Ahmc Seton Medical Center

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 40903 Based on observation, interview and record review the hospital failed to ensure safe practices with labeling IV (or “Into the Vein”, Intravenous,) products for Beyond Use Date (BUD, a date after which the product should not be used) after removal from the outer wrap packaging in the post-surgery unit known as PACU (Post-Anesthesia Recovery Unit, a unit in the hospital when patient recovered from surgery prior to going to regular hospital unit) with patient census of 37 based on manufacturer specification and standards of practice. This failed practice could contribute to unsafe IV use and could compromise the safety of medications given to patients. Findings: During a concurrent observation and interview, on 7/7/25, at 2:50 PM, accompanied by Interim Chief Nursing Officer (ICNO) and Registered Nurse 2 (RN 2), in the PACU unit, the IV product “Dextrose 5% -50 mL” (sterile sugar based solution for mixing IV medications; “%” is a fraction of 100 indication of the strength; “mL” is milliliter, a measure of volume) were stored in a storage rack with no marking on when they were removed from the outer protective wrap. RN 2 stated the IV solution storage rack was supplied by the hospital’s Central Supply department (a department that stocked IV solutions to nursing units). RN 2 stated she was not aware that removing the IV product from its outer wrap created a shorter stability and beyond use date (BUD). RN 2 was observed using an ink marker to put a date on the Dextrose bags. RN 2 stated she did not know the BUD for Dextrose IV bag out of its outer warp and was not sure how long it was safe to use. During a concurrent record review and interview with the Director of Pharmacy (DOP), on 7/10/25, at 10:14 AM, the DOP stated the hospital’s “Material Management” (or Central Supply, a department that stocks IV solutions to nursing units) should not have handled stocking the Dextrose 50mL IV products that have limited BUD upon removal from the outer wrap. The DOP stated the product should have been handled by pharmacy and stocked in the Automated Dispensing Machine (ADM, electronic storage and dispensing of medications) along with other medications. The DOP stated the monthly unit inspection should have looked for the undated IV stocks. During a concurrent review of the hospital’s policy, titled “Pharmaceutical Storage, Security, and Labeling Policy”, dated 6/23/25, and interview with the Director of Pharmacy (DOP), on 7/10/25, at 10:30 AM, the policy indicated “The appropriate storage and handling of pharmaceutical products are essential to ensuring their safety, efficacy, and accessibility within a healthcare setting ... The pharmacy department holds oversight responsibility of pharmaceutical storage and security across the Medical Center. This includes ensuring compliance with all applicable regulations, implementing safeguards to prevent unauthorized access and maintaining the integrity of all medications to ensure their safety and effectiveness. Health care providers involved in medication handling must be trained on the proper procedures for storing, transporting and securing pharmaceuticals in compliance with this policy.” The policy further indicated “Pharmacy department ensures that all stock medications are up to date and available according to the approved floor stock lists as designed by Pharmacy and Therapeutic Committee.” The policy on Labeling of pharmaceutical and chemical” indicated “Proper labeling of pharmaceuticals and chemicals is essential to ensure that healthcare providers can identify medications quickly and accurately. All medication and chemicals used to prepare medications must be labeled. With the following information: ... Expiration date ... or beyond use date. Appropriate warning, including storage instruction ...” Review of the publication by American Society of Health System Pharmacy (or ASHP, a professional organization with focus on pharmaceutical services and safe drug use in in hospitals and health systems) article on drug stability, titled “Applying stability data in sterile compounding”, last accessed on 7/14/25, via https://publications.ashp.org/display/book/9781585286720/ch000.xml, the document on table 7 provided “Manufacturer Storage of Commercial IV Solutions Containers after Removal from Protective Overwrap”. The document indicated the maximum storage time for [Redacted] manufacturer of IV bag (50mL volume), at room temperature and out of overwrap, was 15 days for beyond use date (BUD). The article indicated once an IV bag was removed from its overwrap, the stability of the fluid and drug concentration can be affected, particularly due to potential evaporation and changes in the environment.”

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure that State law requirements are met under California’s Business and Professions Code Section 2290.5(b), requiring that: “Before the delivery of health care via telehealth, the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health. The consent shall be documented.” The hospital’s failure to inform patients that they are being seen remotely by the psychiatrist (MD2/Provider 7) violates the principle of informed consent, which is foundational to medical ethics under the above cited California State law. Patients have the right to know how their care is being delivered and to make informed choices. Findings: During concurrent interview and record review of five random patient discharges on 12/13/24 at 10:48 a.m. with the DHIM (Director of Health Information Management) and the MRA (Medical Record Auditor), one patient (Patient 55) who had been on the Geropsych Unit was found to have no documentation that verbal or written consent was obtained for use of telehealth. Review and discussion of the record deficiency reporting run 12/13/24 for the psychiatrist (MD2/Provider 7) identified one missing discharge summary and fifteen pended (drafts pending signature/date/time) progress notes. Missing documentation for use of telemedicine and patient consent are not audited either concurrently or at discharge. Subsequent record review for all patients on the Geropsych Unit census on the 12/9/24 survey entry date, found zero of eighteen patients (Patients 14, 15, 16, 17, 66, 67, 71, 72, 73, 75, 76, 77, 85, 86, 87, 88, 89, 90) had documentation that verbal or written consent was obtained for use of telehealth. Review of the definition of telemedicine with criteria for inclusion in Current Procedural Terminology, 2024 edition, published by the American Medical Association found the following: “Synchronous Telemedicine Service Rendered Via a Real-Time Interactive Audio and Video Telecommunications System: Synchronous telemedicine service is defined as a real-time interaction between a physician or other qualified health care professional and a patient who is located at a distant site from the physician or other qualified health care professional. The totality of the communication of information exchanged between the physician or other qualified health care professional and the patient during the course of the synchronous telemedicine service must be of an amount and nature that would be sufficient to meet the key components and/or requirements of the same service when rendered via a face-to-face interaction.” Documentation of the telemedicine modality was missing from all nineteen Geropsych Unit patients’ records reviewed (Patients 55, 14, 15, 16, 17, 66, 67, 71, 72, 73, 75, 76, 77, 85, 86, 87, 88, 89, 90). For two of the 19 patients, (Patients 14, 88) the psychiatrist (MD2/Provider 7) instead documented in the record under Identification on the Psychiatric Evaluation a “face-to-face” evaluation. On one (Patient 67) of nineteen Geropsych Unit patients’ records reviewed, the psychiatrist (MD2/Provider 7) endorsed the Multidisciplinary Initial Treatment Plan on 12/9/24 with an inventory of Patient’s Assets including under “Other” “-in-house psychiatrist.” The cumulative effects of the missing and contradictory medical records documentation and operating a telemedicine-based model in a GeroPsych Unit without proper consent and transparency poses heightened risks due to the unique vulnerabilities of geriatric patients. In addition to the Business and Professions Code informed consent law, this systemic failure may violate: 1. Elder Abuse and Dependent Adult Protection: Under Welfare and Institutions Code Section 15610.57, elder abuse includes neglect, defined as the failure to provide medical care for physical and mental health needs. Failing to ensure that the delivery method of care meets the clinical needs of older adults may expose the facility and psychiatrist to allegations of elder neglect. If the psychiatrist’s lack of in-person evaluation or informed consent results in inadequate care or poor patient outcomes, it could be construed as neglect under this law. 2. Patient Rights: California hospitals must adhere to the Patients’ Bill of Rights, which includes the right to participate in treatment decisions and receive information about their care. Failing to inform patients about the use of telemedicine can breach these rights, potentially resulting in administrative penalties. Geriatric patients often have cognitive impairments (e.g., dementia) that can affect their ability to understand telemedicine practices and consent to remote care. This scenario creates specific risks regarding informed consent requirements with cognitively impaired patients. Consent must be obtained in a way that accounts for cognitive limitations. If patients lack the capacity to consent, their legal representatives must be involved. Failure to follow capacity assessment protocols or involve legally authorized representatives may result in non-compliance. 3. Medicare/Medicaid (MediCal in California) and Accreditation Standards: Regulatory agencies like the Centers for Medicare & Medicaid Services (CMS) and accrediting bodies (e.g., The Joint Commission) require that telemedicine practices ensure the same quality of care as in-person services. Misleading documentation and lack of transparency about remote care can lead to non-compliance with these standards. Deceptive charting practices, such as documenting “face-to-face” when the interaction is not in person, may constitute misrepresentation or even fraud, which can have legal implications under both state and federal regulations. Non-compliance with telemedicine consent requirements could jeopardize reimbursements and trigger audits or penalties. 4. Family Involvement and Advocacy Rights: Family members often act as advocates for geriatric patients, especially when decision-making capacity is limited. Complaints about lack of transparency and poor communication could lead to legal challenges under laws protecting patient advocacy and decision-making, including California Probate Code Section 3200. 5. Accessibility of Telemedicine Services Rights: Many geriatric patients may have disabilities, such as hearing or vision impairments, that require accommodations under the Americans with Disabilities Act (ADA) or Section 504 of the Rehabilitation Act. This includes ensuring clear communication about the telemedicine process as well as accessible telemedicine platforms with accommodations for visual, auditory, or cognitive impairments. If the telemedicine setup fails to accommodate these needs, the facility could face liability for discrimination. 6. Professional Standards and Ethics American Psychiatric Association (APA) Telepsychiatry Guidelines recommend transparency in the use of telemedicine and documentation that explicitly states telepsychiatry was used. Geriatric patients are at greater risk of feeling isolated, confused, or dissatisfied with care. The lack of transparency about telemedicine exacerbates these risks, potentially leading to heightened anxiety. Patients may feel distrustful if they discover that sessions were remote without their knowledge or consent. Deceptive practices violate the principles of autonomy and beneficence, key tenets of medical ethics, especially in psychiatry where trust is critical.”

“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: 26674 Based on interview and record review, the facility failed to implement its policies to ensure the medical staff was accountable to the governing body for quality of care when one of three sampled physician peer reviews was not completed (refer to A-347 Part 1), and when one of one sampled incident reports involving the medical staff did not have a documented resolution and was not copied to the medical staff office (refer to A-347 Part 2). The facility failed to monitor the performance of three of three sampled contractors. Refer to A-83 and A-84. The facility’s governing body failed to approve the performance indicators being used by the facility. Refer to A-273 Part 1. The facility’s governing body failed to approve the “PERFORMANCE IMPROVEMENT PLAN 2024” and failed to determine the number of performance improvement projects to be conducted. Refer to A-309. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment.”

“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: 26674 Based on interview and record review, the facility failed to monitor implementation of its corrective action following a patient fall in radiology, failed to maintain records of its work prior to the survey regarding radiology turnaround times (TAT), and failed to monitor the performance of three of three sampled contractors. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment. Findings: 1. Refer to A-286 regarding the facility’s failure to monitor implementation of its corrective action following a patient fall in radiology. 2. Review of an undated physician peer review (when a doctor reviews another doctor’s work) indicated radiology TAT were a concern regarding the care of Patient 49 on 3/26/23. Review of the facility’s quality cabinet minutes dated 12/14/23 indicated there was a recommendation “to improve turnaround time” in radiology. Review of the facility’s quality cabinet minutes dated 8/8/24 and 11/21/24 indicated there was no mention of radiology TAT. Review of the facility’s “ED [emergency department] THROUGHPUT” meeting minutes dated 1/23/24 indicated radiology TAT were discussed, including data definitions, prior improvements, and suggestions for future improvement. No data were present in the document. Review of the facility’s “ED THROUGHPUT” meeting minutes dated 3/1/24 indicated “TAT have been reduce [sic] to 91 minutes since the new Radiology group took over... The importance of granular data for analysis and identification of bottlenecks was emphasized.” No data beyond the 91 minute statistic were present in the minutes. The minutes indicated opportunities for further improvement were discussed. Review of an undated, untitled spreadsheet provided by the radiology manager indicated it included TAT for ten patients who had imaging studies ordered 12/16/24 (after the start of the survey). No earlier information regarding TAT was present on the document. In an interview on 12/17/24 at 11:11 a.m., the radiology manager stated he had begun looking at TAT “this week... actually last week.” The radiology manager stated he was new and did not have access to the work done by his predecessor regarding radiology performance indicators. 3. Refer to A-83 regarding the facility’s failure to monitor the performance of two of two teleradiology contractors. 4. Refer to A-84 regarding the facility’s failure to monitor the performance of one of one blood banking contractor.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 26674 Based on interview and record review, the facility failed to perform proctoring within the required time period for one of one sampled nurse practitioner (NP, Provider 5). Refer to A-339. The facility failed to consider provider-specific quality and licensing data as required by its own policies and procedures during the reappointment process for five of six sampled medical staff (Providers 2, 3, 4, 6, and 7). Refer to A-340. The facility failed to perform proctoring (when an experienced physician temporarily supervises a newly appointed physician’s work) in the manner required by its own policies for one of six sampled medical staff (Provider 1). Refer to A-341. The facility failed to implement its policies to ensure the medical staff was accountable to the governing body for quality of care when one of three sampled physician peer reviews was not completed, and when one of one sampled incident reports involving the medical staff did not have a documented resolution and was not copied to the medical staff office. Refer to A-347. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment.”

“MEDICAL RECORD SERVICES CFR(s): 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. This Condition is not met as evidenced by: 39051 Condition of Participation: Medical Record Services Based on observation, interview and record review the hospital failed to provide medical record services adequate to support prompt completion, secure filing, and ready retrieval of medical records in a safe and secure environment which preserves patient confidentiality with a patient census of 62 as evidenced by: 1. The hospital failed to ensure safe, effective, and secure method of communication with the doctors in the psychiatric unit when mobile phone, commercial emails and unsecured meeting platforms were used to transmit and conduct confidential patient care issues. These unsafe practices could contribute to the loss or compromise of behavioral health patients’ confidentiality and privacy with a patient census of 18 on the GeroPsych Unit (Refer to tag A-0147). 2. The hospital failed to ensure one of 88 sampled patients (Patient 37) had a complete medical history on the history and physical examination and a complete surgical log showing the amount of laser energy administered to the patient. This documentation failure created a potential compromise in the patient’s continuity of care (Refer to tag A-0450). 3. The hospital failed to ensure medical records were accurate and complete for one of 88 sampled patients (Patient 2) when the Verbal Order (VO, an oral directive that is given through any method of communication) to renew the order for “bilateral wrist restraints” (is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely, as per facility policy) was not authenticated (process of verifying the accuracy and validity of information within a patient’s record by confirming the identity of the healthcare professional who made the entry, typically through a signature or electronic equivalent) by the physician within 24 hours. This deficient practice had the potential for inaccurate transcribing of orders and miscommunication which could place the patient’s safety at risk (Refer to tag A-0454). 4. The hospital failed to ensure postoperative dictation was completed by the physician for one of 88 patients reviewed (Patient 30). This failure could affect the postoperative care planning and provision of care to the patient (Refer to tag A-0959). 5. The hospital failed to ensure the pre-anesthesia evaluation was completed within 48 hours prior to the delivery of the first dose of medications given to induce anesthesia (drug induced loss of awareness) for surgery requiring anesthesia services for one of 88 sampled patients (Patient 4), when the evaluation was not authenticated (process of verifying accuracy and validity of information within a patient’s record by confirming the identity of the healthcare professional who made the entry, typically through a signature or electronic equivalent) by the Anesthesiologist (medical doctor that specializes in anesthesia care, pain management, and critical care). Failure to complete medical records with authentication within the time frame required prevented all healthcare team members from having access to critical patient informationnecessary to monitor the patient’s condition and ensure patient safety (Refer to tag A-1003). 6. The hospital failed to ensure that medical records were maintained in a manner that protects against damage, ensures retrievability, and complies with retention requirements. This failure resulted in compromise to the integrity and availability of medical records, which are critical for patient care continuity and regulatory compliance (Refer to tag A-0438). 7. The hospital failed to ensure that unauthorized individuals cannot gain access to or alter patient records. This failure had the potential to result in compromised confidentiality and integrity of medical records, which are essential for patient trust and patient safety (Refer to tag A-0441). 8. The facility failed to ensure that all patient medical record entries are complete, dated, timed and authenticated by the person responsible for providing the service, consistent with hospital policies and procedures. This failure had the potential to result in compromised continuity of patient care, increased risk of medical errors, hindered patient rights and patient trust (Refer to tag A-0450). The cumulative effects of these systemic failures resulted in: 1. The hospital’s inability to protect medical records from damage or loss due to structural failures in storage practices. Safety hazards and disorganization do not ensure record retrievability and risk non-compliance with record retention policies. Mixed use storage practices make medical records potentially accessible to unauthorized individuals with potential breach of privacy. 2. The hospital’s inability to ensure that all patient medical record entries are complete, dated, timed and authenticated by the person responsible for providing the service, consistent with hospital policies and procedures, state and federal law. Due to missing or incomplete records the risk of adverse events may increase through potential errors in diagnosis, treatment or medication administration. Inability to access accurate and complete patient information can lead to delays in care or inappropriate interventions. Continued documentation failures may impact the hospital’s ability to maintain physician credentialing and privileging requirements, undermining accountability among physicians and creating a culture of non-compliance. Hospital leadership’s failure to uphold policies and safeguard the institution’s integrity through compliance with documentation requirements can lead to audits, investigations and enforcement actions potentially jeopardizing funding and contracts, increasing liability exposure, with potential fines, penalties, loss of accreditation, and revenue loss due to delayed or denied reimbursement.”

“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: 40903 Based on observation, interview, and record review the hospital failed to ensure safe pharmaceutical services were provided and met the needs of each patient with census of 62 patients as evidenced by: 1. The hospital failed to ensure high-risk medications (drugs with increased potential to cause serious harm or death if used or stored incorrectly) as floor stock (floor stock means prescription drugs not labeled for a specific patient, maintained at a nursing station, cabinets, or individual sealed trays) were safely stored in two out of five patient care units of the hospital (Surgery unit and 6th floor medical unit) based on standards of practice and hospital’s policy when: a. Concentrated injectable (shot into skin or veins) Potassium Chloride (or KCL, a mineral supplement used to prevent or treat low levels of potassium caused by disease, the concentrated intravenous [or IV, into Vein] form without dilution could cause harm by immediately stopping heart beats and subsequent death) was stored as floor stock in a room next to a surgery room (also called OR, Operating Room) without safety systems in place to prevent unauthorized use and risk of inadvertent use. b. Sterile Water for Inhalation (Sterile means germ free; sterile water bag if given intravenously could cause serious patient harm; inhalation; same as breathing) in one liter bag was stored in hospital’s 6th floor medication room next to similar size and look-alike IV bags with no safety system to prevent inadvertent use. These failed practices had potential to contribute to medication error, patient safety and possibly lead to patient harm, injury and/or death. (Refer to tag A-491) 2. The hospital failed to ensure controlled drug (narcotic or opioid drugs subject to abuse and misuse) use (or narcotics/opioids, drugs with high risk for abuse) from Automated Dispensing Machine (or ADM, a computer-controlled device that stored, dispensed, and tracked medications for patient use) were consistently monitored and discrepancies (when the narcotic dose documented as given plus the narcotic dose documented as wasted does not equal the narcotic dose documented as withdrawn from ADM) or overrides (bypass verification of doctor’s order by pharmacy) were escalated for timely resolution based on standards of practice and facility’s policy with patient census of 62. This failed practice had potential for the risk of opioid drug diversion (unlawful use of prescription drugs) in the hospital, unauthorized use, and possibly lead to patient harm or injury. (Refer to tag A-494) 3a. The hospital failed to ensure non-narcotic (non-opioid) prescription medication override (means bypassed verification of doctor’s order in the computer) from Automated Dispensing Machine (or ADM, a computer-controlled device that stores, dispenses, and tracks medications for patients) were consistently reviewed and accounted for based on standards of practice and hospital’s policy with patient census of 62. This failed practice had potential for unsafe drug use, lack of accountability, risk of prescription drug diversion or unauthorized use and possibly patient harm. (Refer to tag A-500) 3b. Hospital failed to follow FDA (or Food and Drug Administration, a government agency that protects public health by ensuring the safety of drugs) drug warning and guidelines on fentanyl patch (fentanyl skin patch, or transdermal patch contains large amount of a potent opioid called fentanyl, approved for use in severe chronic pain on patients tolerant to frequent opioid use) prescribing and use in two out of two opioid naïve (opioid naïve” means a patient who has not used opioids for more than seven consecutive days during the previous 30 days) patients (Patient 61 and Patient 62) based on manufacturer specification and facility’s policy. These failed practices could contribute to unsafe medication use and risk of adverse effect from a high-risk opioid medication and possibly patient harm, injury and/or death. (Refer to Tag A-500) 3c. Hospital failed to ensure Malignant Hyperthermia cart (or MH cart, a medical cart specifically designed to hold all the necessary emergency medications and supplies needed to rapidly treat a patient experiencing a life-threatening reaction called Malignant Hyperthermia, when muscles become rigid and body temperature climbed very quickly as result of anesthesia drug [drugs that blocks pain sensation during surgery] use during surgery or other similar medical setting) contents followed safe storage practices and matched hospital’s policy for safe use of Sterile Water For Injection (or SWFI, a germ free water used to mix drugs and considered high risk with inadvertent IV use) bag and the availability of the refrigerated contents in safe proximity of the MH cart based on standards of practice with patient census of 62. This failed practice could contribute to unsafe use of high-risk MH cart contents, delay in providing care in an urgent situation during a Malignant Hyperthermia crisis and possibly patient harm, injury, or death. (Refer to tag A-500) 4. The hospital failed to ensure trained Environmental Services staff (or EVS staff, responsible for cleaning the pharmacy’s area where sterile (germ free) Intravenous [or IV, Into the Vein] medications prepared) were assigned to clean and sanitize the IV preparation area (known as IV room or Clean room where sterile IV products were made) per facility’s policy and USP (USP stands for “United States Pharmacopeia”, a non-profit organization that sets standards for the quality and purity of medications, including guidelines specifically for compounding sterile preparations) standards of practice with census of 62 patients. This failed practice could contribute to unsafe sanitization of sterile IV product preparation areas and the risk of contaminated drug products harming a patient. (Refer to Tag A-501) 5. The hospital failed to address medication safety issues including timely review of medication error events, update of pharmaceutical policies affecting patient care via the Pharmacy and Therapeutic committee (or P&T committee; a group of healthcare professionals in hospital who review and approve safe drug use in the hospital based on literature, standards of practice and hospital safety data. P&T committees are typically made up of doctors, pharmacists, nurses, and administrators who meet regularly throughout the year) were conducted based on standards of practice, facility’s policy, and hospital’s bylaws (Bylaws were hospital rules required by law that outlined the responsibilities and procedures ensuring quality patient care) with patient census of 62. This failed practice may have contributed to lack of timely oversight on safe medication use in the hospital. (Refer to Tag A-508) 6. The hospital failed to ensure the policy and procedure on medication security was implemented and medications were left unlocked and unattended for one of one sampled medication cart (perfusion cart, cart used by medical doctor specialized in care of heart disease patients) in hospital’s surgical unit. This failure had the potential for unauthorized access, tampering, theft, and/or diversion (medication taken for use by someone other than whom the medication was prescribed) of prescribed medications. (Refer to Tag A-502) The cumulative effects of these systemic failures resulted in the hospital’s inability to ensure quality and accountable pharmaceutical services in a safe setting to meet the needs of patients.”

“LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This Condition is not met as evidenced by: 17334 Based on observation, staff interview and document review, the hospital failed to maintain adequate laboratory services to meet the patients’ needs, when: 1. The hospital did not evaluate the Vender 1, a blood bank establishment, contract through their quality program to identify potential quality concerns and risks to ensure patient safety. Refer to A-0084. 2. The hospital failed to have a written agreement with Vender 2,a labaratory vender, used by the hospital for multiple laboratory testing. Refer to A-0582. 3. The hospital did not have emergency laboratory services available 24 hours a day either onsite or through contracted lab services. Refer to A-0583 These failures put patients at risk for delay or misdiagnosis and poor patient care outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Laboratory Services.”

“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: 34975 Based on food service observations, dietary staff interview, and dietary document review, the hospital failed to ensure the provision of effective food and nutrition services as evidenced by: 1. A system was developed that delegated authority to the Registered Dietitian (RD) to change diet orders, order tube-feedings, and order medical nutritional supplements. Delegation of the authority was not within the Scope of Practice of a RD in accordance with State law (Refer to A630); 2. Lack of a nutritional analysis of diets commonly served to patients to ensure menus met the daily nutrient needs of patients (Refer to A629); 3. Lack of development of a diet manual that reflected the scope of diets routinely ordered by hospital physicians (Refer to A631); 4. Lack of a system to ensure meals were portioned in accordance with the menu (Refer to A629); 5. Failure to maintain dietetic services in a safe and sanitary manner and in accordance with current standards of practice (Refer to A750); 6. Failure to maintain equipment in accordance with manufacturers’ guidance and standards of practice (Refer to A701); 7. The Director of Food Services did not provide oversight into all areas of dietetic services operations (Refer to A620); The cumulative effects of these systemic problems resulted in the hospital’s inability to provide food and nutrition services in a safe and effective manner in accordance with the statutorily mandated Conditions of Participation for 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: 39723 Based on observation, interview, and record review, the hospital failed to ensure the §482.42 Condition of Participation Infection Prevention and Control and Antibiotic Stewardship Programs were met when, 1. For the outpatient sterile processing department (OP-SPD, a dedicated area within an outpatient setting responsible to clean, prepare, process, and stored medical instruments) decontamination (a process used to remove debris, blood, and other matter from medical devices after use) workroom, the Infection Prevention Control Program (IPCP) failed to ensure traffic patterns in all areas of the OP-SPD were restricted to authorized personnel and all OP-SPD doors had restricted access for one of two sampled OP-SPD doors (OP-SPD Door 1) (Refer to A0749). 2. For the OP-SPD, the IPCP failed to ensure the reprocessing equipment (equipment used for medical devices to allow the device safe for reuse) was functioning properly in accordance with the manufacturer’s instruction for use (IFU) for one of two sampled washer/disinfectors (Washer/Disinfector # 2) (Refer to A0749). 3. For the OP-SPD, the IPCP failed to ensure medical supplies were stored properly and the terminal cleaning (the thorough environmental cleaning process that is performed at the end of each day when the area is being used) procedures were implemented to prevent cross-contamination (the transfer of harmful germs from one person, object, or place to another) in accordance with the hospital’s policy and procedure (P&P) for one of two sampled OP-SPD workrooms (OP-SPD decontamination workroom) (Refer to A0749). 4. For the ambulatory surgical center (ASC, same day surgery care), the IPCP failed to ensure the hospital’s P&P was implemented on traffic patterns in surgical services and 86 corrugated boxes (external shipping cartons) were stored in one of two sampled storage areas (Storage Area 2) (Refer to A0749). 5. For the OP-SPD, the IPCP failed to ensure elevators used to transport sterile (germ-free) surgical instruments from the medical office buildings to the hospital’s operating rooms were sanitary for four of four sampled elevators (MOB 1A, MOB 1B, MOB 2A, and MOB 2B) (Refer to A0749). 6. For the radiology department, the IPCP failed to ensure equipment was calibrated to indicate accurate high-level disinfection (HLD, a process used to kill most germs on medical equipment to prevent the spread of infection) documentation for one of one sampled HLD system (Trophon) (Refer to A0749). 7. For the radiology department, the IPCP failed to ensure appropriate personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) was worn while performing HLD for one of two sampled ultrasound technicians (US Tech 1) (Refer to A0749). 8. For the engineer department, the IPCP did not ensure emergency equipment was inspected weekly for 20 of 20 sampled eyewash stations (Station 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11,12,13, 14, 15, 16, 17, 18, 19, and 20) (Refer to A0749). 9. For the Infection Control Professional Responsibilities, the Infection Preventionist (IP) failed to develop or implement a hospital policy and procedure in accordance with nationally recognized infection prevention and control guidelines to transport potentially infectious (harmful) instruments between buildings (MOB 1, MOB 2, and the Hospital) (Refer to A0772). 10. For the radiology department, the IPCP failed to ensure contaminated (unclean) endocavity probes (a medical instrument that is used to image internal body structures of the body) were transported from other areas across the medical center to one of two sampled decontamination workrooms (radiology decontamination workroom) in accordance with nationally recognized infection prevention and control guidelines (Refer to A0749). 11. For the Infection Control Professional Responsibilities, the IP failed to perform active surveillance activities to ensure staff performed surgical services and HLD procedures in a manner which prevented the potential risk of cross-contamination (the transfer of harmful germs from one person, object, or place to another) for three of three sampled areas (OP-SPD, the ASC, and the radiological department’s HLD area) (Refer to A0772). The cumulative effects of these systemic problems resulted in the hospital’s inability to provide an effective hospital wide infection control program and to provide patient care in a safe and effective manner to meet the Condition of Participation Infection Prevention and Control and Antibiotic Stewardship Programs.”

“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: 40358 Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. The hospital failed to comply with the §482.51 Condition of Participation for Surgical Services when, 1. Washers, ultrasonic machines, and steam sterilizers were not maintained per manufacturer’s instructions for use. (Refer to A-0951). 2. Surgical instruments in the major and minor trays were damaged or stained. (Refer to A-0951). 3. Hospital hang times for endoscopes were outdated and manufacturer’s instructions for use were not followed for reprocessing the scopes. (Refer to A-0951). 4. There were missing ceiling tiles in the Sterile Processing Department. (Refer to A-0951). 5. The hospital did not ensure temperature levels and humidity levels were maintained in an acceptable range in the surgical services department as per nationally infection prevention and control standards (ASHRAE and AORN) (Refer to A-0951). The cumulative effect of these systemic problems had the potential to transmit infectious microorganisms to patients and increased the risk of infections to all patients who received care. The hospital failed to deliver care in a safe setting and therefore failed to comply with the §482.51 Condition of Participation for Surgical Services. On December 11, 2024, at 5:54 P.M., an Immediate Jeopardy (IJ) situation was declared in the presence of the hospital’s leadership team, including the Hospital Administrator (HA) via telephone, the Chief Health Officer (CHO), the Corporate Quality Director (CQD), the Associate Chief Operating Officer, (ACOO), the Chief Nursing Officer (CNO), the Director of Pharmacy (DOP), Operating Room Manager (ORM)1, the Sterile Processing Department Manager (SPDM), the Infection Preventionist (IP), Clinical Quality Analyst’s (CQA) 1,CQA 2,and CQA 3, the Acting Plant Operations Director (ENG D), the Director of Emergency Department (DED), the Admitting Director (AD), the Skilled Nursing Facility Director (SNFD), the Director Health Information Management (DHIM), House Supervisor (HS) 1, the Manager Materials Management (MM), and the Chief Engineer (ENGC) who were verbally notified, after the team identified through observations, interviews, and record reviews, a pattern of ineffective infection control practices, in the Surgical Services Department. The hospital failed to protect all patients requiring surgical services from the potential of nosocomial infections and failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. These failures had the potential to affect the health and safety of all patients, requiring surgical services. On December 16, 2024, at 4:16 P.M., the Immediate Jeopardy Situation was lifted, in the presence of the hospital’s Leadership Team, including the ADM, the CHO, the CQD, ORM 1, the IP, the SPDM, CQA 1, CQA 2, and CQA 3, HS 1, and the Ambulatory Surgery Center Charge Nurse (CN) 1. The Leadership Team was informed that the hospital’s corrective action plan was approved by the team, after observation, interview, and record review confirmed the hospital’s immediate situation was corrected. The corrective action plan included the following components: “1.Washer, ultrasonic machine, and steam sterilizers were not maintained per the manufacturer’s instructions. From January 16, 2024, to December 10, 2024, the hospital failed to monitor the process and maintain the washer, ultrasonic machines, and steam sterilizers, per manufacturer’s instructions by Sterile Processing Technician/Manager. To correct this deficiency, the following actions were implemented December 11, 2024. a. The hospital leadership met with the Infection Preventionist (IP), and the Sterile Processing Manager (SPDM) immediately following the survey to review the findings related to oversight of the processes to prevent, control, and investigate infections and communicable diseases. b. The policies and procedures title “Washer-Disinfection Maintenance Policy” and “Sterilizer Maintenance and Cleaning Policy” for cleaning and sterilizing surgical instruments have been updated to reflect recognized infection prevention and control standards and manufacturer’s guidelines. Revised policies have been presented for approval to the Infection Control Committee, Medical Executive Committee (MEC) on December 12, 2024, and the governing body on December 13, 2024. c. The Sterile Processing Department Manager (SPDM) provided an in-service education and training to the staff regarding the updated cleaning process on December 12, 2024. d. Laminated sterilizer maintenance instruction had been posted in the SPD as a visual guide on December 11, 2024. e. SPDM and IP have created a staff competency checklist. A return demonstration of the step-by-step process of cleaning the washer, ultrasonic machine, and steam sterilizers in accordance with the manufacturing instructions was completed by a trained SPD technician on December 12, 2024. This will be performed annually. f. The SPDM reinforced the process of washer disinfector maintenance per manufacturer’s guidelines. SPDM/designee is responsible for observing and monitoring the following process: 1. Beginning of every shift: Washer cleaning should follow manufacturer’s guidelines concerning the daily inspection of equipment. -Remove coarse screen inside the chamber and rinse thoroughly in water. -Remove any lint of foreign materials from screen. -Return coarse screen to chamber. -Check washer arms for any foreign materials. Disassemble arms and remove any lint of foreign materials. -Clean washer loading cart with a damp cloth, wipe down with manufacturer’s recommended hospital approved disinfectant. -Wipe down both the inside and outside of the washer surface. 2. Descaling occurs once a week every Thursday. -Run a decontamination cycle in washer. -Add manufacturer’s recommendation of hospital approved detergent. -Document the cleaning with date and initial on cleaning log. -If machine is out of service, document on the cleaning log, and notify SPDM and Biomed. g. A monitoring log regarding the above process has been developed to document adherence to the instrument’s process and cleaning. The results will be recorded daily and weekly per manufacturer’s instructions by the SPDM. The monitoring process started on December 12, 2024, by SPDM. h. An audit tool has been established that reflects the washer-disinfector step-by-step maintenance to ensure 100% compliance and will be presented to the Quality Cabinet monthly for one year by the SPDM, with oversight by the CNO. The Quality Cabinet will track, trend, and monitor for compliance that the washer, ultrasonic machine, and steam sterilizers are maintained in accordance with manufacturer’s instructions and according to the hospital policy established. i. If evidence of noncompliance is found, the SPDM will take appropriate corrective action communicated with the responsible employee. Corrective action includes tray recall, employee re-education, reinforcement of the process, and take immediate action of delinquencies. j. The SPDM commenced the maintenance of the washer and ultrasonic machine, per manufacturer’s instructions in the decontamination room on December 11, 2024. k.The washer-disinfector step-by-step maintenance data will be tracked, trended, and reported to the Quality Cabinet monthly for one year by the SPDM, with oversight by the CNO. l. The brown residue in sterilizer 1 and 2 will be removed by a contracted vendor. The vendor has been contacted and will be onsite December 14, 2024. m.The steam sterilizers will be professionally cleaned biannually per hospital policy. 2. Surgical instruments in the major and minor trays were damaged or stained. a. The hospital leadership met with the Infection Preventionist and the SPDM iimmediately following the survey to review the findings regarding the processes to prevent, control, and investigate infections. b. The policy and procedure title “Tray Assembly for Sterilized Instrumentation” was reviewed on December 11, 2024, to identify any potential steps not completed in the appropriate assembly of sterilized instrumentation per infection control standards and manufacturer’s instructions. Reviewed policy presented for approval to the Infection Control Committee, Medical Executive Committee (MEC) on December 12, 2024, and the governing body on December 13, 2024. c. The SPDM initiated inspections of all major and minor trays for damages and stains using the “Assembling and Inspecting Instrument Sets” checklist. Identified damaged and stained instruments have been removed from service December 12, 2024 d. All elective surgeries were postponed until Immediate Jeopardy is lifted by CMS. e. SPDM contacted a vendor to inspect, repair, and refurbish all surgical instruments as needed. All defective items will be removed on December 13, 2024, from service to ensure the integrity of all surgical instruments. The vendor services will be provided twice a week, and on an ongoing basis. f. The Quality Cabinet will track, trend, and monitor for 100% compliance. 3. Hospitals’ hang times for endoscopes were outdated, and the manufacturer’s instructions for use were not followed when reprocessing the scopes. a. During the survey, three endoscopes were identified to be outdated. To correct this deficiency; all scopes were reprocessed per manufacturer’s guideline on December 12, 2024. b. The manufacturer’s instruction for step-by-step process for Maximum Hangtime without use include but not limited to: - Leak Testing - Manual Cleaning (all steps) - Rinsing after cleaning - Visual inspection - High-Level Disinfection - Alcohol Flush - Store in designated area c. The policy for disinfecting endoscopes was reviewed to ensure compliance with AORN and AAMI infection control standards. The policy adhered to the standards, The policy had been presented for approval to the Infection Control Committee and revisions were not indicated, and the review date was changed to December 9, 2024. Medical Executive Committee (MEC) on December 12, 2024, and the governing body on December 13, 2024. d. The SPDM provided the GI technician with an in-service training on the step-by-step process based on manufacturer’s instructions for the maximum hangtime without use on December 12, 2024. The in-service training also included an emphasis on the endoscopic hangtime, and the visual tags are checked for date of process to ensure compliance that the hangtime does not exceed 7 days. e. The SPDM/designee will inspect the endoscopes daily to determine complianc with hangtime. All endoscopes will be entered into a log with 1) date of processing and 2) date the endoscope requires reprocessing, if not used. Results will be reviewed on a weekly basis. Expectation is 100% compliance. In any event, if the scope is found to be outdated, it will be immediately reprocessed, and GI technician will be in-serviced and re-educated. f. The Quality Cabinet will track, trend, and monitor the data for 100% compliance. Data will be presented monthly for one year by the SPDM, with oversight by the CNO. 4.There were missing ceiling tiles in the sterile processing department. a. The Engineering Department contained the ceiling where tiles were missing on 12/11/24. b. The ceiling tiles has been replaced on 12/12/24. c. Terminal cleaning had been performed after ceiling tiles were replaced, then approved by the Infection Preventionist in accordance with the ICRA. d. Inspection of the ceiling tiles in SPD/ASC will be incorporated into EOC rounding to determine 100% compliance. e. Data will be tracked, trended, and reported to the EOC Committee and Quality Cabinet monthly. f. Data will be tracked, trended, and reported to the Quality Cabinet monthly. 28154”

“REHABILITATION SERVICES CFR(s): 482.56 If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients. This Condition is not met as evidenced by: 38612 Based on interview and record review, the facility failed to ensure the Rehabilitation Services Department (RSD) was organized and staffed when: 1. There was no adequate staff to provide physician-ordered occupational therapy (OT) evaluations to nine of 11 patients (Patients 1, 3, 4, and Random Patients [RP] 43, 44, 45, 46, 47, and 64) and speech therapy (ST) evaluations to two of four patients (Patient 20 and RP 64). This failure resulted in the inability of the hospital to furnish rehabilitation services to the patients in a timely manner. (Refer to A-1124) 2. The RSD did not have a qualified Director of Rehabilitation Services. This failure resulted in a lack of oversight to the RSD which was understaffed and unable to complete physician-ordered OT and ST evaluations. (Refer to A-1125). The cumulative effects of these systemic issues resulted to the hospital’s failure in ensuring the patients’ health and safety and in meeting the statutorily mandated Condition of Participation for Rehabilitation Services.”

“Special Medical Record Requirements CFR(s): Condition of Participation: Special Medical Record Requirements for Psychiatric Hospitals The medical records maintained by a psychiatric hospital must permit determination of the degree and intensity of the treatment provided to individuals who are furnished services in the institution. This Condition is not met as evidenced by: 39051 Based on observation, interview and record review the hospital failed to maintain medical records adequate to determine the degree and intensity of the treatment provided to the GeroPsych Unit patients with a patient census of 18 as evidenced by: 1. The hospital failed to ensure safe, effective, and secure method of communication with the doctors in the psychiatric unit when mobile phone, commercial emails and unsecured meeting platforms were used to transmit and conduct confidential patient care issues. This patient information was not linked or downloaded to the patient’s medical record. These unsafe practices could contribute to the loss or compromise of behavioral health patients’ confidentiality and privacy (Refer to tag A-0147). Failure to integrate documentation of patient care issues with the patient’s medical record risks vital patient care concerns and directives being inaccessible to all members of the health care team. 2. Records lacking social work assessments with social work treatment plans (Refer to Tag A-1625), lacking adequate screening neurological exams (Refer to Tag A-1626), lacking psych evals with non-psychiatric medical histories (Refer to Tag A-1632), and discharge summaries lacking physical and functional condition of the patient on day of discharge (Refer to Tag A-1672), are inadequate to determine the degree and intensity of the treatment provided. 3. Dictated psych evals, progress notes and discharge summaries contained one or more blanks for seventeen of nineteen patients (Patients 14, 15, 16, 17, 66, 67, 71, 72, 73, 75, 76, 77, 85, 87, 88, 89, 90). Failure to obtain the missing words from the author and return an amended dictation for authentication (sign/date/time) risks vital patient care documentation being inaccessible to all members of the health care team. 4. Treatment plan forms are reused from prior patients and six of nineteen patients (Patients 14, 17, 66, 67, 71, 90) are documented with previous patients’ names and gender references not reflective of the patient in question. Correction attempts in some instances do not conform to requirements for a medical legal document (line through, note “error,” initial and date). Such discrepancies call into question whether the treatment plan is individualized to the particular patient. The cumulative effects of these systemic failures is compromise to the hospital’s ability to provide safe, effective, and patient-centered care for its GeroPsych Unit patients with a census of 18. Missing or incomplete documentation undermines the hospital’s ability to accurately assess and document the degree and intensity of care provided. This failure hampers continuity of care and effective treatment planning. Reuse of treatment plan forms with incorrect patient identifiers (e.g., names, genders) and improper correction methods create doubt about the validity and accuracy of care plans. This failure calls into question whether care is truly patient-centered and aligned with regulatory and legal documentation standards. The risk in making essential patient information unavailable to the healthcare team is that it could lead to miscommunication, delays in care, or errors in treatment decisions.”

“Special Staff Requirements CFR(s): Condition of Participation: Special Staff Requirements for Psychiatric Hospitals The hospital must have adequate numbers of qualified professional and supportive staff to evaluate patients, formulate written, individualized comprehensive treatment plans, provide active treatment measures and engage in discharge planning. This Condition is not met as evidenced by: 28225 Based on observation, interview, and record review the facility failed to meet Condition of Participation: Special Staff Requirements for Psychiatric Hospitals when: 1. Psychiatrist (MD 2) failed to maintain a comprehensive assessment and evaluation for 18 of 18 sampled psychiatric patients Refer A-1685 2. Psychiatrist (MD 2 did not have any in person encounters with patients, and/or staff; and had limited or no communications with patients, staff, conservators or patient representative(s). Refer A-1685, A-1688 3. Psychiatrist (MD 2) failed to maintain coordination and communication with discharge planning for 18 of 18 psychiatric patients Refer A-1688 The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment.”

“LICENSURE OF HOSPITAL CFR(s): 482.11(b) The hospital must be - o Licensed; or o Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals. This Standard is not met as evidenced by: 38764 Based on observation, interview and record review, the hospital failed to ensure meeting the standards for licensing by the state agency responsible for licensing the hospitals. 1. The hospital failed to notify the California Department of Public Health (CDPH) Licensing and Certification regarding the closure of the hospital’s nuclear medicine (use to diagnose and treat variety of diseases by using a radioactive agent) services. 2 . The hospital’s podiatry services were not being provided by the hospital as shown in the hospital’s license issued by CDPH. These failures to adhere with the state licensure requirements resulted to a potential delay of care. Findings: 1. During a review of the All Facilities Letter (AFL) 21-04 dated 1/13/21 issued by the CDPH, showed effective January 1, 2021, AB 2037 (Chapter 95, Statutes of 2020) increases the timelines for the notices a hospital must provide to the CDPH, the local government entity in charge of the provision of health services, all health care service plans or other entities under contract with the hospital to provide services to enrollees of the plan or other entity, and the public of planned reductions or eliminations of emergency medical services, hospital closures, or the relocation or elimination of supplemental services. During a review of a hospital record (undated), showed the hospital’s Nuclear Medicine department was last used on 9/15/22. During a review of a hospital record signed on 7/26/23, showed a letter addressed to the CDPH Radiological Health Branch showing the hospital had ceased the nuclear medicine procedures on 8/30/22. During a review of the hospital’s licenses issued by CDPH with an effective dates of 1/1/23 and 1/1/24, showed the hospital was approved for Nuclear Medicine services. During a concurrent interview and tour of the hospital on 12/9/24 at 10:45 am with the Radiology Services Manager, a sign was observed showing “1200 Nuclear Medicine.” The Radiology Services Manager was asked about the services provided by the nuclear medicine department. The Radiology Services Manager stated the department had been closed for a while. The Radiology Services Manager further stated the manager did not know the actual closure date of the hospital’s Nuclear Medicine Department. During an interview on 12/13/24 at 12:35 PM with the HA, the HA acknowledged hospital closed the nuclear medicine department on 2022. The HA was asked if the hospital notified CDPH Licensing and Certification about the closure of the nuclear medicine department. The HA stated the HA was not sure or could have been an oversight of the hospital if CDPH was notified about the closure of the nuclear medicine department. During an interview on 12/18/24 at 8:30 AM with the CQA 1 , the CQA verified the hospital did not have a record to show CDPH was notified about the closure of the hospital’s Nuclear Medicine department.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to implement its policies to ensure the medical staff was accountable to the governing body for quality of care when one of three sampled physician peer reviews was not completed (refer to A-347 Part 1), when one of one sampled incident reports involving the medical staff did not have a documented resolution and was not copied to the medical staff office (refer to A-347 Part 2), and when five of six sampled medical staff files (Providers 1, 3, 4, 6, and 7) did not have OPPE (ongoing professional practice evaluation, a summary of provider-specific quality data) within the past year (refer to A-340 and A-347 Part 3). The deficient practices limited required reviews of physician quality, and therefore had the potential to allow substandard care to go unnoticed and unchanged for future patients.”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d) The institution must have an overall institutional plan that meets the following conditions: (1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles. (2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense. (3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable. (4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following: (i) Acquisition of land; (ii) Improvement of land, buildings, and equipment; or (iii) The replacement, modernization, and expansion of buildings and equipment. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to include detailed sources of financing as well as planned expenditures for building improvements at its satellite campus on the capital plan. The deficient practice had the potential to reduce stakeholder input and accountability regarding prioritization of financial resources. Findings: Review of the facility’s hospital license (effective 1/1/24 through 12/31/24) indicated the hospital had a satellite campus in Moss Beach referred to as “AHMC Seton Medical Center Coastside”. Review of the facility’s governing body minutes dated 10/28/24 indicated building improvements were in progress at Seton Coastside. Review of the facility’s undated “SIX YEARS BUSINESS PLAN” indicated the listing of capital projects did not include expenditures for building improvements at Seton Coastside. The capital plan indicated, “private funding for all projects”, but did not provide additional detail regarding the anticipated sources of financing. In an interview on 12/12/24 at 9:35 a.m., the Hospital Administrator (HA) stated there was no additional detail regarding the source of funds for capital projects other than the funds were private. The HA stated building improvements at Coastside were not considered a capital project because the storm damage there was being handled as an insurance claim. The HA stated the projected dollar amount for repairs to Coastside was fifteen to twenty million dollars. In an interview on 12/12/24 at 2:01 p.m., the HA stated building improvements at Coastside were a remedial project, were not listed as a capital project, and were being handled through an insurance claim.”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d)(7) The plan must be prepared- o Under the direction of the governing body; and o By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to have its budget and capital plan prepared by a committee consisting of representatives from the governing body, medical staff, and hospital administration. The deficient practice limited stakeholder input and consensus building necessary to ensure allocation of financial resources met facility and patient needs. Findings: Review of the facility’s undated “SIX YEARS BUSINESS PLAN” indicated the document included a budget and a line listing of capital projects. No notations were present indicating who developed the document or when. In an interview on 12/12/24 at 9:21 a.m., the hospital administrator (HA) stated there is no formal committee for the budget and capital plan, but the chief of the medical staff is very involved. In a concurrent interview and record review on 12/12/24 at 2:40 p.m., the HA stated the medical executive committee (MEC) minutes show the chief of staff’s involvement in the capital plan and provided a stack of documents to the surveyor. Review of the documents provided by the HA indicated they included MEC minutes dated 1/24/23 in which the president-elect of the medical staff and the HA informed the MEC of the status of capital expenditures and the MEC voted to approve $500 donations to two charities as well as $5000 in attorney fees to attempt to gain control of unreleased funds from a foundation. An undated document titled “CARDIOLOGY AS A PRIORITY SERVICE LINE” indicated hospital administration and the facility’s parent company had met on 5/17/24 and decided on capital expenditures for the cardiac catheterization lab (cath lab). MEC minutes dated 5/28/24 indicated hospital administration presented an update regarding building improvements, and the president-elect of the medical staff presented an update regarding improvements to the cath lab. MEC minutes dated 9/24/24 indicated the HA informed the MEC of planned capital expenditures. None of the documents presented by the HA contained evidence of joint decision making regarding the overall budget and capital plan by representatives of hospital administration, medical staff, and governing body within the past year.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to monitor the performance of two of two teleradiology contractors. The deficient practice created the potential for inaccurate interpretation of diagnostic imaging to go unnoticed and continue unchanged for all patients receiving services from the teleradiology contractors. Findings: In an interview on 12/11/24 at 1:33 p.m., the Lead Medical Staff Coordinator stated the facility had a contract with Radiology Contractor 1 (RC 1) to provide overnight interpretation of diagnostic imaging and the facility relied on RC 1’s credentialing decisions. Review of the facility’s contract with RC 1 dated 8/20/24 indicated, “Group understands that Facility may on an ongoing basis desire to obtain information and data related to the quality of Telemedicine Services provided by Group providers to Facility patients as part of its Quality Improvement (“QI”) program. Upon request of Facility to this Agreement, Group and its providers hereby agree to provide a reasonable amount of quality-related information and data for Group provider performing Services... Performance improvement indicators will be developed, tracked, and maintained by Facility.” In an interview on 12/17/24 at 11:11 a.m., the Radiology Manager (RM) stated the facility had two contracts for teleradiology. The RM stated Radiology Contractor 2 (RC 2) provided diagnostic imaging interpretation 8AM to 10PM seven days a week, RC 1 provided diagnostic imaging interpretation overnight. The RM stated he was new, had not yet developed a routine regarding performance indicators, and did not have access to what his predecessor had done. Review of the facility’s undated list of physician contracts indicated it included RC 2. In an interview on 12/17/24 at 2:15 p.m., Clinical Quality Analyst 1 (CQA 1) stated he would ask the RM regarding performance indicators for the RC 1 & RC 2 contracts. CQA 1 stated he did not think he had any information regarding the two contractors. In a concurrent interview and record review on 12/17/24, CQA 1 stated, “These are the quality metrics for [RC 1] and [RC 2].” Review of the documents provided by CQA 1 indicated they included two undated flowcharts describing the adoption of hospital and departmental policies (“Hospital Policy Flowchart” and “Departmental Policy Flowchart”), an undated listing of “Policy and Procedure Owners and Approvers”, a line listing of mortality reviews for September 2024 dated 10/17/24, a line listing of mortality reviews for October 2024 dated 11/13/24, a line listing of mortality reviews for November 2024 dated 12/10/24, a line listing of quality reviews for October 2024 dated 11/13/24, and a line listing of quality reviews for November 2024 dated 12/10/24. No metrics describing the performance of either teleradiology contractor were present. Review of the line listings of mortality and quality reviews indicated no conclusions regarding the performance of either teleradiology contractor were present. In an interview on 12/18/24 at 1:38 p.m., CQA 1 stated he thought the document he had provided was wrong, the chief health officer was calling the contractors to obtain performance indicators, but the contractors had not responded yet. The facility had provided no further information regarding the teleradiology contractors at the conclusion of the survey on 12/19/24 at 3:55 p.m.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 17334 Based on interview and document review the facility failed to ensure quality matrix were included in the contract with Vendor 1, a blood bank establishment. The hospital did not evaluate the contract through their quality program to identify potential quality concerns and risks to ensure patient safety. Findings: On 12/09/24 at 2:15 p.m., the Director of Laboratory Services (DLS) was asked if the hospital had a blood bank, or they had a contract. She stated, they did not have a blood bank, they were receiving blood for transfusions from Vendor 1. The DLS was not aware of any contracts. She did not know the process for the blood bank activities. On 12/17/24, a request was made from the leadership for any written agreement the hospital had related to blood bank services. On 12/17/24 at 1:40 p.m. the Clinical Quality Analyst (CQA1) presented a contract between Vendor 1 and Hospital A for blood products and services, signed 8/24/20, renewable every 12 months. The contract was reviewed for terms and to identify what performance standards and metrics were outlined. The contract contained no quality matrix and did not include quality indicators for the hospital to review or evaluate, to ensure the vendor adhered to quality standards. No data from the vendor related to blood bank quality was provided. In a follow up interview on 12/17/24 at 1:50 p.m. CQA 1 confirmed that the blood bank contract did not have any quality matrix. He stated the hospital was made aware by Joint Commission that the Quality requirement and matrix components were not built into their contracts, including the Blood Bank contract. The CQA stated, no quality data was collected from the blood bank and the hospital did not have any quality activity for monitoring of the contracted blood bank establishment.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to maintain an accurate listing of all contractors. Three of three listings of contractors provided by the facility were incomplete. The deficient practice had the potential to limit the facility’s monitoring of the omitted contracts to ensure quality and safety. Findings: Review of an undated listing of contract services provided by the facility indicated the listing included contracts with physicians and medical groups and an organ donor network, as well as contracts for perfusion (artificial circulation) and security. No other types of contracts were listed. In an interview on 12/10/24 at 2:25 p.m., Clinical Quality Analyst 2 (CQA 2) stated he was working on a list of all contracts. Review of a second, undated “List of Contracts” provided by CQA 2 indicated it included thirteen additional contracts beyond those on the initial list. In a concurrent interview and record review on 12/11/24 at 1:33 p.m., the Lead Medical Staff Coordinator (LMSC) stated the facility had a contract with Radiology Contractor 1 (RC 1) to provide overnight interpretation of diagnostic imaging and provided a copy of the contract. Review of the contract provided by the LMSC indicated it was an agreement between the facility and RC 1 dated 8/20/24 for telemedicine services. In a concurrent interview and record review on 12/12/24 at 9:08 a.m., Clinical Quality Analyst 2 (CQA 2) stated the facility only had one telemedicine contract. Review of the undated document “Telemedicine Services Provided” provided by CQA 2 indicated it included “Geropsychiatric” but not teleradiology. In an interview on 12/17/24 at 11:11 a.m., the Radiology Manager (RM) stated the facility had two contracts for teleradiology, and RC 1 provided diagnostic imaging interpretation overnight. Review of the three listings of contractors provided by the facility indicated none of them included RC 1. Review of a blood bank services agreement provided by the facility indicated it consisted of an amendment signed 8/24/20 to a contract signed 8/9/19 between Vendor 1 and the facility’s parent company. The amendment indicated the facility was added to the contract; the contract indicated it automatically renewed every 12 months until terminated by either party. Review of the three listings of contractors provided by the facility indicated none of them included Vendor 1.”

“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: 31794 Based on interviews and record reviews the facility failed to ensure the “An Important Message from Medicare (IM)” Notice was provided to 20 Medicare Beneficiary (MB) patients out of the 30 sampled patients when: 1. There was no documented evidence the IM Notice was provided on admission to six (6) of 20 MB patients (Patients 11, 14, 15, 16, 17, and 18). 2. There was no documented evidence the IM Notice was provided on admission to two (2) of 20 MB patients (Patients 8 and 26) who were “unable to sign” and did not have the signature of a legal representative on the IM Notice. 3. There was no documented evidence a copy of the IM Notice was provided upon discharge for three (3) of 20 MB patients (Patients 7, 9, and 26). 4. For Patient 2, the copy of the IM Notice was not provided in a timely manner upon discharge (“no more than two calendar days before the day of discharge and no less than four hours before the time of discharge,” as per facility policy). The copy of the IM Notice was provided to the patient on 12/4/24, five (5) days prior to discharge. These deficient practices had the potential for the hospitalized Medicare Beneficiary patients to not receive the necessary Medicare information as an inpatient and the information needed to make an appeal or request a review of the discharge decision if they wish to do so. Findings: 1. In an interview on 12/17/24 at 9:02 AM, with the Supervisor Patient Access (SPA 1), SPA 1 stated, after searching the Electronic Health Record (EHR) there were 20 Medicare Beneficiary (MB) patients on the list of the 30 sampled patients provided. SPA 1 explained, the document titled, An Important Message from Medicare or “IM” was the “first thing” the admission staff would give to the patients upon admission, the staff would explain what it was, and the patients would sign the form. The IM Notice was offered “immediately”, if not done the first day, it would be offered the next day because it has a “deadline”. The SPA 1 further stated, the IM has “information” so the patient could “appeal” if they want to. Review of the Form CMS (Centers for Medicare and Medicaid Services, is a federal agency that manages health programs in the United States) 10065-IM, with expiration date of 12/31/25 , “Important Message from Medicare” indicated, “Your Rights as a Hospital Inpatient: You can receive Medicare covered services. ... You can be involved in any decisions about your hospital stay. You can report any concerns you have about the quality of care you receive ... You can speak with your doctor or other hospital staff if you have concerns about being discharged ... .” In a concurrent record review and interview on 12/17/24, at 9:10 AM, with the SPA 1, the Face Sheet and the IM Notice were reviewed. The SPA 1 stated, Patient 11 was admitted on 12/7/24 and verified there was no signed IM Notice on file. The SPA 1 stated, Patient 14 was admitted on 11/2/24, currently inpatient on the 8th floor, and did not have a signed IM Notice on file. The SPA 1 stated, Patient 15 was admitted on 11/23/24, currently inpatient on the 8th floor, and verified there was no signed IM Notice on file, “I don’t see it”, “it was not offered.” The SPA 1 stated, Patient 16 was admitted on 10/27/24, currently inpatient on the 8th floor, and verified there was no signed IM Notice on file. The SPA 1 stated, Patient 17 was admitted on 8/2/24, currently was inpatient on the 8th floor, and verified there was no signed IM Notice on file. The SPA 1 stated, Patient 18 was admitted on 4/29/24 in the Intensive Care Unit (ICU, a special area in the hospital that require close observation and monitoring of critically ill patients) and was discharged on 4/30/24. The SPA 1 stated, it was a short stay but “we need the signed IM notice form too,” and she had gone through the EHR but did not see a signed IM Notice on file. Review of the facility’s Policy and Procedure (P&P) titled, “Important Message from Medicare (IM)”, with the last revised date of 12/19 indicated, “Purpose: “An Important Message from Medicare” (IM) Notice must be given at admission and prior to discharge. ... Upon admission the IM must be provided within two calendar days of admission, but no more than seven days before admission ... Policy: To assure that Hospital A meets the Medicare regulations related to initial and follow-up delivery of the Important Message from Medicare. ... .” 2. In a concurrent record review and interview on 12/17/24, at 9:27 AM, with the SPA 1, the Face Sheet and the IM Notice were reviewed. The SPA 1 stated, Patient 8 was admitted on 12/2/24 and the IM Notice had “pt (patient) unable to sign” handwritten on the line that asked for “Signature of Patient or Representative”, it did not have the patient and/or legal representative’s signature. The SPA 1 stated, Patient 26, was admitted on 11/16/24 and the IM Notice did not have the patient and/or legal representative’s signature, “pt (patient) unable to sign” was handwritten on the line that asked for Signature of Patient or Representative. The SPA 1 explained, the facility’s practice was to have a staff, a “Registered Nurse”, to sign the IM Notice as “witness” in the presence of the admission staff if the patient was unable to sign. The SPA 1 stated, that did not happen, there were no staff signatures on the IM Notice for Patients 8 and 26. The SPA 1 stated, she would search and provide the surveyor with the policy that supports the facility ‘s practice. No facility P&P was received by the surveyor. In an interview on 12/18/24, at 10:40 AM, with the Clinical Quality Analyst (CQA 1), a follow- up request was made for facility policy on patients who were incapacitated and/or unable to sign. The CQA stated, he would follow-up. In an interview on 12//19/24, at 11:15 AM, with the Corporate Quality Director. (CQD), CQD verified, the facility did not have P&P on how to proceed when the patient was unable to sign and/or incapacitated. Review of the facility’s P&P titled, “Important Message from Medicare (IM)”, with the last revised date of 12/2019 indicated, “The document Explanation of the IM must be completed and the beneficiary signature ... must be obtained as well. ... .” There was no mention of a witness signature required if the patient(s) was /were unable to sign. Review of the Form CMS 10065-IM, Important Message from Medicare indicated, “Please sign below to indicate you received and understood this notice”. “I have been notified of my rights as a hospital inpatient and that I may appeal my discharge by contacting my QIO (Quality Improvement Organization, is the independent reviewer authorized by Medicare to review the decision to discharge patient). There was a line that indicate, “Signature of Patient or Representative”, and the “Date /Time”. The IM Notice did not have a line that requires witness signature if patient was unable to sign or incapacitated. 3. In an interview on 12/18/24, at 11:10 AM, with the Director of Case Management, (DCM), DCM stated, the IM Notice was provided to the patients two days before discharge and patients have the right to “appeal” if they do not agree with the discharge. The DCM further stated, the staff would print the original copy of the IM Notice, a copy would be given to the patient before discharge, and once it was given to the patient the staff would document it on the Case Management Discharge Summary (CMDC), no signature of the patient was required. Review of the Form CMS 10065-IM, with expiration date of 12/31/25, Important Message from Medicare indicated, Your Rights to Appeal Your Hospital Discharge: You have the right to an immediate, independent review (appeal) of the decision to discharge you from the hospital. ... If you choose to appeal the independent reviewer will ask for your opinion. ... If the QIO finds that you are not ready to be discharge from the hospital, Medicare will continue to cover your hospital services. ... If you do not appeal, you may have to apply for any services you receive after your discharged date. ... “ In a concurrent record review and interview on 12/18/24, at 1:07 PM, with the DCM, the Face sheet and the CMDS, were reviewed. The DCM stated, Patient 7 was admitted on 12/10/24, was discharged on 12/13/24 and verified, there was no documentation a copy of the IM Notice was provided to the patient on discharge. The DCM stated, Patient 9 was admitted on 12/8/24, was discharged on 12/11/24 and there was no documentation a copy of the IM Notice was provided on discharge. The DCM stated, Patient 26 was admitted on 12/16/24, was discharged on 12/11/24, and there was no documentation the a copy of the IM Notice was provided on discharge. Review of the facility’s P&P titled, Important Message from Medicare (IM), with the last revised date of 12/19 indicated, “No changes as of 4/2020. CMS guidelines states that a copy of the original signed IM letter be delivered to the patient/family in advance of discharge, although no more than two calendar days before the day of discharge and no less than four hours before the time of discharge. ... 1. Procedure: ... 2. The CM (Case Manager)/designee will: A. Print a copy of the original signed IM from admission ... C. Document the date and time the copy of the IM letter was delivered ... .” 4. In a concurrent record review and interview on 12/18/24, at 1:30 PM, with the DCM, the Face sheet and the Patient Progress Notes (PPN) dated 12/4/24, were reviewed. The DCM stated, Patient 2 was admitted on 11/24/24, was discharged on 12/9/24 and stated, the copy of the IM Notice was provided on 12/4/24, five (5) days before discharge, it should be provided no more than two days before discharge as per policy. Review of the facility’s P&P titled, Important Message from Medicare (IM), with the last revised date of 12/19 indicated, “CMS guideline states that a copy of the original signed IM letter be delivered to the patient/family in advance of discharge, although no more than two calendar days before the day of discharge, and not less than four hours before the time of discharge. ... .””

