Orange County Global Medical Center

“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 the nursing staff developed the care plan for blood transfusion for one of three sampled patients (Patient 3). This failure posed the risk for potential complications, including undetected changes in the patient’s condition, delayed interventions, and overall compromised patient safety during the blood transfusion process. Findings: Review of the hospital’s P&P titled Standards of Nursing Practice, Generic, Critical Care dated August 2024 showed the following: * An individual plan of care will be initiated within the first eight hours of admission. * Measurable and realistic outcome criteria will be identified. * Plan of care will be reviewed every shift. * The Plan of Care will be consistent with the medical plan of care. * 12-hour chart checks will be completed and documented each shift. On 2/24/26, Patient 3’s medical record was reviewed. Review of Patient 3’s medical record showed Patient 3 was admitted to the hospital on 2/11/26. Review of the IntraOpRecord dated 2/23/26 at 1453 hours, showed the transition of care/hand-off report was given to RN 3 (ICU RN) at 1935 hours. Review of the Order dated 2/23/26 at 1743 hours, showed to transfuse two units of PRBC. Review of the Blood Administration Record Unit 1 dated 2/23/26, showed the indication of the blood transfusion was active bleeding. The Record showed that RN 3 started the blood transfusion at 2048 hours and the transfusion ended at 2140 hours. Review of the Blood Administration Record Unit 2 dated 2/23/26, showed the blood transfusion started at 2205 hours and ended at 2315 hours. Review of the Plan of Care dated 2/23/26, showed that a plan of care addressing the blood transfusion for active bleeding was not initiated for Patient 3. During an interview and record review with the Director of DOU/Telemetry and ICU Manager on 2/24/26 at 1307 hours, the Director of DOU/Telemetry and ICU Manager verified the above findings.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure medical information was secured at all times for one of three sampled patients (Patient 2), creating the risk of violating the patient’s rights. Findings: Review of the hospital’s P&P titled Patient Rights, Responsibilities, and the Ethics dated 9/24, showed the confidential treatment of all communications and records pertaining to your care and stay in the hospital. On 2/24/26 at 1015 hours, the ED was toured with the Director of ED. RN 2 was observed administering medications to Patient 2. The WOW was observed facing the hallway and showing Patient 2’s medical information including name, DOB, and medication list. A phlebotomist was observed walking past the hallway during this time. On 2/24/26 at 1041 hours, the Director of ED verified the above findings.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the medication was administered as per the order for one of three sampled patients (Patient 3). This failure created the risk of medication errors and poor health outcomes to the patients. Findings: On 2/24/26, Patient 3’s medical record was reviewed and showed Patient 3 was admitted to the hospital on 2/11/26. Review of the Order dated 2/23/26 at 1743 hours, showed to transfuse two units of PRBC. Review of the Blood Administration Record Unit 1 dated 2/23/26, showed the indication of the blood transfusion was active bleeding. The record showed RN 3 started the blood transfusion at 2048 hours and the transfusion ended at 2140 hours. Review of the Blood Administration Record showed the following: * At 2025 hours, Patient 3’s temperature was 99.2 degrees Fahrenheit. * At 2100 hours, Patient 3’s temperature was 99.2 degrees Fahrenheit. * At 2110 hours, Patient 3’s temperature was 99.5 degrees Fahrenheit. * At 2140 hours, Patient 3’s temperature was 102.5 degrees Fahrenheit. * At 2200 hours, Patient 3’s temperature was 101.9 degrees Fahrenheit. Review of the Blood Transfusion Reaction Note dated 2/23/26 at 2140 hours, showed Patient 3 developed blood reaction symptoms including dyspnea, flushing of the skin, and fever. Review of the Order dated 2/16/26 at 1602 hours, showed to administer acetaminophen (a medicine to bring down an elevated temperature) 1000 mg IVPB every eight hours as needed for temperature over 101 degrees Fahrenheit. Review of the Order dated 2/11/26 at 1957 hours, showed to administer Benadryl (a medicine for allergy relief) 25 mg IV every six hours as needed for itching. Review of the MAR dated 2/23/26, showed Benadryl 25 mg IV was administered at 2145 hours, and acetaminophen 1,000 mg IVPB was administered at 2211 hours. During an interview and record review with the Director of DOU/Telemetry and the ICU Manager on 2/24/26 at 1307 hours, the Director of DOU/Telemetry and the ICU Manager verified Benadryl was not administered as ordered by the physician.”

“ACCEPTING VERBAL ORDERS FOR DRUGS CFR(s): 482.23(c)(3)(ii) When verbal orders are used, they must only be accepted by persons who are authorized to do so by hospital policy and procedures consistent with Federal and State law. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the physician’s verbal order for the emergent blood transfusion was entered correctly for one of three sampled patients (Patient 3). Instead, the nurse entered the order as routine for Patient 3, creating a risk of delayed care for the patient. Findings: Review of the hospital’s P&P titled Physician/Practitioners Orders dated 1/22, showed the verbal orders (VO) will only be accepted in emergent situations from lawfully authorized practitioners and Allied Health Staff by licensed personnel per policy. All phone orders and verbal orders must be entered through CPOE by the nurse or licensed person who took the emergent orders. Physicians will authenticate these orders through their action list. On 2/24/26, Patient 3’s medical record was reviewed and showed Patient 3 was admitted to the hospital on 2/11/26. Review of the Anesthesia Record dated 7/23/26, showed “E” was selected for patient status. Review of the Order Status History dated 2/23/26 at 1743 hours, showed RN 4 entered the verbal order of two units of PRBC as a routine order. On 2/24/26 at 1240 hours, the Anesthesiologist was interviewed with the Director of DOU/Telemetry and ICU Manager. The Anesthesiologist stated “E” meant Patient 3 needed emergent blood transfusion due to unexpected blood loss. The Anesthesiologist stated the verbal order for the emergent blood transfusion was made. Review of the Blood Administration Record Unit 1 dated 2/23/26, showed the blood transfusion started at 2048 hours and the transfusion ended at 2140 hours. Review of the Blood Administration Record Unit 2 dated 2/23/26, showed the blood transfusion started at 2205 hours and ended at 2315 hours. During an interview and record review with the Interim Director of Perioperative Services on 2/24/26 at 1323 hours, the Interim Director of Perioperative Services verified the verbal order for the blood transfusion should have been placed as STAT, not routine.”

“REPORTING ADVERSE REACTIONS AND ERRORS CFR(s): §482.23(c)(5) - There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the process for the blood transfusion reaction was followed for one of three sampled patients (Patient 3) as per the hospital’s P&P. This failure created the risk of putting the patient in unsafe care as the blood reaction was not managed immediately. Findings: Review of the hospital’s P&P titled Blood Administration and Transfusion Reactions dated 2/24, showed the following: 1. During the administration, assess for signs and symptoms of a possible blood transfusion reaction including, but not limited to: a. fever (rise in temperature from baseline equal or greater than 1C/2F and to equal or greater than 38 C/100.4F). c. respiratory distress, including wheezing, SOB, coughing, hypoxia, and dyspnea 2. If a transfusion reaction is suspected - IMMEDIATELY a. stop infusion c. notify attending/ordering physician/provider. 3. If a suspected transfusion reaction occurs: c. obtain first post-transfusion urine specimen and send it to the laboratory services for urinalysis. On 2/24/26, Patient 3’s medical record was reviewed and showed Patient 3 was admitted to the hospital on 2/11/26. Review of the Order dated 2/23/26 at 1743 hours, showed to transfuse two units of PRBC. Review of the Blood Administration Record Unit 1 dated 2/23/26, showed the indication of the blood transfusion was active bleeding. The Record further showed the blood transfusion was started at 2048 hours and the transfusion ended at 2140 hours. Review of the Blood Administration Record showed the following: * At 2025 hours, Patient 3’s temperature was 99.2 degrees Fahrenheit. * At 2100 hours, Patient 3’s temperature was 99.2 degrees Fahrenheit. * At 2110 hours, Patient 3’s temperature was 99.5 degrees Fahrenheit. * At 2140 hours, Patient 3’s temperature was 102.5 degrees Fahrenheit. * At 2200 hours, Patient 3’s temperature was 101.9 degrees Fahrenheit. Review of the MAR dated 2/23/26, showed Benadryl 25 mg IV was administered at 2145 hours, and acetaminophen 1,000 mg IVPB was administered at 2211 hours. Review of the Blood Administration Record Unit 2 dated 2/23/26, showed the blood transfusion was started at 2205 hours and the transfusion ended at 2315 hours. Review of the Blood Transfusion Reaction Note dated 2/23/26 at 2140 hours, showed Patient 3 developed blood reaction symptoms including dyspnea, flushing of the skin, and fever. The physician was notified on 2/24/26 at 0000 hours (two hours and 20 minutes later). During an interview and record review with the Director of DOU/Telemetry and the ICU Manager on 2/24/26 at 1307 hours, the Director of DOU/Telemetry and the ICU Manager stated that no urine collection was obtained following the transfusion. The Director of DOU/Telemetry and ICU Manager verified the above findings.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the Conditions of Service were completed for one of nine sampled patients (Patient 1). This failure increased the risk that Patient 1’s rights were not fully recognized. Findings: On 12/10/25, a review of Patient 1’s medical record was initiated. Patient 1’s medical record showed Patient 1 was admitted to the hospital on 8/29/25 and discharged on 8/30/25. Review of Patient 1’s Conditions of Service showed a family member signed the Conditions of Service on behalf of the patient. The document failed to show a reason the patient did not sign the consent. The section labeled “Patient unable to sign because:” was blank. On 12/11/25 at 1039 hours, an interview was conducted with Admitting Staff 1 and Patient Experience. Admitting Staff 1 stated the hospital staff typically requested the patient to sign the Conditions of Service first. Admitting Staff 1 further stated if the patient was unable to sign, staff were required to document the reason on the consent form. The above concern was shared and acknowledged by Admitting Staff 1 and Patient Experience.”

“PATIENT RIGHTS: REVIEW OF GRIEVANCES CFR(s): 482.13(a)(2) [The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.] The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure Patient 1’s grievance submission letter was entered into the grievance log for one of nine sampled patients (Patient 1) in accordance with the hospital’s P&P. As a result, the hospital failed to ensure compliance with its grievance process, which increased the risk for Patient 1 to not receive a timely investigation and written response to the grievance. Findings: Review of the hospital’s P&P titled Complaints/Grievances, Patient/Family dated 3/2022 showed the following steps to investigate and process a grievance within the determined timeframes: a. The grievance will be dated using the date of receipt. b. The grievance will be entered into the electronic incident/event reporting system (Quantros) if not entered already. c. The grievance will be placed on a Patient Grievance Tracking Log. d. The patient or their authorized representative will receive written communication from the Quality Department within seven (7) days of the receipt of the grievance. This written communication outlines the results of the investigation, actions taken, and resolution. e. When a grievance will not be resolved or the investigation will not be completed within the 7-day timeframe, the patient or patient’s representative will be informed within those 7 days that follow up will be provided in the form of a written response within thirty (30) days. 7. Collaboratively the Quality Department and department director/manager will investigate the grievance... On 12/11/25 at 0950 hours, an interview and concurrent review of Patient 1’s grievance documents was conducted with the CQO and Patient Experience. The Patient Experience stated Patient 1’s complaint was received and given to an employee who no longer worked for the hospital. Upon returning back to work after a brief time off, Patient Experience stated the grievance was not logged as to when it was received with any timelines to verify it was within the time frames required in the P&P. The CQO added the grievance was investigated and a letter was sent to Patient 1 on 10/27/25. The above concern was shared with the CQO and Patient Experience.”

“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 interview and record review, the hospital failed to ensure one of nine sampled patients (Patient 1)’s documented adhesive allergy was honored during the patient’s hospitalization. As a result, staff applied adhesive dressings to Patient 1, which placed the patient at risk for an allergic reaction. Findings: On 12/10/25, Patient 1’s medical record review was initiated. Patient 1’s medical record showed the patient was admitted on 8/29/25 and discharged on 8/30/25. Review of the ED Provider Aware Note dated 8/29/25 at 1926 hours, showed Patient 1 was allergic to “Other” for adhesives, which developed a minor rash on contact. Review of the Access Devices section dated 8/29/25 at 1924 hours, showed Patient 1 had a left median cubital IV secured with a transparent film dressing. On 8/30/25 at 0245 hours, the same documentation was shown. On 12/12/25 at 1147 hours, the above concern was shared with the Director of DOU/Telemetry.”

“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: 36703 Based on interview and record review, the hospital failed to maintain a steam pipe in the plants department, resulting in a potentially unsafe environment. Findings: Review of the hospital’s P&P titled Work Order Assignment, Priority and Completion dated 8/2023 showed urgent life safety concerns were addressed within three days of submission and completed within 30 days of the request. Assigned work is expected to be completed every shift unless circumstances prevent the completion. This will be communicated to the immediate supervisor and the department supervisor. An estimated time of completion will be communicated. On 12/10/25 at 1220 hours, an interview and concurrent review of facility documents was conducted with the Corporate Director of Facilities and the Lead Central Plant. Review of the vendor’s itemized quote to service the steam pipe was dated 9/19/25. Review of the Work Order dated 10/9/25 at 1323 hours, showed the main steam valve flange was leaking steam. Further review of the work order showed the issue was not completed and still open. The Corporate Director of Facilities stated the steam pipe located in the boiler plant was leaking steam for about a month and a half, but it was currently isolated and the other outlets were maintaining the domestic hot water in the hospital. The Corporate Director of Facilities stated the supplies needed to repair the leaking gasket on the valve were recently authorized by corporate to purchase and would be addressed urgently. On 12/12/25 at 1345 hours, the above concern was shared with the CNO and Patient Experience.”

“REGULAR FIRE AND SAFETY INSPECTIONS CFR(s): 482.41(b)(8) (6) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to provide documented evidence of regular inspection and approval by State or local fire control agencies. This failure posed the potential of unsafe environment. Finding: Review of the Medicare Condition of Participation 482.41(b)(6) for hospitals, under the Code of Federal Regulations (CFR) concerning the Physical Environment, mandates that hospitals must keep official records proving they’ve been regularly inspected and approved by state or local fire authorities to ensure patient safety and compliance with fire codes. Review of the Orange County Fire Authority (OCFA) Fire and Life Safety Inspection Notice dated 9/23/25, showed the Fire Life Safety Inspection notice indicated a reinspection of the hospital was conducted on 12/11/25. The document showed several violations of the California Fire Code were found. During an interview on 12/11/25 at 1400 hours, with the Corporate Director of Facilities, the Corporate Director of Facilities stated the hospital did not pass their most recent Fire and Life Safety Inspection on 12/11/25 and the hospital did not have current approval from the OCFA, and they were expecting a revisit in about two weeks. On 12/11/25 at 1400 hours, the Corporate Director of Facilities acknowledged the above findings.”

“SPRINKLER SYSTEM CFR(s): (8) When a sprinkler system is shut down for more than 10 hours, the hospital must: (i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or (ii) Establish a fire watch until the system is back in service. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to ensure a fire watch was implemented when the annual fire alarm performance test showed the system did not meet all applicable codes and standards. This failure put the patients, staff, and visitors at risk of injury or death in the event of a fire due to the fire alarm system not functioning properly. Findings: Review of the hospital’s P&P titled Fire Response Plan dated 8/2023, showed (the hospital) maintains fire safety equipment and fire safety building features to all associated Joint Commission and NFPA Standards. During a review of the hospital’s P&P titled Fire Watch dated 8/2023, the P&P showed under purpose, to provide a mechanism for monitoring a building or portions of a building for potential or actual fire and smoke conditions during fire protection system shutdown or operational failure. During a review of Pyro-Comm Systems, inc. Annual Fire Alarm Performance test completed on 8/21/25, the document showed testing of the hospital’s fire alarm system failed due to not meeting all applicable codes and standards on the date the initial test was performed. During an interview on 12/11/25 at 0905 hours, with the Corporate Director of Facilities, the Corporate Director of Facilities stated a fire watch should have been initiated in the areas affected by the failing Annual Fire Alarm Performance test on 8/21/25. During an interview on 12/11/25 at 1400 hours, with the Lead Central Plant, the Lead Central Plant acknowledged no fire watch was implemented in the areas affected by the failed Annual Fire Alarm Performance test on 8/21/25. On 12/11/25 at 1400 hours, the Corporate Director of Facilities was notified and acknowledged 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: 36703 Based on observation, interview, and record review, the hospital failed to maintain the hospital elevators and call lights in the ED, resulting in a potentially unsafe environment for the patients receiving services at the hospital. Findings: 1. On 12/10/25 at 0925 hours, a tour of the ED was conducted with the Director of Trauma Services and the Director of DOU/Telemetry. During observation, the nurse call light system in Bay A and Bay B in the ED was randomly selected and tested. In both bays, activation of the call light illuminated the indicator light at the entrance to each bay; however, the system failed to alert the nursing station that assistance was requested. 2. On 12/10/25 at 0950 hours, the patient and visitor elevators were inspected. Elevator A was not operational. Elevator B had scuffing and marked indentations at the entrance flooring that exposed the underlying sub-floor. Elevator C had a brown liquid-patterned stain on the ceiling. On 12/10/25 at 1020 hours, an interview was conducted with the Corporate Director of Facilities and the Lead Central Plant. The Corporate Director of Facilities stated the elevators required frequent servicing due to the overall age of the system. The elevators needed ongoing repairs despite the completion of annual preventative maintenance. On 12/12/25 at 1345 hours, the above concern was shared with the CNO and Patient Experience.”

“SURGICAL PRIVILEGES CFR(s): 482.51(a)(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to implement a consistent system-wide process to disable patient access and additionally failed to maintain effective fail-safe mechanisms to prevent non-credentialed and unprivileged practitioners from providing patient care. This failure resulted in an increased risk to patient safety and compromised the hospital’s ability to ensure that only properly credentialed and privileged practitioners provided care in accordance with hospital policy and regulatory requirements. Findings: Review of the Medical Staff Bylaws dated 11/22/21, Article 5.1 showed no person will exercise the clinical privileges in the hospital unless and until that person applies for and receives appointment to the medical staff or is granted privileges. 1. Review of the hospital’s P&P titled Scheduling Regulations dated 11/2024 showed the scheduling office will verify the MD’s privileges for the scheduled procedure. The suspension list will be reviewed. MDs on the active list will be required to complete medical records before scheduling elective procedures. Review of MD 1’s Appointment letter dated 1/24/23, showed MD 1 was granted provisional staff with clinical privileges as delineated in General Surgery. Further review of the document showed the appointment would expire on 12/31/24. Review of the Resignation letter dated 12/23/24, showed MD 1’s voluntary resignation was effective 12/24/24. a. Patient 2’s medical record review was initiated on 12/10/25 at 1441 hours. Patient 2 was admitted to the hospital on 9/19/25 and discharged on 9/24/25. Review of Patient 2’s Consult Note - General Surgery dated 9/23/25 at 0334 hours, showed MD 1 authored the document. MD 1 documented replacing a PEG tube which became dislodged. Review of the Patient 2’s Progress Note dated 9/23/25 at 1648 hours, showed MD 1 authored the document. The document showed the PEG tube was in the right position and might be used for tube feedings. On 12/10/25 at 1250 hours, an interview was conducted with the CQO and the Director of Medical Staff. The CQO stated when MD 1’s resignation was posted, IT was notified. But communication should have gone to IT, Medical Records, Human Resources, Security, Pharmacy, Dietary, and Administration. The CQO stated MD 1 came to Patient 2 with his own PEG supplies, which weren’t a part of the hospital’s regular stock inventory. The CQO stated MD 1 performed a PEG replacement on Patient 2 at the bedside without the help of any additional staff. Staff were not aware MD 1 entered the hospital at the time of the event. b. Review of the Surgery Schedule Scheduled Print from 12/24/24 through 9/25/25 showed MD 1 performed seven procedures in the OR. On 12/12/25 at 1230 hours, an interview was conducted with the OR Scheduler and the Administrative Director of Perioperative Services. The OR Scheduler stated when a surgeon wanted to schedule a procedure, a review of active privileges was checked to verify the surgeon was allowed to perform the procedure. The OR Scheduler stated the suspension list was also reviewed during the scheduling process. The Administrative Director of Perioperative Services and the OR Scheduler were informed MD 1 was scheduled and performed seven procedures in the OR despite not being credentialed. 2. Review of MD 2’s Appointment letter dated 10/23/23, showed MD 2 was granted as courtesy staff with specialty in Pediatrics. Further review of the document showed the reappointment would expire on 10/31/25. Review of the Resignation letter dated 10/27/25, showed MD 2’s voluntary resignation was effective 10/28/25. Review of the activity list dated 10/31/25 through 11/19/25 for MD 2, showed the practitioner’s name was used on 12 patients. a. Review of the hospital’s P&P titled Admission to Newborn Nursery dated 11/2024 showed RNs may perform standard routine orders for admission into the newborn nursery prior to obtaining a physician order. The RN will enter the Newborn Admission Orders in the EHR as the attending MD is notified of the admission. Review of Patient 9’s medical record was initiated on 12/12/25. Patient 9 was admitted on 11/7/25 and discharged on 11/10/25. A sample review of physician orders showed the following orders were entered by RN 6 using MD 2 as the ordering provider for Newborn General Admission dated 11/7/25 at 0100 hours, for “Blood Typing, Cord Blood”; and another physician’s order showed MD 2 requested the Glucose POCT to be started on 11/7/25 at 0020 hours. However, further review of the orders for MD 2 showed they were not authenticated by MD 2. On 12/10/25 at 1325 hours, an interview was conducted with the CQO regarding Patient 9. The CQO stated the communication for MD 2’s resignation was sent via email on 10/28/25, to all the departments for deactivation. However, the IT portion had many layers, and this event alerted the hospital to create a more hospital-site specific access for practitioners who worked among the other sister facilities. On 12/12/25 at 1137 hours, an interview was conducted with the Director of Perinatal Services. The Director of Perinatal Services confirmed the orders entered for MD 2, were not authenticated and was currently being addressed with MD 3. The Director of Perinatal Services stated MD 2 was a part of MD 3’s medical group which rounded on the patients. On 12/12/25, the CQO, Patient Experience, Director of Perinatal Services, and the Administrative Director of Perioperative Services were informed and acknowledged the above findings.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the GB effectively carried out the responsibilities for the conduct of the hospital as evidenced by: 1. The hospital’s GB failed to ensure the contracted dialysis services were performed in a safe manner. Cross reference to A0084. 2. The hospital’s GB failed to oversee the contracted dialysis service when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Provider B). Cross reference to A083. The cumulative effect of these systemic failures resulted in the Governing Body’s inability to ensure provision of quality healthcare in a safe environment.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the GB oversight of the contracted dialysis service when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Provider B). This failure creates the increased risk of poor healthcare outcomes for the patients undergoing HD treatment in the hospital. Findings: Review of the hospital’s memo dated 10/24/25, showed “This memo serves as an official notification regarding the transition of inpatient dialysis and outpatient” from Provider A to Provider B. The transition considers Center for Medicare & Medicaid Services (CMS) and California Department of Public Health (CDPH) requirements to ensure contracted providers are compliant with applicable standards. Effective 23:59 (11:59 PM) on Saturday, October 25, 2025, Provider A will conclude dialysis services across all facilities. Beginning 00:00 (12:00 AM) on Sunday, October 26, 2025, Provider B provides dialysis care. Review of the Dialysis Services Agreement showed this Dialysis Services Agreement effective as of 10/25/25, was entered into by and between the hospital and Provider B. The Dialysis Services Agreement was signed by Provider B’s CEO and the corporate CFO of the hospital. On 10/29/25 at 0905 hours, the CNO and Patient Experience Advocate were interviewed. The CNO stated there was no interruption of the hemodialysis treatment since Provider B’s contract was immediately effective after the contract termination with Provider A on 10/25/25 at 2359 hours. The CNO stated there was no hospital’s GB’s oversight. It was purely informing after the decision was made by the executive level. On 10/29/25 at 1231 hours, the CNO stated Provider B was not licensed by the State Department. On 10/31/25 at 0620 hours and 11/3/25 at 1115 hours via email correspondence, the hospital verified that the acute inpatient dialysis was referring to both emergent and maintenance dialysis for inpatient. The hospital was notified that the contracted dialysis vendor, Provider B was not licensed to provide dialysis services.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the contracted dialysis services were performed in a safe manner as evidenced by: 1. Failure to validate dialysis staff’s competency and HR profile prior to providing HD treatment to two of three sampled patients (Patients 1 and 2). 2. Failure to monitor and maintain the dialysis machine before and after the HD treatment as per the contracted dialysis vendor (Provider B)’s P&P. 3. Failure to develop a plan to evaluate a new contracted service’s performance prior to the annual evaluation. These failures create the increased risk of poor healthcare outcomes for the patients undergoing HD treatment in the hospital. Findings: 1. Starting on 10/29/25, medical records for Patients 1 and 2 were reviewed. a. Review of Patient 1’s open medical record showed Patient 1 was admitted to the hospital on 10/26/25. Review of the Order Requisition dated 10/27/25 at 0933 hours, showed to perform HD treatment. The Priority/Time section showed “Routine.” Review of the Hemodialysis Treatment Flowsheet dated 10/27/25, showed Patient 1 received HD treatment by RN 4, starting at 1645 hours. b. Review of Patient 2’s open medical record showed Patient 2 was admitted to the hospital on 10/25/25. * Review of the physician’s order dated 10/26/25 at 0829 hours, showed to perform HD treatment. Review of the Hemodialysis Treatment Flowsheet dated 10/26/25, showed Patient 2 received HD treatment by RN 5, starting at 1625 hours. * Review of the physician’s order dated 10/27/25 at 0859 hours, showed to perform HD treatment. Review of the Hemodialysis Treatment Flowsheet dated 10/27/25, showed Patient 2 received HD treatment by RN 4, starting at 1300 hours, On 10/29/25 at 1047 hours, RN 4 was interviewed. RN 4 stated he was an employee of Provider C. RN 4 stated he had no badge or access to the hospital. RN 4 stated he had to ask primary nurse to open the clean utility for supplies. On 10/29/25 at 1234 hours, the CFO of Provider B was interviewed. The CFO of Provider B stated he was the CEO of Provider C as well. The CFO of Provider B stated due to the urgency, RNs from Provider C were sent to the hospital prior to validation of staff’s HR profile and competency. The decision was discussed with the hospital’s cooperate level. On 10/29/25 at 1410 hours, the DON of Provider B was interviewed. The DON stated she was the DON of Provider B. When asked the relationship between Provider B and Provider C, the DON stated Provider B and Provider C were completely different entity. There were common owners between two Providers. The DON stated there was no contract between Providers B and C. The DON also stated the HR profile for RN 4 and RN 5 was still in the process. The DON stated RN 4 and RN 5 provided HD treatment before completing competency and HR profile due to time constraints. On 10/29/25 at 1450 hours, RNs 4 and 5’s personnel files were requested. On 10/30/25, RN 4’s personnel file was reviewed. Review of RN 4’s personnel file showed the following: * There was no job application or job offering letter for Provider B. * Color Blindness Test was completed for Provider C on 10/3/25. * Employee Physical Examination was completed for Provider C on 9/29/25. As of the exit on 11/4/25 at 0929 hours, RN 5’s personnel file was not provided. 2. Review of Provider B’s P&P titled Portable RO Disinfection dated January 2025 showed the portable RO will be disinfected weekly, when there is a repair performed on the system, during a prolonged down-time of greater than 48 hours or when culture or endotoxin levels exceeds the allowable AAMI limits. Review of Provider B’s P&P titled Water Cultures under Documentation (undated) showed the following: * Documentation of all routine maintenance, disinfection activities and study results will be kept in a log. * Log shall be maintained in a central location and results should be made available for seven years. On 10/29/25 at 1047 hours, RN 4 was interviewed. RN 4 stated he tested and documented the HD machine including total chlorine, pH, conductivity ready, conductivity, and rinse before and after HD treatment in water log for each machine. RN 4 stated he did not record in the log since there was no binder available. The hospital was new to Provider B and the binder was not ready to use. RN 4 stated he tested the HD machine for each patient and sent the test results to his supervisor via e-mail. The e-mail was requested. On 11/4/25, the hospital was not able to provide the e-mail that RN 4 mentioned. 3. On 10/30/25 at 0921 hours, the contracted services was reviewed with the CNO. The CNO showed the all the contracted services in shared drive. Each contracted services was assigned to a person who was in charge of completing evaluation annually. During an interview with the CNO, the CNO stated new contracted dialysis services (Provider B) would be evaluated annually. When asked if there was periodic evaluation prior to reaching one year evaluation to ensure new contracted services provided safe and quality care, the CNO stated no. During the exit conference on 11/4/25 at 0929 hours, the CNO and Chief Medical Advisor verified the above findings.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital’s GB failed to ensure the safe and effective operation of the hospital as evidenced by: 1. The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients. The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results. This situation represented an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions. An IJ was called on 10/10/25 at 1539 hours. The IJ was abated on 10/22/25 at 1107 hours. Cross reference to A582, example # 1 2. The GB failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576. 3. The GB failed to protect and promote the rights of the patients. Cross reference to A115. 5. The GB failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained. Cross reference to A263. On 10/20/25 at 1100 hours, the CNO provided the following information: - Governing Board meetings would be conducted monthly. - The CNO started employment in June 2025 and did not receive a formal “hand-off” from the previous CEO, whose position was currently vacant following their separation from the hospital. - The CNO was unaware that the vendor had placed a credit hold on the Troponin 1 Quality Control (QC) materials. As a result, expired Troponin QC was used by the laboratory starting in May 2025. - The CNO was also unaware of the POC or monitoring status related to deficiencies found during previous surveys. Review of the GB meeting minutes from February to September 2025 did not show evidence that the Board was informed of a credit hold on Troponin 1 Quality Control materials. As a result of this credit hold, the laboratory was using expired Troponin QC. The meeting minutes did not address the POC or monitoring status related to deficiencies identified in previous surveys dated 2/25/25 and 7/2/25. On 10/22/25 at 1435 hours, an interview with concurrent record review was conducted with the Governing Body or Physician 2. When asked, Physician 2 stated Physician 2 was aware of the “credit hold” related to the February Complaint Validation Survey and was not aware of the present situation. Physician 2 further stated Physician 2 was not aware of the ongoing “credit holds” until this IJ came out specific to the use of expired QC Troponin Level 1. When asked, Physician 2 stated Physician 2 was not aware of the STAT orders send-out to referral laboratory taking longer than the allotted time specified by the receiving laboratory. The cumulative effect of these practices prevented the Governing Board from effectively ensuring safe, high-quality healthcare delivery.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital failed to protect and promote the rights of the patients as evidenced by: 1. The hospital failed to ensure Patient 6 was provided with the notice of rights. Cross reference to A116. 2. The hospital failed to ensure the patients received care in a safe setting. Cross reference to A144. The cumulative effect of these deficient practices resulted in the hospital’s inability to protect patient rights and ensure a safe care environment.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained as evidenced by: The hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement related to the laboratory services. Cross reference to Q273. The cumulative effect of these failings meant the hospital did not implement and maintain a quality improvement program to ensure the safety and quality of the services provided.”

“LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This Condition is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet needs of its patients as evidenced by: 1. On 10/10/25 at 1539 hours, the survey team notified the hospital’s administrative staff including the CNO, ACNO, Chief of Staff, and Chief Medical Advisor of an Immediate Jeopardy (IJ) due to the following deficient practices related to the laboratory services: The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients. The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results. This situation represents an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions. On 10/16/25 at 1246 hours, the CNO provided the survey team with the finalized accepted plan of action which included a summarized corrective action to be completed by 10/17/25. On 10/22/25 at 1033 hours, the CQO provided the survey team with an updated and finalized accepted plan of action which included a summarized corrective action to be completed by 10/22/25. The IJ was abated on 10/22/25 at 1107 hours. Cross reference to A582, example # 1. 2. The hospital failed to ensure the availability and use of non-expired quality controls for hematology. Cross reference to A582, example # 2. 3. The hospital failed to ensure that the Plan of Correction (POC) from previous Complaint Validation Surveys related to laboratory services was fully and effectively implemented, resulting in a recurrence of previously identified deficiencies. Cross reference to A582, example # 3. 4. The hospital failed to ensure the TAT of the STAT lab results for the STAT Sent-out were implemented for four of seven sampled patients (Patients 1, 2, 3, and 5) as per the hospital’s P&Ps. Cross reference to A582, example # 4. 5. The hospital failed to implement its contingency plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services. Cross reference to A582, example # 5. 6. The hospital failed to ensure the laboratory’s pneumatic tubing system was in operational condition. Cross reference to A582, example # 6. The cumulative effect of these systemic problems resulted in the inability of the hospital to provide safe and effective laboratory services to the patients.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a) Patients’ Rights: Notice of Rights This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure that one of seven sampled patients (Patient 6) was informed of their rights upon admission as evidenced by the absence of a completed Condition of Services form in the patient’s medical record. This deficient practice placed the patient at risk of not being fully informed of their rights and potentially affecting their involvement in their own care. Findings: Review of the hospital’s P&P titled Consent Form Requirements dated July 2023 showed: “To ensure regulatory guidelines are followed, allow for patients to provide consent for treatment, and to ensure patients are informed of all conditions of admission and rights while they are receiving care within the hospital...It is the responsibility of Patient Access to complete the required consent forms with the patient, or the patient’s legal representative. Patient Access must explain each form in a capacity in which the patient understands. The patient must then sign and date the consent forms...Copies of all appropriate consent forms will be provided to the patient and/or representative...Patient Access will make a reasonable effort to contact a family member, legal guardian...in the even [sic] a patient lacks the capacity to make health care decisions, upon admission...Basic Consent Form Packet: These forms are provided to all patients...Condition of Services: (COS): Lists the terms and condition to being admitted to the hospital...Verbal Consent: If the patient is unable to physically sign the forms, if the legal representative is not available to sign, Patient Access may receive verbal consent. Verbal consent must be documented on the forms and the follow up process outlined below must be followed to try to obtain an actual signature at a later time...In the event the consent forms could not be signed at the time of the admission, Patient Access will properly document the reason on the COA [sic] in the provide [sic] space, make a note of in the registration system, and then follow up by reviewing the inpatient census. Over the following 24 hour period, (usually completed by the Patient Access morning staff), Patient Access will make an additional attempt to obtain signature form [sic] the patient or legal representative...” Review of Patient 6’s medical record conducted on 10/23/25, showed the patient was admitted to the hospital on 10/8/25, with diagnosis of GI bleed. Patient 6 was discharged on 10/12/25. During an interview and concurrent review of Patient 6’s medical record on 10/23/25 at 1300 hours, Director DOU/Tele stated the COS form was not found in the patient’s medical record. Director DOU/Tele stated there was documentation showing the patient was unable to sign initially. Director DOU/Tele confirmed Patient Access staff failed to perform the necessary follow-up to ensure the COS was completed as per the hospital’s P&P.”

