San Antonio Regional Hospital

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 46917 Based on interview and record review, the facility’s Quality Assessment and Performance Improvement (QAPI- a data-driven framework used by healthcare organizations to continuously evaluate and improve patient care and safety) program failed to reflect an ongoing program to identify opportunities for performance improvement focused on the Cardiac Catheterization Laboratory (CCL -specialized room with advanced diagnostic technology) Adverse Event (AE-an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof),as required by its policies and by federal and state reporting requirements for one of three sampled patients for CCL (Patient 32). This failure resulted in the facility not reporting a patient death that occurred following a Transcatheter Aortic Valve Replacement (TAVR-Replacement- minimal invasive procedure used to treat stiffened or narrowed heart valves without the need for traditional open heart surgery) procedure performed under general anesthesia and had the potential to misidentify recurring trends, patterns, missed opportunities to implement timely corrective actions that place the health and safety of the patients at risk for harm. Findings: During a review of Patient 32’s “History and Physical Examination”(H&P), dated March 30, 2026, the H&P indicated “ ... she [Patient 32] gets palpitations [feelings of flutter inside chest], but no chest pain, shortness of breath, or syncopal [fainting] episodes ... she is an active woman that walks frequently ...” During a review of Patient 32’s “Consultation Physician” Report, dated May 18, 2026, the “Consultation Physician” Report indicated, “she [Patient 32] presents to [facility name] for elective TAVR ... R/B/A [risks/benefits/adverse events] D/W [discussed with] pt [patient] who agree to proceed with TAVR.” During a review of Patient 32’s “Cardiac Procedures” (CP) Report, dated May 18, 2026, the CP indicated, “ ... general anesthesia [state of controlled unconsciousness where the patient feels no pain and has no awareness of procedure] provided by the anesthesia team ...the patient began to decompensate [lose ability to maintain body function] and became hypotensive [low blood pressure] and then became tachycardic [elevated heart rate] and lost her pulse on several occasions. CPR [cardiopulmonary resuscitation -emergency lifesaving procedure performed when a patient heart or breathing stops] was started and ROSC [return of spontaneous circulation- patient heart starts to beat on its own] was achieved ... COMPLICATIONS: distal abdominal [low position in stomach] dissection [layer of a vessel tears] described ...” During a review of Patient 32’s “[NAME] Anesthesia Record” (AR), dated May 18, 2026, AR indicated, at 10:33 AM, anesthesia method was “general”. During a review of Patient 32’s “Operative Reports” (OR) dated May 18, 2026, the OR indicated, the date and the start time of the procedure was on May 18, 2026, at 10: 38 AM. The OR further indicated, “ ...Complications abdominal aortic ...perforation [emergency where the wall of aorta (large vessel) tears] resulting in hemorrhagic shock [medical emergency caused by severe blood loss] ...pt developed abdominal compartment syndrome [emergency caused by increased pressure in lower belly area] requiring decompressive laparotomy [surgical procedure where the abdomen is opened] ... TRALI with ARDS [transfusion related acute lung injury with acute respiratory distress syndrome- life threatening complication of blood transfusions which causes severe breathing difficulty] ... multiple hours of intermittent CPR ...” During a review of Patient 32’s “Cardiac Catheterization Lab Procedure Log” (CCL Log), dated May 18, 2026, the CCL Log indicated the procedure was complicated by “dissection leading to instability” and Patient 32 expired (died). During an interview on June 3, 2026, at 3:48 PM, with the Director of Cardiac Catheterization Lab (DCCL), the DCCL stated Patient 32’s death was an adverse event. The DCCL further stated Patient 32’s death was reported to the internal incident report system. During an interview on June 3, 2026, at 4:04 PM, with the Director of Patient Services and Risk Management (DPSRM), the DPSRM stated Patient 32’s death was not reportable to State Agencies, as it was an unfortunate complication from Patient 32’s medical condition. The DPSRM further stated a root cause analysis (RCA-structured problem-solving process used to identify the underlying cause of undesired event) was in process and any case related to physician care it is sent to the peer review process (formal system where physicians evaluate the clinical work of their peers). During an interview on June 4, 2026, at 10:07 AM, with the Medical Director of Cardiology (MDC), the MDC stated the operator should have recognized the potential challenges that could have arisen. The MDC further stated perforation should not have occurred. During a concurrent interview and record review on June 4, 2026, at 10:45 AM, with the DPSRM, the facility’s P&P titled, “Adverse Event Reporting to the California Department of Health Services,” dated revised June 2025, was reviewed. The P&P indicated, “ ... to comply with the mandated reporting requirements of Health and Safety Code 1279.1(b) and to support the improvement of patient safety ...it shall be the policy of [name of the facility] to report an adverse event, as defined within Health and Safety Code 1279.1 to the California department of health services (CDHS) no later than five days after the event has been detected ... it is also our policy to investigate the source of event, initiate any mitigation actions that may be indicated and cooperate fully with CDHS ...DEFINITIONS: “Adverse Event” includes any of the following: ... BB. An adverse event or series of adverse events that cause the death or serious disability of a patient ...” The DPSRM stated Patient 32’s death would not be considered an adverse event at that time. During a concurrent interview and record review on June 4, 2026, at 5:20 PM, with the DCCL, “Cardiology Statistics 2026” (CS), undated was reviewed. The CS indicated mortality (death) and bleeding events (complications where blood leaks from puncture site or bleeds internally) are being tracked in the CCL. The DCCL further stated she does not attend the hospital’s quality performance improvement meetings, but the information is shared by the Program Development and Clinical Ops Director (PDCOD) at the general hospital monthly performance improvement meetings. During a review of the “QUALITY MANAGEMENT COMMITTEE MEETING” (QMCM) dated March 4, 2026, the PDCOD was present in the meeting and there was no document discussion of CCL data recorded in the QMCM minutes. The PDCOD was present at only one meeting for the QMCM reviewed from February 4, 2026, through May 6, 2026. During an interview on June 5, 2026, at 9:58 AM, in the conference room, with three members of the QAPI committee including the Director of Quality Management (DQM), the Chief Operating Officer (COO) and the Performance Improvement Director (PID), the DQM stated that each department manager is responsible for its own performance improvement (PI) project, including collecting and bringing all the collected data and significant issues to the Quality Committee meeting. During a concurrent interview and record review on June 5, 2026, at 10:08 AM, in the conference room, with the DQM, the facility’s “QMCM” dated February 4, 2026, through May 6, 2026, were reviewed. The QMCM did not contain documented evidence to indicate that CCL data for mortality and bleeding events were shared for the months of February through May 2026. The DQM stated she was unable to locate the inclusion of CCL data from the QMCM minutes. The DQM further stated that adverse events are tracked through their internal reporting system MIDAS (a software used by hospitals to manage risk, patient safety, and regulatory compliance) because this case was physician related it gets escalated to peer review (an internal evaluation process where healthcare professionals assess the clinical performance and decisions of their colleagues) and then escalated to MPEC (Multi-Specialty Physician Excellence Committee- physician members from various departments who review physician cases and review of compliance). The DQM further stated she was not aware if Patient 32’s death was reported to external agencies, and the case has been classified as mortality unexpected death. During a review of the facility’s “Quality Management Plan” (QMP), dated 2025, the QMP indicated, “ ...are responsible for ensuring that there is a planned, systematic hospital-wide approach for designing, measuring, assessing and improving care, patient safety and service ...the process identifies the most important aspects of care/service ...event/safety issues ... The Quality Management Committee functions as the hospital’s oversight for all patient care, patient safety, quality management, and risk management activities ...””

“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: 51269 Based on interview and record review, the Governing Body (GB- a group of people responsible for the overall direction and management of an organization) failed to provide adequate oversight to ensure safe and effective quality of care were implemented for infection prevention and control practices for a universe of 38 sampled patients when: 1. The GB did not have an oversight in endoscope (a long, thin, flexible tube with a light and camera on the end that goes through the mouth to see the stomach) drying and storage practices, reuse of single-use devices, and cleaning of reprocessing sinks between uses. Additionally, concerns were also noted in staff competency, sterile processing (cleaning, disinfecting, and sterilizing medical instruments), and documentation of cleaning in between patients and end of day terminal cleaning (a thorough, deep cleaning and disinfection of a room or area after a patient leaves, especially if there is a risk of infection) on isolation precautions (an infection control method used to prevent spreading of infection) patients. (Refer to A-0049) 2. The GB did not have an oversight of the contracted services for equipment maintenance for the autoclave chambers (a high-pressure, high temperature machine used to sterilize medical instruments) in the Sterile Process Department (SPD-a unit that ensures surgical instruments are clean and ready for use by performing decontamination, assembly, sterilization, storage, and distribution). (Refer to A-0084) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in preventing the transmission of infection among patients from infection control practices. Inappropriate oversight could cause spread of microorganisms (small living things such as bacteria, viruses and fungi that can cause infection), exposure to infectious agents, and compromise vulnerable populations within the facility.”