“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: 28225 Based an interview and record review , the facility failed to ensure one ( Patient 13) of one sampled patients was safe during transport when the siderail was not up while Patient 13 was on the Magnetic Resonance Imaging (MRI),( a noninvasive medical imaging test that produces detailed images of almost every internal structure in the human body, including the organs, bones, muscles and blood vessels) gurney (a wheeled stretcher used for transporting hospital patients). The deficient practice resulted in a fall and a broken collarbone. Findings: During an interview on 12/11/24 at 12:30 PM, in the Radiology (a specialty that uses imaging techniques, such as X-ray (a type of radiation called electromagnetic waves. X-ray imaging creates pictures of the inside of your body) and ultrasound, to diagnose and treat a variety of conditions) MRI Department, MRI technician, (MRIT) 1 stated, Patient 13 was transported from his room to the Radiology MRI Department on a standard patient gurney. Patient 13 was on a MRI gurney for his procedure. During an observation and concurrent interview on, 12/11/24 at 12:30 PM, MRIT 1 stated, Patient 13’s procedure was done in Zone IV (four). MRIT 1 demonstrated and stated, the gurney that was used to transport Patient 13 to the Radiology MRI Department was positioned by the wall next to Zone III (three) during Patient 13 ‘s procedure. During an interview on 12/11/24 at 12:47 PM, MRIT 1 stated, after Patient 13’s procedure was completed, Patient 13 needed to be transferred from the MRI gurney back to the standard patient gurney to transport Patient 13 from the MRI Department back to Patient 13’s room. During an interview on 12/11/24 at 12:47 PM, MRIT 1 stated, as Patient 13 was wheeled out of Zone IV, towards the standard patient gurney, he (MRIT 1) was by the door of Zone IV, positioned at the foot of MRI gurney that Patient 13 was on. MRIT 2 was situated in the hallway of Zone 3 and Zone 4, at the head part the MRI gurney, Meanwhile, when Patient 13 was on the MRI gurney, Patient 13 laid on an air transfer mattress (allows caregivers to safely transfer patients on a cushion of air, without lifting or straining, which increases safety and reduces injury) that was inflated. During an interview on 12/11/24 at 12:47 PM, MRIT 1 stated, as Patient 13 was transported out of Zone IV, when Patient 13 was on the MRI gurney, the side rail was not up. Before he and MRIT 2 could transfer Patient 13 from the MRI gurney to the standard patient gurney, Patient 13 turned to his side and fell off the MRI gurney. During an interview on 12/11/24 at 12:47 PM, MRIT 1 stated, the siderail was down when Patient 13 was on the MRI gurney, the side rail should have been up. During an interview on 12/11/24 at 1:13 PM, the MRI Supervisor stated, when a patient is on a MRI gurney and transported, both MRI gurney side rails should be up. During record review of, Nursing Order Detail, Order Information, dated 6/25/24 15:45 (3:45 PM), For Patient 13, the Nursing Order Detail, Order Information, indicated, “Nursing Order: May go to MRI ...” During record review of, Xray Report, Shoulder, dated 6/25/24, 10:27 PM, For Patient 13, the Xray Report, Shoulder, indicated, “Exam right shoulder. Clinical History: Shoulder pain ... impression: Acute (sudden) displaced distal (farther away from the center of) clavicle( connects the shoulder blade to the breastbone) shaft fracture (a break in the bone). During an interview on 12/19/24 at 3 PM, the Clinical Quality Analyst (CQA 1) stated, Risk (Quality) Manager that reported facility incident CA00 FRI 932958 no longer worked at the facility. The facility could not find competency training for MRIT 1 and MRIT 2. CQA 1 stated, the facility used a video to train staff regarding the air transfer mattress, but the facility did not have a user manual for the air transfer mattress . In addition, CQA 1 stated, the facility did not he did not have a user manual for the MRI gurney equipment.”

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records. This Standard is not met as evidenced by: 40903 Based on observation, interview, and record review the hospital failed to ensure safe, effective, and secure method of communication with the doctors in the psychiatric unit when mobile phone, commercial emails and unsecured face to face application such as Zoom (a commercial video conference that allows users to connect online for meetings and live chat) and FaceTime (a video and audio calling service developed by Apple company that allowed users for live chat) was used to transmit and conduct confidential patient care issues with census of 62. These unsafe practices could contribute to and compromise patient’s confidentiality and privacy. Findings: During a concurrent interview and record review of Patient 48’s electronic medical record, on 12/18/24, at 1:12 PM, in psychiatric unit, accompanied by Registered Nurse 3 (RN 3), the record indicated the nursing staff communicated with the mental health Medical Doctor (MD 2) via phone call, text messages, Zoom meeting (a commercial video conference that allows users to connect online for meetings and live chat) and/or FaceTime (a video and audio calling service developed by Apple company that allowed users for live chat) using hospital’s smart phone devices. Further review of medical record’s admission documents indicated Patient 48 was re-admitted to hospital on 12/12/24 more than 24 hours after discharged from the hospital on 12/11/24. RN 3 stated the nursing staff called or texted MD 2 with patient updates and/or if new issues came up. RN 3 stated the documents that needed signature, were emailed, or faxed to the MD 2 by unit secretary. RN 3 stated MD 2 made his patient rounds by using the “FaceTime” audio/video to see and assess the patients while a nurse was holding the phone and going from one room to another. In an interview with Patient 48, in his room, on 12/18/24, at 1:44 PM, Patient 48 stated he had been hospitalized in this hospital in the past and had never seen MD 2 in person. Patient 48 stated MD 2 spent less than 2 minutes with him when nurses brought the phone to him, and he was in a rush all the time. In a concurrent observation and interview on 12/18/24, at 1:40 PM, in psychiatric unit, accompanied by RN 3, the hospital owned smart phone that had a “home button” (same as push button, an older model of the phone without the new security upgrades) was located at the nurse station and had text messages on its screen. RN 3 stated the doctors preferred text messages for routine non-urgent issues and for patient updates. RN 3 stated the smart phone was approved by the unit, belonged to hospital and was not a personal phone. RN 3 stated the staff should have used minimal information when sending text messages to the doctor. The review of the recent phone text messages exchanged with MD 2, from 12/14/24 to 12/1/24, included patient names, medical/mental condition, and laboratory results were as follow: [Definitions for terms used in the text communications: “5150 hold”: Psychiatric hold refers to an involuntary psychiatric detention for 72 hours, where someone experiencing a mental health crisis and held in a hospital) “5250 hold”: a legal term in California that refers to a 14-day involuntary mental health commitment, used when a person is deemed to be a danger to themselves or others due to a mental health condition and requires additional treatment and evaluation beyond the initial 72-hour “5150” hold. “DTS”: Danger To Self, As a result of mental disorder, the person must be suicidal or expresses significant harm to self or engage in behavior that puts him/her at serious Danger to Self. “CBC”: Complete Blood Count, a test that measured blood health.] Phone text communications with MD 2 who cared for patients on the psychiatric unit of the hospital: 12/14/24 at 12:44 PM: “Doctor (MD 2), we have a consent form to send you. Can we send it to your e-mail at ’ ... @Gmail.com’ Thanks.” The doctor’s response: “OK”. 12/15/24 at 7:33 AM: “Good AM Dr (MD 2), Pt [Patient 48], 5150 DTS expiring today at 13:54 (1:54 PM). Please send 5250. Thank you” 12/15/24, at 10 AM: “Hi Dr (MD 2) can we changed the level of observation for Patient 71 to Q5 (every 5) from LOS (Length of Stay)?” 12/15/24 at12:53 PM: MD 2’s response 5 hours later “Can I call you later?” Response: “okay Dr” “just reminder dr. for Patient 48, 5150 is expiring today at 13:54 (1:54 PM)” 12/16/24 at 7:43 AM “Good AM Dr (MD 2)! FYI, Patient 16 verbalized hopelessness “I have only 1 week to live.” No concrete plans. For close observation” “Dr (MD 2), I just emailed a packet of forms needing your signature- (staff name)” MD’s response: “ok” (no time stamp noted) “Hello Dr (MD 2). Good morning. Just wanna let you know that Pt Patient 48 and Patient 72 won the hearing, but they wanted to sign voluntary. Patient 48 wanted to leave next week. We will let you know during IDT (team meeting)” “Dr (MD 2) can we change Patient 73 to Q5 from LOS monitoring. He’s been calm and cooperative throughout the morning till afternoon. And can we also place Patient 67 on LOS monitoring from 1:1 (one on one) He has been calm and cooperative as well.” 12/16/24 at 4:26 PM; “Dr (MD 2) Patient 15 refuses to take his Clonazepam (drug used to reduce anxiety) and Abilify (mood altering drug) this evening. He says he feels weak and tired all day long and prefers to take it once a day only. Would you like to change the order? Thank you” “Dr (MD 2), CBC results of Patient 75 (for Clozaril) [Clozaril is a mind-altering drug] is pictured below”; Screenshot/photo of one page laboratory results dated 12/16/24 was on text page. 12/17/24 at 6:11 AM: “Good morning Just an update with Patient 76, She verbalized “I wish I was gone” during interview last night.” 12/18/24 at 5:50 AM: “Good morning, Dr (MD 2) Just an update with Patient 76, Pt still continues to be sad and depressed, still noted with poor appetite. Pt still continues to verbalize “I Just want to be gone.” 12/18/24 at 7:57 AM: “good morning, Dr (MD 2), Just update, Patient 48 last night during med pass he was very drowsy. I was able to give the Paxil (drug for depression) and Lamictal (used to stabilize mood) But have to omit some of his medications. Vitals WNL (Within Normal Limit and BG (Blood Sugar) is 99 last night ...”. “good morning, Dr (MD 2), update Patient 16 still complaining of having difficulty sleeping despite giving Ambien (sleep medication). According to him Ambien is not effective. He have 5 hours and 45 minutes of sleep last night. ...”. 12/18/24 at 10:29 AM: MD 2’s response “Can I call you later?” During a concurrent observation and interview, in psychiatric unit, on 12/19/24, at 12:38 PM, accompanied by Unit Coordinator (UC), the hospital owned smart phone was located on the front desk. The review of the recent text messages exchanged with Medical Doctor 3 (MD 3), from 12/18/24 to 12/19/24, included patient names, medical condition, and pictures of patient’s face and body part as follow: 12/18/24 at 10:51 PM: Patient’s picture (face with red rashes) on the screen; “Hi Dr (MD 3), can we get some ointment? Patient says it’s very itchy. Probably hydrocortisone (a topical steroid)?” 12/18/24 at 10:51 PM: Patient 77’s body part/skin image with red inflamed area posted on the screen with the patient’s name at the bottom of the photo: “Good evening, Dr (MD 3), Patient 77 is asking for nystatin powder (antifungal drug). Did you want to order nystatin powder or other order dr. Thank you”? 12/19/24 at 5:44 AM: MD 3’s response: “Apply nystatin cream bid (twice a day) x 30 days. An Lidoderm (a skin patch containing numbing drug) or lidocaine cream (numbing cream) every 6 hours PRN (as needed)” “to clarify: apply Lidoderm or lidocaine cream to the redden/irritated area.” MD 3’s response; “Either is ok.” “What would you like for me to put as indication for the nystatin cream? How about for the Lidoderm? “checking with pharmacy if they have lidocaine cream or Lidoderm.” “Orders entered. Thank you, Dr!” The UC stated they had multiple group chats for team communication including communication with the doctors. UC stated the group chat for staffing (filling work shifts), or referral (accepting new patient) used the staff’s personal phone. UC stated she was not sure how nurses transferred doctor’s text communication notes into the medical record. In a telephone interview with Medical Doctor 2 (MD 2), on 12/19/24, at 10:42 AM, MD 2 stated he was the director of the Geriatric-Psychiatric unit (or Geri-Psych unit, a unit that cared for elderly with mental health issues) and he communicated with psychiatric unit staff and patients via smart phone and the use of the face-to-face communication method. MD 2 stated the staff should not be using patient specific information in the text communication and should be calling for urgent issues. MD 2 stated he was using Zoom and/or FaceTime for communication and it was a safe system of communication. MD 2 stated he covered the Geri-Psych unit every day and he had been on call to address any urgent patient care issues. In an interview with Social Worker 1 (SW 1), on 12/19/24, at 12:54 PM, the SW 1 stated the Geriatric-Psychiatric unit was using Zoom to conduct team meeting with MD 2 and used the smart phone’s FaceTime for MD 2 conduct his patient visit. SW 1 stated they were told the phone text messages and Zoom communication were compliant with patient privacy rules and regulations. SW 1 stated the staff used own smart phone as they were not given hospital owned phones. SW 1 stated she was not aware if the patients were warned prior to admit that mental health doctor care was not in-person, and it was via tele-health (doctor and patients interacted and received care without being physically present in the same location) audio/visual communication. In an interview with hospital’s Director of Information Technology (DIT), on 12/19/24, at 1:31 PM, outside of the conference room, the DIT stated the hospital had been trying to get a secure communication platform or software to incorporate it into the electronic health record and smart phone technology owned by the hospital. The DIT stated, to the best of his knowledge, the smart phone communication without secure software was not safe to communicate patient information. The DIT stated the medical and clinical staff should have used hospital email to communicate and exchange confidential information and they should not have sent confidential information to the personal email of a doctor that worked for the hospital. The DIT stated the hospital had not drafted a policy on safe use of facility owned smart phone on texting or audio-visual communications among health care providers and doctors. In a concurrent interview with Chief Nursing Officer (CNO) and Chief Health Officer (CHO), on 12/19/24, at 2:41 PM, outside of the conference room, the CNO stated the staff should not have used smart phone text messages to communicate patient information with the doctors. The CHO stated the hospital was looking into getting a secure software for text messaging and staff should have called the doctor to communicate patient sensitive information. Review of hospital policy titled “Confidentiality, Privacy and Data Security of Patient Information”, last revised on 3/2017, the policy indicated “Confidentiality is defined as ... Any document/record that contains treatment and/or medical information that is “patient identifiable”- i.e. contains a patient name, medical record number, or account number.” The hospital did not provide any policy, procedure, or guide on use of smart phone text messaging and internet enabled audio-visual platforms for communication among hospital care givers and providers.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) 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 improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility’s governing body failed to approve the performance indicators being used by the facility. For one of three sampled performance indicators (pain reassessment), the facility failed to collect data at the specified interval, check results at different points in time, include the emergency department (ED), and break down the results by the units which were included. For one of three sampled performance indicators (ED length of stay, ED LOS), the facility failed to specify the methods of data collection and aggregation and ensure that the data were collected according to specifications. The deficient practices eliminated board-level decision-making regarding what priorities the facility’s quality assessment and performance improvement (QAPI) program would have, created ambiguity regarding its data, and limited the analysis of that data, creating the potential to limit the effectiveness of the QAPI program. Findings: 1. Review of ten undated “2024 Performance Improvement Quality Indicator Worksheet[s]” indicated each described two performance indicators for a hospital department. Each worksheet contained a field for “QM Director (2nd Review)” which had been left blank, none of the sheets indicated it had been reviewed or approved by the governing body. Review of an undated “Performance Improvement Report (CY 2024)” indicated it included three dashboards for core measures regarding the emergency department (ED), sepsis, and stroke which all contained no data. A fourth dashboard regarding hospital-based inpatient psychiatric services (HBIPS) core measures indicated all values were zero. No notation was present regarding who had approved the performance indicators included on the dashboards. In an interview on 12/12/24 at 2:03 p.m., Clinical Quality Analyst 2 acknowledged the quality dashboards contained no data. He stated the facility was “building it out,” the process had started in November and was discussed in “the last quality minutes.” Review of the facility’s quality cabinet minutes dated 11/24/24 indicated the dietary and health information management departments had presented their performance measures. No approvals of the presented measures were noted, and no discussion of the core measures regarding ED, sepsis, stroke, or HBIPS was documented. Review of the quality cabinet minutes dated 8/28/24 indicated the committee discussed the facility’s core measures for the first and second quarters of 2023, discussed measures required by CMS (Centers for Medicare & Medicaid Services) for 2024, and discussed reinstatement of hospital-wide performance improvement measures and the need for performance improvement projects. No determination or approval of performance indicators to be used for 2024 was documented. In an interview on 12/17/24 at 12:01 p.m., Clinical Quality Analyst 1 (CQA 1) stated the quality cabinet reports to the medical executive committee (MEC), which reports to the board. CQA 1 stated he didn’t think the surveyor would be able to locate governing body approvals of the performance indicators, but he would check. In an interview on 12/17/24 at 1:34 p.m., the Chief Health Officer (CHO) stated he is a guest at the MEC, and quality cabinet minutes, findings, and conclusions are presented there. The CHO stated the chief of staff runs MEC and has a seat on the board, he presents a summary and highlights of MEC to the board and the board approves. The CHO stated he had been requested to present information to the governing body regarding length of stay, survey findings, CMS star ratings, and medical records delinquencies. When the surveyor asked the CHO to show specific governing body approval of the performance indicators being used by the facility, the CHO stated it would be in the form of an e-mail from the assistant administrator requesting a certain topic or a request for a review from the MEC. When the surveyor asked if there was documentation the governing body, rather than the assistant administrator or MEC, had approved specific metrics, the CHO replied, “I have not seen a list.” Review of the facility’s governing body minutes dated 11/8/23, 12/13/23, 1/17/24, 2/14/24, 3/13/24, 4/17/24, 5/22/24, 6/12/24, 7/10/24, 8/14/24, 9/11/24, and 10/28/24 indicated the governing body had approved MEC minutes, MEC recommendations regarding medical staff, quality cabinet minutes, and policies and procedures. None of the governing body minutes included governing body approval of specific performance indicators. The facility had provided no further information regarding governing body approvals of its performance indicators at the conclusion of the survey on 12/19/24 at 3:55 p.m. 2. Review of an undated “2024 Performance Improvement Quality Indicator Worksheet” indicated the medical/surgical telemetry unit would conduct weekly audits of the percentage of patients receiving pain management who have a documented pain level reassessment after intervention. No quality indicator worksheet was present for the ED. Review of a “Pain Management Audit” worksheet dated 12/10/24 indicated the data had been collected for the “Week/Month of 12/10/24”. The worksheet indicated Audit frequency and duration: Monthly until 100% compliance is achieved; then every month for 3 months until 100% is compliance [sic] achieved; then annually.” Review of a summary of “Pain Management Compliance” dated April - July 2024 indicated “Pain Level Reassessed and Documented” was 75.43%.. The document did not include results for different points in time or a breakdown by unit. In an interview on 12/18/24 at 9:07 a.m., CQA 1 stated the nurses did pain management audits almost daily, and sent stacks of audit worksheets to the quality department. In an interview on 12/18/24 at 11:02 a.m., CQA 1 stated the pain management audits were monthly, but the facility was doing them daily. CQA 1 stated the only services included in the pain management audit were ICU (intensive care unit) and the medical/surgical units. CQA 1 stated the facility did not have comparisons of the results at different points in time, and there was no breakdown by unit. 3. Review of an undated slide deck titled “ED Throughput 2.0” indicated the facility’s ED LOS had been calculated on 9/3/24 for the time periods June 2024, July 2024, and August 2024. No information was present regarding how the ED LOS metric was defined, or how the data were collected, aggregated, or validated. Review of the facility’s “ED THROUGHPUT” minutes dated 1/23/24 indicated, “The Definition of Data Management points and the significance of accurate data for effective decision-making was emphasized. There are concerns about data quality and the need for reliable information.” Review of the “ED THROUGHPUT” minutes dated 3/1/24 indicated, “An overview of the current data highlighted issues with data accuracy...” In an interview on 12/18/24 at 1:52 p.m., the Director of Emergency Department (DED) stated she accessed LOS data on the intranet and couldn’t answer regarding the process for generating the data. The DED stated she didn’t know if the data came from the corporate office or the quality department. In an interview on 12/19/24 at 11:01 a.m., the DED stated all ED throughput data are generated at the corporate level, she accessed it through a portal. The DED stated the data was pulled from the electronic medical record system, but she did not know how to navigate the details of that process. The DED stated she did not know how often the data were collected, she was guessing daily, and the ED staff were not involved in data collection other than being responsible for accurate documentation in the medical record.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 26674 Based on interview and record review, for one of three sampled performance indicators (pain reassessment), the facility failed to measure whether its efforts to modify the results were effective. The deficient practice had the potential to allow ineffective performance improvement activities to continue indefinitely. Findings: Review of a summary of “Pain Management Compliance” dated April - July 2024 indicated “Pain Level Reassessed and Documented” was 75.43%.. The document did not include results for different points in time. In an interview on 12/18/24 at 11:02 a.m., Clinical Quality Analyst 1 (CQA 1) stated the goal for pain reassessments was 100%. CQA 1 stated the follow-up to the data showing the actual rate was below the goal was that the chief nursing officer presented the data in daily huddles, and there was no documentation of the daily huddles. CQA 1 acknowledged there was no comparison of the pain management compliance data over different points in time.”

“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: 26674 Based on interview and record review, the facility failed to monitor implementation of its corrective actions for one of two sampled patient safety events, a patient fall in radiology. The deficient practice had the potential to allow unsafe practices identified by the facility’s own analysis to continue unchanged, creating the risk for injury for future radiology patients. Findings: Review of a “Root Cause Analysis POC [plan of correction] Follow-up” dated 7/23/24 indicated in follow-up to a patient fall in radiology, the facility revised its policy regarding safe patient transfer to emphasize use of siderails on gurneys, developed on-line training for all staff, and in-person training and a post-fall algorithm for staff involved in the incident. The document did not indicate the facility had verified whether its staff were implementing the revised practices addressed in the policy change and training. In an interview on 12/16/24 at 2:41 p.m., Clinical Quality Analyst 1 (CQA 1) stated the facility had created “LMS training” (learning management system, a portal for on-line training) and was “following up on LMS compliance” (whether staff were completing the required training). CQA 1 stated there was monthly reporting in the facility’s quality cabinet regarding falls and that “the radiology department will present quarterly compliance with policies related to falls.” CQA 1 stated he did not know whether he could find what had already been done regarding staff compliance with policies because the director of radiology had accepted a new position, the trainer was out on a family emergency, and the new radiology manager and supervisor were settling in. The Risk and Quality Leader (RQ) stated the facility had discussed the need to update its transfer policy and had conducted training for transporters. CQA 1 stated the documents provided to the surveyor reflected “all we’ve done so far.” In an interview on 12/16/24 at 2:55 p.m., CQA 1 acknowledged the ideal would be to check if the side-rails were now up.”

“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: 26674 Based on interview and record review, the facility’s governing body failed to approve the “PERFORMANCE IMPROVEMENT PLAN 2024” and failed to determine the number of performance improvement projects to be conducted. The deficient practices eliminated board-level oversight and priority settting for the facility’s quality asessment and performance improvement (QAPI) tasks, thereby creating the possibility the facility’s QAPI activities would either focus on the wrong areas or lack focus. Findings: Review of the facility’s “PERFORMANCE IMPROVEMENT PLAN 2024” (revised 12/23) indicated the responsible person was the “Director, Quality”. No notation was present on the document indicating it had been approved by the governing body. In a concurrent interview and record review on 12/10/24 at 2:37 p.m., Clinical Quality Analyst 2 (CQA 2) stated the quality indicator worksheet contained the list of performance improvement projects. Review of the document provided by CQA 2 indicated it included ten undated sheets, each titled, “2024 Performance Improvement Quality Indicator Worksheet”, each describing two performance indicators. Each sheet contained a field for “QM Director (2nd Review)” which had been left blank, none of the sheets indicated it had been reviewed or approved by the governing body. In an interview on 12/17/24 at 12:01 p.m., Clinical Quality Analyst 1 (CQA 1) stated the quality cabinet reports to the medical execuitve committee (MEC), which reports to the board. CQA 1 stated he didn’t think the surveyor would be able to locate governing body approvals of the performance improvement plan and number of performance projects, but he would check. In an interview on 12/17/24 at 1:34 p.m., the Chief Health Officer (CHO) stated he is a guest at the MEC, and quality cabinet minutes, findings, and conclusions are presented there. The CHO stated the chief of staff runs MEC and has a seat on the board, he presents a summary and highlights of MEC to the board and the board approves. When the surveyor asked the CHO to show specific governing body approval of the performance improvement plan and number of performance improvement projects, the CHO stated he had not seen a number of performance improvement projects or a listing of their topics. The CHO did not directly address the surveyor’s request to show governing body approval of the performance improvement plan, but instead stated QAPI issues were presented in committees which rolled up to the governing body. Review of the facility’s governing body minutes dated 11/8/23, 12/13/23, 1/17/24, 2/14/24, 3/13/24, 4/17/24, 5/22/24, 6/12/24, 7/10/24, 8/14/24, 9/11/24, and 10/28/24 indicated the governing body had approved MEC minutes, MEC recommendations regarding medical staff, quality cabinet minutes, and policies and procedures which did not include the performance improvement plan. None of the governing body minutes included governing body approval of the performance improvement plan or a governing body determination of the number of performance improvement projects to be conducted. The facility had provided no further information regarding governing body approvals of the performance improvement plan and number of performance improvement projects at the conclusion of the survey on 12/19/24 at 3:55 p.m.”

“ELIGIBILITY & PROCESS FOR APPT TO MED STAFF CFR(s): 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope of practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to follow its own policies regarding oversight of one of one sampled nurse practitioner (NP, Provider 5). The facility did not perform proctoring within the required time period and did not ensure Provider 5 had current malpractice coverage. The deficient practice eliminated sources of early warnings of potential problems, creating the potential to allow substandard care by a newly appointed NP to escape notice and continue unchanged for future patients. Findings: Review of Provider 5’s credentials file indicated she was appointed to the facility’s allied health professional staff on 5/10/23 for a two year term. Provider 5’s appointment letter dated 5/11/23 indicated, “In order to ensure competence, proctoring is required for all new practitioners... Proctoring Instruction: First 6 cases must be proctored. If applicable, you will need to contact your proctor(s) in advance and make arrangements to be proctored prior to scheduling your case(s). Attached are the procedures for which proctoring is required and the forms for your use. You should submit the completed forms are submitted [sic] to the Medical Staff Services Department following each proctored case. Please note proctoring is required until the recommendation is received from your proctor to waive further proctoring. Your proctor(s) are also required to perform retrospective chart reviews.” Provider 5’s “Clinical Privileges” dated 5/10/23 to 4/25/25 indicated her nurse practitioner standardized procedure had been “Granted with Proctoring”. No proctoring reports were present in Provider 5’s file. Provider 5’s malpractice insurance certificate indicated “Policy Period: From: 12/08/2023 To: 12/08/2024”. In an interview on 12/11/24 at 1:45 p.m., the Lead Medical Staff Coordinator (LMSC) stated he would have to check for Provider 5’s proctoring reports. After reviewing Provider 5’s file, the LMSC stated, “She may still be on it [proctoring] for all I know.” In an interview on 12/11/24 at 2:10 p.m., the LMSC acknowledged Provider 5’s malpractice insurance certificate was expired. Review of the facility’s “ALLIED HEALTH PROFESSIONAL [AHP] GUIDELINES” (revised July 2014) indicated, “AHPs must maintain in force professional liability insurance in addition to being endorsed onto the professional liability insurance policy of their Supervising Physician(s) and/or employer, and shall submit proof of such coverage, satisfactory to the Medical Staff Executive Committee, to the Medical Staff Services... Observation/Proctoring... The Interdisciplinary Practice Committee, the appropriate Department Chairperson, the President of the Medical Staff, the Medical Staff Executive Committee, or the Governing Body shall have the authority at any time to require that an AHP be subject to a period of observation, to last as long as deemed appropriate, and shall have the authority to adopt any rules or procedures considered necessary to implement this requirement... Observation may consist of any of the methods customarily used at hospitals, including concurrent or retrospective chart review, proctoring, or the requirement of consultation. The first six (6) cases shall be proctored within one (1) year from the date of initial appointment unless released by the Department Chair.” In an interview on 12/10/24 at 2:25 p.m., Clinical Quality Analyst 2 (CQA 2) stated the 2014 AHP policy “is the most current we have.” CQA 2 stated the 2014 AHP policy was still in effect.”

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to consider provider-specific quality and licensing data as required by its own policies and procedures during the reappointment process. For two of six sampled medical staff files (Providers 6 and 7), the facility did not have evidence that it had considered OPPE (Ongoing Professional Practice Evaluation, a summary of quality data regarding a specific provider), the results of peer reviews, or individual performance metrics. For two of six sampled medical staff (Providers 3 and 4), there was no evidence the facility had considered OPPE. For three of six sampled medical staff (Providers 2, 3, and 4), the facility failed to obtain 805 reports (a report from the Medical Board of California showing whether any facility had taken adverse action). The deficient practices skipped consideration of multiple sources of potential red flags during the reappointment process, and therefore had the potential to allow substandard care by the facility’s medical staff to escape notice and continue unchanged for future patients. Findings: Review of Provider 2’s credentials file indicated he was reappointed to the facility’s medical staff 8/9/23 for a two year term. No documentation was present in the file indicating the facility had checked for the presence or absence of 805 reports in the six months prior to Provider 2’s reappointment. Review of Provider 3’s credentials file indicated she was reappointed to the facility’s medical staff on 7/10/24 for a two year term. The most recent OPPE was dated 7/1/21 through 6/30/22. No documentation was present in the file indicating the facility had checked for the presence or absence of 805 reports in the six months prior to Provider 3’s reappointment. In an interview on 12/11/24 at 12:30 p.m., the Lead Medical Staff Coordinator (LMSC) stated the facility did not check Provider 3’s 805 reports at reappointment because the facility only checks those at a provider’s initial appointment. The LMSC stated there was no OPPE in Provider 3’s file more recent than 10/22, that report contained data through 6/30/22, and the other OPPE in Provider 3’s file was based on dates older than 2022. Review of Provider 4’s credentials file indicated she was a telemedicine neurologist who was reappointed to the facility’s medical staff on 11/8/23 for a two year term. No documentation was present in the file indicating the facility had checked for the presence or absence of 805 reports in the six months prior to Provider 4’s reappointment. No OPPE was present in Provider 4’s file. In an interview on 12/11/24 at 1:33 p.m., the LMSC stated the facility did its own credentialing for telemedicine providers in neurology rather than relying on an outside source. In an interview on 12/11/24 at 1:45 p.m., the LMSC stated the facility only checks 805 reports at initial appointment, and acknowledged that the quality data in Provider 4’s file was limited to proctoring reports and case logs from an outside hospital. Review of the facility policy “Credentialing and Privileging Process for the Medical Staff and Allied Health Professionals” (revised 1/23) indicated, “Reappointment Application... Upon receipt of a complete application and signed authorization for release, the Medical Staff Office will begin the verification process by the primary source, including but not limited to... LVS [license verification system]/805 Report... Activity Report including OPPE documents provided by the QA [quality assurance] Department will be included on the reappointment application...” Review of the facility policy “Ongoing Professional Practice Evaluation (OPPE)” (revised 1/23) indicated, “OPPE data will be produced no frequently [sic] than every 10 months and no less frequently than every 12 months. The Quality Department will provide the following documents: 1. QA Peer Review Report 2. Incident Management Portal Report 3. Post-procedure infection rates report...” 17334 On 12/16/24 at 2:00 p.m. and 12/17/24 at 2:00 p.m. a review of credentialing files was conducted with the Lead Medical Staff Coordinator (LMSC) for providers Providers 6 and 7, both on medical staff roster providing patient care at Hospital 1. Provider 6’s file showed the provider was reappointed to medical staff with granted privileges on 2/14/2024. Provider 7’s file showed the provider was reappointed to medical staff with privileges granted on 8/28/2024. Neither file reviewed included verification that OPPE (Ongoing Professional Practice Evaluation) records or any qualitative data, peer reviews, patient complaints, individual performance trends, were submitted to be considered during the reappointment process. Review of Medical Staff Policy and Procedure (P&P) titled “Ongoing Professional Practice Evaluation (OPPE)”, last revised 1/23, stated, “The Ongoing Professional Practice Evaluation process applies to all credentialed practitioners with granted privileges. The (OPPE) process allow early detection of performance issues that could negatively impact patient outcomes. The intent of OPPE is to identify professional practice trends that may require taking steps to improve performance.” Review of Medical Staff P&P titled “Credentialing and Privileging Process for the Medical Staff and Allied Health Professionals” last revised 1/23, included a requirement that Activity Report and OPPE documents will be provided by the QA Department and be included on the reappointment application. The P&P further required that “All verifications are completed electronically and will be maintained in the Provider’s credentials file ... The application will be deemed complete upon receipt of all verifications requested.” In concurrent interviews during the file review on 12/16/24 and 12/17/24 at 2:00 p.m., the LMSC confirmed that OPPE files, including the results of peer reviews, or any qualitative data were not submitted and were not verified as reviewed, as part of the reappointment process.”

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 17334 26674 Based on interview and record review, the facility failed to perform proctoring (when an experienced physician temporarily supervises a newly appointed physician’s work) in the manner required by its own policies for one of six sampled medical staff (Provider 1). For three of six sampled medical staff (Providers 1, 2, and 3), the facility also failed to provide copies of the requested privileges (a list of procedures a physician is allowed to perform) to peer references when requesting an opinion regarding the applicant’s competence. The deficient practices limited both the awareness of peer references regarding for which procedures they were being asked to provide an opinion on an applicant’s competence, as well as the extent of the final check of the applicant’s competence through proctoring as assigned by the facility governing body. The deficient practices therefore had the potential to allow newly appointed physicians to perform procedures for which they had limited competence, creating the risk of preventable poor outcomes for future patients. Findings: 1. Review of Provider 1’s credentials file indicated she was appointed to the facility’s medical staff on 6/14/23 for a two year term. Provider 1’s appointment letter dated 6/15/23 indicated, “In order to ensure competence, proctoing is required for all new practitioners... Proctoring Instruction: Please see attached report of proctoring case requirements... If applicable, you will need to contact your proctor(s) in advance and make arrangements to be proctored prior to scheduling your case(s). Attached are the procedures for which proctoring is required and the forms for your use. You should submit the completed forms are submitted [sic] to the Medical Staff Services Department following each proctored case. Please note proctoring is required until the recommendation is received from your proctor to waive further proctoring. Your proctor(s) are also required to perform retrospective chart reviews.” No proctoring instructions were attached to the copy of the letter provided to the surveyor. Review of Provider 1’s delineation of privileges (DOP, a list of procedures a physician is allowed to perform) dated 6/14/23-5/31/25 indicated all of Provider 1’s privileges were “Granted with Proctoring”. The DOP did not specify a duration or number of cases required for proctoring. Review of Provider 1’s file indicated proctoring reports were present for two cases performed on 11/6/23 and 12/29/23. A memo dated 6/20/24 indicated Provider 1’s department chair had released Provider 1 from proctoring. No other proctoring reports were present in Provider 1’s file. In an interview on 12/10/24 at 1:24 p.m., the Lead Medical Staff Coordinator (LMSC) stated he saw proctoring reports for two cases for Provider 1. The LMSC stated proctoring requirements varied by department, and Provider 1 was in the department of medicine. The LMSC provided a document to the surveyor and stated, “These are the most recent department rules and regulations.” Review of the Department of Medicine Rules and Regulations (revised June 2023) indicated, “GUIDELINES FOR PROCTORING (See individual privilege lists for Specific Numbers of Time-Frames established for proctoring requirements within Sections) To ensure proficiency both of new applicants and those seeking an extension of privileges a period of proctoring shall be imposed that is determined by bylaws... All cases and procedures will be proctored until a volume sufficient to allow proper appraisal has been achieved... The function of the proctor will be that of case evaluation rather than consultation or involvement (emergencies excepted). Specific duties will include chart review, observation of invasive procedures and patient interview or examination if indicated... Physicians being proctored will notify their proctor as soon as possible and not less than 24 hours before case admissions and will give adequate notice when invasive procedures are planned... A written report (form attached) will be submitted for each case or procedure... Reports will be forwarded by the proctor to the Department Chairman for review and approval. The Chairman will forward the reports to the Medical Staff department, where they will be filed in the physician’s credentials file... The Department Chairman will notify the applicant and the Medical Staff Services Department when proctoring has been completed... Proctoring requirements can be fulfilled at another facility pending review and approval by the Department Chair.” In an interview on 12/11/24 at 9:45 a.m., the LMSC confirmed Provider 1’s proctoring requirement was all cases proctored until released from proctoring. Review of intra-operative nursing notes in Patient 18’s medical record indicated Patient 18 had an invasive procedure at the facility performed by Provider 1 on 4/29/24. The listing of staff present in the procedure room did not include any physician aside from Provider 1, indicating Patient 18’s case was not proctored, even though Provider 1 was not released from proctoring until 6/20/24. Review of the facility’s medical staff bylaws (revised 2/8/23) indicated, “Each new Provisional Staff member shall undergo a period of proctoring by designated proctors on the medical staff. Proctoring shall follow whatever frequency and format each Department deems appropriate (as specified in its Department Rules and Regulations) in order to adequately evaluate the individual, including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation at this Hospital or another hospital. Recent proctoring reports from other accredited hospitals may be considered.” 2. Review of Provider 1’s credentials file indicated it included three peer references dated 2/24/23, 3/14/23, and 3/24/23. All three references requested responses regarding the applicant’s competence for privileges, but none of the three documents indicated a listing of Provider 1’s requested privileges had been provided to the reference. The third question of each reference indicated the peer could “request privilege list if necessary”. In a concurrent interview and record review on 12/10/24 at 12:52 p.m., the LMSC stated he would generate the document which would have been sent to Provider 1’s peer references, then handed a printout to the surveyor and stated, “The printout is what we send.” Review of the document provided by the LMSC indicated it included an undated, untitled questionnaire with eleven questions regarding the applicant, three of which pertained to the applicant’s competence to perform privileges. The document provided by the LMSC also included a release from Provider 1 dated 3/7/23. No copy of Provider 1’s requested privileges was present. Review of Provider 1’s credentials file indicated it included a verification of fellowship (subspecialty training) completion dated 3/20/23 which did indicate the respondent had received and reviewed a list of Provider 1’s proposed privileges. In an interview on 12/10/24 at 1:36 p.m., the LMSC stated a list of requested privileges “goes out for educational verification, not for peer references.” Review of Provider 2’s credentials file indicated it included two peer references dated 6/2/23 and 8/28/23. Both references requested responses regarding the applicant’s competence for privileges, but neither document indicated a listing of Provider 2’s requested privileges had been provided to the reference. The third question of each reference indicated the peer could “request privilege list if necessary”. In a concurrent interview and record review on 12/11/24 at 10:41 a.m., the LMSC stated Provider 2’s peer references would have gotten the same packet as was sent for Provider 1, but with a different release form. Review of the packet provided by the LMSC indicated it included an undated, untitled questionnaire with eleven questions regarding the applicant, three of which pertained to the applicant’s competence to perform privileges. The document provided by the LMSC also included a release from Provider 2 dated 5/16/23. No copy of Provider 2’s requested privileges was present. Review of Provider 3’s credentials file indicated it included two peer references dated 4/22/24 and 4/28/24. Both references requested responses regarding the applicant’s competence for privileges, but neither document indicated a listing of Provider 3’s requested privileges had been provided to the reference. The third question of each reference indicated the peer could “request privilege list if necessary”. In an interview on 12/11/24 at 12:30 p.m., the LMSC stated it was reasonable to assume the same packet had been sent to Provider 3’s peer references.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to implement its policies to ensure the medical staff was accountable to the governing body for quality of care when one of three sampled physician peer reviews was not completed, when one of one sampled incident reports involving the medical staff did not have a documented resolution and was not copied to the medical staff office, and when five of six sampled medical staff files (Providers 1, 3, 4, 6, and 7) did not have OPPE (ongoing professional practice evaluation, a summary of provider-specific quality data) within the past year. The facility failed to ensure the departmental placement of the psychiatry, endocrinology, and dermatology services was consistent between its medical staff bylaws and its departmental rules and regulations. The deficient practices limited required reviews of physician quality, created confusion regarding who was responsible for the quality of care for three specialties, and therefore had the potential to allow substandard care to go unnoticed and unchanged for future patients. Findings: 1. Review of a “CASE REVIEW REFERRAL FORM A” dated 7/31/24 indicated the quality department had referred an incident which occurred on 5/3/24 to peer review. No response to the request for peer review was present in the documents provided by the facility. In an interview on 12/13/24 at 12:18 p.m., the risk and quality leader (RQ) stated requests for peer review arising from an incident report are sent on Form A, and the response from the reviewer is recorded on Form C. In an interview on 12/13/24 at 1:54 p.m., the RQ stated the peer review log indicated the peer review request dated 7/31/24 had been submitted to the director of the emergency department who never responded and subsequently left the facility. The RQ stated the peer review request should have been redirected, but that did not happen. Review of the facility’s undated peer review log indicated an incident with the same patient account number as the “CASE REVIEW REFERRAL FORM A” dated 7/31/24 had been sent to a reviewer. The log indicated the “Date requested 1st attempt” was 8/5/24, the “Date requested 2nd attempt” was 8/22/24, and the “Date Form C returned” was “Pending”. A comment indicated the peer reviewer was “not [sic] longer with Seton. Will redirect peer review request.” Review of the facility’s “MEDICAL STAFF PEER REVIEW POLICY AND PROCEDURE” (revised 5/24) indicated, “The department chair or section chief will be assigned as reviewer and they may assign a designee as reviewer... The reviewer shall provide an assessment in order to determine the need for further interventions and to provide a grading score using their evaluation of the situation. It us up to the section chief to take any additional actions warranted in order to complete the assessment... The section chief can also submit the case for further review by a different provider... If the Section Chief is unable to review the case due to conflict of interest, lack of expertise, or other justifiable reason(s), the case will be forwarded to the Chair of the department and an assessment to call for an [sic] special meeting of the department may be warranted. During the department meeting it will then be determined if there is necessity for an External Peer Review.” 2. Review of an “Incident Management Portal” report dated 4/30/24 indicated three members of the medical staff were involved in an incident on 4/29/24. The section of the report titled “Risk Managers Investigation” indicated, “Event Status Closed... Outcome/Injury Unknown Event Severity Level E - Error, Harm (An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention)”. The “Risk Discussion” section of the report indicated the PACU (post anesthesia care unit or recovery room) manager had been notified 5/2/24, and on 5/3/24 had replied with two concerns, one of which involved a member of the medical staff. No other follow-up to the incident or the PACU manager’s concerns was documented, and there was no documentation that the medical staff office had been copied on the incident or the follow-up. Review of the facility’s “Incident-Reporting Policy” (revised 11/24) indicated, “The IMP portal [incident management portal] is screened and triaged by the risk management representation of the hospital with assistance of legal counsel as needed. The risk management designee shall determine if the reported incident requires additional investigation and once the information suffices, the incident shall be submitted to the appropriate director, manager or Medical Staff Department (Chair or and/or [sic] Section Chief) in order to evaluate the incident and determine corrective actions. The Risk Management designee will follow up with department managers or medical staff chair/section chief within five business days to obtain the result of their investigation. If no response is received within two weeks, the Risk Management designee will escalate the matter by contacting the individual’s direct supervisor. The Medical Staff Services Department shall be included in all communications if a medical staff member is involved... All incident reports, investigation documents, and corrective actions will be kept by the Risk Management department...” In an interview on 12/13/24 at 12:18 p.m., the RQ stated she discusses IMP reports with the Chief Health Officer (CHO) if they involve a member of the medical staff. The RQ stated she then reaches out to the unit manager who decides the disposition. The RQ stated she discusses all IMP reports with reviewers, and for the report dated 4/30/24 the incident was closed because it was deemed standard procedure. The RQ stated there was a peer review involving how to navigate communication issues, but it was not documented because the CHO either talks to the medical staff himself or reaches out to the department director. The RQ stated she discusses incidents with the CHO, “He reviews and decides if an incident needs peer review or meets standard of care.” In an interview on 12/13/24 at 1:54 p.m., the RQ stated she gathers information regarding incident reports, but does not make any decisions. The RQ stated she discusses incidents with the CHO, who either resolves the issue himself or directs her to contact the department. The RQ stated the end of the documentation on the IMP report is the end of the investigation. The RQ stated there was no notification of the medical staff office. The RQ stated for incidents involving physicians, the facility does peer review, the director of the department decides and speaks to the physician. 3. Review of the facility policy “Ongoing Professional Practice Evaluation (OPPE)” (revised 1/23) indicated, “The (OPPE) process allow [sic] early detection of performance issues that could negatively impact patient outcomes. The intent of OPPE is to identify professional practice trends that may require taking steps to improve performance. Such identification may require intervention by the organized medical staff when necessary. OPPE data will be produced no frequently [sic] than every 10 months and no less frequently than every 12 months. The Quality Department will provide the following documents: 1. QA Peer Review Report 2. Incident Management Portal Report 3. Post-procedure infection rates report...” Review of Provider 1’s credentials file indicated she was appointed to the facility’s medical staff on 6/14/23 for a two year term. No QA Peer Review Report, Incident Management Portal Report or Post-procedure infection rates report were present in Provider 1’s file. In an interview on 12/10/24 at 1:36 p.m., the Lead Medical Staff Coordinator (LMSC) stated, “We haven’t done whole lot of OPPE.” The LMSC stated OPPE normally came up at reappointment, not every quarter, the facility was trying to nail it down, and so far had done OPPE at reappointment. In an interview on 12/11/24 at 10:34 a.m., the LMSC stated he did not believe the facility was doing OPPE. Refer to A-340 regarding the facility’s failure to perform OPPE within the past year for Providers 3, 4, 6 and 7. 4. Review of the facility’s medical staff bylaws dated 2/8/23 indicated, “The Department of Medicine shall include but not be limited to the following sections... Dermatology... Endocrinology... Psychiatry...” Review of the Department of Medicine Rules and Regulations (revised June 2023) indicated, “The Department of Medicine shall procure care in the following subspecialties: 1. Cardiology 2. Gastroenterology 3. Hematology and Oncology 4. Hospitalist Service 5. Nephrology 6. Neurology 7. Critical Care... The Department of Medicine shall be a separate and distinct Department of the Medical Staff with Sections in the subspecialty areas as listed above.” In an interview on 12/18/24 at 10:49 a.m., the Chief Health Officer (CHO) stated the facility had not found an endocrinologist until two months ago. The CHO stated the bylaws were idealistic, psychiatry and dermatology might be their own departments, dermatology might be under surgery, and psychiatry was its own entity. When asked who the department chair for psychiatry was, the CHO stated, “That was part of the discussion.” The CHO then stated psychiatry had recently been under the department of medicine, and the medical executive committee concluded psychiatry was “under the medicine chair.””

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to enforce its medical staff bylaws when two of six sampled medical staff credentials files (Providers 1 and 2) did not have evidence of current malpractice insurance. The deficient practice had the potential to allow an early warning of potential problems with medical staff to escape notice. Findings: Review of the facility’s medical staff bylaws (revised 2/8/23) indicated, “Each practitioner granted clinical privileges (including temporary privileges) shall maintain professional liability insurance in an amount not less than one million dollars ($1,000,000) per occurrence, three million dollars ($3,000,000) aggregate and with a carrier approved to market such insurance in the State of California or with a mutual cooperative trust that meets the standards of the State of California... A Medical Staff member who fails to maintain such insurance, or to provide verification of coverage, as required herein, shall be automatically terminated from the Medical Staff.” Review of Provider 1’s credentials file indicated she was appointed to the facility’s medical staff on 6/14/23 for a two year term. Provider 1’s undated malpractice insurance certificate indicated the expiration date of the policy was 9/1/24. An e-mail from the medical staff office to Provider 1 dated 8/2/24 requesting Provider 1 to update her malpractice insurance information was present in the file. No response from Provider 1 and no updated malpractice certificate were present in the file. In an interview on 12/10/24 at 12:52 p.m., the Lead Medical Staff Coordinator (LMSC) stated he was checking the e-mail inbox for a response from Provider 1. The LMSC then stated he was able to find the policy which expired 9/24 and the e-mail reminding Provider 1 that her malpractice certificate on file was expiring. In an interview on 12/10/24 at 1:48 p.m., the LMSC stated there was nothing from Provider 1 in the inbox. Review of Provider 2’s credentials file indicated he was reappointed to the facility’s medical staff on 8/9/23 for a two year term. Provider 2’s undated malpractice insurance certificate indicated the policy had expired on 12/8/24. In an interview on 12/11/24 at 9:45 a.m., the LMSC stated he would have to check the e-mail inbox for Provider 2’s insurance, and Provider 2 had been sent a notice that his malpractice was expiring. In an interview on 12/11/24 at 12:30 p.m., the LMSC stated he had reached out to Provider 2 and obtained an updated certificate of malpractice insurance.”

“MEDICAL STAFF RESPONSIBILITIES - ASSESSMENT CFR(s): An assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii) of this section) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at paragraph (c)(5)(v) of this section, specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. The assessment must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to limit its bylaws provisions allowing for a focused assessment in lieu of a comprehensive medical history and physical examination (H&P) to outpatients meeting criteria regarding age, diagnosis, scheduled procedure, and comorbidities, all specified in a facility policy and conforming to a national guideline. The deficient practice had the potential to allow limited assessments of the overall health of patients needing hospital admission or in situations where standards of practice did not allow a more focused assessment. Findings: Review of the facility’s medical staff bylaws dated 2/8/23 indicated, “A Short Form History and Physical may be substituted for the complete History and Physical for admissions to Observation Units, and for other admissions which are not anticipated to extend past forty-eight (48) hours... Rules and Regulations of the Medical Staff shall be a part of these Bylaws.” Review of the facility’s medical staff rules and regulations dated 2/8/23 indicated, “The history and physical shall meet the following medical record documentation requirements: I. For all inpatients and any patient undergoing general, spinal epidural anesthesia, the medical history shall include: 1. The chief complaint 2. Present illness 3. Past history 4. Personal and social history 5. Family history 6. Review of systems 7. Physical examination of all major body systems II. For patients undergoing a surgical procedure where no I.V. sedation is required and involves either no local anesthesia or local anesthesia used for topical/local, infiltrative, hand/ankle blocks, documentation in the Medical Record shall include: 1. Indications and symptoms for the surgical procedure; 2. Current medications and dosages; 3. Any known allergies, including medication reactions; 4. Existing co-morbid conditions if any; 5. Assessment of mental status; 6. An examination specific to the procedure proposed to be performed III. For patients requiring I.V. conscious sedation all information as in B above is necessary in addition to the examination of the heart and lungs by auscultation. IV. For patients requiring outpatient observation, the history and physical examination shall be documented as in C above in addition to documentation detailing the necessity for observation of the patient. If the patient is transferred to observation status from outpatient procedure/surgery a progress note reflecting the need for observation is sufficient. Documentation for patients admitted to inpatient status from outpatient observation status shall meet the documentation requirements as of I above.” No provisions were present requiring a policy based on national guidelines which further limited focused assessments based on patient age, comorbidities, or type of procedure. In an interview on 12/9/24 at 2:41 p.m., the Chief Health Officer (CHO) stated the bylaws allowed a less comprehensive assessment, but “everybody needs an H&P” even though the bylaws give more leeway. The CHO stated there was no policy specifying to which patients the focused assessment applied because the provision wasn’t being used. The CHO stated, “Everyone should be doing a full H&P.””

“MED STAFF RESPONSIBILITIES - POLICY CRITERIA CFR(s): The medical staff, if it chooses to develop and maintain a policy for the identification of specific patients to whom the assessment requirements in paragraph (c)(5)(iii) of this section would apply, must demonstrate evidence that the policy applies only to those patients receiving specific outpatient surgical or procedural services as well as evidence that the policy is based on: (A) Patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure. (B) Nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures. (C) Applicable state and local health and safety laws. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility’s medical staff bylaws failed to include a requirement for a medical staff policy limiting focused assessments in lieu of a comprehensive medical history and physical examination (H&P) to outpatients meeting criteria conforming to a national guideline (age, comorbidities, type of procedure), and dependent upon receiving a state regulatory waiver for the usual H&P requirement. The deficient practice had the potential to allow limited assessments of the overall health of patients in situations where standards of practice and state law did not allow a more focused assessment. Findings: Review of the facility’s medical staff bylaws dated 2/8/23 indicated, “A Short Form History and Physical may be substituted for the complete History and Physical for admissions to Observation Units, and for other admissions which are not anticipated to extend past forty-eight (48) hours... Rules and Regulations of the Medical Staff shall be a part of these Bylaws.” Review of the facility’s medical staff rules and regulations dated 2/8/23 indicated, “The history and physical shall meet the following medical record documentation requirements: I. For all inpatients and any patient undergoing general, spinal epidural anesthesia, the medical history shall include: 1. The chief complaint 2. Present illness 3. Past history 4. Personal and social history 5. Family history 6. Review of systems 7. Physical examination of all major body systems II. For patients undergoing a surgical procedure where no I.V. sedation is required and involves either no local anesthesia or local anesthesia used for topical/local, infiltrative, hand/ankle blocks, documentation in the Medical Record shall include: 1. Indications and symptoms for the surgical procedure; 2. Current medications and dosages; 3. Any known allergies, including medication reactions; 4. Existing co-morbid conditions if any; 5. Assessment of mental status; 6. An examination specific to the procedure proposed to be performed III. For patients requiring I.V. conscious sedation all information as in B above is necessary in addition to the examination of the heart and lungs by auscultation. IV. For patients requiring outpatient observation, the history and physical examination shall be documented as in C above in addition to documentation detailing the necessity for observation of the patient. If the patient is transferred to observation status from outpatient procedure/surgery a progress note reflecting the need for observation is sufficient. Documentation for patients admitted to inpatient status from outpatient observation status shall meet the documentation requirements as of I above.” No provisions were present requiring a policy based on national guidelines which further limited focused assessments based on patient age, comorbidities, or type of procedure. In an interview on 12/9/24 at 2:41 p.m., the Chief Health Officer (CHO) stated the bylaws allowed a less comprehensive assessment, but “everybody needs an H&P” even though the bylaws give more leeway. The CHO stated there was no policy specifying to which patients the focused assessment applied because the provision wasn’t being used. The CHO stated, “Everyone should be doing a full H&P.” Review of Title 22, California Code of Regulations (22 CCR) section 70749(a)(2) indicated hospital patient medical records are required to include an H&P. Review of 22 CCR section 70129(a) indicated California Department of Public Health is authorized to grant program flexibility via written approval for alternate concepts and methods of compliance. In an interview on 12/10/24 at 2:00 p.m., Clinical Quality Analyst 1 stated the facility did not have an approved program flexibility for focused assessments in lieu of a comprehensive H&P.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 38764 Based on interview, and record review, the hospital failed to ensure the licensed nurses supervised and evaluated the nursing care for two of 30 sampled patients (Patients 23 and 26). 1. For Patient 23, there was no documentation to show an appropriate assessment was conducted for the patient who had a rectal tube (a flexible tube inserted in the rectum acting like a drainage system). 2. For Patient 26, there was no documentation to show the mean arterial pressure (MAP, an indicator of how well the blood is flowing to the vital organs of the body) of the patient was monitored consistently while the patient was on a continuous vasopressor (medication administered through the veins to increased the blood pressure) infusion. These failures created an increased risk of poor health outcomes to the patient. Findings. 1. Review of Patient 23’s admission record, showed the patient was admitted to the hospital on 12/8/24. Review of Patient 23’s Order Chronology dated 12/11/24 at 4:49 pm, showed a physician’s order to place a rectal tube to the patient. Review of Patient 23’s Assessment Flowchart dated 12/12/24, showed the patient had a rectal tube. However, there were no additional assessment addressing the use of the rectal tube. During a concurrent interview and observation on 12/12/24 at 2:15 pm with RN 20 and RN 21, Patient 23 was observed to have a white-colored bag hanging on the patient’s bed frame. RN 20 and RN 21 was asked about the white bag hanging on Patient 23’s bed frame. RN 20 stated the bag was a collecting bag for the patient’s rectal tube. RN 20 was asked why Patient 23 had a rectal tube. RN 20 stated the rectal tube was used for medication administration and fecal drainage. During a concurrent interview and record review on 12/13/24 at 1:27 pm with RN 7, acknlowedged the above findings. RN 7 was asked to describe the care provided to Patient 23 who had a rectal tube. RN 7 stated a nurse would ensure there was a physician’s order for the patient for the use of a rectal tube and an assessment of the patient to address the use of a rectal tube. RN 7 was asked to describe about the assessment for Patient 23. RN 7 stated the patient would be assessed for the presence of a skin breakdown around the rectal area, signs of bleeding from the rectal area, the consistency of the stool and ensure the tube is sitting properly in the rectal area. RN 7 was asked to review the assessment conducted for Patient 23 as described above. RN 7 acknowledged there was no documented evidence to show an assessment was conducted to the patient addressing the use of a rectal tube. Review of the product’s Direction for Use (undated), showed including precautions and observations for the use of a rectal tube. For example: - the skin surrounding the rectal area should be kept clean, dry and protected with a moisture barrier; - ensure that the patient does not lie or sit on the catheter as this could lead to localized pressure damage and contribute to the development of anal skin breakdown and/or restrict fecal flow; - with the use of any rectal device adverse events could occur including leakage of stool around the device, rectal/anal bleeding due to pressure necrosis (tissue death), ulceration (forming a break on the skin) of rectal or anal mucosa (moist tissue that lines inside the anus), - temporary loss of anal sphincter (muscles at the end of the rectum) muscle tone. However, there was no documentation to show an assesment was conducted for Patient 23 ensuring the precautions and observations, as described above, were implemented to the patient. 2. Review of Patient 26’s admission record, showed the patient was admitted to the hospital on 11/16/24. Review of Patient 26’s Progress Note - Critical Care Medicine dated 11/17/24 at 10:44 am, showed the patient had a cardiact arrest. Review of Patient 26’s Order Chronology dated 11/25/24 at 9:25 pm, showed a physician’s order to administer continuous norepinephrine (a medication use to increase blood pressure) intravenously. The instructions showed to maintain MAP of greater than 60mmHg per the protocol. The norepinephrine drip was started on 11/25/24 at 9:25 pm and the drip was stopped on 12/1/24 at 9:28 pm Review Patient 26’s Vital Signs flowsheet showed, for example: - On 11/25/24 at 9:47 pm, the patient’s blood pressure was 81/49 mmHg. However, there was no documented MAP, - On 11/27/24 at 4:00 am, the patient’s blood pressure was 104/62 mmHg. However, there was no documented MAP, - On 11/27/24 at 5:00 am, the patient’s blood pressure was 116/71 mmHg. However, there was no documented MAP, - On 11/27/24 at 6:00 am, the patient’s blood pressure was 110/78 mmHg. However, there was no documented MAP, - On 11/27/24 at 11:00 pm, the patient’s blood pressure was 78/47 mmHg. However, there was no documented MAP, - On 11/28/24 at 12:00 am, the patient’s blood pressure was 98/61 mmHg. However, there was no documented MAP. During a concurrent interview and record review with RN 7 on 12/17/24/ at 1:00 pm, the RN acknowledged the above findings. RN 7 stated the value of the MAP was used to titrate the continuous norepinephrine infusion to support the blood pressure of Patient 26. RN 7 was asked the importance of monitoring continuously the MAP for Patient 26. RN 7 stated monitoring the patient’s MAP continuously was to ensure the patient was receving adequate medication dose or wean the patient off the medication when the patient would have a MAP of greater than 60 mmHg. Review of the hospital’s P&P titled Continuous Intravenous Medication Titration effective on 8/23, showed in part: - Standardized practices promote consistency in care, improve communication among healthcare teams, and contribute to better clinical outcomes. By reinforcing proper documentation and monitoring, the policy facilitates continuous qaulity improvement and improves compliance to regulatory standards. - Titration is the process in which the continuous IV medication dose is progressively increased or decreased to achieve the best defined measured goals and clinical response. - Continuous monitoring of the patient’s response to titration is required. This includes assessing vital signs, clinical status, and any adverse reactions to medication changes.”

“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: 28154 Based on observation, interview, and facility policy review, the facility failed to ensure medication vials were disinfected prior to access. This failure had the potential to contribute to patient infections. The survey census was 62. Findings include: Observation of the anesthesia preparation on 12/10/24 at 1:37 PM identified Physician 2 with a vial of Diprivan (a sedative-hypnotic agent). Physician 2 popped the cap off the vial and accessed the rubber stopper with an intravenous (IV) tubing spike. Physician 2 did not disinfect the rubber stopper prior to access. The IV tubing was attached to the patient’s IV line who was on the operating room (OR) table. In an interview on 12/11/24 at 10:30 AM regarding the disinfection of the Diprivan rubber stopper, Physician 2 stated, “Do they really have information that under the cap isn’t clean? It’s one of those things that happens.” During an interview on 12/13/24 at 2:21 PM, Operating Room Manager (ORM) 1 stated an expectation that “rubber stoppers should be done [cleaned] every time before use of the medication.” Review of the facility policy titled, “Infection Control - Anesthesia Equipment and Supplies,” reviewed April 2017, revealed, “ ...6. Aseptic technique shall be used when preparing medications, ... B. Clean vial stoppers before puncturing them.” Review of the website “American Society of Anesthesiologists” (https://www.asahq.org/about-asa/newsroom/news-releases/2018/12/shea-guidance) revealed, “The key recommendations include: ...IV drug injection recommendations include using syringes and vials for only one patient; and that injection ports and vial stoppers should only be accessed after disinfection.””

“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: 40903 Based on interview and record review the hospital failed to ensure high-risk medication (drugs that pose risk if not used or administered safely) use followed safe standards of practice and facility’s policy during administration of Intravenous (IV, Into the Vein) insulin (a medication used to treat Blood Sugar, or BG) and IV heparin (a blood thinner with bleeding side effect) infusion (flow of medication into the veins on a continuous basis) in two out of two patients ( Patient 60 and Patient 63) reviewed for high risk medication use when: 1. Patient 60’s insulin infusion and dose adjustments were not double checked and co-signed by two registered nurses and testing for blood sugar was not done as ordered based on doctor’s order and hospital policy on administration of high-risk drugs. 2. Patient 63’s heparin infusion restart was not initiated, laboratory monitoring (blood tests) levels were not addressed, and physician notification was not documented for laboratory blood test results and possible interference with another drug. These failed practices could put patients at risk for adverse effects such as extreme variation in blood sugar and risk of internal bleeding. Findings: 1. During a concurrent interview and review of Patient 60’s medical record and insulin administration record, on 12/12/24, at 12:18 PM, in the ICU (Intensive Care Unit), accompanied by Registered Nurse 8 (RN 8), the record indicated Patient 60 was on insulin infusion from 10/31/24 through 11/3/24. The record and the doctor’s order indicated the nurse should have measured Blood Sugar (BG) every hour until the BG was in stable normal range between 120-180 mg/dL (“mg/dL” or “milligram per deciliter” is a measure of unit for blood sugar) for three consecutive times then changed the BG test to every 3 hours. Further review of the records indicated on 10/31/24 at 6:24 AM after three normal/stable BG levels, the follow-up BG testing should have been performed around 9:30 AM on 10/31/24. The record indicated BG test was done 9 hours later on 10/31/24, at 3:15 PM, with a BG level of 336 mg/dL, higher than the target normal range. The nursing documentation did not show any notes explaining the delay in BG measurement and the dose increase after a high BG was not double checked or co-signed by another licensed nurse. RN 8 stated there was no documentation on delay in testing and lack of co-signature for insulin dose increase in patient’s electronic medical record. During a concurrent interview and review of Patient 60’s medical record and insulin administration record, on 12/13/24, at 9:52 AM, in the ICU (Intensive Care Unit), accompanied by Registered Nurse 7 (RN 7), Patient 60’s insulin infusion administration and blood sugar monitoring for 10/31/24, 11/1/24, 11/2/24 and 11/3/24 was reviewed. The record did not show co-signature for independent double check verification for the following date and times for insulin dose changes: 10/31/24 at 1:57 AM, 3:15 AM, and 4:13 PM 11/1/24 at 12:10 AM, 1:21 AM, 2:12 AM and 3:37 AM 11/2/24 at 3:27 PM, 6:20 PM 11/3/24 at 10:32 AM, 2:05 PM, 6:02 PM, 8:20 PM RN 7 acknowledged the findings and stated the computer system had no easy way to facilitate the co-signature based on his working experience. In an interview with Chief Nursing Office (CNO), on 12/18/24, at 3 PM, the CNO stated high risk IV infusions required independent double check for when a new IV bag was started and when there were dose adjustments. The CNO stated she was not sure how the hospital’s computer system facilitated the verification and nursing co-signature. Review of the hospital’s policy, titled “High Risk/High Alert ... Medication Management”, dated 9/24/24, the policy listed insulin as a category of medication designated as high alert medication. The policy further indicated “high alert medications ... bear a heightened risk of causing significant harm when they are used inappropriately ... the consequences of an error involving these drugs generally result in greater magnitude of patient harm.” The policy on section titled “Strategies for the Use and Storage of High Risk/High Alert Medication” on insulin, indicated “All insulin doses are double checked by two licensed nurses for accuracy on dose, time, and order of insulin.” Review of the hospital’s policy titled “Medication Administration”, last revised on 7/2021, the policy indicated “All ... IV insulin ... will be checked by two licensed caregivers against the ... order before the dose is administered.” 2. During a concurrent interview and review of Patient 63’s medical record and heparin infusion administration record, on 12/13/24, at 10:32 AM, in the ICU (Intensive Care Unit), accompanied by Registered Nurse 7 (RN 7), the record indicated Patient 63 was admitted to hospital with breathing and heart rhythm issues requiring medications to prevent formation of blood clot. Patient 63 was ordered to start heparin infusion, on 11/11/24, in anticipation of a TEE procedure (or Transesophageal echocardiography, a procedure that provides images of the heart to detect blood clots or guide treatment of abnormal heartbeats) to prevent blood clot formation. Further review of Patient 63’s medication profile indicated three other oral (by mouth) blood thinner medications called aspirin (drug used to thin the blood), Plavix (clopidogrel used to prevent clot in the heart), and apixaban (or Eliquis, a blood thinner used to treat or prevent blood clots). During a concurrent interview and review of Patient 63’s medical record on heparin infusion administration, on 12/13/24, at 10:32 AM, in the ICU (Intensive Care Unit), accompanied by Registered Nurse 7 (RN 7), the record instructed nursing staff to start the cardiac (heart) version with special dose adjustment indicating “See heparin order set; Call MD (Medical Doctor) if target goal not reached at max (maximum) dose.” The heparin order-set (a set of medication and testing orders guided use of the drug) additionally instructed nursing staff to measure a test called Anti-Xa (anti-Xa test, also known as a chromogenic anti-Xa assay; a laboratory test that measured the activity of heparins in the blood. It’s used to monitor and ensure that a patient is receiving the correct amount of heparin) every 6 hours while the patient was on apixaban (an oral blood thinner that can affect the Anti-Xa level and testing). Nursing documentation on the heparin flowsheet indicated the drug was never started. Patient 63’s medical record under “lab results” section indicated 4 records on Anti-Xa test results on 11/11/24 at 11:26 AM, 7:20 PM, and 11:15 PM and one test result on 11/12/24 at 4:54 AM with all results marked as “HC” or High level and Critical. Patient 63’s electronic medical record did not show any nursing note or any call to MD to address the high and critical levels without starting the heparin infusion. RN 7 stated the nursing staff should have called the doctor and ordered the aPPT level (“aPTT” or Activated Partial Thromboplastin Time blood test used to monitor the effectiveness of heparin therapy, indicating how well the blood was clotting to prevent blood clot formation) to accurately monitor the heparin infusion. During a concurrent interview with RN 7 and review of the paper version of heparin order-set, dated 7/2021, the order-set required use of Anti-Xa for heparin dose adjustments and monitoring. The order-set did not address concurrent use oral blood thinners that could affect or interfere with accurate Anti-Xa testing. RN 7 stated there needed to be more education and/or computer prompts to remind doctors and nurses when they order blood thinners. In an interview with Director of Pharmacy (DOP), on 12/17/24, at 1:08 PM, the DOP stated the hospital had previous reports of concurrent use of blood thinners affecting Anti-Xa level and heparin infusion monitoring. The DOP stated an informational flyer prepared by pharmacy to educate medical and nursing staff. The DOP stated the heparin order set needed an update to address drug-lab test interaction with increased use of newer generation of blood thinners. In an interview with Chief Nursing Office (CNO), on 12/18/24, at 3 PM, the CNO stated high risk IV infusions required independent double check by two licensed nurses and any critical lab should have been reported to Medical Doctor to address. Review of the hospital’s policy, titled “High Risk/High Alert ... Medication Management”, dated 9/24/24, the policy listed heparin as a category of medication designated as high alert medication. The policy under “Strategies for the use and storage of High Risk/High alert medications”, indicated “Pre-printed orders and protocols are utilized for heparin infusion ...” Review of the hospital’s policy titled “Medication Administration”, last revised on 7/2021, the policy indicated “Before administering a medication, ... the health care professional administering the medication does the following: ... Become familiar with the action the drug, ... and the monitoring responsibilities ... Discuss any unresolved, significant concerns about the medication with the patient’s physician, prescriber ... and/or relevant staff involved ...” Review of the hospital’s policy titled “Medication Administration”, last revised on 7/2021, the policy indicated “All heparin ... will be checked by two licensed caregivers against the ... order before the dose is administered.” Review of medical research by Brown University, titled “When Apixaban ... Interfere With Anti-Xa Assays: A Cohort Study”, dated 10/1/23, last accessed via https://bhm.scholasticahq.com/article/85155-when-apixaban-and-rivaroxaban-interfere-with-anti-xa-assays-a-cohort-study, on 1/5/24, the research conclusion indicated “Patients who are on direct factor Xa inhibitors (drugs like apixaban) as part of their home medication regimen may require bridging to unfractionated heparin (or UFH, same as heparin) when they are admitted to the hospital. This bridging is often necessary for various reasons ... it should be noted that the use of apixaban ... can potentially impact anti-Xa levels, increasing the risk of bleeding or thrombotic (blood clot) events. Therefore, it is essential to establish baseline anti-Xa levels to guide the subsequent use of UFH or determine the suitability of alternative assays, such as the activated partial thromboplastin time (aPTT).” Review of medical research, titled “Journal of the American Heart Association: Direct Oral Anticoagulant Use: A Practical Guide to Common Clinical Challenges”, dated 2020, last accessed via https://www.ahajournals.org/doi/pdf/10.1161/JAHA.120.017559 on 1/5/24, the guide on switching between from oral blood thinners to drugs like heparin, indicated “Stop DOAC (same as oral blood thinner) and start parenteral anticoagulant at the same time that the next dose of DOAC would have been given.””

