Coastal Communities Hospital

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure nursing staff obtained a physician’s order for the use of restraints for one of six sampled patients (Patient 4). This failure placed the patient at risk for unsafe care and poor clinical outcomes. Findings: Review of the hospital’s P&P titled Restraint and Seclusion dated 3/24, showed physician, NP, PA are authorized to order restraints. In emergencies, restraints can be initiated by a nurse at which time a physician order must be obtained as soon as possible after the emergency has subsided but no later than one hour from initiation. On 5/4/26, Patient 4’s medical record was reviewed and showed Patient 4 was admitted to the hospital on 4/26/26 and was discharged on 5/1/26. Review of the orders dated 4/30/26 at 0956 hours, showed an order to apply soft restraints to Patient 4’s bilateral wrists. Review of the Restraints Flowsheets dated 4/30/26 at 0800 hours, showed that Patient 4 continued to pull at lines, tubes, drains, dressing, and electrodes. On 5/4/26 at 1430 hours, an interview and concurrent review of Patient 4’s medical record was conducted with the Director of Quality. The Director of Quality stated RN 3 initiated soft restraints on Patient 4 at 0630 hours on 5/4/26 hours, but did not document the restraint use. The Director of Quality stated that the first documented restraint entry was at 0800 hours, and the restraint order was not entered until 0956 hours. On 5/5/26 at 1305 hours, the CNO, the CQO, and the Director of Quality acknowledged the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(iii) [there must be documentation in the patient’s medical record of] Alternatives or other less restrictive interventions attempted (as applicable); This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure that least restrictive interventions were documented prior to the initiation of restraint use for one of six sampled patients (Patient 4). This failure created a risk of unsafe care and poor clinical outcomes for the patient. Findings: Review of the hospital’s P&P titled Restraint and Seclusion dated 3/24, showed the hospital uses restraint or seclusion only when less restrictive interventions are ineffective. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, or others. On 5/4/26, Patient 4’s medical record was reviewed and showed Patient 4 was admitted to the hospital on 4/26/26. Review of the orders dated 4/30/26 at 0956 hours, showed an order to apply soft restraints to Patient 4’s bilateral wrists. On 5/4/26 at 1430 hours, an interview and concurrent review of Patient 4’s medical record was conducted with the Director of Quality. The Director of Quality stated that RN 3 initiated soft restraints on Patient 4 at 0630 hours on 5/4/26. The Director of Quality stated that the restraint order was not entered until 0956 hours. Review of the record did not show documentation that least restrictive interventions were attempted before the initiation of the soft restraint. On 5/5/26 at 1305 hours, the CNO, the CQO, and the Director of Quality acknowledged the findings.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure that the ICU was staffed with sufficient nursing personnel. According to the hospital’s documented ICU Staffing Grids, one RN and one charge nurse were required when the census was one or two patients. This required staffing was not provided, resulting in one of six sampled patients (Patient 1), who required ICU-level care, being transferred to a medical-surgical unit. This practice placed the patient at risk for delayed recognition of clinical deterioration, inadequate monitoring, and lack of timely interventions associated with ICU-level care due to reduced access to critical-care-trained nursing staff. This staffing deficiency also created a facility-wide risk. If another patient in a different unit, such as the Emergency Department, required ICU-level care, the hospital would not have had the capacity to safely provide that level of care due to insufficient nursing personnel to staff the ICU. Findings: Review of the hospital’s undated ICU Staffing Grids showed that for both the day shift (7 a.m.-7 p.m.) and the night shift (7 p.m.-7 a.m.), a census of 1-2 patients requires staffing with one charge nurse and one RN. On 5/4/26, review of Patient 1’s medical record showed the patient was admitted on 1/29/26. Review of the CCU Staff Assignments dated 2/26/26 for the night shift, showed RN 1 was assigned to care for one ICU level of care patient and one medical surgical level of care patient. Review of the Progress Notes dated 2/27/26 at 0000 hours, showed Patient 1 was transferred to the medical surgical unit as an ICU overflow patient, while maintaining ICU status/level of care with continuous telemetry monitoring. The transfer occurred on 2/26/26 at approximately 2345 hours. Review of the Progress Notes dated 2/27/26 at 0015 hours, showed RT 1 received a call reporting that RN 1 needed assistance with Patient 1. While en route, a Code Blue was announced overhead. RT 1 connected an ambu bag to the oxygen flowmeter and attempted to turn dial to flush (15L). However, the metal ball on the flowmeter remained at approximately 6 L, and no oxygen flow was heard. The issue was immediately corrected, and Patient 1 received 100 % FiO2 via ambu bag connected to a portable oxygen tank. It was also noted that Patient 1 was wearing a HFNC; however, HFNC device was completely silent, with no audible oxygen flow. Review of the Code Blue Record dated 2/27/26 showed the following: * The time of arrest was at 0018 hours. * Patient 1 was asystole at 0020 hours. * Patient 1 was intubated at 0025 hours. On 5/5/26 at 0749 hours, RN 1 was interviewed in the presence of the Director of Quality. RN 1 stated that RN 1 began the shift with two patients assigned to RN 1 in the ICU. On 5/5/26 at 1107 hours, the CEO was interviewed and stated the CEO made a decision to relocate Patient 1, who required ICU level of care, to the medical surgical unit because no additional nurse was available to staff the ICU. On 5/5/26 at 1305 hours, the CNO, the CQO, and the Director of Quality acknowledged the above findings.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to follow its Rapid Response Team P&P when staff did not activate a RRT for one of six sampled patients (Patient 1) despite acute change in condition. This failure created a risk of harm to Patient 1 because the lack of a Rapid Response Team activation delayed the escalation of care needed to assess and respond to the patient’s acute change in condition. Findings: Review of the hospital’s P&P titled Rapid Response Team (RRT) dated 2/11, showed: * A RRT may be deployed for any employees/visitors with sudden onset of life threatening emergencies. * Any hospital team member who identifies a patient at risk according to the criteria listed below has the authority and responsibility to call the RRT. * Call the RRT when a patient has an acute change in condition or when staff is concerned/worried about the patient’s condition, e.g. acute change in respiratory rate less than 10 or greater than 28 breaths per minute and acute change in SpO2 (pulse ox) saturation less than 90 %. On 5/4/26, review of Patient 1’s medical record showed the patient was admitted on 1/29/26. Review of the Progress Notes dated 2/27/26 at 0000 hours, showed Patient 1 was transferred to the medical surgical unit as an ICU overflow patient, while maintaining ICU status/level of care with continuous telemetry monitoring. The transfer occurred on 2/26/26 at approximately 2345 hours. Review of the Progress Notes dated 2/27/26 at 0015 hours, showed RT 1 received a call reporting that RN 1 needed assistance with Patient 1. While heading to Patient 1, a Code Blue was announced overhead. RT 1 connected an ambu bag to the oxygen flowmeter and attempted to turn dial to flush (15L). However, the metal ball on the flowmeter remained at approximately 6 L, and no oxygen flow was heard. The issue was immediately corrected, and Patient 1 received 100 % FiO2 via ambu bag connected to a portable oxygen tank. It was also noted that Patient 1 was wearing a HFNC; however, HFNC device was completely silent, with no audible oxygen flow. Review of the Code Blue Record dated 2/27/26, showed the following: * The time of arrest was at 0018 hours. * Patient 1 was asystole at 0020 hours. * Patient 1 was intubated at 0025 hours. On 5/5/26 at 0724 hours, RT 1 was interviewed in the presence of the Director of Quality. RT 1 stated that no urgency was communicated when the call for assistance was received. RT 1 stated RT 1 completed the current task before proceeding toward Patient 1, and while en route, a code blue was initiated. On 5/5/26 at 0749 hours, RN 1 was interviewed in the presence of the Director of Quality. RN 1 stated that Patient 1’s condition changed immediately after transfer to the medical surgical unit. There was no documentation showing that a RRT had been called. On 5/5/26 at 1305 hours, the CNO, the CQO, and the Director of Quality acknowledged the above findings.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure that nursing staff developed a nursing care plan for one of six sampled patients (Patient 3) who received a blood transfusion. This failure created a risk of not providing the necessary care and services to meet the patient’s needs. Findings: Review of the hospital’s P&P titled Charting dated 3/14, showed all current diagnosis/problems must have an affiliated care plan entry. Each care plan must be reviewed and updated per shift. On 5/5/26, review of Patient 3’s medical record showed Patient 3 was admitted to the hospital on 5/2/26. Review of the physician’s order dated 5/3/26 at 0447 hours, showed that packed red blood cells were ordered due to a hemoglobin level of less than 7.0 g/dL. At 0938 hours, the physician ordered the blood product to be administered over two hours. Review of the Blood Administration Record dated 5/3/26, showed the blood transfusion was started at 1030 hours and ended at 1230 hours. Review of the Plan of Care for Patient 3 was completed. Patient 3’s medical record failed to show that a nursing care plan had been developed to address the blood transfusion. On 5/5/26 at 1305 hours, the CNO, the CQO, and the Director of Quality acknowledged the above findings.”

“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: 36703 Based on interview and record review, the hospital failed to ensure the medical staff was accountable to the GB for the quality of care and services provided to patients in regard to implementation of ongoing professional practice evaluation (OPPE) for the medical staff. This failure increased the risk for substandard outcomes for patients receiving care from the medical staff. Findings: Review of the hospital’s Medical Staff Bylaws and General Rules and Regulations dated April 2025, indicated; * Article 2, Section 1.B. showed the Medical Staff is accountable to the Governing Board for the quality and appropriateness of the professional performance and ethical conduct of its members, and to strive for achievable quality patient care, efficiently delivered and maintained consistently with available resources. * Article 5, Section 3 showed Medical Staff members are subject to ingoing evaluation based on peer review criteria. The information collected will be evaluated and used as part of the reappointment process. Data will be collected no less than every six months and no more than every nine months. Review of the hospital’s P&P titled Professional Practice - Ongoing (OPPE) and Focused (FPPE) dated September 2023 showed annually, an OPPE Report Card for each practitioner scheduled for review will be prepared with data that has been collected, collated, and transcribed onto the Report Card by the Quality Management Department. The reports will be given to the Department Chair who will review the information and identify any unsatisfactory triggers or trends which would require a focused review. A summary of his/her assessment will be reported to the Credentials Committee, Medical Executive Committee, and the Governing Board, including any recommendations for focus review. Each practitioner’s OPPE report will be maintained in the Medical Staff Office and will be incorporated with the practitioner’s reappointment information. During a concurrent interview and record review on 10/29/25 at 1130 hours, with the Director of Medical Staff and the Medical Staff Coordinator, the hospital’s credential files were reviewed. The Director of Medical Staff stated the OPPE was last conducted in 2023. The Director of Medical Staff stated the OPPEs were not currently being conducted. On 10/31/25 at 1236 hours, the above concern was shared and acknowledged by the CNO, the Director of Quality and the Director of CCU. The CNO shared there were 213 practitioners currently undergoing the initial credentialing and reappointment process.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the Governing Body maintained oversight of contracted dialysis service as evidenced by: 1. The Governing Body failed to verify that the contracted dialysis vendor (Vendor B) was licensed to provide dialysis services. 2. The Governing Body failed to ensure a registered nurse (RN 1) working under the contracted dialysis vendor (Vendor B) completed the required competency validation prior to providing patient care. These deficient practices resulted in the hospital’s lack of oversight of contracted dialysis services and created a risk that dialysis care and documentation were inconsistent with the hospital’s quality and safety standards. Findings: On 10/29/25 at 1020 hours, an interview was conducted with the CNO. The CNO stated the hospital’s dialysis contract with Vendor A ended on 10/25/25 and a new contract was executed with Vendor B on the same date. The CNO stated Vendor B would provide acute dialysis services to hospital patients. Review of the Dialysis Services Agreement showed this Dialysis Services Agreement effective as of 10/25/25 between the hospital and Vendor B. Further review of the Dialysis Services Agreement showed all agency personnel who provide dialytic services under this agreement must be approved by the hospital before such personnel provide services at the hospital. The agency shall review each nurse’s competency prior to permitting such nurse to perform dialytic services at the hospital. The agency shall require, maintain, provide, and have promptly available for hospital’s review the following documents for each agency nurse providing services: the licensure, evidence of current certification BLS, health status, certification of liability insurance, and documented training on OSHA standards for blood borne pathogens. 1. On 10/29/25 at 1437 hours, an interview was conducted with the Clinical Nurse Manager for Vendor B. The Clinical Nurse Manager for Vendor B stated Vendor B did not need a certification license as it was providing acute care services. The Clinical Nurse Manager for Vendor B stated this was communicated with the hospital. On 10/31/25 at 1030 hours, the CNO stated she was unaware that Vendor B was not certified by the CMS and stated all communications between Vendor B and the hospital were conducted at the corporate level. The CNO acknowledged the hospital failed to verify Vendor B’s licensure status before initiating dialysis services at the hospital. 2. On 10/29/25 at 1052 hours, review of Patient 1’s medical record showed Patient 1 was admitted to the hospital on 10/26/25 and transferred to another hospital on 10/28/25. Review of the Hemodialysis Treatment Flowsheet showed Patient 1 received hemodialysis on 10/26/25 at 2100 hours and on 10/28/25 at 1230 hours. However, documentation for both treatments was completed by RN 1 using the hemodialysis treatment flowsheet for Vendor C, not Vendor B. On 10/31/25 at 1111 hours, an interview was conducted with RN 1 and the Clinical Nurse Manager for Vendor B. RN 1 stated RN 1 worked for both Vendor B and Vendor C and used Vendor C’s flowsheet because it was the only one available. The Clinical Nurse Manager for Vendor B confirmed RN 1 was assigned under Vendor B’s contract when he performed the dialysis treatments for Patient 1. Review of RN 1’s competency file showed the last completed competency verification for hemodialysis initiation and pre-dialysis functions was dated 9/6/24, under Vendor C, not Vendor B. On 10/31/25 at 1133 hours, the CNO, Director of Quality, and Director of CCU reviewed and acknowledged the findings.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to provide the sanitary environment and an active infection control program in the perioperative area as evidenced by: 1. The hospital failed to ensure the infection control program implemented the hospital’s P&Ps and professional standards and employed methods for preventing and controlling the transmission of infection within the hospital. Cross reference to A749. 2. The hospital failed to ensure the infection control staff provided sufficient oversight of the perioperative services. Cross reference to A750. The cumulative effect of these systemic failures resulted in the hospital’s inability to minimize the risk of spread of infections in the hospital.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to ensure services provided under contracted vendors were provided in a safe and effective manner by establishing complete and regularly scheduled contract evaluations for the vendors in the hospital. This failure had the potential for the risk of substandard services being provided in the hospital. Findings: The hospital was unable to provide a policy and procedure on evaluation of contract services when requested. On 9/18/25, a review of the hospital’s vendor contract evaluation was initiated. On 9/18/25 at 1500 hours, a request was made to review the contract evaluations for Vendors A and B. The VP of Business Development/Interim CNO was unable to provide the contract evaluations for Vendors A and B. The VP of Business Development/Interim CNO stated the hospital only had contract evaluations on vendors that provided direct patient care. On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to ensure the contract list was site-specific within the hospital’s health system to include a complete list of all contracted services for the hospital. This failure had the potential for the risk of substandard services being provided in the hospital. Findings: On 9/18/25 at 1500 hours, a review of the hospital’s contracted services was conducted with the VP of Business Development/Interim CNO. Review of the hospital’s contracted list showed Vendor A was missing from the list provided during the survey. The VP of Business Development/Interim CNO acknowledged Vendor A was not listed on the hospital’s contracted services list as required. On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the QAPI program included an ongoing program related to infection control in the perioperative area. This failure created an increased risk of poor health outcomes for the patients receiving care in the hospital. Findings: During an interview with the VP of Business Development/Interim CNO on 9/18/25 at 1300 hours, the VP of Business Development/Interim CNO provided the 2023 Hospital Performance Improvement Plan and stated that it was also the plan used for 2025. Review of the 2023 Hospital Performance Improvement Plan showed “The Performance Improvement Plan describes the systematic, organization-wide approach to quality that is used to plan, design, measure, assess, and improve organizational performance... 4. Measurement and Evaluation... - Departmental quality improvement activities... - Regulatory and compliance standard... Performance Improvement Priorities... A. Priorities are based on: 1. Strategic planning priorities; 2. The needs identified for major patient populations served; 3. The needs identified in operational processes; 4. Consideration of the entire scope of services and operations; 5. High risk, high/low volume, or problem prone areas; 6. Consideration of prevalence and severity of problems and impact on patient safety 7. Patient care and organizational functions; 8. The overall resources available...” Review of the hospital’s Quality Performance Improvement Report for Operating Room for the year 2025, showed the following performance measures: * Universal Protocol followed * H&P 24 hours update on file * Consent signed by Patient and MD * Unexpected surgical complication * Labeling of fluids on sterile field * Prophylactic antibiotic timing During observation, interview, and record review from 9/16/25 to 9/19/25, the following deficient practice was identified: * The hospital failed to provide the sanitary environment and an active infection control program in the perioperative area. Cross reference to A 0747. During an interview and concurrent record review with the VP of Business Development/Interim CNO, Infection Preventionist, OR Charge Nurse, and Facility Director on 9/19/25 at 1037 hours, the CNO stated staff who was in charge of the QAPI program, was off. The OR Charge Nurse and Facility Director stated two department worked so closely and no work order needed to be filed. The Facility Director stated there was no tracking system to follow up with issues. The VP of Business Development/Interim CNO verified that the QAPI program did not include infection control issues within the surgical department. The QAPI lacked a system to track, measure, and analyze infection control issues, including issues with rusty equipment, the physical environment, and out-of-range temperature and humidity levels that were previously identified.”