“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: 51269 Based on interview and record review, the facility failed to maintain an effective and ongoing hospital wide, Quality Assessment and Performance Improvement (QAPI-identify, analyzes, addresses performance issues in the facility) program for a universe of 38 patients who admitted on December 15, 2025, when: 1. The QAPI program did not ensure to monitor, collect, and analyze quality data in infection prevention and control practices during the reprocessing (thoroughly cleaning and disinfecting), drying, storage, and environmental handling of medical equipment and patient care areas. Issues were identified in endoscope (a long, thin, flexible tube with a light and camera on the end that goes through the mouth to see the stomach) drying and storage practices, reuse of single-use devices, cleaning of reprocessing sinks (clean soiled surgical tools and medical equipment) between uses, and documentation of terminal cleaning (a thorough, deep cleaning and disinfection of a room or area after a patient leaves, especially if there is a risk of infection) in between patients on isolation precautions (an infection control method used to prevent spreading of infection by touching a patient or their surroundings) and staff competency. (Refer A-0273) 2. The facility did not ensure to identify the collected data to utilize the opportunities for improvement to measure its success, and track performance to ensure that improvements are sustained and effective in infection prevention control related to sterile processing (cleaning, disinfecting, and sterilizing medical instruments), equipment maintenance, and end of the day documentation of terminal cleaning on isolation precautions. (Refer- A-0283) The cumulative effects of these systemic problems resulted in the hospital’s inability to identify problem prone areas and ensure the provision of quality health care and infection control services in a safe environment and had the potential to cause adverse health outcomes (undesirable and harmful effects on someone’s health) such as cross-contamination (the transfer of harmful bacteria) of a preventable infection and increase the risk of acquiring a hospital infection (HAI), which could interfere with the patients’ medical care and may jeopardize the health and safety of other patients.”

“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: 28020 Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by: 1. One of one Dri-Scope Aid Jet Stream (a crucial medical device for infection control, providing a constant flow of HEPA-filtered air to thoroughly dry the internal channels of endoscopes after cleaning, preventing bacteria from growing in damp environments, and ensuring scopes are ready safely for reuse), was located and used in the clean scope storage room and was used to purge air into the scopes and not performed according to the infection control national standards (AAMI ST 91) the hospital followed (Refer to A-0749 finding 1). 2. Twenty of twenty-three clean flexible endoscopes (patient diagnostic and therapeutic instruments used to visualize the interior of hollow organs and used to collect tissue samples), located in the scope cabinet room contained lint & the facility was not using non-linting cloths to dry them (Refer to A-0749 finding 2). 3 (a) Two of two sinks used to clean soiled flexible endoscopes were not cleaned between each use (Refer to A-0749 finding 3a) (b) One single-use (designed to be used once and then disposed of) scissors were used as multi-use in the GI Decon room (a room used to clean and disinfect reusable patient endoscopes) Refer to A-0749 3b). (c) Two of two single-use Hi Flow canisters (specialized medical containers, designed for efficient, high-volume collection of bodily fluids during suctioning and intended to be used as suction canisters) were used as multi-use in GI decontamination room during reprocessing of flexible scopes (Refer to A-0749 finding 3c). 4. The facility did not perform additional manual purging of instrument air (continuously flowing clean, dry air through endoscopes that get stored in one non-drying scope cabinet to prevent moisture, dust, and contamination) into the scope channels outside of the AER (Automated Endoscope Reprocessor - a specialized machine that automatically cleans, disinfects reusable medical endoscopes after patient use) and in accordance with the AAMI standards the hospital followed (Refer to A-0749 finding 4). This had the potential for moisture accumulation in the channels of the scopes which could result in bacterial growth and the potential for hospital acquired infections to patients requiring the use of the scopes. 5. One (1) towel clamp (a surgical instrument used to secure sterile drapes to a patient’s skin or hold drapes/cables together, creating a clean operating field and preventing infection) was sterilized in the latched position (closed position) and contained brown staining (Refer to A-0749 finding 5). 6. Multiple storage bins (every bin inspected) used to store sterile supplies contained black substances and grey fuzzy substances (Refer to A-0749 finding 6). 7. Two (2) of 2 autoclave chambers (high-pressure steam sterilizers used to sterilize reusable patient instruments) contained thick, white, yellow and orange coarse buildup (Refer to A-0749 finding 7). 8. One soiled rigid sterilization basket container (a reusable, hard-cased container used to package surgical instrument sets for cleaning, sterilization, transport, and storage, acting as a protective barrier to keep items sterile, prevent damage, and improve efficiency) was not cleaned prior to re-placing clean surgical instruments into the basket (Refer to A-0749 finding 8). 9. One ultrasound transducer (an automated, closed-system device for high-level disinfection {HLD} of ultrasound probes) located in radiology was not cleaned according to manufacture IFU (Refer to A-0749 finding 9). 10. The facility failed to ensure two SPD (sterile processing technicians {SPDT 1 and SPDT 2} - healthcare professionals who clean, decontaminate, inspect, assemble, package, and sterilize reusable surgical instruments and medical devices) were certified after 1 year of employment, in accordance with the hospital job description and the AAMI standards the hospital followed (Refer to A-0749 finding 10). This failure had the potential for inadequate cleaning and processing of surgical equipment used for all patients requiring surgical and invasive procedures. 11. There was no documented evidence of cleaning between patients on isolation precautions patients in the Operating Room (OR-Special highly cleaned room in the hospital where surgeries and procedures are performed) (Refer to A-0749 finding 11). The cumulative effects of these systemic problems resulted in the hospital’s inability to provide an effective hospital wide Infection Control Program resulting in the hospital’s inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services.”

“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: 51269 Based on interview and record review, the Governing Body (GB- a group of people responsible for the overall direction and management of an organization) failed to identify and ensure a safe environment and provide quality of care for a universe of 38 sampled patients when the GB did not have an effective oversight of infection control practices and process in endoscope (a long, thin, flexible tube with a light and camera on the end that goes through the mouth to see the stomach) drying and storage practices, reuse of single-use devices, and cleaning of reprocessing sinks between uses. Additionally, concerns were also noted in staff competency, sterile processing (cleaning, disinfecting, and sterilizing medical instruments), and documentation of cleaning in between patients and end of day terminal cleaning (a thorough, deep cleaning and disinfection of a room or area after a patient leaves, especially if there is a risk of infection) on isolation precautions (an infection control method used to prevent spreading of infection) patients. These failures had resulted in the facility’s failure to identify the problem prone areas and deliver care with the GB oversight and to provide a safe patient care environment causing risk for acquiring hospital infection which could jeopardize the health and safety of the patients and prolonged the hospitalization. Findings: During an interview on December 17, 2025, at 4:30 PM, in the conference room with two members of the Governing Board (GB): The Chief Executive Officer (CEO) and the Chief of Staff (COS), the CEO stated that the board of trustees meet once a month and the GB has the overall responsibility of the facility. The CEO added that the facility has subcommittees, and significant fall out will be escalated to GB. During a follow-up interview on December 17, 2025, at 4:32 PM, in the conference room with the CEO and COS, the survey team discussed all the findings identified during the survey as follows: -Endoscope channel-drying device (a device that blows filtered air through the internal channels of an endoscope after reprocessing to remove any moisture) being located and used in the clean storage room and was used to purge air into the gastrointestinal scopes (GI scope- long, flexible tube with a camera to view the inside of your digestive tract, most commonly the esophagus, stomach, and upper small intestine) which is not in accordance with the hospitals Infection Control National