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 39051 Based on observation, interview and record review, the facility failed to ensure that medical records were maintained in a manner that protects against damage, ensures retrievability, and complies with retention requirements. This failure resulted in compromise to the integrity and availability of medical records, which are critical for patient care continuity and regulatory compliance. Findings: During observations on 12/10/24 at 11:09 a.m. in Materials Management off the dock, down the hall in the former Central Services, in the former Community Room, and in two additional unlabeled rooms across from the Medical Records Department, and on 12/12/24 at 09:13 a.m.in three additional unlabeled rooms across from the Medical Records Department, for a total of eight separate record storage locations toured on hospital premises, the following conditions were noted: 1. Storage areas for medical records showing signs of overcrowding, with boxes stacked unsafely in clusters without walking space to access records. One vertical column of piled, plastic-wrapped boxes was observed leaning forward at approximately a 45 degree angle. 2. Stacking of medical records boxes without proper weight distribution, resulting in structural damage to records stored at the bottom. Bottom boxes of records were visibly crushed under the weight of the boxes stacked vertically above them. 3. Cluttered storage area with boxes containing medical records placed on the floor. An avalanche of medical records onto the floor was observed along one row. Potential pest intrusion in the storage area was observed, with signs of debris or droppings near stored records. 4. Rows of open shelving units with medical records stacked horizontally, without protective covering or proper organization. The observed lack of protective measures includes GeroPsych patient records stored in the open in folders flagged with blue labels. 5. Records stored near exposed electrical wiring. 6. Records stored near potential sources of water damage, such as leaking pipes and nearby janitorial stations. Removal of ceiling tiles observed with a fan running, apparently due to water intrusion. Access to this area was obstructed and appeared unsafe to permit further inspection. 7. Exposed records with visible dust accumulation, and lack of temperature or humidity monitoring. 8. Medical records stored alongside other hospital departments’ clinical and business records along with medical equipment in questionably secured areas. 9. Open shelving with records stacked haphazardly. No visible labeling on storage boxes or systematic indexing. During concurrent interview with the Director of Health Information Management (DHIM) on 12/10/24 and 12/12/24, she stated that in her past three to four months’ tenure with the hospital, she had not been fully advised of all onsite medical record storage locations for medical records nor does she have key access to all these locations. When asked who serves as Custodian of Records for the hospital, the DHIM responded “I do.” During concurrent interview with the Medical Records Clerk III (MRC3) on 12/12/24, he stated that he does have need to retrieve active medical records from storage areas across from the Medical Records Department. MRC3 acknowledged record retrieval requires he lift and move storage boxes above eye level, stacked upon one another, weighing an estimated 20 to 30 pounds each. During a review of the facility’s policy and procedure titled “Storage Policies” dated 05/1990, date last revised 10/22, sections covering Confidentiality, Protection, and Security were noted to address only those records previously stored with an offsite storage vendor for the years 2005 through 2013. A grid is shown listing this storage vendor location along with eight hospital-based storage locations for the years 2014 through most of 2020. Records (Inpatient/Outpatient/Emergency) for visits October 01, 2020 to present are noted to be in the hospital’s EHR (Electronic Health Record). During a review of a printout entitled “HIM GRM Inventory,” it was noted that back in 2012 the total records placed with the offsite storage vendor was 21,990. Since that time, through the year 2022, the inventory shows a grand total of 32,677 records, which were subsequently recalled by the hospital in 2024. During a review of the facility’s policy and procedure titled “Record Retention” dated 11/1997, date last revised 04/21, records retention is 10 years for adult patients, for minors 7 years following discharge or 1 year after the patient reaches the age of 18, whichever is longer. For moms and babies, retention is 1 year after discharge plus the patient reaches the age of 18 (19 years).”

“PROTECTING PATIENT RECORDS CFR(s): 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. This Standard is not met as evidenced by: 39051 Based on observation, interview and record review, the facility failed to ensure that unauthorized individuals cannot gain access to or alter patient records. This failure had the potential to result in compromised confidentiality and integrity of medical records, which are essential for patient trust and patient safety. Findings: During an observation on 12/9/24 at 10:35 a.m. on a tour of the Medical Records/HIM (Health Information Management) Department located on the Ground Floor of the main hospital at 1900 Sullivan Ave., Daly City, 94015, the door to the department entrance was noted to be unlocked. A small table serves as a partition with a sign indicating the area is restricted access. There is no wall or reception desk or other physical barrier restricting access to the rest of the department. The department’s location is the former Medical Library and journal shelves serve as file shelving for paper medical records abundant throughout the department. In an adjacent office are recently scanned records for the past 3 months awaiting quality control checks prior to being shredded. In addition to the Medical Records/HIM (Health Information Management) staff are individuals who are not hospital employees within the span of the Director Health Information Management’s (DHIM’s) control also working in the office in the vicinity of the medical records files. The rear door to the department was observed to be propped open and within a few feet of that door is a large bin for paper records to be shredded. The padlocks on the top of the container were unlocked. During concurrent interview with the DHIM and the Medical Records Clerk III (MRC3) on 12/9/24 at 10:45 a.m., the DHIM explained that the front door is left unlocked for patient convenience, as the department has approximately four walk-in requestors a day. Staff closest to the entrance watch for movement or sound up front indicating an individual is waiting for assistance. The DHIM explained that Housekeeping delivers the shred bin to a contracted vendor MediWaste approximately every 3 weeks. When asked whether the bin is locked after hours when her staff is gone, the DHIM stated “No” and the MRC3 stated the bin is unlocked for staff convenience, noting the narrow opening on the top of the bin. During a review of the facility’s policy and procedure titled “Confidentiality, Privacy and Data Security of Patient Information” dated 05/1990, date last revised 02/22, under Policy it states “The Medical Record Department will ensure that department staff are oriented and trained with respect to the confidentiality, privacy and data security of patient information in all stages of health care information gathering and processing. The department will develop and implement its services so that the confidentiality, privacy and data security of the medical record and the Medical Record Department computer systems are protected and secure.” Under Procedure it states “Confidential paperwork will be disposed of in the designated container in accordance with the hospital’s procedure for disposal of confidential information. A. Staff will use recycle bin to dispose of confidential paperwork at their workstation. B. When the recycle bin is full, staff will dispose of the contents in the designated container. C. Environmental Services staff or contracted vendor will lock and remove the full container, and replace it with an empty container on a weekly basis or as needed.””

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure the completeness, accuracy, and authentication of patient medical records in accordance with its policies and procedures. This systemic failure was evident in the documentation practices for one patient (Patient 37), including an incomplete medical history and surgical log entry, as well as global findings that medical record entries were not consistently completed, dated, timed, or authenticated. These deficiencies created the potential for compromised continuity of care, increased risk of medical errors, and hindered patient rights and trust. Findings: During a review of a printout titled “Seton Medical Center, Deficiency Report by Physician, Statistics of Deficiencies,” run date 12/13/24, time 09:55 a.m., it was noted this report is limited to outstanding reports requiring dictation or completion, broken down by age of the deficiency and by responsible physician. The report displays a total of 5 incomplete and 32 missing documents, including discharge summaries, ED (Emergency Department) notes, procedure reports, and a physician query [response]. Sixteen of the 37 incomplete records had deficiencies which fell within 0-15 days of discharge. Nineteen different physicians were responsible for the 37 record deficiencies. Types of deficiencies broke down as follows: ED (Emergency Department) Notes = 17, Discharge Summary = 11, Procedure Report = 8, Query = 1. During a review of a printout titled “Seton Medical Center, MR [Medical Record] Electronic Signature Deficiency Report, Deficiencies For All Dates ...” run date 12/13/24, time 09:53 a.m., it was noted this report is limited to missing signatures for various report types, broken down by physician and type of document. After filtering out GeroPsych Unit patients [addressed under Special Medical Record Requirements for Psychiatric Hospitals], cancelled dictations, Subacute Unit patients [out of scope for this survey] cancelled surgeries and system test patients, it was found that over half of the report could be attributed to one physician, an internal medicine/cardiovascular disease specialist. Missing signatures for this physician extend as far back as May 2024. Missing signatures for the remaining 28 physicians in the report extend as far back as January 2023. During a review of a spreadsheet report titled “Unsigned Verbal Orders, December 19, 2024,” it was noted the report breaks down whether the order is for co-signature, a telephone order, a protocol order or a verbal order. The report also breaks the unsigned orders down by physician and groups the physicians by type. The report displays a total of 987 unsigned orders for Community Physicians, a total of 3,446 unsigned orders for Emergency Physicians, a total of 140 unsigned orders identified as having errors by primarily one out of 4 physicians listed, a total of 176 unsigned orders for Hospitalists, a total of 6 unsigned orders for Radiologists, and a total of 78 unsigned orders for Residents, for a Grand Total of 4,833 unsigned orders as of 12/19/24. During a review of the facility’s policy and procedure titled “Suspension of Medical Staff Clinical Privileges Due to Incomplete Medical Records” dated 01/96, date last revised 04/24, it was noted the Record Completion Policy section states “ ...Seton Medical Center Medical Staff are responsible for completing/authenticating the entire medical record, of a discharged patient, with final diagnosis, within fourteen (14) days post discharge.”. The section on Authentication of Medical Records states “ ...All entries must be legible and complete, and must be authenticated, dated/timed promptly by the person (identified by name and discipline) who is responsible for ordering, providing, or evaluating the service furnished.” Timeliness is then defined by document type as follows: History & Physical - “This document is considered delinquent if not in the medical record within 24 hours post admission.” Operative Reports - “This document is considered delinquent if not in the medical record within 12 hours post procedure.” Discharge Summary - “This document is considered delinquent if not in the medical record within 48 hours post discharge.” Verbal/Telephone Orders - “This document is considered delinquent if not authenticated in the medical record within 48 hours post the time the order was given.” Under the section Post Discharge Medical Record Review it states “Failure to meet completion deadlines within 72 hours post discharge will result in the temporary suspension of clinical privileges ....” Under the section on Procedure/Responsibilities it states “The Health Information Management Department [is] responsible for the analysis and tracking of record completion requirements in the medical record. In order to help facilitate the timely completion of all medical records, the HIM (Health Information Management) Department ...will notify every physician who has incomplete medical records.” During a review of the document titled “Seton Medical Center, Medical Staff Bylaws, February 2023” on page 188, paragraph e. it was noted that “A medical staff member shall sign, date and time verbal orders for medications within forty-eight (48) hours of ordering. Failure by a physician involved in the care of the patient to sign verbal orders within 48 hours, following appropriate notification, may result in suspension of a Medical Staff member’s privileges, effective until the verbal order has been signed.” On page 119, paragraph k. states “The surgeon shall complete an operative progress report for the chart immediately following surgery. Failure to dictate an operative report within 24 hours following surgery and following appropriate notification may result in a suspension of a Medical Staff member’s privileges, effective until the operative report has been dictated. On page 120, paragraph 1. states “ ...all medical records of discharged patients shall be completed, including signatures, within two weeks following the patients’ discharge.” “A medical record shall not be permanently filed until it is completed, including signatures, by the responsible practitioners or is ordered filed by the Medical Records Committee of the Medical Staff upon approval by the President of the Medical Staff.” During an interview on 12/13/24 at 9:26 a.m. with the Director of Health Information Management (DHIM) and the Medical Records Clerk III (MRC1) the notification process described is that the MRC1 emails or calls physicians as frequently as every other day, but no less than once a week regarding their medical records requiring completion, and can also fax physicians reminders. However, physicians have not been suspended for delinquent records in over a year. The Supervisor Health Information Management (SHIM) coordinates the piece of the suspension process which identifies physicians with delinquent records eligible for suspension. A review of the document “Suspension Log - 2023” print date 11/8/2023 at 8:42 a.m. showed a total of 31 physicians last suspended, between 09/15/2023 and 11/03/23 for records delinquent due to missing Emergency Physician (ED MD) Notes, Discharge Summaries, Operative Reports, Queries [responses], and unsigned verbal orders and other unsigned documents. One physician alone had 1,087 unsigned verbal orders. Total delinquencies for all physicians were 1,669 as of the last suspension on 11/03/2023 as attested to by the SHIM. A review of the document “AHMC - Seton Medical Center, Suspension Log - 2024” print date 12/10/2024 at 10:45 a.m. reveals an attempt to suspend physician privileges based on the delinquencies listed for a total of 30 physicians on 01/19/2024 as attested to by the SHIM. Records were delinquent due to missing Emergency Physician (ED MD) Notes, Discharge Summaries, Operative Reports, Queries [responses], unsigned verbal orders and other unsigned documents. One physician alone had 1,387 unsigned verbal orders. Total delinquencies for all physicians were 3,344 as of the last attempted suspension on 01/19/2024. A review of the document “AHMC - Seton Medical Center, Suspension Log - 2024” print date 12/10/2024 at 1:29 p.m. shows medical records delinquencies by responsible physician were the facility to suspend physician privileges effective 12/13/24, as attested to by the SHIM. Excluding the Skilled Nursing and Subacute units [out of scope for this survey] a total of 40 physicians had medical records delinquent due to missing Emergency Physician (ED MD) Notes, Discharge Summaries, Operative Reports, Queries [responses], unsigned verbal orders, other unsigned documents and an incomplete History and Physical Exam. One physician alone had 371 unsigned verbal orders and other unsigned documents. Total delinquencies for all physicians who would have been eligible for suspension on 12/13/24 was 1,086 at the time of the report run 12/10/24. 38764 2. Review of Patient 37’s admission record, showed the patient was admitted on 12/5/24. During a review of Patient 37’s History and Physical for all Patients Undergoing... Anesthesia (undated), did not show information for the following: - Indications/symptoms for the procedure; - Current medications and dosages; - Allergies and/or known medication reactions; - Existing co-morbid conditions. During a concurrent interview and record review on 12/10/24 at 10:29 am with CN 2, CN 2 acknowledged the above findings. CN 2 stated Patient 37 had undergone a laser surgery on both eyes and the surgery required a topical anesthesia for the patient. CN 2 acknowledged the history and physical assessment for patient 37 was not documented completely by the physician. Review of the hospital’s P&P titled Medical Records and Completion Requirements revised on 4/17 showed, in part: the history and physical shall meet the following medical record documentation requirement. This includes, for patients undergoing surgical procedure... involves either no local anesthesia or local anesthesia used for topical/local..., documentation in the medical record shall include: - Indications and symptoms for the surgical procedure; - Current medications and dosages; - Allergies known allergies including medication reactions; - Existing co-morbid conditions, if any. 3. Review of Patient 37’s Eye Laser Log, showed YAG (a type of laser, Ytrrium-Aluminum-Garnet) was administered to the patient’s left eye and right eye. The log included the power setting for the laser was 3.8 mj (millijoule, unit of measurement), and the number of bursts/spot were 10 for each eye. However, there was no information on the amount of energy for the laser administered to the patient. During a concurrent interview and record review on 12/10/24 at 10:29 am with CN 2, CN 2 acknowledged the above findings. CN 2 was asked to explain the meaning of amount of energy in the laser log for Patient 37. CN 2 stated the amount of energy was the amount of laser energy administered to the patient during the surgery. CN 2 acknolwedged the physician should have documented the amount of energy in the laser log of the patient.”

“CONTENT OF RECORD: ORDERS DATED & SIGNED CFR(s): 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. This Standard is not met as evidenced by: 31794 Based on interview and record review the failed to ensure the medical records was accurate and complete for one of 30 sampled patients (Patient 2) when, the Verbal Order (VO, an oral directive that is given through any method of communication) to renew the order for “bilateral wrist restraints (is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely, as per facility policy) was not authenticated (process of verifying the accuracy and validity of information within a patient’s record by confirming the identity of the healthcare professional who made the entry, typically through a signature or electronic equivalent) by the Physician within “24 hours.” This deficient practice had the potential for inaccurate transcribing of orders and miscommunication which could place patient ‘s safety at risk. Findings: Review of the Face Sheet dated 12/13/24 indicated, Patient 2 was admitted to the hospital on 11/24/24 and was discharged on 12/9/24. Review of the History and Physical (H&P) dated 11/24/24 indicated, Patient 2 presented with the chief complaint of “pale looking and altered mental status”. The Assessment section of the H&P indicated, the diagnoses that included sepsis (body’s extreme reaction to an infection), lactic acidosis (when the body produces lactic acid [a chemical compound produced in the body when cells breakdown carbohydrates for energy] and can’t clear it), and urinary tract infection (UTI, infection in any part of the urinary system). In a concurrent record review and interview on 12/13/24, at 11:10 AM, with the Charge Nurse (CN 4), CN 4 stated, the bilateral soft wrist restraint was ordered on 11/24/24, it was applied due to patient “pulling lines and tubes,” and the restraint orders were renewed every 24 hours. In a follow-up interview and record review on 12/17/24, at 10:05 AM, with the Corporate Quality Director (CQD), Chief Nurse Officer (CNO), and the CN 4, the Order Chronology document was reviewed. The CQD stated, the Order Chronology indicated there was a VO placed on 12/5/24 at 1:15 PM to renew the order for bilateral wrist restraints and it was not authenticated by the Physician. The CNO stated, VO should only be used for emergency cases, it should not happen because physician was available 24/7, and the staff should just have called the “Hospitalist (a physician who cares for inpatients), to authenticate the order, it’’s for patient’s safety. Review of the facility’s Policy and Procedures titled, Use of Restraint and Seclusion, with the last revised date of 10/18/ indicated, “Purpose: ... B. To protect the patient’s health and safety while preserving the patient’s dignity, rights and wellbeing ... Policy: ... Verbal ... and Telephone orders for restraints are to be authenticated within 24 hours. ... .””

“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: 40903 Based on observation, interview, and record review the hospital failed to ensure high-risk medications (drugs with increased potential to cause serious harm or death if used or stored incorrectly) as floor stock (floor stock means prescription drugs not labeled for a specific patient, maintained at a nursing station, cabinets, or individual sealed trays) were safely stored in two out of five patient care units of the hospital (Surgery unit and the 6th floor medical unit) based on standards of practice and hospital’s policy when: 1. Concentrated injectable (shot into skin or veins) Potassium Chloride (or KCL, a mineral supplement used to prevent or treat low levels of potassium caused by disease, the concentrated intravenous [or IV, into Vein] form without dilution could cause harm by immediately stopping heart beats and subsequent death) was stored as floor stock in a room next to a surgery room (also called “OR”, Operating Room) without safety systems in place to prevent unauthorized access and risk of inadvertent unsafe use. 2. Sterile Water for Inhalation (Sterile means germ free water; sterile water bag if given intravenously could cause serious patient harm; “Inhalation” same as breathing), in one-liter size bag, was stored in hospital’s 6th floor medication room next to similar size and look alike IV bags with no safety system to prevent inadvertent use. These failed practices had potential to contribute to medication error, patient safety, and possibly lead to patient harm, injury and/or death. Findings: 1. During a concurrent interview and observation, in the main pharmacy, accompanied by the Director of Pharmacy (DOP) and Registered Pharmacist 1 (RPH 1), on 12/10/24, at 11:13 AM, three ready-made floor stock bins for heart surgery contained concentrated injectable potassium vials wrapped in a plastic Ziplock bag with a broken red plastic tape. The bin did not have an alert warning for use of concentrated potassium in patient care areas. The DOP stated the floor stock bin, and the use of concentrated potassium was in place long before him for use in cardiac (heart) surgery. During a concurrent interview and observation, in the surgical unit, accompanied by the Director of Pharmacy (DOP) and Charge Nurse 6 (CN 6), on 12/11/24, at 12:04 PM, three bins of floor stock medications containing concentrated injectable potassium vials kept in a cabinet next to Operating Room (OR, a surgical room) number 11 in the surgery unit. The three floor stock bins were inside a large plastic Ziplock bag with red plastic tape and no secure storage system. The CN 6 after opening the cabinet could not lock it and stated she needed to call the facility’s engineer to fix it. The CN 6 stated the storage room was accessible to all staff working in the surgery department. During a concurrent interview with DOP, on 12/19/24 at 10:40 AM, and review of hospital’s policy titled “Strategies for the Use and Storage of High risk/ High Alert Medications” last revised on 9/2024, the policy indicated “Storing concentrated vials of electrolytes (potassium considered an electrolyte) outside the pharmacy may lead to errors. Mixing KCL (or potassium Chloride) extemporaneously (without being pre-made) on the floor has resulted in patient injury, including death. Lack of standardized policy and procedure for the administration of electrolyte infusions has resulted in patient injury.” The policy on “strategy” section indicated “Concentrated vials of potassium are not permitted in any patient care areas. Exception: open heart perfusionist (individual managing the patient’s blood flow during heart surgery): will be dispensed potassium chloride (KCL) concentrated vials for perfusion pump installation and cardiac emergencies during CABG (or Coronary Artery Bypass Graft; a type of Cardiac surgery) in a CV (CV stands for Cardiovascular or heart surgery) surgery Med (medication) tray. The KCL 20 MEQ (“MEQ” stands for milliequivalents, a measure of drug strength) vial will be double bagged, stapled closed and warning labels regarding dilution required.” The DOP stated the policy had been in place for heart surgeons to use the concentrated potassium and there needed to be more safety measures to prevent unsafe or inadvertent use. 2. During a concurrent observation and interview, in the facility’s 6th floor medication room, accompanied by Charge Nurse 3 (CN 3), on 12/16/24, at 10:40 AM, a multilevel metal rack stored IV fluid bags in yellow plastic bins. On the third shelf two one-liter bags of “Sterile Water for Inhalation” was stored. The water bags were located next to one-liter intravenous (IV, into the Vein) bags on the shelves. CN 3 stated IV bags were supplied and stocked by the hospital central supply department. CN 3 was not sure why the inhalation bags were stored in the medication room. During a concurrent observation and interview, in the facility’s 6th floor medication room, accompanied by Respiratory Therapist (RT), on 12/17/24, at 10:42 AM, RT stated her department had its own supply room and cart to care for patient. When revisited the medication room on the 6th floor, the bags of Sterile Water for Inhalation were still on the shelves next to IV bags. RT stated the Sterile Water for Inhalation bags should not have been in the medication room and could have posed a risk for inadvertent use. RT was observed removing the bags from the medication room. In an interview with Chief Nursing Office (CNO), on 12/18/24, at 3 PM, the CNO stated she expected the staff to follow hospital’s policy on high-risk and look-alike products that posed serious risk if not used properly. During a concurrent Interview with DOP, on 12/19/24, at 10:39 AM and record review of hospital’s policy, titled “High Risk/High Alert and Look-Alike/Sound- Alike Medication Management”, dated 9/2024, the policy indicated “The following medications utilized at hospital [redacted] ... have been identified as high alert medication, those medications that bear a heightened risk of causing significant patient harm when they are used inappropriately. Although medication errors may or may not be more common with these drugs, the consequences of an error involving these drugs generally result in greater magnitude of patient harms.” The policy further indicated “While medication usage processes will follow our policy and procedure to decrease the risk of medication errors, additional emphasize will be focused on medications defined as high alert medications. To improve patient safety, the ordering, storage, preparation, and administration of these products will follow recommended processes, including ... Limiting access to high alert medications, using auxiliary labels, ... and using redundancies such as automated or independent double check when necessary.” The policy included “Sterile Water for Injection, inhalation, and irrigation ... in containers of 100 mL (“mL” is milliliter, a unit of volume) or more.” The policy in table 2, titled “Strategies for the use and storage of high Risk / High Alert medications”, did not include common risk factors and strategy to prevent inadvertent use of Sterile Water in an IV bag form. The DOP stated the hospital policy on safe handling of high-risk medications was recently reviewed and required hospital wide education of the patient care staff. Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP List of High-Alert Medications in Acute Care Settings”, dated 1/2024, last accessed on 12/30/24 via https://www.ismp.org/sites/default/files/attachments/2024-01/20240111.pdf , the document indicated “High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.” The document listed drugs with potential significant harm and recommended the hospitals to use special safeguards and strategies to reduce risk of errors. The ISMP list of high-risk drugs included concentrated electrolytes and Sterile Water for injection and inhalation. Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 10 (archived)” indicated “Eliminate all 1,000 mL bags of sterile water (labeled for “injection,” “irrigation,” or “inhalation”) from all areas outside of the pharmacy. Use alternatives to avoid the storage and use of 1,000 mL (1 liter) bags of sterile water for injection, irrigation, or inhalation in patient care areas ... Establish a policy that 1,000 mL bags of sterile water can only be ordered by the pharmacy. The pharmacy needs to work with respiratory therapy and other relevant departments of the hospital to establish guidelines regarding the safest way to provide large volumes of sterile water when needed for patient care.””

“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: 40903 Based on observation, interview, and record review the hospital failed to ensure controlled drug (narcotic or opioid drugs subject to abuse and misuse) use (or narcotics/opioids, drugs with high risk for abuse) from Automated Dispensing Machine (or ADM, a computer-controlled device that stored, dispensed, and tracked medications for patient use) were consistently monitored and discrepancies (when the narcotic dose documented as given plus the narcotic dose documented as wasted does not equal the narcotic dose documented as withdrawn from ADM) or overrides (bypass verification of doctor’s order by pharmacy) were escalated for timely resolution based on standards of practice and facility’s policy with census of 62. This failed practice had potential for the risk of opioid drug diversion (unlawful use of prescription drugs) in the hospital and possibly lead to patient harm or injury. Findings: During an interview with Director of Pharmacy (DOP) and Registered Pharmacist 1 (RPH 1), in the pharmacy, on 12/10/24, at 10:35 AM, the DOP stated the hospital’s policy allowed the Emergency Department (ED, a unit in the hospital) to override (bypass verification of doctor’s order by pharmacy) medications from Automated Dispensing Machine (or ADM, a computer-controlled device that stores, dispenses, and tracks medications for patient use) without pharmacy order review. RPH 1 stated the controlled medications use and removal from ADM were reviewed by pharmacy on daily basis and they contacted the charge nurses or doctors via email with any issues they could not resolve. RPH 1 stated pharmacy kept track of the narcotic discrepancies in an excel sheet (a document that organizes information in rows and columns) manually. The DOP stated the hospital departments like ED and Surgery did not have a profiled system to connect the doctor’s order to the ADM and the nursing staff were able to remove any medications without a medication profile in the system. In a concurrent observation and interview with Registered Nurse 9 (RN 9), in the ED unit, on 12/11/24, at 4:30 PM, RN 9 demonstrated how he removed medications from the ADM by searching the drug name without use of override function. RN 9 stated most medications were available for removal from ADM and sometimes they had to call the pharmacy to deliver. During a concurrent interview with Registered Pharmacist 2 (RPH 2), on 12/16/24, at 2:10 PM, in the main pharmacy, and review of hospital’s document, titled “Audit Reports” for controlled drug (or narcotic/opioid drugs with risk of abuse and diversion) use, dated 12/10/24, RPH 2 stated the report included all hospital departments that used Automated Dispensing Machine (or ADM, a computer-controlled device that stores, dispenses, and tracks medications for patient use) to remove controlled medications for patient use. RPH 2 stated the report included hospital units that did not require order authentication and verification by pharmacy before medication removal, including Emergency Department (ED), Surgery department, and Operating Room (OR) with anesthesia use (anesthesia; a medical intervention that block or reduces pain and sensation during surgical procedures). The report further indicated date/time, patient name and the name of the nurse who removed the controlled drug and transaction type (included removal, wasting the drug, or returning the drug to the ADM). Further review of the document for narcotic removal from the ADM in ED, the document did not display the corresponding doctor’s order that matched with the medication removal process. During a concurrent interview with Registered Pharmacist 2 (RPH 2) on 12/16/24, at 2:25 PM, and review of hospital’s document in excel format, titled “Anesthesia Tracker”, with date range of 10/2024 to 12/2024, the record indicated narcotic use and waste discrepancy dated back to 10/7/24 for Patient 68, Patient 69, and Patient 70 from ADM devices in Anesthesia and Radiology (or diagnostic imaging like Xray) was still pending without resolution. RPH 2 stated narcotic removal included two meperidine (or Demerol, a narcotic sedative medication used to treat pain) doses, a midazolam (or Versed, a sedative drug) dose and a fentanyl (strong opioid used for pain) dose that did not have documentation of the use or waste in the medical record. RPH 2 stated the process of response from providers or nursing was dependent on how often they worked in the hospital despite repeated emails. Further review of the record on excel sheet did not show consistent follow up to address the narcotic discrepancy. RPH 2 stated the process of screening and follow up was manual and time consuming. RPH 2 stated the cases that needed follow up were highlighted in yellow manually in the excel sheet and the staff could have addressed and escalated the discrepancy to the unit manager. In an interview with DOP, on 12/19/24, at 10:39 AM, the DOP stated they recently revised and updated the policy on use of ADM in which tracked the controlled substance medication use in the hospital. The DOP stated the facility did not have monitoring software resources to implement and improve monitoring and surveillance. The DOP stated the current system was labor intensive and required cooperation with other departments for timely resolution of discrepancies. Review of the hospital policy, titled “ADM [redacted brand name] Medication Access and Utilization”, dated 12/3/24, the policy indicated “This policy outlines guideline for setup, access, use, maintenance, and discrepancy resolution of ADM [redacted] ensuring compliance with regulatory standards for pharmacist review of medication orders before administration.” The policy further indicated “Non-profile MedStations (or ADM) used in areas where physician directly oversee medication management (e.g. the Emergency Department), and the ... profile interface, which requires pharmacist approval prior to medication administration in units where physician do not directly manage this process. Override to the ADM [redacted] profile interface are permitted only in specific situations, including physician manage orders, urgent cases where patient care would otherwise be compromised. Regular inventory reconciliation is required to track medication usage, and any discrepancy or losses must be promptly reported.” The policy under section titled “Discrepancy for Controlled Substances” indicated “Any discrepancy that cannot be resolved within 72 hours requires the completion of an incident report and notification from pharmacy. Pharmacy will print and review daily “ADM [redacted] discrepancy report” for the prior day transaction for discrepancies, which may require further investigation. The assigned pharmacist will contact the nurse manager or designee to review and resolve discrepancies in a timely manner.” Review of American Society of Health-System Pharmacists (or ASHP, a professional organization that advocates for medication and patient safety) guideline on “Preventing Diversion of Controlled Substances”, dated 2022, last accessed via https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/preventing-diversion-of-controlled-substances.pdf, on 12/30/24, the guideline under “Automation and technology” indicated “Automated dispensing technology ... and diversion monitoring software, have been developed to assist with the management of CS (Controlled Substances), including inventory control; documentation of removal, administration, and waste; billing; chain of custody tracking; and auditing ... Automated dispensing and surveillance solutions that support adequate control, surveillance, and auditing processes should be implemented, at minimum, in high-risk areas.” The guideline under “Monitoring and surveillance” indicated “The healthcare organization assigns a pharmacist, with adequate support staff and dedicated time for surveillance monitoring, who is accountable for optimizing the implementation and functionality of ADCs (Automated Dispensing Cabinet, same as ADM) and diversion monitoring software reporting capabilities.””

“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: 40903 Based on observation, interview, and record review the hospital failed to ensure safe pharmaceutical services were provided and met the needs of each patient with census of 62 patients when: 1. Hospital failed to ensure non-narcotic (non-opioid) prescription medication override (means bypassed verification of doctor’s order in the computer) from Automated Dispensing Machine (or ADM, a computer-controlled device that stored, dispense, and tracked medications for patients) were consistently reviewed and accounted for based on standards of practice and hospital’s policy. This failed practice had potential for unsafe drug use, lack of accountability, risk of prescription drug diversion in the hospital and possibly patient harm. 2. Hospital failed to follow FDA (or Food and Drug Administration, a government agency that protects public health by ensuring the safety of drugs) medication warning and guidelines on fentanyl patch (fentanyl skin patch, or transdermal patch contains large amount of a potent opioid called fentanyl, approved for use in sever chronic pain on patients tolerant to frequent opioid use) prescribing and use in two out of two opioid naïve (opioid naïve” means a patient who has not used opioids for more than seven consecutive days during the previous 30 days) patients (Patient 61 and Patient 62) based on manufacturer recommendation and facility’s policy. These failed practices could contribute to unsafe medication use and risk of adverse effect from a high-risk opioid medication and possibly lead to patient harm, injury and/or death. 3. Hospital failed to ensure Malignant Hyperthermia cart (or MH cart, a medical cart specifically designed to hold all the necessary emergency medications and supplies needed to rapidly treat a patient experiencing a life-threatening reaction called Malignant Hyperthermia, when muscles become rigid and body temperature climbed very quickly as result of anesthesia drug [drugs that blocks pain sensation during surgery] use during surgery or other similar medical setting) contents followed safe storage practices and matched hospital’s policy for safe use of Sterile Water For Injection (or SWFI, a germ free water used to mix drugs and considered high risk for inadvertent IV use) bag and the availability of the refrigerated contents in safe proximity of the MH cart based on standards of practice. This failed practice could contribute to unsafe use of MH cart contents, delay in providing care in an urgent situation during a Malignant Hyperthermia crisis and possibly patient harm, injury, or death. Findings: 1. During a concurrent interview with Director of Pharmacy (DOP) and Registered Pharmacist 1 (RPH 1), in the pharmacy, on 12/10/24, at 10:35 AM, RPH 1 stated the review of non-narcotic prescription medications used and overridden from ADM devices, were not part of pharmacist’s daily workflow. The DOP stated the hospital’s policy allowed the Emergency Department (ED, a unit in the hospital) and surgery unit to override (bypass verification and review of doctor’s order by pharmacy) all medications from Automated Dispensing Machine (ADM) without pharmacy’s concurrent order review. The DOP stated hospital’s other patient care units were assigned a list of medication that could be overridden by nursing staff for urgent patient’s needs. The DOP stated the hospital departments like ED and Surgery did not have a profiled system to connect the doctor’s order to the ADM and the nursing staff were able to remove any medications without patient specific medication profile. The DOP stated the hospital most recently updated the ADM override policy. The DOP stated any medications taken from the ADM should have an accompanying physician order for safety and accountability purposes. Review of the facility’s policy, titled “ADM [redacted] Medication Access and Utilization”, dated 12/3/24, the policy under “Reports” indicated “Override Report: Printed daily for auditing override appropriateness, with pharmacists addressing any discrepancies in patient profiles.” The policy under “Daily Tasks” indicated “ADM [redacted] override reports are reviewed daily to ensure appropriateness.” The policy under “Deviation and Compliance”, indicated “Non-controlled medication discrepancies are reported as appropriate.” Review of American Society of Health-System Pharmacists (or ASHP, a professional organization that advocates for medication and patient safety) guideline on “Safe Use of Automated Dispensing Cabinets (or ADC, also known as Automated Dispensing Machine or ADM)”, dated 2022, the guideline indicated “ADCs can be configured as either open-access or restricted devices. Restricted machines only allow access to medications via a verified medication order or defined automatic override list. In open-access devices, individuals administering medications have unrestricted access to all medications in the machine. The Institute for Safe Medication Practices (ISMP, a patient/medication safety advocate) does not recommend the use of open- access devices ... The number and types of overrides should be regularly reviewed for process improvement and identification of safety issues ... Dispense transactions can be considered reconciled when matched to a prescriber’s order and the dose dispensed is equal to the dose charted as administered plus any amount of drug documented as wasted or returned. These transactions should be reconciled in a timely manner during the normal course of a clinician’s work shift ... Because manual data and report review are tedious and time consuming, diversion detection software options should be evaluated and employed to facilitate the review process ...” Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 16” for use of ADC indicated “a) Limit the variety of medications that can be removed from an automated dispensing cabinet (ADC) using the override function. b) Require a medication order (e.g., electronic, written, telephone, verbal) prior to removing any medication from an ADC, including those removed using the override function. c) Monitor ADC overrides to verify appropriateness, transcription of orders, and documentation of administration. d) Periodically review for appropriateness the list of medications available using the override function. The document further indicated “Restrict medications available using override to those that would be needed emergently (as defined by the organization) such as antidotes, rescue and reversal agents, life-sustaining drugs, and comfort measure medications such as those used to manage acute pain or intractable nausea and vomiting. Another “override” safety concern involves the process that should be in place for pharmacists and nurse managers to retrospectively review medications removed using the override feature. Too often this step is absent or inadequate, or important findings never reach nurse leaders who have oversight of nursing practice. ISMP has repeatedly received reports of harmful and fatal medication errors that involved practitioners removing medications using the override feature of an ADC.” 2a. During a concurrent interview with Registered Pharmacist 2 (RPH 2) and record review of Patient 61’s medical record and medication list, on 12/16/24, at 1 PM, the record indicated Patient 61 was admitted to hospital on 7/8/24 with history of lung cancer and cancer pain. Further review of the Patient 61’s medication list indicated a fentanyl patch 12 mcg/hr (“mcg/hr” or microgram per hour, a unit of measure and drug potency per hour) was ordered on 7/8/24, at 4:15 PM, with pharmacy order verification of the doctor’s order at 4:27 PM. RPH 2 stated there was no documentation if the order was reviewed for safe use per manufacturer guidelines or if medical doctor was contacted. RPH 2 acknowledged the use of fentanyl 12 mcg/hr patch was reserved for dosage adjustment of the patients already taking the patch. During a concurrent interview with RPH 2 on 12/16/24, at 1 PM, and record review of Patient 61’s medical record, titled “History and Physical” (or H&P), dated 7/8/24, the record written by medical doctor, indicated “Pt (patient) was taking PO (by mouth) Dilaudid 1 mg (opioid pain medication, “mg” is milligram a unit of measure) Q4H (Every 4 Hours) at home, however lately he has not been able to take any medication by mouth.” RPH 2 stated patient’s history of opioid use was unclear and inconsistent to assess opioid tolerance and start the fentanyl patch 12 mcg/hr. In an interview and review of hospital policy on fentanyl patch with DOP, on 12/19/24, at 10:39 AM, The policy on “procedure” section indicated “upon order entry, the physician has to answer “Yes” to three questions: 1. My patient is already receiving opioid therapy who has demonstrated opioid tolerance and who require a total daily dose of at least equivalent to fentanyl, 25 microgram per hour. 2. My patient is opioid tolerant who has been taking one of the following for at least one week ... 3. I understand that transdermal fentanyl is only for use in patients who are already tolerant opioid therapy of comparable potency ... The pharmacist shall verify the appropriate use of transdermal fentanyl based on black box warning (or BBW, the higher level of warning issued by FDA on a drug) prior to dispensing the medication. Any medication order not meeting the criteria specifically established to address the black box warning will be reviewed with prescribing physician ...” The DOP stated the current policy, which was last revised on 3/2021, was not followed and electronic health system (computer) did not trigger a safety alert or hard stop. The DOP stated he had tabulated a revised policy and resources to guide the pharmacists and the medical staff to follow the FDA warnings and manufacturers safety guidelines. 2b. During a concurrent interview with Registered Pharmacist 2 (RPH 2) and record review of Patient 62’s medical record and medication list, on 12/16/24, at 1 PM, the record indicated Patient 62 was admitted to hospital on 8/7/24 with abdominal pain and subsequent pancreatic cancer diagnosis (a type of cancer that develops when abnormal cells in the pancreas grow out of control and form a tumor. The pancreas is a gland that produces digestive juices and hormones). The review of the Patient 62’s medication list indicated a fentanyl patch 50 mcg/hr (“mcg/hr” or microgram per hour, a unit of measure and drug potency per hour) was ordered on 8/15/24, at 1PM, with pharmacy order verification of the doctor’s order at 1:50 PM. Further review of Patient 62’s admission record and medication reconciliation (a formal process that ensures a patient’s medication information history compiled accurately and completed upon admission to hospital) from Emergency Room (ER) did not include the name or use of any opioid (narcotic pain medication) medication for treatment of pain while at home. RPH 2 stated there was no documentation if the order was reviewed for safe use per manufacturer guidelines or if medical doctor was contacted. RPH 2 acknowledged the use of fentanyl 50 mcg/hr patch as starting dose was not recommended based on drug labeling information and patient’s opioid use history in the previous seven days of stay in the hospital. During an interview and review of policy on “Fentanyl Patch” with DOP, on 12/19/24, at 10:39 AM, The policy on “procedure” section indicated “upon order entry, the physician has to answer “Yes” to three questions: 1. My patient is already receiving opioid therapy who has demonstrated opioid tolerance and who require a total daily dose of at least equivalent to fentanyl, 25 microgram per hour. 2. My patient is opioid tolerant who has been taking one of the following for at least one week ... 3. I understand that transdermal fentanyl is only for use in patients who are already tolerant opioid therapy of comparable potency ... The pharmacist shall verify the appropriate use of transdermal fentanyl based on black box warning (or BBW, the higher level of warning issued by FDA on a drug) prior to dispensing the medication. Any medication order not meeting the criteria specifically established to address the black box warning will be reviewed with prescribing physician ...” The DOP stated the current policy, which was last revised on 3/2021, was not followed and electronic health system (computer) did not trigger a safety alert or hard stop. The DOP stated he had tabulated a revised policy and resources to guide the pharmacists and the medical staff to follow the FDA warnings and manufacturer safety guidelines. Review of DailyMed (drug information website operated by the U.S. National Library of Medicine [NLM, operated by the United States federal government, is the world’s largest medical library] and publishes up-to-date and accurate drug labels [also called a “package insert”]) fentanyl drug information, last accessed on 12/30/24 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=67cb9ea4-5adb-4a3a-9568-266b6f472078 , the document under “boxed warning”, (known as a “black box” warning, alerts healthcare providers to serious adverse reactions or restrictions on use. The boxed warnings issued when a drug has a serious adverse reaction that may lead to death or serious injury. Boxed warnings are the most severe warning the FDA [Food and Drug Administration, a federal agency who approve and monitor safe use of drug] can give to an approved drug) indicated “Fentanyl transdermal (same as patch) system contains a high concentration of a potent ... fentanyl ... Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means ... Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine (opioid pain killer) daily, ... or at least 8 mg of oral hydromorphone (same as Dilaudid) daily ... Because serious or life-threatening hypoventilation (unable to breath) could occur, fentanyl transdermal system is contraindicated: ... in patients who are not opioid-tolerant ..., in the management of acute pain or in patients who require opioid analgesia for a short period of time ...”’ Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 15” indicated “Eliminate the prescribing of fentaNYL patches for opioid-naïve patients and/or patients with acute pain ... Verify and document a patient’s opioid status (naïve versus tolerant) and type of pain (acute versus chronic) before prescribing and dispensing ... Eliminate the prescribing of fentaNYL patches for opioid-naïve patients and/or patients with acute pain ... FentaNYL patches are intended for opioid-tolerant patients for the management of pain, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” 3. During a concurrent observation and interview, accompanied by with the DOP and surgical unit Charge Nurse 6 (CN 6), at the hospital’s surgical unit, on 12/11/24, at 12:26 PM, the multi-drawer MH cart content list indicated the fifth drawer held five bags of Sterile Water for Injection (or SWFI, germ free water used to mix drugs in powder form) 1000 mL (“mL” is milliliter, a unit of volume), along with 60 mL syringe sizes. Further observation indicated a typed note on top of the MH cart stating to find insulin (drug used in regulating blood sugar levels and used to treat high potassium levels which is a common complication of an MH crisis) and cold Saline bags (sterile saltwater used to hydration) in a refrigerator in the CV surgery area (“CV” stands for Cardiovascular or heart surgery room) away from MH cart location. CN 6 stated during a MH crisis the staff needed to get cooled saline bag and insulin from the CV surgery refrigerator. The DOP stated use of SWFI one liter bag could pose safety risk for inadvertent IV use in an emergency situation. During a concurrent observation and interview, accompanied by with the DOP and surgical unit Charge Nurse 6 (CN 6), at hospital’s surgical unit, on 12/11/24, at 12:26 PM, a large, unlocked refrigerator in a side-room next to heart surgery room, contained 4 bags of Saline and a vial of insulin wrapped in plastic bag with a notation “Do not remove, reserve for MH cart”. CN 6 stated the wrapped bag with cold Saline belonged to MH cart for emergency use. During a review of facility’s policy titled “Medications: Malignant Hyperthermia, Diagnosis and Management”, dated 7/2021, the policy on page 11 listed the content of MH tray and indicated the fifth drawer included 36 “Sterile Water 100 mL vials” (for mixing drug) and noted to find cold Saline bag 1000 mL and insulin vial in the “Heart Refrigerator”. During a concurrent interview with the DOP on 12/19/24, at 10:39 AM, and review of facility’s policy on “Malignant Hyperthermia”, last revised on 7/2021, the policy’s list of MH drug contents did not match what MH cart actually stored. The DOP stated he was not sure why one-liter bags of SWFI was replaced with a safer version of sterile water vials in the MH cart against the policy. The DOP acknowledged the policy had not been updated for a couple of years. Review of MHUS standards on MH (“MHUS” stands for Malignant Hyperthermia Association of the United States; a non-profit organization focused on improving medical care for patients at risk of malignant hyperthermia), last accessed on 12/30/24 via https://www.mhaus.org/healthcare-professionals/mhaus-recommendations/ , the record indicated Malignant Hyperthermia is a potentially fatal disorder usually associated with the administration of certain anesthetics used during surgery or procedures. The MAHUS guideline outlined best practices for identifying, managing, and treating potential MH cases, including the requirement for a dedicated and readily accessible “MH cart” stocked with necessary medications and protocols for patient assessment and emergency response in case of an MH crisis. Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 10 (archived)” indicated “Eliminate all 1,000 mL bags of sterile water (labeled for “injection,” “irrigation,” or “inhalation”) from all areas outside of the pharmacy. Use alternatives to avoid the storage and use of 1,000 mL (1 liter) bags of sterile water for injection, irrigation, or inhalation in patient care areas ... Establish a policy that 1,000 mL bags of sterile water can only be ordered by the pharmacy. The pharmacy needs to work with respiratory therapy and other relevant departments of the hospital to establish guidelines regarding the safest way to provide large volumes of sterile water when needed for patient care.” Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 15” indicated “Eliminate the prescribing of fentaNYL patches for opioid-naïve patients and/or patients with acute pain ... Verify and document a patient’s opioid status (naïve versus tolerant) and type of pain (acute versus chronic) before prescribing and dispensing ... Eliminate the prescribing of fentaNYL patches for opioid-naïve patients and/or patients with acute pain ... FentaNYL patches are intended for opioid-tolerant patients for the management of pain, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” Review of the Institute for Safe Medication Practices (or ISMP, a non-profit organization that works to prevent medication errors) document, titled “ISMP Targeted Medication Safety Best Practices for Hospitals”, for 2024-2025, last accessed on 12/30/24 via https://online.ecri.org/hubfs/ISMP/Resources/ISMP_TargetedMedicationSafetyBestPractices_Hospitals.pdf, the document under “Best practice 16” for use of ADM indicated “a) Limit the variety of medications that can be removed from an automated dispensing cabinet (ADC) using the override function. b) Require a medication order (e.g., electronic, written, telephone, verbal) prior to removing any medication from an ADC, including those removed using the override function. c) Monitor ADC overrides to verify appropriateness, transcription of orders, and documentation of administration. d) Periodically review for appropriateness the list of medications available using the override function. The document further indicated “Restrict medications available using override to those that would be needed emergently (as defined by the organization) such as antidotes, rescue and reversal agents, life-sustaining drugs, and comfort measure medications such as those used to manage acute pain or intractable nausea and vomiting. Another “override” safety concern involves the process that should be in place for pharmacists and nurse managers to retrospectively review medications removed using the override feature. Too often this step is absent or inadequate, or important findings never reach nurse leaders who have oversight of nursing practice. ISMP has repeatedly received reports of harmful and fatal medication errors that involved practitioners removing medications using the override feature of an ADC.””

“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: 40903 Based on interview and record review the hospital failed to ensure Environmental Services staff (or EVS staff, responsible for cleaning the pharmacy’s area where sterile (germ free) Intravenous [or IV, Into the Vein] medications prepared) assigned to pharmacy for cleaning and sanitization of the IV preparation area (known as IV room or Clean room where sterile IV products were made) were trained and consistently serviced the IV preparation area per facility’s policy and the USP (USP stands for “United States Pharmacopeia,” a non-profit organization that sets standards for the quality and purity of medications, including guidelines specifically for compounding sterile preparations) standards of practice with census of 62 patients. This failed practice could contribute to unsafe sanitization of sterile IV product preparation areas and the risk of contaminated drug products harming a patient. Findings: During a concurrent interview with Registered Pharmacist 1 (RPH 1), and review of hospital’s document, titled “EVS Daily and Weekly IV Area Cleaning Log”, with date range of 8/2024 to 12/2024, the record indicated a table with documentations of daily cleaning and sanitization of the hospital’s IV preparation area. RPH 1 stated the EVS staff were trained by pharmacy on the requirements of how to enter, clean and sanitize the IV preparation areas. RPH 1 stated she expected the EVS department assign the trained staff to clean and sanitize the pharmacy per policy. The review of the cleaning logs indicated multiple days of missed cleaning documentations in August, September, and October of 2024. Further review of cleaning records indicated EVS staff without the required training were assigned to IV preparation area and documented their signature on the cleaning log. RPH 1 stated the pharmacy should have checked the training status of EVS staff assigned to clean the IV preparation area. In an interview with Environmental Services Tech Lead 1 (ESTL 1) on 12/18/24, at 11:51 AM, the ESTL 1 stated EVS staff followed the step by step written instruction in the pharmacy’s IV preparation areas in addition to the annual training they received from pharmacy. ESTL 1 stated schedule conflict, vacation or staffing issues may have caused the untrained EVS staff cover pharmacy’s specialized clean area. In an interview with Director of Pharmacy (DOP), on 12/19/24, at 10:39 PM, the DOP stated the facility’s policy followed USP guidelines and pharmacy staff should have checked the training status of EVS staff assigned to cleaning pharmacy IV preparation areas. Review of hospital’s policy, titled “Intravenous Sterile Compounding Overview”, dated 9/24/24, the policy under “Environmental Services (EVS) cleaning of ... Segregated Compounding Area (or SCA, means the area designed for IV preparation)” indicated “EVS is responsible for daily and weekly cleanings of the Segregated Compounding Area (or SCA). All EVS personnel engaged in cleaning the SCA shall be trained by pharmacy prior to cleaning. Documentation and training shall be maintained by both EVS and pharmacy ... In the event that EVS is not available to perform a daily cleaning of the SCA, triple cleaning performed on Friday’s will compensate for prior daily cleaning not performed that week.” Review of the 2024 version of United States Pharmacopeia (or USP), the leading non-profit organization that sets the quality standards for compounded medications, including sterile IV preparations, last accessed on 12/30/24 via https://www.usp.org/compounding/general-chapter-797, the document indicated “All cleaning and disinfecting activities must be performed by trained and appropriately garbed personnel using facility-approved agents and procedures, which must be described in written SOPs (or Standard Operating Procedure, same as policy). Personnel must be trained if there are any changes in the cleaning and disinfecting procedures.””

“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: 39723 Based on observation, interview, and record review, the hospital did not ensure the policy and procedure on medication security was implemented and medications were left unlocked and unattended for one of one sampled medication cart (perfusion cart). This failure had the potential for unauthorized access, tampering, theft, and/or diversion (medication taken for use by someone other than whom the medication was prescribed) of prescribed medications. Findings: A tour was conducted of the cardiovascular (the heart and blood vessels system) operating room (CVOR) on 12/10/24, at 11:23 a.m., with Operating Room Registered Nurse (ORRN) 1. The perfusion cart was observed unlocked and unattended. The following medications were observed: 1. Two vials of Albumin (medication used to increase the volume of blood plasma) 12.5 grams (gm, unit of measurement); 2. Four vials of Aminocaproic Acid (medication used to treat serious bleeding conditions) 5 gm; 3. Two vials of Amiodarone (medication used to treat heart rhythm disorders) 150 mg; 4. Two syringes of Calcium Chloride (medication used to treat low calcium levels in the blood) 10%; 5. One syringe of Dextrose (medication used to treat very low blood sugar) 50%; 6. One bottle of Forane (a medication used for induction and maintenance of general anesthesia) 100 milliliters (ml, unit of measurement); 7. Two vials of Furosemide (medication used to treat high blood pressure) 10 mg; 8. Seven vials of Heparin (medication used to prevent clotting of the blood) 1000 units; 9. Three syringes of Lidocaine (medication used to prevent pain) 2%; 10. Three vials of Mannitol (medication used to reduce swelling) 50 mls; 11. One vial of Phenylephrine (medication used to treat congestion) 10 mg; 12. Five syringes of Sodium Bicarbonate (medication used to neutralizing excess stomach acid) 1 milliequivalent (mEq, unit of measurement); and 13. Six vials of Potassium Chloride (medication used to treat low potassium levels) 40 mEq. An interview was conducted with ORRN 1, on 12/10/24, at 11:30 a.m., in the CVOR. ORRN 1 confirmed the medication count was accurate. ORRN 1 stated she was not aware the perfusion cart was unlocked and, “I don’t know how long the cart had been left unlocked.” ORRN 1 stated the cardiac perfusionist (CP) was responsible for ensuring the perfusion cart was locked after each surgical case. An interview was conducted with Operating Room Manager (ORM) 1, on 12/10/24, at 12:45 p.m., in the OR nurse station. ORM 1 stated the CP should have locked the medication cart at the conclusion of the procedure and the registered nurse assigned to the CVOR should have double checked the perfusing cart to ensure that all medications were secured. An interview and record review were conducted with Pharmacist (PharmD) 1, on 12/13/24, at 9:48 a.m., outside of the administration conference room. The hospital document titled “Perfusion Cart: Charge Form,” (a document that shows the medication content of the cart) dated 11/9/24, was reviewed. PharmD 1 confirmed the pharmacy department was responsible for the hospital’s pharmaceutical inventory and authorized personnel on the nursing care units had access to the unit’s medication delivery systems. PharmD 1 stated the perfusion cart’s charge form indicated the medications which should have been securely stored in the cart. PharmD 1 stated the hospital’s P&P was not followed because “the medication cart should not have been left unlocked if the cart was not in use.” The hospital’s P&P titled “Pharmacy: Security,” revised 3/2023, indicated “ ...Procedure: ...3. All medications in the nursing patient care areas must remain locked at all times except when in use (includes, floor stock, patient specific medication cassettes and Pyxis machine drawers) ...””

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 40903 Based on interview and record review the hospital failed to address medication safety issues including timely review of medication error events, update of pharmaceutical policies affecting patient care via the medical staff’s Pharmacy and Therapeutic committee (or P&T committee; a group of healthcare professionals in hospital who review and approve safe drug use in the hospital based on literature, standards of practice and hospital safety data. P&T committees are typically made up of doctors, pharmacists, nurses, and administrators who meet regularly throughout the year), or similar committees based on standards of practice, facility’s policy, and hospital bylaws (Bylaws were hospital rules required by law that outlined the responsibilities and procedures ensuring quality patient care) with patient census of 62. This failed practice may have contributed to lack of timely oversight of safe medication use in the hospital. Findings: During a concurrent observation and interview, accompanied by Infection Prevention (IP), in the ED (emergency department, a unit in the hospital), on 12/11/24, at 5:08 PM, the pediatric emergency cart’s (a mobile cart containing drugs, supplies and resources to treat infants and children’s emergency needs) Broselow reference tape (also called the Broselow pediatric emergency tape, a color-coded length-based tape measure that is used for pediatric emergencies. The Broselow tape relates a child’s height as measured by the tape to their weight to provide medical instructions including medication dosages that should be used) did not have the most updated reference tape and instruction information in the cart when it was stocked with 2017 version of Broselow. The binder on top of the pediatric emergency cart had multiple outdated algorithm (algorithm in emergency response is a set of defined steps or rules used to make decisions in real-time during an emergency situation) and policy pages. The pediatric emergency cart P&P had not been updated by P&T since 1/2011. IP acknowledged the findings and stated he will check with ED leadership. During a concurrent interview and review of Patient 63’s medical record and heparin (blood thinner) administration record, on 12/13/24, at 10:32 AM, in the ICU (Intensive Care Unit), accompanied by Registered Nurse 7 (RN 7), the order instructed nursing staff to start the heparin infusion using a test called Anti-Xa (anti-Xa test, also known as a chromogenic anti-Xa assay; a laboratory test that measured the activity of heparins in the blood. It’s used to monitor and ensure that a patient is receiving the correct amount of heparin) every 6 hours for monitoring. The record further indicated the patient concurrently was taking another blood thinner called apixaban (a blood thinner that can affect the Anti-Xa level). Nursing documentation on the heparin flowsheet indicated the drug was never started. Patient 63’s medical record under “lab results” (“lab” means laboratory tests or blood test) section indicated 4 records on Anti-Xa test results on 11/11/24 at 11:26 AM, 7:20 PM, and 11:15 PM and one test result on 11/12/24 at 4:54 AM with all the results marked as “HC” or High level and Critical. RN 7 stated the nursing staff should have called the doctor and ordered the aPPT level (“aPTT” or Activated Partial Thromboplastin Time, another type of blood test used to monitor the effectiveness of heparin therapy, indicating how well the blood was clotting to prevent blood clot formation) instead to accurately start and monitor the heparin infusion. During a concurrent interview with hospital Risk and Quality leader (RQ) and the Director of Pharmacy (DOP), on 12/17/24, at 1:08 PM, and the review of one of the hospital’s medication error events dated 8/9/24, the record indicated a similar error in monitoring and use of heparin infusion when the patient was concurrently on newer generation of blood thinner similar to apixaban. The DOP acknowledged the repeat of similar error and stated they recently had created an educational flyer to inform the nursing staff, doctors, and pharmacists in preventing occurrences of similar errors in addition to plans for updating of the policy and order-sets. During a concurrent interview with hospital Risk and Quality leader (RQ), on 12/17/24, at 1:08 PM, and the review of hospital reports on medication error events (when an error or incident could affect safety of patients), titled “Medication Errors”, with date range of January 2024 to August of 2024, the report had a total of 24 medication error or adverse events for a span of 8 months with one near-miss (a type of error reporting that prevented and did not reach the patient) event. The reports furthermore did not show outcome resolutions for a system approach to medication safety. The RQ stated the medication error events were reported by staff electronically and each error was sent to department head for review and response. RQ stated most communications on incident reports were through the electronic portal (internet or computer documentation and reporting of the errors). The RQ stated the medication error events had not been presented or reviewed by hospital’s P&T or medication safety committees for some time. The RQ stated the resolution and outcome of the medication error events, if serious, were shared in daily safety huddle for further awareness. The RQ acknowledged the workflow and multidisciplinary (a group of health care professionals with different skills and experiences who work together to achieve a common goal of patient and medication safety) nature of the medication error analysis needed to improve. During a concurrent interview with DOP on 12/17/24, at 1:08 PM, and review of an undated hospital document, titled “Pharmacy and Therapeutic (P&T) Committee Charter”, the DOP stated he recently created the new charter document (a formal document describing roles and responsibilities of the committee) addressing roles and responsibility of the P&T committee on safe medication use and services. The Charter indicated “The P&T committee is responsible for overseeing policies and procedures related to all aspects of medication use within an institution to ensure compliance with regulatory standards, medication safety standards, and medication formulary management.” The charter document further indicated “The Pharmacy and Therapeutic Committee is co-chaired by the DOP/CHO (Chief Health Office) and meets monthly. Minutes reflect the members in attendance, items discussed, and decisions reached ...” The DOP stated that the P&T Committee was not conducted to address medication policy and medication safety issues within the hospital from 2/2024 to 7/2024 due to leadership changes. During a concurrent interview with Director of Pharmacy (DOP) on 12/19/24, at 10:39 AM, and review of hospital’s committee meeting minutes for P&T committee, the record indicated P&T committee meeting had not been conducted from February to August 2024. The records further indicated the medication error and adverse events data had not been reviewed or evaluated by the P&T committee and other subcommittee (a smaller committee reported to P&T). The review of the hospital’s Policy and Procedures (P&P) requested by the Department indicated they had not been updated or reviewed as follow: 1. Policy on “Medication Reconciliation”; Last revised on 7/2021. 2. Policy on “Pediatric Crash Cart ...”; Last revised on 1/2011. 3. Policy on Medication preparation and dispensing”; Last revised on 7/2021. 4. Policy on “Malignant Hyperthermia ...”; Last revied on 7/2021. 5. Policy on “Medication: Patient’s Own”; Last revised on 7/2021. 6. Policy on “Medication: Automatic Stop Order”; Last revised on 1/2020. 7. Policy on “Medication Administration”; Last revised on 7/2021. 8. Policy on “Medication: Fentanyl Patch”; Last revised on 3/2021. These P&P shared a similar statement that [Hospital] complied with all applicable regulation and professional standards of practice. The DOP stated there had been a gap in having regular P&T committee meetings due to leadership changes and turnover rate of key staff. The DOP stated policy and procedures had not been reviewed or updated. The DOP stated the P&P were required to go through P&T committee with a multidisciplinary team of medical, pharmacy, and nursing leadership for review and approval. The DOP stated the monthly P&T meetings had restarted since August of 2024 and at each meeting a number of policies had been updated. During a concurrent interview with Director of Pharmacy (DOP) on 12/19/24, at 10:39 AM, and review of the hospital’s documents on medication safety, titled “Medication Safety Committee Charter”, dated 11/2024, the document indicated “The Medication Safety Committee is a subcommittee of Pharmacy and therapeutic Committee. The committee meets quarterly and more frequently as needed, depending on the urgency and amount of reported events ...” The DOP acknowledged the hospital did not conduct quarterly or routine medication safety meetings and reports to P&T from 2/2024 to 8/2024. Review of the hospital’s document titled “Medical Staff: Bylaws and Rules and Regulations”, dated 2/2023, the document on page 102 indicated “Pharmacy and Nutrition Committee” consistent of 6 medical staff members, director of nursing, director of pharmacy and clinical dietitian. The document further indicated “The committee shall meet at least quarterly, or more often as necessary to accomplish its charge ... The committee shall provide for the development and surveillance of all drug utilization policies and practices in the hospital, including the use of all-investigational drugs and procedures to assure optimal clinical results and minimum potential for hazard ... The committee shall assist in the formulation of professional standards regarding the evaluation, appraisal, selection, procurement, storage, distribution, safety procedures, and all other matters related to the pharmaceuticals in the Hospital ... The committee shall review and report on drug effectiveness, medication errors, adverse drug reactions and the prescribing, distribution, and administration of pharmaceuticals (drugs) within the Hospital.” Review of American Society of Health-System Pharmacists (or ASHP, a professional organization that advocates for medication and patient safety) guidelines, titled “ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System”, dated 2021, last accessed on 12/31/24 via https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/gdl-pharmacy-therapeutics-committee-formulary-system.ashx, the guideline indicated “The P&T committee should be responsible for overseeing policies and procedures related to all aspects of medication use within an institution ... The P&T committee should review all medications used in the health system ... 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. The organization’s medical staff leadership (i.e. the body to which the P&T committee reports) should complete the final policy approval. Policy review and revision should occur as new information becomes available and at regularly established intervals (e.g. annually) ... The P&T committee should have formal interactions (i.e. communication lines) with other committees whose functions may affect the medication-use process.” .... “The P&T committee should systematically address medication and patient safety issues as part of its deliberations. The P&T committee should ensure that medication-use policies adequately address potential risk and safety issues.” Review of American Society of Health-System Pharmacists (or ASHP) document, titled “Guidelines on Preventing Medication Errors in Hospitals”, dated 2018, last accessed on 12/30/24 via https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/preventing-medication-errors-hospitals.ashx, the guideline indicated “Safe medication practices begin with placing medication safety as an organizational and departmental priority, and implementing a system that will support these practices. The organization must have a comprehensive program that includes a medication safety leader, key elements in place to provide the structure for safe medication practices, and a successful strategic plan.” ... “A multidisciplinary medication safety team provides a collaborative and systematic approach to addressing medication safety issues and problems as well as proactively assessing risk ...the organization must evaluate and adopt technologies that will help reduce the risk of medication errors and help prevent patient harm ... Pharmacists must be involved in technology decisions to ensure the safety and effectiveness of technology that impacts the medication-use process.””