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 45560 Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity was maintained in the dry food storage area of the kitchen. These failures created a potential risk for an unsafe food storage environment. Findings: Review of the hospital’s provided document titled Serving Safe Food Certification Coursebook, Page 92 (undated) showed under Dry Storage: Keep packages of dried fruits and vegetables, cereals and other grain products, sugar, flour, and rice intact and dry. These foods may be stored for long time periods, but water and high humidity may cause bacterial growth. Storage area temperatures should be 50 degrees to 70 degrees Fahrenheit with a relative humidity of 50-60%. On 9/17/25 at 1042 hours, an observation and concurrent interview was conducted with the Director of Dietary Services in the hospital’s dry food storage area. A posting was noted on the wall of the dry food storage area showing: Temperature: between 50-70 degrees Fahrenheit; Humidity: at 50-60%. On observation of the digital thermometer in the dry food storage area it showed the temperature to be 75.7 degrees Fahrenheit and the humidity at 45%. The Director of Dietary Services acknowledged the temperature in the dry food storage area should be between 50 and 70 degrees Fahrenheit and humidity should be between 50-60%. The Director of Dietary Services acknowledged the temperature and humidity of the dry food storage area were both out of range. On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the infection control program implemented the hospital’s P&Ps and professional standards, and employed methods for preventing and controlling the transmission of infection within the hospital as evidenced by: 1. Soft water was not available for the instrument washer from 7/31/25 to 9/16/25. 2. The routine maintenance for the instrument washer and sterilizers was not conducted as per the manufacturer’s IFU. 3. The air exchange was not tested annually. 4. The Rapicide PA (a high-level disinfectant) Minimum Required Concentration (MRC) Test Strips was not used as per the manufacturer’s IFU. 5. Instruments were soaked in saline (a mixture of salt ans water) after the procedure and before being transported to the decontamination area, a method not in compliance with AORN’s guidelines. 6. Sterile supplies were not stored as per AORN’s Guidelines. 7. There was no cleaning verification test conducted to confirm the effectiveness of manual cleaning on high-risk scopes as per AORN’s guidelines. 8. There is no lighted magnification inspection of scopes prior to the HLD as per AORN’s guidelines. 9. The physical environment in the peri-operative area was not maintained in a sanitary condition. 10. For two sterilizers, the manual was not readily available to review when to perform sterilizer inspection, routine maintenance, and cleaning. 11. Surgeon 1 failed to perform surgical scrubbing as per the manufacturer’s IFU. 12. There was no clock or timer to ensure surgical scrub followed the manufacturer’s IFU. 13. Hinged instruments were not sterilized in an open position as per AORN’s Guidelines. These failures had the potential for spread of infections and negative impacts to the patients’ health conditions. Findings: During an interview on 9/16/25 at 0835 hours, the Infection Control Preventionist and OR Charge Nurse stated the hospital followed the AORN’s Guidelines as their practice for the perioperative services. 1. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Instrument Cleaning 2025 edition showed under 3. Water Quality. 3.2. Water should be monitored and controlled to the values. Chloride is damaging to stainless steel and can cause pitting corrosion. During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the communication board was observed. The board showed “both water tanks out 7/31/25.” During an interview with the Instrument Technician and Senior Instrument Technician in the presence of the OR Charge Nurse on 9/17/25 at 1019 hours, the Instrument Technician and Senior Instrument Technician stated two soft water tanks were used for the instrument washer. When the first soft water tank was empty, the second tank was used. The Senior Instrument Technician stated that both soft water tanks were empty on 7/31/25. The soft water tanks were replaced on 9/16/25 around 3 or 4 PM. On 9/19/25 at 1037 hours, an interview with the VP of Business Development/Interim CNO, Infection Preventionist, Facility Director, OR Charge Nurse, and Instrument Technician was conducted. The Infection Preventionist stated the Infection Preventionist was aware of the lack of soft water from 7/31/25 to 9/16/25. The Infection Preventionist also stated there was no random inspection and monitoring of the surgical tray. The VP of Business Development/Interim CNO verified the above findings. 2. Review of the hospital’s P&P titled Autoclave Testing, Cleaning and Maintenance dated August 2023 showed the following: * Chamber drain will be flushed weekly following the manufacturer’s IFU. See attachment “A” for IFU step by step directions and cleaning product to be used and how to dilute. * Check Control and Status Signals will be performed weekly following the manufacturer’s IFU. See attachment “A” for IFU step by step directions. * Float Switch Assembly will be checked quarterly following the manufacturer’s IFU. See attachment “A” for IFU step by step direction. Float switch assembly will be performed by company that performs preventative maintenance. Review of Attachment A under 4.2 Recommended Periodic Maintenance showed the following: * 4.2.2 Weekly. - 1. Flush chamber drain as follows: a. Turn off steam supply valve. Wait until jacket pressure is zero. Wait until chamber has cooled to room temperature b. Remove chamber drain strainer c. Rinse drain with a solution of one quart of hot water and 1/2 cup of STERIS Liqui- Jet instrument detergent d. Wait five minutes. e. Flush drain with one quart of hot water f. Place strainer back in drain g. Turn Manual control to off h. Turn steam supply valve back on - 2. Check control and status signals as follows: a. Select and start a short cycle b. Observe gauges, display and printed tape for proper functioning - 3. Flush Steam Generator, if sterilizer is equipped with optional steam generator Review of the AMSCO 3000 Series Operator Manual under Table 6-1. Routine Maintenance Guide showed the following: * 5.0 Chamber Components - 5.1 Inspect rotary spray arm assemblies for free movement and clogged holes once a week. - 5.3 Remove hard water deposits from interior of chamber using decontamination cycle once a week. - 5.4 Clean washer/disinfector exterior once a week. - 5.5 Clean water outlet connection in chamber once a week. * 9.0 Manifold Racks - Inspect rotary spray arm assemblies of manifold racks for free movement and clogged holes once a week During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the Instrument Technician stated there were two sterilizers and one instrument washer. The Instrument Technician stated the Instrument Technician performed cleaning outside of the sterilizer daily. During an interview with the Instrument Technician and Senior Instrument Technician on 9/17/25 at 1014 hours, the Instrument Technician and Senior Instrument Technician stated the drainer was cleaned daily but the vendor cleaned the inside of the chambers for the sterilizers. For the instrument washer, the cleaning process was followed when the washer prompted to clean. The Instrument Technician and Senior Instrument Technician verified there was no weekly routine maintenance performed for the sterilizers and washer. On 9/19/25 at 1037 hours, the VP of Business Development/Interim CNO verified the above findings. 3. During an entrance conference on 9/16/25 at 0850 hours, the air exchange report for the surgery department was requested. On 9/17/25, the air exchange report was provided. Review of the Air Balance report dated 9/17/25, showed the air exchange was tested in surgical department. During an interview with the Facility Director on 9/17/25 at 1209 hours, the Facility Director stated the air exchanges would be performed annually. The previous air exchange report was requested. Review of the Annual Crucial Area Validation showed the air exchange test was performed on 12/12/23. On 9/19/25 at 1037 hours, the VP of Business Development/Interim CNO verified the above findings. 4. Review of the manufacturer’s IFU for Rapicide PA Minimum Required Concentration (MRC) Test Strip showed to dip the strip into the solution for one second; shake off the excess solution; wait for 30 seconds and then compare the strip color to the color chart on the bottle. Ready within one minute of testing to determine if the result matches PASS or FAIL. During an interview with the Instrument Technician on 9/16/25 at 1010 hours, the Instrument Technician stated the test strip was used to validate the HLD’s efficacy. The Instrument Technician stated to dip in a couple seconds like eight to 10 seconds. On 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings. 5. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Instrument Cleaning 2025 edition showed under 6. Point-of-Use Treatment. 6.4 Keep instruments moist until they are cleaned by using either saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments. Do not use saline. During an observation in the OR on 9/17/25 at 1300 hours, the dirty instrument soaked in clean solution were observed in the basket. Surgical Technician 1 stated the dirty instruments were soaked in saline. On 9/17/25 at 1340 hours, the OR Charge Nurse acknowledged the findings. 6. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Sterilization. 2025 edition showed under 4. Storage of Sterile Items. 4.1.3. Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts. During a tour of the OR area on 9/17/25 at 1329 hours, with the OR Charge Nurse, the sterile supplies were observed stored in the OR hallway. The sterile supplies were stored in the closed cabinet, and some sterile supplies were stored in the open cart in the OR hallway. It was observed the door of the closed cabinet was open. The OR Charge Nurse verified the above findings. 7. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2025 edition showed under 9. Cleaning Verification and Inspection. 9.5 Use cleaning verification tests to verify manual cleaning of flexible endoscopes before sterilization or HLD when new endoscopes are purchased and at established intervals (e.g., after each use, daily). 9.5.1. For flexible endoscopes that are identified as high risk by the health care organization (e.g., duodenoscopes, bronchoscopes), verify manual cleaning efficacy with a cleaning verification test after each use. 9.5.2. Cleaning effectiveness may be evaluated by testing for one or more of following: ATP, protein, carbohydrate, and hemoglobin. During a tour of GI Reprocessing room with the Instrument Technician and OR Charge Nurse on 9/16/25 at 1010 hours, the Instrument Technician and OR Charge Nurse stated there were no cleaning verification tests after the manual scope cleaning and prior to the HLD. During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings. 8. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2025 edition showed under 9. Cleaning Verification and Inspection. 9.3. Use lighted magnification to inspect the external surfaces of flexible endoscopes and accessories before sterilization or HLD. During an interview with the Instrument Technician and Senior Instrument Technician on 9/17/25 at 1041 hours, the Instrument Technician stated the Instrument Technician inspected the external surfaces of scopes with bare eyes, not with the lighted magnification. During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings. 9. During a tour of the surgical department with the OR Charge Nurse on 9/17/25 at 1329 hours, the following were identified: * Rusty wheels of the back table and stainless-steel kick bucket in OR 3. * Worn out OR table mattress in OR 3. * A rectangular plastic seal, black tape on the ceiling next to sprinkler in OR 3. * The fluorescent light fixture on the ceiling with translucent plastic cover displayed irregular blotchy discoloration in the decontamination room. During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings. 10. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Sterilization 2025 edition showed under 10. Quality. 10.15.2. Perform sterilizer inspection and routine maintenance including cleaning as specified in the manufacturer’s written IFU. During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the Instrument Technician stated there were two sterilizers and one instrument washer. The Instrument Technician stated the Instrument Technician performed cleaning outside of the sterilizer daily and no routine maintenance for inside of the chamber. During an interview with Biomedical Technician 3 on 9/16/25 at 1330 hours, Biomedical Technician 3 stated the Biomedical Technician 3 did not have manuals for the two sterilizers at the hospital. On 9/17/25, the hospital provided manuals for the sterilizers. During an interview with the OR Charge Nurse on 9/17/25 at 1034 hours, the OR Charge Nurse stated the manuals for the sterilizers were prepared on 9/16/25. 11. Review of the manufacturer’s IFU for BD E-Z Scrub 107 (4% CHG) showed the following: * Wet hands and forearms to the elbows with warm water. * Use nail cleaner and apply scrub solution from sponge side. * Scrub nails, cuticles, and interdigital spaces thoroughly for three minutes with brush side and hands and forearms with the sponge side. * Rinse with warm water. * Repeat scrub for three more minutes, use the sponge side only. * Rinse hands and arms thoroughly. On 9/17/25 at 1002 hours, Surgeon 1 was observed performing surgical scrub with the BD E-Z Scrub 107. It was observed the OR Charge Nurse dialed the timers. At 1003 hours, Surgeon 1 rinsed both forearms and hands. At 1005 hours, Surgeon 1 opened another BD E-Z Scrub 107 and started to scrub the forearms and hands. At 1006 hours, Surgeon 1 rinsed the forearms and hands. At 1007 hours, the OR Charge Nurse told Surgeon 1 to wait until the timer rang. At 1009 hours, Surgeon 1 opened another BD E-Z Scrub 107 and repeated the surgical scrub. At 1013 hours, Surgeon 1 rinsed the scrubbed forearms and hands. At 1014 hours, Surgeon 1 entered the OR. 45560 12. Review of the manufacturer’s IFU for BD E-Z Scrub 107 (4% CHG) showed the following directions: * Wet hands and forearms to the elbows with warm water * Use nail cleaner and apply scrub solution from sponge side * Work up lather * Scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side * Rince with warm water * Repeat scrub for three more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds. * Rinse hands and arms thoroughly * Dry thoroughly During a tour of the OR area on 9/16/25 at 0928 hours, hand scrub sinks were observed in the OR hallway. There was no clock or timer observed around hand scrub sinks. On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings. 13. Review of the AORN’s Guidelines for Perioperative Practice: Packaging Systems dated 2025, showed under section 3.9.2, place items to be sterilized in an open or unlatched position within the sterilization package. The open or unlatched position facilitates sterilant contact of all surfaces of the item. During a concurrent observation and interview on 9/16/25 at 1005 hours, with the Instrument Technician in the sterile surgical instrument storage area in the main hallway of the OR, several hinged sterilized packaged instruments were found sterilized and packaged in the closed position. The Instrument Technician acknowledged the sterile surgical instruments should have been placed in the sterilization pouch and sterilized in the open position. On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 36703 Based on observation, interview, and record review, the hospital failed to ensure the Infection Control Preventionist provided sufficient oversight of the surgical services when the deionized water filtration system was not functional, increasing the risk of compromised surgical instrument integrity during reprocessing and patient harm. Findings: Review of the hospital’s P&P titled Infection Prevention and Control Program dated April 2025 showed the goal of the program is to facilitate the prevention of hospital-acquired infections. The Infection Control Preventionist, with the guidance of the Chairperson has the responsibility for the daily management of infection prevention and control activities. The Infection Control Preventionist has the authority to take steps to prevent or control acquisition and transmission of infectious agents. During an observation, interview, and record review from 9/16/25 to 9/19/25, the following deficient practice was identified: * The hospital failed to ensure deionized water was available for the processing of soiled surgical instruments. Cross reference to A749, example # 1. On 9/19/25 at 1038 hours, an interview and record review were conducted with the Infection Control Preventionist, the Instrument Technician, the OR Charge Nurse, and the VP of Business Development/Interim CNO. The Infection Control Preventionist stated the water filtration system, responsible for providing deionized water for surgical instrument processing, was due for preventive maintenance and had not been functional since 7/31/25. The Instrument Technician mentioned that during this period, instruments were inspected more closely and specially cleaned with a chemical to safely remove any build-up, as well as another chemical for lubricating them. The Instrument Technician also showed pictures of the instruments to the Infection Control Preventionist. The OR Charge Nurse added that any rusty instruments were always removed from service at any point during processing and before use on a patient during surgery. The Infection Control Preventionist stated the primary concern in getting the water filtration system operational was addressing the credit hold, which required a balance and service payment before the vendor could provide the service. Review of the vendor receipt showed the water filtration system was serviced and functional as 9/17/25. However, a more comprehensive and proactive oversight of infection prevention related to the non-functional water filtration system was not performed by the Infection Control Preventionist. For example, the Infection Preventionist failed to instruct to open sample trays for inspection of the surgical instruments or considered alternative methods to ensure surgical instruments were processed using deionized water while the system was down. Rather, the Infection Preventionist stated a responsive approach for overseeing the post-surgical complications from an infection prevention standpoint was to review post-surgical patient cultures for any potential contaminants or return-to-surgery rates. The above concerns were shared and acknowledged by the Infection Control Preventionist, the Instrument Technician, the OR Charge Nurse, and the VP of Business Development/Interim CNO.”

“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: 35310 Based on observation, interview, and record review, the hospital failed to ensure the surgical services were provided in a safe manner. This failure could result in the potential for poor health outcomes to patients receiving surgical services in the hospital. Findings: 1. The hospital failed to ensure the infection control program implemented the hospital’s P&Ps and professional standards and employed methods for preventing and controlling the transmission of infection within the hospital. Cross reference to A749. 2. The hospital failed to ensure the Infection Control Preventionist provided sufficient oversight of the surgical services when the deionized water filtration system was not functional from 7/31/25 to 9/16/25. Cross reference to A750.”

“ORDERS FOR REHABILITATION SERVICES CFR(s): 482.56(b) Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital’s medical staff to order the services in accordance with hospital policies and procedures and State laws. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to provide rehabilitation services as ordered by the physician for two of five sampled patients (Patients 4 and 5). This failure created the risk of substandard health outcomes for patients. Findings: Review of the hospital provided document titled Rehab Services Department (undated) showed under the section titled, Patient Assessment/Reassessment, Initial evaluations of inpatients will be performed within 24 hours of the department notified of the referral. During an interview on 9/17/25 at 1345 hours, the Director of Rehabilitation Services stated that the contracted rehabilitation service provider was unable to provide enough staff at times to provide all rehabilitation services ordered by the hospital’s providers for inpatients. 1. Review of Patient 5’s medical record initiated on 9/19/25 at 0855 hours, showed Patient 5 was admitted to the hospital on 8/19/25 and was discharged on 9/2/25. Review of the orders for Patient 5 showed an order for a physical therapy evaluation and treatment was entered on 8/25/25. The orders also showed an order for occupational therapy evaluation and treatment ordered on 8/28/25. During a concurrent interview and record review on 9/18/25 at 0855 hours, with LVN 1, LVN 1 was unable to locate any documentation showing Patient 5 was evaluated and/or treated by a Physical Therapist or an Occupational Therapist during their hospitalization. 2. Review of Patient 4’s medical record initiated on 9/19/25 at 0920 hours, showed Patient 4 was admitted to the hospital on 9/3/25 and was discharged on 9/5/25. Review of the orders for Patient 4 showed an order for a physical therapy evaluation and treatment was entered on 9/4/25. The orders also showed an order for occupational therapy evaluation and treatment ordered on 9/5/25. During a concurrent interview and record review on 9/18/25 at 0920 hours, with LVN 1, LVN 1 was unable to locate any documentation showing Patient 4 was evaluated and/or treated by a Physical Therapist or an Occupational Therapist during their hospitalization. On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.”