“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: 37548 Based on observation, interview, record review, the hospital failed to ensure the patients received care in a safe environment as evidenced by: 1. The hospital failed to ensure the availability of laboratory services to meet needs of its patients. 2. The hospital failed to maintain a secure environment for medications, as evidenced by one unlocked crash cart containing a stocked medication tray found unsecured in the central supply department, an area accessible to unauthorized individuals. These failures created the risk of substandard health outcomes for the patients in the hospital. Findings: 1. During observation, interview, and record review from 10/7/25 to 10/23/25, the hospital failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576. 2. Review of the hospital’s P&P titled Crash Carts dated January 2024 showed, “Scope, licensed clinical staff...Purpose, Crash carts must be locked in a secure area or under constant observation, so that unauthorized individuals do not have access to them...Standard emergency medications (e.g., epinephrine and cardiopulmonary medications...Crash Cart Exchange Procedure...Provide Central Supply (CPD) with the patient’s medical record number...Call CDP to exchange crash cart...Remove medication tray for pharmacist to return to Pharmacy. If pharmacist is temporarily unavailable, place tray in medication room for prompt pickup by pharmacy staff...” A tour of the Central Supply Department was conducted on 10/13/25 at 1134 hours, with the Director of Central Supply Department. On 10/13/25 at 1155 hours, a crash cart was observed in the central supply department. The cart was unlocked and unsecured, and one stocked medication tray containing various medications was present inside. The Director of Central Supply Department confirmed the findings and stated they were not aware that the medication tray was still in the crash cart. The Director of Central Supply Department was asked to provide specific details including the patient’s information, the time the code occurred, and when the cart arrived in central supply. The requested documentation was not provided before the exit date of the survey.”

“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: 29798 Based on observation, interview, and record review, the hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement related to the laboratory services. This failure of the QAPI program to monitor the effectiveness and safety of services and quality of care in the hospital had the potential for an unsafe patient care environment, and potential serious harm to patients. Findings: Review of the hospital’s titled Organization-Wide Quality Assessment and Performance Improvement Program dated March 2024 showed the following: * Mission,Vision,Values: - The hospital system is committed to providing the very best quality healthcare to our current and future patients through a broad range of specialty care services and resources. - We aspire to earn a reputation among patients as offering high quality, technologically advanced and compassionate medical care in a SAFE and clean environment. * Introduction: - The hospital is dedicated to meeting the needs of our patients in a manner which is consistent with our mission, vision, and belief statements. The Organization Quality Assessment and Performance Improvement Plan is designed to provide a systemic and organized program for the promotion of safe, quality patient care and services. - Through an interdisciplinary and integrated process, patient care and processes that effect patient care outcomes shall be continuously monitored and evaluated to promote optimal achievement, with appropriate accountability assumed by the Governing Board, Medical Staff, Administration, and support personnel. - The organization wide QAPI Plan encompasses major important aspects of care provided by the hospital and Medical Staff in support of the achievement of the hospital’s mission and strategic goals. - QAPI activities will be integrated across all the care and service areas of our organization. Each area should have a representative on the committee. Our QAPI activities will cross service areas and departments, and we will work together to ensure we address all concerns and strive to continuously improve the services provided. On an annual basis, and as needed, a Facility Assessment will be conducted to include an overview of the services and care areas that are provided. - Patient Safety and Quality: Improving patient safety by proactively identifying and improving systems causes of medical errors. We will promote a fair culture of identification of risks to patient safety. - Data-Driven Leadership: Rather than guess, we will measure our performance and progress, discovering where we are, deciding where we could be, and determining how to get there. - Goals of the Quality Improvement Program are as follows: to improve the quality, safety and reliability of patient care processes and outcomes; to promote patient safety by prevention and reduction of medical errors; to integrate the principles of high reliability into our quality structure and culture. - Scope of Activities: The scope of the Organizational Quality Assessment and Performance Improvement Program encompasses measurement and activities of the Medical Staff, Nursing and Ancillary or support services that includes every department and service of the hospital. Processes and outcomes of care are designed, measured, and analyzed. Quality Improvement activities will address both clinical and organizational functions. These activities are designed to address key functions of patient care and to identify, study, and correct problems, and improvement opportunities found in the process of care delivery. The Governing Board, Administration, Department Leaders and leaders of organized Medical Staff regularly communicate with each other on issues of safety and quality. * Program Organization and Responsibility of Leaders: Responsibility of Leaders - Participation in Quality Improvement activities are the responsibility of everyone employed by, on the medical staff of, or contracted with the organization. The organizational Plan for Quality is reviewed and approved annually by the Quality/Patient Safety Committee, MEC, and Governing Board. - The Governing Board shall be responsible to ensure the provision of optimal quality care, safety, and organization-wide performance. The Board is ultimately accountable for the safety and quality of patient care provided in every department and service of the hospital and has legal responsibility and operational authority for hospital performance. The Board delegates operational responsibility to the Medical Staff and administration. - The Board shall facilitate Quality Improvement by: The Governing Board authorizes the establishment of a committee structure to implement the QAPI Program; ensuring the quality program reflects the complexity of the hospital’s organization and services; providing adequate resources, both material and manpower, to accomplish the QAPI function; assuring clear expectations for safety are established. - Senior leadership supports the maintenance of the QAPI process through allocation of staff and resources necessary to fulfill the requirements of the program. Leaders also analyze data and information in decision making that supports the safety and quality of care; perform evaluation of clinically contracted service in collaboration with respective department directors and reporting the results of the evaluation through the Quality/Patient Safety Committee structure to the Medical Staff Committee and the Board; and regularly evaluate the culture of safety and quality using valid and reliable tools. - The Department Directors and Managers are responsible for systemic monitoring and analysis of the quality and safety of care provided in their departments. Directors will monitor, analyze, and report the processes in their areas that effect patient care, safety, outcomes and satisfaction; report QAPI data and actions as appropriate; and communicate the status of departmental quality, patient safety, and survey readiness initiatives regularly to departmental staff members. - The Quality/Patient Safety Committee is the hospital - based multidisciplinary body that serves to coordinate organizational quality improvement activities. Activities include but are not limited to receive and review reports regarding the effectiveness of organization-wide QAPI activities; to analyze and identify trends or patterns that might suggest an improvement opportunity. - It is essential the patient Safety Program and Quality Assessment and Performance Improvement Program are integrated to assure the flow of information to the appropriate areas for review, action, and/or follow-up. * Design - Quality Approach and Framework: - Data Collection: The staff collects, analyzes data necessary to determine root causes, track performance, benchmarking, etc. Data is organized in such a manner as to facilitate comparison and trends. The data collection is conducted in a timely and efficient manner. - Compilation of Data: Data shall be compiled in a manner that is usable to those individuals and entities charge both with analyzing the data and taking action on the information derived from data analysis. - Analysis of Data: Data on performance measures will be analyzed to monitor the effectiveness and safety of services and quality of care and to identify opportunities for improvement and changes that will lead to improvement. During the Complaint Validation Survey conducted from 10/7/25 to 10/23/25, the deficient practice was identified as follows: * The hospital failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576. On 10/22/25 at 1300 hours, an interview with concurrent record review was conducted with the CNO. When asked, the CNO stated the CNO attended the QAPI monthly meetings. The CNO further stated the meeting chairperson was Physician 1. Review of the documents provided titled Quality/Patient Safety Council showed the following: * No documented evidence to show the QAPI meeting was held in January 2025. * The QAPI meeting was held on 2/25/25. The meeting minutes of Performance Improvement Dashboard failed to show ongoing concerns with the laboratory services in regard to shortage of supplies due to credit hold. * The QAPI meeting was held on 3/25/25. Review of the Laboratory Topic of the QAPI meeting minutes showed the following: - The section of “Problems Identified/Opportunities to Improve” showed staffing shortage for TAT and laboratory created and implemented a new send-out process which delay TAT. - The section of “Focus Studies/Activities” showed laboratory manager and QA coordinator will monitor real time the specimen collection/received screen in Alab to remind staff if any test approaches the required TAT. The March meeting minutes failed to address the ongoing shortage of supplies in the laboratory due to account blocked. * The QAPI June meeting was held on 6/5/25, the meeting minutes showed the following meetings were canceled and reason for cancellation: - January 28,2025 meeting was canceled due to Joint Commission Revalidation Visit. - April 22,2025 meeting was canceled due to staffing challenges in quality. - May 21,2025 meeting was canceled due to OCEMS visit. However, the QAPI June meeting failed to mention the ongoing laboratory’s shortage of supplies and the vendors refusal to process the orders due to nonpayment. - The July QAPI meeting was held on 7/22/25, review of the July meeting minutes failed to show the ongoing issues with the laboratory’s shortage of supplies due to “nonpayment,” and refusal of the vendors to process the orders. - The August QAPI meeting was held on 8/26/25, the August QAPI minutes showed “Laboratory - CDPH POC Monitoring - July 2025. Met goal for all indicators. Continue with plan.” Per the CNO, the September QAPI meeting minutes was not available. On 10/22/25 at 1350 hours, an interview and concurrent record review was conducted with the QAPI Chair or Physician 1. When asked the QAPI Chair stated the QAPI Chair was not aware of lack of supplies in the laboratory, became aware about two weeks ago by the laboratory manager, also became aware of the laboratory staff using the expired QC in the last month or so. The QAPI Chair, further stated the data was collected by the QAPI personnel, sent to MEC, and forwarded to the Governing Board. When asked, the QAPI Chair stated they did not recall any discussion in the QAPI meetings related to the laboratory’s shortage of supplies addressed in the February Complaint Validation Survey POC. On 10/22/25 at 1435 hours, an interview with concurrent record review was conducted with the Governing Body or Physician 2. When asked, Physician 2 stated Physician 2 was aware of the “credit hold” related to the February Complaint Validation Survey and was not aware of the present situation. Physician 2 further stated Physician 2 was not aware of the ongoing “credit holds” until this IJ came out specific to the use of expired QC Troponin Level 1. When asked, Physician 2 stated Physician 2 was not aware of the STAT orders send-out to referral laboratory taking longer than the allotted time specified by the receiving laboratory. On 10/22/25, the above findings were verified by the CNO.”

“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: 37548 Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet the patient’s care needs as evidenced by: 1. The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients. The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. 2. The hospital failed to ensure the availability and use of non-expired quality controls for hematology. 3. The hospital failed to ensure that the Plan of Correction (POC) from previous Complaint Validation Surveys related to laboratory services was fully and effectively implemented, resulting in a recurrence of previously identified deficiencies. 4. The hospital failed to ensure the TAT of the STAT lab results for the STAT Sent-out were implemented for four of seven sampled patients (Patients 1, 2, 3, and 5) as per the hospital’s P&Ps. 5. The hospital failed to implement its contingency plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services. 6. The hospital failed to ensure the laboratory’s pneumatic tubing system was in operational condition. These failures had the potential to result in missed or incorrect diagnosis, delay in treatment, and longer hospital stay for the patients. Findings: 1. Review of the manufacturer package insert for Multichem hsTN undated showed “...Do not use the product past the expiration date...” Review of the hospital’s P&P titled Reagent Extension Procedures dated 3/28/24, showed, “Laboratories may use expired supplies until unexpired supplies become available...’Reagent Extension’ may ONLY be allowed under extreme circumstances in which the inability to perform critical testing would cause serious patient harm or delays in critical treatment or surgery under the direction and discretion of the Laboratory Medical Director...Laboratories are sometimes faced with limited reagent, kit and material inventories, with some reagents approaching or passing expiration dates. Critical supply shortages may necessitate the use of expired reagents to maintain testing...Procedures...Attempt to borrow from local medical centers...If all efforts to secure the necessary reagent/materials are unsuccessful, notify the Medical Director, the Regional Director, and Manager/Supervisor of the need to extend a reagent/material ... Consult the reagent’s manufacture to check whether expiration dates have been extended for specific lots. Also, notify manufacture when testing has been interrupted because of expired test kits and supply shortages. When possible, request that the manufacture provide a letter of expiration extension for the reagent or test kit, or if applicable, document in writing that the manufacture would vouch for the accuracy and reliability of the reagents while in use past the expiration date. Place these letters in the laboratory’s binder of QVRs...If possible, consult with the medical center’s regulatory agency such as CAP, the AABB, TJC, or the California Department of Public Health (CDPH) for guidance and advice as to how to handle a need for reagent extension...Additionally, when using outdated QC material, it is also required that patient samples be re-examined to assess previous results as an added measure of acceptability...” Review of the hospital’s P&P titled Quality Variance Patient Safety Report (QVR) Submission, Tracking dated 4/3/24, showed, “This Standard Operating Procedure (SOP) outlines the process for recording and submission of all events/“variances”...that range from minor events to reports requiring notification of agencies outside our facility...such as the state of California Department of Public Health (CDPH). Additionally, the QVR will allow tracking and trending of “variances” (errors, accidents, omissions etc.) for quality assurance (QA) and allow for careful examination for focused performance improvement (IP)...This can also assist in identifying opportunities to develop and implement new SOPs, which may not be in place to assist in reducing errors, omissions, etc. and improved outcomes and enhance patient safety...”. Any potential sentinel event [see reference (a)] to be recorded immediately to the Laboratory Services Manager, the Regional Director ... Laboratories, the Quality Assurance/Performance Improvement (QAPI) Department and the Medical Director, Laboratory Services. Staff will utilize LS Form 019 (Enclosure 1), Quality Variance/Patient Safety Report (QVR) to record/complete the QVR and submit the “Type of Variance”, the “Description of Variance” and whether an SOP exists or not, to his/her direct report “Supervisor” or his/her “Coordinator.” The respective lead may assist in the completion of the QVR by selecting the “Contributing Factors” and the “Immediate Corrective Action.” Submitting staff will note in the description of the variance if an RLDatix report has been submitted. The Manager, Laboratory will determine whether to forward the QVR to the Quality or Compliance Department and/or the Medical Director. During a tour of the Laboratory on 10/9/25 at 1421 hours, CLS 5 was interviewed and stated the laboratory had been using expired Troponin QC for testing. CLS 5 stated the Laboratory Director had approved the use of the expired QC and had signed the “QVR.” On 10/9/25 at 1503 hours, an observation and concurrent interview was conducted with Med LabTech 1. Medical Lab Tech 1 confirmed the laboratory had been using expired Troponin QC for testing. The vial of QC provided by Med Lab Tech 1 showed the expired date of 3/22/25. Med Lab Tech 1 stated having to utilize the expired Troponin QC due to a vendor credit issue. Med LabTech 1 stated the Laboratory Manager/Director had instructed the staff to utilize the expired Troponin QC. On 10/10/25 at 1332 hours, CLS 4 was interviewed and stated the laboratory had not received in-date supply of Troponin QC due to an internal “credit hold.” CLS 4 stated the laboratory had been using expired Troponin QC for testing. On 10/10/25 at 1336 hours, Med Lab Tech 2 was interviewed about the expired QC for troponin and stated a QVR existed and permitted the use of expired Troponin QC. Med Lab Tech 2 confirmed that the Troponin QC currently in use had a manufacturer-assigned expiration date of March 31, 2025. Review of the Quality Variance/Patient Safety Report (QVR) showed the following: “Date Initiated 3/31/25 ...Date of Variance/Event 3/31/25, Variance Initiated by [Name of Laboratory Manager/Director] ...Description of Variance ...QC for HsTrop expired on 3/31/25 - will be using QC past expiration date due to order not being released from [name of vendor] Not -paid ...Ok to use per [Name of Laboratory Manager/Director] ...” The QVR form was signed by the Laboratory Manager/Director and by the Medical Director. On 10/9/25 at 1519 hours, the Laboratory Manager/Director stated being notified on 3/31/25 that the Troponin QC had expired on 3/31/25 and authorizing the staff to utilize the expired Troponin QC. The Laboratory Manager/Director confirmed that the laboratory had not received its new supply of Troponin QC materials due to a “credit hold” with the vendor. The Director stated that this issue was escalated internally, and the CNO was notified of the supply disruption. On 10/10/25 at 1135 hours, the Laboratory Manager/Director was interviewed and stated the laboratory’s internal P&P permitted the use of QC materials past their manufacturer-assigned expiration dates. The Laboratory Manager/Director stated that there were no manufacturer guidelines or documented approvals from the manufacturer that approved the use of expired QC materials. The Laboratory Manager/Director acknowledged that there was no documented evidence or literature from accredited sources that supported or validated this practice. The Laboratory Manager/Director confirmed regulatory agencies had not been contacted for guidance for Troponin QC extensions. On 10/10/25 at 1539 hours, the survey team notified the hospital’s administrative staff including the CNO, ACNO, Chief of Staff, and Chief Medical Advisor of an Immediate Jeopardy (IJ) due to the following deficient practices related to the laboratory services: The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients. The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results. This situation represented an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions. On 10/13/25 at 1431 hours, the CNO was interviewed and stated they were unaware that the laboratory was actively using expired Troponin QC materials. The CNO stated they were unaware of a “credit hold” issue with the vendor until after the Immediate Jeopardy (IJ) situation was declared on October 10, 2025. The CNO provided email correspondence with the Accounts Payable (AP) Supervisor, which was reviewed and showed: - CNO Email dated 10/13/25 at 1110 hours: The CNO requested validation of an “aging AP” report, noting the hospital appeared to owe the vendor $16,256. - AP Supervisor Email dated 10/13/25 at 1113 hours: The AP Supervisor responded that the cited amount was not owed by this hospital. The supervisor clarified that the outstanding balance was actually for two sister hospitals. The CNO confirmed that the vendor had placed a credit hold impacting all connected hospitals, and this action prevented the hospital from receiving its new supply of necessary Troponin QC materials. 2. Review of the hospital’s P&P titled Hematology Quality Control Policy dated May 2022 showed the following: * Appropriate commercially prepared control materials will be used whenever possible for all assays and procedures. * All control material will be prepared according to the manufacturer’s recommendations. * All materials are to be labeled with the prepared date (or the date they were put into use) and the expiration date, if applicable. All expired reagents are to be discarded. * Controls will be run according to the specific policy for each assay. * Expected results for each control will be defined by the manufacturer for each assay. Review of the manufacture’s instruction for use titled Coulter 6C Cell Control/QC revision history June 2025 showed 6C Cell Control is a hematology control material used to monitor the performance of UniCel DxH Coulter Cellular Analysis Systems listed in the table of expected results, in conjunction with specific Coulter reagent. It is not recommended to use the reagent after shelf-life expiration indicated on the label. Review of the Quality Variance/Patient Safety Report (QVR) dated 9/20/25, showed the following: - Description of Variance: 6 c QC, expires on 9/19/25 - SOP Title: Reagent Extension Procedure KPC-Gen-003 - Contributing Factors/Causes: “Credit Hold” - Immediate corrective action taken: QC 6C has been ordered, awaiting payment for Vendor 2. - Unit/Clinic/ED notified: No - The Director of Laboratory Services and the Medical Director notified: Yes - The section of “Pending Corrective Action” was left blank. The acknowledgement signature of the Laboratory Director was dated 9/22/25. The Medical Director section showed the physician signed and dated the form on 9/29/25. Review of the report provided of the number of CBC /Differential testing dated 9/19 to 10/10/25 when the expired QC was used showed the following: * Total tests: 1,325 * Total patients: 188 On 10/8/25 at 1005 hours, an interview with concurrent record review was conducted with CLS 2. When asked, CLS 2 state CLS 2 was responsible for the hematology in the core laboratory. CLS 2 further stated about a year or two, supplies had been taken a long time to deliver and had been running out of supplies for the last 12 months; the last six months had been worse. CLS 2 had been informed by the Laboratory Director that the shortage of laboratory supplies was related to non-payment. The hospital’s laboratory had short of QC supply for CBC and differential. The QC testing was done 3 x/day, and the QC bottle expired in 16 days when opened. For the last two to four weeks, the laboratory staff had been using expired QC. This had been reported to the management. When asked, CLS 2 stated CLS 2 was not sure of the CBC/Differential accuracy of the results using the expired QC. On 10/14/25 at 1010 hours, an interview and concurrent document review was conducted with the CNO. The CNO was asked about the P&P related to the use of expired supplies in the laboratory. The CNO stated the CNO was not aware and would look into correcting the P&P. The CNO was also informed about the manufacturer ’ s instruction for use, related to the use of expired QC for CBC testing from 9/19 to 10/10/25. On 10/23/25 at 1635 hours, an interview and review of the documents was conducted with the Chief Quality Officer. The document showed the CBC validation started on 10/10/25 at 1144 hours and completed on 10/17/25 at 1505 hours. Per the manufacturer’s instructions, the results should be compared to a non-expired QC which was not available at the time of testing. Per the Chief Quality Officer, the available three QC boxes expired on 9/19/25, the machine showed it was passed, but unable to verify the accuracy of the test results. 3. Review of the POC accepted on 4/8/25, for the Complaint Validation Surveys completed on 2/25/25, showed the following: Compliance and Monitoring: - Once a week, the Director of the Lab/designee will update the CEO (via email or in person) on any issues related to the usage of [name of reference laboratory] services and any delays in send out labs. Any issues reported will be addressed immediately for resolution. - Once a week, the Director of the Lab/designee will update the CEO (via email or in person) on any issues related to supplies, reagents, broken equipment, or credit holds. Any issues reported will be addressed immediately for resolution including escalation to the CFO, CMO, and the Governing Body. - Data will be collected until 90% compliance is achieved for three consecutive months. - Data collected from the above-listed audits will be added to the hospital-wide QAPI and presented quarterly to the Medical Executive Committee and the Governing Body. Responsible Person: - CEO and Director of Laboratory Compliance and Monitoring: - Once a week the CEO/Director of the Laboratory will round in the lab to ensure reagents and supplies are available, the equipment is functional and there are no reported issues impacting the adequacy of laboratory services. Any reported issues will be corrected and escalated through the appropriate Chain of Command. Records of rounding and findings/corrective actions will be kept. - Once a month the Director of the Laboratory will audit 30 STAT orders to ensure the results are available timely as per hospital policies. Any issues identified will be corrected and the staff will be educated. Records of the audits and any corrective actions will be kept. - Data will be collected until 90% compliance is achieved for three consecutive months. - Data collected from the above listed audits will be added to the hospital wide QAPI and presented quarterly to the MEC and the GB. Responsible Person: CEO and Director of Laboratory Corporate CFO Compliance and Monitoring: - Once every 2 weeks, the CEO will meet with the Director of the Laboratory to ensure all services are available in- house or via contracted services, equipment is functional, turnaround times are acceptable and within hospital policy, and reagents and supplies are available. Any issues identified will be corrected. Unresolved issues will be escalated to corporate leadership and the GB. - Data will be collected until 90% compliance is achieved for three consecutive months. - Data collected from the above listed audits will be added to the hospital wide QAPI and presented quarterly to the MEC and the GB. Responsible Person: CEO and Director of Laboratory Review of the POC with a date of completion of 8/16/25, for the Complaint Validation Surveys completed on 7/2/25, showed: MONITORING: - Once a month, The Laboratory Manager or designee will audit 20 STAT send out tests to ensure they were processed timely as per the vendor listed/promised times. Any issues identified will be corrected and the staff will be reeducated. - Once a month the Laboratory Manager/designee will audit 30 send out test and the report provided by the vendor on processing times to ensure tests are process I accordance with agreed upon/promised/listed times. And delays noted will be addressed with the vendor immediately - Daily, The Laboratory Manager or designee will monitor any laboratory services disruptions and ensure that appropriate staff, patients and physicians are aware. Any disruptions will be reported to the CNO and all other impacted parties as per the contingency plan. - Once a week, the Laboratory Manager or designee will audit quality control for hematology to ensure that staff followed P&P on the use of expired reagents/quality control (if applicable). Any issues identified will be corrected and the staff will be reeducated. - Data will be collected until 90% compliance is achieved for three consecutive months. - The data collected from these audits will be added to the hospital wide QAPI and presented quarterly at Quality Council Meetings, the Medical Executive Committee and the Governing Board. RESPONSIBLE PERSON: Laboratory Manager/Director/Designee During an interview on 10/20/25 at 1100 hours, the CNO stated they began employment in June 2025 and did not receive formal “hand-off” from the former CEO whose position was currently vacant following their separation from the hospital. The CNO was unaware of the POC or monitoring status related to deficiencies found during previous surveys. On 10/22/25 immediately following the QAPI meeting, at approximately 1400 hours, the survey team requested this missing POC data from the CNO, CQO, Patient Experience, Trauma Program Director, and ACNO. This requested information was never provided to the survey team before the survey exit conference. 29798 4. On 10/7/25 at 1650 hours, during an interview with the Laboratory Quality Coordinator regarding the hospital’s P&P for TAT for STAT orders send-out to referral laboratory, the Laboratory Quality Coordinator stated the hospital did not have a P&P for STAT TAT send out tests. Review of the hospital’s P&P titled STAT Specimen Handling, Testing and Reporting showed the P&P was revised/reviewed on 10/20/25, for “Addition of #7 to procedure part III.A” and on 10/21/25, for “Addition of STAT Referral Testing TAT to .... (number 8 to part A).” Further review of the P&P titled STAT Specimen Handling, Testing and Reporting showed in part: * Scope: All Laboratory Staff * Procedure for Specimen Handling: - All specimens requested STAT will be brought or tubed to Triage within 15 minutes of collection. - For send out testing, the facility will attempt to deliver the specimen to the outside laboratory as quickly as possible depending on the courier availability. TAT for send out tests depend on the receiving laboratory policies. - All referral testing ordered as STAT will be called and documented in the “LS FORM 134 - STAT Referral Test Tracking Log.” CPTs are responsible for keeping track of the time called Courier and pick up time. CLS are responsible for keeping track of the date/time result is finalized. The Courier will try to come to pick up within the hour called and deliver to the receiving lab as soon as possible. Actual TAT will depend upon transport time and destination, as well as the Reference Laboratory’s Policy and Procedures. - LS FORM 134 will be reviewed DAILY by the Chemistry Clinical Lab Scientist to ensure all STAT Send-outs are finalized in the LIS system in a timely manner once results are faxed to the Mail Lab printer. If results are not faxed within the appropriate TAT, the LAB will follow up to obtain status update from the STAT Referral Lab. - Per [name of outside laboratory]’s Laboratory Outreach and Client Services Supervisor, providing a specific TAT from call for courier service to final report in-hand is test dependent. Published TATs are available in the [name of outside laboratory] Lab Test Directory. The two tables below would be considered a minimum/maximum for tests that are offered STAT. Reports are auto-faxed and available in LifePoint immediately upon completion. Courier TAT also varies based on our vendor’s resources at time of call, but 2 hours is the outside limit of acceptability in Central Orange County. - For basic chemistry/hematology tests with analytical time of one hour: STAT Courier (from client call to delivery at [name of the outside laboratory]): 2 hours Processing Time: 0.5 hours Analytical time: 1.0 hours Total: 3.5 hours. - For specialty tests offered STAT such as pentobarbital with analytical time of eight hours: STAT courier (from client call to delivery at [name of the outside laboratory]): 2 hours Processing time: 0.5 hours Analytical Time: 8 hours Total: 10.5 hours * Responsibilities: - Phlebotomy and Triage staff is responsible for the timely collection of all STAT laboratory tests. Significant problems/delays should be documented using the Lab QI form. - Lab Management will be responsible for monitoring TAT on at least a monthly basis or more frequently as required. * If a delay of greater than 30 minutes beyond the expected TAT, the CLS should notify the affected floor of the expected time until completion or if the delay will be considerable, to offer testing at alternative sites. Review of the random STAT send-out orders audit from 9/8/25 to 9/30/25, showed the following: * For Patient 1, the urine urea test was picked up on 9/8/25 at 0824 hours. The urine urea test result was available on 9/11/25 at 2245 hours, which was approximately 86 hours later. * For Patient 2, the fentanyl (an opioid) test was picked up on 9/14/25 at 1702 hours. The fentanyl test result was available on 9/16/25 at 1300 hours, which was approximately 43 hours later. * For Patient 3, the acetaminophen (a pain medication) and salicylate (chemical used in products like aspirin [a pain medication]) tests were picked up on 9/23/25 at 1545 hours. The acetaminophen test result was available on 9/25/25 at 1700 hours and salicylate test results were available on 9/25/25 at 1703 hours, which was approximately 49 hours later. * For Patient 5, the ETOH (ethanol, a type of alcohol) test was picked up on 9/28/25 at 2153 hours. The ETOH test result was available on 9/29/25 at 1927 hours, which was approximately 22 hours later. On 10/23/25 at 1420 hours, the findings were verified by the CNO and Trauma Program Director. 5. Review of the hospital’s Continuity of Operations Plan (undated) showed in part, “Laboratory Continuity of Operations Procedures...Notify physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services...” On 10/8/25 at 0905 hours, the Director of Laboratory Services stated some of the reagents to perform the laboratory testing were not available. The Director of Laboratory Services communicated the issue to the administration team via email. Upon request for evidence of reporting, the Director of Laboratory Services provided the email correspondence. Review of the codependence between the laboratory staff, Laboratory Director, and the hospital’s administration, showed the following: * On 6/23/25 at 0946 hours, the Laboratory Director emailed that chemistry testing disruptions had occurred and would occur at multiple OC sites. The recipients included the CNO and the corporate CFO. * On 7/8/25 at 1515 hours, an email from CLS 3 showed CLS 3 had just been notified by Vendor 1 that no reagents will be shipped due to a credit account blockage. On 7/21 at 1316 hours, and 8/4/25 at 0730 hours, the email showed the account was still blocked. * A letter dated 7/29/25, showed the Laboratory Medical Director sent the hospital’s CNO about the shortage of Blood Bank Reagents in the laboratory. Further review of the letter showed this served as official notification from the Laboratory Department of [Hospital B]. There would be testing disruption in the Blood Bank unless reagents are received by next week. * On 7/29/25 at 1137 hours, an email from the Laboratory Director showed the reagents from Vendor 1 had not shipped and testing interruption was imminent due to a credit hold on the account. The email was addressed to the CNO and the corporate CFO. * On 7/31/25 at 1040 hours, an email from the Laboratory Quality Coordinator showed Vendor 1 would not ship-out any products unless full payment is received. The recipients included the Laboratory Director, the CNO, the Laboratory Medical Director, and the Accounts Payable. * On 7/31/25 at 1116 hours, an email from the Laboratory Medical Director to the Laboratory Director, the CNO, the Laboratory Quality Coordinator, and the Accounts Payable showed “please be advised that if we run out of requested reagents, there is no choice but to close the [Hospital B]’s blood bank down.” * On 8/4/25 at 1149 hours, an email from CLS 3 showed “Kindly process this order STAT ... This is a new order as replacement to the one created on 7/21/25.” Per Vendor 1, no pending orders to process due to the credit backlog. * On 9/9/25 at 1320 hours, CLS 3 sent an email with the subject line as “URGENT: Credit Hold and Critical Shortage” of Vendor 1 Red Cell Reagents. The recipients included the Laboratory Director, the CNO, and the Laboratory Quality Coordinator. * On 10/15/25 at 1534 hours, an email from the Laboratory Quality Coordinator to the Laboratory Director, the CNO, and the Purchasing Department showed “Can we please get our hold clear from Med Water System? We are unable to borrow from other sites. The quality of our DI water used for testing will be below recommended level if this is unresolved.” Review of the Requisition dated 9/23/25, showed the requestor who was CLS 3. The handwritten note on this form showed on 10/16/25 at 1200 hours, it was still on credit hold. On 10/16/25 at 1405 hours, an interview was conducted with CLS 1. CLS 1 stated orders dated 7/24, 9/3, and 9/19/25, for hematology reagents have not been received as of today or 10/16/25. CLS 1 further stated an email dated 10/12/25 at 1743 hours, was sent to the Laboratory Director, the CNO, and the Laboratory Quality Coordinator regarding these orders. On 10/16/25 at 1635 hours, an interview was conducted with the Laboratory Director. The Laboratory Director stated there was no notification to the physicians (explore alternative comparative testing), CDPH, and patients of the disruption in services. 6. On 10/16/25 at 1505 hours, an interview was conducted with CLS 1. CLS 1 stated the laboratory’s pneumatic tubing system had not been working for three to fourth months. The triage CLS had to go to each unit to collect the specimens for processing which contributed to the delay in results for in-house and send-out to the referral laboratory. Therefore, the results were not obtained within the allotted time of four to six hours. When asked, CLS 1 stated they were not aware of the reason for the delay with the work order. Review of the hospital’s P&P titled Work Order Assignment, Priority & Completion dated August 2023 showed the following: * Scope: Facilities/Engineering Department * Purpose: To establish a methodology for the prioritization and completion of both maintenance work order and preventive maintenance work orders (called PMs) * Policy: Work orders classified as Emergency/Urgent have priority over work orders classified as Non-Emergency/Routine. Non - Medical Equipment work orders shall be completed in the following priority as identified by its equipment classification: - Unscheduled Non-emergency or House HELP calls, projects and the remaining work orders shall be managed according to the Facility Manager workflow and priority based, first on risk, second on age/importance. (Less than 30 days is the established benchmark for work orders). * Procedure: - Assigned work is expected to complete on every shift by each individual unless the circumstances preventing the completion of the assigned work is communicated to your immediate supervisor. - If the assigned work cannot be completed, notify the department supervisor of the circumstances surrounding the delay. - Additionally, if applicable, notify the affected department supervisor/manage/director of the delay in completing the requested work and provide them with an estimated time of completion. Review of the hospital’s Continuity of Operations Plan (undated) showed the following: - Laboratory & Pathology Services is a mission critical department requiring the continuity or immediate recovery of services and processes - Interdependencies: To perform mission critical processes, the department depends on the following internal and external services... Pneumatic Tubing System. Review of the document titled Request Work Order showed the following: * WO# 723200 * Account: Plant maintenance * Date Orig: 9/10/25 at 1425 hours * Sub-status: Issued, Being Worked * The sections of “Completed By:” “Date:” and “Time” were left blank. * Comments section showed “Board is obsolete. Pending system upgrade.” On 10/16/25 at 1615 hours, the laboratory’s pneumatic tubing system work order dated 9/10/25 was shared with the CNO. The CNO stated the CNO was aware of the issue with the tubing system being obsolete throughout the hospital and needed to be replaced. The replacement of the tubing system has been evaluated at the cost of $90,000 for replacement, and the administration had been working with the headquarters regarding replacement of the system. On 10/23/25, the above findings were verified with the CNO and the Chief Quality Officer. On 10/22/25 at 1140 hours, an interview was conducted with CLS 3. When asked, CLS 3 stated on October 8 or 9, 2025 at 0700 hours, a meeting was called by the Laboratory Manager. The Laboratory Manager stated per the administration, “whoever is calling CDPH to complain if this keeps happening, the staff will loose their job. This was repeated two times.” CLS 3 further stated “I was offended, the staff is here to serve the patients and we rely on our paycheck we are going above and beyond what we need to do. Two staff members are leaving due to the laboratory’s instable situation related to the ongoing shortage of supplies.” On 10/22/25 at 1200 hours, an interview was conducted with CLS 4. When asked, CLS 4 stated on 10/8/25 at 0700 hours, the Laboratory Manager held a meeting with the laboratory staff. The Laboratory Manager stated the Laboratory Manager had a message from the administration “someone keeps calling CDPH about the shortage of laboratory supplies. If you keep doing this we’ll have to close the laboratory, and you’ll loose your job.” CLS 4 further stated “I felt threatened plan to leave the facility due to lack of supplies, lack of support, and feeling threatened by the laboratory manager.” On 10/22/25 at 1225 hours, an interview was conducted with CLS 5. When asked, CLS 5 stated CLS 5 attended the meeting with the Laboratory Manager regarding calls to CDPH. CLS 5 stated “felt more uncertain about my job, the CNO came and talk to us stating if we keep calling CDPH we’ll loose our job. We need better leadership and support in the Laboratory. Hope your report will make some changes for bettering this department.” On 10/22/25 at 1305 hours, an interview was conducted with CLS 6. When asked, CLS 6 stated “the supplies are short, we are borrowing from other facilities. Micro scan used to verify the results was ordered four months ago, has not received. Spoke to the Laboratory Manager an email was sent to the Material Management with no follow-up. We do not have any support from the Laboratory Manager.” On 10/22/25 at 1340 hours, an interview was conducted with CLS 7. When asked, CLS 7 stated “Attended the meeting with the Laboratory Manager on 10/8/25. The manager said if we continue with the calls to CDPH, then we’ll loose our job or they shutdown. Felt confused, threatened and disgusted. We are receiving contradictory messages, we have no support from the Laboratory Manager. The Laboratory Manager is underperforming, not trustworthy. I refuse to go to the Laboratory Manager with any issues, there is no follow thru, nothing happens with the Laboratory Manager.” On 10/22/25, the above findings were shared with the CNO and the Chief Quality Officer.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 29558 Based on observation, interview, and record review, the GB failed to ensure the safe and effective operation of the hospital as evidenced by: 1. The GB 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 evaluations (OPPE) for the medical staff. Cross reference to A049. 2. The GB failed to ensure a detailed institutional plan and budget included the operating budget, all anticipated income and expenses, a three-year period of capital expenditures, including in the present year, and sources of financing for planned expenditures in the capital plan. Cross reference to A073. 3. The GB failed to ensure contracted services were evaluated regularly to confirm they provided safe and effective care. Cross reference to A084. 4. The GB failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained. Cross reference to A263. 5. The GB failed to ensure the facilities and equipment used for patient care were maintained to ensure the safety of patients and staff. Cross reference to A700. The cumulative effect of these systematic practices resulted in the GB’s inability to provide high quality healthcare in a safe environment.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 29558 Based on observation, interview, and record review, the hospital failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained as evidenced by: 1. The hospital failed to ensure the QAPI program collected data and identified opportunities for improvement and change in the physical plant. Cross reference to A283. 2. The hospital failed to ensure the QAPI program maintained an ongoing program and recognized the measurable indicators as opportunities for improvement health outcomes for ED Trauma, Facilities, EVS, and Nutrition Services. Cross reference to A297. 3. The hospital’s GB failed to ensure the POCs related to the kitchen was implemented. Cross reference to A309. 4. The hospital failed to ensure adequate resources were allocated to improving and sustaining the hospital’s performance of medical equipment due to a credit hold. Cross reference to A315. The cumulative effect of these failings meant the hospital did not implement and maintain a quality improvement program to ensure the safety and quality of the services provided.”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 29558 Based on observation, interview, and record review, the hospital failed to ensure facility and equipment used for patient care were maintained to ensure the safety of patients and staff as evidenced by: 1. The hospital failed to conduct the EOC rounding in 2025 as scheduled. Cross reference to A701. 2. The hospital failed to ensure the proper and safe storage and disposal of sharp and pharmaceutical waste. Cross reference to A713. 3. The hospital failed to ensure the facility and equipment were maintained at an acceptable level of safety and quality. Cross reference to A724. 4. The hospital failed to maintain ventilation and humidity levels as per the hospital’s P&P. Cross reference to A726. The cumulative effect of these systemic practices resulted in the hospital’s inability to provide quality healthcare in a safe and sanitary environment creating the risk of poor health outcomes for the hospital’s patients.”

