to clean the IV sterile compounding areas. EVSS stated she placed EVS 1 on the schedule to clean the IV sterile compounding area even though EVS 1 had not completed or pass the competency required by the pharmacy department because she did not have any other staff and did not communicate with pharmacy. EVSS stated having an EVS staff who was not properly trained to clean the IV sterile compounding areas could potentially lead to contamination of the pharmacy and medications. During an interview on 11/1/24 at 3:55 p.m. with DOP, DOP acknowledged potential for contamination of the IV sterile compounding areas and sterile medications, and stated the expectation was for EVS to notify pharmacy and pharmacy would have a trained pharmacy staff clean the IV sterile compounding areas. During a review of the hospital’s “EVS Cleaning/Disinfecting/Decontaminating Observational Competency (EVS Competency)” undated, the EVS Competency indicated, “Minimum acceptable score: 100% compliance with procedures and techniques. Personnel must attend [hospital] new product education. Personnel will be provided MDSD MSDS [Material Safety Data Sheet provides information on how to safely handle chemical products] for current cleaning and disinfecting products for their review. Personnel will be provided information on decontamination of surfaces soiled with hazardous drugs. Personnel will understand and demonstrate the following procedures listed below for cleaning/disinfecting/decontaminating secondary engineering controls (SEC [germ free area with increased air supply, filtration, and pressure where equipment for making sterile medications are housed]) in order to successfully pass competency.” During a review of the hospital’s Policy and Procedure (P&P) titled, “Intravenous Admixtures,”, dated 5/23/24, the P&P indicated, “All cleaning and disinfecting activities will be performed by trained and appropriately garbed [clothed] personnel using facility approved agents and procedures.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 46393 Based on observation, interview, and document review, the hospital failed to ensure: 1a. Controlled Substance (CS, those with high potential for abuse and addiction) medications were stored according to hospital policy and procedures (P&P) for one of four randomly sampled patients (Patient 47); and 1b. Patient’s medication brought from home was reconciled and accounted for one of four randomly sampled patients (Patient 48). These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. Findings: 1a. During a tour of the hospital’s Pharmacy on 10/30/24 at 2:03 p.m. with the Pharmacy Manager (PM) and the Director of Pharmacy (DOP), an inspection of pharmacy cabinets designated for storage of patient’s home medications was conducted. Patient 47’s ten medications brought from home were identified inside the pharmacy cabinets, including the following CS medications: - Morphine (a potent controlled medication for pain) 15 milligrams (mg, unit of measure) tablets; and -Norco (hydrocodone-acetaminophen, a potent controlled medication for pain) 5/325 mg tablets. During an interview on 10/30/24 at 2:09 p.m. with Pharmacy Technician Supervisor (PTS) 1, in the presence of the PM and DOP, the PTS 1 stated any licensed pharmacy staff could have accessed the pharmacy cabinets designated for storage of patient’s home medications. During an interview on 10/30/24 at 2:15 p.m. with PM, in the presence of the DOP, the PM described process for use of patient’s CS medication brought from home during admission to the hospital as follows: - If the hospital did not stock the CS medication, the patient’s CS medication brought from home would have been used when the patient was admitted to the hospital; - When received from the nurse, a pharmacist would count the CS medication tablets and secure the CS medication inside the CII Safe (automated system that stores, tracks and monitors controlled substances inventory); and - When needed by the patient, the nurse would have signed out each dose from the pharmacy. During the same interview, the PM stated Patient 47’s CS medications brought from home were not used because the pharmacy stocked both morphine and Norco. The PM stated Patient 47’s morphine and Norco brought from home were handled as belongings, stored in the pharmacy cabinet designated for storage of patient’s home medications, and not counted by a pharmacist. 1b. During an interview on 11/1/24 at 9:36 a.m. with the PTS 2, in the presence of the PM and DOP, the PTS 2 stated every month a pharmacy technician reviewed documentation of all patient medication brought from home in EPIC (the hospital’s electronic health records system) and reconciled with the medications brought from home stored in the pharmacy cabinet. During a concurrent interview and record review on 11/1/24 at 9:51 a.m. with the PTS 2, in the presence of the PM and DOP, Patient 48’s electronic medical record was reviewed. Patient 48’s medical record titled, “Patient Home Meds [medication],” dated 8/13/24, indicated medication brought by Patient 48 was an “unlabeled medication bottle” stored in the pharmacy cabinet. When PTS 2 searched for Patient 48’s medication inside the pharmacy cabinet, PTS 2 was unable to locate it. Furthermore, PTS 2 was unable to provide documentation in the medical record that indicated the medication was returned to Patient 48. PTS 2 was unable to account for Patient 48’s medication brought from home. During an interview on 11/1/24 at 11 a.m. with the DOP, the DOP stated the expectation was for all medications (CS or non-CS) to be stored and accounted for in a traceable manner to avoid diversion, and for medication brought from home to have been returned to the patient. When asked if the patient home medication monthly reconciliation process was being done adequately, the DOP said, “No.” During a review of the hospital’s policy and procedure (P&P) titled, “Medication From Home,” dated 2/10/22, the P&P indicated, “Storage of patient’s home medication...non-Emergency Department...pharmacy staff receive the patient’s Medicine Inventory bag (for medication safe keeping)...” During a review of the hospital’s P&P titled, “Controlled Substances - Storage,” dated 1/8/24, the P&P indicated, “All Controlled substances are stored in the pharmacy and in the CII safe that are not being used for patient specific purposes.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 46393 Based on observation, interview, and document review, the hospital failed to ensure: 1a. Controlled Substance (CS, those with high potential for abuse and addiction) medications were stored according to hospital policy and procedures (P&P) for one of four randomly sampled patients (Patient 47); and 1b. Patient’s medication brought from home was reconciled and accounted for one of four randomly sampled patients (Patient 48). These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. Findings: 1a. During a tour of the hospital’s Pharmacy on 10/30/24 at 2:03 p.m. with the Pharmacy Manager (PM) and the Director of Pharmacy (DOP), an inspection of pharmacy cabinets designated for storage of patient’s home medications was conducted. Patient 47’s ten medications brought from home were identified inside the pharmacy cabinets, including the following CS medications: - Morphine (a potent controlled medication for pain) 15 milligrams (mg, unit of measure) tablets; and - Norco (hydrocodone-acetaminophen, a potent controlled medication for pain) 5/325 mg tablets. During an interview on 10/30/24 at 2:09 p.m. with Pharmacy Technician Supervisor (PTS) 1, in the presence of the PM and DOP, the PTS 1 stated any licensed pharmacy staff could have accessed the pharmacy cabinets designated for storage of patient’s home medications. During an interview on 10/30/24 at 2:15 p.m. with PM, in the presence of the DOP, the PM described process for use of patient’s CS medication brought from home during admission to the hospital as follows: - If the hospital did not stock the CS medication, the patient’s CS medication brought from home would have been used when the patient was admitted to the hospital; - When received from the nurse, a pharmacist would count the CS medication tablets and secure the CS medication inside the CII Safe (automated system that stores, tracks and monitors controlled substances inventory); and - When needed by the patient, the nurse would have signed out each dose from the pharmacy. During the same interview, the PM stated Patient 47’s CS medications brought from home were not used because the pharmacy stocked both morphine and Norco. The PM stated Patient 47’s morphine and Norco brought from home were handled as belongings, stored in the pharmacy cabinet designated for storage of patient’s home medications, and not counted by a pharmacist. 1b. During an interview on 11/1/24 at 9:36 a.m. with the PTS 2, in the presence of the PM and DOP, the PTS 2 stated every month a pharmacy technician reviewed documentation of all patient medication brought from home in EPIC (the hospital’s electronic health records system) and reconciled with the medications brought from home stored in the pharmacy cabinet. During a concurrent interview and record review on 11/1/24 at 9:51 a.m. with the PTS 2, in the presence of the PM and DOP, Patient 48’s electronic medical record was reviewed. Patient 48’s medical record titled, “Patient Home Meds [medication],” dated 8/13/24, indicated medication brought by Patient 48 was an “unlabeled medication bottle” stored in the pharmacy cabinet. When PTS 2 searched for Patient 48’s medication inside the pharmacy cabinet, PTS 2 was unable to locate it. Furthermore, PTS 2 was unable to provide documentation in the medical record that indicated the medication was returned to Patient 48. PTS 2 was unable to account for Patient 48’s medication brought from home. During an interview on 11/1/24 at 11 a.m. with the DOP, the DOP stated the expectation was for all medications (CS or non-CS) to be stored and accounted for in a traceable manner to avoid diversion, and for medication brought from home to have been returned to the patient. When asked if the patient home medication monthly reconciliation process was being done adequately, the DOP said, “No.” During a review of the hospital’s policy and procedure (P&P) titled, “Medication From Home,” dated 2/10/22, the P&P indicated, “Storage of patient’s home medication...non-Emergency Department...pharmacy staff receive the patient’s Medicine Inventory bag (for medication safe keeping)...” During a review of the hospital’s P&P titled, “Controlled Substances - Storage,” dated 1/8/24, the P&P indicated, “All Controlled substances are stored in the pharmacy and in the CII safe that are not being used for patient specific purposes.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 46393 Based on observation, interview, and document review, the hospital failed: 1a. To ensure unusable IV (intravenous, into the vein) medications were not available for use when two opened and used medication vials, intended for single use, were not discarded according to manufacturer’s instructions in one of two inspected Operating Rooms (Trauma OR); and 1b. To ensure IV bags removed from the manufacturer’s protective overwrap were labeled with an expiration date in one of two inspected Operating Rooms (Trauma OR). These failures had the potential for patients in the hospital to receive expired medications. Findings: During a tour of the hospital’s Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following was observed: 1a. Two opened and used IV medication vials, intended for single use, were identified stored inside an anesthesia supply cart as follows: - One IV propofol (used for sedation during surgery) 200 milligrams (mg, unit of measurement)/20 milliliters (ml, unit of measurement), 20 ml single use vial; and - One IV protamine (used to reverse the effects a blood thinner, heparin) 50 mg/5 ml, 5 ml single use vial. 1b. Two unwrapped and undated normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 liter (L, unit of measurement) IV bags were identified inside the same anesthesia supply cart as mentioned above; and one unwrapped and undated NS 1 L IV bag was identified on top of surgery equipment. During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart. The PM further added, IV bags should have been kept in the manufacturer wrapper or dated when the wrapper was removed. During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated the expectation was for opened single use IV medication vials to have been discarded. During an interview on 11/1/24 at 11:08 a.m. with the Director of Pharmacy (DOP), the DOP stated the expectation was for medications to have been secured to prevent diversion (illegal use of prescription medication or use for purposes not intended by the prescriber). The DOP stated medications that were opened and unusable should not have been available due to the potential for contamination and patient harm if used. During a review of the hospital’s policy and procedures (P&P) titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, the P&P indicated, “All medications...that are not immediately administered are to be labeled...Immediately discard any medication or solution that is found unlabeled...” A review of propofol IV manufacturer instructions, retrieved from DailyMed (a public website operated by the U.S. National Library of Medicine), dated September 2023, indicated, “Propofol ...must be prepared for single patient use only. Any unused propofol...must be discarded at the end of the anesthetic [surgery] procedure...” Review of protamine IV manufacturer instructions, retrieved from DailyMed, dated November 2022, indicated, “Preservative free. Discard unused portion.” Review of the manufacturer instructions on the NS 1 L IV bag’s outer packaging, indicated, “Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit]) until ready to use.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 46393 Based on observation, interview, and document review, the hospital failed: 1a. To ensure unusable IV (intravenous, into the vein) medications were not available for use when two opened and used medication vials, intended for single use, were not discarded according to manufacturer’s instructions in one of two inspected Operating Rooms (Trauma OR); and 1b. To ensure IV bags removed from the manufacturer’s protective overwrap were labeled with an expiration date in one of two inspected Operating Rooms (Trauma OR). These failures had the potential for patients in the hospital to receive expired medications. Findings: During a tour of the hospital’s Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following was observed: 1a. Two opened and used IV medication vials, intended for single use, were identified stored inside an anesthesia supply cart as follows: - One IV propofol (used for sedation during surgery) 200 milligrams (mg, unit of measurement)/20 milliliters (ml, unit of measurement), 20 ml single use vial; and - One IV protamine (used to reverse the effects a blood thinner, heparin) 50 mg/5 ml, 5 ml single use vial. 1b. Two unwrapped and undated normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 liter (L, unit of measurement) IV bags were identified inside the same anesthesia supply cart as mentioned above; and one unwrapped and undated NS 1 L IV bag was identified on top of surgery equipment. During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart. The PM further added, IV bags should have been kept in the manufacturer wrapper or dated when the wrapper was removed. During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated the expectation was for opened single use IV medication vials to have been discarded. During an interview on 11/1/24 at 11:08 a.m. with the Director of Pharmacy (DOP), the DOP stated the expectation was for medications to have been secured to prevent diversion (illegal use of prescription medication or use for purposes not intended by the prescriber). The DOP stated medications that were opened and unusable should not have been available due to the potential for contamination and patient harm if used. During a review of the hospital’s policy and procedures (P&P) titled, “Medications - Orders, Administration, Storage, Documentation,” dated 12/19/23, the P&P indicated, “All medications...that are not immediately administered are to be labeled...Immediately discard any medication or solution that is found unlabeled...” A review of propofol IV manufacturer instructions, retrieved from DailyMed (a public website operated by the U.S. National Library of Medicine), dated September 2023, indicated, “Propofol...must be prepared for single patient use only. Any unused propofol...must be discarded at the end of the anesthetic [surgery] procedure...” Review of protamine IV manufacturer instructions, retrieved from DailyMed, dated November 2022, indicated, “Preservative free. Discard unused portion.” Review of the manufacturer instructions on the NS 1 L IV bag’s outer packaging, indicated, “Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit]) until ready to use.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 51223 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Clean utility rooms, medication rooms and nursing stations had peeling stickers leaving adhesive residue on the surface, and 2. IV tubing labels did not have a discard date in place. These failures placed staff and patients at risk of cross contamination and infection in Hospital A and Hospital B (Antepartum, Labor & Delivery, Neonatal Intensive Care Unit, Obstetric Triage, Pediatric, Cardiovascular Unit, Medical/Surgical/Telemetry, Post Anesthesia Care Unit). Findings: 1. During an observation and concurrent interview on 10/30/24 at 4:23pm at Hospital B with the Manager of Med/Surg/Telemetry (FMMS) and Manager of PACU (FMP), the 3rd Floor clean utility room and 2nd Floor Phase 2 clean utility room cabinet and shelves had paper labels that were lifting, peeling, and leaving adhesive residue on the surface. The FMMS stated the peeling labels were a potential source of infection because staff cannot clean the surface completely. The FMP stated the peeling and lifting labels harbor bacteria and staff are unable to clean which creates the potential to transmit bacteria from staff hands to the sticker and to a patient. During an observation and concurrent interview on 10/31/24 at 9:17am Hospital A with the Director of Pediatrics (DPED) and the Manager of 4NICU (M4NICU), the 4NICU’s clean utility room, medication room, Respiratory Therapy storage room, and soiled utility room cabinets, drawers, supply storage containers and biohazard containers had paper labels lifting and/or peeling leaving adhesive residue on the surface. At 9:35am, the M4NICU stated the area where the paper labels were peeling or lifting cannot be cleaned properly which may lead to an infection prevention concern. During an observation and concurrent interview on 10/31/24 at 9:42am Hospital A with DPED and M4NICU, the 4NICU patient care area Room 467 had tape used to secure laminated printed signage on cabinets. The DPED stated they previously did not use tape to secure signs. The DPED stated tape can be a source that harbors bacteria and may create an infection risk. During an observation on 10/31/24 at 10:43am at Hospital A with the Director of Pediatrics (DPED), the Labor & Delivery Med Room (H3150) had paper labels on the cabinet shelves and in OB Triage on cabinets 6, 7, 8. During an interview on 10/31/24 at 1:21pm Hospital A Director’s office with VPSC, SCM, and SCD, the SCD stated they reviewed the photos of the peeling labels with adhesive exposed or residue left on the surface at Hospital A and Hospital B. SCD stated they are in the process of a 6-month conversion optimization re-labeling project. SCD stated they will create a day-to-day process to audit the condition of the labels to ensure staff escalate to leadership when labels need to be replaced and utilize QAPI to audit for compliance. 2. During an observation and concurrent interview on 10/30/24 at 3:50p.m., in Hospital B with the Manager of Medical/Surgical/Telemetry (FMMS) and CPCU Clinical Supervisor (FCCS), Room 305 had an intravenous line (within a vein, a tube or needle is placed inside a vein for giving medication or fluids into the bloodstream) sticker without the date to be changed. FCCS stated the IV tubing stickers have different colors for days of the week the tubing change is due and the IV tubing maybe changed from every 3 days to every 7 days. During an observation on 10/31/24 at 9:42am Hospital A with the Director of Pediatrics (DPED) and Manager of NICU (M4NICU), in 4W NICU Room 467C the IV-line sticker did not identify the discard date. During an interview on 11/7/24 1:04pm at Hospital A Directors Office with the Director of Pediatrics (DPED), the DPED stated the IV tubing is changed every 72 hours and labeled using a color-coded label identifying the day of the week it should be changed, example Saturday, Sunday, Monday etc. The DPED stated the IV tubing label should be dated/timed per the policy to ensure the tubing is changed timely to avoid tubing being changed on the second or third Saturday. The DPED stated the risk of not changing an IV tubing timely could increase the risk to develop a blood stream infection. During a conference call interview and hospital policy review on 11/7/24 2:30pm in Hospital A Directors Office with the Director of Inpatient Cardiovascular Service (DICS) and the Clinical Supervisor (RN13), RN 13 stated the iv tubing labels are color coded and should state the day the label must be changed. RN 13 stated IV tubing labels should be changed every 7 days. RN 13 stated they do not need to write a date on the label because staff may change the IV tubing before 7 days. RN 13 reviewed the hospital policy and procedure titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites” dated 6/14/24. RN13 stated “if you take it word for word, you should write the date the IV tubing should be changed on the IV tubing label”. RN 13 stated the patient would have an increased risk of infection iv the IV tubing is not changed timely because the tubing may collect bacteria as some medications may corrode and cause cracking in the tubing. During a review of the hospital’s policy and procedure titled, “Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites”, dated 6/14/2024, section “V. PROCEDURE” indicated, “C. Label new IV tubing with date to be changed.” According to the American Journal of Infection Control, dated 9/2021, retrieved 11/14/24 from https://www.ajicjournal.org/article/S0196-6553(21)00139-5/fulltext, “ ...Tape cannot be cleaned or disinfected ...Study identified microorganisms grew on the adhesive and non-adhesive side of tape ...The authors concluded that adhesive tape may transmit pathogenic bacteria that may contribute to infection ...””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to implement interventions meant to support the effectiveness of their policy and procedure (P&) titled “Universal Protocol - Procedural Areas.” On 9/23/24, the facility self-reported to the California Department of Public Health (CDPH), a wrong site biopsy (a procedure to remove a piece of tissue or a sample of cells from your body so that it can be tested in a laboratory) procedure was performed on Patient (Pt) 1 on 9/19/24. The hospital reported a Root Cause Analysis (RCA- a tool used to help healthcare organizations retrospectively study events where patient harm or undesired outcomes occurred to identify and address the root causes) was conducted. The RCA indicated hospital staff did not identify the wrong side had been sampled until after the procedure had been completed. This failure resulted in a biopsy to the incorrect side for Pt 1, and had the potential for future patients to unnecessarily suffer from the effects of wrong site surgery/procedures such as pain, injury, and additional surgery/procedures. Findings: During a review of Pt 1’s “Short Form History & Physical (H&P)” dated 9/19/24, the H&P indicated Pt 1 “...76-year-old... Reason for visit: Image-guided biopsy (a biopsy test performed using a CT (CT-Computed Tomography: images used to check the position of a biopsy needle) needed...Past Medical History (PMD): Dementia (a progressive state of decline in mental abilities), Diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), hypertension (HTN-high blood pressure), liver abscess (a pus-filled mass that develops in the liver)...Diagnosis: right lung mass (an abnormal growth in the lungs)...” During a review of Pt 1’s physician order “CT Biopsy Lung Left (Order Number) dated 9/18/23, the order indicated “...Reason for Exam newly diagnosed bronchogenic adeno ca[rcinoma] (a type of cancer that starts in mucus-producing (glandular) cells), heme[otologist] (a doctor or scientist who specializes in diagnosing and treating diseases of the blood, bone marrow, and lymphatic system)/onc[ologist] (A doctor who has special training in diagnosing and treating cancer) rec[ommends] IR (IR-Interventional Radiology- IR is a therapeutic and diagnostic specialty that uses imaging techniques like X-rays, CT scans, ultrasounds, and MRIs to guide doctors as they perform procedures) consult to biopsy (a procedure that removes cells or tissue from your body) the 6 mm (mm-is the abbreviation for millimeter, a unit of length in the metric system that is equal to one thousandth of a meter) nodule (a growth or lump that may be malignant (cancer) or benign (not cancer) in Left lower lobe (LLL) [of the lung]...” During a review of Pt 1’s “Discharge Summary” dated 9/25/24, the summary indicated “...Admit date: 9/11/24... Discharge Date: 9/25/24...Chief Complaint:... Headache... Admission Diagnosis: Lung mass... During a review of Pt 1’s “Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services (Consent)” dated 9/19/24 signed by Pt 1’s [medical decision maker] via telephone and witnessed by hospital staff, the Consent indicated “...Operation or procedure...Computed Tomography (CT) Guided Left Lung Mass Biopsy (a procedure that uses a CT scan to guide a needle to remove a tissue sample from an abnormal area in the body) with Possible Chest Tube Placement (a hollow, flexible tube placed into the chest) with Procedural Sedation (a medical technique. It’s used to calm a person before a procedure)...” During a review of Pt 1’s “Post Procedural Note: CT Biopsy (Procedural Note)” dated 9/19/24, the Procedural Note indicated “...Preoperative Diagnosis: right lung cancer, LLL 6 mm nodule...Post-operative Diagnosis: Same as preoperative diagnosis...Findings: Biopsy performed of 6 mm LLL lung nodule biopsy... Specimen: Core biopsy specimen(s) were collected...” During a concurrent interview and record review on 11/7/24 at 3:13 p.m., with the Interim Director of Imaging (IDIS), the Clinical Nurse Supervisor (CS) 1 and Registered Nurse (RN) 11, RN 11 stated he is new to the role of nurse in the Interventional Radiology department, has worked in IR for about a year. RN 11 stated before that he was an Emergency Department (ED) RN for 6 years. RN 11 stated he prepares for the time out (a pause to confirm the correct patient, procedure, and site before a medical procedure begins. It’s a safety measure to prevent errors like performing the wrong procedure on the wrong patient or body part) by reviewing the patient’s (Pt’s) Electronic Health Record (EHR) for provider order, laboratory results, Pt allergies, etc. then he reads the consent, word-for-word, including Pt Name and Medical Record Number (MRN) to be ready when the doctor [performing the procedure] enters the procedure room. RN 11 stated once the doctor enters the room, he waits until everyone is at attention, not doing other tasks and says “are we ready for a timeout?” He then calls out the Pt name, MRN verified with data on screen [monitor staged in procedure room with Pt information displayed for the team], also calling out medication(s) to be given to Pt for sedation (administration of a drug to produce a state of calm or sleep), any additions or questions are discussed at this time. RN 11 stated the CT Technician (Tech) will verbalize the specimen to be collected during the procedure if indicated. RN 11 stated he ends with verbalizing “do we all agree?” If yes, then the time-out is complete. During a review of Pt 1’s consent with RN 11, RN 11 confirmed Pt 1’s consent indicated the biopsy was to be performed on Pt 1’s left [lung] side. RN 11 stated he “can’t speak to why the doctor did the wrong side,” the procedure is image guided and site marking is not indicated. CS 1 stated even experienced IR RN’s (such as himself) do the time out “exactly the same way” [as RN 11 described]. CS 1 stated they (IR RNs) are focused on their task(s) in monitoring the patient and ensuring the patient is safe under moderate sedation that they do not watch as other team members do their tasks. RN 11 stated he was focused on his role, due to his being new to it and did not observe the IRMD prepare the patient for the insertion of the biopsy needle. RN 11 explained patients in IR are frequently positioned for a procedure for insertion with the imaging guided technology used by the IRMD to guide their progress from insertion through and to the destination for sampling. RN 11 stated because of the nature of the procedure, he would not have been able to determine if the IRMD was accessing the [correct] site ordered for sampling. IDIS and CS 1 confirmed they do not believe there is anything more that hospital staff could have done in this situation. IDIS and CNS 1 stated a RCA was done by the Risk Management department. The IDIS and CNS 1 stated the opportunities identified during the RCA were: implementation of a trial using and avatar (an individual’s avatar is the virtual equivalent of a single real person) on which the MD marks the site to identify the correct side when there is a laterality (specifying which side of the body a medical condition affects) indicated. IDIS stated they started a 3-month trial of this “avatar” process on in Computed Tomography (CT) procedural area on 10/5/24. IDIS and CNS 1 stated they also identified the need to “jog the provider’s thought process.” The IDIS and CNS 1 stated they have implemented a requirement for the doctor to “verbalize the procedure to be done by the proceduralist so the team has the opportunity to speak up.” IDIS stated the doctor [in this case] “self-reported this incident” with leadership making report of the event to Risk Management “immediately.” During an interview on 11/7/24 at 4:09 p.m., via telephone with the IRMD and Director of Risk Management Regulatory Patient Safety (RMD), the IRMD stated in “looking back, in reviewing, he saw this [wrong side biopsy] that day [9/19/24] in his review [after the procedure had been completed]. The IRMD stated as part of his regular practice, he reviewed [Pt 1’s] past imaging showing Pt 1 had a transbronchial biopsy [under] fluoroscopy done first, then a CT biopsy was ordered of the left lung. The IRMD stated the order was “clear on the order, [he] confused the patients, in dictating report.” IRMD stated he saw that Pt 1 was “still prone (positioned face down) and on the table, [he] did the right side.” IRMD stated he “made assumptions, it was a stressful day in the department.” IRMD stated he has been performing biopsies for 35 years and was “shocked about it and self-reported.” The IRMD stated he was not involved in the RCA review, he was out of town, but he is aware of interventions made to prevent this from happening again. The IRMD stated the avatar process “doesn’t seem to help. It is a trial, why not try it?; it could be helpful.” IRMD stated that with “most of what we (as providers) do, “you do not see the abnormality. IRMD stated the doctor is preparing a clean site on insertion, everything we [doctor] do is to a visible lesion (An area of abnormal or damaged tissue caused by injury, infection, or disease) and where you enter isn’t always where you need to end up. The IRMD stated that marking the site for this kind of procedure “that kind of marking doesn’t help.” The IRMD stated he “mixed up the patients” and this led to Pt 1’s having a biopsy to the wrong side [right when left was ordered]. IRMD stated what could have been done differently is “if the MD changes an order, because they do change orders, the original indicated Pt 1’s right [lung] and he changed [the order] to left, after speaking with the ordering doctor. , the initial order was blank side, we are doing this site if this were included in the time-out. The IRMD stated that using the order for readback during the time-out process and not the consent would be most helpful. The IRMD stated if the team read off the order instead of consent that would have helped prevent this event. The IRMD stated his recommendations had not been shared with others on the leadership team. During a review of hospital P&P “Universal Protocol (UP- a set of guidelines for healthcare professionals that aims to prevent surgical errors) - Procedural Areas” dated 12/19/23, the P&P indicated “ ...I. PURPOSE: A. To provide guidance to [hospital] personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures ... B. To provide guidance for improving team communication through a culture of sfety in order to reduce the incidence of medical errors ... III. POLICY: B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR) ...Interventional Radiology (IR) ...etc.) ... D. The UP is composed of the following elements: 1. Pre-Procedure verification. 2. Marking the site, when applicable ... V. PROCEDURE: ... B: Site Marking... 7. For procedures on a lateralized internal organ via a minimally invasive approach (a surgical technique that uses smaller incisions and specialized equipment to perform procedures), whether percutaneous (a medical procedure or method that involves accessing tissue or inner organs by puncturing the skin with a needle, instead of making a large incision) or through a natural orifice (an opening in the body that can be used to access the abdominal cavity for surgery), mark the intended side at or near the insertion site that will remain visible after completion of the skin prep[aration] and sterile draping... C. Procedural Briefing...b. Correct procedure and laterality as consented. c. Site marked... D. Time Out 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out... 2. ... b. ... i. The written consent will be utilized as a guide for the patient’s identification and procedure... d. Time Out addresses and verbally confirms among all team member the following elements:... II. Correct procedure and laterality (when applicable) as consented... VI. DOCUMENTATION... C. If provider cannot mark a site that requires marking, ensure that a verification of the site/side with patient/substitute decisionmaker is documented in the EHR (Electronic Health Record)...””