“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: 29558 Based on observation, interview, and record review, the hospital failed to ensure the nursing staff provided the necessary care and services to ensure the health and safety of the patients as evidenced by: 1. The hospital failed to ensure the nursing staff were maintained at all times for the CCU as required. Cross reference to A392. 2. The hospital failed to ensure the nursing staff provided the necessary care and services to three of 22 sampled patients (Patients 2, 3, and 22). Cross reference to A395. 3. The hospital failed to ensure the nursing staff administered the heparin (blood thinner) IV drip medication to one of 22 patients (Patient 9) as per the physician’s order. Cross reference to A405. 4. The hospital failed to ensure the nursing staff administered the blood transfusion to two of 22 sampled patients (Patients 2 and 8) as per the hospital’s P&P and physician’s order. Cross reference to A410. The cumulative effect of these systemic practices resulted in the hospital’s inability to provide safe and effective nursing services.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure the nursing staff were maintained at all times for the CCU as required. This failure created the risk for substandard health outcomes to the patients. Findings: Review of the hospital’s 2023 Plan for Provision of Patient Care showed for CCU, the CCU nurses required special skills and advanced education or experience in the care of critically ill patients. The CN acts as a resource person to staff that are floated to the unit to provide patient care. Nursing staff in the CCU includes a department director, CN, and staff nurses (RNs). Staffing ratios are 1:1 and 1:2 depending on acuity criteria. A nurse is assigned to monitoring of telemetry or cardiac monitors. The Department Director or designee will classify patients and forecast staffing needs daily for the next 24 hours. The Staffing Coordinator or Administrative Supervisor will collaborate with the Director or designee to adjust staffing up or down according to the census and patient acuity to each shift. The Department Director and Staffing Coordinator or Administrative Supervisor will make arrangement to meet changing increased patient census. Review of the hospital’s P&P titled Telemetry/Cardiac Monitoring dated June 2024 showed in part: * Policy: All patients admitted to CCU will be monitored via hard wire monitoring or telemetry. All patients admitted to other nursing units with a physician ’ s order for “Telemetry or Cardiac Monitoring” will have the cardiac rate and rhythm monitored by CCU team members as per procedure below. * Designated Team Members: RN and LVN. * Procedure: CCU team members will - Observe monitor rate or rhythm at central station in CCU and document on telemetry log every four hours. - Obtain ECG strip on initiation or admission, every shift and with rhythm changes. - Interpret strip for rhythm, rate presence and configuration of P waves, length of PR interval, QRS complexes, T waves, length of Q-T intervals, and presence of dysrhythmias. - Set the alarms on the basis of the patient’s current clinical status and heart rate. - Notify the patient’s nurse of any rate or rhythm changes. - Document on rhythm strip any reported signs or symptoms, timing of drugs or other treatments that may have affected or cause change in patient rate or rhythm. All symptomatic tachy-or brady arrhythmia and all rhythms that require immediate treatment will be documented in the patient’s medical record. - Mount rhythm strips on patient medical record. It is not acceptable to substitute written diagnostic statements for the tracing themselves. Review of the hospital’s P&P tilted Staffing Intensive Care Unit: 1:1 Acuity Patient - Nurse Ratio dated September 2023 showed in part: * Policy: A 1:1 status work sheet will be used to identify patients whose acuity required continuous non-interrupted nursing care by Intensive Care RN. * Procedure: The CN or Assigned Nurse will determine acuity of all ICU patients each shift. The CN will determine those patients requiring status using the status scale worksheet. A score of greater than five determines that the patient’s condition is appropriate for 1:1 status. On 3/10/25 at 1500 hours, a tour of the ICU was conducted with Director 1 and Director 3. RN 9 was asked about the nurse-to-patient ratios in the ICU. RN 9 stated when they were short of staff and mostly happened during the night shifts, the M/S/telemetry nurses or LVNs from the subacute unit would float to the ICU, have their own patients, team up with the CN like the team nursing where the M/S/telemetry RNs or LVNs would administer the medications through GT, FT, or PO and medication drips, and the patient assessments were left for the CN to do. RN 9 was asked about the ICU acuity assessments. RN 9 stated the RNs filled out the acuity forms and the CN endorsed the acuity to the incoming CN including the procedures for the day. RN 9 was asked about the Monitor Technician. RN 9 stated at times, if there was no MT, the CN became the MT and would have their own patients. On 3/10/24 at 1600 hours, review of the CCU Staff Assignments was conducted with Director 1 and showed the following: - For 11/24/24 7 A to 7 P shift, four RNs were assigned to care for eight patients; one RN assignment was for “helping hands” and there was a MT. One RN had two patients from the 1000 to 7 P shift. There were eight telemetry patients in the M/S Telemetry unit. There was no assigned CN and a nurse was assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank. - For 11/24/24 7 P to 7 A shift, two RNs were assigned to care for six patients and there was a MT. One RN was assigned to three patients on ventilator. There were eight telemetry patients in the M/S Telemetry unit. There was no assigned CN and a nurse was assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank. - For 12/14/24 7 A to 7 P shift, two RNs were assigned to care for three patients and there was a MT. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one patient and also functioned as the CN. One RN was assigned to care for two CCU patients. There was no nurse assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank. - For 12/14/24 7 P to 7 A shift, two RNs were assigned to care for three patients and a MT. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one patient and also functioned as the CN. One RN was assigned to care for two CCU patients. There was no nurse assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank. - For 12/21/24 7 A to 7 P shift, one RN was assigned as the CN and aslo to monitor the telemetry or cardiac monitors. There were nine telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient. There was no MT. The patient acuity was left blank. - For 12/21/24 7 P to 7 A shift, one RN was assigned as the Resource RN and also to monitor the telemetry or cardiac monitors. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient. There was no MT. The patient acuity was left blank. - For 12/22/24 at 7 A to 7 P shift, one RN was assigned to care for one CCU patient, functioned as the CN, and also monitored the telemetry or cardiac monitors. There were 10 telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for two CCU patients. There was one RN on orientation. There was a MT. The patient acuity was left blank. - For 12/22/24 at 7 P to 7 A shift, one RN was assigned as the Resource RN. There were 10 telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient and the first patient to be admitted to the CCU. One RN was assigned to care for two CCU patients. There was a MT. The patient acuity was left blank. - For 1/17/25 at 7 A to 7 P shift, one RN was assigned as the CN and also to monitor the telemetry or cardiac monitors. The CCU had three patients. One RN was assigned to care for two patients and one RN was assigned to care for one patient. One RN was on orientation. There was no MT. The patient acuity was left blank. - For 1/17/25 at 7 P to 7 A shift, The CCU had six patients with 3 RNs. Two patients were on ventilators. There was no RN assigned as the CN and there was nurse assigned no monitor the telemetry or cardiac monitors. Each RN was assigned to care for two patients. There was a MT. There were five patients on telemetry. - For 1/18/25 at 7 A to 7 P shift, the CCU had six patients with 5 RNs. One of the 5 RNs was assigned to monitor the telemetry or cardiac monitors for both CCU (for six patients) and Telemetry Unit (for 10 patients). There was no RN assigned as the CN for the CCU. There was no RN assigned for the code blue and RRT for this shift. - For 1/18/25 at 7 P to 7 A shift, the CCU had four patients. There was no RN assigned as the CN for the CCU. There was no RN assigned to monitor the telemetry or cardiac monitors for both CCU (for four patients) and Telemetry Unit (for 10 patients). There was a MT. There was no RN assigned for code blue and RRT for this shift. On 3/10/25 at 1600 hours, an interview and concurrent record review was conducted with Interim CNO and Director 1. Director 1 was asked who the Director for CCU was. Director 1 stated he and the Interim CNO had been overseeing the ED and CCU since December 2024 when the Director was on leave. Director 1 verified the ICU staffing on 11/24/24, for the 7 P - 7A shift was out of ratio. The Interim CNO was asked about the M/S nurse who had floated to the CCU. The Interim CNO stated the M/S nurses were trained with ACLS and would monitor the patients on telemetry. The Interim CNO was asked who had monitored the cardiac monitors for telemetry patients if there was no assigned MT. The Interim CNO stated there was a central monitor in the telemetry nursing station and the telemetry CN could monitor the patients and alert the nurses. The EKG strips were run and interpreted by the ICU nurses. If there was a MT, the MT could run the EKG strips and interpret. The CCU CN looked at it and initialed the EKG strips. The Interim CNO was asked about the RN who was assigned as “helping hands” in the ICU. The Interim CNO stated the RN, who was assigned as “helping hands,” was the M/S/Telemetry nurses to help admininster the PO, FT, and IV medications but not the medication drips. The Interim CNO was asked about the patient acuity in the CCU. The Interim CNO stated she did not see the acuity was done for the patients, but if the ratio was 1:1, the nurses would do the acuity. However, as per the hospital’s P&P, the acuity would be done on all patients in ICU. The findings were shared with the Interim CNO.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital failed to ensure the nursing staff provided the necessary care and services to three of 22 sampled patients (Patients 2, 3, and 22) as evidenced by: 1. For Patient 2, a. The oxygen was administered to Patient 2 without a physician’s order as per the hospital’s P&P. b. Patient 2 was not monitored every two hours while on Bi-PAP as per the hospital’s P&P. c. The physician was not informed of the patient’s change in condition when the oxygen was changed from the nasal cannula to NRM for Patient 2. d. The MT failed to accurately interpret Patient 2’s EKG rhythm strips and inform the CCU or telemetry nurses for the change in cardiac rate and rhythm for 29 minutes, prompting the telemetry nurse to call a code blue after finding the patient was unresponsive and not breathing with dilated pupils. e. The code blue record did not document the medication doses administered during the code blue for Patient 2. 2. Failure to ensure the alarm of central telemetry monitor was set at the default level or audible to be heard for Patient 22. 3. Failure to collect the urine sample for Streptococcus Pneumoniae Ag laboratory test for Patient 3 as per the physician’s order. These failures created the increased risk of poor health outcomes to the patients receiving services in the hospital. Findings: 1. On 3/11/25, Patient 2’s closed medical record was reviewed and showed Patient 2 was admitted to the hospital on 1/15/25 at 0856 hours, with the chief complaint of syncope. Review of the ED Provider Aware Note dated 1/15/25 at 0956 hours, showed on 1/15/25 at 0930 hours, Patient 2’s SpO2 was 88% on room air. The patient was placed on NRM. The patient had hypoxia. The patient was admitted to the Telemetry at 1440 hours. a. Review of the hospital’s P&P titled Oxygen Therapy dated September 2023 showed the following: * Policy: - All free flow oxygen will be delivered via a compensated flowmeter at the exact liter flow as ordered by the physician. - All oxygen delivered that is more than three liter per cannula or 6 liters per mask will be humidified via the approved humidification equipment. - RCP’s will be responsible for setting up patients/residents on oxygen. Nursing may also start patients/residents on oxygen and will notify the RCP immediately after initiation (except in ER, PACU, and L&D). * Procedure: Verify the physician’s order. On 3/11/25 at 1505 hours, an interview and concurrent review of Patient 2’s closed medical record review was conducted with LVN 1. Review of Patient 2’s oxygen therapy dated 1/18/25, showed the following: - At 0030 hours, the patient was receiving FIO2 60% via BiPAP. The patient’s SPO2 was 96% and the patient’s RR was 20 breaths per minute. - At 0428 hours, the patient was receiving FIO2 60% via BiPAP. The patient’s SPO2 was 95 % and the patient’s RR was 23 breaths per minute. - At 0716 hours, the patient was receiving 8 L/min oxygen via nasal cannula with humidification. The patient’s SPO2 was 94 % and the patient’s RR was 20 breaths per minute. - At 1110 hours, the patient was receiving 8 L/min oxygen via nasal annual with humidification. The patient’s SPO2 was 95 % and the patient’s RR was 18 breaths per minute. - At 1506 hours, the patient was receiving 8 L/min oxygen via nasal annual with humidification. The patient’s SPO2 was 94 % and the patient’s RR was 18 breaths per minute. - At 2020 hours, the patient was receiving 15 L/min or FIO2 100 % oxygen via NRM. The patient’s SPO2 was 96 % and the patient’s RR was 18 breaths per minute. - At 2350 hours, “CODE BLUE,” the patient was receiving 15 L/min or FIO2 100% oxygen via bag valve mask. However, there was no documented evidence to show the physician’s order was obtained for the use of oxygen via nasal cannula and NRM for Patient 2. On 3/12/25 at 1510 hours, an interview and concurrent review of Patient 2’s medical record was conducted with RN 7. RN 7 was asked for Patient 2’s physician’s order for the use of oxygen. RN 7 stated the physician ordered on 1/16/25 at 0636 hours, BiPAP at bedtime, IPAP 12 cm H2O, EPAP 5 cm H2O, back up rate 15, FIO2 80%, and RT adjust settings for patient’s comfort. However, there was no physician’s order for oxygen therapy via NRM and nasal cannula for Patient 2. On 3/13/25 at 1606 hours, an interview and concurrent review of Patient 2’s medical record was conducted with Manager 2. Manager 2 was asked about Patient 2’s oxygen therapy with 8 L/min via nasal cannula. Manager 2 stated there was no physician’s order for the supplemental oxygen and the oxygen could not be given via nasal cannula at 8 L/min, it would not be effective. b. Review of hospital’s P&P titled Bi-PAP, Non-Invasive Ventilatory Support dated April 2024 showed in part: * Initiation of therapy will be based upon a valid physician’s order which must include: - FIO2: supplemental oxygen will be administered based upon the patient’s needs as determined by ABG analysis and/or pulse oximetry. * Clinical monitoring: all patients receiving non-invasive ventilation must continuously monitored a minimum of every two hours and should include but not limited to - Cardiac and respiratory rate. - Use of accessory muscles. - Auscultation. - Pulse oximetry. On 3/12/25 at 1510 hours, an interview and concurrent review of Patient 2’s medical record was conducted with RN 7. RN 7 was asked for Patient 2’s physician’s order for the use of oxygen. RN 7 stated the physician ordered on 1/16/25 at 0636 hours, BiPAP at bedtime, IPAP 12 cm H2O, EPAP 5 cm H2O, back up rate 15, FIO2 80%, and RT adjust settings for patient’s comfort. Review of Patient 2’s oxygen therapy dated 1/18/25, showed Patient 2 was receiving FIO2 60% via BiPAP at 0030 and 0428 hours. At 0716 hours, the patient was receiving 8 L/min oxygen via nasal cannula with humidification. Review of RN’s assessment and reassessment showed Patient 2’s respiratory assessment was conducted once a shift or on 1/17/25 at 2000 hours and 1/18/25 at 0800 hours. The section of Respiratory Assessment showed Patient 2 ’ s breath sounds were crackles on all lung fields on 1/17/25 at 2000 hours and 1/18/25 at 0800 hours. There was no documented evidence to show the auscultation of the patient’s lungs was performed when the patient was receiving the BiPAP on 1/18/25 from 0030 to 0428 hours, as per the hospital’s P&P. Review of the oxygen therapy showed Patient 2’s SPO2 levels were assessed on 1/18/25 at 0030 and 0428 hours. However, there was no documented evidence to show the patient’s SPO2 levels were assessed every two hours when the patient was receiving the BiPAP on 1/18/25 from 0030 to 0428 hours, as per the hospital’s P&P. On 3/12/25 at 1530 hours, an interview and concurrent review of Patient 2’s closed medical record was conducted with RT 1 and RN 7. RT 1 was asked about Patient 2’s oxygen delivered via nasal cannula and NRM, BiPAP orders, and monitoring with BiPAP use. RT 1 stated the patient’s oxygen could be changed from nasal cannula or mask as per the patient’s comfort based on the physician’s order. The oxygen delivered via nasal cannula could only be at maximum of 6 L/min humidified, the patient was monitored every four hours when the patient was on BiPAP on M/S/Telemetry unit. The RT was asked about Patient 2’s ABG, RT 1 stated the patient’s oxygen level was low. When asked about how he would maintain and adjust Patient 2’s FIO2, RT 1 stated he would titrate the FIO2 as long as the SPO2 was kept above 92%. However, there was no physician’s order to titrate FIO2 to maintain SPO2 level above 92%. On 3/17/25 at 1515 hours, interview was conducted with Interim CNO and Director 3 about Patient 2’s assessment and monitoring while the patient was on Bi-PAP. The Interim CNO stated the RNs had the pulse oximeter to check for the SPO2. However, the nursing documentation did not show the SPO2 was monitored every two hours. The findings were shared with the Interim CNO and Director 3. c. Review of the hospital’s P&P titled Assessment and Reassessment dated September 2023 showed in part: * Policy: Each patient is reassessed every shift by a RN (or as unit specific policies dictate) or more frequently as warranted by the patient’s condition. The RN may delegate basic assessment and data collection to the LVN to perform as long as it is within the LVN’s scope of practice. The scope and intensity of any further assessment is based on the patient’s diagnosis, the care setting, the patient’s desire for care, and the patient’s response to any previous care. * Reassessment: Complete daily assessment and reassessment will be done every shift and/or change of condition or per unit policy. The RN must reassess the patient when there is a significant change in condition or diagnosis (example: change in respiratory condition, pain, change of level of consciousness). * Documentation: Nursing is to document patient’s condition and findings, action plan, and how patient responds to treatment, communication with the physician and other disciplines pertinent to the patient’s plan of care. On 3/11/25 at 1505 hours, an interview and concurrent review of Patient 2’s medical record was conducted with LVN 1. Review of RN’s documentation for Patient 2 showed on 1/18/25 at 0800 hours, Patient 2 was on 6 L/min oxygen via nasal cannula. At 2000 hours, the RN documented Patient 2 received 11 L/min oxygen via NRM. There was no documented evidence the reason why the patient’s oxygen therapy was changed to 11 L/min oxygen via NRM at 2000 hours. There was no documented evidence to show the physician was notified when the patient ’ s condition