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 17334 Based on observation, interview and document review, the facility failed to have a written agreement with Vender 2, a laboratory vender used by the hospital for multiple laboratory testing. The hospital presented no evidence of any quality evaluation of vender services to ensure accuracy and safety. Findings: During a 12/09/24 at 2:15 p.m. tour of the onsite laboratory located on the 1st floor, toured the Director of Laboratory Services (DLS) was asked for any services provided under contracts. The DLS stated, she was not aware of any contracted services the hospital had for laboratory. On 12/10/14 at 11:14 a.m. a follow up laboratory visit was conducted. At 11:25 a.m., a cabinet was observed with specimens labeled with Vender 2’s name, an outside laboratory vendor. In concurrent interview with a lead specialist for chemistry ( Lab staff 1) she confirmed the specimens were routinely prepared for transport to be picked up by Vender 2. Lab staff 1 stated, many routine labs were not performed on site and were sent out to Vender 2. No STAT (emergent) labs went to Vender 2 because of time constraints. On 12/17/24 at 08:27 a.m. CQA 1 presented the venders documents showing expired agreement to pay for services by Vender 2 but no contract. CQA 1 confirmed the vender document was expired and it showed hospital agreement to pay for tests send to them but was not an actual contract or agreement, since there was no part of the document signed by Vender 2. CQA1 presented no evidence of any quality evaluation of Vender 2 services to ensure accuracy and safety, or of laboratory certification.”

“EMERGENCY LABORATORY SERVICES CFR(s): 482.27(a)(1) Emergency laboratory services must be available 24 hours a day. This Standard is not met as evidenced by: 38764 49264 Based on interview and record review, the hospital failed to have emergency lab services available 24 hours either onsite or through a contracted lab when 2 out of 2 machines (Lab Machine 1 and Lab Machine 2, machines used to run groups of tests that are routinely and emergently ordered to determine a person’s general health status) were both unavailable beginning 12/01/24 at 11:35 PM until 12/02/24 at 2:24 PM. This failure has the potential for a delay in the collection, processing, and provision of emergency laboratory results causing a delay in care or clinical action. Findings: During an interview on 12/09/24 at 2:20 PM with the Director of Laboratory Services (DLS), the DLS stated that lab machines are used to run certain laboratory work (tests of blood collected from patients) for the hospital both went out of service in December 2024. The DLS stated that since both were not operational, some laboratory work was sent to an outside hospital to be tested; the DLS stated that there was no written agreement between the hospital and outside facilities that ran the tests. The DLS further stated, “We never anticipated our instruments going down.” A review of facility policy titled “Departmental Plan for Patient Care”, last reviewed 12/24/23, indicated that the laboratory scope of services included, “To preform clinical laboratory tests accurately and precisely upon request 24 hours per day, seven days per week. Those tests not available at Seton Medical Center are referred to outside reference laboratories selected by our Laboratory and approved by the Medical Executive committee” A review of a facility report titled, “Analyzers Problem/Troubleshooting Workups”, dated 11/28/24 indicated that Lab Machine 1 was “Completely NOT WORKING” and the troubleshooting hotline was called at 11:40 [AM]. The facility report indicated that a technician “came at 1500 [3:00 PM] 11/29/24 ...will come back Monday.” The facility report further indicated that on “12/02/2024” a technician was “to come back 12/02-“. A review of a report for Lab Machine 1 titled “Field Service Report”, dated 12/02/24, indicated that Lab Machine 1 “Tests, checks, inspections and/or repairs have been preformed ...” This service was completed “12/02/2024 14:24 [2:24 PM]”. A review of a facility report titled, “Analyzers Problem/Troubleshooting Workups”, dated 12/01/24 indicated that Lab Machine 2 “Reagent arm issue still present ...” and the problem was reported to the hotline on 12/01/24 at 11:35 PM. The report further indicated that a technician “will dispatch ...in the morning.” A review of a report for Lab Machine 2 tilted “Field Service Report”, dated 12/02/24, indicated that Lab Machine 2 “Tests, checks, inspections and/or repairs had been performed ...” This service was completed on “12/02/2024 1442 [2:42 PM]”.”

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 34975 Based on observation, interview, and document review, the hospital failed to ensure oversight of the entirety of dietary services by the director of food and dietetic services when the director did not have oversight of the patient food refrigerator in the Geriatric Psychiatric unit. This failure resulted in: 1. A patient food refrigerator/freezer not cleaned according to hospital policy and procedures and/or manufacturer’s instructions for the cleaning product used; and 2. A patient food refrigerator not monitored for safe food storage temperatures according to standards of practice. Findings: Review of the undated job description titled “Director, Nutrition & Food Services”, showed the Director of Nutrition and Food Services (DNF) is responsible for overseeing the day-to-day Clinical Nutrition and Food Service operations for the hospital. Primary responsibilities included but were not limited to managing foodservice and clinical nutrition staff to assure quality food and nutrition services; reviewing and updating policy and procedures. In addition, the DNF is responsible for keeping up to date with latest evidence based practices and utilizing best industry standards in the day-to-day functions of the position. The DNF will ensure services are in compliance with nutritional, safety, sanitation and quality standards for local, state and federal regulatory requirements. 1. Review of the P&P titled “Food Safety Standards” revised 2/2022, showed for reach-in refrigerators, spills are cleaned immediately. Shelves, walls, and floors are washed and sanitized and left to air dry. Surfaces will be sanitized using an approved chemical sanitizing agent to effectively reduce pathogens on the surface to safe levels. Only clean cloths and “No-Rinse Oasis 146 Multi-Quat (Quaternary; a type of sanitizer) sanitizer” is used for cleaning all surfaces. An observation and interview on 12/9/24 at 2 PM, showed a refrigerator/freezer in the Geriatric Psychiatric (Geri Psych) unit used to store food for patients such as sandwiches in the refrigerator and individual serving containers of ice cream in the freezer. The bottom inside surface of the freezer had a significant amount of particles, debris, and residue resembling food, and hair strands. Registered Nurse (RN) 3 stated the freezer needed to be cleaned and Mental Health Technicians (MHTs) were responsible for cleaning the refrigerator/freezer. RN3 stated if nursing felt the refrigerator/freezer needed to be cleaned, they would ask the MHT. During an observation and interview on 12/11/24 at 9:57 AM, MHT1 stated she cleaned the patient refrigerator/freezer (cooler) in the Geri Psych unit once a week. MHT1 stated she removed food from the cooler then used wipes to clean the inside surfaces. MHT1 stated there were no other steps taken before putting the food back inside the refrigerator/freezer. MHT1 showed the container of wipes she used. The label on the container showed they were “Germicidal Disposable Wipe”. The manufacturer’s instructions on the container showed areas of use included hospital settings and critical care areas in which there is a likelihood of soiling inanimate surfaces/objects with blood or body fluids. The label showed for food contact surfaces, after wiping and allowing to remain wet for two minutes, a potable water rinse is required. Then MHT1 stated sometimes she only used soap and water to clean the inside of the cooler. MHT1 stated she did not receive training regarding cleaning of the cooler. During an interview on 12/11/24 at 2:40 PM, DNF stated Nutrition and Food Service Staff were not allowed in the Geri Psych unit, so she was not familiar with what Geri Psych staff used to clean the cooler used to store patient food on that unit. When DNF was informed the staff used the Germicidal Disposable wipes, DNF stated she was familiar with the product, and she did not think the wipes should be used to clean the cooler. 2. Review of the P&P titled “Food Safety Standards” revised 2/2022, showed refrigerators are set to maintain food at 41 degrees Fahrenheit (F) or below. According to the 2022 Federal Food Code, Time/Temperature Control for Safety (TCS) Food (a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation) is to be maintained at 41 degrees F or less during cold holding. An observation, interview, and document review on 12/9/24 at 2 PM, showed a refrigerator/freezer in the Geriatric Psychiatric (Geri Psych) unit used to store food for patients such as ham and turkey sandwiches. A refrigerator temperature log, titled “Food Fridge” dated December 2025, was posted on the outside of the refrigerator. The temperature log was formatted so two temperatures could be logged per day, however there was one signature documented per day. Directions printed on the temperature log showed “read and record temperature twice daily ...” In addition, the log showed “Normal at or below 41 degrees F”. RN3 stated he thought one temperature was logged once per day, in the morning even though there were two spaces for documentation daily. During an observation and interview on 12/11/24 at 9:57 AM, RN4 stated MHTs were responsible for monitoring the patient food refrigerator temperature. MHT1 stated she checked refrigerator temperatures every shift and confirmed there was only one temperature logged per day. MHT1 stated if the refrigerator temperature was over 41 degrees F, she would lower the refrigerator temperature and would not take any additional steps to ensure food safety. MHT1 stated she did not have training regarding monitoring the patient food refrigerator. During an interview on 12/11/24 at 2:40 PM, DNF stated the process was for the Geri Psych staff to transport patient nourishments/snacks from the kitchen to the Geri Psych unit because Nutrition and Food Service staff were not allowed on the Geri Psych unit. DNF said, therefor she was not aware of how staff monitored the patient food refrigerator on that unit.”

“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: 34975 Based on observation, interview, and hospital document review, the hospital failed to ensure that menus served met individual patient nutritional needs in accordance with recognized dietary practices when: 1. There was a lack of a daily nutrient analysis for regular and therapeutic diets; and 2. Meals were not portioned in accordance with the approved menus. These failures had the potential for the hospital to serve meals that did not meet the nutritional needs of the patients. Findings: Review of the hospital’s policy and procedure (P&P) titled “Menus” revised May 2017, showed: Policy - the dietetic service shall provide food of the quality and quantity to meet the patient’s needs in accordance with physician’s orders and to the extent medically possible. The food must meet regulations found in the Recommended Daily Allowances. Procedure/Responsibilities - Therapeutic diets shall be provided as prescribed by a person lawfully authorized to give such an order and shall be planned, prepared, and served with supervision and/or consultation from the dietitian. 1. Dietary Reference Intake (DRI) is a system of nutrition recommendations from the Food and Nutrition Board of the Institute of Medicine. DRI is the general term for a set of reference values used to plan and assess nutrient intakes of healthy people. The averages vary by age and sex. DRIs include the Recommended Dietary Allowance (RDA) which is an average daily level of intake to meet the nutrient requirements of 97 to 98 percent of healthy people. The DRIs represent the most current scientific knowledge on nutrient needs of healthy populations. During a concurrent interview and document review on 12/13/24 at 1 PM, with Registered Dietitian (RD)1 and the Director of Nutrition and Food Services (DNF), RD 1 was asked how she assessed patient calorie intake when the diet manual did not contain calorie content for therapeutic diets (Cross-reference A631). RD1 stated she had a document which showed the nutrients content of the therapeutic diets. RD1 provided the document titled “Nutritional Breakdown ... Fall 2020”. RD1 stated she did not know the parameters for the nutrient breakdown, such as whether it was an analysis for one day or if it was an average over multiple days. The DNF reviewed the nutrient breakdown document and stated she thought it was an average of nutrients for the entire 3-week menu cycle. DNF confirmed patient hospital stays were on the average less than one week and there was not a nutrient analysis of the menu to show the daily nutrient content of the diets served. 2. Review of the hospital’s P&P titled “Food Production” revised 2/2023, showed standardized recipes shall be maintained and used in food production. The portion sizes of products served should follow dietary requirements and facility specific guidelines. This document included a chart with scoop sizes. A number 12 scoop equals 3 ounces, and a number 8 scoop equals 4 ounces. During a concurrent observation, interview, and document review during the lunch trayline (the process of plating patient meals) on 12/10/24 beginning at 11:50 AM, Food Service Aide (FSA) 4, placed scoops of hot food on to patient lunch plates, and Kitchen Supervisor (KS) 1, monitored trayline. The untitled menus dated Week 3, Day 2, Tuesday, showed the main course was Curry Lemon Chicken with dhal (lentils) and seasoned peas/onions. The menus showed patients with Regular, Consistent Carbohydrate (CCHO; a diet for controlling blood sugar), 2-gram sodium (a diet limiting salt to two grams per day), and Prudent Heart (a diet intended for patients with heart disease) diets received regular dhal and patients with Pureed (mechanically altered to a smooth consistency) diets received pureed dhal. FSA 4 used a number 8 (4-ounce), gray handle scoop to serve the regular and pureed textured dhal. There were no portion sizes on the menus and the Director of Nutrition and Food Services (DNF) stated the serving sizes were listed on the recipes. During a consecutive interview and document review during trayline on 12/10/24 beginning at 11:50 AM, the undated recipe “Dhal (Savory Lentils)”, was reviewed with DNF. The recipe showed the portion for regular and pureed textured dhal was a number 12 scoop (1/3 cup). DNF reviewed the recipe and stated the portion for the pureed dhal served on trayline by FSA4 was incorrect. DNF stated the portion should be a number 12 scoop versus the number 8 scoop used by FSA4. During an interview and document review on 12/10/24 at the end of trayline at 12:30 PM, the undated recipe “Dhal (Savory Lentils), was reviewed again. DNF confirmed the regular texture portion for dahl was also a number 12 scoop and the incorrect portion was served on trayline (a number 8 scoop was used). During an interview and document review on 12/11/24 at 11:40 AM, KS1 stated staff serving food on trayline used standardized portions. The portion for carbohydrates such as the dahl, was always a number 8 scoop (gray, 4 ounces). KS1 also stated the portion for vegetables and meat/entrées were also standard and was a number 8 (4 ounces) for vegetables and a number 12 (3 ounces) for meat. KS1 referred to an undated document posted by the trayline area titled “Portion Scoop/Sizes for... Trayline”. The document showed the standard portions for food items, including carbohydrate food items such as mashed potatoes, noodles, rice, and stuffing were 4 ounces for a regular portion and 2 ounces for a small portion. There were also standard portions for meat, vegetables, entrees, etc., listed on the document. In a consecutive interview on 12/11/24 at 11:45 AM, DNF stated the process of always using the same scoop sizes on trayline did not necessarily match the portion sizes according to the recipes. DNF stated the portion, as listed, in the recipes needed to be followed.”

“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: 34975 Based on observation, interview, and record review, the hospital failed to ensure Registered Dietitians (RDs) provided care within the scope of practice guidelines of the California Business and Professions Code (BPC) 2586 (a)(1) when the hospital allowed order writing privileges to the RDs related to writing therapeutic diet orders, tube feeding orders and orders for nutritional supplements. As a result, the hospital approved a policy and procedure which is not supported in the California Business and Professions Code (BPC) 2586 (a)(1) for Registered Dietitians. Findings: According to the “Business and Professions Code - BPC Division 2. Healing Arts [500 - 4999.129] Chapter 5.65. Dietitians [2585 - 2586.8]: “2586 (a) (1) Notwithstanding any other law, a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585 may, upon referral by a health care provider authorized to prescribe dietary treatments, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop and recommend nutritional and dietary treatments, including therapeutic diets, for individuals or groups of patients in licensed institutional facilities or in private office setting. The referral for medical nutrition therapy shall be accompanied by a written prescription signed by the health care provider detailing the patient’s diagnosis and including either a statement of the desired objective of dietary treatment or a diet order. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility’s approved nutrition screening policy and procedure. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, shall collaborate with a multidisciplinary team, which shall include the treating physician and the registered nurse, in developing the patient’s nutrition care plan. Unless otherwise stated in the diet order by a patient’s provider, the registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may individualize the patient’s nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. Any modification, and the rationale for the modification, shall be documented in the patient’s record for review by the practitioner, or other licensed health care professional, who is legally authorized to prescribe and is responsible for the care of the patient. Nothing in this subdivision shall be construed to authorize a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, to order or administer a central vein or peripheral vein nutrition. (2) The services described in this subdivision may be termed “medical nutrition therapy.” Review of the hospital’s Policy and Procedure (P&P) titled “Diet Orders” revised 2/2023, showed “Authorized individuals prescribe or order food and nutrition products in a timely manner. Therapeutic diets shall be provided as prescribed by a person lawfully authorized to give such an order ...” Review of the facility document titled “Medical Nutrition Therapy [MNT] Protocol/Standardized Procedure” revised on 12/20/23, showed the purpose was to increase accuracy and timeliness of nutrition intervention and to optimize the nutrition status of patients at risk for malnutrition. A definition in the MNT protocol included: The California Business and Professions Code 2586 defines “Medical Nutrition Therapy” as when: pursuant to a referral by a health care provider authorized to prescribe dietary treatments, a registered dietitian: Provides nutritional and dietary counseling; Conducts nutritional and dietary assessments; and/or Develops nutritional and dietary treatments, including therapeutic diets, oral supplementation, and enteral (oral feeding/fluids through a tube to the stomach or small intestine) and parenteral nutrition (feeding tube inserted into a vein whereby nutrients enter the bloodstream directly), for individuals or groups of patients at the hospital. The MNT Protocol/Standardized Procedure revised 12/20/23 also included the following: Policy: MNT protocol/standardized procedure for adolescent and adult inpatients at [Hospital Name] will be specific to: Therapeutic diet; Oral supplements and modulars; Nutrition related laboratory tests; Micronutrient supplementation (multivitamins, vitamin C, zinc sulfate). Physicians diet order, tube feeding order will authorize the dietitian to initiate the MNT protocol/standardized procedure. Procedures included: the MNT protocol/standardized procedure authorized the dietitian to initiate, manage and monitor MNT as outlined in the protocol. MNT protocol/standardized procedure authorizes the Registered Dietitian (RD) to initiate or discontinue an oral nutrition supplement as determined by ongoing assessment following the established guidelines in the protocol; MNT protocol/standardized procedure authorizes the RD to manage and modify enteral nutrition therapy following the outlined guidelines. On 12/12/24 at 11:45 AM, RD1 was interviewed regarding the Medical Nutrition Therapy Protocol/Standardized Procedure. RD1 explained a doctor might order a consult for a nutritional assessment on a patient. After the RD nutritional assessment was completed and the RD decided a nutritional supplement was appropriate for the patient, the RD ordered a supplement without communicating with the doctor. RD1 stated the hospital’s Medical Nutrition Therapy (MNT) protocol allowed RDs to write diet, tube feeding, and supplement orders. RD1 further explained, nutrition assessments were also completed per parameters outlined in the protocol, without a doctor’s consult request, which could also result in a supplement and/or diet change order placed by the RD. RD1 stated a doctor’s diet order for a patient triggered the MNT protocol. When the MNT protocol was triggered, RDs had permission to use the protocol to assess if patient nutritional needs were met and to order supplements and change diets to optimize nutrition. On 12/13/24 at 1 PM, the Hospital’s “Diet Manual” approved by the Director of Nutrition and Food Services, the Chief Medical Officer, and the Chairman of Quality Cabinet on 8/7/23 was reviewed with the Director of Nutritional and Food Services (DNF) and RD1. A review was conducted for the following diets: regular, renal (a diet for kidney disease), consistent carbohydrate (CCHO/diet for diabetes) and Prudent Heart Healthy (a diet for heart disease). The Diet Manual included a description of each of the diets, however, did not include the provision of any oral nutritional supplements. DNF and RD1 verified that the “Description” did not include parameters or any mention of oral nutrition supplements. During an interview on 12/19/24 at 9:45 AM, DNF stated when diets and supplements are ordered by the RDs, the orders are started almost immediately. Medical record reviews were conducted intermittently on 12/12/24, 12/13/24, 12/16/24, 12/17/24, and 12/18/24 between the hours of 9 AM to 3 PM. 1. A review of Patients 7’s Medical Record showed Patient 7 was 72 years old and was preadmitted to the emergency department on 12/8/24 then admitted on 12/10/24 with diagnosis of altered mental status and history of diabetes (a disease characterized by elevated blood sugars) and bilateral below the knee amputations. Review of orders for Patient 7 showed a tube feeding order was placed by a Medical Doctor (MD) on 12/10/24 for Glucerna 1.2 (a liquid feeding) at a rate of 20 milliliters (ml) per hour ... stop tube feed at 6 PM and resume at 8 AM. In addition, a “Dietician or Nutritional Services Consult: optimize tube feed ...” order was placed by a Medical Doctor (MD) on 12/9/24. Another tube feeding order was placed by a Medical Doctor (MD) on 12/10/24 for Glucerna 1.2 at a rate of 30 milliliters (ml) per hour (hr) and increase to 40 ml/hr in 4 hrs. Review of Patient 7’s medical record under Patient Progress Notes, showed a nutrition assessment was documented by RD1 on 12/12/24. RD1’s “Recommended Nutrition interventions” included to optimize tube feeding for wound healing and recommend Glucerna 1.2 at 50 ml per hour.” Review of Patient 7’s medical record, showed on 12/12/24 at 11:10 AM, a tube feeding order was placed by RD1 on for Glucerna 1.2 at a rate of 50 milliliters (ml) per hour. During a concurrent interview and record review with RD 1 on 12/12/24 at 11:45 AM, RD 1 reviewed Patient 7’s Electronic Medical Record (EMR) and stated Patient 7 received tube feeding when admitted and she (RD1) just changed the tube feeding order today. In the EMR, RD1 showed the Glucerna 1.2 at 50 ml per hour order dated 12/12/24 with her initials by the order. RD 1 explained she received a referral from a doctor to “optimize” the tube feeding on 12/9/24. RD1 confirmed she ordered a tube feeding on 12/12/24 based on her nutritional assessment and was ordered and implemented without a MD signing off or communicating the order to an MD. RD1 stated once she received the referral, the “optimization is in my hands”. RD1 stated she was not sure if the doctor saw the order after she put it in. During an interview and record review with RD on 12/18/24 at 10:45 AM, RD1 reviewed the “Medical Nutrition Therapy Protocol/Standardized Procedure” revised 2/2024. RD1 stated changing Patient 7’s tube feeding order was allowed under sections 5.10 and 2.10.1 in the MNT protocol. Sections “5.10 MNT protocol/standardized procedure authorizes the RD to manage and modify enteral nutrition therapy with the following additional guidelines: 5.10.1 The enteral nutrition order provides less than 75% or it provides over 100 % of the estimated energy requirements as determined by the nutritional assessment.” 2. A review of Patients 35’s Medical Record showed Patient 35 was 88 years old and admitted from the Emergency Department on 12/9/24 with a diagnosis of cellulitis (an inflammation of the tissue) of the right lower limb. Orders showed a Prudent Heart, 2 Gram Sodium diet was ordered by an MD on 12/9/24. Then on 12/10/24 a Prudent Heart, 2 Gram Sodium (a diet limiting the amount of salt to 2 grams per day), Puree (mechanically altered to a smooth consistency), nectar thick diet was ordered by an MD. A medical record review for Patient 35 showed under Patient Progress Notes, a nutrition assessment was documented by RD1 on 12/12/24. RD1 comments included Patient 7 would favor liberalizing dietary restrictions given limited intake of food by mouth and advanced age. RD1’s recommended interventions included liberalize Prudent Heart, 2 Gram Sodium restrictions, and add Ensure Enlive (a supplemental nutrition shake) three times a day to boost (increase) intake. A medical record review for Patient 35 showed on 12/12/24 10:51 a Puree Nectar thick diet and oral supplement Ensure Enlive three times a day with meals was entered by RD1 on 12/12/24. In an interview and record review with RD1 on 12/12/24 at 11:45 AM, RD1 reviewed the EMR for Random Patient 35. RD1 stated a nutritional assessment was completed for Patient 35 per the MNT protocol and not a doctor’s request. RD1 stated the patient was not eating, so she liberalized the diet by changing the MD diet order from Prudent Heart, 2 Gram Sodium, Puree Nectar Thick Liquids to Puree, Nectar Thick Liquids and added a supplement. RD1 confirmed she did not know if the doctor was aware of the supplement order or the diet order change. During an interview and record review with RD1 on 12/18/24 at 10:45 AM, RD1 reviewed the “Medical Nutrition Therapy Protocol/Standardized Procedure” revised 2/2024, and stated the RD removing 2 Gram Sodium, Prudent Heart Healthy from the doctor’s order was allowed under 5.3.4 in the MNT protocol. Section 5.3.4 showed if a patient’s oral intake does not meet greater or equal to 75% of estimated energy requirements, the RD may liberalize (loosen restrictions) the diet order to ensure adequate intake. 3. A review of Patient 33’s medical record showed Patient 33 was 68 years old and admitted on 12/9/24 with a local skin infection, and history of Diabetes Mellitus, on insulin therapy, and End Stage Renal Disease (ESRD-a decline in kidney function where the kidneys can no longer function on their own). Under orders, a CCHO, Renal diet was ordered by an MD on 12/9/24. A review of Patient 33’s medical record under “Patient Progress Notes”, a nutrition assessment was documented on 12/11/24 by RD2. Comments by RD2 included “reported intake is inadequate. Consistent carb/Renal diet appropriate d/t [due to] h/o [history of] DM [diabetes] and ESRD [End Stage Renal Disease] on PD [Peritoneal dialysis-a way to filter the blood when the kidneys are not working]; Glucose levels intermittently high, on insulin PRN [as needed] ... Present with diabetic foot wound. Needs adjusted to promote wound healing. ONS [Oral nutrition supplement] indicated to help meet increased needs.” Recommended nutrition interventions by RD2 included continue diet as ordered and Nepro (nutrition supplement intended for patients with kidney disease) three times a day. A medical record review for Patient 33 showed supplement 4 ounce Nepro, three times a days with meals, was entered by RD2 on 12/11/24 During a concurrent interview and record review with RD 1 on 12/13/24 at 10:45 AM, RD 1 reviewed Patient 33’s record. RD 1 stated RD 2 ordered a nutritional supplement for Patient 33 for poor food intake. RD 1 confirmed Patient 33 received a CCHO, diet so only four ounces of the supplement was provided. RD1 stated oral supplements were not counted as carbohydrates in the patient diets. RD1 stated supplements ordered for CCHO diets were not necessarily consistent at each meal. For instance, the supplement could be ordered from one per day to more than three per day. As the concurrent interview and record review with RD 1 on 12/13/24 at 10:45 AM continued, the RD reviewed the facility Diet Manual. RD 1 stated supplements were not part of the diet manual. In addition, RD1 stated in the MNT protocol, there were no limits for the number of supplements an RD could order. 4. A review of Patient 34’s medical record showed Patient 34 was 88 years old and admitted 12/6/24 with a diagnosis of shortness of breath, a history of Chronic Heart Failure (CHF-a failure of the hearts ability to pump blood). Orders showed a Prudent Heart Healthy diet was ordered by an MD on 12/6/24. A medical record review for Patient 34, Under “Patient Progress Notes”, RD2 documented a nutrition assessment on 12/9/24 and commented Patient 34 had a Deep Tissue Injury (DTI-when a pressure injury is suspected but cannot be confirmed) per a nursing evaluation, and nutrition needs adjusted to promote wound healing. RD2’s recommended nutrition intervention was Ensure Original 1 time per day. On 12/9/24 at 11:42 AM Ensure Original (nutrition supplement shake) 1 time per day at breakfast was entered by RD2. During a concurrent interview and record review with RD1 and RD2 on 12/17/24 at 11:40 AM, RD1 and RD2 reviewed the EMR for Patient 34. RD2 confirmed he ordered a supplement for Patient 34 on 12/9/24 to increase protein and calories for wound healing. RD1 stated a doctor did not need to be involved in the order because the MNT protocol was followed. During an interview and record review with RD1 on 12/18/24 at 10:45 AM, RD1 reviewed the “Medical Nutrition Therapy Protocol/Standardized Procedure” revised 2/2024. RD1 confirmed a nutritional assessment was done by RD2 on 12/9 and ordered a supplement once daily at breakfast for wound healing. RD1 stated section 5.4 and 5.4.1 in the MNT protocol allowed this. During an interview on 12/19/24 at 9:20 AM, the President of Medical Staff (PoMS) was asked how hospital leadership ensured policy and procedures met California Law and RDs worked within their scope of practice. PoMS stated Registered Dietitians were not considered allied health staff at the hospital. Review of the hospital’s document titled “Allied Health Professional Guidelines” revised July 2014, showed an “Allied Health Professional” or “AHP” is a person, other than a licensed physician, dentist or podiatrist, who exercises independent judgement within the areas of his or her professional competence and the limits established by the Governing Body, the Medical Staff and the applicable State Practice Acts; who is qualified to render direct or indirect patient care under the supervision or direction of a Medical Staff member possessing privileges to provide such care in the Hospital; and who may be eligible to exercise practice privileges and prerogatives in conformity with the rules adopted by the Governing Body and these Guidelines. AHPs who practice in categories which have been accepted for admission to this Hospital by the Governing Body are eligible for appointment to AHP status. The following categories have been accepted for admission: a. Physician’s Assistant; b. Nurse Practitioner; c. Perfusionist (a member of the cardiovascular surgical team); d. Perfusion Assistant; e. Certified Registered Nurse Anesthetist; f. Clinical Psychologist; g. Psychological Assistant; h. Registered Nurse First Assistant.”

“THERAPEUTIC DIET MANUAL CFR(s): 482.28(b)(3) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel. This Standard is not met as evidenced by: 34975 Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure the development of a comprehensive diet manual that fully presented descriptive elements of the hospitals’ routinely ordered diets. Failure to provide comprehensive information for the hospitals’ diets may hinder the hospitals’ ability to provide nutrition care that met patient needs. Findings: According to the California Department of Public Health, All Facilities Letter 14-32, “diet manuals establish a common language and practice for physicians and other health care professionals to use when providing nutrition care to patients, residents, and/or clients. The diet manual includes the purpose and principles of each diet, the meal pattern, the foods allowed and not allowed, and the nutritional adequacy and inadequacy of each diet. The facility’s diet manual and the diets ordered by the physician should mirror the nutritional care provided by the facility. The analysis of the menu is the foundation of meal planning to assure that the nutritional needs of the patient/resident/client are in accordance with the physician order and the Recommended Dietary Allowances (RDAs). Menu analysis includes all life stages and gender groups based on the specific population of each facility. For menus and diets that do not meet the RDAs, facilities must have an established system that addresses any nutritional inadequacies of the diet. Although the RDA may serve as the basis for such guidance, qualified medical and nutritional personnel should make adaptations for specific situations” Review of the hospital’s Policy and Procedure (P&P) titled “Diet Manual” revised 3/2021, showed nutrition care practices are standardized throughout the organization. A current diet manual approved by the dietitian and the medical staff shall be used as the basis for diet orders and for planning modified diets. The diet manual shall include the standards for nutrition care in accordance with the Dietary Reference Intakes (2011 Food and Nutrition Board, Institute of Medicine, and National Academies). On 12/13/24 at 1 PM, the Hospital’s “Diet Manual” approved by the Director of Nutrition and Food Services, the Chief Medical Officer, and the Chairman of Quality Cabinet on 8/7/23 was reviewed with the Director of Nutritional and Food Services (DNF). The information for each diet was very limited. For instance, information available in the diet manual did not include calorie content for each therapeutic diet, there were no foods allowed and not allowed for each therapeutic diet, there were no sample menus and or meal patterns for the therapeutic diets, and there were no descriptions of the nutritional adequacy/inadequacy of the diets in relation to a nutrient analysis of menus. DNF explained there was a diet manual available on-line. The on-line manual was titled “Nutrition Care Manual (NCM).” It was explained that the facility’s approved diet manual used some diet names that differed from the NCM manual so there was a “crosswalk” used for the manuals to match the nutrition information from the NCM manual to the names of the diets used at the hospital. During an interview and document review on 12/18/24, the on-line NCM diet manual was reviewed with DNF. The NCM diet manual contained general descriptions of therapeutic diets from a professional organization, but it did not specifically reflect the menus/recipes used at the hospital. DNF confirmed the on-line NCM diet manual did not include sample menus that reflected the hospital’s menus, and it was also missing nutrient information specific to the hospital menus.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 34975 Based on observation, interview, and record review the hospital failed to ensure that the condition of physical plant and overall hospital environment was maintained to ensure the safety and well-being of patients as evidence by: 1. Multiple equipment had water leaks in the dishroom; 2. Holes in the partition wall in the dishroom; 3. Flooring in the dishroom was peeling exposing a rough, difficult to clean surface; 4. Compromised gaskets on two freezer doors on Freezer Number 1 resulting in ice buildup around the doors; 5. Sagging ceiling tiles in Freezer Number 1; 6. The temperature of the wash and rinse cycle of the dishwasher was not consistently maintained in accordance with the manufacturer’s specifications; and 7. The “B” service elevators connecting the hospital building to radiology service, MRI (Magnetic Resonance Imaging), were out of service for about a year. Failure to maintain the physical environment may result in areas that are soiled with food residue which in turn may promote harborage of pests and rodents. Failure to maintain kitchen equipment may result in equipment failure which may result in compromising food safety, quality, and cleanliness of equipment. Failure to maintain the service elevators resulted in an observed patient (Patient 19) being transported to MRI via an outdoor sidewalk exposed to weather elements. Findings: 1. During an observation and interview on 12/10/24 at 10:20 AM, the 3-compartment warewashing sink, located in the kitchen dishroom, was leaking from two areas under the sink. One leak was from the sink drain and the other leak was from the garbage disposal drain. Pans were on the floor under the sink to catch the leaking water. The Director of Nutrition and Food Services (DNF) confirmed the sink drain and the garbage disposal drain were leaking and stated, “old equipment”. DNF stated the garbage disposal needed to be replaced and was an upcoming project. During an observation of the 3-compartment warewashing sink and concurrent interview with the Interim, Assistant Chief Engineer (IACE) on 12/10/24 at 1:40 PM, IACE stated the garbage disposal leak was not fixable and the garbage disposal needed to be replaced. IACE stated the leak from the sink drain was an old leak and the drain valve needed to be tightened. During an interview on 12/16/24 at 12:30 PM DNF stated despite looking into replacing the garbage disposal there were no quotes yet for replacing it. 2. During an observation in the kitchen on 12/9/24 at 11:30 AM, the tiled partition wall adjacent to the 3-compartment warewashing sink had two missing tiles where the garbage disposal drainpipe entered the wall. The missing tiles created a large hole in the wall greater than six-by-six inches in length and width. There was also a hole in the opposite side of the wall above the garbage disposal access drain. In addition to the hole around the garbage disposal access drain, the wall around the access drain was rough with uneven drywall and the drywall was flaking off onto the kitchen floor. There was dark brown residue on the wall under the access drain. During an observation in the kitchen and interview with IACE on 12/9/24 at 1:40 PM, IACE stated the garbage disposal drain used to have a metal plate around the drain where it entered the wall, but the metal plate came off, exposing the hole in the wall. IACE stated metal plate came off when the floor in the dishroom was redone. IACE stated the hole would be covered after the garbage disposal was replaced. During an interview on 12/16/24 at 12:30 PM DNF stated there were no quotes yet for replacing the garbage disposal. 3. During an observation in the kitchen and interview with DNF on 12/9/24 at 10:50 AM, the surface of floor in the dishroom was rough in areas where the surface was peeled off, including the floor around a drain close to the center of the room, and under the 3-compartment warewashing machine, where it was also wet and had pooling water. The floor area around the drain had black residue imbedded in the rough surface. DNF stated the floor was redone recently but it was peeling already. DNF stated the floor was porous and was difficult to keep free of residue. During an interview and concurrent review of documents on 12/10/24 at 11:15 AM, DNF provided emails regarding the dishroom floor. The first email was dated 12/28/23 from herself to whom she stated was the “facility project person”. The email read “the floor was redone by [the company name], is in really bad shape. It is peeling off the floor covings around the drains. There must be some warranty on the work that was done. Can we look into this...” Additional emails dated 1/8/24 and 6/20/24 showed correspondence between the hospital and the flooring company. DNF confirmed despite communicating with the flooring company, the issue of the peeling floors was not resolved yet. During an interview on 12/16/24 at 12:30 PM, DNF stated once the garbage disposal was replaced, the floor will get redone. DNF also stated despite looking into replacing the garbage disposal, there no quotes yet for replacing it. 4. An observation of walk-in freezer number one (1) in the kitchen on 12/9/24 at 11:13 AM, showed there were two doors into the freezer. The door that was used, had thick ice build-up around the frame of the door. The door that was not used had a rack in front of it and also had ice build-up around the door frame. During an observation of freezer number 1 and concurrent interview with IACE on 12/10/24 at 1:50 PM, IACE stated the ice build-up around door frames was from missing rubber gaskets (a seal around the freezer door that fills the gap between the door and the door frame to keep cold air in and outside air out). IACE pointed out on the in-use door there was at least six inches of gasket missing; and on the door that was frozen closed, there pieces of gasket missing. IACE stated the missing gaskets allowed air to go through, creating ice build-up. During a consecutive interview on 12/10/24 at 2 PM, DNF stated doors were replaced on all the other walk-in coolers in the kitchen but not for freezer number. DNF stated she wanted freezer number 1 to be replaced however a project request was not yet submitted. 5. An observation of walk-in freezer number one (1) in the kitchen on 12/9/24 at 11:13 AM, showed 2 large sections covering the ceiling were warped creating gaps between the covering and the ceiling. During an observation of freezer number 1 and concurrent interview with IACE on 12/10/24 at 1:50 PM, IACE stated the sagging ceiling was due to an old leak from a ceiling sprinkler. IACE stated the ceiling covers needed to be fixed. 6. Review of the document titled “[Name of dish machine manufacturer and dish machine model number] Installation and Operation manual” dated 2020, showed under the preventative maintenance section, a common problem for dishmachines has to do with temperatures being too low. It is necessary to verify that the water temperature coming to the dishmachine matches the requirements listed on the machine data plate (an information plate attached to the dishmachine, showing information such as minimum wash and rinse temperatures). The manual also explained the process to adjust the external rinse booster heater to achieve the required minimum temperature for the final rinse. In hot water sanitizing dish machine (high temperature machine), the final rinse temperature is 180 degrees Fahrenheit (F). In addition, the document showed the National Sanitation Requirements (NSF) wash water for a high temperature machine during operation is 160 degrees F minimum. Review of the P&P titled “Food Safety Standards” revised 2/2022, showed the objective of service standards is to maintain a high-quality product while maintaining compliance with state and local health codes. Warewashing procedures ensure sanitized service ware and prevent recontamination. Dishmachine start-up procedures include ensuring the temperature gauges are within designed range and running a test strip to ensure the final rinse is adequate. During an observation and interview on 12/10/24 at 2 PM, Food Service Aide (FSA) 2 ran items such as patient plates and serving trays from the lunch meal service, through the dish machine. The temperature dial on the machine showed 120 degrees F for the wash and for the rinse cycle. When FSA2 was asked how the water temperature was tested, he stated a test strip was used. FSA2 attached a test strip to a pan and ran it through the dish machine. The test strip was checked by FSA2 after it ran through the dish machine cycles and confirmed the strip did not change color. Directions printed on the test strip showed, “When indicator turns black stated temperature has been achieved.” The stated temperature on the test strip showed 160 degrees F. The manufacturer’s information plate attached to the dish machine showed the minimum wash tank temperature was 160 degrees F and the minimum rinse temperature was 180 degrees F. In a consecutive observation and interview on 12/10/24 at 2:10 PM, the Director of Nutrition and Food Services (DNF) looked at the dish machine temperature dials and stated the dish machine water needed to be warmed up. DNF explained there was a water temperature booster which heated the sanitizer cycle water and sometimes it “tripped”. DNF stopped staff from running the machine for a few minutes. DNF reset the booster and the dish machine water temperature went up according to the temperature dials. The rinse temperature increased to 195 degrees F and the wash temperature range increased to 140 -160 degrees F, however, did not consistently maintain the manufacturer’s recommendation of a minimum of 160 degrees F. When a test strip was sent through the machine, the color of the test strip turned black. Staff began to wash dishes. During an interview on 12/10/24 at 2:20 PM, FSA2 stated he normally washed dishes using the dish machine, however he forgot to check the water temperature before he began cleaning the lunch dishes. During an interview on 12/10/24 at 2:21 PM, DNF stated dish machine water temperatures were not documented on a log for lunch, only for breakfast and dinner. During an interview with DNF and the Dishwasher Technician Vendor (DTV1) on 12/10/24 at 3:40 PM, DTV1 stated the dish machine water temperature was low because the booster was tripping, and the water temperature would go down if the booster tripped. DTV1 stated he found and repaired a small leak in the booster, but the booster could still trip. DNF stated staff had to watch the temperature dial continuously to make sure the dial did not trip. During an observation and interview on 12/11/24 at 2 PM, FSA3 washed items in the dishmachine including, dishes, cups, and cutlery. Initially when FSA3 started washing the items, the wash temperature dial showed the water was over 160 degrees F. As FSA3 continued to wash items in the dish machine, the wash water temperature dial decreased to under 135 degrees F. FSA3 stated it was okay for the wash temperature dial to show 120 to 160 degrees F and 135 degrees was okay. An observation, interview, and record review on 12/13/24 at 10:15 AM, showed FSA5 washing pans in the dish machine. The rinse temperature was at 120 degrees F and went up as she fed pans through to machine to a maximum of 160 degrees. Review of the “Dishmachine Temperatures” log dated December 2024, showed there were no temperatures documented for 12/13/24. Kitchen Supervisor 1 (KS1) stated the morning dishmachine temperature should have already been documented. During an observation on 12/16/24 at 12:30 PM, the dish machine was not used but was on. The wash temperature dial showed 160 degrees F. DNF ran multiple racks through the machine. As she fed racks through the machine, the wash temperature dial dropped to 150 degrees F and remained at 150 degrees F as DNF continued to feed racks through the machine. 17334 7. On 12/9/24 at 11:32 a.m. the Emergency Room RN 6 was asked about whereabouts of Patient 19 from room 2. RN 6 stated, the patient went to adjacent building for MRI test. Director of Emergency Department (DED) was asked to show surveyor the way to MRI as taken by staff with patient, to avoid missing her on the way back. The DED was not sure and asked RN 6 to lead the way. Initially the RN led surveyors and the DED to elevators B, but the elevators were observed out of service. RN 6 stated elevators B would connect the hospital to the adjacent building were MRI was located. She stated, because B elevators were not working, there was no way to take patients via a gurney to MRI without going outside. RN 6 led surveyors and DED to the ground floor then outside to a ramp and sidewalk leading to the next building. While outside at 11:51 a.m. the surveyors and DED met with staff wheeling Patient 19 on a gurney out of adjacent building, to the outdoor sidewalk heading back to hospital building. Patient 19 was asked how she was doing, and she replied, while shivering, “cold”. The outdoor temperature was in 60s and windy, although no rain. The patient was covered with a blanket, feet with socks sticking out from underneath the blanket. Staff transporting the patient confirmed, because elevators B were out, there was no other way to take patients to MRI in a gurney, without going outside.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 38764 Based on observation, interview and record review, the hospital failed to ensure the facilities and equipment were maintained at an acceptable level of safety and quality. 1. The humidity level in the CT Mobile unit was outside the normal range for multiple days. 2. Three expired sterile supply kits found stored in one of twelve emergency department rooms. These failures could negatively impact the care and safety of all patients. Findings: During a record review of the Room Temperature/Humidity Log for the CT Trailer ( dated 12/2024, showed including the following: -The normal humidity range information; however, the value of the normal range was marked off; - If the temperature and humidity are outside of the normal range, contact the Engineering by phone and record in the Comments section of the log; - The log showed the documented humidity levels showed, for example: - On 12/1, the humidity level was 26%; - On 12/2, the humidity level was 24%; - On 12/3, the humidity level was 20%; - On 12/4, the humidity level was 23%; - On 12/5, the humidity level was 26%; - On 12/7, the humidity level was 26%. During a concurrent interview and record review with the Radiology Services Manager (RM) on 12/11/24 at 2:20 pm, the manager acknowledged the above findings. The RM was asked about the purpose of monitoring the humidity level in CT Mobile Unit (CT Trailer). The manager stated the purpose of monitoring humidity in the mobile unit was to ensure patient comfort and for optimal equipment performance. The RM was asked about the normal range of the humidity level in the CT Mobile Unit. The manager stated, according to the hospital’s P&P, the normal range for the humidity level was 30% to 60%. The RM acknowledged the humidity levels, as described above, were outside the normal range. The RM was asked about the responsibility of a radiology staff when the humidity level was outside the normal range. The manager stated the radiology staff should contact the engineering department when the humidity level was outside the normal range. The RM acknowledged there was no documentation to show if the humidity levels as described above was reported by a radiology staff to the engineering department. During a review of the hospital’s P&P titled CT Trailer Temperature and Humidity Monitoring Policy effective 11/25/24, showed including, -Purpose: Ensure that environmental conditions in the CT trailer meet the requirements for the equipment functionality, image quality, and patient safety -Normal range for the humidity level was 30%-60% -Radiology staff to notify engineering promptly if deviations occur 49264 2. During a concurrent observation and interview on 12/09/24 at 11:07 AM with the Director of the Emergency Department (DED) in Emergency Department room one, three expired sterile kits were found in a cabinet. One kit was a “Thora-Para 5 Fr Non-Valved Catheter Drainage Tray” (a kit used to insert a tube into the chest or abdomen to drain fluid) that expired on 10/31/2024. Two kits were labeled as “Pediatric/Infant Lumbar Puncture Trays” (a kit use to insert a needle into the lower part of the back to drain or collect fluid) that expired 10/31/24. The DED stated that all three kits were expired. During an interview on 12/09/24 at 11:32 AM with Registered Nurse (RN) 6, RN 6 stated that the nurses “don’t monitor ...” the stock in the cabinet with expired materials in Emergency Department room one. RN 6 stated that “central supply” department is responsible for stocking the cabinet. RN 6 further stated that the supplies in the Emergency Department room 1 cabinet are used “if we need it.” A review of facility policy and procedure (P&P) titled “Stock Rotation”, last revised 03/17/17, indicated that “all items maintained in inventory will be rotated on a first in first out basis to prevent stock from expiration and to contribute to better patient care ...product expiration date are checked on packages during the rotation procedure. Any stock items discovered that have reached or within 30 days of expiration will be pulled and processed according to policy””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 39723 Based on observation, interview, and record review, the infection prevention and control program (IPCP) failed to establish and implement hospital wide policies and procedures (P&P) on methods to prevent and control infections among patients, personnel, and visitors as evidenced by, 1. For the outpatient sterile processing department (OP SPD, a dedicated area within an outpatient setting responsible to clean, prepare, process, and store medical instruments), the IPCP did not ensure reprocessing equipment (a machine used to automatically clean and inactivate infectious germs on surgical instruments) was functioning properly prior to use for one of two sampled washer/disinfectors (Washer/Disinfector # 2, an automatic machine used to clean reusable instruments). 2. For the OP SPD, the IPCP did not ensure medical supplies were stored properly and the terminal cleaning (the thorough environmental cleaning process that is performed at the end of each day when the area is being used) procedures were implemented for one of three sampled decontamination workrooms (OP SPD decontamination workroom, a designated area where soiled medical instruments are initially received,sorted, and prepared for the cleaning process). 3. For the OP SPD, the IPCP did not ensure traffic patterns in all areas of the SPD were restricted to authorized personnel and all SPD doors had restricted access for one of two sampled work room doors (OP SPD Door 1). 4. For the ambulatory surgery center (ASC, designated for same day surgery), the IPCP did not ensure clean and sterile supplies were not stored with 86 corrugated cardboard boxes (external shipping cartons) for one of two sampled storage areas (Storage Area 2). 5. For the OP SPD, the IPCP did not ensure elevators used to transport sterile (germ free) surgical instruments from the medical office buildings to the hospital’s operating rooms were sanitary for four of four sampled elevators (MOB 1A, MOB 1B, MOB 2A, and MOB 2B). 6. For the radiology department, the IPCP did not ensure equipment was calibrated to indicate accurate high level disinfection (HLD, a process used to kill most germs on medical equipment to prevent the spread of infection) documentation for one of two sampled HLD systems (Trophon). 7. For the radiology department, the IPCP did not ensure employees wore appropriate personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) while performing HLD procedures for one of two sampled ultrasound technicians (US Tech 1). 8. For the engineer department, the IPCP did not ensure emergency equipment was inspected weekly for 20 of 20 sampled eyewash stations (Station 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11,12,13, 14, 15, 16, 17, 18, 19, and 20). 9. For the radiology department, the IPCP did not ensure employees were offered training and completed infection prevention competencies to transport contaminated (unclean) reusable endocavity probes (a medical instrument that is used to image internal body structures of the body) from areas within the hospital to one of two sampled HLD workrooms (radiology decontamination workroom). 10. Cleaning and sanitizing shared glucometer (a device that measured blood sugar) based on hospital’s policy and the manufacturer instruction in one out of five patients observed for medication administration (Patient 84). These failures resulted in substandard infection control practices thereby increasing the risk for cross contamination (the process by which germs are unintentionally transferred from one substance or object to another, with harmful effect) and/or poor health outcomes for 62 out of 62 patients, personnel, and visitors within the hospital and between other healthcare settings. Findings: During an interview on 12/9/24, at 11:01 a.m., outside of the administration conference room, with the Sterile Processing Department Manager (SPDM). The SPDM stated the hospital followed the following nationally recognized guidelines: A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States); B. Association of Perioperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas); C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and E. Association for Professionals in Infection Control and Epidemiology (APIC, a professional association for infection prevention). 1. During an observation on 12/9/24, at 11:55 a.m., with the Sterile Processing Department Manager (SPDM), in OP SPD’s decontamination work room. The hospital’s bed linen was observed on the floor between Washer/Disinfector # 2 and the pass through window system (a workflow pattern that allows items to move from being contaminated to being safe to handle in the SPD). The SPDM was observed picking the linen up from the floor and exiting the OP SPD’s decontamination work room. During an interview on 12/9/24, at 12:01 p.m., in the OP SPD workroom, with the SPDM, the SPDM confirmed the linen she had removed from the workroom was damp and contained brown stains. The SPDM stated Washer/Disinfector # 2 had been leaking water for “approximately” one week and she did not have documentation that showed the date as to when the washer/disinfector started to leak water. The SPDM stated the hospital continued to use the reprocessing equipment and placed bed sheets and blankets on the floor to absorb the water. The SPDM stated she did not know if the water that leaked from Washer/Disinfector # 2 was contaminated. The SPDM confirmed the surgical instruments that were being processed in Washer/Disinfector # 2 were considered contaminated instruments. The SPDM stated the washer/disinfector should not have been used to process contaminated instruments if the equipment was not working properly. During an interview on 12/11/24, at 12:10 p.m., in the ASC, with the IP, the IP stated the hospital’s sterile processing department was under construction and the OP SPD was being utilized to process the hospital’s reusable surgical instruments and the ASC’s reusable surgical instruments. The IP stated he was not aware the OP SPD’s washer/disinfector was not functioning properly, nor did he know if the washer/disinfector was leaking contaminated water. The IP stated the equipment should have been removed from service until the equipment was functioning properly. The IP stated bed linen should not have been used to absorb the water because moisture provided the perfect environment for germs to grow and potentially cause cross contamination. A review of the hospitals P&P titled “Decontamination of Instrumentation and Equipment,” revised 2/2023, indicated “ ... G. Preparation Area: ...2. Check mechanics of washer to see if it is in working order according to instructions for use (IFU) ...” A review of the manufacturer’s IFU titled “AMSCO 7000 Series: Washer/Disinfector,” dated 2/17/21, showed “ ... 7.50 Water Leaks From the Washer/Disinfector General Trouble Shooting: 1. Door gasket is dirty: Clean door gasket 2. Spray gasket arms are not turning: Ensure spray arms are turning properly 3. Verify piping is leaking: Contact Steris ...” 2. During an observation on 12/9/24, at 11:10 a.m., of the OP SPD decontamination work room, with the SPDM, six bottles of cleaning solution (a chemical mixture used to remove dust and other harmful particles from the surface of surgical instruments) stored on the floor. There was fuzzy grey matter observed scattered throughout the SPD’s windowsill which covered one bottle of descaler/neutralizer cleaning agent (a solution to assist in the removal of mineral buildup), PPEs, two yellow supply trays, and disposal instrument brushes. A review of the manufacturer’s instruction for use (IFU) titled “Prolystica Restore Descaler and Neutralizing Agent, dated 9/11/22, indicated “ ...Section 2: Hazard Identification ...Hazard Statements ...Store locked up ...Section 7.2 Conditions for Safe Storage: ...Storage Area: ...Store in dry, cool, well ventilated area ...” During a concurrent observation and interview on 12/9/24, at 11:32 a.m., in the SPDS decontamination workroom, with the SPDM, the SPDM stated the fuzzy grey matter was dust and debris. The SPDM stated the descaler/neutralizer cleaning solution should have been stored in a cool and secured area and the windowsill was not considered a cool and secured area. The SPDM was observed reviewing the expiration date on the descaler/neutralizer’s solution bottle. The SPDM stated the descaler/neutralizer solution had an expiration date of 6/28/23, and the cleaning solution was available for use. The SPDM stated the cleaning solution should have been removed from the OP SPD’s decontamination workroom more than 16 months ago. The SPDM stated the supplies were stored improperly and she could not explain why the OP SPD’s windowsill was being used as a storage area. During a concurrent observation and interview on 12/9/24, at 11:40 a.m., in the OP SPD’s decontamination workroom, with the SPDM, the SPDM stated the six bottles of cleaning solution should not have been stored on the floor. The SPDM confirmed the following manufacturer’s expiration dates: Cleaning solution bottle # 4 had an expiration date of 12/1/24. The SPDM stated cleaning solution bottle #4 should have been removed from the SPD’s decontamination work room eight days ago; Cleaning solution bottle # 5 had an expiration date of 9/1/24. The SPDM stated cleaning solution bottle # 5 s hould have been removed from the SPD’s decontamination work room more than three months ago; and Cleaning solution bottle # 6’s expiration date was not readable. The SPDM stated the expiration date had been “rubbed off.” The SPDM stated Bottles #4, # 5, and # 6 should not have been stored in the OP SPD’s decontamination workroom or available for use. The SPDM stated, “After the cleaning solution had expired or the expiration date was not readable, the manufacturer could not guarantee the proper dosage or strength of the cleaning solution.” The SPDM stated Bottles #4, # 5, and # 6 cleaning solution could potentially harm patients because the active ingredient in the chemicals may be greatly reduced or no longer work to destroy and/or limit the growth of infectious microorganisms (germs). The review of the hospitals P&P titled “Decontamination of Instrumentation and Equipment,” revised 2/2023, indicated “ ... G. Preparation Area: 1. Check detergent for expiration ...” During concurrent observation and interview on 12/9/24, at 12:20 p.m., in the OP SPD’s decontamination workroom with the Environmental Service Technician Lead (EVS Lead Tech), the EVS Lead Tech was observed viewing the floor and the windowsill. The EVS Lead Tech stated the hospital’s EVS staff were responsible for the terminal cleaning procedures in the ASC and OP SPD. The EVS Lead Tech stated terminal cleaning should have been performed daily when the decontamination workroom was used. During a concurrent interview and record review on 12/16/24, at 9:55 a.m., outside of the administration conference room were conducted with the EVS Lead Tech. The hospital documents titled “Assignment Sheet,” dated 11/25/24, to 12/6/24, were reviewed. The documents showed that terminal cleaning had been performed daily in the OP SPD. The EVS Lead Tech stated the EVS staff assigned to perform terminal cleaning for the OP SPD were not available for interview. The EVS Lead Tech stated he could not explain the dust and debris on the windowsill, or the bottles observed throughout the floor. The EVS Lead Tech stated the hospital’s P&P on terminal cleaning was not followed and additional education was needed on terminal cleaning procedures. The review of the hospitals P&P titled “Environmental and Terminal Cleaning Policy of the Perioperative Areas [the environment where a patient receives care before, during, and after surgery or a procedure] including Operating Rooms, Procedure Rooms, and Sterile Processing Department (SPD),” reviewed 12/2018, indicated “ ... Terminal Cleaning (at end of day): Operating and procedures rooms are cleaned daily or within 24 hours by EVS staff: ....2. Perform high dusting with a clean damp microfiber high duster with cleaner disinfectant on ceilings, walls ...4. Disinfect all floor using either a wet mop or a double mop technique ...” 3. During an observation on 12/9/24, at 11:05 a.m., of the ASC’s waiting roomwith the SPDM. The ASC’s waiting room double doors which lead to the OP SPD’s corridor did not have signage which indicated to patients and visitors that the corridor was restricted to authorized personnel. The OP SPD’s decontamination workroom door did not have restricted access and plastic tape was observed applied to the strike plate to prevent the door from closing and latching properly. During an interview was on 12/9/24, at 11:20 a.m., in the corridor outside of the OP SPD decontamination work room with the SPDM and Sterile Processing Department Technician (SPD Tech) 1. The SPDM stated the door was not secured because the hospital did not have a key to the door. The SPDM stated if the plastic tape was removed from the strike plate, the door would lock, and the SPD staff would not have access to the decontamination workroom. The SPDM stated the door should be secured to minimize exposure to potentially infectious (harmful) materials and to minimize the risk of potentially infectious airborne germs cross contaminating other areas in the ASC. The SPDM stated she had placed a hospital work order for the door’s lock and latching system “about one year ago,” and the lock and latching system were not repaired. On 12/9/24, at 11:50 a.m., a request was made for the lock and latching system work order and the SPDM stated she had placed the work order by telephone, and she did not have documentation that showed a work order had been placed to repair the lock and latching system. During an interview on 12/11/24, at 9:20 a.m., in the corridor outside of the OP SPD decontamination work room, with the IP, the IP confirmed the corridor beyond the ASC’s double doors was restricted to authorized personnel wearing proper attire. The IP stated signage should have been posted to alert patients and visitors of the restrictions. The IP stated he was not aware the door to the decontamination work room was not secured, or that medical tape had been applied to the strike plate to prevent the door from closing and latching properly. The IP stated all corridor doors should have been closed properly to prevent cross contamination and to provide a safe environment. The review of the hospital’s P&P titled “Traffic Patterns in Surgical Services,” reviewed 5/2017, indicated “Policy: To protect personnel, patient, supplies, and equipment from potential sources of cross contamination and safeguard the privacy of patients, providing a safe secure environment according to National Standards ...Procedure: 1. Traffic patterns are designed to facilitate movement of patients and personnel into, through, and out of defined areas. Signs should clearly indicate the appropriate environmental controls and surgical attire required...” 4. A tour was conducted of the ASC’s storage room on 12/10/24, at 10:04 a.m., with Charge Nurse (CN) 2. There were 76 corrugated boxes observed stacked on supply carts and there were 10 broken down corrugated boxes observed propped against the wall. During an interview on 12/10/24, at 10:15 a.m., in the ASC’s nurse station, with CN2, CN 2 stated the 76 corrugated boxes were filled with sterile and clean supplies that were used for surgical and invasive procedures (a medical procedure that enters the body, usually by cutting or puncturing the skin or by inserting instruments into the body). CN 2 stated a request was made by the physicians to save the 10 broken down corrugated boxes for the purpose of relocating the physician’s personal belongings. CN 2 stated the ASC’s storage room had been used for the last four months to store supplies in corrugated boxes because the breakout area (an area in the hospital used to remove medical supplies from external shipping cartons) had been converted into medical offices. CN 2 stated “I am aware corrugated boxes should not be stored in the supply room, but I have not had the opportunity to transfer the supplies into plastic storage bins.” During a concurrent observation and interview, on 12/11/24, at 12:20 p.m., in the ASC’s storage room with the IP, the IP stated the hospital followed AAMI standards on corrugated boxes, and he was not aware that corrugated boxes were being stored in the ASC’s storage room. The IP stated corrugated boxes should not have been permitted to enter sterile or clean storage rooms because the boxes were potentially contaminated with dust and insects. The IP stated the hospital’s P&P, nor the nationally recognized infection prevention and control guidelines were followed on cardboard shipping boxes and the corrugated boxes should be removed from the ASC’s storage room immediately. The review of the hospital’s P&P titled “Traffic Patterns in Surgical Services,” reviewed 5/2017, indicated “ ...C. supplies and equipment are removed from external shipping containers (cardboard, etc.) in an unrestricted area before transfer into semi restricted and restricted areas [areas where traffic is limited to authorized personal only]. D. No cardboard shipping boxes are allowed in either clean or sterile storage areas. These containers should never be used as storage containers. Corrugated cardboard boxes my harbor dust, bacteria in their groves and small insects that have entered during shipping. F. Supplies in storage room are to be stored in clear plastic containers for easy viewing and covered to prevent any contamination by contact during handling or by airborne contaminates ...” The review of ANSI/AAMI ST79: 2017 standard, indicated: “The 3.3.6.5 Breakout area/room: A breakout area/room should be located near or adjacent to a surgical or supply processing department. The purpose of this area/room is to remove items from external shipping cartons, as shipping cartons can harbor and transport dust and debris that should not enter a sterile processing department. Rationale: To eliminate the risk of introducing contaminants [dust and other harmful particles] that could be present on external shipping cartons, these cartons should not be permitted in clean/sterile storage areas/rooms. External shipping containers and web edged (corrugated) boxes can collect dust, debris,and insects during shipment and can carry contaminants into the area.” 5. During an observation on 12/9/24, at 12:10 p.m., of the path of travel from the OP SPD to the hospital’s operating Rooms, with the SPDM. The following was identified: Sterile surgical instruments were transported in a cart from the OP SPD to the MOB 1’s public elevators through the MOB 1’s lobby to the MOB 2’s lobby to the MOB 2’s public elevators through the hospital to the operating rooms. For the MOB 1’s elevators, the following were observed in the MOB 1A and the MOB 1B: Patients, visitors, and staff. MOB 1A and MOB 1B contained grey fuzzy matter mixed with black and brown debris throughout the floor. A brown liquid matter was observed scattered throughout the MOB 1A and the MOB 1B floor. For MOB 2’s elevators, the following were observed in the MOB 2A and the MOB 2B: Patients, visitors, staff, several blue bags on a cart that was labeled linen, and staff transporting patients to procedures. MOB 2A and MOB 2B had several broken or missing floor tiles. The MOB 2A and the MOB 2B contained grey fuzzy matter mixed with black and brown debris throughout the floor. Black and brown liquid substance were observed scattered throughout the MOB 2A and the MOB 2B floor and within the broken floor tiles. During an interview on 12/9/24, at 12:20 p.m., in the OP SPD with the EVS Lead Tech, the EVS Lead Tech stated the hospital EVS team was not responsible for cleaning or maintaining the MOB elevators. The EVS Lead Tech confirmed the elevators were unsanitary and stated a contracted service was responsible for cleaning and maintaining the MOB 1 and the MOB 2 elevators. During an interview on 12/16/24, at 11:55 a.m., in the OP SPD clean room with the IP, the IP stated the hospital was not responsible for the MOB 1 and MOB 2 elevators. The IP did not explain as to why it was acceptable or safe to transport sterile instruments through unsanitary environmental conditions. The IP stated the IPCP had not completed an infection control risk assessment (a systematic process that determines level of risk to patients and defines controls to reduce risk) for the transport of sterile items from the OP SPD to the hospital’s operating room. The IP stated the hospital did not have documented surveillance activities to show the path of travel was safe or infection prevention method that were implemented to minimize the risk of cross contamination. The IP stated, there should have been training on who was responsible for cleaning spillage and/or potentially infectious matter throughout the pathway from the OP SPD to the hospital’s operating rooms. A request was made for the nationally recognized infection prevention and control guidelines the hospital used to minimize the risk of cross contamination. The nationally recognized infection prevention and control guidelines were not provided. 6. A review of the hospital document titled “Trophon Processing Log” dated 12/13/24, to 12/17/24. The log’s disinfection documentation showed the following: Date; Time; Cycle Number; Equipment Number; Disinfection: Pass or Fail; Indicator: Pass or Fail; Probe Number and Patient Medical Record Number. During a concurrent observation, interview, and record review on 12/17/24, at 10:45 a.m., in the radiological decontamination area with US Tech 1 and the Imaging Services Manager (ISM), the time stamped on the high level disinfection equipment was observed to be incorrect. US Tech 1 confirmed the time stamp on the high level disinfection equipment did not match the actual time and stated, “The equipment is one hour off.” US Tech 1 was observed to be reviewing several processing logs and stated the equipment was not calibrated when the time had change in 3/2024 to reflect daylight saving time. The ISM stated the equipment’s date and time should be accurate to reflect accurate and complete documentation. The review of the hospital’s document titled “Competency Validation Trophon EPR High Level Disinfection System for Ultrasound Probe,” dated 5/2017, indicated “Documentation on Log: Disinfection of Probe 1. Affix patient medical record label to Trophon High Level Disinfection Log 2. Document Identification of Probe by pre assigned label 3. Document initials of Staff starting Disinfection cycle 4. Affix printer label to the Trophon High Level Disinfection Log ...” 7. During an observation on 12/17/24, at 10:15 a.m., while on a tour of the radiological decontamination workroom with the ISM. US Tech 1 was observed performing HLD procedures on the endocavity probe and US Tech 1 was not wearing a face shield or eye protection. During an interview on 12/17/24, at 10:25 a.m., in the radiological decontamination workroom with US Tech 1, US Tech 1 stated the appropriate PPEs for performing HLD procedures were gloves, and she did not need a gown to perform HLD procedures. US Tech 1 stated during the HLD procedure, she did not know if there was the potential of splashing chemicals, blood, body fluids, or potentially infectious materials from the contaminated endocavity probe into her eyes or onto her uniform. During an interview conducted with the ISM on 12/17/24, at 2:10 p.m., in the ISM office, the P&P on appropriate PPEs for the HLD procedure was reviewed. The ISM stated he did not know if a liquid resistant gown was required during the HLD process. The ISM stated US Tech 1 did not follow the hospital’s P&P because she did not protect her eyes or wear a face shield. During an interview 12/17/24, at 2:49 p.m., in the IP’s office with the IP, the IP stated the IPCP did not have documented surveillance activities for the HLD procedures that were performed in the radiological department. The IP stated the IPCP should have surveyed all locations where HLD procedures were performed to minimize the risk for cross contamination of infectious agent to patients and/or staff. The IP stated US Tech 1 should have protected her eyes during the HLD procedure. The review of the hospital’s P&P titled “Trophon System for High Disinfection of Endocavity Probes,” revised 3/23/17, indicated “A. Don appropriate personal protective equipment, consisting of: eye protection, face shield, gloves ...” The review of the hospital’s document titled “Infection Prevention Plan: 2024,” indicated “ ...u. High Level Disinfection (HLD) 1. What: Assess each area where HLD is performed to ensure appropriate processes are in place ...” 8. During a concurrent interview and record review on 12/12/24, at 2:55 p.m., outside of the administration conference room with the Chief Engineer (ENGC). The hospital’s documents, titled “Weekly Eye Wash Station Inspection Logs,” dated 11/4/24, to 12/4/24, were reviewed. The ENGC confirmed the type of equipment and the hospital location of each eye wash station. There was no documented evidence observed that showed the following eyewash stations were inspected from 11/14/24, to 12/3/24 (20 days): For Station 1, the Main Nurses Station. For Station 2, the Hemodialysis Nurse Station (an area used for patient treatments to filter wastes and water from the blood). For Station 3, the Dietary Kitchen Food Preparation Area. For Station 4, the Dietary Dish Room. For Station 5, the Dietary Inside Closet by Kitchen Entry. For Station 6, the Surgery Operating Room (OR, between OR 5 and OR 6). For Station 7, the Surgery OR (Scrub Room Between OR 2 and OR 3). For Station 8, the Nuclear Medicine Isotope Storeroom (an area used to store radiation material). For Station 9, the Laboratory Microbiology. For Station 10, the Laboratory Main Area. For Station 11, the Gastroenterology Laboratory Room (an area where harsh chemicals are used to clean medical devices). For Station 12, the Ultrasound Cleaner (an area where harsh chemicals are used to clean the medical equipment). For Station 13, the Central Supply. For Station 14, the Intensive Care Unit. For Station 15, the Pharmacy near Southwest Sink. For Station 16, the Loading Dock Eastside Ramp (an area of a used to load and unload supplies and equipment). For Station 17, the Autopsy Room Main Area (an area used to examine a dead body to determine the cause of death). For Station 18, the Engineering near Sink in Front. For Station 19, the Engineering Generator Room. For Station 20, the Engineering Chiller Room (an area that may contain hazardous products). The ENGC confirmed that there was no documentation to indicate the eyewash stations had been inspected from 11/14/24, to 12/3/24. The ENGC stated the engineering department was responsible for inspecting the eyewash station for proper functioning at weekly intervals. The ENGC stated the eyewash stations were used in emergent situations to remove dust, harmful particles, chemicals, germs, or radiative substances from the eyes. The ENGC stated ENG 1 was on vacation and the eyewash stations were “missed” because the eyewash stations were not assigned to another engineer. The ENGC stated the hospital’s P&P was not followed for inspecting the equipment weekly and he was aware of the importance and the current national standard on inspecting eyewash stations weekly. The ENGC stated, “There is no excuse for not inspecting the eyewash stations weekly.” The review of the hospital’s P&P titled, “Environment and Terminal Cleaning Policy of Perioperative Areas Including Operating Rooms, Procedure Rooms and Sterile Processing Department (SPD),” reviewed 12/2018, indicated “ ...Scheduled cleaning: ...Area/Equipment: Eyewash station inspection ... Frequency: Weekly ...Personnel Responsible: Engineering ...” The review of the AORN’s guidelines for Perioperative Practice (2018), Guideline for Environment of Care indicated the following, “...Recommendation: 10. Chemicals...10.10.2. Plumbed eyewash stations should be flushed weekly...Rationale: “Weekly flushing removes stagnant water, which may contain microbial contamination, from the system...” 9. During an interview on 12/17/24, at 10:55 a.m., in the radiological decontamination workroom, with US Tech 1 and the ISM. US Tech 1 stated endocavity probe ultrasound procedures were routinely performed in the radiological department. US Tech 1 stated endocavity probe ultrasound procedures could be performed in the emergency department or other areas of the hospital if the physician orders indicated the procedure should be performed in a specific area for safety reasons. US Tech 1 could not articulate the competencies that she had completed or the education that she had received from the hospital on transporting contaminated items from the point of use to the radiological decontamination workroom for HLD reprocessing. During an interview on 12/17/24, at 2:49 p.m., in the ISM’s office, with the ISM, the ISM stated the hospital did not have documentation of completed competencies for US Tech 1 on transporting contaminated instruments from the point of use to the radiological decontamination workroom. The P&P on transporting contaminated items from areas in the hospital to the radiological decontamination workroom was requested. The ISM stated the hospital did not have a policy or protocol for US Techs to transport contaminated endocavity probes from the point of use to the radiological decontamination workroom. 40358 34975 40903 10. Hospital failed to ensure safe practices on cleaning and sanitizing shared glucometer (a device that measured blood sugar) based on hospital’s policy and the manufacturer instruction in one out of five patients observed for medication administration (Patient 84). 10. During an observation and interview on 12/16/24, at 11:33 a.m., on hospital’s 6th floor, with Registered Nurse 10 (RN 10), RN 10 stated he needed to measure Patient 84’s blood sugar to see if she needed her diabetes (disease of irregular blood sugar control) medication called insulin (a drug in shot form [Injection] help regulate blood sugar). RN 10 picked up a glucometer device, with brand name of “ACCU-CHEK Inform II”, and supplies located in the back room of the nursing station. RN 10 used an interpretation service to communicate in Spanish with Patient 84, who was sitting on a chair in her room. RN 10 with gloved hands placed the glucometer on the bedside table, wiped Resident 84’s right point finger with alcohol wipe and then poked it with lancet device (a small, sharp needle used to prick the skin to obtain a blood sample) to get blood. RN 10 then soaked the test strip (a small, disposable plastic strip that measures blood sugar) attached to glucometer with blood and stated the blood glucose (same as blood sugar) level was 127 (normal blood sugar level is 80-125 milligrams per deciliter [mg/dL], which is measure of unit) and no insulin was needed with lunch. RN 10 then exited the room to the nursing station where he, with gloved hand, removed one wipe from a container labeled as “Super Sani-Cloth” (a disposable wipe to kill germs) and wiped the outer surface of the glucometer quickly for less than 20 seconds. RN 10 then marked the glucometer screen to indicated it was disinfected, then return the device to glucometer station. In a concurrent interview with RN 10 and review of the hospital’s instruction sheet, laminated on the wall next to glucometer station, titled “Accu-Chek Inform II blood glucose Meter Cleaning and Disinfection”, dated 4/11/24, the instruction sheet described two-step process for cleaning and disinfecting shared glucometer in-between patient use. RN 10 stated the glucometer needed to stay wet for 2 minutes. RN 10 was not aware of the two-step process by using one wipe to clean and then a second wipe to sanitize before entering “Disinfected” button on the glucometer screen. In a concurrent interview and observation with Charge Nurse 7 (CN 7), in the presence of Infection Preventionist (IP), at the nursing station, CN 7 stated to clean the glucometer in-between patient use the nurse should clean it before and after each use with Purpure color Sani-Wipe (disposable wipe to kill germ) for 30 seconds then let it dry for 2 minutes. The CN 7 could not find the laminated instruction poster on how to clean the glucometer. Another staff member was able to find the glucometer cleaning instruction poster in between a pile of other papers in a bin where it was not visible to staff. The IP stated the quick instruction poster was part of the hospital policy and was created for quick review of the cleaning and sanitizing the shared glucometer. Review of the hospital policy, titled “Point Of Care Testing (quick tests perform on the spot): Accu-Chek Inform II Glucose System”, dated 12/6/24, the policy indicated “ ... personnel for whom this testing is within their scope of practice may perform this point of care test. The employee must have been trained through the clinical laboratory ... The employee must demonstrate competency in performing this test.” The policy further indicated “The Accu-Chek Inform II devices must be cleaned and disinfected after each patient use. The cleaning activity must be documented in the meter by the user ... Step 1: Clean the meter to remove visible soil and organic material prior to disinfecting ... Gently wipe the outside of the meter and around the test strip port area ... Discard used Super Sani-Cloth. Step 2: Disinfect the meter. Use a fresh Super Sani-Cloth ... Gently wipe outside of the meter three times horizontally and three times vertically ... The meter surface should stay moist with the disinfecting solution during the required contact time. After two minutes, dry the meter thoroughly with the dry cloth ...Touch the glucometer screen maintenance ... Enter “DIS” (Disinfected) ...” Review of hospital preferred germicidal wipe called “Super Sani-Cloth Germicidal Disposable Wipe”, the label on the container indicated “Cleaning procedure. All blood and other body fluids must be thoroughly cleaned from surface and objects before disinfection by germicidal wipe ... Use second germicidal wipe to thoroughly wet surface. Allow surface to remain wet for two (2) minutes. Let air dry.””