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 47205 Based on observation, interview, and record review the hospital failed to secure two of seven anesthesia carts, when the anesthesia carts in operating room (OR) 4 and OR 2 were not locked and the medication inside was accessible to anyone. This failure had the potential to result in drug diversion (this happens when healthcare providers obtain or use prescription medicines illegally) or unauthorized access and use of prescription medications. Findings: During the initial tour of the Endoscopic (Endo) OR areas on 10/30/24 at 10:40 a.m., with the Director of Endo, there were seven procedure rooms, Patient (Pt) 28 was seen leaving procedure room 4 with the Anesthesiologist (ANS) 1 pushing his gurney; Doctor (MD) 2 was seen sitting inside the room charting with his back to the anesthesia cart which was across the room. The Endo Tech in the room was seen cleaning the environment for the next patient to come in, she stopped and took the dirty scope which was in a red closed biohazard bag and a hard outside container to the dirty endoscope room. The ANS medication cart was blue and was located in the right-hand corner of room 4. The ANS cart had plastic trash on top of it. When the top drawer of the ANS cart was pulled it opened. The ANS cart had a lock on the outside, but it was not set. Inside the cart top drawer were the following medications: Phenylephrine (used to treat low blood pressure) 100 mcg/mL (units of measurement- micrograms/milliter) in a 10 mL syringe; Propofol (anesthetic causes relaxation and sleepiness before and during surgery) 1 % (percent) 20 mL; ephedrine (medication to treat low blood pressure during surgery) 50 mg/mL 1 mL; Ondansetron (medication used to prevent vomiting) 2 mg/mL 1 mL; Dexamethasone (medication used to prevent nausea and vomiting after surgery) 10 mg/mL 1 mL; Succinylcholine (Paralytic- can relax the muscles during surgery) 200 mg/10 mL; Epinephrine (used to improve the quality and duration of anesthesia, and to reduce bleeding) 1 mg/ml; Rocuronium (Paralytic- can relax muscles during surgery) 10 mg/mL 5 mL vial; Glycopyrrolate (used prior to surgery to reduce/stop salivary gland and respiratory secretions) 2 mL. The Director stated this anesthesia cart should be locked when left unattended. During an interview on 10/31/24 at 10:55 a.m., with ANS 1, ANS 1 stated he takes his anesthesia medications out of the locked pyxis (Automated dispensing machines provide secure medication storage on patient care units, along with electronic tracking of the use of narcotics and other controlled medications) in the morning and puts them in his anesthesia cart, and keeps the cart unlocked all day until his last procedure then he returns any leftover medication back to the pyxis. ANS 1 explained that he wants to be able to have access to those medications as soon as possible for his patients. ANS 1 stated he understood the anesthesia cart should be locked when he leaves the room, but this was not his practice. During a concurrent observation and interview on 10/31/24, at 11 a.m., with the DOE, while in Endo operating room 2 after the Anesthesia provider (ANS 2) and patient had left, the DOE reached over and pulled the top drawer of the blue anesthesia cart. The top drawer partially opened and on the second pull, the drawer completely opened, and the anesthesia cart was unlocked. The DOE stated the drawer was caught on the medication box and inside this anesthesia cart were the same medications as the anesthesia cart in room 4. A couple of minutes later the Anesthesia provider (ANS 2) came into the room and stated he thought he had locked the anesthesia cart. ANS 2 stated his normal practice is to lock the anesthesia cart when he leaves the room. During an interview on 10/31/24, at 11:05 am with the DOE, the DOE stated the anesthesia carts should be locked before the anesthesia provider leaves the room. During a review of the hospital’s policy titled, “Medications for Anesthesia in Surgery and Endoscopy,” dated 10/28/23, indicated, “I. PURPOSE To provide guidelines for the provision and safeguarding of narcotic and non-narcotic anesthesia medications in the Operating Room (OR) and Endoscopy areas, so that they are readily available for administration to the patient by an anesthesia provider. II. DEFINITION ... B. Anesthesia medication tray: a compartmentalized tray containing non-narcotic medications routinely used by the anesthesia provider for a procedure requiring anesthesia care. The compartments are labeled with the medication name, strength, and the inventory Periodic Automatic Replacement (PAR) level of each compartment in the tray. No controlled substances are to be part of the inventory of this tray. II. POLICY ... a. Anesthesia medication trays, may be stocked by persons holding the following job titles, within their scope of practice: i. Registered Nurse (RN) ii. Licensed Vocational Nurse (LVN) iii. Pharmacy Technician (Tech) iv. Pharmacist v. Anesthesia Provider vi. Anesthesia Technician ... 3. Anesthesia cart medication drawers and ADSs are to be locked when unattended by licensed personnel ...” During a review of the hospital’s document titled, “Anesthesiology Delineation of Privileges,” dated 7/14/22, indicated, “ ... Acknowledgement of Applicant ... A. In exercising any clinical privileges granted. I am constrained by Hospital and Medical Staff policies and rules applicable generally and any applicable to the particular situation ...” During a review of a professional reference titled, “Healthcare-Associated Infections (HAI) Drug Diversion Planning and Response Toolkit for State and Local Health Departments,” date June 2019 was written by Council of State and Territorial Epidemiologist (CSTE), it indicated, “ ... Toolkit Introduction Drug diversion is defined as “any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient,” including everything from outright theft of the drug to doctor shopping, prescription forging, manufacture or sales of counterfeit drugs and international smuggling. While any medication may be involved in a diversion event, some drugs are more commonly targeted than others: Anti-anxiety medications and sedatives ... Prescription pain medications ... sleep aids ... Anesthetics, such as Propofol These high-value medications are often sought for their particular psychoactive effects, and many are habit-forming ... Alarming in 2007, the U.S. Substance Abuse and Mental Health Services Administration estimated that an average of 103,000 doctors, nurses, medical technicians, and healthcare aids a year were abusing or dependent on illicit drugs. HCP (healthcare personnel) may divert drugs via several mechanisms: False documentation (e.g., the medication is not administered to the patient, as indicated, or is falsely listed as “wasted”) Scavenging wasted medication ... Theft by tampering (e.g., substituting medication in a container or syringe with a similar-looking substance, which may then be administered to patients in place of the intended drug) and this diversion can harm patients in at least four ways: reduced quality of care given by impaired HCP Failure to receive essential medications, possibly resulting in pain and suffering Exposure to infectious agents Falsification of patient records which could lead to additional medication administered to the patient to make up for medication unknowingly not received ...””

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 42321 Based on observation, interview, and record review the hospital failed to secure two of seven anesthesia carts, when the anesthesia carts in operating room (OR) 4 and OR 2 were not locked and the medication inside was accessible to anyone. This failure had the potential to result in drug diversion (this happens when healthcare providers obtain or use prescription medicines illegally) or unauthorized access and use of prescription medications. Findings: During the initial tour of the Endoscopic (Endo) OR areas on 10/30/24 at 10:40 a.m., with the Director of Endo, there were seven procedure rooms, Patient (Pt) 28 was seen leaving procedure room 4 with the Anesthesiologist (ANS) 1 pushing his gurney; Doctor (MD) 2 was seen sitting inside the room charting with his back to the anesthesia cart which was across the room. The Endo Tech in the room was seen cleaning the environment for the next patient to come in, she stopped and took the dirty scope which was in a red closed biohazard bag and a hard outside container to the dirty endoscope room. The ANS medication cart was blue and was located in the right-hand corner of room 4. The ANS cart had plastic trash on top of it. When the top drawer of the ANS cart was pulled it opened. The ANS cart had a lock on the outside, but it was not set. Inside the cart top drawer were the following medications: Phenylephrine (used to treat low blood pressure) 100 mcg/mL (units of measurement- micrograms/milliter) in a 10 mL syringe; Propofol (anesthetic causes relaxation and sleepiness before and during surgery) 1 % (percent) 20 mL; ephedrine (medication to treat low blood pressure during surgery) 50 mg/mL 1 mL; Ondansetron (medication used to prevent vomiting) 2 mg/mL 1 mL; Dexamethasone (medication used to prevent nausea and vomiting after surgery) 10 mg/mL 1 mL; Succinylcholine (Paralytic- can relax the muscles during surgery) 200 mg/10 mL; Epinephrine (used to improve the quality and duration of anesthesia, and to reduce bleeding) 1 mg/ml; Rocuronium (Paralytic- can relax muscles during surgery) 10 mg/mL 5 mL vial; Glycopyrrolate (used prior to surgery to reduce/stop salivary gland and respiratory secretions) 2 mL. The Director stated this anesthesia cart should be locked when left unattended. During an interview on 10/31/24 at 10:55 a.m., with ANS 1, ANS 1 stated he takes his anesthesia medications out of the locked pyxis (Automated dispensing machines provide secure medication storage on patient care units, along with electronic tracking of the use of narcotics and other controlled medications) in the morning and puts them in his anesthesia cart, and keeps the cart unlocked all day until his last procedure then he returns any leftover medication back to the pyxis. ANS 1 explained that he wants to be able to have access to those medications as soon as possible for his patients. ANS 1 stated he understood the anesthesia cart should be locked when he leaves the room, but this was not his practice. During a concurrent observation and interview on 10/31/24, at 11 a.m., with the DOE, while in Endo operating room 2 after the Anesthesia provider (ANS 2) and patient had left, the DOE reached over and pulled the top drawer of the blue anesthesia cart. The top drawer partially opened and on the second pull, the drawer completely opened, and the anesthesia cart was unlocked. The DOE stated the drawer was caught on the medication box and inside this anesthesia cart were the same medications as the anesthesia cart in room 4. A couple of minutes later the Anesthesia provider (ANS 2) came into the room and stated he thought he had locked the anesthesia cart. ANS 2 stated his normal practice is to lock the anesthesia cart when he leaves the room. During an interview on 10/31/24, at 11:05 am with the DOE, the DOE stated the anesthesia carts should be locked before the anesthesia provider leaves the room. During a review of the hospital’s policy titled, “Medications for Anesthesia in Surgery and Endoscopy,” dated 10/28/23, indicated, “I. PURPOSE To provide guidelines for the provision and safeguarding of narcotic and non-narcotic anesthesia medications in the Operating Room (OR) and Endoscopy areas, so that they are readily available for administration to the patient by an anesthesia provider. II. DEFINITION ... B. Anesthesia medication tray: a compartmentalized tray containing non-narcotic medications routinely used by the anesthesia provider for a procedure requiring anesthesia care. The compartments are labeled with the medication name, strength, and the inventory Periodic Automatic Replacement (PAR) level of each compartment in the tray. No controlled substances are to be part of the inventory of this tray. II. POLICY ... a. Anesthesia medication trays, may be stocked by persons holding the following job titles, within their scope of practice: i. Registered Nurse (RN) ii. Licensed Vocational Nurse (LVN) iii. Pharmacy Technician (Tech) iv. Pharmacist v. Anesthesia Provider vi. Anesthesia Technician ... 3. Anesthesia cart medication drawers and ADSs are to be locked when unattended by licensed personnel ...” During a review of the hospital’s document titled, “Anesthesiology Delineation of Privileges,” dated 7/14/22, indicated, “ ... Acknowledgement of Applicant ... A. In exercising any clinical privileges granted. I am constrained by Hospital and Medical Staff policies and rules applicable generally and any applicable to the particular situation ...” During a review of a professional reference titled, “Healthcare-Associated Infections (HAI) Drug Diversion Planning and Response Toolkit for State and Local Health Departments,” date June 2019 was written by Council of State and Territorial Epidemiologist (CSTE), it indicated, “ ... Toolkit Introduction Drug diversion is defined as “any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient,” including everything from outright theft of the drug to doctor shopping, prescription forging, manufacture or sales of counterfeit drugs and international smuggling. While any medication may be involved in a diversion event, some drugs are more commonly targeted than others: Anti-anxiety medications and sedatives ... Prescription pain medications ... sleep aids ... Anesthetics, such as Propofol These high-value medications are often sought for their particular psychoactive effects, and many are habit-forming ... Alarming in 2007, the U.S. Substance Abuse and Mental Health Services Administration estimated that an average of 103,000 doctors, nurses, medical technicians, and healthcare aids a year were abusing or dependent on illicit drugs. HCP (healthcare personnel) may divert drugs via several mechanisms: False documentation (e.g., the medication is not administered to the patient, as indicated, or is falsely listed as “wasted”) Scavenging wasted medication ... Theft by tampering (e.g., substituting medication in a container or syringe with a similar-looking substance, which may then be administered to patients in place of the intended drug) and this diversion can harm patients in at least four ways: reduced quality of care given by impaired HCP Failure to receive essential medications, possibly resulting in pain and suffering Exposure to infectious agents Falsification of patient records which could lead to additional medication administered to the patient to make up for medication unknowingly not received ...””

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to follow the State of California reporting requirements for one of one patient, Patient 13, when Patient (Pt) 13 died while in restraints within minutes after medications to sedate him were given and the occurrence was not reported to the California Department of Public Health (CDPH). This failure delayed the investigations of the incident by CDPH and had the potential to place other patients at risk of unreported adverse events that could lead to harm or death. Findings: During a review of Pt 13’s “Electronic Health Record (EHR)” dated 5/19/22 to 5/23/22, the EHR indicated, Pt 13 was a 38-year-old man who arrived at the Emergency Department (ED) on 5/19/22 at 4:05 p.m. from the County Jail and was admitted to the Neurocritical Care Unit on 5/20/22 at 3:41 a.m., for Altered Mental Status (AMS- a change in the mental function that stems from illness, disorders and injuries that have affected the brain) left thalamic mass (brain tumor) and developing hydrocephalus (buildup of fluid in the brain). The EHR indicated that Pt 13 had a past medical history of Diabetes Mellitus (bodies inability to produce or respond to insulin is impaired, resulting in elevated sugar in the blood and urine), Schizoaffective Disorder (mental illness that can affect your thoughts, mood and behavior) and sleep apnea (a disorder that causes a person’s breathing to stop or get very shallow) requiring a CPAP (a machine that uses mild air pressure to keep breathing airways open while you sleep) machine while asleep on the unit. The EHR indicated Pt 13 had a bedside procedure of an External Ventricular Drain (EVD- temporary method of draining fluid from the brain) placed in his skull on 5/20/22. The EHR indicated no issues with the EVD during Pt 13’s stay. The EHR indicated the patient required non-violent soft restraints for his upper extremities (hands and arms) during his entire hospital admit stay for interference with medical treatment, as well as a prisoner shackle around his left ankle. An additional restraint was added to the right ankle on 5/23/22 at 2:40 p.m. for interference with medical treatment as well. The EHR indicated a biopsy (a procedure to remove cells, tissue, or fluid for examination by a medical pathologist [a Medical Doctor who determines if there is presence of disease in tissue sampled]) of the thalamic mass was ordered, but never fulfilled due to Pt 13 expiring (died) before transfer to the Operating Room (OR). During an interview on 7/31/24 at 1:35 pm. with the Director of Risk Management, Regulatory, and Patient Safety (RMD), Pt 1’s death in May 2022 was discussed. RMD stated and confirmed Pt 1 was in restraints at the time of death, and death occurred within minutes after being given sedative medication. The RMD stated, “We [meaning the hospital] did not report this incident.” RMD stated the case was reviewed and it was decided that the hospital would not report. During a review of hospital policy titled, “Adverse Event Reporting to the California Department of Health Services” dated 01/03/2022, the policy indicated, “ PURPOSE: A. to comply with the mandated reporting requirements of health and safety code 1279. B. to support the improvement of patient safety and quality improvement initiatives. II. Definitions - A. Adverse Event includes any of the following... 23. A patient death or serious disability associated with the use of restraints or bedrails ...” The Health and Safety Code, Division 2, Licensing Provisions [1200 - 1796.70], Chapter 2 Health Facilities [1250 - 1339.59], Article 3. Regulations [1275 - 1289.5] section 1279.1. indicates: “ (a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b) For purposes of this section, “adverse event” includes any of the following: ... 5 ...(E) A patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility. The California Code of Regulations, Title 22 section 76551 - Unusual Occurrences indicates: “(a) Occurrences such as epidemic outbreaks, poisonings, fires, major accidents, deaths from unnatural causes or other catastrophes and unusual occurrences which threaten the welfare, safety or health of clients, personnel or visitors shall be reported by the facility within 24 hours either by telephone with written confirmation, or telegraph to the local health officer and the Department. (b) In the event of any unusual occurrence, including serious illness or accident, impending death or death, the client’s parent, guardian or authorized representative shall be notified promptly. (c) An unusual occurrence report shall be retained on file by the facility for five years. The facility shall furnish such other pertinent information related to such occurrences as the local health officer or the Department may require ...””

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47888 Based on observation, interview and record review, the facility failed to protect and promote patient’s rights for seven of seven sampled patients when: 1. Resident physician broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a Pt 3 when doing a chest tube bedside procedure. (Refer to A144 finding 1) 2. Patient 2 had a Penrose drain placed after a procedure that was charted removed by a Resident when it was not. That Penrose drain was found incidentally in a CT scan 4 days after it was charted removed. The drain was then removed bedside, without informed consent. (Refer to A144 finding 2) 3. Pt 1 had physician ordered Intravenous (IV- into or within a vein. IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein) access and continuous cardiac telemetry monitoring (technique or device that enables continuous tracking of your heartbeat. It measures the electrical activity of your heart), was removed, without first notifying the ordering physician in accordance with hospital policies and procedures (P&P). ED LNs then moved Pt 1 from the green zone to the ED Special Care unit (SCU) where Pt 1’s complex medical needs could not be met. ED LNs did not adhere to criteria for admission to SCU for Pt 1. (Refer to A144 finding 3) 4. Pt 9 and Pt 10 were admitted to inpatient beds and remained in the ED. The hospital did not provide privacy curtains and showers for Pt 9 and Pt 10. (Refer to A144 finding 4) 5. Patient (Pt) 32, was provided appropriate information about advance directives in accordance with the Policy and Procedure, Advance Care Planning. (Refer to A132) 6. The hospital failed to ensure non-violent restraints were discontinued at the earliest possible time and in accordance with hospital Policy and Procedure (P & P) “Restraints and Seclusion” for one of 68 patients, Patient (Pt) 30, when there was no documentation of behaviors that supported use of the restraints. (Refer to A174) 7. The hospital failed to follow reporting requirements when a Patient (Pt) 13 died while in restraints and the occurrence was not reported to the California Department of Public Health (CDPH) within five days after the event was detected. (Refer to A213) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 22968 Based on observation, interview and record review, the hospital failed to ensure an organized nursing service that provides 24-hour nursing when: 1. Emergency Department (ED) nurses assigned to care for Pt (Patient) 1 did not provide the level of care for which Pt 1 was admitted and did not follow physician orders and did not follow criteria for admission to the Special Care Unit (SCU - a secure, restricted area in the ED for behavioral patients) in accordance with hospital policy and procedure. (Refer to A398, Finding 1) Because of the possible avoidable death of Pt 1 and the serious potential harm related to not following policies and procedures meant to provide Pt 1 CPCU (Cardiac Progressive Care Unit) telemetry (patients with chronic cardiac conditions are monitored remotely using medical equipment) level of care and nurses not following policies related to criteria for admission to the SCU, an Immediate Jeopardy (IJ- a situation where a provider’s noncompliance with requirement has, or could, cause serious harm to resident) situation was called on 7/26/24 at 1 p.m. with the Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Director of Nursing Operations (DNO) under A398, CFR 482.23(b)(6). The CMS (Centers for Medicare and Medicaid Services) IJ Template form was provided to the hospital and instructions were given to submit a Plan of Removal (PoR) to address the IJ situation. Version 1.1 of the PoR (Version 1 was rescinded by the hospital) was submitted and determined to be unacceptable on 7/29/24 at 10:35 p.m. PoR Version 2 was submitted and acceptable as of 7/29/24 at 2:25 p.m. The survey team validated all actions on the PoR were implemented and the IJ was removed on 7/30/24 at 9 a.m., while onsite, with CNO, COO and DNO. After removal of the IJ, the hospital remained in substantial non-compliance. 2. Nurses in the Cardiovascular (relating to heart and blood vessels) Intensive Care Unit of Hospital B did not date control solutions for two of four sampled glucometers in accordance with hospital policy and procedure and manufacturer instructions (glucometer -- a device for measuring the concentration of sugar in the blood; control solutions - a liquid used to test the functionality of meter and strips). (Refer to A398, finding 2) 3. Nurses in the ED did not develop, implement and update a current nursing care plan (a patient-centered health document designed to facilitate communication among members of the care team and with the patient) for six of six patients (Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40) in accordance with their policy and procedures (P&P) titled “Admission & Ongoing Assessment - Nursing (Acute Care)” and “Interdisciplinary Plan of Care”. (Refer to A398, finding 3) 4. Nurses assigned to one of four sampled patients in the ED (Pt 66) for Hospital A did not perform vital signs (measurements of the body’s most basic functions) and pain assessments and monitoring in accordance with hospital P&P. (Refer to A398, finding 4) 5. Nurses in the ED assigned to care for Pt 67 did not follow monitoring protocol in accordance with physician order, hospital P&P and Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar-an instrument used by medical professionals to assess and diagnosis the severity of alcohol withdrawal (symptoms that may occur when a person who has been drinking too much alcohol on a regular basis suddenly stops drinking alcohol). (Refer to A398, finding 5) 6. Nurses in the ED stored empty oxygen tanks in the cage reserved for full oxygen tanks and not accordance with hospital policy and procedure and professional standard. (Refer to A398, finding 6) 7. Nurses in the ED assigned to Pt 70 did not label Pt 70’s inhaler in accordance with facility policy and procedure. (Refer to A398, finding 7) 8. Nurses assigned to Pt 28 did not assess Pt 28’s chest tubes (plastic tube that is used to drain fluid or air from the chest) within two hours of admission as per the hospital’s P&P titled “Standards of Practice - Acute Medical/Surgical, Telemetry, Step-Down (area that provides intermediate-level care between the Intensive care unit and the general medical-surgical wards) and Critical Care Units” dated 2/22/23. (Refer to A398, finding 8) 9. Nurses assigned to Pt 29 and Pt 46 performed electroencephalogram (EEG, test that measures electrical activity in the brain) monitoring while the patients were in a medical-surgical nursing unit and not in accordance with hospital policy and procedure. (Refer to A398, finding 9) 10. Nurses caring for Pt 31, Pt 32 and Pt 33 did not ensure the assigned patient monitor (or a sitter) did not exceed two patients in accordance with hospital policy and procedure. (Refer to A398, finding 10) 11. Nurses did not develop an individualized care plan for Pt 28’s chest tube (a plastic tube that is used to drain fluid or air from the chest) care and management. (Refer to A396, finding 1) 12. Nurses did not update and include Pt 45’s right buttock and sacral (near the lower back and spine) wounds in the care plan. (Refer to A396, finding 2) 13. Nurses did not develop and are plan interventions to address use of patient monitor for Pts 31, 32 and 33. (Refer to A396, finding 3) 14. Registered Nurse (RN) 2 did not follow the Policy and Procedure (P&P) titled “Blood Products Transfusion” for one of one patient, Patient 44. RN 2 failed to fill the filter drip chamber (a chamber with a filter used to remove contaminants from the infusion of fluids before it enters the bloodstream) with normal saline (a mixture of water and salt concentration of 0.9) above the filter. (Refer to A410) The cumulative effect of these system problems resulted in the hospital’s inability to provide care in a safe and quality setting.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 45977 Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when: 1. Sterile Processing Technician (SPT) was observed in the decontamination (area where reusable medical equipment is cleaned, disinfected, and sterilized [process of complete elimination and destruction of all forms of microbial life]) area of the Sterile Processing Department (SPD) scrubbing instruments above the enzymatic (cleaner that uses a natural process of breaking down bacteria and organic waste) cleaning solution water line. The SPT failed to follow hospital policy and procedure and AAMI (Association for the Advancement of Medical Instrumentation- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) standards of practice. (Refer to A750 Finding 1) 2. Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2 broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a patient when doing a chest tube bedside procedure. This placed Pt 3’s safety at-risk due to the possibility of infection. (Refer to A750 Finding 2) 3. Nursing staff did not clean three of three sampled pill crushers (turn pills into powder) in the Emergency Department (ED) were visibly soiled with white-colored chalk-like residue, and orange-colored stains to metal pieces and throughout the device. (Refer to A750 Finding 3) 4. Staff did not ensure equipment, supplies and floors were clean and organized, in two of three sampled ED Supply and Medication Rooms. Patient care supplies found on the floor, outside their designated clean supply storage cupboards and floor surfaces were visibly soiled, dusty with stains and trash on them. (Refer to A750 Finding 4) 5. Hospital staff did not perform hand hygiene according to hospital policies and procedures. (Refer to A750 Finding 5) 6. Staff did not ensure proper infection control practices were implemented during a wound care treatment for one of one sampled patient (Pt 45). (Refer to A750 Finding 6) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality patient care in a safe environment.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 38764 Based on interview, and record review, the hospital failed to ensure one of 68 patients, Patient (Pt) 32, was provided appropriate information about advance directives in accordance with the Policy and Procedure, Advance Care Planning. This failure resulted in denying Pt 32 the right to elect to have a person make healthcare decision on their behalf. Findings: During a record review of the hospital’s policy and procedure titled Advance Care Planning effective 4/13/23, showed each adult patient, upon admission, is to be provided written information including when an adult individual is incapacitated at the time of admission and is unable to receive information (due to the incapacitating condition or mental disorder) or articulated whether or not he or she has executed an Advance Directive, information about Advance Directives maybe provided to the family members or Substitute Decision Maker. During a record review of Pt 32’s medical record showed the patient was admitted to the hospital on 6/13/24. During a record review of Pt 32’s Hospitalist History & Physical dated 6/13/24 at 4:54 pm, showed the patient was gravely disabled who came from a skilled nursing facility, and included a medical history of dementia. The patient’s primary emergency contact information was included in the documentation. During a record review of Pt 32’s Advance Directives (a document that would inform healthcare providers who should speak for a patient and what medical decisions they should make for the patient if a patient lost the ability of speaking for herself/himself) documentation dated 6/14/24 at 10:37 pm, showed the following; -the patient did not have a healthcare directive, -the patient did not request about information on advance care planning, -the patient did not have an appointed surrogate decision maker. Further review on the admission assessment of Pt 32 dated 6/21/24 at 2:08 am, showed the patient was unable to provide reliable information and did not have family members to contact for information. During a concurrent interview and record review on 7/26/24 at 10:34 am with Medical Surgical Director (MSD), MSD acknowledged the above findings. MSD was asked to explain “Information on Advance Care Planning Requested” meant as shown on the Advance Directives documentation of Patient 32’s medical record. MSD stated the patient was offered information including advance directives; however, the patient declined to receive information about advance directives. MSD acknowledged Pt 32 did not have the capacity to receive information about advance directives.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47888 Based on, interview and record review, the hospital failed to ensure care was provided in a safe setting for five of five patients (Patient (Pt) Pt 1, 2, 3, 9 and 10) when: 1. Resident physician broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a Pt 3 when doing a chest tube bedside procedure. This failure had the potential to put Pt 3’s safety at-risk due to the possibility of infection. 