was changed. LVN 1 was asked for the RN’s documentation of Patient 2’s change in condition. LVN 1 showed the RN’s progress note; however, the RN progress note did not show the physician was notified and communication with other discipline such as the RT about the change in condition when Patient 2’s oxygen was increased from 6 L/min humidified oxygen via nasal cannula to 11 L/min via NRM. The findings were shared with the Interim CNO. d. Review of the hospital’s P&P titled Telemetry/Cardiac Monitoring dated June 2024 showed the following: * Policy: All patients admitted to CCU will be monitored via hard wire monitoring or telemetry. All patients admitted to other nursing units with physician order for “Telemetry Cardiac Monitoring” will have the cardiac rate and rhythm monitored by CCU team members as per P&P. * Designated Team Members: RN and LVN * Telemetry Monitoring on General Nursing Unit: - Verify order for telemetry. - Assess the patient history for cardiac dysrhythmias or other cardiac problems and send telemetry request to CCU with the following information: patient’s name (addressograph), diagnoses, medications, and other pertinent information such as potassium level or cardiac history. - If contacted by CCU nurse of any change in patient rate or rhythm, go to the patient’s bedside, call CCU nurse from patient bedside at ext. 5522 and report patient condition and any changes made (battery change, electrode change etc.); report any significant changes to patient’s physician. * CCU Team Members will - Observe monitor rate/rhythm at central station in CCU and document on telemetry log every 4 hours. - Obtain EKG strips on initiation or admission, every shift, and with rhythm changes. - Interpret strips for rhythm, rate, presence, and configuration of P waves, length of PR interval, length of QRS complexes, T waves, length of QT intervals, and presence of dysrhythmias. - Set the alarms on the basis of patient’s clinical status and heart rate. - Notify patient’s nurse of any rate or rhythm changes. - Document on the strip any reported signs and symptoms, timing of drugs or other treatments that may have effects or cause change in patient rate or rhythm. All symptomatic tachy or brady arrhythmias and all rhythms that require immediate treatment will be documented in the patient’s medical record. - Mount rhythm strips on patient medical record. It is not acceptable to substitute written diagnosis statements for the tracings themselves. - If any significant changes in patient rate or rhythm, call rapid response or code blue as appropriate and notify patient’s nurse and physician. * Points of emphasis: Place the strips of significant changes in center page with strips of before and after the event. Do not fold or wind rolls of ECG strips onto the chart as data is lost when chart is copied or scanned. Review of the CCU Staff Assignment for 1/18/25, for the 7P to 7A shift showed two CCU RNs were assigned to care for four CCU patients, one M/S RN was assigned for “helping hands”, one sitter was assigned for a 1:1 patient, and one MT to monitor the CCU and Telemetry Unit’s cardiac monitors. There was no RN assigned as the CCU CN. There was no RN assigned for code blue and RRT. On 3/10/25 at 1610 hours, interview with the Interim CNO was conducted. The Interim CNO was asked who monitored the patients’ telemetry if there was no assigned CN and/or MT in the CCU. The interim CNO stated the CN in M/S unit could monitor the patients who were on telemetry. There was a central monitor in the nursing station and could alert the nurses if there was arrhythmia. The CCU nurses ran and interpreted the telemetry EKG strips. If there was a MT, the MT ran and interpreted the EKG strips, and the CCU CN looked at it and verified the interpretation. Review of Patient 2’s EKG strips showed the following: - On 1/16/25 at 0701 hours, the patient’s heart rate was 80 bpm and the patient’s had SR. And at 1927 hours, the patient’s heart rate was 83 bpm, and the patient had SR. - On 1/17/25 at 0854 hours, the patient’s heart rate was 86 bpm, and the patient had SR. And at 2125 hours, the patient’s heart rate was 83 bpm, and the patient had SR. - On 1/18/25 7A to 7P shift, there was no documentation of the EKG strip. - On 1/18/25 at 1900 hours, the patient’s heart rate was 82 bpm, and the patient had SR. At 2316 hours, the patient’s heart rate was 58 bpm, and the patient had “SB/pacemaker not firing.” At 2326 hours, the patient’s heart rate was 47 bpm, and the patient had “Brady” and “pacemaker starts.” At 2344 hours, the patient’s heart rate was 61 bpm, and the patient had “paced/PEA?” At 2345 hours, the EKG strip showed “CPR”; however, there was no rhythm interpretation. There was no documented evidence to show the CCU nurse or Patient 2’s primary nurse was notified of the change in the patient’s cardiac rate and rhythm on 1/18/25 at 2316, 2326, 2344, and 2345 hours. There was no documented evidence to show the patient’s cardiac rhythm was interpreted by the CCU nurse on 1/18/25 at 2316, 2326, 2344, and 2345 hours as per the hospital’s P&P. On 3/11/25 at 1330 hours, interview and concurrent review of Patient 2’s closed medical record was conducted with the Interim CNO. The Interim CNO verified MT 2 ran the recorded EKG strips for 1/18/25, for the 7P to 7A shift, and there was no documented evidence the nurse in CCU or Telemetry was notified when the patient’s rate and rhythm had changed. Patient 2 had changes in the cardiac rate and rhythm from 2316 hours to 2345 hours (29 minutes), the MT was noting the patient had pacemaker or having PEA without notifying the nurse to verify of the condition change prompting the telemetry nurse to call a code blue at 2350 hours when RN 6 and the RT found the patient unresponsive and not breathing with dilated pupils. The Interim CNO was asked about the hospital’s P&P for Telemetry or Cardiac Monitoring did not include the MT as one of the CCU’s Team Members. The Interim CNO stated the MT stayed in CCU to monitor the Telemetry. The Chief Quality and Patient Safety Officer stated there was another hospital’s P&P that she could provide. Review of the hospital’s P&P titled Telemetry Criteria: Standardized Procedure dated May 2024 showed the following: * Purpose: To provide evidenced based guidelines for implementation of cardiac telemetry monitoring including criteria for initiation and discontinuation based on Medical Staff approval of the American Heart Association Practice Standards for Electrocardiographic Monitoring in the hospital setting. * Policy: RN and MT who have met the required education requirements may access and interpret cardiac rhythms for patients on cardiac monitoring. On 3/11/25 at 1505 hours, an interview and concurrent record review for Patient 2 was conducted with LVN 1. Review of the ED Provider Aware Note dated 1/15/25 at 0956 hours, showed Patient 2 came to the ED from home complaining of syncopal episode. Patient 2 had the history of ESRD, on HD, DM, HTN, and five stents placed 4 years ago. Patient 2’s EKG showed normal sinus rhythm. The patient’s disposition was to admit to the telemetry unit. Patient 2 did not have a history of pacemaker; however, on 1/18/25, the EKG strips showed the MT documented “paced” or “pacemaker starts”. On 3/11/25 at 1605 hours, a tour and observation at telemetry nursing unit was conducted with LVN 1. RN 4 was asked about the telemetry monitoring at the nursing station and how she would know or be notified if the patient was having arrhythmia. RN 4 stated the telemetry monitor in their nursing station did not alarm, it would only flash, the MT would notify them when the MT identified arrhythmia. They always had a MT that was in CCU. On 3/12/25 at 1025 hours, interview and record review for Patient 2 was conducted with RN 3, the Interim CNO and MT 1. RN 3 was asked about the monitoring of telemetry patients. RN 3 stated when she had patients, she did not have time and could not sit and keep an eye on the monitor for the telemetry patients. When asked how she would know if the telemetry patient had change in rhythm or arrythmia that needed attention. RN 3 stated the MT would inform her. RN 3 was asked about the EKG logbook. RN 3 showed the logbook documentation for every 4 hours monitoring of the patient ’ s heart rate and rhythm; however, the log for Patient 2 on 1/18/25 from 0800 hours to 2000 hours were left blank. e. Review of hospital’s P&P titled Code Blue dated April 2024 showed in part: *Post Code Procedures: the following are duties of the primary nurse; however, may be delegated as needed: - Ensure complete documentation, including code blue form completed and a copy to be sent to Pharmacy and copies of the EKG strips. On 3/12/25 at 0800 hours, interview and concurrent review of Patient 2’s medical record was conducted with Director 1. Review of the Code Blue Record for Patient 2 showed a code blue was called on 1/18/25 at 2350 hours, due to cardiopulmonary arrest. Patient 2 was found unconscious, not breathing, pulseless, and pupils were dilated. An intraosseous was inserted on the left and right knee for ACLS medication administration. Epinephrine (an emergency medication used during the code blue) was administered three times; however, the dose of epinephrine was not documented each time that the medication was administered. Calcium (an emergency medication used during the code blue) was administered; however, the dose of calcium and completed name of calcium was not accurately documented. Sodium Bicarb (an emergency medication used during the code blue) was administered at 2355 hours and 0003 hours; however, there were no doses of the medications (epinephrine, calcium, and sodium bicarb) each time it was given. Director 1 was asked to clarify the medications administered during the code blue. Director 1 verified the medication doses given were not documented. On 3/12/25 at 1505 hours, the Interim CNO was asked to show the EKG strips recorded when Patient 2 had cardiopulmonary arrest and expiration after performing the code blue measures. The Interim CNO stated she would ask and look for it; however, there was no EKG strip documentation provided for the code blue and at the time the patient was pronounced dead on 1/19/25 at 0008 hours. 2. Review of the hospital’s P&P titled Clinical Alarms dated April 2024 showed in part: * Definition: Clinical alarm - a patient generated physiologic monitoring and diagnostic system that contains audible and/or visual alarms designed to alert staff to life-threatening or critical changes in a patient’s condition. Equipment with clinical alarm systems include but not limited to defibrillators, ventilators, infusion pumps, ECG monitors, blood pressure monitors, bedside telemetry, central station monitors, anesthesia machines, bed alarms, feeding pumps, and laboratory analyzers. * Policy: - All hospital and medical staff who use medical equipment will check alarm settings prior to device use to ensure that they are appropriate and that audible alarms will be clearly discernable relative to ambient and competing noise. - At no time will hospital staff bypass, shut off or adjust medical equipment alarm volumes to a level that cannot be readily heard when the alarm activates. On 3/17/25 at 1248 hours, an observation at the telemetry unit was conducted with RN 7. The central telemetry monitor was observed to have a patient’s heart rate of more than 176 bpm and flashing red tachy. The patient was Patient 22 assigned on Telemetry 6. The monitor alarm sound was not audible. When being very near the telemetry monitor, the alarm sound was very soft and short. RN 4 was asked to show the alarm setting for Patient 22’s telemetry. The alarm setting sound was at level 2; however, the default alarm sound was at level 6. RN 7 stated the setting of the central telemetry monitor was controlled in CCU by the MT. A telephone interview with MT 3 and RN 7 was conducted. MT 3 was asked about the alarm level for Patient 22. MT 3 stated Patient 22 had high heart rate which was up to 170s for two hours and was about to be transferred to ICU. MT 3 stated he silenced the monitor alarm on his side at the CCU. 38660 3. On 3/11/25, review of Patient 3’s closed medical record was initiated with LVN 1. Patient 3’s closed medical record showed the patient was admitted to the hospital on 2/2/25, with a diagnosis of pneumonia and influenza. Review of the physician’s order dated 2/5/25, showed to collect urine sample for Streptococcus pneumonia antigen laboratory test for Patient 3. Further review of Patient 3’ s medical record showed the urine sample was not collected for Streptococcus pneumonia Ag testing as ordered by the physician, and did not show the reason the urine was not collected. The findings were verified with LVN 1.”

“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: 37663 Based on interview and record review, the nursing staff failed to ensure the heparin IV drip medication was administered as per physician’s order for one of 22 patients (Patient 9). This failure created the risk of substandard health outcomes to the patient. Findings: Review of the hospital’s P&P titled Anticoagulation, Therapeutic Heparin dated November 2023 showed the nursing department responsibilities include verification (documented) must be done for initial and any changes to therapy by a second nurse. If there is difficulty in determining the change in rate, the nurse may contact the on-call pharmacist for assistance. Review of the heparin protocol for AMI/ACS showed the APTT goal is between 59 to 96 seconds and the first APTT was scheduled 6 hours after the bolus (loading dose). When the APTT level is between 50 - 59 seconds, the rate will be changed by increasing 1 unit per kg per hour. When the APTT level is between 60 - 85 seconds, there will be no change in the rate. On 3/13/ 25 at 1430 hours, an interview and concurrent review of Patient 9’s medical record was conducted with RN 7. Patient 9’s medical record showed Patient 9 was admitted to the hospital on 3/7/25. Further review of Patient 9’s medical record showed on 3/7/25 1506 hours, the physician ordered for heparin drip 25,000 units in 250 ml D5W (Dextrose 5% in Water, an IV solution) with the initial dose of 15 units per kg per hour, IV rate of 10 ml per hour for chest pain. The baseline PTT was 29.1 seconds (the normal range is between 25.1 to 36.5 seconds). Review of Patient 9’s eMAR showed on 3/7/25 at 1720 hours, a bolus of 3000 units IV was administered and the drip was started at 1723 hours with the rate of 9 ml per hour. However, the physician’s order for the IV rate was 10 ml per hour. Further review of Patient 9’s medical record showed the APTT level was drawn at midnight of 3/8/25 and resulted at 0100 hours with the level of 61.9 seconds. At 0600 hours, the APTT was drawn and resulted at 0712 hours with the level of 56.2 seconds. At 0748 hours, the heparin drip was stopped. However, according to the heparin protocol, for the APTT level between 50 to 59 seconds, the rate should be changed by increasing 1 unit per kg per hour. RN 7 stated there was a physician’s order on 3/8/25 at 0826 hours, to administer heparin 1900 units IV once, then increase the drip to 10 ml or 1000 units per hour. When asked for the reason of stopping the heparin drip at 0748 hours, RN 7 verified it was not as per protocol and could not find documentation to show the reason why the heparin drip was stopped.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 38660 Based on interview and record review, the hospital failed to ensure the nursing staff administered the blood transfusion to two of 22 sampled patients (Patients 2 and 8) as evidenced by: 1. For Patient 2, the blood transfusion was not administered in the morning as per the physician’s order. 2. For Patient 8, the blood transfusion was not started and monitored as per the hospital’s P&P. These failures increased the risk of substandard care for the patients receiving care in the hospital. Findings: 1. Patient 2’s closed medical record was reviewed and showed Patient 2 was admitted to the hospital on 1/15/25. Review of Patient 2’s laboratory result showed on 1/18/25 at 0126 hours, Patient 2’s platelet level was critical low or was 14 K/uL (normal range: 152 - 348 K/uL). Review of the physician’s order dated 1/18/25 at 0209 hours, showed the order to transfuse one unit of platelet over one hour in the morning for the platelet level of 14 K/uL. Review of the nurses’ notes dated 1/18/25 at 0800 hours, showed Patient 2 was waiting for the unit of platelet from the blook bank. Review of the blood bank documentation showed the blood bank received one unit of platelet on 1/18/25 at 1014 hours, from Vendor 1 and the unit of platelet was issued to the nurse at 1306 hours. Review of Patient 2’s medical record showed on 1/18/25, the platelet transfusion was started at 1322 hour and stopped at 1352 hours. On 3/17/25 at 1200 hours, an interview and concurrent review of Patient 2’s closed medical record was conducted with Director 7, CLS 1, and the Interim CNO. When asked if the blood bank staff had notified the nurse when the platelet was ready for transfusion, CLS 1 confirmed there was no documented evidence to show the blood bank staff had called the nurse when the platelet was received from Vendor 1 at 1014 hours. Closed medical record review showed Patient 2 did not receive the platelet transfusion in the morning as per the physician’s order. The findings were verified with the Interim CNO. 37663 2. Review of the hospital’s P&P titled Blood Administration and Transfusion Reactions dated February 2024 showed in part: * Prior to blood and blood product transfusion, vital signs will be taken with 15 to 30 minutes before transfusion begins. * Record date or time the transfusion was started (when blood hits the vein) as the time the blood entered the patient venous access on the blood transfusion form or in the patient’s electronic record. - Note: It is critical to correctly document this time as the first 15 - 30 minutes of a transfusion is when many reactions occur. Perform vital signs 15 minutes after the product hits the vein. A nurse must remain with the patient for the first 15 minutes of every blood and blood products transfusion. * Administer blood or component slowly for the first 15 minutes at a rate between 60 to 120 ml/hour (1-2 ml/min). * Vital signs must be taken at the following intervals: - 15 to 30 mins prior to start of transfusion time. - 15 minutes after start of transfusion (the time the blood entered the patient venous access). - 30 minutes - One hour - Two hours - Three hours - Completion time - 15 to 30 mins after completion On 3/12/25 at 1335 hours, interview and concurrent review of Patient 8’s closed medical record was conducted with LVN 1 and RN 7. Patient 8’s closed medical record showed the patient was admitted to the hospital on 2/17/25 and discharged on 3/9/25. Review of Patient 8’s order for blood transfusion showed on 2/27/25 at 1316 hours, an order to transfuse one unit PRBC over three hours. Review of Patient 8’s blood transfusion vital signs record showed on 2/27/25, the vital signs were taken as follows: - At 1529 hours, the pre vital signs prior to the blood transfusion. - At 1545 hours, the vital signs for the start of the blood transfusion. - At 1615 hours, the vital signs for 30 minutes after the start of the blood transfusion. - At 1715 hours, the vital signs for one hour after the start of the blood transfusion. - At 1815 hours, the vital signs for two hours after the start of the blood transfusion. RN 7 was asked for the completion time of Patient 8’s blood transfusion. RN 7 stated the completion time was at 1815 hours. RN 7 was asked for the vital signs that would be taken 15 to 30 minutes after the blood transfusion was completed. RN 7 could not show documentation of the vital signs was taken 15 to 30 minutes after the blood transfusion was completed. RN 7 was asked for the documentation of the blood flow rate of 60 to 120 ml/hour for the first 15 minutes of the blood transfusion. RN 7 stated there was no documentation to show the rate was documented in Patient 8’s medical record.”

