Loma Linda University Medical Center

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 51099 Based on interview and record review, facility failed to ensure patient education and communication were provided in a manner that supported informed decision-making for one of 30 sampled patients (Patient 19), when nursing documentation reflected education on safety and fall prevention was provided without evidence of interpreter involvement. This failure had the potential to result in the patient not being fully informed and or understanding of instructions to make decisions regarding medical care, and to create a distrust toward the healthcare team, which could have contributed to the patient’s fall and jeopardized health and safety. Findings: During a review of Patient 19’s face sheet (contains demographic and medical information), undated, the face sheet indicated, Patient 19 was admitted to the facility on May 14, 2025, with diagnoses which included End-Stage Renal Disease (ESRD- kidneys have stopped working well enough to keep one alive) on peritoneal (belly) dialysis (way to clean out blood when kidneys are not working properly); anemia (body does not have enough healthy red blood cells to carry oxygen to the body); peritoneal dialysis catheter leakage [the fluid that is supposed to stay inside the belly during peritoneal dialysis (PD) starts leaking out through catheter (soft, thin, flexible tube used to put fluids in or take fluids out of the body) site or surrounding tissues (group of cells that team up to do a specific job)]. During a review of Patient 19’s “[name] Fall Risk Score,” dated May 22, 2025, the record indicated Patient 19 was identified as a “high fall risk” with a score of 16, based on the fall assessment risk (a tool used to determine the patient is at risk for falling; scoring from 7-10 is low risk; scoring 11-14 is moderate risk; scoring above 15 is high risk). During a review of Patient 19’s “Learning Assessment,” dated February 1, 2024, (previous admission) reflected Japanese as the preferred language, with interpreter services recommended. During a review of Patient 19’s “Physician Progress Note,” dated May 15, 2025, the record indicated, “ ...Pt (patient) preferred to use translator app on her phone during discussion ...” During a review of Patient 19’s “Learning Assessment,” dated June 6, 2025, indicated the patient’s primary/preferred language was Japanese and English, with a recommendation for interpreter services. A further review of Patient 19’s multidisciplinary (different types of specialties working together as a team) notes indicated language barrier and interpreter services were used to provide education and care instructions to the patient as follows: Physician Progress Note dated May 15, 2025. Social Worker Note dated May 15, 2025. Physician Progress Note dated May 18, 2025. Physical Therapy Note dated May 18, 2025. Case Manager Note dated May 19, 2025. Physician Progress Note dated May 19, 2025. Physical Therapy Note dated May 21, 2025. A concurrent interview and record review on September 10, 2025, at 8:10 AM, with Patient Safety 2 (PS 2), Patient 19’s “Learner Documentation,” dated May 17, 2025, to May 22, 2025, was reviewed. The record indicated patient education was provided regarding safety and fall prevention, including call light (device used to call for help) with, “acceptance, explanation, teach back/verbalized understanding,” however, there was no documentation that interpreter services were used by nursing staff during patient education specifically about fall prevention interventions. PS 2 confirmed documentation of interpreter and other alternative services, such as reading materials or pictures could be noted in documentation but none were found. During an interview on September 10, 2025, at 8:20 AM, with Registered Nurse Educator 1 (RNE 1), the RNE 1 stated the use of interpreter services was determined by a “nurse’s judgement” rather than consistently based on the learning assessment. RNE 1 further stated, there should be documentation of refusal of interpreter services for every education opportunity if the patient prefers any interpreter usage. During a concurrent interview and record review during September 10, 2025, at 8:25 AM, with Unit Manager 1 (UM 1), the facility’s policy and procedure (P&P) titled, “Communication with patients who have limited English proficiency and/or hearing, speech, or vision impaired,” revised February 2025, was reviewed. The P&P indicated, “ ...General Principle: ...Healthcare information must be communicated plainly in a language or mode that can be understood by the patient or surrogate decision-maker ...Purpose: ...interpretation is the use of a third party to facilitate accurate communication between two or more individuals ...2.1 ...This offer to the patient and the response shall be documented in the patient’s medical record ...” UM 1 stated there was no documentation of the nurses using a translator or offering translation services to Patient 19. UM 1 further stated, it should have been documented per policy.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47360 Based on interview and record review, facility failed to ensure policies and procedures (P&P) were followed for two of 30 sampled patients (Patient 15 and 19) when: 1. For Patient 15, a critical laboratory test result (patient blood work that is far outside normal values it is considered to be life-threatening unless something is done promptly) of potassium (K- an electrolyte essential to the body’s function and maintaining a regular heartbeat) for Patient 15 was not reported to patient’s physician within 10 minutes as per the facility P&P. 2. For Patient 19, a hospital bed alarm, that was documented to be armed (activated and on), in use for a high risk fall patient and was reported failed to activate during a fall, was not removed from patient care service and evaluated by maintenance service. These failures resulted in an inadequate nursing process (to gather information, identify patient problems, set goals, carry out interventions, and then evaluate how effective those interventions were in improving the patient’s health) and failure of communication between the interdisciplinary team (a group of healthcare professionals who collaborate to achieve patient care goals through joint assessments and interventions) that delayed interventions to promote quality of care and patient safety. Findings: 1. During a review of Patient 15’s “History and Physical”(H&P- a document containing patient story, physical exam and planned treatment) dated August 26, 2025, the “H&P” indicated, Patient 15 was admitted to the facility on August 26, 2025, with diagnoses including ileus (when your intestines temporarily stop working properly, so they can’t move food, fluid, and waste through your body) and hydroureteronephrosis (swelling of the upper urinary tract, including the kidney and its drainage tube [ureter], due to a buildup of urine caused by a blockage). During a review of Patient 15’s “Basic Metabolic Panel” (BMP - a blood test that checks on the health of your kidneys, your blood sugar level, and your body’s fluid and electrolyte balance) dated August 29, 2025, the “BMP” indicated, Patient 15’s potassium (K) was 2.9 [normal refence range 3.5-5.0] and “ ...Comment: Critical K result called and read back from [name of nurse]” on August 29, 2025 at 7:13 AM. During a concurrent interview and record review, on September 10, 2025, at 9:45 AM, with the Manager of Patient Care (MPC), Patient 15’s “BMP” dated August 29, 2025, and Patient 15’s “Flowsheet” dated August 29, 2025, was reviewed. The “Flowsheet” indicated, the attending physician was notified by nursing, Patient 15’s critical potassium at 10:10 AM on August 29, 2025. The MPC stated, the nurse has 10 minutes to notify the attending physician of a critical lab result and then document that interaction and any orders to correct the critical result from the attending physician in the patient’s chart. The MPC further stated Patient 15’s critical laboratory value of potassium was not communicated to the attending physician in a timely manner and the attending physician should have been notified by 7:23 AM on August 29, 2025. During a review of the facility’s P&P titled, “Reporting of Critical Test Results”, dated September 2023, the P&P indicated, “ ...B. CRITICAL TEST RESULTS 1. Critical test results shall be called to the patient’s licensed caregiver ...The results should be read back to the reporting individual to ensure accuracy and documented in the medical record. 2. All subsequent notifications shall also be read back, e.g., physician reads back test results to nurse who calls him or her. 3. All critical test results shall be reported immediately as is practicable ...Preferred time frames shall be as follows ...3.3 Nursing staff/RCP to physician or other licensed practitioner (when critical values are called to the unit instead of directly to the physician): 10 minutes ...”. 51099 2.During a review of Patient 19’s face sheet (contains demographic and medical information), undated, the face sheet indicated, Patient 19 was admitted to the facility on May 14, 2025, with diagnoses which included End-Stage Renal Disease (ESRD- kidneys have stopped working well enough to keep one alive) on peritoneal (belly) dialysis (way to clean out blood when kidneys are not working properly); anemia (body does not have enough healthy red blood cells to carry oxygen to the body); peritoneal dialysis catheter leakage [the fluid that is supposed to stay inside the belly during peritoneal dialysis (PD) starts leaking out through catheter (soft, thin, flexible tube used to put fluids in or take fluids out of the body) site or surrounding tissues (group of cells that team up to do a specific job)]. During a review of Patient 19’s medical record, dated May 22, 2025, the “Fall Occurrence” indicated Patient 19 was identified as a “high fall risk” with a score of 16, (a tool used to determine the patient is at risk for falling; scoring from 7-10 is low risk; scoring 11-14 is moderate risk; scoring above 15 is high risk). A further review of the document indicated with the following fall prevention measures: non-skid (not slippery) socks, call light (device used to call for help) in reach, bed locked in lowest position, and bed alarm on. During a review of Patient 19’s “Multidisciplinary Progress Note,” dated May 22, 2025, at 1:30 PM, the progress note stated, “Called by staff to pt’s [patient] room. Pt seen sitting on the floor. Says she came from the bathroom and forgot to pull the cord and tried to make it back to bed. Says she hit right side of face. [Physician NAME] (MD 1) made aware and ordered stat (as soon as possible) head CT (computed topography - super-powered x-ray that gives doctors detailed pictures of the inside of the body) ...”. A review of the “CT Head WO (without) Contrast,” dated May 22, 2025, at 3:44 PM, the result indicated “intracranial (inside the skull) hemorrhage (bleeding).” During a concurrent interview and record review on September 8, 2025, at 10:34 AM, with Unit Manager 1 (UM 1), Patient 19’s “Fall Risk Preventions,” dated May 22, 2025, was reviewed. The medical record indicated the bed alarm was armed and in use at the time of the fall. UM 1 stated, staff documented the alarm was on, but the alarm did not sound during the incident. UM 1 further stated staff did not hear the alarm during the incident. During an interview on September 10, 2025, at 11:14 AM, with Patient Safety 1 (PS 1), PS 1 confirmed there was no work order put in for Patient 19’s bed. PS 1 stated, nursing staff inspected the bed post-fall, and the alarm was working then, so staff decided not to place in a work order. However, there was no documentation staff evaluated the patient bed or the bed was removed from patient care. During a concurrent interview and record review on September 10, 2025, at 12:11 PM, with UM 1, the policy and procedure (P&P) titled, “Medical Equipment Management and Safety,” revised April 2024, was reviewed. The P&P indicated, “1. [NAME of the facility] shall provide a Medical Equipment Management Program to ensure that medical equipment is safe and effective for use by patients and staff ...3.6. Ensure that equipment problems, failures, repairs, and operator errors shall be identified and actions of resolution taken and documented ...4.1 Ensure staff is knowledge in the following areas: ...d. Process for reporting equipment defects (e.g., failure, problem, error) ...5. Staff shall be responsible to: 5.1. Use equipment safely, checking it prior to use, and leaving it in good condition after use ...5.4. Identify equipment defects (e.g., failure, problem, error) and taking the following action: ...a. Immediately removing equipment from service if it compromises safety ...c. Notifying service staff in established manner to achieve a timely repair ...” UM 1 stated there was no documentation the bed alarm was removed from service or evaluated by maintenance after the fall event. UM 1 further stated the facility did not follow the P&P.”