2. Patient 2 had a Penrose drain placed after a procedure that was charted removed by a Resident when it was not. The Penrose drain was later identified incidentally in a CT scan four days after it was charted removed. The drain was then removed during a bedside procedure, without informed consent. This failure had the potential for infection for Pt 2. 3. Pt 1 had physician ordered Intravenous (IV- into or within a vein. IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein) access and continuous cardiac telemetry monitoring (technique or device that enables continuous tracking of your heartbeat. It measures the electrical activity of your heart) removed without first notifying the ordering physician in accordance with hospital policies and procedures (P&P). Emergency Department (ED) Licensed Nurses (LN) then moved Pt 1 from the green zone to the ED Special Care unit (SCU) where Pt 1’s complex medical needs could not be met. ED LNs did not adhere to criteria for admission to SCU for Pt 1. These failures resulted in nurses not providing the level of care and monitoring ordered by the physician, led to Pt 1 lying on the floor unnoticed for several minutes and later found pulseless with a large amount of blood on the floor next to him and from his mouth and possibly contributed to a delay in nurses recognizing and responding to Pt 1’s change in condition. Pt 1 died after unsuccessful attempts at CPR. These failures denied Pt 1 care in a safe setting. 4. Pt 9 and Pt 10 were admitted to inpatient beds and remained in the ED. The hospital did not provide privacy curtains and showers for Pt 9 and Pt 10. These failures resulted in a violation of Pts 9 and 10’s right to have the same level of individualized nursing care, privacy, courtesy and dignity as other patients occupying inpatient beds. Findings: 1. During a review of Pt 3’s “History and Physical (H&P)”, dated 11/19/23 at 8:17 p.m., the H&P indicated, “ ...54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...”. During a review of Pt 3’s “Surgical Operative Report (SOR)”, dated 11/22/23 at 10:52 p.m., the SOR indicated, “ ...Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...”. During a review of Pt 3’s “Retained Foreign Object Picture (RFO)”, dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately 1-inch (unit of measurement) in length. During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMO stated a “broken barrier” should be addressed, acknowledged and rectified. The CMQO stated the resident physician should have “spoke up” when the glove was torn and notified his Attending Physician. The CMQO stated the retained glove could have caused an infection. During an interview on 8/2/24 at 5:30 p.m., with Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2’s interview on 6/6/24 at 12:30 p.m., was validated, and MDR 2 stated he was the person that put in the original chest tube for Pt 3. MDR 2 stated the chest tube insertion was a sterile procedure. MDR 2 stated during the chest tube insertion was performed by feeling into the pleural cavity (space that surrounds the lungs), so he had to digitally enter (stick finger in) the cavity. MDR 2 stated while in the pleural cavity he manually exploraed the area and this is when his right sterile glove index finger ripped. MDR 2 stated he “didn’t think the glove could be in the patient”. MDR 2 stated when his glove ripped, he did not notify any staff (three different physicians were with him) involved that it happened. MDR 2 stated in hindsight he should have notified his Attending Physician that was present. MDR 2 stated the expectation for the procedure was that the glove stay intact and not be left inside the patient. MDR 2 stated the patient had the potential to develop an infection. MDR 2 stated Pt 3 could have been harmed by the piece of glove that was left inside. During an interview on 8/2/24 at 5:30 p.m., with the Director of General Surgery Residency (DGSR), the DGSR’s interview on 6/6/24 at 12:50 p.m., was validated, and the DGSR stated the chest tube insertion was a sterile procedure and the sterile field was compromised when the glove ripped inside of Pt 3. The DGSR stated Pt 3 had the potential to develop an infection due to the glove piece being left inside. The DGSR stated MDR 2 did not follow the hospital policy and procedure (P&P) for patient’s safety and infection control. The DRSR stated when MDR 2 broke his glove, he should have notified the staff members what happened, removed the gloves and put on new sterile gloves. During an interview on 8/2/24 at 6 p.m., with the Quality Outcomes Manager (QOM), the QOM stated Medical Doctor- Fellow (MDF) 2 who found the glove in the procedure, no longer was with the organization and the previous interview from 6/6/24 at 1:20 p.m., could be used. The MDF 2 stated he found the piece of glove during Pt 3’s procedure. The MDF 2 stated Pt 3 had a potential for an infection by having the glove piece left inside of her after the chest tube was placed. The MDF 2 stated Pt 3’s infection risk would be “great”. The MDF 2 stated there was ultimately a potential for death for Pt 3 by leaving a glove behind because of her acuity (severity level of an illness or medical condition) level at that time. During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was “that this doesn’t happen” and maintain the sterile field. The MIP stated this incident was “concerning”. The MIP stated “our intention” was for this not to happen to reduce the “likelihood” of cross-contamination into the sterile field. During a review of the facility’s policy and procedure (P&P) titled, “Safety Management Plan”, dated 3/21/23, the P&P indicated, “I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...”. 2. During a review of Patient (Pt) 2’s “History & Physical (H&P)”, dated 2/8/24, the H&P indicated, “ ... Chief Complaint: Generalized Weakness ... History or Present Illness: ... 72-year-old ... female with Type II Diabetes Mellitus (a disease that occurs when your blood sugar is too high) and hypertension (high blood pressure) who presents with malaise (weakness), right lower extremity pain an abnormal labs. Patient recently had a prolonged hospitalization after a pedestrian vs. automobile (accident) resulting multiple fractures (broken bones) ... [right tibia/fibula (leg) status/post ORIF (Open reduction and internal fixation is a surgical procedure for repairing fractured bone using either plates, screws to stabilize the bone), left tibial plateau fracture (broken shin), multiple sacral (bottom of the spine) and pelvic fractures, right proximal humerus (shoulder)] ... discharged to (Skilled Nursing Facility) on 2/2/24 ... Per nursing staff ... patient was more confused than usual and found to have leukocytosis (high white blood cell count) ... she received 1 dose intramuscular (in the muscle) ceftriaxone (antibiotic) prior to transport to the Emergency Department (ED) ... Hospital problems: Healthcare associated pneumonia ... Anasarca (generalized swelling of the body) ... tibia/fibula fracture ... type II diabetes ... Hypertension ...”. During a review of Pt 2’s “Consult Note (CN)”, dated 2/13/24, the CN indicated, “ ...fluid collection anterior (toward the front of the body) right ... shoulder joint ... status/post right shoulder aspiration (a procedure to remove fluid) ... Orthopedics on board and plan for Incision and Drainage (I&D- surgical procedure to release pus or pressure built up under the skin) of right shoulder today ...”. During a review of Pt 2’s “Orthopedic Surgery Operative Report (SOR)”, dated 2/14/24, the SOR indicated, “ ... Postoperative diagnosis: right humerus (upper arm bone) fracture infected hematoma ... Drains: 1 Penrose drain (a soft, flat, flexible tube made of latex. It lets blood and other fluids move out of the area of your surgery) ... Complications: none ... Condition: Stable ...”. During a review of Pt 2’s “Progress Note: Orthopedic Surgery (PNOS)”, dated 2/17/24 at 9:12 a.m., the PNOS indicated, “ ...Hospital course: ... She reports pain everywhere and it is difficult to get a story out of her. She is very ill appearing ... Patient is now status post right shoulder I&D 2/14 ... Objective: ... Right upper extremity: visual: surgical incision clean, dry and intact without surrounding erythema (redness)/edema (swelling) ... Assessment/Plan: ... She is much improved. Patient in stable condition from orthopedic perspective. No further orthopedic intervention indicated ... Drain: Penrose drain s/p (status/post) removal ... (signed) Medical Doctor/Fellow (MDF) 1 ...”. During a review of Pt 2’s “CT (a procedure where a computer linked to an x-ray machine takes detailed pictures of the inside the body) Chest Abdomen and Pelvis with Contrast”, dated 2/21/24 at 2:12 a.m., the CT indicated, “ ... Reason for exam: sepsis, worsening leukocytosis ... Findings: ... Right humeral surgical neck fracture. An internalized drain fragment measuring 8 cm (centimeter- unit of measurement) in length is positioned along the anterior margin of the fracture and does not extend to the dermis. Consider orthopedic consultation ...”. During a review of Pt 2’s “Treatment Plan- Orthopedics Update (OU)”, dated 2/21/24 at 1:09 p.m., the OU indicated, “ ...Ortho service paged regarding incidental finding of retrained surgical Penrose drain in right shoulder ... previously thought Penrose drain was removed previously given it was loosely wedged in tissue, however, it was found incidentally to have been within the subcutaneous tissue (deepest skin layer that lies closest to the muscle) on CT scan ... the finding was communicated with family (daughter) at bedside ortho service then evaluated wound at bedside no signs of gross purulence (pus). Wound clean, dry, intact. Sutures removed at bedside, 10CC’s (cubic centimeters equal to milliliters- unit of measurement) lidocaine (numbing medicine) injected into subcutaneous tissue about wound. Wound then prepped and draped in usual sterile fashion. 15 blade scalpel (small and extremely sharp bladed instrument used for surgery or dissection) used to reopen surgical wound. Kelley (forceps- surgical instrument used for holding and manipulating tissue) used to superficially spread tissue. White Penrose drain immediately visible within field and removed. Wound then irrigated (cleaned) with 1L (liter- unit of measurement) saline. Wound then closed with 4-0 (size) nylon (type of thread) suture. Wound dressed (a dressing is applied to protect the wound from complications resulting from contamination or disturbance) ...”. During an interview on 7/26/24 at 3:35 p.m., with Medical Doctor/Resident (MDR) 1, MDR 1 stated he was a first-year resident at the time of the incident. MDR 1 stated he and MDF 2 “did the procedure”. MDR 1 stated if they drain was not found incidentally by CT, the drain “might just stay in there and scar”. MDR 1 stated if an infection did arise from the drain left in the shoulder, it wouldn’t be “overly surprising”. MDR 1 stated from his OU, it did not appear that informed consent was documented. The MDR 1 stated he did not feel informed consent was necessary because it was “a very brief superficial intervention”. MDR 1 stated he did not think “anything should have been done differently”. During an interview on 7/26/24 at 4:15 p.m., with MDF 2, MDF 2’s interview on 6/7/24 at 3 p.m., was validated, the MDF 2 stated he “supervised” MDR 1 completing the bedside procedure. The MDF 2 stated “the biggest error was I charted status post removal and I didn’t communicate or investigate very deeply about what happened to the drain”. The MDF 2 stated that if there were not incidental CT finding of the drain, the drain could have been an “itis for infection”. The MDF 2 stated he and MDR 1, should have gotten consent from Pt 2’s family member before the bedside procedure of the drain removal. MDF 2 stated any procedure there should be risk and benefits explained to the patient or family member, regardless of “how small the risk”. The MDF 2 stated this procedure for Pt 2 could have taken place in the operating room (OR), but she was “very ill” and the risk for Anesthesia was “far greater” than the risk of a bedside procedure. The MDF 2 stated this bedside procedure was invasive because they had to “pass skin” in order to “retrieve something”. The MDF 2 stated when “someone comes at them with a knife, they need to consent that”. The MDF 2 stated this procedure should have required informed consent and charted accordingly. During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMQO stated MDF 2’s documentation should have reflected what he did or did not do. The CMO stated informed consent should have been obtained and documented for Pt 2’s bedside procedure. The CMO stated Pt 2’s rights “were not honored” by not having a documented informed consent. The CMO stated a foreign body could have potentially caused an infection. The CMO stated there was “inappropriate documentation” in this case and also “inappropriate consent”. During a review of the facility’s policy and procedure (P&P) titled, “Safety Management Plan”, dated 3/21/23, the P&P indicated, “I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...”. During a review of the facility’s P&P titled, “Consents”, dated 4/13/23, the P&P indicated, “I. Purpose: A. To describe the principles of consent, protect the rights of patients ... B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent and the physician’s responsibilities for obtaining and documenting informed consent ... III. POLICY: ...D. 1. The physician has the legal and ethical duty to obtain the patient’s informed consent, or the informed consent of the patient’s legal representative, for medical treatment, or for procedures which have been determined to be invasive ... in nature ... ii. Informed consent responsibilities may be delegated to another ... resident privileged to perform the same procedure ... vii. Physician documentation of informed consent must occur prior to commencement of the procedure. If there’s no physician documentation the procedure shall not begin ...”. During a review of the facility’s P&P titled, “Patient’s Rights and Responsibilities”, dated 2/10/22, the P&P indicated, “I. PURPOSE: to define the rights and responsibilities of patients who receive services at (Hospital) ... IV. PATIENT RIGHTS: ... 6. To receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment ... 7. To be informed and, when appropriate, for the for their families to be informed about the outcomes of care including unanticipated outcomes ...”. 47205 3. During a concurrent observation and interview on 7/22/24 at 10:15 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the Special Care Unit (SCU). DED stated the purpose of the SCU is to care for patients that require a safe, stripped-down area (hazards are removed) and nursing care to address mental health needs and manage behavioral problems. DED stated the rooms are completely stripped, meaning in the room there is a gurney/bed and that is it; there are no countertops or sinks. DED stated patients that have suicidal ideation or aggressive behaviors are taken care of in the SCU. The SCU patient may be on “a hold such as 5150 (the temporary, involuntary psychiatric commitment of individuals who present a danger to themselves or others) or have behaviors such as suicidal ideation (thoughts of self-harm) and/or anxiety (a group of mental health conditions that cause fear, dread and other symptoms that are out of proportion to the situation).” DED stated the SCU does not take care of any patients requiring cardiac monitoring or intravenous (IV) fluids or IV medications. During a review of Pt 1’s EHR 62-year-old conserved [a legal status in which a court appoints a person to manage the financial and personal affairs of a minor or incapacitated person] male patient with past medical history of schizophrenia [a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions], substance abuse [The use of illegal drugs or the use of prescription or over-the-counter drugs or alcohol for purposes other than those for which they are meant to be used], smoker ...” During a concurrent interview and record review on 7/23/24 at 9:35 a.m., with the DED, MED 1 and MED 2, the DED stated patients who are conserved and who do not have a need for complex medical care are the types of patients cared for in the SCU. In the SCU, patients who are on oxygen (O2) therapy or IV therapy are not candidates for this unit because of need to strip the rooms/gurneys in the SCU to ensure patient safety from self-harm or injury to staff . DED stated “ “in general we have a process where patients are reviewed by primary RN, charge RN, clinical supervisor.” DED stated the ED LNs receive training in the care of the Mental/Behavioral Health patient in the ED. DED stated the ED is “fluid [patients move throughout the unit depending on level of medical care they need].” DED stated there are no protocols to guide this decision making, the nursing staff decide to place patients where there is staff that can provide the level of care ordered. DED stated the self-report was submitted due to the event not being part of their normal process in the ED. DED stated there were gaps in the care which led facility to self-report. DED stated the findings of the facility’s review/RCA (RCA - root cause analysis - a process that aims to identify the cause of the problem and correct it) indicated Pt 1 did not meet the criteria for admission to SCU. DED stated facility internal investigation findings were that the cardiac monitoring was discontinued, and IV was discontinued as well to place the patient in the SCU. DED stated the documentation that the discussion was had between provider and nursing staff to discontinue the IV and cardiac monitoring was not present in Pt 1’s EHR. DED and MED 1 stated the removal of the IV and cardiac monitoring was done without a physician order. During an interview and viewing of video recording on 7/24/24 at 2 p.m. with DED and MED 2, the video recording was without audio and began with viewing Pt 1 in the SCU on his gurney/bed. The video recording started on 7/11/24 at 11:08 p.m. Shortly after the viewing started, Pt 1 was on his gurney/bed and appeared to be turning from one side to another, sitting up in bed, and back down again. This back-and-forth behavior occurred many times for the next 30-45 minutes. At one point Pt 1 placed his feet on the floor while sitting on the gurney and then went back to lie down. At around midnight 7/12/24, Pt 1 was viewed face down on the floor next to the gurney. Several minutes passed before the security guard looked in on Pt 1 and then tapped on the security window which enclosed the nurse’s station. Soon after LVN 1 appeared on the video, went beside Pt 1, turned him over, and a large pool of blood could be seen on the floor. LVN 1 immediately started CPR and soon after a team of nurses entered with a gurney and continued CPR and transported Pt 1 out of view of the video recording. That was the end of the viewing of the video recording. DED was asked if a cardiac monitor was on Pt 1 would that have helped identify a change of condition in Pt 1? To which DED responded “yes.” 4. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the unit. The ED was observed to be very busy, with many patients of all ages on gurneys or hallway beds as well as in rooms. DED stated the unit was experiencing high volumes of ED patients coming to the ED, and over 100 patients waiting in the ED for an inpatient bed assignment. DED stated the 1 East (1E) overflow hall area, used to place ED patients when the main ED is full, was just being demobilized. During the tour, patients were observed to be waiting, eating, sitting on gurneys interacting with the 1 visitor allowed at bedside or receiving infusions of IV medications. DED stated that patients are provided with privacy screens upon request. Privacy screens observed while providing patient privacy, contributed to the already cluttered state of the hallways, and made visualization of patients without a means to alert staff for help (there are no call bells available to hallway bed patients) difficult. DED provides a department map to facilitate understanding of the ED orientation. During a review of the facility “ED Map” dated 11/22, with DED, the map indicated the ED can accommodate up to 246 patients within each of the designated zones in the ED: Green Zone: 60 patients, Yellow Zone: 24 patients, Red Zone: 19 patients, Trauma Zone 11 patients, SCU (Special Care Unit) 12 patients, East Hallway: 45 patients and the PAT (Provider At Triage)/LOBBY area: 75 patients. DED stated patients may be moved to a “procedure room” as needed, but otherwise they are out in the open. The ED map indicated the number of shared restrooms available in that zone/area are as follows (compared to capacity provided by DED): Trauma Zone: 3 for capacity of 11 beds; Red Zone: 3 for capacity of 19; Green Zone: 4 for capacity of 60; Yellow Zone: for capacity of 12; SCU: 1 for capacity of 12; Waiting room: 2 for capacity of 75. TOTAL: 13 restrooms for capacity of 246 patients. DED stated patients in the ED are not allowed to go out to smoke, the patient who wants to smoke would have to sign out AMA (AMA-against medical advice). During a concurrent interview and record review on 7/24/24, at 9:37 a.m., with the DED, MED 1, and MED 2, Pt 9’s EHR was reviewed. Pt 9’s “ED Pt Care Timeline” dated 7/24/23 indicated “ ...Arrival ...7/4/24 at 11:36 p.m. ...TT [time spent in the ED before being moved to the inpatient bed] 74:35 (hours:minutes) ...11:42 Start Triage Initiated ...Ground level fall - loss of consciousness Pain mid-cervical (neck) ...94/M ...witnessed fall by caregiver from standing in the shower this AM Patient was reported to fall back striking head on the ceramic bath tub Denies loss of consciousness ...” “ ...Past Medical History: Dizziness, follicular lymphoma (very slow-growing cancer that may appear in your lymph nodes, your bone marrow and other organs), Glaucoma (a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of your eye called the optic nerve), Hearing loss, Hypertension (high blood pressure), Peripheral vascular disease (an accumulation of plaque (fats and cholesterol) in the arteries in your legs or arms), Senile macular degeneration (n eye disorder that slowly destroys sharp, central vision), wears eyeglasses ...” Care was provided in the ED with plan to admit Pt 9. On “ ...7/4/24 at 18:04 (6:04 p.m.) Place in Observation Status [admission] ...Neuro Med Surg (Medical-Surgical floor) ...7/6/24 at 16:23 (4:23 p.m.) Order updated ...Admit to Inpatient ...7/7/24 at 13:30 [bed] Assigned: 2C MS ...226-A ...14:11 (2:11 p.m.) to department 2C Med Surg ...” During a concurrent interview and record review on 7/23/24, at 2:05 p.m., with the DED, MED 1, and MED 2, Pt 10’s EHR was reviewed. Pt 10’s “ED Pt Care Timeline” dated 7/24/23 indicated “ ...Arrival 4/16/24 at 15:39 (3:39 p.m.) ... TT [time spent in the ED before being moved to the inpatient bed] 113:21 (hours:minutes) ... 15:40 (3:40 p.m.) Start Triage Initiated ...73 y.o. female with past medical history including GERD (a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus), CAD (a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart), ETOH (alcohol) abuse, depression, diabetes mellitus (A disease in which the body does not control the amount of glucose (a type of sugar) in the blood and the kidneys make a large amount of urine), hypertension (high-blood pressure), skin cancer, ESRD (End Stage Renal Disease- a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life) on hemodialysis M/W/F, anemia (a problem of not having enough healthy red blood cells or hemoglobin to carry oxygen to the body’s tissues) and DVT (Deep vein thrombosis- occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs) who presents with altered mental status ...Patient is admitted with dx (diagnosis) of sepsis (An extreme immune response to infection that can lead to tissue damage, organ failure, or death if not treated right away) ... 4/16/24 20:29 (8:29 p.m.), Orders Placed ...Admit to Inpatient ...20:33 (8:33 p.m.) ...Patient Admit Service: Medicine Requested Bed Type CPCU Tele ...4/21/24 09:00 (9:00 a.m.) Patient admitted to department 4C CPCU ...” During a concurrent interview and record review on 7/23/24 at 3:31 p.m., with DED, MED 1 and MED 2, DED stated ED nurses are trained to provide and do provide appropriate level of care to patients holding in the ED for an inpatient bed assignment. During an interview on 7/24/24 at 3:15 p.m., with RN 9, RN 9 stated admitted patients waiting for an inpatient bed have different orders [they are] waiting in the ED “so we take care of them.” RN 9 stated the physician decides the level of care the patient is to be admitted to. The RN role is to reach out to the doctor [for any concerns], “every level of care is different, you do different things based on the level of care they are admitted to.” RN 9 stated nurses follow the physician’s plan of care and are trained to provide care per zone you are trained to work in. RN 9 stated for any admitted patient you would follow the [physician] plan of care, cardiac monitor and vital signs every 4-hours. RN 9 stated there is a nurses reference guide located in the yellow zone training didactic and she would follow that. RN 9 stated this training is also offered in the training and on the computer (computer-based learning modules). RN 9 stated she is not sure what the CPCU level of care on the CPCU floor “looks like, hasn’t gone up there, but states the level of care RN provides in the ED is same as on the [inpatient] unit. During an interview on 7/25/24 at 8:49 a.m., with DCVS, DVCS stated as director of the CPCU it is her expectation that the LNs in the ED are following the standard of care for the care level ordered for the patient, including the development of a care plan. DVCS stated it is her expectation that telemetry monitoring box is maintained as ordered and this is done throughout the hospital, nurses are to follow MD orders. During an interview on 7/25/24 at 5:00 p.m., with CNO, DNO, DED, COO, and RMD, the assembled acknowledged holding inpatients in the ED is not ideal and are actively working on the “gaps” observed as well as tracking and trending the volume of patients seen and held in the ED to ensure compliance with regulatory standards. During a concurrent interview and record review on 7/29/24 at 3:00 p.m., with LVN 3, LVN 3 stated her role in the ED is to support the RN “work as a team.” LVN 3 stated she part of her responsibility is to ensure she is monitoring orders regarding [patient care] and ensuring they are done. LVN 3 stated for inpatients “IP (IP-inpatient)” charting is up to date. During a review of the facility P&P titled “Non-Smoking - Patients” dated 6/8/23 the P&P indicated “ ...III. POLICY A. Smoking (including the use of electronic cigarettes/cigars) is prohibited in all areas within ....50 feet of any entrance ...B. A Provider must write an order allowing the patient to leave the patient care unit to smoke in designated areas ...F. The patient needs to be able to independently light their own cigarette and manage their own device or depend on family ...G.. The patient should notify staff prior to leaving the patient care unit to smoke, make every attempt to return within an hour of leaving the unit for a smoke break, and notify staff when they have returned ...V. PROCEDURE ...B. Provider orders 1. Providers may consider several options for the patient who smokes: a. Write an order for a nicotine replacement therapy (NRT) , (e.g., nicotine patch) ... b. Write an order and document justification for the patient to smoke in designated areas only ...” 45977”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 38764 Based on observation, interview, and record review, the hospital failed to ensure non-violent restraints were discontinued at the earliest possible time and in accordance with hospital Policy and Procedure (P & P) “Restraints and Seclusion” for one of 68 patients, Patient (Pt) 30,when there was no documentation of behaviors that supported use of the restraints. This failure resulted in not ensuring the patient’s rights to be free from restraints and could possibly lead to adverse health outcomes. Findings: During a review of the hospital’s P&P titled “Restraint and Seclusion” dated 6/8/23, the P&P indicated “ ...Restraints must be discontinued at the earliest possible time once the unsafe situation ends, regardless of the length of time identified in the order. Restraint may only be employed while the unsafe situation (clinical justification) continues ...Physicians, residents, APPs (Advanced Practice Provider) and RNs involved in the patient’s care are authorized to determine whether or not restraint should be discontinued based on determination that the patient’s behavior is no longer a threat.” The P&P also indicated to “...Document the following information in the EHR (electronic health record - an electronic record of health related information on an individual) for each restraint or seclusion episode: ...Patient behavior, condition or symptom(s) that warranted restraint or seclusion use and intervention(s) used ...” During a review of Pt 30’s “Hospitalist (a physician who works exclusively in the hospital) History & Physical” dated 12/23/23 at 09:05 p.m., the document indicated Pt 30 was admitted on 12/23/23. The H&P indicated “ ...Per reports, patient has been acting out of the normal for the past week. Has outbursts of yelling and hits other residents. Patient is oriented x4 (an individual who is oriented to person, place, time, and event), calm, and cooperative now. Admits to having outburst of yelling. Reports she hit 3 other residents because they have been mean and bullying her ...” During a review of Pt 30’s “Restraints Non-Violent or Non-Self Destructive (Order 414937581)” dated 7/17/24 at 04:48 p.m., the order indicated to place Pt 30 on continuous soft restraints to bilateral (both) wrists and bilateral ankles due to interference with medical treatment. During a concurrent observation and interview on 7/23/24 at 10:37 a.m. at Pt 30’s room, Pt 30 was observed awake, lying flat in bed, with the call light within reach. Pt 30 was calm and stated she did not know why she was in restraints and wanted to have them removed. Pt 30 had bilateral wrists and bilateral ankles soft restraints tied to the bed frame. During a concurrent follow-up observation and interview on 7/24/24 at 02:55 p.m. with 1 East Manager (1EM), Pt 30 was asleep in bed. Pt 30 still had soft restraints on her bilateral wrists and bilateral ankles. 1EM stated Pt 30 had been sleeping on and off throughout the day. 1EM stated she had not been informed by the staff of any instances of aggressive behavior from Pt 30 recently. During a review of Pt 30’s “Restraint Documentation” dated 7/22/24 at 04:00 p.m. to 7/26/24 at 02:00 p.m., under “Visual Check,” the staff documented the patient was “CF” and/or “A.” Review of the “Restraint Type” legend showed “CF” meant confused, and “A” meant the patient was asleep. There was no documented evidence showing the specific type of behavior Pt 30 was exhibiting to justify the continued use of restraints. During a review of Pt 30’s eMAR (electronic Medication Administration Record - an electronic record facilities used to document medications), the documentation indicated the nursing staff administered the following medications: -Ativan (antianxiety) 0.5 mg (milligrams) PO (by mouth) every 6 hours PRN (as needed) for anxiety was administered on 7/22/24 at 12:03 a.m., 7/22/24 at 07:53 p.m., 7/23/24 at 01:52 a.m., 7/23/24 at 06:03 p.m., and 7/24/24 at 06:36 a.m. -Zyprexa (antipsychotic) 5 mg PO every 8 hours PRN for agitation was administered on 7/22/24 at 04:30 a.m., 7/22/24 at 07:53 p.m., 7/23/24 at 04:10 a.m., 7/24/24 at 06:36 a.m., and 7/26/24 at 01:00 a.m. There was no documented evidence showing the specific behavior Pt 30 was exhibiting and the reasons for administration. During a concurrent interview and record review on 7/26/24 at 09:50 a.m. with Medical-Surgical Director (MSD) and Manager 1EM, Pt 30’s “Restraint Documentation” dated 7/22/24 at 04:00 p.m. to 7/26/24 at 02:00 a.m., eMAR from 7/22/24 to 7/24/24, and all nursing progress notes dated 7/22/24 to 7/24/24 were reviewed. MSD verified the above findings. MSD stated Pt 30 was placed on restraints due to interference with medical treatment. MSD verified the nursing staff did not document Pt 30’s specific behaviors and rationale for the continued use of restraints. MSD acknowledged that based on the medical records reviewed, Pt 30’s restraints could have been discontinued earlier. MSD stated Pt 30’s restraints were not discontinued until 7/26/24 at 02:05 a.m.”