“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 Governing Board Bylaws dated 3/28/24, showed * Section 6.3 showed the Board will delegate to the Medical Staff the responsibility and authority to evaluate all matters relating to medical staff and forward specific recommendations with appropriate supporting documentation for the Governing Board to make an informed decision. The Board will consider the recommendations. * Section 6.7 showed the Medical Staff will be responsible to the Board for general quality of medical care provided in the hospital. The Governing Board will assure that specific review and evaluation activities are undertaken in order to assess, preserve and improve the overall quality and efficiency of patient care in the hospital. The Governing Board will further assure that the Medical Staff will implement and report to the Board on the activities and mechanisms for monitoring and evaluating the quality of patient care. The Board will support and advise the Medical Staff’s activities for monitoring, reviewing, and appraising the quality of patient care. Review of the Medical Staff Bylaws dated 11/11/21, 6.3.2 Ongoing Performance Practice Evaluation (OPPE) showed all members are subject to ongoing evaluation based on medical staff peer review criteria. Evaluation results are used in privileging, system improvement and corrective action. Departments will develop and routinely update peer review criteria based on current practices and standards of care. Data will be collected no less frequently than semi-annually on each member. Department Chair analysis will be conducted and reported monthly to the MEC. During a concurrent interview and record review on 08/25/25 at 1012 hours, with the Director of Medical Staff, the hospital’s credential files, and Medical Staff Bylaws were reviewed. The Director of Medical Staff stated the OPPE was reviewed by the department chair, who signed and forwarded it with recommendations to the MEC and the Governing Body, after which the physician was informed of the reappointment status. The Director of Medical Staff stated the OPPEs were not currently being conducted, and the neurosurgery specialty was the only established evaluation created recently. The Director of Medical Staff stated the hospital had approximately 53 medical staff specialties. At present, medical staff performance was assessed through peer references and hospital activity rather than through the OPPE process. On 08/25/25 at 1330 hours, the above findings were shared with the Interim Administrator, CMO, CQO, and Patient Experience.”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d) The institution must have an overall institutional plan that meets the following conditions: (1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles. (2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense. (3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable. (4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following: (i) Acquisition of land; (ii) Improvement of land, buildings, and equipment; or (iii) The replacement, modernization, and expansion of buildings and equipment. This Standard is not met as evidenced by: 36703 Based on observation, interview, and record review, the hospital failed to include a detailed institutional plan and budget to include the operating budget, all anticipated income and expenses, a three-year period of capital expenditures including in the present year, and sources of financing for planned expenditures in the capital plan. This deficient practice had the potential to reduce stakeholder input and accountability regarding prioritization of financial resources. Findings: Review of the Governing Board Bylaws dated 3/28/24, showed the Finance Committee shall develop and submit to the Board the budget for the next fiscal year and ensure the implementation of an effective fiscal accounting system. During an observation, interview, and record review from 8/20/25 to 8/25/25, the hospital failed to ensure the facility and equipment used for patient care were maintained to ensure the safety of patients and staff. Cross reference to A700. No institutional budget or plan was provided on request. Review of the Medical Equipment Log showed multiple equipment replacement requests in the departments: Surgery, SPD, OR/Trauma, Cardiology, Radiology, and ED. Review of the Governing Board Meeting Minutes dated 11/25/24, showed the advisement to escalate financial concerns with a letter to corporate by the Board. Review of the Governing Board Meeting Minutes dated 3/10/25, showed the Chief of Staff requested a letter to corporate leadership emphasizing the need for full visibility into the hospital’s financial standing in order to support long-term improvements and sustainability. On 8/25/25 at 1330 hours, the above findings were shared with the Interim Administrator, CMO, the CQO and Patient Experience.”

“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 GB failed to ensure contracted services were evaluated regularly to confirm they provided safe and effective care. This failure increased the risk that contracted providers were not fulfilling the terms of the agreements and ensuring patient safety. Findings: Review of the hospital’s P&P titled Annual Contract Evaluation dated January 2024 showed contract monitoring is a key component of contract administration and is imperative to effective enforcement of a contract. The goal is to ensure the contract is satisfactorily performed. A contract will require annual evaluation if a vendor provides a service that can impact patient health outcomes or directly involves the care or treatment of patients in the hospital. On 8/25/25 at 1109 hours, an interview and concurrent review of facility documents was conducted with the Executive Assistant, the Patient Experience, and the CQO. The Executive Assistant confirmed contract evaluations were not conducted on a known schedule following the departure of the previous CEO who had been responsible for overseeing the evaluations. The Executive Assistant stated there was no transition of the contract schedule when evaluations became due after the CEO left. Typically, the CEO assigned each contract to the appropriate department, which then reported the evaluation back to the CEO. Review of the contract list showed 267 active contracts. The column listed to show if the contract service agreement was met or unmet for all the listed active contracts, was blank for the entire report. The Executive Assistant provided three contract evaluations on file, all dated 1/10/24 for a transport service, a medical group, and an ED contract. However, no additional evaluations were provided to demonstrate reviews were conducted during the current year. The above findings were shared and acknowledged by the Executive Assistant, the Patient Experience and the CQO.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 36703 Based on observation, interview, and record review, the hospital failed to ensure the QAPI program collected data and identified opportunities for improvement and change in the physical plant, creating the risk for substandard outcomes for patients in the hospital. Findings: Review of the Governing Board Bylaws dated 3/28/24, showed the Quality Management Committee (QM) will objectively and systematically monitor and evaluate safety and risk factors and the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. The committee will review the Statement of Deficiencies and Plans of Corrections. During an observation, interview, and record review from 8/20/25 to 8/25/25, the following deficient practices were identified: * The hospital failed to ensure facility and equipment used for patient care were maintained to ensure the safety of patients and staff. Cross reference to A700. * The hospital’s GB failed to ensure the POC related to the kitchen was implemented. Cross reference to A309. On 8/22/25 at 1200 hours, an interview and concurrent review of facility documents was conducted with the Vice Chief of Staff, Chairperson, Interim Administrator, CMO and Patient Experience. Review of the Quality/Patient Safety Council Meeting Minutes dated 3/25/25, showed the Committee reviewed the evaluation of the 2024 dashboard and the proposed plan for 2025. However, the Facilities department had no 2024 goals listed, nor goals for 2025. Review of the Quality/Patient Safety Council Meeting Minutes dated 6/5/25, showed the Committee reviewed the PI Dashboard and noted there was no data for Facilities Management performance improvement projects as the Director position was vacant. Review of the Quality/Patient Safety Council Meeting Minutes 7/22/25, showed no facilities data was presented. The Interim Administrator stated there was a large amount of data which was reported at various meetings as many of the QM topics were moved through committee to committee. However, the challenge was presented with the resignation of key leadership roles related to QAPI in the physical plant. The Interim Administrator stated the systems were fragmented but the Committee was meeting weekly to go over systems and metrics. The Vice Chief of Staff stated there was a need to create alignment and identify the gaps and action plans as many of the system work was not in alignment. On 8/25/25 at 1330 hours, the above findings were shared and acknowledged by the Interim Administrator, CQO, CMO and Patient Experience.”

“QAPI PERFORMANCE IMPROVEMENT PROJECTS CFR(s): 482.21(d) As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital’s services and operations. (2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes. (3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. (4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the QAPI program maintained an ongoing program and recognized the measurable indicators as opportunities for improvement health outcomes for ED Trauma, Facilities, EVS, and Nutrition Services. This failure could potentially affect health outcomes and poor quality care. Findings: Review of the hospital’s Governing Board Bylaws dated 3/28/24, showed the QM Committee will objectively and systematically monitor and evaluate safety and risk factors and the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified issues. The QM Committee will be responsible for reviewing the written QAPI program and ensuring appropriate resource allocation to ensure proper implementation of the program. Review of the Organization-Wide Quality Assessment and Performance Improvement program dated March 2024 showed measures for periodic assessment and improvement including problem-prone, high risk, high volume processed and patient safety. The data collection determines root causes, track performance, and benchmarking and will be organized in a way to facilitate comparisons and trends. The Governing Board will approve the program and determine that data collection will be sufficient in detail to provide the user of that data with information to make timely, accurate and data-driven decisions. Further review showed the aggregation and analysis of data will establish a baseline level of performance, determine the stability and effectiveness of the process, identify opportunities for improvement, and the need for more focused data collection, and determine whether improvement has been achieved or sustained. On 8/22/25 at 1351 hours, an interview and concurrent review of the Quality/Patient Safety Council Meeting Minutes dated 3/25/25 was conducted with the Patient Experience. Review of the Quality/Patient Safety Council Meeting Minutes dated 3/25/25, showed the following: - The Trauma department showed a 2024 goal #1 was to have Trauma closure hours at 0%. However, the goal was not met with a 3.2% occurrence. Goal #2 was to have the Massive Transfusion Activation at 100%, with the goal not met at 92.2%. Goal #3 had a CAGE screening of all admitted trauma patients at 100%, with the goal not met at 81.7%. However, review of the goals for 2025 showed the comment “Same as 2024, adding more?”, and “Do you want to decrease goal of 2%, 80%, 90%, 95% and 100%.” Instead of identifying specific action plans to meet the goals, the discussion was to lower the benchmark. - Review of the Facilities, EVS and Nutrition Service departments failed to have 2024 goals or 2025 goals and metrics discussed. On 8/22/25 at 1200 hours, the above concern was shared and acknowledged by the Vice Chief of Staff, Chairperson, Interim Administrator, the CMO, and the Patient Experience.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital’s GB failed to ensure the POC related to the kitchen was implemented. This failure created an increased risk of poor health outcomes for the patients. Findings: During an observation, interview, and record review from 8/20/25 to 8/25/25, the following deficient practices were identified: * The hospital failed to ensure the kitchen equipment was maintained in good working conditions. Cross reference to A724, example # 1. * The hospital failed to ensure the work orders for kitchen equipment were completed. Cross reference to A724, example # 2. Review of the hospital’s POC for the previous CV surveys completed on 2/25/25, showed once a week the Director of the FNS will round the kitchen to ensure ... the kitchen is in good condition, safe working conditions .... equipment is functional and maintained .... Any issues identified will be corrected .... Rounding will be documented and records of reeducation or corrections made will be kept.” Review of the kitchen weekly rounding dated 5/16/25, showed refrigerators 2 D and 9 D, and Box #1 were identified not functioning until July 16, 2025 rounding. On the comment section, there was no annotation that correction was made for the equipment. Review of the open work orders from May to August 2025 did not show the refrigerators 2 D, 1 D, 11 D, and the portable food warmer heating cabinet were out of order. On 8/21/25 at 1107 hours, an interview and record review were conducted with the Corporate Director of Facilities and the Lead Central Plant. The Lead Central Plant stated he was not aware that the refrigerators 2 D and 11 D were broken or not functioning, the 1 D refrigerator was reported today, and someone was here now to look at it. On 8/25/25 at 1255 hours, an interview was conducted with the Lead Central Plant. The Lead Central Plant was asked for the documented evidence of the PM for the refrigerators and freezers in the kitchen. The Lead Central Plant stated the PM for the freezers and refrigerators in the kitchen were not done.”

“PROVIDING ADEQUATE RESOURCES CFR(s): 482.21(e)(4) [The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients. This Standard is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital failed to ensure adequate resources were allocated to improving and sustaining the hospital’s performance of medical equipment due to a credit hold, creating the increased risk of poor health outcomes for the patients receiving services at the hospital. Findings: An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. One balloon pump, identified as critical patient equipment, was found with an expired preventative maintenance (PM) sticker. A yellow-colored label was affixed to the machine. The label showed “GETINGE” and “PM Due Date 6-2025.” The Director ICU confirmed the PM was overdue. An interview and concurrent review of the vendor PM documentation for five (5) balloon pumps was conducted on 8/22/25 at 1415 hours, with Biomed 3. Review of the vendor PM documentation showed the last PM for the five balloon pumps was done on 12/20/24. Biomed 3 stated the PM was due semi-annually. Biomed 3 stated the balloon pumps were in Surgical Services, the ICU, and the Cath Lab, with one balloon pump being a mobile float and another in the Biomed shop. Biomed 3 stated the vendor had not performed PM on these devices because the hospital had not pre-paid for the service. Biomed 3 confirmed that the hospital was on a credit hold for $50,000 with the vendor, preventing scheduled PM on the balloon pumps until the amount was paid upfront. A request was submitted to the Patient Experience on 8/25/25 at 1020 hours, for all documentation and correspondence related to the credit hold and efforts to secure payment. An interview with the Chief Nursing Officer was also requested. An unsolicited interview with the Director of Perioperative Services occurred on 8/25/25 at 1024 hours. The Director of Perioperative Services stated that Biomed 3 would provide all information regarding the credit hold. The request to interview the Chief Nursing Officer was re-emphasized. An interview was conducted on 8/25/25 at 1032 hours, with Biomed 3. Biomed 3 stated that the check request for the credit hold was initiated on 8/22/25. A request for an interview with the CNO was submitted, and a follow-up request was made. Neither request resulted in an interview with the CNO. The credit hold documentation requested on 8/25/25, was not provided by the time of the exit conference with the hospital on 8/25/25 at 1330 hours.”

“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: 36703 Based on observation, interview, and record review, the hospital failed to maintain the physical plant to ensure patient safety when the hospital failed to conduct Environment of Care (EOC) rounding in 2025 as scheduled. This failure posed the increased the risk for substandard outcomes for the patients in the hospital. Findings: Review of the hospital’s P&P titled Environment of Care Management Plan dated August 2023 showed the environmental rounds process as follows: - Preparation - Scheduling: Environmental rounds are scheduled by the Facilities Department. All hospital departments are surveyed during the year; on a minimum, patient care areas are surveyed bi-annually, non-patient care areas are surveyed once per year. - Touring and Discrepancies Reports: Departments are notified at the beginning of the month if their unit is scheduled for inspection. Discrepancies identified during the environmental rounds are recorded and entered into a facilities work order database and captured as urgent or routine. - Discrepancy Resolution: Appropriate action is taken to remedy identified discrepancies and corrective actions are documented for work order closure. Environmental work orders not completed in a timely manner, are reported at the EOC Committee meeting and the Quality Council meetings for follow-up - Trend analysis: Environmental round summary reports are announced at least quarterly in the EOC Committee. Issues found during Environmental Tours are monitored for trends and systemic issues. During an observation, interview, and record review from 08/20/25 to 08/25/25, the following deficient practices were identified: * The hospital failed to ensure the facilities and equipment were maintained at an acceptable level of safety and quality. Cross reference to A724. * The hospital failed to maintain ventilation and humidity levels as per the hospital’s P&P. Cross reference to A726. Review of the environmental rounds 2025 schedule showed 28 patient-care areas were scheduled for EOC rounds bi-annually and 13 non-patient-care areas were scheduled annually. However, no EOC rounding data for 2025 was provided. And no EOC Committee Meeting Minutes for 2025 were provided. On 8/20/25 at 1447 hours, the Patient Experience confirmed no EOC rounding was conducted according to the Environmental Rounds 2025 schedule.”

“DISPOSAL OF TRASH CFR(s): 482.41(b)(6) (4) The hospital must have procedures for the proper routine storage and prompt disposal of trash. This Standard is not met as evidenced by: 37548 Based on observation, interview, and record review, the hospital failed to ensure the proper and safe storage and disposal of sharp and pharmaceutical waste. This failure created the increased risk of unsafe environment. Findings: Review of the hospital’s P&P titled Biohazard Medical Waste dated 10/1/20, showed all sharps shall be placed in a leak-proof, rigid, puncture-resistant container with the lid locked closed. The container will then be placed in a steritub, segregated from other biohazard waste and the steritub will be labeled “Sharps only.” Review of the hospital’s P&P titled Hazardous Materials and Waste Management Plan dated August 2023 showed “Pharmaceutical Waste...EVS or an appropriate service vendor...shall place these containers within the locked area designated and labeled for this purpose located at the basement dock...” 1. An inspection of the CCU and the ICU was conducted on 8/20/25 at 1016 hours, with the Director ICU. In soiled utility room 3, one sharp container was stored in an unlocked cabinet within a soiled utility room that could not be secured. The container was found overfilled past the designated fill line. The sharp container was not securely closed with a lid. No designated “Sharps Only” biohazard container (Steritub) was present in the room. The findings were confirmed by the Director of the ICU. An inspection of the soiled utility room 3 in the ICU was conducted on 8/21/25 at 1518 hours, with the EVS Supervisor. One sharp container was stored in an unlocked cabinet within a soiled utility room. The EVS Supervisor confirmed the sharps container was above the fill line and lacked a secure lid. It was stored in an unlocked cabinet, which was accessible from an unsecured room. The EVS Supervisor stated that sharps containers should be properly disposed of in a designated red biohazard bin. The EVS Supervisor also confirmed that the required “Sharps Only” biohazard container was not present in the room. 2. During a tour of the basement dock on 8/25/25 at 0942 hours, conducted with the EVS Supervisor, one blue pharmaceutical waste container was discovered stored outside of the designated biohazard waste storage area. The container was both unsecured and unattended. The EVS Supervisor confirmed the improper storage and acknowledged that the container should not have been left unsecured and outside of its proper location.”

“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 facility and equipment were maintained at an acceptable level of safety and quality as evidenced by: 1. Failure to ensure the kitchen equipment was maintained and in good working condition. 2. Failure to ensure the work orders for kitchen equipment were completed. 3. Failure to ensure trash and cardboard compactors were maintained and in working condition. 4. Failure to ensure the ceiling tiles in corridor to the facilities department and loading dock were maintained in a sanitary condition. 5. Failure to ensure the work order for Rooms B and C was completed. 6. Failure to ensure the Biomedical Engineering implemented the hospital’s P&P for Medical Equipment Management Plan. The PM for the ventilator heater and SCD was not completed. The PM sticker posted on the ventilator and BiPAP machine was incorrected. There was no documentation of the equipment inventory list with scheduled PM. 7. Failure to ensure the ED maintained in a safe and functional manner. 8. Failure to ensure the mobile CT unit maintained in a safe and functional manner. 9. Failure to ensure the OR maintained in a safe and functional manner. 10. Failure to ensure the hospital ’ s lobby elevators A, B and C maintained in a sanitary manner. 11. Failure to ensure all the fetal monitors had their annual preventative maintenance. 12. Failure to ensure the ICU and CCU maintained in a sanitary and safe manner. 13. Failure to ensure the air conditioning ventilation system in ICU and CCU was maintained. 14. Failure to ensure the work order for the pneumatic tube system in the critical care department was completed. 15. Failure to ensure the PM for balloon pump was completed. 16. Failure to ensure the PM for hospital beds in ICU and CCU was completed. 17. The PM labels for an IV pump showed discrepancies in maintenance and service. 18. Failure to ensure the work order for the nonfunctional code blue buttons in CCU was completed. 19. Monthly rounding by facilities and Biomed was not implemented as per the POC. These failures created the increased risk of unsafe care to the patients. Findings: During a review of the hospital’s P&P titled “Medical Equipment Management Plan,” dated August 2023, the P&P indicated: - The hospital conducts environmental tours every six months in patient care areas to evaluate the effectiveness of previously implemented activities intended to minimize or eliminate environmental risks. - Every 12 months, the hospital evaluates each environment of care management plan, including a review of the plan’s objective, scope, performance, and effectiveness. - The Equipment Maintenance Management/Inventories section showed. “Inventories...Biomedical Engineering maintains accurate maintenance records (CMMS) of all inventoried medical equipment. Records are electronic, except when hard copy documents are supplied by vendors.” “Preventive Maintenance...equipment is risk assessed into ten categories. Those ten categories make up the Life Support and Non-Life Support groups....Life Support Equipment ... Biomedical Engineering inspects, tests and maintains all life-support equipment and documents these activities in the CMMS. All preventive maintenance activities are to be completed 100% each month. This data is reported to EOC quarterly...Non-Life Support Equipment ... Biomedical Engineering inspects, tests and maintains all non-life-support equipment and documents these activities in the CMMS. Preventive maintenance activities are to be completed 95%, minimally, each month. This data is reported to the EOC quarterly.” * “Preventive Maintenance Procedure ... Biomedical Engineering maintains written maintenance procedures (CMMS) for all inventoried medical equipment ... Biomed technicians review procedures for their accuracy and completeness.” 1. During a review of the hospital’s P&P titled “9. Maintenance of Equipment” dated February 2014 indicated “The Director of Nutrition Services is responsible for assuring all equipment is maintained in good repair and that all equipment meets all safety and regulatory requirements ... Facilities Department is responsible for the repair and maintenance of all foodservice equipment with the exception of computer equipment ... Nutrition Services is responsible for promptly notifying Facilities Department of any repair and/or maintenance issue through the generation of a work order ... The Facilities Department may authorize Nutrition Services to call vendors to perform work on behalf of the medical center.” During a tour of the hospital kitchen on 8/20/25 at 1000 hours with the Director of RDN and the Kitchen Supervisor, the following equipment was observed to be nonfunctional: - A large block of ice in the small ice machine bin had pushed a metal component out of place. - Refrigerator D used for tray line food holding was observed to have a temperature of 48 degrees F. Refrigerator D contained 22 bottles of reduced milk and several cups of pale yellow-beige pudding. No temperature monitoring log was present in Refrigerator D. The Director of RDN stated the milk should be kept at 32 to 41 degrees F. - 2D Refrigerator had an “out of order” signage posted on the door. The Director of RDN stated the refrigerator 2D1 and 2D2 had been broken for a long time. - 1D Refrigerator. The Director of RDN stated the refrigerator was also reported as broken for a long time. - The dishwashing machine was not in use. The Director of RDN stated it had been down since 8/19/25. - At the cooking area, the portable food warmer heating cabinet was not working. The Director of RDN stated it had been out of service for two months. - 11D refrigerator was broken. - Walk-in refrigerator 1 called as dairy refrigerator used for holding food the foe patient’s meal, did not have temperature monitoring. - There was a leak from the ceiling at the cooking area where a hose was connected from the ceiling down to a pile. Review of the Refrigeration Temperature Log Monthly for Month of August 2025 for 2D Refrigerator showed the temperatures must be recorded a minimum of twice within each 24 hour period; record the temperature as indicated by thermometer on inside the refrigerator; the record refrigerator temperature must be within range between 32 degrees F to 41 degrees F; if the temperature is outside this range, must record corrective action in the comment column. However, further review of the Refrigeration Temperature Log Monthly for Month of August 2025 for 2D Refrigerator did not show the corrective action when the temperature was recorded 60 degrees F in the am and 68 degrees F in the pm on 8/17/25. The comment section showed the refrigerator was out order on 9/17, 8/18, 8/91, 8/20/25. The Director of RDN was asked about the refrigerators that were not functioning or broken. The Director of RDN stated the kitchen did not need it, the kitchen had enough refrigerator storage, and the hospital census had been low. 2. During a review of the open work orders from May to August 2025, the records did not show the refrigerators 2D, 1D, 11D, and the portable food warmer heating cabinet were out of order. On 8/21/25 at 1107 hours, an interview and record review was conducted with Corporate Director of Facilities and the Lead Central Plant. The Lead Central Plant stated he was not aware that refrigerators 2D and 11D were broken or not functioning, the 1D refrigerator was reported today and someone was here now to look at it. Review of the Preventive Maintenance Work Order Work Orders for the Quarterly PM of three upright freezers (F1341, F1344 and F1355) showed the following: - For the upright freezer F1341, the quarterly PM was active from 5/1/25. - For the upright freezer F1344, the quarterly PM was active from 5/1/25. - For the upright freezer F1355, the quarterly PM was active from 8/1/24. Review of the Preventive Maintenance Work Order for the Semi-Annual PM of the two walk-in freezers (F1336 and F1337) showed the following: - For the walk-in freezer F1336, the semi-annual PM was active from 11/1/23. - For the walk-in freezer F1337, the semi-annual PM was active from 11/1/23. On 8/25/25 at 1255 hours, an interview and record review were conducted with the Lead Central Plant. The Lead Central Plant verified the above PM Work Orders were not completed. 3. During an observation on 8/20/25 at 1130 hours at the docking area, with the Director of RDN, the Director of RDN stated the “bailer” machine that used to compact the cardboard, had not been used. The machine needed wires to be able to work. The Director of RDN stated the hospital was not in good standing to purchase the wires from the vendor. At the docking area, a large trash bin was observed overflowing above the rim line. The Director of RDN stated the trash compactor was broken. The trash had been picked up and the Facilities would know how often the trash would be picked up. Review of the Hydraulic Service for the estimate repair for the compactor dated 3/13/25, showed the estimate was signed on 8/21/25. On 8/25/25 at 1230 hours, an interview and record review was conducted with the Patient Experience. The Patient Experience stated the staff who requested the work estimate for the compactor did not follow-up. 4. On 8/25/25 at 0935 hours, a tour of the loading dock was conducted with the EVS Supervisor and the Director of RDN. Brown stains were observed on at least 14 ceiling tiles in the corridor leading to the facilities department and loading dock. One ceiling tile with a fire sprinkler was bulging. The Director of RDN stated the stains were from a water leak that had been there for “awhile” and had gotten “worse.” The Director of RDN stated the tile with the fire sprinkler was bulging and looked like it was about to rupture. During an interview on 8/25/25 at 0948 hours, with the Lead Central Plant, the Lead Central Plant stated the leak originating from a steam relief valve on the kitchen’s steam kettles had been ongoing for at least one month. This information was unknown to the Director of RDN, who was present during the interview on 8/25/25. The Lead Central Plant further stated that parts had not been ordered as they were still awaiting a quote. 5. During a tour of the Telemetry/DOU unit on 8/20/25 at 1430 hours with RN 2 and RN 3, Rooms B and C in the Telemetry/DOU unit were observed with signs on the doors indicating they were closed. RN 2 stated the rooms had been closed since 8/16/25. There was a repair on the 7th floor that affected Room B and C. During an interview and record review on 8/21/25 at 1054 hours, with the Corporate Director of Facilities and the Lead Central Plant, the Lead Central Plant stated Rooms B and C were affected by plumbing work being done on Rooms F and G. The work order for Rooms F and G did not include Rooms B and C. The Corporate Director of Facilities stated Rooms B and C were now added to the work order. 6. On 8/20/25, a tour of the hospital units was conducted with RN 2 and RN 3. The following was identified: - At 1412 hours, in Room A of the medical-surgical unit, an SCD machine was observed with a PM sticker dated 7/22. - At 1436 hours, in Room D of the Telemetry/DOU unit, a BiPAP machine on standby for patient use at night was observed with a PM sticker dated 11/24. A heater attached to the BiPAP machine had a PM sticker with a due date of 7/25. - At 1445 hours in Room E of the Telemetry/DOU unit, a patient ventilator was observed with a PM sticker dated January 2005. A heater attached to the ventilator had a PM sticker with a due date of July 2025. During a concurrent interview and record review on 8/21/25 at 1445 hours, with Biomed 3 and the Patient Experience, Biomed 3 stated the PM for the ventilator was scheduled every year as per the manufacturer’s recommendation. Biomed 3 stated the Biomed staff would change the PM stickers after the PM was completed. Biomed 3 showed the PMs for the ventilator and BiPAP machines were completed; however, the stickers on the ventilator and BiPAP machine were incorrect. The Patient Experience stated there was a new P&P for the PM stickers but was unable to provide a copy of it. Biomed 3 stated the PM for the ventilator heater and SCD was scheduled every year; Biomed 3 verified the PMs were past due; however, the SCD was not hospital owned equipment. On 8/25/225 at 1030 hours, Biomed 3 was asked to show documentation of the equipment inventory list with scheduled PM and the list of stickers used to tag the equipment after the PM was completed. Biomed 3 was unable to show documentation of the equipment inventory list with scheduled PM and the list of stickers used to tag the equipment after the PM was completed. 36703 7. On 8/20/25 at 1000 hours, an inspection of the ED was conducted with the ED Director and the Trauma Program Director. The following concerns were identified: - The lobby water fountain’s push bar to dispense water was partially broken off and sharp edges. - Trauma bay 3 had an undercounter cabinet with a broken handle. The ED Director and Trauma Program Director acknowledged the findings. On 8/21/25 at 1041 hours, the findings were shared with the Lead Central Plant. 8. On 8/20/25 at 1431 hours, an inspection of the Mobile CT Unit was conducted with the Director of Radiology and CT Technician 1. The following concerns were identified inside the Mobile CT Unit: - The one hand washing sink was not connected to running water. - Brown staining marked the ceiling tile above and adjacent to the handwashing sink, and a dried liquid trail extended down the wall to the floor. 9. On 8/20/25 at 1135 hours, an inspection of the OR core was conducted with the Director of Perioperative Services and Patient Experience. The following concerns were identified: - OR 2’s door metal door guard had scattered large dents. Chips in the metal door frame exposed underlying red-stained metal. - The scrub sink faucet to the left of OR 5 failed to produce warm water after three minutes. - A large puncture damaged the wall next to the entrance of OR 3. - OR 3’s and 4’s outer door had a chipped door guard as well as a chipped door frame. - Paper and plastic trash was present in the scrub sink near OR 11. - A puncture damaged the wall in the hallway near the storage room. The Director of Perioperative Services acknowledged the finding. 10. An inspection of the hospital’s main elevators adjacent to the lobby showed the following: - Elevator A had staining in a liquid spill pattern on the ceiling. - Elevators B and C had exposed and lifted vinyl flooring at the threshold of the elevator. 11. On 8/20/25 at 1102 hours, an inspection of the L&D was conducted with the Director of Perinatal Services and Patient Experience. The fetal monitor machine in Room H had a preventative maintenance sticker showing a PM was due on 6/25. Review of the Preventative Maintenance Work Order forms showed 16 out of 22 fetal monitor machines had their annual PMs on June 2024 and 8/20/25. On 8/21/25 at 1500 hours, an interview was conducted with Biomed 3. Biomed 3 stated the fetal monitors were on a yearly schedule to have their preventative maintenance. On 8/25/25 at 1330 hours, the above findings were shared with the Interim Administrator, the Patient Experience, the CQO, and the CMO. 37548 12. a. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. The following concerns were identified: * One door near CCU patient Rooms K and L, with keypad access leading to a corridor, was observed to be ajar. The door was labeled from the outside “Authorized Personnel Only.” During testing from the corridor, the door was manually opened and closed. On multiple attempts, the door failed to close and latch securely, instead remaining slightly open. * At the Nursing Station a medical gas cylinder (oxygen tank) was observed to be unattended and not secured in a proper holder. * In the clean utility room, the following was observed: - The light fixture on the ceiling contained visible debris. Small objects were noted inside the cover of the light fixture. - Two metal boxes labeled “TV 1-17” and TV 18-32” mounted on the wall and in between the two boxes an open penetration in the ceiling tile. Tube feeding supplies were observed being stored directly below the non-intact ceiling tile. - Paint was observed chipping around a wall panel labeled “A6L.” - Cracks and debris on the ceiling tiles, specifically near the air conditioning vent. - A white, chalky, thick and crusty powdery substance was observed on the wall’s surface next to the ice machine. - Unsanitary and disrepair medical supply carts (including the cart stored immediately outside of the clean utility room). Supply carts had rust, broken parts, were dusty and stained medical tape and/or bandages were improperly used to secure supply bins. - Visible dust and debris accumulated inside plastic bins containing clean medical supplies and drinking supplies (including water pitchers). - Damaged, gapped, and/or stained ceiling tiles were observed at the nursing stations and in general unit areas and corridors. * Three soiled utility rooms were inspection and the following was observed: - In soiled utility room 1, multiple ceiling tiles were lifted out of place, leaving gaps that provided a direct pathway into the space above the ceiling. The walls in the soiled utility room had drywall damage, with sections completely missing and the internal structure of the wall exposed. - In soiled utility room 2, the wall was compromised by both physical damage to the drywall and an unsecured opening/access panel. * In Room I, the following was observed: - The ceiling tile directly above the air conditioning vent was observed to be lifted and broken. * In Room J, the following was observed: - The two poles mounted behind the head of the bed, intended for hanging IV fluids or medications, were observed with multiple areas of rust. * In Room K, the following was observed: - The oxygen connector for the patient’s oxygen supply was observed secured with multiple pieces of tape. In a concurrent interview the Director ICU stated the oxygen must be “leaking from connection.” - The patient call light was observed to be damaged. The call button was chipped and the cord leading to the call button had multiple strands of exposed electrical wires visible at the point of damage. - The clip intended to secure the patient call light to the bed linen was observed to be rusty and bent out of shape. - The non-disposable holder for the suction canister had visible writing on it and tape was observed on the canister. In a concurrent interview, the Director ICU acknowledged the writing likely indicating output measurements from a previous patient. - The hand washing sink cabinet was found to be unsecure, lacking a proper latching mechanism. Inside the cabinet, multiple mouse and insect glue traps were observed. Multiple brown stains, residue/dust, and visible cracks within the cabinet. Two metal screws were observed sticking out from the cabinet doors. - The light fixture above the patient’s bed was not functioning. Attempts to turn the light on via its pull chain were unsuccessful. The pull chain for the fixture was observed to be so short that it was difficult to access and operate. - Multiple areas of the countertops had laminate that was peeling and lifting in various spots, exposing the underlying surface. - A wall-mounted manual sphygmomanometer, intended for taking blood pressure, was observed to be missing its cuff. During a concurrent interview, the Director of the ICU stated the device was non-functional, incomplete as it was missing the cuff and that it should have been removed. - During inspection of the patient room doors, one door was found to have a sharp, lifted metal strip along the bottom edge. This strip was partially detached and bent, creating a jagged, exposed point. - The partial countertop or “island” next to the patient bed which provided mounted oxygen, suction, and medical air connections, as well as power outlets, was not in a safe or sanitary condition. The TV mount had visible rust. The TV mounting base remained, but no TV was mounted. - The ceiling light cover was observed to have orange/brown stains. * In Room L, the following was observed: - The partial countertop next to the patient bed had laminate that was damaged, chipped off or broken in multiple areas, exposing the underlying porous surface. - The hand washing sink cabinet was found to be unsecure, lacking a proper latching mechanism. Inside the cabinet doors, two metal screws were observed sticking out. - Multiple ceiling tiles were observed to be broken and visible holes in various areas. - On one of the glass panels of the patient room door a visible crack was observed. During a physical inspection, the surface of the crack was noted to be sharp to the touch. * In Room M, the following was observed: - The wall above the head of the bed had a crack and the drywall was damaged. * In Room N, the following was observed: - Multiple areas of the countertops had chipped laminate exposing the pressed wood. * In Room O, the following was observed: - The TV mount located on the partial countertop next to the patient’s bed was observed to be in poor repair. The painted surface was chipped, and areas of rust were visible underneath. The baseboard (hard plastic/rubber material) trim was peeling away from the bottom edge of the partial countertop. The exposure created a gap that showed accumulation of dust, making it difficult to clean/sanitize. - One chair was observed with a rip on the seat, exposing the internal foam padding. - The hand washing sink cabinet was found to be unsecure, lacking a proper latching mechanism. The interior of the cabinet was observed to be unsanitary and in disrepair. The cabinet’s internal surface had multiple brown stains, visible residue, dust accumulation, and multiple cracks. b. An inspection of the critical care department continued on 8/20/25 at 1401 hours, with the Director ICU. * The following was observed in the “neuro” room (4 beds): - Small pieces of chalky or fibrous materials were found on the sheets at the foot of the bed. The Director ICU stated the debris looked like material from the ceiling tiles. - Multiple partial countertops were in a state of disrepair. The integrity of both the countertop surfaces and the TV mounts were compromised. The countertops were visibly lifted, creating a gap between it and the base. The base of the TV mount had chipped paint, and visible gaps were present where it met the countertop. The ICU Director stated that the weight of the TV and its mount was possibly causing the countertop to lift and create gaps. - A handwashing sink was found to be leaking at the base of the faucet when in use. - Approximately 2 feet of physical damage to the drywall near the floor line, including punctures and gouges. These damages created rough, non-intact surface. - The cabinet doors below a handwashing sink were damaged and unsecured. The inside of the cabinet was also unsanitary, with cracks, dust, and brown/orange stains or splatters. - The emergency call light located in the patient bathroom did not have a pull string. - One computer on wheels had a handwritten note dated 10/09/24, indicating a non-functional scanner. - Another computer on wheels was found with a work order dated 3/18/25, noting a battery that would not hold a charge. - A third computer on wheels had a handwritten sign dated 6/29/25, showing the battery was not holding a charge. - One chair had a handwritten “Broken Do Not Sit” note. - Another chair had multiple large rips in the seat, exposing the foam padding. * In Room P, the following was observed: - The partial countertop has multiple areas with chipped laminate exposing the pressed wood. * In Room Q, the following was observed: - One IV pole with rust throughout. - Door with peeling paint. - The ceiling light fixture had visible stains and debris inside the transparent cover. - The partial countertop laminate was cracked in multiple areas. The walls at the base of the partial countertop had physical damage, including holes and chipped paint. - Countertops with chipped laminate, exposing the porous, pressed wood core beneath. * In Room R, the following was observed: - The ceiling light fixture had visible stains and debris inside the transparent cover. - The light fixture above the patient’s bed was not functioning and had multiple stains and debris inside its transparent cover. - The partial countertop laminate was cracked, with a piece removed and left on the surface. When lifted, it exposed the porous pressed wood core, which had loose pieces that could scatter. The metal frame was bent, and the countertop was visibly lifted, creating a gap. The base of the TV mount (though the TV was absent) had chipped paint and rust. An exposed sharp screw was noted on the base of the TV mount, posing a significant puncture hazard. The baseboard on the partial countertop was cracked and had multiple gaps where it pulled away from the wall. The walls of the partial countertop were damaged, and the paint was peeling. * In Room S, the following was observed: - The room door with physical damage including gouges and areas of peeling paint. - The hand washing sink cabinet was found to be unsecure, lacking a proper latching mechanism. The interior of the cabinet was observed to be unsanitary and in disrepair. The cabinet’s internal surface had multiple brown stains, visible residue, dust accumulation, and multiple cracks. - The base of the TV mount on the partial countertop had chipped paint and rust, and the countertop laminate was cracked. The metal framing that supported the countertop was also lifted, exposing the porous pressed wood core underneath. * In Room T, the following was observed: - Damage to the bed footboard’s surface, with visible cracks and sections of the material broken off. * In Room U, the following was observed: - Damage to the bed footboard’s surface, with visible cracks and sections of the material broken off. - An exposed and sharp screw was found on the window blind pull mechanism for the window. - The bed had a fitted sheet was damaged with multiple tears. * In Room ICU A, the following was observed: - The partial countertop had a crack extending across its entire width. - Ceiling tiles with multiple brown/orange stains. - Damage to the bed footboard’s surface, with visible cracks and sections of the material broken off. * In Room ICU B, the following was observed: - The ceiling light fixture had visible brown and/or orange residue or stains. - The partial countertop was visibly lifted, creating a gap between it and the base. The metal framing that supports the countertop was also lifted and bent, exposing the porous pressed wood core underneath. - The light fixture above the patient’s bed was not functioning. Attempts to turn the light on via its pull chain were unsuccessful. - The rubber or hard plastic baseboard on a wall corner was observed pulling away from the wall, creating an unsealed, visible gap. - A Tram 250SL was observed with a broken or lifted piece of its plastic cover. The device was left on the countertop. There was no work order attached to the device, and the Director ICU was unaware that the Tram was damaged. 13. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. The following concerns were identified: * Three soiled utility rooms were inspection and the following was observed: - In soiled utility room 1, the ceiling vent for the air conditioning system was visibly dirty with accumulated dust. * In Room I, the following was observed: - The ceiling vent for the air conditioning system was visibly dirty and with accumulated dust. * In Room J, the following was observed: - The ceiling vent for the air conditioning system was visibly soiled with an accumulation of dust and a fibrous, hair-like substance. * In Room K, the following was observed: - The ceiling vent for the air conditioning system was visibly dirty and with accumulated dust. * In Room M, the following was observed: - The ceiling vent for the air conditioning system was visibly dirty and with accumulated dust. * In Room N, the following was observed: - The ceiling vent for the air conditioning system was visibly dirty and with accumulated dust. * In Room O, the following was observed: - The ceiling vent for the air conditioning system was visibly dirty and with accumulated dust. An interview with the Corporate Director of Facilities and the Lead Central Plant was conducted on 8/21/25 at 1150 hours, about the findings in the ICU and CCU including the condition of the air conditioning vents. The Lead Central Plant stated the PM for air conditioning vents should be done semi-annually. The Lead Central Plant stated the PM was not done for the air conditioning vents in the ICU. Documentation for the last PM for the air conditioning vents was requested on 8/21/25 but was not provided by the time of the exit conference with the hospital on 8/25/25 at 1330 hours. 14. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. The following concerns were identified: - The pneumatic tube system was found in an unsanitary and unmaintained condition. The drop area was covered with multiple layers of chux pads, bed sheets, and other materials. Once these layers were removed, a green-colored egg crate with significant black and brown stains was exposed. The walls surrounding the area showed splash marks of a reddish-brown liquid, and rust was visible on nearby metal surfaces. A posted work order dated 6/2/25 (approximately 2.5 months prior to the survey), noted mold in the carpeted area. The Director ICU confirmed the work order and acknowledged that the sanitation and maintenance problems in the tube system’s drop area had been known to the facilities department without correction. An interview with the Corporate Director of Facilities and the Lead Central Plant was conducted on 8/21/25 at 1150 hours, about the findings in the ICU and CCU including the work order for the pneumatic tube system. The Lead Central Plant confirmed the work order for the pneumatic tube system dated 6/2/25, for mold in the carpeted area was not addressed. During an interview and concurrent review of the hospital’s P&P titled Work Order Assignment, Priority & Completion dated August 2023, the Corporate Director of Facilities confirmed the work order for the pneumatic tube system was classified as unscheduled non-emergency and that less than 30 days was the established benchmark for the work order. 15. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. The following concerns were identified: - One balloon pump, identified as critical patient equipment, was found with an expired PM sticker. A yellow-colored label was affixed to the machine. The label showed “GETINGE” and “PM Due Date 6-2025.” 16. a. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. The following concerns were identified: * In Room J, the following was observed: - The Stryker patient bed had a sticker affixed to the bed and showed the PM was overdue. The sticker specified “Next PM Due 6/24.” * In Room N, the following was observed: - One Stryker patient bed had a sticker affixed to the bed and showed the PM was overdue. The sticker specified “Next PM Due 6/24.” b. An inspection of the critical care department continued on 8/20/25 at 1401 hours, with the Director ICU. * The following was observed in the “neuro” room (4 beds): - The Stryker patient bed had a sticker affixed to the bed and showed the preventative maintenance (PM) was overdue. The sticker showed “Next PM Due 6/24.” * In Room T, the following was observed: - The Stryker patient bed had a sticker affixed to the bed and showed the preventative maintenance (PM) was overdue. The sticker specified “Next PM Due 6/24.” * In Room U, the following was observed: - The Stryker patient bed had a sticker affixed to the bed and showed the preventative maintenance (PM) was overdue. The sticker specified “Next PM Due 6/24.” * In Room ICU A, the following was observed: - The Stryker patient bed had a sticker affixed to the bed and showed the preventative maintenance (PM) was overdue. The sticker showed “Next PM Due 6/24.” An interview with the Corporate Director of Facilities and the Lead Central Plant about the PM for hospital beds was conducted on 8/21/25 at 1539 hours. The Lead Central Plant stated the PM for hospital beds should be done yearly. The Lead Plant confirmed the PM for the hospital beds was last done in 2023. 17. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. In Room L, the following was observed: - One IV pump was mounted to an IV pole. The equipment showed discrepancies in maintenance and service labeling. The IV pump label “ARJO PREVENTATIVE MAINTENANCE” showed a due date of “7/23” and a “Battery” replacement date of “10/23,” both of which had expired. A conflicting “Clinical Engineering” label was also present, dated “1...2025.” The Director ICU stated that they did not understand why the equipment had multiple labels and was not sure if the equipment had been serviced or if the PM was done or due. 18. An inspection of the CCU and the ICU was conducted with the Director ICU on 8/20/25 at 1016 hours. In Room M, the following was observed: - On the wall above the head of the bed a Code Blue button was visible, labeled “Press.” Adjacent to the button, a document labeled “Work Order Details” was posted on the wall. The work order was dated/timed “10/19/2024, 6:11 AM” and showed “Code blue button in CCU 7 not working...” The Director ICU acknowledged the work order, dated approximately 10 months prior to this observation. The Director ICU stated that a total of four (4) Code Blue buttons within the unit were non-functional. The Director ICU stated that the non-functional buttons prevented the use of these rooms for critically ill patients. The Director ICU stated the hospital was aware of the non-functional code blue buttons. The Corporate Director of Facilities and the Lead Central Plant were interviewed on 8/21/25 at 1453 hours, and confirmed the work order for the code blue button dated 10/19/24, was not addressed. The Corporate Director of Facilities confirmed there were no work orders for the additional three (3) ICU Code Blue buttons that were not functioning. 19. Review of the POC for the previous CV surveys completed on 2/25/25, accepted by the Department on 4/8/25, showed “Compliance and Monitoring...Once a month, the Biomed Lead will round in various patient care units and the kitchen to ensure equipment is maintained per hospital policy and stickers are present. Any issues identified will be corrected and staff will be educated. Records of rounding and any corrective actions taken will be documented....Once a month, the Interim Director of Facilities will review all open/pending work orders and the progress in closing them. Any issues identified will be corrected and orders will be addressed and closed. Data will be collected until 90% compliance is achieved for three consecutive months...Data collected from the above listed audits will be added to the hospital wide QAPI and presented quarterly to the MEC and the GB...Responsible Person: CEO, CNO...” Records of rounding by Biomed and Facilities were requested from the Patient Experience on 8/21/25 at 1352 hours. The Patient Experienced confirmed on 8/25/25 at 1018 hours, there was no documentation showing rounding was done as per the POC.”