“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: 46696 Based on interview and record review, the hospital did not ensure identify and documentation of effective oversight by the Governing Board that carried out the functions required of a Governing Board to provide a safe and secure environment for a universe of 455 sampled patients as evidenced by: 1.The facility failed to maintain an effective, ongoing, and hospital-wide data-driven quality assessment and performance improvement (QAPI) program by failing to: A. Ensure nursing staff followed facility’s policy and procedure for nursing care (Refer to A049) B. Ensure Operating Room (OR) staff followed its policy and process for surgical counting prior to closure following surgery (Refer to A049) C. Ensure a vaginal packing was removed after surgery, resulting in a retained surgical item that had the potential to cause severe infection, injury, and harm to the patient. (Refer to A049) D. Ensure high-risk drugs (medicines that have a high risk of causing significant patient harm or death when used in error) were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to treat life threatening low blood pressure) was left unattended. (Refer to A049) The cumulative effects of these systemic practices resulted in the hospital ’ s inability to provide 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: 46696 This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for a universe of 455 patients as evidenced by: The hospital did not ensure to identify and documentation of problem prone areas and quality of care were identified, tracked, or documentation of performance improvement actions were implemented and monitored for sustained improvement when: 1.The facility failed to ensure Operating Room (OR) staff followed its policy and process for surgical counting prior to closure following surgery in three of 35 sampled patients, when no documented facility QAPI elements related to surgical count monitoring could be identified. (Refer to A-283) 2.The facility failed to ensure one of 35 sampled patients (Patient 19) received safe postoperative care when it failed to ensure a vaginal packing was removed after surgery, resulting in a retained surgical item that had the potential to cause severe infection, injury, and harm to the patient. (Refer to A-283) 3.The facility failed to develop a process which ensured the safe and accurate accountability for patient’s own medication storage handling. This failure had the potential to result in patient own medications being diverted from the hospital for potential misuse. (Refer to A283). 4.The facility’s Pharmacy failed to their own recipe for compounding this medication and correctly assigned the finished product it’s correct Beyond Use Date (BUD-date and time the drug must not be stored)/expiration date of 9 days. This failure had the potential to affect the drug efficacy of the drugs which had been made by the pharmacy for patient administration. (Refer to A283) 5.The facility failed to ensure high-risk drugs (medicines that have a high risk of causing significant patient harm or death when used in error) were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to treat life threatening low blood pressure) was left unattended in patient 1’s room for over 18 hours. This failure had the potential to result in drug diversion or misuse of these medications which if used inappropriately can cause severe harm, injury, or death for a universe of 455 inpatients. (Refer to A-283) 6.The facility failed to ensure nursing staff followed facility’s policy and procedure for nursing care in three of 35 sampled patients when: a. Patient 2 was administered an incorrect dose of IV Insulin (medicine to treat high blood sugar). b. Patient 28 was dialyzed (a treatment for people with kidney failure to remove excess waste and body fluids form the kidney) with the incorrect potassium bath concentration. c. Patient 42 had an IV (intra venous-a tube was inserted in to the vein to administer medicine or fluids) placed in their foot without a physician order. (Refer to A-0283). The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 46696 Based on interview, and record review, the hospital failed to maintain organized Nursing Services to patients, when: 1. For Patient 28, the facility failed to ensure nursing staff followed the physician’s order per the parameters set for hemodialysis (a procedure where a dialysis machine and a special filter are used to clean you blood) potassium concentration as per Patient 28’s resulted labs and changed during treatment to an incorrect potassium concentration. This failure had the potential to result in receiving an undesired outcome of the dialysis treatment and may cause hyperkalemia (High potassium) which could pose life-threatening cardiac dysrhythmias (abnormal heart rhythms). (Refer A-398) 2.For Patient 42, a physician order was not obtained before inserting a peripheral intravenous catheter (small, short plastic catheter that is placed through the skin into a vein, used to give fluid or medications) on Patient 42’s right foot. This failure may have contributed to an avoidable nosocomial infection (infection acquired during the process of receiving health care that was not present during the time of admission), antibiotic therapy (medications that inhibits the growth or destroys bacteria), readmission to the hospital on March 23, 2022 (within five days after initial discharge from hospital) with a diagnosis of sepsis bacteremia (life-threatening complication of infection). (Refer A398). 3.Facility failed to ensure the crash cart (a cart on wheels containing emergency supplies, that can be transported to a patient in need of life-saving care) in the Emergency Department (ED) was checked daily to ensure medications, supplies and equipment were ready for a life-threatening emergency. This failure had the potential to result in delay of life-saving care in the Emergency Department. (Refer A 398) 4.For Patient 2, the nursing staff administered the incorrect dose of IV insulin (a medication used to lower blood sugar). This failure resulted in Patient 2 receiving a wrong dose of medication and suffered hypoglycemia (low blood sugar) which jeopardized the health and safety of one of the 35 sampled patients (Patent 2). (Refer A405) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“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: 47682 Based on observation, interview and record review, the facility failed to meet the needs of the patient by not promoting a safe medication storage and tracking of high-risk drugs (drugs that has a high risk of causing significant patient harm or death when used in error) when: 1.The facility failed to develop a process which ensured the safe and accurate accountability for patient’s own medication storage handling. This failure had the potential to result in patient own medications being diverted from the hospital for potential misuse. (Refer A-500) 2 The facility’s Pharmacy failed to their own recipe for compounding this medication and correctly assigned the finished product it’s correct Beyond Use Date (BUD-date and time the drug must not be stored)/expiration date of 9 days. This failure had the potential to affect the drug efficacy of the drugs which had been made by the pharmacy for patient administration. (Refer A 501). 3.The facility failed to ensure high-risk drugs (medicines that has a high risk of causing significant patient harm or death when used in error) were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to treat low blood pressure) was left unattended in Patient 1’s room for over 18 hours. This failure had the potential to result in drug diversion or misuse of these medications which if used inappropriately can cause severe harm, injury, or death for a universe of 455 inpatients. (Refer A 502) In addition, this failure jeopardized the health and safety of all patients in the facility and unauthorized access to all individuals in the facility including the visitors. The cumulative effect of these systemic problem resulted in the facility’s failure to deliver care in compliance with the Condition of Participation for Pharmaceutical Services and failure to provide care to their patients in a safe environment.”

“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: 46917 Based on interview and record review, the facility failed to ensure that surgical services were provided in accordance with acceptable standards of practice when the facility failed to ensure: 1.A broken piece of a Castro needle (Castroviejo- surgical instrument used for microsurgery requiring precise control and manipulation of small needles) holder bracket was not removed from the chest cavity of Patient 41 before the final closing suture was performed. This failure resulted in the facility reopening the chest cavity of Patient 41 to retrieve the broken piece of the Castro needle which jeopardized the health and safety of Patient 41 (Refer A 951). 2.A Davinci robotic instrument (instrument used in a surgical robot) tip cover was retained and unidentified inside Patient 18 for three months. This failed practice jeopardized Patient 18’s health and safety when Patient 18 underwent another surgery to remove the retained object, experienced prolonged pain, and delayed healing. (Refer A951). 3.A surgical laparotomy pad (surgical absorbent gauze) was unintentionally retained in Patient 20 when Operating Room (OR) staff failed to implement the facility’s policy and procedure (P&P) requiring a mandatory X-ray prior to final closure of a previously opened abdomen. This failure resulted in Patient 20 undergoing another surgery to remove the retained foreign object (laparotomy pad) and subjected him to prolonged discomfort, infection, and delayed healing which significantly jeopardized his health and safety.(Refer A951) 4.One of 35 sampled patients (Patient 19) received unsafe postoperative care when a vaginal packing was not removed after surgery. This failed practice resulted in a retained surgical item (RSI) that had the potential to cause severe infection, injury, and harm to the patient. (Refer A 957) The cumulative effect of these systemic problems resulted in the facility’s failure to deliver care in compliance with the Condition of Participation for Surgical Services and failure to provide care to their patients in a safe environment.”

“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: 46696 Based on interview and record review, the hospital failed to ensure the medical staff is accountable to the governing body (GB) for the quality of care (QOC) provided to the patient’s for a universe of 455 patients when: 1. A physician’s order was not obtained before inserting a peripheral intravenous catheter to the lower extremities (PIV - small, short plastic catheter that is placed through the skin into a vein, used to give fluid or medications) for Patient 42. This failure may have contributed to an avoidable nosocomial infection (infection acquired during the process of receiving health care that was not present during the time of admission), antibiotic therapy (medications that inhibits the growth or destroys bacteria), readmission to the hospital on March 23, 2022 (within five days after initial discharge from hospital) with a diagnosis of sepsis bacteremia (life-threatening complication of infection) and death on April 2, 2022. 2. Ensure Operating Room (OR) staff followed its policy and process for surgical counting prior to closure following surgery in three of 35 sampled patients. 3. Ensure a vaginal packing was removed after surgery for one of 35 sampled patients, resulting in a retained surgical item that had the potential to cause severe infection, injury, and harm to the patient. 4. Ensure high-risk drugs (medicines that have a high risk of causing significant patient harm or death when used in error) were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to treat life threatening low blood pressure) was left unattended in a patient’s room for over 18 hours (December 3, 5:23 PM, to December 4, 11:30 AM). This failure had the potential to result in drug diversion or misuse of these medications which if used inappropriately can cause severe harm, injury, or death. In addition, this failure jeopardized the health and safety of all patients in the facility and unauthorized access to all individuals in the facility including the visitors. These failed practices jeopardized the health and safety of the patients in the facility by not holding the ultimate responsibility of the hospital’s compliance with the QOC provided to the patients. Findings: 1. During a review of Patient 42’s “History and Physical” (H&P), dated February 26, 2022, the H&P indicated, Patient 42 was admitted to the hospital with the diagnoses of altered mental status (change in mental function from illness, disorders, and/or injury) , dementia (group of conditions characterized by impaired judgement and memory loss), vocal cord atrophy (thinning of the vocal fold muscles and tissues), and COPD (disease that blocks the airflow and makes it difficult to breathe) following an unwitnessed fall at home. During a review of Patient 42’s “Vital Signs Flowsheet” (essential body functions including heart beat, breathing rate, body temperature and blood pressure), dated February 26, 2022, to March 2, 2022, the “Vital Signs Flowsheet” indicated, Patient 42’s body temperature was within normal limits (normal body temperature is 98.6 degree Fahrenheit [F-unit of measurement]). A review of Patient 42’s “Vital Signs Flowsheet”, dated March 3, 2022, to March 7, 2022, the “Vital Signs Flowsheet” indicated, Patient 42’s body temperature measurements were elevated on the following dates: March 3, 2022: Patient 42’s body temperature measurement was 100.2 -degree F. March 4, 2022: Patient 42’s body temperature measurement was 103.3 -degrees F. March 5, 2022: Patient 42’s body temperature measurement was 102.2 -degrees F. March 6, 2022: Patient 42’s body temperature measurement was 100.8 -degrees F. March 7, 2022: Patient 42’s body temperature measurement was 101.7 -degrees F. During a telephone interview with Family Member (FM) 1, on December 8, 2023, at 9:41 AM, FM 1 stated that on March 7, 2022, Patient 42’s PIV was removed from his right foot. FM 1 further stated the nurse informed him that Patient 42’s PIV was infiltrated (when fluid or medications leak from the vein into the surrounding tissues). During a review of Patient 42’s “Culture, Blood” (laboratory test to check for bacteria or other germs in a blood sample) dated March 7, 2022, the “Culture, Blood” indicated, a blood specimen was obtained from the peripheral line and indicated the following result: “! Positive” for Staphylococcus aureus (major bacterial human pathogen that causes a wide variety of clinical infections). During a review of Patient 42’s “Infectious Disease Consult” dated March 8, 2022, the “Infectious Disease Consult” indicated, Patient 42 “ ...has been without fever and upon admission did not have leukocytosis. On 3/2 he started to develop elevated temperatures ...On 3/7 he spiked more fevers to 101.7 ...blood cultures were obtained that grew MSSA (Methicillin-Sensitive Staphylococcus aureus -infection caused by this bacteria commonly found on the skin) in 1 of 2 peripheral blood cultures ...Per RN, had an PIV on his right dorsal foot that infiltrated this AM and was removed ...Skin: Erythema (reddening of the skin) and associated TTP (thrombotic thrombocytopenic purpura -bleeding under the skin) at the site of prior PIV on right ankle ...”. During a concurrent telephone interview and record review on December 6, 2023, at 10:59 AM, with the Infectious Disease Physician (IDMD 1) and Hospital Scribe (HS 1), the “ID Consult Note”, dated March 8, 2022, was reviewed. The “ID Consult Note” indicated, “ ...Hospitalization complicated by nosocomial Staph Aureus Bacteremia (infection in the blood) ...Staph aureus bacteremia is never considered a contaminate given the invasive nature of this bacterium ...most common etiology of nosocomial staph bacteremia is IV lines, including PIV ...”