Standard Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use of medical technology). -The facility did not perform manual purging (intentionally forcing filtered or medical grade air through medical device channels) of instrument air into the scope channels outside of the automated endoscope reprocess (AER-a medical device that automatically cleans, disinfects, rinses, and may dry flexible endoscopes) in accordance with the AAMI standards that the hospital follows. -Single use scissors and hi flow canisters (designed to handle large volumes of suction fluids) were observed being reused. -Sinks used to clean soiled scopes were not cleaned between each use. -Storage bins used to store sterile supplies were found containing black and grey fuzzy substances. -Rigid sterilization (any process that removes or kills all bacteria or infection) basket containers were not cleaned prior to replacing clean surgical instruments. -Two technicians in the Sterile Processing Department (SPD-a unit that specialized in cleaning, disinfecting, sterilizing, and preparing medical instruments) were not certified after two years of employment. -The Trophon (a high-level disinfection system) located in radiology (department in the hospital that uses imaging technology to diagnose and sometimes treat medical conditions) was not cleaned according to the Manufacture Instruction for Use (IFU). -Clean endoscopes located in the scope cabinet room contained lint and the facility was not using non-linting cloths to dry them. -Two of two autoclave chambers (high-pressure steam sterilizers used to sterilize reusable patient instruments) contained thick white, yellow/orange coarse buildup. -There was no documented evidence of cleaning in between patients and end of day terminal cleaning on isolation precautions patients in the Operating Room (OR-Special highly cleaned room in the hospital where surgeries and procedures are performed). The CEO and COS verified and stated that the GB was not aware of the above issues prior to the survey. During a follow-up concurrent interview and record review on December 17, 2025, at 4:35 PM, with the CEO and COS, the facility’s document titled, “Board Quality Committee Minutes” (Board Minutes), dated from May 27, 2025, through November 24, 2025, were reviewed. The Board Minutes dated from August 5, 2025, through November 24, 2025, did not identify any infection control issues such as endoscope, SPD, and autoclaves. The CEO added that the minutes would only reflect the discussions about the issues that the facility was aware of. During a follow-up concurrent interview and record review on December 17, 2025, at 4:38 PM, with the CEO and COS, the “2025 CDPH [California Department of Public Health] monitoring Dashboard,” dated August 5, 2025, was reviewed. The survey team explained that according to the “2025 CDPH monitoring Dashboard” the Year to Date (the progress the facility has made so far this year in a specific area) indicated that the facility was at 100% for the monthly deep cleaning of sterilizer, the weekly monitoring of non-lint cloth use, and Environmental Service (EVS-department that specialized in cleaning) in daily terminal cleaning compliance, however that did not reflect the survey findings. The CEO stated that the GB had to ensure that the facility logs reflect the audits and not just check the boxes for compliance. The CEO further stated, the major fall outs need to get escalated to the GB. A review of “Medical staff Bylaws [facility name],” August 5, 2025, indicated, “ ... 2.6 Responsibilities of the Medical Staff .....Account to the board for the quality and efficiency of patient care through regular reports and recommendations concerning with implementation, operation, and results of quality review, evaluation and monitoring activities ...3.2.3 Responsibilities ....each active member shall meet the basic responsibilities .....in fulfilling the obligations related to patient care within the area of the Member’s professional competence, including but not limited to: emergency service and back up function;’ quality assurance monitoring, peer review, utilization review; quality evaluation; and related monitoring activities requires of the Medical staff ...””

“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: 51269 Based on observation, interview, and record review, the Governing Body (GB- a group of people responsible for the overall direction and management of an organization) failed to ensure an effective oversight of a contracted service responsible for cleaning the autoclave chamber or sterilizer (sealed space inside a sterilization machine where medical instruments are placed to be cleaned using high heat, steam, and pressure to kill germs) for two of two autoclave chambers as evidence by thick white and yellow, orange coarse buildup on interior (inside) surface. This failure had potential to affect the effectiveness of sterilization (any process that removes or kills all bacteria or infection), which can negatively cause the increased risk for acquiring hospital infection which could jeopardize patient safety, and prolonged hospitalizations. Findings: During a concurrent observation and interview on December 15, 2025, at 1:55 PM, in the Sterile Processing Department (SPD- department responsible for cleaning, disinfecting, and sterilizing medical instruments), with the Sterile Processing Department Manager (SPDM), two of two autoclave chamber machines were observed and contained thick, yellow, orange and white coarse buildup. The SPDM stated that the autoclave machine gets cleaned monthly by a contracted vendor and that the staff was not responsible for the cleaning of the chambers. During a follow-up concurrent interview and record review on December 16, 2025, at 3:30 PM, with the SPDM, the sterilizer manufacture manual (manual), dated 2019, was reviewed. The manual indicated that the frequency of cleaning is to be determined by the facility based on water quality and the conditions of the chambers. The SPDM stated “maybe they [the company] need to perform cleaning more frequently.” A review of the facility’s policy and procedure (P&P) titled, “Supply Processing and Distribution Cleaning and Inspection of Steam Sterilizers, effective date 12/25 [December 2025],” indicated, “All steam sterilizers will be inspected and cleaned on a regular daily basis by the SPD staff and will be cleaned monthly and annually by a professional cleaning service-according to the manufacturer written instructions for use and AAMI [Association for the Advancement of Medical Instrumentation] guidelines ...” There was no documented evidence to demonstrate that the sterilizers were cleaned daily by SPD staff. During a follow-up interview on December 17, 2025, at 8:51 AM, with the SPDM, the SPDM stated there is no oversight of the monthly deep cleaning by the vendor since it is done during night shift over the weekend when there is no leadership and was not sure if the sterilizers were cleaned according to the manufacture instructions. The SPDM stated that a report is provided by the vendor after the cleaning. During an interview on December 17, 2025, at 11:58 PM, with the Infection Prevention Manager (IPM), the IPM stated that during the environmental rounds done by infection control (IC), the chambers are typically being used, preventing IC to see inside of the chambers. During a concurrent interview and record review on December 17, 2025, at approximately 2:35 PM, with the Assistant Chief Nursing Officer (ACNO), the facility’s document titled, “Purchase Order Number,” dated October 27, 2025, was reviewed. The ACNO stated the [contracted company name] was providing service for the autoclave cleaning. During an interview on December 17, 2025, at 4:30 PM, in the conference room, with two members of the Governing Board (GB): The Chief Executive Officer (CEO) and the Chief of Staff (COS), the CEO stated that the board of trustees meet once a month and the GB has the overall responsibility of the facility and over contracted services. The CEO added that the facility has subcommittees, and significant fall out will be escalated to GB. The CEO added that the GB follows closely on issues identified. During a follow-up interview on December 17, 2025, at 4:31 PM, in the conference room, with the GB, the CEO stated that a copy goes to the executives with the financial aspect and eventually presented to the board of trustees, who has the overall responsibility of contracted services. The survey team brought up the issue regarding the contracted service with the autoclaves and mentioned that the autoclaves were found with thick yellow, orange coarse buildup. The CEO stated, the autoclaves have not been an area of focus since the previous survey. A review of “Medical staff Bylaws [facility name]” approved by the board of trustees dated August 5, 2025 indicated, “2.6 Responsibilities of the Medical Staff .....Account to the board for the quality and efficiency of patient care through regular reports and recommendations concerning with implementation, operation, and results of quality review, evaluation and monitoring activities ...3.2.3 Responsibilities ....each active member shall meet the basic responsibilities .....in fulfilling the obligations related to patient care within the area of the Member’s professional competence, including but not limited to: emergency service and back up function;’ quality assurance monitoring, peer review, utilization review; quality evaluation; and related monitoring activities requires of the Medical staff.””