“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: 38612 Based on observation, interview, and facility policy review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Staff did not wear proper personal protective equipment (PPE- equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses) while working with patients (Patient 5 and Patient 8) on contact precautions (a set of steps taken to prevent the spread of germs from a person or their environment to others); 2. Patient equipment was not maintained in a manner to allow for disinfection; 3. The kitchen meat slicer was not cleaned thoroughly after use; and 4. Proper glove use procedures were not followed while handling ready to eat food. These failures had the potential to spread germs, causing infections in patients and contamination of food and/or food equipment, leading to foodborne illness, especially in vulnerable patients. Findings: 1.a Review of Patient 5’s Face Sheet, dated 12/10/24, indicated Patient 5 was admitted on 10/16/24 with diagnoses that include back pain after spinal surgery (a medical procedure that treats the spine). During an observation on 12/9/24 at 12:09 PM, a sign posted outside Patient 5’s room indicated “Contact Isolation (also known as contact precautions),” listing the need for a gown and gloves when entering the room, and hand hygiene (practice of cleaning hands to remove germs, dirt, or other harmful substances) when entering and leaving the room. A cleaning cart was parked outside the room. Environmental Staff (EVS Staff) 1 was inside Patient 5’s room wearing a surgical mask and gloves but no gown, holding two garbage bags. Patient 5 was not in the room. At 12:10 PM, EVS Staff 1 left the room to dispose the garbage bags. Without changing his gloves and without putting on a gown, EVS Staff 1 re-entered Patient 5’s room to mop the floor. At 12:12 PM, Patient 5 walked into the room, and EVS Staff 1 offered his arm to help guide Patient 5 to the bed, which Patient 5 accepted. At 12:14 PM, EVS staff 1 exited the room, put the mop back in the cart, and removed his gloves. EVS Staff 1 did not perform hand hygiene after glove removal. During an interview on 12/9/24 at 12:16 PM, EVS Staff 1 acknowledged the observation and stated, “I should have changed my gloves. It’s ok not to wear a gown, that’s only for the nurses because they’re touching the body (of the patient).” EVS Staff 1 added, “I should the gel (after glove removal.” During an interview on 12/10/24 at 9:48 AM, Charge Nurse (CN) 1 stated Patient 5 was on Contact Isolation for methicillin-resistant staphylococcus aureus (MRSA, bacteria that does not respond to many antibiotics) infection in the surgical wounds on the lower back. CN 1 stated the sign was posted to remind anyone entering Patient 5’s room of what type of PPE to wear. CN 1 added, “Before we go inside the room, we need to do hand hygiene, put on gloves and gown. When we leave, discard both gloves and gown, and do hand hygiene again. That’s our policy.” CN 1 further stated, “EVS (EVS Staff) should wear the same PPE as everyone else because they are touching surfaces inside the room that could be contaminated.” Review of Patient 5’s care plan, dated 11/25/24, indicated “Contact Precautions ...MRSA (wound)” with interventions including, “c. Gloves must be worn by all upon entering patient’s room. d. Gowns should be worn when there is likelihood of significant contact with patient or the patient’s environment. e. Remove gloves and gown before leaving patient’s room. Complete hand hygiene prior to exiting patient’s room ...” 1.b. Review of Patient 8’s Face Sheet, dated 12/10/24, indicated Patient 8 was admitted on 12/2/24 with diagnoses that include septic shock (a life-threatening condition where a severe infection causes the blood pressure to drop dangerously low). During an observation on 12/10/24 at 10:32 AM, a sign posted outside Patient 8’s room indicated “Contact Isolation,” requiring a gown and gloves when in the room, and hand hygiene when entering and leaving the room. Registered Nurse (RN) 1 and Magnetic Resonance Imaging (MRI, a test that can create detailed images of structure and organs inside the body) Technician (MRIT) 1 were inside the room transferring Patient 8 from a cardiac chair (a special type of equipment that is designed to transport elderly, disabled, and injured people) to the bed using a blanket. RN 1 adjusted Patient 8’s gown and touched several areas of the bed, while MRIT 1 moved a pillow under the Patient 8’s head. RN 1 and MRIT 1 then covered Patient 8 with a blanket. Both staff were wearing gloves but no gown. During an interview on 12/10/24 at 10:34 AM, MRIT 1 acknowledged the observation. The sign “Contact Isolation” was pointed to MRIT 1. MRIT 1 stated, “We should have worn a gown.” During an interview on 12/10/24 at 10:58 AM, RN 1 stated, “We transported (Patient 8) to and from MRI.” RN 1 stated, “(Patient 8) was on contact isolation for MRSA and E. Coli (Escherichia Coli) ESBL (bacteria that produce an enzyme called extended-spectrum beta-lactamase, which can make some antibiotics less effective, making lung infections harder to treat). We should have worn a gown when we were with him ...for infection control.” Review of Patient 8’s care plan, dated 12/4/24, indicated “Contact Precautions” with interventions including, “d. Gowns should be worn when there is likelihood of significant contact with patient or the patient’s environment...” During a concurrent interview and record review on 12/11/24 at 11:48 AM with the Infection Preventionist (IP), Patient 5’s and Patient 8’s laboratory records were reviewed. Patient 5’s wound culture (a laboratory test to find germs, such as bacteria, virus, or fungus, that can cause an infection), dated 12/4/24, showed light MRSA growth. Patient 8’s respiratory culture (a laboratory test that checks a person’s phlegm or mucus for bacteria that produce ESBL), dated 12/2/24, showed moderate MRSA growth and light E. Coli ESBL growth. The IP stated, “That means both patients have active infection. We expect the staff to wear PPE, like gloves, gowns, inside the room...do hand hygiene before they go in and before they go out...to prevent cross-contamination (the physical movement or transfer of harmful bacteria from one person, object, or place to another).” The IP added, “It’s for infection control.” Review of the facility’s policy and procedure (P&P), titled, “Isolation Practices - Transmission Based Precautions (a set of guidelines and practices implemented in healthcare facilities to protect patients, healthcare workers, and visitors from transmitting infectious agents),” last revised on 6/2023, indicated: “Purpose: Isolation practices are aimed to reduce the risk of transmission of epidemiologically (refers to anything related to how diseases spread and affect groups of people) important pathogens (microorganisms that case diseases) within the hospital... Policy: Transmission based precautions shall be used for patients and residents known or suspected to be colonized (presence of bacteria on a body surface, like on the skin, mouth, intestines or airway, without causing illness) with epidemiologically important microorganisms that can be transmitted by direct contact with the patient or indirect contact with environmental surfaces or patient care items in the patient’s environment. Definitions...2. Transmission-Based Precautions. a. Contact. Contact or touch is the most common method of transmission of infectious pathogens in the healthcare environment. Transmission occurs after being in contact with the patient, patient’s environment, contaminated gloves, or equipment ... Wear gowns and gloves while performing the following high contact task associated with the most significant risk for MDRO (multidrug resistant organisms, bacteria that have become resistant to certain antibiotics) contamination of HCP (health care provider). Hands, clothes, and the environment...Any care activity where close contact with the resident (patient) is expected to occur... Any care activity involving contact with environmental services likely contaminated by the resident, including cleaning and disinfection performed by environmental services (EVS) Personnel...” Further review of the P&P indicated, “General Principles of Isolation Precautions. 1. Gloves and Hand Cleansing: A. Hand hygiene... should be included in every patient encounter...C. Gloves shall be used in patient care if contact with bodily fluids is expected. [sic] Including blood, saliva, open wounds, sweat, stool, etc (etcetera). D. Gloves shall be removed before leaving the patient’s room and followed by hand hygiene. 2. Gowns: A. A gown shall be worn prior to entering patient’s room. B. The gown shall be removed before leaving the patient’s room...3. Patient Transport...C. Transporters shall wear proper PPE when assisting with the movement of the patient to the gurney (a hospital bed with wheels that makes it easy to move patients around)...” 28154 2. Observation of Patient (P) 31’s pre-operative set up on 12/10/24 at 12:55 PM in operating room (OR) 3 revealed two IV (intravenous) poles (poles on wheeled stands to hang intravenous fluids or medications) with rust colored areas on the chrome-like caster covers and rust colored areas on the blue stand legs. On 12/10/24 at 1:05 PM, Operating Room Registered Nurse (ORRN) 1 confirmed the first IV pole had areas of rust and discoloration. On 12/10/24 at 1:07 PM, Operating Room Manager (ORM) 1 confirmed the second IV pole had areas of rust and discoloration and Charge Nurse (CN) 1 removed the two IV poles from the operating room. During an interview on 12/13/14 at 2:59 PM regarding the rusty IV poles, ORM1 stated an expectation that all staff should be looking at the condition of patient equipment and if equipment is found not in good condition, the equipment should be removed from use and escalate it to the OR manager. condition of patient equipment under the biomedical domain. Review of the website “OR Today” (https://ortoday.com/value-of-looking-up-down-all-around/) revealed, “ ...Upon entering the pre-operative area and the OR, clinicians shoustes to make a deliberate scan of the space from the perimeter to the surgical table. Look at: ...Horizontal surfaces that are free from dust, soil and rust. -Medical equipment must be similarly free from dust, debris, rust, tape and its residue ...Danger of rust in the OR- Rust is a silent risk in the operating room. Rusty objects increase the potential for healthcare-acquired infections (HAIs) because rust produces irregularities in surfaces making appropriate cleaning impossible thereby creating an environment for potentially dangerous bacteria. Rust found on surgical instruments, medical equipment and other objects during an accreditation or state survey can be a serious finding that requires immediate remediation. Medical equipment includes castors, IV poles, instruments, cabinets, surgical tables and carts. Rust is most commonly found on equipment resting on or close to the floor due to repeated exposure to moisture from cleaning. Nickel plated castors on moveable medical equipment are especially susceptible to rust and should be checked frequently and replaced when necessary.” 34975 3. Review of the Policy and Procedure (P&P) titled “Food Service Equipment Safety and Sanitation” dated 9/2023, showed the meat slicer shall be cleaned thoroughly after use following manufacturers guidelines. According to the 2022 Federal Food Code, equipment food-contact surfaces are to be clean to sight and touch. In addition, nonfood-contact surfaces of equipment are to be kept free of an accumulation of food residue. During an observation in the kitchen and interview with the Director of Nutrition and Food Services (DNF) on 12/9/24 at 11:20 AM, a meat slicer stored in the kitchen on a preparation table had brown residue on the back surface of the blade and the surface around the blade. DNF stated the meat slicer was cleaned after each use. DNF stated it should be clean now, but she did not consider it clean. DNF stated cooks were responsible for cleaning the meat slicer. During an interview on 12/9/24 at 1:30 PM, Cook 1 stated he used the meat slicer this the morning (12/9/24) at around 9 AM. Cook 1 stated he missed cleaning the back of the meat slicer. 4. Review of the P&P titled “Uniform Dress Code (HACCP [Hazard Analysis Critical Control Point; A system to identify safety hazards in critical stages of food production, like cooking and serving])/Personal Hygiene” revised 2/2022, showed whenever gloves are worn, they shall be changed or replaced as often as hand washing is required. Touching multiple areas with gloves will require changing of gloves after each touch point. According to the 2022 Federal Food code, if used, single-use gloves shall be used for one task, such as working with ready-to-eat food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation. During an observation in the kitchen on 12/10/24 at 11:50 AM, FSA4 served hot food during trayline foodservice. FSA4 wore gloves and handled different pieces of equipment while she served food, such as the handles of serving scoops, and the handle of the food warmer. FSA4 also used her gloved hands to pick up pieces of parsley to sprinkle on the patient food she served after touching the scoop handles and food warmer handles. FSA4 did not change her gloves and wash her hands after handling equipment and before touching the parsley. During an interview on 12/11/24 at 2:40 PM, DNF stated she also observed FSA4 serving the parsley with her gloved hands during lunch service on 12/10/24. DNF stated FSA4’s gloves had the potential to contaminate the parsley because the gloves also touched handles of equipment and her eyeglasses. DNF stated the FSA4 should use tongs to serve the parsley during trayline.”

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 39723 Based on observation, interview, and record review, the Infection Preventionist (IP) failed to ensure the hospital policy and procedure was developed and/or implemented in accordance with nationally recognized infection prevention and control guidelines when, 1. The hospital did not have a protocol on transporting potentially infectious instruments (instruments that may contain harmful germs) between buildings for three of three buildings (MOB 1, MOB 2, and the Hospital). 2. The hospital did not implement surveillance activities to ensure staff performed surgical services and high level disinfection (HLD, a process used to kill most germs on medical equipment to prevent the spread of infection) procedures in a manner which prevented the potential risk of cross-contamination (the transfer of harmful germs from one person, object, or place to another) for three of three sampled departments (OP-SPD, the outpatient sterile processing department is a dedicated area within an outpatient setting responsible to clean, prepare, process, and store medical instruments), the ambulatory surgical center (ASC, same day surgery care), and the radiological department. These failures had the potential to result in unsafe and unsanitary healthcare practices thereby increasing the risk of patient, employee, and the community to be exposed to avoidable infectious agents and disease outbreaks. Findings: An interview was conducted with the Sterile Processing Department Manager (SPDM), on 12/9/24, at 11:01 a.m., outside of the administration conference room. The SPDM stated the hospital followed the following nationally recognized guidelines: A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States); B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas); C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and E. Association for Professionals in Infection Control and Epidemiology (APIC, a professional association for infection prevention). 1. An interview was conducted with the Sterile Processing Technician (SPD Tech) 1 on 12/10/24, at 12:05 p.m., in the endoscope (a reusable medical device) workroom (a designated area used to clean, prepare, process, and store endoscopes). SPD Tech 1 stated he did not know if the hospital had a written protocol on transporting contaminated instruments between buildings. An interview was conducted with the Sterile Processing Manager (SPDM) on 12/11/24, at 8:33 a.m., in the OP-SPD. The SPDM confirmed the hospital did not have a policy and procedure or a written protocol on transporting contaminated instruments outside the controlled environment of the hospital. The SPDM stated the SPD Techs did not receive formal education on transporting potentially infectious instruments between buildings. There was no documented evidence observed that showed the hospital had a prevention protocol in place to protect patients, employees, and/or the community from accidental infectious exposures to harmful germs and/or accidental infectious spills, that may have occurred while transporting potentially infectious instruments from the hospital, through MOB 1, and prior to arriving at the OP-SPD in the MOB 2. An interview was conducted with the IP on 12/17/24, at 2:22 p.m., in the IP’s office. The IP stated the Infection Prevention and Control Program (IPCP) did not perform a risk assessment when staff began transporting contaminated instruments outside of the controlled environment (hospital). The IP stated the hospital did not collect or analyze data on the change in practice when transporting potential infectious instrument between buildings was identified a significant change in practice. The IP stated the infection control risk identification prioritization worksheet should have been used to evaluate the change in practice and to identify the probability of patients, visitors, or staff being accidentally exposed to contaminated spills or infection agents including any education that may have been needed for the staff. The review of the hospital’s policy and procedure titled, “Infection Prevention Plan” dated 2024, indicated “ ...Identification of Risk: [Name of the Hospital] Infection Prevention and Control Programs are based on the IC Risks identified from the Risk Assessment, Daily Surveillance, and Data Analysis. Those with the highest relative risk at our facility receive the highest priority. ...issue to consider, but are not limited to, increases in rates above the national standards or internal benchmarks, increase in influx of disease, results of tracers and environmental care rounds, etc. We also consider ...high volume and high-risk procedures. The probability of occurrence, risk of the event, and preparedness are used in evaluating and potential event ...” 2. An interview was conducted with the IP on 12/11/24, at 12:20 p.m., in the ASC. The IP stated the IPCP was a hospital-wide program and the program applied to all hospital services. The IP stated the hospital’s IPCP: 2024 adhered to the following nationally recognized infection prevention and control guidelines for the OP-SPD, the ASC, and the HLD procedures: a. AORN b. ANSI/AAMI c. CDC d. OSHA e. APIC The IP did not explain how the nationally recognized infection prevention and control guidelines and surveillance activities for the OP-SPD, the ASC, and the HLD procedures were included in the hospital’s IPCP. A follow-up interview was conducted with the IP, on 12/17/24, at 9:30 a.m., in the IP’s office. The IP stated he had not conducted infection prevention and control surveillance activities for the ASC, the OP-SPD, or the radiology HLD area. The IP stated the IPCP did not have documentation that showed specific surveillance data had been collected, analyzed, or reported to ensure staff performed surgical services or HLD procedures in a manner which prevented hospital acquired infections (HAIs, infections people get while they are receiving health care for another condition). The IP could not explain how the IPCP analyzed and monitored surgical services if the reprocessing of surgical instruments and the ASC were not included in the IPCP. The IP stated the ASC, the OP-SPD, and the radiology HLD area, should have been included in the IPCP surveillance activities to ensure surgical services and HLD procedures were consistent with the nationally recognized infection and control guidelines. The review of the hospital’s P&P titled “Infection Prevention and Control Plan,” dated 2024 indicated, “Purpose: The purpose of the infection prevention and control plan for the year 2024 is to establish and continually improve a comprehensive program designed to prevent the transmission of infectious disease among our patients, healthcare providers as well as volunteers, students, and visitors. This is an organization-wide program. As such, the plan applies to all services and settings of [Name of Hospital]. This plan will coordinate, and monitor policies, procedures, and programs related to the prevention, surveillance, identification, and control of disease ...9. Performance and Metrics: ... u. High Level Disinfection (HLD): 1. Assess each area where HLD is performed to ensure appropriate processes are in place ...4. Length of time: ...b. Established areas: semi-annually...””

“OPO AGREEMENT CFR(s): 482.45(a)(1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose; This Standard is not met as evidenced by: 38066 Based on interview and record review, the hospital failed to have a written agreement with an Organ Procurement Organization (OPO). This failure resulted in the hospital’s inability to ensure patients were given the opportunity to participate in an organ, tissue, or eye procurement program. Findings: During record review, Clinical Quality Analyst (CQA) 1 was unable to provide documentation that the hospital had a written agreement with an OPO. On 12/19/24 at 12:40 PM, the Corporate Quality Director (CQD) stated, “We do not have a signed agreement.” On 12/19/24 at 1:08 PM, the Hospital Administrator (HA) stated that the hospital did not have a signed agreement with an OPO, and he had not been aware of the requirements for organ, tissue, and eye procurement. Review of facility policy titled “Organ and Tissue Donation for Transplantation” with revision date of 6/2020, indicated, “ ...is the designated Organ Procurement Organization (OPO), as defined in a signed agreement, for the procurement, processing, preservation, storage and distribution of eyes and tissues ...””

“SURGICAL PRIVILEGES CFR(s): 482.51(a)(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. This Standard is not met as evidenced by: 26674 Based on observation, interview, and record review, the facility failed to ensure one of six sampled medical staff (Provider 3) had a current delineation of surgical privileges (a list of procedures a doctor is allowed to perform). The deficient practice had the potential to reduce hospital staff awareness of which procedures Provider 3 was allowed to perform, creating the potential to allow Provider 3 to perform procedures for which she was not qualified. Findings: In a concurrent observation, interview, and record review on 12/11/24 at 12:30 p.m., the Lead Medical Staff Coordinator (LMSC) accessed Provider 3’s credentials file, stated “let me activate this,” and clicked buttons to activate Provider 3’s privileges. Review of the delineation of privileges (DOP) activated by the LMSC indicated they were effective 7/10/24-6/30/26. Each of Provider 3’s privileges indicated the status was “Requested” rather than “Granted”. When the surveyor asked the LMSC to show Provider 3’s privileges which were in effect prior to the changes he had just made, the LMSC opened a DOP with effective dates 10/12/22-9/30/24. The status of Provider 3’s privileges on the expired DOP was “Granted”. The LMSC stated the current privileges were showing a status of requested rather than granted because the system hadn’t updated yet. Review of a letter to Provider 3 dated 8/13/24 indicated her request for reappointment to the medical staff had been approved by the governing body on 7/10/24, no notation was present indicating that any of Provider 3’s privilege requests had been denied.”

“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: 40358 Based on observations, interviews, and record reviews, the hospital failed to provide surgical services including gastroenterology (GI-an area focused on the digestive system and its diseases), services in a well-organized manner, in accordance with the hospital’s own policies, acceptable national standards of practice, and in a manner to prevent the risk of cross contamination (The transfer of harmful bacteria from one person, object, or place to another), when: 1. The hospital failed to clean and maintain three (3) of 3 sampled sterilizers, and 3 of 3 sampled loading carts (carts that hold instrument trays) in the Prep and Pack Area of the Sterile Processing Department (SPD, an area of a health care facility where devices are decontaminated, cleaned, inspected, assembled into trays, and prepared for high-level disinfection and/or sterilization) routinely as indicated in their policy and procedure (P&P), and in a manner to avoid sources and transmission of infections. 2. The hospital failed to clean and maintain two (2) of 2 sampled instrument washers, and 2 of 2 sampled ultrasonic machines (high pressure instrument washer) used to process reusable patient equipment, as indicated in their policy and procedure (P&P), and in a manner to avoid sources and transmission of infections. 3. Two (2) of 2 sampled processed (previously sterilized and ready for patient surgical procedures) surgical trays (one (1) major tray and 1 minor tray) had multiple surgical instruments with brown staining and discoloration, and multiple instruments were damaged. 4. The hospital failed to follow their policy and procedure for endoscope outdated hang times for three (3) of nine (9) sampled endoscopes. 5. The hospital failed to follow their policy and procedure, and nationally recognized guidelines, for reprocessing three (3) of nine (9) sampled outdated endoscopes. 6. There was one (1) damaged, and 1 missing ceiling tile in the Sterile Processing Department (SPD - an area of a health care facility where devices are decontaminated, cleaned, inspected, assembled into trays, and prepared for high-level disinfection and/or steam sterilization) Prep and Pack Area that contributed to ineffective air balance and the potential spread of microorganisms (a tiny living thing that can only be seen under a microscope. They include bacteria, viruses, and fungi that can cause diseases). 7. The hospital did not ensure a fire risk assessment was conducted prior to Laser Surgery (medical procedure involving the use of a special light energy instead of surgical instruments.) for one of 54 random sampled patients (Patient 37). 8. The hospital did not ensure temperature levels and humidity levels were maintained in an acceptable range in the surgical services department as per nationally infection prevention and control standards (American Society of Heating, Refrigerating, and Air-Conditioning Engineers, ASHRAE and the Association of perioperative Registered Nurses, AORN) 9. The hospital failed to ensure the Surgical Services policies and procedures addressed Identification of infected/non-infected cases; Temperature/Humidity levels in the department; Discharge instructions from the Post Anesthesia Care Unit (PACU); and Post Operative Recovery on other Hospital Units. 10. The hospital Surgical Services policy titled “Fluid and Blanket Warming Cabinets” had inconsistent temperatures throughout the policy. 11. The hospital failed to ensure the policy titled “Infection Control - Anesthesia Equipment and Supplies” had updated disinfection procedures. 12. The hospital failed to ensure Surgical Services Policies and Procedures were updated regarding pediatric surgeries. 13. The hospital failed to ensure the pre-surgical time out in the operating room addressed a fire risk assessment for Patient (P) 31. These failures resulted in a lack of oversight in surgical services and lack of acceptable infection control practices that had the potential to result in cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and poor health outcomes for the patients receiving surgical services, and GI services in the hospital. Findings: 1. On December 9, 2024, at 2:04 P.M., a tour was conducted with the Sterile Processing Department Manager (SPDM), in the SPD Prep and Pack Area. An observation was made for two (2) of three (3) sampled (Sterilizer 2 [Amsco 600 series], and Sterilizer 3 [Amsco 400 series]) sterilizers (machines used to sterilize surgical instruments). The interior walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had a moderate amount of brownish staining on the sides and bottom of the interior chamber. Sterilizer 2 had a significant amount of whitish staining on the left side of the chamber. During a concurrent interview with the SPDM, she acknowledged the white staining on the interior side wall of Sterilizer 2, and the brown staining in Sterilizer 2 and 3. The SPDM was asked to provide sterilizer cleaning logs and manufacturer’s instructions for use (IFU’s). On December 10, 2024, at 8:25 A.M., an interview was conducted with the Infection Preventionist (IP), during a tour of the SPD. The IP stated the hospital followed nationally recognized guidelines from: 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. CDC - Centers for Disease Control On December 10, 2024, at 8:53 A.M., an interview was conducted with the SPDM. The SPDM stated there were no sterilizer cleaning logs documented. The SPDM stated the sterilizers were not cleaned per the manufacturers IFU’s for cleaning and maintenance. On December 11, 2024, at 8:43 A.M., a concurrent interview, and record review of the manufacturer’s sterilizer operating manual was conducted with the SPDM in the SPD. The SPDM validated the manufacturer’s IFU indicated the sterilizer drains should be cleaned daily, and sterilizer chambers should be cleaned weekly. The SPDM stated the manufacturer’s IFU’s had not been followed for cleaning. The SPDM stated the bi-annual sterilizer cleaning occurred on January 17, 2024. The SPDM stated the bi-annual cleaning was done by an outside vendor when the hospital called to schedule the cleaning. The SPDM stated a second cleaning for 2024 had not been scheduled. The SPDM stated Sterilizer 3 (V-Pro low temp sterilizer) was not cleaned because the hospital was looking for more information on the detergent and towel used for cleaning. The SPDM stated “three years was sufficient time to find information for the detergent and towel”, she had not done it. There was no documented evidence to indicate the hospital cleaned and maintained the 3 sterilizers. A review of the hospital’s policy titled, “Sterilizer Maintenance and Cleaning,” effective 02/2023, indicated, “Steam autoclaves are cleaned weekly by staff ...Follow facility procedures and manufacturer’s instructions ...Cleaning is logged and recorded ...Drain Strainer: a. Strainer will be cleaned during every shift or when the strainer is clogged ...Descaling i. Maintained according to manufacturer’s instructions ...Cleaning is done biannually by the manufacturer ...” A review of the manufacturer’s manual titled, “Steris Operator Manual AMSCO 400 series,” dated 05/22/15, indicated the following routine maintenance, “8.2 Daily Maintenance Procedures: Clean Chamber Drain Strainer. Recommended Frequency: Clean the drain strainer each day sterilizer is used. Important: The chamber drain strainer must be cleaned at least once a day, preferable before running the first cycle ...Remove obvious debris from the strainer. If necessary, clear the screen in the strainer using a brush, wire, or similar tool ...8.3 Routine Maintenance Procedure ...Flush chamber drain whenever the line becomes clogged ...8.3.2 Chamber Cleaning. Recommended Frequency: Clean chamber whenever it becomes soiled, or as needed to maintain clean appearance ...” A review of the manufacturer’s manual titled, “Steris Operator Manual AMSCO 600 series,” dated 2020, indicated the following routine maintenance, “6.2 Clean chamber drain strainer (daily). Recommended Frequency: Clean the drain strainer each day the sterilizer is used. IMPORTANT: The Drain strainer must be cleaned at least once a day, preferable before running the first cycle ...Chamber Cleaning Frequency ...when spills or other soiling have occurred. Routinely to maintain sterilizer cleanliness and appearance ...” A review of the manufacturer’s manual titled, “Steris Operator Manual V-PRO maX 2,” undated, indicated the following, “5.2 Routine Operator Maintenance. 5.2.1 Daily Check printer paper supply ...5.2.2 Weekly ...2. If dirty, clean Sterilization Unit chamber and shelving per instructions ...Clean touch screen per instructions ...5.2.3 Monthly ...3. Perform leak test on Sterilization Unit per instruction listed in Section 5.4 Leak Test ...”. 2. On December 10, 2024, at 8:25 A.M., an interview was conducted with the Infection Preventionist (IP), during a tour of the Sterile Processing Department (SPD). The IP stated the hospital followed nationally recognized guidelines from: 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. CDC -Centers for Disease Control On December 10, 2024, at 8:53 A.M., an observation was conducted with the Sterile Processing Department Manager (SPDM) in the decontamination area (to remove dangerous germs from objects so they are safe to handle or reuse) of the SPD. There were no cleaning logs observed for the washer/disinfector and ultrasonic irrigator. 2a. On December 11, 2024, at 8:43 A.M., a concurrent interview, and record review of the manufacturer’s washer/disinfector manual was conducted with the SPDM in the SPD. The SPDM validated the manufacturer’s IFU’s for the washer/disinfector daily, weekly, and monthly cleaning requirements. The SPDM stated daily washer cleaning, and weekly descaling was not completed following the hospitals policy & procedure (P&P), and the manufacturer’s IFU for cleaning. There was no documented evidence that showed the SPD’s washer/disinfector had been cleaned daily, weekly, or monthly. A review of the hospital’s policy and procedure titled, “Washer-Disinfector Maintenance,” effective date 02/2023 indicated, “Procedure: A. Beginning of every shift 1. Washer cleaning should follow manufacturer’s guidelines concerning the daily inspection of equipment. a) Remove coarse screen inside the chamber and rinse thoroughly with water. 1) Remove any lint or foreign materials from screen ...b) Check washer arms for any foreign materials. Disassemble arms, ...remove any lint of foreign materials. C. Clean washer loading belt ...2. Descaling occurs once a week on the weekend ...c. Document clean with date and initial on cleaning log ...” A review of the manufacturer’s manual titled, “Steris Operator Manual AMSCO 7000 Series Washer/Disinfector,” dated 2/17/2021, indicated the following, “Table 6-1. Routine Maintenance - Check List ...2.0 Once Per Day clean debris screen in chamber 3.0 Once Per Week inspect rotary spray arm assemblies for free movement and clogged holes. Remove hard water deposits from interior of chamber. Clean washer/disinfector interior and exterior. Clean water outlet connection in chamber. Inspect rotary spray arms assemblies of manifold racks for free movement and clogged holes. Once per month ...Clean each door gasket by brushing them and disinfect gaskets using a germicidal detergent ...” 2b. On December 11, 2024, at 8:43 A.M., a concurrent interview, and record review of the manufacturer’s the ultrasonic irrigator manual was conducted with the SPDM in the SPD. The SPDM validated the manufacturer’s IFU’s for the ultrasonic irrigator daily and weekly cleaning inspection requirements. The SPDM stated the ultrasonic irrigator daily/weekly cleaning and inspection was not completed following the hospitals policy & procedure (P&P), and the manufacturer’s IFU for cleaning and inspection. There was no documented evidence that showed the SPD’s ultrasonic irrigator was cleaned and inspected daily or weekly. A review of the hospital’s policy and procedure titled, “Washer-Disinfector Maintenance,” effective date 02/2023 indicated, “Procedure: A. Beginning of every shift 1. Washer cleaning should follow manufacturer’s guidelines concerning the daily inspection of equipment. a) Remove coarse screen inside the chamber and rinse thoroughly with water. 1) Remove any lint or foreign materials from screen ...b) Check washer arms for any foreign materials. Disassemble arms, ...remove any lint of foreign materials. C. Clean washer loading belt ...2. Descaling occurs once a week on the weekend ...c. Document clean with date and initial on cleaning log ...” A review of the manufacturer’s manual titled, “Steris InnoWave Unit and Unity 20 Sonic Irrigators Operating Manual,” dated 2020, indicated, “6.0 Daily cleaning inspection 1. Make sure there is sufficient chemical in the chemical bottle for the day’s planned wash cycles. 2. Open the lid. Inspect the lid seal. Make sure that the lid seal is in good condition. 3. Remove the basket from the tank and inspect it. Make sure the basket flush ports are undamaged and free of blockages or debris ...4. Inspect the tank docking ports. Make sure ports are clear of any soil and are in good condition ...5. Pull the filter up and away to remove it from the tank. Remove any soil from the filter, wipe filter with disinfectant cleaner ...6. With a clean cloth and disinfectant cleaner, wipe all internal surfaces of tank ...7. With a clean cloth and disinfectant cleaner, wipe all surfaces of lid ...8. With clean cloth and disinfectant cleaner, wipe all external surfaces. 9. With clean wet cloth, remove any trace of disinfectant cleaner from internal and external surfaces of equipment and lid. 10. Cleaning performance should be tested each day equipment used, and all test results recorded. 6.3 Weekly cleaning and inspection. 1 Perform all daily cleaning and inspection ...4. Perform a Full Decontamination ...” 3. On December 11, 2024, at 10:03 A.M., in the Sterile Processing Department (SPD) in the Ambulatory Surgical Center (ASC) two sampled (2) sterilization containers (a major and a minor tray) filled with multiple previously cleaned and sterilized surgical instruments were observed and inspected in the presence of the Sterile Processing Department Manager (SPDM), the Infection Preventionist (IP), and Sterile Processing Technician (SPD Tech) 2. The following concerns were identified upon observation of the surgical instruments: In the minor tray, 50 of 87 sampled instruments contained the following: A) 46 instruments were discolored/stained. B) Four (4) instruments were damaged. In the major tray four (4) of 97 sampled instruments contained the following: A) Three (3) instruments were discolored/stained. B) One instrument was damaged. Concurrent with observation, SPD Tech 2 acknowledged the surgical instruments had brownish discoloration/damage. SPD Tech 2 acknowledged that two (2) instruments in the major tray had discolored spots that were easily removed. SPD Tech 2 stated removable spots were dirt or bioburden, and discolored/damaged instruments should have been pulled from the tray. The SPDM stated discolored/stained and damaged instruments could cause a potential surgical site infection. The IP stated the brownish discoloration could cause corrosion. The IP stated microorganisms could grow in the rough gaps caused by corrosion and the rough gaps could not be sanitized. The IP stated discoloration and corrosion could lead to cross contamination and a potential infection. The IP stated the stained/discolored and damaged instruments could create an infection risk and should not be used in the operating room. On December 16, 2024, at 11:45 A.M., a concurrent interview and record review was conducted of the “Infection Control Risk Assessment Tool” dated fiscal year 2022, with the IP. The IP validated the SPD was not included in the “Infection Control Risk Assessment Tool” and it should have been. The IP stated the SPD was at high risk for the potential of infection. The IP stated an acceptable discolor/damage threshold for a surgical tray was less than one (1) percent. The IP stated 54 discolored/stained and damaged instruments out of 184 was not acceptable. The IP stated he did not participate in quality audits inspecting sterilized instruments. The IP state surgical instrument audits were not part of the Environment of Care (EOC) rounds. On December 17, 2024, at 2:04 P.M., an interview was conducted with the SPDM, she stated the hospitals’ tray assembly policy had an audit form for random tray inspections, but she had not done an audit since 2023. There was no documented evidence that showed sterilized instrument tray audits had been done. A review of the hospital’s policy titled, “Tray Assembly for Sterilized Instrumentation,” dated 02/2023, indicated, “ ...Trays will be reviewed by Sterile Processing Management for any discrepancies in the proper assemblage of instrumentation ...Purpose: To identify any potential steps not completed in the appropriate assembly of instrumentation. Policy: Trays will be reviewed by Sterile Processing Management for any discrepancies in the proper assemblage of instrumentation. All audits shall be documents on the audit sheet with date and initials of person completing task. Procedure A. Trays will be randomly picked on a continuous basis. B. Audit Sheet will be completed for each item ...2. Inside of packaging a. Check for bioburden b. Check instrumentation for staining, spotting, cracks, functionality ...” A review of the hospital’s document titled, “Infection Control Plan 2024,” indicated, “ ... u. High Level Disinfection (HLD) 1) What: Assess each area where HLD is performed to ensure appropriate processes are in place, to include maintenance of documentation log in accordance with policy. 2) Why: Appropriate level of equipment cleaning and disinfection is essential to prevent transmission of organisms between patients. 3) Areas: All locations where HLD is performed. 4) Length of Time: Based upon time of HLD process initiation: a. New Areas: Weekly for 1 month, then monthly for 3 months, then semi-annually thereafter. ... 5) Method: A qualified SPD or IC designee will visually survey identified areas for proper performance of HLD process and review documentation for completeness and accuracy. Identified discrepancies will be corrected immediately. 6) Reporting: Immediate feedback will be provided to personnel; issues will be reported as needed to appropriate personnel and ICC for corrective actions; routine reports will be provided to ICC, MEC and other appropriate departments/groups as warranted ...” A review of ANSI/AAMI ST 79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, showed the following standards for processing reusable surgical instruments: “7.6 Cleaning - 7.6.1 General considerations: Effective sterilization depends on minimizing the contamination, including detergent and water residues present on items before the sterilization cycle, and thorough cleaning procedures are essential during pre-sterilization processing...g) Devices should be inspected for flaws, damage, debris, detergent residue, and completeness, then dried ...7.6.4.5 Verification of the cleaning process: After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil. Rationale: Steam sterilization cannot be assured unless proper cleaning of the device and reduced bioburden and soil was achieved ...” A review of AORN (Association of Perioperative Registered Nurses - leaders in advocating for excellence in Perioperative practice and healthcare) guidelines, indicated the following, “ ...Instruments should undergo an inspection for proper function and cleanliness. 1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects 2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ...” 4. On December 9, 2024, at 2:36 P.M., a concurrent tour and interview was conducted of the Gastrointestinal Department (GI, an area focused on the digestive system and its diseases), with the Sterile Processing Department Manager (SPDM) The SPDM stated they follow nationally recognized guidelines from: a. AORN - Association of Perioperative Registered Nurses b. AAMI - Association for the Advancement of Medical Instrumentation c. CDC -Centers for Disease Control The SPDM stated the hospital followed a seven (7) day expiration hang time standard and endoscopes were reprocessed when they exceeded the hang time expiration date. The SPDM stated a tag with last reprocessed date was attached to each endoscope. During the endoscope sterile storage room tour, three (3) of nine (9) sampled endoscopes (Endoscope 1, Endoscope 2, and Endoscope 3) observed in the scope storage cabinet had expired hang times. The following endoscope expiration dates were observed: Endoscope 1, dated 11/12 (expired 20 days ago) Endoscope 2 dated 11/27 (expired 9 days ago), and Endoscope 3 dated 11/27(expired 9 days ago). The SPDM validated Endoscope 1, Endoscope 2, and Endoscope 3 were past the hospital’s 7-day hangtime expiration date.. The SPDM stated the 3 endoscopes needed to be reprocessed. A review of the hospital’s policy titled “Cleaning and Disinfection of Scopes,” dated 4/2017, indicated, “Storage ...Maximum hang time is 7 days after processing. A dated tag will be employed with the date that the scope was last cleaned. Maximum semi rigid Hang Time Without Use. For all scopes is 7 days ...All areas using flexible, and endoscopes are required to reprocess endoscope ...” A review of the manufacturer’s manual titled, “Olympus Reprocessing Manual,” dated 2020, indicated the following instructions for use, “ ...1.2 Importance of reprocessing: The medical literature reports incidents of cross-contamination resulting from improper reprocessing. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual ...1.4 An insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them ...8.3 Storing the sterilized endoscope and accessories ...Store the sterilized endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices ...” A review of AAMI ST91 “Flexible and Semi-Rigid Endoscope Processing in Healthcare Facilities” guidelines indicated, “1.2.4 Maximum safe storage time for high-level disinfected endoscopes ...11.2.4.1 General considerations ...The accepted maximum safe storage time (previously referred to as “hang time” or shelf life) for processed endoscopes before they can no longer be considered safe for patient use is not well defined ...11.2.4.2 Risk assessment ... Due to the lack of consensus and evidence on the storage time, it is recommended that the health care facility conduct a risk assessment to determine the maximum time storage time for endoscope before it should be reprocessed ...i) manufacturer’s written IFU for storage; j) compliance with professional organization guidelines for storage; k) relevant research studies ...Based on the results of the risk assessment, the health care facility should develop policies and procedures to address the maximum endoscope storage time. Compliance should be audited to determine if changes to storage time need to be made. The facility should define circumstances or conditions that could occur during storage that would mean that an endoscope should be processed before use on the next patient ...” 5. On December 9, 2024, at 2:36 P.M., an observation and concurrent interview was conducted with the Sterile Processing Department Manager (SPDM) who provided a tour of the GI Department. The SPDM stated they follow nationally recognized guidelines from: a. AORN - Association of Perioperative Registered Nurses b. AAMI - Association for the Advancement of Medical Instrumentation c. CDC -Centers for Disease Control The SPDM stated the hospital followed a seven (7) day expiration hang time standard and expired endoscopes should be reprocessed. During an interview with SPD Tech 1, on December 10, 2024, at 11:49 A.M., in the GI reprocessing room, SPD Tech 1 stated an expired endoscope could go from the storage cabinet “straight into the Medivator” for reprocessing. During an interview with SPDM on December 10, 2024, at 11:52, she stated an expired endoscope should be reprocessed without skipping steps according to the endoscopes IFU’s. A review of the hospital’s policy titled “Cleaning and Disinfection of Scopes,” dated 4/2017, indicated, “Storage ...Maximum hang time is 7 days after processing. A dated tag will be employed with the date that the scope was last cleaned. Maximum semi rigid Hang Time Without Use. For all scopes is 7 days ...All areas using flexible, and endoscopes are required to reprocess endoscope are required to reprocess endoscope which include the following steps: -Leak Testing -Manual Cleaning (all steps) -Rinsing after cleaning -High-Level Disinfection -Alcohol Flush ...” 6. On December 9, 2024, at 2:04 P.M., during a tour of the Sterile Processing “Prep and Pack Area” with the Sterile Processing Department Manager (SPDM) the following was observed: a. One (1) ceiling tile was broken. b. One (1) ceiling tile was missing. c. A temporary plastic cover tile replacement had significant space between the plastic cover and ceiling tile. The space between ceiling tiles and plastic cover, and the broken tile could affect air changes and allow dust particles that “harbor infection” to enter the SPD. During an interview immediately following the observations, the SPDM validated a noticeable gap between the damaged ceiling tile and the temporary plastic cover that replaced the missing ceiling tile. The SPDM stated the tile had “been missing for a couple of months” and she had placed a work order. The SPDM stated dust particles falling through the space between tile and plastic in the “Prep and Pack Area” where sterile surgical instruments were stored was an infection control concern. A copy of the work order was requested. On December 10, 2024, at 9:36 A.M., during an interview with the Corporate Quality Director (CQD), in the SPD “Prep and Pack Area”, she validated the broken and missing tiles with a significant gap. The CQD stated dust from the ceiling could come into the sterilized supply storage area and the missing/damaged tiles were an infection control risk that needed to be replaced. The CQD stated she was aware the tiles were broken/missing, the engineering department had been notified, and the repair was in process. The CQD acknowledged the delayed process time was too long and a concern. On December 11, 2024, at 9:50 A.M., during an interview with the Infection Preventionist (IP), he stated he was aware the tiles were broken/missing during environment of care (EOC) rounds. The IP validated the ceiling tiles The IP stated EOC detected the issue two (2) months ago and submitted a work order ticket. The IP stated he was not responsible for the tile, that his role was more involved with antibiotic stewardship, focused on clinical aspects, and hospital acquired infection reporting. On December 11, 2024, at 2:48 P.M., during an interview with the Acting Plant Operations Director (ENG D) in the administration office lobby, she stated the Ambulatory Surgery Center Medical Office Building (ASCMOB) was not staffed by the hospital engineering department. The ENG D validated the SPD was in the ASCMOB and stated the Project Coordinator for Medical Office Buildings (PCMOB) provided maintenance and repairs for the ASCMOB. On December 12, 2024, at 10:48 A.M., during an interview with the PCMOB, in the ASCMOB lobby, he stated was aware the ceiling tiles were broken/missing for two (2) months. The PCMOB stated he was not aware the ceiling needed a special tile, covered the hole with a plastic bag and thought everything was “fine”. The ASCMOB stated he became aware his ceiling tile fix ‘was not the right way to do it” during the survey on December 9, 2024. The PCMOB stated he was not aware of an air test and balance report from an outside vendor from September 2024 that indicated the airflow in the SPD did not meet baseline standards. The PCMOB stated his role was more of an environmental service role, he “managed projects” and he was not a hospital engineer. The PCMOB stated he thought the hospital’s chief engineer was responsible for the ASCMOB and “we need to have a meeting because I’m not sure who is responsible.” On December 12, 2024, at 11:10 A.M., with the ENG D, in the ASCMOB lobby, the ENG D stated again the hospital’s engineer did not cover the ASCMOB. The ENG D stated the PCMOB was the engineer for the ASCMOB. The ENG D stated the hospital owns the Ambulatory Surgery Center (ASC) and SPD but did not manage the building it was housed in and there was confusion about who was responsible for the building maintenance. The hospital did not have a written plan identifying responsible parties for the hospital’s SPD while it was temporarily located in the ASCMOB. On December 16, 2024, at 9:50 A.M., with Quality Risk Manager (QRM) 2, she stated immediate hospital concerns were discussed during the daily morning huddle. QRM 2 stated the missing tile issue was not discussed in the morning huddle and the ASCMOB was not represented at the morning huddles. On December 17, 2024, at 9:22 A.M., with the CQD, she stated the SPD air balance report was not sent to quality. The CQD stated there was not an integration process connecting the hospital and SPD. On December 17, 2024, at 9:34 A.M., with the IP, he stated he had not heard the air changes were out of range in the SPD. The IP stated the ineffective air exchange in the SPD increased the risk for microorganism growth. The IP stated that he did not have a checklist for IP rounds, and no policy specific for SPD rounding. On December 17, 2024, at 2:08 P.M., with the SPDM, she stated the hospital had a work order tracking system and the ASCMOB did not. The SPDM stated she was unsure where her telephoned work order went after she called the ASCMOB. The SPDM stated there was no documented work order. The SPDM stated she reported to the Administrator (ADMIN) but did not contact him about the delayed process to getting the ceiling tiles fixed. The SPDM stated she was not aware of the report from an outside vendor that indicated the air changes in the SPD had not achieved the minimum approved levels. The SPDM stated when the SPD moved to the ASCMOB, the department was “off the hospital’s radar”. The SPDM stated there was no written policy or protocol for the temporary relocation of the SPD to the ASCMOB or oversite for the building. On December 18, 2024, at 10:05 A.M., with the ADMIN, in an office, the ADMIN stated “clearly we dropped the ball” in getting the ceiling tiles fixed. The ADMIN stated the broken/missing tiles affected the air flow and the plastic was “not the best” solution. The ADMIN stated the hospital did not have a policy or protocol for the temporary relocation of the SPD to the ASCMOB and oversite responsibilities. The ADMIN acknowledged the confusion between the hospital and ASCMOB oversite contributed to their failures. There was no policy or plan documented for the operational oversite of the SPD when it was relocated to a different building. A review of the document titled “Test & Balance Report”, dated 9/27/2024 indicated, “The project scope consisted of testing specific critical ventilation rooms determined by the facility. Rooms were tested for total CFM, relative pressures to adjacent areas and air changes per hour ...3.0 Sterile Processing is currently not achieving required Air Changes per hour. Sterile Processing Air changes required 4-12, actual 2.0 ...” A review of AAMI ST79 “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities” guidelines indicated, “ ...3.3.6.2 Clean work area/room, The area/room used for the preparation and assembly of instruments and other items to be sterilized ...Preparation of textile packs and of individual wrapped textiles, when performed in the clean work area/room, should be carried out in an enclosed space separate from the remainder of the clean work area/room. The air flow should be of a down-draft type, and the number of air exchanges per hour should be sufficient to minimize lint particles in the air ...” A review of AORN (Association of Perioperative Registered Nurses - leaders in advocating for excellence in Perioperative practice and healthcare) guidelines, indicated the following, “ ...What conditions are necessary for storage of sterile supplies? Sterile items should be contained in an US Food and Drug Administration-approved sterile barrier system and stored under environmentally controlled conditions which include ...a minimum of four air exchanges per hour ...” A review of CDC (Center for Disease Control) guidelines, indicated the following, “How much Ventilation Is Enough? ...Mitigation strategies ... When possible, aim for 5 or more air changes per hour (ACH) to help reduce the number of viral particles in the air at workplace ...” 38764 7. During a review of Patient 37’s admission record, the record showed the patient was admitted on 12/5/24. During a review of Patient 37’s Authorization Form and Consent to Surgery or Special Diagnostic or Therapeutic Procedures form, showed the patient procedure was for a bilateral eye with YAG (Yttrium aluminum garnet, a specific type of crystal to produce a concentrated beam of light) Laser Posterior Capsulotomy (procedure uses a special laser to treat secondary cataracts, clouding of the eye lens after a cataract surgery). During a review of Patient 37’s Eye Laser Log dated 12/5/24, showed the YAG laser was administered to the right and left eye of the patient. During a concurrent interview and record review on 12/10/24 at 10:29 am with Charge Nurse (CN) 2, the CN acknowledged the above findings. CN 2 was asked about the risks of a laser surgery on a patient. CN 2 stated the risks of a laser surgery included the laser could potentially cause a fire. CN 2 was asked if a fire risk assessment was conducted for Patient 37 prior to the surgery. CN 2 stated there was no documentation to show if a fire risk assessment was conducted for the patient before the surgery. CN 2 explained a fire risk assessment should be conducted for patient prior to a laser surgery. A review of the hospital’s P&P titled Universal Protocol and Time Out Verification revised on 6/19, showed the purpose of the P&P was to prevent wrong patient, wrong procedure, or wrong site surgeries by providing patient care providers with specific expectations and procedures to follow throughout the perioperative (around the time of surgery) process. To assure availability of all relevant documents, implants, equipment and supplies prior to surgeries and to improve overall patient care and safety by improving communication among patient care providers. The P&P included during the intra-operative (the phase when the patient enter the operating room (OR) and ending when the patient leaves the OR.) preparation was to confirm a fire risk assessment of the patient. 28154 8. Review of the “Temperature and Humidity Tracking Logs” provided in a binder by the OR Nurse Manager (ORNM1) revealed, “If temperature and humidity are outside of the normal range, contact Engineering by phone at . . . .and document in the log. Engineering to initial after corrective action has been{sic}and the correct value range to achieved {sic} . . . The columns across the top of the log revealed, “Temperature 68-75F [Fahrenheit],” “Humidity 30-60%,” “ENGR (Engineering) Called Y/N,” and the last column was for “Engr [Engineering] initials.” Review of the November 2024 Temperature and Humidity Tracking Logs (two days documented as on call) revealed the temperature/humidity was not within the required range for the following number of days: Room 1 & 2 -22 days/6 days Room 3 - 15 days/6 days Room 4 - 24 days/13 days Room 5 - 14 days/7 days Room 6 - 7 days/3 days Room 7 - 17 days/5 days Room 8 - 25 days /15 days Room 9 - 25 days/14 days Room 10 - 23 days/9 days Room 11- 24 days/12 days Room 12 - 22 days/11 days Sterile Room - 21 days/9 days Cardiac Storage - 24 days/11 days Anesthesia - 22 days/7 days Review revealed documentation that engineering was contacted for all dates listed above when temperature or humidity were out of range, however, engineering did not initial/document that corrective action was taken. Review of the December 2024 Temperature and Humidity Tracking Logs (through 10/10/24 with one day noted as on call) revealed the temperature/humidity was not within required range for the following number of days: Room 1 & 2 - 8 days/0 days Room 3 - 6 days/0 days Room 4 - 7days/1 day Room 5 - 5 days/0 day Room 6 - 4 days/0 day Room 7 - 4 days/0 day Room 8 - 9 days/1 day Room 9 - 8 days/1 day Room 10 - 8 days/0 day Room 11 - 8 days/1 day Room 12 - 8 days/0 day Sterile Room - 9 days/0 day Cardiac Storage - 9 days/0 day Anesthesia -9 days/0 day Review revealed documentation that engineering was contacted for all dates when temperatures or humidity were out of range, however, engineering did not initial/document that corrective action was taken. During an interview on 12/13/24 at 2:18 PM regarding temperatures and humidity that were out of normal values, the ORNM1 stated, “Engineering is contacted and notified when the temperature/humidity is out of range. On the phone they say they will turn up or down (make adjustments) or if nothing can be done (they tell us we just need a new HVAC system) we have to close the OR. We do close the rooms and move to another OR; but I don’t have a policy, and I don’t keep a record of closing rooms.” During an interview on 12/13/24 at 1:40 PM regarding the blank engineering initial columns, the Interim Facilities Director stated, “Yes, Engineering should be initialing when they check the OR’s.” In a follow up interview on 12/13/24 at 3:00 PM, the ORNM1 confirmed, “There is no policy for the temperature/humidity in the OR, but we should be meeting ASHRAE (American Society of Heating, Refrigerating, and Air-Conditioning Engineers) and AORN (Association of perioperative Registered Nurses) standards.” Review of the “Infection Control Today website revealed, (https://www.infectioncontroltoday.com/view/what-ips-need-to-know-about-ventilation) “ASHRAE Standard 170 requires temperatures ranging from 68 °F to 75 °F for most patient care areas. Cool temperature standards (68 °F-73 °F [20 °C-23 °C]) are usually related to operating rooms, clean workrooms, and endoscopy suites. Review of the Centers for Disease Control (CDC) website revealed, (https://www.cdc.gov/infection-control/media/pdfs/Guideline-Environmental-H.pdf) “ ...Cool temperature standards (68°F-73°F [20°C-23°C]) usually are associated with operating rooms, clean workrooms, and endoscopy suites ... For most areas within health-care facilities, the designated comfort range is 30%-60% relative humidity.120, 214 Relative humidity levels >60%, in addition to being perceived as uncomfortable, promote fungal growth. . . .” 9. Review of the facility provided “Surgical Services” three ring binder of policies revealed policies for the following topics were not addressed: Identification of infected/non-infected cases; Temperature/Humidity levels in the department; Discharge instructions from the Post Anesthesia Care Unit (PACU); and Post Operative Recovery on other Hospital Units. During an interview on 12/13/24 at 3:02 PM, Operating Room/PACU Manager (ORM) 1 confirmed there were currently no policies for identification of infected/noninfected cases, temperature/humidity levels in the department, discharge instructions from the PACU, and Post Operative Recovery on other Hospital Units. ORM 1 stated there should be policies. 10. Review of the “Surgical Services” three ring binder of policies revealed a policy titled, “Fluid and Blanket Warming Cabinets,” revised 03/19, revealed, “ ...blanket warming cabinets (page 3 of 10) ...1. Blanket warming device setting should not exceed 130 degrees F [Fahrenheit] or 54 degrees Centigrade ...Page 4 of 10 ...3. Signs shall be posted on blanket warmers warning that the recommended temperature is 130 degrees F (no action is necessary for blanket warmers found to be 140 degrees F or less). ...Page 8 of 10 had a sign to be posted ...Recommend 130 degrees F if temp exceeds 140 degrees F turn off unit - no action necessary for blanket warmers found to be 140 degrees F or less ...Page 10 of 10 of the policy revealed, “ ...Organizational Position After due consideration, the hospital has adopted the following position ...The maximum achievable temperature for blanket warmers through the hospital shall be 150 degrees F. Signs shall be posted on blanket warmers warning that the recommended temperature is 130 degrees F (No action is necessary for blanket warmers found to be 150 degrees F or less) ...” Observation of the surgical area blanket warmer on 12/10/24 at 1:55 PM with the ORM 1 revealed the sign on the warmer had the 140o F warning. The ORM 1 stated the policy should be consistent. 11. Review of the facility policy titled “Infection Control - Anesthesia Equipment and Supplies,” reviewed April 2017, revealed, “ ...2. Anesthesia equipment are terminally cleaned daily. A. After each procedure (between cases), the exterior surfaces of anesthesia machines, instruments attached to and kept on them, storage drawers, all anesthesia monitor equipment, and supply carts are cleaned with 70% alcohol.” Observation of the anesthesia area in an endoscopy room on 12/10/24 at 9:01 AM showed Physician 1 using a PDI Sani-Cloth disinfectant wipe on pumps from a canister on the anesthesia cart. On 12/11/24 at 3:00 PM, the ORM1 stated the PDI Sani-Cloth disinfectant wipe was to be used to disinfect equipment, not 70% alcohol. 12. Review of the Surgical Services policy binder revealed a facility policy titled, “Pediatric Patient Care in Surgery,” reviewed August 2011. After verifying, ORM1 emailed on 12/16/24 at 12:06 PM (central time) that pediatric surgeries have not been performed at the hospital for “about 15 years.” During an interview on 12/13/24 at 2:25 PM, the ORM1 stated, “There is no policy regarding the review/revision of policies. My thought is they should be reviewed every three years.” 13. Observation of Patient (P) 31’s pre-operative set up on 12/10/24 at 12:55 PM and the pre-surgical time-out performed at 1:44 PM included the patient name, date of birth, medical record number, and the procedure to be completed. All present in the OR were in verbal agreement and P31 was sedated. The ORM 1, present during the time out, confirmed on 12/10/24 at 1:45 PM that fire risk was not addressed. During an interview on 12/14/24 at 2:58 PM regarding the fire risk, ORM1 stated an expectation “for the OR that it be addressed even if it is a low fire risk.””