. The IDMD 1 confirmed that Patient 42 was admitted on to the hospital on February 26, 2022, and Patient 42 did not have an infection during the time of admission. The IDMD 1 stated Patient 42 developed a nosocomial infection nine days (March 7, 2022) after Patient 42 was admitted to the hospital. IDMD 1 stated the most likely source of the infection was a complication of Patient 42’s PIV site. During a concurrent interview and record review on December 6, 2023, at 2:28 PM, with Nurse Educator (NE 1), Patient 42’s “Physician’s Orders”, undated and the facility’s policy and procedure (P&P) titled, “Nursing Standard of Practice” dated January 2019, was reviewed. The P&P indicated, “ ...1. Written policy and procedures, e.g., Clinical Skills, protocols, techniques, standardized procedures, guidelines and job descriptions; for patient care shall be developed, maintained and implemented by nursing services ...1.2. Based on current standards of nursing practice and shall be consistent with the nursing process which includes: assessment, nursing diagnosis, planning, intervention, evaluation and, as circumstances require, patient advocacy.” NE 1 was not able to locate a physician order for the PIV to the right ankle for Patient 42. NE 1 stated that when PIV’s are placed in the lower extremities, the PIV should have an order from the physician due to the risk of blood clots, tissue damage, and ulceration (open sores or lesions). The NE 1 confirmed there was no physician order for the PIV to the right ankle for Patient 42. NE 1 further stated the nurse who placed the PIV was a contracted nurse (CRN 1) and CRN 1 was no longer with the hospital organization. NE 1 stated CRN 1 did not follow the policy. The facility document titled “Skills: Peripheral Intravenous (PIV) Catheter: Insertion, Maintenance & Documentation” revised April 2021, indicated “ ...Alert: Prior to attempting peripheral intravenous (PIV) catheter placement, assess patient using Difficult IV Access score (DIVA) ...If needing to request VAT [Vascular Access Team] based on DIVA score, please communicate that score in the request ...PIVs placed in areas outside of the upper extremities [arms, hands, wrist] will require an MD [medical doctor] order for placement in the decided area ...Site Selection and Preparation for Insertion: ...6. Do not use veins of the lower extremities unless needed or an emergent insertion (remove as soon as possible), due to risk of a. Tissue damage b. Thrombophlebitis c. Ulceration ...Discontinuation: ...5. Assess site for any complication such as infiltration and phlebitis ...9. Observe site for redness, pain, drainage, or swelling ...11. Document the procedure in the patient’s record.” 2a. A broken piece of a Castro needle (Castroviejo- surgical instrument used for microsurgery requiring precise control and manipulation of small needles) holder bracket was not removed from the chest cavity of Patient 41 before the final closing suture was performed. This failure resulted in the reopening of the chest cavity of Patient 41 to retrieve the broken piece of the Castro needle which jeopardized the health and safety of Patient 41. 2b. A Davinci robotic instrument (a mechanical surgical tool) tip cover was retained and unidentified inside Patient 18 for three months. This failed practice resulted in Patient 18 undergoing an unnecessary second surgery, pain and prolonged healing process. 2c. A surgical laparotomy pad (surgical absorbent gauze) was unintentionally retained in Patient 20 when Operating Room (OR) staff failed to implement the facility’s policy and procedure (P&P) requiring a mandatory X-ray prior to final closure of a previously opened abdomen. This failure resulted in Patient 20 undergoing another surgery to remove the retained foreign object (laparotomy pad) and subjected him to prolonged discomfort, infection, and delayed healing which significantly jeopardized his health and safety. 3. During a review of Patient 19’s “History and Physical” (H&P) dated November 15, 2023, the “H&P” indicated Patient 19 had a diagnosis of cystocele, (weakened wall between bladder and vagina) rectocele, (weakening of tissue between the rectum and vagina) uterine prolapse (sagging of the uterus from a weakening of pelvic muscles) and stress urinary incontinence (leakage of urine). During a review of Patient 19’s “Surgery Report” (SR) dated November 15, 2023, the “SR” indicated, Patient 19 underwent surgery for cystocele and rectocele repair, (repair of the vaginal walls) uterine suspension and vaginal wall sling (tightening of the tissue holding the uterus and strengthening the vagina) on November 15, 2023. During an interview on December 7, 2003, at 11:00 AM, with the Surgical Hospital Perioperative Services Director (SHDPS), the SHDPS stated, it was common for these cases to have vaginal packing that was removed in the PACU (Post Anesthesia Care Unit), but it was done with a Physician’s order. The SHDPS stated, in this case, our investigation found that there was no order, and the physician assumed the resident with her wrote the order for removal of packing. The SHDPS stated, we required a Physician’s order placed by the surgical team when vaginal packing needs to be removed in PACU. During an interview on December 8, 2023, at 9:15 AM, with the attending physician (GYNMD), GYNMD stated, vaginal packing was a standard of care for this procedure. GYNMD stated, for the past 12 years her standard practice was to remove packing before discharge of the patients. GYNMD stated, this was also her intent for Patient 19’s procedure. GYNMD stated, vaginal packing removal was done by the nurses in PACU. I document that I leave in an intentionally retained vaginal packing, in this case it was Kerlex with Clindamycin (antibiotic cream). GYNMD stated, a physician would then write an order to the PACU nurse with instructions for the packing. GYNMD further stated usually, I would rely on the medical resident to put the order in for post-operative care. In this case there was no order written. There should have been an order to remove the packing. During an interview on December 8, 2023, at 11:20 AM, with PACU RN 1 (PRN 1), PRN 1 stated, she was the nurse for Patient 19 on November 15, 2023. PRN 1 stated, she did not see any packing upon PACU nursing assessment. PRN 1 stated, usually there would be a tail, or gauze showing to indicate there is a packing. PRN 1 stated, if she saw there was packing, she would have clarified with the physician what they wanted to do, either leave it in or remove before discharge. “There was no order, and I would not remove packing without an order.” PRN1 further stated, if packing like this was left in too long, there could be harmful effects like infection or sepsis. 4. On December 5, 2023, at 4:06 PM, an Immediate Jeopardy (IJ- a situation with the potential to significantly harm patients) was called in the presence of the Assistant Vice President of Quality and Patient Safety (AVPQPS) and the Director of Accreditation and Clinical Effectiveness (DACE). The Facility Administrators were verbally notified of the hospital’s failure to secure the following medications that were left unattended and accessible (From 5:23pm December 3,2023 untill 11:50am on December 4, 2023) on the bedside table of Patient 1 in the Surgical / Trauma Intensive Care Unit (STICU): 1 unused Rocuronium syringe 1 unused labeled Succinylcholine syringe 1 unused labeled Propofol syringe 1 unused, labeled Ephedrine syringe 1 unused, labeled Phenylephrine syringe 1 unused, unlabeled syringe with milky white liquid 2 unopened vials of Rocuronium On December 5, 2023, 6: 52 PM, a Corrective Action Plan (CAP) was reviewed and accepted. On December 7, 2023, at 9:38AM, Immediate Jeopardy was removed in the presence of the AVPQPS and DACE, after the surveyors verified implementation of the CAP through observation, interviews, and record reviews. The Corrective Action Plan included the following process; education of the anesthesia providers and OR charge nurses and other hospital staff regarding the importance of securing high-risk medications, completion of a new Post Anesthesia Transportation Checklist by anesthesia prior to transporting the patient and submitting the completed checklist to the OR charge nurse upon return from transport. During a concurrent observation and interview on December 4, 2023, at 11:30 AM, with Registered Nurse 1 (RN1), in Patient 1’s room, a tray of medications and syringes was seen on the bedside table partly covered with a surgical cloth. These medications were identified as: 1 unused Rocuronium syringe 1 unused labeled Succinylcholine syringe 1 unused labeled Propofol syringe 1 unused, labeled Ephedrine syringe 1 unused, labeled Phenylephrine syringe 1 unused, unlabeled syringe with milky white liquid 2 unopened vials of Rocuronium RN1 stated that Patient 1 was transferred from surgery to Patient 1’s room on December 3 at 5:23 PM. RN1 further stated that she did not realize there were medications left in the room otherwise she would have taken care of it immediately. “These were brought up with him from surgery yesterday. If I had seen these earlier, I would have removed them from the room, they should not be in the room.” During a review of Patient 1’s “Anesthesia Record” (AR) dated December 3, 2023, the “AR” indicated that Patient 1 left the operating room on December 3, 2023 at 5:17 PM and was signed off to the Surgical / Trauma Intensive Care Unit (STICU) at bedside by Anesthesiology Resident 1 (AR1) at 5:23 PM. During an interview on December 4, 2003, at 11:50 AM, with Anesthesia Resident 2 (AR2), AR2 stated, this was an emergency intubation kit, brought up with the patient from Surgery. It should not have been left unattended inside Patient 1’s room; they should have taken it back down to surgery when they left the room. During an interview on December 5, 2023, at 10:00 AM, with AR1, AR1 stated that during transport of critically ill patients, anesthetists often bring medications up from surgery with them for use in potential emergencies and which are then brought back with them to the operating room. AR1 confirmed that medications brought to a patient’s room are the responsibility of the provider who brought them. AR 1 stated, “ultimately it is our responsibility to keep the meds in our possession, to ensure the chain of custody. Leaving meds in a patient room is not the standard and is potentially very dangerous.” AR1 further stated, these medications could cause harm to a patient, if it was given inappropriately. I would consider them as high-risk medications. AR 1 further stated, “Bad things can happen if they are used incorrectly. Especially if it lands in the hands of someone with the intention to do harm.” During an interview on December 5, 2023, at 11:00 AM, with the Surgery Department Medical Director, (SDMD), the SDMD stated, “There is certainly a cause for concern when the accountability for those (medications) is unclear. We take that incredibly seriously. We take control of these meds as a high priority. We do expect the provider to maintain chain of control at all times.” During a concurrent interview and record review on December 5, 2023, at 2:00 PM, with the Surgical / Trauma Intensive Care Unit Manager, (STICUM), the facility’s Policy and Procedure (P&P) titled “Pharmaceutical Storage”, dated October 2023, was reviewed. The P&P indicated, “7. While Pharmacy shall be responsible for ensuring proper storage of medications, all [Name] departments and nursing units shall comply with policy specifications regarding: 7.1 Proper storage of medications in their areas, according to specifications listed in this policy, 7.2 Supervision of access to medications stored in their areas ... 9.3 Security: Medications shall be stored in a secure place until used and be under the control of authorized persons at all times.” The STICUM stated, these medications were not kept under control of an authorized person while on the unit in accordance with our policy when it was left unattended at the patient’s bedside. The STICUM further stated, they were not stored properly, and access was not supervised or restricted.”

“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: 46696 Based on interview, and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program when: 1.The facility failed to ensure OR staff followed its policy and process for surgical counting prior to closure following surgery in two of 35 sampled patients. 2.The facility failed to ensure one of 35 sampled patients (Patient 19) received safe postoperative care when it failed to ensure a vaginal packing was removed after surgery, resulting in a retained surgical item that had the potential to cause severe infection, injury, and harm to the patient 3.The facility failed to identify and/or implement a process that provide for pharmaceutical services that ensure patient safety through the appropriate control and distribution of patient’s own medications. 4.The facility’s Pharmacy failed to their own recipe for compounding this medication and correctly assigned the finished product it’s correct Beyond Use Date (BUD-date and time the drug must not be stored)/expiration date of 9 days. This failure had the potential to affect the drug efficacy of the drugs which had been made by the pharmacy for patient administration. 5.The facility failed to ensure high-risk drugs were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to treat life threatening low blood pressure) was left unattended in Patient 1’s room for over 18 hours. This failure had the potential to result in drug diversion or misuse of these medications which if used inappropriately can cause severe harm, injury, or death for a universe of 455 inpatients. 6.The facility failed to ensure nursing staff followed facility policy and procedure for nursing care in Three of 35 sampled patients when: a. Patient 2 was administered an incorrect dose of IV Insulin (medicine to treat high blood sugar). b. Patient 28 was dialyzed (a treatment for people with kidney failure to remove excess waste and body fluids form the kidney) with the incorrect potassium bath concentration. c. Patient 42 had an IV (intra venous-a tube was inserted in to the vein to administer medicine or fluids) placed in their foot without a physician’s order. These failures resulted in the hospital inability to focus on high risk, problem prone areas to ensure the provision of quality nursing and patient safety and had the potential to cause adverse health outcomes which could interfere with patients’ medical care. Findings: 1. A review of Patient 41’s “Surgery Report” dated March 16, 2021, indicated, Patient 41 underwent surgery for a heart transplant and axillary impella removal. The report further indicated that Patient 41’s surgery “ ...All instruments, sponge, and needle counts were confirmed to be correct x 2 at the end of the operation. However, a piece (bracket) of a needle holder ‘Castro’ was found to be missing during the count, subsequently a CXR [chest x-ray - used to visualize the chest cavity] was taken and it was found to be in the mediastinum. During a concurrent interview and record review on December 5, 2023, at 2:20 PM, with the Operating Room Manager (ORM), Patient 18’s “Operating Note” (ON) dated November 30, 2022, was reviewed. The “ON” indicated the surgery was successful, and the Initial, Relief, Closing and Final surgical counts were all correct. The ORM stated, in this case, the team did not include this tip cover in the count. The counts were correct. They did not include it in the initial count so when it went missing, it was not identified in the final count. If they added the scissors and tip later in the procedure, the tip cover should also be counted under ‘accessories’. During a review of “[Name of the facility] Patient Safety and Quality Plan” dated 2023-2024, indicated “Patient safety and reliability committee [PSRC], The quality committee of the board has delegated to the PSRC responsibility for the ongoing oversite of the patient safety and quality activities. Interdisciplinary sub committees of the PSRC provide information and feedback to PSRC which is provided to MSEC, QCB, Board of trustees and other committees as needed. These leaders meet monthly to: Provide a system for overall evaluation of the quality/performance of care in the organization. Assign responsibility for the follow up with specific time frames. Implement and monitor the integrated patient safety and quality program throughout [Name].” The [Name] Patient Safety and Quality plan” Further stated “Specific areas of patient safety and reliability focus for 2023-24: 1. Hospital acquired infections 2. Surgical site infections (SSI) colon and abdominal hysterectomy 3. C.diff reduction 4. Central line associated blood stream infections 5. Catheter associated Urinary tract infections 6. Readmission reduction 7. Complete at least 2 sessions of mini advanced training program 8. Development and implementation of 3-4 shared Baseline Protocols with [Name] Hospitals 9. Patient throughput, including Emergency Department length of stay 10. Throughput access to Operating room 11. Establishment and implementation of action plans surrounding at least one domain of focus related to culture of safety.” The facility had not identified any aeras of focus regarding Surgical counting. During a review of “Appendix D: [Name] QAPI Reporting schedule” dated 2023, the “Appendix D: [Name]QAPI Reporting schedule” indicated “QAPI elements to be reported including Procedure outcomes: Invasive, Procedure outcomes Surgery” No documented facility QAPI elements related to surgical count monitoring could be identified. 