“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: 36703 Based on observation, interview, and record review, the hospital failed to maintain ventilation and humidity levels as per the hospital’s P&P as evidenced by: 1. The hospital failed to conduct air balance revalidation testing after failed results in critical patient care areas, including the OR Decontamination Room, ICUs A and B, CATH Labs A and B, and ED Trauma. 2. The hospital did not maintain the humidity levels in the OR as per the hospital’s P&P. These failures increased the risk for substandard outcomes for the patients in the hospital. Findings: Review of the hospital’s P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated October 2024, showed * The hospital follows the 2008 ASHRAE 170 temperature and humidity ranges, air cycle and pressure relationships. * Functional space requirements: - The OR has humidity parameters of 30% to 60%. - The Soiled or Decontamination Room has negative pressurization and a minimum of 6 ACH and exhaust out. - The Sterile Storage room has a max humidity of 60%. - The Airborne Isolation Room has negative pressurization and a minimum of 12 ACH. - The Trauma Room has positive pressurization and a minimum of 15 ACH. * Engineers will ensure all temperature and humidity changes are reported back to the unit requester. If the equipment is unable to maintain temperature or humidity, the corrective actions taken and the non-compliance information will be reported to the department affected and the facilities manager. Review of the hospital’s P&P titled Air Balance Annual Certification dated August 2023 showed a certified vendor shall test isolation rooms, operating rooms, and identified procedure/sensitive areas at least annually. The results of the test must be documented. Problems found shall be corrected in a reasonable period of time. If the problem(s) prevents the room from providing the standards required, then the room shall not be for that purpose until the condition is corrected. Review of the Annual Crucial Air Area Validation 2025 dated 4/7/25, showed the following outstanding items: - The OR Decontamination Room failed to meet ACH and negative pressurization requirements. The space had zero exhaust. - CATH Lab A failed to meet the CMC for 20 ACH and positive pressurization. - CATH Lab B failed to meet the ACH requirement. - ICU A failed to meet the negative space pressurization requirement. - ICU B failed to meet the ACH and negative pressurization requirements. - ED Trauma failed to meet the ACH and positive pressurization requirements. On 8/21/25 at 1129 hours, an interview and concurrent review of the hospital documents was conducted with the Lead Central Plant and the Corporate Director of Facilities. The Lead Central Plant stated all the necessary repairs were completed internally by facilities with WOs generated on 4/22/25 for OR Decon, CATH Lab A, CATH Lab B, ICU A, ICU B, and ED Trauma. Additionally, on 4/25/25 the Lead Central Plant ordered needed parts for repairs with a contracted service provider making an onsite visit. However, the air balance testing to verify if the rooms were in compliance, was not formally conducted. The Corporate Director of Facilities stated they wanted to make sure all the readings were correct before having the air balance re-tested again. The Corporate Director of Facilities stated a resolution ideally would be within 90 days with the goal of completing the task as soon as possible. The Lead Central Plant stated all the rooms were in use except for CATH Lab A, which was under construction. The above concerns for not timely correcting the above service areas and providing validation testing prior to patient-use per the hospital’s P&P were shared with the Lead Central Plant and the Corporate Director of Facilities. 2. On 8/25/25 at 0938 hours, an inspection of the OR was conducted with RN 5, the Director of Perioperative Services, and the Director of Perinatal Services. Humidity readings were randomly checked and out of range for the following ORs: - OR 3 was at 72.8% humidity level. Staff were present and setting up for a surgical case. - OR 7 was at 83% humidity level. Wrapped instruments were stored in closed cabinets. - OR 11 was at 85% humidity level. Wrapped instruments were stored in closed cabinets. Review of the temperature and humidity logs for August 2025 showed the following: - ORs 1, 2, 3, 4, 6, 7, 8, 9, 11, the OR Sterile Storeroom and the OR’s Inner Core had humidity ranges which had not been documented within the range as 30% to 60% or with a maximum of 60%. “Out of range, Actions Taken” were not consistently documented, nor the “Resolution” of the rooms coming back into a compliant humidity range. During an interview on 8/20/25 at 1131 hours with the Director of Perioperative Services, the Director of Peri-operative Services stated the ORs had fluctuating humidity levels throughout the day. If the humidity level was out of range, each room could be adjusted in the boiler room with a phone call. On 8/20/25 at 1441 hours, an interview was conducted with the Lead Central Plant and the Corporate Director of Facilities. The Lead Central Plant stated not knowing how long the out-of-range humidity in the OR was an issue. Vendors came out previously and determined the reheat coils for each individual room needed to have work done. Additionally, there were plumbing issues of water leakage onto the reheating coils affecting the humidity as well. Review of work orders related to the OR humidity showed the internal work order repairs on 11/6/24, with leak testing performed. A plumbing vendor was onsite on 8/5/25 to repair multiple leaks on a pipe related to the reheating coils. No additional service calls or WOs were provided. The above findings were shared with the Interim Administrator, CQO, CMO and Patient Experience.”

“WRITTEN DESCRIPTION OF SERVICES CFR(s): 482.27(a)(2) A written description of services provided must be available to the medical staff. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet the patient’s care needs as evidenced by: 1. The lactate level for one of 14 sampled patients (Patient 1) was not available within the sepsis protocol time. The lactate level ordered as STAT was assigned a routine priority level. 2. The audit of 30 STAT orders conducted by the hospital as part of the POC addressing previous deficiencies did not include the send-out STAT orders. 3. There was no P&P developed to address the processing turnaround time for send-out STAT laboratory orders. 4. The facility failed to implement its Contingency Plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services. 5. The laboratory failed to follow the P&P for expired quality controls for hematology. These failures created the risk of delayed treatment for the patients. Findings: Review of the hospital’s P&P titled Adult Sepsis Screening dated 3/23 showed the primary care nurse assesses the patient for possible sepsis using the sepsis tab under daily assessment. If the patient exhibits SIRS criteria, the nurse will complete the Sepsis RN Checklist Tool. Upon identification of a positive sepsis screening, the nurse will inform the physician and initiate the sepsis order set. Review of the Sepsis RN Checklist showed the following: * For Sepsis Bundle 4 Hour Checklist, initial lactate level. * For Sepsis Bundle 6 hour Check list, check on second lactic acid, if trending up, or still greater than 2, reassess for need of further fluid resuscitation and repeat lactic acid level. Review of the Contractor Services Agreement dated December 2021, showed in part, “...During the term, Contractor agrees to provide courier Services to Hospital as follows...0600 hours...1500 hours...2130 hours...Any pickups/delivery outside of the routine scheduled pickups, will be charged separately...” Review of the STAT Specimen Handling, Testing, and Reporting dated 3/2025 showed all STAT test results will be made available to the nurse or physician immediately upon verification of the results. The P&P also showed occasionally, a physician will request a test be performed STAT that is not on the attached list. The CSL should consult with a supervisor or the Medical Director to determine the appropriateness of the request. Review of the attachment titled STAT TEST AVAILABILITY dated 2/2025 showed the test turnaround time goal for BNP was less than 45 minutes. The attachment showed, “These TAT goals are very aggressive goals. Instrument performance, staffing, overall workload, and other external factors can have a significant impact on the ability of the lab to meet these goals. Theses TAT goals are applicable to in house testing only and do not apply to send-out testing.” The test menu did not include the lactate level. Review of the hospital’s P&P titled Reagent Extension Procedures dated 3/28/24, showed a “Reagent Extension”, may only be allowed under extreme circumstances in which the inability to perform critical testing would cause serious patient harm or delays in critical treatment or surgery under the direction and discretion of the Laboratory Medical Director. If the Laboratory Medical Director deems a reagent extension necessary, then specific conditions must be met to ensure the accuracy and efficacy of the reagent’s use. The procedure is as follows: - Ensure that a valid requisition exists for the soon to expire reagent. - Attempt to borrow from the local medical centers. If the reagents are borrowed from any site the respective site’s CEO will be informed via email for documentation purposes. In any case, the borrowing of reagents will be documented on the LS Form 018. Document all efforts to borrow. - Attempt to borrow from any contracted services such as blood bank suppliers if possible. Document all efforts in the LS Form 018. - If all effort to secure the necessary reagent is unsuccessful, notify the Medical Director, the Regional Director, and Manager of the need to extend a reagent. - Consult the reagent’s manufacturer to check whether expiration dates have been extended for specific lots. Also, notify manufacturers when testing has been interrupted because of expired test kits and supply shortages. When possible, request the manufacturer to provide a letter of expiration extension for the reagent. - If possible, consult with the medical center’s regulatory agency for guidance and advice as to how to handle a need for reagent extension. 1. On 6/27/25 at 0926 hours, the Laboratory Department was toured with the Quality PI/Review RN. During the tour, Laboratory Technical Assistant 1 was interviewed. Laboratory Technical Assistant 1 stated the reagents for lactate level, Salicylate, BUP, and BNP tests were not available and the specimens were sent to another facility for testing. Laboratory Technical Assistant 1 stated the contracted courier service picked up the specimens routinely and upon request for STAT orders. On 6/27/25, Patient 1’s closed medical record was reviewed and showed Patient 1 was admitted to the hospital on 6/19/25, and discharged on 6/24/25. Review of the ED Provider Aware Note dated 6/19/25 at 2125 hours, showed the patient’s ED diagnosis was septic shock. Review of the Physician’s Order dated 6/19/25 at 2120 hours, showed to test lactate level STAT. Review of the Reference Lab Report dated 6/19/25 at 2155 hours, showed the blood sample for lactate level was collected. On 6/20/25 at 1213 hours, the lactate level result was 2.4 mmol/L (14 hours and 18 minutes after the blood sample was collected). Review of the Status History for the reference lab dated 6/19/25 at 2155 hours, showed the lactate level test ordered as STAT was assigned a routine priority level. Review of the Physician’s Order dated 6/20/25 at 0929 hours, showed to test lactate level routine. Review of the Status History for the reference lab dated 6/20/25 at 1200 hours, showed the lactate level test ordered as routine was assigned a STAT priority level. Review of the Reference Lab Report dated 6/20/25 at 1200 hours, showed the blood sample for lactate level was collected. On 6/20/25 at 2011 hours, the lactate level result was released as 1.8 mmol/L. On 6/27/25 at 1227 hours, the Director of the Laboratory Services was interviewed. The Director of the Laboratory Services stated the priority level of send-out testing would be assigned to the computer as ordered. The Director of the Laboratory Services verified the priority level for the lactate level was not entered correctly. On 6/28/25 at 1124 hours, an interview and concurrent medical record review was conducted with the Quality PI/Review RN. The Quality PI/Review RN verified the sepsis bundle protocol was not followed because the result of the lactate level was not available within the sepsis bundle timeline. 2. The acceptable POC for the survey completed on 2/25/25, showed once a month, the Director of the Laboratory would audit 30 STAT orders to ensure the results were available timely as per hospital policies. Any issues identified would be corrected and the staff would be educated. Records of the audits and any corrective actions would be kept. On 6/27/25 at 0926 hours, the Director of Laboratory Services was interviewed. The Director of Laboratory Services stated the auditing of 30 STAT orders was conducted monthly. The Director of Laboratory Services stated the audits were only conducted for in house STAT orders and not for send-out tests. When asked why the send-out tests were not included in the audit, the Director of Laboratory Services stated there was no policy for the TAT of the send-out STAT orders, so the Director of Laboratory Services was not able to audit the send-out tests. 3. On 6/27/25, a record review was conducted for Patients 4, 5, 6, 7, and 8. a. Patient 4’s medical record showed Patient 4 was admitted to the ED on 6/26/25. Review of the Physician’s Order dated 6/26/25 at 2240 hours, showed to test BNP STAT. Review of the Status History for Patient 4 dated 6/27/25 at 0350 hours, showed the BNP level was high and released five hours and 10 minutes after the blood sample was collected. b. Patient 5’s medical record showed Patient 5 was admitted to the ED on 6/26/25. Review of the Physician’s Order dated 6/26/25 at 1323 hours, showed to test BNP STAT. Review of the Status History for Patient 5 dated 6/26/25 at 2110 hours, showed the BNP level was released seven hours and 47 minutes after the blood sample was collected. c. Patient 6’s medical record showed Patient 6 was admitted to the ED on 6/26/25. Review of the Physician’s Order dated 6/26/25 at 2247 hours, showed to test BNP STAT. Review of the Status History for Patient 6 dated 6/27/25 at 0350 hours, showed the BNP level was high and released four hours and 57 minutes after the blood sample was collected. d. Patient 7’s medical record showed Patient 7 was admitted to the ED on 6/26/25. Review of the Physician’s Order dated 6/26/25 at 0842 hours, showed to test BNP STAT. Review of the Status History for Patient 7 dated 6/26/25 at 1536 hours, showed the BNP level was high and released six hours and 54 minutes after the blood sample was collected. e. Patient 8’s medical record showed Patient 8 was admitted to the ED on 6/26/25. Review of the Physician’s Order dated 6/26/25 at 1523 hours, showed to test BNP STAT. Review of the Status History for Patient 8 dated 6/26/25 at 2112 hours, showed the BNP level was released five hours and 49 minutes after the blood sample was collected. On 6/30/25 at 1309 hours, ED Physicians 1 and 2, and the ED PA were interviewed. ED Physicians 1 and 2, and the ED PA stated the STAT BNP results should be released less than 60 minutes of the test order. When asked if it was acceptable for the STAT lactate level result to be released eight hours from the test order, ED Physicians 1 and 2, and the ED PA stated no. When asked how about four hours from the test order, they stated no. In a concurrent interview, the Quality PI/Review RN stated the facility did not have a P&P for TAT for send-out tests. 4. Review of the hospital’s Continuity of Operations Plan undated showed in part, “Laboratory Continuity of Operations Procedures...Notify physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services...” On 6/27/25 at 0926 hours, the Director of Laboratory Services stated some of the reagents to perform the laboratory testing were not available. The Director of Laboratory Services stated the Director of Laboratory Services communicated the issue to the Administration team via email. Upon request for evidence of reporting, the Director of Laboratory Services provided the email correspondence. Review of the Director of Laboratory Services’ email showed the following: * On 6/10/25 at 0828 hours, the Director of Laboratory Services received an email from the vendor. The email showed the list of orders were awaiting payment processing. * On 6/10/25 at 0852 hours, the email showed the Director of Laboratory Services requested urgent assistance with the invoices and that the Director of Laboratory Services would be initiating a contingency plan for disruption of testing services on that day. The recipients included the CNO and Corporate CFO. On 6/27/25 at 1437 hours, a follow-up interview was conducted with the Director of Laboratory Services. The Director of Laboratory Services stated the Laboratory Services placed supply order requests on 5/31/25, and the Purchasing Department placed final supply orders to the vendor on 6/19/25. The Director of Laboratory Services stated the Director of Laboratory Services followed up with the vendor regarding the order status. On 6/27/25 at 1508 hours, the Director of Laboratory services stated there was no notification to the physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services. 36703 5. On 6/27/25 at 0926 hours, the Laboratory Department was toured with the Quality PI/Review RN. An observation revealed the QC for the hematology testing had expired on 6/14/25. Clinical Laboratory Scientist 1 was interviewed. Clinical Laboratory Scientist 1 stated the QC was to be performed every shift and there were three shifts per day. On 6/27/25 at 1335 hours, an interview and concurrent review of facility documents was conducted with the Director of Laboratory Services. Review of the LS Form 018 dated 6/8/25, showed the variance was for a “Reagent Extension.” The description of the variance showed, “Hematology CBC Quality Control - Beckman Coulter 6C control Levels 1, 2, 3...Expired 6/7/24.” The contributing factors showed, “Materials Management/Accounts Payable “Credit Hold”. The immediate corrective action taken showed, “Running 6C control - Still all values within normal range.” Further review of the document showed the Director of Laboratory Services and Medical Director were notified. The pending corrective action showed, “No.” On 6/13/25, the Medical Director signed the document; however, there was no further recommendations. The Director of Laboratory Services stated there was no documented evidence of other measures attempted as per the P&P to secure the necessary reagents. The Director acknowledged the above findings.”