“POST-OPERATIVE CARE CFR(s): 482.51(b)(4) There must be adequate provisions for immediate post-operative care. This Standard is not met as evidenced by: 28154 Based on record review, observation, interview, and facility policy review the facility failed to ensure accurate discharge instructions were provided for one of six surgical patients (Patient (P) 29) reviewed. This failure had the potential for patients to follow discharge recommendations that did not relate to the procedure that was performed. The facility census was 62 during the survey. Findings include: Observation in Operating Room (OR) 4 on 12/10/24 at 9:09 AM identified the physician inserting an endoscopic ultrasound into P29’s mouth. The procedure, which included a sample from a two-centimeter pancreatic cyst, was completed by 9:20 AM and P29 was taken to the post anesthesia care unit (PACU) at 9:44 AM. Review of P29’s discharge instructions located in the paper medical record on 12/10/24 showed P29 should follow “Post Polypectomy Instructions for [handwritten] 3 Days.” Review of the “Post Polypectomy Instructions” revealed, “ ...Your Doctor has completed you [sic] colonoscopy test and has cauterized and/or removed polys from your colon. ...” During an interview on 12/13/14 at 2:22 PM, the OR/PACU Manager (ORM) 1 stated an expectation that discharge instructions provided to the patient would match the procedure that was performed in the hospital. Review of the facility policy titled, “Operative and Other Invasive Procedures,” reviewed June 2020, revealed, “ ...10. ...Education is provided to the patient, family and/or patient representatives regarding post discharge care which includes: a practitioner’s name and phone number to call in case of complications; activity limitations (as indicated); dietary precautions (as indicated); and follow-up instructions ....””

“OPERATIVE REPORT CFR(s): 482.51(b)(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. This Standard is not met as evidenced by: 28154 Based on record review, interview, and facility policy review, the facility failed to ensure post operative dictation was completed by the physician for one of six surgical patients (Patient (P) 30) reviewed. This failure could affect the post operative care planning and provision of care to patients. The facility census was 62 during the survey. Findings include: Review of P30’s “Moderate Sedation/Procedure Record” dated 12/10/24 on 12/12/24 revealed, the endoscopic retrograde cholangiopancreatography (ERCP) procedure was started at 3:51 PM and completed at 4:17 PM. Physician 3 noted via check mark that the “Physician’s Post-Procedure Note” had been dictated. No post operative report was found in the hard (paper) chart. During a review of P30’s records on 12/12/24 at 11:15 AM, Operating Room Manager (ORM) 1 stated, “I do not see the dictation or post op [operative] report. I checked, I don’t see a job number [from dictation].” ORM1 contacted medical records via telephone and requested they look and ORM1 reported medical records did not see any post operative dictation by Physician 3. At 11:30 AM, ORM1 stated he/she was not seeing any dictation or typed note by Physician 3. ORM1 located a consultation note that was documented prior to the procedure on 12/10/24 at 10:03 AM. P30 was admitted to the hospital, and a review of his/her floor chart was completed at 11:30 AM with ORM1 who found the “Post-Procedure Note” was checked that it was dictated, however, no post operative dictation was located. During an interview on 12/13/14 at 2:24 PM, ORM 1 stated an expectation that doctors should follow the facility policy regarding post operative reports. Review of the facility policy titled, “Operative and Other Invasive Procedures,” reviewed June 2020, revealed, “ ...5. An operative report is dictated or written immediately after the procedure,[sic] and records the name of the licensed independent practitioner and assistants; procedures performed, and description of the procedure; findings; estimated blood loss; specimens removed; and postoperative diagnosis ...a. An operative or other high risk procedure progress note shall be entered in the medical record immediately after the procedure, if the full operative or other high-risk procedure report cannot be entered into the record immediately after the operation or procedure ...””

“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: 28154 Based on observation, interview, and facility policy review, the facility failed to ensure medication drawn up into a syringe to induce anesthesia was labeled. This failure had the potential to contribute to medication errors and increase the chance of an adverse to patients. The survey census was 62. Findings include: Observation of the anesthesia area of endoscopy room 4 on 12/10/24 at 9:02 AM showed a syringe with white fluid in a pump with an intravenous (IV) tubing to attach to Patient (P) 29’s IV. Operating Room Manager (ORM) 1 who was present during the observation confirmed there was no label on the syringe. In an interview on 12/10/24 at 9:03 AM regarding the lack of a label on the syringe, Physician 1 identified the medication as propofol (a short-acting intravenous anesthetic medication used to induce and maintain general anesthesia), reached back to the anesthesia cart to take a label from a roll and attached it to the syringe. Physician 1 stated, “Please note that it was labeled before given to the patient.” During an interview on 12/13/24 at 2:21 PM, ORM 1 stated the expectation is that, “Proper labeling is completed per policy.” Review of the facility policy titled, “Anesthesia Medication Management,” reviewed May 2017, revealed: “A. Patient Care a. The Anesthesiologist selects and prepares medications prior to the commencement of the anesthetic induction .... i. Medication drawn up into a syringe is labeled with the name of the drug, the concentration, the date and the initials of the physician ....””

“PRE-ANESTHESIA EVALUATION CFR(s): 482.52(b)(1) [The policies must ensure that the following are provided for each patient:] A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services. This Standard is not met as evidenced by: 31794 Based on interview and record review the facility failed to ensure the pre- anesthesia evaluation was completed within 48 hours prior to the delivery of the first dose of medications given to induce anesthesia (drug induce loss of awareness) for the surgery requiring anesthesia services for one of 30 sampled patient’s (Patient 4) when, the “Anesthesia Preoperative Evaluation,” dated 12/5/24, was not authenticated (process of verifying the accuracy and validity of information within a patient’s record by confirming the identity of the healthcare professional who made the entry, typically through a signature or electronic equivalent) by the Anesthesiologist (medical doctors that specializes in anesthesia care, pain management, and critical care). Failure to complete medical records with authentication within the time frame required prevented all healthcare team members from having access to critical patient information necessary to monitor the patient’s condition and ensure patient safety. Findings: Review of the Face Sheet dated 12/17/24 indicated, Patient 4 was admitted to the hospital on 12/5/24 and was discharged on 12/10/24. Review of the Admission History and Physical (H &P) of Patient 4, dated 12/6/24 indicated, patient had a medical history which included diabetes mellitus (high blood sugar level), coronary artery disease (type of a heart disease) with three vessel disease and underwent coronary artery bypass (CABG, a surgical procedure that improves blood flow to the heart) on 12/5/24. In a concurrent record review and interview on 12/16/24, at 9:39 AM, with the Charge Nurse (CN 3), the Operative/Procedure Report dated 12/5/24, the “Anesthesia Preoperative Evaluation” Notes dated 12/5/24, and the Anesthesia Record dated 12/5/24, were reviewed. The Operative/Procedure Report indicated, the primary procedure as “Coronary artery bypass graft x 3”, the Anesthesia Record indicated, patient was “re-assessed immediatley prior to induction”, patient was monitored and the medicaitons given were listed. The CN 3 stated, the patient was a “direct admit” to the hospital on 12/5/24, had CABG surgery on 12/5/24, and the Anesthesia Preoperative Evaluation was a “draft”, it was typed on the top of the document as “Draft”. In a concurrent record review and interview on12/17/24, at 11:15 AM, with the Registered Nurse (RN 7), the Anesthesia Preoperative Evaluation Notes dated 12/5/24, was reviewed. The RN 7 stated, “it was drafted” on 12/5/24, “I don’t see an electronic signature” on this. In an interview on 12/17/24, at 1:45 PM, with the Director of Health Information Management DHIM), DHIM stated, for Physicians they have “15 days” for closure of chart including electronic signature. When asked for hospital Policy and Procedure that reflect the above statement, the DHIM stated, after she checked the facility’s Medical Bylaws, all medical records of discharged patients shall be completed, including signatures, within “two weeks” following the patient’s discharge. Review of the facility’s Medical Bylaws, dated 2/23 indicated, MEDICAL RECORDS, a. A legible medical record shall be maintained for every individual who is evaluated or treated at the Hospital. ... I. Medical Records should be complete at the time of discharge of the patient. ... In any event, all medical records of discharged patients shall be completed, including signatures, within two weeks following the patient’s discharge. A medical record shall ordinarily be considered complete when the required contents are assembled and authenticated, including any required clinical resume (discharge summary) or final progress note and recording, ... .” The facility’s Medical Bylaws is not aligned with the Condition of Participation (CoP) on Anesthesia Services, 482.52 (b) (1) in completing the pre anesthesia evaluation within the required time frame (48 hours prior to the delivery of services ). Review of the American Society of Anesthesiologist (ASA), Standard or Practice Parameters, “Statement Documentation of Anesthesia Care”, with the last amended date of 10/23 indicated, “Depending upon local factors, documentation may be provided on a paper record or within an electronic health record. ... Documentation should meet all applicable regulatory, legal, and compliance requirements.” Review of Title- 22 California Code of Regulations (CCR) 72543, Patients’ Health Records indicated, “All entries in the health record shall be authenticated with the date, name, and title of the persons making the entry.””

“ORGANIZATION AND DIRECTION CFR(s): 482.55(a) Organization and Direction. If emergency services are provided at the hospital -- This Standard is not met as evidenced by: 38764 Based on observation, interview, and record review, the hospital failed to ensure the Emergency Department (ED) was organized to ensure the delivery of safe patient care for one of 54 sampled patients. The triage nurse failed to implement the hospital’s P&P to care for Patient 78 who had (Emergency Severity IndeX (ESI) of Level 2 (high risk conditions, including immediate life/organ threat and high liability risk, which require high resource intensity). Findings: During a review of Patient 78’s Admission Data dated 10/14/24 at 11:00 am, showed the patient arrived in the ED on 10/12/24 at 1:34 pm. During a review of Patient 78’s medical record dated 10/14/24 at 11:00 am, showed the Triage Date and Time of the patient was on 10/12/24 at 1:51 pm. The patient passed out while walking in the hallway of the house and had a fall incident. The patient was assessed to have a triage level of 2-emergent. After the patient was assessed in the Triage station of the ED. The patient was sent to the Waiting Room. During a concurrent interview and record review with RN 12 on 12/18/24 at 1:28 pm, RN 12 acknowledged above findings. RN 12 was asked to explain the purpose of assigning a triage level for a patient. RN 12 stated the purpose of a triage level assessment was to identify the severity of the patient’s condition and the number of resources needed to care for the patient. RN 12 acknowledged triage level was the same as an ESI level (Emergency Severity Index, tool used to measure physiologic stability and risk for deterioration of a patient in the ED). During a concurrent interview and further record review with the DED on 12/18/24 at 2:35 pm, the DED acknowledged the findings as described above. The DED was asked how to care Patient 78 with a triage level of 2. The DED stated the nurse should have communicated the findings to the ED Charge Nurse and to a physician. The DED was asked if the charge nurse or a physician was notified by the nurse about the triage findings of Patient 78. The DED stated there was no documentation to show if the the nurse notified the Charge Nurse or a physician about the triage findings of the patient. The DED acknowledged the nurse should not had sent Patient 78 to the waiting room. Review of the hospital’s P&P titled Triage Standards of Care revised/reviewed on 11/24, showed including the following: - to provide a standardized system whereby patients presenting to the ED are treated in order of priority based upon acuity, utilizing the ESI Five-Level Triage system; - the triage RN will triage all patients presenting to the Emergency Department to identify life-threatening conditions and to prioritize according to the acuity based ESI Level - determine the ESI level based on presentation and resources required. For a Level 2 presentation (a high risk situation), the triage process stops and the triage nurse communicates findings to the ED Charge Nurse and physician intervention is requested. The patient may be taken immediately to a treatment area.”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 38066 Based on interview and record review, the facility failed to ensure a computerized tomography (CT - a noninvasive medical imaging procedure that uses x-rays to create detailed pictures of the inside of the body) scan ordered STAT (immediately) for an Emergency Department (ED) patient (Patient 49) was completed in a timely manner. The failure of the immediate availability of this diagnostic service for six hours resulted in the potential for a direct impact on the overall provision of emergency medical interventions for this patient. Findings: Patient 49 was brought to the ED on 3/26/23 at 9:34 AM via Emergency Medical Services (EMS) ground transport with a chief complaint of altered mental status. Admission data indicated, “Pt found by police department (PD) in car, altered, arrives arousable to painful stimuli.” Physical assessment revealed an emergency severity index (ESI - a tool for use in ED triage) level 2 - high risk of deterioration, or signs of a time-critical problem (e.g. altered mental status). Review of Provider 6’s ED Note “Emergency Medicine Evaluation Note” dated 3/26/23, evaluated at 9:35AM, indicated, “Decreased mental status, responds to painful stimuli, appears under the influence of intoxicants, does not respond verbally or follow commands, A&O x0 (patient is completely disoriented and unaware of their surroundings or situation).” Reassessment at 2:00 PM indicated, “Pending ambulation trial to assess for metabolization of EtOH (alcohol) and readiness for DC (discharge) home ...CT head pending upon transfer of care to oncoming afternoon shift MD (physician) at 2:00 PM ...Diagnosis: EtOH intoxication. Disposition: Pending.” Review of Patient 49’s “Radiology Diagnostic Requisition Form” indicated, on 3/26/23 at 9:42 AM, a STAT head or brain CT was ordered. Review of Patient 49’s “ED Miscellaneous Nursing Note” dated 3/26/23 indicated, at 11:05 AM: “Patient continues to be somnolent (sleepy), arouses to loud verbal and painful stimuli. Continue to monitor.” Note did not indicate a follow up on STAT order for CT scan. at 11:50 AM: “Patient moans and moves. Vital signs within normal limits.” Note did not indicate a follow up on STAT order for CT scan. at 12:35 PM: “Patient to be discharged once she wakes up.” Note did not indicate a follow up on STAT order for CT scan. at 12:40 PM: “Patient is lethargic and sleeping. Patient is arousable to voice and tactile stimuli. Patient does not appear to be ready for discharge. ERMD aware.” Note did not indicate a follow up on STAT order for CT scan. at 2:30 PM: “Patient is difficult to arouse with sternal rub. Patient moans and opens her eyes. Patient is grinding teeth and biting down on tongue, with excess salivation. Patient suctioned.” Note did not indicate a follow up on STAT order for CT scan. at 2:43 PM: “Patient continues to be somnolent and difficult to arouse. Pupils are non-reactive to light. ERMD notified. Note did not indicate a follow up on STAT order for CT scan. Review of Radiology Department’s “Turn Around Time” report for CT indicated, the date and time the CT scan was completed was 3/26/23 at 3:38 PM and signed by the radiologist at 4:05 PM, six hours after the STAT CT scan was ordered. Review of Patient 49’s “Report Details” for CT examination of the head indicated, “Procedure Date: 3/26/23 3:38 PM ...Impression: Large right subdural hematoma ...There is subfalcine herniation with a significant leftward midline shift (a collection of blood in the brain that is causing the brain structures to shift off-center, usually signifying significant pressure on the brain and requiring immediate medical attention). Critical findings were communicated to Provider 8 at 3:57 PM, 3/26/23 ...” Review of Provider 8’s ED Note “Continued Care Observation Note” dated 3/26/23 indicated, at 2:00 PM: “Patient was signed out to me by Provider 6 pending re-evaluation prior to discharge for presumed alcohol intoxication. Patient re-evaluated, continues to be unresponsive. CT pending. CT tech contacted. at 3:57 PM: Spoke with radiologist who reported that patient had a subdural with midline shift and concern for subfalcine herniation. Patient re-evaluated, minimally responsive pupils, GCS 3 (Glasgow Coma Scale - tool used to measure decreases in consciousness. A GCS score of 3 is the lowest possible score and is associated with an extremely high mortality rate). at 4:08 PM: Spoke with neurosurgeon on-call who recommended intubation and transfer to OR (Operating Room). at 4:22 PM: Intensivist (doctor who specializes in treating patients in intensive care units [ICUs] who are critically ill) at bedside to intubate patient prior to transfer to OR. Diagnosis: acute SDH (subdural hematoma) Disposition: admit to ICU.” Review of Patient 49’s “History and Physical Report” dated 3/26/23 indicated, “Plan: Immediate craniotomy, craniectomy (both procedures involve removing a portion of the skull, the difference is that after a craniotomy the bone is replaced and after a craniectomy the bone is not immediately replaced) ...No guarantees given. She is in very bad shape and may very well not survive. Risks of death and coma and other medical complications as well ...” During an interview on 12/16/24 at 1:22 PM, Registered Nurse (RN) 16 stated, for a patient with an order of STAT CT, the expectation is, the patient will be taken within 30 minutes to an hour. If there is a delay, it is expected for the RN to follow up. RN 16 stated, “I document, followed up with CT and spoke with ...” During an interview on 12/16/24 at 1:38 PM, RN 6 stated, for a patient with an order of STAT CT, the expected turnaround time for the patient to be taken is 30 minutes to an hour. If there is a delay, “We call the CT and let the MD know.” RN 6 further stated, documentation can be written as a miscellaneous note like, “CT delayed due to whatever reason.” During an interview on 12/19/24 at 8:55 AM, the Director of Emergency Department (DED) stated, “We have been experiencing delays in CT results. STAT CT should be done within 30 minutes and the policy is to escalate to Radiology Department what is causing the delay. The RN should call CT technologist to follow up.” DED further stated, “Everything should be documented. If not, it didn’t happen.” Review of facility policy titled “Imaging: STAT Order Processing” revised on 5/17 indicated, “All computer orders shall be checked upon receipt for a STAT status. All STAT requests will be brought to the attention of the supervising or other relevant technologist and every effort shall be made to have the exam performed as quickly as possible and prioritizing the STAT exam above prescheduled patients if necessary. Nursing Units are also encouraged to call the Radiology Department to alert staff that a STAT order is being requested.””

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 40903 Based on observation, interview, and record review the hospital failed to ensure pediatric emergency cart (a mobile cart set up to contain emergency medications, supplies, and information on how to treat infants, toddlers, and children) in Emergency Department (or ED, a unit that treated emergency visits by public) was updated with most recent Broselow (also called the Broselow pediatric emergency tape, is a color-coded length-based tape measure that is used for pediatric emergencies. The Broselow Tape relates a child’s height as measured by the tape to their weight to provide medical instructions including medication dosages that should be used) pediatric emergency tape/documents along with the hospital’s Policy and Procedure (P&P, a document that describe the use and safety procedure during emergency) for use of pediatric emergency cart based on standards of practice with census of 62. This failed practice could contribute to unsafe use of the emergency cart due to outdated information and possible patient harm during emergency use. Findings: During a concurrent observation and interview, accompanied by Infection Prevention (IP), in the ED, on 12/11/24, at 5:08 PM, the pediatric emergency cart had a large Broselow reference tape attached to the wall, next to the cart, and was marked with “2017 Edition”. The binder on top of the pediatric emergency cart had multiple outdated algorithm (algorithm in emergency response is a set of defined steps or rules used to make decisions in real-time during an emergency situation) and policy pages. The IP stated he needed to check with ED managers for an updated Broselow reference tape. In an interview with ED’s lead Registered Nurse 2 (RN 2), on 12/12/24, at 2:43 PM, RN 2 stated all nurses in the ED were certified for pediatric emergency care. RN 2 stated the ED director was looking into getting an updated Broselow emergency reference tape and documents. In an interview with Chief Nursing Officer (CNO), on 12/18/24, at 3 PM, the CNO stated the emergency carts in the hospital, including pediatric carts should have had updated guidelines and resources for safe and effective resuscitation (revival of the heart). Review of the hospital’s nursing P&P, titled “Pediatric Crash Carts/Supplies/Resuscitation Equipment” (a cart with medication and equipment to treat medical emergency and revive stopped heartbeat), dated 1/2011, the policy indicated “Pediatric Crash Carts are to be used to store Broselow equipment. The Broselow color-coded system is a means to expedite and organize pediatric resuscitation.” The nursing policy was last renewed about 13 years ago in 2011 and indicated the responsible person for the policy was chair of “Code Blue Committee” (a team of hospital experts assessed emergency events and outcomes) and Director of Pharmacy. ED director was not available for interview on updated P&P for pediatric emergency cart. Review of the American Heart Associations (or AHA) a medical association that plays a leading role in standard guidelines and best practices for emergency events and was followed by healthcare providers, last accessed on 12/30/24, via https://cpr.heart.org/-/media/cpr-files/cpr-guidelines-files/highlights/hghlghts_2020_ecc_guidelines_english.pdf, the guideline indicated the most recent guideline was published in 2020. The guideline indicated “The 2020 Guidelines are a comprehensive revision of the AHA’s guidelines for adult, pediatric, neonatal, resuscitation education science, and systems of care topics.” The guidelines further indicated use of “Medication dosing for children is based on weight, which is often difficult to obtain in an emergency setting. There are numerous approaches to estimating weight when an actual weight cannot be obtained.””

“ORGANIZATION OF REHABILITATION SERVICES CFR(s): 482.56(a) The organization of the service must be appropriate to the scope of the services offered. This Standard is not met as evidenced by: 38612 Based on interview and record review, the hospital failed to ensure adequate staffing of the Rehabilitation Services Department (RSD) when: 1. There was no available Occupational Therapist (OT- a licensed health care professional who help people find ways to do activities of daily living [ADLs] such as eating, bathing, etcetera) to provide physician-ordered evaluations to nine of 11 sampled patients (Patients 1, 3, 4, and Random Patients [RP] 43, 44, 45, 46, 47, and 64). 2. There was no available Speech Language Pathologist (SLP, also known as speech therapist [ST] - a health care professional who diagnoses and treats speech, language, and swallowing disorders) to provide physician-ordered evaluations to two of four sampled patients. (Patient 20 and RP 64). This failure resulted in the inability of the hospital to furnish rehabilitation services to the patients in a timely manner which could potentially result to patient functional decline or delayed progress towards goals. Findings: 1. During a concurrent interview and record review on 12/10/24 at 1:27 PM with Rehabilitation Services Staff (RSS) 2, the hospital’s “OT/SLP Schedule-Final (OT/SLP Schedule),” dated 11/24/24 to 12/21/24, was reviewed. The OT/SLP Schedule showed the OT last worked on 11/27/24 for eight hours and was next scheduled for five hours on 12/14/24, with a 16-day gap in between. No other OT for the hospital was listed. The SLP last worked on 12/1/24 for six hours and was scheduled for six hours again on 12/14/24, with a 12-day gap in between. No other SLP was listed. RSS 2 stated, “There is only one OT and one ST for the whole hospital, both are per diem (employees who work on as-needed-basis). Most of the time, not full (work) shift. They only come on weekends, unless requested by the physicians but that depends if they are available.” RSS 2 stated the full work shift is eight hours. RSS 2 added, “There are OT and ST evaluation orders that are not being done. We have been asking for additional staff (OT and ST). One OT and ST staff cannot do it (evaluations) all. They (patients) get discharged without getting the services they need.” During an interview on 12/13/24 at 9:59 AM, RSS 1 confirmed evaluation orders were not carried out timely. RSS 1 stated, “I’m not happy about that. Once we receive the orders, they should be carried out the same day, if possible, but I only work per diem, two days out of a four-week schedule, most of the time not full shift.” RSS stated, “I attempt to see all the patients when I’m there (hospital) but sometimes the patients have already been discharged.” RSS 1 stated patients could become deconditioned (decline in physical function of the body because of physical inactivity) if evaluations are delayed or not performed. RSS 1 further stated, “They (patients) are typically already presenting with generalized weakness. We cannot create goals to address their needs if we don’t see them.” Review of RP 46’s Face Sheet, dated 12/18/24, indicated RP 46 was admitted to the hospital on 12/5/24 and was discharged on 12/11/24. Review of RP 46’s History and Physical (H&P), dated 12/5/24, indicated RP 46 presented with significant right knee pain following surgery. During a concurrent interview and review of RP 46’s EHR on 12/16/24 at 12:12 PM with RSS 2, RP 46’s physician’s order (PO) for OT evaluation and treatment, dated 12/5/24 at 9:51 AM was reviewed. RP 46’s PO indicated “OT Eval (evaluation) & (and) TX (treatment) Order” for total knee replacement (surgical replacement of parts of injured or worn-out knee joints). There was no documentation RP 46 received OT evaluation. RSS 2 stated, “I don’t see anything here (EHR) that shows it (OT evaluation) was done.” Review of Patient 4’s Face Sheet, dated 12/16/24, indicated Patient 4 was admitted to the hospital on 12/5/24 and was discharged on 12/10/24. Review of Patient 4’s H&P, dated 12/6/24, indicated Patient 4 presented with a chief complaint (main reason for seeking medical care) of unstable angina (a condition in which the heart does not get enough blood flow and oxygen). During a concurrent interview and review of Patient 4’s EHR on 12/16/24 at 12:21 PM with RSS 2, Patient 4’s PO for OT evaluation and treatment, dated 12/6/24 at 10:07 AM was reviewed. Patient 4’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to Patient 4. RSS 2 stated, “There’s no note of initial assessment. There should be one if patient was evaluated.” Review of Patient 1’s Face Sheet, dated 12/13/24, indicated Patient 1 was admitted to the hospital on 12/7/24 and was discharged on 12/11/24. Review of Patient 1’s H&P, dated 12/7/24, indicated Patient 1 presented with a chief complaint of unsteady gait and trouble speaking. During a concurrent interview and review of Patient 1’s EHR on 12/16/24 at 12:27 PM with RSS 2, Patient 1’s PO for OT evaluation and treatment, dated 12/7/24 at 5:46 PM was reviewed. Patient 1’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to Patient 1. RSS 2 stated, “It (OT evaluation) was not done.” RSS 1 added, “ This (EHR) is where we document if we did the evaluation. This is the proof we saw the patient. I can’t find anything here to show it was done.” Review of RP 47’s Face Sheet, dated 12/16/24, indicated RP 47 was admitted to the hospital on 12/6/24 and was discharged on 12/11/24. Review of RP 47’s H&P, dated 12/6/24, indicated RP 47 was admitted due to coronary artery pass grafting (a procedure to restore blood flow to areas of the heart). During a concurrent interview and review of RP 47’s EHR on 12/16/24 at 12:31 PM with RSS 2, RP 47’s PO for OT evaluation and treatment, dated 12/7/24 at 5:46 PM was reviewed. RP 47’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to RP 47. RSS 2 confirmed OT evaluation was not provided to RP 47. Review of RP 45’s Face Sheet, dated 12/16/24, indicated RP 45 was admitted to the hospital on 12/6/24 and was discharged on 12/11/24. Review of RP 45’s H&P, dated 12/6/24, indicated RP 45 presented with a chief complaint of chest discomfort. During a concurrent interview and review of RP 45’s EHR on 12/16/24 at 12:38 PM with RSS 2, RP 45’s PO for OT evaluation and treatment, dated 12/8/24 at 11: 33 AM was reviewed. RP 45’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to RP 45. RSS 2 confirmed OT evaluation was not provided to RP 45. Review of RP 64’s Face Sheet, dated 12/16/24, indicated RP 64 was admitted to the hospital on 12/6/24 and was discharged on 12/13/24. Review of RP 64’s H&P, dated 12/6/24, indicated RP 64 presented with a chief complaint of shortness of breath. During a concurrent interview and review of RP 64’s EHR on 12/16/24 at 12:46 PM with RSS 2, RP 64’s PO for OT evaluation and treatment, dated 12/8/24 at 12:14 PM was reviewed. RP 64’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to RP 64. RSS 2 confirmed OT evaluation was not provided to RP 64. Review of RP 44’s Face Sheet, dated 12/16/24, indicated RP 44 was admitted to the hospital on 12/10/24 and was discharged on 12/14/24. Review of RP 44’s H&P, dated 12/8/24, indicated RP 44 presented with a chief complaint of hip pain. During a concurrent interview and review of RP 44’s EHR on 12/16/24 at 12:51 PM with RSS 2, RP 44’s PO for OT evaluation and treatment, dated 12/8/24 at 4:42 PM was reviewed. RP 44’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to RP 44. RSS 2 confirmed OT evaluation was not provided to RP 44. RSS 2 stated, (Patient 44) was not seen (by the OT).” Review of RP 43’s Face Sheet, dated 12/16/24, indicated RP 43 was admitted to the hospital on 12/9/24 and was discharged on 12/11/24. Review of RP 43’s H&P, dated 12/9/24, indicated RP 43 presented to the Emergency Department by ambulance after unwitnessed syncopal episode. During a concurrent interview and review of RP 43’s EHR on 12/16/24 at 12:59 PM with RSS 2, RP 43’s PO for OT evaluation and treatment, dated 12/9/24 at 6:44 PM was reviewed. RP 43’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to RP 43. RSS 2 confirmed OT evaluation was not provided to RP 43. Review of Patient 3’s Face Sheet, dated 12/16/24, indicated Patient 3 was admitted to the hospital on 12/6/24 and was discharged on 12/11/24. Review of Patient 3’s H&P, dated 12/6/24, indicated Patient 3 presented with a chief complaint of fast heart rate. During a concurrent interview and review of Patient 3’s EHR on 12/16/24 at 1:08 PM with RSS 2, Patient 3’s PO for OT evaluation and treatment, dated 12/10/24 at 1:05 PM was reviewed. Patient 3’s PO indicated “OT Eval & TX Order” for muscle weakness. There was no documentation to indicate OT evaluation was provided to Patient 3. RSS 2 confirmed OT evaluation was not provided to Patient 3. 2. Review of Patient 20’s Face Sheet, dated 12/16/24, indicated Patient 20 was admitted to the hospital on 12/9/24 and was discharged on 12/12/24. Review of Patient 20’s H&P, dated 12/9/24, indicated Patient 20 presented with a chief complaint of hypertensive urgency (a very high blood pressure with potentially life-threatening symptoms). During a concurrent interview and review of Patient 20’s EHR on 12/16/24 at 1:20 PM with RSS 2, Patient 20’s PO for Speech Therapy (ST) evaluation, dated 12/9/24 at 5:10 PM was reviewed. Patient 20’s PO indicated an order for ST evaluation for dysphagia (difficulty swallowing) and dysarthria (a condition that makes it hard to speak clearly due to weak muscles used for speech). There was no documentation to indicate ST evaluation was provided to Patient 20. RSS 2 confirmed ST evaluation was not provided to Patient 20. RSS 2 stated, “The nurses do the bedside swallow (a quick assessment done by nurses to check if a patient has difficulty swallowing) but still needs follow up by ST.” Review of RP 64’s Face Sheet, dated 12/16/24, indicated RP 64 was admitted to the hospital on 12/6/24 and was discharged on 12/13/24. Review of RP 64’s H&P, dated 12/6/24, indicated RP 64 presented with a chief complaint of shortness of breath. During a concurrent interview and review of RP 64’s EHR on 12/16/24 at 1:26 PM, RSS 2 reviewed RP 64’s PO for ST evaluation, dated 12/10/24 at 12:43 PM. The PO indicated “Dysphagia Eval & TX Order ... Reason for Swallow (a test for difficulty swallowing): Suspected dysphagia.” There was no documentation to indicate ST evaluation was provided to RP 64. RSS 2 confirmed ST evaluation was not provided to RP 64. During an interview on 12/16/24 at 1:31 PM, RSS 2 stated RSD staff receive the PO via computer print outs right after the order was entered in the patient’s electronic health record (EHR) and noted by the nurse. RSS 2 stated the RSD’s policy is to carry out the PO within 24 to 48 hours upon receipt of the order. RSS 2 stated, “In this case, those (patients) who were discharged before the 14th (12/14/24), none of them were seen (by the OT and SLP) because there was no staff (to conduct the evaluation). Since they last worked, both of them (OT and SLP) did not come until the 14th (12/14/24).” During an interview on 12/17/24 at 10:03 AM, the Chief Nursing Officer (CNO) stated, “There’s no director (for the RSD) at this moment.” The CNO stated she assists the RSD with clinical and staffing issues. The CNO stated she was not aware the OT and ST orders were not being carried out, and added, “It’s imperative that they would be carried out.” The CNO stated, “It could affect the airway, the eating ability of the patient if ST (evaluation) was not done.” The CNO also stated, “It could affect patients’ ability to perform ADLs and could be a barrier to discharge,” if OT evaluation was not provided to the patients in a timely manner. Review of the hospital’s policy and procedure (P&P), titled “Staffing Patterns and Productivity Standards - Physical Therapy; Occupational Therapy; Speech Language Pathology (SPPS),” last revised on 4/2017 and approved on 7/14/17, indicated, “Policy: It shall be the purpose of this service to provide an adequate number of therapists to meet the daily patient care requirements, including holidays.” The SPPS also indicated, “The manager shall periodically evaluate and justify staffing patterns to meet Service Goals and Needs.” Review of the hospital’s P&P, titled “Orders: Physician Orders for Therapy Services,” last revised on 4/2017 and approved on 7/14/17, indicated “Policy: The Rehabilitation Services Department shall follow written procedures for the standard administrative procedures to increase efficiency in processing patient orders for Rehabilitation Services...Procedure: 1. Treatment is by prescription. The physician shall order Physical Therapy, Occupational Therapy, or Speech Language Pathology Evaluation and Treatment. These orders should be entered into the Electronic Health Record (EHR)...6. Orders shall be completed within 24-48 hours of receipt from the nursing units via computer. As staffing scheduling allow, attempts shall be made to see patients on the same day...””

“DIRECTOR OF REHABILITATION SERVICES CFR(s): 482.56(a)(1) The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services. This Standard is not met as evidenced by: 38612 Based on interview and record review, the facility failed to have a qualified director for the Rehabilitation Services Department (RSD, a specialized unit that helps patients recover physical function, daily living skills, and communication abilities after injury, illness, or surgery). This failure led to insufficient oversight of the understaffed RSD, which was unable to provide physician-ordered rehabilitation services to 11 of 15 sampled patients. (Refer to A-1124) Findings: During a joint interview on 12/12/24 at 2:38 PM with Rehabilitation Services Staff (RSS) 2 and RSS 3, when asked to interview the director of the RSD, RSS 2 stated the RSD currently does not have a director and the Chief Nursing Officer (CNO) is covering the department. RSS 3 stated, “The last director left in February (2024). Have not had one since.” RSS 2 stated, “I go to (name of CNO) if we have concerns but there is no one overseeing the day-to-day operations (of the RSD).” RSS 2 expressed concerns about physician-ordered evaluation orders not being carried out timely because of understaffing of Occupational Therapist (OT- a licensed health care professional who help people find ways to do activities of daily living [ADLs] such as eating, bathing, etcetera) and Speech Language Pathologist (SLP, also known as speech therapist [ST] - a health care professional who diagnoses and treats speech, language, and swallowing disorders). During an interview on 12/17/24 at 10:03 AM, the CNO stated, “There is no director (for the RSD) at this moment.” She stated she assists the RSD with clinical and staffing issues and confirmed the RSD is understaffed with OT and SLP. When asked about the occupational therapy (rehabilitation therapy that helps people recovering from physical or mental illness by engaging in daily activities) and speech therapy (rehabilitation therapy that focuses on helping people with speech, language, communication, and swallowing disorders) orders not being completed, the CNO replied, “I was not aware the orders were not being carried out.” During a concurrent interview and record review on 12/17/24 at 2:26 PM with the Hospital Administrator (HA), the hospital’s organizational chart (OC), dated 11/1/24, was reviewed. The Director of Laboratory Services (DLS) is also listed as the department head for the RSD in the OC. The HA stated, “The last Rehab Director left sometime in January or February this year. We hired (name redacted) as Lab (laboratory) and Rehab (Rehabilitation) Director. Her focus is on lab right now.” During an interview on 12/19/24 at 8:50 AM, the DLS confirmed she is also the RSD director. She stated she is a Clinical Laboratory Scientist and had no educational background or experience in rehabilitation services. The DLS stated she does not oversee the daily operations or staffing of the RSD, adding, “my focus is on the lab.” Review of the hospital’s undated document, titled “Job Description (JD),” indicated “Job Title: Director, Rehabilitation...Job Summary: The Director - Rehabilitation is responsible for the operation of each area of responsibility. This includes financial, human resources, quality, regulatory compliance, and leadership of each department.” Further review of the JD indicated, “Performance Responsibilities: Principal Accountabilities - Oversees... Physical (rehabilitation therapy that helps people regain movement and function after an injury or illness), Occupational Therapy, and Speech Language Pathology... Demonstrates competency as a clinical manager by planning, organizing and managing the personnel and resources in order to provide the highest quality of care with trained, professional and competent staff in the most cost-effective and productive manner... Responsible for management and development of clinical staff, functions, activities and case management development and implementation for all patients, ensuring comprehensive care with appropriate staffing levels.” Further review of the JD indicated “Qualifications/Job Requirements: Certifications/Licensure: CA (California) PT (Physical Therapy), OT or Speech Pathologist license.””

“Social Service Records CFR(s): The social service records, including reports of interviews with patients, family members, and others, must provide an assessment of home plans and family attitudes, and community resource contacts as well as a social history. This Standard is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure that social service records included a social work assessment for all patients. This failure had the potential to compromise the determination of current social functioning needed for the multidisciplinary care team to formulate adequate discharge planning and anticipate social work’s role in that process. Findings: Three of 19 patients (Patients 66, 71, 76) lacked a Geriatric Behavioral Health Unit Social Work Treatment Plan. During review of medical records requested 12/19/24, it was found that one discharged patient (Patient 66) was hospitalized nine days with a Social History documented on admission by the psychiatrist (MD 2/Provider 7) as “currently homeless, single, very limited resource. Receives SSDI.” A second inhouse patient (Patient 71) had been hospitalized twelve days, had a Social History documented on admission by the psychiatrist (MD 2/Provider 7) as “currently living with his wife and son-in-law ...currently not working. Reports that he is receiving SSDI.” A third inhouse patient (Patient 76) had been hospitalized 22 days, had a Social History documented on admission by the psychiatrist (MD 2/Provider 7) as “The patient did not provide.” During concurrent interview and record review with the DHIM (Director of Health Information Management) on 12/13/24 at 10:48 a.m. of the medical record deficiency reporting, it was identified that documentation for a Geriatric Behavioral Health Unit Social Work Treatment Plan is not audited either concurrently or at discharge.”

“Neurological Examination CFR(s): When indicated, a complete neurological examination must be recorded at the time of the admission physical examination. This Standard is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure that, as part of the GeroPsych Unit patient’s physical examination, an adequate “screening” neurological examination was conducted by the medical physician. This failure had the potential to miss positive neurological symptoms indicative of the need for a complete neurological exam. Findings: During review of medical records requested 12/19/24, three patients (Patients 86, 88, 90) out of nineteen patients had neurologic examinations by the medical physician which had no documentation indicating assessment of gross function of Cranial Nerves II through XII. The neurologic examination for one patient (Patient 86) consisted of “Alert, following commands.” The neurologic examinations for two patients (Patient 88, 90) consisted of “AAO X3 (awake, alert, oriented to person, place and time), talking and answering questions.” During concurrent interview and record review with the DHIM (Director of Health Information Management) on 12/13/24 at 10:48 a.m. of the record deficiency reporting it was identified that missing documentation for the neurological examination is not audited either concurrently or at discharge.”

“Psych Eval - Medical History CFR(s): [Each patient must receive a psychiatric evaluation that must--] Include a medical history; This Standard is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure that each Geropsych Unit patient’s Psychiatric Evaluation included a non-psychiatric medical history. This systemic failure had the potential to compromise determination of whether past medical conditions, surgeries and disabilities contributed to the patient’s psychiatric condition and how likely they will impact the patient’s recovery/remission. Findings: During review of medical records requested 12/19/24, twelve of nineteen patients (Patients 14, 15, 16, 17, 55, 73, 75, 76, 86, 88, 89, 90) had Medical History on the Psychiatric Evaluation recorded by the psychiatrist (MD 2/Provider 7) as “per internist.” Five of nineteen patients (Patients 66, 72, 77, 85, 87) had Medical History on the Psychiatric Evaluation recorded by the psychiatrist (MD 2/Provider 7) as “denies,” with reliance on the patient as medical historian and no evidence of validation against the medical history and physical examination. One of nineteen patients (Patient 67) had no mention of Medical History on the Psychiatric Evaluation whatsoever. Three of nineteen patients (Patients 66, 76, 77) had incomplete or discrepant documentation of Allergies in the Medical History on the Psychiatric Evaluation. One patient (Patient 76) had a list of allergies recorded, including an allergy left blank in the dictated report. Two patient had allergies recorded as “None” when one patient (Patient 66) had an allergy to an antibiotic noted in the medical history and physical exam, and one patient (Patient 77) had multiple allergies listed in the medical history and physical exam. During concurrent interview and record review with the DHIM (Director of Health Information Management) on 12/13/24 at 10:48 a.m. she acknowledged that a requestor receiving the Psychiatric Evaluation report would not have access to the non-psychiatric medical history information referenced by the psychiatrist (MD 2/Provider 7) as “per internist.” The cumulative effect of these documentation failures is that the Psychiatric Evaluation does not stand on its own as a complete assessment of the patient’s illness to justify the diagnoses and treatment. Failure to acknowledge and document a complete and accurate accounting of patient’s known allergies risks prescribing contraindicated medication.”

“Discharge Summary - Patient Condition CFR(s): [The record of each patient who has been discharged must have] a brief summary of the patient’s condition on discharge. This Standard is not met as evidenced by: 39051 Based on interview and record review, the hospital failed to ensure the record of each patient who has been discharged has a discharge summary that includes status of the patient on the day of discharge, including physical and functional condition. This failure had the potential for compromising the patient’s continuity of care and the ability to adequately cover the patient’s post discharge needs. Findings: Record review of three discharged patients from the GeroPsych Unit (Patients 55, 66, 73) found incomplete or missing documentation of the patient’s physical and functional condition. The discharge summary for one patient (Patient 55) with multiple serious intercurrent medical diagnoses requiring medical intervention had no documentation of the patient’s physical and functional condition and plan for aftercare. The discharge summary for another patient (Patient 66) with multiple serious intercurrent medical diagnoses requiring medical intervention indicated the patient would be on unspecified “medications” and that the patient “appears to be stable.” The discharge summary for a third patient (Patient 73) with multiple serious intercurrent medical diagnoses requiring medical intervention indicated the patient had “signs of active bleeding” requiring discharge to the Emergency Department for further workup and diagnosis. There was no description of what events led up to the bleeding concern, or whether internal or external bleeding was involved. The patient’s condition “in terms of his thought process” upon discharge was described as “guarded” with no plan mentioned as to how the patient’s psychiatric needs would be managed once in Emergency. During concurrent interview and record review with the DHIM (Director of Health Information Management) on 12/13/24 at 10:48 a.m. of the record deficiency reporting run 12/13/24 it was identified that deficiency analysis for discharge summaries consists of assessment of presence or absence of a discharge summary.”

“Personnel - Evaluate Patients CFR(s): Standard: Personnel The hospital must employ or undertake to provide adequate numbers of qualified professional, technical, and consultative personnel to: Evaluate Patients This Standard is not met as evidenced by: 28225 Based on observation, interview, and record review the facility failed to ensure Psychiatrist (MD 2) conducted a comprehensive admission assessment for one (Patient 15) of 18 sampled patients when a 11/23/24 transfer psychotropic (drugs that affect the brain and nervous system to treat mental illnesses) medication was not ordered. The deficient practice resulted in non-directable aggressive behavior, scratch marks on (Patient 15) left side of his back, wound noted on (Patient 15) right hand, a fall; and injury to a nurse. Findings: During an interview on 12/9/24 at 11:00 a.m., with Registered Nurse (RN) 5, RN 5 stated, Patients admitted to the unit mainly had psychiatric (psychiatry, a branch of medicine focused on the diagnosis, treatment, and prevention of mental, emotional, and behavioral disorders) diagnoses that included Schizophrenia (a serious mental health condition that affects how people think, feel and behave) Bipolar (bipolar disorder, formerly called manic depression, is a mental health condition that causes extreme mood swings) and Major Depressive Disorders (MDD - mood disorder that causes a persistent feeling of sadness and loss of interest). During a concurrent observation and interview on 12/9/24 at 11:24 a.m., with RN 5, in Patient 15’s room, Patient 15 was in bed, awake, a walker was by his bedside. RN 5 stated Patient 15 was transferred to (Hospital A)’s Acute Psychiatric Unit from a General Acute Care Hospital in another County. RN 5 stated Patient 15 was on fall risk precautions because he had a fall since he was admitted to the unit. During a concurrent record review on 12/9/24 at 11:24 a.m., facility document that listed Patient Room(s), Bed(s), and Patient(s) List (Unit Census), dated and received on 12/9/24 at 11 AM, for Patient 15 Indicated, “Admit: 11/23/2024. DX: MDD (Major Depressive Disorder) Referral Presentation: SI (self-injury), agitated and hitting self, refusing to eat and drink, auditory (hearing) hallucinations (false perceptions, where you sense an object, person, or event even though it is not really there or didn’t happen , poor sleep, history of catatonia (a state where someone appears awake but unresponsive to their surroundings) recent hospital admit for similar presentation, mild cog(nitive) disorder, decomp(ensated) after med(ication) change ...” RN 5 stated, Patient 15 understood and could say a few words in English, but Patient 15’s primary language was another language. Staff used an interpreter to communicate with Patient 15. Also, staff communicated with Patient 15’s Patient Representative who advocated for Patient 15’s needs. During interviews on 12/13/24 at 2:07 p.m., SW 1, RN 14, and Staff 1 all stated, Provider (MD 2) was the only psychiatrist for all patients admitted to the unit. MD 2 had no in person encounter with any of the patients admitted to the unit and/or any of the staff in the unit. During interviews on 12/13/24 at 2:07 PM, SW 1 stated, if MD 2 was not available, MD 2 designated Nurse Practitioner 1 (NP an advanced practice registered nurse (APRN) with advanced clinical training who provides direct patient care) as alternate Psychiatric Provider. However, SW 1 stated, NP 1 could only be called if instructed by MD 2. During interviews on 12/13/24 at 2:07 p.m., with RN 14 stated, a negative outcome with regard to MD 2 not responding to staff calls in a timely manner occurred on 11/27/24, wherein (Patient 15’s) primary care nurse was injured. During interviews on 12/13/24 at 2:07 p.m., with RN 14, RN 14 stated, Staff initially called MD 2 on 11/27/27 at 4:15 a.m. regarding Patient 15 was not redirectable and aggressive. MD 2 was called numerous times but did not respond. NP 1 was also called and also did not respond. At 4:47 a.m., ER (emergency room) doctor was called, medications were ordered. Thereafter, medications were administered as ordered by MD3. MD 2 responded on 11/27/24 at 5:30 a.m. Nurse informed MD 2, Patient 15 had no psychotropic medications ordered since admission (11/23/24). In addition, on 11/27/24 (later that morning) Patient 15 fell. During an interview and on 12/16/24 at 10:04 a.m., with RN 5, RN 5 stated, Patient 15 did not get psych(otropic) med(ication)s that was prescribed on 11/23/24 transfer to the unit. As a result, on 11/27/24, Patient 15 was not directable and was aggressive; his nurse was hurt during the incident, and Patient 15 had a fall later in the day. During a record review of TRANSFER REPORT, dated 11/23/2024 3:09 PM, for Patient 15, the TRANSFER REPORT, indicated, “Admission Info(rmation ) Inpatient (Adm(it) 11/21/24 Medication list, Start taking these medications, OLANZapine(a medication to treat severe mood disorder), ... Hospital Problem List. MDD (major depressive disorder), recurrent, severe, with psychosis (HCC), Severe episode of recurrent major depressive disorder, without psychotic features. During a review of facility document, Nursing Narratives, dated 11/27/24, indicated, “SHIFT ASSESSMENT Narrative: Around 0415, (Patient 15) was non-redirectable? (sic) aggressive, posturing at staff. refusing to go back to his room, banging his arms on the walls and elevator doors, going into another patient? (sic)S room, spitting at staff, and attempting to grab RN?(typo)s WOW (computer on wheels).”Further review of Nursing Narrative indicates staff attempted to call MD 2 two times at 4:19 a.m., and 4:25 a.m., with no response. Charge RN followed up with phone calls at 4:43 a.m., 4:45 a.m., and 4:46 a.m., also with no response. Charge RN then attempted to call NP1 with no response and again, attempted to reach MD 2 at 4:47 a.m., with no response. During a review of facility document, Nursing Narratives, dated 11/27/24, indicated, “0511 (AM)- The patient was physically aggressive, agitated and an order of Olanzapine 10mg x 1 STAT was obtained from (MD 4). (MD 4) stated, “continue calling (MD 2) and tell him to follow up with his patients.” The Nursing Narrative also indicated, “At 0522 (AM), Olanzapine 10mg IM was administered with no effect. (Patient 15) continued to be physically aggressive? spitting at staff. attempting to hit and kick staff. In addition, the patient was pulling on his pubic hair, putting it in his mouth, and spitting the pubic hair towards the staff ...”. Then, “At around 0540 (AM), Patient 15 was observed resting on his bed, calm, eyes closed, chest rising even and unlabored ...” During a review of facility document, Nursing Narratives, dated 11/27/24, indicated, “: At 0541 (AM), (Patient 15’s primary care nurse) yelled for help and the charge RN found him (primary care nurse) leaning on the wall in severe distress. He (primary care nurse) came from the break room and complained of severe left rib/flank pain and difficulty breathing. He verbalized that he was in? (sic) excruciating pain? (sic) and slowly slid himself down to the floor repeatedly stating? (sic) l? (sic)m in so much pain. Bring me to the emergency room.? (sic) Staff brought a wheelchair, but (primary care nurse) was in tears and was unable to stand and transfer due to excruciating pain. Security was called to assist with transfer to wheelchair and transport to ED. During a review of facility document, Nursing Narratives, dated 11/27/24, for Patient 15 indicated, indicated, “Around l050 a.m., when asked patient if he remember what happened last night he verbalized “I was running from a tsunami, I need to go back there near the ocean.” Noted scratch marks on his left side of his back and wound noted on his right hand, patient agreed to take picture, notified (MD 3) ...” Nursing Narrative goes on further to indicate Patient 15 had a fall around 11:23 a.m.”

“Personnel - Discharge Planning CFR(s): [The hospital must employ or undertake to provide adequate numbers of qualified professional, technical, and consultative personnel to:] Engage in discharge planning; This Standard is not met as evidenced by: 28225 Based on observation, interview, and record review the facility failed to ensure Psychiatrist (MD 2) maintained coordination and communication with discharge planning when: 1. MD 2 did not have any in person encounters with patients, and/or staff; had limited or no communications with patients, staff, conservators (a court-appointed guardian to make decisions for someone who needs help) or patient representative(s). 2. For Patient 50, Abilify ( a medication used to treat certain mental/mood disorders) was ordered instead of Zyprexa (a different medication used treat mental/mood disorders) on discharge). The deficient practice resulted in 2 missed doses after discharge. 3. For Patient 51, Lorazepam (a medication to treat anxiety ) was not included on discharge. The deficient practice resulted in manifestation of self-injurious behaviors. Findings: 1.During a concurrent observation and interview on 12/9/24 at 10:58 a.m., escorted by Social Worker 1 (SW, assesses social and financial/economic needs of patient(s) and assists patient(s) responsible party conservator (a person appointed by the judge to make decisions and act on behalf of the person, and/or the patient(s) representative, (designated family member or friend), with development and use of skills and resources needed to resolve social and economic issues or concerns), SW 1 stated (Hospital A) services included a Distinct Part (D/P, a unique unit or level of care at a hospital requiring the issuance of a separate claim to a payer) Acute (symptoms or signs that begin and worsen quickly) Psychiatric (Psychiatry, a branch of medicine focused on the diagnosis, treatment, and prevention of mental, emotional, and behavioral disorders) Unit. During a record review on 12/9/24 at 11:00 a.m., facility document that listed Patient Room(s), Bed(s), and Patient(s) List (Unit Census), dated and received on 12/9/24 at 11:00 a.m., indicated the total patient census was 18. During an interview on 12/9/24 at 11:00 a.m., with Registered Nurse (RN 5), RN 5 stated, Patients admitted to the unit mainly had) diagnoses that included Schizophrenia (a serious mental health condition that affects how people think, feel and behave), Bipolar (a mental health condition that causes extreme mood swings) and Major Depressive Disorders (MDD - a mental health condition characterized by low mood). RN 5 stated, no patients were currently on restraints or seclusion. During an interview and record review on 12/9/24 at 11:24 a.m., with RN 5, RN 5 stated, Patient 15 lived with his family prior to being hospitalized. Patient 15 had a history of depression. He was hospitalized) for refusing to eat and drink, and poor sleep. Patient 15 decompensated (condition worsened) after his psychotropic medication was changed. RN 5 stated Patient 15 understood and could say a few words in English, but Patient 15’s primary language was another language. Staff communicate with Patient 15’s patient representative, who advocates for the patient’s needs. During an interview on 12/9/24 at 2:35 p.m., SW 1 stated, only one psychiatrist (a medical doctor who specializes in mental health, including substance use disorders) provided psychiatric services to the psychiatric unit. MD 2 was the only psychiatrist for all patients admitted until discharged. SW 1 stated the unit did not have an on-ground psychologist to assist patient(s) and staff with psychiatric service’s needs. During a concurrent observation and interview on 12/10/24 at 10:53 a.m., in Patient 15’s room, with RN 5 Patient 15, in bed and awake. When asked for an interview, Patient 15 nodded. However, when asked how he was doing, Patient 15 just stared and did not respond. During an interview on 12/10/24 at 11:11 a.m., with RN5, RN 5 stated, the IDT (interdisciplinary team - a group of people with different areas of expertise who work together to achieve a common goal) meetings were conducted on Zoom (video conferencing) calls only. No patients, conservators, patient representatives attended the IDT meetings. The IDT meetings were usually conducted each day either at 11:30 AM or 1:30 PM, depending on MD 2’s schedule or availability. After the IDT meetings were completed, patient rounds were often conducted, by MD 2 and each patient’s primary care nurse by phone. RN 5 further stated, during patient rounds, if a family member was visiting with the patient, MD 2 would not conduct the patient rounds for that patient. MD 2 would skip talking to the patient. MD 2 avoided talking with patient’s family (patient representative(s). RN 5 also stated, patient round calls for each patient lasts an average of 1 minute or less. If a patient had concerns/issues he or she wanted to talk to MD 2 about that would take time, MD 2 would cut the patient off from talking. RN 5 stated, “(MD 2) would tell the patient, talk to the nurse or SW about it”. During an interview on 12/10/24 at 12:12 p.m., with Registered Nurse (RN) 13, RN 13 stated, MD 2 did not want staff to discuss with MD 2 any medical issues/problems patients’ had. MD 2 instructed staff to call the internist or hospitalists on call for all patients in the unit with medical health issues.MD 2 only wanted to focus on the patients’ psychiatric problems. RN 13 stated, since her employment MD 2 had not been onsite to conduct in person assessments of patients admitted to the unit or with any of the staff in the unit. All of the patients’ psychiatric service’s needs, treatments, and medications were provided and ordered by MD by telephone (verbal) calls only. During an interview on 12/10/24 at 2:45 p.m., SW 1 stated, staff on the unit were very concerned, MD2 did not have any in person encounters with any of the patients admitted to the unit or with any of the staff in the unit. All communications with MD 2 with patients, patient’s family, patient representative(s) or conservators, and staff were conducted by cellular phone calls only. Additionally, SW 1 stated, patient(s) family complained about patient(s) psychiatric services provided by MD 2 were by video calls only. During interviews on 12/13/24 at 2:07 p.m., SW 1 and RN 14 both stated, staff complained regarding difficulty with getting “Certification (permission)” (for 5250 hold; 5250 - a involuntary 14-hold in a mental health facility because one is a danger to themselves or others) documentation from MD2 after 72 hours. SW 1 stated, if MD 2 was not available, MD 2 designated Nurse Practitioner 1 (NP an advanced practice registered nurse (APRN) with advanced clinical training who provides direct patient care. SW 1 stated, NP 1 could only be called if instructed by MD 2. RN 14 stated, a negative outcome regarding MD 2 not responding to staff calls in a timely manner occurred on 11/27/24, where (Patient 15’s) primary care nurse was injured. RN 14 stated, Staff initially called MD 2 on 11/27/27 at 4:15 AM regarding Patient 15 was not redirectable and aggressive. MD 2 was called numerous times but did not respond. NP 1 was also called and also did not respond. During an interview on 12/16/24 at 10:38 a.m., RN 5 stated, IDT meetings were conducted on video calls. The nurse connected video calls to MD 2 on computer tablet. Initial psychiatric evaluation were done during patient rounds (video calls) on cellular phone. During a telephone interview on 12/16/24 at 10:40 a.m., Patient 14 Conservator 1 (C1) stated, “I have some contact with the treatment team (psychiatric staff). I haven’t heard from the psychiatrist.” During an interview on 12/16/24 at 10:45 a.m., SW 1 stated Patient 17 conservator complaint regarding MD 2’s refusal to complete Affidavit B (a form which gives a conservator the right to require the conservatee to receive treatment). Numerous communications were sent to MD 2, but MD 2 would not respond. During a video call interview on 12/16/24 at 12:10 p.m., MD 2 stated, Psychiatric Evaluations were conducted through telemedicine (video calls). During a telephone interview on 12/16/24 at 2:41 p.m., Patient Representative (PR 1) stated, Patient 15 spoke another language. The psychiatrist only called me once, after my (Patient 15) was admitted. “Our talk (with MD 2) was brief. I did not feel I was interviewed thoroughly by him (MD2) to know what I felt (Patient 15) needed help with”. When surveyor asked, if PR 1 had communicated with MD 2 after Patient 15 fell, PR 1 said, “No.” PR 1 said he was not informed psychiatrist provided telehealth visits only before Patient 15 was admitted in to the unit. During a concurrent observation and concurrent interview on 12/16/24 at 2:50 p.m., Patient Rounds with MD 2 was not conducted after the 11:30 AM IDT meeting. SW 1 concurred patient rounds had not yet been done for the today. During an interview on 12/17/24 at 10:30 a.m., with RN 3, RN 3 stated, he assisted with (patient) placement, updated treatment plans and discharge planning, communicated with patient, patient representatives, outside resources. Also, RN 3 stated, “We’ve had difficulty getting (MD 2) to reach out to the family and conservators. Mainly, the (psychiatric) staff and social workers are the ones that communicate with the patient, family and conservators.” During an interview on 12/17/24 at 11: 03 a.m., with RN 3 and SW 2, RN 3 stated, “I’ve not seen the psychiatrist come to the unit since I started working here.” RN 3 stated, all patient and staff communications with MD 2 are by phone or video phone calls. MD 2 had no specific schedule for patient rounds. His interviews with the patients are brief, “sometimes, less than a minute,” RN 3 further stated, during MD 2 calls with patients, staff are present because staff needed to hold the phone or iPad so MD 2 could communicate with the patient. SW 2 stated, “It would be more beneficial if either the NP 1 or psychiatrist were available on site.” During an interview on 12/17/24 at 11:53 a.m., with Patient 66, Patient 66 stated, “He talked so fast. We talked about my medication, but not very thorough. It seems like he was rushing to get off the phone. He should be here in person, instead of talking to me on the phone. “ During an interview on 12/17/24 at 12:02 p.m., in Patient 17’s room, Patient 17, Patient 17 stated, Patient 17 stated he talked to MD 2 on the phone and has not seen MD 2 on the unit. During an interview on 12/17/24 at 12:10 p.m., with Patient 16, Patient 16 stated “His interactions are short, and he’s not been here”, when asked about care provided by MD 2. During an interview on 12/17/24 at 12:31 p.m., RN 15 stated, “I’ve worked her eight (8) years. I’ve only heard of (NP 1’s) name. I’m not familiar with (NP1), I don’t have a number to call NP 1.” RN 15 stated, “I call the nurse supervisor if the psychiatrist cannot be reached. “ During an interview on 12/17/24 at 12:55 p.m., RN 15 further stated, “There had been times, when staff were on a call with MD 2 regarding patients on the unit, MD 2 put the staff on hold so he could take calls not pertaining to patients admitted in our unit. During an interview on 12/17/24 at 1:25 p.m., RN 3 stated, “IDT meetings were conducted every day, unless MD2 cancels or is a no show. IDT video meetings included SW, nurses, recreational therapist, (group) activities coordinator, psychiatrist (MD2), and the unit manager (if available). Family or patients are not included in the IDT meeting.” During a telephone interview on 12/19/24 at 10:41 a.m., Psychiatrist (MD 2) stated he was the Clinical Director for (Hospital A’s D/P) Psychiatric Unit. He was not board certified. MD2 stated, (currently) he only provided psychiatric services to patients that were hospitalized to the psychiatric units. MD2 stated, he lived (a few hundreds of miles away from (Hospital A’s D/P Psychiatric Unit). MD 2 stated, he was contracted to provide psychiatric services via telemedicine (video call) visits. MD 2 stated, patients, and patient representatives (conservator and family) were informed prior to admission to (Hospital A’s D/P) Psychiatric Unit that psychiatric services provided by MD 2 were video call visits only. MD 2 stated this information was indicated on the patient referral intake forms. During an interview on 12/19/24 at 12:30 p.m., SW 1 and RN 5 stated, prior to patients’ admission to the unit, the patients and family were not aware MD 2 only provided psychiatric services by video call visits only. SW 1 stated, patients and patients’ family complained about psychiatrist not having any in person encounters with patients. Also, SW 1 and RN 5 both stated, information about telehealth (video call) visits by psychiatrist were not indicated on the patient’s referral intake forms. 2. During an interview on 12/16/24 at 10:06 a.m., with RN 5, RN 5 stated MD 2 ordered the wrong discharge medication for Patient 50. Patient 50 was supposed to be on Zyprexa, but Abilify was ordered instead. MD2 was called throughout the day but did he did not respond. Patient 50 did not get Zyprexa dose(s) of medication because the pharmacy was closed by the time MD2 responded. During an interview on 12/16/24 at 10:20 a.m., with RN 5, RN 5 stated, discharge medications (MD 2) calls or electronically sends it to the pharmacy. We give discharge instructions to patients or responsible party including discharge medications instructions that are on discharge medication list. During an interview on 12/18/24 at 2:19 p.m., with RN 4, RN 4 she stated she was the nurse who called Abilify to pharmacy. During a record review of, NURSING DISCHARGE SUMMARY for Patient 50, dated 7/27/24 Discharge Summary, indicated attempts at 10:59 a.m., and 2:50 p.m., staff “notified MD via text message to remind him to do the Med Recon(ciliation) ... no response.” At 2:27 pm., staff notified MD 2 that patient was taking Zyprexa but a prescription for Abilify had been sent to the patient’s pharmacy. At 4:24 p.m., staff spoke to pharmacy staff and pharmacy staff confirmed there was no e-prescription for Zyprexa. The pharmacy received the e-prescription for Abilify and the family member had already picked up the medications. A new prescription was sent, however medication would not be available until the next business day (2 days). 3. During an interview on 12/16/24 at 10:20 a.m., with SW 1 and RN 5, SW 1 stated, she received a call from Patient 51’s POA (Power of Attorney, a legal document that allows someone to act on behalf of another person) and POA reported patient wanted to self-harm. The patient was on Lorazepam (a medication to treat anxiety) but was not included on discharge list. POA left a message to (MD 2) but she did not receive a call back from (MD 2). RN 5 stated, (MD 2) calls or electronically sends discharge medications to the pharmacy. RN 5 further stated “We give discharge instructions to patients or responsible party including discharge medications instructions that are on discharge medication list.” During a record review of Social Worker Progress Note, dated 10/07/2024, for Patient 51, the Social Worker Progress Note, indicated, “SW received a call from patient’s POA [who] reported that last night she saw patient holding a knife wanting to stab herself to death and to jump off the house to kill herself. POA reviewed patient’s medications while at (Hospital A’s D/P Acute Psychiatric Unit) and the discharge medication list. POA noted that patient was on Lorazepam but this medication was not included in the discharge medication list. POA stated that there was no discussion with (MD 2) that this medication will be discontinued ... POA left a message to (MD 2) to discuss this matter, but she did not receive a call back from (MD 2). During a record review of Patient 51’s Medication Record, dated 10/06/24, the Medication Record, indicated,” Lorazepam 0.5 mg (milligrams), Tablet, 0.5 MG, BID (two times a day), (route)ORAL ...” During a record review of Patient 51’s Discharge Medication List, dated 10/7/2024, Discharge Medication List indicated Lorazepam was not included in the discharge medication list.”