2. During a review of Patient 19’s “History and Physical” (H&P) dated November 15, 2023, the “H&P” indicated Patient 19 had a diagnosis of cystocele, (weakened wall between bladder and vagina) rectocele, (weakening of tissue between the rectum and vagina) uterine prolapse (sagging of the uterus from a weakening of pelvic muscles) and stress urinary incontinence (leakage of urine). During a review of Patient 19’s “Surgery Report” (SR) dated November 15, 2023, the “SR” indicated, Patient 19 underwent surgery for cystocele and rectocele repair, (repair of the vaginal walls) uterine suspension and vaginal wall sling (tightening of the tissue holding the uterus and strengthening the vagina) on November 15, 2023. During an interview on December 5, 2023, at 2:26 PM, with the Operating Room Manager (ORM1), the ORM1 stated, any type of packing that we leave intentionally in the Operating Room should be documented and included in the handoff report. This information follows through with the patient to PACU. The ORM1 stated, it should also be mentioned in a post-operative order to remove the packing, otherwise packing should be removed by the surgeon. During an interview on December 7, 2003, at 11:00 AM, with the Surgical Hospital Perioperative Services Director (SHDPS), the SHDPS stated, it was common for these cases to have vaginal packing that was removed in the PACU (Post Anesthesia Care Unit), but it was done with a Physician’s order. The SHDPS stated, in this case, our investigation found that there was no order, and the physician assumed the resident with her wrote the order for removal of packing. The SHDPS stated, we required a Physician’s order placed by the surgical team when vaginal packing needs to be removed in PACU. During an interview on December 8, 2023, at 9:15 AM, with the attending physician (GYNMD), GYNMD stated, vaginal packing was a standard of care for this procedure. GYNMD stated, for the past 12 years her standard practice was to remove packing before discharge of the patients. GYNMD stated, this was also her intent for Patient 19’s procedure. GYNMD stated, vaginal packing removal was done by the nurses in PACU. I document that I leave in an intentionally retained vaginal packing, in this case it was Kerlex with Clindamycin (antibiotic cream). GYNMD stated, a physician would then write an order to the PACU nurse with instructions for the packing. GYNMD further stated usually, I would rely on the medical resident to put the order in for post-operative care. In this case there was no order written. There should have been an order to remove the packing. 3. The Pharmacy’s: “Pharmacy log sheet for Patient Own Medications (Meds)”, had several entries of drugs which had been taken in by the Pharmacy on various dates, however at least 5 different drugs had been written onto the log, but the log did not contain any documentation or evidence that these medications had been destroyed, yet none of these medications could be found in the Patient’s Own Medication storage container. It appeared that these medications had gone missing as the hospital did not have any documented records of what had happened to these medications. The hospital had failed to develop a system based on the ASHP standards of Practice above, as the hospital’s Pharmacy had not developed a system which identified the two Pharmacists who had been destroying patient’s own medications, as well as any nurse who had picked up these medications. During a review of “Appendix D: [Name] QAPI Reporting schedule” dated 2023, the “Appendix D: [Name]QAPI Reporting schedule” indicated “QAPI elements to be reported including Medication Safety and antibiotic steward ship” The facility QAPI program failed to identify potential gaps staff handling of patient owned medication. 4. Review of the hospital Pharmacy’s Sterile drug compounding logs dated December 8, 2023, at 9:00 AM, revealed that on November 30, 2023, at 4:40 am, the hospital’s Pharmacy had compounded 40 (forty) bags with Vancomycin 750 mg in 150 ml of D5W. This medication had been given a BUD date of December 9, 2023, at 11:59 PM, even though the correct BUD which should have been assigned for these medications would have been December 9, 2023, at 4:40 am, based on the 9-day BUD dating from the hospital Pharmacy’s compounding recipe for this medication under refrigeration. The hospital’s Pharmacy had assigned had a BUD to these medications which had exceeded the hospital’s accepted recipe BUD by 19 hours and 20 minutes. During a review of “Appendix D: [Name] QAPI Reporting schedule” dated 2023, the “Appendix D: [Name]QAPI Reporting schedule” indicated “QAPI elements to be reported including Medication safety and antibiotic stewardship” The facility QAPI program failed to identify potential gaps BUD expiration date compliance. 5.On December 5, 2023, at 4:06 PM, an Immediate Jeopardy (IJ- a situation with the potential to significantly harm patients) was called in the presence of the Assistant Vice President of Quality and Patient Safety (AVPQPS) and the Director of Accreditation and Clinical Effectiveness (DACE). The Facility Administrators were verbally notified of the hospital’s failure to secure the following medications that were left unattended and accessible (for approximately 18 hours) on the bedside table of Patient 1 in the Surgical / Trauma Intensive Care Unit (STICU): 1 unused Rocuronium syringe 1 unused labeled Succinylcholine syringe 1 unused labeled Propofol syringe. 1 unused, labeled Ephedrine syringe. 1 unused, labeled Phenylephrine syringe 1 unused, unlabeled syringe with milky white liquid 2 unopened vials of Rocuronium On December 5, 2023, 6: 52 PM, a Corrective Action Plan (CAP) was reviewed and accepted. On December 7, 2023, at 9:38AM, the Immediate Jeopardy was removed in the presence of the AVPQPS and DACE, after the surveyors verified implementation of the CAP through observation, interviews, and record reviews. The Corrective Action Plan included the following process: education of the anesthesia providers and OR charge nurses and other hospital staff regarding the importance of securing high-risk medications, completion of a new Post Anesthesia Transportation Checklist by anesthesia prior to transporting the patient and submitting the completed checklist to the OR charge nurse upon return from transport. During a review of “[Name] Patient Safety and Quality Plan” dated 2023-2024, indicated “Patient safety and reliability committee [PSRC], The quality committee of the board has delegated to the PSRC responsibility for the ongoing oversite of the patient safety and quality activities. Interdisciplinary sub committees of the PSRC provide information and feedback to PSRC which is provided to MSEC, QCB, Board of trustees and other committees as needed. These leaders meet monthly to: Provide a system for overall evaluation of the quality/performance of care in the organization. Assign responsibility for the follow up with specific time frames. Implement and monitor the integrated patient safety and quality program throughout [Name].” The “[Name]Patient Safety and Quality plan” Further stated “Specific areas of patient safety and reliability focus for 2023-24: 12. Hospital acquired infections 13. Surgical site infections (SSI) colon and abdominal hysterectomy 14. C.diff reduction 15. Central line associated blood stream infections 16. Catheter associated Urinary tract infections 17. Readmission reduction 18. Complete at least 2 sessions of mini advanced training program 19. Development and implementation of 3-4 shared Baseline Protocols with [Name] Hospitals 20. Patient throughput, including Emergency Department length of stay 21. Throughput access to Operating room 22. Establishment and implementation of action plans surrounding at least one domain of focus related to culture of safety.” The facility had not identified any aeras of focus or concern regarding the potential for Unsecured medication related to Anesthesia services. During a review of “Appendix D: [Name] QAPI Reporting schedule” dated 2023, the “Appendix D: [Name] QAPI Reporting schedule” indicated “QAPI elements to be reported including Procedure outcomes: Invasive, Procedure outcomes Surgery” No documented facility QAPI elements could be identified regarding the Potential for Unsecured Medication related to Anesthesia services. 6.a. During a review of Patient 2’s “medication administration record” (MAR) dated August 10, 2023, the MAR indicated Patient 2 received 5 units of regular insulin (a fast acting medication for lowering blood sugar), intravenous on August 10, 2023, at 11:23 PM, documented by Registered Nurse (RN9) and dually signed off by registered nurse (RN 10). During a review of Patient 2’s “multidisciplinary progress notes” by RN 9 dated August 14, 2023 at 10:55 AM, the progress note indicated,” Late entry for August 11, 2023 at 0545, (Patient 2) was administered 50 units of insulin at 11:27 PM on August 10, 2023 instead of 5 units per order, MD notified at the time noted.” During an interview and concurrent record review on December 6, 2023, at 2:18 PM, with RNE 4 the facility’s policy and procedure (P&P) titled, “Medication administration and errors” dated August 2022, was reviewed. The P&P indicated “21. Medication administration errors shall be defined as: 21.1 Wrong patient, 21.2 wrong route, 21.3 Wrong dose/rate, 21.4 Wrong medication.” RNE 4 Stated, RN 9 made a medication error because they administered the wrong dose of medication.” b. During a review of Patient 28’s “Hemodialysis Flowsheets”, dated December 4, 2023, the “Hemodialysis Flowsheet”, indicated, Patient 28’s hemodialysis treatment was started at 2:15 PM, with the Dialysate K [Potassium] (mEq/L) =3K. The “Hemodialysis Flowsheet”, further indicated, at 4:45 PM, the Dialysate K [Potassium] (mEq/L) was changed from 3K to 1K “per order”. During a review of Patient 28’s “Plan of Care”, dated December 4, 2023, the “Plan of Care” indicated, “Problem: Adequacy of Dialysis: Goal: Fluid and electrolyte balance are achieved/maintained ... Note: ...Reviewed lab results prior of HD [hemodialysis] initiation. Use 1 K+ today ...”. During a concurrent interview and record review, on December 8, 2023, at 8:55 AM, with RNDART1, Patient 28’s “Active Hemodialysis Orders” and “Basic Metabolic Panel: Results, dated December 4, 2023, was reviewed. The “Active Hemodialysis Orders” indicated the following parameters for Potassium (K) Concentration, “ ...Potassium (mEq/L-milli equivalent per liter - unit of measurement): >5.8=1K, 5-5.8=2K, 3.9-4.9=3K, <3.9=4K ...”. DARTRN1 stated, the labs were received prior to the hemodialysis treatment start and the dialysis potassium concentration should have been 2K per the physician orders. c. A concurrent interview and review of Patient 42’s “Physician Orders” dated February 26, 2022, to March 7, 2022, were conducted with the Nurse Educator (NE) 1 on December 6, 2023, at 2:28 PM, in the conference room. NE 1 was not able to locate a MD order (physician order for care) for the PIV to the right ankle for Patient 42. NE 1 stated that when PIVs are placed in the lower extremities, the PIV should have a order from the physician due to the risk of blood clots, tissue damage, and ulceration (open sores or lesions). The facility document titled “Skills: Peripheral Intravenous (PIV) Catheter: Insertion, Maintenance & Documentation” revised April 2021, indicated “ ...Alert: Prior to attempting peripheral intravenous (PIV) catheter placement, assess patient using Difficult IV Access score (DIVA) ...If needing to request VAT based on DIVA score, please communicate that score in the request ...PIVs placed in areas outside of the upper extremities [arms, hands, wrist] will require an MD [medical doctor] order for placement in the decided area ...Site Selection and Preparation for Insertion: ...6. Do not use veins of the lower extremities unless needed or an emergent insertion (remove as soon as possible), due to risk of a. Tissue damage b. Thrombophlebitis c. ulceration. During a review of “[Name]Patient Safety and Quality Plan” dated 2023-2024, indicated “Patient safety and reliability committee [PSRC], The quality committee of the board has delegated to the PSRC responsibility for the ongoing oversite of the patient safety and quality activities. Interdisciplinary sub committees of the PSRC provide information and feedback to PSRC which is provided to MSEC, QCB, Board of trustees and other committees as needed. These leaders meet monthly to: Provide a system for overall evaluation of the quality/performance of care in the organization. Assign responsibility for the follow up with specific time frames. Implement and monitor the integrated patient safety and quality program throughout [Name].” The “[Name]Patient Safety and Quality plan” Further stated “Specific areas of patient safety and reliability focus for 2023-24: 12. Hospital acquired infections 13. Surgical site infections (SSI) colon and abdominal hysterectomy 14. C.diff reduction 15. Central line associated blood stream infections 16. Catheter associated Urinary tract infections 17. Readmission reduction 18. Complete at least 2 sessions of mini advanced training program 19. Development and implementation of 3-4 shared Baseline Protocols with [Name] Hospitals 20. Patient throughput, including Emergency Department length of stay 21. Throughput access to Operating room 22. Establishment and implementation of action plans surrounding at least one domain of focus related to culture of safety.” The facility had not identified any aeras of focus or concern regarding nursing staff standards of care. During a review of “Appendix D: [Name]QAPI Reporting schedule” dated 2023, the “Appendix D: [Name] QAPI Reporting schedule” indicated “Department specific Quality Measures: Clinical laboratory, Dialysis inpatient/ Outpatient, Imaging services/nuclear medicine, medical records, Nursing strategic plan, nutritional services, Rehabilitative services, Respiratory services. To be reviewed Semiannually” Nursing strategic planning was ineffective in preventing the identified nursing failures for theree (3) of 35 sampled patients.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 46917 Based on observation, interview, and record review, the facility failed to ensure nursing staff followed the facility’s policy and procedure (P&P) when: 1) A physician’s order was not obtained before inserting a peripheral intravenous catheter to the lower extremities (PIV - small, short plastic catheter that is placed through the skin into a vein, used to give fluid or medications) for Patient 42. This failure may have contributed to an avoidable nosocomial infection (infection acquired during the process of receiving health care that was not present during the time of admission), antibiotic therapy (medications that inhibits the growth or destroys bacteria), readmission to the hospital on March 23, 2022 (within five days after initial discharge from hospital) with a diagnosis of sepsis bacteremia (life-threatening complication of infection) and death on April 2, 2022. 2) The crash cart (a cart on wheels containing emergency supplies, that can be transported to a patient in need of life-saving care) in the “Green Pod” area of the Emergency Department (ED) was not checked daily to ensure medications, supplies and equipment were ready for a life-threatening emergency. This failure had the potential to result in delay of life-saving care in the Emergency Department. 