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 38660 Based on interview and record review, the hospital failed to maintain the adequate blood product inventory levels to meet the patient needs. This failure posed the risk of substandard care to the patients. Findings: Review of the hospital’s P&P titled Inventory Control - Ordering, Stocking and Returning Blood Products dated January 2018, showed the following: * It is the responsibility of the Transfusion Service Technologist on all shift to maintain adequate blood product inventory levels to meet the needs of our patients. * All routine stock orders will be delivered the same day between 1600-1800. * Inventory: Par levels that should be maintained daily - O positive: 12 PRBC and 4 FFP. - A positive: 10 PRBC and 3 FFP. - B positive: 6 PRBC and 6 FFP. - AB positive: 2 PRBC and 2 FFP. - O negative: 2 PRBC and 2 FFP. - A negative: 2 PRBC - B negative: 2 PRBC If Vendor 1 is low in inventory in times of blood shortage, Vendor 1 will stock at only 50% of this inventory. Call the secondary provider for units not met by Vendor 1. Review of the Daily Blood Product Inventory Management showed the following: * Liquid Plasma minimum of one for Group A and one for Group AB based on availability from the supplier. * These amounts are minimum requirement to have in the laboratory at all times. * A negative: a minimum of 2 RBC. * A positive: a minimum of 3 RBC. * B negative: a minimum of 2 RBC. * B positive: a minimum of 2 RBC. * O negative: a minimum of 4 RBC. * O positive: a minimum of 12 RBC. On 3/11/25 at 0900, an observation of the laboratory service area was conducted with Manager 1 and LVN 1. The blood bank refrigerator was observed to not have the minimum requirement of blood products in their blood bank inventory. Manager 1 stated the CLS called Vendor 1 every morning and determined how much blood products the hospital might need. The CLS could get the blood products from the sister hospitals or could use the O negative blood type (universal blood type) for A negative and B negative blood type patients. Review of the Daily Blood Product Inventory Management forms dated 1/17 and 1/18/25, showed the hospital’s blood bank had the following blood products: * A positive: 2 RBC * B positive: 2 RBC * O negative: 2 RBC * O positive: 7 RBC Review of the Daily Blood Product Inventory Management forms dated 3/1 and 3/4/25, showed the hospital’s blood bank had the following blood products: * A positive: 4 RBC * B positive: 2 RBC * O negative: 2 RBC * O positive: 6 RBC Review of the Daily Blood Product Inventory Management form dated 3/2/25, showed the hospital’s blood bank had the following blood products: * A negative: 1 RBC * A positive: 4 RBC * B positive: 2 RBC * O negative: 1 RBC * O positive: 6 RBC * A negative and A positive: 2 cryoprecipitate * B negative and B positive: 2 cryoprecipitate * O negative and O positive: 1 cryoprecipitate * AB negative: 2 FFP * AB positive: 3 FFP Review of the Daily Blood Product Inventory Management form dated 3/3/25, showed the hospital’s blood bank had the following blood products: * A negative: 1 RBC * A positive: 4 RBC * B positive: 2 RBC * O negative: 2 RBC * O positive: 6 RBC * A negative and A positive: 2 cryoprecipitate * B negative and B positive: 2 cryoprecipitate * O negative and O positive: 1 cryoprecipitate * AB negative: 2 FFP * AB positive: 3 FFP Review of the Daily Blood Product Inventory Management form dated 3/5/25, showed the hospital’s blood bank had the following blood products: * A positive: 4 RBC * B positive: 2 RBC * O negative: 1 RBC * O positive: 6 RBC * A negative and A positive: 2 cryoprecipitate * B negative and B positive: 2 cryoprecipitate * O negative and O positive: 1 cryoprecipitate * AB negative: 2 FFP * AB positive: 3 FFP. Review of the Daily Blood Product Inventory Management form dated 3/6/25, showed the hospital’s blood bank had the following blood products: * A positive: 4 RBC * B positive: 2 RBC * O negative: 1 RBC * O positive: 4 RBC * A negative and A positive: 2 cryoprecipitate * B negative and B positive: 2 cryoprecipitate * O negative and O positive: 1 cryoprecipitate * AB negative: 2 FFP * AB positive: 3 FFP. The number of blood products ordered and received were left blank in the Daily Blood Product Inventory Management forms on the above days. An interview and concurrent review of the Daily Blood Product Inventory Management forms was conducted with CLS 1 and the Chief Quality and Patient Safety Officer on 3/12/25 at 1351 hours. CLS 1 stated the CLS called Vendor 1 in the morning and documented the blood products ordered and received in the Daily Blood Product Inventory Management forms. CLS 1 confirmed the above Daily Blood Product Inventory Management forms did not document the blood products which were ordered and received by the hospital’s blood bank and the reason why they did not meet the required minimum blood product inventory. CLS 1 verified the amount of blood products inventory of hospital’s P&P titled Inventory Control - Ordering, Stocking and Returning Blood Products and the Daily Blood Product Inventory Management form did not match. CLS 1 stated they would change the hospital’s P&P to reflect the blood product requirement in the hospital. The Chief Quality and Patient Safety Officer verified the above findings.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital failed to ensure the facilities, supplies, and equipment were maintained in multiple patient care areas to assure the safety and quality for patient care. This failure posed the increased risk of substandard health outcomes to the patients. Findings: Review of the hospital’s P&P titled Preventative Maintenance Verification System dated 4/12/17, showed the following: * Policy: Biomedical Engineering is to use a color-coded sticker system to identify equipment’s preventive maintenance due date, performance verification indication, and functional status. * Procedure: - Preventive Maintenance color-coded stickers will be used based on the month or year that the service is due and frequency of service (Reference, “Preventive Maintenance and Performance Sticker Chart,” attached) - Preventive maintenance stickers must have the following information by the biomedical technician: date of service; serviced by initials; next inspection due date, month and year minimum; and service performed indicated. Review of the hospital’s P&P titled Equipment Testing dated 4/12/17, showed the following: - Scope: Biomedical Engineering - Purpose: To establish specific guidelines for the testing and inspection of all Clinical Equipment, defined as follows: “any device whose use is therapeutic or diagnostic in nature.” - Policy: Preventive and corrective maintenance actions shall be made in accordance with manufacturer’s specifications and accepted industry standards. * Procedure: - All hospital owned clinical equipment will be tested for safety, proper operation and proper function: before initial use; after major repairs or upgrades; as indicated in the Quality Assurance or Risk Assessment Policy; after any accident or damage, real or suspected; before a unit is removed from temporary storage and placed in service. - Preventive maintenance shall be performed in accordance with the manufacturer specifications, accepted industry standards, or by application of the alternate equipment management (AEM) program allowed by CMS. - An electrical safety inspection shall be completed at least annually on equipment powered by greater than pr equal to 110 VAC. Review of the hospital’s P&P titled Clinical Alarms dated April 2024 showed in part: * Definition: Clinical alarm - a patient generated physiologic monitoring and diagnostic system that contains audible and or visual alarms designed to alert staff to life-threatening or critical changes in a patient’s condition. Equipment with clinical alarm systems include, but not limited to defibrillators, ventilators, pumps, ECG monitors, blood pressure monitors, bedside telemetry, central station monitors, anesthesia machines, bed alarms, feeding pumps, and laboratory analyzers. * Policy: - The biomedical engineering will ensure that all clinical alarms are functional at the appropriate settings and are sufficiently audible with respect to distances and competing noises within the unit. * Procedure: The Biomedical Engineer will inspect all medical equipment prior to use. The evaluation of equipment includes a determination of the processes that will be used to test, inspect, and maintain the equipment. These strategies include: - Inspections based on the manufacturer’s specifications. - Equipment with clinical alarm systems on a regular preventive maintenance schedule. Biomedical Engineer tracks the inspection, testing, and maintenance of the medical equipment. - Biomedical Engineer shall be responsible for maintaining a master inventory listing which includes all devices with design incorporated clinical alarm features. - Biomedical Engineer shall test and document the proper function of clinical alarms on all applicable equipment as a component of scheduled inspections. Inspections are performed as defined in the Medical Equipment Management Plan. Review of hospital’s P&P titled Safety Maintenance Plan dated November 2023 showed in part: * Safety Risk Management: The Safety Officer is designated to manage risk, coordinate risk reduction activities in physical environment, collect deficiency information, and disseminate summaries of actions and results. The Safety Officer assures that compliance with applicable codes and regulations, as applied to the buildings and services are provided at the hospital. 1.a. On 3/17 45 at 1045 hours, an observation of the ED was conducted with LVN 1. The following critical equipment was observed to have the PM with its expiration dates: - One ETCO2 channel - One IV pump channel - One portable vital sign machine b. On 3/18/25 at 0840 hours, an observation at the cardiology room with Biomedical Technician 1 and Lead Technician Echocardiology. A thermometer was observed to have PM with its past due date. c. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following equipment was observed: - One cardiac monitor in Room 9 did not have a PM sticker. - One portable doppler had the overdue PM. - One Hoyer lift had no PM stickers. d. On 3/18/25 at 1010 hours, observation of the central supply room next to ICU was conducted with RN 7. The following equipment was observed: * Ventilators showed the PM sticker dated 2023. * One hypothermia blanket had no PM sticker. * One TF machine had overdue for PM. e. On 3/18/25 at 1010 hours, an observation of the Telemetry Unit was conducted with RN 7. The following equipment was observed: * Central Telemetry Monitor, Eye scope, and Otoscope had no PM stickers. f. On 3/18/25 at 1050 hours, during the observation in the ICU with RN 3 and RN 7, the following equipment was observed with its expiration dates: - Two Thora-Para French 8 catheter drainage trays g. On 3/18/25 at 1122 hours, during an observation in Radiology Room 3 with RN 7 and the Radiology Technician, the following equipment was observed with its expiration dates: - One 2-lumen hemodialysis catheter. - Five 2-lumen PICC lines. - Nine midline 2- lumen. - One Thora Para 8-french catheter drainage. - Three soft tissue biopsy trays. 2. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following was observed: * In ICU 7, wall vacuum for wall suction outlet was inoperable An interview with RN 3 and RN 7 was conducted regarding the note posted by the door of ICU 7 dated 2/19/25. RN 3 stated the vacuum has not been working since 2024. The date posted on the door was the last date RN had communicated with engineering department staff. On 3/18/25 at 1220 hours, interview with Director 6 was conducted. When asked about the vacuum at the ICU 7. Director 6 stated he had not received any approval from the corporate office for the vendor to repair. 3. Review of the hospital’s P&P titled Medical Radiation Physicist dated September 2023 showed in part: * Policy: - Radiology Services retains a Qualified Physicist (QMP) for the performance of surveys of imaging equipment on an annual basis for proper operation. - The QMP works collaboratively with the Radiologist and Technologists to ensure that all radiation producing, and related equipment remains safe and suitably calibrated, that radiation dose determinations are accurate, and that all imaging modalities are functioning at their optimal levels. The QMP ensures that all such equipment, policies and procedures are in compliance with state and federal regulations and in keeping with published standards. The QMP’s primary professional responsibility is to the staff and patient’s safety and welfare. On 3/17/25 at 1158 hours, an observation of the radiology service area and concurrent interview was conducted with RN 7 and Director 8. A portable x-ray machine showed the quality assurance sticker with the date of 10/2023. Director 8 was asked for the annual medical physicist report. Director 8 stated the portable x-ray machine needed the battery change to be done in December 2024; however, the battery was changed on 1/15/25, and he did not call the physicist before the machine was put in service again. 4. On 3/18/25 at 1132 hours, observation of the L&D and Newborn unit was conducted with RN 7, RN 11, and RN 12. RN 12 was asked about the central bedside fetal monitoring at the nursing station. RN 12 stated it had not worked for years. RN 12 stated the nurses would go back and forth to the room to monitor the baby. It was also observed to have a leaking faucet in the hearing test room for the neonates. On 3/18/25 at 1310 hours, interview was conducted with Biomedical Technician 1. Biomedical Technician 1 was asked about the central monitor at the L&D. Biomedical Technician 1 stated the PC of the central monitor was not working, it needed a new PC, and he informed the CEO and CNO at that time. Biomedical Technician 1 showed the work order dated 10/4/23, showing the L&D central bedside monitor computer had crashed and could not be repaired. 5. On 3/17/25 at 1500 hours, interview was conducted with the Biomedical Technician 1 about the PM. Biomedical Technician 1 stated after checking the machines he changed the PM sticker. When asked about the color-coded sticker system to identify equipment’s PM, the Biomedical Technician 1 stated we ran out of the stickers. a. On 3/17/25 at 1045 hours, an observation of the ED was conducted with LVN 1. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - One Pediatric Zoll defibrillator - One adult defibrillator - Cardiac monitors - Thermometers - IV pumps (pump and channel) - One portable vital signs machine - One EKG machine b. On 3/17/25 at 1158 hours, an observation of the radiology service area was conducted with RN 7 and Director 8. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - One portable x-ray #2 - One C-arm and monitor c. On 3/18/25 at 0840 hours, an observation at the cardiology room with Biomedical Technician 1 and Lead Technician Echocardiology. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - One echocardiogram machine - One treadmill and EKG - One vital signs machine d. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - IV pumps and channel - Bedside cardiac monitors - TF pumps - Ventilators - SCD machines - Thermometers e. On 3/18/25 at 1008 hours, an observation of the respiratory therapy room was conducted with RN 7. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - One ABG analysis machine - One high flow oxygen therapy device f. On 3/18/25 at 1010 hours, an observation of the central supply room next to ICU was conducted with RN 7. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - Ventilators - Telemetry boxes - One TF machine - IV pumps f. On 3/18/25 at 1010 hours, an observation of the Telemetry Unit was conducted with RN 7. The following equipment’s PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital’s P&P): - One vital sign machine 6. On 3/18/25 at 0830 hours, an observation of the radiology service hallway area was conducted was with Biomedical Technician 1. The middle hallway was observed to have a garbage can with cloth under. On 3/18/25 at 1220 hours, an interview was conducted with Director 6. Director 6 was asked about the garbage can at the radiology service hallway area. Director 6 stated the hospital requested for a crane to remove the AC from the roof to repair the leaking roof. 29558 7. On 3/18/25 at 1000 hours, a tour of the kitchen was conducted with the Clinical Dietitian and Dietary Clerk. The following was observed: * Ice buildup on the ceiling and black pipe in the ceiling of the walk-in refrigerator. * Multiple trays used to serve food were chipped. * The floor was broken in multiple area and was unable to be cleaned. On 3/18/25 at 1122 hours, Director 6 was informed the findings. 8. On 3/12/25 at 0813 hours, a tour of the OR was conducted with RN 2. One of four hand washing sinks was observed being leaked. RN 2 confirmed the findings.”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity was maintained in ICU, Radiology, and the OR. These failures created a potential risk for an unsafe environment. Findings: Review of the hospital P&P titled Climate Control dated August 2023 showed in part: * Purpose: to ensure a comfortable and safe environment for all patients, visitors, and staff members. * Policy: The facilities department is responsible for maintaining comfort ambient temperatures throughout all buildings. * Normal temperature ranges will be maintained between 68- and 74-degrees F excluding the L&D and OR where the temperatures may be selected to a lower temperature. Review of the hospital’s titled Humidity Readings dated August 2023 showed in part: * Policy: Humidity readings for the operating rooms, delivery rooms, and nurseries will be recorded by the individual departments. Calibration of the indicating equipment will be performed by the Facilities Department. * Procedure: Humidity readings will be recorded by those departments needing to maintain a record of humidity levels. The documents will remain with the recording department for as long as necessary. 1. On 3/17/25 at 1203 hours, an observation of Radiology Room 3 was conducted with RN 7 and Director 8. Director 8 stated Radiology Room 3 had not been used for years and used now for storage of other machines and supplies. The room was observed to have packs of PICC lines, hemodialysis catheters that contained 1% lidocaine (a local anesthetic, a numbing medication) 5 ml to be kept between 20 to 25 degrees C (68 - 77 degrees F). The air condition thermostat was observed not working. When asked for the temperature monitoring for this room, Director 8 could not show documented evidence showing the room temperature was monitored. On 3/18/25 at 1220 hours, an interview was conducted with Director 6. Director 6 was asked about the non-working thermostat at Radiology Room 3. Director 6 stated he would check. 2. On 3/18/25 at 1050 hours, an observation of the ICU clean utility room was conducted with RN 7 and RN 3. The portable thermometer showed the temperature level was less than 20 degrees C (or less than 68 degrees F). When asked what was stored in the clean utility room, RN 3 showed the following sterile packs that contained 1% lidocaine 5 ml to be kept between 20 to 25 degrees C (68 - 77 degrees F). - Arterial Line - TLC - Lumbar puncture trays - Soft tissue biopsy trays - 2 Lumen CVC trays RN 3 verified the findings. 29558 3. Review of the hospital’s P&P titled Temperature and Humidity Monitoring - OR dated September 2023 showed the temperature and humidity in the surgical services are assessed twice a day during every day of operation by the assigned personnel who is competent of the procedure. The temperature and humidity readings are recorded, including decimal points, on the designated log and kept in the department. If the temperature and humidity is out of range, wait for 30 minutes and repeat the reading. If it is still out of range, notify Engineering for correction. For humidity measurements higher than the targeted range of 60%, engineering will assess the situation and determine if the humidity can be brought down with any adjustments to the temperature control or HVAC system. The temperature and humidity levels will be in accordance with the AORN. According to the AORN’s Guidelines for Design and Maintenance dated 7/20/23, the design parameters for HVAC are as following: * For OR and Cesarean Delivery Room: - The temperature level will be between 68 and 75 degrees F. - The relative humidity level will be between 20 to 60%. * For Sterile Processing Clean Assembly Workroom: - The temperature level will be between 68 and 73 degrees F. - The maximum relative humidity level will be 60%. a. Review of the Temperature & Humidity form showed if temperature and/or humidity is out of range, wait for 30 minutes and repeat the reading, if it is still out of range, follow these steps: * Immediately notify engineering. * Document on the Temperature & Humidity follow-up and correction log any correction action taken to correct temperature and/or humidity. * If still unable to maintain appropriate temperature and humidity in required area, notify nursing supervisor, infection control, affected department manager and senior management immediately. * The temperature range for OR and L&D will be between 68 and 75 degrees F. * The relative humidity range for OR and L&D will be between 20 to 60 %. * The temperature range for SPD will be between 68 and 73 degrees F. * The maximum relative humidity level for SPD will be 60%. Further review of the Temperature & Humidity forms for February and March 2025 showed there was no documented evidence any correction actions were taken to correct the temperature levels when they were out of ranges. For example, * On 2/1/25, the temperature levels of OR 1, OR 2, and L&D 1 were 61.3, 64.8, 65.4 degrees F, respectively. * On 2/3/25, the temperature level of OR 1 was 63.2 degrees F. * On 2/5/25, the temperature level of OR 1 was 66.8 degrees F. * On 2/8/25, the temperature levels of OR 1 and L&D 1 were 61.6 and 64.9 degrees F, respectively. * On 2/16/25, the temperature levels of OR 1, OR 2, OR 3, and L&D 1 were 59.6, 67, 61.5, 64.5 degrees F, respectively. * On 2/22/25, the temperature levels of OR 1, OR 2, OR 3, and OR 5 were 64.2, 64.3, 66.4, and 66.3 degrees F, respectively. * On 2/27/25, the temperature levels of OR 1, OR 3, and L&D 1 were 67, 65, and 66.5 degrees F, respectively. * On 3/4/25, the temperature levels of OR 1, OR 3, and L&D 1 were 66.2, 64.3, and 67 degrees F, respectively. * On 3/8/25, the temperature levels of OR 1, OR 2, OR 3, and L&D 1 were 67, 67.7, 67.8, and 65.1 degrees F, respectively. * On 3/9/325, the temperature levels of OR 1, OR 2, and L&D 1 were 66.2, 67.4, and 66.3 degrees F, respectively. * On 3/10/25, the temperature levels of OR 1, OR 3, and L&D 1 were 65.5, 67, and 66.5 degrees F, respectively. * On 3/11/25, the temperature levels of OR 1, OR 3, SPD, and L&D 1 were 65.5, 64.1, 74, 67.2 degrees F, respectively. b. On 3/12/25 at 0813 hours, a tour of the OR was conducted with RN 2. The following was observed: * OR 1, the temperature level was 65 degrees F, and the relative humidity level was 65%. * OR 2, the relative humidity level was 61%. * OR 3, the temperature level was 63.8 degrees F. RN 2 stated the engineering checked the temperature level every day; and today, the temperature levels was 66.6 degrees F, 67.8 degrees F, and 67.3 degrees F for ORs 1, 2, and 3. The humidity level for OR 2 was 67%. The surgical cases were delayed until the OR’s temperature level reached the temperature and humidity ranges. During an observation on 3/12/25 at 0930 hours, the scheduled surgical cases were observed not being started. Review of the Surgery Schedule dated 3/12/25, showed the following: * Patient 5’s surgery was scheduled on 3/12/25, from 1000 to 1100 hours. * Patient 6’s surgery was scheduled on 3/12/25, from 1100 to 1200 hours. * Patient 7’s surgery was scheduled on 3/12/25, from 0900 to 1000 hours. However, review of medical records for Patients 5, 6, and 7 showed the surgeries were not started for Patients 5, 6, and 7 as scheduled. * Patient 5’s medical record showed on 3/12/25, Patient 5’s surgery was started at 1156 hours and ended at 1215 hours. * Patient 6’s medical record showed on 3/12/25, Patient 6’s surgery was started at 1238 hours and ended at 1305 hours. * Patient 7’s medical record showed on 3/12/25, Patient 7’s surgery was started at 1114 hours and ended at 1129 hours. On 3/13/25 at 1400 hours, an interview was conducted with the Quality Coordinator, the Chief Quality and Patient Safety Officer, Director 3, and RN 2. They verified that the issues related to the temperature and/or humidity levels was not reported or tracked by QAPI. On 3/13/25 at 1427 hours, an interview was conducted with the Administrator Assistant and the Lead Engineer. They were informed about the above temperature levels which were outside the acceptable ranges.