“K3 BUILDING: 01 - AHMC Seton Medical Center (1900 Sullivan Avenue, Daly City, CA 94015) K6 PLAN APPROVAL: 6/18/1986 K7 SURVEY UNDER: 2012 EXISTING K12 TYPE OF STRUCTURE: TWELVE STORY BUILDING WITH BASEMENT, CONSTRUCTION TYPE II (III), FULLY SPRINKLERED. Cenus- 62 K3 BUILDING: 02 - AHMC Seton Medical Center, Ambulatory Surgury Center (4th floor) (1850 Sullivan Avenue, Daly City, CA 94015) K6 PLAN APPROVAL: 1989 K7 SURVEY UNDER: 2012 EXISTING K12 TYPE OF STRUCTURE: FIVE STORY BUILDING, TYPE I (332), FULLY SPRINKLERED. Census- 8 The following reflects the findings of the California Department of Public Health, during a Full Medicare Validation Life Safety Code Survey. The findings are in accordance with 42 Code of Federal Regulations (CFR) §482.41(b)(c)(e), National Fire Protection Association (NFPA) 101 - Life Safety Code, 2012 Edition, and NFPA 99 - Health Care Facilities Code, 2012 Edition.”

“Building Construction Type and Height CFR(s): NFPA 101 Building Construction Type and Height 2012 EXISTING Building construction type and stories meets Table 19.1.6.1, unless otherwise permitted by 19.1.6.2 through 19.1.6.7 19.1.6.4, 19.1.6.5 Construction Type 1 I (442), I (332), II (222) Any number of stories non-sprinklered and sprinklered 2 II (111) One story non-sprinklered Maximum 3 stories sprinklered 3 II (000) Not allowed non-sprinklered 4 III (211) Maximum 2 stories sprinklered 5 IV (2HH) 6 V (111) 7 III (200) Not allowed non-sprinklered 8 V (000) Maximum 1 story sprinklered Sprinklered stories must be sprinklered throughout by an approved, supervised automatic system in accordance with section 9.7. (See 19.3.5) Give a brief description, in REMARKS, of the construction, the number of stories, including basements, floors on which patients are located, location of smoke or fire barriers and dates of approval. Complete sketch or attach small floor plan of the building as appropriate. This Standard is not met as evidenced by: 46858 Based on observation and interview, the facility failed to maintain the integrity of the building construction. This was evidenced by penetrations in the ceiling. This could increase smoke spread in the event of a fire. This affected the tenth floor of the Hospital and the offsite fourth-floor Surgery Center. Findings: During a tour of the facility, and interview with staff, the building construction was observed. 1. On 12/9/24 at 11:12 a.m., a penetration in the ceiling of the tenth floor of the Hospital was observed. A ceiling tile in the corridor outside of Room 1028 was observed with a penetration measuring approximately 14 inches by 18 inches. During a concurrent interview, Staff 7 stated that a portion of the ceiling tile had been removed due to water damage which resulted of a leak in the roof. Staff 7 stated that the leak in the roof was first noticed after a storm had occurred approximately a month. Staff 7 stated that he was unsure if the leak had been repaired since it was first noticed. (refer to complaint intake CA933012) 2. On 12/10/24 at 11:05 a.m., two ceiling penetrations were observed in the ceiling of the Sterilization Room of the offsite fourth-floor Surgery Center. The ceiling penetrations were a result of the ceiling tiles being removed. One ceiling penetration measured approximately 22 inches by 44 inches. The other penetration measured approximately 15 inches by 22 inches. During a concurrent interview, Staff 6 confirmed the finding and stated that the ceiling tiles were removed by a vendor during a recent service to the facility’s smoke damper system.”

“Means of Egress - General CFR(s): NFPA 101 Means of Egress - General Aisles, passageways, corridors, exit discharges, exit locations, and accesses are in accordance with Chapter 7, and the means of egress is continuously maintained free of all obstructions to full use in case of emergency, unless modified by 18/19.2.2 through 18/19.2.11. 18.2.1, 19.2.1, 7.1.10.1 This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the means of egress from impediments to full instant use. This was evidenced by an egress door that failed to open. This affected the ground floor of the Hospital and could result in delayed evacuation in the event of an emergency. NFPA 101, Life Safety Code, 2012 Edition 19.2 Means of Egress Requirements. 19.2.1 General. Every aisle, passageway, corridor, exit discharge, exit location, and access shall be in accordance with Chapter 7, unless otherwise modified by 19.2.2 through 19.2.11. Chapter 7 Means of Egress 7.1.10 Means of Egress Reliability. 7.1.10.1 General. Means of egress shall be continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency. Findings: During a tour of the facility and interview with staff, the egress doors were tested. On 12/10/24 at 10:08 a.m., the Hospital exterior egress exit double doors to the loading dock on the Ground level were tested. The doors were held open by magnetic hold open devices that were connected to the fire alarm system. The doors were closed, and the right-side door leaf failed to open when tested. Upon interview, Staff 4 acknowledged that the latching hardware was not working properly.”

“Horizontal Sliding Doors CFR(s): NFPA 101 Horizontal-Sliding Doors Horizontal-sliding doors permitted by 7.2.1.14 that are not automatic-closing are limited to a single leaf and shall have a latch or other mechanism to ensure the door will not rebound. Horizontal-sliding doors serving an occupant load fewer than 10 shall be permitted, providing all of the following criteria are met: o Area served by the door has no high hazard contents. o Door is operable from either side without special knowledge or effort. o Force required to operate the door in the direction of travel is less than or equal to 30 lbf to set the door in motion and less than or equal to 15 lbf to close or open to the required width. o Assembly is appropriately fire rated, and where rated, is self-closing or automatic-closing by smoke detection per 7.2.1.8, and installed per NFPA 80. o Where required to latch, the door has a latch or other mechanism to ensure the door will not rebound. 19.2.2.2.10 This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the sliding glass doors in the Intensive Care Unit (ICU). This was evidenced by a broken sliding door to an isolation room in the ICU. This affected the first floor of the hospital and could result in the increased risk of the door falling out of its track and hurting someone in the ICU. Findings: During a tour of the facility, and interview with staff, the ICU was observed. On 12/10/24, at 11:26 a.m., the Hospital ICU in Pod 2 on the first floor was observed. The left side glass sliding door to ICU room 7 was observed with caution tape across it and red tape on its right side and left side. Upon interview, Staff 9 stated that the door fell on a nurse approximately four years ago and has not been repaired.”

“Emergency Lighting CFR(s): NFPA 101 Emergency Lighting Emergency lighting of at least 1-1/2-hour duration is provided automatically in accordance with 7.9. 18.2.9.1, 19.2.9.1 This Standard is not met as evidenced by: 46858 Based on record review and interview, the facility failed to maintain the emergency backup lighting system. This was evidenced by the failure to conduct the required testing to the emergency battery-backup lighting system. This could result in delayed egress in the event of an evacuation. This affected the offsite fourth-floor Surgery Center. NFPA 101, Life Safety Code, 2012 Edition 21.2.9 Emergency Lighting and Essential Electrical Systems. 21.2.9.1 Emergency lighting shall be provided in accordance with Section 7.9. 7.9.3 Periodic Testing of Emergency Lighting Equipment. 7.9.3.1 Required emergency lighting systems shall be tested in accordance with one of the three options offered by 7.9.3.1.1, 7.9.3.1.2, or 7.9.3.1.3. 7.9.3.1.1 Testing of required emergency lighting systems shall be permitted to be conducted as follows: (1) Functional testing shall be conducted monthly, with a minimum of 3 weeks and a maximum of 5 weeks between tests, for not less than 30 seconds, except as otherwise permitted by 7.9.3.1.1(2). (2) *The test interval shall be permitted to be extended beyond 30 days with the approval of the authority having jurisdiction. (3) Functional testing shall be conducted annually for a minimum of 1 1/2 hours if the emergency lighting system is battery powered. (4) The emergency lighting equipment shall be fully operational for the duration of the tests required by 7.9.3.1.1(1) and (3). (5) Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction. Findings: During record review and interview with staff, the emergency lighting testing records were requested. 1. On 12/12/24 at 10:07 a.m., the facility failed to conduct 12 of 12 monthly 30-second tests to the emergency lighting system of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he was under the impression the engineering team of the Main Hospital building were in charge of maintaining the emergency lighting system. 2. On 12/12/24 at 10:08 a.m., the facility failed to conduct the annual 90-minute test to the emergency lighting system of the fourth-floor Surgery Center. The date of the last 90-minute test for the emergency lighting system was unknown. During a concurrent interview, Staff 6 confirmed the finding and stated that he was under the impression that the engineering team of the Main Hospital building were in charge of maintaining the emergency lighting system.”

“Exit Signage CFR(s): NFPA 101 Exit Signage 2012 EXISTING Exit and directional signs are displayed in accordance with 7.10 with continuous illumination also served by the emergency lighting system. 19.2.10.1 (Indicate N/A in one-story existing occupancies with less than 30 occupants where the line of exit travel is obvious.) This Standard is not met as evidenced by: 43380 Based on observation, record review and interview, the facility failed to maintain the exit signs. This was evidenced by exit signs that failed to pass a monthly 30 second illumination test and missing monthly and annual testing records. This affected Hospitals and the offsite fourth-floor Surgery Center, and could result in confusion or delay of evacuation during an emergency power outage. NFPA 101: Life Safety Code, 2012 Edition 21.2.10 Marking of Means of Egress. Means of egress shall have signs in accordance with Section 7.10. 19.2.10 Marking of Means of Egress. 19.2.10.1 Means of egress shall have signs in accordance with Section 7.10, unless otherwise permitted by 19.2.10.2, 19.2.10.3, or 19.2.10.4. 7.10.1.2 Exits. 7.10.1.2.1 * Exits, other than main exterior exit doors that obviously and clearly are identifiable as exits, shall be marked by an approved sign that is readily visible from any direction of exit access. 7.10.1.2.2 * Horizontal components of the egress path within an exit enclosure shall be marked by approved exit or directional exit signs where the continuation of the egress path is not obvious. 7.10.5 Illumination of Signs. 7.10.5.1 * General. Every sign required by 7.10.1.2, 7.10.1.5, or 7.10.8.1, other than where operations or processes require low lighting levels, shall be suitably illuminated by a reliable light source. Externally and internally illuminated signs shall be legible in both the normal and emergency lighting mode. 7.10.9 Testing and Maintenance. 7.10.9.1 Inspection. Exit signs shall be visually inspected for operation of the illumination sources at intervals not to exceed 30 days or shall be periodically monitored in accordance with 7.9.3.1.3. 7.10.9.2 Testing. Exit signs connected to, or provided with, a battery-operated emergency illumination source, where required in 7.10.4, shall be tested and maintained in accordance with 7.9.3. 7.9.3 Periodic Testing of Emergency Lighting Equipment. 7.9.3.1 Required emergency lighting systems shall be tested in accordance with one of the three options offered by 7.9.3.1.1, 7.9.3.1.2, or 7.9.3.1.3. 7.9.3.1.1 Testing of required emergency lighting systems shall be permitted to be conducted as follows: (1) Functional testing shall be conducted monthly, with a minimum of 3 weeks and a maximum of 5 weeks between tests, for not less than 30 seconds, except as otherwise permitted by 7.9.3.1.1(2). (2)* The test interval shall be permitted to be extended beyond 30 days with the approval of the authority having jurisdiction. (3) Functional testing shall be conducted annually for a minimum of 11/ 2 hours if the emergency lighting system is battery powered. (4) The emergency lighting equipment shall be fully operational for the duration of the tests required by 7.9.3.1.1(1) and (3). (5) Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction. Findings: During a tour of the facility, record review and interview with staff, the exit signs were observed, tested and records reviewed. 1. On 12/12/24 at 8:34 a.m., the Hospital battery back-up exit sign 30 second functional monthly test and inspection records for November 2024 were reviewed. The monthly 30 second test record listed the following deficiencies: Lower Level- four exit signs failed the 30 second functional test. Lower Level- CPR exit sign failed the 30 second functional test. Lower Level- C Tower Stairwell exit sign failed the 30 second functional test. Lower Level- Engineering Plant- 10 exit signs failed the 30 second functional test. Lower Level- LL Training Room exit sign failed the 30 second functional test. Lower Level- CCE Southwest to E Tunnel exit sign failed the 30 second functional test. Lower Level- Emergency Tunnel- four exit signs failed the 30 second functional test. Lower Level- Radiation Oncology- two exit signs failed the 30 second functional test. Lower Level- POD Southwest Stairwell exit sign failed the 30 second functional test. Ground Floor- Engineering Shop- three exit signs failed the 30 second functional test. Ground Floor- Southwest Stairwell exit sign failed the 30 second functional test. Ground Floor- Central Supply- three exit signs failed the 30 second functional test. Ground Floor- Cath Lab/Hall- eight exit signs failed the 30 second functional test. Ground Floor- Loading Deck /Ground Floor- 21 exit signs failed the 30 second functional test. Ground Floor- Laundry- seven exit signs failed the 30 second functional test. Ground Floor- Pharmacy- three exit signs failed the 30 second functional test. Ground Floor- CCU exit sign failed 30 second functional test. Ground Floor- Medical Records- two exit signs failed the 30 second functional test. Ground Floor- Command Center- 10 exit signs failed the 30 second functional test. 1st. Floor- ICU By Double Doors exit sign failed the 30 second functional test. 1st. Floor- Radiology- four exit signs failed the 30 second functional test. 1st. Floor- Surgery/PACU- 15 exit signs failed the 30 second functional test. 1st. Floor- Infusion (ICC)- two exit signs failed the 30 second functional test. 1st. Floor- Main Lobby and Hallways- 25 exit signs failed the 30 second functional test. 1st. Floor- Diagnostic Services- four exit signs failed the 30 second functional test. 1st. Floor- Emergency Department- seven exit signs failed the 30 second functional test. 1st. Floor- Nuclear Medicine- two exit signs failed the 30 second functional test. 1st. Floor- Admitting exit sign failed the 30 second functional test. 1st. Floor- Laboratory- four exit signs failed the 30 second functional test. 2nd Floor- 14 exit signs failed the 30 second functional test. 3rd Floor- 21 exit signs failed the 30 second functional test. 4th Floor- nine exit signs failed the 30 second functional test. 5th Floor- nine exit signs failed the 30 second functional test. 6th Floor- eight exit signs failed the 30 second functional test. 7th Floor- three eight exit signs failed the 30 second functional test. 8th Floor- five eight exit signs failed the 30 second functional test. 9th Floor- four eight exit signs failed the 30 second functional test. 10th Floor- six eight exit signs failed the 30 second functional test. Upon interview, the Staff 1 stated that new battery backup exit signs were ordered, and the facility was in the process of replacing the failed exit signs. 46858 2. On 12/12/24 at 10:09 a.m., the facility failed to conduct 12 of 12 monthly 30-second tests to the battery-powered exit signs located of the offsite fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he was under the impression that the engineering team of the Main Hospital building were in charge of maintaining the exit signs. 3. On 12/12/24 at 10:10 a.m., the facility failed to conduct the annual 90-minute test to the battery-powered exit signs of the offsite fourth-floor Surgery Center. The date of the last 90-minute test to the exit signs was unknown. During a concurrent interview, Staff 6 confirmed the finding and stated that he was under the impression that the engineering team of the Main Hospital building were in charge of maintaining the exit signs.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 46858 Based on observation and interview, the facility failed to maintain the hazardous area enclosures. This was evidenced by an obstructed door to a hazardous area. This could result in the passage of a smoke and fire in the event of a fire originating from a hazardous area. This affected the second floor of the Hospital. Findings: During a tour of the facility and interview with staff, the facility’s hazardous area enclosures were observed. On 12/10/24 at 8:35 a.m., the egress door to the Dry Storage Area in the Second Floor Kitchen of the Hospital was observed obstructed from closure by an orange step ladder. The ladder was observed at the base of the door. The Dry Storage Area measured approximately 320 square feet and stored approximately 13 metal frames filled with dry food supplies. The metal framing was observed lined along the center and the perimeter of the room. During a concurrent interview, Staff 1 stated that the Kitchen Staff should have known not to obstruct the door to the Dry Storage Area.”

“Anesthetizing Locations CFR(s): NFPA 101 Anesthetizing Locations Areas designated for administration of general anesthesia (i.e., inhalation anesthetics) are in accordance with 8.7 and NFPA 99. Zone valves are: located immediately outside each life-support, critical care and anesthetizing location of moderate sedation, deep sedation, or general anesthesia for medical gas or vacuum; readily accessible in an emergency; and arranged so shutting off any one anesthetizing location will not affect others. Area alarm panels are provided to monitor all medical gas, medical-surgical vacuum, and piped WAGD systems. Panels are at locations that provide for surveillance, indicate medical gas pressure decreases of 20 percent and vacuum decreases of 12 inch gauge HgV, and provide visual and audible indication. Alarm sensors are installed either on the source side of individual room zone valve box assemblies or on the patient/use side of each of the individual zone box valve assemblies. The EES critical branch supplies power for task illumination, fixed equipment, select receptacles, and select power circuits, and EES equipment system supplies power to ventilation system. Heating, cooling, and ventilation are in accordance with ASHRAE 170. Medical supply and equipment manufacturer’s instructions for use are considered before reducing humidity levels to those allowed by ASHRAE, per S&C 13-58. 19.3.2.3 (LSC) 5.1.4.8.7, 5.1.4.8.7.2, 5.1.9.3, 5.1.9.3.4, 6.4.2.2.4.2 (NFPA 99) This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain the anesthetizing locations. This was evidenced by records of relative humidity (RH) and temperature that were out of range and incomplete documentation. This affected operating rooms in the hospital and could lead to patient discomfort, and the potential of increased blood loss, a higher risk of surgical site infections, complications with blood clotting, potential cardiac issues, and a prolonged recovery time. Findings: During record review and interview with staff, the temperature and RH logs were reviewed. 1. On 12/12/24 at 11:10 a.m., the Hospital document titled, “TEMPERATURE & HUMIDITY TRACKING LOG” for 12 operating rooms was reviewed. The instructions on the log indicated “If temperature & Humidity are outside of the normal range, contact engineering by phone at ....and document in the log. Engineering to initial after corrective action has been and the correct value range to achieved. (If Dept. services are closed on the date, indicate “closed” in the comment section.” The logs have columns for “Date, Temperature at 68-75 degree Fahrenheit (F), Humidity at 30%-60%, Initials, ENGR. Called (Y/N), W/O/comments/corrective actions taken (re-document values after corrective action taken), ENGR. Initials.” The temperature and humidity logs for the Month of September 2024 were reviewed and were out of range: Operating Rooms 1&2 9/3/24 the temperature was recorded at 67.7 degrees Fahrenheit. 9/4/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was recorded at 67.6%. 9/5/24 the RH was recorded at 67.5%. 9/6/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 67.3%. 9/9/24 the temperature was recorded at 67.9 degrees Fahrenheit, and the RH was recorded at 66.6%. 9/10/24 the temperature was recorded at 66.2 degrees Fahrenheit, and the RH was recorded at 63.2%. 9/11/24 the temperature was recorded at 66.5 degrees Fahrenheit, and the RH was recorded at 65.1%. 9/12/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was recorded at 61.9% 9/16/24 the temperature was recorded at 66.3 degrees Fahrenheit. 9/17/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 63.2%. 9/18/24 the RH was recorded at 68.4%. 9/19/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 68%. 9/20/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 67.7%. 9/22/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 70%. 9/23/24 the temperature was recorded at 66.6 degrees Fahrenheit, and the RH was recorded at 65.9%. 9/25/24 the RH was recorded at 65.1%. 9/26/24 the temperature was recorded at 67.8 degrees Fahrenheit, and the RH was recorded at 68%. 9/27/24 the RH was recorded at 68.9%. 9/29/24 the RH was recorded at 69%. 9/30/24 the RH was recorded at 65%. Operating Room 3 9/2/24 the RH was recorded at 64.4%. 9/3/24 the RH was recorded at 61.3%. 9/4/24 the RH was recorded at 65.6%. 9/5/24 the RH was recorded at 61.3%. 9/6/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 65.8%. 9/9/24 the RH was recorded at 66.2%. 9/10/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 63.2%. 9/11/24 the temperature was recorded at 66.5 degrees Fahrenheit, and the RH was recorded at 64.8%. 9/12/24 the RH was recorded at 61.1%. 9/13/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 63.2%. 9/17/24 the temperature was recorded at 67.5 degrees Fahrenheit 9/18/24 the RH was recorded at 68.54. 9/19/24 the RH was recorded at 64%. 9/20/24 the RH was recorded at 64.7%. 9/22/24 the RH was recorded at 67%. 9/23/24 the RH was recorded at 63.3%. 9/25/24 the RH was recorded at 65.1%. 9/26/24 the RH was recorded at 66%. 9/27/24 the RH was recorded at 67.1%. 9/29/24 the RH was recorded at 67%. 9/30/24 the RH was recorded at 64%. Operating Room 4 9/2/24 the RH was recorded at 64.2%. 9/3/24 the temperature was recorded at 67.6 degrees Fahrenheit, and the RH was recorded at 61.4%. 9/4/24 the temperature was recorded at 66.5 degrees Fahrenheit, and the RH was recorded at 69.8%. 9/5/24 the temperature was recorded at 64.8 degrees Fahrenheit, and the RH was recorded at 69.2%. 9/6/24 the temperature was recorded at 64.9 degrees Fahrenheit, and the RH was recorded at 69.3%. 9/9/24 the temperature was recorded at 66.6 degrees Fahrenheit, and the RH was recorded at 67.8%. 9/10/24 the temperature was recorded at 64.9 degrees Fahrenheit, and the RH was recorded at 65.8%. 9/11/24 the temperature was recorded at 64.8 degrees Fahrenheit, and the RH was recorded at 66.8%. 9/12/24 the temperature was recorded at 66 degrees Fahrenheit, and the RH was recorded at 64.6%. 9/13/24 the temperature was recorded at 64.7 degrees Fahrenheit, and the RH was recorded at 66.7%. 9/16/24 the temperature was recorded at 64.7 degrees Fahrenheit, and the RH was recorded at 63.3%. 9/17/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 63.7%. 9/18/24 the RH was recorded at 69%. 9/19/24 the temperature was recorded at 63.1 degrees Fahrenheit, and the RH was recorded at 76%. 9/20/24 the temperature was recorded at 63.6 degrees Fahrenheit, and the RH was recorded at 76%. 9/22/24 the temperature was recorded at 63.9 degrees Fahrenheit, and the RH was recorded at 78.3%. 9/23/24 the temperature was recorded at 67.9 degrees Fahrenheit, and the RH was recorded at 67.3%. 9/25/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was recorded at 67.4%. 9/26/24 the temperature was recorded at 64.9 degrees Fahrenheit, and the RH was recorded at 65%. 9/27/24 the temperature was recorded at 66.6 degrees Fahrenheit, and the RH was recorded at 70.2%. 9/29/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 69%. 9/30/24 the temperature was recorded at 66.2 degrees Fahrenheit, and the RH was recorded at 71.5%. Operating Room 5 9/2/24 the RH was recorded at 64.5%. 9/3/24 the RH was recorded at 61.6%. 9/4/24 the RH was recorded at 65.9%. 9/5/24 the RH was recorded at 65.8%. 9/6/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 65.8%. 9/9/24 the RH was recorded at 62.5%. 9/10/24 the temperature was recorded at 66 degrees Fahrenheit, and the RH was recorded at 63.1%. 9/11/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 64%. 9/12/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was recorded at 63%. 9/13/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 64%. 9/16/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was within the value range. 9/17/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 62.6%. 9/18/24 the RH was recorded at 69%. 9/19/24 the RH was recorded at 66%. 9/20/24 the RH was recorded at 66.3%. 9/22/24 the RH was recorded at 69%. 9/23/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 66.3%. 9/25/24 the temperature was recorded at 67.9 degrees Fahrenheit, and the RH was recorded at 66%. 9/26/24 the RH was recorded at 68%. 9/27/24 the RH was recorded at 65%. 9/29/24 the RH was recorded at 65.1%. 9/30/24 the RH was recorded at 66%. Operating Room 6 9/2/24 the RH was recorded at 61%. 9/4/24 the temperature was recorded at 67.8 degrees Fahrenheit, and the RH was recorded at 66.8%. 9/6/24 the temperature was recorded at 66.9 degrees Fahrenheit, and the RH was recorded at 66.2%. 9/10/24 the temperature was recorded at 65 degrees Fahrenheit, and the RH was within the value range. 9/11/24 the RH was recorded at 62%. 9/13/24 the RH was recorded at 62.1%. 9/18/24 the temperature was recorded at 64.5 degrees Fahrenheit, and the RH was recorded at 68.7%. 9/19/24 the RH was recorded at 64%. 9/20/24 the RH was recorded at 65%. 9/22/24 the RH was recorded at 69%. 9/26/24 the RH was recorded at 67.7%. 9/27/24 the RH was recorded at 61.4%. 9/29/24 the RH was recorded at 67.5%. 9/30/24 the RH was recorded at 66%. Operating Room 7 9/2/24 the temperature was recorded at 67.7 degrees Fahrenheit, and the RH was recorded at 65.8%. 9/4/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 68.5%. 9/5/24 the temperature was recorded at 67.7 degrees Fahrenheit, and the RH was recorded at 63%. 9/6/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 68%. 9/9/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 68.7%. 9/10/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was within the value range. 9/11/24 the temperature was recorded at 66.9 degrees Fahrenheit, and the RH was recorded at 64.2%. 9/12/24 the temperature was recorded at 67.4 degrees Fahrenheit, and the RH was recorded at 62.8%. 9/13/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 64.2%. 9/16/24 the temperature was recorded at 65.7 degrees Fahrenheit, and the RH was recorded at 62.2%. 9/17/24 the temperature was recorded at 66.5 degrees Fahrenheit, and the RH was recorded at 63.6%. 9/18/24 the temperature was recorded at 67.9 degrees Fahrenheit, and the RH was recorded at 69.4%. 9/19/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 66.3%. 9/20/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 67.3%. 9/22/24 the temperature was recorded at 67.9 degrees Fahrenheit, and the RH was recorded at 70%. 9/23/24 the RH was recorded at 64.5%. 9/24/24 the temperature was recorded at 64.2 degrees Fahrenheit, and the RH was recorded at 63.9%. 9/25/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was recorded at 70%. 9/26/24 the RH was recorded at 67.7%. 9/29/24 the RH was recorded at 61%. 9/30/24 the RH was recorded at 67%. Operating Room 8 9/2/24 the temperature was recorded at 67.7 degrees Fahrenheit, and the RH was recorded at 63.8%. 9/3/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 61.9%. 9/4/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 70.9%. 9/5/24 the temperature was recorded at 66.7 degrees Fahrenheit, and the RH was recorded at 61.8%. 9/6/24 the temperature was recorded at 63.9 degrees Fahrenheit, and the RH was recorded at 71.6%. 9/9/24 the temperature was recorded at 64.9 degrees Fahrenheit, and the RH was recorded at 71.1%. 9/10/24 the temperature was recorded at 59.2 degrees Fahrenheit, and the RH was recorded at 64.3%. 9/11/24 the temperature was recorded at 64.6 degrees Fahrenheit, and the RH was recorded at 67.8%. 9/12/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 65.6%. 9/13/24 the temperature was recorded at 64.7 degrees Fahrenheit, and the RH was recorded at 67.9%. 9/16/24 the temperature was recorded at 63.1 degrees Fahrenheit, and the RH was recorded at 65.5%. 9/17/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 65.2%. 9/18/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 69.5%. 9/19/24 the temperature was recorded at 63.3 degrees Fahrenheit, and the RH was recorded at 76.%. 9/20/24 the temperature was recorded at 64 degrees Fahrenheit, and the RH was recorded at 76%. 9/22/24 the temperature was recorded at 64.6 degrees Fahrenheit, and the RH was recorded at 78.3%. 9/23/24 the temperature was recorded at 66.6 degrees Fahrenheit, and the RH was recorded at 67.9%. 9/24/24 the temperature was recorded at 63.5 degrees Fahrenheit, and the RH was recorded at 62.6%. 9/25/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 68.7%. 9/26/24 the temperature was recorded at 63.7 degrees Fahrenheit, and the RH was recorded at 79%. 9/27/24 the temperature was recorded at 64.4 degrees Fahrenheit, and the relative humidity was recorded at 64.5%. 9/29/24 the temperature was recorded at 64.5 degrees Fahrenheit, and the RH was recorded at 61%. 9/30/24 the temperature was recorded at 65 degrees Fahrenheit, and the RH was recorded at 67%. Operating Room 9 9/2/24 the temperature was recorded at 64 degrees Fahrenheit, and the RH was recorded at 70.7%. 9/3/24 the temperature was recorded at 64.3 degrees Fahrenheit, and the RH was recorded at 65.6%. 9/4/24 the temperature was recorded at 66.3 degrees Fahrenheit, and the RH was recorded at 68.8%. 9/5/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 68.7%. 9/6/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 69.2%. 9/9/24 the temperature was recorded at 64.6 degrees Fahrenheit, and the RH was recorded at 70.9%. 9/10/24 the temperature was recorded at 61.6 degrees Fahrenheit, and the RH was within the value range. 9/11/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 65.9%. 9/12/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was recorded at 73.9%. 9/13/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 65.7%. 9/17/24 the temperature was recorded at 65.2 degrees Fahrenheit, and the RH was recorded at 65.3%. 9/18/24 the temperature was recorded at 66.5 degrees Fahrenheit, and the RH was recorded at 69.4%. 9/19/24 the temperature was recorded at 64 degrees Fahrenheit, and the RH was recorded at 74.%. 9/20/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 74%. 9/22/24 the temperature was recorded at 66.1 degrees Fahrenheit, and the RH was recorded at 75%. 9/23/24 the RH was recorded at 64.8%. 9/24/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was recorded at 62.6%. 9/25/24 the temperature was recorded at 65.5 degrees Fahrenheit, and the RH was recorded at 64.1%. 9/26/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 76%. 9/27/24 the temperature was recorded at 62.6 degrees Fahrenheit, and the RH was recorded at 67.1%. 9/29/24 the temperature was recorded at 62.7 degrees Fahrenheit, and the RH was recorded at 67.1%. 9/30/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 67%. Operating Room 10 9/2/24 the temperature was recorded at 66.1 degrees Fahrenheit, and the RH was recorded at 65.9%. 9/3/24 the temperature was recorded at 67.4 degrees Fahrenheit, and the RH was recorded at 61.6%. 9/4/24 the temperature was recorded at 67.2 degrees Fahrenheit, and the RH was recorded at 67.2%. 9/5/24 the temperature was recorded at 67.4 degrees Fahrenheit, and the RH was recorded at 61.7%. 9/6/24 the temperature was recorded at 65.9 degrees Fahrenheit, and the RH was recorded at 67.2%. 9/9/24 the RH was recorded at 63.2%. 9/10/24 the temperature was recorded at 65 degrees Fahrenheit. 9/11/24 the temperature was recorded at 65.6 degrees Fahrenheit, and the RH was recorded at 66.1%. 9/12/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was recorded at 70.4%. 9/13/24 the temperature was recorded at 65 degrees Fahrenheit, and the RH was within the value range. 9/17/24 the temperature was recorded at 65.9 degrees Fahrenheit, and the RH was recorded at 64.4%. 9/18/24 the temperature was recorded at 67.7 degrees Fahrenheit, and the RH was recorded at 70.5%. 9/19/24 the temperature was recorded at 65.3 degrees Fahrenheit, and the RH was recorded at 70%. 9/20/24 the temperature was recorded at 65.8 degrees Fahrenheit, and the RH was recorded at 70%. 9/22/24 the temperature was recorded at 67.2 degrees Fahrenheit, and the RH was recorded at 70%. 9/23/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 68.3%. 9/24/24 the temperature was recorded at 63.7 degrees Fahrenheit, and the RH was recorded at 64.5%. 9/25/24 the temperature was recorded at 62.1 degrees Fahrenheit, and the RH was recorded at 65.4%. 9/26/24 the temperature was recorded at 66.2 degrees Fahrenheit, and the RH was recorded at 65%. 9/27/24 the temperature was recorded at 66 degrees Fahrenheit, and the RH was recorded at 63.6%. 9/29/24 the temperature was recorded at 66.1 degrees Fahrenheit, and the RH was recorded at 64%. 9/30/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 65%. Operating Room 11 9/2/24 the temperature was recorded at 64.4 degrees Fahrenheit, and the RH was recorded at 66.6%. 9/3/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 62.6%. 9/4/24 the temperature was recorded at 67.4 degrees Fahrenheit, and the RH was recorded at 66.7%. 9/5/24 the temperature was recorded at 67.3 degrees Fahrenheit, and the RH was recorded at 67.6%. 9/6/24 the temperature was recorded at 65.6 degrees Fahrenheit, and the RH was recorded at 68.5%. 9/10/24 the temperature was within the value range and the RH was recorded at 63%. 9/11/24 the temperature was recorded at 65.1 degrees Fahrenheit, and the RH was recorded at 66.3%. 9/12/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 65.1%. 9/13/24 the temperature was recorded at 66.3 degrees Fahrenheit, and the RH was recorded at 65.3%. 9/17/24 the temperature was recorded at 65.2 degrees Fahrenheit, and the RH was recorded at 65.3%. 9/18/24 the temperature was recorded at 67.2 degrees Fahrenheit, and the RH was recorded at 70.3%. 9/19/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was recorded at 76%. 9/20/24 the temperature was recorded at 64.2 degrees Fahrenheit, and the RH was recorded at 75%. 9/22/24 the temperature was recorded at 65.2 degrees Fahrenheit, and the RH was recorded at 76%. 9/24/24 the temperature was recorded at 62.1 degrees Fahrenheit, and the RH was recorded at 65.4%. 9/25/24 the temperature was recorded at 65.7 degrees Fahrenheit, and the RH was recorded at 68.9%. 9/26/24 the temperature was recorded at 64.2 degrees Fahrenheit, and the RH was recorded at 68%. 9/27/24 the temperature was recorded at 64 degrees Fahrenheit, and the RH was recorded at 67%. 9/29/24 the temperature was recorded at 64.1 degrees Fahrenheit, and the RH was recorded at 67.1%. 9/30/24 the temperature was recorded at 65 degrees Fahrenheit, and the RH was recorded at 67%. Operating Room 12 9/2/24 the temperature was recorded at 64.3 degrees Fahrenheit, and the RH was recorded at 66.6%. 9/3/24 the temperature was recorded at 67.1 degrees Fahrenheit, and the RH was recorded at 63%. 9/4/24 the temperature was recorded at 66.8 degrees Fahrenheit, and the RH was recorded at 67.5%. 9/5/24 the temperature was recorded at 66.7 degrees Fahrenheit, and the RH was recorded at 67.4%. 9/6/24 the temperature was recorded at 65.2 degrees Fahrenheit, and the RH was recorded at 67.5%. 9/10/24 the temperature was recorded at 67.5 degrees Fahrenheit, and the RH was within the value range. 9/11/24 the temperature was recorded at 66.3 degrees Fahrenheit, and the RH was recorded at 64.7%. 9/18/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 71.4%. 9/19/24 the temperature was recorded at 66.4 degrees Fahrenheit, and the RH was recorded at 66.3%. 9/20/24 the temperature was recorded at 65.7 degrees Fahrenheit, and the RH was recorded at 71%. 9/22/24 the temperature was recorded at 66 degrees Fahrenheit, and the RH was recorded at 74%. 9/24/24 the temperature was recorded at 61.1 degrees Fahrenheit, and the RH was recorded at 68.1%. 9/25/24 the temperature was recorded at 65 degrees Fahrenheit, and the RH was recorded at 68.9%. 9/26/24 the temperature was recorded at 64.2 degrees Fahrenheit, and the RH was recorded at 68%. 9/27/24 the temperature was recorded at 62.6 degrees Fahrenheit, and the RH was recorded at 67.5%. 9/29/24 the temperature was recorded at 63 degrees Fahrenheit, and the RH was recorded at 67.4%. 9/30/24 the temperature was recorded at 67 degrees Fahrenheit, and the RH was recorded at 68%. Upon interview, Staff 1 acknowledged that the temperature and humidity in the operating rooms were outside the threshold listed on their log. 2. On 12/12/24 at 11:11 a.m., the Hospital document titled, “TEMPERATURE & HUMIDITY TRACKING LOG” for the 12 operating rooms was reviewed. The instructions on the log indicated “If temperature & Humidity are outside of the normal range, contact engineering by phone at ....and document in the log. Engineering to initial after corrective action has been and the correct value range to achieved. (If Dept. services are closed on the date, indicate “closed” in the comment section.” The logs have columns for “Date, Temperature at 68-75 degree Fahrenheit (F), Humidity at 30%-60%, Initials, ENGR. Called (Y/N), W/O/comments/corrective actions taken (re-document values after corrective action taken), ENGR. Initials.” The column for the engineer initial was blank, the log failed to show corrective action had been made and failed to indicate if the correct value had been achieved for all 12 operating rooms. Upon interview, Staff 1 acknowledged that the corrective action was not documented in the log.”

“Fire Alarm System - Notification CFR(s): NFPA 101 Fire Alarm - Notification 2012 EXISTING Positive alarm sequence in accordance with 9.6.3.4 are permitted in buildings protected throughout by a sprinkler system. Occupant notification is provided automatically in accordance with 9.6.3 by audible and visual signals. In critical care areas, visual alarms are sufficient. The fire alarm system transmits the alarm automatically to notify emergency forces in the event of a fire. 19.3.4.3, 19.3.4.3.1, 19.3.4.3.2, 9.6.4, 9.7.1.1(1) This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the fire alarm system. This was evidenced by fire alarm notification devices that did not activate when the fire alarm was tested. This affected the third floor in the hospital and could result in confusion during a fire. NFPA 101: Life Safety Code, 2012 Edition 19.3.4.1 General. Health care occupancies shall be provided with a fire alarm system in accordance with Section 9.6. 9.6 Fire Detection, Alarm, and Communications Systems. 9.6.1.3 A fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code, unless it is an approved existing installation, which shall be permitted to be continued in use. NFPA 72: National Fire Alarm and Signaling Code, 2010 Edition 18.2 Purpose. Notification appliances shall provide stimuli for initiating emergency action and provide information to users, emergency response personnel, and occupants. Findings: During a tour of the facility and interview with staff, the fire alarm system was tested. On 12/11/24 at 10:26 a.m., the fire alarm on the third floor of the hospital was tested. The floor was under construction due to a flooding event in 2022 and was not occupied by patients or staff. During testing, the audible fire alarm notification devices failed to emit any sound. Upon interview, Staff 3 stated that the floor was under construction and the chime loop may have been disabled.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm System - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 43380 Based on observation, record review and interview, the facility failed to maintain the fire alarm system (FAS). This was evidenced by the fire alarm control panel (FACP) indicating a trouble condition, deficiencies on the semiannual FAS inspection, obstructed smoke detectors, missing semiannual inpsection records and missing smoke detector sensitivity test records. This affected Hospital and the offsite fourth-floor Surgery Center and could result in the delay of notification to emergency forces in the event of an emergency. NFPA 101: Life Safety Code, 2012 Edition 21.3.4 Detection, Alarm, and Communications Systems. 21.3.4.1 General. Ambulatory health care facilities shall be provided with fire alarm systems in accordance with Section 9.6, except as modified by 21.3.4.2 through 21.3.4.4. 19.3.4.1 General. Health care occupancies shall be provided with a fire alarm system in accordance with Section 9.6. 9.6.1.3 A fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code, unless it is an approved existing installation, which shall be permitted to be continued in use. NFPA 72: National Fire Alarm and Signaling Code, 2010 Edition 10.19 * Impairments. 10.19.1 The system owner or their designated representative shall be notified when a fire alarm system or part thereof is impaired. Impairments to systems shall include out-of-service events. 10.19.2 A record shall be maintained by the system owner or designated representative for a period of 1 year from the date the impairment is corrected. 10.19.3 * Where required, mitigating measures acceptable to the authority having jurisdiction shall be implemented for the period that the system is impaired. 10.19.4 The system owner or owner ’ s designated representative shall be notified when an impairment period is completed or discontinued. Table 14.3.1 Testing Frequencies 9.Initiating devices (a) Air sampling; Semiannually (b) Duct detectors; Semiannually (c) Electromechanical releasing devices; Semiannually (d) Fire extinguishing system(s) or suppression system(s) switches; Semiannually (e) Manual fire alarm boxes; Semiannually (f) Heat detectors; Semiannually (g) Radiant energy fire detectors: Semiannually (h) Smoke detectors (excluding one- and two-family dwellings); Semiannually (i) Supervisory signal devices; Semiannually (j) Waterflow devices; Semiannually 14.4.5* Testing Frequency. Unless otherwise permitted by other sections of this Code, testing shall be performed in accordance with the schedules in Table 14.4.5, or more often if required by the authority having jurisdiction. Table 14.4.5 Testing Frequencies 1. Control equipment systems connected to supervising station (a) Functions-Initial/Reacceptance, Annually (b) Fuses-Initial/Reacceptance, Annually (c) Interfaced equipment-Initial/Reacceptance, Annually (d) Lamps and LEDs-Initial/Reacceptance, Annually (e) Primary (main) power supply-Initial/Reacceptance, Annually (f) Transponders-Initial/Reacceptance, Annually 6. Batteries-fire alarm systems (d) Sealed lead-acid type (1) Charger test (Replace battery as needed.) - Initial/Reacceptance; Annually (2) Discharge test (30 minutes) - Initial/Reacceptance; Annually (3) Load voltage test - Initial/Reacceptance; Semiannually 14.5.1 System equipment shall be maintained in accordance with the manufacturer’s published instructions 14.4.5.3.1 Sensitivity shall be checked within 1 year after installation. 14.4.5.3.2 Sensitivity shall be checked every alternate year thereafter unless otherwise permitted by compliance with14.4.5.3.3. 14.4.5.3.3 After the second required calibration test, if sensitivity tests indicate that the device has remained within its listed and marked sensitivity range (or 4 percent obscuration light gray smoke, if not marked), the length of time between calibration tests shall be permitted to be extended to a maximum of 5 years. 14.4.5.3.3.1 If the frequency is extended, records of nuisance alarms and subsequent trends of these alarms shall be maintained. 17.4.3 Where subject to mechanical damage, an initiating device shall be protected. A mechanical guard used to protect a smoke, heat, or radiant energy-sensing detector shall be listed for use with the detector. Findings: During a tour of the facility, record review and interview with staff, the FACP was observed and FAS records requested and reviewed. 1. On 12/9/24 at 10:58 a.m., both Honeywell FACPs located in the lower level of the Hospital, in the engineering area were observed with the Trouble light illuminated, the Panel Silence light illuminated and the Disable light illuminated. There were 28 trouble codes stored on the visual display. The FACP display screen showed the following trouble codes: “0001 COMMON TRBL ACT ROOF-DUCT DET. #57 SUPPLY FAN SF-1” “0002 COMMON TRBL ACT 1ST FLR SMOKE DET. GI Lab Exam Area Rear” “0003 COMMON TRBL ACT 1ST FLR SMOKE DET. DIAG. SERVICES office” “0004 LOCAL TRBL ACT 0203067 Unprogrammed Device DataCard1” “0005 COMMON TRBL ACT 1ST FLR SMOKE DET. ICU NURSE STATION” “0006 COMMON TRBL ACT 3RD FLR-CHIMES” “0007 COMMON TRBL ACT Ground Chimes Zone1 No./W.” “0008 COMMON TRBL ACT 3RD FLR-PATIENT LIGHT SUPERVISION ALARM” “0009 DISABLED ACTIVE ROOF DUCT-DET. #57SUPPLY FAN SF-1” “0010 LOCAL TRBL ACT First Disable Response” “0011 DISABLED ACTIVE 10TH FLR-SMOKE DET. No Patient Rm1009” “0012 DISABLED ACTIVE 10TH FLR-SMOKE DET. No Patient Rm1010” “0013 DISABLED ACTIVE 9TH FLR-SMOKE DET. So Patient Rm920” “0014 DISABLED ACTIVE 6TH FLR-SMOKE DET. North Patient Rm606” “0015 LOCAL TRBL ACT 02060672Map Fault DataCard1” “0016 DISABLED ACTIVE 1ST FLR-SMOKE DET. GI Lab Exam Area Rear” “0017 DISABLED ACTIVE 1ST FLR-SMOKE DET. DIAG. SERVICES office” “0018 DISABLED ACTIVE 1ST FLR-SMOKE DET. ICU NURSE STATION” “0019 LOCAL TRBL ACT 0205067Map Fault DataCard1” “0020 DISABLED ACTIVE 6TH FLR-SMOKE DET. North Patient Rm609” “0021 DISABLED ACTIVE GROUND SMOKE DET. Eng/Maint Shop” “0022 DISABLED ACTIVE GROUND SMOKE DET. Eng/Maint Shop” “0023 DISABLED ACTIVE GROUND SMOKE DET. Eng/Maint Shop” “0024 DISABLED ACTIVE GROUND SMOKE DET. Eng/Maint Shop” “0025 COMMON TRBL ACT 10TH FLR-SMOKE DET. Electrical Clst East” “0026 DISABLED ACTIVE 10TH FLR-SMOKE DET. Electrical Clst East” “0027 DISABLED ACTIVE 1ST FLR SMOKE DET. ER TREATMENT Room 1” “0028 DISABLED ACTIVE 8TH FLR-SMOKE DET. Dining Rm N/E” Upon interview, Staff 2 stated that they were having work done on the elevators which was why the chimes were disabled and they had ordered spare smoke detectors, and they were waiting for them to be deliver so it could replace the smoke detectors that had failed in the building. 2. On 12/11/24 at 2:16 p.m., the Hospital semiannual fire alarm inspection report dated 6/11/24 was reviewed. The report listed the following corrective actions that remain open following the system inspection, testing or maintenance activities: “Ground floor waterflow switch in the North/East Stairwell failed to respond to panel.” “Ground floor waterflow switch in the South/East stairwell failed to respond to panel.” “Ground floor sprinkler tamper switch in the North/East stairwell failed to respond to panel.” “Ground floor sprinkler tamper switch in the South/East stairwell failed to respond to panel.” “Lower level B electrical room booster power supply fire alarm control box the batteries are outdated and need to be replaced.” The facility failed to provide documentation to show the deficiencies had been repaired. Upon interview, Staff 1 acknowledged that there were no repair documentation available for review. 46858 3. On 12/10/24 at 2:00 p.m., the smoke detector in the egress corridor outside the Cardiac Supplies Instrument Room on the first floor of the Hospital was observed to be covered with a sheet of office paper. The sheet of paper completely covered the opening of the smoke detector. During a concurrent interview, Staff 2 confirmed the finding and stated that he was unsure why the smoke detector had been covered. 4. On 12/10/24 at 3:00 p.m., the smoke detector in the egress corridor outside the Neurology Lab on the first floor of the Hospital was observed to be covered with a sheet of office paper. The sheet of paper completely covered the opening of the smoke detector. During a concurrent interview, Staff 2 confirmed the finding and stated that he was unsure why the smoke detector had been covered. 5. On 12/12/24 at 10:44 a.m., the facility failed to provide documentation to show that a semi-annual FAS inspection had been conducted for the fourth-floor Surgery Center. The date of the last semi-annual FAS inspection was unknown. During a concurrent interview, Staff 6 stated that he was unsure if the semi-annual FAS inspection had been conducted but, stated that the facility would contact their vendors to confirm. No semiannual FAS inspection records were received before the end of the survey. 6. On 12/12/24 at 10:47 a.m., the facility failed to provide records to show that smoke detector sensitivity testing for the fourth-floor Surgery Center had been conducted. The date of the last smoke detector sensitivity testing was unknown. During a concurrent interview, Staff 7 stated that he would contact his FAS vendor to request testing records. The facility failed to submit sensitivity testing before the end of the survey. 7. On 12/12/24 at 10:49 a.m., the facility failed to conduct one of two semi-annual load voltage tests for the Fire Alarm Control Panel (FACP) batteries of the fourth-floor Surgery Center. The date of the last load voltage test was 9/19/24. During a concurrent interview, Staff 6 confirmed the finding and stated that he was unsure if the vendor had conducted load voltage testing before the most recent test on 9/19/24.”

“Fire Alarm System - Out of Service CFR(s): NFPA 101 Fire Alarm - Out of Service Where required fire alarm system is out of services for more than 4 hours in a 24-hour period, the authority having jurisdiction shall be notified, and the building shall be evacuated or an approved fire watch shall be provided for all parties left unprotected by the shutdown until the fire alarm system has been returned to service. 9.6.1.6 This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain interim fire measures. This was evidenced by the failure to provide a written fire watch policy. This affected the hospital and the offsite fourth-floor Surgery Center and could result in not having procedures in place to initiate a fire watch when the fire alarm system was inoperable. Findings: During record review and interview with staff, the interim fire measures and policies were requested. 1. On 12/12/24 at 8:40 a.m., the facility failed to provide a Hospital fire watch policy and procedure that the facility would use in the event the fire alarm system was out of services for more than 4 hours in a 24-hour period. There was no policy and procedure available for review. Upon interview, Staff 1 acknowledged that there was no policy available for review. 46858 2. On 12/12/24 at 10:31 a.m., the facility failed to provide a written policy for a fire watch in the event the facility’s fire alarm system was down for more than four hours in the offsite fourth-floor Surgery Center. During a concurrent interview, Staff 6 stated that he was unsure if the facility had a written fire watch policy to provide.”

“Sprinkler System - Installation CFR(s): NFPA 101 Spinkler System - Installation 2012 EXISTING Nursing homes, and hospitals where required by construction type, are protected throughout by an approved automatic sprinkler system in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems. In Type I and II construction, alternative protection measures are permitted to be substituted for sprinkler protection in specific areas where state or local regulations prohibit sprinklers. In hospitals, sprinklers are not required in clothes closets of patient sleeping rooms where the area of the closet does not exceed 6 square feet and sprinkler coverage covers the closet footprint as required by NFPA 13, Standard for Installation of Sprinkler Systems. 19.3.5.1, 19.3.5.2, 19.3.5.3, 19.3.5.4, 19.3.5.5, 19.4.2, 19.3.5.10, 9.7, 9.7.1.1(1) This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the fire sprinkler system. This was evidenced by missing fire sprinkler valve signage. This affected the hospital and could result in delay and confusion of identifying the fire sprinkler valve that serves the facility. NFPA 101: Life Safety Code, 2012 Edition 19.3.5 Extinguishment Requirements. 19.3.5.1 Buildings containing nursing homes shall be protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7, unless otherwise permitted by 19.3.5.5. 9.7 Automatic Sprinklers and Other Extinguishing Equipment. 9.7.1 Automatic Sprinklers. 9.7.1.1 * Each automatic sprinkler system required by another section of this Code shall be in accordance with one of the following: (1) NFPA 13, Standard for the Installation of Sprinkler Systems NFPA 13: Standard for the Installation of Sprinkler Systems, 2010 Edition 6.7.4 * Identification of Valves. 6.7.4.1 All control, drain, and test connection valves shall be provided with permanently marked weatherproof metal or rigid plastic identification signs. 6.7.4.2 The identification sign shall be secured with corrosion-resistant wire, chain, or other approved means. 6.7.4.3 The control valve sign shall identify the portion of the building served. Findings: During a tour of the facility and interview with staff, the fire sprinkler system was observed. On 12/9/24 at 11:05 a.m., the Hospital electric fire pump and associated fire sprinkler piping were observed. Three valves on the piping near the electric fire pump were in the closed position and were missing identification signs. Upon interview, Staff 2 acknowledged that valves were missing identification signs.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 43380 Based on observation, record review and interview, the facility failed to maintain the fire sprinklers. This was evidenced missing and failed inspection, testing and maintenance (ITM) documentation, missing fire department connection (FDC) cap, and a painted/corroded sprinklers. This affected hospital and the offsite fourth-floor Surgery Center and could result in the malfunction of the sprinkler system in the event of a fire. NFPA 101: Life Safety Code, 2012 Edition 21.3.7.2 Every story of an ambulatory health care facility shall be divided into not less than two smoke compartments, unless otherwise permitted by one of the following: (2) This requirement shall not apply to facilities of less than 10,000 ft2 (929 m2) that are protected throughout by an approved, supervised automatic sprinkler system installed in accordance with Section 9.7. 19.3.5 Extinguishment Requirements. 19.3.5.1 Buildings containing nursing homes shall be protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7, unless otherwise permitted by 19.3.5.5. 9.7 Automatic Sprinklers and Other Extinguishing Equipment. 9.7.1 Automatic Sprinklers. 9.7.5 Maintenance and Testing. All automatic sprinkler and standpipe systems required by this Code shall be inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 2011 edition 4.1.1 * Responsibility for Inspection, Testing, Maintenance, and Impairment. The property owner or designated representative shall be responsible for properly maintaining a water-based fire protection system. 4.1.4.1 The property owner or designated representative shall correct or repair deficiencies or impairments that are found during the inspection, test, and maintenance required by this standard. 4.3 Records. 4.3.1 * Records shall be made for all inspections, tests, and maintenance of the system and its components and shall be made available to the authority having jurisdiction upon request. NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 2011 Edition 5.1.1.2 Table 5.1.1.2 shall be used to determine the minimum required frequencies for inspection, testing, and maintenance. Gauges (dry, preaction, and deluge systems) - Weekly/monthly 5.2.4.2, 5.2.4.3, 5.2.4.4 Control valves Table 13.1 Waterflow alarm devices - Quarterly 5.2.5 Valve supervisory alarm devices - Quarterly 5.2.5 Supervisory signal devices (except valve supervisory switches) - Quarterly 5.2.5 Gauges (wet pipe systems) - Monthly 5.2.4.1 Hydraulic nameplate - Quarterly 5.2.6 Buildings - Annually (prior to freezing weather) 4.1.1.1 Hanger/seismic bracing - Annually 5.2.3 Pipe and fittings - Annually 5.2.2 Sprinklers - Annually 5.2.1 Spare sprinklers - Annually 5.2.1.4 Information sign - Annually 5.2.6.1 Fire department connections Table 13.1 Valves (all types) Table 13.1 Obstruction, internal inspection of piping -5 years 14.2 5.2.1.1.1 * Sprinklers shall not show signs of leakage; shall be free of corrosion, foreign materials, paint, and physical damage; and shall be installed in the correct orientation (e.g., upright, pendent, or sidewall). 5.2.1.1.2 Any sprinkler that shows signs of any of the following shall be replaced: (1) Leakage (2) Corrosion (3) Physical damage (4) Loss of fluid in the glass bulb heat responsive element (5) *Loading (6) Painting unless painted by the sprinkler manufacturer 13.3.2 Inspection. 13.3.2.1.1 Valves secured with locks or supervised in accordance with applicable NFPA standards shall be permitted to be inspected monthly. 13.3.2.2 * The valve inspection shall verify that the valves are in the following condition: (1) In the normal open or closed position (2) *Sealed, locked, or supervised (3) Accessible (4) Provided with correct wrenches (5) Free from external leaks (6) Provided with applicable identification 13.7 Fire Department Connections. 13.7.1 Fire department connections shall be inspected quarterly to verify the following: (1) The fire department connections are visible and accessible. (2) Couplings or swivels are not damaged and rotate smoothly. (3) Plugs or caps are in place and undamaged. (4) Gaskets are in place and in good condition. (5) Identification signs are in place. (6) The check valve is not leaking. (7) The automatic drain valve is in place and operating properly. (8) The fire department connection clapper(s) is in place and operating properly. 14.2 Internal Inspection of Piping. 14.2.1 Except as discussed in 14.2.1.1 and 14.2.1.4 an inspection of piping and branch line conditions shall be conducted every 5 years by opening a flushing connection at the end of one main and by removing a sprinkler toward the end of one branch line for the purpose of inspecting for the presence of foreign organic and inorganic material. Findings: During a tour of the facility, record review, and interview with staff, the automatic sprinkler system was observed and ITM records reviewed. Hospital 1. On 12/9/24 at 2:04 p.m., a Tyco Red-E fire protection cabinet containing a pre-action fire suppression system was observed in a closet, in the corridor outside the Radiology/Oncology department on the lower level. The facility failed to provide documentation that ITM had been done on the system within the last 12 months. An inspection sticker on the cabinet indicated the last ITM was conducted in 2020. Upon interview, Staff 1 acknowledged that there was no maintenance documentation available for review. 2. On 12/10/24 at 10:01 a.m., the FDC on the Northwest side of the campus, outside of the cooling towers was observed. The connection on the left side was missing a cap. Upon interview, Staff 4 acknowledged that the cap was missing. 3. On 12/10/24 at 11:12 a.m., the single fire sprinkler in the ceiling of the bathroom between Lab 1 and Lab 2 on the ground floor was observed with paint on the frame and deflector. upon interview, Staff 2 acknowledged the paint on the sprinkler. 4. On 12/10/24 at 2:46 p.m., the sprinkler protecting the Biohazard Cool Storage Area in the Pharmacy of the Hospital was observed corroded and covered with green debris along the body and deflector. During a concurrent interview, Staff 1 confirmed the finding and stated that he was not aware the sprinkler had been in that condition. 5 On 12/12/24 at 7:55 a.m., the annual fire sprinkler ITM dated 4/29/24 was reviewed. The annual ITM failed due to the following deficiencies and no repairs were provided: “Replace 2 - Leaking 1 - 1/4” 90s and 1 - 1- 1/4” Close nipple on Drain could not perform main drain due to heavy leakage 4th floor Stair 4” “Replace 1- Leaking 1” 90 and 1” pipe on inspectors test at riser on Ground floor Yellow Stair * need 1” TxT 90. 1” x 2-0 TxT and 1” megapress coupling with Megapress Gun/Jaws” “Replace 1 - Leaking 1” x 0-3” nipple and 1 - Leaking 1” Globe Valve 1” x 0-3” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on 2pc chrome trim ln room 1004” “Replace 1 - Damaged Chrome 1/2” 155 SR 5.6K SSP on Chrome 401 trim In hallway leading tosupply room” “Replace 1 - Painted Chrome 112” 155 SR 5.6K SSP on 2pc Chrome 401 trim next to Mechanical room door behind front desk” “Replace 1 - Damaged Chrome 1/2” 155 SR 5.6K SSP on Chrome 2pc trim in front of room 1024” “Replace 1 - Damaged Chrome 1/2’” 155 SR 5.6K SSP on Chrome 2pc trim in room in room next to 1025” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 2pc trim in bathroom of room 1028” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in bathroom of room 921” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 2pc trim in front of room 705” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in room 321” “Replace 1 - Missing Chrome 401 skirt in room 313A” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in room 312” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K HSW on Chrome 2pc trim in room 312 “Replace 1 - Mishing Chrome Escutcheon 3rd floor shower” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in room 302” “Replace 1 - Missing Chrome 401 Skirt in 3rd floor Men’s Lockerroom” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in preoperative nurse training lab on 3rd floor” “Adjust 1 - Upside down 401 Skirt in Surgical suite 2 on 3rd floor” “Replace 1 - Damaged Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in obstetrical surgery area on 3rd floor” “Replace 1 - Missing Chrome 401 Skirt in Equipment storage area on 3rd floor” “Replace 1 - Missing Chrome 401 Skirt in Obsterical sleep room #6 on 3rd floor” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in surgery call room #3 on 3rd floor” “Replace 1 - Missing Chrome 401 Skirt in engineering storage/nursery room #1 on 3rd floor” “Replace 1 - Damaged Brass 1/2” 165 SR on Chrome 401 trim in hallway outside radiologist reading room #4 on 1st floor SSP-1-80-OSO” “Replace 1 - Painted Chrome 1/2” 165 1855 SR SSP on Chrome 2pc trim in hard lid near room1140 diagnostic services on 1st floor” “Replace 1 - Painted Brass 1/2” 165 SR SSP on Chrome 401 trim in elevator lobby B on 1st floor” “Replace 1 - Damaged Brass 1/2” 165 SR SSP on Chrome 401 trim G210 admin hallway outside men’s restroom on 1st floor SSP-1-80-OSO” “Replace 1 - Missing Chrome 401 Skirt outside G210 admin on 1st floor” “Replace 1 - Painted Chrome 1/2” 165 1855F SSP on 2pc chrome trim in hallway hard lid employee health office on Ground floor” “Replace 1 - Painted Chrome 1/2” 165 1855F SSP on chrome 2pc trim in hallway hard lid across from room G250 on Ground floor” “Replace 1 - Painted Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim in G150 hallway outside women’s staff lockers on Ground floor” “Replace 1 - Damaged Chrome 1/2” 155 QR 5.6K SSP on Chrome 401 trim G150 hallway near storage/ office RMS” “Replace 1 - Missing Chrome 401 Skirt outside LL110HRon LL floor” “Replace 1 - Painted Chrome 1/2” 165 1855F SSP on chrome 2pc trim outside blue stairwell on Ground floor” “Replace 1 - Broken 2-1/2” Breakaway Cap at FDC in front of emergency parking” “Replace 2 - Missing VK Model H 165 QR 1/2” Chrome SSP to headbox” Upon interview, Staff 1 acknowledged that the annual fire sprinkler ITM had failed. 6 .On 12/12/24 at 8:38 a.m., the facility failed to provide the five-year fire sprinkler ITM documentation. An inspection sticker on a pipe in the fire pump room indicated the last 5-year inspection was conducted in March of 2017. Upon interview, Staff 1 acknowledged that they did not have current 5-year fire sprinkler system ITM documentation. 46858 7. On 12/12/24 at 10:12 a.m., the facility was missing records for 12 of 12 monthly inspections for the sprinkler gauges and valves of the offsite fourth-floor Surgery Center. During a concurrent interview, Staff 6 stated that he had recently taken over maintenance responsibilities for the Surgery Center and confirmed there were no records of gauge and valve inspections available. 8. On 12/12/24 at 10:13 a.m., the facility was missing records for three of four quarterly sprinkler inspections for the offsite fourth-floor Surgery Center. The facility failed to conduct inspections during the first (January, February, March) and second quarter (April, May, June) of 2024 and, the fourth quarter (October, November, December) of 2023. The date of the last annual inspection was 9/19/24. During a concurrent interview, Staff 6 stated that he had recently taken over maintenance responsibilities for the Surgery Center and confirmed there were no records of quarterly inspections available. 9. On 12/12/24 at 10:14 a.m., the facility was missing records for semi-annual water flow sprinkler system test for the offsite fourth-floor Surgery Center. The date of the last semi-annual sprinkler system test were unknown. During a concurrent interview, Staff 6 stated that he had recently taken over maintenance responsibilities for the Surgery Center and confirmed there were no records of semi-annual test available. 10. On 12/12/24 at 10:15 a.m., the facility was missing records to show that a five-year inspection/test had been conducted on the automatic sprinkler system of the offsite fourth-floor Surgery Center. The date of the last five-year sprinkler system inspection/test was unknown. During a concurrent interview, Staff 6 stated that he had recently taken over maintenance responsibilities for the Surgery Center and confirmed there were no records of a five-year test available.”