3) A physician’s order of hemodialysis (a procedure where a dialysis machine and a special filter are used to clean blood) was not followed and the wrong dialysate potassium concentration was used during a hemodialysis treatment for one of three sampled patients (Patient 28). This failure had the potential to result in receiving an undesired outcome of the dialysis treatment and may cause hyperkalemia (a potassium level in your blood higher than normal that is important for nerve and muscle function) which could pose life threatening cardiac dysrhythmias (an abnormal or irregular heartbeat). Findings: 1) During a review of Patient 42’s “History and Physical” (H&P), dated February 26, 2022, the H&P indicated, Patient 42 was admitted to the hospital with the diagnoses of altered mental status (change in mental function from illness, disorders, and/or injury) , dementia (group of conditions characterized by impaired judgement and memory loss), vocal cord atrophy (thinning of the vocal fold muscles and tissues), and COPD (disease that blocks the airflow and makes it difficult to breathe) following an unwitnessed fall at home. During a review of Patient 42’s “Vital Signs Flowsheet” (essential body functions including heart beat, breathing rate, body temperature and blood pressure), dated February 26, 2022, to March 2, 2022, the “Vital Signs Flowsheet” indicated, Patient 42’s body temperature was within normal limits (normal body temperature is 98.6 degree Fahrenheit [F-unit of measurement]). During a review of Patient 42’s “CBC (complete blood count [medical laboratory test that provides information about the cell’s in a person’s blood])”, dated February 26, 2022, to March 2, 2022, the CBC indicated, WBC (white blood cells [cells that fight infection in the body]) were within normal limits (normal WBC’s are 4.80 -11.80 bil/L [bil-billion, /-per, L-liter - units of measurement]) and Patient 42 did not have leukocytosis (elevated white blood cell count) upon admission to the hospital. A review of Patient 42’s “Vital Signs Flowsheet”, dated March 3, 2022, to March 7, 2022, the “Vital Signs Flowsheet” indicated, Patient 42’s body temperature measurements were elevated on the following dates: March 3, 2022: Patient 42’s body temperature measurement was 100.2 -degree F. March 4, 2022: Patient 42’s body temperature measurement was 103.3 -degrees F. March 5, 2022: Patient 42’s body temperature measurement was 102.2 -degrees F. March 6, 2022: Patient 42’s body temperature measurement was 100.8 -degrees F. March 7, 2022: Patient 42’s body temperature measurement was 101.7 -degrees F. During a telephone interview with Family Member (FM) 1, on December 8, 2023, at 9:41 AM, FM 1 stated that on March 7, 2022, Patient 42’s PIV was removed from his right foot. FM 1 further stated the nurse informed him that Patient 42’s PIV was infiltrated (when fluid or medications leak from the vein into the surrounding tissues). During a review of Patient 42’s “Culture, Blood” (laboratory test to check for bacteria or other germs in a blood sample) dated March 7, 2022, the “Culture, Blood” indicated, a blood specimen was obtained from the peripheral line and indicated the following result: “! Positive” for Staphylococcus aureus (major bacterial human pathogen that causes a wide variety of clinical infections). During a review of Patient 42’s “Infectious Disease Consult” dated March 8, 2022, the “Infectious Disease Consult” indicated, Patient 42 “ ...has been without fever and upon admission did not have leukocytosis. On 3/2 he started to develop elevated temperatures ...On 3/7 he spiked more fevers to 101.7 ...blood cultures were obtained that grew MSSA (Methicillin-Sensitive Staphylococcus aureus -infection caused by this bacteria commonly found on the skin) in 1 of 2 peripheral blood cultures ...Per RN, had an PIV on his right dorsal foot that infiltrated this AM and was removed ...Skin: Erythema (reddening of the skin) and associated TTP (thrombotic thrombocytopenic purpura -bleeding under the skin) at the site of prior PIV on right ankle ...”. During a concurrent telephone interview and record review on December 6, 2023, at 10:59 AM, with the Infectious Disease Physician (IDMD 1) and Hospital Scribe (HS 1), the “ID Consult Note”, dated March 8, 2022, was reviewed. The “ID Consult Note” indicated, “ ...Hospitalization complicated by nosocomial Staph Aureus Bacteremia (infection in the blood) ...Staph aureus bacteremia is never considered a contaminate given the invasive nature of this bacterium ...most common etiology of nosocomial staph bacteremia is IV lines, including PIV ...”. The IDMD 1 confirmed that Patient 42 was admitted on to the hospital on February 26, 2022, and Patient 42 did not have an infection during the time of admission. The IDMD 1 stated Patient 42 developed a nosocomial infection nine days (March 7, 2022) after Patient 42 was admitted to the hospital. IDMD 1 stated the most likely source of the infection was a complication of Patient 42’s PIV site. During a concurrent interview and record review on December 6, 2023, at 2:28 PM, with Nurse Educator (NE 1), Patient 42’s “Physician’s Orders”, undated and the facility’s policy and procedure (P&P) titled, “Nursing Standard of Practice” dated January 2019, was reviewed. The P&P indicated, “ ...1. Written policy and procedures, e.g., Clinical Skills, protocols, techniques, standardized procedures, guidelines and job descriptions; for patient care shall be developed, maintained and implemented by nursing services ...1.2. Based on current standards of nursing practice and shall be consistent with the nursing process which includes: assessment, nursing diagnosis, planning, intervention, evaluation and, as circumstances require, patient advocacy.” NE 1 was not able to locate a physician order for the PIV to the right ankle for Patient 42. NE 1 stated that when PIV’s are placed in the lower extremities, the PIV should have an order from the physician due to the risk of blood clots, tissue damage, and ulceration (open sores or lesions). The NE 1 confirmed there was no physician order for the PIV to the right ankle for Patient 42. NE 1 further stated the nurse who placed the PIV was a contracted nurse (CRN 1) and CRN 1 was no longer with the hospital organization. NE 1 stated CRN 1 did not follow the policy. A review of Patient 42’s “Discharge Summary” dated April 2, 2022, indicated Patient 42 was transferred to the medical intensive care unit due to worsening respiratory status (difficulty breathing). Patient 42’s condition at discharge indicated “decease” and methicillin susceptible staphylococcus aureus (diagnosed on March 7, 2022) was present at discharge. The facility document titled “Skills: Peripheral Intravenous (PIV) Catheter: Insertion, Maintenance & Documentation” revised April 2021, indicated “ ...Alert: Prior to attempting peripheral intravenous (PIV) catheter placement, assess patient using Difficult IV Access score (DIVA) ...If needing to request VAT [Vascular Access Team] based on DIVA score, please communicate that score in the request ...PIVs placed in areas outside of the upper extremities [arms, hands, wrist] will require an MD [medical doctor] order for placement in the decided area ...Site Selection and Preparation for Insertion: ...6. Do not use veins of the lower extremities unless needed or an emergent insertion (remove as soon as possible), due to risk of a. Tissue damage b. Thrombophlebitis c. Ulceration ...Discontinuation: ...5. Assess site for any complication such as infiltration and phlebitis ...9. Observe site for redness, pain, drainage, or swelling ...11. Document the procedure in the patient’s record.” 47360 2) During an observation on December 5, 2023, at 3:10 PM, in the Emergency Department, the crash cart (a cart with life-saving medications and devices that can be moved to the patient) log (a daily checklist ensuring emergency medications and equipment are readily available and in working order) was incomplete, missing code cart equipment inspection checks for December 1, 2023 and December 2, 2023. During a concurrent interview and record review, on December 5, 2023, at 3:10 PM, with the Director of the Emergency Department (EDD), the “ABC Cart Equipment Inspection Record”, dated Dec-23 (December 2023) was reviewed. The ABC Cart Equipment Inspection Record indicated, the crash cart inspection was not completed on December 1, 2023, and December 2, 2023. The EDD stated, the “Green Pod” emergency crash cart was not checked on December 1, 2023, and December 2, 2023. The EDD further stated the Emergency Department Techs assigned to the pod are to check the cart each morning, but it was missed. The EDD stated, if the crash cart was not checked and found to be incomplete, this could delay patient care in an emergency. During a review of the facility’s policy and procedure (P&P) titled, “Medication Tray and Code Cart Inspection and Maintenance - Emergency Department”, dated August 2023, the P&P indicated, “ .... Emergency Department Personnel ...Daily Inspection Code Cart 1. Completes daily exterior inspection as follows: 2. Verifies expiration dates are current and written on code cart medication expiration card and code cart item expiration card attached to front of Code Cart. 3. Verifies Code Cart blue and red locks are intact and numbers are documented. 4. Records inspection date, all lock numbers, and signature on code cart check log ...”. During a review of the facilities P&P titled, “Inspecting Code Carts, Defibrillators, and Airway Kits - [facility names] “, dated August 2023, the P&P indicated, “ ...Initiator of Action: Department/Unit Designee ... Action: Daily Assigned Duties Frequency as follows: a. Minimum of once each calendar day for all departments/units ... Code Cart Inspection: Completes daily exterior inspection as follows ...2. Verifies code cart blue and red locks are intact and numbers documented. 3. Records inspection date, all lock numbers, and signature on Code Cart check log ... 4. Verifies standard white back board. 5. Verifies presence of oxygen tank and visually inspects integrity of regulator. Verifies the oxygen tank is full ... Defibrillator (an electronic device that applies an electric shock to restore heart rhythm) Inspection: Note: The defibrillator inspection is for all defibrillators in unit/departments 8. [Name of brand] defibrillators: Visually confirms that the defibrillator is plugged in and the AC power light is green, the battery charge light is yellow or green, and a green check mark is in the ready window. 9. Visually confirms that all required accessories are present and ready for use ... a. EKG cables (heart monitoring device) b. OneStep cable End Tidal CO2 cable (carbon dioxide detection device) c. Spo2 cable ( oxygen detection device) ...”. During a review of the facility’s policy and procedure titled, “Maintenance and Quality Control of Code Equipment”, dated August 2023, the P&P indicated, “ ...2. Each Department with a code cart shall be responsible for: 2.1 Inspecting the carts for which they are accountable, as outlined by regulatory agency requirements and procedure ...2.2 Documenting completion of inspection on Code Cart record ...”. 3) During a review of Patient 28’s “Admission Information”(AI), dated December 1, 2023, the “AI” indicated, Patient 28 was admitted to the hospital with the diagnoses of Diabetic Ketoacidosis (DKA - a life-threatening problem when your body does not have enough insulin to allow sugar into your cells for use as energy), and End Stage Renal Disease (ESRD - permanent stage of kidney disease where kidneys are unable to function on their own). During a concurrent observation and interview on December 4, 2023, at 3:05 PM, with Dialysis/Apharesis Registered Nurse 2 (RNDART2), in Patient 28’s room, Patient 28 was receiving hemodialysis. RNDART2 stated, Patient 28 ‘s hemodialysis potassium concentration was set at 3K (concentration of potassium in dialysis fluid) per the hemodialysis orders. RNDART2 then displayed the screen on the hemodialysis machine to show dialysate (the dialysis fluid used in hemodialysis to remove waste and fluids from the patient) the hemodialysis machine displayed 3K dialysate fluid. During a review of Patient 28’s “Active Hemodialysis Orders”, dated December 4, 2023, the “Active Hemodialysis Orders”, indicated the following parameters for Potassium (K) Concentration, “ ...Potassium (mEq/L - [milli equivalent per liter - unit of measurement]): >5.8=1K, 5-5.8=2K, 3.9-4.9=3K, <3.9=4K ...” (If Potassium greater than 5.8, use 1K hemodialysis potassium concentration, potassium level ranged between 5-5.8 use 2K, potassium level ranged between 3.9-4.9, use 3K concentration ...). During a review of Patient 28’s “Basic Metabolic Panel: Results” (a blood test detecting the body’s fluid balance and levels of electrolytes), dated December 4, 2023, the “Basic Metabolic Panel: Results”, indicated, Patient 28’s serum (blood) potassium level was 5.8 m/Mol/L (unit of measurement) and was last resulted on December 4, 2023 at 1:42 PM. During a review of Patient 28’s “Hemodialysis Flowsheets”, dated December 4, 2023, the “Hemodialysis Flowsheet”, indicated, Patient 28’s hemodialysis treatment was started at 2:15 PM, with the Dialysate K [Potassium] (mEq/L) =3K. The “Hemodialysis Flowsheet”, further indicated, at 4:45 PM, the Dialysate K [Potassium] (mEq/L) was changed from 3K to 1K “per order”. During a review of Patient 28’s “Plan of Care”, dated December 4, 2023, the “Plan of Care” indicated, “Problem: Adequacy of Dialysis: Goal: Fluid and electrolyte balance are achieved/maintained ... Note: ...Reviewed lab results prior of HD [hemodialysis] initiation. Use 1 K+ today ...”. During a concurrent interview and record review, on December 8, 2023, at 9:00 AM, with RNDART1, Patient 28’s “Active Hemodialysis Orders” and “Basic Metabolic Panel: Results, dated December 4, 2023, was reviewed. The “Active Hemodialysis Orders” indicated the following parameters for Potassium (K) Concentration, “ ...Potassium (mEq/L): >5.8=1K, 5-5.8=2K, 3.9-4.9=3K, <3.9=4K ...”. DARTRN1 stated, the labs were received prior to the hemodialysis treatment start and the dialysis potassium concentration should have been 2K per the physician orders. During a concurrent interview and record review, on December 8, 2023, at 9:00 AM, with RNDART1, Patient 28’s “Hemodialysis Flowsheets”, dated December 4, 2023, was reviewed. The “Hemodialysis Flowsheets” indicated, Patient 28’s hemodialysis treatment was started at 2:15 PM with the Dialysate K [Potassium] (mEq/L) =3K. The “Hemodialysis Flowsheet”, further indicated, at 4:45 PM, the Dialysate K [Potassium] (mEq/L) was changed from 3K to 1K “per order”. RNDART1 stated, both the 3K and change to 1K potassium concentration did not follow physician orders. RNDART1 stated, it was the best practice to check patient potassium levels and doctor’s parameters for potassium concentration before staring the hemodialysis treatment. RNDART1 further stated, Potassium was very important, and hyperkalemia can cause arrythmias which can be life threatening. During an interview on December 8, 2023, at 9:05 AM, with the Director of Dialysis/Apheresis Department (DHD), the DHD stated, it was the expectation that staff follow doctor’s orders as written. During a review of facility’s document “Clinical Nurse B-Dart Job Summary”, undated, the “Clinical Nurse B-Dart Job Summary” indicated, “ ...Essential Duties: ...3. Functions in a patient-centered care model of practice and preforms the nursing process (assessment, care planning, intervention, evaluation) ... 17. Functions within the registered nurse scope of practice and in accordance with established policies, procedures, protocols, techniques, guidelines and productivity standards ...”. During a review of the facility’s policy and procedure (P&P) titled, “Nursing Standards of Practice”, dated June 2022, the P&P indicated, “Nursing standards of practice are a required level of staff performance according to a set of conditions (unit or patient) determined to be acceptable by a designated authority and which include, but are not limited to structure standards, (policies, administrative procedures) and process standards, ( Clinical Skills, protocols, techniques, standardized procedures, guidelines, job descriptions). ...1. Written policy and procedures, e.g., Clinical Skills, protocols, techniques, standardized procedures, guidelines and job descriptions; for patient care shall be developed, maintained and implemented by nursing services ...1.2. Based on current standards of nursing practice and shall be consistent with the nursing process which includes: assessment, nursing diagnosis, planning, intervention, evaluation and, as circumstances require, patient advocacy ...”.”