“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 provide the safe and effective environment and maintain the acceptable standards of care for the patients receiving surgical services as evidenced by: 1. Patient 9’s surgical case was canceled because the instrument requested by the surgeon could not be sterilized. 2. There was no comprehensive written contingency plan for sterilizing the surgical instruments during the weekend. 3. During the SPD tour, a soiled instrument was observed not to be kept moist as per the AORN’s Guidelines. 4. Disposable supplies, which were not intended for reprocessing, were observed in sterilized peel packs. 5. Compromised sterile supplies were identified in the sterile storage room. 6. The OR team failed to perform the Fire Risk Assessment in accordance with the hospital’s P&P. 7. The medical staff failed to perform proper hand antisepsis prior to surgery. 8. The hospital failed to ensure the temperature and humidity in the OR were maintained within range. 9. One expired auto-suture stapler was found stored in the OR 2 cabinet. In addition, an OR mattress with visible tears was in use for patient care. These failures created the potential for poor health outcomes for the patients receiving surgical services in the hospital. Findings: 1. On 7/1/25 at 1142 hours, the Director for Cardiology and Perioperative Services stated the hospital followed the AORN Guidelines for their infection control practices. On 6/30/25 at 0905 hours, the Director for Cardiology and Perioperative Services and Lead SPD Tech were interviewed. As of 6/30/25, the hospital did not have a functional sterilizer. The Director for Cardiology and Perioperative Services stated the hospital’s SPD staff transported the instruments to Hospital A for sterilization, where Hospital A’s SPD staff performed the sterilization. The Director for Cardiology and Perioperative Services stated that SPD staff at Hospital A was unavailable on weekends. The Director for Cardiology and Perioperative Services stated they had to come up with a weekend process. Review of the Interoffice Memo dated 6/25/25, showed the primary autoclave was currently out of service and awaiting replacement parts for repair. As an immediate intervention, the smaller autoclave located in the OR was being serviced and assessed for temporary use to support essential sterilization needs. To maintain the availability of sterile instruments and ensure uninterrupted patient care, the used instruments were being appropriately transported to Hospital A for sterilization and returned in compliance with all infection control and sterilization standards. On 6/30/25, Patient 9’s closed medical record was reviewed and showed Patient 9 was admitted to the hospital on 6/26/25, and transferred to another hospital on 6/29/25. On 6/30/25 at 1030 hours, SPD Tech 1 was interviewed. SPD Tech 1 stated SPD Tech 1 was informed to sterilize the loaner surgical instrument requested by Surgeon 1. SPD Tech 1 informed the OR that Hospital A’s SPD was not open on weekends. On 6/30/25 at 1456 hours, RN 1 was interviewed. RN 1 stated Patient 9’s case was added on 6/28/25 around 1100 hours. However, the surgery was canceled because the instrument requested by the Surgeon could not be sterilized. Review of the Progress Note Dated 6/27/25 at 1758 hours, showed the plan for Patient 9 was to receive the surgery once medically optimized. Review of the DC Planner Progress Note dated 6/28/25, showed to transfer Patient 9 to higher level of care for left hip arthroplasty surgery due to no sterilizer. Review of the DC Planner Progress Note dated 6/29/25 at 1626 hours, showed Surgeon 1 was unaware of the sterilizer issue in the OR. The transfer center would proceed with the patient’s transfer for surgery now that the surgeon was informed. On 7/2/25 at 0925 hours, the Quality PI/Review RN verified the above findings. 2. Review of the CNO’s email dated 6/26/25 at 0825 hours, showed the steps for using the van to transport surgical instruments to Hospital A, included the following: * Wipe down the van surface with antiseptic prior to use to ensure cleanliness. * Double wrap sterilized instruments and remove the outer plastic wrap before placing them on the shelves * Check van temperature, record, and attach reading to the sterilization log from Hospital A before loading and unloading to ensure the van temperature is at 72 to 78 degrees F. * When instruments are used...the patient sticker is attached to load sticker for recording keeping. On 7/1/25 at 0900 hours, the Director for Cardiology and Perioperative Services was interviewed. The Director for Cardiology and Perioperative Services stated Hospital A’s SPD team would train the hospital’s SPD staff. The hospital’s SPD staff would be signed off by the trainer. The SPD staff would use the sterilizers at Hospital A during the weekend. When asked about loaner instruments, the Director for Cardiology and Perioperative Services stated the OR charge nurse would communicate with the vendor and request to bring double trays in case the instruments were dropped. If the vendor was unable to bring a duplicate set of instruments, the patients would be transferred to another hospital. The Director for Cardiology and Perioperative Services verified the memo did not fully address the contingency plan. 3. Review of the AORN’s Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Instrument Cleaning, Recommendation 6.4. showed to keep instruments moist until they are cleaned by using either saturation with an enzymatic pretreatment or a towel moistened with water placed over the instruments. Do not use saline. On 7/1/25 at 1114 hours, the Decontamination area was toured with the Lead SPD Tech and Quality PI/Review RN. The contaminated surgical instrument was observed in the enclosed cart. The Lead SPD Tech stated the instrument in the cart was used during the surgery. The Lead SPD Tech stated the dirty instrument was moist in the OR. However, dry blood was observed on the instrument. The Lead SPD Tech and Quality PI/Review RN verified the finding. 4. Review of the hospital’s P&P titled Sterilization - Packaging Systems, Selection and Use of dated 5/24 showed all items to be sterilized will be packaged in accordance with the AORN’s “Recommended practice for selection and use of packaging systems.” The AORN’s Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Packaging Systems, Recommendation 10.1.2 showed to monitor activities related to selection and use of packaging systems, including the following: * Using packaging systems according to their IFU * Verifying the compatibility of packaging systems with sterilization processes * Storing packaging materials * Assembling, handling, and packaging wrapped, pouched, and containerized items; labeling packages for sterilization On 7/1/25 at 1130 hours, a storage room was toured with the Lead SPD Tech and Quality PI/Review RN. The disposable toothbrushes, cotton balls, and measurement tapes were observed in sterilized peel packs. A request for the IFU to confirm the sterilizability of these items was made. On 7/2/25 at 0925 hours, the Quality PI stated the instructions could not be found. 5. Review of the hospital’s P&P titled Sterilization - Packaging Systems, Selection and Use of dated 5/24 showed to be appropriate to the item(s) being sterilized. The package system will maintain sterility of package contents until opened. The AORN’s Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Sterilization, Recommendation 4.2. showed to establish a process for determining the shelf life of sterilized items. The shelf life should be event-relatedness otherwise specified by the packaging system manufacturer’s labeled expiration date. On 7/1/25 at 1130 hours, a storage room was toured with the Lead SPD Tech and Quality PI/Review RN. It was observed that four peel packs containing sterilized lens paper were labeled with a sterilization date of 8/18/2014. The lens paper was observed to have a light yellowish discoloration. The Lead SPD Tech verified the above findings and stated they should have been discarded. 38660 6. Review of the hospital’s P&P titled Universal Protocol - Comprehensive Surgical Checklist dated 3/24 showed the following: * Fire Risk Assessment is to be completed by the procedure team prior to the time-out and results reported during the time out process. * Follow the Fire Risk Assessment tool on the back for the UP (Universal Protocol) Form * Assign a number to each question: Procedure site or incision above the xiphoid or airway procedure; open oxygen source (face mask/ nasal cannula, LMA (Laryngeal Mask Airway) or ET (endotracheal tube) tube; ignition source (uni-polar cautery, laser, and/or fiber-optic light source). * A score of 1-2 is a low risk and precautions are limited to alcohol drying, removing alcohol from the field, placing the cautery in the holster, and any other actions that may be taken. On 7/1/25, a review of Patient 14’s medical record was conducted and showed the patient was admitted to the hospital for the right thyroid lobectomy surgery. On 7/1/25 at 1515 hours, Patient 14’s intraoperative care in OR 4 was observed. During an observation of the time-out procedure, RN 6 failed to communicate Patient 14’s fire risk assessment to the OR team, which was inconsistent with the hospital’s P&P. The finding was verified with the Quality PI/Review RN. Review of the Intraoperative Record dated 7/1/25 at 1505 hours, showed RN 1 documented the fire risk assessment as 2, signifying a low risk with potential to convert to high risk. An electrosurgical unit was documented in use during the surgery for Patient 14. On 7/2/25 at 1100 hours, an interview was conducted with the Director for Cardiology and Perioperative Services. The Director for Cardiology and Perioperative Services stated a fire precaution assessment was required for all surgeries, and the nurse confirmed the precautions out loud during the time-out procedure. 7. Review of the hospital’ s P&P titled Hand Scrub Procedure, Surgical dated 3/22, showed before donning a sterile gown and gloves for operative or other invasive procedures, perioperative personnel will perform surgical hand antisepsis using a surgical hand antiseptic or an alcohol-based surgical hand rub designed and interned for use as a surgical hand antiseptic and provided by the health care organization. Procedure for brushless, waterless hand antisepsis: - Wash hands and forearms with soap and running water immediately before beginning the surgical hand antisepsis procedure. - Prior to the first case of the day, clean the subungual areas of both hands under running water using a nail cleaner. - Rinse hands and forearm under running water. - Dry hands and forearm under running water. - Dispense one pump (2 ml) of antiseptic hand prep into the palm of one hand. - Dip fingertips of the opposite hand into the hand prep and work it under the fingernails. - Spread the remaining hand prep over the hand and up to just above the elbow, covering all surfaces. - Dispense another pump (2ml) of antiseptic hand prep; repeat above procedure with the other hand. - Dispense final pump (2 ml) of antiseptic hand prep into either hand and reapply to all aspect of both hands up to the wrist. - Rub hands and forearms thoroughly until completely dry. - Allow to dry before donning sterile surgical gown and gloves. During an observation of Patient 14’s intraoperative care in OR 4 on 7/1/25 at 1635 hours, the Surgeon was observed performing surgical hand antisepsis at a sink area outside OR 4 using only waterless hand antiseptic. The surgeon was not observed washing his hands and forearms with soap and running water immediately before beginning the surgical hand antisepsis procedure. Following the observation, the Surgeon entered OR 4 to begin the surgery for Patient 4. The findings were shared with the Quality PI/Review RN. On 7/1/25 at 1700 hours, an interview was conducted with the Surgery Tech in the presence of the Quality PI/Review RN about performing surgical hand antisepsis. The Surgery Tech stated the OR staff performed a 10 minute scrub using soap, water, and antimicrobial scrub agent in the morning; and they used an alcohol based antiseptic surgical hand rub during the day. 8. Review of the hospital’s P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated 10/24 showed high risk and sensitive areas and room require daily monitoring of temperature and humidity in each department level. When temperature or humidity is out of range, the following steps will be taken: Local department will adjust the thermostat and humidistat. After 30 minutes, if not resolved, a work order will be created through the intranet. Record the work order number in the Temperature and Humidity form. If an immediate resolution is needed, call Facilities and reference the work order number. Record the temperature and humidity one hour after Facilities repair and follow-up as needed. Review of the form titled Temperature & Humidity showed the following: * If temperature or humidity is out of range, call engineering * Normal temperature range for OR will be between 68 and 75 degrees F * Normal humidity range for OR will be between 20 to 60% On 7/1/25 at 1300 hours, an observation of ORs 2 and 4 was conducted with the OR Charge Nurse and Quality PI/Review RN. The humidity level in OR 2 was 62.6% and in OR 4, it was 64.7%. During Patient 14’s surgery in OR 4, which began on 7/1/25 at 1611 hours, there was no documented evidence that correction actions were taken when the humidity levels were out of range prior to the surgery. Further review of the Temperature & Humidity form for June 2025 showed the following: * The humidity levels of OR 2 from 6/11 to 6/30/25, were out of range varying from 61.4% to 76%. The work order was submitted on 6/5, 6/20, 6/24, and 6/26/25. The resolution of the issues showed, “none.” * The humidity levels of OR 3 from 6/11 to 6/23/25, and 6/25 to 6/30/25, were out of range varying from 64% to 68.8%. The work order was submitted on 6/20, 6/24, and 6/26/25. The resolution of the issues showed, “none.” * The humidity levels of OR 4 on 6/11- 6/16/25, 6/18- 6/23/25, and 6/25 - 6/30/25 were out of range varying from 61% to 72.4%. The work order was submitted on 6/20, 6/24, and 6/26/25. There was no documented evidence the out-of-range humidity issues were followed up. There was no documented evidence of the correction actions taken to correct the humidity levels when they were out of range. Review of the Surgery Schedule dated 7/1/25, showed two patients were scheduled for surgery in OR 2, and one patient was scheduled for surgery in OR 3. On 7/2/25 at 1400 hours, an interview was conducted with the OR Charge Nurse. The OR Charge Nurse verified the above findings and stated the OR night shift staff would check the temperature and humidity levels in all the ORs. When the temperature and humidity levels were out of range, the night shift staff would call the Facilities to adjust the temperature and humidity and to put in work order. The OR Charge Nurse stated the night shift staff failed to notify the Facilities when the humidity levels were out of range. 9. According to the AORN’s Perioperative Standards and Recommended Practices 2012 Edition, under Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, Recommended Practice 1 showed patients should be provided with a safe, visibly, and clean environment. Health care-associated infections have been linked to external sources, which can include environmental surfaces. Review of the hospital’s P&P titled Storage of Sterile dated 3/24 showed the following: - All sterilized materials are packaged, labeled, and stored in a manner to ensure sterility. - All storage items are rotated according to the principle of “first-in, first-out.” On 7/1/25 at 1300 hours, during an observation of OR 2 with the OR Charge Nurse and Quality PI/Review RN , the following was observed: - The mattress of the OR table was observed with tears. - In the cabinet, one TA Auto-suture Stapler was observed with an expiration date of 5/31/25, and another TA Auto-suture Stapler had no expiration date. The findings were verified with the OR Charge Nurse.”

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the patient’s rights to confidentiality of their medical records as evidenced by: 1. The electronic medical records were secured for two of 10 sampled patients (Patients 2 and 3). 2. The display board in the ED included the ED patients’ full names and laboratory results. These failures had the potential for the unauthorized individuals to access and view the patients’ electronic medical records and violating the patients’ rights. Findings: Review of the hospital’s P&P titled Confidentiality dated January 2020 showed the purpose of the P&P is to ensure that each patient is afforded the right to full consideration of privacy regarding their medical care and confidential treatment of all communications and records pertaining to their care and stay in the hospital. The P&P also showed the following: * Every patient admitted to the hospital has a right to confidentiality. * Patient information and carts should not be left out in areas not attended and supervised by appropriate hospital personnel. 1. On 6/12/25 at 1000 hours, the Med/Telemetry unit was toured with the Director of Med/Telemetry. a. Patient 2’s electronic medical record was observed on the computer screen at the nursing station. Patient 2’s electronic medical record was opened and unattended. b. Patient 3’s electronic medical record was observed on the computer screen at the nursing station. Patient 3’s electronic medical record was opened and unattended. When asked, the Director of Med/Telemetry stated other disciplinary departments such as EVS, rehabilitation staff who had no business with Patients 2 and 3 could enter the nursing station. The Director of Med/Telemetry verified the above findings. 2. On 6/13/25 at 1005 hours, the ED was toured with the Director of Emergency Department. It was observed the ED patients’ log was displayed at nursing station on the big screen. The screen showed each patient’s full name, age, and laboratory report (for one patient). When asked, the Director of Emergency Department stated other disciplinary department which had no business with the patients could see the information. The Director of the Emergency Department verified the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(i) The use of restraint or seclusion must be-- (i) in accordance with a written modification to the patient’s plan of care. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the care plan was updated to reflect the use of violent restraints for one of 10 sampled patients (Patient 1). This failure created the risk of substandard outcomes to the patient. Findings: Review of the hospital’s P&P titled Restraints dated May 2024 showed the use of restraint or seclusion (including drugs or medications used as restraint as well as physical restraint) must be documented in the patient’s plan of care or treatment plan. On 6/12/25, Patient 1’s closed medical record was reviewed. Patient 1’s closed medical record showed Patient 1 was admitted to the hospital on 5/14/25 and left the hospital AMA on 5/15/25. Review of the physician’s order dated 5/14/25 at 0914 hours, showed to apply hard restraints to all limbs; and restraints or seclusion shall be observed at intervals not greater than 15 minutes. Review of the Flowsheets dated 5/14/25, showed the restraints were initiated at 0910 hours and were released at 1240 hours. However, further review of Patient 1’s medical record failed to show the care plan for the use of restraints. On 6/12/25 at 1250 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Emergency Department. When asked, the Director of Emergency Department verified there was no care plan updated for the use of the restraint for Patient 1.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(i) When restraint or seclusion is used, there must be documentation in the patient’s medical record of the following: The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the face-to-face evaluation was performed within one hour of the initiation of the restraints for one of 10 sampled patients (Patient 1). This failure had the potential to result in the unsafe care and poor clinical outcomes to the patient. Findings: Review of the hospital’s P&P titled Restraints dated May 2024 showed when restraint or seclusion is used to manage violent or self-destructive behavior, a physician or other LIP, or a registered nurse or physician assistant trained in accordance with this policy must see the patient face-to-face within one hour after the initiation of the intervention. The P&P also showed the following: * The one hour face-to-face patient evaluation must be conducted in person. A telephone call or telemedicine methodology is not permitted. * The one hour face-to-face evaluation should include both a physical and behavioral assessment of the patient. An evaluation of the patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient’s history, drugs and medication, most recent lab results, etc., as well as to evaluate the patient’s immediate situation, the patient’s reaction to the intervention, the patient’s medical and behavioral condition; and the need to continue or terminate the restraint or seclusion. On 6/12/25, Patient 1’s closed medical record was reviewed. Patient 1’s closed medical record showed Patient 1 was admitted to the hopsital on 5/14/25 and left the hospital AMA on 5/15/25. Review of the physician’s order dated 5/14/25 at 0914 hours, showed to apply hard restraints to all limbs; and restraints or seclusion shall be observed at intervals not greater than 15 minutes. Review of the Flowsheets dated 5/14/25, showed the restraints were initiated at 0910 hours and were released at 1240 hours. However, further review of Patient 1’s medical record failed to show the face-to-face evaluation was conducted within one hour after the initiation of the intervention. On 6/12/25 at 1256 hours, the Director of the Emergency Department verified the above findings.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the nursing staff documented the blood transfusion record as it was ordered and developed the care plan for blood transfusion for one of 10 sampled patients (Patient 6) as per the hospital’s P&P. This failure posed the risk for potential complications, including undetected changes in the patient’s condition, delayed interventions, and overall compromised patient safety during the blood transfusion process. Findings: Review of the hospital’s P&P titled Blood Administration and Transfusion Reactions dated February 2024 showed to record date/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 electronic record. It is critical to correctly document this time as the first 15-30 minutes of a transfusion is when many reactions occur. On 6/13/25, Patient 6’s medical record was reviewed. Review of Patient 6’s medical record showed Patient 6 was admitted to the hospital on 6/6/25. 1. Review of the physician’s order dated 6/12/25, showed to transfuse one unit of PRBC STAT over 30 minutes due to active bleeding. Review of the Blood Bank dated 6/12/25 at 0508 hours, showed the volume of the blood unit was 300 ml. Review of the Blood Administration Record dated 6/12/25 at 0520 hours, showed the following: * Transfusion Start Date/Time: 6/12/25 at 0520 hours * Transfusion Rate: 999 ml/hr (about 18 minute to complete the transfusion one unit or 300 ml blood to the patient) * Transfusion Stop Date/Time: 6/12/25 at 0550 hours (in 30 minutes) On 6/13/25 at 1000 hours, an interview and concurrent review of Patient 6’s medical record was conducted with the Director of ICU. When asked, the Director of ICU verified if the transfusion rate was 999 ml/hr, then the transfusion would have finished earlier than 30 minutes. 2. Review of the hospital’s P&P titled Standards of Nursing Practice, Generic, Critical Care dated August 2024 showed the following: * An individual plan of care will be initiated within the first eight hours of admission. * Measurable and realistic outcome criteria will be identified. * Plan of care will be reviewed every shift. * The Plan of Care will be consistent with the medical plan of care. * 12-hour chart checks will be completed and documented each shift. Review of the Plan of Care dated 6/12/25, failed to show the plan of care for the blood transfusion due to active bleeding was not initiated for Patient 6. On 6/13/25 at 1000 hours, the Director of ICU verified the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to ensure the use of restraints for the management of violent or self-destructive behaviors was renewed within two hours for one of three sampled patients (Patient 1). This failure posed the risk of unnecessary restraint use and substandard outcomes for the patient. Findings: Review of the hospital’s P&P titled Restraints dated June 2024 showed each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be obtained and renewed in accordance with the following limits for up to a total of 24 hours: - Up to two hours for children and adolescents ages 9-17. On 3/19/25 at 1530 hours, review of Patient 1’s closed medical record was initiated. Patient 1’s closed medical record showed the patient came to the emergency department on 2/17/25. The initial physician’s order for restraints to manage the violent behaviors was issued on 2/17/25 at 1755 hours. Review of Patient 1’s Restraint Documentation dated 2/17/25, showed the hard restraints were applied to Patient 1’s bilateral wrists and ankles on 2/17/25 at 1755 hours, and discontinued on 2/17/25 at 2018 hours, for a total duration of 143 minutes (2 hours and 23 minutes). On 3/20/25 at 1005 hours, a concurrent interview and record review was conducted with Director of Emergency Department. The Director of Emergency Department was unable to locate an order renewing the violent restraints for Patient 1 after two hours from the initial order time. The Director of Emergency Department acknowledged an additional order to renew the violent restraints for Patient 1 should have been obtained after two hours. On 3/20/25 at 1420 hours, the Chief Executive Officer, Chief Nursing Officer, and Chief Quality and Patient Safety Officer were notified of the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 45560 Based on interview and record review, the hospital failed to ensure the staff reassessed and monitored one of three sampled patients (Patient 2) as per the hospital’s P&P while Patient 2 was restrained. This failure had the potential to result in unsafe care for the patient. Findings: Review of the hospital’s P&P titled Restraints dated June 2024 showed under the section for Ongoing Assessment of a Patient Placed in Restraint or Seclusion, the ongoing assessment means the patient will be evaluated to determine the patient’s response to the restraint or seclusion and if the patient has any care needs. This assessment shall include checking the patient vital signs, hydration and circulation, the patient’s level of distress and agitation, or skin integrity; and may also provide for general care needs (e.g., eating, hydration, toileting, and range of motion exercises). This assessment shall also determine if the patient continues to require restraint or seclusion. Patients placed in restraint for safety, non-violent, and non-destructive behavior should be assessed at least every two hours. On 3/20/25 at 1330 hours, an interview and concurrent review of Patient 2’s medical record was conducted with the Director of ICU. Patient 2’s medical record showed the patient was admitted to the hospital on 2/28/25. Review of Patient 2’s Order Requisition dated 3/18/25 at 0800 hours, showed an order for the non-violent soft restraints to be applied to Patient 2’s bilateral wrists. The order also showed the patients in non-violent restraints shall be observed at intervals not greater than two hours and documented every two hours. Review of Patient 2’s Restraint Flowsheet dated 3/18/25, showed no restraint monitoring documentation on 3/18/25 from 1000 to 1800 hours (eight hours). During a concurrent interview and record review, the Director of ICU was unable to locate any restraint monitoring documentation for Patient 2 on 3/18/25 from 1000 to 1800 hours. The Director of ICU acknowledged the restraint monitoring documentation for the patients in non-violent restraints should be completed every two hours. On 3/20/25 at 1420 hours, the Chief Executive Officer, Chief Nursing Officer, and Chief Quality and Patient Safety Officer were notified and acknowledged the above findings.”

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the patient’s personal privacy was maintained for one nonsampled patient (Patient A) and the ICU developed the written guidelines for the use of a camera in the patient rooms. These failures had the potential for the patients’ personal privacy to not be protected. Findings: On 12/26/24 at 0904 hours, the ICU was toured with the Director of ICU. One computer monitor with video surveillance of nine patient rooms was observed at the nursing station. Three patients including Patients 3 and A were observed on the monitor. Patient A was observed to be topless on the computer screen monitor. When asked, the Director of ICU stated Patient A had high temperature. When asked, the Director of ICU stated the cameras were not recording and the privacy curtain in the patient’s room would be closed when providing personal hygiene. When asked, the Director of ICU stated staff who did not provide direct patient care, had access to view the monitor since it was located at the nursing station. When Patient 3’s room was toured, the camera and signage (for your safety, closed circuit cameras are in used in this area) was observed on the upper right-hand corner of the ceiling. When asked, Patient 3 stated Patient 3 was not sure what the camera was for, and no staff had talked about it. On 12/26/24 at 1340 hours, a follow-up interview was conducted with the Director of ICU. When requested, the Director of ICU stated the hospital did not have any written guidelines for the use of cameras in the patient rooms.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the patients received care in a safe environment as evidenced by: 1. The known issue of the documented unavailable supply on 7/14/24, by MD 2 was not investigated until 12/31/24. 2. There was no OPPE for the physicians as per the Medical Staff Bylaws. 3. The reappointment and privileges were granted when the qualifications were not met for two physicians (Neurosurgeons 1 and 2). These failures created the risk of substandard healthcare outcomes to the patients in the hospital. Findings: 1. On 12/27/24, Patient 8’s closed medical record was reviewed. Patient 8’s medical record showed Patient 8 was admitted to the hospital on 7/14/24. Review of the ED Provider Aware Note dated 7/14/24 at 1231 hours, showed MD 1 discussed with MD 2 regarding Patient 8’s medical condition. The ED Provider Aware Note showed MD 2 would take care of it later today as MD 2 needed to find a vendor that was able to come in with supplies. Review of the Progress Note dated 7/14/24 at 1555 hours, showed MD 2 called back and stated MD 2 was waiting for the vendor to give him supplies required for surgery that the hospital did not have it available. On 12/31/24 at 1033 hours, the Director of Imaging Services was interviewed in the presence of the Director of Quality. When asked, the Director of Quality stated the above documentation was well known due to the previous survey in 7/16/24. When asked, the Director of Imaging Services stated there was no issue for MD 2 to perform the surgery. There were enough supplies and staff. The Director of Imaging Services also stated the supplies that would be used during the surgery, would be approved by the hospital’s department. MD 2 could not just bring the supplies and performed the surgery. When asked, the Director of Imaging Services stated she was not known what type of supply the MD needed. The Director of Imaging Services and Director of Quality verified the known issues were not investigated until 12/31/24. 2. Review of the hospital’s Medical Staff Bylaws dated 11/22/21, showed under 6.3.2 Ongoing Performance Practice Evaluation (OPPE), all members are subject to ongoing evaluation based on medical staff peer review criteria. Evaluation results are used in privileging, system improvement, and when warranted, corrective action. Department shall develop and routinely update peer review criteria based on current practices and standards of care. At a minimum, departments shall, where relevant, collect and evaluate department members’ data pertaining to: * Operative and other clinical procedure(s) performed and their outcomes * Pattern of blood and medication usage * Morbidity and mortality * Documentation (timeliness, clinical pertinence) Data shall be collected no less frequently than semi-annually on each member. Department Chair analysis shall be conducted and reported monthly to the Medical Executive Committee. Members are kept apprised of reviews of their performance. On 12/31/24 starting at 0921 hours, the credential files of Neurosurgeon 1, Neurosurgeon 2, MD 1, MD 2, and MD 4 were reviewed with the Medical Staff Director. When asked, the Medical Staff Director stated there was no OPPE program. The Medical Staff Director verified the above findings. 3. Review of the hospital’s Department of Surgery Rules and Regulations dated March 2023 showed for Neurosurgery Trauma, voluntary panel unless there is an insufficient number of surgeons to adequately cover the panel as determined by the Director of Neurosurgical Services. The Director will review and reassess coverage needs annually. Members providing coverage will be required to: * Document 16 hours annually of verifiable, external trauma- related CME. * Be regularly involved in the care of head and spinal injury patients by documentation of 20 head cases and 10 spinal cases in the past two years. * Attend 50 % of Trauma Operations Committee and Trauma M&M meetings. On 12/31/24 starting at 0921 hours, Neurosurgeons 1 and 2’s credential files were reviewed with the Medical Staff Director. When asked, the Medical Staff Director stated Neurosurgeon 1 was on the call panel for the neurosurgery trauma. a. Review of Neurosurgeon 2’s credential file showed Neurosurgeon 2 was reappointed on 12/1/2023 and the reappointment would be expiring on 11/30/2025. Review of the Clinical Privileges for Neurosurgeon 2 showed Neurosurgeon 2’s privileges status was Class I, meaning unrestricted privilege and the following: * Maintenance of privileges at reappointment for Level 2 - spinal, peripheral nerve & extracranial vascular privileges required three cases of carotid endarterectomy. * Maintenance of privileges at reappointment for Level 3 - functional and stereotactic radiosurgery privileges required six cases of endoscopic third ventriculostomy. There were no recorded cases performed for carotid endarterectomy and endoscopic ventriculostomy for Neurosurgeon 2. b. Review of Neurosurgeon 1’s credential file showed Neurosurgeon 1 was reappointed on 8/1/23 and the reappointment would be expiring on 7/31/25. Further review of the Neurosurgeons 1’s credential file showed the following: * There was no evidence of 16 hours annually of verifiable, external trauma related CME for Neurosurgeon 1. * No attendance record of Trauma Operations committee and Trauma M&M meetings for Neurosurgeon 1. The Medical Staff Director verified the above findings.”

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the electronic medical record was secured for two of 12 sampled patients (Patients 3 and 7). This failure had the potential for unauthorized individuals to access and view the patients’ electronic medical records and violating the patients’ rights. Findings: Review of the hospital’s P&P titled Patient Rights, Responsibilities, and Ethics dated September 2024 showed the patient has the rights to the confidential treatments of all communications and records pertaining to the care and stay in the hospital. On 12/26/24, the ICU was toured with the Director of ICU. 1. At 0915 hours, Patient 4’s electronic medical record was observed on the computer screen. Patient 4’s electronic medical record was opened and unattended. 2. At 0925 hours, Patient 7’s electronic medical record was observed on the computer screen. Patient 7’s electronic medical record was opened and unattended. The Director of ICU verified 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 observation, interview, and record review, the hospital failed to ensure the nursing staff developed the care plan for camera monitoring for one of 12 sampled patients (Patient 3). This failure created the risk of not providing necessary care and services to meet the care needs for the patients. Findings: On 12/26/24 at 0904 hours, the ICU was toured with the Director of ICU. One computer monitor with video surveillance of nine patient rooms was observed at the nursing station. Patient 3 was observed on the monitor. When Patient 3’s room was toured, the camera and signage (for your safety, closed circuit cameras are in used in this area) was observed on the upper right-hand corner of the ceiling. When asked, Patient 3 stated Patient 3 was not sure what the camera was for, and no staff had talked about it. On 12/26/24 at 1228 hours, Patient 3’s medical record was reviewed with the Director of ICU. Patient 3’s medical record showed Patient 3 was admitted to the hospital on 12/25/24. Patient 3’s medical record did not show a care plan for camera monitoring. The Director of ICU verified the above findings.”

“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: 35310 Based on observation, interview, and record review, the hospital failed to ensure: 1. The medications were administered as per the hospital’s P&P for one of 12 sampled patients (Patient 2). 2. The medications were not left unattended. These failures created the risk of medication errors and poor health outcomes to the patients. Findings: Review of the hospital’s P&P titled Storage & Security of Medications dated June 2024 showed the medications are not permitted to be stored at the patient’s bedside. Review of the hospital’s P&P titled Tube Feeding, Protocol for Enteral Nutrition (Adult) dated April 2022 showed the following: * Administer each medication separately. * Prior to administering medication, stop the feeding and flush the tube with at least 15 ml water. * Flush tube with at least 15 ml water between medication administrations. 1. On 12/26/24 at 0920 hours, RN 3 was observed administering the medications to Patient 2 with the Director of ICU. Patient 2 was observed receiving the enteral tube feeding. RN 3 was observed crushing all four medications (Vitamin C [a supplement], amiodarone [an antiarrhythmic, a medication used to treat abnormal heart rhythm], lisinopril [a medication used to treat high blood pressure], and carvedilol [a medication used to treat high blood pressure and heart disorder]) in a medication bag. RN 3 left the crushed medications at bedside unattended and then returned with sterile water. RN 3 mixed the crushed medications with sterile water. RN 3 checked the placement of feeding tube by auscultating and injecting air with a syringe into the feeding tube. RN 3 administered all the mixed medications via the enteral tube without flushing the tube with at least 15 ml of water. 2. On 12/26/24 at 0925 hours, during a tour of the ICU with the Director of ICU, a computer in WOW was observed on the hallway. Beside the WOW, two bags of D5 in water (Dextrose 5%, a type of IV solution) and sodium bicarbonate (electrolytes) 8.4% 50 ml and two bottles of sodium polystyrene sulfonate (a medication used to treat high levels of potassium in the blood [a mineral]) 15 g/60 ml were observed unattended. The Director of ICU verified the above findings.”

“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: 29798 Based on interview and record review, the hospital failed to maintain the adequate blood product inventory levels as per the hospital’s P&P. This failure posed the risk to patient safety. Findings: Review of the hospital’s P&P titled Blood Product Inventory Management dated 9/16/24, showed in part: * Scope: Trained Blood Bank Staff. * Purpose: It is the responsibility of the Blood Bank Technologist on all shifts to maintain the adequate blood product inventory levels to meet the needs of our patient. The CLS will provide adequate supplies of blood for routine and emergency use while minimizing outdating. * Policy: The CLS will provide adequate supplies of blood for routine and emergency use while minimizing outdating. * Procedure: B. Ordering Blood Components: - In cases of blood shortages, blood products may order from American Red Cross (ARC) and San Diego Blood Bank (SDBB). Inventory levels are evaluated and recorded daily. - Minimum and maximum inventory levels are established (refer to current inventory worksheet) and stock levels are based on the established maximum level. C. Inventory Levels 1. RBC: Type Minimum O Pos 20 O Neg 6 A Pos 20 A Neg 4 B Pos 6 B Neg 2 2. Fresh Frozen Plasma: No Rh preference. Group O 10 Group A 10 Group B 10 Group AB 4 3. Pooled Cryoprecipitate: No Rh preference. Group O 1 Group A 1 Group B 1 Group AB 1 5. Liquid Plasma A and Liquid Plasma B are ordered daily for a quantity of five each, if available. D. Notes: - If possible, always keep 6 units of Platelets available at all times. If the platelet is down to 3 units make sure to place an additional 3 units ASAP. On 10/31/24 at 1005 hours, an interview with concurrent review of Patient 1’s medical record was conducted with the Blood Bank Supervisor. Patient 1’s medical record showed the patient was admitted to the hospital on 9/26/24. Patient 1’s medical record showed the patient had multiple blood transfusions on 9/26/24. Review of the Daily Blood Product Inventory Management form dated 9/23/24, did not show Liquid Plasma A (LP-A) and Liquid Plasma AB (LP-AB) were ordered for a quantity of five each as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 9/24/24, did not show the adequate numbers of RBC A Negative and A Positive, LP-A, and LP-B were on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 9/25/24, did not show the adequate numbers of RBC A Negative, A Positive, LP-A, and LP-B were on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 9/26/24, did not show the adequate numbers of RBC A Negative, A Positive, O Negative, LP-A, and LP-B were on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management forms dated 9/27, 9/28, 9/29, and 10/8/24, did not show the adequate numbers of RBC O Negative were on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 9/29/24, did not show the adequate number of LP-A was on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management forms dated 10/8, 10/9, and 10/12/24, did not show the adequate numbers of RBC O Negative and LP-AB were on supply as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 10/27/24, did not show the adequate number of LP-AB was available as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 10/31/24, did not show the adequate numbers of RBC A Negative, A Positive, B Positive, O Positive, LP-A, and LP-AB were available as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management forms dated 11/1 and 11/2/24, did not show the adequate numbers of RBC A Negative, LP-A, and LP-AB were available as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management form dated 11/3/24, did not show the adequate numbers of LP-A and LP-AB were available as per the hospital’s P&P. Review of the Daily Blood Product Inventory Management dated 11/4/24, did not show an adequate number of RBC B Negative and O positive, LP-A, and LP-AB were available as per the hospital’s P&P. On 11/4/24, the above findings were verified by the Blood Bank Supervisor and Chief Quality Officer.”

“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: 22553 Based on interview and record review, the hospital failed to ensure a specialty bed was provided to one of five sampled patients (Patient 1) as per the hospital’s P&P. This failure created the increased risk of poor health outcomes to the patient. Findings: Review of the hospital’s P&P titled Skin Integrity dated June 2024 showed the purpose of this P&P is to provide the guidelines for the care of the patient with wounds and/or pressure injuries; to define interventions for prevention of pressure injury; to provide educational information for prevention and treatment for pressure injuries, wounds, and those patients at risk for developing aimed at all healthcare providers. Patients with a pressure injury (PI), suspected PI or who are identified at risk for skin breakdown (Braden scale is 16 or less than 16) shall have the appropriate interventions and documented. Initiating and maintaining pressure prevention strategies may include but are not limited to inquiring about placement onto a specialty surface as appropriate (see Attached B). Review of the Attachment B showed the Integrated Pressure Relief Surface with Advance Micro-Climate Management and Active Therapy Citadel C200 Therapy System with Skin IQ Cover is the bed that can be used for patient with Deep Tissue Injury (DTI) on the trunk and pelvis. According to the National Pressure Injury Advisory Panel, a pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. A Deep Tissue Pressure Injury the intact or non-intact skin with localized area of persistent non-blanchable deep red, maroon, purple discoloration or epidermal separation revealing a dark wound bed or blood filled blister On 10/9/24 at 0859 hours, the ICU was toured with the CNO, Director of ICU, Director of Quality, Quality PI/ Review RN, ICU Charge Nurse 1, ICU Educator, and ICU RN 1. ICU Charge Nurse 1 stated Patient 1 was admitted to the ICU on 9/24/24 due to the respiratory distress; the patient’s Braden Scale was 10. The patient received wound care services due to having multiple skin issue including a community acquired pressure injury to the sacrum. The patient was on a basic Stryker bed (a type of bed) and was waiting to have a Citadel bed (a specialty mattress provides an integrated pressure redistribution surface). Review of Patient 1’s medical record was initiated on 10/9/24. Review of the Wound/Burn Treatment Note signed on 8/29/24 at 0706 hours, for the date of service as of 8/27/24, showed Patient 1 had a suspected DTI to the sacrum. The recommendations included to use the pressure reduction mattress. Review of the Wound/Burn Treatment Note dated 10/8/24 at 1724 hours, showed Patient 1 had a suspected DTI with open skin to the sacrum. Review of the Progress Note dated 10/8/24 at 0800 hours and 10/9/24 at 0800 hours, showed a Citadel bed was requested and was not available. The charge nurse and Director were aware. On 10/9/24 at 1316 hours, during a follow-up interview with the Director of ICU, the Director of ICU stated she was aware of the request and addressed the issue during the morning leadership safety huddle. The Director of ICU stated the morning leadership safety huddle included all department leaders, was informal, and no notes were documented. She stated the hospital did not track or trend the locations or usage of specialty beds. The Director of ICU stated that the directors could have used the Management Text to communicate with other units about specialty bed availability, but there was no documented evidence that a text was sent to request a specialty bed for Patient 1. On 10/9/24 at 1316 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Wound Care Consultant (WCC). The WCC stated the most recent evaluation and treatment for Patient 1 was on 10/8/24. The WCC stated the initial wound consult for the patient was on 8/27/24; the patient had a community acquired pressure injury to sacrum; and the recommendation was to use a pressure reduction mattress. On 10/9/24 at 1528 hours, an interview was conducted with the Director of Material Management regarding to the request for Citadel bed. The Director of Material Management stated if they received a request for that mattress, the vendor could provide it in four to six hours. When asked, the Director of Material Management could not locate the request of a Citadel bed for Patient 1.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 35310 Based on observation, interview, and record review, the GB failed to assume full responsibility for determining, implementing, and monitoring policies governing the hospital’s functions to ensure compliance with CoPs under 482.21 (QAPI) and 482.42 (Infection Control) as evidenced by: 1. Failure to ensure the hospital - wide, data-drive, effective QAPI program was implemented and maintain. Cross reference to A263. 2. Failure to ensure the sanitary environment and the active IC program. Cross reference to A747. 3. The GB failed to ensure that consistent temperature and humidity parameters were defined in the hospital’s P&P for the perioperative services. Review of the hospital’s P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 showed the temperature and humidity within all operative and invasive procedure areas will be monitored daily and maintained as follows: * Clean workrooms: 68 to 73 degrees F. * Decontamination Areas: 60 to 73 degrees F. * SPD/OR sterile storage areas: 75 degrees maximum. Review of the hospital’s P&P titled Temperature, Humidity, and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range and air cycle and pressure relationship requirement. Further review of the hospital’s P&P showed the temperature range levels are as follows: * Clean workrooms: 72 to 78 degrees F. * Soiled or decontamination room: 72 to 78 degrees F. * Sterile storage: 72 to 78 degrees F. Review of the SPD Clean Workroom Daily Temperature Record showed the temperature level should be between 68 degrees F to 73 degrees F. Review of the SPD Decontamination Area Daily Temperature Record showed the temperature level should be between 60 to 73 degrees F. Review of the SPD Sterile Storage Daily Temperature Record showed the temperature level should be less than 75 degrees maximum. On 9/9/24 at 1411 hours, the IC Manager was interviewed with the presence of the Director of Quality. When asked, the IC Manager stated the new P&P titled Temperature, Humidity, and Ventilation Requirement in Health Care Facility dated 8/23/24 was for the hospital-wide, but the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 was for the perioperative areas. The SPD staff followed the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 when monitoring the temperature level in the SPD. The IC Manager stated the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 was in the process of removing it and new P&P should have been adopted in the SPD. The IC Manager and Quality Director verified the above findings. During the meeting with the GB, the CEO and Chief Quality and Patient Safety Officer on 9/11/24 at 1004 hours, the CEO and Chief Quality and Patient Safety Officer verified the above findings were ultimately GB’s responsibility. The cumulative effect of these systemic practice resulted in the GB’s inability to provide high quality healthcare to the patients in a safe environment.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure the hospital - wide, data-drive, effective QAPI program was implemented and maintain as evidenced by: 1. Failure to ensure the QAPI program included an ongoing program related to the IC in the perioperative area. Cross reference to A273. 2. Failure to ensure the sanitary environment and the active IC program. Cross reference to A747. The cumulative effect of these systemic failures resulted in the hospital’s inability to implement and maintain a QAPI program designed to maximize the quality healthcare in a safe environment.”