“PATIENT RIGHTS:RESTRAINT/SECLUSION DEATH RPT CFR(s): 482.13(g)(1) & (3)(i) [Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.] (1) With the exception of deaths described under paragraph (g)(2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient’s death: (i) Each death that occurs while a patient is in restraint or seclusion. (ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion. (iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient’s death, regardless of the type(s) of restraint used on the patient during this time.”Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.... (3) The staff must document in the patient’s medical record the date and time the death was: (i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or .... This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to follow reporting requirements when a Patient (Pt) 13 died while in restraints and the occurrence was not reported to the California Department of Public Health (CDPH) within five days after the event was detected. This failure delayed the investigations of the incident by CDPH and had the potential to place other patients at risk of unreported adverse events that could lead to harm or death. Findings: During a review of Pt 13’s “Electronic Health Record (EHR)” dated 5/19/22 to 5/23/22, the EHR indicated, Pt 13 was a 38-year-old man who arrived at the Emergency Department (ED) on 5/19/22 at 4:05 p.m. from the County Jail and was admitted to the Neurocritical Care Unit (critical care for patients with illness or injuries to the brain or nervous system on 5/20/22 at 3:41 a.m., for Altered Mental Status (AMS- a change in the mental function that stems from illness, disorders and injuries that have affected the brain) left thalamic mass (brain tumor) and developing hydrocephalus (buildup of fluid in the brain). The EHR indicated that Pt 13 had a past medical history of Diabetes Mellitus (body’s inability to produce or respond to insulin is impaired, resulting in elevated sugar in the blood and urine), Schizoaffective Disorder (mental illness that can affect your thoughts, mood and behavior) and sleep apnea (a disorder that causes a person’s breathing to stop or get very shallow) requiring a CPAP (a machine that uses mild air pressure to keep breathing airways open while you sleep) machine while asleep on the unit. The EHR indicated Pt 13 had a bedside procedure of an External Ventricular Drain (EVD- temporary method of draining fluid from the brain) placed in his skull on 5/20/22. The EHR indicated no issues with the EVD during Pt 13’s stay. The EHR indicated the patient required non-violent soft restraints for his upper extremities during his entire hospital admit stay for interference with medical treatment, as well as a prisoner shackle around his left ankle. An additional restraint was added to the right ankle on 5/23/22 at 2:40 p.m. for interference with medical treatment as well. The EHR indicated a biopsy (a procedure to remove cells, tissue, or fluid for examination by a medical pathologist [a Medical Doctor who determines if there is presence of disease in tissue sampled]) of the thalamic mass was ordered, but never fulfilled due to Pt 13 expiring (died) before transfer to the Operating Room (OR). During a review of Pt 13’s “Certified Registered Nurse Anesthetist (Progress Note (CRNA- a Registered Nurse who has specialized training in anesthesia, PN)”, dated 5/23/22 at 3:25 p.m., the CRNA PN indicated, “ ...Summary: Pre-code blue (adult in a medical emergency usually cardiac or respiratory arrest [cessation of breathing]) events ... 2:15 p.m., Patient in four-point restraints. Glasgow coma scale 14 (GCS- range from 3 completely unresponsive to 15- responsive, an objective tool to describe the extent of impaired consciousness in all types of acute medical and trauma patients), hypervigilant (a state of heightened awareness and watchfulness), able to converse (talk) in short phrases, pulling against restraints, restless. Pending (MDNS) note prior to transport to operating room. Pulled own condom catheter (urine collection device) off, kicking legs against bottom of bed. Patient given 25 mcg (micrograms- unit of measurement) fentanyl (a potent synthetic opioid [drug used to treat moderate to severe pain] drug approved by the Food and Drug Administration for use as an analgesic (pain relief) and anesthetic [a drug that causes a loss of feeling or awareness) with no noticeable effect after few minutes, then given 50 mcg fentanyl more. I remained immediately available to monitor patient ... 2:55 p.m., MDNS note noted as documented. Preparing to take patient downstairs for surgery. Ambubag (a handheld tool to provide respiratory support) available. Attached to transport monitor. HR (heart rate) 60’s, NSR (normal sinus rhythm- cardiovascular rhythm). SpO2 (Oxygen monitor) inconsistent due to patient moving constantly. Determination made that patient too agitated to transport safely, given 25 mcg fentanyl with minimal effect. An additional 50 mcg fentanyl and 30 mg (milligrams- unit of measurement) propofol (used to induce or maintain anesthesia during certain surgeries, tests, or procedures) IVP (Intravenous [in the vein] Push). Shortly thereafter, patient noted to have eye deviation (abnormal eye movement) to one side, respiratory rate decreased. Jaw thrust (a maneuver for opening the airway of an unconscious patient) initiated, called for airway equipment. 100 mm (millimeter- unit of measurement) oral airway (a device that maintains or opens the airway) in place, jaw thrust (lifting the jaw into a position to open the airway) ongoing patient breathing with respiratory rate 6-8 breaths per minute. Placed on nonrebreather mask (a type of oxygen mask that gives a person a lot of oxygen, typically in an emergency) 100% O2 (oxygen) 25 L (liters- unit of measurement). Within a minute, I noted respiratory effort decreasing and started to mask ventilate via Ambubag (a device place over the nose and mouth to force air into a person’s lungs) great seal, mist (patient breath) noted in mask with each exhalation. HR decreased to 50’s (50 beats per minute (bpm) - normal is 60-100), lead 2 (cardiac monitor) appeared to have no p wave (an integral part of an EKG) on EKG (measurement of the heart’s electrical activity). Difficulty getting noninvasive blood pressure. 1mg atropine (medication that treats a low heart rate) given IV and 0.4 mg Narcan (medication that was designed to rapidly reverse an opioid overdose) given IV with no response. Difficulty reading O2 saturation on finger, switched to nasal probe (device that goes on the nose) then earlobe. At this time, femoral (located in the groin) and carotid (artery on either side of the neck) pulse was checked, and no pulse could be felt. Patient noted to be in pulseless electrical activity (a condition where your heart stops) rhythm with heart rate in the 40’s (bpm). Code blue (an adult is having a medical emergency, usually cardiac or respiratory arrest) initiated and crash cart (a cart with emergency life-saving medications on it) brought into room by other RN (registered nurse). Code blue initiated ...”. During a review of Pt 13’s “Addendum by Registered Nurse (RN) 14”, dated 5/23/22 at 7:29 p.m., the Addendum indicated, “ ... [at]2:30 p.m., writer walked into patient’s room to find him agitated ... attempting to put new pulse ox (oximeter - a medical device that measures how much oxygen in in the blood) on finger. At the same time OR team walked into the room to get him ready to go to biopsy of thalamic mass. Attempted to verbally calm down patient, but with no effect. Patient attempting to kick writer with right foot- right ankle restraint placed and left ankle in cuffs. CRNA 2 attempted to pull dexmedetomidine (a non-opioid drug used to manage pain and sedation) but medication was not inpatient profile and was unable to be overridden. CRNA 2 pulled propofol and fentanyl instead ... [at] 2:45 p.m., patient still agitated and pulled condom catheter off and urinated in bed. Writer attempted to clean up patient but very agitated at this point. CRNA 2 Pushed medications total of 75mcg fentanyl and 30mg propofol. Less than a minute after medications being pushed patient started to snore, eye deviation (unintentional eyes moving to the side) and seizure (a burst of brain activity that often causes involuntary shaking) like activity- unresponsive. CRNA 2 Attempt chin thrust (lifting the into a position to open the airway) to open air ... no change in respiratory status. Pulse ox unable to get accurate read due to patient movement. Oral pharyngeal airway placed, and patient bagged with no improvement. Narcan was given- no improvement. Decision was made to intubate at bedside. Writer grabbed supplies and notified other staff of event. Crash cart was pushed to bedside. Patient started to Brady (bradycardia - slowing heart rate) down in 30’s, (bpm) atropine given, pulse was checked, and none found ... [at]3:02 p.m., Code blue called, and CPR (Cardiopulmonary resuscitation - chest compressions to try to restart the heart and air forced into the lungs to help the patient breath) initiated ... [at]3:17 p.m., pronounced dead. Code ended. During an interview on 7/31/24 at 1:35 pm. with the Director of Risk Management, Regulatory, and Patient Safety (RMD), Pt 1’s death was discussed. Pt 1 was in restraints at the time of death, and death occurred within minutes after being given sedative medication. The RMD stated, “We did not report this incident.” RMD stated the case was reviewed and it was decided that they would not report. During a review of hospital policy titled, “Adverse Event Reporting to the California Department of Health Services,” dated 01/03/2022, the policy indicated, “ PURPOSE: A. to comply with the mandated reporting requirements of health and safety code 1279. B. to support the improvement of patient safety and quality improvement initiatives. II. Definitions a period adverse event includes any of the following... 23. A patient death or serious disability associated with the use of restraints or bedrails ...” During a review of hospital policy titled, “Restraint and Seclusion,” dated 6/08/2023, the policy indicated, “ ...V. DOCUMENTATION A. Document the following information in the EHR for each restraint or seclusion episode:... 9. Death associated with the use of restraint or seclusion and time and date reported to Centers for Medicare and Medicaid Services (CMS) or recorded in the hospital log.... B. Reporting of Deaths - 2. [name of organization] facility leadership will report deaths associated with the use of seclusion or restraint to CMS. The following will be reported: ...d. Each death referenced above must be reported directly to CMS regional office by risk management. E. Risk management will report electronically using CMS 10455, by no later than the close of the next business day following knowledge of the patient’s death. Staff must document in the patient’s EHR the date and time the death was reported to CMS. The Health and Safety Code, Division 2, Licensing Provisions [1200 - 1796.70], Chapter 2 Health Facilities [1250 - 1339.59], Article 3. Regulations [1275 - 1289.5] section 1279.1. indicates: “ (a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b) For purposes of this section, “adverse event” includes any of the following: ... 5 ...(E) A patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility. The Center for Clinical Standards and Quality/Quality, Safety & Oversight Group memorandum QSO-20-04-Hospital-CAH DPU, revised January 17, 2020, indicated, “ In accordance with the requirements at 42 CFR 482.13(g), Death Reporting Requirements, all patient deaths associated with restraint and/or seclusion (except 2-point soft wrist restraints that must be recorded in an internal hospital log or other system) are required to be reported to the Centers for Medicare and Medicaid Services (CMS) Regional Locations using the Form CMS-10455, Report of a Hospital Death Associated with the Use of Restraint or Seclusion by all types of hospitals (including Psychiatric Hospitals, Rehabilitation Hospitals, Long Term Care Hospitals, Short Term Acute Care Hospitals) and Critical Access Hospital (CAH) Rehabilitation and/or Psychiatric Distinct Part Units (DPUs).” The memorandum explains the process of electronically submitting reports. During a review of Professional Reference from https://www.ncbi.nlm.nih.gov/books/NBK558963/, titled, “Adverse Events”, dated 8/2023, indicated, “ ... Adverse events (AE) frequently occur in our medical system, and at least one in ten patients are affected. An AE is a harmful and negative outcome that happens when a patient has been provided with medical care ... Treatment / Management ... Databases of reported adverse events can provide valuable information that can be used to make the necessary changes in care that can decrease or eliminate adverse events ... There has been a discussion about the under-reporting of adverse events. To promote a true culture of doing no harm, clinicians must adopt the approach of reporting all adverse events. The analysis of the information reported will determine the appropriate system management ...””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital’s governing body, medical staff and administrative officials failed to identify and act on two of two adverse events promptly. The Quality Assurance and Performance Improvement (QAPI) program did not collect data, track data, or develop or implement performance improvement measures meant to ensure the events would not re-occur when Patient (Pt) 2 was identified as having a drain (a tube to remove fluid after surgery) in her shoulder that was thought to be removed on 2/21/24, and the investigation did not begin until 4/11/24, and Pt 3 had part of a surgical glove retained in her chest after a chest tube insertion that wasn’t investigated until 3/1/24. These failures resulted in the delay in the implementation of necessary corrective measures resulting in continued risk of injury and infections to patients who received surgical procedures. Findings: During a review of Patient (Pt) 2’s “History & Physical (H&P)”, dated 2/8/24, the H&P indicated, “ ... Chief Complaint: Generalized Weakness ... History or Present Illness: ... 72-year-old ... female with Type II Diabetes Mellitus (a disease that occurs when your blood sugar is too high) and hypertension (high blood pressure) who presents with malaise (weakness), right lower extremity pain, and abnormal labs. Patient recently had a prolonged hospitalization after a pedestrian vs. automobile (accident) resulting multiple fractures (broken bones) ... [right tibia/fibula (leg) status/post ORIF (Open reduction and internal fixation is a surgical procedure for repairing fractured bone using either plates, screws to stabilize the bone), left tibial plateau fracture (broken shin), multiple sacral (bottom of the spine) and pelvic fractures, right proximal humerus (shoulder)] ... discharged to (Skilled Nursing Facility) on 2/2/24 ... Per nursing staff ... patient was more confused than usual and found to have leukocytosis (high white blood cell count) ... she received 1 dose intramuscular (in the muscle) ceftriaxone (antibiotic) prior to transport to the Emergency Department (ED) ... Hospital problems: Healthcare associated pneumonia ... Anasarca (generalized swelling of the body) ... tibia/fibula fracture ... type II diabetes ... Hypertension ...”. During a review of Pt 2’s “Consult Note (CN)”, dated 2/13/24, the CN indicated, “ ...fluid collection anterior (toward the front of the body) right ... shoulder joint ... status/post right shoulder aspiration (a procedure to remove fluid) ... Orthopedics on board and plan for Incision and Drainage (I&D- surgical procedure to release pus or pressure built up under the skin) of right shoulder today ...”. During a review of Pt 2’s “Orthopedic Surgery Operative Report (SOR)”, dated 2/14/24, the SOR indicated, “ ... Postoperative diagnosis: right humerus (upper arm bone) fracture infected hematoma ... Drains: 1 Penrose drain (a soft, flat, flexible tube made of latex. It lets blood and other fluids move out of the area of your surgery) ... Complications: none ... Condition: Stable ...”. During a review of Pt 2’s “Progress Note: Orthopedic Surgery (PNOS)”, dated 2/17/24 at 9:12 a.m., the PNOS indicated, “ ...Hospital course: ... She reports pain everywhere and it is difficult to get a story out of her. She is very ill appearing ... Patient is now status post right shoulder I&D 2/14 ... Objective: ... Right upper extremity: visual: surgical incision clean, dry and intact without surrounding erythema (redness)/edema (swelling) ... Assessment/Plan: ... She is much improved. Patient in stable condition from orthopedic perspective. No further orthopedic intervention indicated ... Drain: Penrose drain s/p (status/post) removal ... (signed) Medical Doctor/Fellow (MDF) 1 ...”. During a review of Pt 2’s “CT (a procedure where a computer linked to an x-ray machine takes detailed pictures of the inside the body) Chest Abdomen and Pelvis with Contrast”, dated 2/21/24 at 2:12 a.m., the CT indicated, “ ... Reason for exam: sepsis, worsening leukocytosis ... Findings: ... Right humeral surgical neck fracture. An internalized drain fragment measuring 8 cm (centimeter- unit of measurement) in length is positioned along the anterior margin of the fracture and does not extend to the dermis. Consider orthopedic consultation ...”. During a review of Pt 2’s “Treatment Plan- Orthopedics Update (OU)”, dated 2/21/24 at 1:09 p.m., the OU indicated, “ ...Ortho service paged regarding incidental finding of retrained surgical Penrose drain in right shoulder ... previously thought Penrose drain was removed previously given it was loosely wedged in tissue, however, it was found incidentally to have been within the subcutaneous tissue (deepest skin layer that lies closest to the muscle) on CT scan ... the finding was communicated with family (daughter) at bedside ortho service then evaluated wound at bedside no signs of gross purulence (pus). Wound clean, dry, intact. Sutures removed at bedside, 10CC’s (cubic centimeters equal to milliliters- unit of measurement) lidocaine (numbing medicine) injected into subcutaneous tissue about wound. Wound then prepped and draped in usual sterile fashion. 15 blade scalpel (small and extremely sharp bladed instrument used for surgery or dissection) used to reopen surgical wound. Kelley (forceps- surgical instrument used for holding and manipulating tissue) used to superficially spread tissue. White Penrose drain immediately visible within field and removed. Wound then irrigated (cleaned) with 1L (liter- unit of measurement) saline. Wound then closed with 4-0 (size) nylon (type of thread) suture. Wound dressed (a dressing is applied to protect the wound from complications resulting from contamination or disturbance) ...”. During an interview on 7/26/24 at 3:35 p.m., with Medical Doctor/Resident (MDR) 1, MDR 1 stated he was a first-year resident at the time of the incident. MDR 1 stated he and MDF 2 “did the procedure”. MDR 1 stated if they drain was not found incidentally by CT, the drain “might just stay in there and scar”. MDR 1 stated if an infection did arise from the drain left in the shoulder, it wouldn’t be “overly surprising”. MDR 1 stated from his OU, it did not appear that informed consent was documented. The MDR 1 stated he did not feel informed consent was necessary because it was “a very brief superficial intervention”. MDR 1 stated he did not think “anything should have been done differently”. During an interview on 7/26/24 at 4:15 p.m., with MDF 2, MDF 2’s interview on 6/7/24 at 3 p.m., was validated, the MDF 2 stated he “supervised” MDR 1 completing the bedside procedure. The MDF 2 stated “the biggest error was I charted status post-removal, and I didn’t communicate or investigate very deeply about what happened to the drain”. The MDF 2 stated that if there were not incidental CT finding of the drain, the drain could have been an “itis for infection”. The MDF 2 stated he and MDR 1, should have gotten consent from Pt 2’s family member before the bedside procedure of the drain removal. MDF 2 stated any procedure there should be risk and benefits explained to the patient or family member, regardless of “how small the risk”. The MDF 2 stated this procedure for Pt 2 could have taken place in the operating room (OR), but she was “very ill” and the risk for Anesthesia was “far greater” than the risk of a bedside procedure. The MDF 2 stated this bedside procedure was invasive because they had to “pass skin” in order to “retrieve something”. The MDF 2 stated when “someone comes at them with a knife, they need to consent that”. The MDF 2 stated this procedure should have required informed consent and charted accordingly. During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMQO stated MDF 2’s documentation should have reflected what he did or did not do. The CMO stated informed consent should have been obtained and documented for Pt 2’s bedside procedure. The CMO stated Pt 2’s rights “were not honored” by not having a documented informed consent. The CMO stated a foreign body could have potentially caused an infection. The CMO stated there was “inappropriate documentation” in this case and also “inappropriate consent”. During an interview and record review on 8/2/24 at 11:30 a.m. with the Director of Risk Management Regulatory Patient Safety (RMD), a document titled, “Apparent Cause Analysis (ACA)” was reviewed. The RMD stated an ACA was a shorter, less involved version of an RCA (Root Cause Analysis - a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions.) The document indicated the retained drain was discovered and removed on 2/21/24, and the Risk Management Department was made aware of the incident on 2/29/24. On 4/11/24 the decision was made to do an ACA for the incident. The RMD did not have a response as to why the investigation wasn’t started until 7 weeks after the error was discovered. When asked if a similar event could have occurred between the time of discovery of this incident and the time that the investigation was completed, the RMD stated there was a risk of recurrence. The ACA did not include how long (measured length) the drain was initially, outside the body. The analysis did not address whether the drain was cut off or if the entire drain tubing migrated (got sucked in) into the shoulder. There was no plan listed for how to keep the situation from happening again. In response to the thoroughness of the investigation, the RMD stated, “the investigation is sparse.” During a review of Pt 3’s “History and Physical (H&P)”, dated 11/19/23 at 8:17 p.m., the H&P indicated, “ ... 54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...”. During a review of Pt 3’s “Surgical Operative Report (SOR)”, dated 11/22/23 at 10:52 p.m., the SOR indicated, “ ... Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...”. During a review of Pt 3’s “Retained Foreign Object Picture (RFO)”, dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately 1-inch (unit of measurement) in length. During an interview and record review on 8/2/24 at 11:30 a.m. with the Dir of Risk Management Regulatory Patient Safety (RMD), a document titled, “Apparent Cause Analysis (ACA)” was reviewed. The document indicated the retained portion of a surgical glove was discovered inside Pt 3’s chest on 11/19/23, and the ACA was completed on 3/1/24, over 3 months after the event. The RMD stated the analysis of the occurrence was sparse. An intervention was put into place on 3/1/24 which included changing the color of surgical gloves used for procedures so that it would be more apparent if a surgical glove tore and part of it was retained inside the patient. The RMD stated there was a risk that the same type of incident could happen again between the time that this event occurred, and corrective measures were put into place. During a review of hospital document titled, “Performance Excellence Plan Fiscal Year 2024,” the Table of Contents included 15 pages including 4 attachments, all of which were reviewed. The document indicated, “Annual Review and Goal Setting ... Each year, [corporate name] licensed care facilities will conduct a formal review of its Quality Assurance and Performance Improvement program ... Attachment C - Root Cause Analysis - An RCA is a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions. The RCA process gives you a way to identify system vulnerabilities so that they can be eliminated or mitigated. The purpose is to find out what happened, why it happened, and determined what changes need to be made.... This team will utilize performance improvement tools listed within the Performance Excellence Plan along with root cause analysis tools (CMS, QAPI and NPSF RCA2) such as: RCA checklist, Safety Assessment Code (SAC) Matrix, Risk-based prioritization ranking vulnerabilities/events to drive resources and timelines, Triggering Questions for RCA - Drives areas of inquiry, no answers may drive 5 Whys, Interviewing Tips, Timeline, Event and Causal Flow Diagram, 5 Whys, Final Flow Diagram, Cause and Effect Diagram, Fishbone Diagram, Action Plan, Root Causes and Contributing Factors (CMS QAPI) , Measures of Success (CMS QAPI), Action Hierarchy ... Immediate actions to care for patient, ensure safety for others that could be affected. Sequester equipment, products, materials ...within 72 hours. “ The document does not include ACA as an accepted tool for the organization. In a professional article retrieved from https://journals.lww.com/pqs/fulltext/2017/05000/Improving_Apparent_Cause_Analysis_Reliability__A.7.aspx on 8/8/24 titled, “Improving Apparent Cause Analysis Reliability: A Quality Improvement Initiative,” an ACA is defined as follows: “An ACA is a limited investigation of an event with 2 purposes: to identify actions to address the problem/immediate condition and to collect event information that aids in the identification of organizational trends.2 The ACA format gives structure to learning and understanding about the event and facilitates the construction of an action plan to prevent recurrence.3 ACAs typically focus on events that result in no harm, minimal harm, and near miss events that occur in discrete work settings and conventionally do not cross boundaries.””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 38764 Based on observation, interview, and record review, the hospital failed to ensure nursing staff updated and developed individualized care plans related to wound care management, chest tube (flexible tube placed into the chest acting as a drain) care, and elopement ( the act of leaving a healthcare facility without authorization and without being noticed, and may be a danger to themselves or others) risk for five of five sampled patients (Pt 28, 31, 32, 33, and 45) as evidenced by the following: 1. Nurses did not develop an individualized care plan for Pt 28’s chest tube care and management. 2. Nurses did not update and include Pt 45’s right buttock and sacral (near the lower back and spine) wounds in the care plan. 3. Nurses did not develop care plan interventions to address use of patient monitor for Pts 31, 32 and 33. These failures had the potential to cause inconsistent delivery of care which can result in the decline or lack of improvement of the patients’ health condition. Findings: During a review of the hospital’s policy and procedure (P&P) titled “Interdisciplinary Plan of Care” dated 10/12/23, the P&P showed to “... initiate the Plan of Care based on the patient’s comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders.” 1. During a review of Pt 28’s “Hospitalist (a physician who works exclusively in a hospital to care for inpatients) History & Physical (H&P)” dated 7/17/24 at 12:02 a.m., the H&P indicated Pt 28 was admitted to the hospital on 7/16/24. The H&P indicated Pt 28 was a transfer from an acute care hospital for a “ ...higher level of care ...with pulmonology (a branch of medicine that specializes in treating the respiratory system) for intervention of subcutaneous emphysema (a condition that occurs when air or gas gets into the tissues under the skin) with the history of 2 chest tubes (a flexible, hollow plastic tube that is inserted into the chest cavity to drain air, blood, or other fluids) to drain his right-sided pneumothorax (a condition that occurs when air leaks into the space between the lung and chest wall).” During a review of the “Nursing communication (Order 418124647” at 7/16/24 at 1053 p.m., the “Comments” indicated to “place chest tubes back to suction ...” During a review of Pt 28’s “LDA (Lines/Drains/Airways) Documentation” flowsheet dated 7/23/24 at 8:30 a.m., the documentation showed Pt 28 had right lateral (side) and right anterior (front) chest tubes. During an observation on 7/23/24 at 09:35 a.m. at Pt 28’s bedroom, the chest tube drainage system was observed on the floor. There were two tubes connected from the patient to the drainage system. The collection chamber showed approximately 60 ml (milliliters) of serosanguinous (contains or relates to both blood and the liquid part of blood) fluid. During a concurrent interview and record review on 7/26/24 at 10:33 a.m. with Director 6, Pt 28’s “Care Plan Audit Trail” dated 6/30/24 to 7/29/24 was reviewed. The “Care Plan Audit Trail” showed there was a care plan problem initiated for “Problem: Gas Exchange (the exchange of oxygen and carbon dioxide between bloodstream and the lungs) - Impaired” on 7/17/24. However, there was no documented evidence showing an individualized care plan was developed to address Pt 28’s chest tube management and care. When asked to show the care plans for Pt 28’s chest tubes, Director 6 verified the care plan was not developed. Director 6 stated the care plan should have been initiated on admission and show the current interventions. 2. During a review of the hospital’s P&P titled “Pressure Injury (sores [ulcers] that happen on areas of the skin that are under pressure) Risk Assessment, Prevention, Staging (categorizing into four stages based on the depth of skin damage), and Treatment” dated 8/11/22, the document indicated under “Documentation” to “ ...update patient care plan to incorporate pressure injury prevention strategies, interventions and individual patient care treatments/needs.” During a review of Pt 45’s “History and Physical” dated 7/4/24 at 6:10 p.m., the H&P indicated Pt 45 was admitted to the hospital on 7/4/24. The H&P indicated “since 3/2024 she has had multiple admissions with sepsis due to UTI [Urinary tract infection- a serious condition in which the body responds improperly to an infection], pyelonephritis [a bacterial infection causing inflammation of the kidneys], pressure ulcer [Damage to an area of the skin caused by constant pressure on the area for a long time] complications and failure to thrive. Her last admission was from 6/20 - 7/2/24. She had wound consult with application of wound vac [vacuum-assisted closure therapy to help wounds heal] for the pressure ulcer.” During a review of Pt 45’s “LDA Documentation” flowsheet dated 7/4/24, the document indicated Pt 45 had wounds on the sacrum (large, triangle-shaped bone in the lower spine that forms the part of the pelvis) and right buttock upon admission. During a review of Pt 45’s “Order” dated 7/11/24 at 10:30 a.m., the order indicated Pt 45 had a right buttock wound. The “Comments” showed the following: “1. Cleanse the wound bed by moistening gauze with Vashe [wound cleaner] and lay in wound bed for at least 3-4 minutes. Then pat dry. 2. Next apply no sting barrier film (a skin protectant or prep used to protect the skin from mechanical injury and moisture) to the periwound [the surrounding area of the wound edge] skin. 3. Cut small piece of Therahoney [type of dressing] Sheet to the size of slough [outer layer] in the wound bed and place over slough avoiding peri wound. 4. Cover with silicone foam bordered border (a type of dressing with a soft silicone layer that borders the dressing and forms a seal around the wound) dressing. 