“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: 46696 Based on interview and record review, the facility failed to ensure the nursing staff administered high risk medications (drugs that have a risk of causing significant harm when they are used in error) as ordered for one of 35 sampled patients (Patient 2), when Patient 2 received 50 units (insulin is measured in units) of Insulin (a medication for lowering blood sugar) instead of the ordered 5 units. This failure resulted in the Patient 1’s blood sugar dropping to an extreme low leading to subsequent intubation (placing a tube down the airway to support breathing) and brain damage. Findings: During the survey a past non compliance situation was identified which is an immediate jeopardy situation level. The survey team was able to confirm during the survey that the facility corrected the need for immediate action. During a review of Patient 2’s “History and Physical” (H&P), dated August 8th, 2023, the H&P indicated Patient 2 was admitted for chronic congestive heart failure (a condition in which the heart does not pump blood as well as it should) and acute renal failure (failure of the kidneys). A review of Patient 2’s “Physician Order”, dated August 10, 2023, at 11:11 PM, documented by Medical Doctor (MD 1) indicated, Patient 2 was ordered “Insulin regular, 5 units, Intravenous (In the vein), once” Scheduled to be administered on August 10, 2023, at 11:15 PM. During a review of Patient 2’s “medication administration record” (MAR) dated August 10, 2023, the MAR indicated Patient 2 received 5 units of regular insulin (a fast acting medication for lowering blood sugar), intravenous on August 10, 2023, at 11:23 PM, documented by Registered Nurse (RN9) and dually signed off by registered nurse (RN 10). During a review of Patient 2’s “Progress note” dated August 11,2023, at 6:36 AM, by Medical Doctor (MD 2), the progress note indicated, “Called to bedside at approximately 6:00 AM to assess patient at bedside for low GCS [Glasgow comma scale, a method for determining a person’s level of consciousness]. Upon assessment at approximately 6:10 AM patient was GCS 3 [indicating the lowest possible score] with right pupil sluggish response ... Patient was last seen normal and interacting at 3-3:30 AM this morning when she was on her phone. Patient had a blood glucose of 2 on BMP [Basic metabolic panel, a blood test that checks the bodies electrolyte levels] that was drawn at 5:20 AM and results at 6:30 AM. A point of care (bedside) blood glucose at 6:05 AM was <20 [normal range of blood sugar is 70-120] so 25grams of D50[dextrose 50%- medicine to restore blood sugar level] was given and additional D50. Follow up arterial blood gas [a blood test showing electrolytes and oxygen, carbon dioxide levels] at 6:14am was [blood glucose] 133 and 229 at 6:41 AM.” During a review of Patient 2’s “multidisciplinary progress notes” by RN 9 dated August 14, 2023 at 10:55 AM, the progress note indicated,” Late entry for August 11, 2023 at 0545, (Patient 2) was administered 50 units of insulin at 11:27 PM on August 10, 2023 instead of 5 units per order, MD notified at the time noted.” During a review of Patient 2’s “Significant event note” by MD 1 dated August 11,2023, at 3:44 PM, the significant event note indicated, “Family meeting, formal meeting with three of the patients’ children ...Patient was diagnosed with hyperkalemia (high potassium) late PM and received glucose and insulin to address this. She became minimally responsive early AM requiring ventilatory assistance and intubation.” The significant event note” further indicated, “As the team conveyed more information, we learned that the patient had inadvertently received more insulin than intended or ordered. Hypoglycemia (Low blood sugar) was treated aggressively once the test results were determined ... Currently the patient does not open eyes to deep stimulus and has decerebrate posturing [an abnormal body posture that involves arms and legs being straight out usually indicating severe damage to the brain]. Lower limbs with minimal response upper limbs ... When queried about the predicted outcome of her brain, I requested that they be patient with us and allow some days to pass prior to us trying to determine potential brain damage that may be permanent.” During an interview on December 6, 2023, at 2:06 PM, with MD 1, MD 1 stated, when a patient receives an excessive dose of insulin this could lead to hypoglycemia. MD 1 stated, during hypoglycemia the main organ to focus on to maintain normal function was the brain, the brain can be easily harmed. MD 1 stated, Patient 2’s potassium level was high and was treated with insulin and glucose administration to normalize potassium. MD 1 stated, the amount of insulin given was 10-fold from what was ordered. There was not a realization of an issue until the patient lost GCS around 6:00 AM. MD 1 further stated “Regular insulin is quite rapid onset, the time frame of administration till identifying the low blood sugar was a sufficient amount of time to drop the patients’ blood sugar.” During an interview with RN 10, on December 6, 2023, at 2:00 PM, RN 10 stated, “They taught us about IV insulin administration in our RN residency program. The process for insulin administration is to check identifiers, including arm band with what’s shown in the MAR, have another nurse verify your correct dose, medication, patient, and time. We then sign off that we verified the correct information. It appeared to be the correct amount in this case, so I verified the 5 units, it appeared to be the correct syringe as well.” During an interview with Registered Nurse educator (RNE 4), on December 6, 2023, at 2:15 PM, RNE 4 stated Both RN 9 and RN 10 completed the RN residency program which included insulin administration, high risk medications administration, medication double check and RN verification for nurses. Both nurses have completed the required competencies. During an interview and concurrent record review on December 6, 2023, at 2:18 PM, with RNE 4 the facility’s policy and procedure (P&P) titled, “Medication administration and errors” dated August 2022, was reviewed. The P&P indicated “21. Medication administration errors shall be defined as: 21.1 Wrong patient, 21.2 wrong route, 21.3 Wrong dose/rate, 21.4 Wrong medication.” RNE 4 Stated, “RN 9 made a medication error because they administered the wrong dose of medication.” RN 9 was unable to interview due to RN 9 was no longer working with the facility.”

“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: 13095 Based on inspection of the hospital’s Narcotic Room, interview with Pharmacy Administrative staff, review of the hospital’s Patient Own Medication policy and procedure as well as the hospital’s Controlled Substance Expiring policy and procedure, the hospital failed to develop a process which ensured the safe and accurate accountability for patient’s own medication storage handling. This failure had the potential to result in patient own medications being diverted from the hospital for potential misuse. Findings: Review of the hospital’s policy and procedure, entitled: “Patient’s Own Medications Left at Hospital Upon Discharge”, dated 8/11/2023, read: “Purpose: to establish methods for handling medication(s) brought into the hospital by patients and left behind at discharge.” This policy based on its title and purpose language appeared to imply that the hospital only handled these patient own medications at the time of discharge, yet based upon record review and interview with Pharmacy Administrative staff, patient own medications are being collected for storage in the hospital’s Narcotic room in the main Pharmacy at the time of the patient’s admission into the hospital (rather than upon “discharge from the hospital”). Various controlled drugs were found in the Patient’s Own Medication storage supply, for example Oxycodone with Tylenol (which is a schedule II narcotic) 10 mg-325 mg (#115 tablets) had been stored in the Patient’s Own Medication cabinet on 4/1/2023, yet this medication had been documented on 4/10/2023 that a nurse had supposedly picked up this controlled medication to return it to the patient. Further review of the Patient’s Own medication log record and interview with the hospital’s Pharmacy Director revealed that no one could identify which nurse had picked this controlled drug up from the Pharmacy to return it to the patient. There was also no documentation of a Pharmacist or a Pharmacy Technician who had gone into the controlled drug room to give this medication to a nurse. Along with the Oxycodone for this patient, was also stored Pregabalin (Lyrica) 75 mg capsules (a Schedule V narcotic), which contained 45 tablets of this medication, which was supposedly given to the same unknown nurse, by an unknown Pharmacist or Pharmacy Tech. A second patient had brought in another schedule II narcotic (Oxycodone HCL 15mg), a total of 73 tablets which he had obtained from Costco and brought into the hospital on 11/15/2023. Again, this medication had been stored in the patient’s own medication cabinet and a nurse had supposedly picked up this controlled medication to return it to the patient. Further review of the Patient’s Own medication log record and interview with the hospital’s Pharmacy Director (DOP) on 12/6/2023 at 3:30 pm revealed that no one could identify which nurse had picked this controlled drug up from the Pharmacy to return it to the patient. There was also no documentation of a Pharmacist or a Pharmacy Technician who had gone into the controlled drug room to give this medication to a nurse. ASHP (American Society of Hospital Pharmacists) has stated the following in regards to Controlled Substances: “There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion .... The delivery of CS (controlled substances) to a storage location without a witness and receipt confirmation by another authorized HCW (Health Care Worker) may not meet the intent of the chain of custody requirement. Procedures are established to address special circumstances to ensure controls are in place to secure CS and prevent diversion of CS brought into the organization by patients. Patients should be encouraged to return their own medications to home via a household member or authorized agent when possible. CS should be stored in a secure location until disposition and chain of custody documented (eg, the patient or patient’s authorized agent signs to affirm receipt of the medication and its quantity.) Policies and procedures should define how waste will be accounted for, tracked, and disposed of to prevent unauthorized access. The wasting of all CS requires an independent witness and documentation; at least one, but preferably both, of the witnesses should be licensed. Procedures should define what constitutes complete and timely documentation of waste. An individual witnessing CS wasting should verify the product label, that the volume or amount being wasted matches the documentation, that the drug product being wasted physically matches the drug product in the documentation.” This was taken from: (American Journal of Health System Pharmacist) AM J HEALTH-SYST PHARM | VOLUME 79 | NUMBER 24 | December 15, 2022, who sets the standards for hospitals. The hospital had failed to develop a system based on the ASHP standards of Practice above, as the hospital’s Pharmacy had not developed a system which identified the two Pharmacists who had been destroying patient’s own medications, as well as any nurse who had picked up these medications. The Pharmacy’s: “Pharmacy log sheet for Patient Own Medications (Meds)”, had several entries of drugs which had been taken in by the Pharmacy on various dates, however at least 5 different drugs had been written onto the log, but the log did not contain any documentation or evidence that these medications had been destroyed, yet none of these medications could be found in the Patient’s Own Medication storage container. It appeared that these medications had gone missing as the hospital did not have any documented records of what had happened to these medications.”