“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: 51269 Based on interview and record review, the Quality Assessment and Performance Improvement (QAPI-identify, analyzes, addresses performance issues in the facility) program did not ensure to monitor, collect and analyze quality data for a universe of 38 patients who were admitted on December 15, 2025, when the QAPI did not effectively collect, track, and analyze the infection control practices and process regarding the storage of endoscope (a long, thin, flexible tube with a light and camera on the end that goes through the mouth to see the stomach), reuse of single-use devices, and cleaning of reprocessing sinks (clean soiled surgical tools and medical equipment) between uses. Additionally, concerns were also noted in staff competency, sterile processing (cleaning, disinfecting, and sterilizing medical instruments), and documentation of cleaning in between patients with isolation precautions (an infection control method used to prevent spreading of infection) patients. These failures resulted in the hospital’s inability to identify the problems prone (likely to cause errors) areas and created changes to improve patients’ health outcomes and had the potential to increase the risk for cross-contamination (the transfer of harmful bacteria) and infection transmissions, healthcare associated infections and prolnged hospitalization. Findings: During an interview on December 17, 2025, 11:55 AM, in the conference room with the Infection Prevention Manager (IPM), the IPM stated infection control concerns are initially reported to the director of the department where rounds are being conducted and if it needs to be escalated it will get reported to QAPI. During an interview on December 17, 2025, at 3:25 PM, in the conference room with the QAPI team including the performance improvement manager, Chief Operating Officer (COO), Infection Prevention Manager (IPM), Director of Quality Management (DOQ), Assistant Chief Nursing Officer (ACNO), and the Executive Director of Support Services (EDSS), the COO stated issues related to infection control go to the infection control committee, the department of the issue found, and the infection control committee is also sent to the COO and DOQ. During a follow-up concurrent interview and record review on December 17, 2025, at 3:32 PM, with the QAPI team, the “2025 CDPH [California Department of Public Health] Monitoring Dashboard,” undated, was reviewed. The “2025 CDPH Monitoring Dashboard” indicated, the facility was monitoring in Sterile Processing Department (SPD-ensures surgical instruments are clean and ready for use by performing decontamination, assembly, sterilization, storage, and distribution), daily cleaning of sterilizer [autoclave -a machine used to kill germs on surgical instruments), and staff competency] (100%), monthly deep cleaning of sterilizer by vendor (100%), weekly monitoring of non-linting cloth use (100%), IP [infection preventionist] team weekly monitoring of instruments free of stains, spots, or white residue. IP team weekly monitoring use of non-linting cloths (100%), Environmental services (EVS- the hospital team responsible for cleaning and disinfecting rooms and areas) daily terminal cleaning compliance (100%). The COO acknowledged the dashboard and stated that all of the logs go to the admin office where the quality team will calculate the percentages and if there is a noncompliance it is corrected in real time and the directors of the departments will be notified. During a follow-up interview on December 17, 2025, at 3:32 PM, with the QAPI team, the survey team brought up some of the issues identified during survey as follows: -Endoscope channel-drying device (a device that blows filtered air through the internal channels of an endoscope after reprocessing to remove any moisture) being located and used in the clean storage room and was used to purge air into the gastrointestinal scopes (GI scope- long, flexible tube with a camera to view the inside of your digestive tract, most commonly the esophagus (a hollow muscular tube in the body carries food and liquid from throat to stomach), stomach, and upper small intestine), which is not in accordance with the hospital’s Infection Control National Standard Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use of medical technology). -The facility did not perform manual purging (intentionally forcing filtered or medical grade air through medical device channels) of instrument air into the scope channels outside of the automated endoscope reprocess (AER-a medical device that automatically cleans, disinfects, rinses, and may dry flexible endoscopes) in accordance with the AAMI standards that the hospital follows. -Single use scissors and hi flow canisters (designed to handle large volumes of suction fluids) were observed being reused. -Sinks used to clean soiled scopes were not cleaned between each use. -Storage bins were found containing black and grey fuzzy substances. -Rigid sterilization (any process that removes or kills all bacteria or infection) basket containers were not cleaned prior to replacing clean surgical instruments. -Two technicians in the Sterile Processing Department (SPD-a unit that specialize in cleaning, disinfecting, sterilizing, and preparing medical instruments[SPDT 1 and SPDT 2]) were not certified after two years of employment in accordance with the hospital job description and the AAMI standards the hospital followed. This failure had the potential for inadequate cleaning and processing of surgical equipment used for all patients requiring surgical and invasive procedures.. -The Trophon (a high-level disinfection system) located in radiology (department in the hospital that uses imaging technology to diagnose and sometimes treat medical conditions) was not cleaned according to the Manufacture Instruction for Use (IFU). -There was no documented evidence of cleaning in between patients on isolation precautions patients in the Operating Room (OR-Special highly cleaned room in the hospital where surgeries and procedures are performed). The QAPI team was unable to provide quality measures regarding action plans, trends, interventions, and evaluations regarding these survey findings. The QAPI team was not aware of the findings and did not have effective tracking or analyzing of the issues identified. During a review of the facility’s document titled, “Quality Management Plan 2025,” dated August 2025, the “Quality Management Plan 2025” indicated, “The 2025 Quality Management Program Goals and Priorities are: ...Establish and maintain a robust Quality Assurance and Performance Improvement (QAPI) program by consistently integrating key performance data into the hospital’s copy dashboard. This supports continuous monitoring, brand analysis, quality assessments, and the development and implementation of targeted corrective action plans. Ensure effective oversight and accountability through regular review by the hospital’s governing body...””

“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: 51269 Based on interview and record review, the facility failed to maintain an effective and ongoing hospital wide, Quality Assessment and Performance Improvement (QAPI-identify, analyzes, and addresses performance issues identified in the facility) program to identify the collected data of the facility’s issues and worked on opportunities for improvement for a universe of 38 sampled patients when: 1. The Gastrointestinal scopes (GI scope- long, flexible tube with a camera to view the inside of your digestive tract, most commonly the esophagus, stomach, and upper small intestine) were found with lint. 2. Two of two autoclave chambers (sealed space inside a sterilization machine where medical instruments are placed to be cleaned using high heat, steam, and pressure to kill germs) contained thick white, yellow/orange coarse buildup. 3. A terminal cleaning (a deep cleaning done after a procedure to remove germs and prevent infection) log was signed off by the supervisor prior to the cleaning being completed. These failures resulted in the hospital’s inability to already identified problem prone areas and set priorities to improve quality of infection control practices and ensure a safe environment for their patients and the improvements are sustained. Findings: During a review of the facility’s document titled, “2025 CDPH [California Department of Public Health] Monitoring Dashboard,” undated, was reviewed. The “2025 CDPH Monitoring Dashboard” indicated the facility was monitoring, all area received 100 percents (%) in compliance as follows: -Sterile Processing Department (SPD-ensures surgical instruments are clean and ready for use by performing decontamination, assembly, sterilization, storage, and distribution) -Daily cleaning of sterilizer (autoclave -a machine used to kill germs on surgical instruments) and staff competency -Monthly deep cleaning of sterilizer by vendor -Weekly monitoring of non-linting cloth use -Infection Prevention (IP) team weekly monitoring of instruments free of stains, spots, or white residue -IP team weekly monitoring use of non-linting cloths -Environmental service (EVS-the hospital team responsible for cleaning and disinfecting rooms and areas) daily terminal cleaning compliance During a concurrent interview and record review on December 17, 2025, 12:00 PM, with the Infection Prevention Manager (IPM), facility;s document “2025 CDPH Monitoring Dashboard” was reviewed. The IPM stated that the facility was focusing on the above issues since they were findings from the previous survey. The IPM added, the dashboard on “YTD [year to date-up to date with the current process]” is 100% on everything because when the IP team is doing the rounds, the IP team are tracking to see only the completion of the logs and to the IPM’s knowledge as long as the IP team is doing the audits there will still be 100% compliance. The IPM further stated if there is any noncompliance while doing the audits the facility will take immediate action and notify the director of the department. 1. During an interview on December 17, 2025, 12:02 PM, with the IPM, the IPM stated, in relation to the lint being found on the GI scopes, during the IP rounds the focus of lint free was in the SPD and decontamination area, which is why the weekly audits have been 100%. During an interview on December 17, 2025, at 3:25 PM, in the conference room, with the QAPI team including the Performance Improvement Manager (PIM), Chief Operating Officer (COO), Infection Prevention Manager (IPM), Director of Quality Management (DOQ), Assistant Chief Nursing Officer (ACNO), and the Executive Director of Support Services (EDSS), the COO stated, that the facility had been tracking in SPD, however, after the survey finding, the GI team (a group of healthcare professionals who take care of the digestive system- stomach intestines esophagus, liver, and bowels) was asked about the non-lint and the GI team stated the GI team thought the items were non-lint not low lint. The COO stated that the tracking for this area was not being logged. 2. During an interview on December 17, 2025, at 12:04 AM, with the IPM, the IPM stated that when rounds are being conducted in SPD, the sterilizer chambers are being used, however, the IP team will look at the daily cleaning log of the autoclave sterilizer for compliance. The IPM indicated that the cleaning of the autoclave is done on the weekends. The survey team discussed with IPM the lack of oversight on the autoclave. During an interview on December 17, 2025, at 3:26 PM the survey team brought up the observation that was verified by the Sterile Processing Manager and the Assistant Chief Nursing Officer of the two of two autoclave chambers containing thick white, yellow/orange coarse buildup. During a follow up interview on December 17, 2025, at 3:27 PM, with the QAPI team, the COO stated that the company that comes to clean the chambers can only clean them after the chambers have been off for eight hours. It is typically done on the weekend. The survey team mentioned and notified that there was a lack of oversight of the cleaning of the chambers when the outside company comes to cleaning the chambers. The COO stated that the facility cannot expect the directors to be present at the time the contracted company comes to do the cleaning. The survey team stated, the facility has to ensure the contracted company follows the manufactures instructions for use (IFU). 3. During a concurrent interview and record review on December 17, 2025, at 1:42 PM, with the EDSS and the director of Environmental staff (EVD) the “[facility name] Operating Room Terminal Cleaning Log,” dated December 12, 2025, was reviewed. The “[facility name] Operating Room Terminal Cleaning Log” indicated EVS staff completed terminal cleaning on December 12, 2025, at 10:30 PM, and it was signed off by the EVS supervisor on December 12, 2025, at 9:20 PM. The EDSS stated it was an error done by the supervisor. The EDSS stated, manager has the responsibility to oversee the completion of the terminal cleaning and should have gone back to evaluating the sanitary environment after EVS staff completed the terminal cleaning. The EDSS confirmed that the terminal cleaning log did not show a complete oversight of management with the cleaning process. The EDSS stated that the management missed the opportunity to do any real time or spot check to ensure quality and infection control prevention process. During an interview on December 17, 2025, at 3:29 PM, with the QAPI team, the EDSS stated that once the logs are completed the logs are sent to the EVD, the EDSS stated that the error would have been caught by the EVD once the logs were received. The EDSS stated this issue has not been identified before. During a review of the facility document titled, “Quality Management Plan 2025” dated August 2025, the “Quality Management Plan 2025” indicated, “The 2025 Quality Management Program Goals and Priorities are: ...Establish and maintain a robust Quality Assurance and Performance Improvement (QAPI) program by consistently integrating key performance data into the hospital’s copy dashboard. This supports continuous monitoring, brand analysis, quality assessments, and the development and implementation of targeted corrective action plans. Ensure effective oversight and accountability through regular review by the hospital’s governing body...””