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure the hospital’s P&Ps were implemented for two of 22 sampled patients (Patients 16 and 17) as evidenced by: 1. The ED nursing staff did not assess Patient 16 every two hours as per the hospital’s P&P. 2. The ED nursing staff did not notify the ED physician and did not implement the hospital’s P&P related to leaving the hospital AMA for Patient 17. These failures created the unsafe care environment for the patients. Findings: 1. Review of the hospital’s P&P titled Triage and Assessments of Patients Using the Emergency Severity Index (ESI) dated September 2023 showed in part: * Purpose: To ensure that every patient receives efficient and appropriate medical care based on his or her ESI level, an evidenced based triage tool. * Policy: - The patient’s level of urgency is indicated using the ESI. - Triage is used to determine the patient’s clinical urgency and to assess patient acuity based on their presentation in the ED and the expected level of care they will require. * Responsibility of the Triage RN: - Respond upon notification of a patient requesting medical treatment. - Perform an overview of the patients waiting to be seen to determine if any patients appear to require priority triage and categorization. If any patients appear to require priority triage and categorization. If priority triage is not indicated, triage will be conducted based on the patient’s time of arrival. - ESI Methodology: After a triage assessment is completed, the triage RN will categorize the patient with ESI level of 1 (most urgent) to 5 (least urgent). - ESI level 3 (Urgent): patient is stable with multiple types of resources needed to investigate or treat (such as laboratory test and X-ray imaging). Conditions that require prompt but not immediate care, utilizing two or more resources. The patient presents with a condition that could progress to a serious problem requiring emergency interventions. The vital signs of a Level 3 patient may or may not be outside normal limits (danger zone). - Periodically reassess the triage status of registered ED patients waiting for emergency care. - Patients should be reassessed upon change in status. For levels 3, 4, and 5, patients should be reassessed every two 2 hours and with significant change in status. - Communicate with the Charge RN/designee and ED physician about the number of patients waiting at triage, triage categories, and other problems affecting patients care. On 3/13/25 at 1207 hours, an interview and concurrent review of Patient 16’s closed medical record was conducted with RN 7. Patient 16’s closed medical record showed Patient 16 arrived to ED on 2/24/25 at 1944 hours, and complained of vomiting of blood. Patient 16 was triaged at 2010 hours. The Triage RN determined Patient 3 had ESI level 3. After triage, Patient 16 was sent to the ED waiting area. RN 7 was asked when the ED physician had seen Patient 16 for MSE. RN 7 stated the patient left the ED and had not seen by the ED physician. When asked for the RN’s documentation to show when the patient had left the ED, RN 7 stated there was no RN’s documentation to show when the patient had left the ED. However, the Registration Report showed the procedure and treatment were not carried out due to patient leaving prior to being seen by the health care provider. The patient was discharged on 2/25/25 at 0010 hours (four hours after the patient was triaged). 2. Review of the hospital’s P&P titled Leaving Hospital Against Medical Advice dated September 2023 showed in part: * Policy: An adult with capacity to make health care decisions has the right to leave the hospital even against the advice of the physician. If the patient lacks capacity to make health care decisions, the patient has the right to have a legal representative make the decision to stay or leave for him or her. The “Leaving Hospital Against Medical Advice” release form will be completed whenever a patient decides to leave the hospital before treatment is completed and this decision is contrary to the advice of the physician. * Procedure: - Notify the physician as soon as the patient states he or she wants to leave the hospital before a discharge order is written. - Request the patient to stay until they have the opportunity to talk to the physician (in person or per phone) who will explain the risk and consequences of leaving. - Notify the Department Manager or Administrative Supervisor. - Ensure the patient leaves the hospital in a safe manner. Arrange transportation (example: family member, taxi, ambulance). Do not attempt to accompany the patient once he or she leaves the hospital campus. * Documentation: - Document the facts surrounding the patient’s departure and all actions taken to assure safety. - Present release form to patient and request he or she to sign it, in the presence of a witness. - Record “patient refused to sign” if indeed he or she refused to sign the form. - Note the date and time and witness on the form. On 3/13/25 at 1207 hours, interview and concurrent review of Patient 17’s closed medical record was conducted with RN 7. Review of ED Triage Aware Note dated 1/22/25 at 2317 hours, showed the triage time was 2130 hours. RN 7 was asked for the RN’s triage assessment. RN 7 stated there was no RN’s triage assessment documentation. However, the Triage RN documented Patient 17’s chief complaint was that the patient had left before being triaged in the stretcher, the patient did not to want to go on a chair, and no bed was available at that time. RN 7 was asked for Patient 17’s AMA documentation. RN 7 stated there was no other documentation for Patient 17 regarding the AMA. RN 7 verified the ED physician was not informed when the patient left.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure one of six sampled patients (Patient 1) had the Condition of Admission form completed as per the hospital’s P&P, creating the risk for the patient to not consent to the provisions of the hospital. Findings: Review of the hospital’s P&P titled Consent Form Requirements dated 9/2023 showed it is the responsibility of the Patient Access to complete the required forms with the patient or the patient’s representative. The Condition of Service lists the terms and conditions of being admitted to the hospital. In the event the consent forms cannot be signed at the time of the admission, Patient Access will properly document the reason on the consent in the provided space, make a note in the registration system, and then follow up by reviewing the inpatient census. Over the following 24-hour period, Patient Access will make an additional attempt to obtain signatures from the patient or legal representative. On 12/17/24 at 1451 hours, Patient 1’s closed medical record was reviewed with LVN 1. Patient 1 was admitted to the hospital on 12/3/24, and discharged on 12/8/24. Review of the Conditions of Service on 12/3/24 at 1645 hours, showed, “Patient unable to sign due to medical condition. Follow up required.” Review of the registration system showed a second attempt to get a consent from Patient 1 was performed on 12/4/24 at 0904 hours. However, there was no documented reason to show why the second attempt to acquire Patient 1’s signature did not occur. LVN 1 acknowledged the finding.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 36703 Based on observation, interview, and record review, the hospital failed to ensure the process for the appropriate functioning of critical patient care equipment was implemented as evidenced by: 1. The hospital failed to maintain the medical vacuum system prior to the system failure, which affected the whole hospital’s ability to provide suctioning for patient care. 2. The hospital failed to perform the annual testing for the hospital’s medical air unit despite already identifying a leaking malfunction in the system. These failures increased the risk of substandard care for the patients receiving care in the hospital. Findings: 1. On 12/6/24, the CDPH, Licensing and Certification Program was informed by the hospital of a medical vacuum pump system failure which disabled all of the wall suctions in the hospital. On 12/17/24 at 1410 hours, an interview and concurrent review of hospital documents and email correspondences between the Director of Facilities and the hospital’s corporate finance department was conducted with the Director of Facilities. The Director of Facilities stated the medical vacuum pump system was replaced on 7/1/24. On 9/13/24, the hospital’s contracted vendor, Vendor 1, recommended performing the preventative maintenance on the unit. The Director of Facilities stated a purchase order was requested with the hospital’s corporate finance department on 9/16/24. However, the Director of Facilities stated Vendor 1 was also on a credit hold with the hospital for another job unrelated to the medical vacuum system. By 11/15/24, the Director of Facilities stated a purchasing order was generated but still required a check to pay Vendor 1’s COD; therefore, the vendor did not perform the testing or repairs. Review of the Hospital Incident Command System Activity Log showed on 12/6/24 at 1645 hours, the alarm system was activated for the medical vacuum pump, showing the system was down. At 1953 hours, a non-contracted vendor, Vendor 2, was able to come onsite to evaluate the medical vacuum pumps and recommended replacing both medical vacuum compressors. The Director of Facilities stated the COD checks were generated on 12/10/24, by the corporate’s purchasing department. With the credit hold resolved, Vendor 1 came onsite on 12/13/24 at 1300 hours, to perform the repairs. Vendor 1 repaired one of the two medical vacuum pump systems, and the second system’s repairs were completed on 12/16/24. 2. On 12/17/24 at 0900 hours, a tour to the machine room was conducted with the Director of Facilities. The medical air machine was observed emitting loud noises. The Director of Facilities stated the hospital identified an air leak in the medical air machine, which was causing the noise. Review of the Engineering Equipment Testing Schedule showed medical gas which included medical air, was last tested on 7/13/23, and due for preventative maintenance by 8/31/24. On 12/18/24 at 0945 hours, an interview was conducted with the Director of Facilities. The Director of Facilities confirmed although the maintenance schedule was due by 8/31/24, the facility did not have the financial resources available for repairs, and thus the issue had not yet been addressed. Despite multiple requests for approval for the necessary repairs from the corporation, a check was not generated yet for payment to Vendor 3 for preventative maintenance or repairs of the medical air unit. The Director of Facilities stated the unit was still functional and providing the needed medical air for the hospital. On 12/18/24 at 1002 hours, an interview was conducted with the CEO. The above findings were shared with the CEO. The CEO confirmed there were financial struggles which led to the delay of payments for preventative maintenance or repairs of the medical vacuum pump system and medical air unit. The CEO stated this was an ongoing issue on how to manage and prioritize which vendors were going to get the COD payments when the hospital had already had a lack of liquidity related to decreased cashflow in the recent years. The CEO stated however, the hospital staff were resourceful and innovative despite these challenges and made these situations work for the safety of the patients. On 12/18/24 at 1546 hours, the above findings were shared and acknowledged by the Interim CNO, Quality Manager, and Director of the Medical Surgical Unit.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 36703 Based on interview and record review, the nursing staff failed to ensure one of six sampled patients (Patient 1) had the ongoing assessments at least every 15 minutes for violent restraints, creating the risk for substandard outcomes to the patient. Findings: Review of the hospital’s P&P titled Restraints dated 8/2023 showed the ongoing assessments will be evaluated to determine the patient’s response to the restraint and if the patient has any care needs. The assessment will include checking the patient’s vital signs, hydration and circulation, the level of the patient’s distress and agitation, skin integrity, and the provision of general care needs. On 12/17/24 at 1230 hours, Patient 1’s closed medical record review was initiated with LVN 1. Patient 1 was admitted to the hospital on 12/3/24, and discharged on 12/8/24. Review of the physician’s order dated 12/3/24 at 1200 hours, showed to place Patient 1 on the violent soft restraints for all the limbs due to physical attack. The order showed to observe and document on Patient 1 every 15 minutes. Review of the physician’s order dated 12/3/24 at 1530 hours, showed Patient 1’s restraints were changed to non-violent soft wrist restraints for agitation and restlessness, cognitive impairment, lack of judgement, and noncompliance to prevent the disruption of care and pulling at lines. The order showed to observe and document on the patient every 2 hours. However, further review of Patient 1’s medical record showed the ongoing assessment was not performed as per the hospital’s P&P or the physician’s order. For example: - Review of Patient 1’s Restraints Safety/Rationale/Response/Type/Status dated 12/3/24 at 1200 hours, showed Patient 1 was placed on bilateral wrist and ankle soft restraints; however, the restraint type showed the restraints were non-violent. The restraint-type showed as non-violent again at 1245 hours. Further review of this section showed the “Safety Measures,” “Precautions,” “Restraint Alternatives,” “Education,” “Criteria For Restraint Release,” and “Restraint Response” were only documented on 12/3/24 at 1200, 1245, 1400, 1500, and 1530 hours. - Review of Patient 1’s Assessments showed Patient 1’s neurological assessment, skin assessment with circulation checks, and musculoskeletal assessment were documented on 12/3/24 at 1200, 1300, 1400, 1500, and 1530 hours. LVN 1 acknowledged the findings. On 12/18/24 at 1546 hours, the above findings were shared with the Interim CNO, Quality Manager, and Director of the Medical Surgical Unit.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 29798 Based on interview and record review, the hospital failed to ensure one sampled patient (Patient 1) was provided with the information regarding the care and health care requirements following the discharge from the hospital as evidenced by: * Patient 1 was given the discharge instructions in a language that was not the patient’s preferred spoken language. * Patient 1 was presented with the incomplete discharge instructions upon discharge from the hospital when the physician’s order for the post procedure pain medications was not included in the discharge instructions. These failures posed the increased risk of unsafe care to the patient. Findings: Review of the hospital’s P&P titled Discharging Outpatients from the Hospital dated September 2023 showed in part: * Policy: Only a Registered Nurse (RN) who has been certified in standardized procedure of “Discharging Outpatients” may discharge patients from the hospital using established protocols following a physician order. * Scope: A standardized procedure will be implemented for any outpatient who has undergone an invasive procedure and has a physician order to be discharged but is not evaluated by the physician at the time of discharge. * Procedure: Outpatient department will provide verbal and written instructions to the hospital and/or responsible party regarding type of procedure, diagnosis (printed diagrams or brochures as applicable), follow up appointment with the physician, diet, medications, activities, complications to be aware of and who to contact should symptoms be demonstrated or for any questions. * Documentation: Document assessment, interventions, patient outcome and the instructions given and patient/family understanding of the instructions on the unit specific form; document patient’s condition and time of discharge on the unit specific form. On 12/3/24 at 0920 hours, an interview with concurrent Patient 1’s medical record review was conducted with the ICNO and CQO. Patient 1’s medical record review showed the patient was presented to the hospital outpatient area for a procedure. Review of Patient 1’s PreOp Assessment dated 11/8/24 at 0725 hours, showed the preferred patient’s spoken language was Language 1. Review of the Discharge Order dated 11/8/24 showed Percocet (a pain medication) as needed for pain. The Discharge Order was verified by a RN on 11/8/24 at 1035 hours. However, review of the Discharge Instructions, Inpatient dated 11/8/24 at 0743 hours, showed the following: * The discharge instructions form presented to the patient upon discharge from the hospital was in English. * The discharge signatures were missing from the discharge instructions form. * The discharge order for pain management was not included in the discharge instruction upon discharge from the hospital. On 12/3/24, the above findings were verified by the CQO.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 22553 Based on interview and record review, the hospital failed to ensure one of one sampled physician (MD 1) followed the hospital’s Medical Staff Department of Surgery Rules and Regulations when performing the surgical procedure for one of six sampled patients (Patient 1). The failure posed the potential to result in an unsafe environment for the patients the hospital. Findings: Review of the hospital’s Medical Staff Department of Surgery Rules and Regulations dated February 2015 showed the surgeon shall be in the hospital prior to and during the induction of anesthesia and in the operating room immediately following the induction of anesthesia and continuously until the conclusion of the case. On 9/13/24 at 1434 hours, an interview and concurrent review of Patients 1 and 2’s medical records was conducted with the Charge Nurse. * Patient 1’s medical record showed Patient 1 had a surgical procedure on 8/27/24. The surgical procedure was for the hernia repair ventral and performed by MD 1. The Surgery Case Details showed MD 1’s “Time In” was at 0922 hours and “Time Out” was at 1046 hours. The procedure was started at 0924 hours and ended at 1051 hours. * Patient 2’s medical record showed Patient 2 had a surgical procedure on 8/27/24. The surgical procedure was for the excision axillary mass and performed by MD 1. The Surgery Case Details showed MD 1’s “Time In” was at 1027 hours and “Time Out” was at 1243 hours. The procedure was started at 1029 hours and ended at 1043 hours. During the concurrent interview with the Charge Nurse, the Charge Nurse confirmed Patients 1 and 2’s medical records showed on 8/27/24 from 1027 hours to 1046 hours, MD 1 was in both Patients 1 and 2’s ORs. On 9/17/24 at 1006 hours, RN 2 was interviewed for documenting the physician’s OR Time In/Out. RN 2 stated she was an OR circulating nurse (a RN who works in the operating room to ensure the patient safety and comfort during surgery). The OR circulating nurse was responsible to document the time when the surgeon came in and left the OR. RN 2 recorded the time when the surgeon walked into the OR, the time when the Time Out (a brief pause in the surgical procedure to confirm the correct patient, procedure, and site before the surgical incision initiated) was conducted, and the time when the surgeon left the room. RN 2 would write those times on the room white board and then transferred those data into the patient’s medical record. RN 2 stated all OR circulating nurses were required and responsible to record the Time In/Out accurately. On 9/18/24 at 1205 hours, MD 1 was interviewed regarding to the recorded Time In/Time Out for Patients 1 and 2’s surgical procedures on 8/27/24. MD 1 confirmed on 8/27/24, MD 1 performed the surgical procedures for both patients. MD 1 reviewed both medical records and stated on 8/27/24, MD 1 first performed the procedure for Patient 1 and MD 1 left the OR to have the assisting PA continue finishing the rest. MD 1 went to the Patient 2’s OR and performed Patient 2’s procedure. MD 1 read the hospital’s Medical Staff Department of Surgery Rules and Regulations that showed the surgeon shall be in the operating room continuously until the conclusion of the case. MD 1 confirmed he did not follow the Rules and Regulations.”

“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: 22553 Based on record review and interview, the hospital failed to maintain the high standards of care for the patients receiving the surgical services as evidenced by: 1. The hospital failed to ensure the hospital’s P&Ps and Standardized Procedure were reviewed as per the hospital’s P&P. 2. The hospital failed to the physician’s order was obtained to discharge one of six sampled patients (Patient 5) as per the hospital’s P&P. These failures had the potential to result in an unsafe patient care environment. Findings: 1. Review of the hospital’s P&P titled Policy & Procedures Development, Approval and Review Process dated September 2020 showed it is the policy of the hospital that a consistent method of documenting, approving, and reviewing policy and procedures will be used. All policies and procedures will be reviewed at least every three years by the CNO and others as assigned. On 9/18/24 at 1454 hours, the hospital’s P&Ps were reviewed with the CNO/DON and Chief Quality and Patient Safety Officer. The following was identified: * The hospital’s P&P titled Policy & Procedures Development, Approval and Review Process of the Nursing Manual showed the last reviewed date was September 2020. * The hospital’s P&P titled Anesthesia Awareness, Intraoperative of the Nursing Manual showed the last reviewed date was September 2020. * The hospital’s P&P titled General Anesthesia Induction Out Side Of the Surgical Suite of the Surgical Services Manual had the last reviewed date was March 2021. * The hospital’s P&P titled Discharging Patients After Outpatient Surgery of the Surgical Services Manual showed the last reviewed date was March 2021. * The hospital’s P&P titled Discharge Criteria for the Surgical Services department showed the last reviewed date was November 2017. * The hospital’s P&P titled Standards of Practice/Standards of Care of the Surgical Services department showed the last reviewed date was November 2017. * The hospital’s Standardized Procedure titled Discharge from PACU of the Nursing department showed the effective date was June 2008. During the concurrent interview, the CNO/DON and Chief Quality and Patient Safety Officer confirmed the above findings and stated those were the current and active P&Ps for patient care units including the hospital’s P&P for Policy & Procedures Development, Approval and Review Process with the last reviewed date of September 2020. 2. Review of the hospital’s P&P titled Standard Procedures: Discharging Outpatients from the Hospital dated September 2023 showed the physician must write an order to discharge the patient “per criteria” before the standardized procedure can be implemented. On 9/17/24 at 1046 hours, an interview and concurrent review of Patient 5’s medical record was conducted with Quality Manager 1. Patient 5’s medical record showed on 9/13/24, Patient 5 came to the hospital for a laparoscopic cholecystectomy (a minimally invasive surgical procedure used for the removal of a gallbladder). The patient was under general anesthesia. Patient 5’s medical record showed the patient was admitted to the PACU on 9/13/24 at 1312 hours, moved to the Women’s Center at 1427 hours, and discharged home at 1630 hours. Review of the Post-Anesthesia and Discharge Orders showed the physician’s initial on 9/13/24 at 1317 hours. The box of “Once discharge criteria met, may discharge patient to:...POR... ICU...Med/Surg...Women’s Center” were left blank. During the concurrent interview, Quality Manager 1 stated the Women’s Center was used as an extension recovery unit for the outpatient surgery. Quality Manager 1 confirmed there was no documented evidence the RN had obtained a physician’s order to discharge the patient as per the hospital’s P&P.”