“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 the active IC program as evidenced by: 1. The hospital failed to ensure the IC 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 IC staff provided sufficient oversight the IC issues related to the perioperative services. Cross reference to A772. The cumulative effect of these systemic failures resulted in the hospital’s inability to minimize the risk of spread of infections in the hospital.”

“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 their QAPI program included an ongoing program related to the IC in the perioperative area. This failure created the increased the risk of poor health outcomes for the patients receiving care in the hospital. Findings: Review of the hospital’s P&P titled Organization-Wide Quality Assessment and Performance Improvement Program dated March 2024 showed the following: * The Quality and Regulatory Compliance department shall be responsible to be support the organization’s Quality Improvement principles, strategies, priorities, approach, and methodologies, which includes but is not limited to the following tasks: - To maintain the database for all QAPI activities including quality improvement teams, departmental quality measures, medical staff quality and peer review activities. - To provide reports using statistical tools & techniques to analyze and display data. -To compares internal data over time to identify patterns, trends and variations. * The Department Leaders are accountable for the quality and safety of care/services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the quality and safety of care provided in their departments. - Directors will communicate opportunities for improvement for prioritization. - Directors will promote the development of standards of care and criteria to objectively measure the quality and safety of care/services rendered in their departments. - Report QAPI data and actions taken as appropriate. - Communicate the status of departmental quality, patient safety, and survey readiness initiatives regularly to departmental staff members. During an observation, interview, and record review from 9/9/24 to 9/11/24, the following deficient practice was identified: 1. The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle due to unavailability of the sterilizers. Cross reference to A749, example #8. On 9/10/24 at 1129 hours, the Director for Cardiology and Perioperative Services and IC Manager were interviewed. When asked, the Director for Cardiology and Perioperative Services stated he reported to the facility department for the unavailability of the sterilizers. However, the Director for Cardiology and Perioperative Services did not communicate with IC or QAPI committees. When asked, the Director for Cardiology and Perioperative Services stated he was not aware of the inappropriate transporting surgical equipment to Hospital A. 2. The temperature in SPD decontamination area was not monitored and maintained as per the hospital’s P&P. Cross reference to A749, example #11. On 9/9/24 at 1411 hours, the IC Manager verified the temperature of the SPD decontamination area had been consistently out of range. However, the IC Manager was not aware of it. Review of the Quality/Patient Safety Council dated 8/27/24, failed to show the above issues were addressed.”

“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: 35310 Based on observation, interview, and record review, the hospital failed to ensure the hospital’s environment and equipment were maintained in a safe and sanitary manner as evidenced by: 1. The physical environment in the SPD was not in good repair at all times. 2. The broken equipment were observed in the OR hallway. And there was no action taken when the work orders for those broken equipment were placed on 8/24/24 and 9/3/24. 3. The surgical equipment in OR 3 was not maintained in a sanitary condition. These failures could create the increased risk of unsafe environment and safety for patients, staff, and visitors. Findings: 1. On 9/10/24 at 1031 hours, the SPD Clean work area was toured with the SPD Supervisor, IC Manager, Quality PI/Review RN, and Director of Quality. The followings were identified: a. The flooring in front of Sterilizer #3 was stripped off in two vertically parallel lines, exposing the subflooring beneath. b. The vent and the surrounding wall below Sterilizer #3 had matted collections of dark dust matter. c. The inside door of the Sterilizer #3’s chamber was observed with residual burnt and dry tape. d. The dust accumulation was observed on the margin between the door and the door jamb for Sterilizer #3. e. The pipe underneath of Sink #2 in the decontamination room was observed with green substances. f. In SPD clean work area, Sterilizer # 4 was observed with rust and dust accumulation. When asked, the SPD Supervisor stated Sterilizer # 4 was not functioning more than five years. The IC Manager stated she recommended to put the barrier over Sterilizer #4 when she performed EOC round in August 2024. 2. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager and OR Charge Nurse 1. The following was observed: * Three Mayo stands were observed in the OR hallway behind the red line (semi-restricted area). The work order was posted on the Mayo Stands. Review of the Work Order Details dated 8/26/24 at 1400 hours, showed “Biomed: Please print this for your records, reference, or attach it to the equipment needing repair.” The Work Order Details showed the problem description was the three mayo stands not going up or down. * Three stepping stools were observed in the OR hallway behind the red line (semi-restricted area). The work order was posted on one of the stepping stools. Review of the Work Order Details dated 9/3/24 at 1856 hours, showed “Biomed: Please print this for your records, reference, or attach it to the equipment needing repair.” The Work Order Details showed the problem description was three stepping stools with uneven/unbalanced bottom. The IC Manager and OR Charge Nurse 1 verified the above findings. 3. During a tour of OR 3 with the IC Manager and OR Charge Nurse 1 on 9/10/24 at 1005 hours, the following were observed to be rusty. * Three ring stands wheels * Back table wheels * IV pole wheels * Two stools wheels The IC Manager and OR Charge Nurse 1 verified 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 IC 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. The GI staff performed the endoscope cleaning by manually flushing channels and HLD without documented competency. In addition, the hospital’s P&P related to the endoscope cleaning did not address the manual HDL to guide the staff on how to perform the manual HLD for the endoscopes. 2. The GI cleaning room did not have the minimum two decontamination sinks as per AORN’s guidelines. 3. The GI staff failed to verbalize the drying step for the scope cleaning prior to the HLD as per the hospital’s P&P. 4. The Wavicide-01 (a high-level disinfectant) MEC Strips Indicator was not used as per the manufacturer’s IFU. 5. The Wavicide-01 solution temperature was not maintained as per manufacturer’s IFU. 6. The GI staff did not wear appropriate PPE during the scope cleaning as per the AORN’s Guidelines. 7. There was no cleaning verification test to verify the manual cleaning efficacy for the scopes that were identified as high risk as per AORN’s guidelines. 8. The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle. 9. There was limited quantity of surgical equipment that was frequently used for surgical procedure. 10. The SPD physical environment was not maintained in sanitary condition. 11. Temperature in SPD decontamination area was not monitored and maintained as per the hospital’s P&P. 12. OR 6’s humidity level was not maintained as per the hospital’s P&P. 13. There no clock or timers for surgical scrub sinks between OR 1 and OR 2. 14. Staff crossed the red line in OR area without appropriate attires. 15. The surgical equipment in OR 3 was not maintained in a sanitary condition. These failures had the potential for spread of infections and negative impacts to the patients’ health conditions. Findings: On 9/9/24 at 0915 hours, the Director for Cardiology and Perioperative Services was interviewed. When asked, Director for Cardiology and Perioperative Services stated the hospital followed the AORN’s Guidelines as their practice for the perioperative services including OR and GI services. 1. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated the GI department had 10 scopes, including four scopes used for upper GI procedure, three scopes used for colonoscopy procedure, one scope used for ERCP procedure, one scope used for pediatric, and one bronchoscope to be reprocessed in GI cleaning room. When asked, GI Tech 1 stated two AER machines were not in use since June of 2024 and the Scope Buddy was not in function since July of 2024. When asked, GI Tech 1 stated he performed manual flushing into the scope chambers and manual HLD. Review of the hospital’s P&P titled Endoscopes-Cleaning of Flexible dated March 2022 showed the procedure includes the automated reprocessing-high level disinfection. However, the P&P did not address the manual HLD to guide the staff on how to perform the manual HLD. Review of the Olympus’s OnTrack Reprocessing In-Service/Customer Competency for the Endoscope showed the steps of manual HLD were not demonstrated because GI technicians would be using a non-Olympus automated endoscope reprocessing unit to perform these steps. When requested the documented competency for the manual HDL for three GI technicians, the hospital was not able to provide it. 2. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 3. Sterile Processing Area, endoscope processing areas should have a minimum of two decontamination sinks or sink basins, preferably three, that are deep and wide enough to allow complete submersion of the endoscope without tight coiling. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. The following was observed: * The Endoscope Cleaning Guide was observed posted on the wall next to the sink. Review of the Endoscope Cleaning Guide showed precleaning, leakage testing, manual cleaning, rinsing are steps to clean an endoscope. The steps for rinsing include to immerse the entire instrument in clean water and gently agitate to rinse after the manual cleaning. * It was observed there was only one compartment sink in the GI cleaning room. When GI Tech 1 was asked to demonstrate how to clean the used scope, GI Tech 1 demonstrated it with one compartment sink. GI Tech 1 stated he drained all the water from the sink after the manual cleaning the scopes and filled up the water in the same sink to rinse the scopes. When asked, GI Tech 1 stated he did not clean the sink after draining water for the manual cleaning steps and before filling up the water for the rinsing steps. On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 3. Review of the hospital’s P&P titled Endoscopes- Cleaning of Flexible dated March 2022 showed the procedure of cleaning an endoscope include precleaning, transporting, leak testing, manual cleaning, inspection, and automated reprocessing - HDL. The manual cleaning section showed to dry the exterior surfaces of the endoscope with a soft, lint-free cloth and purge all channels with instrument air. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated he performed manual scope cleaning prior to HLD. GI Tech 1 was asked to demonstrate the manual scope cleaning in the sink. GI Tech 1 stated after the rinsing the scope in the sink, the scope would be transferred for HLD. When asked, GI Tech 1 stated he did not dry the exterior surfaces of the scope prior to the HLD. On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 4. Review of the manufacturer’s IFU for Wavicide-01 MEC Strips Indicator showed to dip the strip in the test solution for one second, remove the excess solution by gently shaking the strip. compare the strip color with the color blocks at 30 seconds. Review of Wavicide MEC Indicator Log for September 2024 showed 30 seconds between the test start time and test end time. On 9/10/24 at 1344 hours, the area for HLD GI cleaning was toured with the CN in PACU and GI Tech 1 in the presence of the Director of Quality, Quality PI/Review RN, and IC Manager. GI Tech 1 was asked to demonstrate how to use Wavicide-01 MEC strips indicator. GI Tech 1 demonstrated dipping the Wavicide - 01 MEC strip into the solution for 30 second. GI Tech 1 stated he was checking the time with his own watch. When asked, GI Tech 1 stated he was told to dip the Wavicide - 01 MEC strip in the solution for 30 seconds. The CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 5. Review of the manufacturer’s IFU for Wavicide-01 showed the Wavicide-01 is a high level disinfectant when used according to directions at full strength and 22 degrees C with an immersion time of at least 45 minutes. Review of the Wavicide MEC Indicator Log for September 2024 showed the solution temperature would be from 20 to 22.5 degrees C. the following: * On 9/3/24, the solution temperature was 23.5 degrees C. * On 9/4/24, the solution temperature was 24.2 degrees C. * On 9/5/24, the solution temperature was 25.2 degrees C. * On 9/6/24, the solution temperature was 25.0 degrees C. * On 9/7/24, the solution temperature was 25.9 degrees C. * On 9/8/24, the solution temperature was 23.9 degrees C. * On 9/9/24, the solution temperature was 24.2 degrees C. * On 9/10/24, the solution temperature was 24.0 degrees C. Further review of the Wavicide MEC Indicator Log failed to show if there was any action taken when the above tested solution temperature level was higher than the temperature level instructed by the manufacturer. On 9/11/24 at 1100 hours, the Director of Quality and IC Manager verified the above findings. 6. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 4. Personal Protective Equipment, personnel working in the decontamination area of the endoscope processing room should wear PPE that corresponds with the degree of anticipated exposure, including general purpose utility gloves with fitted cuffs that extend beyond the cuff the gown and preferably that extend to the elbow. Examination gloves may be worn underneath the decontamination gown and utility gloves with extended cuffs. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. GI Tech 1 was asked to demonstrate the manual scope cleaning. GI Tech 1 demonstrated the PPE that he would wear prior to the manual scope cleaning. GI Tech 1 stated he would use regular disposable Nitrile gloves. 7. Review of the AORN’s Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 9. Cleaning Verification and Inspection, using cleaning verification tests to verify manual cleaning of flexible endoscopes before sterilization of HLD when new endoscopes are purchased and at established intervals (eg, after each use, daily). 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. Cleaning effectiveness may be evaluated by testing for one or more of following: ATP, protein, carbohydrate, and hemoglobin. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated there was no such cleaning verification tests to verify manual cleaning of endoscopes. On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 8. On 9/10/24 at 1129 hours, the Lead SPD Technician was interviewed in the presence of the Director for Cardiology and Perioperative Services, Director of Quality, and IC Manager. When asked, the Lead SPD Technician stated she had transported the packaged items to be sterilized via her private vehicle, sterilized them at Hospital A, and transported back to the hospital via her private vehicle when three low temperature sterilizers could not use due to lack of proper cassettes. When asked, the Lead SPD Technician stated OR Charge Nurse 2 instructed to do so. The Director for Cardiology and Perioperative Services stated OR Charge Nurse 2 was no longer working in the hospital. On 9/11/24 at 1110 hours, SPD Tech 1 was interviewed in the presence of the Director of Quality, Quality PI/Review RN, and IC Manager. When asked, SPD Tech 1 stated she had transported the packaged items to be sterilized via her private vehicle, sterilized them at Hospital A, and transported back to the hospital via her private vehicle on 9/7/24. When asked, SPD Tech 1 stated OR Charge Nurse 3 instructed to do so. When asked, SPD Tech 1 stated the sterilizer at Hospital A was not the same sterilizer she used at the hospital. SPD Tech 1 stated there was no one at Hospital A’s SPD clean work area. SPD Tech 1 stated that she had to follow the steps showing on the sterilizer monitor. Review of the Multi-Record Envelope dated 9/7/24, showed Hospital A’s Sterilizer #3 was used to sterilize four Stryker HD Camera, seven Stryker batteries, and one Olympus Lens tray. On 9/11/24 at 1400 hours, the Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 9. On 8/21/24, the hospital reported to the CDPH that an unprocessed power drill was used during the surgical procedure for Patient 5. On 9/9/24, Patient 5’s medical record was reviewed. Patient 5’s medical record showed Patient 5 was admitted to the hospital on 8/19/24. Review of the Operative Report dated 8/19/24, showed Patient 5 presented as critical trauma with multiple injuries including a traumatic amputation of his left leg. The patient was brought emergently to the OR after being informed of need for emergent surgery. Review of the IntraOp Record dated 8/19/24 at 0454 hours, showed Patient 5’s surgical procedure was started on 8/19/24 at 0415 hours and ended on 8/19/24 at 0531 hours. The form showed “All sterile supply packaging verified as acceptable condition for use in a surgical procedure.” On 9/9/24 at 0828 hours, the Director for Cardiology and Perioperative Services was interviewed. When asked, the Director for Cardiology and Perioperative Services stated there were two large power head drill; but being a trauma center, the head drill was frequently used at the hospital. One power head drill was broken and there was only one large power head drill was available. The Director for Cardiology and Perioperative Services stated on 8/19/24, the OR Nurse picked up the surgical tray including the large power head drill, which was not sterilized yet and used it for the patient’s surgical procedure. On 9/9/24 at 0846 hours, the SPD clean work area was toured with the SPD Supervisor, Lead SPD Technician, Director for Cardiology and Perioperative Services, and Quality PI/Review RN. When asked, the SPD Supervisor stated the surgical tray which included the large power head drill, was placed on the table to be sterilized next morning. On 9/11/24 at 1110 hours, SPD Tech 1 was interviewed. When asked, SPD Tech 1 stated only one large power head drill was available at the hospital. SPD Tech 1 sated the drill was sterilized almost every day due to high frequent usage. On 9/10/24 at 1310 hours, the Chief Quality and Patient Safety Officer was interviewed with the Director of Quality. When asked, the Chief Quality and Patient Safety Officer stated only one available large power head drill was one of the contributing factors for the event. 10. The SPD physical environment was not in sanitary condition at all time. Cross Reference to A 724, example #1. 11. Review of the hospital’s P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range, and air cycle and pressure relationship requirement. The local department will adjust the thermostat and humidistat. After 30 minutes, if not resolved, a work order will be created through the intranet. Record the work order number in the Temperature and Humidity form. If immediate resolution is needed, call facilities and reference the work order number. Record the temperature and humidity one hour after facilities repair and follow-up as needed. Individual departments are responsible to record accurate relative temperature and humidity readings and corrective actions responses. The P&P showed the temperature of the soiled or decontamination room should be between 72 to 78 degrees F. During a tour of the decontamination area on 9/9/24 at 1413 hours with the Quality PI/Review RN, it was observed the temperature level was 80.4 degrees F in the decontamination room. Review of the SPD Decontamination Area Daily Temperature Record for August and September 2024 showed the temperature level was out of range, the temperature level was too high, notified the facilities, and order was placed. Further record review showed there was no temperature level documented at all for whole month of August and September 2024. Review of the Work Order Details dated 6/25 and 7/12/24, showed the temperature level was too high in decontamination area. During an interview with the Lead SPD Technician on 9/10/24 at 1129 hours in the presence of the Director for Cardiology and Perioperative Services, Director of Quality, and IC Manager, the Lead SPD Technician stated the SPD decontamination was operated when the temperature level was out of range for August and September 2024. On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings. 12. Review of the hospital’s P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range, and air cycle and pressure relationship requirement. The P&P showed the OR’s humidity level should be 20 to 60%. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, Director of Quality, and OR Charge Nurse 1. OR 6 was in use. OR Charge Nurse 1 was asked to verify the temperature and humidity levels in OR 6. OR Charge Nurse 1 stated OR 6’s humidity level was 71.6%. 13. Review of the manufacturer’s IFU for BD E-Z Scrub 205 (Providone-Iodine) showed the following: * Clean under nails with nail pick. * Wet hands and forearms. * Scrub thoroughly for three minutes paying particular attention to the nails, cuticles, and interdigital spaces. * Rinse thoroughly. * Repeat scrub for three more minutes. * Rinse thoroughly. 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 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, Director of Quality, and OR Charge Nurse 1. The double scrub sinks were observed between OR 1 and OR 2. Two types of scrubs (BD E-Z Scrub 205 and 107) were observed above the sink. When asked, OR Charge Nurse 1 stated the physicians and scrub techs were to manually scrub for the first surgical case, but they could use Avagard Antiseptic Surgical Hand Scrub between cases. It was also observed no timer or clock near or on the sinks. When asked how the physicians and scrub techs were ensure for three minutes scrub times as per the manufacturer’s IFU, OR Charge Nurse 1 was not able to answer. 14. Review of the hospital’s P&P titled Dress Code-Surgical dated June 2024 showed the purpose is to maintain environmental control and promote a high level of cleanliness and hygiene within the surgical setting. Further review of the P&P showed the following: * Surgical attire in the surgical semi restricted and restricted areas. * Scrub Clothes: Approved, clean and freshly laundered surgical attire will be donned daily and will be changed whenever they become soiled or wet. * Masks: Disposable masks must be worn at all times in the restricted area when there are open sterile items and equipment present. * Surgical Hats/Hoods: A clean, low-lint surgical head cover or hood that confines all hair should be worn. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, OR Charge Nurse 1 in the presence of the Director of Quality. When asked, OR Charge Nurse 1 stated behind redline was the restricted area that required appropriate attire. The following was observed: * Broken equipment was placed in the OR hallway (semi-restricted area). Cross Reference to A724, example # 2. * Two hospital staff were observed walking behind the red line (semi-restricted area) and picking up the broken equipment located behind red line. Two hospital staff did not wear the approved scrub clothes and surgical hats. The IC Manager and OR Charge Nurse 1 verified the above findings. 15. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager and OR Charge Nurse 1 in the presence of the Director of Quality. The surgical equipment in OR 3 was not maintained in a sanitary condition. Cross Reference to A724, example # 3.”

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital ensure the IC staff provided sufficient oversight the IC issues related to the perioperative services. This failure created the risk for substandard of care for patients receiving the care in the hospital. Findings: During the observation, interview, and record review from 9/9/24 to 9/11/24, the following deficient practice was identified: * The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle. Cross Reference to A749, example #8. * The GI staff performed the endoscope cleaning by manually flushing channels and HLD without documented competency. Cross reference to A749, example # 1. * The GI cleaning room did not have the minimum two decontamination sinks as per AORN’s guidelines. Cross reference to A749, example # 2. * The GI staff failed to verbalize the drying step for the scope cleaning prior to the HLD as per the hospital’s P&P. Cross reference to A749, example # 3. * The Wavicide-01 MEC Strips Indicator was not used as per the manufacturer’s IFU. Cross reference to A749, example # 4. * The Wavicide-01 solution temperature was not maintained as per manufacturer’s IFU. Cross reference to A749, example # 5. On 9/9/24 at 1402 and 1413 hours, the IC Manager was interviewed. When asked, the IC Manager stated she was not aware of the inappropriate transporting surgical supply/equipment. When asked, the IC Manager stated she was not aware that the machines in GI Cleaning room were not in use. The IC Manager stated she was not able to provide guidelines or recommendations for manual cleaning process.”

“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: 26756 Based on observation, interview, and record review, the hospital failed to maintain the adequate blood product inventory levels in accordance with its P&P. This failure could potentially lead to the critical blood products being unavailable during the emergency situations, posing the risk to patient safety. Findings: Review of the hospital’s P&P titled Blood Product Inventory Management dated 7/2/2019, showed in part: * Purpose/Principle: - it is the responsibility of the Blood Bank Technologist on all shifts to maintain adequate blood product inventory levels to meet the needs of our patients. To provide adequate supplies of blood for routine and emergency use while minimizing outdating. * Procedure: - LifeStream Blood Bank is the primary supplier and is a contracted service for mobile blood drive. - All orders for stock are to be placed by phone before 0800 am to be delivered between 1100 to 1200 noon; and before 05:00 pm to be delivered between 8:00 - 9:00 pm daily (Monday - Sunday). - Inventory Levels: O Pos: Minimum 50 units, Critical 20 units O Neg: Minimum 20 units, Critical 10 units A Pos: Minimum 45 units, Critical 20 units A Neg: Minimum 20 units, Critical 8 units B Pos: Minimum 15 units, Critical 5 units B Neg: Minimum 2 units, Platelets: Aim to keep 6 units available at all times. - Inventory must be done, every morning, to determine ordering needs. - Log in must be done, every morning, to determine ordering needs. On 8/21/24 at 0900 hours, a tour to the hospital’s blood bank was conducted and accompanied by the Blood Bank Supervisor. Review of the blood bank log titled Daily Blood Product Inventory Management dated 8/21/24, showed the following: * O Pos: available 28 units (out of 50 units; 22 units below minimum inventory level) * O Neg: available nine units (out of 25 units; 14 units below minimum inventory level) * A Pos: available 28 units (out of 45 units; 17 units below minimum inventory level) * A Neg: available three units (out of 20 units; 17 units below minimum inventory level) * B Pos: available 14 units (out of 15 units; 1 unit below minimum inventory level) * B Neg: available 0 (out of 2 units; 2 units below minimum inventory level) * Platelets: available four units (out of 6 units; 2 units below minimum inventory level) On 8/21/24 at 0900 hours, an interview was conducted with the Blood Bank Supervisor. The Blood Bank Supervisor acknowledged the hospital’s P&P for the minimum inventory levels of the blood products was not updated, and the efforts were underway to seek the corporate approval to decrease the minimum inventory levels of the blood products. The Blood Bank Supervisor stated the suppliers typically faced the shortages of the blood products, especially in the summer months. On 9/21/24 at 0950 hours, an interview was conducted with the Regional Director, Laboratory Services. The Regional Director, Laboratory Services confirmed the blood bank had inadequate supply of the blood products. The Regional Director, Laboratory Services stated the adequate blood supply should have been maintained as per the hospital’s P&P. The Regional Director, Laboratory Services stated the inventory of blood products should be attached to the blood products refrigerator door and updated daily. The Regional Director, Laboratory Services confirmed the Governing Body still needed to approve a new policy reducing the minimum inventory of blood products.”

“Standard-level Tag for Pharmaceutical Service CFR(s): 482.25 Standard-level Tag for §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients... This Standard is not met as evidenced by: 26756 Based on interview and record review, the hospital failed to ensure the pharmaceutical services met the needs of the patients when a TPN was not available for one of six sampled patients (Patient 3) based on the physician’s orders. This failure had the potential to increase the risk of adverse health outcomes such as malnutrition and glucose fluctuations to the patients. Findings: Review of Patient 3’s closed medical record was initiated on 8/21/24. Patient 3’s closed medical record showed Patient 3 was admitted to the hospital on 8/10/24, and discharged on 8/20/24. Review of the Admission History and Physical dated 8/11/24 at 0755 hours, showed the consulted pharmacy for TPN, but there was a logistic issue with the TPN at the hospital; to continue with the IV fluid and follow up with the pharmacy in the morning. Review of the Progress Notes dated 8/12/24 at 0753 hours, showed Patient 3 was admitted to the hospital with a GT leak. The Assessment & Plan section showed pending TPN to be started and to proceed with the PICC line placement. Review of the physician’s order dated 8/12/24 at 2000 hours, for the TPN, with an order frequency of every 24 hours, intravenous, continuous, with the start date of 8/12/24 at 20:00. Review of the Procedure: PICC Line Insertion showed a right PICC line was inserted for the patient on 8/13/24. Review of the Progress Note for Parenteral Monitoring, showed the following: * On 8/12/24, Patient 3 was on NPO. The patient’s GT was removed. The MD wanted TPN for bowel rest. There was no PICC line. PPN was started. * On 8/13/24, Patient 3 was scheduled for PICC Line today and advanced to TPN. * On 8/14/24, Patient 3 PICC Line was placed on 8/13/24. The TPN was started. * On 8/15/24, the TPN was not available. * On 8/16/24, the TPN was not available on 8/15/24. The MD ordered D5NS with 20 mEq KCL to be run at 75 ml/hr. The patient’s blood sugar was stable. On 8/21/24 at 0900 hours, during an interview with Quality Manager 1, Quality Manager 1 confirmed the physician’s order for TPN. On 8/21/24 at 0900 hours, a concurrent interview and review of Patient 3’s medical records was conducted with the Director of Pharmacy. The Director of Pharmacy stated the hospital’s pharmacy could premix certain drugs for infusion, but TPN should be obtained from an outsourced supplier. The Director of Pharmacy stated the supplier withheld the TPN (did not deliver) due to an outstanding payment issue. The Director of Pharmacy stated he escalated the problem to the CEO and to the corporate account team to expedite the supplier payment. The Director of Pharmacy stated eventually Patient 3 received the TPN after a delay of 24 hours. The Director of Pharmacy stated he sometimes had to run to the sister facility to get medications when they run out of stock.”

“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 and L&D Department Logs were accurately maintained for four of 20 sampled patients (Patients 4, 14, 16, and 18) and for three nonsampled patients (Patients 21, 22, and 23). 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 and L&D department for the treatments of their emergency medical conditions. Findings: Review of the hospital’s P&P titled EMTALA - Central Log Policy dated March 2023 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. a. On 7/16/24, a random review of the L&D Department Logs for May, June, and July 2024 showed the L&D Department Logs were not completed in its entirety as evidenced by: * On 5/20/24, the mode of arrival was not completed for Patient 21. * On 6/20/24, the disposition time was not completed for Patient 22. * On 7/2/24, the disposition time was not completed for Patient 23. On 7/16/24 at 1445 hours, the Director Perinatal Services acknowledged the findings and confirmed the L&D Department Log had not been maintained. 45560 b. On 7/17/24 at 1400 hours, an interview and concurrent record review was conducted with the Quality Manager. Review of Patient 14’s ED Triage Aware Note dated 6/9/24, showed Patient 14 arrived to the ED at 2136 hours with a chief complaint of “wound check”. However, review of the ED Central Log dated June 2024 showed Patient 14’s chief complaint was “5150 Hold”. On 7/18/24 at 1045 hours, an interview was conducted with the Interim Director of ED Services, the Interim Director of ED Services acknowledged the above findings and confirmed the chief complaint listed on the ED Central Log for Patient 14 was incorrect. c. On 7/17/24 at 1400 hours, an interview and concurrent record review was conducted with the Quality Manager. Review of the ED Central Log dated June 2024 showed Patient 16’s Disposition was “Hold.” Review of Patient 16’s Patient Information sheet dated 7/16/24, showed under encounter information, Patient 16 was admitted on 6/9/24 at 1237 hours under the service of telemetry. On 7/18/24 at 1045 hours an interview was conducted with the Interim Director of ED Services, the Interim Director of ED Services acknowledged the above findings and stated the ED Central Log for Patient 16 should have shown the disposition of “admitted”. 39199 d. On 7/16/24 at 1400 hours, an interview and concurrent record review was conducted with the Interim Director of ED Services. Review of Patient 18’s Progress Notes dated 7/2/24, showed Patient 18 arrived to the ED at 1259 hours but had left prior to being triaged. The Progress Notes showed Patient 18 was called for triage multiple times at 1307, 1316, and 1352 hours but was not found. However, review of the ED Central Log dated July 2024 showed Patient 18’s Disposition was “Treatment in.” The above findings were verified by the Interim Director of ED Services who stated the ED Central Log should have shown Patient 18 had left before being triaged. e. On 7/16/24 at 1400 hours, an interview and concurrent record review was conducted with the Interim Director of ED Services. Review of Patient 4’s ED Trauma Team Assessment dated 7/4/24, showed Patient 4 arrived to the ED at 2138 hours and was admitted to inpatient on 7/5/24 at 0405 hours. However, review of the ED Central Log dated July 2024 showed Patient 4’s Disposition was “433.” The above findings were verified by the Interim Director of ED Services who stated the ED Central Log should have shown Patient 4 was admitted.”