“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: 28020 Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when: 1. The Dri-Scope Aid Jet Stream (a crucial medical device for infection control, providing a constant flow of HEPA-filtered air to thoroughly dry the internal channels of endoscopes after cleaning, preventing bacteria from growing in damp environments, and ensuring scopes are ready safely for reuse), was located and used in the clean scope storage room and was used to purge air into the scopes and not performed according to the infection control national standards (AAMI ST 91) the hospital followed. 2. Twenty of twenty-three clean flexible endoscopes (patient diagnostic and therapeutic instruments used to visualize the interior of hollow organs and used to collect tissue samples), located in the scope cabinet room contained lint & the facility was not using non-linting cloths to dry them. 3 (a) Two of two sinks used to clean soiled flexible endoscopes were not cleaned between each use. (b) One single-use (designed to be used once and then disposed of) scissors were used as multi-use in the GI Decon room (a room used to clean and disinfect reusable patient endoscopes). (c) Two of two single-use Hi Flow canisters (specialized medical containers, designed for efficient, high-volume collection of bodily fluids during suctioning and intended to be used as suction canisters) were used as multi-use in GI decontamination room during reprocessing of flexible scopes. 4. The facility did not perform additional manual purging of instrument air (continuously flowing clean, dry air through endoscopes that get stored in one non-drying scope cabinet to prevent moisture, dust, and contamination) into the scope channels outside of the AER (Automated Endoscope Reprocessor - a specialized machine that automatically cleans, disinfects reusable medical endoscopes after patient use) and in accordance with the AAMI standards the hospital followed. This had the potential for moisture accumulation in the channels of the scopes which could result in bacterial growth and the potential for hospital acquired infections to patients requiring the use of the scopes. 5. One (1) towel clamp (a surgical instrument used to secure sterile drapes to a patient’s skin or hold drapes/cables together, creating a clean operating field and preventing infection) was sterilized in the latched position (closed position) and contained brown staining. 6. Multiple storage bins (every bin inspected) used to store sterile supplies contained black substances and grey fuzzy substances. 7. Two (2) of 2 autoclave chambers (high-pressure steam sterilizers used to sterilize reusable patient instruments) contained thick, white, yellow/orange coarse buildup. 8. One soiled rigid sterilization basket container (a reusable, hard-cased container used to package surgical instrument sets for cleaning, sterilization, transport, and storage, acting as a protective barrier to keep items sterile, prevent damage, and improve efficiency) was not cleaned prior to re-placing clean surgical instruments into the basket. 9. One ultrasound transducer (an automated, closed-system device for high-level disinfection (HLD) of ultrasound probes) located in radiology was not cleaned according to manufacture IFU. 10. The facility failed to ensure two SPD (sterile processing technicians {SPDT 1 and SPDT 2} - healthcare professionals who clean, decontaminate, inspect, assemble, package, and sterilize reusable surgical instruments and medical devices) were certified after 1 year of employment, in accordance with the hospital job description and the AAMI standards the hospital followed. This failure had the potential for inadequate cleaning and processing of surgical equipment used for all patients requiring surgical and invasive procedures. 11. The facility did not ensure staff maintained a clean and sanitary environment to prevent and control potential infection issues for one of 11 operating rooms (OR 2) when daily terminal cleaning (a deep cleaning method used in healthcare environments to control the spread of infections) was not appropriately evaluated after it was completed on December 12, 2025, at the end of the procedure for two of 10 sampled patients (Patient 10 , Patient 11). These cumulative failures had potential for an unclean and unsafe environment, resulting in the hospital’s inability to provide patient care in a safe and effective manner and had the potential to result in cross contamination (the transfer of harmful bacteria) of a preventable infection and increase the risk of acquiring hospital infections. Findings: 1. During an interview on December 15, 2025, at 8:40 AM during a validation survey and interview was conducted with the Infection Prevention Nurse (IPN) who stated that the hospital followed Infection Control National standards from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), AORN (Association of periOperative Registered Nurses, a professional organization for nurses working before, during, and after surgery {perioperative care}. It sets evidence-based guidelines, provides education, advocates for patient and staff safety, and supports career development for its members, ensuring high standards in surgical settings). During a concurrent observation an interview on December 15, 2025, at 8:50 AM a tour of the GI Department’s storage of clean flexible scopes was conducted. An observation was made of a “Dri-Scope Aid Jet-Stream” (a device used to continuously flow pressured air into the scopes to ensure they are completely dried before they are stored). The GI Manager (GIM) stated they used the machine to dry some of the scopes in the clean storage area while the scopes were coiled in the storage bins. A GI SPD Technician (GIT), validated the process and stated that the scopes should not be dried while they are coiled in the storage bins and should hang freely. During a review on December 15, 2025, at approximately 12:20 PM, a document review was conducted of the Infection Control National standards (AAMI ST 91:2021 Flexible and semi-rigid endoscope processing in health care facilities) the hospital followed. According to AAMI ST91, “4.2.2 Physical separation: Facilities should have two separate rooms for processing endoscopes. Until such time (major renovations or new construction) that two separate processing rooms can be provided, strict unidirectional (one way movement in a single, continuous direction) processing procedures should be in place to reduce risks of cross-contamination...The endoscope processing area should also include a designated drying area, when applicable, to dry the device with forced instrument air prior to patient use, storage, or in preparation for packaging and terminal sterilization”. The Dri-Scope equipment used to dry the scopes was used in a clean scope storage area not in the endoscope processing area. 2. During a concurrent observation and interview on December 15, 2025, at 9 AM, during a tour of the GI Department in the room where the clean flexible scopes were stored, one scope storage cabinet contained 10 clean and ready-to-use scopes. Seven of the scopes contained small particles of white lint particles throughout the exterior of the scopes and around the segment where the lenses were located. One scope drying cabinet contained 13 clean and ready to use scopes, all 13 scopes contained small white particles of lint on the exterior and the segment where the lenses were located. During the same tour concurrent interviews were conducted with the IPN and the Gastrointestinal Department Manager (GIM), who were present during the observations of the scopes, verified the findings and the IPN stated that all the scopes would have to be reprocessed and they should not contain lint. GIM provided a package of the cloths that SPD staff used to dry the scopes. The packaging did not provide written evidence to indicate the cloths were non-linting. Further investigation revealed the cloths were “low linting”. GIM and IPN verified the findings. During a review on December 15, 2025, at 12 PM, a document review of the Infection Control National standards (AAMI ST 91:2021 Flexible and semi-rigid endoscope processing in health care facilities) the hospital followed was reviewed. The Standards stipulated, “8.2.5.2 Manual drying ...b) Thoroughly dry endoscope exterior and all removable endoscope parts with a clean, non-linting cloth ...” During an interview on December 17, 2025, at 11:50 AM, the Infection Prevention Manager (IPM) was interviewed and was asked why the Infection Prevention Team did not identify that they were not using non-linting cloths to dry the scopes. The IPM stated, because they were focusing on previous findings in the sterile processing department (an area where soiled patient equipment is cleaned and disinfected) not the GI Department. 3. During a concurrent observation and interview on December 15, 2025, at 10 AM during a tour of the GI Decontamination Room, a GI Sterile Processing Technician (GIT) was cleaning soiled flexible scopes. The following observations and concerns were identified. (a) GIT did not clean the sink between each scope. GIT stated that she cleaned the sink at the end of her shift or if it was needed. (b) GIT reused scissors that were soaked in 70% alcohol during the process of cleaning the scopes. (c) 2 Plastic bins were placed above the sink were soiled scopes were being cleaned. During a concurrent interview with the GIT, she stated that the sink did not get cleaned between each use, it gets cleaned at the end of the day or as needed. GIT also stated that the scissors were reused throughout the day and disposed of at the end of the day. In addition, GIT stated the buckets got cleaned when needed or disposed of at the end of the day. GIT and the IPN were unsure if the buckets were re-usable however, IPN informed GIT that the scissors should not be re-used and the sinks should be cleaned between each use. During a review on December 15, 2025, at 12:10 PM, a document review of the Infection Control National standards (AAMI ST 91:2021 Flexible and semi-rigid endoscope processing in health care facilities) the hospital followed was reviewed. The document stipulated, “7.2.2 Procedure ...