“OPERATING ROOM REGISTER CFR(s): 482.51(b)(5) The operating room register must be complete and up to date. This Standard is not met as evidenced by: 22553 Based on interview and record review, the hospital failed to ensure the log for the patients seen for surgical procedure was completed. This failure had the potential to negatively affect the patients in the hospital. Findings: On 9/17/24, the surgical schedules for 8/27, 9/13, 9/10, and 9/17/24 were requested. Review of the these surgical schedules showed the OR number, scheduled procedured, duration of the procedures, patient names, patient sex and age, case numbers, medical record numbers, visit numbers, visit types, types of anesthesia, and names of the surgeons. On 9/17/24 at 1006 hours, the Surgery Scheduler was interviewed. The Surgical Scheduler stated she received the surgery schedule requested from the individual physician clinic/office. She entered it into the Sunrise system (the hospital computer system) to generate the surgical schedules for the staff to use. The Surgery Scheduler stated the surgery schedules would be the final one once it was made. The Surgery Scheduler was not told to update or revise when adding the cases, canceling the cases, or delay the cases. The Surgery Scheduler stated the hospital was utilizing Sunrise system which was difficult to use. On 9/17/24 at 1613 hours, the Chief Quality and Patient Safety Officer was interviewed. The Chief Quality and Patient Safety Officer stated she was aware of the requirement for the OR register, but the hospital failed to have it. Therefore, the hospital could not show the following information: * Inclusive or total time of the operation. * Name of any assistants. * Name of nursing personnel (scrub and circulating). * Name of the person administering anesthesia. * Pre and post-op diagnoses.”

“PHARMACY PERSONNEL CFR(s): 482.25(a)(2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. This Standard is not met as evidenced by: 32097 Based on interview and record review, the hospital failed to provide an adequate number of personnel to ensure pharmaceutical services which meets patients’ needs for three of three sampled patients (Patients 1, 2, and 3). The hospital failed to ensure that the pharmacist reviewed each medication ordered for appropriateness before the first dose was dispensed. New medication orders received after pharmacy hours, were not reviewed by a pharmacist prior to being administered to a patient. The hospital pharmacy hours were between 0600 and 2130 hours, Monday to Friday; 0600 and 2100 hours on Saturday and Sunday. All medication orders received between 2100 and 0600 hours were not reviewed by a pharmacist prior to administration when pharmacy was closed. This failure has a potential to result in patients’ medication errors and adverse events leading to poor health outcome. Findings: Review of the hospital’s P&P titled Medication Procurement After Hours dated 9/23, showed the hospital has established a mechanism for providing medications for patient care in the absence of a pharmacist ... All emergency and physician written “Now” or “Stat” medications will be procured. Review of the hospital’s P&P titled Pharmacist Review of Medication Orders dated 11/22, showed each medication order is reviewed for appropriateness by a pharmacist prior to the dispensing and administration of the medication, unless specific conditions exist. Pharmacist review prior to the initiation of medication therapy has been shown to decrease medication errors and adverse events ... Prospective review of medication orders by a pharmacist must take place prior to the administration of a medication with the following exceptions: o The physician directly controls the ordering, preparation, and administration of the medication and is available to provide immediate intervention should a patient experience an adverse medication event, or o Urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status (e.g., new onset of nausea). Review of the hospital’s P&P titled Medication Administration (General) dated 3/23, showed the hospital pharmacy is open from 0600 to 2130 hours on weekdays and 0600 to 2100 hours on Saturday and Sunday. Review of some medication orders administered while pharmacy was closed showed: Patient 1, LORazepam (used to treat alcohol withdrawal) 1 milliGRAM intravenous every 4 hours as needed ordered on 8/11/2024 at 2131 hours, administered at 2145 hours and on 8/12/24 at 0310 hours while pharmacy was closed. Patient 2’s orders of 8/29/24 at 0251 hours, for lisinopril (used to treat high blood pressure) oral 20 milliGRAM(s) daily and hydralazine oral (used to treat high blood pressure) 50 milliGRAM(s) every 8 hours as needed for SBP > 160 or DBP >90. Patient 3’s acetaminophen 325 milliGRAM(s) tablet every 6 hours as needed for mild pain ordered on 9/6/2024 at 2252 hours and administered. On 9/9/24 at 1505 hours, an interview and concurrent record review was conducted with the DOP in the presence of the Quality Manager and Chief Quality Officer. The DOP verified above orders were maintenance and not emergency orders. The DOP stated new medication orders received after pharmacy hours were not verified prior to administration to patients. The DOP also stated a pharmacist was on call for consultation when pharmacy was closed, and medication orders were reviewed when pharmacist came in at 0600 hours.”

“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: 32097 Based on interview and record review, the hospital failed to provide safe and effective pharmaceutical services to ensure patient safety as evidenced by: Failure of the Pharmacy & Therapeutic (P&T) Committee to develop and implement P&P for nursing compounding of sterile products in emergency situations as specified in state law. This failure created the potential of exposing patients to infections and medication related negative outcomes for the patients. Findings: Title 22, California Code of Regulations, Section 70263 (c)(1) requires the committee (P&T) to develop the written policies and procedures for the establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. On 9/9/24 at 1045 hours, during an inspection of the medications in the ED, RN 1 stated they did not compound any medications in ED during the day shift, pharmacy was responsible for compounding their intravenous medications. During an interview on 9/9/24 at 1100 hours by the ED medication room, the DOP stated nursing compounded some medication drips and intravenous fluids during the night when pharmacy was closed. Review of the nursing staff compounded sterile medication competencies showed it did not include sanitizing the medication vial septum and the intravenous (IV) bag port prior to entry. During an interview on 9/9/24 at 1200 hours, the ED/ICU Director verified above and stated there were no other handouts/in-services done for compounding sterile medications other than the competency test and the return demonstration at the time of orientation. Review of the hospital’s Compounded Sterile Products P&P showed it did not mention nursing compounding medications. During an interview on 9/9/24 at 1330 hours with the DOP, in the presence of the Quality Manager and Chief Quality Officer. The DOP verified the hospital did not have a P&P for nursing compounding medications. The DOP also verified nursing sterile compounded medication competencies did not include sanitizing the medication vial septum and the bag port prior to entry. During an interview on 9/9/24 at 1530 hours, the DOP stated the hospital do not have a record of medications compounded by nursing. During a telephone interview on 9/12/24 at 1030 hours, RN 2 stated she worked night shifts in ED. RN 2 stated there was no training handout or manual. RN 2 signed off night shift RNs competencies. RN 2 stated they did not compound a lot of drips but commonly used premix pressor medications (used to increase blood pressure and constrict blood vessels). RN 2 stated they reviewed how to make common drips during competency. RN 2 went over the process of compounding intravenous medication but did not mention sanitizing the vial septum and the intravenous bag port prior to entry until prompted. During a telephone interview on 9/12/24 at 1050 hours, RN 3 stated they did not use any training handout. RN 3 signed off staff for competency. RN 3 went over the process of compounding sterile products. She mentioned they used aseptic technique; they cleaned the compounding area with Sani wipes (a disinfectant) and wipe the intravenous fluid bag hub/port. RN 3 described how to transfer the medication from the vial to the bag but did not sanitize the medication vial septum until prompted.”

“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: 29798 Based on interview and record review, the hospital failed to ensure the medical staff was accountable to the Governing Body for quality of care for one of three sampled patients (Patient 3) as evidenced by: * A physician’s progress note was not prepared timely as per the hospital Bylaws. * There was no documented evidence to show the reason for Patient 3 to be transferred to the other hospital’s NICU. These failures had the potential for substandard level of care. Findings: Review of the hospital’s Medical Staff Bylaws and General Rules & Regulations dated November 2021 showed pertinent progress notes shall be signed, dated, and timed at the time of each visit. Notes shall be sufficient to permit continuity of care and transferability. Whenever possible each of the patient’s clinical problems should be clearly identified in the progress notes and correlated with specific orders as well as results of tests and treatments. On 7/31/24 at 1335 hours, an interview with concurrent review of Patient 3’s medical records was conducted with the Interim CNO and RN 1. Review of Patient 3’s medical record showed Patient 3 was born on 7/15/24 at 2133 hours. Review of the Admission Note Newborn Nursing dated 7/15/24 at 2245 hours, showed the following: * Delivery date and time was 7/15/24 at 2133 hours. * The Estimated Gestational age (EGA) was 36.2 weeks * The birth type was Cesarean Section. * The patient’s temperature was 97.7 degrees Fahrenheit. The patient’s heart rate was 130 bpm. The patient’s respiratory rate was 52 breaths per minute. * The patient’s admit weight was 2295 gram. * The patient’s Apgar was eight at one minute and nine at five minutes. * For the initial exam, there was no abnormalities observed * The discharge planning section showed the anticipated discharge was to home. Review of the Process Notes dated 7/16/24 at 0104 hours, showed at 0005 hours, Patient 3 was transferred out to the other hospital’s NICU. Review of the Newborn Admission Note dated 7/31/24 at 0829 hours, showed the General Exam section showing Patient 3 was alert, active non-dysmorphic-appearing infant, and in no acute distress. The Assessment and Plan section showed to continue normal newborn care and follow up with pediatrician in two to three days. There was no documented evidence to show the physician dictated a note following the delivery of Patient 3 as per the hospital’s Bylaws and General Rules & Regulations There was no physician’s note to show the reason for Patient 3 to be transferred out to the other hospital’s NICU. The above findings were verified by the Interim CNO and RN 1.”

“CARE OF PATIENTS - MD/DO ON CALL CFR(s): 482.12(c)(3) [ ...the governing body must ensure that the following requirements are met:] A doctor of medicine or osteopathy is on duty or on call at all times. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure MD 1 saw and evaluated one of three sampled patients (Patient 1) in the ICU within six hours of admission. This failure increased the risk for substandard outcome to the patient. Findings: Review of the hospital’s Medical Staff Bylaws and General Rules & Regulations dated November 2021 showed all patients admitted to the Critical Care Unit shall be seen by a staff physician on staff within six hours or less from the time of admission. Upon the request of the emergency physician, the physician responsible for the care of the patient must respond immediately. On 8/1/24 at 0901 hours, an interview and concurrent review of Patient 1’s medical record was conducted with LVN 1. LVN 1 stated Patient 1 walked into the ED on 7/16/24 for methamphetamine (highly addictive stimulant that affects the central nervous system) overdose and was admitted to the ICU on the same day. Patient 1’s medical record showed Patient 1 visited the ED on 7/16/24 at 1258 hours. Review of the ED Provider Aware Note dated 7/16/24 at 1340 hours, showed the ED provider, MD 1 spoke with MD 2 at 1406 hours. MD 2 agreed to accept Patient 1 in the ICU as the attending physician. The ED Provider Aware Note showed MD 3 was also consulted on Patient 1’s case. The ED Provider Aware Note showed Patient 1 was on a BiPAP. Review of the location history showed Patient 1 was moved to the ICU on 7/16/24 at 1544 hours. Review of the Event Note dated 7/16/24 at 1751 hours, showed the RN documented informing MD 3 of Patient 1’s respiratory status. The RN received new orders for Patient 1’s BiPAP settings. The RN documented Patient 1’s respiratory rate was 38 breaths per minute and a temperature of 104.8 degrees Fahrenheit. Review of the Consult Note dated 7/16/24 at 2119 hours, showed MD 4 from the ED intubated Patient 1 due to severe respiratory distress, as the BiPAP that Patient 1 was on, could no longer maintain Patient 1’s oxygenation. Review of the Consult Note dated 7/16/24 at 2318 hours, showed Patient 1 had a Code Blue response at 2218 hours with cardiac arrest and had a death pronouncement at 2246 hours. Review of the Progress Note dated 7/18/24 at 0900 hours, showed MD 2 documented Patient 1 was admitted to the ICU and shortly after arriving, the patient was intubated. MD 2 documented Patient 1 became bradycardia, and a Code Blue was called. MD 2 documented Patient 1 passed away on 7/16/24 at 2246 hours (approximately seven hours after the admission to ICU). On 8/1/24 at 1331 hours, an interview and concurrent review of the hospital’s Medical Staff Bylaws and General Rules and Regulations was conducted with the Director of Medical Staff. The Director of Medical Staff stated the attending physician was required to see a patient in the ICU within six hours of admission. On 8/1/24 at 1500 hours, the above findings were shared with the CEO, ED and ICU Director, Interim CNO, and Quality Manager.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 29798 Based on observation, interview, and record review, the hospital failed to maintain the overall hospital environment in such a manner that the safety and well-being of patients were assured as evidenced by: 1. Inoperable equipment stored in Room D. 2. Delivery room light without preventive maintenance. 3. Two janitor’s closets: one unlocked with a rusty sink and the other with a rusty drain. 4. Broken supplies stored in the bedside drawer of Room B. 5. A linen hamper filled with soiled linens in an unoccupied patient’s bathroom. 6. Inoperable hopper in the dirty utility room. 7. Cleaning log for the ice machine not up to date. 8. Kitchen with rusty areas behind the faucet. 9. Inoperable light above the bed in Room C. 10. No thermostat in the unit’s medication room. 11. A storage cart in the nursery’s hearing room with a broken drawer. 12. A linen hamper filled with “rejected linens” in the nursery’s hearing anteroom. 13. Leaking sink in the CCU and no P&P in place to track and maintain maintenance issues in the facility for the Engineering Department. 14. Two corrugated boxes filled with one- liter bags of Normal Saline were observed stacked directly on the floor of the central supply. These failures had the potential to compromise patient safety and increase the risk of infections. Findings: On 7/31/24 at 0945 hours, a tour of the Labor and L&D unit was conducted with the Interim CNO, Charge Nurse L&D, and Maintenance Supervisor. During the tour the following were observed: 1. During a tour of Room D, two inoperable pediatric and adult ventilators were observed stored in the room. The Charge Nurse L&D stated Room D was set up as a vaginal delivery room overflow. In another interview with the BioMed Technician, he stated the two ventilators were plugged into an outlet in the room waiting to be repaired. 2. In Room E, a delivery light was observed without the preventive maintenance sticker. In an interview the BioMed Technician, he stated the light was a loaner. 3. One janitor closet in the hallway was observed unlocked with brown rusty sink. The second closet had a mop stains and rusty drain sink. The Maintenance Supervisor locked the unlocked closet. 4. Room B which was an unoccupied room, was prepared for a new patient. Broken plastic items and plastic bags were stored in the bedside nightstand. The Charge Nurse L&D responded by disposing the broken items and plastic bags. 5. In Room B, the linen hamper was filled with soiled linens. The Charge Nurse L&D stated the hamper should have been emptied when the room was cleaned. 6. A hopper in the dirty utility room was observed in a disrepair condition. The Maintenance Supervisor stated the Maintenance Supervisor was not aware of the problem with the hopper. When asked, the Maintenance Supervisor stated regarding any repairs or maintenance issues, the nursing unit staff would notify the Engineering Department via an email or a phone call. 7. The cleaning log for the ice machine located in the nutrition room was not up to date. The Charge Nurse L&D stated the EVS cleaned the ice machine daily. The last date on the cleaning log showed 7/17/24. 8. A double sink in the kitchen was observed with rusty areas behind the faucet. The Maintenance Supervisor stated was unaware of the issue. 9. In Room C which was prepared for a new patient admission, a light above the bed was observed in a disrepair condition, the light frame was hanging from the lamp. The Maintenance Supervisor was unaware of the broken lamp. 10. During a tour of the unit’s medication room Pyxis machine (automated medication dispensing systems) was observed, an anesthesia cart and several one-liter IV fluid bags were stored in the medication room. No thermostat (a device that controls the temperature) was observed in the room. The Maintenance Supervisor provided a portable thermostat. 11. A storage cart with a broken drawer was observed in the nursery’s hearing room. RN 1 stated the infants hearing tests were performed by an outside company, contracted with the hospital, and the individual performing the hearing test was responsible to notify the unit’s nursing staff of the broken drawer. 12. A linen hamper in the nursery’s hearing room’s anti-room was labeled “Rejected Linens”. The hamper was filled with dirty linens. RN 1 stated the EVS was responsible for the daily pick up of the dirty linens. The above findings were verified by the Interim CNO, RN 1, Maintenance Supervisor, and BioMed Technician. 38492 13. Review of the hospital’s P&P titled Work Order Reporting, Assignment & Completion, dated August 2023 showed if staff identifies a non-critical corrective issue in their department, staff is to notify the Engineering department by email and/or phone. For critical issues, staff is to notify Engineering immediately by calling during Engineering business hours or Nursing Supervisor after the engineering business hours. Nursing Supervisor will contact Engineering on-call after hours. There was no information about the process engineering would follow to prioritize or address the issue in the policy. On 7/31/24 at 0945 hours, a tour of the CCU was conducted in CCU with Charge Nurse 1, in the presence of the Quality Nurse. A sink was observed in Room A with a sign “Do not use” taped to the faucet. When asked why there was a sign, Charge Nurse 1 stated there was something wrong with the sink. Charge Nurse 1 turned on the faucet, and water was observed leaking from the pipes underneath the sink onto the floor, and a large rust colored stain was observed. When asked how long the sink had been out of order, Charge Nurse 1 stated possibly a couple of weeks. When asked the process to let the Engineering know about the issue, Charge Nurse 1 stated they called or emailed the Engineering. Charge Nurse 1 stated she did not call Engineering herself, but she thought it had been reported already. On 7/31/24 at 1320 hours, an interview was conducted with the Maintenance Supervisor and the Admin Assistant, Engineering. The Maintenance Supervisor was asked for a work order regarding the leaking sink in CCU. The Maintenance Supervisor stated the Engineering Department was not made aware of the leaking sink. When asked the process for staff to report an issue to Engineering, the Maintenance Supervisor stated staff would call or email. The Maintenance Supervisor stated there was no other record keeping. On 7/31/24 at 1421 hours, an interview was conducted with the Quality Manager. The Quality Manager stated there was no system in place for work orders, they were only discussed during the daily huddle meetings. On 8/1/24 at 1314 hours, an interview was conducted with the Maintenance Director. The Maintenance Director was asked about the process for logging and tracking work orders for the Engineering department. The Maintenance Director stated the staff would call or email the Engineering department, but they did not track the work orders. When asked for a P&P regarding the process for prioritizing and logging work orders, the Maintenance Director stated there was none. 14. According to the CDC, sterile supplies should be stored far enough from the floor (8 to 10 inches), the ceiling (5 inches unless near a sprinkler head [18 inches from sprinkler head]), and the outside walls (2 inches) to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes (e.g., supplies must be at least 18 inches from sprinkler heads). Medical and surgical supplies should not be stored under sinks or in other locations where they can become wet. Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces. On 7/31/24 at 1020 hours, a tour of the central supply alternate storage area located within the Physical Therapy department and concurrent interview with the Materials Supervisor, in presence of the Quality Nurse was conducted. Two corrugated boxes filled with one-liter bags of Normal Saline were observed stacked directly on the floor. The Materials Supervisor stated the boxes should be off the floor to avoid contamination. On 8/1/24 at 0930 hours, an interview was conducted with the Epidemiologist. The Epidemiologist was asked about storing boxes on the floor. The Epidemiologist stated boxes needed to be stored six to seven inches off floor because floor could get wet and items could get contaminated.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 29798 Based on observation and interview, the hospital failed to ensure supplies and equipment were updated and stored to ensure an acceptable level of safety and quality as evidenced by: 1. A box of expired suture kit was found available for patient use in Room D/sterile supply room. 2. An IV pump module was found in the ED with a preventive maintenance date of 2/2024. These failures had the potential to compromise patient safety and increase the risk of infections. Findings: 1. On 7/31/24 at 0945 hours, a tour of the L&D was conducted with the Interim CNO and Charge Nurse L&D. During the tour of Room D (an OR), Charge Nurse L&D stated the room was used for storing sterile supplies. A box of expired suture kit dated 1/31/24 was found in Room D/sterile supply room available for patient use. The Charge Nurse L&D responded by disposing of the box. The above finding was verified by the Interim CNO and Charge Nurse L&D. 45560 2. On 7/31/24 at 0932 hours, a tour of the ED with concurrent interview with the ED and ICU Director was conducted. An IV pump module #9948 was found with a preventative maintenance dated 2/2024. During an interview with the ED and ICU Director, she verified and acknowledge the findings. On 8/1/24 at 1458 hours, an interview was conducted with the BioMed Technician. The BioMed Technician acknowledged the IV pump module #9948 did not have preventive maintenance completed as scheduled, because it was unable to be found.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 29558 Based on interview and record review, the hospital failed to comply with the 24 CFR 489.24, special responsibilities of Medicare hospitals in emergency cases. This failure had the potential to result in poor health outcomes and serious adverse events to the patients receiving the ED services. Findings: 1. The hospital failed to ensure the MSE was provided in a timely manner to determine whether or not an EMC existed for two of 20 sampled patients (Patients 1 and 15) and failed to ensure the annual performance was completed for RN 1. Cross reference to A2406. 2. The hospital failed to ensure the necessary stabilizing treatment was provided within the capabilities of the hospital for three of 20 sampled patients (Patients 8, 17, and 18). Cross reference to A2407.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 45560 Based on observation, interview, and record review, the hospital failed to ensure the signage for EMTALA rights with respect to the examination and treatment for EMC and women in labor were posted conspicuously in the ED areas as evidenced by: * Failure to ensure the EMTALA signage was posted in the ED’s team triage room. * Failure to ensure the EMTALA signage was posted in the ED’s obstetric exam room. * Failure to ensure the EMTALA signage was posted in the ED’s behavioral room. These failures had the potential to result in the individuals to not be aware of their rights to the examination and treatment in the event of an EMC. Findings: Review of the hospital’s P&P titled EMTALA - Definitions and General Requirement dated December 2022 showed signage refers to the hospital requirement to post signs conspicuously in a DED or in a place or places likely to be noticed by all individual entering the DED as well as those individuals waiting for examination and treatment in areas other than the DED located on hospital property (e.g., outpatient departments, labor and delivery, waiting room, admitting area, entrance and treatment areas), informing individuals of their rights under federal law with respect to examination and treatment for medical conditions, EMCs and women in labor. The sign must also state whether or not the hospital participates in the state’s Medicaid program in a stated plan approved under Title XIX. On 7/31/24 at 0932 hours, the hospital’s ED was toured with the ED and ICU Director. There was no EMTALA signage posted in the team triage room, obstetric exam room, and behavioral room. In a concurrent interview, the ED and ICU Director verified and acknowledge the findings. On 8/1/24 at 1515 hours, a conference was held with the CEO, Interim CNO, Quality Manager, Quality Nurse, and ED and ICU Director. They were notified and acknowledged the above findings.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure the ED Central Logs were accurately maintained for five of 20 sampled patients (Patients 6, 7, 8, 9, and 14). This failure had the potential to result in the hospital not being able to accurately track the care provided to the individuals who presented to the ED for the treatments of their emergency medical conditions. Findings: Review of the hospital’s P&P titled EMTALA - Central Log Policy dated December 2022 showed in part: * The hospital must maintain the Central Log in an electronic or paper format. * The logs must contain at a minimum, the name of the individual; the date, time and means of the individual’s arrival; the individual’s age; the individual’s sex; the individual’s record number; the nature of the individual’s complaint; the individual’s disposition; the individual’s time of departure; and whether the individual: refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged or expired. 1. On 7/31/24 at 1409 hours, an interview and concurrent record review was conducted with the ED and ICU Director. Patient 8’s closed medical record showed Patient 8 presented to the ED on 7/9/24, with a chief complaint of weakness. Review of the ED Triage Aware Note dated 7/9/24 at 0705 hours, showed Patient 8 also had right shin pain and headache. The patient had no suicide risk and no further interventions required at this time. However, review of the ED Central Log dated July 2024 showed Patient 8’s chief complaint was “SUICIDAL IDEATION.” The ED and ICU Director acknowledged the above findings and confirmed the chief complaint listed on the ED Central Log for Patient 8 was incorrect. 2. On 7/31/24 at 1421 hours, an interview and concurrent record review was conducted with the ED and ICU Director. Patient 9’s closed medical record showed Patient 9 presented to the ED via EMS on 6/30/24, with a chief complaint of shoulder pain/injury. Review of the ED Triage dated 6/30/24 at 1005 hours, showed Patient 9 had no suicide risk and no further interventions required at this time. However, review of the ED Central Log dated June 2024 showed Patient 9’s chief complaint was “5150 HOLD” and the mode of arrival was “Walk In.” The ED and ICU Director acknowledged the above findings and confirmed the chief complaint and mode of arrival listed on the ED Central Log were wrong. 39199 3. On 7/31/24 at 1350 hours, an interview and concurrent record review was conducted with LVN 1. Review of Patient 6’s closed medical record showed Patient 6 arrived at the ED on 7/14/24 at 0412 hours and was transferred to the L&D Department on 7/14/24 at 0423 hours. Review of Patient 6’s Admission Note Obstetric Nursing dated 7/14/24 at 0521 hours, showed Patient 6 was admitted for spontaneous rupture of membranes. However, review of the ED Central Log showed Patient 6’s disposition was “Routine Home or Self Care.” 4. On 7/31/24 at 1350 hours, an interview and concurrent record review was conducted with LVN 1. Review of Patient 14’s closed medical record showed Patient 14 arrived at the ED on 7/15/24 at 1748 hours, presenting with complaints of abdominal pain while 38.5-weeks pregnant; Patient 14 was transferred to the L&D Department on 7/15/24 at 1805 hours. However, review of the ED Central Log showed Patient 14’s disposition was “Routine Home or Self Care.” 5. On 7/31/24 at 1350 hours, an interview and concurrent record review was conducted with LVN 1. Review of Patient 7’s closed medical record showed Patient 7 arrived at the ED on 7/23/24 at 1116 hours, presenting with complaints of chest pain. Review of the ED Provider Aware Note dated 7/23/24 at 1143 hours, showed Patient 7 was admitted to the ICU for acute coronary syndrome. However, review of the ED Central Log showed Patient 7’s disposition was transferred to another hospital. On 7/31/24 at 1550 hours, the above findings for Patients 6, 7, and 14 were verified by both the ED and ICU Director and Quality Manager. The ED and ICU Director stated the ED central log showed the patients’ final disposition rather their ED disposition.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the MSE was provided in a timely manner to determine whether or not an EMC existed for two of 20 sampled patients (Patients 1 and 15) and failed to ensure the annual performance was completed for RN 1 as evidenced by: 1. For Patient 1, the ED staff triaged and assigned Patient 1 with the ESI level of 3 which was not accurately as per the hospital’s P&P. 2. RN 1 did not have an annual performance review of his role in the ED since becoming an ED RN. 3. For Patient 15, the triage nurse failed to implement the Triage P&P and the patient LWBT. These failures had the potential to result in poor clinical outcomes and serious adverse events to the patients receiving the ED services. Findings: Review of the hospital’s P&P titled EMTALA - Definitions and General Requirements dated December 2022 showed EMTALA requires the hospital to provide an appropriate MSE to the individual within the capability of the hospital’s emergency department to determine whether or not an EMC exists. Review of the hospital’s P&P titled Triage and Assessments of Patients Using Emergency Severity Index (ESI) dated September 2023 showed the following: * All patients presenting to the ED requesting emergency care services will be initially triaged by a qualified RN or ED physician in a timely manner to determine priority of medical screen and care based on physical, psychological, and social needs. * Triage is a dynamic process and may require that the patient be re-triaged if their condition changes or deteriorates prior to being seen by a treating clinician. * The patient’s level of urgency is indicated using the ESI. * Triage is used to determine the patient’s clinical urgency and to assess patient acuity based on their presentation in the ED and the expected level of care they will require. * Responsibilities of the Triage RN include to respond upon notification of a patient requesting medical treatment; perform an overview of the patients waiting to be seen to determine if any patients appear to require priority triage and categorization; if priority triage is not indicated, triage will be conducted based on the patient’s arrival. * After a triage assessment is completed, the triage RN will categorize the patient with an ESI level of 1 (most urgent) to 5 (least urgent). - An ESI level 2 is an emergency condition which requires immediate care and has a strong potential for a major injury or illness. When an ESI level 2 condition is identified, the triage process stops, and the patient is taken directly to a treatment area if available and immediate physician intervention is requested. - An ESI level 3 is an urgent condition which requires prompt but not immediate care. The patient with ESI level 3 is stable with multiple types of resources to investigate and treat. The patient presents with a condition that could progress to a serious problem requiring emergency interventions. Review of the ESI Triage Attachment A of the hospital’s P&P titled Triage and Assessments of Patients Using Emergency Severity Index (ESI) showed an ESI Triage algorithm. The first prompt is “requires immediate life-saving intervention?”. A “yes” response will suggest an ESI level 1. A “no” response will lead to the second prompt which is “high risk situation? or confused/lethargic/disoriented? or severe pain/distress?”. A “yes” response will suggest an ESI level 2. A “no” response will lead to the third prompt which is “how many different resources are needed?”. If many resources are needed, the fourth prompt will lead back to the ESI level 2 if the heart rate is greater than 100 bpm, the respiratory rate is greater than 20 breaths per minute, or the oxygen saturation is less than 92%. If vital signs are not in the danger zone, then the ESI level is 3. 1. On 8/1/24 at 0901 hours, Patient 1’s closed medical record was conducted with LVN 1. Patient 1’s medical record showed Patient 1 visited the ED on 7/16/24 at 1258 hours. Review of the ED Triage Aware Note dated 7/16/24 at 1300 hours, showed RN 1 documented Patient 1’s chief complaint as “meth overdose” after swallowing an “8ball of meth 3 hours ago.” RN 1 documented Patient 1 was diaphoretic and slightly nauseous. Further review of the document showed Patient 1’s blood pressure was 163/124 mmHg, the patient’s heart rate was 120 bpm, and the patient’s temperature was 99.2 degrees Fahrenheit. RN 1 assessed Patient 1 with the ESI level of “3”. Review of the ED Provider Aware Note dated 7/16/24 at 1340 hours, showed MD 1 performed an MSE on Patient 1. The MDM/ED Course Narrative section showed at 1330 hours (or 30 minutes later), MD 1 assessed Patient 1; it was determined that an EMC existed after the initial MSE; MD 1 reviewed the ABG results which were consistent with respiratory acidosis; the patient was highly agitated, tachycardic, diaphoretic, paranoid, and unable to sit still; the patient was placed on a BiPAP with improvement; and the patient was admitted to ICU. On 8/1/24 at 1145 hours, an interview and concurrent review of Patient 1’s closed medical record was conducted with the ED and ICU Director and Quality Manager. When asked if Patient 1’s ESI level was assessed according to the hospital’s P&P, the Quality Manager stated Patient 1 was considered high risk, according to the algorithm on the hospital’s P&P. The Quality Manager stated Patient 1’s ESI level should have been the ESI level 2. When asked what the normal process was if a patient was assigned with the higher acuity ESI, the ED and ICU Director stated the RN would immediately share a severe case with the ED MD. The ED and ICU Director stated the MD would also monitor the tracking board and know from there which patients needed to be seen according to the ESI level and presenting symptoms. The ED and ICU Director acknowledged and verified the above findings. 2. On 8/1/24 at 1304 hours, an interview and concurrent review of RN 1’s training and personnel file was conducted with the HR Generalist and the ED and ICU Director. Review of RN’s personnel file showed RN 1’s last performance evaluation was on 11/4/22. Review of RN 1’s job description showed RN 1 transitioned from a Telemetry RN to an ED RN role on 11/9/22. Further review of RN 1’s personnel and training file failed to show an annual performance evaluation for RN 1 since 11/4/22. When asked, the HR Generalist stated the ED and ICU Director role was vacant for some time and no annual evaluations were conducted as expected. When asked, the ED and ICU Director stated the annual performance evaluation for each employee involved conducting observations, getting feedback from the charge nurses and doctors, and reviewing triage notes. The ED and ICU Director stated the performance evaluation should be done annually. On 8/1/24 at 1310 hours, the above findings were shared and acknowledged by the Quality Manager. 37548 3. On 7/31/24 at 1446 hours, an interview and concurrent record review of Patient 15’s closed medical record was conducted with the ED and ICU Director. Patient 15’s medical record showed the patient presented to the ED on 5/11/24 at 2040 hours, with leg pain. Review of the ED Triage RN Note dated 5/11/24 at 2140 hours, showed Patient 15 was called to triage with no response at 2140 (one hour after arrival to the ED), 2150, and 2200 hours. The documentation showed the patient LWBT. On 8/1/24 at 1502 hours, an interview and concurrent record review was conducted with the Interim CNO. The Interim CNO confirmed there was a delay of one hour before the Triage RN called the patient to triage. And there was no documentation to show the Triage RN performed an overview of Patient 15 upon arrival to the ED to determine if the patient appeared to require priority triage and categorization. The Interim CNO confirmed and acknowledged the findings.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure the necessary stabilizing treatment was provided within the capabilities of the hospital for three of 20 sampled patients (Patients 8, 17, and 18) as evidenced by: 1. For Patient 18, the ED staff failed to discuss with the patient the risk and benefits involved in leaving against medical advice and take all reasonable steps to secure the individual’s written informed consent to refuse or withdraw from such examination and treatment by having the individual sign the AMA Form as per the hospital’s P&P. 2. For Patients 8 and 17, the ED staff did not implement the hospital’s P&P related to pain management for the patients. a. The ED staff failed to assess the pain level when Patient 8 complained of a headache and pain to the right shin. b. The ED staff failed to assess the pain level for Patient 17 (a pediatric patient) who had dysuria. These failures had the potential to result in poor clinical outcomes and serious adverse events to the patients receiving the ED services. Findings: Review of the hospital’s P&P titled EMTALA - Definitions and General Requirement dated December 2022 showed in part: * If the hospital determines that an individual does have an EMC, provide necessary stabilizing treatment to the individual or provide for an appropriate transfer. * Leaving DED after the MSE: for those individuals indicating a desire to leave the DED against medical advice (“AMA”) after receiving an MSE, the facility should use its best efforts to: - Discuss with the individual the risk and benefits involved in leaving against medical advice and document same; - Take all reasonable steps to secure the individual’s written informed consent to refuse or withdraw from such examination and treatment by having the individual sign the AMA Form, if possible; - Describe, in the medical record, the examination and treatment that was refused or the request for treatment was withdrawn; and - Sign, date, and time the entry. 1. On 7/31/24 at 1448 hours, an interview and concurrent review of Patient 18’s closed medical record was conducted with the ED and ICU Director. Patient 18’s closed medical record showed Patient 18 presented to the ED on 6/3/24, with suspected alcohol intoxication. Review of the ED Provider Aware Note dated 6/3/24, showed Patient 18 presented via ambulance complaining of intoxication and alcohol use. The patient attempted to step in front of a bus earlier today. The patient denied suicidal ideation. The MDM/ED Course Narrative section showed “Patient wishes to go home.” The Disposition Status from ED was documented as “eloped.” There was no documentation showing the physician discussed with the patient the risk and benefits involved in leaving against medical advice, took all reasonable steps to secure the individual’s written informed consent to refuse or withdraw from such examination and treatment by having the individual sign the AMA Form as per the hospital’s P&P. On 8/1/24 at 1359 hours, an interview and concurrent record review was conducted with the Interim CNO. The Interim CNO confirmed and acknowledged the findings. 2. Review of the hospital’s P&P titled Pain Management dated August 2023 showed in part: * Pain will be assessed in all patients. * When pain or the potential for pain is identified, a more comprehensive assessment is performed. This assessment includes a measure of pain intensity and quality, appropriate to the patient’s age. * The patient and family can expect the patient in pain to be assessed and treated promptly, effectively and for as long as pain persists. * The pain assessment tools used at the hospital include the numeric 0-10 pain intensity scale and FLACC scale. * The Numeric Intensity Scale is: 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain. * FLACC (face, legs, activity, crying, and consolability) pain scale is developed to help medical observers measure the level of pain in children who are too young to cooperate verbally. This scale can be used for patients 2 months old to 7 years old. Zero indicates that patient is relaxed and comfortable. 1-3 indicates the patient has mild discomfort. 4-6 indicates the patient has moderate pain. 7-10 indicates the patient has severe discomfort/pain. * Where pain is identified, the patient is treated or referred for treatment. a. On 7/31/24 at 1409 hours, an interview and concurrent review of Patient 8’s closed medical record was conducted with the ED and ICU Director. Patient 8’s closed medical record showed the patient presented to the ED on 7/9/24, with a chief complaint of weakness. Review of the ED Triage Aware Note dated 7/9/24 at 0705 hours, showed Patient 8 had the right shin pain and headache. Review of the Visit Record showed Patient 8 was discharged from the ED on 7/9/24 at 0810 hours. In a concurrent interview, the ED and ICU Director confirmed there was no documentation to show Patient 8’s pain was assessed or addressed. b. On 7/31/24 at 1500 hours, an interview and concurrent review of Patient 17’s closed medical record was conducted with the ED and ICU Director. Patient 17’s closed medical record showed the patient (a pediatric) presented to the ED on 5/8/24. Review of the ED Triage Aware Note dated 5/8/24 at 0924 hours, showed Patient 17 had dysuria. Review of the Visit Record showed Patient 17 was discharged on 5/8/24 at 1116 hours. In a concurrent interview, the ED and ICU Director confirmed there was no documentation to show Patient 17 was assessed for pain.”