“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: 37663 Based on interview and record review the hospital failed to ensure the medical staff provided quality of care to two of two sampled patients (Patients 1 and 2) as per the Medical Staff General Rules and Regulations as evidenced by: 1. For Patient 1: a. Physician 1 had not dictated the progress note at or near the time of observation and did not ensure the physician’s order had reflected the treatment plan written on the progress notes. b. Physician 1 did not ensure Patient 1’s informed consents for the psychotropic medications were accurate and completed as per the hospital’s P&P. c. Patient 1’s Master Treatment Plan was not completed. There was no documented evidence Physician 1 attended Patient 1’s IDTP team meeting. 2. For Patient 2: a. The physician’s order had not been reflected in the treatment plan written on the progress notes. b. Physician 1 did not ensure Patient 1’s informed consents for the psychotropic medications were accurate and completed as per the hospital’s P&P. c. Physician 1 did not date Patient 2’s IDTP team meeting accurately. These failures created the risk of substandard medical care to the patients in the hospital. Findings: Review of the hospital’s Medical Staff General Rules and Regulations dated 8/23/21, showed in part: * Progress Notes: An admitting progress note should be entered by the admitting physician, podiatrist, or designee. Sufficient progress notes shall be recorded at or near the time of observation. Whenever possible, each of the patient’s clinical problems should clearly identified in the progress notes and correlated with specific orders as well as results of tests and treatments. Progress notes shall be entered at least daily on all patients by a physician of record. Physician must authenticate all progress notes by signature, date, and time. * Gero-Psychiatric Unit: - Medical Record: Patient’s Medical records must indicate the psychiatric components of the record, including history of findings and treatment provided for the psychiatric condition for which the patient was admitted. - Treatment Plans: Each patient must have an individual comprehensive treatment that must be based on inventory of the patient’s strengths and disabilities. The plan must include a DSMV-IV TR diagnosis, short term and long-term range goals, specific treatment modalities utilized, responsibilities of member of the treatment plan, adequate documentation to justify the diagnosis, treatment, and rehabilitation carried out. - Progress Notes: Patients shall be seen daily. Progress notes must contain recommendations or revisions in the treatment plan as indicated as well as precise assessment of the patient’s progress in accordance with the original or revised treatment plans. 1. On 7/8/24 at 1143 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of BHU. Patient 1’s medical record showed the patient was admitted to the BHU on 5/24/24 at 1344 hours and discharged on 6/11/24 at 1717 hours. a. Review of the Consultation dictated on 5/25/24 at 1415 hours by Physician 1, showed the DOS was 5/25/24. Patient 1 was uncooperative. The patient’s mood was irritated. The patient’s affect was labile. The patient’s speech was incoherent. The patient’s thought process was loose with paranoia. The patient had verbal and physical aggression towards the staff. The treatment plan was to start the patient on olanzapine (an antipsychotic) 5 mg two times per day for acute psychosis and mood symptoms. Review of the physician’s order dated 5/25/24 at 1233 hours showed Physician 1 ordered to give Patient 1 olanzapine 2.5 mg by mouth two times per day. Review of the Progress Note for the DOS of 5/26/24 showed Physician 1 dictated the progress note on 5/28/24 at 0450 hours (or two days later). The plan was to continue Zyprexa (same as olanzapine) titration. Review of the Progress Note for the DOS of 5/27/24 showed Physician 1 dictated the progress note on 5/28/24 at 0451 hours (or a day later). The plan included titrating Zyprexa. Review of the Progress Note for the DOS of 5/28/24 showed Physician 1 dictated the progress note on 6/11/24 at 0725 hours (or 13 days later). The progress note showed Patient 1 was very confused, disorganized, getting easily agitated and had mood swings and outbursts. Patient 1 was tolerating medications well without side effect. The plan was to continue medication titration. Review of the Progress Note for the DOS of 5/29/24 showed Physician 1 dictated the progress note on 6/2/24 at 2251 hours (or four days later). The progress note showed Patient 1 remained actively manic and psychotic, was unable to care for herself with moments of agitation. The plan was to continue Zyprexa 5 mg two times per day. However, review of the physician’s orders did not show Physician 1 ordered Zyprexa 5 mg two times per day. The physician’s order dated 5/19/24 at 0936 hours, showed Physician 1 ordered to give Patient 1 olanzapine 5 mg IM once for severe agitation. Review of the Progress Note for the DOS of 5/30/24 showed Physician 1 dictated the progress note 5/30/24 at 1146 hours, showed Patient 1 remained actively psychotic and manic; and was not able to care for self with mood swings and outbursts requiring emergent medications. The plan was to increase Zyprexa 7.5 mg two times per day. However, review of the order did not show Physician 1 ordered Zyprexa for Patient 1 as planned despite of Patient 1’s behavior required an emergent IM medication due to worsening behavior. Patient 1 had been on Zyprexa 2.5 mg twice a day since 5/26/24. Review of the Progress Note for the DOS of 5/31/24 showed Physician 1 dictated the progress note on 6/11/24 at 0726 hours (or 11 days later), showed Patient 1 was gradually improving but still with mood swings, outbursts, and delusional thoughts. The plan was to continue medication titration. Review of the physician’s order dated 5/31/24 at 1342 hours, showed to administer olanzapine 5 mg by mouth twice per day; however, this physician’s order was discontinued. On 5/31/24 at 1343 hours, Physician 1 ordered to administer olanzapine 5 mg three times per day to the patient. Review of the Progress Note for the DOS of 6/1/24 showed Physician 1 dictated the progress note on 6/11/24 at 0726 hours (or 10 days later), showed Patient 1 was gradually improving, but still with acute psychosis and agitation, The plan was to continue medication titration. Review of the Progress Note for the DOS of 6/2/24, showed Physician 1 dictated the progress note on 6/2/24 at 2254 hours, showed Patient 1 remained actively psychotic, manic, and with poor self-care. The plan was to continue Zyprexa 7.5 mg by mouth two times per day. However, review of the physician’s orders did not show Physician 1 ordered Zyprexa 7.5 mg two times per day for Patient 1. On 7/8/24 at 1447 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Health Information Coordinator. The Health Information Coordinator verified above findings. The Health Information Coordinator verified Physician 1’s progress notes did not showed Physician 1 dictated the progress note at or near the time of observation. The Health Information Coordinator was asked how the hospital had ensured the patients were seen daily. The Health Information Coordinator stated there was no monitoring for daily progress notes. On 7/8/24 at 1455 hours, the Director of BHU verified the above findings that Physician 1’s orders did not reflect the planned treatment for Patient 1. On 7/9/24 at 1357 hours, an interview and concurrent review of Patient 1’s medical record was conducted with Physician 1. Physician 1 was asked when he planned to initiate or start the planned treatment, he wrote on his progress notes for the patients. Physician 1 stated he usually started the medication on the same day after he saw his patients. Physician 1 was asked about the physician’s order dated 5/25/24, showed olanzapine 2.5 mg two times per day; and the physician’s note dated 5/25/24 showed treatment plan for the patient was to start the patient on olanzapine 5 mg two times per day. Physician 1 stated he might have changed his mind because Patient 1 had low platelets. Physician 1 was asked about the progress note he wrote on 5/26/24 if he documented the reason for the medication treatment plan was changed. Physician 1 verified there was no documented evidence to show the reason he changed the treatment plan for Patient 1. Physician 1 verified the physician’s order did not reflect the treatment plan written on the progress note. Physician 1 was asked what the expectation would be, Physician 1 stated the expectation would be the treatment plan written on the progress notes should be the same with the orders. Physician 1 verified he did not order Zyprexa 5 mg two times per day and Zyprexa 7.5 mg two times per day as he documented on his progress note treatment plan. b. The informed consents for the psychotropic medications were not completed for Patient 1. Cross reference to A 0131, example #1. On 7/9/24 at 0858 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of BHU. The Director of BHU was asked about the listed medications on the consent form. The Director of BHU stated Patient 1 was ordered for psychotropic medications, including Zyprexa, Ativan (benzodiazepine), and Restoril (benzodiazepine) only. On 7/9/24 at 1423 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 was asked about Patient 1’s Consent for Psychotropic Medication. Physician 1 stated the physician had to complete the consent form. Physician 1 stated he discussed the medications with the patient verbally; however, he acknowledged he did not mark or document that he had discussed the medication with the patient. Physician 1 stated if the patient asked for the medication information, he would mark check he provided information of the listed psychotropic medications. However, as per hospital’s P&P, information of the medications should be provided for voluntary and involuntary patients admitted to the MHS. Physician 1 stated he failed to document in the medical record that Patient 1 declined to sign and refused to give voluntary consent. c. Review of the hospital’s P&P titled Treatment Plan dated 5/2023, showed in part: * Purpose: to develop a coordinated, focused plan of care that all staff utilizes to meet the specific needs of the patient and provide optimal care. * Policy or Procedure: Each patient admitted to the Senior Mental Health (SMH) Program shall have an individualized treatment plan with medical and psychiatric components based on the needs identified from the initial assessment, reassessment. The treatment plan includes consideration of inter-disciplinary input and is coordinated by the attending psychiatrist. The treatment planning process is continuous, beginning at the time of patient admission and continuing until discharged. Patients and families (with patient consent) are involved in selecting behavior and treatment interventions. The treatment meeting occurs no less than weekly. * Initial Implementation: - Upon admission, the admitting RN will review the intake documents, H&P, Nursing Initial Assessment, SMH Initial Assessment Addendum, any transfer documents if the patient was transferred from another facility and consult with admitting psychiatrist and any staff involved in the intake process. The admitting RN initiates the Interdisciplinary Plan of Care and SMH Master Problem List and IDTP. * Interdisciplinary Team Meetings: The first IDT team meeting occurs soon after admission, at which the Inter-Disciplinary Plan Care and Master Problem List are developed, and interventions are initiated. The attendees may include the Psychiatrist, Program Manager, Nursing, Social Services and the patient and family, if available and with patient consent. When necessary, it may also include psychologist, Case Manager, Dietician, Pharmacy, and any other disciplines involved in the care of the patient. The attending Psychiatrist will chair the interdisciplinary treatment team meetings. The interdisciplinary staff will review, evaluate, and provide input to the patient’s expected outcomes and interventions planned. * Interdisciplinary Plan of Care or Master Treatment Plan: The attending Psychiatrist actively participates in developing the plan and signs after it has been formulated. Review of Patient 1’s Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/24, 5/28, and 6/4/24, showed the following: - The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/24/24 showed the sections of “Continued Behavioral Symptoms:”, “Prior Living Situation:”, “Discharge Plan:”, and “Is patient able to return to prior living arrangements:” were left blank. Physician 1’s signature was dated 5/25/24 (1 day after the meeting date). - The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 5/28/24, showed Physician 1’s signature was dated 5/30/24 (2 days after the meeting date). - The Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan dated 6/4/24, showed Physician 1’s signature was dated 6/5/24 (1 day after the meeting). On 7/8/24 at 0900 hours, an interview was conducted with RN 1. RN 1 was asked for Physician 1’s participation in the IDTP team meetings for his patients. RN 1 stated no. RN 1 stated the RN had not seen the physician participated with the IDTP team meetings. On 7/10/24 at 1055 hours, the Director of BHU was asked for the schedule of Physician 1’s IDTP meeting. The Director of BHU stated the IDTP meeting schedule was every Tuesday at 1200 hours. On 7/8/24 at 1458 hours, an interview and concurrent record review of the Behavioral Health IDTP was conducted with the LCSW Manager. The LCSW Manager was asked about Patient 1’s Behavioral Health IDTP and team meeting. The LCSW Manager stated the first encounter with Patient 1 was on 5/24/24. Physician 1 might have left for the day and might had come back the next day on 5/25/24. The patients’ needs were identified on the initial IDTP and there was no team meeting. The LCSW was responsible for the discharge planning assessment. The LCSW Manager stated Physician 1 would talk to the LCSW Manager or the SW assigned to his patients if Physician 1 was not in the team meeting or Physician 1 would stop at his office to sign the IDTP. The LCSW Manager stated the SW would also call the physician. Review of the RN notes and the LCSW notes did not show Physician 1 attended the IDTP team meetings for Patient 1. On 7/9/24 at 0858 hours, the Director of BHU verified the above findings; and stated Physician 1 informed her that he did not attend the IDTP team meetings on 5/24, 5/28 and 6/4/24. The Director of BHU verified Physician 1 was not in attendance during the IDTP team meetings. On 7/9/24 at 1423 hours, interview and record review was conducted with Physician 1. Physician 1 stated he attended the IDTP team meetings for Patient 1. He stated he might have stepped out of the room and attended on his patients and/or the IDTP might not be available for signing and he signed the IDTP on the following day. However, there was no documented evidence Physician 1 was present on the days of IDTP team meetings as per the LCSW notes and the RN notes. On 7/10/24 at 1020 hours, an interview was conducted with RN 2. RN 2 was asked if she had attended the IDTP team meeting of Physician 1’s patients. RN 2 stated yes; however, Physician 1 had never attended the IDTP team meetings of his patients. There was no schedule of Physician 1’s IDTP team meeting that she was aware of. 2. On 7/9/24 at 0930 hours, an interview and concurrent review of Patient 2’s record review was conducted with the Director of BHU. Patient 2’s medical record showed Patient 2 was admitted voluntarily to the BHU on 6/26/24 at 2315 hours, for severe worsening psychosis, delusions, and agitation. Review of the Consultation dictated on 6/27/24 at 1309 hours for the DOS of 6/27/24, showed Patient 2 was observed talking to the wall and to unseen others, not making any sense. Patient 2 was uncooperative. The patient was irritable. The treatment plan was to resume Risperdal (an antipsychotic) 1 mg two times per day for acute psychosis. Review of the physician’s order dated 6/27/24 at 0047 hours, showed Physician 1 ordered to give Patient 2 lorazepam (same as Ativan) 0.5 mg by mouth every six hours as needed for agitation or anxiety. There was no order for Risperdal 1 mg two times per day for acute psychosis as per the treatment plan. Review of the Progress Note for the DOS of 6/28/24 showed Physician 1 dictated the progress note on 6/28/24 at 1039 hours. The plan was to start the patient on 5150 holds for grave disability, continue to encourage the patient to remain in adherent to her medication, and review the risk, benefits, and alternatives. Review of the physician’s order did not show Physician 1 ordered Risperdal for the patient. Review of the Progress Note for the DOS of 6/29/24 showed Physician 1 dictated the progress note on 7/1/24 at 0656 hours (two days later). The patient was still very delusional and bizarre, very restless, and anxious, and actively hallucinating. The plan was to continue Risperdal titration and increase it to three times per day. Review of the physician’s order dated 6/29/24 at 1112 hours, Physician 1 ordered risperidone (same as Risperdal) 1 mg by mouth three times per day. Review of the Progress Note for the DOS of 6/30/24 showed Physician 1 dictated the progress note on 7/1/24 at 0658 hours (one day later). Patient 1’s Risperdal had now been increased to three times per day. The patient appeared to be tolerating it well. Physician 1 discussed about long-acting injectable to Patient 2, but the patient continued to be very delusional, getting increasingly agitated for no reason. The plan was to continue to discuss risk, benefits, and alternative of a long- acting injectable. Review of the Progress Note for the DOS of 7/1/24 showed Physician 1 dictated the progress note on 7/2/24 at 0737 hours (one day later). Patient 2 remained very delusional and bizarre. The plan was to continue titration of Risperdal. Review of the Progress Note for the DOS of 7/2/24 showed Physician 1 dictated the progress note on 7/3/24 at 1211 hours (one day later). Patient 2 would sometimes take her antipsychotic medications, sometimes would refuse. The patient signed for voluntary admission. Review of the Progress Note for the DOS of 7/3/24 at 0845 hours showed Physician 1 electronically signed on 7/9/24 at 1036 hours. Patient 1 remained selective with medications, but staff reported the patient had better adherence with meals and food. The Director of BHU verified the above finding; the progress note dictation was late and the physician’s orders did not reflect Physician’s 1’s treatment plan documented on progress notes with his orders. On 7/9/24 at 1435 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 verified the above findings. b. The informed consents for the psychotropic medications were not completed for Patient 2. Cross reference to A 0131, example # 2. On 7/9/24 at 1423 hours, an interview and concurrent record review was conducted with Physician 1. Physician 1 was asked about Patient 2’s Consent for Psychotropic Medication. Physician 1 stated he discussed the medications with the patient. However, he acknowledged he did not mark or document that he had discussed the medications with the patient. Physician 1 stated the patient would be provided of the listed psychotropic medication information if the patient asked or requested for it. However, as per hospital’s P&P, information of the medications should be provided for voluntary and involuntary patients admitted to the MHS. When asked if he documented on his progress note Patient 2’s refusal to sign the informed consent for the use of psychotropic medication, Physician 1 stated he failed to document on his notes that Patient 2 declined to sign and refused to give voluntary consent. c. Review of Patient 2’s Senior Mental Health Behavioral Health Interdisciplinary Treatment Plan showed the Psychiatrist, Nursing, LCS, and Activity Therapist signed the form on 6/27/24. The Director of BHU was asked about the IDTP team meeting on 6/26/24 for Patient 2. The Director of BHU stated the nursing staff had initiated the MTP when the patient was admitted on 6/26/24 at 2313 hours. However, the LCSW showed had seen and evaluated Patient 2 on 6/27/24. On 7/9/24 at 1435 hours, interview and concurrent record review was conducted with Physician 1. Physician 1 verified he did not meet with the IDTP team on the night of 6/26/24. However, the IDTP showed Physician 1 signed the form on 6/26/24.”

“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: 37663 Based on interview and record review, the hospital failed to ensure the informed consents to receive psychotropic medications were obtained for two of two sampled patients (Patients 1 and 2). This failure had the potential for the patients and/or the patients’ responsible parties not being allowed to make medical care decisions. Findings: Review of the hospital’s P&P titled Informed Consent for Psychotic/Psychotropic medications dated 9/2023, showed the following: * Scope: All prescribing Psychiatrist * Purpose: To provide a system of informed consent for those patients receiving antipsychotics or psychotropic medications. * Psychotropic medications or drugs are those medications administered for the purpose of affecting the central nervous system to treat psychiatric disorder or illnesses. These medications include, but not limited to anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, antiparkinson agents, hypnotics, medications for dementia, Alzheimer’s, and psychostimulants. * Policy: It is the policy that all persons who are voluntary or on an involuntary hold (5150, 5250, 5260, 5270), who are receiving medications for their psychiatric condition, are given both oral and written information about the medication. The procedure will apply to all hospital in patients who will be prescribed and/or administered antipsychotic or psychotropic medication by their treating psychiatrist. The patient is given information regarding the medication by the psychiatrist who obtains the patients signature on the consent form. * Procedure: - Every patient who will be prescribed an antipsychotic or psychotropic medication or an adjunctive medication, directly related to the treatment of the patient’s mental disorder, shall have the content of the appropriate informed consent form discussed with him or her by the prescribing psychiatrist. - The psychiatrist shall enter on the form the specific medication, the dosage range of the medication to be prescribed or administered, and the date of discussion. Subsequent changes in doses within the specific range will not require a new informed consent. - After the psychiatrist has discussed the recommended medication, nature and effect and the patient indicates understanding the content of the informed consent, the patient shall sign and date the consent form showing that he or she agrees to the administration of the recommended medications. - In the event that the patient has been shown but refused to sign the informed consent, it shall be sufficient for the psychiatrist to place the unsigned consent into the patient’s chart together with a notation in the medical record that while the patient understands the nature and effect of the medication, the patient declines such medications and refuses to give voluntary consent. 1. On 7/9/24 at 0858 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of BHU. Patient 1’s medical record showed Patient 1 was admitted to the hospital on 5/24/25. Review of Patient 1’s Medication Consent Sheet showed the patient would receive eight psychotropic medications including Risperdal, Depakote (an anticonvulsant or mood stabilizer), Ativan, Restoril, Seroquel (an antipsychotic), Zyprexa, Aricept (a medication used to treat Alzheimer), and Namenda (a medication used to treat Alzheimer). The section of the Patient/Conservator’s Signature was left blank for eight psychotropic medications listed. The boxes of “I have not disclosed the risks related to the proposed medication to the Patient (or their surrogate) ..., but I have provided other information material:”, “As part of this consent process the Patient and/or their surrogate have been provided information sheets for the above listed medications” were not checked. The Director of BHU stated the Medication Consent Sheet was not completed for Patient 1. Patient 1 refused to sign the consent. Physician 1 was responsible to obtain the consent from the patient. The Director of BHU verified the consent did not show the medications were reviewed with the patient and did not show the medication information had been provided to the patient. The Director of BHU was asked to show documented evidence that Physician 1 discussed the medications with Patient 1. The Director of BHU stated Physician 1 failed to show on his notes that he had discussed the psychotropic medications listed on the consent with the patient, the patient refused to sign the consent, and the patient verbalized of willing to take medications. The physician should have documented on his notes the risks and benefits were discussed with the patient. Patient 1 was taking her psychotropic medications on and off. The nurses could still offer the medications and some patients would take their medications without signing the consent. On 7/10/24 at 0900 hours, an interview and concurrent record review of Patient 1’s MAR was conducted with the Director of BHU. Review of the MAR showed Patient 1 received the following psychotropic medications without informed consent: - Restoril 15 mg on 5/26/24 at 2225 hours, 5/28/24 at 0156 hours, and 5/28/24 at 2308 hours. - Ativan 0.5 mg on 5/24/24 at 1547 hours, 5/25/24 at 1215 and 2300 hours, 5/26/24 at 2054 hours and 5/27/24 at 2213 hours. - Zyprexa 2.5 mg on 5/25/24 at 1344 and 2047 hours, 5/26/24 at 0816 and 2111 hours, 5/27/24 at 2052 hours, and 5/28/24 at 0839 and 2148 hours. 2. On 7/9/24 at 0930 hours, an interview and concurrent review of Patient 2’s medical record were conducted with the Director of BHU. Patient 2’s medical record showed Patient 2 admitted to the hospital on 6/26/24. Review of Patient 2’s Medication Consent Sheet showed the patient would receive six psychotropic medications, including Risperdal, Depakote, Ativan, Restoril, Zyprexa, and Seroquel. The section of Patient/Conservator Signature was left blank for six psychotropic medications listed. The boxes of “I have not disclosed the risks related to the proposed medication to the Patient (or their surrogate) ..., but I have provided other information material:”, “As part of this consent process the Patient and/or their surrogate have been provided information sheets for the above listed medications” were not checked. The Director of BHU stated the Medication Consent Sheet was not completed for Patient 2. Patient 2 refused to sign the consent. The Director of BHU verified the consent did not show the medications were reviewed with the patient and did not show the medication information had been provided to the patient. The Director of BHU was asked to show documented evidence that Physician 1 had discussed the medications with Patient 2. The Director of BHU stated Physician 1 failed to show on his notes that he had discussed the psychotropic medications listed on the consent with the patient, the patient refused to sign the consent, and the patient verbalized of willing to take medications. The physician should have documented on his notes the risks and benefits were discussed with the patient. Patient 2 was taking her psychotropic medications on and off per nursing notes. On 7/10/24 at 0900 hours, an interview and concurrent record review of Patient 1’s MAR was conducted with the Director of BHU. Review of the MAR showed Patient 2 received the following psychotropic medications without informed consent: - Restoril 7.5 mg on 6/27/24 at 2304 hours. - Ativan 0.5 mg on 6/27/24 at 0056 and 1327 hours, 6/28/24 at 2335 hours, and 6/29/24 at 0917 hours. - Risperdal 1 mg on 6/29/24 at 1433 and 2035 hours. On 7/10/24 at 1020 hours, a tour of the BHU was conducted with the Director of the BHU. RN 2 was asked what the RN would do if the patient refused to sign the consent for psychotropic medications. RN 2 stated she was informed that the nurses could offer the psychotropic medication and document on the patient’s chart with another nurse to sign as a witness that patient agreed verbally to take the medication. On 7/10/23 at 1300 hours, the Director of BHU stated as per the County’s Mental Health Patient Rights Advocate the nurse should get a verbal consent from the patient with another nurse to witness and attempt to get the patient to sign the consent few days later.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 29558 Based on interview and record review, the hospital failed to ensure the hospital’s QAPI activities affecting the patient care contained plan of action to prevent further events and promote sustained improvement, and the report of the QAPI monthly meetings were sent to the MEC and/or the Governing Board as per the hospital’s P&P. This failure had the potential in the hospital’s ability to ensure the provision of quality health care in a safe environment. Findings: Review of the hospital’s P&P titled Organization-Wide Quality Assessment And Performance Improvement Program dated 03/2024, showed the following: * Purpose: The Organizational Quality Assessment and performance Improvement Plan is designed to provide systemic and organized program for the promotion of safe, quality patient care and services. Activities are interdisciplinary and collaborative in order to respond to the needs of the customer, patient, physician, employee, and community. Through an interdisciplinary and integrated process, patient care and processes that effect patient care outcomes shall be continuously monitored and evaluated to promote optimal achievements, with appropriate accountability assumed by the Governing Board, Medical Staff, administration, and support personnel. QAPI activities will be integrated across all the care and service areas of the organization. On an annual basis and as needed, a Facility Assessment will be conducted to include an overview of the services and care areas that are provided. To prevent further events and promote sustained improvement the organization develops action plans to address the identified root causes and/or contributing factors of an issue/event that will effect changes at the systems level. * Goals of the Quality Improvement program are as follows: - To improve the quality, safety and reliability of patient care processes and outcomes. - To promote patient safety by prevention and reduction of medical errors. - To integrate the principles of high reliability into the quality structure and culture. - To enhance communication between the Medical Staff, Hospital Department/Services, and the Governing Body regarding the conclusions and recommendations resulting from data analysis and the actions taken to address the findings and recommendations. * Participation in Quality Improvement activities are the responsibility of everyone employed by, on the medical staff of, or contracted with the hospital. The organizational plan for Quality is reviewed and approved annually by the Quality/Patient Safety Committee, MEC, and Governing Board. * The Governing Board shall be responsible to ensure the provision of optimal quality care, safety, and organization wide. The board is ultimately accountable for the safety and quality of patient care and service of the hospital and has legal responsibility in every department and service of the hospital and has legal responsibility and operational authority for hospital performance. While maintaining overall responsibility, the Board delegates operational responsibility to the Medical Staff and Administration. The Board shall facilitate Quality Improvement by: - The Governing Board authorizes the establishment of a committee structure to implement the QAPI program; ensure the quality program reflects the complexity of the hospital’s organization and services. - Approve the QAPI plan. - Provide adequate resources, both material and manpower, to accomplish the QAPI function. - Receives reports of QAPI data from all departments and services of the hospital including those provided through contracts. - Reviewing, accepting, or rejecting periodic action plans based on findings, actions, and results of program activities regarding the effectiveness of organization-wide quality and safety activities. - Assuring clear expectations for safety are established; and providing a mechanism in which the Chief of the Medical Staff (the individual assigned the responsibility for the organization and conduct of the hospital’s medical staff.)/designee to consult no less than twice a year with the Board of Trustees regarding the quality of care provided to the patients of the hospital. * Medical Executive Committee (MEC) and the organized Medical Staff. - The Medical Executive Committee, accountable to the Board, has the primary authority for activities related to self-governance of the medical staff and for performance improvement of the professional services provided by licensed independent practitioners and other practitioners privileged through the medical staff process. The MEC makes recommendations directly to the governing body based on the conclusion of the MEC’s review of QAPI reports from medical staff committees, departments, and other assigned activity groups. - The organized medical staff identifies and analyzes problems and opportunities, recommends actions to the MEC, and monitors the effect of the actions taken to determine that problems have been resolved; reports Medical Staff related quality indicators/data results through the Quality/Patient Safety Committee structure, then to the MEC and Board by way of written reports and summaries. * Senior leadership supports the maintenance of the QAPI process through allocation of staff and sources necessary to fulfill the requirements of the program. * Quality and Regulatory Compliance department shall be responsible to support the organizations’ Quality Improvement principles, strategies, priorities, approach, and methodologies which includes but is not limited to the following tasks: - Works with the Medical Staff, and all hospital departments/services, and teams to effectively measure, assess, analyze, and improve the quality of care and services. - Works with the Medical Staff Leadership and hospital leadership to prepare an annual organization-wide evaluation of the Quality Program. * The department leaders are accountable for the quality and safety of care/services and performance of their staff and departments. The department Directors will monitor, analyze, and report the processes in their areas that effect patient care, safety, outcomes, and satisfaction. * Quality/Patient Safety Committee: Membership includes but is not limited representative from both clinical and non-clinical areas including the Medical Staff, Senior Leadership (CEO, CNO, CQO, CFO), Quality Coordinator, Risk Management/Patient Safety Officer, and other clinical and non-clinical staff as appropriate on as ad hoc basis. Activities include assisting the Governing Board and MEC with evaluating the effectiveness of the QAPI activities of the hospital departments/services and teams; assisting the Governing Board and MEC with evaluating and validating corrective action has resulted in improvement; and maintaining records of committee proceedings. * Quality and Patient Safety Integration: Reports the results of monitoring activities and the improvement action plans as appropriate to the Medical Executive Committee and Governing Board at the frequency specified by the Governing Board. On 7/10/24 at 1105 hours, upon request, the hospital provided documents titled Quality/Pt Safety Council, and the dashboards dated April 8, May 28, and June 25, 2024, were reviewed with the CQO. The monthly QAPI reports dated 4/23, 5/28, and 6/25/24, showed “all fallouts were discussed, and/or there was no data available-deferred”. However, there was no documented evidence to show action plans to prevent further events, to address the identified root cause and/or contributing factors, and to promote sustained improvement as per the hospital’s P&P. On 7/10/24 at 1440 hours, an interview with concurrent record review was conducted with the CNO and CQO. When asked as a member of the QAPI how the quality of care and the effectiveness of the action plans were monitored to prevent further events and sustained improvements. The CNO stated the quality of care was ensured through the monthly QAPI team meetings, and the daily huddles. The CNO was informed the QAPI reports reviewed (May, June, & July 2024) did not show an action plan to prevent further events. The CNO did not respond. The CNO was asked how the monthly QAPI meetings information reached the MEC and the Governing Board. The CNO stated a physician member of the MEC chaired the QAPI meetings and the chair would share the report of the meeting with the MEC team members. When asked how this information reached the Governing Board, the CQO stated the Administrative Staff Secretary sent the monthly meeting minutes to the Medical Staff Director’s office to forward to the Governing Board. When asked to provide a copy of the monthly QAPI report for May, June and July 2024 forwarded to the Governing Board as per the hospital’s P&P, the CQO stated per the administrative secretary the reports have not been received by the respective office to be forwarded to the MEC team and/or the Governing Board. The CNO and the CQO verified the findings.”

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 29798 Based on interview and record review, the hospital failed to ensure the Ongoing Professional Practice Evaluation was completed for one of two physicians (Physician 1) credential files reviewed as per the hospital’s P&P. This failure posed an increased risk of substandard health outcomes to the patients. Findings: Review of the hospital’s Medical Staff Bylaws adopted on 11/22/21, showed the section of Focused Professional Practice Evaluation (FPPE) - Initial Members and Members Granted New Clinical Privileges showing the following: * Except as otherwise recommended by the Medical Executive Committee and approved by the Governing Board, all practitioners initially appointed to the medical staff and all members granted new clinical privileges, shall be subject to a period of focused professional practice evaluation. * The chair of the department, or the chair’s designee(s), shall conduct the evaluation in accordance with criteria specified in the department’s rules and regulations and approved by the Medical Executive Committee. Each member requesting new clinical privileges shall undergo the same evaluation by the appropriate department(s) to determine eligibility to exercise the clinical privileges requested. * The practitioner shall remain subject to such evaluation as specified in the department’s rules and regulations, until the Medical Executive Committee has been finished with the following: - A report signed by the chair of the department(s) to which the member is assigned describing the types and numbers of cases observed and the evaluation of the practitioner’s performance, a statement that the practitioner appears to meet all of the qualifications for unsupervised practice in that department, has discharged all of the responsibilities of staff membership, and has not exceeded or abused the prerogatives of the category to which the practitioner was made, and meets the qualifications to continue to exercise the new clinical privileges initially granted in that department. Review of the hospital’s P&P titled Professional Practice Evaluation - Ongoing (OPPE) and Focus (FPPE), reviewed date 11/19/21, showed the following: * Scope: Medical Staff and Allied Health Professional Members, Medical Staff Services and Quality Management Departments. * Purpose: To ensure the Medical Staff, through its activities, assesses the professional practice and competence of its members via a systemic process that is clearly defined, objective, equitable, defensible, timely and useful. * The Ongoing Professional Practice Evaluation (OPPE) is an adjunct program to the current peer review process which provides the medical staff with the ability to identify professional practice trends that impacts quality of care and patient safety on an ongoing basis. The program includes: - The evaluation of a practitioner’s professional performance includes opportunities to improve care based on recognized standards - Uses multiple sources of information, including but not limited to the review of aggregate data, compliance with hospital’s policies, the rules and regulations and the Bylaws of the Medical Staff, recognized clinical standards and the use of rates compared against established benchmarks or norms. - Individual evaluation is based on generally recognized standards of care. This process provides practitioners with feedback for personal improvement or confirmation of personal achievement related to the effectiveness of their professional, technical and interpersonal skills in providing patient care. * The Focused Professional Practice Evaluation (FPPE) is a process initiated when the OPPE results raise questions/concerns regarding a currently privileged practitioner’s ability to provide safe, high quality patient care. - The proctoring program, for initial and new privileges, as defined in each Medical Staff Department’s Rules and Regulations is a component of the FPPE program. * The OPPE is based on six areas of general competency: - Patient Care - Medical/Clinical Knowledge - Practice Based Learning Environment - Interpersonal and Communication Skills - Professionalism - System Based Practice * The OPPE shall be conducted for all practitioners with clinical privileges. Reviews shall be conducted at eight months, 16 months, and 24 months from the practitioner’s appointment date or last reappointment date by the governing Board. * Monthly, the Medical Staff Office will prepare an OPPE Report for each practitioner scheduled for review. Data will be collected, collated, and transcribed onto the report. * Each practitioner’s OPPE report will be maintained in the Medical Staff Office and will be incorporated with the practitioner’s reappointment information. On 7/9/24 at 0905 hours, interview and concurrent record review was conducted with the hospital’s Medical Staff Director. Review of Physician 1’s credential file showed Physician 1 was granted hospital privileges as of 3/28/23. When asked for the practitioner’s OPPE documentation, the Medical Staff Director stated no documented reports were available. On 7/10/24 at 1000 hours, the findings were shared with the Chief Quality Officer and the Quality Director. On 7/10/24 at 1025 hours, an interview was conducted with Physician 2. When asked about the ongoing performance evaluation of Physician 1 in relation to the documentation, rounding, attending the weekly treatment plan meeting, ordering the psychotropic medication orders, and obtaining informed consent. Physician 2 stated Physician 2 was not aware of any issues regarding to Physician 1’s performance on the unit. When asked about the hospital’s P&P regarding to the ongoing performance evaluation of a recently privileged practitioner, Physician 2 stated the physician would be notified by the hospital’s Medical Staff regarding proctoring a recent privileged provider. Physician 2 also stated “I’m not proactive, I’m reactive.” When asked, Physician 2 stated he would review three medical records of Physician 1’s patients and submit an evaluation to the Medical Staff.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37548 Based on observation, 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 provision of on-call coverage to provide further evaluation and/or treatment necessary to stabilize an individual with an EMC for two of 21 sampled patients (Patients 1 and 15). Cross reference to A2404. 2. The hospital failed to ensure the MSE was provided in a timely manner to determine whether or not an EMC existed for two of 21 sampled patients (Patients 14 and 16). Cross reference to A2406. 3. The hospital failed to ensure the necessary stabilizing treatment was provided within the capabilities of the hospital for five of 21 sampled patients (Patients 2, 9, 15, 18, and 21). Cross reference to A2407. 4. The hospital failed to ensure the ED staff appropriately transferred the patient from the ED to other hospital. Cross reference to A2409. 5. The hospital (the receiving hospital) failed to ensure the hospital staff properly responded to the calls as per the hospital’s P&P when the transferring hospital (Hospital A) requested to transfer the patients to the hospital for two of 21 sampled patients (Patients 1 and 20). Cross reference to A2411.”

“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: 37548 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 and in L&D department as evidenced by: * Failure to ensure the EMTALA signage was posted in the ED’s triage/treatment areas and ED’s trauma treatment area. * Failure to ensure the EMTALA signage was posted in the L&D department’s main entrance. 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 - Signage Policy dated March 2023 showed in part: * To establish guidelines for providing all individuals with the opportunity to be aware of and view their right to medical screening examination and stabilization for an emergency medical condition. * All Emergency Department and any other place likely to be noticed by all individuals entering the Emergency Department and those individuals waiting for examination and treatment in areas of the hospital other than the traditional Emergency Department such as the entrance area, admitting areas, waiting rooms, and treatment areas located on hospital property must post conspicuously, appropriate signage notifying individuals of their right to an MSE and stabilization or treatment for an EMC and require services for women in labor as specified under EMTALA as well as information indicating whether or not the hospital participates in the Medicaid program. 1. On 11/28/23 at 1044 hours, the hospital’s ED was toured with the Quality Review/Process Improvement RN, Interim ED Nursing Director, and Chief Quality and Patient Safety Officer. There was no EMTALA signage posted in the trauma treatment area. In a concurrent interview, the Interim ED Nursing Director acknowledge the findings. The Interim ED Nursing Director also acknowledged there was no EMTALA signage posted in all triage/treatment areas in the ED. 2. On 11/28/23 at 1050 hours, the L&D department was toured with the Quality Review/Process Improvement RN, Nursing Manager of Perinatal Services, and Chief Quality and Patient Safety Officer. When asked, the Nursing Manager of Perinatal Services acknowledged there was no EMTALA signage posted at the main entrance of the L&D department.”

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure the provision of on-call coverage to provide further evaluation and/or treatment necessary to stabilize an individual with an EMC for two of 21 sampled patients (Patients 1 and 15) as evidenced by: 1. The ED failed to ensure the ED and on-call physicians jointly approved the decision to have a non-physician practitioner respond to the call instead of the on-call physician for Patient 15 as per the hospital’s P&P. 2. The ED failed to ensure the direct telephone number of Neurosurgeon 1 was available when the Neurosurgeon 1 was listed as an on-call neurosurgeon as per the hospital’s P&P. The ED failed to maintain the ED on-call schedule by including the direct telephone number of the physicians as per the hospital’s P&P. These failures could result in the delay in the stabilizing treatments and substandard health outcomes to the patients. Findings: Review of the hospital’s P&P titled EMTALA-Definitions and General Requirements dated March 2023 showed the on-call list should be maintained in accordance with the resources available to the hospital and should include the name and the direct telephone number or direct pager of each physician who is required to fulfill on-call duties. A practice group’s name, answering service, and general office phone numbers are not acceptable under EMTALA. The purpose of the on-call list is to ensure that the DED is prospectively aware of which physicians, including specialists and sub-specialists, are available to provide treatment necessary to stabilized individuals with EMCs. 1. Review of the hospital’s P&P titled EMTALA -Provision of On-Call Coverage dated March 2023 showed the ED physician must be able to first confer with the on-call physician. Midlevel practitioners (usually physician assistants or advanced practice registered nurses) who are employed by and have protocol agreements with the on-call physician, may appear at the hospital and provide further assessment or stabilizing treatment to the individual only after the on-call physician and ED physician confer and the on-call physician so directs the licensed non-physician practitioner to appear at the hospital. The ED physician and the on-call physician must jointly approve the decision to have a non-physician practitioner respond to the call instead of the on-call physician. On 11/29/23 at 1500 hours, an interview and concurrent review of Patient 15’s medical record was conducted with the Quality Review/Process Improvement RN and the Chief Quality and Patient Safety Officer. Patient 15’s medical record showed Patient 15 presented to the ED by EMS on 11/21/23 at 0923 hours, after an unwitnessed fall. Review of the ED Provider Aware Note dated 11/21/23 at 1051 hours, showed Patient 15 was upgraded to a moderate trauma and care would be transferred to trauma services. Review of the Neurosurgery NP Note dated 11/21/23 at 1241 hours, showed, “Contacted by Trauma for assessment on acuity of ICH found on CTH today.” The Plan section showed, “No neurosurgical intervention is indicated...OK to DC back to care facility...” Review of the Trauma Report dated 11/21/23, showed it was unknown whether Patient 15 lost consciousness after the unwitnessed fall. The Plan section showed, “A consultation with neurosurgery was obtained while the patient was in the Emergency Room. He stated that the CT scan of the brain showed no acute findings: The patient was therefore transferred back to the rehabilitation center.” In a concurrent interview, the Quality Review/Process Improvement RN stated there was no documentation showing the ED physician and the on-call physician jointly approved the decision to have a non-physician practitioner respond to the call instead of the on-call physician. The findings were discussed and acknowledged by the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer stated the ED had not implemented the provision of on-call coverage P&P. 2. Review of the hospital’s P&P titled EMTALA -Provision of On-Call Coverage dated March 2023 showed in part: * To established guidelines for the hospital and its personnel to be prospectively aware of which physicians, including specialists and sub-specialists, are available to provide additional medical evaluation, and treatment necessary to stabilize individuals with emergency medical condition. * The Hospital Administrator is responsible to develop an Emergency Department On-Call Schedule via a contractual relationship with the various specialists. Practice group names and general office numbers are not acceptable for contacting the on-call physician. Individual physician names with accurate contact information including the direct telephone number or direct pager where the physician can be reached, are to be put on the on-call list. The hospital MUST be able to contact the on-call physician with the number provided on the list. If the on-call physician decides to list an answering service number as the preferred method of contact, his/her mobile phone number must be provided to the hospital as a backup number to reach the on-call physician. a. On 11/30/22 at 1258 hours, a tour of the ED was conducted with the Chief Quality and Patient Safety Officer and the Quality Review/Process Improvement RN. On 11/30/23 at 1304 hours, a concurrent interview and review of the ED on-call schedule dated 11/30/23 was conducted with RN 5. When asked, RN 5 stated the telephone numbers on the on-call schedule were not the direct telephone numbers for the on-call physicians. RN 5 stated the telephone numbers listed on the on-call scheduled were to the physician’s office or a “call center.” Ophthalmologist 1 was randomly selected from the ED on-call scheduled and RN 5 called the Ophthalmologist 1’s telephone number listed on the ED on-call schedule dated 11/30/23 (7 am to 7 am). RN 5 confirmed the telephone number was not the direct telephone number for Ophthalmologist 1. The telephone number was for Ophthalmologist 1’s office, “[Name of Business] Eye Care.” On 11/30/23 at 1312 hours, a concurrent interview and review of the ED on-call schedule dated 11/30/23 was conducted with ED Unit Secretary 2. ED Unit Secretary 2 stated the ED on-call schedule dated 11/30/23 did not list the direct telephone numbers for the on-call physicians. ED Unit Secretary 2 stated the ED on-call schedule was posted throughout the ED and that it was not appropriate for the physician’s direct telephone number (e.g., cell phone) to be displayed and for the ED staff to have access to the physician’s contact information. The findings were shared and acknowledged by the Chief Quality and Patient Safety Officer. 38764 b. Review of the hospital’s Transfer Request tracker list for October 2023, showed a request of transfer for Patient 1 as “ER-ER” on 10/17/23; Patient 1 had a diagnosis of stroke. Review of the Transfer Center notes for Patient 1 dated 10/17/23 showed at 0125 hours, Neurosurgeon 1 was called by a Transfer Center staff for a physician-to-physician communication; however, there was no answer from the physician. The documentation showed the telephone number was not the direct telephone number of Neurosurgeon 1. Review of the hospital’s ED Call Schedule - Neurosurgery for October 2023, showed Neurosurgeon 1 was listed on the ED Call Schedule as an on-call physician on 10/16 to 10/20/23. The telephone number shown on the ED Call Schedule - Neurosurgery was the same telephone number as described on the transfer center’s documentation. On 11/29/23 at 1103 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer acknowledged the above findings. The Chief Quality and Patient Safety Officer verified the telephone number of Neurosurgeon 1 as shown on the on-call schedule list was not the direct telephone number of Neurosurgeon 1. The Chief Quality and Patient Safety Officer acknowledged the telephone number was the physician’s office number during business hours, and after business hours, the number would be transferred over to an answering service company.”