“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: 13095 Based on review of the Hospital Pharmacy’s Sterile drug compounding logs, interview with the hospital’s Director of Pharmacy, and the hospital’s compounding and repackaging recipe for Vancomycin (medicine to treat serious bacterial infection) 750 milligrams (mg- unit of measurement) in 150 milliliters (ml) of Dextrose 5% water (D5W) solution, the hospital’s Pharmacy failed to their own recipe for compounding this medication and correctly assigned the finished product it’s correct Beyond Use Date (BUD-date and time the drug must not be stored)/expiration date of 9 days. This failure had the potential to affect the drug efficacy of the drugs which had been made by the pharmacy for patient administration. Findings: Review of the hospital Pharmacy’s Sterile drug compounding logs on December 8,202,3 at 9:00 AM, revealed that on November 30, 2023, at 4:40 AM, the hospital’s Pharmacy had compounded 40 (forty) bags with Vancomycin 750 mg in 150 ml of D5W. This medication had been given a BUD date of December 9, 2023, at 11:59 PM, even though the correct BUD which should have been assigned for these medications would have been December 9, 2023, at 4:40 AM, based on the 9-day BUD dating from the hospital Pharmacy’s compounding recipe for this medication under refrigeration. The hospital’s Pharmacy had assigned had a BUD to these medications which had exceeded the hospital’s accepted recipe BUD by 19 hours and 20 minutes. During an interview on December 8, 2023, at 9:30 AM, with the hospital’s Director of Pharmacy (DOP), Assistant Vice President of Pharmacy (AVPP), and the Medication Safety and Quality Management Coordinator (MSQ) confirmed that the hospital’s Pharmacy had made an error in assigning the 9 day and 19 hour and 20-minute BUD to these medications.”

“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: 47682 Based on observation, interview and record review, the facility failed to ensure high-risk drugs (medicines that has a high risk of causing significant patient harm or death when used in error) were secured when an anesthesia tray containing Rocuronium, Succinylcholine (drugs that paralyze the body), Propofol (a sedative that causes unconsciousness), Phenylephrine and Ephedrine (drugs to trat life threatening low blood pressure) was left unattended in Patient 1’s room for approximately 18 hours (December 3, 5:23 PM, to December 4, 11:30 AM). This failure had the potential to result in drug diversion or misuse of these medications which if used inappropriately can cause severe harm, injury, or death for a universe of 455 inpatients. Findings: On December 5, 2023, at 4:06 PM, an Immediate Jeopardy (IJ- a situation with the potential to significantly harm patients) was called in the presence of the Assistant Vice President of Quality and Patient Safety (AVPQPS) and the Director of Accreditation and Clinical Effectiveness (DACE). The Facility Administrators were verbally notified of the hospital’s failure to secure the following medications that were left unattended and accessible (From 5:23pm December 3,2023 untill 11:50am on December 4, 2023) on the bedside table of Patient 1 in the Surgical / Trauma Intensive Care Unit (STICU): 1 unused Rocuronium syringe 1 unused labeled Succinylcholine syringe 1 unused labeled Propofol syringe 1 unused, labeled Ephedrine syringe 1 unused, labeled Phenylephrine syringe 1 unused, unlabeled syringe with milky white liquid 2 unopened vials of Rocuronium On December 5, 2023, 6: 52 PM, a Corrective Action Plan (CAP) was reviewed and accepted. On December 7, 2023, at 9:38AM, Immediate Jeopardy was removed in the presence of the AVPQPS and DACE, after the surveyors verified implementation of the CAP through observation, interviews, and record reviews. The Corrective Action Plan included the following process; education of the anesthesia providers and OR charge nurses and other hospital staff regarding the importance of securing high-risk medications, completion of a new Post Anesthesia Transportation Checklist by anesthesia prior to transporting the patient and submitting the completed checklist to the OR charge nurse upon return from transport. During a review of Patient 1’s “History and Physical” (H&P) dated December 03, 2023, the “H&P” indicated, Patient 1 was brought in by ambulance from another hospital after an unrestrained motor vehicle accident. Patient 1 had multiple fractures (broken bones), splenic laceration (cuts to his spleen) and was sent to the operating room for an Open Reduction Internal Fixation (ORIF) of his left femur and tibia (a surgery that stabilizes the leg bones with metal hardware). During a concurrent observation and interview on December 4, 2023, at 11:30 AM, with Registered Nurse 1 (RN1), in Patient 1’s room, a tray of medications and syringes was seen on the bedside table partly covered with a surgical cloth. These medications were identified as: 1 unused Rocuronium syringe 1 unused labeled Succinylcholine syringe 1 unused labeled Propofol syringe 1 unused, labeled Ephedrine syringe 1 unused, labeled Phenylephrine syringe 1 unused, unlabeled syringe with milky white liquid 2 unopened vials of Rocuronium RN1 stated that Patient 1 was transferred from surgery to Patient 1’s room on December 3 at 5:23 PM. RN1 further stated that she did not realize there were medications left in the room otherwise she would have taken care of it immediately. “These were brought up with him from surgery yesterday. If I had seen these earlier, I would have removed them from the room, they should not be in the room.” During a review of Patient 1’s “Anesthesia Record” (AR) dated December 3, 2023, the “AR” indicated that Patient 1 left the operating room on December 3, 2023 at 5:17 PM and was signed off to the Surgical / Trauma Intensive Care Unit (STICU) at bedside by Anesthesiology Resident 1 (AR1) at 5:23 PM. During an interview on December 4, 2003, at 11:40 AM, with the STICU Manager (STICUM), the STICUM stated, “I agree that these meds should not be here unattended in the room. They could be taken by anyone and used inappropriately. They are potentially dangerous medications - paralytics and sedatives.” During an interview on December 4, 2003, at 11:50 AM, with Anesthesia Resident 2 (AR2), AR2 stated, this was an emergency intubation kit, brought up with the patient from Surgery. It should not have been left unattended inside Patient 1’s room; they should have taken it back down to surgery when they left the room. During an interview on December 5, 2023, at 10:00 AM, with AR1, AR1 stated that during transport of critically ill patients, anesthetists often bring medications up from surgery with them for use in potential emergencies and which are then brought back with them to the operating room. AR1 confirmed that medications brought to a patient’s room are the responsibility of the provider who brought them. AR 1 stated, “ultimately it is our responsibility to keep the meds in our possession, to ensure the chain of custody. Leaving meds in a patient room is not the standard and is potentially very dangerous.” AR1 further stated, these medications could cause harm to a patient, if it was given inappropriately. I would consider them as high-risk medications. AR 1 further stated, “Bad things can happen if they are used incorrectly. Especially if it lands in the hands of someone with the intention to do harm.” During an interview on December 5, 2023, at 11:00 AM, with the Surgery Department Medical Director, (SDMD), the SDMD stated, “There is certainly a cause for concern when the accountability for those (medications) is unclear. We take that incredibly seriously. We take control of these meds as a high priority. We do expect the provider to maintain chain of control at all times.” During a concurrent interview and record review on December 5, 2023, at 2:00 PM, with the Surgical / Trauma Intensive Care Unit Manager, (STICUM), the facility’s Policy and Procedure (P&P) titled “Pharmaceutical Storage”, dated October 2023, was reviewed. The P&P indicated, “7. While Pharmacy shall be responsible for ensuring proper storage of medications, all [Name] departments and nursing units shall comply with policy specifications regarding: 7.1 Proper storage of medications in their areas, according to specifications listed in this policy, 7.2 Supervision of access to medications stored in their areas ... 9.3 Security: Medications shall be stored in a secure place until used and be under the control of authorized persons at all times.” The STICUM stated, these medications were not kept under control of an authorized person while on the unit in accordance with our policy when it was left unattended at the patient’s bedside. The STICUM further stated, they were not stored properly, and access was not supervised or restricted.”

“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: 46917 Based on observation, interview, and record review, the facility failed to ensure that surgical services were provided in accordance with the facility’s policy and procedure “Sponge, Sharp, & Instrument Count” and acceptable standards of practice when: 1. A broken piece of a Castro needle (Castroviejo- surgical instrument used for microsurgery requiring precise control and manipulation of small needles) holder bracket was not removed from the chest cavity of Patient 41 before the final closing suture was performed. This failure resulted in the reopening of the chest cavity of Patient 41 to retrieve the broken piece of the Castro needle which jeopardized the health and safety of Patient 41. 2. A Davinci robotic instrument (a mechanical surgical tool) tip cover was retained and unidentified inside Patient 18 for three months. This failed practice resulted in Patient 18 undergoing an unnecessary second surgery, pain and prolonged healing process. 3. A surgical laparotomy pad (surgical absorbent gauze) was unintentionally retained in Patient 20 when Operating Room (OR) staff failed to implement the facility’s policy and procedure (P&P) requiring a mandatory X-ray prior to final closure of a previously opened abdomen. This failure resulted in Patient 20 undergoing another surgery to remove the retained foreign object (laparotomy pad) and subjected him to prolonged discomfort, infection, and delayed healing which significantly jeopardized his health and safety. Findings: 1. During a review of Patient 41’s “Cardiology History and Physical”, dated February 4, 2021, the Cardiology H&P indicated Patient 41 was admitted to the hospital with the diagnoses of dyspnea (difficult or labored breathing), chronic systolic heart failure with reduced ejection fraction with severe Mitral regurgitation (heart lower left chamber doesn’t pump blood out to the body as well as it should), and coronary artery disease (plaque buildup in the wall of the arteries). During a review of “Consent To Surgery OR Special Procedure” dated March 15, 2021, the consent to surgery indicated, Patient 41 consented to orthotopic heart transplant (taking out the recipient’s heart and implanting of donor’s heart in the chest of the recipient), removal of right axillary impella (implanted heart pump used to pull blood from the ventricle and push it out into the aorta to deliver oxygen rich blood to the body) performed by Cardiothoracic Surgeon (CTMD 1). During a review of Patient 41’s “Surgery Report” dated March 16, 2021, the surgery report indicated, Patient 41 underwent surgery for a heart transplant and axillary impella removal. The report further indicated that Patient 41’s surgery “ ...All instruments, sponge, and needle counts were confirmed to be correct x 2 at the end of the operation. However, a piece (bracket) of a needle holder ‘Castro’ was found to be missing during the count, subsequently a CXR [chest x-ray - used to visualize the chest cavity] was taken and it was found to be in the mediastinum [area between the lungs - includes the heart and its large blood vessels]. The patient was re-prepped and draped, and the sternotomy [cut in the skin over the breastbone which leads to the heart and nearby blood vessels] was reopened. We carefully looked for the missing piece, and finally was able to retrieve it ...sternotomy was reclosed in the same fashion ...”. During a review of Patient 41’s “OR Nursing Notes” dated March 16, 2021, the OR Nursing Notes indicated, during surgery of Patient 41, “One of the brackets from the Jacobsen needle holder was missing early in the case, and intra-op [inside the operating room] chest x-ray was done prior to the patient’s departure from the operating room. It was read by the radiologist ...who’s findings indicated that it [bracket] was inside the chest cavity. The patient was then re-prepped and draped ... [CTMD 1] was able to remove the item. The chest was eventually closed and dressed ...”. During a review of “Counts” dated March 16, 2021, the counts indicated “ ...Reason: Initial ...Count correct? Yes ...Reason: Relief ...Count correct? Yes ...Reason Cavity Closure ...Count correct? Yes ...Reason: Final ...Count correct? Yes ...”. The counts were performed by CN 5 and Scrub nurse (Scrub RN 1). During a concurrent interview and record review on December 5, 2023, at 2:00 PM with Scrub RN (Scrub RN 1) and OR Manager (ORM 1), Patient 41’s “Surgery Report” and “Counts”, both dated March 16, 2021, were reviewed. Scrub RN 1 stated she informed the surgeons regarding the missing bracket from the needle holder before the chest cavity closure. Scrub RN 1 further stated that the surgeons informed her that the missing piece was not inside the chest cavity. Scrub RN 1 and ORM 1 reviewed Patient 41’s “Counts” and Scrub RN 1 stated she did not follow the policy when documenting the counts were correct when there was a missing piece of the needle holder. ORM 1 further stated the counts should have been documented as “no” because a piece of the needle holder was missing. During a follow up concurrent interview and record review on December 5, 2023, at 2:10 PM, with Scrub RN 1 and ORM 1, the hospital’s policy and procedure (P&P) titled, “Sponge, Sharp & Instrument Count”, dated November 23, 2020, was reviewed. The P&P indicated, “ ...3.1 Retained Surgical Item (RSI) a. A foreign surgical item that is not intended to remain in the patient at the end of the surgery that remains in the patient after the last suture has been placed ...3.2 Count a. Accounting of all counted items including instruments, sponges, sharps, and miscellaneous items ...5.7 Broken Items -account for all items that were broken during a procedure in their entirety ...11.1 Procedure for incorrect count: d. If the count remains incorrect, a mandatory x-ray is required ...11.3 Mandatory x-ray for incorrect/un-reconciled count: a. An x-ray is mandatory before the patient leaves the rooms for an incorrect/un-reconciled count.” The Scrub RN 1 stated the P&P was not followed. During a concurrent interview and record review on December 6, 2023, at 3:29 PM, with Circulator Nurse (CN 5) and ORM 1, the P&P titled, “Sponge, Sharp & Instrument Count”, dated November 23, 2020, and Patient 41’s “Counts” dated March 16, 2021, was reviewed. CN 5 stated she was informed by Scrub RN 1 that a piece of the needle holder was missing. CN 5 and ORM 1 reviewed the counts and P&P. CN 5 stated she did not follow the policy when documenting the counts were correct when there was a missing piece of the needle holder. 