(m) Sinks should be cleaned, disinfected, and rinsed between uses with a disinfectant approved by a multidisciplinary team (see Section 5) and in accordance with the IFUs for the disinfectant and the sink”. During a review of facility’s document on December 16, 2025, at 9 AM, a facility document review was conducted of the manufacturer’s instructions of the plastic bins that GIT re-used during the scope cleaning process. The document stipulated, “CAUTION single use only. Do not attempt to clean sterilize or reuse canister ...” The “INTENDED USE: Intended for use with suction equipment to allow for the collection and disposal of bodily fluids ...” During a review on December 16, 2025, at 9 AM, a review of the manufacture’s packaging of the scissors that GIT re-used during reprocessing of the soiled scopes stipulated, “Do not reuse. Single use only.” 4. During a concurrent observation and interview on December 15, 2025, at 10:35 AM, during the tour of the GI Decontamination room, the Sterile Processing Manager (SPM) and the GIT were asked to explain the drying process of the scopes. SPM stated that after the scopes were washed in the automated endoscope reprocessor (OER scope high level disinfectant {HLD} washing machine), they go through a drying cycle and after the cycle was completed, the scopes were stored in the clean area scope storage cabinets. SPM was asked if they performed an additional 10 minute purging of air through the scopes using the Dri-Scope Aid Jet-Stream. SPM stated, no because the washer has a drying cycle. GIT confirmed the statement and stated that after the scopes were out of the washer they got stored in the cabinets. During a review on December 15, 2025, at approximately 12:20 PM, a document review of the Infection Control National standards (AAMI ST 91:2021 Flexible and semi-rigid endoscope processing in health care facilities) the hospital followed was reviewed. The document stipulated, “8.2.3.2 Automated high-level disinfection/liquid chemical sterilization procedure (referring to the scope washers) ... (n) Endoscopes that have completed an HLD cycle in an AER should undergo additional drying internally with instrument air to remove moisture, dried externally (see 8.2.5), and then stored in accordance with Section 11 to avoid contamination.” AAMI ST 91;2021 8.2.5.2 stipulated, “8.2.5.2 Manual drying: Unless otherwise directed by the endoscope manufacturer, drying of endoscope channels is accomplished by flowing instrument air or HEPA-filtered air through all endoscope channels for a specified period of time and pressure according to the endoscope manufacturer’s written IFU. Research has demonstrated that a minimum 10-minute dry time is effective in drying the channels and should be implemented (Alfa, 1991 [53]; Ofstead, 2018 [242]; Barakat, 2019 [79]) (see Annex K) ...) 5. During an observation on December 15, 2025, at 10:40 AM during a tour of the hospital Sterile Preparation Department (an area where they assemble, package and sterilize reusable patient instruments) was conducted. An inspection of a “Large Instrument Set” (a tray filled with sterilized and ready to use surgical instruments) was conducted. One sponge forcep was sterilized in the latched (closed position) and contained dark staining. SPM who was present during the inspection, validated the findings and stated that the forcep should have been sterilized in the open position and any instruments that contained dark staining were to be returned for reprocessing. During a review on December 15, 2025, at approximately 12:30 PM, a document review of the Infection Control National standards (AAMI ST 79:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities) the hospital followed was reviewed. The standard stipulated, “8.2 Instruments: d) Ratcheted instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the unlatched position ...” 6. During a concurrent observation and interview on December 15, 2025, at 9:35 AM, during a tour of the hospital sterile storage room (an area where sterile patient supplies are stored) multiple (every bin that was inspected) contained black particles and grey fuzzy substances. SPDM who was present during the inspection, stated that the bins were supposed to get cleaned monthly. She validated the findings and stated that there was no process in place and no oversight to ensure they were cleaned. In addition, SPDM stated they did not have a policy in place that covers cleaning of sterile storage bins. During the same tour of sterile storage supplies in the “Case Cart Room” (an area where sterile items are stored) multiple bins (every bin) which contained sterile supplies, contained black particles and large amounts of grey fuzzy substances. During an interview on December 15, 2025, at 2:55 PM, the Materials Director (MD) who was present during the inspection stated that cleaning the bins was a shared responsibility between the Materials Department and Environmental Services (EVS). MD also stated they did not have a cleaning schedule or a policy in place to address cleaning of the bins. In addition, MD stated he did not know the last time the bins were cleaned. During an interview on December 15, 2025, at 3:15 PM with the Environmental Services Director (EVSD) who stated that it was not the responsibility of EVS to clean bins which were used to store sterile supplies. During a record review of the Infection Control National Standards the hospital followed, (AAMI ST79:2017) it stipulated, “11.1 Sterile storage: 11.1.1 Storage facilities Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry ...” 7. During a concurrent observation and interview on December 15, 2025, at 1:55 PM during the tour of SPD Sterile Preparation Room, two of two sterilizer machine chambers contained thick, yellow, orange and white coarse buildup. The SPDM who was present during the observation stated that the sterilizers got cleaned monthly by a contracted vendor and that the facility staff were not responsible for cleaning the inside of the chambers. During a review of the facility’s policy and procedure titled “Supply Processing and Distribution Cleaning and Inspection of Steam Sterilizers, effective date 12/25” stipulated, “All steam sterilizers will be inspected and cleaned on a regular daily basis by the SPD staff and will be cleaned monthly and annually by a professional cleaning service-according to the manufacturer written instructions for use and AAMI guidelines ...” There was no observable documented evidence to demonstrate that the sterilizers were cleaned on a daily basis by SPD staff. During an interview on December 16, 2025, at 2:40 PM, an interview was conducted with the SPDM who stated that there was no process in place to assure there was oversight of the vendor’s cleaning process, they did not know if the sterilizers were cleaned according to the manufacture instructions, they did not know what products the vendor used and they only received a report from the vendor indicating the sterilizers were cleaned. SPDM stated that the vendor cleaned the chambers during the night shift on weekends and leadership did not work on weekends. During a concurrent interview and record review on December 16, 2025, at 3:30 PM of the sterilizers manufacturer manual, it stipulated that the frequency of cleaning was to be determined by the facility based on the water quality and the conditions of the chambers. SPDM stated, “maybe they need to perform cleaning more frequently.” During a concurrent interview and record review on December 17, 2025, at 8:50 AM, with SPDM, the sterilizers manufacturer manual and a document provided by the vendor who cleaned the chambers, were reviewed. SPDM and surveyor reviewed the vendors report and it was determined that the vendor did not use the products described by the manufacturer as “Materials required.” The manufacturer described a product that was required to be used to clean the sterilizer chambers and the vendor’s document described different products that were used, not reflective of the manufacturer’s products. During a review on December 17, 2025, at 12 PM, a record review of the Infection Control National standards the hospital followed, “AAMI ST79:2017” which stipulated, “12.4 Routine care Sterilizers should be inspected and cleaned daily according to the manufacturer’s written IFU. Examples of items requiring daily care and/or cleaning are ... door gaskets, the chamber drain, the internal chamber, and external surfaces. Weekly or other prescribed inspection and cleaning should be performed as specified in the manufacturer’s written IFU.” 8. During a concurrent observation and interview on December 16, 2025, at 9:30 AM, during the tour and inspection of the SPD Decontamination Room (an area where soiled reusable patient instruments get cleaned” a Sterile Processing Technician (SPDT 1) was cleaning soiled instruments. SPDT 1 removed the soiled surgical instruments that contained red substances from the rigid sterilization basket that they were stored in and transported to SPD from the operating room. SPDT 1 did not clean the basket prior to re-placing the instruments that she previously cleaned. During a concurrent interview, SPDT 1 was asked if the basket got cleaned in the same manner the soiled instruments do, in which she stated, “they only get rinsed,” they do not get manually cleaned. During a concurrent interview and record review on December 16, 2025, at 11:30 AM, a record review provided by the facility of the manufacturer “Instructions for Use” stipulated, “4.0 Decontamination and Cleaning Process, follow facility’s policies, procedures and AAMI ST 79 recommended guidelines ...” The manufacture described a detailed process for “Decontamination and Manual Cleaning” of the baskets. During a review on December 16, 2025, at 12 PM, a record review of the Infection Control National standards the hospital followed were reviewed. “AAMI ST 79:2017 7.5.2.2 Rigid sterilization container systems 7.5.2.2.1 General considerations: Before acquiring rigid sterilization container systems, the health care facility (or organization) should confirm that the facility has the capability to follow the manufacturer’s validated decontamination methods. The method