“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: 38764 Based on interview and record review, the hospital failed to ensure the Emergency Department Logs and the L&D Central Logs were accurately maintained. 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 and L&D department for the treatments of their emergency medical conditions. Findings: Review of the hospital’s P&P titled EMTALA - Central Log Policy dated March 2023 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.a. Review of the hospital’s Emergency Department Logs for June and October 2023 showed the Emergency Department Logs were not completed in its entirety as the mode of arrival, chief complaint, and disposition were not documented in the Emergency Department Logs for two sampled patients (Patients 4 and 5) and two nonsampled patients (Patients 22 and 23). On 11/29/23 at 1445 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer verified the Emergency Department Logs were not completed in its entirety. In addition, the Chief Quality and Patient Safety Officer verified there were patients included in the log but did not come to the hospital’s ED as patients. 37548 b. On 11/27/23, a random review of the Emergency Department Logs for September and November 2023 showed the Emergency Department Logs were not completed in its entirety as the mode of arrival, chief complaint, and disposition were not documented in the Emergency Department Logs for at least 12 patients for November 2023 and at least 15 patients for September 2023. On 11/28/23 at 1410 hours, during an interview with the Chief Quality and Patient Safety Officer, the Chief Quality and Patient Safety Officer acknowledged the findings and confirmed the Emergency Department Logs had not been maintained. c. On 11/30/23 at 1100 hours, an interview and concurrent review of the Emergency Department Log for November 2023 and Patient 19’s medical record was conducted with the Quality Review/Process Improvement RN. Patient 19’s medical record showed Patient 19 presented to the ED by EMS on 11/19/23 at 2232 hours, after a motor vehicle accident. Review of the ED Provider Aware Note dated 11/20/23 at 0101 hours, showed Patient 19 was to be admitted inpatient to ICU. The Disposition section showed the patient left against medical advice. In a subsequent record review, the Quality Review/Process Improvement RN stated Patient 19 had not left AMA; the patient was admitted to the ICU and then discharged home. Review of the Emergency Department Log for November 2023 showed the Disposition section showed Patient 19 had left the ED AMA. The findings were discussed and acknowledged by the Quality Review/Process Improvement RN. The Quality Review/Process Improvement RN stated the ED Disposition was incorrect. The Disposition should have been documented as admitted and should not be documented as AMA. 2.a. On 11/27/23, a random review of the L&D Central Logs for June, July, August, September, October, and November 2023 showed the L&D Central Logs were not completed in its entirety. The time of arrival, means of arrival, disposition or discharge time was not always documented. For example, at least 15 patients had no disposition documented in the logs from June through November 2023. On 11/28/23 at 1100 hours, during an interview and concurrent review of the L&D Central Log with the Chief Quality and Patient Safety Officer, the Chief Quality and Patient Safety Officer acknowledged the L&D Central Logs had not been maintained. b. On 11/27/23 at 1056 hours, an interview and concurrent review of the L&D Central Log for October 2023 was conducted with the Quality Review/Process Improvement RN and the Nursing Manager of Perinatal Services. Review of the log entry for Patient 14 dated 10/30/23, showed the time of arrival was 0406 hours; there was no documentation of the departure time or of the patient’s disposition. In addition, the log entry had been crossed off. When asked, the Nursing Manager of Perinatal Services stated the log entry for Patient 14 had been cross off because the patient had arrived in active labor and delivered quickly; the L&D nurses had not conducted the MSE; the MSE was conducted by the physician. On 11/29/23 at 1416 hours, an interview and concurrent review of Patient 14’s medical record was conducted with the Quality Review/Process Improvement RN and the Chief Quality and Patient Safety Officer. Patient 14’s medical record showed Patient 14 presented to the ED on 10/30/23 at 0359 hours with contractions and was immediately transported to L&D. Review of the L&D nursing documentation dated 10/20/23 at 0410 hours through 04040 hours showed, “Notified [name of physician] ...about patient’s complain, fetal tracing...Received admission orders.” The findings were discussed and acknowledged by the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer stated the log entry should have been completed in its entirety and the entry should not have been crossed off.”

“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: 37548 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 21 sampled patients (Patients 14 and 16) as evidenced by: 1. For Patient 16, the ED staff did not implement the P&P for EMTALA general requirements when the patient was observed leaving the ED without having an MSE. 2. For Patient 14, the ED staff did not implement the P&P for triage of pregnant patient. These failures had the potential to result in poor clinical outcomes and serious adverse events to the patients receiving the ED services. Findings: 1. Review of the hospital’s P&P titled EMTALA - Definitions and General Requirements dated March 2023 showed in part: * Leaving DED after Triage but before an MSE. If an individual presents to the DED and requests services for a medical condition, is triaged and then indicates a desire to leave prior to the MSE (LWBS), the facility should use its best efforts to: - Offer the individual further medical examination and treatment as may be required to identify and stabilize an EMC. - Discuss with the individual the risks and benefits involved in leaving prior to the medical screening and document same. - Ask the patient to sign the Refusal to Permit Medical Treatment Form. - If the individual refuses to sign the Refusal to Permit Medical Treatment Form, hospital personnel should document that the Refusal to Permit Medical Treatment Form was provided, and the individual refused to sign the form. - Document the individual’s waiver of his or her right to MSE, or the attempts to locate the individual if he or she left without notifying someone - Describe, in the medical record, the examination and treatment that was refused or the request for treatment was withdrawn; and - Sign the form, adding date and time. On 11/29/23 at 1449 hours, an interview and concurrent review of Patient 16’s medical record was conducted with the Quality Review/Process Improvement RN and the Chief Quality and Patient Safety Officer. Patient 16’s medical record showed the patient presented to the ED on 9/3/23 at 1427 hours, for shortness of breath. Review of the ED Triage Aware Note dated 9/3/23 at 1443 hours, showed Patient 16 complained of feeling SOB in the morning and did not have her inhaler. The patient’s ESI acuity level was four. Review of the Progress Note signed by the PA on 9/3/23 at 1507 hours, showed, “I was informed by the front desk that patient was seen leaving the emergency department. Patient had left without being seen.” When asked, the Quality Review/Process Improvement RN stated there was no documentation an MSE was conducted for Patient 16. The Quality Review/Process Improvement RN confirmed there was no documentation the ED staff implemented the hospital’s P&P for a patient that left the ED without an MSE. The findings were shared and acknowledged by the Chief Quality and Patient Safety Officer. 2. Review of the hospital’s P&P titled Labor Patients, Observation dated August 2021 showed in part: * Purpose: To provide appropriate maternal/fetal evaluation and assessment. * Patients presenting with pregnancy related complaints or signs of active labor will be assessed and triaged in the ED by a triage RN and/or ED Physician/Physician Assistant. On 11/29/23 at 1416 hours, an interview and concurrent review of Patient 14’s medical record was conducted with the Quality Review/Process Improvement RN and the Chief Quality and Patient Safety Officer. Patient 14’s medical record showed Patient 14 presented to the ED on 10/30/23 at 0353 hours with contractions. The patient was 40 weeks pregnant. The Quality Review/Process Improvement RN confirmed there was no documentation a completed triage assessment was conducted in the ED for Patient 14 as per the hospital’s P&P. On 11/30/23 at 1041 hours, during an interview with the Interim ED Nursing Director, the Interim ED Nursing Director confirmed the hospital’s form titled ED to L&D Quick Triage Form, which was the triage assessment by the ED Triage RN, was not found in Patient 14’s medical record. The findings were shared and acknowledged by the Chief Quality and Patient Safety Officer.”

“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 observation, interview, and record review, the hospital failed to ensure the necessary stabilizing treatments were provided within the capabilities of the hospital for five of 21 sampled patients (Patients 2, 9, 15, 18, and 21) and failed to ensure the ED equipment was available and properly maintained as evidenced by: 1. For Patient 15, the trauma physician failed to document Patient 15’s emergency medical condition had been stabilized before discharging the patient. 2. For Patient 21, the hospital failed to ensure the AMA P&P was implemented for the patient. 3. For Patients 2 and 18, the ED staff failed to conduct a thorough contraband search for Patients 2 and 18 as per the hospital’s P&P. In addition, the ED staff failed to complete the Close Observation Flowsheet for Patient 18 which consisted of documenting the patient’s location and the patient’s behavior every 15 minutes. 4. For Patient 9, the ED staff did not conduct the pain reassessment after administering the pain medication to the patient as per the hospital’s P&P. 5. The hospital did not ensure the ED pediatric crash cart were maintained as per the hospital’s P&P for the patient use in the emergent event. In addition, the L&D staff failed to ensure the adult crash cart was stored in a location where it would be always readily available and accessible. 6. The hospital staff failed to ensure the last maintenance date was posted on the HEPA filter in the patient care area, failed to inspect and maintain the overhead exam lights used in the patient care areas in the ED, and failed to ensure the call lights in the ED patient restrooms provided with safety measures for vulnerable patients. These failures had the potential to result in poor health 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 March 2023 showed EMTALA requires the hospital to do the following: * If the hospital determines that an individual does have an EMC, provide necessary stabilizing treatment to the individual or provide for an appropriate transfer. 1. On 11/29/23 at 1500 hours, an interview and concurrent review of Patient 15’s medical record was conducted with the Quality Review/Process Improvement RN and Chief Quality and Patient Safety Officer. Patient 15’s medical record showed Patient 15 presented to the ED by EMS on 11/21/23 at 0923 hours, after an unwitnessed fall. Review of the ED Provider Aware Note dated 11/21/23 at 1051 hours, showed Patient 15 would be upgraded to a moderate trauma and care and transferred to trauma services. Review of the Neurosurgery NP Note dated 11/21/23 at 1241 hours, showed “Contacted by Trauma for assessment on acuity of ICH found on CTH today.” The Plan section showed, “No neurosurgical intervention is indicated...OK to DC back to care facility.” Review of the Trauma Report dictated on 11/21/23 at 2106 hours, showed dated 11/21/23, showed it was unknown whether Patient 15 lost consciousness after the unwitnessed fall. The Plan section showed, “A consultation with neurosurgery was obtained while the patient was in the Emergency Room. He stated that the CT scan of the brain showed no acute findings: The patient was therefore transferred back to the rehabilitation center.” In a concurrent interview, the Quality Review/Process Improvement RN stated there was no documentation showing Patient 15’s medical condition had been stabilized and the patient could be discharged from the hospital. The findings were discussed and acknowledged by the Chief Quality and Patient Safety Officer. 2. Review of the hospital’s P&P titled Against Medical Advice, Leaving dated February 2022 showed in part: * Before a patient is discharged prior to the completion of treatment or contrary to medical advice, the patient’s physician must first attempt to provide the patient or legal representative with information regarding why continued hospitalization is recommended, the potential consequences of leaving, the benefits of continued hospitalization and any alternatives such as transfer to another facility or outpatient treatment for the patient can make an informed decision on whether or not to leave the hospital. * If the physician is not available to speak with the patient in person, the physician may provide the informed consent on leaving against medical advice by telephone. The nurse shall document in the progress notes date, time, and a notation that the physician spoke with the patient via phone to provide informed consent. The physician dictates in the discharge summary that he provided the informed consent. On 11/29/23 at 1121 hours, an interview and concurrent review of Patient 21’s medical record was conducted with the Quality Review/Process Improvement RN and the Nursing Manager of Perinatal Services. Patient 21’s medical record showed Patient 21 presented to the ED on 11/24/23 at 1803 hours, with a chief complaint of hypertension. The patient’s EGA was 38 weeks and five days. Review of the ED Triage Aware Note dated 11/24/23 at 1828 hours, showed Patient 21 was triaged at 1818 hours. The patient’s ESI level was two. Review of the L&D nursing documentation dated 11/24/3 at 1900 hours, showed Patient 21 was referred to the hospital to rule out pre-eclampsia. Physician 3 was notified of the patient’s status and ordered laboratory tests. Further review of the L&D nursing documentation dated 11/24/23, showed the following: * At 1920 hours, Patient 21 refused laboratory tests. * At 1933 hours, “Informed [name of the physician] regarding pt’s refusal for labs and pt willing to be discharged by AMA. MD stated she did not want to speak with pt via the telephone. No new orders received.” Review of the Nursing Discharge Summary dated 11/24/23 at 2027 hours, showed Patient 21 left AMA on 11/24/23 at 1948 hours. In a concurrent interview, the Nursing Manager of Perinatal Services confirmed Physician 3 did not implement the AMA P&P for Patient 21. 3. Review of the hospital’s P&P titled Suicide Patient, Assessment and Care Of dated November 2022 showed the following: * The purpose is to identify patients at risk for suicide and to assure that their immediate safety needs are met in the most appropriate care setting within the scope of services provided by the organization. * Patients with a diagnosis/admission complaint of, purposeful overdose, current attempt to harm self/suicide, or suicidal ideation with concrete plan will be considered HIGH RISK. Any patient identified as an active high risk for suicide will be placed on suicide precautions. * In the ED: - The patient is in continuous observation. - Assess patient room and remove any items with potential for self-harm; utilize the Suicide Safety Checklist Form, which will be a part of the patient’s permanent medical record and utilize the “Contraband List” as a guide of items to remove from patient room. Review of the Contraband List showed the contraband items which are not allowed in the patient care areas, include pins of any kind, glass objects, shoelaces and clothing with strings, metal items, or sharp items. a. On 11/29/23 at 1525 hours, an interview and concurrent review of Patient 18’s medical record was conducted with the Quality Review/Process Improvement RN and the Interim ED Nursing Director. Patient 18’s medial record showed Patient 18 presented to the ED on 11/10/23 at 1325 hours, with suicidal thoughts. The patient was transferred to other facility on 11/11/23 at 1000 hours. Review of the ED Triage Aware Note dated 11/10/23 at 1343 hours, showed “Pt placed on 5150 DTS.” Patient 18 was identified as “HIGH RISK for suicide. Needs 1:1 monitoring.” Review of the ED Provider Aware Note dated 11/10/23 at 1347 hours showed, “Patient’s work-up reveals significant alcohol intoxication...patient will be watched.” The Impression section showed “Suicidal Ideation/5150.” Review of the Suicide Safety Checklist dated 11/10/23 at 1508 hours, showed the box of “1:1 Observer to keep the patient In Line of Sight at All Time” was checked. * Review of the Close Observation Flowsheet did not show documentation Patient 18’s locations and the patient’s behaviors were observed every 15 minutes on 11/10/23 from 2315 hours through 11/11/23 at 0700 hours. The findings were shared and acknowledged by the Quality Review/Process Improvement RN. * When asked about the contraband search, the Interim ED Nursing Director confirmed there was no documentation showing a contraband search was conducted for Patient 18. b. Review of Patient 2’s medical record showed the patient came to the ED on 6/26/23. Review of the ED Triage Aware Note dated 6/26/23 at 2102 hours, showed Patient 2’s chief complaint was overdose. Patient 2 reported the patient intended to harm self. A suicide screening was conducted for Patient 2 and the patient was identified as high risk for suicide. On 11/29/23 at 1408 hours, an interview and concurrent record review of Patient 2’s medical record was conducted with the Clinical Educator. The above documentation on Patient 2’s medical record was acknowledged by the Clinical Educator. On 11/30/23 at 1421 hours, an interview was conducted with the Chief Quality and Patient Safety Officer, the Interim ED Nursing Director, the Nursing Manager of Perinatal Services, and the Quality Review/Process Improvement RN. The Chief Quality and Patient Safety Officer and Interim ED Nursing Director acknowledged there was no documentation to show if Patient 2’s room was assessed and removed any items with potential for self-harm by utilizing the contraband list as per the hospital’s P&P. 38764 40431 4. Review of the hospital’ P&P titled Pain Management dated March 2021 showed in part: * Purpose: to assure that patients receive an assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings. The goal is to keep the pain level of every patient at three or less. * Emergency Department - Initial Assessments: Patient seen in the ED shall receive a screen during the triage or initial assessment process to identify the presence pain. If the screen is positive, then the patient shall receive an assessment to gather sufficient information to identify the pain. The information that may be obtained during this assessment includes, but is not limited to: the intensity of pain using age or condition appropriate assessment tools; the location and nature of pain; and the patient’s tolerance to pain and acceptable intensity of pain (pain goal). - Reassessment Following Treatment of Pain: If a treatment intervention for pain is provided, then the response to that intervention must be assessed. Reassessment is recommended to occur within 15-60 minutes following treatment (depending on the type of intervention). On 11/28/23 1100 hours, Patient 9’s medical record was reviewed with the Quality Review/Process Improvement RN. Patient 9’s medical record showed Patient 9 arrived to the hospital ED via paramedic on 8/2/23 at 0902 hours, with the chief complaint of burns on his face and arms. Review of the ED Triage Aware Note showed Patient 9 was triaged on 8/2/23 at 0908 hours. The patient’s pain level was seven out of 10. Review of Patient 9’s MAR (Medication Administration Record) showed Dilaudid (a pain medication) 1 mg IV was administered to the patient on 8/2/23 at 0908 hours. Another dose of Dilaudid 1 mg IV was administered to the patient on 8/2/23 at 0933 hours. Review of the Pain Assessment flowsheets showed there was no documented evidence showing the ED staff reassessed Patient 9 for pain after the patient was receiving IV pain medication on 8/2/23 at 0908 and 0933 hours. On 11/28/23 at 1330 hours, an interview and concurrent review of Patient 9’s medical record was conducted with the Interim ED Nursing Director. The Interim ED Nursing Director confirmed the findings. 5. Review of the hospital’s P&P titled Equipment Check dated June 2021 showed the purpose is to maintain ED equipment that is functional and adequately stocked. Department equipment is checked and stocked every shift: - Crash carts (adult and pediatric) - Defibrillators: ED RN signatures are placed on the crash cart checklist indicating that the defibrillators were checked and are in functional order. Review of the hospital’s P&P titled Crash Carts dated July 2020 showed the contents of each crash cart including the supplies and medications, will be listed and available for reference in each crash cart. Crash carts are inspected daily by the nursing staff in each patient care area where crash carts are located. a. On 11/27/23 at 0800 hours, a tour of the ED patient care areas was conducted with the Infection Control Manager, Trauma Service Manager, and RN 3. The ED’s pediatric crash cart did not have a defibrillator and the pediatric crash cart checklist for monitoring and checking the crash cart supplies or testing of a defibrillator as per the hospital’s P&P. When asked if there should be a defibrillator on every crash cart, RN 3 stated they had defibrillators in the other areas of the ED. RN 3 stated the pediatric defibrillation pad could be able to hook up to the adult defibrillator. When asked about the daily crash cart check list for checking the defibrillator, supplies, and medications, the Trauma Service Manager and RN 3 stated it was part of all the ED staff’s responsibility to check the crash carts daily and sign off. When asked to view the pediatric crash cart check list, the Trauma Service Manager stated the nurses probably just used the adult crash cart check list. When asked, the Trauma Service Manager and RN 3 was unable to show documented evidence the daily check list for the pediatric crash cart was completed for the ED pediatric crash cart. On 11/28/23 at 0915 hours, an interview was conducted with the Chief Quality and Patient Safety Officer about the pediatric crash cart not having a defibrillator and no having crash cart checklist. The Chief Quality and Patient Safety Officer confirmed the above findings and stated every crash cart including the pediatric crash cart, should have its own defibrillator and daily crash cart checklist. b. On 11/28/23 at 1050 hours, a tour of the L&D department was conducted with the Chief Quality and Patient Safety Officer, the Quality Review/Process Improvement RN, and the Nursing Manager of Perinatal Services. During a concurrent interview, Nursing Manager of Perinatal Services confirmed the L&D department had only one adult crash cart and it was stored in the PACU which was locked with keypad access only. The findings were acknowledged by the Nursing Manager of Perinatal Services. 6. On 11/27/23 at 0800 hours, a tour of the ED patient care areas was conducted with the Infection Control Manager and Trauma Service Manager, and RN 3. The following was identified: a. A HEPA Filter machine in one of the ED’s patient bays was not labeled with the last maintenance date. When asked what the equipment was being used for, the Infection Control Manager stated it was used for patients who needed isolation precautions. When asked when the last maintenance date was and if the equipment was functional, the Trauma Service Manager had to call and verify with the facilities department. The facilities staff informed the Infection Control Manager the machine was still operational and could be used whenever needed. When asked how often the equipment would be checked for maintenance, the Infection Control Manager and Chief Quality and Patient Safety Officer stated equipment would be checked and maintained on an annual basis and should be posted on the equipment. b. The ED’s patient care area showed the overhead exam lights did not have dates posted to show when their last maintenance was done. When asked when the last maintenance was done for the overhead electric lights that were positioned over the beds of the patients, the Chief Quality and Patient Safety Officer stated they had never been done until she mentioned it and after it was brought to her attention. c. The patients’ restrooms showed the cords of the call light was not long enough for the patients who could be at risk of potential fall patients. When asked about the short cord attached to the call light system, the Infection Control Manager stated it was probably short like that to keep patients from using it as a ligature. When asked about vulnerable patients who might experience a fall, the Infection Control Manager stated she was unaware of the breakaway cords that could assist the patients who might experience a fall while in the restroom as well as provide a safety measure for suicidal patients at risk. On 11/28/23 at 0915 hours, an interview was conducted with the Chief Quality and Patient Safety Officer about the overhead exam lights and the call lights in the patient’s restrooms for safety measures. The Chief Quality and Patient Safety Officer confirmed the above findings. The Chief Quality and Patient Safety Officer also confirmed the exam lights were not being monitored every year by the facilities department as they should be, especially, since one of the overhead exam lights needed a bulb replacement.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure the ED staff appropriately transferred the patient from the ED to other hospital as evidenced by: 1. The hospital failed to ensure the ED and the L&D department utilized the approved Transfer Summary and Certification Form and the Patient’s Request/Refusal/Consent to Transfer Form. 2. The hospital failed to ensure the ED contracted services were evaluated annually. 3. The ED staff did not accurately complete the ED Interfacility Patient Transfer Acknowledgement & Consent form for one of 21 sampled patients (Patient 7). These failures had the potential to result in poor clinical outcomes and serious adverse event to the patients receiving ED services. Findings: 1. On 11/28/23 at 1014 hours, an interview and concurrent review of the hospital’s P&P titled EMTALA - Transfer Policy dated March 2023 was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety confirmed the ED and the L&D department were not utilizing the approved Transfer Summary and Certification Form and the Patient’s Request/Refusal/Consent to Transfer Form; and the ED was utilizing the form titled ED Interfacility Patient Transfer Acknowledgement & Consent. On 11/28/23 at 1100 hours, a tour of the L&D department was conducted with the Chief Quality and Patient Safety Officer and the Nursing Manager of Perinatal Services. When asked about the Transfer Summary and Certification form, the Nursing Manager of Perinatal Services stated the forms were not maintained in the L&D department. On 11/28/23 at 1117 hours, during an interview with RN 6, RN 6 stated that it was rare for an L&D patient to be transferred out and RN 6 was not sure which form had to be completed if a patient had to be transferred to HLOC. The Chief Quality and Patient Safety Officer acknowledged the findings. 2. On 11/28/23, a review of the list of ED contract services agreements was conducted. The list of agreements included but was not limited to ambulance services, transfer to HLOC, telehealth services, ED physicians, and physicians on-call. On 11/30/23 at 1430 hours, the Chief Quality and Patient Safety Officer was interviewed and stated the ED contract services agreements should have been evaluated yearly but were not. 40431 3. On 11/29/23 at 0900 hours, an interview and concurrent review of Patient 7’s medical record was conducted with the Quality Review/Process Improvement RN and the Interim ED Nursing Director. Patient 7’s medical record showed Patient 7 came to the ED on 7/1/23 at 0857 hours, for stroke symptoms and was transferred to other hospital on 7/1/23 at 1329 hours. Review of the ED Provider Aware Note dated 7/1/23 at 0902 hours, showed the ED physician spoke with a physician who would accept Patient 7 for transferring for further stroke work-up. Review of the ED Interfacility Patient Transfer Acknowledgement & Consent form signed by the ED physician on 7/1/23 at 1213 hours, showed Patient 7 was transferred for further medical care. The form showed the accepting physician’s name was not the same as the name the ED physician had spoken to and referred to as the accepting physician. When asked, the Interim ED Nursing Director acknowledged the accepting physician’s name on the ED Interfacility Patient Transfer Acknowledgement & Consent form was incorrect and should have been the same physician’s name who the ED physician had spoken to. The Interim ED Nursing Director confirmed the findings.”

“RECIPIENT HOSPITAL RESPONSIBILITIES CFR(s): 489.24(f) A participating hospital that has specialized capabilities or facilities (including, but not limited to, facilities such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers, which, for purposes of this subpart, means hospitals meeting the requirements of referral centers found at §412.96 of this chapter) may not refuse to accept from a referring hospital within the boundaries of the United States an appropriate transfer of an individual who requires such specialized capabilities or facilities if the receiving hospital has the capacity to treat the individual. This requirement applies to any participating hospital with specialized capabilities, regardless of whether the hospital has a dedicated emergency department. This Standard is not met as evidenced by: 38764 Based on interview and record review, the hospital failed to ensure Hospital B’s staff (Hospital B was the receiving hospital) properly responded to the calls as per Hospital B’s P&P when the transferring hospital (Hospital A) requested to transfer the patients to Hospital B for two of 21 sampled patients (Patients 1 and 20) as evidenced by: 1. For Patient 1, Neurologist 1 did not respond to the call as per the hospital’s Medical Staff General Rules and Regulations. 2. For Patient 20, Neurologist 1 requested not to connect the call with Hospital A’s ED physician. The ED staff did not direct the call to Hospital B’s ED physician when Hospital A’s ED physician requested to transfer Patient 20 to Hospital B via the transfer center. Hospital B’s admitting staff informed the Transfer Center that an insurance authorization was required for Patient 20’s transfer into Hospital B. These failures had the potential to result in poor clinical outcomes and serious adverse event to the patients receiving ED services in the hospital. Findings: Review of the hospital’s P&P titled EMTALA-Transfer Policy dated March 2023 showed a hospital with specialized capabilities or facilities shall accept from a transferring hospital an appropriate transfer of an individual with an EMC who requires specialized capabilities if the receiving hospital has the capacity to treat the individual. The transfer of an individual shall not consider an individual’s insurance status and ability to pay for medical services. Hospitals may utilize a Transfer Center to facilitate the transfer of any individual from or to the ED of the transferring facility to the receiving facility. At the ED physician’s request, the Transfer Center must facilitate a discussion between the ED Physician and the on-call physician of the receiving facility. The on-call physician does not have authority to refuse an appropriate transfer on behalf of the facility. Review of hospital’s P&P titled Transfer of Patient from an Outside Facility to the ED dated June 2021 showed the transfer will be arranged by direct and appropriate physician-to-physician conversation. For the documentation about the transfer, the EMTALA Transfer Acceptance or Denial Form must be completed by the ED Charge RN or Trauma Clinician or nurse designee. Review of the hospital’s Medical Staff General Rules and Regulations effective on 8/23/21, showed the primary objective of a “hand off” is to provide accurate information about a patient’s care, treatment, current condition, and any recent or anticipated changes. The information communicated during a hand off must be accurate. Circumstances requiring Physician-to-Physician hand-off communication include, but are not limited to request for consultation, admissions facilitated by the Emergency Department, or transfer of patient from the ED to another healthcare facility. Medical staff and allied health professional members should respond to pages and telephone messages within thirty (30) minutes. 1. Review of Patient 1’s Transfer Center notes dated 10/17/23, showed the following: - At 0116 hours, the Transfer Center received a call from Hospital A’s RN who stated Hospital A had a patient with an ischemic stroke. - At 0143 hours, the Transfer Center staff reported to Neurosurgeon 1 about Patient 1. Neurosurgeon 1 stated the patient needed a neurologist. - At 0145 hours, voicemail message was left to Neurologist 1. - At 0147 hours, the Transfer Center staff placed a call to the Transfer Center Manager and informed the Transfer Center Manager about Patient 1. The Transfer Center staff contacted Hospital B’s House Supervisor to verify the telephone number of Neurologist 1. Hospital B’s House Supervisor stated Hospital B’s House Supervisor would send a text message to Neurologist 1. Further review of the Transfer Center note did not show Neurologist 1 called back the Transfer Center. Review of Hospital B’s ED Call Schedule - Neurology for October 2023, showed Neurologist 1 was the on-call physician on 10/16 and 10/17/23. The telephone number of Neurologist 1 shown on the Hospital B’s ED Call Schedule - Neurology was the same telephone number documented in the transfer center notes for Patient 1. On 11/29/23 at 1103 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer verified there was no documentation to show Neurologist 1 called back the Transfer Center. 2. Review of Hospital B’s ED Call Schedule - Neurology for October 2023, showed Neurologist 1 was the on-call physician on 10/16 and 10/17/23. Review of Patient 20’s medical record showed the patient came to Hospital B’s ED from Hospital A on 10/16/23 at 1721 hours. Review of the ED Triage Aware Note dated 10/16/23 at 1730 hours, showed Patient 20 was triaged on 10/16/23 at 1722 hours. The patient’s chief complaint was stroke symptoms. Review of Patient 20’s EMTALA Transfer Acceptance or Denial form dated 10/16/23 at 1430 hours, showed the following: - Patient 20 had a diagnosis of stroke. - The CT scan result was “likely ischemic.” - The patient was unstable and required a higher level of care. - The ED staff requested to page Neurologist 1 so Neurologist 1 could discuss with the ED physician; however, “unsure why” Neurologist 1 refused the physician-to-physician communication with the ED physician. a. Review of the Transfer Center notes for Patient 20 dated 10/16/23, showed the following: - Per Hospital A’s ED physician, Patient 20’s stroke was likely ischemic and emergent. - Transfer Center staff contacted Neurologist 1 and the staff presented about Patient 20’s case. - Transfer Center staff requested Neurologist 1 if the staff could connect the call to Hospital A’s ED physician. However, Neurologist 1 requested not to connect the call to Hospital’s A ED physician and stated the patient just needed to be sent over ASAP. On 11/29/23 at 1103 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer verified the transfer center documentation for Patient 20. The Chief Quality and Patient Safety Officer stated Neurologist 1 should had spoken to the Hospital A’s ED physician. On 11/30/23 at 1255 hours, an interview and concurrent record review was conducted with the Interim ED Nursing Director. The Interim ED Nursing Director verified the EMTALA Transfer Acceptance or Denial form for Patient 20. The Interim ED Nursing Director acknowledged, according to the transfer form Neurologist 1 refused to speak to Hospital A’s ED physician. b. Review of ED Staff 1’s job description modified on 3/16/21, showed the staff will accept and relay other communications, answers phone timely and directs call appropriately. Review of the Transfer Center notes for Patient 20 dated 10/16/23, showed at 1423 hours, the Transfer Center staff received a call from Hospital A’s ED staff about Patient 20 who had a stroke. The Transfer Center staff contacted the Hospital B’s ED and informed ED Staff 1 that Neurologist 1 advised to send Patient 20 emergently to Hospital B’s ED. ED Staff 1 informed the Transfer Center staff that Neurologist 1 needed to call Hospital B’s ED physician. The Transfer Center staff informed ED Staff 1 that Hospital A’s ED Physician was on the other telephone line and requested to connect with Hospital B’s ED physician; however, ED Staff 1 informed the Transfer Center staff to have Neurologist 1 to call Hospital B’s ED physician first. On 11/29/23 at 0935 hours, an interview was conducted with ED Staff 1. ED Staff 1 was asked to describe the process when receiving a call from the Transfer Center. ED Staff 1 stated when the ED Staff received a call from the Transfer Center, the ED Staff would ask the type of transfer from the Transfer Center. ED Staff 1 stated for example, if the transfer was related to a stroke, the ED staff would transfer the call to the ED charge nurse. On 11/29/23 at 0940 hours, an interview was conducted with RN 4. RN 4 acknowledged the process related to receiving a call from the Transfer Center as described above. RN 4 stated the RN would take the information provided by the Transfer Center staff and would inform the ED physician about the call from the Transfer Center. On 11/29/23 at 1103 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer verified the above findings. The Chief Quality and Patient Safety Officer acknowledged the ED Staff should had the Transfer Center staff connected the telephone call of the transferring ED physician to the receiving ED physician. On 11/30/23 at 1255 hours, an interview and concurrent record review was conducted with the Interim ED Nursing Director. The Interim ED Nursing Director verified Patient 20’s EMTALA Transfer Acceptance or Denial form. c. Review of the Transfer Center notes for Patient 20 dated 10/16/23, showed the following: - At 1510 hours, according to an admitting staff, Patient 20 had an active health insurance and an authorization from the insurance was required for the patient’s transfer. - At 1513 hours, the Transfer Center Manager approved to bypass authorization from the insurance due to the emergent higher level of care for the patient. On 11/29/23 at 1103 hours, an interview and concurrent record review was conducted with the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer verified the above findings. The Chief Quality and Patient Safety Officer stated an insurance information of a patient was not required for a transfer. The Chief Quality and Patient Safety Officer stated by asking insurance information could potentially delay the care of a patient or a patient would not further seek for a medical care.”