47682 2. During a review of Patient 18’s “Surgery Report” (SR) dated November 30, 2022, the “SR” indicated, Patient 18 was diagnosed with Fibroid Uterus (non-cancerous growths in the uterus) and underwent robot-assisted total laparoscopic hysterectomy (surgery to remove her uterus) on November 30, 2022. During a review of Patient 18’s “Operating Note” (ON) dated November 30, 2022, the “ON” indicated, the surgery was successful, and the Initial, Relief, Closing and Final surgical counts were all correct. During a review of Patient 18’s “History and Physical” (H&P) dated March 3, 2023, the “H&P” indicated, Patient 18 had persistent pelvic pain since her surgery in November. A Computed Tomography (CT) scan (a procedure providing visualization inside the body) revealed a foreign body on March 2, 2023, at 1:54 PM. During a review of Patient 18’s “Operating Notes” (ON) dated March 3, 2023, the “ON” indicated, Patient 18 had laparoscopic surgery to remove a foreign body which was identified as the retained Da Vinci accessory insulated sheath for monopolar (instrument using an electrical current) scissors. During a concurrent interview and record review on December 5, 2023, at 2:20 PM, with the Operating Room Manager (ORM 1), Patient 18’s “Operating Note” (ON) dated November 30, 2022, was reviewed. The “ON” indicated the surgery was successful, and the Initial, Relief, Closing and Final surgical counts were all correct. The ORM 1 stated, in this case, the team did not include this tip cover in the count. They did not include it in the initial count so when it went missing, it was not identified in the final count. The ORM 1 stated, if they added the scissors and tip later in the procedure, the tip cover should also be counted under “accessories.” The ORM 1 stated, the tip should have been logged on the whiteboard and included in the final count. The ORM 1 further stated, “Accessories should also be counted, including tip covers. Anything in the surgical field. They should also be counted during the surgery.” During an interview on December 6, 2023, at 9:45 AM, with Circulating Nurse 4 (CN 4), CN 4 stated, the circulating nurse was ultimately responsible for the surgical count. CN 4 stated, it was their responsibility to ensure the count matches, and to communicate that to the surgical team. CN 4 stated, it was most important to have an accurate initial count, updated whenever anything was added to the surgical field. It is updated on the whiteboard anytime something is added. New sponges, needles, accessories - anything added to the surgical field. CN 4 further stated, a tip cover should also be included in the count. During a concurrent observation and interview on December 7, 2023, at 10:30 AM, in the [name of facility] Operating Suite 7, a robot-assisted laparoscopic hysterectomy was observed on Patient 26. Circulating Nurse 1 (CN 1) stated, all soft count (lap pads, 4x4’s, needles, accessories) was kept on the whiteboard. CN 1 stated all instrument count was kept on a paper log. CN 1 further clarified, “Yes, a Davinci Tip Cover should be counted under accessories on the whiteboard.” During a concurrent interview and record review on December 7, 2023, at 11:00 AM, with the Surgical Hospital Director of Perioperative Services (SHDPS), the Sign-in Record for “In-service on DaVinci Robotic Shear Tip Cover Counting” was reviewed. SHDPS stated, when this tip was unintentionally retained, we reviewed our counting process and through this incident we have identified areas for improvement. Part of that was education for staff regarding the requirement to include the Davinci Tip cover on every count. During a concurrent interview and record review on December 5, 2023, at 2:25 PM, with the Operating Room Manager (ORM 1), the facility’s Policy & Procedure (P&P) titled, “Sponge, Sharp & Instrument Count” dated April 3, 2022, was reviewed. The P&P indicated,” 3.2 Count a. Accounting of all counted items including instruments, sponges, sharps, and miscellaneous items.” The ORM stated, “according to our policy, a tip cover or any such accessory should also be counted. In this case it was missed.” 3. During a review of Patient 20’s “History and Physical” (H&P) dated October 16, 2023, the “H&P” indicated, Patient 20 had a past medical history of end stage renal disease (ESRD - a disease where the kidneys stop functioning), cirrhosis (damage to the liver) and hypertension (high blood pressure) who received robotic assisted umbilical hernia repair (repair of abdominal wall) with small bowel resection and anastomosis (removal of a portion of intestines) on September 27, 2023. On October 16, 2023, he returned for surgical treatment of diffuse peritonitis (widespread infection in his abdomen). During a review of Patient 20’s “Surgical Progress Note” (SPN) dated November 7, 2023, the “SPN” indicated, Patient 20 had a series of four surgeries since his re-admission on October 16, 2023: On October 16, 2023, Patient 20 had a laparotomy (opening of the abdomen) with removal of a portion of small intestine, aspiration of ascites (removal of fluid in the abdomen), with 10 Lap pads intentionally retained. The incision was not closed. On October 16, 2023, Patient 20 was returned to surgery for control of bleeding, nine (9) lap pads were removed, 13 quick clot sponges were placed. Patient 20 was left without closing the incision. On October 18, 2023, Patient 20 was returned to surgery for a lavage (washing) of abdomen, 13 clotting sponges and 9 lap pads were removed and the incision was not closed. On October 20, 2023, Patient 20 was returned to surgery for another small bowel resection, gastrostomy tube placement (a tube placed through the abdomen into the stomach), and final abdominal closure. During a review of Patient 20’s “Surgery Report” (SR) dated October 31, 2023, the “SR” indicated, Patient 20 had a diagnosis of sepsis (widespread infection in the body) from an unintentionally retained surgical laparotomy pad above the liver. The SR further indicated, an exploratory laparotomy (surgical opening of the abdomen) was performed on October 31, 2023, to remove the retained lap pad and control bleeding. During a concurrent interview and record review on December 5, 2023, at 2:20 PM, with the Operating Room Manager (ORM 1), Patient 20’s “Surgery Report” (SR) dated October 20, 2023, was reviewed. The “SR” indicated that all surgical sponge counts were documented as correct and no X-ray was taken during or after the procedure. The ORM 1 stated, the retained pad was purposely retained through the various surgeries but missed in the final closure on this surgery. The ORM 1 further stated, “However, in our policy, a fascial [skin] closure on a previously opened cavity will trigger an x-ray. Following this policy would have prevented this from happening.” During a concurrent interview and record review on December 5, 2023, at 2:22 PM, with the ORM 1, the facility’s policy and procedure (P&P) titled “Sponge, Sharp & Instrument Count” dated March 15, 2023 was reviewed. The P&P indicated “Regardless of count outcomes, a mandatory x-ray is required prior to leaving the operating room when one or more of the following apply: b. Patients coming to the Operating Room for final closure of an open abdominal or thoracic cavity shall have an x-ray taken prior to closing.” The ORM 1 stated, “we did not follow our policy, we would have caught it if we had. Following this case, we reiterated a mandatory x-ray.” During a follow up interview on December 5, 2023, at 2:25 PM, with the ORM 1, the ORM 1 stated, “Since this case we made changes in documentation to make it more robust and easier to identify intentionally retained packing.” If there is still packing remaining, we need to manually create a new entry, saying there is retained packing. The ORM 1 stated, this will create a flag in the flowsheet that will carry over to any subsequent surgeries. “Either way we should have caught it, we would have caught it if we had followed our policy on mandatory x-rays.” During an interview on December 6, 2023, at 9:45 AM, with Circulating Nurse 4 (CN 4), CN 4 stated, we have been emphasizing the count process over the last few months. CN 4 stated, we are now enforcing a ‘surgical sweep’ where we gather the pads, and the surgeon checks the cavity before start of closure. We also have a closing time out before final skin closure, all counts are verified. CN 4 further stated, “an Xray is required if there is a count discrepancy, or we use 50 or more sponges, or if they come already open from a previous surgery. This is policy and everyone is aware of it.” CN 4 further stated, “we know if there are pads retained or carried over because the nurse from previous surgery should have it in the Intra-Operative Notes. You can also read the surgeons Operation Note, it tells where and how many retained pads are there. If there is a retained pad, it is human error.” During a concurrent observation and interview on December 6, 2023, at 1:00 PM, in Surgical Suite #5, with Circulating Nurse 3 (CN3), a final surgical count process and documentation was observed. CN 3 stated, “we have recently revised our count documentation process, to make it more detailed, especially concerning any intentionally retained items.” During an interview on December 6, 2023, at 2:05 PM, with Circulating Nurse 2 (CN 2), CN 2 stated, we count everything that we placed on the surgical field and it was logged on the whiteboard. CN 2 stated, every time we add anything, from the smallest needle, it will be added to the count and will be included in the final count. CN 2 stated, “if something was missed we search for it, on the floor, under the drapes, everywhere. If the count remained off, we would do an Xray to ensure it was not in the patient.” CN 2 stated, an Xray was also required if we used 50 lap pads or more, or it is the final closure on an open abdomen.”

“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: 47682 Based on interview and record review, the facility failed to ensure one of 35 sampled patients (Patient 19) received safe postoperative care when a vaginal packing was not removed after surgery. This failed practice resulted in a retained surgical item that had the potential to cause severe infection, injury, and harm to the patient. Findings: During a review of Patient 19’s “History and Physical” (H&P) dated November 15, 2023, the “H&P” indicated Patient 19 had a diagnosis of cystocele, (weakened wall between bladder and vagina) rectocele, (weakening of tissue between the rectum and vagina) uterine prolapse (sagging of the uterus from a weakening of pelvic muscles) and stress urinary incontinence (leakage of urine). During a review of Patient 19’s “Surgery Report” (SR) dated November 15, 2023, the “SR” indicated, Patient 19 underwent surgery for cystocele and rectocele repair, (repair of the vaginal walls) uterine suspension and vaginal wall sling (tightening of the tissue holding the uterus and strengthening the vagina) on November 15, 2023. During an interview on December 5, 2023, at 2:26 PM, with the Operating Room Manager (ORM1), the ORM1 stated, any type of packing that we leave intentionally in the Operating Room should be documented and included in the handoff report. This information follows through with the patient to PACU. The ORM1 stated, it should also be mentioned in a post-operative order to remove the packing, otherwise packing should be removed by the surgeon. During an interview on December 7, 2003, at 11:00 AM, with the Surgical Hospital Perioperative Services Director (SHDPS), the SHDPS stated, it was common for these cases to have vaginal packing that was removed in the PACU (Post Anesthesia Care Unit), but it was done with a Physician’s order. The SHDPS stated, in this case, our investigation found that there was no order, and the physician assumed the resident with her wrote the order for removal of packing. The SHDPS stated, we required a Physician’s order placed by the surgical team when vaginal packing needs to be removed in PACU. During an interview on December 8, 2023, at 9:15 AM, with the attending physician (GYNMD), GYNMD stated, vaginal packing was a standard of care for this procedure. GYNMD stated, for the past 12 years her standard practice was to remove packing before discharge of the patients. GYNMD stated, this was also her intent for Patient 19’s procedure. GYNMD stated, vaginal packing removal was done by the nurses in PACU. GYNMD stated, in this case it was Kerlex with Clindamycin (antibiotic cream). GYNMD stated, a physician would then write an order to the PACU nurse with instructions for the packing. GYNMD further stated usually, I would rely on the medical resident to put the order in for post-operative care. In this case there was no order written. There should have been an order to remove the packing. During a concurrent interview and record review on December 8, 2023, at 11:00 AM, with the Surgical Hospital Peri anesthesia charge nurse (CRNP), Patient 19’s “Operative Note” (ON) dated November 15, 2023, was reviewed. The “ON” indicated Patient 19 had a Clindamycin cream soaked vaginal Kerflex packing placed during the procedure. The CRNP stated, there was no order in the chart to remove the packing and without an order you would not remove it. The CRNP stated, if it was a verbal order the nurse would have put it in Nursing Communication as a verbal physician order. There is nothing in the chart. During an interview on December 8, 2023, at 11:20 AM, with PACU RN 1 (PRN 1), PRN 1 stated, she was the nurse for Patient 19 on November 15, 2023. PRN 1 stated, she did not see any packing upon PACU nursing assessment. PRN 1 stated, usually there would be a tail, or gauze showing to indicate there is a packing. PRN 1 stated, if she saw there was packing, she would have clarified with the physician what they wanted to do, either leave it in or remove before discharge. “There was no order, and I would not remove packing without an order.” PRN1 further stated, if packing like this was left in too long, there could be harmful effects like infection or sepsis.”