selected should be guided by the container system manufacturer’s written IFU in conjunction with the mechanical cleaning equipment manufacturer’s written IFU. Rigid sterilization container systems should be cleaned a) before sterilization, either manually or mechanically; b) according to the container system manufacturer’s written IFU; and c) by personnel following accepted practices for decontamination and employee safety, including PPE. Only cleaning agents intended for cleaning rigid sterilization containers and not contraindicated in the device manufacturer’s validated IFU should be used.” 9. During an observation on December 16, 2025, at 10:50 AM a tour of the hospital’s Radiology Department (camera room of a hospital or clinic, where doctors and specialized staff use various imaging machines to look inside a body without needing surgery) was conducted. An ultrasound transducer (a disinfection system used in healthcare settings to quickly and safely clean and disinfect ultrasound probes) was located inside a patient procedure room. During a concurrent interview and record review of the ultrasound transducer manufacturer instructions were conducted with a Sonographer (SG), (the person who performs the ultrasound exam). SG was asked how the ultrasound transducer was cleaned. SG stated that they did not clean the inside of the chamber, they only wipe the exterior. The manufacturer instructions provided “Regular Cleaning” detailed instructions how to clean the chamber. SG reviewed the document and reiterated they did not clean the chamber. 10. During a concurrent observation and interview on December 16, 2025, at 9:30 AM, during the tour of the SPD Decontamination room and during the observations of SPDT 1 cleaning soiled surgical instruments. SPDT 1 stated that she was not certified as a Sterile Processing Technician. SPDM who was present during the interview stated that SPDT 1 was “grandfathered” in as a sterile processing technician and so was another SPD technician “SPDT 2”. According to SPDM, all SPDs were certified except for SPDT 1 and 2. During a review on December 16, 2025,at 12:00 PM a record review of the AAMI standards the hospital followed was conducted. The standards stipulated, “4.2.2 Sterile processing personnel. The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing, including biohazard transportation, decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices ...All personnel performing sterile processing activities should be certified within two years of employment and should maintain that certification (a formal process by which an individual is evaluated and validated by a recognized organization to demonstrate they have the knowledge, skills and competency required to perform their role safely and effectively) throughout their employment”. During employee file reviews on December 17, 2025, at 10:00 AM, during employee file reviews, SPDT 1 and SPDT 2 files did not contain written documentation to demonstrate SPDT 1 and SPDT 2 were SPD certified. During the same employee file reviews, SPDT 1s file showed she was hired on 12/28/09 and SPDT 2 was hired on 1/29/07. SPDT 1 and SPDT 2 “Job Description for SPD Technician”, stipulated, “D. License/Certifications: Central Processing Technician certificate within one year of hire date.” As of 12/17/25, 16 years after SPDT 1’s hire date, there was no observable documented evidence to demonstrate SPDT 1 was certified as a Sterile Processing Technician and as of 12/17/25, 18 years after SPDT 2’s hire date, there was no observable documented evidence to demonstrate SPDT 2 was certified as a Sterile Processing Technician. 51269 11a. During a review of Patient 10’s “History and Physical” (H&P-demographic information), dated November 15, 2025, the H&P indicated, Patient 10 was admitted to the facility because of palpitations (the sensation of your heart pounding, racing, fluttering, or skipping beats, felt in the chest, neck, or throat) and right lower quadrant pain (pain on the lower right abdomen). Patient 10 had medical history including hypertension (high blood pressure) and cardiac arrhythmia (abnormal heart rhythm). During a concurrent interview and record review on December 16, 2025, at 1:50 PM, with the Infection Prevention Manager (IPM), Patient 10’s “Orders” for isolation (infection control methods used to stop germs from spreading from one person to another) dated November 16, 2025, through November 19, 2025, were reviewed. The “Orders” for isolation indicated, Patient 10 had orders for contact isolation precaution (an infection control method used to prevent spreading of infection by touching a patient or their surroundings) as follows: -On November 16, 2025: contact isolation for methicillin resistant staphylococcus aureus (MRSA-a type of bacterial infection that resistant to many antibiotics) infection. -On November 19, 2025, contact isolation for extended spectrum beta lactamase (ESBL-an enzyme that make the body resistant to many common antibiotics) The IPM verified and confirmed that Patient 10 had orders to be in contact isolation. During a concurrent interview and record review on December 16, 2025, at 1:53 PM, with the IPM, “Main OR Nursing Record” dated December 12, 2025, was reviewed. The “Main OR Nursing Record” indicated, Patient 10 had an “Exploration Laparotomy, colectomy (right)” (surgical procedure where the surgeon opens the abdomen to examine the organs, then removes the right portion of the colon that’s diseased) which started at 7:50 AM, through 8:50 AM. The IPM verified the date and time of Patient 10’s procedure and stated that Patient 10 was in OR 2. During an interview on December 16, 2025, at 3:45 AM with the surgery manger (SM), the SM stated, the Operation Room (OR) staff are responsible for doing the in-between patient cleaning and if the patient was on isolation the OR staff will do the terminal cleaning. The SM added that the OR staff does not have any documentation to provide for terminal cleaning in between patients who were on isolation. During an interview on December 17, 2025, 9:51 AM with the anesthesia tech (AT), the AT stated that the OR staff is not required to document the terminal cleaning conducted in between patients. During an interview on December 17, 2025, at 1:48 PM with the Executive Director of Support Services (EDSS) and the Director of Environmental Staff Service (EVSD-unit specialized in cleaning and waste management), the EDSS stated that EVS staff are responsible for the terminal cleaning every day after the scheduled OR procedures are completed. The EDSS further stated that OR staff are responsible for cleaning the room between each OR procedure. The EDSS added that EVS staff would complete the daily terminal cleaning log which manager would review and check off. 11b. During a review of Patient 11’s H&P dated November 26, 2025, the H&P indicated, Patient 11 was admitted to the facility because of the malfunction and dislodgment of the gastrointestinal tube (G-tube-a flexible tube delivering nutrition, fluid, and medication directly to patient stomach). Patient 11 had medical history including clostridioides difficile (c. diff-a bacterial infection causing diarrhea), extended spectrum beta lactamase (ESBL-an enzyme that make the body resistant to many common antibiotics) klebsiella pneumonia (bacterial infection in the lung), and) infection. During a concurrent interview and record review on December 16, 2025, at 10:20 AM, with the Director of Patient Service (DPS), Patient 11’s “Main OR Nursing Record,” dated December 12, 2025, was reviewed. The “Main OR Nursing Record” indicated, Patient 11 had a “laparoscopy” (a minimally procedure using a camera to see and operate inside abdomen) with gastrectomy recession (a type of stomach surgery used most to fix the infected area of stomach) which started at 5:46 PM, through 9:04 PM. The DPS verified date and time of Patient 11’s procedure and stated that Patient 11 was in OR 2. During an interview on December 16, 2025, at 10:50 AM, with Infection Preventionist Nurse (IPN 1), IPN 1 stated, the terminal cleaning should be completed daily at the end of each day to prevent spreading of infection. A follow-up concurrent interview and record review on December 16, 2025, at 10:55 AM, with the DPS and IPN 1, Patient 11’s “Orders” for isolation (infection control methods used to stop germs from spreading from one person to another), dated from November 25, 2025, through November 26, 2025, was reviewed. The “Orders” for isolation indicated, Patient 11 had orders for contact isolation precaution (an infection control method used to prevent spreading of infection by touching a patient or their surroundings) as follows: On November 25, 2025: contact isolation for carbapenemas producing organism (CPO-an enzyme that make the body resistant to certain antibiotic) and MRSA On November 26, 2025: contact isolation for C. diff IPN 1 verified and confirmed, Patient 11 had orders to be in contact isolation. IPN 1 further stated, the procedure room should be terminally clean after Patient 11’s procedure was completed. During an interview on December 16, 2025, at 11:05 AM, with the DPS, the (EDSS) and the EVSD), the EDSS stated that EVS staff are responsible for the terminal cleaning every day after the scheduled OR procedures are completed. The EDSS further stated that OR staff are responsible for cleaning the room between each OR procedure. The EDSS added that EVS staff would complete the daily terminal cleaning log which manager would review and check off. A follow-up concurrent interview and record review on December 16, 2025, at 11:10 AM, with the DPS, EDSS and EVSD, the facility’s document titled, “Operating Room Terminal Cleaning Log,” dated December 12, 2025, was reviewed. The “Operating Room Terminal Cleaning Log” indicated that EVS 1 completed the terminal cleaning for OR 2 at 10:30 PM, and manager of EVS (MEVS 1) signed off (approved) at 9:20 PM (1 hour and 10 minutes before the terminal cleaning completed). The EDSS verified and confirmed, manager signed off the log before the cleaning completed. The EDSS stated, manager has the responsibility to oversee the completion of the terminal cleaning and should have gone back to evaluating the sanitary environment after EVS staff completed the terminal cleaning. The EDSS and DPS confirmed that the terminal cleaning log did not show a complete oversight of management with the cleaning process. The EDSS stated that the management missed the opportunity to do any real time or spot check to ensure quality and infection control prevention process. During a concurrent interview and record review on December 16. 