5. Change the dressing every 3 days and as needed for soilage, saturation over 75% and/or dislodgement [the action of something moving or being removed from a fixed position, for example inside the body] by bedside nurse.” During a review of Pt 45’s “Negative Pressure Wound Therapy (a treatment that uses subatmospheric [pressure that is lower than atmospheric pressure] pressure to help wounds heal) Non-Instillation 2 Wounds Associated (Order 418261811)” dated 7/21/24 at 3:28 p.m., the order indicated Pt 45 had a sacral wound. The “Comments” indicated the following: “May apply collagen (natural protein that plays a vital role in wound healing) to wound bed. If bedside nurse is unable to correct via troubleshooting, and/or is unable to change independently, and/or the wound specialist is unavailable to change within 2 hours, bedside nurse to discontinue the wound vac and place a normal saline (a mixture of salt and water with a salt concentration of 0.9%) wet to moist ( type of dressing used to keep the wound moist which uses a primary dressing that touches the wound and a secondary dressing that covers it) dressing. Change the dressing twice a day and as needed for saturation >75% and/or dislodgement until wound vac is replaced.” The “Order Questions” showed to use a low intensity of 125 mmHg (millimeters of mercury - a unit of pressure generated by a column of mercury that is one millimeter high). During a concurrent interview and record review on 7/25/24 at 1:47 p.m. with Educator 7, Pt 45’s “Order” dated 7/11/24 at 10:30 a.m. and “Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)” dated 7/21/24 at 3:28 p.m. were reviewed. Educator 7 verified Pt 45 currently had healing Stage 4 (the most severe type characterized by full-thickness tissue loss that exposes bone, tendon, or muscle, and the surrounding tissue may begin to die) wounds on the right buttock and sacrum. Educator 7 stated both wounds were present on admission and were treated separately as per the physician’s orders. Educator 7 stated the right buttock wound was treated with Therahoney, and the sacral wound was treated using a wound VAC. During a concurrent interview and record review on 7/26/24 at 9:36 a.m. with Manager 4 and Director 9, Pt 45’s “Care Plan Audit Trail” dated 6/26/24 to 7/25/24 was reviewed. The “Care Plan Audit Trail” indicated there were care plan problems initiated for “Risk of Impaired Skin Integrity” on 7/4/24, “High Risk for Skin Integrity Impairment” on 7/5/24, and “Pressure Injury Care and Treatment” on 7/9/24. The care plans listed the goals and interventions. However, there was no documented evidence showing the care plan was updated to indicate the care, goals, and interventions for Pt 45’s healing Stage 4 wounds on the right buttock and sacrum. When asked to show the care plans for Pt 45’s wounds, Director 9 verified the care plan was not updated. Director 9 stated the expectation was for the staff to include all current interventions for each wound in the care plan. 3. During a concurrent observation of Room A and interview on 7/23/24 at 10:38 am with RN 8, RN 8 acknowledged Pts 31, 32 and 33 were in Room A and the patients were at risk for elopement. RN 8 explained there was one patient monitor assigned to Pts 31, 32 and 33 who was closely monitoring the patients due to the risk for elopement. During an interview on 7/23/24 at 10:33 am was conducted with Patient Care Technician, the Patient Care Technician acknowledged the technician was assigned to observe closely Patients 31, 32, and 33 at all times. The Patient Care Technician was asked the reason of observing Pts 31, 32, and 33. The Patient Care Technician stated the patients were at risk for elopement and could lead to a potential harm. During a concurrent interview and concurrent record review on 7/25/24 at 2:50 pm with the Director 9, Director 9 acknowledged the above findings. The Director explained patient monitor was the same as a patient sitter. Director 9 stated patient monitor should be included in the care plan interventions for Pts 31, 32 and 33.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 22968 Based on observation, interview and record review, the hospital failed to ensure nurses followed policies and procedures for 16 of 16 patients (Patient [Pt] 1, Pt 9, Pt 10, Pt 28, Pt 29, Pt 31, Pt 32, Pt 33, Pt 37, Pt 38, Pt 39, Pt 40, Pt 46, Pt 66, Pt 67 and Pt 70) when: 1. Emergency Department (ED) nurses assigned to care for Pt 1 did not provide the level of care for which Pt 1 was admitted and did not follow physician orders and did not follow criteria for admission to the Special Care Unit (SCU - a secure, restricted area in the ED for behavioral patients) in accordance with hospital policy and procedure. Pt 1 was brought in by ambulance into the Emergency Department on 7/10/24, provided an appropriate medical evaluation and the ED physician determined the need to admit as an inpatient for telemetry (patients with chronic cardiac conditions are monitored remotely using medical equipment) level of care on 7/10/24 at 10:17 p.m. The hospitalist (a physician who works exclusively in a hospital to care for inpatients) who admitted Pt 1 to telemetry level of care ordered intravenous (IV- administered into a vein) fluids, medications, cardiac monitoring (a way of watching the electrical activity oof the heart to ensure it is working normally) and frequent vital signs on 7/10/24 at 11:39 p.m. The hospitalist ordered CPCU (Cardiac Progressive Care Unit) telemetry level of care for Pt 1. Pt 1 remained in the ED for a CPCU telemetry inpatient bed to open up. Nurses in the ED discontinued the IV and cardiac monitor on 7/11/24 around 6 p.m. without first notifying the physician and did not adhere to policies and procedures meant to provide CPCU telemetry level of care. Nurses moved Pt 1 into the Special Care Unit of the ED without first determining if Pt 1 met the criteria for admission to the SCU and without first notifying the physician. While in SCU, Pt 1 was without an IV and cardiac monitor and nurses did not provide assessments, cardiac monitoring and care in accordance with policies and procedures for CPCU telemetry level of care. These failures resulted in nurses inappropriately moving Pt 1 to the SCU, not providing telemetry level of care, and not noticing Pt 1 was on the floor next to his gurney/bed in the SCU for several minutes around midnight 7/12/24. Licensed Vocation Nurse (LVN) 1 was called to the room, turned Pt 1 face up, noted a large pool of blood on the floor and coming from his mouth and immediately started CPR (cardiopulmonary resuscitation - an emergency lifesaving procedure performed when the heart stops beating). The rapid response team was called, Pt 1 was then moved to the trauma room in the ED where CPR continued until Pt 1 was pronounced dead at 12:44 a.m. on 7/12/24. Because of the possible avoidable death of Pt 1 and the serious potential harm related to not following policies and procedures meant to provide Pt 1 CPCU telemetry level of care and nurses not following policies related to criteria for admission to the SCU, an Immediate Jeopardy (IJ- a situation where a provider’s noncompliance with requirement has, or could, cause serious harm to resident)situation was called on 7/26/24 at 1 p.m. with the Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Director of Nursing Operations (DNO) under A398, CFR 482.23(b)(6). The CMS form IJ Template was provided to the hospital and instructions were given to submit a Plan of Removal (PoR) to address the IJ situation. Version 1.1 of the PoR (Version 1 was rescinded by the hospital) was submitted and determined to be unacceptable on 7/29/24 at 10:35 p.m. PoR Version 2 was submitted and acceptable as of 7/29/24 at 2:25 p.m. The survey team validated all actions on the PoR were implemented and the IJ was removed on 7/30/24 at 9 a.m., while onsite, with CNO, COO and DNO. After removal of the IJ, the hospital remained in substantial non-compliance. 2. Nurses in the Cardiovascular (relating to heart and blood vessels) Intensive Care Unit of Hospital B did not date control solutions for two of four sampled glucometers in accordance with hospital policy and procedure and manufacturer instructions (glucometer -- a device for measuring the concentration of glucose in the blood; control solutions - a liquid used to test the functionality of meter and strips). This failure had the potential for glucose testing to be inaccurate for patient samples being used with the expired controls. 3. Nurses in the ED did not develop, implement and update a current nursing care plan (a patient-centered health document designed to facilitate communication among members of the care team and with the patient) for six of six patients (Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40) in accordance with their policy and procedures (P&P) titled “Admission & Ongoing Assessment - Nursing (Acute Care)” and “Interdisciplinary Plan of Care”. These failures had the potential for the needs of Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40 to go unmet. 4. Nurses assigned to one of four sampled patients in the ED (Pt 66) for Hospital A did not perform vital signs (measurements of the body’s most basic functions) and pain assessments and monitoring in accordance with hospital P&P. These failures had the potential for Patient 66’s health to decline and/or continue to have unrelieved pain and no further interventions implemented to decrease the patient’s pain. 5. Nurses in the ED assigned to care for Pt 67 did not follow monitoring protocol in accordance with physician order, hospital P&P and Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar-an instrument used by medical professionals to assess and diagnosis the severity of alcohol withdrawal (symptoms that may occur when a person who has been drinking too much alcohol on a regular basis suddenly stops drinking alcohol)). This failure had the potential for Patient 67’s signs and symptoms of alcohol withdrawal to go undetected and result in worsening health and death. 6. Nurses in the ED stored empty oxygen tanks in the cage reserved for full oxygen tanks and not accordance with hospital policy and procedure and professional standard. This failure resulted in the potential harm of full oxygen tanks not being readily available for patient use. 7. Nurses in the ED assigned to Pt 70 did not label Pt 70’s inhaler in accordance with facility policy and procedure. This failure resulted in the potential of administering the wrong medication to the wrong patient. 8. Nurses assigned to Pt 28 did not assess Pt 28’s chest tubes within two hours of admission as per the hospital’s P&P titled “Standards of Practice - Acute Medical/Surgical, Telemetry, Step-Down (area that provides intermediate-level care between the Intensive care unit and the general medical-surgical wards) and Critical Care Units” dated 2/22/23. This failure had the potential to place Pt 28’s safety at risk and possibly not meet Pt 28 healthcare needs. 9. Nurses assigned to Pt 29 and Pt 46 p performed electroencephalogram (EEG) monitoring while the patients were in a medical-surgical nursing unit and not in accordance with hospital policy and procedure. These failures had the potential to place Pt 29 and 46 at risk of complications for EEG. 10. Nurses caring for Pt 31, Pt 32 and Pt 33 did not ensure the assigned patient monitor (or a sitter) did not exceed two patients in accordance with hospital policy and procedure. This failure had the potential to place patients’ safety at risk of negative health outcomes. Findings: 1. Record review of the hospital’s Facility Reported Incident (FRI) submitted to the California Department of Public Health on 7/16/24 indicated the following: “We are self-reporting a significant event for the Community Regional Medical Center (CRMC) Emergency Department (ED): On 7/10/24 at 19:44 PM [7:44 p.m.], 62-year-old conserved male patient with past medical history of schizophrenia [a serious mental illness that affects how a person thinks, feels and behaves], substance abuse, smoker, brought in by ambulance on 7/10/24 at 1944 from skilled nursing facility for weakness x [times] 3 days and unsteady gait resulting in a fall, and low blood pressure. Labs showed hemoglobin [a protein inside the red blood cells that carries oxygen from the lungs to the tissues and organs in the body and carries carbon dioxide back to the lungs] of 6.5 [normal range 13.5-17.5g/dl (grams per deciliter - unit of measure)], stool [the solid matter excreted during a bowel movement] negative [result] for occult blood [blood in the stool that is not visible to the naked eye], and CT [computerized tomography - is a specialized imaging equipment that produces 3-dimensional images] head negative. Patient was treated for low blood pressure, blood products transfused (therapeutic substances derived from human blood that are critical to health care transferred from one person to another), and patient admitted to CPCU (Cardiac Progressive Care Unit) Telemetry level of care with continuous cardiac monitoring. Cardiac monitoring placed on 7/11/24 at 1045 (10:45 a.m.): normal sinus rhythm (the normal rhythm of a healthy human heart characterized by a regular rate), slight tachycardia (a heart rate faster than 100 beats per minute) in low 100s. Hemoglobin increased to 7.2 and then 8.11. Blood pressure also increased to systolic (the blood pressure when the heart is contracting; normal pressure is at or lower than 120) of 100s to 120s/ diastolic (the pressure in the arteries when the heart rests between beats; normal pressure is at or lower than 80) of 60s - 70s. On 7/11/24 at 2012 (8:12 p.m.), decision was made to move patient to Special Care Unit (SCU) as he was conserved and was considered an elopement (the act of leaving a healthcare facility without authorization and without being noticed and may be a danger to themselves or others) risk. On 7/12/24, just after midnight, patient laid down on floor (did not fall, purposely laid down on floor). A few minutes later, a large amount of blood came from patient’s mouth onto the floor. Security notified nursing, CPR was immediately started, patient moved to gurney, then to red zone (a zone for patients with more complex issues that may require resuscitation and ongoing medical care, or closer observation) for ACLS (advanced cardiac life support - a set of clinical guidelines established for the urgent and emergent treatment of life-threatening cardiovascular conditions). 3 units (1 unit approximately 350 milliliters) Packed Red Blood Cells (PRBCs - prepared from the whole blood by removing plasma [liquid component of blood that contributes to 55% of blood’s total volume) given emergently, return of spontaneous circulation (ROSC - the resumption of a sustained heart rhythm and circulation after cardiac arrest) was not achieved, and patient was pronounced deceased at 0044 (12:44 a.m. 7/12/24). Hospitalist and conservator notified. Upon review, we found that the cardiac monitoring was removed on transfer to SCU without a physician review/order. We have identified opportunities for improvement and we are reporting out of an abundance of caution and transparency. We met with our Leadership and implemented immediate action items to address the identified opportunities and next steps. We will conduct an RCA (Root Cause Analysis) and continue to review potential gaps and continue to develop appropriate action items.” During a concurrent observation and interview on 7/22/24 at 10:15 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the tour of the ED included a tour of the Special Care Unit (SCU). DED stated the purpose of the SCU is to care for patients that require a safe, stripped-down area (hazards are removed) and nursing care to address mental health needs and manage behavioral problems. DED stated the rooms are completely stripped, meaning in the room there is a gurney/bed and that is it; there are no countertops or sinks. DED stated patients that have suicidal ideation (thoughts of killing oneself), or aggressive behaviors are taken care of in the SCU. The SCU patient may be on “a hold such as 5150 (a temporary, involuntary psychiatric hold - a legal process that allows someone to be detained in a psychiatric facility against their will if they are experiencing a mental health crisis and are considered a danger to themselves or others) of individuals who present a danger to themselves or others).” DED stated the SCU does not take care of any patients requiring cardiac monitoring or intravenous (IV) fluids or IV medications. DED explained the SCU is configured into five rooms (1, 2, 3, 4 and 5) and seven (7) hallway beds (A, B, C, D, E, F, G) for a total capacity of 12 patients. Hall beds can be moved as needed to meet patient needs (into room 5 or between hall beds B and D). Rooms have nothing inside except the bed the patients are on. DED stated SCU patients are admitted to the SCU and are placed in burgundy paper scrubs (paper scrubs- or disposable scrubs, are single-use garments made from lightweight, non-woven materials) then all property, including cell phones, are removed, inventoried and secured by a Security Guard (SG). DED stated Room 4 has built-in cabinets or lockers for this purpose. DED stated nursing personnel are located inside the locked unit, in an enclosed, badge-entry only nurses’ station. The nurses’ station is encased with clear plastic windows that separate patient areas from staff area. SCU is staffed by two (2) licensed nurses LNs (one Registered Nurse (RN), one LVN, one Patient Observer (PO) and one SG who is stationed out in the hallway at the locked unit entry door. The Yellow zone (where emergent ED patients are treated) Team Lead (TL) is the supervising RN for the SCU. If patient safety concerns are present, the SCU may staff a 1:1 sitter (one staff per patient) to ensure patient safety. POs are seated at the nurses’ station where they are assigned to continuously observe patient activity on 2 video monitoring screens. PO can view the activity of up to 12 patients (each patient is sectioned off into sectors by location (room or hallway) on the 2 video screens). PO can only be relieved for breaks, lunches, etc. by another PO or similarly trained employee. The PO is not to leave the monitors for any reason and does not go into patient area. The PO is responsible for completing an “Emergency Department 24 Hour Continuous Observation” log on which PO documents patient activity every 15 minutes, one log for each patient in the SCU. The PO alerts SCU nurses to any change in patient behaviors for licensed nurse intervention and may call for additional help by pressing a red button located on the wall to the right of the PO’s workstation. During a concurrent interview and record review on 7/23/24 at 9:30 a.m. with Director of the Emergency Department (DED), Manager of the ED, (MED 1, day shift) 1 and MED 2 (night shift), DED stated the self-report submitted by the hospital to CDPH on 7/16/24 regarding the unexpected death of Pt 1 was basically accurate except that Pt 1 was moved to SCU at 6 p.m. rather than 8 p.m. DED stated and confirmed the hospitalist admitted Pt 1 to CPCU telemetry level of care with physician orders on 7/10/24 at 21:56 (9:56 p.m.). The DED stated and confirmed the clinical record did not include a physician order to discontinue the cardiac monitor and IV. DED stated there was no physician order to discontinue the CPCU telemetry level of care. DED stated and confirmed that at the time Pt 1 was moved to SCU, nursing staff discontinued the cardiac monitor and IV without first notifying the physician. DED stated criteria to admit to SCU does not include a patient requiring CPCU telemetry level of care, such as Pt 1. DED stated Pt 1 did not meet the criteria to be admitted to the SCU. DED stated the SCU is an extension of the ED and is a restricted unit for patients with safety risks or behaviors that can best be handled in the SCU. DED stated, “ ...because of this, we go through extensive review to determine the need to admit to SCU. The norm did not occur with [Pt 1].” DED stated Pt 1 was an outlier and not the norm for SCU and Pt 1 should not have been moved to the SCU. DED stated nurses were aware of the inpatient status of Pt 1 and a RCA was started but not completed, as of yet. DED stated immediate measures to correct identified gaps of care included training, following physician orders, not discontinuing services without a physician order and following the escalation process to supervisors and managers. DED, MED 1 and MED 2 stated they were aware inpatients in the ED required the level of care for which they are admitted; for example, Pt 1 was admitted for CPCU telemetry and required CPCU telemetry level of care in the ED. During a concurrent interview and record review on 7/23/24 at 3:30 p.m., with Licensed Vocational Nurse (LVN) 1, LVN 1 stated he has worked at the hospital for 6.5 years, only in the ED. LVN 1 stated he worked in the SCU and other areas of the ED. LVN 1 stated he was familiar with Pt 1’s case and was the nurse assigned to Pt 1 the night he died. LVN 1 stated Pt 1 was cooperative, alert and talkative and in no distress when he assessed Pt 1 at the beginning of his shift, which was 7 p.m. on 7/11/24. LVN 1 stated he was not aware Pt 1 was in the red zone and moved to the green zone and was not involved in the decision to move Pt 1 to SCU. LVN 1 stated he was unaware Pt 1 was ordered to have CPCU telemetry level of care. LVN 1 stated and confirmed Pt 1 was not on a cardiac monitor and no IV because the SCU did not support that level of medical care. LVN 1 stated there was no other nurse in the SCU the night of 7/11/24 and he had six assigned patients including Pt 1. Prior to being called to Pt 1’s room, LVN 1 stated the last interaction was about 9 p.m. to provide oral medications and vital signs. LVN 1 stated the vital signs were normal and Pt 1 was alert and cooperative. LVN 1 stated a few minutes after midnight on 7/12/24, he was alerted by the Security Guard to go to Pt 1’s room because Pt 1 was on the floor next to his gurney/bed, facedown with a small amount of blood. LVN 1 stated when he went to Pt 1’s room, Pt 1 did not respond to his name, and then turned Pt 1 over face up and noticed a large amount of blood on the floor and coming from Pt 1’s mouth. LVN 1 stated Pt 1 did not have a pulse and immediately started CPR. LVN 1 stated the rapid response team came and continued the CPR and transported Pt 1 to the ED Trauma room. LVN 1 stated CPR was unsuccessful and Pt 1 died. When asked what he would do differently if confronted with similar occurrence, LVN 1 stated he would review the past medical history more thoroughly including the reason to admit to the SCU and escalate concerns to his supervisor. LVN 1 stated he was aware Pt 1 was admitted as an inpatient but was not aware the cardiac monitor was discontinued without first notifying the physician. LVN 1 was aware Pt 1 was moved from the green zone to SCU but was not aware Pt 1 was first treated in the red zone. During an interview and viewing of video recording on 7/24/24 at 2 p.m. with DED and MED 2, the video recording was without audio and began with viewing Pt 1 in the SCU on his gurney/bed. The video recording started on 7/11/24 at 11:08 p.m. Shortly after the viewing started, Pt 1 was on his gurney/bed and appeared to be turning from one side to another, sitting up in bed, and back down again. This back and forth behavior occurred many times for the next 30-45 minutes. At one point Pt 1 placed his feet on the floor while sitting on the gurney and then went back to lie down. At around midnight 7/12/24, Pt 1 was viewed face down on the floor next to the gurney. Several minutes passed before the security guard looked in on Pt 1 and then tapped on the security window which enclosed the nurse’s station. Soon after LVN 1 appeared on the video, went beside Pt 1, turned him over, and a large pool of blood could be seen on the floor. LVN 1 immediately started CPR and soon after a team of nurses entered with a gurney and continued CPR and transported Pt 1 out of view of the video recording. That was the end of the viewing of the video recording. DED was asked if a cardiac monitor was on Pt 1 would that have helped identify a change of condition in Pt 1 and DED stated yes. During an interview on 7/24/24 3:15 p.m. with RN 9 and DED, MED 1 and MED 2, RN 9 stated she has worked at the hospital as an RN for 3 years and works only in the ED. RN 9 stated she was familiar with Pt 1’s case and was assigned to Pt 1 at the end of her shift on 7/11/24. RN 9 stated her shift is 7 a.m. to 7 p.m. RN 9 stated she was assigned to the SCU on 7/11/24. RN 9 stated the decision to move Pt 1 to SCU had already been made by the lead RN in the green zone, RN 10, and the clinical supervisor for the ED, CS 1. RN 9 stated she was aware Pt 1 was an inpatient but did not know CPCU telemetry level of care was ordered. RN 9 stated by the time Pt 1 was assigned to her, Pt 1 no longer had a cardiac monitor and she removed his IV in order to comply with the safety rules for SCU. RN 9 stated she did not notify the physician prior to discontinuing the IV. RN 9 stated that her assessment of Pt 1 indicated he was alert, cooperative and had not received any IV medications and Pt 1’s vitals signs were stable. RN 9 stated she was aware what happened to Pt 1 and had died. RN 9 stated she should have questioned the move of Pt 1 to the SCU but did not. RN 9 stated she was told because Pt 1 was “conserved” he fit the criteria for SCU. RN 9 stated in the future she would escalate concerns to the supervisor or manager if needed and would always double check information in the patient’s electronic health record (HER) and to strictly follow physician orders. During an interview on 7/24/24 at 4:15 p.m. with Clinical Supervisor (CS) 1, DED, MED 1 and MED 2, CS 1 stated he has been an RN since 2001 and a supervisor in the hospital ED for the past 8 years. CS 1 stated his role was to manage the flow of ED patients, address concerns and to elevate issues, if needed. CS 1 stated he reports to the MED 1 and to DED. CS 1 stated he was familiar with Pt 1’s case but was not the supervisor the night he died. CS 1 stated he was aware of the sequence of events that led to Pt 1 moving to SCU. CS 1 stated that on 7/11/24 toward the end of his shift about 6 p.m., there was a large influx of patients into the ED and that he called RN 10 to find a patient who is stable and “on hold” to move to the SCU. CS 1 stated the purpose of moving a patient from the green zone (area where the patients are in a stable condition) to SCU was to free up a yellow or red zone bed in order to evaluate patients coming into the ED. CS 1 stated he was unaware Pt 1 was CPCU telemetry level of care and that the physician was not called prior to moving Pt 1. CS 1 stated he did not review Pt 1’s EHR (electronic health record - an electronic version of a patients medical history that is maintained by the provider over time and may include all clinical data relevant to the person) to familiarize himself with physician orders and the reason for admission to the hospital at the time Pt 1 was moved to SCU. CS 1 stated he was aware Pt 1 was waiting for an inpatient bed. CS 1 stated he was aware Pt 1 was conserved and was assessed as clinically stable. CS 1 stated he was aware of what occurred to Pt 1 and that he died. CS 1 stated he expected nurses to report accurate information to him in order to make safe decisions. CS 1 stated in the future he will double check information from RNs and would escalate concerns to managers as needed. CS 1 stated the problems that occurred with Pt 1 included miscommunication from RN to RN, not following physician orders and not escalating concerns to supervisors and managers. During an interview on 7/25/24 at 9:40 a.m. with interview with Director of Inpatient Cardiovascular Services (DCVS) and Manager CPCU (MCPCU), DCVS and MCPCU stated they were not aware of Pt 1’s case. DCVS and MCPCU stated the expectation for patients requiring CPCU telemetry level of care is that nurses should follow physician orders and not to discontinue cardiac monitor without first notifying the physician. DCVS and MCPCU were unaware of the number of inpatients in the ED requiring CPCU telemetry level of care. DCVS and MCPCU stated they were available to the ED as a resource, if needed. DCVS and MCPCU stated nurses on the floor are well acquainted with the need to develop and implement care plans and follow all policies and procedures. DCVS and MCPCU stated nurses provide a level of care on the floor that meets the needs of patients and provides CPCU telemetry level of care. Once patients are admitted to the floor, DCVS and MCPCU stated nurses orient patients to the room, provide instructions on the use of equipment in the room, and explain patient rights, privacy and the expectations for nursing care. DCVS and MCPCU stated they were unaware of what ED nurses provided to inpatients in the ED. During an interview on 7/25/24 at 11:35 a.m. with RN 10 and DED, RN 10 stated she has been an RN for about 5.5 years and worked at the hospital for the entire time and has been a charge nurse for about 4 years. RN 10 stated she was familiar with Pt 1’s case and was the RN lead on the day Pt 1 was moved to the SCU. RN 10 stated her role as an RN lead in the green zone was to be a resource for RNs and to manage the patient flow and be accessible to the supervisor for changes that were needed. RN 10 stated on 7/11/24 she received a call from the CS 1 to move a patient from the green zone to the SCU. RN 10 stated the instructions provided to her was to find a clinically stable patient “on a hold” and to move the patient to the SCU. RN 10 stated Pt 1 was “conserved” and her understanding was that conserved patients were on a hold. RN 10 stated that Pt 1 was clinically stable, alert, cooperative and “talkative”, and the cardiac monitor strips were “normal” and vital signs were stable, and these were the reasons she used to move Pt 1 to the SCU. RN 10 stated she was unsure how the cardiac monitor was taken off. RN 10 stated, looking back “communication was mixed up” and Pt 1 should have stayed in the green zone and not moved to SCU. RN 10 stated physician orders should be strictly followed and the cardiac monitor not discontinued. RN 10 stated for Pt 1 the expectation would have been to provide nursing care as ordered by the physician for CPCU level of care and not to move to the SCU. During an interview on 7/25/24 at 2:21 p.m., with MED 1, MED 2, Patient Observer (PO) 1, PO 1 stated she has been a PO for 5 years, only in the ED, only for this hospital. PO 1 stated she was familiar with Pt 1’s stay and that he died. PO 1 stated she received training and an orientation for the role of PO. PO 1 stated escalation of behavior and de-escalation techniques training was completed through the facility computer-based learning training and she does not require certification for the role. PO 1 stated her job is to notify nurses if patients behave in a manner that may harm themselves. Her role is to watch the monitor which has a video feed for each of the rooms and patient areas in the SCU. PO 1 stated that on the night of the event she was stationed at the PO monitor station in the locked nurses station. PO 1 stated at the time Pt 1 was on the floor, she was giving hand-off to a fellow worker for break. PO 1 stated she was not watching the monitor at the time Pt 1 was on the floor. PO 1 stated she did not notice any behavior that night from Pt 1 that needed to be brought to the attention of nurses. During an interview on 7/31/24 at 2:19 p.m., with Medial Doctor Hospitalist (MDH), MDH stated he works from 7:00 a.m. to 7:00 p.m. (12-hr shift). MDH stated he is familiar with Pt 1’s case. MDH Stated P1 needed to be on a cardiac monitor, as indicated by order placed, and he expected that any patient with an order for a cardiac monitor would be placed on the monitor as possible and remain on the monitor. MDH stated he was not notified by staff that the patient was not on a monitor for more than 4 hours; his expectation is that they are “supposed to tell me ... They [nurses] are supposed to reach out to me to ask if patient could be downgraded to the Medical Surgical floor level, where he would not need the cardiac monitor.” MDH stated he has seen patients in the SCU area before. They are kept safe in the SCU until they go to a psychiatric facility. MDH stated as a provider, and interested in quality care for patients, it is his expectation that he would be notified before the nursing team made the decision to discontinue the cardiac monitoring and IV. MDH stated he did not discontinue the orders. MDH stated that if he was called to discontinue the monitor that night, he would have denied the request for Pt 1 to be downgraded. During an interview on 8/2/24 at 12:05 p.m., with the CNO and DNO, CNO stated it is his expectation that staff follow policy on orders and standards of care for each unit. The CNO stated his expectations for care plans include ensuring that education has been done and are ensuring that the care plans are pt