“Sprinkler System - Out of Service CFR(s): NFPA 101 Sprinkler System - Out of Service Where the sprinkler system is impaired, the extent and duration of the impairment has been determined, areas or buildings involved are inspected and risks are determined, recommendations are submitted to management or designated representative, and the fire department and other authorities having jurisdiction have been notified. Where the sprinkler system is out of service for more than 10 hours in a 24-hour period, the building or portion of the building affected are evacuated or an approved fire watch is provided until the sprinkler system has been returned to service. 18.3.5.1, 19.3.5.1, 9.7.5, 15.5.2 (NFPA 25) This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain interim fire measures. This was evidenced by the failure to provide a written fire watch policy. This affected the hospital and the offsite fourth-floor Surgery Center, and could result in not having procedures in place to initiate a fire watch when the fire sprinkler system was inoperable. Findings: During record review and interview with staff, the interim fire measures and policies were requested. 1. On 12/12/24 at 8:39 a.m., the facility failed to provide a Hospital fire watch policy and procedure that the facility would use in the event the fire sprinkler system was out of services for more than 10 hours in a 24-hour period. There was no policy and procedure available for review. Upon interview, Staff 1 acknowledged that there was no policy available for review. 46858 2. On 12/12/24 at 10:32 a.m., the facility failed to provide a written policy for a fire watch in the event the sprinkler system was down for more than ten hours in the offsite fourth-floor Surgery Center. During a concurrent interview, Staff 6 stated he was unsure if the facility had a written fire watch policy to provide.”

“Portable Fire Extinguishers CFR(s): NFPA 101 Portable Fire Extinguishers Portable fire extinguishers are selected, installed, inspected, and maintained in accordance with NFPA 10, Standard for Portable Fire Extinguishers. 18.3.5.12, 19.3.5.12, NFPA 10 This Standard is not met as evidenced by: 46858 Based on observation and interview, the facility failed to maintain the portable fire extinguishers. This was evidenced by an obstructed fire extinguisher. This could result in a delay of fire protection in the event of a fire. This affected the second floor of the Hospital. NFPA 101: Life Safety Code, 2012 Edition 19.3.5.12 Portable fire extinguishers shall be provided in all health care occupancies in accordance with 9.7.4.1. 9.7.4.1 * Where required by the provisions of another section of this Code, portable fire extinguishers shall be selected, installed, inspected, and maintained in accordance with NFPA 10, Standard for Portable Fire Extinguishers. NFPA 10: Standard for Portable Fire Extinguishers, 2010 Edition 6.1.2 Extinguisher Readiness. Portable fire extinguishers shall be maintained in a fully charged and operable condition and shall be kept in their designated places at all times when they are not being used. 6.1.3.1 Fire extinguishers shall be conspicuously located where they are readily accessible and immediately available in the event of fire. 6.1.3.3.1 Fire extinguishers shall not be obstructed or obscured from view. Findings: During a tour of the facility and interview with staff, the portable fire extinguishers were observed. On 12/10/24 at 8:26 a.m., the fire extinguisher on the east wall of the second floor Serving Area of the Hospital was observed. The fire extinguisher was observed obstructed from access by a metal food cart. The food cart was observed directly in front of the fire extinguisher. During a concurrent interview, Staff 1 confirmed the finding and stated the food cart should not have been placed in that location.”

“Corridor - Doors CFR(s): NFPA 101 Corridor - Doors Doors protecting corridor openings in other than required enclosures of vertical openings, exits, or hazardous areas resist the passage of smoke and are made of 1 3/4 inch solid-bonded core wood or other material capable of resisting fire for at least 20 minutes. Doors in fully sprinklered smoke compartments are only required to resist the passage of smoke. Corridor doors and doors to rooms containing flammable or combustible materials have positive latching hardware. Roller latches are prohibited by CMS regulation. These requirements do not apply to auxiliary spaces that do not contain flammable or combustible material. Clearance between bottom of door and floor covering is not exceeding 1 inch. Powered doors complying with 7.2.1.9 are permissible if provided with a device capable of keeping the door closed when a force of 5 lbf is applied. There is no impediment to the closing of the doors. Hold open devices that release when the door is pushed or pulled are permitted. Nonrated protective plates of unlimited height are permitted. Dutch doors meeting 19.3.6.3.6 are permitted. Door frames shall be labeled and made of steel or other materials in compliance with 8.3, unless the smoke compartment is sprinklered. Fixed fire window assemblies are allowed per 8.3. In sprinklered compartments there are no restrictions in area or fire resistance of glass or frames in window assemblies. 19.3.6.3, 42 CFR Parts 403, 418, 460, 482, 483, and 485 Show in REMARKS details of doors such as fire protection ratings, automatics closing devices, etc. This Standard is not met as evidenced by: 46858 Based on observation and interview, the facility failed to maintain the corridor doors. This was evidenced by non-latching and obstructed corridor doors. This can increase the passage of smoke through smoke compartments. This affected the tenth, eighth and, sixth floors of the Hospital and, the offsite fourth-floor Surgery Center. Findings: During a tour of the facility and interview with staff, the corridor doors were observed. 1. On 12/9/24 at 11:03 a.m., the corridor door to the tenth-floor Center Medical Room of the Hospital was observed with a self-closing mechanism. The corridor door failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the door had failed to latch due to the strike plate being covered with medical tape. 2. On 12/9/24 at 11:21 a.m., the corridor door to Room 1022 of the Hospital failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the unadjusted strike plate prevented the door from closure. 3. On 12/9/24 at 11:24 a.m., the corridor door to Room 1015 of the Hospital failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the unadjusted strike plate prevented the door from closure. 4. On 12/9/24 at 11:26 a.m., the corridor door to Room 1013 of the Hospital was observed obstructed from closure by a biohazard bin. The bin was observed at the base of the door. During a concurrent interview, Staff 7 confirmed the finding and stated that the Nursing Staff should have known to avoid placing items in front of the doors. 5. On 12/9/24 at 11:51 a.m., the corridor door to the south entrance of the eighth-floor Activities Room of the Hospital was observed obstructed from closure by a blue plastic chair. The chair was observed at the base of the door, preventing it from closure. During a concurrent interview, Staff 7 confirmed the finding and stated that the chair should have not been placed in that location. 6. On 12/9/24 at 2:07 p.m., the corridor door to the sixth-floor Staff Lounge of the Hospital was observed with a self-closing mechanism. The corridor door failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the door had failed to latch due to the strike plate being covered with medical tape. 7. On 12/10/24 at 10:35 a.m., the corridor door to the Registration Office of the offsite fourth-floor Surgery Center failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the door failed to close due to sticky latching hardware. 8. On 12/10/24 at 2:11 p.m., the corridor door to Operating Room 3 on the first floor of the Hospital was observed with a self-closing mechanism. The corridor door failed to latch when tested for closure. The door was tested for closure approximately three times. During a concurrent interview, Staff 7 confirmed the finding and stated that the unadjusted closing mechanism prevented the door from closure.”

“Subdivision of Building Spaces - Smoke Barrie CFR(s): NFPA 101 Subdivision of Building Spaces - Smoke Barrier Doors 2012 EXISTING Doors in smoke barriers are 1-3/4-inch thick solid bonded wood-core doors or of construction that resists fire for 20 minutes. Nonrated protective plates of unlimited height are permitted. Doors are permitted to have fixed fire window assemblies per 8.5. Doors are self-closing or automatic-closing, do not require latching, and are not required to swing in the direction of egress travel. Door opening provides a minimum clear width of 32 inches for swinging or horizontal doors. 19.3.7.6, 19.3.7.8, 19.3.7.9 This Standard is not met as evidenced by: 46858 Based on observation and interview, the facility failed to maintain the smoke barrier doors. This was evidenced by obstructed fire-barrier doors. This can increase the passage of smoke through smoke compartments. This affected the first floor of the Hospital. Findings: During a tour of the facility and interview with staff, the fire-barrier doors were observed. 1. On 12/9/24 at 11:38 a.m., the cross-corridor fire barrier doors on the Lower Level of the hospital, near the training rooms were observed. Both doors were held open by magnetic hold open devices. A blue plastic bag containing linens was on the floor, up against the right-side door leaf. Upon interview, Staff 2 acknowledged that the door was obstructed by the blue plastic bag. 2. On 12/11/24 at 9:24 a.m., the first-floor fire-barrier doors connecting the Hospital and the 1800 Building were observed with self-closing mechanisms. The fire barrier doors were observed being held open by an approximately 50-gallon trash bin and linen sheets. The left door was observed with the trash bin at the base of the door, preventing it from closure. The right door was observed with linen sheets being wedged under the base of the door, preventing it from closure. During a concurrent interview, Staff 1 confirmed the finding and stated that she was aware the doors were being held open.”

“HVAC CFR(s): NFPA 101 HVAC Heating, ventilation, and air conditioning shall comply with 9.2 and shall be installed in accordance with the manufacturer’s specifications. 18.5.2.1, 19.5.2.1, 9.2 This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain the integrity of the heating, ventilation, and air-conditioning (HVAC) system. This was evidenced by deficiencies on the fire damper inspection that were not repaired. This affected the hospital and could result in the spread of smoke in the event of a fire. NFPA 101: Life Safety Code, 2012 Edition 19.5.2 Heating, Ventilating, and Air-Conditioning. 19.5.2.1 Heating, ventilating, and air-conditioning shall comply with the provisions of Section 9.2 and shall be installed in accordance with the manufacturer ’ s specifications, unless otherwise modified by 19.5.2.2. 9.2 Heating, Ventilating, and Air-Conditioning. 9.2.1 Air-Conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air-conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air-Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating and Air-Conditioning Systems, as applicable, unless such installations are approved existing installations, which shall be permitted to be continued in service. NFPA 90A: Standard for the Installation of Air-Conditioning and Ventilating Systems, 2012 Edition 5.4.8 Maintenance. 5.4.8.1 Fire dampers and ceiling dampers shall be maintained in accordance with NFPA 80, Standard for Fire Doors and Other Opening Protectives. NFPA 80: Standard for Fire Doors and Other Opening Protectives, 2010 Edition 19.3.4 Documentation. All inspections and testing shall be documented, indicating the location of the fire damper, date(s) of inspection, name of inspector, and deficiencies discovered. The documentation shall have a space to indicate when and how the deficiencies were corrected. 19.4 * Periodic Inspection and Testing. 19.4.1.1 The test and inspection frequency shall then be every 4 years, except in hospitals, where the frequency shall be every 6 years. During record review and interview with staff, the fire dampers inspection records were reviewed. At 4:14 p.m., the Hospital document labeled “Fire Damper Inspection Sheet” was reviewed. The inspection report indicated the fire dampers were inspected in April and May of 2024 and listed the following failed dampers: Damper LL-033 failed- “Broken Volume Control Thermal Link” Damper LL-116 failed- “Needs New Round CRD, Needs New Volume Control Thermal Link” Damper LL-130 failed- “Needs New Belimo FSLF-120” Damper LL-136 failed- “No Power Needs Electrician” Damper LL-140 failed- “Needs New Belimo FSLF-120” Damper LL-142 failed- “Needs New Belimo FSLF-120” Damper LL-143 failed- “Needs New Belimo FSLF-120” Damper G-053 failed- “No Power Needs Electrician” Damper G-110 failed- “No Access, Under Construction” Damper G-111 failed- ‘No Access, Under Construction” Damper G-152 failed- “No Access, Under Construction” Damper G-153 failed- “No Access, Under Construction” Damper G-156 failed- “No Access, Under Construction” Damper G-157 failed- “No Access, Under Construction” Damper G-192 failed- “Needs New Belimo FSLF-120” Damper G-249 failed- “Needs New Belimo FSLF-120” Damper G-250 failed- “Needs New 12”x12” Spring Loaded Damper” Damper G-251 failed- “Needs New 12”x12” Spring Loaded Damper” Damper G-252 failed- “Needs New 12”x12” Spring Loaded Damper” Damper G-253 failed- “Needs New 12”x12” Spring Loaded Damper” Damper 1-002 failed- “Broken Volume Control Thermal Link” Damper 1-011 failed- “Broken Volume Control Thermal Link” Damper 1-082 failed- “Needs New Belimo FSLF-120” Damper 1-110 failed- “No Access, Under Construction” Damper 1-111 failed-“ No Access, Under Construction” Damper 1-112 failed- “No Access, Under Construction” Damper 1-119 failed- “Needs New Belimo FSLF-120” Damper 1-158 failed- “No Access, Under Construction” Damper 1-181 failed-“ Damper Closed, No Air, Facility Issue” Damper 1-203 failed- “No Access, Under Construction” Damper 1-383 failed- “No Access, Under Construction” Upon interview, Staff 1 acknowledged that the dampers had not been repaired.”

“Elevators CFR(s): NFPA 101 Elevators 2012 EXISTING Elevators comply with the provision of 9.4. Elevators are inspected and tested as specified in ASME A17.1, Safety Code for Elevators and Escalators. Firefighter’s Service is operated monthly with a written record. Existing elevators conform to ASME/ANSI A17.3, Safety Code for Existing Elevators and Escalators. All existing elevators, having a travel distance of 25 feet or more above or below the level that best serves the needs of emergency personnel for firefighting purposes, conform with Firefighter’s Service Requirements of ASME/ANSI A17.3. (Includes firefighter’s service Phase I key recall and smoke detector automatic recall, firefighter’s service Phase II emergency in-car key operation, machine room smoke detectors, and elevator lobby smoke detectors.) 19.5.3, 9.4.2, 9.4.3 This Standard is not met as evidenced by: 43380 Based on observation, record review and interview, the facility failed to maintain the elevators. This was evidenced by the service elevators that were out of service and missing monthly testing and inspection documentation. This affected the Hospital and could result in the malfunction of the elevators. Findings: During a tour of the facility, record review and interview with staff, the elevators were observed, and maintenance records requested. 1. On 12/9/24 at 11:48 a.m., the Hospital B elevators were observed on the lower level. Yellow barriers were placed in front of the elevator vestibule, preventing staff from accessing the elevators on the lower level. Upon interview, Staff 2 stated that one of the B elevators was being decommissioned and the other was being retrofitted because they could no longer locate parts to keep the B elevators in service. Staff 2 also stated that this elevator project was scheduled for completion in February of 2025. (refer to complaint intake CA933012) 2. On 12/12/24 at 8:32 a.m., the Hospital failed to provide written records of monthly Firefighter’s Service tests for nine elevators. No records were available for review. Upon interview, Staff 2 stated that their elevator vendor conducts those monthly tests.”

“Evacuation and Relocation Plan CFR(s): NFPA 101 Evacuation and Relocation Plan There is a written plan for the protection of all patients and for their evacuation in the event of an emergency. Employees are periodically instructed and kept informed with their duties under the plan, and a copy of the plan is readily available with telephone operator or with security. The plan addresses the basic response required of staff per 18/19.7.2.1.2 and provides for all of the fire safety plan components per 18/19.2.2. 18.7.1.1 through 18.7.1.3, 18.7.2.1.2, 18.7.2.2, 18.7.2.3, 19.7.1.1 through 19.7.1.3, 19.7.2.1.2, 19.7.2.2, 19.7.2.3 This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to train the staff on the fire procedures on the psychiatric floor. This was evidenced by a staff member who was unable to explain how to access the fire extinguishers on the floor. This affected the Hospital 8th floor and could result in a delay to accessing the fire extinguisher and activating the fire alarm. Findings: During a tour of the facility, and interview with staff and a Housekeeper, the fire procedures were reviewed. On 12/11/24 at 10:09 a.m., staff in the psychiatric ward on the Hospital 8th floor were interviewed regarding the procedure for accessing the fire extinguishers. A housekeeper was interviewed and was not aware that the fire extinguishers were in locked cabinets and did not know who on the floor had a key to the fire extinguisher cabinets. The Housekeeper stated that if she could not access a fire extinguisher, she would go to the Nurse station. Upon interview, Staff 3 acknowledged that the Housekeeper was not aware the fire extinguishers were in a locked cabinet.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift. The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 19.7.1.4 through 19.7.1.7 This Standard is not met as evidenced by: 46858 Based on record review and interview, the facility failed to maintain fire drill records. This was evidenced by the failure to maintain fire drill records. This could result in a delay in staff response in the event of a fire or disaster emergency. This affected the offsite fourth-floor Surgery Center. Finding: During record review and interview with staff, the facility’s fire drill records were requested. On 12/12/24 at 11:00 a.m., the facility failed to provide any documentation for fire drills for the offsite fourth-floor Surgery Center. During a concurrent interview, Staff 6 stated that he was under the impression that the Engineering Team of the Main Hospital was responsible for conducting the fire drills for the Surgery Center. Staff 1 stated that she was not sure if the fire drills were being conducted at the Surgery Center.”

“Portable Space Heaters CFR(s): NFPA 101 Portable Space Heaters Portable space heating devices shall be prohibited in all health care occupancies, except, unless used in nonsleeping staff and employee areas where the heating elements do not exceed 212 degrees Fahrenheit (100 degrees Celsius). 18.7.8, 19.7.8 This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to follow manufacturer’s directions on space heaters. This was evidenced by a space heater plugged into power strip. This affected the Hospital ground floor and could result in an increased risk of fire. Findings: During a tour of the facility and interview with staff, the space heaters were observed. On 12/9/24 at 2:39 p.m., a portable space heater was observed under the desk of the Payroll Office on the Hospital Ground floor in POD C. The space heater was under the desk, in the on position and was plugged into a power strip on top of the desk. According to the manufacturer’s instructions on a caution label on the portable space heater, the heater should be plugged directly into a wall electrical outlet. Upon interview, Staff 3 acknowledged that the space heater was plugged into a power strip.”

“Construction, Repair, and Improvement Operati CFR(s): NFPA 101 Construction, Repair, and Improvement Operations Construction, repair, and improvement operations shall comply with 4.6.10. Any means of egress in any area undergoing construction, repair, or improvements shall be inspected daily to ensure its ability to be used instantly in case of emergency and compliance with NFPA 241. 18.7.9, 19.7.9, 4.6.10, 7.1.10.1 This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the means of egress in construction areas. This was evidenced by the failure to document egress inspections in areas undergoing construction, repair, or improvements. This affected the Hospital third floor and could result in obstructed egress during an emergency. Findings: During a tour of the facility and interview with staff, the areas undergoing construction, repair, or improvements were observed, and inspection records requested. On 12/12/24 at 8:51 a.m., the Hospital 3rd floor was observed under construction and the daily egress inspection records were requested. The facility failed to provide daily inspection records that would ensure the means of egress could be used instantly in case of emergency. Upon interview, Staff 2 stated that Engineering staff conduct rounds on that floor daily but did not document it.”

“Electrical Systems - Wet Procedure Locations CFR(s): NFPA 101 Electrical Systems - Wet Procedure Locations Operating rooms are considered wet procedure locations, unless otherwise determined by a risk assessment conducted by the facility governing body. Operating rooms defined as wet locations are protected by either isolated power or ground-fault circuit interrupters. A written record of the risk assessment is maintained and available for inspection. 6.3.2.2.8.4, 6.3.2.2.8.7, 6.4.4.2 This Standard is not met as evidenced by: 46858 Based on record review and interview, the facility failed to maintain the electrical system components. This was evidenced by the failure to provide a wet procedure risk assessment. This could result in an electrical fire and affected the fourth-floor Surgery Center. Findings: During record review, and interview with staff, the facility’s electrical system components were observed, and maintenance records were requested. On 12/12/24 at 2:30 p.m., the facility failed to provide documentation to otherwise show that the fourth-floor Surgery Center was deemed not a wet procedure location. The facility provided a general policy and procedure outlining when the facility would conduct risk assessments. There was not sufficient evidence to show the operating rooms were protected by ground-fault circuit interrupters or isolated power. During a concurrent interview, Staff 8 stated that Staff only conducted ocular, gynecological, podiatric surgery and performed local incisions in the facility. Staff 8 stated that the facility used general anesthesia in some cases but was not considered a wet-procedure location.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Alarm Annunciator A remote annunciator that is storage battery powered is provided to operate outside of the generating room in a location readily observed by operating personnel. The annunciator is hard-wired to indicate alarm conditions of the emergency power source. A centralized computer system (e.g., building information system) is not to be substituted for the alarm annunciator. 6.4.1.1.17, 6.4.1.1.17.5 (NFPA 99) This Standard is not met as evidenced by: 43380 Based on observation and interview, the facility failed to maintain the emergency power supply system (EPSS). This was evidenced by the absence of a remote annunciator. This affected the Hospital and could result in staff not being alerted to a generator malfunction in the event of a power outage. NFPA 101, Life Safety Code, 2012 Edition 19.5.1 Utilities. Utilities shall comply with the provisions of section 9.1. 9.1.3.1 Emergency Generators and standby power systems shall be installed, tested, and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems. NFPA 99, Health Care Facilities Code, 2012 edition. 6.4.1.1.17 Alarm Annunciator. A remote annunciator that is storage battery powered shall be provided to operate outside of the generating room in a location readily observed by operating personnel at a regular work station (see 700.12 of NFPA 70, National Electrical Code). The annunciator shall be hard-wired to indicate alarm conditions of the emergency or auxiliary power source as follows: (1) Individual visual signals shall indicate the following: (a) When the emergency or auxiliary power source is operating to supply power to load (b) When the battery charger is malfunctioning (2) Individual visual signals plus a common audible signal to warn of an engine-generator alarm condition shall indicate the following: (a) Low lubricating oil pressure (b) Low water temperature (below that required in 6.4.1.1.11) (c) Excessive water temperature (d) Low fuel when the main fuel storage tank contains less than a 4-hour operating supply (e) Overcrank (failed to start) (f) Overspeed 6.4.1.1.17.1 * A remote, common audible alarm shall be provided as specified in 6.4.1.1.17.4 that is powered by the storage battery and located outside of the EPS service room at a work site observable by personnel. [110:5.6.6] 6.4.1.1.17.2 An alarm-silencing means shall be provided, and the panel shall include repetitive alarm circuitry so that, after the audible alarm has been silenced, it reactivates after the fault condition has been cleared and has to be restored to its normal position to be silenced again. [110:5.6.6.1] 6.4.1.1.17.3 In lieu of the requirement of 5.6.6.1 of NFPA 110, a manual alarm-silencing means shall be permitted that silences the audible alarm after the occurrence of the alarm condition, provided such means do not inhibit any subsequent alarms from sounding the audible alarm again without further manual action. [110:5.6.6.2] 6.4.1.1.17.4 Individual alarm indication to annunciate any of the conditions listed in Table 6.4.1.1.16.2 shall have the following characteristics: (1) It shall be battery powered. (2) It shall be visually indicated. (3) It shall have additional contacts or circuits for a common audible alarm that signals locally and remotely when any of the itemized conditions occurs. (4) It shall have a lamp test switch(es) to test the operation of all alarm lamps. Findings: During a tour of the facility, and interview with staff, the EPSS was observed. On 12/10/24 at 9:50 a.m., the Hospital was observed with two 1000-Kilowatt diesel fueled generators in the lower level of the Engineering Plant. There was no remote annunciator provided to operate outside of the generating room in a location readily observed by operating personnel at a regular workstation. Upon interview, Staff 3 stated that the Engineering Plant was staffed 24 hours a day and if the generators kicked on, it would be obvious.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Maintenance and Testing The generator or other alternate power source and associated equipment is capable of supplying service within 10 seconds. If the 10-second criterion is not met during the monthly test, a process shall be provided to annually confirm this capability for the life safety and critical branches. Maintenance and testing of the generator and transfer switches are performed in accordance with NFPA 110. Generator sets are inspected weekly, exercised under load 30 minutes 12 times a year in 20-40 day intervals, and exercised once every 36 months for 4 continuous hours. Scheduled test under load conditions include a complete simulated cold start and automatic or manual transfer of all EES loads, and are conducted by competent personnel. Maintenance and testing of stored energy power sources (Type 3 EES) are in accordance with NFPA 111. Main and feeder circuit breakers are inspected annually, and a program for periodically exercising the components is established according to manufacturer requirements. Written records of maintenance and testing are maintained and readily available. EES electrical panels and circuits are marked, readily identifiable, and separate from normal power circuits. Minimizing the possibility of damage of the emergency power source is a design consideration for new installations. 6.4.4, 6.5.4, 6.6.4 (NFPA 99), NFPA 110, NFPA 111, 700.10 (NFPA 70) This Standard is not met as evidenced by: 46858 Based on document review, observation and interview, the facility failed to maintain the Emergency Power Supply System (EPSS). This was evidenced the failure to conduct required tests to the EPSS. This affected the Hospital and the fourth-floor Surgery Center. NFPA 101, Life Safety Code, 2012 Edition 21.5.1 Utilities. 21.5.1.1 Utilities shall comply with the provisions of Section 9.1. 9.1.3 Emergency Generators and Standby Power Systems. Where required for compliance with this Code, emergency generators and standby power systems shall comply with 9.1.3.1 and 9.1.3.2. 9.1.3.1 Emergency generators and standby power systems shall be installed, tested, and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems. NFPA 110, Standard for Emergency and Standby Power Systems, 2010 Edition 5.6.5.6 * All installations shall have a remote manual stop station of a type to prevent inadvertent or unintentional operation located outside the room housing the prime mover, where so installed, or elsewhere on the premises where the prime mover is located outside the building. 5.6.5.6.1 The remote manual stop station shall be labeled. 8.1* General. 8.1.1 The routine maintenance and operational testing program shall be based on all of the following: (1) Manufacturer ’ s recommendations (2) Instruction manuals (3) Minimum requirements of this chapter (4) The authority having jurisdiction 8.3.7.1 Maintenance of lead-acid batteries shall include the monthly testing and recording of electrolyte specific gravity. Battery conductance testing shall be permitted in lieu of the testing of specific gravity when applicable or warranted. 8.3.8 A fuel quality test shall be performed at least annually using tests approved by ASTM standards. 8.4 Operational Inspection and Testing. 8.4.1* EPSSs, including all appurtenant components, shall be inspected weekly and exercised under load at least monthly. 8.4.2* Diesel generator sets in service shall be exercised at least once monthly, for a minimum of 30 minutes, using one of the following methods: (1) Loading that maintains the minimum exhaust gas temperatures as recommended by the manufacturer (2) Under operating temperature conditions and at not less than 30 percent of the EPS nameplate kW rating Findings: During document review and interview with staff, the generator inspection and testing records were requested. 1. On 12/11/24 at 9:51 a.m., the Hospital automatic transfer switch (ATS) alarm panel on a wall above a work bench in the Engineering Plant was observed. The alarm panel indicated that there were six ATS’s and the red light for ATS A2 was illuminated. Upon interview, Staff 5 stated that ATS 2 was not working and needed to be replaced and the electrical load had been switched from ATS 2 to ATS 1 while they develop a plan to replace ATS 2. 2. On 12/12/24 at 9:09 a.m., the facility failed to conduct 52 of 52 weekly generator visual inspections for the facility’s 350-kilowatt (kW) diesel generator of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he had not conducted any weekly inspections to the generator. Staff 6 stated he was under the impression that the Engineering Team of the Main Hospital was responsible for conducting the weekly generator inspection. 3. On 12/12/24 at 9:10 a.m., the facility failed to conduct 12 of 12 monthly load tests for the facility’s 350-kW diesel generator of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he had not conducted any monthly load tests to the generator. Staff 6 stated he was under the impression that the Engineering Team of the Main Hospital was responsible for conducting the monthly load tests. 4. On 12/12/24 at 9:11 a.m., the facility failed to conduct 12 of 12 monthly conductance tests for the facility’s 350-kW diesel generator batteries of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he had not conducted any monthly conductance tests to the generator batteries. Staff 6 stated he was not aware conductance testing was required. 5. On 12/12/24 at 10:37 a.m., the facility failed to conduct the annual fuel quality test for the facility’s 350-kW diesel generator of the fourth-floor Surgery Center. The date of the last fuel-quality test was unknown. During a concurrent interview, Staff 6 confirmed the finding and stated that the annual fuel test had not been conducted during the four-hour load test dated 8/9/24. 6. On 12/12/24 at 2:38 p.m., the facility’s 350-kilowatt diesel generator was observed without a remote stop switch of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 confirmed the finding and stated that he was not aware the emergency generator was required to be equipped with a remote stop switch.”

“Gas Equipment - Testing and Maintenance Requi CFR(s): NFPA 101 Gas Equipment - Testing and Maintenance Requirements Anesthesia apparatus are tested at the final path to patient after any adjustment, modification or repair. Before the apparatus is returned to service, each connection is checked to verify proper gas and an oxygen analyzer is used to verify oxygen concentration. Defective equipment is immediately removed from service. Areas designated for servicing of oxygen equipment are clean and free of oil, grease, or other flammables. Manufacturer service manuals are used to maintain equipment and a scheduled maintenance program is followed. 11.4.1.3, 11.5.1.3, 11.6.2.5, 11.6.2.6 (NFPA 99) This Standard is not met as evidenced by: 46858 Based on document review and interview, the facility failed to maintain the medical gas supply system. This was evidenced by the failed medical gas equipment and missing medical gas service records. This could result in a malfunction in the medical gas supply system. This affected the Hospital and the offsite fourth-floor Surgery Center. Findings: During a tour of the facility and interview with the staff, the medical gas supply service records were requested and reviewed. 1. On 12/12/24 at 8:23 a.m., the facility’s preventative maintenance records for the Hospital medical gas system were reviewed. The medical gas service records dated 6/19/24 displayed 73 deficient items to have failed. The failed items include: FIRST FLOOR OR 11 HOSE DROP B - VACUUM (B) LEAKS WITHOUT ADAPTER - FAIL OR 11 HOSE DROP C - VACUUM (C) REDUCED FLOW - FAIL OR 12 HOSE DROP A - VACUUM (A) REDUCED FLOW - FAIL OR 12 HOSE DROP B - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL OR 12 HOSE DROP C - VACUUM (B) REDUCED FLOW - FAIL PACU 8 - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL RESPIRATORY WORK ROOM - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL ED TREATMENT ROOM 5 - VACUUM - LEAKS WITHOUT ADAPTER & REDUCED FLOW - FAIL ED TREATMENT ROOM 8 - OXYGEN - LEAKS WITHOUT ADAPTER - FAIL ED TREATMENT ROOM 12 - VACUUM (B) REDUCED FLOW - FAIL FIRST FLOOR -CONTINUED ICU 3 - OXYGEN (C) LEAKS WITH & WITHOUT ADAPTER - FAIL ICU 4 - OXYGEN (A) & MEDICAL AIR (B) LEAKS WITH ADAPTER INSERTED & OXYGEN (C) ADAPTER WILL NOT LATCH - FAIL ICU 10 - OXYGEN (C) LEAKS WITH & WITHOUT ADAPTER & VACUUM (D) ADAPTER WILL NOT LATCH - FAIL ICU 13 - OXYGEN (B) LEAKS WITH & WITHOUT ADAPTER - FAIL CENTRAL SUPPLY 6 - OXYGEN (B) LEAKS WITHOUT ADAPTER - FAIL THIRD FLOOR MOTHER/BABY ROOM 313 A, B - OXYGEN (A, B) LEAKS WITHOUT ADAPTER - FAIL MOTHER/BABY ROOM 314 A, B - OXYGEN (B) LEAKS WITH ADAPTER INSERTED - FAIL MOTHER/BABY ROOM 315 A, B - OXYGEN (B) LEAKS WITH & WITHOUT ADAPTER - FAIL MOTHER/BABY ROOM 316 A, B - OXYGEN (A, B) LEAKS WITH & WITHOUT ADAPTER - FAIL MOTHER/BABY ROOM 318 A, B - OXYGEN (A, B) LEAKS WITH & WITHOUT ADAPTER - FAIL MOTHER/BABY ROOM 319 A, B - OXYGEN (B) LEAKS WITH ADAPTER INSERTED - FAIL MOTHER/BABY ROOM 320 A, B - OXYGEN (B) LEAKS WITH & WITHOUT ADAPTER - FAIL NURSERY 1 -1 - MEDICAL AIR- LEAKS WITH ADAPTER INSERTED - FAIL LABOR & DELIVERY 300 - OXYGEN - LEAKS WITH & WITHOUT ADAPTER - FAIL LABOR & DELIVERY 302 - MEDICAL AIR (A) LEAKS WITH & WITHOUT ADAPTER - FAIL C-SECTION 1 WALL - OXYGEN (B) LEAKS WITH & WITHOUT ADAPTER - FAIL EXAM 404A - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL EXAM 404 B - OXYGEN - KEY DISC CRACKED WITH EARS & VACUUM - REDUCED FLOW - FAIL EXAM 407 B - VACUUM· REDUCED FLOW - FAIL EXAM 411 - VACUUM· REDUCED FLOW - FAIL EXAM 414 D - KEY DISC CRACKED WTH EARS - FAIL EXAM 419 B - OXYGEN - NEEDS TO BE LABLED - FAIL EXAM 421 B - OXYGEN - NEEDS TO BE LABLED - FAIL FIFTH FLOOR ROOM 517 A, B - VACUUM (A) REDUCED FLOW - FAIL SIXTH FLOOR NURSE MANAGER ROOM 600 - VACUUM - KEY DISC CRACKED WITH EARS - FAIL ROOM 602 A, B - VACUUM -KEY DISC CRACKED WITH EARS - FAIL ROOM 610 A, B - VACUUM (B) KEY DISC CRACKED WITH EARS - FAIL ROOM 615 A, B - VACUUM (A) REDUCED FLOW - FAIL ROOM 616 - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL ROOM 619 A, B - VACUUM (A) REDUCEDFLOW - FAIL SEVENTH FLOOR ROOM 718 - OXYGEN - LEAKS WITHOUT ADAPTER - FAIL ROOM 727 - OXYGEN - LEAKS WITH ADAPTER INSERTED - FAIL NINTH FLOOR ROOM 912 - OXYGEN -KEY DISC CRACKED WITH EARS - FAIL ROOM 916 - VACUUM - LEAKS WITH ADAPTER INSERTED - FAIL ROOM 921 A, B - OXYGEN (A) - LEAKS WITH ADAPTER INSERTED - FAIL ROOM 923 - OXYGEN (A) - LEAKS WITH ADAPTER INSERTED - FAIL TENTH FLOOR HEMODIALYSIS 1 - OXYGEN (B) LEAKS WITHOUT ADAPTER - FAIL HEMODIALYSIS 2 - MEDICAL AIR {B) LEAKS WITH ADAPTER INSERTED - FAIL STORAGE - OXYGEN (B) LEAKS WITH ADAPTER INSERTED - FAIL ROOM 1010 - OXYGEN - LEAKS WITHOUT ADAPTER - FAIL ROOM 1016 - OXYGEN - LEAKS WITHOUT ADAPTER - FAIL ROOM 1017 - VACUUM - REDUCED FLOW - FAIL ROOM 1022 - VACUUM - LEAKS WITHOUT ADAPTER - FAIL ROOM 1023 - VACUUM - REDUCED FLOW - FAIL ROOM 1029 A, B - VACUUM (A) LEAKS WITHOUT ADAPTER - FAIL GROUND FLOOR CATH LAB 3 - NEEDS TO BE LABELED FOR AREA SERVED - FAIL ZONE VALVES FIRST FLOOR PRE-OP/ RESPIRATORY WORK ROOM - NEEDS TO BE LABELED FOR AREAS SERVED - FAIL EQUIPMENT STORAGE - NEEDS TO BE RELABELED: “PRE-OP, TEMPORARY STORAGE, POST-OP OVERFLOW’ - FAIL THIRD FLOOR C-SECTION 2 TRAINING ROOM - OXYGEN LEAKS AT GAUGE PORT - FAIL EIGHTH FLOOR ROOMS 800-808 - ALL OUTLETS HAVE BEEN BLANKED OFF - ZONE VALVES NEED TO BE TURNED OFF, HANDLES REMOVED AND LABLED “NOT IN SERVICE” - FAIL ROOMS 809-817 - ALL OUTLETS HAVE BEEN BLANKED OFF - ZONE VALVES NEED TO BE TURNED OFF, HANDLES REMOVED AND LABLED “NOT IN SERVICE” - FAIL TENTH FLOOR ROOMS 1030-1033 - ZONE VALVE DOOR COVER IS BROKEN WARNING ALARMS MASTER ALARMS ENGINEERING - GROUND FLOOR - NORMAL LIGHT OUT - FAIL PBX MASTER - NORMAL LIGHT OUT - FAIL WARNING ALARMS AREA ALARMS GROUND FLOOR CCU ROOMS 1-7 - NORMAL LIGHT OUT - FAIL CCU ROOMS 8-14 - NORMAL LIGHT OUT - FAIL FIRST FLOOR PACU A-0, ANESTHESIOLOGY, NURSE’S STATION - NORMAL LIGHT OUT - FAIL ER BEDS 1 -12 - NORMAL LIGHT OUT - FAIL CENTRAL SUPPLY 1 - 6 - NORMAL LIGHT OUT - FAIL CENTRAL SUPPLY 7 - 12 - NORMAL LIGHT OUT - FAIL ICU 1-7 - NORMAL LIGHT OUT - FAIL OR 8&9 - NORMAL LIGHT OUT - FAIL During a concurrent interview, Staff 1 stated that she was unsure if the failed medical gas equipment had been serviced. Staff 1 stated that she would search for the repair records of the failed equipment. No service records were submitted before the end of the survey. 2. On 12/12/24 at 11:34 a.m., the facility failed to provide yearly inspection records for the medical gas supply system of the fourth-floor Surgery Center. During a concurrent interview, Staff 6 stated that a vendor had done the yearly service to the medical gas system in July. Staff 6 confirmed that he could not provide service records at the time of the survey. Staff 6 stated that he was under the impression that the Main Hospital Engineering Team was responsible on maintaining the medical gas service records.”

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 31794 Based on observation, interview, and record review the facility failed to ensure the Medical Bylaws Rules and Regulations was implemented when, 1. A. The Emergency Department (ED, also known as Emergency Room (ER), an area in the hospital open 24/7 that treats patients with illnesses and injuries requiring immediate care.) Physician (ED Physician 1) left the ED on 8/1/24 at 10:00 AM and the ED was “left uncovered” (from 10:00 AM to 1:00 PM) for three (3 hours) while the facility was on “diversion (when the ED is temporarily unable to accept new patients and will redirect ambulances to other hospitals). One ED Nurse Practitioner (ED/NP, also called Allied Health Professionals, an Advance Practice Provider) was on site in the ED and one Hospitalist 1 (physician who practices hospital medicine) came to the ED (to provide physician coverage) during the diversion until the ED Physician 3 arrived 1:00 PM. 1.B. One patient (Patient 1) was still in the ED awaiting transfer to the Intensive Care Unit (ICU, area in the hospital where patients with severe or life-threatening receive care and close monitoring) without the “hand off (means “signing out patient to the next provider)” to the next ED Physician (Physician 3) who arrived at 1:00 PM on 8/1/24. These deficient practices had the potential to negatively impact the quality of care rendered to patients and could not ensure patient’s safety. 2. Hospitalist 1 did not have evidence of Influenza (known as flu, is a contagious viral infection that affects the air passages of the lungs) vaccination or declination during the 2023 flu season. 3. Hospitalist 1 did not have evidence Tuberculosis Screening (a process used to detect whether an individual has been infected with the Mycobacterium tuberculosis [TB] that can cause infection in the lungs or other tissues) was completed on Initial appointment (a permission granted to a physician to render specific patient care service in the hospital), on 10/18/23. Failure to ensure staff providing care to the patients was adequately vaccinated /received proper immunization had the potential to place the patients at risk of exposure to communicable diseases (illnesses caused by viruses or bacteria that people spread to one another through contact with contaminated surfaces, bodily fluids, blood products, insect bites, or through the air). Findings: 1. A. During the Entrance Conference group interview on 8/19/24, at 9:41 AM, with the Chief Executive Officer/Administrator, Chief Health Officer (CHO), Emergency Services Department Director (ESD), Corporate Quality Director CQD), Associate Chief Operating Officer (ACOO), Chief Nursing Officer (CNO), Administrator Nursing Supervisor (ANS), Quality Analyst (QA), Clinical Data Analyst (CDA), CHO stated, the ED Providers (ED Physicians, NPs, and the ED Medical Director (EDMD) belonged to the Contracted Group of Providers (CGoP) for the hospital. The ESD stated, when the ED Physician 1 left the ED, the ED went on “diversion” from 10:00AM till 1:00 PM on 8/1/24, the reason for the “diversion” was there was no ED Physician in-person onsite in the ED, and the Providers present were the Hospitalist 1 and the ED/NP 1 until the ED Physician 3 arrived at 1:00 PM on 8/1/24. The ESD stated, the Hospitalist 1 did not have the “competency” and “training” of an ED Physician and one patient (Patient 2) was brought in by the ambulance during the diversion because of “delay in communication” between the hospital and the County. Record review of the document titled, “Narrative of the Investigation”, dated 8/1/24 indicated, the diversion started at “10:29 AM” until “12:53 PM” on 8/1/24. In an interview on 8/19/24, at 10:10 AM, with the CHO, CHO stated, he was part of the CGoP for the hospital and member of the Medical Staff. CHO explained, the ED Physician 1 started her shift in the ED on 7/31/24 at 6:30 PM and her shift was supposed to end at 6:30 AM on 8/1/24, and the ED Physician 2 was scheduled and supposed to come on 8/1/24 at 6:30 AM but “called in sick”. The CHO stated, the ED Physician 1 stayed, the ED/NP 1 started her shift at 9:00 AM, and the ED Medical Director (EDMD 1) called him (CHO) to request the Hospitalist 1 to come to the ED to provide physician coverage. The CHO further stated, when the ED Physician 1 left the ED on 8/1/24 at 10:00 AM, there was no on-site ED Physician, only the Hospitalist 1 and the ED/NP 1 were present, the Hospitalist 1 was “not an ED Physician”, and the ED/NP 1 “worked independently”, but if an ambulance came it would need a physician to do the assessment and the medical management of the patient. The CHO stated, the Hospitalist 1 have the skills to manage patients and he was doing the due process before the ED Physician 3 arrived, however, if a physician was not credentialed, for example a pediatric patient or a pregnant woman came in the ED, the Hospitalist 1 may be able to do the assessment, but it’s “not in his scope of practice”, “it’s not in his specialty”, it will be an assessment to make sure the patient was stable. The CHO stated, at this time the Hospitalist 1 was on vacation and could not be reached for an interview, the ED Physician 1 no longer work for the hospital, and the EDMD 1 whose first day to work as Medical Director for the ED on 8/1/24, no longer work in the hospital. The Regional Director for the CGoP has taken over the position and was now the Interim EDMD 2 beginning 8/2/24. Review of the facility’s Medical Bylaws Rules and Regulations, with the last revised date of 2/8/23 indicated, “ARTICLE XVII, MEDICAL SCREENING EXAM, 17.1 For all patients presenting to xxx (name of Hospitals 1 and 2) Emergency Room, a licensed physician or allied health professional with Emergency Medicine privileges at xxx (name of Hospitals 1 and 2) will perform the medical screening exam.” In an observation and interview on 8/19/24, at 11:53 am, with the ESD with the Corporate Quality Director (CQD) present, the ED located on level 1 (one) of the hospital was observed. The ESD stated, the ED has 12 rooms, and the census was 10 including one “14-year-old”. The ESD further stated, “walked -in” patients were triaged in the Triage area located in the “front”, and the patients with higher acuity were in the “main” ED. Two Providers were present on 8/19/24, one ED Physician 4 and one ED/NP 1. In an interview on 8/19/24, at 12:34 PM, with the ED Registered Nurse (ED/ RN 1), ED/RN 1 stated, she worked in the ED on 8/1/24, morning shift. ED/RN 1 stated, when the ED Physician 1 left the ED on 8/1/24 the Hospitalist 1 came to the ED to provide physician coverage. ED/RN 1 stated, she transferred one patient out with “bleed” who was evaluated by ED Physician 1 before the diversion. The ED/RN 1 stated, she recalled there was one patient (Patient 1) who “coded (medical emergency)” and was evaluated by the ED Physician 1 before she left the ED on 8/1/24. Record review of “ER (Emergency Room Log Report (ERLR)” dated 8/1/24 indicated, Patient 1 was admitted to the ED on 8/1/24 at 8:20 AM with the chief complaint of weakness, “critical”, discharged from the ED on 8/1/24 at 11:03AM, and was transferred out to the ICU. In an interview on 8/19/24, at 12:54 PM, with the ED/NP 1 stated, ED/NP 1 stated, she was NP since 2014, she was part of the CGoP who provided coverage for the ED, her shifts usually start at 12 noon but was asked to come early and she came at 9:00 AM on 8/1/24. When she arrived, the day shift Physician (ED Physician 2) who was supposed to come was not there, the ED Physician 1 was still in the ED, and told her (ED/NP 1) she had “gone thru” all patients in the ED and have to leave. The Hospitalist 1 came to the ED to provide physician coverage after the ED Physician 1 left. The ED/NP 1 stated, as member of the CGoP, “we have a responsibility as a company to provide safe care and as a nurse, “you can’t abandon your patients”, and there was a system to contact the site manager if unable to work. During the diversion, one patient (Patient 2) was brought by the ambulance due to congestive heart failure (CHF, means weak heart), tested positive for Covid (contagious disease caused by a virus), and eventually was transferred out to the ICU. Record review of the ERLR dated 8/1/24 indicated, Patient 2 arrived in the ED on 8/1/24 at 11:23 AM with the chief complaint of shortness of breath, “Condition: Critical”, and was transferred out to the ICU on 8/1/24 at 5:14 PM. In a phone interview on 8/21/24, at 2:02 PM, with the Interim EDMD 2, Interim EDMD 2 stated, he was the Regional Director for the CGoP and worked 30 years in his career. The Interim EDMD 2 stated, the ED Physician 1 was an “independent” staff employed by the CGoP for the hospital. The ED was “left uncovered” when the ED Physician 1 left the ED on 8/1/24, although there was one NP present, the ED Physician 1 should have stayed (till the next ED physician arrived) and not leave the ED without coverage, it’s the most “appalling” thing for a physician to do. In a concurrent interview and record review 8/23/24, at 12:30 PM, with the ESD, the ERLR dated 8/1/24, was reviewed. ESD stated, on 8/1/24 the ED Physician 1 evaluated total of four (4) patients including Patient 1 who was brought in by the ambulance at 8:20 AM and was transferred out to the ICU at 11:03 AM. After the ED Physician 1 left, one patient (Patient 2) was brought in by the ambulance and additional five (5) walked-patients (Patients 3, 4, 5, 6, and 7) presented to the ED during the diversion period (from 10:29 Am to 12:5 PM on 8/1/24). Record review of the ERRL dated 8/1/24 indicated, there were five (5) patients who presented to the ED during the diversion period: Patient 3 arrived at 10:29 AM with the chief complaint of abdominal pain, and was discharged to home at 10:59 AM. Patient 4 arrived at 10:55 AM with the chief complaint of chest, covid positive, and was discharged to home at 11:54 AM. Patient 5 arrived at 11:55 AM with the chief complaint of “unable to eat for seven (7) days” and was discharged to home at 2:21 PM. Patient 6 arrived at 12:01 with the chief complaint of “urine pain” and was discharged to home at 12:55 PM. Patient 7 arrived at 12:41 PM with the chief complaint of “right hand pain” and was discharged to home at 1:41 PM. In an interview on 8/22/24, at 11:37 AM, with the Chief of Staff (CoS), CoS stated, on 8/1/24 he received report the ED Physician 2 did not show and the ED Physician 1 left the ED. The CoS stated, he expected the ED Physician 1 should have stayed until “someone came over,” it was “appalling” to leave patients, it’s as “abandonment” of care, and it’s “against the code of ethics”. The Hospitalist 1 went to the ED, it was a “patch” to fill in, (to provide doctor coverage), but it was a “weak gap”. There was the ED/NP 1 but “they should not be put in that position”, that was the “best we can do” at that moment because the ED did not have an ED Physician. When asked if the EDMD 1 should have shown up after the ED Physician 1 left, CoS nodded his head and stated, he (EDMD 1) should have shown up in the ED on 8/1/24. Review of the facility’s Medical Bylaws Rules and Regulations, with the last revised date of 2/8/23 indicated, “3.3 Basic Responsibilities of Staff Membership. Each member of the Medical Staff shall: 3.3.1 Provide for continuous care of their patients and, in their absence, delegate the responsibility for that care only to other qualified Medical Staff members. 3.3.2 Comply with the provisions of these Bylaws, Department Rules and Regulations, policies of the Medical Staff and policies and rules of the Hospital applicable to members of the Medical Staff. ... . 3.3.4 Be present to provide the care for which they charge. ... .” 1.B. In a concurrent record review and interview on 8/23/24, at 12:38 PM, with the ESD and the CHO, the Emergency Medicine Evaluation Note (EMEN) for Patient 1 done by the ED Physcian1, dated 8/1/24 at 9:01 AM, was reviewed. The EMEN indicated, Patient 1 came with the chief complaint of “syncope (fainting or passing out), had “syncopal posturing (sudden drop in blood pressure and heart rate due to quick change of position), “CPR (cardiopulmonary resuscitation, life saving measures)” was started and was “ventilated (life supports that helps a person breathe).” The ESD stated, Patient 1 was still in the ED when the ED Physician 1 left at 10:00 AM and the patient was transferred out to the ICU at 11:03 AM. Further review of the EMEN indicated, “Patient was discussed with hospitalist and intensivist.” The CHO stated, hand off meant “signing out patient to the next provider” and after he verified the ED practice of “hand off” with the on duty ED Physician 4, the expectation was to document on the patient’s medical record, she/he was signing out the care to the next (ED) Physician. Review of the facility’s Medical Bylaws Rules and Regulations, with the last revised date of 2/8/23 indicated, “ARTICLE XX, ... RULES AND REGULATION OF THE MEDICAL STAFF OF xxx (name of Hospital 1). 1. ADMISSION AND DISCHARGE OF PATIENTS, a. The Hospital shall accept patients for care and treatment of disease for which there are appropriate physical facilities and appropriately trained staff. ... b. For all patients presenting to xxx (name of Hospitals 1 and 2) Emergency Room, a licensed physician with privileges xxx (name of Hospitals 1 and 2) will perform the medical screening exam. ... e. The attending physician shall be responsible for the overall management of the patient. Whenever these responsibilities are transferred to another staff member, a note shall be entered on the order sheet of the medical record. f. Each physician shall be responsible for providing continuous care to all of his patients. ... .” 38612 2. During a concurrent record review and interview on 8/22/24, at 1:20 PM, with Medical Staff Credentialing Coordinator (MSCC) 1, Hospitalist 1’s Credential File (CF, a comprehensive collection of documents and records that verify qualifications of the physician) was reviewed. The CF indicated the Initial Appointment for Hospitalist 1 was on 10/18/23. The CF contained Hospitalist1’s Medical History that includes TB Screening indicating it was administered on 6/16/23 and expired on 6/16/24, and the annual “Tuberculosis Individual Risk Assessment Questionnaire (a TB screening tool used to determine a person’s risk for TB infection) was completed on 7/23/23. MSCC 1 stated TB screening is required annually. MSCC 1 acknowledged Hospitalist 1’s TB screening was expired and did not have a current TB screening. 3. During a concurrent record review and interview with MSCC 1 on 8/22/24 at 2:23 PM, Hospitalist 1’s “Individual Immunization (a process by which a person becomes protected against a disease through vaccination) Compliance Report (IICR),” which included influenza vaccination, dated 7/10/23, was reviewed. MSCC 1 stated the influenza vaccination was completed and administered on 11/17/22 and Hospitalist 1 was due for annual influenza vaccination on 9/1/23. MSCC 1 further stated if physicians refused influenza vaccination, the “Influenza Vaccination Declination Form/2022-23 [2023] (IVDF)” must be completed and signed. MSCC 1 stated Hospitalist 1 did not have a completed and signed IVDF. MSCC 1 stated, “We don’t have a current up to date flu shot (vaccination) on our records (for Hospitalist 1).” During a concurrent interview and review of the facility’s policy and procedure, titled “Employee Health Requirements 2024 (EHR 2024),” on 8/23/24 at 12:36 PM, the CHO verified the EHR 2024 should be implemented by the facility. The EHR 2024 indicated “The following documentation should be submitted to the Medical Staff Office along with new appointment application for [Hospital’s name]. These requirements apply to all directed new hired Healthcare Workers (HCW), affiliated physicians, contract personnel, students, and volunteers ... Influenza vaccine - Documentation to support immunization during flu season. Usually, influenza season runs between October and March OR Declination form following Joint Commission (an accreditation group that develops and upholds patient safety and care standards for hospitals and other healthcare organizations) standards ([Hospital’s name] can provide form if needed). The EHR 2024 further indicated, “Latent Tuberculosis (it means a person is infected with the TB bacteria but has no symptoms of the disease) Screening - Screening within the prior 12 months (PPD [purified protein derivative, a solution administered under the skin to test for TB] or a blood test) AND [Hospital’s name] TB questionnaire (use the most recent version provided by [hospital’s name]). No outside versions accepted. In absence of a latent TB screening test in the past 12 months a 2 (two) -step PPD (a method used to detect latent TB infection that involves two separate skin tests conducted a few weeks apart) may be required ...” Review of facility’s policy and procedure, titled “Credentialing and Privileging Process for the Medical Staff and Allied Health Professionals,” with last revision dated 1/2023, indicated “Policy: this applies to all licensed independent practitioners applying for initial appointment and reappointment to the Medical Staff or AHP (Allied Health Professionals) of [Hospital’s name] ...Procedure ...Privileging and Approval Process ...II. Reappointment Application ...3. The applicant shall submit a complete application that shall include, but not limited to the following: ...l. Recent TB test result ...Flu vaccination record ...” Review of facility’s “Medical Staff Bylaws Rules and Regulations,” with last revision dated 2/2023, indicated “MEDICAL STAFF MEMBERSHIP ... 3.3 Basic Responsibilities of Staff Membership. Each member of the Medical Staff shall ... 3.3.2 Comply with the provisions of these Bylaws, Department Rules and Regulations, policies of the Medical Staff and policies and rules of the Hospital applicable to members of the Medical Staff.””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 38534 Based on interview and record review, the hospital failed to provide stabilizing treatment to one of 23 sampled patients (Patient 19), and failed to ensure one of 23 sample selected patients (Patient 7) received and signed all the paperwork for Against Medical Advise (AMA) before leaving the facility. The deficient practices had the potential to cause serious injury or death for Patient 19, resulting in immediate jeopardy, had the potential to cause serious consequences for Patient 7’s health, and had the potential to recur for other patients. Findings: 1. Refer to A-2407 regarding the hospital’s failure to provide stabilizing treatment to Patient 19. 2. A review of Patient 7’s “Outpatient/ER (emergency Room) Record” indicated Patient 7 arrived at the ER at 11:42 a.m., and left 1:18 p.m., on the same day. A review of Patient 7’s “Physical assessment” indicated Patient 7 left AMA and “ ...AMA disclosure signed ...” During a concurrent interview and record review on 4/24/24 at 3:00 p.m., with the Quality Nurse (QN), QN reviewed the chart for Patient 7 and could not find AMA and stated she could not find AMA documents for Patient 7. During an interview on 2/25/24 at 10:15 a.m., with the Quality Director (QD), QD stated he could not find any AMA documents for Patient 7. Furthermore stated, it is important for the patients to sign the AMA forms because the facility want to make sure patients understand the possibility of outcome of leaving facility against medical advise. A review of the facility’s policy and procedure “AMA (Against Medical Advise) revised 06/2022 indicated “ ... 5. The patient shall be requested to sign the form” leaving Hospital Against Advise.” This form shall be to be kept in the patient’s medical record ...””

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 48116 Based on observation, interview and record review, the facility failed to have the required patient rights signage posted at the pedestrian and ambulance (a vehicle equipped for transporting sick or injured people to the hospital especially in emergencies) Emergency Department (ED) entrances on the first floor. This failure had the potential for individuals to be uninformed of their rights to receive emergency medical care under EMTALA (Emergency Medical Treatment and Labor Act, law which required emergency departments to screen and provide stabilizing treatment to any individual coming to that department). Findings: During a concurrent observation and interview on 4/23/24, at 10:19 a.m. with Quality Analyst 1 (QA1) at the pedestrian entrance of the ED, there was no visible EMTALA sign. QA1 confirmed there was no EMTALA sign. During a concurrent observation and interview on 4/23/24, at 10:24 a.m. with QA1 and the Emergency Department Manager (EDM) at the ambulance entrance of the ED, there was no visible EMTALA sign. QA1 and EDM confirmed there was no EMTALA sign. A review of the facility’s policy and procedures (P&P), titled “Emergency Medical Treatment & Active Labor Act (EMTALA)” dated 8/21, showed “ ...General Policies: 1. Signage: A ...Signs shall be posted in the Emergency Department ...where patients may present for emergency services ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 26674 Based on interview and record review, the hospital failed to provide stabilizing treatment within its capability and capacity to 1 of 23 sampled patients (Patient 19). Patient 19 had a worsening subdural hematoma (bleeding between the layers of membranes surrounding the brain) and an elevated INR (international normalized ratio, a measure of blood clotting in which elevated values indicate poor clotting ability), but did not receive fresh frozen plasma (FFP, the liquid portion of blood used to treat clotting disorders) which had been ordered by the ED (Emergency Department) Physician (MD 1) prior to Patient 19’s transfer to Hospital B over eight hours later. The deficient practice had the potential to cause Patient 19 to suffer brain damage or death, and had the potential to recur for other patients, resulting in immediate jeopardy. Findings: Review of Patient 19’s medical record indicated Patient 19 was seen in the hospital’s ED on 4/17/24. Patient 19’s “EMERGENCY MEDICINE EVALUATION NOTE” dated 4/17/24 indicated, “He is currently non-verbal ... the patient appeared to be verbal as recently as March 18th on an emergency visit here ... INR 1.52 [a ratio indicating the prothrombin time, a measurement of how long blood takes to clot, is 1.52 times normal] ... The head CT [computed tomography, an imaging technique in which a computer constructs cross-sectional images from multiple x-rays] shows a large right-sided subacute [recent onset] versus chronic subdural hematoma with midline shift [a sign of blood squeezing the brain] ... of 1.5 cm [centimeters] ... The patient was seen most recently on March 18th in the emergency department here and was found to have a subdural hematoma ... today’s CT is considerably worse. It does appear he was transferred to [Hospital B] for his last subdural ... Given the significant interval worsening in the subdural with midline shift, I spoke with the [Hospital B] transfer center to discuss transfer back to [Hospital B] given that we do not have neurosurgery available here ... I spoke with the accepting neurosurgeon ... She requests FFP given that the INR is elevated ... According to family the patient was walking as recently as 3 days ago with a walker but then became weak and could no longer walk. He was speaking at least somewhat until today. The family does give verbal consent for blood transfusion ... The patient presents with a very extensive subdural hematoma versus hygroma [when the fluid which normally surrounds the brain leaks between the membranes which normally surround the fluid] has evidence of midline shift. He is at risk of deterioration including death.” Patient 19’s nursing progress notes indicated, “Date and Time of Transfer: 4/17/2024 13:20”. Review of the “Order Chronology” in Patient 19’s electronic medical record indicated an order for “BB FFP [blood bank fresh frozen plasma] (ORDER)x1” dated 4/17/24 was present. Review of the “ORDER INFORMATION” screen indicated Patient 19’s “BB FFP” order was electronically signed by MD 1 on 4/17/24 at 4:47 AM and verified by an unspecified nurse at the same date and time. A field marked “Questions:” indicated, “Date of Transfusion Now Indications SDH [subdural hematoma], elevated INR”. Review of the “ORDER HISTORY” screen indicated Patient 19’s “BB FFP” order was assigned order number 1723512 and was completed on 4/18/24 at 2:23 p.m. (after Patient 19 had been transferred to Hospital B). Review of the “MEDICATION ADMINISTRATION RECORD” for “Date Range: 4/17/2024 04:00 - 4/25/2024 10:00” indicated there was no documentation the FFP had been administered. Review of an undated printout from the hospital’s Sunquest lab information system indicated for Patient 19’s “BB FFP (ORDER) ORDER # 23512” ordered “4/17/2024 0447”, two units of FFP had both been thawed, then “REL FROM ALLOC” (released from allocation). In a concurrent interview and record review on 4/24/24 from 4:05 p.m. to 4:30 p.m., the Blood Bank Director (BBD) stated her records indicated that FFP was ordered for Patient 19, two units FFP were thawed by the Blood Bank and were available approximately 6:30 a.m. on 4/17/24 to be picked up by the ED Nursing staff, who were to be notified the FFP was ready. Review of the “Order Receipt/Modification” screen on the BBD’s computer indicated an order to “TRANSFUSE FFP” dated 4/17/24 for Patient 19 was assigned accession number W6470. Review of the undated screen in the BBD’s computer titled “Blood Order Processing - W6470” indicated the screen showed Patient 19’s name, serial numbers for two units of FFP (unit numbers W 2006 23 882344 1 and W 2006 23 105356 0), and indicated both units had status “RL”. The BBD stated the notations on the screen meant the two units were allocated to Patient 19 but were released from allocation. Review of two documents titled “Unit History” (printed 4/24/24), one each for FFP unit numbers W 2006 23 882344 1 and W 2006 23 105356 0, indicated each unit had been allocated to Patient 19 on 4/17/24 at 6:35 a.m., then released from allocation on 4/18/24 at 2:22 p.m. The documents indicated both units were discarded on 4/18/24. The BBD stated both units of FFP assigned to Patient 19 were discarded, and the most likely explanation was that they were never picked up from the blood bank. Review of the “Blood Bank Department Communication Log for Blood Components Issuance and Delay” indicated there were no entries between 4/16/24 and 4/21/24. The BBD stated blood products ready for pick-up were normally entered on the communication log. She acknowledged there were no entries for Patient 19’s FFP on 4/17/24. The BBD stated she would speak with the staff member who processed Patient 19’s FFP. In a concurrent interview and record review on 4/25/24 at 12:59 p.m., the ED Manager (EDM) presented a second copy of the Sunquest printout regarding Patient 19’s “BB FFP (ORDER)”. The document had a hand written notation adjacent to “REL FROM ALLOC” indicating, “means wasn’t transfused”. The EDM stated the notation “REL FROM ALLOC” on the Sunquest printout meant the units had been released from allocation to a specific patient because they had not been given. The EDM stated the hospital had not been aware of the problem prior to the survey. In an interview on 4/25/24 at 1:10 p.m., the Director of Quality (DQ) stated that the hospital had not done any quality analysis regarding Patient 19’s “FFP issue” because it “only happened a week ago.” In an interview on 4/26/24 at 9:45 a.m., the BBD stated the lab technician who processed Patient 19’s FFP on 4/17/24 did notify the ED the FFP was ready, but couldn’t remember who he spoke with or explain why he didn’t enter the communication on the log. The BBD stated there was no other documentation that the ED had been notified Patient 19’s FFP was ready for pick-up. The BBD did not provide the name of the lab technician. In an interview on 4/26/24 at 09:50 a.m., the DQ stated a failure to administer a transfusion of blood products on 4/17/24 would normally be reviewed by the Quality Committee on 4/29/24. In an interview on 4/26/24 at approximately 11:15 a.m., the Chief Nursing Officer (CNO) stated MD 1 had refused to be interviewed, one of the two nurses involved in Patient 19’s care was on leave, and the other nurse could not remember Patient 19. Review of the UpToDate (an online medical reference) article “Subdural hematoma in adults: Management and prognosis” indicated, “Subdural hematoma (SDH) can be a neurologic emergency that may cause irreversible brain injury and death caused by hematoma expansion, elevated intracranial [inside the skull] pressure (ICP), and brain herniation [when pressure on the brain squeezes it through openings in membranes inside the skull or through an opening at the base of the skull]. Patients with SDH require urgent assessment of clinical status, the management of any antithrombotic [blood thinning] medications, and evaluation of the need for immediate surgery...” The surveyors declared an immediate jeopardy situation on 4/25/24 at 4:34 p.m. in the presence of the DQ, the EDM, the CNO, and the chief health officer. On 4/26/24, the hospital submitted a removal plan stating the facility would retrain its ED and blood bank staff regarding their responses to blood product orders, that the hospital would modify its ED policies to require reassessments of patients awaiting transfer and retrain its ED staff on the policy changes, and that the hospital would monitor compliance. On 4/30/24, the hospital presented documentation that ED and blood bank employees were being retrained as they reported for duty. The surveyors therefore declared the immediate jeopardy removed on 4/30/24 at 12:18 p.m. in the presence of the DQ, the EDM, the CNO, and the chief health officer.”