specific, expectation is the staff will follow the plan and policy to provide safe care, continuity of care and are meeting the patient needs. The CNO stated harm can occur if DC (discharge) is done on admission, not documented, and planned will delay the DC care and the other IDT (interdisciplinary team - a group of healthcare professionals from different disciplines who work together to provide specialized care to patients) members to ensure patient care is being provided and patient education is provided as needed during the stay; goals, wounds skin assessments, turning/offloading, etc. Needs to be updated/current to provide consistent care. During a review of the facility’s (P&P) titled, “Provider Orders”, dated 8/25/23, the P&P indicated “ ...III. Policy A. Orders may only be given by members of the [GACH - General Acute Care Hospital] physicians and Advance Practice Providers (APPs - healthcare professionals who have graduate-level education and additional training, and are board certified in the state where they practice) who are privileged to do so within their scope of practice ...B. Physician’s orders must be obtained on all patients prior to initiating treatments or therapies ...L. The licensed personnel will clarify with the prescriber any order that would be contraindicated [anything, including a symptom or medical condition, that is the reason for a person to not receive a particular treatment or procedure because it may be harmful] based on patient’s current condition, diagnostic test results, or medical history ...Q. The RN is to notify the Clinical Supervisor/Manager when unable to follow an order due to a lack of equipment and/or supplies ...R. Questions and concerns regarding carrying out physician’s orders ...3. The RN, LVN, and LPT [licensed physical therapist] are health practitioners and must act prudently to deliver optimal patient care ...” During a review of the facility’s policy and procedure (P&P) titled, “Provider Notification Regarding Patient Status”, dated 11/141/23, the P&P indicated “...I. Purpose To provide staff with guidelines for keeping the resident, attending physician, consulting physician and /or Advanced Practice Professional (APP) informed of the patient’s status ...III. Policy ...The attending physician/APP is to be notified by the RN: ...2. When there is a deterioration in patient condition, i.e., clinical, physical, psychological, behavioral ...6. To coordinate or clarify patient care orders ...VI. Documentation ...B. Document the patient’s condition change, physician notification, actions taken, and the patient’s response in the EHR ...” During a review of the facility’s guidelines titled, “Special Care Unit Guidelines”, undated, the guidelines indicated ...The Special Care Unit (SCU) is a locked unit within the Emergency Department (ED). This space holds up to 12 total patients. The space consists of 5 treatment rooms, 3 gurneys in the dayroom and 4 gurneys in the hallways (1,435 square feet). SCU is utilized as a care area for patients that are in psychiatric crisis that do not require complex medical treatments or devices/equipment, i.e.: IV therapy, cardiac monitoring, etc. If complex medical treatments are required, contact Team Leader or Clinical Supervisor for placement outside of the SCU. Additional mental health patients are placed in the various zones of the Emergency Department depending on medical need and available capacity.” During a review of the facility’s policy and procedure (P&P) titled, “Cardiac and Remote Monitoring - Inpatients 14 and Older”, dated 6/14/24, the P&P indicated “ ...I. Purpose A. To provide guidelines for cardiac monitoring of patients 14 and older at [GACH]. II Definitions A. Cardiac Monitoring: Continuous cardiac monitoring, which is the visualization of the electrical activity in the heart, through a portable or hardwired monitoring system with the use of a telemetry transmitter. B. Telemetry Box: Transmitter used to transmit the patient’s rhythm to a signal to a central bank of monitors. There is no physical connection between the patient and the monitor ...III. Policy ...B. Patients are to receive the care appropriate for their diagnoses or procedure including cardiac monitoring as ordered by a provider .... D. All telemetry/cardiac monitored patients are to receive continuous cardiac monitoring unless otherwise ordered by a provider ...H. Any issue identified with telemetry equipment will be escalated to the appropriate personnel (Registered Nurse (RN), Clinical Supervisor (CS) (Monitor Tech) MT, biomedical services, etc.) ...IV. Procedure A. Upon receiving a provider order for cardiac monitoring, the MT/CS/Designee will be responsible for assigning the requested cardiac monitoring box ...P. A provider’s order is required for a patient to go off the unit unmonitored ...U. A provider’s order will be obtained to discontinue cardiac monitoring when criteria is met for discontinuation ...” During a review of the facility’s policy and procedure (P&P) titled, “Standards of Practice - Acute Adult Medical/Surgical, Telemetry Step-Down and Critical Care Units”, dated 2/22/23, the P&P indicated “ ...I. Purpose ...The purpose of these standards is to outline the basic care each patient can expect to receive in the Critical Care, Step-Down/Progressive Care, Telemetry and Medical Surgical units ...III. Policy ...C. Patients shall have a patent IV access unless otherwise ordered by physician ...H. Amy patient being monitored via a portable telemetry monitor and then being switched over to the centralized monitoring system must have the following done: 1. Communication between the monitor tech and the nurse must occur before the patient is removed from monitoring ...” During a review of the facility’s policy and procedure (P&P) titled, “Admission, Discharge, Transfer: Telemetry”, dated 12/13/21, the P&P indicated “ ...I. Purpose A. To provide appropriate guidelines for patient admission, transfer, and discharge in Telemetry care units ...III. Unit Description A. Care provided to Telemetry patients is not limited by geography but is based on the needs and required interventions of the patient ...IV. Policy A. A physician’s order is required for the admission of a patient to Telemetry ...B. An order for cardiac monitoring will be required per the Standards of Practice - Acute Adult Medical/Surgical, Telemetry, Step-Down and Critical Care Units ...G. Need for cardiac monitoring is reassessed on an ongoing basis and discussed with physician per the Cardiac and Remote Monitoring - Inpatients 14 and Older Policy ...V. Procedure A. Admission Guidelines 1. All patients must have orders for cardiac monitoring and admission ...6. Special Considerations: There are many specialties within units that provide cardiac monitoring. Those units have specific competencies related to the area expertise. Patient placement is always directly related to nursing competency of the area ...VI. Documentation Document assessment, interventions, plan of care, medication prescribed/administered, and education provided in the EHR ...” During a review of the facility’s policy and procedure (P&P) titled, “Patient Assessment”, dated 6/8/23, the P&P indicated “ ...I. Purpose To define initial patient assessment and reassessment time frames and the criteria that are utilized in the assessment process by all care givers ...II. Policy ...A. All patients receiving care at [GACH] will undergo an assessment and reassessment of their needs, stability of the patient condition, and goals as a foundation for role-based provision of care ...1. The initial assessment using the nursing process will be initiated by the Registered Nurse (RN) within two hours of the patient’s admission. The information will be entered into the electronic health record (EHR) and a complete admission and plan of care will be documented within 24 hours (refer to the Admission and Ongoing Assessment- Nursing (Acute Care) and Plan of Care policies) ...C. The assessment process is ongoing throughout the patient’s contact with the health care system to ensure continuity of care ...” During a review of Pt 1’s EHR titled, “ED Note”, dated 7/11/24 at 6:55 a.m., the ED Note indicated the RN documented “Pt on wait list for tele box [telemetry box].” During a review of Pt 1’s physician orders dated 7/10/24 at 23:29 (11:29 p.m.), the order indicated “Admit to Inpatient (Order 4174383638) ...Requested Bed Type CPCU/Tele ...” During a review of Pt 1’s physician orders dated 7/10/24 at 23:39 (11:39 p.m.), the order indicated “Cardiac monitoring (Order 417438640) ...Frequency: continuous ...Duration: Until specified ...Level: Tier II: Indicated for patients that may benefit from cardiac monitoring for prognosis, not essential ...Indication(s) for monitoring: New and/or Potential for cardiac arrhythmia (a heart rhythm that isn’t normal) ...” 2. During a concurrent observation and interview on 7/22/24, at 11:30 a.m. with RN 13 and the Director of Inpatient Care (DIPC), at Hospital B, in the Cardiovascular Intensive Care Unit (CVICU), at nurses’ station, a glucometer was observed to have two vials of glucose control solution (solution use to test the functionality of meter and strips) next to Glucometer 1 with the date of 12/10/24, which is 141 days from 7/22/24. Pictures were taken of the vials. RN 13 validated the labeled discard date on the glucose control solution vials was 12/10/24. RN 13 stated the glucose control solution should be changed every three months or discarded by expiration date on the vial, whichever date was first. RN 13 stated the vials are not dated according to policy. The DIPC stated, the discard date written on the vial should be 90 days from when the vial is opened. The DIPC stated, if the date is not correct, staff could end up using solutions that are actually not according to manufacturer’s recommendations. The DIPC stated, the results from the glucometer machine could be erroneous and result in harm to a patient. During an interview on 8/2/24 at 12:05 p.m. with the Chief Nursing Officer (CNO), the CNO stated, nursing staff are expected to follow the hospital’s policies for all equipment and patient care. The CNO stated, nurses should follow the policies as it is important to patient safety. During a record review, the facility’s policy and procedure (P&P) titled, “[Brand Name of glucometer] Glucose Meter,” dated 5/16/2023, indicated,” ... Quality control testing is performed as a primary means of ensuring ongoing proper performance of the ... glucose meter system. The accurate analysis of known levels of glucose solutions ensures that the system and the operator’s technique used in testing producing accurate results for patient tests ... The open-expiration date must be documented onto liquid controls and test strips, at time of opening. ... Control Solution 1 ... Open Expiration is 90 days, or until expiration date printed on label, whichever is first ...”. During a record review, “Instructions for use Manual [IFU] [Brand Name] of Glucose Hospital Meter System” dated 8/19 was reviewed. The IFU indicated, “ ... Run 2 different levels of the [Brand Name of Glucometer] Glucose Control Solutions during each 24 hours of testing prior to testing of patient specimens Consumable items, including quality control solutions, are warranted to be free of defects until the end of the expiration date or 90 days after the date opened ...”. 3. During a concurrent interview and record review on 7/24/24, at 9:37 a.m., with the DED, MED 1, and MED 2, Pt 9’s EHR was reviewed. Pt 9’s “ED Pt Care Timeline” dated 7/24/23 indicated “ ...Arrival ...7/4/24 at 11:36 p.m. ...TT [time spent in the ED before being moved to the inpatient bed] 74:35 (hours: minutes) ...11:42 Start Triage Initiated ...Ground level fall - loss of consciousness Pain mid-cervical (neck) ...94/M [94 years old, male] ...witnessed fall by caregiver from standing in the shower this AM Patient was reported to fall back striking head on the ceramic bath tub Denies loss of consciousness ...” “ ...Past Medical History: Dizziness, follicular lymphoma (very slow-growing cancer that may appear in your lymph nodes [small, bean-shaped structures that are part of the body’s -immune system and help fight infection and disease], your bone marrow [soft, spongy tissue that’s found in the center of most bones and contains many blood vessels] and other organs), Glaucoma (a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of your eye called the optic nerve), Hearing loss, Hypertension (high blood pressure), Peripheral vascular disease (an accumulation of plaque (fats and cholesterol) in the arteries in your legs or arms), Senile macular degeneration (an eye disorder that slowly destroys sharp, central vision), wears eyeglasses ...” Care was provided in the ED with plan to admit Pt 9. On “ ...7/4/24 at 18:04 (6:04 p.m.) Place in Observation Status [admission] ...Neuro [relating to nerve and nervous system] Med Surg (Medical-Surgical floor) ...7/6/24 at 16:23 (4:23 p.m.) Order updated ...Admit to Inpatient ...7/7/24 at 13:30 [bed] Assigned: 2C MS ... [room and bed number] ...14:11 (2:11 p.m.) to department 2C Med Surg ...” Care planning activities and documentation were not present in Pt 9’s EHR reviewed. DED stated we “don’t do care plans in the ED.” During a concurrent interview and record review on 7/23/24, at 2:05 p.m., with the DED, MED 1, and MED 2, Pt 10’s EHR was reviewed. “ED Pt Care Timeline” dated 7/24/23 indicated “ ...Arrival 4/16/24 at 15:39 (3:39 p.m.) ... TT [time spent in the ED before being moved to the inpatient bed] 113:21 (hours: minutes) ... 15:40 (3:40 p.m.) Start Triage Initiated ...73 y.o. female with past medical history including GERD (a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus), CAD (a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart), ETOH (alcohol) abuse, depression, diabetes mellitus (A disease in which the body does not control the amount of glucose (a type of sugar) in the blood and the kidneys make a large amount of urine), hypertension (high-blood pressure), skin cancer, ESRD (End Stage Renal Disease- a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis [a treatment that filters the blood to remove waste products and excess fluid when the kidneys are not working properly] or a kidney transplant to maintain life) on hemodialysis [a process wherein a machine filters wastes, salts and fluid from the blood when the kidneys are unable to do this work effectively] M/W/F [Mondays, Wednesdays and Fridays], anemia (a problem of not having enough healthy red blood cells or hemoglobin to carry oxygen to the body’s tissues) and DVT (Deep vein thrombosis- occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs) who presents with altered mental status [a change in mental function] ...Patient is admitted with dx (diagnosis) of sepsis (An extreme immune response to infection that can lead to tissue damage, organ failure, or death if not treated right away) ... 4/16/24 20:29 (8:29 p.m.), Orders Placed ...Admit to Inpatient ...20:33 (8:33 p.m.) ...Patient Admit Service: Medicine Requested Bed Type CPCU Tele ...4/21/24 09:00 (9:00 a.m.) Patient admitted to department 4C CPCU ...” Care planning activities and documentation were not present in Pt 10’s EHR reviewed. DED stated we “don’t do care plans in the ED.” During a concurrent interview and record review on 7/25/24, at 9:30 p.m., with the Director of the Emergency Department (DED), Nurse Manager of Emergency department (MED 1), and Evening Nurse Manager of the Emergency Department (MED 2), and Emergency department Registered Nurse (RN 16), Pt 37’s electronic health record (EHR- digital collection of medical information) was reviewed. Pt 37’s “Hospitalist’s History and Physical (H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending)”, dated 7/22/24, “ED Track Board”, undated and “Flow Sheet”, undated, were reviewed. Pt 37’s H&P indicated Pt 37 was admitted on 7/22/24 with a history of congestive heart failure (a disease when the heart does not pump efficiently), methamphetamine induced [caused by a powerful, highly addictive stimulant that affects the central nervous system which takes the form of white odorless, bitter-tasting crystalline powder] cardiomyopathy (an enlargement of the heart), hypertension (high blood pressure), prior alcohol abuse, and medication noncompliance. RN 16 stated, Pt 37 came to the emergency room because he was “altered [altered mental status - change in mental function]”. RN 16 stated, Pt 37 was short of breath and his legs were swollen. RN 16 stated, she had started late and had not been able to get to assess Pt 37 fully yet. RN 16 stated, Pt 37 had been admitted on 7/22/24 at 12:00 p.m. and the inpatient admission requirements had not been completed nor had the care plan been completed. RN 16 stated, “we do not do that here” when referring to completing the care plan. RN 16 stated, about 9 sections of the inpatient admission requirements on the “ED Track Board” needed to be completed still. RN 16 stated, the “care plan is important to guide the care of the patient and is necessary to make sure nothing is missed.” During a concurrent interview and record review on 7/25/24, at 9:50 p.m., with the DED, MED 1, and MED 2, and Emergency department Registered Nurse (RN 15), Pt 38’s electronic health record was reviewed. Pt 38’s “Hospitalist’s History and Physical”, dated 7/23/24, “ED Track Board”, undated and “Flow Sheet (a form that gathers all the important data regarding a patient’s condition)”, undated, were reviewed. Pt 38’s H&P indicated Pt 38 was admitted on 7/22/24 with a history uncontrolled diabetes (a chronic disease characterized by elevated blood sugars), Diabetic neuropathy (a long-term complication of diabetes that occurs when high blood sugar and high levels of fats damage nerves in the body), hypertension (high blood pressure), congestive heart failure (a disease when the heart does not pump efficiently) related to cocaine abuse, left ventricular thrombus (a clot in the heart), pericardial effusion (fluid around the heart), chronic kidney disease, liver cirrhosis (damaged and scarred liver that prevents liver from functioning normally), and chronic back pain with retained bullet fragments in his back. RN 15 stated, Pt 38 was admitted on 7/22 around 6 p.m. for fluid overload, falling, heart failure. RN 15 stated, he used the medical plan for the nursing care plan. RN 15 reviewed the electronic chart and stated, he is unable to find the nursing care plan for Pt 38. During a concurrent observation and interview on 7/25/24 at 10:15 a.m., in the Emergency Department (ED) Yellow Hall, Pt 39 was in a hallway gurney in front of the nurse’s station. Pt 39 looked well-kept and stated he did not want to be “bothered”. During an interview on 7/25/24 at 10:30 a.m., with RN 6, RN 6 stated she was responsible for Pt 39, and he was an inpatient in the ED admitted to the CPCU telemetry floor. RN 6 stated Pt 39 did not have a nursing care plan in place. RN 6 stated care plans were important because they gave a goal for the patient that was patient specific. During an observation on 7/25/24 at 10:37 a.m., in the ED Yellow Hall, Pt 40 looked well-kept and was asleep comfortably. During an interview on 7/25/24 at 10:40 p.m., with RN 19, RN 19 stated she was responsible for Pt 40. RN 19 stated Pt 40 was an inpatient in the ED admitted to the CPCU telemetry floor. RN 19 stated when a patient was admitted to that unit, they are required to have cardiac monitoring which she reviewed every four hours. RN 19 stated Pt 40 did not have any care plan in place. RN 19 stated care plans were important because staff would be able to “identify the things they need”. RN 19 stated care plans were there for patient safety and to make sure the patient was “progressing and improving”. RN 19 stated care plans are also there for continuity of care between staff members. During an interview on 7/25/24 at 10:05 a.m., with the DED, the DED stated, they [the staff] are only doing the essentials like checking belongings and advance directives [a legal document that outlines a person’s wishes for medical care if they are unable to communicate them due to illness or injury] in the first two hours of a patient being admitted and no care plans will be present. The DED stated, “we are just doing the best we can, that’s all we can do.” During an interview with the Chief Nursing Officer (CNO), on 8/2/24, at 12:05 p.m., the findings of missing care plans and admission assessments were reviewed. The CNO stated, he expected nursing staff to follow the policies for care plan development and updating the care plan. The CNO stated, the care plan is important for the care of the patient as it allows anyone to see how the patient is progressing in their care and it allows for the care to be individualized. The CNO stated, the care plan should be developed for patients who have been admitted to the hospital and staff are expected to follow the policies to develop, implement and update a care plan for patients admitted and on hold for an inpatient in the ED. During a review of the facility record titled, “Clinical Nurse 2 -- Job Description”, dated 6/19/2024, the record indicated, “ ... The role of the clinical nurse is to deliver patient care through assessment, planning, implementation, and evaluation of patient needs with the highest professional standard while promoting nursing excellence through continued education and research ... Using the patient assessment and nursing diagnosis, develops and updates an individualized plan of care in collaboration with patient/family significant other and other members of the medical team to meet the patients’ individualized needs, taking into consideration language preference and culture. ... Includes strategies within the plan that address each of the identified diagnoses or issues, as well as expected outcomes. ... Initiates and updates the patient plan of care, using the role based decision making process by considering the stability of the patient and incorporating data collection, patient assessment, implementation, evaluation, patient/family teaching and care coordination ... “ During a review of the facility P&P titled, “Admission & Ongoing Assessment - Nursing (Acute Care)”, dated 8/2022, the P&P indicated, “...To describe the interdisciplinary process for the development of an individualized patient-centered nursing plan of care including safe discharge ... The information will be entered into the electronic health record (EHR) and a complete admission and plan of care will be documented within 24 hours ... Develops a comprehensive and interdisciplinary plan of care that is individualized to the patient’s problems, expected goals/outcomes and treatment plan ... “ During a review of the facility P&P titled, “Interdisciplinary Plan of Care”, dated 10/2023, the P&P indicated, “... To promote interdisciplinary collaboration in order to develop a Plan of Care that is individualized, age and developmentally appropriate, and takes into consideration the physical, psychosocial, spiritual, and cultural needs of the patient and their family ... A Plan of Care is to be initiated as soon as possible and completed within 24 hours of admission or prior to any procedure. (Refer to Admissions/ Assessment/Nursing policy). Elements of the plan of care are found throughout the patient’s EHR ... “ During a review of a professional reference titled, “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...” 4. During a concurrent interview and record review on 7/30/24 at 9:45 a.m. with Manager of Emergency Department (MED) 1, MED 2, Quality Registered Nurse (QRN) 2, Informatics Registered Nurse (IRN) 2, and Informatics Specialist (IS) 2 present, Patient 66’s “Emergency Department Provider Note (Provider Note),” dated 7/25/24 was reviewed. The Provider Note indicated, “Here with multiple complaints but a reluctant historian with an iPad with her concerns of a spontaneous CSF [meaning Cerebral Spinal Fluid] leak [occurs when there is a tear or hole in the membranes surrounding the brain or spinal cord, allowing the clear fluid that surrounds and cushions those organs to escape] with headaches, body pain, insomnia [a sleep disorder in which you have trouble falling and/or staying asleep] ...Progressive symptoms since onset in 9th grade with accelerated course since May 2024. Has had MRI [magnetic resonance imaging-a noninvasive medical imaging test that produces detailed images of almost every internal structure in the human body] C/t/L spine [computed tomography of the spine-to assess the spine for a herniated disk - a slipped, ruptured or bulging disk of the spine, tumors, and other lesions] which was normal in May 2024. Head CT [uses many x-rays to create pictures of the head, including the skull, brain, eye sockets, and sinuses] normal May 2024. Has seen a neurologist [a medical doctor specializing in diagnosing and treating diseases of the brain, spinal cord and nerves] and has a [primary medical doctor-PMD] at [name of clinic] [name of PMD]. Autism spectrum [a broad range of conditions characterized by challenges with social skills, repetitive behaviors, speech and nonverbal communication] , requesting a host of specific outpatient labs and imaging for her presumed diagnosis of CSF leak that is likely outside the scope of an emergency department visit ...Plan ...labs, urinalysis [a simple test that examines a urine sample to detect and manage a variety of health conditions], medications, and screening for organic cause [with measurable change to tissues, organs and body systems] of tachycardia (heart beat is faster than normal, usually more than 100 beats per minute), pain ...Spontaneous CSF leak due to intracranial hypertension [a build-up of pressure around the brain] is rare, but will discuss what workup is appropriate for ED screening today vs outpatient diagnostic management [services provided for the purpose of determining the nature and cause of a condition, illness or injury without requiring a hospital stay] ...” During a concurrent interview and record review on 7/30/24 at 9:50 a.m. with Manager of Emergency Department (MED) 1, MED 2, Quality Registered Nurse (QRN) 2, Informatics [the study, design and development of information technology] Registered Nurse (IRN) 2, and Informatics Specialist (IS) 2 present, Patient 66’s “Medication Administration Report (MAR),” and Patient 66’s “Pain Monitoring,” dated 7/25/24 were reviewed. The MAR indicated Patient 66 was administered acetaminophen [medication used to relieve mild or chronic pain and to reduce fever] 1,000 milligrams (mg-unit of measure) tablet and ketorolac (medication used for short term relief of moderate to severe pain) 15 mg injection at 12:52 p.m. The Pain Monitoring indicated Patient 66’s pain was not assessed at 12:52 p.m. when the two pain medications were administered. During a concurrent interview and record review on 7/30/24 at 9:55 a.m. with MED 1, MED 2, Quality Registered Nurse (QRN) 2, Informatics Registered Nurse (IRN) 2, and Informatics Specialist (IS) 2 present, Patient 66’s “Medication Administration Report (MAR),” and Patient 66’s “Pain Monitoring,” dated 7/25/24 were reviewed. The MAR indicated Patient 66 was administered ketorolac 15 mg at 4:20 p.m. The Pain Monitoring indicated Patient 66’s pain was not assessed at 12:52 p.m. when the pain medication was administered. MED 1 stated, depending on if the medication was by mouth or intravenous, would indicate when the patient’s pain should be reassessed. If the pain medication was intravenous within 30 minutes the patient’s pain should be reassessed and within one hour the patient’s pain should be reassessed when given by mouth medications. MED 1 stated Patient 66’s pain was not initially assessed or reassessed. MED 2 stated the importance of assessing a patient’s pain was to make sure the medication was effective and if the medication was not effective, notify the provider to see if anything else could be administered. During a concurrent interview and record review on 7/30/24 at 10:15 a.m. with MED 1, MED 2, QRN 2, IRN 2, and IS 2 present, Patient 66’s “Vitals,” and Patient 66’s “Emergency Department Patient Care Timeline (Timeline),” dated 7/25/24 was reviewed. The Vitals indicated Patient 66 had vital signs documented at 10:42 a.m. and 12:39 p.m. The Timeline indicated Patient 66 was discharged at 4:52 p.m. MED 1 stated the vital signs assessment frequency in the emergency department (ED) was every four hours and depended on the patient’s acuity (the severity of an illness or medical condition). MED 1 stated vital signs should also be assessed at discharge and transfer to another department. MED 1 stated the Vitals indicated Patient 66 did not have discharge vital signs documented. MED 1 stated Patient 66 should have vital signs completed 30 minutes prior to discharge. MED 2 stated, “The importance of vital signs prior to discharge was to make sure there was nothing out of the norm for the patient and if there was anything abnormal, it could be addressed.” During a concurrent interview and record review on 8/2/24 at 11:05 a.m. with Registered Nurse (RN) 18, DED, IRN 2, and Clinical Educator (CE) 5, Patient 66’s “Pain Monitoring,” dated 7/25/24 was reviewed. RN 18 stated a patient’s pain should be assessed before medication administration and reassessed in one hour when given by mouth medications and 30 minutes for intravenous (IV-into the vein) administered medications. RN 18 stated the Pain Monitoring indicated Patient 66 was administered medications at 12:52 p.m. and at 4:20 p.m. and both times Patient 66’s pain was not initially assessed or reassessed. RN 18 stated according to the Pain Monitoring, the only pain assessment documented was at 10:42 a.m. during triage which was 10/10 pain (patient rates their pain on a scale of 0 to 10, zero means “no pain” and 10 means “the worst possible pain”). RN 18 stated the importance of assessing and reassessing a patient’s pain was to ensure the medication was effective and if not effective, she could message the physician for other interventions. RN 18 stated if the patient’s vital signs and pain were not assessed prior to discharge, the patient could decline, have adverse effects and lead to death. During a concurrent interview and record review on 8/2/24 at 11:29 a.m. with Licensed Vocational Nurse (LVN) 2, present were DED, CE 5, and IRN 2, Patient 66’s “Pain Monitoring,” Patient 66’s “After Care Instruction Acknowledgement (ACIA),” and Patient 66’s “Emergency Department Timeline (Timeline),” dated 7/25/24 were reviewed. LVN 2 stated within an hour of discharge the patient’s vital signs and pain should be assessed, pain controlled or better, alert, and oriented to themselves. LVN 2 stated the importance of vital signs and pain assessment prior to discharge was, pain is another vital sign and should be assessed with vital signs to ensure the patient was stable to go home or if unstable, she could inform the physician. LVN 2 stated the ACIA indicated Patient 66 signed acknowledging she received her discharge instructions at 4:49 p.m. LVN 2 stated the Timeline indicated Patient 66’s vital signs and pain were not assessed before discharge at 4:52 p.m. LVN 2 stated if the patient’s vital signs and pain were not assessed at discharge, this could be a patient safety risk and the patient could possibly not have appropriate follow up. LVN 2 stated the nurse who discharged the patient was responsible to assess the patient’s pain on discharge. During an interview on 8/2/24 at 11:45 a.m. with the DED, the DED stated his expectations of nurses was to follow hospital policy and procedures, ensure appropriate workflow allowed nurses to do what was needed to be done. The DED stated the importance of following hospital policy and procedures was to ensure patient safety, patient rights, and standards of care. During a review of the hospital’s P&P titled, “Pain Assessment & Management-Patients 14 and Older,” dated 6/27/24, the P&P indicated, “ ...Purpose ...to demonstrate [name of hospital system] commitment to a patient’s right to effective pain management ...To establish standards of nursing care and practice that defines the role and responsibilities of the Registered Nurse (RN) to provide pain management at all facilities ...to provide safe and effective pain treatment for all patients, including safe opioid prescribing and, when appropriate, family preferences and cultural, spiritual, and/or ethnic beliefs/practices for pain management. This will be implemented in the pain management plan of care ...Pain is whatever the experiencing person says it is, existing whenever the experiencing person says it does ...Assess and reassess pain using one of the following scales as appropriate ...0-10 pain intensity scale ...The Wong-Baker Faces scale (ages 3 years to adult) ...Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain ...Pain intensity will be reassessed after each unscheduled pharmacological pain management intervention once a sufficient time has lapsed for the treatment to reach peak effect ...Generally, IV medication is effective within 30 minutes and [by mouth/intramuscular-in the muscle injection] medication is effective within 60 minutes. This re-assessment will be documented in the [electronic health record-electronic version of a patient’s medical history] using the appropriate pain scale. The patient’s pain and treatment plan upon discharge and communicated to the appropriate person(s) ...” During a review of the hospital’s P&P titled, “Standard of Practice for Emergency Department,” dated 9/14/22, the P&P indicated, “Purpose ...These Standards of Practice are necessary and realistic levels of the nursing process, which assure that quality of care is given to each patient. The purpose of these standards are to outline the baseline care a patient can expect to receive by the Emergency Department (ED) ...Adhere to all established ...polices/procedures ...Vital signs with pain assessment a minimum of every 4 hours unless otherwise ordered or warranted ...Encourage patient to describe their pain in their own words and instruct patients and/or family on the appropriate pain assessment ...Document the nursing interventions/patient responses in the medical record ...” 5. During a review of Patient 67’s “History and Physical (H&P),” dated 7/29/24, the H&P indicated, “ ... [Patient] had an unwitnessed fall this morning, hit head no loss of consciousness. [Patient] did not want to get medical attention at the time, however, two hours later caregiver checked in on patient and [patient] complains of left sided head pain ...[Patient 67] is a 62 [year old] female patient with past medical history of alcoholism [the most serious form of problem drinking at a level that causes harm to your health], [chronic obstructive pulmonary disease-a common lung disease causing restricted airflow and breathing problems], left hip fracture [a partial or complete break of the femur (thigh bone), where it meets your pelvic bone] status post open reduction internal fixation [the broken bone is realigned during surgery] 2019 ...who presents with headache and left hip pain ...In the [emergency department], [patient] complaints of severe headache and left hip pain. Lab showed [creatinine- a chemical waste product in the body that is excreted in the urine and found in the blood and muscle with a normal range between 0.6 to 1.3 milligrams per deciliter] of 1.7. [Patient] was given 1[liter] bolus [a single, large dose of fluid] and morphine [a drug that affects mood and behavior] for pain control. CT head pending ...Assessment & Plan ...alcoholism ...ciwa with [lorazepam-used to treat severe anxiety (feelings of fear, dread, and uneasiness) and seizures (causes temporary abnormalities in muscle tone or movements, behaviors, or state of awareness)], multivitamin [dietary supplement containing all or most of the vitamins that may not be readily available in the diet] and thiamine [also known as vitamin B] and folic acid [helps to make red blood cells] ...” During a concurrent interview and record review on 7/30/24 at 11 a.m. with MED 1, MED 2, QRN 2, IRN 2, and IS 2 present, Patient 67’s “Physician Orders (PO),” and Patient 67’s “CIWA-Ar Monitoring (Monitoring),” dated 7/29/24 was reviewed. The PO indicated, at 2:23 a.m. “Place in Observation Status” and at 2:47 a.m. CIWA -Ar “ ...Routine Assess once upon admission and then as indicated below according to score: Mild Severity (Score 0-8): Monitor every hour until CIWA-Ar is less than or equal to 8 x 4 hours consecutively, then every 4 hours; Moderate Severity (Score 9-15): Monitor every 30 minutes [as needed] until CIWA-Ar is less than or equal to 8 ...” MED 1 stated the Monitoring indicated the first CIWA assessment was completed on 7/29/24 at 1 p.m., a time lapse of ten hours and 13 minutes after Patient 67’s CIWA orders were placed. MED 1 stated the score at 1 p.m. was zero and the next score was not documented until 10:58 p.m. which was 7 and the following assessment was on 7/30/24 at 12:25 a.m. with a score of 4. MED 1 stated the physician orders were not followed as evidenced by gaps in the documented assessments. MED 2 stated, “The importance of following physician orders was to make sure Patient 67’s treatment was in alignment and if not, notify the physician.” During an interview on 8/2/24 at 12:07 p.m. with the Chief Nursing Officer (CNO) and the Director of Nursing Operations (DNO), the CNO stated his expectations were nurses should follow hospital P&P. The DNO stated the importance of nurses following hospital P&P was to ensure patient safety. During a review of the hospital’s P&P titled, “Provider Orders,” dated 8/25/23, the P&P indicated, “To provide guidelines for initiating and/or updating the physician’s therapeutic treatment pain ...The licensed personnel will clarify with the prescriber any order that would be contraindicated based on patient’s current condition, diagnostic test results, or medical history ...The RN acknowledging of orders indicates they assume responsibility for ensuring implementation of the order within the prescribed period ...The RN is to notify the Clinical Supervisor/Manager when unable to follow an order due to a lack of equipment and/or supplies ...Patient Education ...Inform patient of physician’s treatment plan and answer any questions ...Instruct patient about scheduled tests and any preparations ...” 6. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with DED, MED 1 and MED 2, on a tour of the ED, oxygen (O2) tanks were observed to be stored improperly; there were empty O2 tanks stored in the “full” O2 tank storage cart/stand. DED stated the empty tanks should have been stored in the right storage cage to ensure staff have O2 cylinders that are full and readily available to respond to a patient emergency. During a review of professional reference, “National Library of Medicine- Stat Peals Oxygen Cylinders”, dated 4/23/23, (found at https://www.ncbi.nlm.nih.gov/books/NBK513350/), which indicated, “ ...Oxygen cylinders have more specific storage requirements than other medical gases. While oxygen cylinders can be stored in the same space as other non-flammable medical gases as long as they are properly segregated, full oxygen cylinders and empty oxygen cylinders cannot be stored together. The separation of full and empty cylinders prevents the accidental usage of an empty cylinder during an emergency. Partially full oxygen cylinders may be stored in the same location as full cylinders, provided that they are adequately labeled ...” 7. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with DED, MED 1 and MED 2, included in the tour of the ED, Pt 70’s medication (brand name) inhaler was stored in a shared in-patient drawer in the ED medication room. The inhaler was stored outside of its box, and not labeled according to facility P&P in a drawer labeled “rooms I, J.” Attached to the inhaler was a spacer (the spacer connects to the inhaler mouthpiece, and the medicine goes into the spacer tube first. This allows you to breathe in the medicine more easily.) indicating the medication had been administered previously. DED stated the inhaler should have been labeled and stored according to facility policy and procedure. During a review of the facility’s policy and procedure (P&P) titled, “Medications - Orders, Administration, Storage, Documentation”, dated 12/19/23, the P&P indicated “ ...I. Purpose To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage, and documentation of medications ...V. Procedure ...J. After admixing, preparing, or removing the medication form the packaging, label medication unless it will be administered immediately with no break in the medication administration process ...3. There are special consideration for administration and labeling of medications and solutions removed from their original packaging to another container ...This applies to every area within the facility ...b. The new label on the transfer container or syringe contains the following information: i. Name of solution or medication and diluent (if applicable). ii. Strength and amount. iii. Volume (if not apparent from the container). iv. Expiration date when not used within 24 hours ...v. Expiration time when expiration is within 24 hours ...vi. Date prepared ...” 8. During a review of the hospital’s P&P titled “Standards of Practice - Acute Adult Medical/Surgical, Telemetry, Step-Down and Critical Care Units” dated 2/22/23, the P&P indicated “documentation will be completed in the EHR per Standards of Practice Documentation Grid.” “The Standards of Practice Documentation Grid” indicated full assessments in the General Medical/Surgical, Telemetry, and Progressive Care/Step-Down Unit must be completed within 2 hours of admission and at the beginning of every shift. Review of Pt 28’s face sheet (a document that provides demographics of the patient, admission date, and chief complaint) showed the patient was admitted to the hospital on 7/16/24 at 08:18 p.m. for right pneumothorax (a collapsed lung- occurs when air leaks into the space between the lungs and chest wall). During a review of Pt 28’s “Hospitalist History & Physical” dated 7/17/24 at 12:02 a.m., the H&P indicated Pt 28 was transferred from an acute care hospital for a “ ...higher level of care ...with pulmonology [a medical specialty that deals with diseases involving the respiratory tract] for intervention of subcutaneous emphysema [a condition when gas or air accumulates and seeps under the skin] with the history of 2 chest tubes to drain his right-sided pneumothorax.” The “Assessment & Plan” showed to “ ...Admit to telemetry (a unit where patients undergo continuous cardiac monitoring) and continuous pulse oximetry (a way to measure the amount of oxygen in a person’s blood) ...Chest tube maintenance per previous readings ...” During a concurrent interview and record review on 7/26/24 at 10:33 a.m. with DCVS, Pt 28’s “LDA Documentation” flowsheet dated 7/17/24 at 05:58 a.m. was reviewed. The flowsheet indicated Pt 28’s initial chest tube assessment was completed on 7/17/24 at 05:58 a.m., more than 2 hours after the patient was admitted to the hospital. Director 6 stated when a patient was admitted to the unit, there would be an initial assessment completed within 2 hours of admission. The assessment would include the head-to-toe and chest tube assessments if the patient was admitted with it. DCVS verified the nursing staff did not document Pt 28’s assessment within 2 hours of admission. 9. During a concurrent observation and interview On 7/23/24 at 9:42 a.m. with CS 2, a monitor screen showing multiple rows of waveform was observed at the bedside of Patient 29. CS 2 was asked about the monitor screen Pt 29’s bedside. CS 2 stated the monitor screen at Pt 29’s bedside was for a continuous EEG (electroencephalogram, a test performed that identifies abnormalities of the electrical activity of the brain) monitor. During a review of the hospital’s policy and procedure titled Continuous EEG Monitoring effective on 2/9/23, showed a continuous EEG monitoring is provided for patients with neurological (affects the brain as well as the nerves found throughout the human body and the spinal cord) conditions in the Critical Care and Progressive Care Units (nursing units that provide higher level of care) at the hospital. During a review of Pt 29’s medical record indicated the patient was admitted to the hospital on 7/19/24. During a review of the physician’s order for Pt 29 dated 7/21/24 at 08:20 am, indicated an order for an EEG Video Monitoring for the patient. The reason for the examination was for a Status Epilepticus (continuous seizure activity or recurrent activity without recovery period between seizures). During a review of a physician’s progress notes dated 7/23/24 at 10:06 am, indicated the Pt 29 was evaluated for seizures, and the EEG was done during the awake and drowsy state of the patient. The examination was performed from 7/22/24 to 7/23/24. During a review of the hospital’s EEG Video Monitoring on Med Surg Units dated 2/1 to 7/31/24, showed the monitoring for Pt 29 was started on 7/22/24 at 10:46 am and ended on 7/23/24 at 10:30 am. During a concurrent interview and record review on 7/26/24 at 10:34 am with Medical-Surgical Director (MSD) and RN 20, MSD was asked if the physician’s order for Video EEG Monitoring was a continuous monitoring for Pt 29. MSD stated the director would clarify from the EEG Diagnostic staff. The MSD acknowledged the EEG monitoring was performed while Pt 29 was in the Medical-Surgical Unit. The MSD acknowledged the EEG Monitoring was supposed to be performed in Progressive and Critical Care Units of the hospital as shown on the hospital’s policy and procedure. The MSD was asked about what the nursing staff should have done when there was a physician’s order for a continuous EEG Video Monitoring for a patient in the medical-surgical unit. The MSD stated the nursing staff should have contacted the physician and requested to transfer the patient to a higher level of care. During an interview with RN 20, RN 20 acknowledged the assigned RN worked at Neurodiagnostic (scientific study and recording of the electrical activity of the brain, spinal cord, and peripheral nervous system) Department of the hospital. RN 20 was asked if the physician order for EEG Video Monitoring was a continuous EEG monitoring. RN 20 stated yes. RN 20 was asked if the neurodiagnostic staff were aware a Video EEG monitoring of patients could only be provided in specific nursing units of the hospital. RN 20 stated yes. During an interview with the Nursing Director 9, Nursing Director 9 was asked if the nurses in the medical-surgical unit had completed the competency skills to care for a patient who required a continuous EEG monitoring. The Nursing Director 9 stated the nurses did not have the competency skills to care for a patient who required a continuous EEG monitoring in the medical-surgical unit. During a further review of the hospital’s EEG Video Monitoring on Med Surg Units dated 2/1/24 to 7/31/24, showed the monitoring for Pt 46 was started on 4/19/24 11:20 am and ended on 4/20/24 at 5:20 pm. During a review of Pt 46’s medical record indicated the patient was admitted to the hospital on 4/15/24. During a review of the physician’s order for Pt 46 dated 4/19/24 10:45 am, indicated an order for an EEG Video Monitoring for the patient. The reason for the examination was for an altered mental status. 10. During a concurrent observation of Room A and interview on 7/23/24 at 10:38 am with RN 21, RN 21 acknowledged Pts 31, 32 and 33 were in Room A and the patients were at risk for elopement. RN 8 explained there was one patient monitor assigned to Patients 31, 32 and 33 who was closely monitoring the patients due to the risk for elopement. During a review of the hospital’s policy and procedure titled “Use of Patient Monitors” effective 10/13/22, showed patient monitor were employees of the hospital who were assigned to observe patients and remain in close proximity and visual contact in order to assure patient’s safety. In addition, the policy showed a physician order for a 1:1 direct observation or patient monitor will initiate a nursing assessment. Whenever possible and appropriate, every effort should be made to place two patients who require observation by a single patient monitor within visual proximity of each other. One or more of the criteria are to be met prior to requesting a patient monitor including a patient who exhibits behaviors that may lead to self-harm or disruption of care and alternatives to assigning a patient monitor have been unsuccessful. During an interview on 7/23/24 at 10:33 am was conducted with Patient Care Technician. Patient Care Technician acknowledged the technician was assigned to observe closely Pts 31, 32, and 33 at all times. The Patient Care Technician was asked the reason of observing Pts 31, 32, and 33 Pts 31, 32, and 33. The Patient Care Technician stated the patients were at risk for elopement and could lead to a potential harm. During a review of medical record showed the following patients were admitted to the hospital: -Pt 31 was admitted on 3/30/24 -Pt 32 was admitted on 6/13/24 -Pt 33 was admitted on 6/19/24 During a review of the care plan of Pts 31, 32 and 33 (undated), showed a care plan problem showing the patients were at risk of elopement. During a concurrent interview and record review 7/26/24 10:34 am with the MSD, MSD acknowledged the above findings. MSD verified the P&P titled “Use of Patient Monitors” as described above. MSD explained patient monitor was the same as a patient sitter. MSD stated a patient monitor should not be assigned to observe more than two patients at all times.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 47205 DELETE”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 38764 Based on observation, interview, and record review, the hospital failed to follow the Policy and Procedure (P&P) titled “Blood Products Transfusion” for one of one patient, Patient 44, when RN 22 failed to fill the filter drip chamber (a chamber with a filter used to remove contaminants from the infusion of fluids before it enters the bloodstream) with normal saline (a mixture of water and salt concentration of 0.9) above the filter. This failure had the potential to cause inadvertent complications and suboptimal flow rates. Findings: During a review of the hospital’s P&P titled “Blood Products Transfusion” dated 5/6/24, the P&P indicated the following steps when preparing for blood transfusion (a procedure in which whole blood or parts of blood are put into a patient’s bloodstream through a vein): “ ...3. Prime (the process of removing air from tubing) the blood transfusion filter and tubing with normal saline ...4. Spike the intravenous tubing into the outlet of the normal saline bag ...5. Open clamp above blood filter, making certain that the clamp on the second Y-tubing (a Y-shaped connector set made of plastic tubes used to deliver medication and fluids into the body) is closed ...6. Fill drip chamber with normal saline to just above the filter by squeezing and releasing the drip chamber ...” During a review of the tubing instructions titled “BD Alaris Pump Infusion Blood Set,” the directions indicated to “ ...3. Spike first solution container and hang 4. Open clamp below spiked solution container. 5. Squeeze and release blood filter until filter is completely covered ...” During a review of Pt 44’s face sheet, the face sheet indicated Pt 44 was admitted to the hospital on 7/24/24 at 01:56 p.m. due to pregnancy, lower abdominal pain, preterm labor (labor occurring after 20 and before 37 weeks) in the third trimester (final phase of pregnancy), and labor abnormalities. During a review of Pt 44’s physician orders, the “Transfusion Orders” dated 7/25/24 at 09:54 a.m. indicated to transfuse 1 unit of red blood cells (component of the blood responsible for transporting oxygen and nutrients throughout the body). During a concurrent observation and interview on 7/25/24 at 10:15 a.m. with RN 22 and RN 44, RN 22 stated Pt 44’s consent and vital signs were already obtained prior to the blood transfusion. RN 44 stated an urgent transfusion was ordered due to Pt 44’s history of chronic anemia (a condition in which the body does not have enough healthy red blood cells). RN 22 then sanitized her hands and donned a clean pair of gloves. RN 2 used an alcohol pad to wipe Pt 44’s IV (intravenous - through the veins) hub connector (a device attached to the end of an IV tube that allows for delivering or withdrawal of fluid) on the left arm then flushed the line with normal saline. RN 22 then hung the bag of normal saline on the IV pole and connected one of the plastic spikes of the Y-tubing to the outlet of the normal saline bag. RN 22 primed the tubing by opening the clamp and squeezing the filter drip chamber until it was halfway filled with normal saline. RN 22 continued to prime the entirety of the tubing with normal saline. RN 22 and RN 44 then cross-checked the patient’s information against the transfusion form and blood bag label. After verifying the correct information, RN 4 connected the other plastic spike to the blood bag and transfused the blood. The blood transfusion began at 10:28 a.m. When asked about the filter drip chamber level, RN 44 acknowledged the chamber was filled below the filter level. RN 44 acknowledged the chamber was not filled with normal saline above the filter. During a concurrent interview and document review of the “Blood Products Transfusion” P&P on 7/25/24 at 10:39 a.m. with RN 22, RN 44, Supervisor 8, and Director 8, RN 22 verified the filter drip chamber was not filled with normal saline above the filter as per the hospital’s P&P. When asked about the purpose of having the filter drip chamber filled above the filter, the staff were unable to provide an answer. During a follow-up telephone interview with Director 8 on 7/31/24 at 2:32 p.m., Director 8 stated according to the hospital’s clinical nurse specialist, priming the filter chamber completely with normal saline provided the maximum efficacy of the blood filter.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Sterile Processing Technician (SPT) was observed in the decontamination (area where reusable medical equipment is cleaned, disinfected, and sterilized [process of complete elimination and destruction of all forms of microbial life]) area of the Sterile Processing Department (SPD) scrubbing instruments above the enzymatic (cleaner that uses a natural process of breaking down bacteria and organic waste) cleaning solution water line. The SPT failed to follow hospital policy and procedure and AAMI (Association for the Advancement of Medical Instrumentation- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) standards of practice. 2. Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2 broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a patient when doing a chest tube bedside procedure. This placed Pt 3’s safety at-risk due to the possibility of infection. 3. Nursing staff did not clean three of three sampled pill crushers (turn pills into powder) in the Emergency Department (ED) were visibly soiled with white-colored chalk-like residue, and orange-colored stains to metal pieces and throughout the device. 4. Staff did not ensure equipment, supplies and floors were clean and organized, in two of three sampled ED Supply and Medication Rooms. Patient care supplies found on the floor, outside their designated clean supply storage cupboards and floor surfaces were visibly soiled, dusty with stains and trash on them. 5. Hospital staff did not perform hand hygiene according to hospital policies and procedures. 6. Staff did not ensure proper infection control practices were implemented during a wound care treatment for one of one sampled patient (Pt 45). As a result of these failures all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Findings: 1. During an observation on 7/23/24 at 2:30 p.m., in the Sterile Processing Department (SPD) Decontamination area, a Sterile Processing Technician (SPT) was observed manually cleaning five different surgical instruments out of the cleaning/water solution. During an interview on 7/31/24 at 11 a.m., with SPT, SPT stated she made a mistake and brushed the surgical instruments out of the cleaning/water solution. The SPT stated by brushing the instruments out of the solution, surgical patient’s safety is put at risk. During an interview on 7/31/24 at 11:25 a.m., with the SPD Supervisor (SPDS), the SPDS stated he saw SPT doing the manual clean of surgical instruments out of the water. The SPDS stated the expectation for staff is to follow AAMI guidelines, as well as hospital policies and procedures and she did not. During an interview on 7/31/23 at 11:40 a.m., with the Surgical Services Director (SSD), the SSD stated manually cleaning the surgical instruments out of the water is “ultimately” an infection risk to patients. The SSD stated cross-contamination (transfer of harmful bacteria from one person, object of place to another) can “absolutely” occur. The SSD stated the SPD department uses AAMI as their professional standard. The SSD stated the Decontamination policy and AAMI guidelines were not followed. During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was for the surgical instrumentation to be fully submerged while doing a manual clean. During a review of the facility’s policy and procedure (P&P) titled, “Decontamination”, dated 10/30/23, the P&P indicated, “I. PURPOSE: to provide guidelines for cleaning ... decontaminating ... to maintain infection prevention principles, maintain safety and facilitate optimal patient outcomes ... II. DEFINITIONS: A. Cleaning: a process using friction, detergent, water and enzymatic cleaners to remove organic debris the process by which any type of soil, including organic debris, is removed to the extent necessary for further processing or for the intended use ... B. Decontamination: any physical or chemical process that removes or reduces the number of microorganisms or infectious pathogens and renders reusable medical products safe for handling or disposal; the process by which contaminants are removed, either by manual or mechanical means, using specific solutions capable of rendering blood and debris harmless and removing them from the surface of an object or instrument ...C. Decontamination area: the area in the sterile processing department where all soiled or contaminated surgical instruments and other items are received from the operating room or other user departments for decontamination ... D. Perform manual cleaning: ...10. Perform manual cleaning of submersible instruments underwater to minimize aerosolization of cleaning and contaminated fluids ...”. During a review of the professional reference from AAMI titled, “AAMI 3.3.6 Special area requirements and restrictions”, indicated, “ ...Rationale: Rationale: Airborne microbial and particulate contamination is likely to be high in the decontamination area/room because of the type of work done there (e.g., staging of grossly soiled items and equipment before cleaning, manual cleaning that produces aerosols, and, in some facilities, trash and linen handling from surgical case carts). Contamination can also be spread by personnel who indiscriminately touch environmental surfaces, other devices, or other personnel with contaminated hands. Regular cleaning is necessary to control environmental contaminants. Physical enclosure of the decontamination area is necessary because contaminated aerosols, droplet nuclei, and dust particles can be carried from “dirty” to “clean” areas by air currents ...”. During a review of the professional reference from AAMI titled, “AAMI 7.6.4.2 Manual Cleaning”, indicated, “ ... When manually cleaning devices, personnel should ... d. clean immersible devices under water to minimize aerosolization ...”. 2. During a review of Pt 3’s “History and Physical (H&P)”, dated 11/19/23 at 8:17 p.m., the H&P indicated, “ ...54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...”. During a review of Pt 3’s “Surgical Operative Report (SOR)”, dated 11/22/23 at 10:52 p.m., the SOR indicated, “ ...Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...”. During a review of Pt 3’s “Retained Foreign Object Picture (RFO)”, dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately one inch (unit of measurement) in length. During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMO stated a “broken barrier” should be addressed, acknowledged and “rectified (corrected)”. The CMQO stated the resident should have “spoke up” when the glove was torn and notified his Attending Physician. The CMQO stated the retained glove could have caused an infection. During an interview on 8/2/24 at 5:30 p.m., with Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2’s interview on 6/6/24 at 12:30 p.m., was validated, MDR 2 stated he was the person that put in the original chest tube for Pt 3. MDR 2 stated the chest tube insertion was a sterile procedure. MDR 2 stated during the chest tube insertion he had to feel that he was in the pleural cavity (space that surrounds the lungs), so he had to digitally enter (stick finger in) the cavity. MDR 2 stated while in the pleural cavity he needed to do some manual exploration and that was when his right sterile glove index finger ripped. MDR 2 stated he “didn’t think the glove could be in the patient”. MDR 2 stated when his glove ripped, he did not notify any staff (three different physicians were with him) involved that it happened. MDR 2 stated in hindsight he should have notified his Attending Physician that was present. MDR 2 stated the expectation for the procedure was that the glove stays intact and not be left inside the patient. MDR 2 stated the patient had the potential to develop an infection. MDR 2 stated Pt 3 could have been harmed by the piece of glove that was left inside of them. During an interview on 8/2/24 at 5:30 p.m., with the Director of General Surgery Residency (DGSR), the DGSR’s interview on 6/6/24 at 12:50 p.m., was validated, the DGSR stated the chest tube insertion was a sterile procedure and the sterile field was compromised when the glove ripped inside of Pt 3. The DGSR stated Pt 3 had the potential to develop an infection due to the glove piece being left inside. The DGSR stated MDR 2 did not follow the hospital policy and procedure (P&P) for patient’s safety and infection control. The DRSR stated when MDR 2 broke his glove, he should have notified the staff members what happened, removed the gloves, and put on new sterile gloves. During an interview on 8/2/24 at 6 p.m., with the Quality Outcomes Manager (QOM), the QOM stated Medical Doctor- Fellow (MDF) 2 who found the glove in the procedure, no longer was with the organization and the previous interview from 6/6/24 at 1:20 p.m., could be used. The MDF 2 stated he found the piece of glove during Pt 3’s procedure. The MDF 2 stated Pt 3 had a potential for an infection by having the glove piece left inside of her after the chest tube was placed. The MDF 2 stated Pt 3’s infection risk would be “great”. The MDF 2 stated there was ultimately a potential for death for Pt 3 by leaving a glove behind because of her acuity (severity level of an illness or medical condition) level at that time. During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was “that this doesn’t happen” and maintain the sterile field. The MIP stated this incident was “concerning”. The MIP stated “our intention” was for this not to happen to reduce the “likelihood” of cross-contamination into the sterile field. During a review of the facility’s policy and procedure (P&P) titled, “Safety Management Plan”, dated 3/21/23, the P&P indicated, “I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional, and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...”. During a review of the facility’s policy and procedure (P&P) titled, “Surgical Site Infection Prevention”, dated 11/20/23, the P&P indicated, “I. PURPOSE: A. To define a consistent approach for the prevention of surgical site infections (SSIs) in the (Hospital) surgical patient ... B. Broad areas addressed in this policy include: ... B. Aseptic practices, sterile technique ... III. POLICY: ... B. Preventative measures are to focus both prophylactic interventions and reducing opportunities for microbial contamination of the patients’ tissues or of the sterile surgical field ... D. Specific methods for preventing SSI include the following: 2. Intra-operative care ... b. Strict sterile technique adherence ... V. PROCEDURE: ... G. Adhere to strict aseptic and sterile technique ...”. 3. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with the Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the DED stated ED nurses are responsible in ensuring the equipment used to crush medications for administration to patients are to be cleaned by the ED nurses per facility policy and procedure (P&P). DED stated it is his expectation the pill crushers be cleaned as indicated in the manufacturer’s instructions for use and per P&P. DED stated the potential harm to patients is possible contamination of the medication being given, placing the patient at risk for infection. According to Links Medical Products, undated, retrieved on 8/7/2024 from https://imgcdn.mckesson.com/CumulusWeb/Click_and_learn/IFU_Silent_Knight_Cleaning_Instructions.pdf indicated “(Brand Name) pill crusher cleaning and maintenance instructions ...is made entirely of non-rusting materials and may be cleaned regularly with a damp cloth. A facility approved disinfectant wipe may also be used when indicated. In instances when the Silent Knight Pill Crusher requires a more thorough cleaning, please follow the instructions below: ...” 4. During a concurrent observation and interview on 7/22/24 at 10:27 a.m., with the Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the DED stated if patient care supplies are found on the floor they should be discarded as they would be considered contaminated (infectious). DED stated the floors should be swept and mopped daily and as needed. DED stated the floors did not look as if they had been cleaned of debris and surface stains. During an interview on 8/2/24 at 9:06 a.m., with Infection Prevention and Control (IP) Supervisor (IPS), IP Manager (IPM) and Director of Accrediting (DA). IP team acknowledged there were opportunities for improvement in the cleanliness of the ED. DA stated soiled items, like the pill crushers and floors should be cleaned as indicated by P&P and by following manufacturer instructions. During a review of policy titled, “Cleaning of Equipment” effective date 06/28/24, the policy indicated, “ ...I. Purpose A. To provided guidance to staff on who is responsible for the cleaning and disinfection of certain equipment. B. To prevent transmission of disease within the hospital to patients, staff, and visitors. II Policy A. The Equipment Cleaning Responsibility Grid ...will be used as a reference for all staff to determine the appropriate responsible party for the cleaning and disinfection of equipment. B. It is the responsibility of the individual department to use the document as a template for specialized equipment in their department ...III Procedure A. The attached cleaning grid includes but not limited to: 1. List of equipment/items 2. Frequency of cleaning ...” During a review of policy titled, “8-Step Cleaning Procedure” effective date 01/24/24, the policy indicated, “ ...I. Purpose To reduce the risk of acquiring and transmitting healthcare associated infections (HAIs)/infectious disease to patients, employees ...by defining the standard steps for environmental cleaning and disinfection of or all areas and departments ...III. 8-Step Cleaning Procedure ...F. Clean the floor ...” During a review of policy titled, “Environmental Cleaning and Disinfection Policy” effective date 10/31/23, the policy indicated, “ ...I. Purpose A. To reduce the risk of HAIs by defining the general requirements for cleaning and disinfection performed by the environmental services department ...II. Policy ...B. Cleaning Schedules 1. Tasks sheets have been developed that detail the cleaning and disinfection requirements for designated areas. Tasks sheets also include general reminders about cleaning and disinfection, as well as a room checklist ...” During a review of policy titled, “Cleaning of Clean Utility Room” last reviewed 01/24, the policy indicated, “ ... B... While cleaning, use all-purpose cleaner to remove adhesives and tape ... E. Clean sinks with cream cleanser and scrubbing pad ...” According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, “ Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)” 5. During an observation on 7/24/24 at 1:30 p.m., in Operating Room 10, Certified Registered Nurse Anesthetist (CRNA- a Registered Nurse who has specialized training in anesthesia) 1 did not complete hand hygiene six separate times within a ten-minute span. CRNA 1 failed to do hand hygiene before and after touching the patient (Pt 69), before putting on non-sterile gloves, after taking off non-sterile gloves, before drawing up medications and after administration of medications. During an interview on 7/25/24 at 9 a.m., with CRNA 1, CRNA 1 stated he did not do proper hand hygiene while interacting with Pt 69. CRNA 1 stated an infection could have occurred with Pt 69 because of not performing hand hygiene at the appropriate times. CRNA 1 stated he did not follow the hospitals policy and procedure for Hand Hygiene. During an interview on 7/31/24 at 11:40 a.m., with the Surgical Services Director (SSD), the SSD stated appropriate hand hygiene was important for infection control purposes. The SSD stated CRNA 1 did not do proper hand hygiene put and that put Pt 69 safety at risk. The SSD stated Pt 69 had the potential to acquire an infection and cross-contamination could have occurred. The SSD stated the expectation would be for CRNA 1 to follow policy and procedure for Hand Hygiene and he did not. During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated hand hygiene was the best way to prevent the spread of microorganisms (bacteria). The DIP stated the expectation for CRNA 1 was hand hygiene should have occurred before gloving and after doffing (taking off); which is “contained in the policy”. During a review of Patient 58’s “History and Physical (H&P-the physician’s examination ),” dated 7/25/25, the H&P indicated, “The H&P has been reviewed, the patient examined, and no changes found ...Informed Consent ...Diagnosis:-Squamous cell carcinoma (a type of cancer that starts as a growth of cells on the skin) of tongue ...Procedure:-Wide local excision (remove by cutting out) of tongue, tissue placement, local tissue rearrangement (used to rearrange tissue rather than to close a wound). Possible laser ablation (the process of removing material from a solid substance). Possible mandibular tori (noncancerous bony growths that appear on the floor of your mouth, under the tongue) removal ...[Patient 58] is a 73 [year old] male with biopsy (a procedure to remove a piece of tissue or a sample of cells from your body so that it can be tested) confirmed left lateral (side) tongue superficial (seen on the surface) squamous cell carcinoma ...He presents today for surgery. Denies changes in medical history ...” During an observation on 7/25/24 at 3 p.m., in the Operating Room (OR), CRNA 6 removed his gloves and disposed of them, then taped the tubing onto Patient 58’s nose and then sanitized. During an observation on 7/25/24 at 3:25 p.m., in the OR, CRNA 6 did not perform hand hygiene prior to putting on gloves. During an observation on 7/25/24 at 3:42 p.m., in the OR, RN 17 put on gloves without first performing hand hygiene. During an observation on 7/25/24 at 4:09 p.m., in the OR, RN 17 put on a pair of gloves without performing hand hygiene to assist with moving around a medical device. During an observation on 7/25/24 at 4:33 p.m., in the OR, RN 17 put on gloves to sanitize a cart and did not perform hand hygiene prior to putting on gloves. During an observation on 7/25/24 at 4:51 p.m., in the OR, RN 17 did not perform hand hygiene prior to putting on gloves. During an interview on 8/1/24 at 4 p.m. with RN 17, with Manager of Surgical Services (MSS) 2 and Clinical Nurse Specialist (CNS) 2 present, RN 17 stated hand hygiene should be performed before and after taking off gloves, between touching patients and other objects. RN 17 stated hand hygiene could be carried out by using hand sanitizer or washing hands. RN 17 stated the importance of hand hygiene was preventing infections from spreading. RN 17 stated if hand hygiene was not performed appropriately, an infection could spread. The four instances of the lack of hand hygiene on 7/25/24 was presented to RN 17. RN 17 stated hand hygiene should be performed before and after putting on gloves. During a concurrent interview and record review on 8/1/24 at 4:08 p.m. with RN 17, with MSS 2 and CNS 2 present, the hospital’s P&P titled, “Hand Hygiene,” dated 4/14/22 was reviewed. RN 17 stated the P&P indicated, “ ...Indications for hand hygiene ...Before donning sterile or non-sterile gloves ...After removing sterile or non-sterile gloves ...” RN 17 stated according to the P&P, the policy was not followed when she did not perform hand hygiene prior to putting on gloves. RN 17 stated the importance of following hospital P&P was to prevent infection and patient safety. During an interview on 8/1/24 at 4:15 p.m. with MSS 2, with the Director of Surgical Services (DOS) and CNS 2 present, MSS 2 stated her expectations of nurses performing hand hygiene was prior to and after putting on gloves and taking off gloves, anytime hands were visibly soiled, anytime in the patient’s room, touching different surfaces, and prior to putting on sterile gloves and after removing sterile gloves. MSS 2 stated the importance of hand hygiene was for patient safety, infection prevention, and decreased spread of germs and bacteria from one person to another. MSS 2 stated she ensured staff followed hand hygiene practices by having secret shoppers, internal audits, and discussed hand hygiene during huddles and staff meetings. During an interview on 8/2/24 at 9:08 a.m. with the Infection Prevention Supervisor and Epidemiologist (IPSE), Manager of Infection Prevention (MIP), and the Director of Accreditation, Licensing, and Infection Prevention (DA/DIP) present, the DA/DIP stated he recognize hand hygiene is the best way to prevent the spread of microorganisms (living things that are too small to be seen with the naked eye The DA/DIP stated his expectations of hospital staff and hand hygiene were they should perform hand hygiene before and after glove use. During a review of the facility’s policy and procedure (P&P) titled, “Hand Hygiene”, dated 4/12/22, the P&P indicated, “I. PURPOSE: the purpose of this policy is to promote effective hand hygiene practices and reduce the transmission of microorganisms amongst patients, personnel ... III. POLICY: A. Hand hygiene is the single most important means of preventing the spread of infection and is to be performed in any interaction where transmission of microorganisms is possible ... IV. PROCEDURE: A. Indications for hand hygiene: 1. Before and after touching the patient ... 3. Before donning (putting on) sterile or non-sterile glove... 6. After contact with inanimate surfaces and objects(including medical equipment) in the immediate vicinity of the patient. 7. After removing sterile or non-sterile gloves ... B. In addition to the items above, health care personnel are to clean their hands whether or not there is anticipated contact with the patient or their environment. Including the following moments: ... 3. Before handling medication ...”. During a professional reference review of an article from Cureus titled, “Examining the Importance of Hand Hygiene Policy and Patient Safety Culture on Improving Healthcare Workers’ Adherence to Hand Hygiene Practice in Critical Care Settings in the Sultanate of Oman: A Scoping Review,” dated 11/20/21, the article indicated, “Several studies suggest that adherence to hand hygiene (HH) policy would be enhanced by improving the culture of safety in an organization. This could be achieved through continuous awareness programs about the dramatic effect of HH practice according to the HH policy on improving patient safety and quality care. Understanding the importance and purposes of HH policy by healthcare workers would allow them to prioritize HH policy in their planning. Therefore, healthcare leaders should be responsible and accountable for strengthening their healthcare system by improving infrastructure, providing adequate support and resources, providing comprehensive monitoring and evaluation of patient safety initiatives, monitoring adherence to the regional Gulf Cooperation Council (GCC) and local Oman HH policy and using World Health Organization (WHO) guidelines for patient safety and HH as a basis for providing safer care. This should involve HH policy as a basic and mandatory program during an internship or in new staff orientation programs, spending enough resources on conducting more research studies and benchmarking findings with other international countries or any other organization such as WHO or Centres for Disease Control (CDC) ... In this sense, patient safety and quality care are the most important issues when adopting any policy ...” 6. During an observation on 7/25/24 at 1:15 p.m. at Pt 45’s room, Educator 7 introduced herself and briefly explained the procedure to the patient. Afterwards, Educator 7 performed hand hygiene and donned a new pair of gloves prior to placing the unopened wound care supplies on a clean bedside table. The wound care supplies included clear adherent drapes, black granufoam (a special foam dressing which aids in pulling fluid from the wound over time), wound cleansing solution, no-sting skin barrier swabs, honey dressing, bordered gauze, gauze pads, suction pad, endoform dressing (a dressing designed to treat acute and chronic wounds), and scissors. Educator 7 then elevated the patient’s bed and turned the patient to the right side with the assistance of the primary RN (Registered Nurse). Educator 7 checked the wound VAC settings and proceeded to remove the old dressings on the patient’s right buttock and sacrum wounds. The old, bordered gauze dressing removed from the right buttock was visibly soiled with serosanguinous drainage (a type of drainage secreted by an open wound that is light red or pink). Educator 7 discarded the old dressings in the trash can. Afterwards, Educator 7 touched the wound VAC screen to turn it off while wearing the same pair of gloves used to remove the old dressings. Educator 7 did not disinfect the screen after she touched it. Educator 7 doffed the gloves, sanitized her hands, and then donned a new pair of gloves. Educator 7 prepared the wound dressings by soaking the gauze pads with wound cleansing solution, cutting the dressings to the appropriate sizes, and cleaning around Pt 45’s wound with the no-sting skin barrier swabs. Educator 7 placed the prepared dressings as well as the extra supplies and soiled swabs on the same bedside table. Educator 7 proceeded to apply the new dressings to the patient’s sacral wound as per the physician’s order. After applying the dressing, Educator 7 applied the suction pad and connected the tube to the wound VAC device. Educator 7 touched the wound VAC screen to turn it on and set it to 125 mmHg (millimeters of mercury). Educator 7 then touched the sacral wound dressing, checked for leaks, then touched the screen again to verify the settings. Using the same gloves, Educator 7 proceeded to dress the patient’s right buttock wound. Educator 7 did not disinfect the contaminated wound VAC screen prior to touching it and/or changed gloves prior to touching the sacral wound dressing and applying the new dressing to the right buttock wound. During a concurrent interview and record review on 7/25/24 at 1:47 p.m. with Educator 7, Pt 45’s “Order” dated 7/11/24 at 10:30 a.m. and “Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)” dated 7/21/24 at 5:32 p.m. were reviewed. Educator 7 verified Pt 45 currently had healing Stage 4 (a full-thickness skin and tissue loss with exposed or directly palpable muscle, tendon, ligament, or bone in the ulcer) wounds on the right buttock and sacrum. Educator 7 stated both wounds were present on admission and were treated separately as per the physician’s orders. Educator 7 stated the right buttock wound was treated with a honey dressing, and the sacral wound was treated using a wound VAC. When asked how often the wound VAC device was cleaned, Educator 7 stated it was cleaned every dressing change and during safety checks. Educator 7 stated she did not clean the wound VAC device after performing wound care because the primary RN at the bedside will be responsible for cleaning it. Educator 7 was then informed about the observations regarding not disinfecting the wound VAC screen and/or changing her gloves prior to dressing the right buttock wound and placing discarded items on the same table used for the clean supplies. Educator 7 acknowledged the findings and stated she should have changed her gloves after touching the wound VAC screen. During a review of Pt 45’s “History and Physical” dated 7/4/24 at 6:10 p.m., the H&P (History and Physical) indicated Pt 45 was admitted to the hospital on 7/4/24. The H&P indicated “ ...Since 3/2024 she has had multiple admissions with sepsis (a life-threatening complication of an infection) due to UTI (Urinary Tract Infection - an infection in any part of the urinary system), pyelonephritis (inflammation of the kidney), pressure ulcer (a localized damage to the skin and/or underlying soft tissue usually over a bony prominence or related to a medical or other device) complications and failure to thrive (a syndrome that can include a gradual decline in physical and mental functioning, weight loss, and social withdrawal). Her last admission was from 6/20 - 7/2/24. She had wound consult with application of wound vac for the pressure ulcer...” During a review of Pt 45’s “LDA (Line, Drain, Airway) Documentation” flowsheet dated 7/4/24, the document indicated Pt 45 had wounds on the sacrum (the triangular-shaped bone at the bottom of the spine) and right buttock upon admission. During a review of Pt 45’s “Order” dated 7/11/24 at 10:30 a.m., the order showed Pt 45 had a right buttock wound. The “Comments” showed the following: “1. Cleanse the wound bed by moistening gauze with [brand of wound cleansing solution] and lay in wound bed for at least 3-4 minutes. Then pat dry. 2. Next apply no sting barrier film to the periwound (area around the wound) skin. 3. Cut small piece of Therahoney Sheet (a gauze dressing indicated for use on wounds with any drainage level) to the size of slough (yellow to tan dead tissue) the wound bed and place over slough avoiding peri wound. 4. Cover with silicone foam bordered border dressing (an absorptive dressing consisting of 3 layers). 5. Change the dressing every 3 days and as needed for soilage, saturation over 75% and/or dislodgement by bedside nurse.” During a review of Pt 45’s “Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)” dated 7/21/24 at 5:32 p.m., the order indicated Pt 45 had a sacral wound. The “Comments” showed the following: “May apply collagen to wound bed. If bedside nurse is unable to correct via troubleshooting, and/or is unable to change independently, and/or the wound specialist is unavailable to change within 2 hours, bedside nurse to discontinue the wound vac and place a normal saline wet to moist dressing. Change the dressing twice a day and as needed for saturation >75% and/or dislodgement until wound VAC is replaced.” During a review of the hospital’s P&P (Policy and Procedures) titled “Infection Prevention Plan [Hospital name]” dated 10/28/23, the P&P indicated the “ ...goal of the [Hospital name] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare-associated infections (HAI - an infection that is acquired in a hospital or other healthcare facility)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students and visitors. The overall goals of [Hospital name] Infection Prevention program include: ...Limiting the transmission of infections associated with procedures ...Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies ...” According to the CDC (Centers for Diseases Control and Prevention - an agency that works to protect people from health threats) reference titled “CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” (https://www.cdc.gov/infection-control/hcp/core-practices/index.html) dated 4/12/24, “ ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection ...risk assessment with use of appropriate personal protective equipment (e.g., gloves, gowns, face masks) based on activities being performed ...””

“RECIPIENT HOSPITAL RESPONSIBILITIES CFR(s): 489.24(f) A participating hospital that has specialized capabilities or facilities (including, but not limited to, facilities such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers, which, for purposes of this subpart, means hospitals meeting the requirements of referral centers found at §412.96 of this chapter) may not refuse to accept from a referring hospital within the boundaries of the United States an appropriate transfer of an individual who requires such specialized capabilities or facilities if the receiving hospital has the capacity to treat the individual. This requirement applies to any participating hospital with specialized capabilities, regardless of whether the hospital has a dedicated emergency department. This Standard is not met as evidenced by: 40516 Based on interview and record review, Hospital 2 failed to meet its Recipient Hospital Responsibilities for one of four patients (Patient 1), when Hospital 1 contacted Hospital 2 on 2/19/24 to transfer Patient (Pt) 1 who was diagnosed with a dissecting aortic aneurysm and was in critical condition and Hospital 1 did not have the capability to provide the required surgical services to treat and stabilize Pt 1. Hospital 2 did not accept transfer and had the capacity and capability to provide surgical services to Pt 1. Hospital 2 did not follow its policy and procedure “Transfer of Patients - In Bound”. These failures resulted in the transfer of Pt 1 to Hospital 3 which required a ground ambulance transfer of more than three hours (approximately 220 miles), and delayed the surgical procedure needed to stabilize Pt 1’s emergency medical condition (EMC) and the potential harm of injury and death. Hospital 2 was about one hour or less from Hospital 1 (approximately 43 miles). Findings: During a review of Patient 1’s medical record from Hospital 1, the “Acute Transfer” dated 2/19/24 indicated the following: 9:25 p.m. “Received a call from [Physician 1- Emergency Department (ED)] requesting and [sic] urgent transfer for aortic dissection [medical emergency in which the inner layer of the large blood vessel branching off the heart (aorta) tears].” 9:31 p.m. “Placed a call to [Hospital 2] spoke with [Transfer Nurse 1] to request an urgent transfer for aortic dissection.” 9:33 p.m. “Connected [Transfer Center Nurse 1] with [Physician 1] for report. [Transfer Center Nurse 1] will call once she is able to connect with her cardio thoracic [CT- doctor who performs surgery on the heart and lungs].” 9:40 p.m. “Called [staff at local air ambulance] for weather check to [Hospital 2 - a 43-minute ground ambulance ride from Hospital 1].” 9:42 p.m. “Received a call from [Transfer Center Nurse 1] requesting to connect [Physician 2 - Hospital 2’s Cardiothoracic Surgeon] with [Hospital 1’s] cardio thoracic. Connected [Physician 3 - Hospital 1’s Cardiothoracic Surgeon] with [Physician 2] who refused to take the patient because he believes that [Physician 3] should be able to take care of this patient.” 9:47 p.m. “Called [staff at local air ambulance] to cancel weather check to [Hospital 2] and initiate weather check to [Hospital 3].” 9:48 p.m. “Placed a call to [Hospital 2] spoke with [Transfer Center Nurse (TCN) 1] to advise that it was very inappropriate to deny the patient because [Physician 2] feels that [Physician 3] is [able] to take care of this patient. Per [TCN 1] she will run this up her chain of command.” During a review of Patient 1’s transfer center documentation from Hospital 2, dated 2/19/24, the transfer center documentation indicated: 9:32 p.m. Per CM [case manager] they [Hospital 1] are requesting transfer for Cardiothoracic surgery. Pt [patient] info [information] has been faxed.” 9:33 p.m. Transfer Center Nurse received a call from Physician 1 to provide report on Patient 1. “Emergency Medical Condition/Diagnosis: Acute [severe and sudden in onset] aortic dissection with hemopericardium [blood in the sac surrounding the heart] . . . They [Hospital 1] attempted pericardiocentesis [procedure done to remove fluid that has built up in the sac surrounding the heart], states ‘hard to tell if it was successful’, they [Hospital 1] ‘removed a small amount of blood . . .They [Hospital 1] discussed with their on call Cardiothoracic surgeon who states he did not feel comfortable handling repeat pericardiocentesis or the surgery needed to correct this condition, recommended transfer. Stated he [Physician 3] did not have enough training for this acute life-threatening condition to be comfortable performing procedure, recommending transfer for HLOC [higher level of care].” 9:37 p.m. “[Transfer] Request Began.” 9:39 p.m. “Call to [Physician 2]. MD [Physician 2] called, notified of pt and imaging. States they [Hospital 1] should be able to handle this at [Hospital 1], their CT can call him [Physician 2].” 9:42 p.m. Hospital 1’s case manager notified of Physician 2 request to speak with Physician 3. 9:45 p.m. “Conf [conference] call facilitated with [Physician 3 and Physician 2]. [Physician 2] states they [Hospital 1] can handle this at [Hospital 1]. Per [Physician 3], he talked to the team there [Hospital 1] and they are not prepared to do it. [Physician 2] states they [Hospital 1] are affiliated with [Hospital 3], can reach out to them as well.” 9:50 p.m. Case is being escalated to Hospital 2’s Leadership. “Reason for Escalation: [Physician 2] states pt should be able to be managed at [Hospital 1]. In addition [Hospital 1] is affiliated with [Hospital 3], so they can try there as well.” 9:59 p.m. “Call to CMO [Chief Medical Officer] on supervisor cell. CMO aware of escalation text and is in talks with requested service line.” 10:07 p.m. “Per escalation text, CMO states [Physician 4- Physician 3’s supervisor] is discussing with [Physician 3] now. TC [transfer center] to be updated.” 10:25 p.m. “Writer called and spoke with [case manager at Hospital 1], seeking update on status of transfer. [Case Manager] states pt was accepted at [Hospital 3], however will have to go by ground as they are currently unable to fly. TC [Transfer Center] RN [registered nurse] updated. 10:31 p.m. Call to CMO on supervisor cell. Updated[.] TC spoke [with Physician 2], and per [Physician 2] if pt was accepted at [Hospital 3], to continue with transfer there and can call us back if needed. Advised pt will have to go by ground transport. CMO in agreement.” 10:33 p.m. “Writer updated [Case Manager] at [Hospital 1] that since pt already accepted at [Hospital 3], to continue with transfer there and can call us [Hospital 2] back if needed.” During a review of Patient 1’s “ED Note Physician” dated 2/19/24 at 7:19 p.m., the “ED Note Physician” indicated, Patient 1 had a history of an ascending aortic aneurysm (abnormal bulging and weakening in the upward part of the artery leaving the heart) brought in by ambulance for acute chest pain . . . “Patient was transferred to CT [computed tomography scan- medical imaging technique used to obtain detailed internal images of the body] in stable condition for critical CTA [computed tomography angiography - noninvasive test that uses special X-rays to focus on the coronary arteries to analyze for blockages in the heart arteries]. While waiting for CTA result, patient became hypotensive [abnormally low blood pressure]” was given IV fluids, medication to treat life-threatening low blood pressure, and transfused a unit of packed red blood cells. “CTA [results] demonstrated acute ascending aortic dissection/intramural hematoma [life-threatening aortic disease] with extension into the pulmonary [lung] arteries, with pericardial hemorrhage [bleeding around the heart]. Cardiothoracic surgery is immediately consulted; however, they recommended immediate transfer for HLOC after stabilization with pericardiocentesis . . . This patient was critically ill and at risk for deterioration requiring immediate bedside attention and intervention.” During a review of Hospital 2’s list of required services, the untitled document indicated, “Services required 24/7/365 [24 hours a day, seven days a week, 365 day a year] . . . Level I and II trauma centers must have continuous availability of the surgical expertise listed below . . . Cardiothoracic surgery.” During an interview on 4/9/24 at 11:02 a.m. with Hospital 2’s Vice President of Capacity Management (VPCM), VPCM stated capacity (bed space, nurses, specialty care areas, equipment, etc.) and capability (can the needed service be provided) are considered before accepting a patient transfer from another hospital. VPCM stated only the CMO can ultimately say no to a transfer request that has been escalated to leadership. VPCM stated Hospital 2 does not question the capabilities of a hospital requesting a transfer if that hospital states they are not capable of performing an emergent procedure. During an interview on 4/10/24 at 9:21 a.m. with Physician 4 (Hospital 2), Physician 4 stated he received a call from the CMO regarding Hospital 1’s transfer request for Patient 1. Physician 4 stated he then called Physician 2 and told him to accept Patient 1. During an interview on 4/10/24 at 10:35 a.m. with TCN 1, TCN 1 stated she did not remember if word “accepted” was ever used when speaking to Hospital 1 staff. During an interview on 4/10/24 at 12:39 p.m. with VPCM and Director of Patient Flow (DPF), VPCM and DPF both stated that capacity was not an issue for Patient 1’s transfer request. During an interview on 4/10/24 at 1:29 p.m. with Physician 2 (Hospital 2), Physician 2 stated he received a call from the transfer center regarding Hospital 1’s request to transfer Patient 1 to Hospital 2. Physician 2 stated he worked at Hospital 1 for 12 years and “we” did cases like that [aortic dissection repair] all the time. Physician 2 stated he did not know Physician 3 or his capabilities. Physician 2 stated Physician 3 told him that the staff at Hospital 3 was not prepared to do the surgery Patient 1 needed. Physician 2 stated Hospital 1 has an affiliation with Hospital 3, and they should reach out to Hospital 3. Physician 2 stated he was unsure what having a hospital affiliation entailed. Physician 2 stated he did not accept Pt 1 for transfer and explained this to the transfer center. Physician 2 stated he received a call from Physician 4 to accept the transfer of Pt 1 but did not follow through with that instruction because Hospital 1 had obtained approval to send Pt 1 to Hospital 3, and therefore, he did not accept the transfer. Record review of hospital records from Hospital 3 indicated Pt 1 was transported to the hospital by ambulance on 2/20/24. The travel time for transport from Hospital 1 was approximately 3 hours. Hospital 3’s H&P Addendum for Pt 1 dated 2/20/24 at 3:36 p.m. indicated “Complaint: Type A dissection ... 73 yo male with PMH of COPD, HLD, HTN, prior Ml x 2, hx of dilated ascending aorta, after having dinner when he had sudden onset of acute CP and fainted. Per family, performed chest compressions for a few seconds before return of pulses/consciousness ... CT scan shows Type A Dissection with a pericardia! effusion s/p attempted pericardiocentesis- 5 ml pulled (while in OR found pericardia! drain did not appear to be in pericardium). He was transferred to Stanford and found to have intermural hematoma, without dissection flap. He is now s/p root with valve resuspension, ascending, and hemiarch aortic replacement ...” Hospital 3 Discharge Summary indicated “ ... Surgical Priority: Urgent ... Operation Performed: 1. Ascending aortic replacement (24mm Hemashield WDV graft) with aortic valve resuspension and aortic root remodeling; 2. Hemiarch replacement (30mm Gelweave graft) using RCP and DHCA Aortic Dissection ... [Pt 1] was transferred to [Hospital 3] for HLOC and was found to have intermural hematoma, without dissection flap, on arrival to [Hospital 3] he was taken urgently to the OR ... On POD #22 [3/13/24], patient was thought to be stable for discharge to SNF for further rehab. Family adamantly refused SNF and understand possible risk of taking patient home without facility rehab. Family willing to assume these risks given there is a large amount of help at home. Patient discharged home with HH PT/OT and home RN, HHA for continued symptom and medication management ... Discharge diagnosis: Type A aortic dissection w/ pericardia! effusion/tamponade S/p hemiarch/ascending replacement w/ supracoronary resuspension ...” During a review of Hospital 2’s P&P titled, “Transfer of Patients - In Bound,” dated 10/20/23, the P&P indicated, “III Policy . . . B. [Hospital 2] will fulfill the EMTALA [Emergency Medical Treatment and Labor Act- Federal law to ensure public access to emergency services regardless of ability to pay] obligation to accept an appropriate transfer of an individual with an un-stabilized emergency medical condition who requires specialized capabilities or facilities as long as the Hospital has the capacity and capability to treat the individual.””