2025, at 4:00 PM, with the Assistant Chief Nursing Officer (ACNO), the facility’s document titled, “Preliminary Surgery Schedule,” dated December 12, 2025, was reviewed. The ACNO stated that Patient 11 was not on the surgery schedule provided because Patient 11 was an add on case. During an interview on December 17, 2025, at 2:40 PM, with EVS 2, EVS 2 stated, terminal cleaning in the OR is conducted by EVS staff and upon completion of cleaning the supervisor is responsible for checking and signing off the completion. EVS 2 added, if there is a spot that is missed during the cleaning the supervisor will point it out at the time of checking. A review of the facility’s policies and procedures (P&P) titled, “Area Cleaning,” dated March 2022, indicated, “Purpose: To outline specific cleaning procedures for general and listed areas ... Area Cleaning - Surgical Areas - Terminal cleaning, [Number of Policy] This procedure covers the terminal or end-of-day cleaning instructions for surgical/invasive areas and delivery rooms and meet AORN [Association of perioperative Registered Nurses] requirements ... 10. Inspect the room: report any needed repairs, correct any deficiencies ...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 46696 Based on interview and record review, the Governing Body (GB) failed to provide adequate oversight to ensure a safe and effective quality of patient care for 303 of 303 patients admitted on May 15, 2025, when: The GB did not ensure an effective quality improvement program and provide effective oversight of Infection Control practices and processes when Sterilizer 2 (a machine used to kill germs on surgical instruments) was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer’s Instructions for use. Patient care rooms were not appropriately cleaned between patients use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries and the infection preventionist did not implement an active surveillance activity when there were allegations of mold in the obstetric patient care rooms. (Refer to A049). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 46696 Based on interview and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15,2025 when: 1. the facility failed to monitor, collect and analyze quality data when Sterilizer 2 was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer’s Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries. (Refer to A 273) 2. The facility failed to identify the collected data to utilize the opportunities for improvement of the issues regarding the Sterile processing department cleaned (Pre & Pack) areas floor contained tape, stickers and scattered black spots the infection preventionist did not implement surveillance activities when there were allegations of mold in the obstetric patient care rooms in accordance with the policy and procedure. (Refer to A 283). The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality care and patient safety and had the potential to cause adverse health outcomes (potentially harmful effects on health resulting from various factors such as medication, exposure to chemicals) which could interfere with the patient’s medical care and may jeopardize the health and safety 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: 39723 Based on observation, interview, and record review, the facility failed to provide a sanitary environment and an active infection control program as evidenced by: 1. The facility failed to implement an effective and facility-wide infection prevention and control plan for preventing and controlling the transmissions of infections within the hospital for one of one sampled operating room. Cross reference to A0749. 2. The facility failed to ensure the infection prevention and control program included the prevention and control of hospital acquired infections (HAI, an infection that develops in a hospital while a patient is receiving treatment for a different condition), including maintaining a clean and sanitary environment for seven of seven sampled surgical patients, and jeopardize the health and welfare of other patients experiencing surgical procedures. Cross reference to A0750. 3. The facility failed to ensure infection prevention and control leadership responsibilities were implemented for an allegation of toxic mold (a highly dangerous germ that can cause a range of health problems) infestation on the Maternal Child Health Unit (a unit used to care for mother and baby) for six of six sampled Patients (Patients 3, 31, 32, 34, 36, and 37) and jeopardized the health and welfare of other patients admitted to one of four sampled rooms (Room A). Cross reference to A0772. The cumulative effect of these systemic failures resulted in the facility’s inability to provide quality healthcare in a safe and sanitary environment for the facility’s patients in accordance with §482.42 Condition of Participation for Infection Control Services.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 46696 Based on interview and record review, the Governing Body (GB) failed to ensure the quality of care was provided for 303 of 303 patients admitted on May 15, 2025, when the GB did not have an effective oversight of Infection Control Practices and processes which resulted in Sterilizer 2 (a machine used to kill germs on surgical instruments) was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and readily available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer’s Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period(period after childbirth)) unit Operating room was not appropriately cleaned between surgeries and the infection preventionist did not implement an active surveillance activity when there were allegations of mold in the obstetric patient care rooms. These failures had resulted in the facility’s failure to identify the problem prone areas and deliver care with the GB oversight and to provide a safe patient care environment causing risk for acquiring hospital infection which could jeopardize the health and safety of the patients and prolonged the hospitalization. Findings: During an interview on May 21, 2025, at 10:16 AM, in the conference room, with two members of the Governing Board (GB): the Chief Executive officer (CEO) and the Chief of staff (COS), the survey findings were discussed including, Sterilizer 2 was found to contain greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer’s Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics unit Operating room was not appropriately cleaned between surgeries. The GB stated the Quality Department report to the board each meeting as noted in the GB minutes. Improvement opportunities and interventions are discussed at each GB meeting. The COS stated the, these findings are the responsibility of the governing body, it starts by making sure staff are reporting everything, the facility would have this as part of our governing board going forward and follow up to make sure it comes back because the GB should know about this. During a concurrent interview and record review on May 21, 2025, at 10:20 AM, with the CEO and COS, the facility’s document “Board of Trustees agenda,” dated April 24, 2025, was reviewed. The “Board of Trustees agenda” indicated, “Quality report was presented, by the COS”. The COS stated, “I presented the quality report to the board of trustees, I present what was discussed in the quality committee meeting, if quality issues were not in the quality meeting, the board would not have likely been aware.” During a review of the facility’s policy and procedure (P&P) titled, “Governing Body Bylaws,” dated March 5, 2019, the P&P indicated, “The powers of the corporation shall be exercised, its property controlled, and its affairs conducted by or under the direction of the Board of Directors to be known as the board of trustees ... 5.5(6) Quality Committee The Quality committee shall provide assistance to the board of trustees in fulfilling their oversight responsibilities to assure the highest quality of clinical care, patient safety and customer service provided to patients of [facility name]. The committee also assists the Board in exercising its responsibilities to maintain a relationship with medical staff and to approve and oversee medical policies and professional staff appointments, reappointments and clinical privileges ...””

“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: 46696 Based on interview and record review, the hospital failed to maintain an effective and ongoing hospital wide data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15, 2024, to monitor, collect and analyze quality data when Sterilizer 2 was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer’s Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries. These failures resulted in the hospital’s inability to identify the problem prone (likely to cause errors) areas and create changes to improve patients’ health outcomes and had the potential to cause preventable adverse patient outcomes that could negatively affect patients’ health and safety. Findings: During a interview on May 21, 2025, at 9:20 AM, with the Chief Operating Officer (COO) and Chief executive officer (CEO) the survey team’s following findings were discussed: Sterilizer 2 was found to contain greyish white residue throughout the chamber, multiple reusable surgical instruments were not cleaned and/or were damaged and was readily available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes were not stored in a clean storage cabinet in accordance with the manufacturer’s instructions for use. Patient care rooms in the maternity unit were not appropriately cleaned between patient use, the Obstetrics unit Operating room was not appropriately cleaned between surgeries were discussed. The COO acknowledged these findings and stated, the facility will work to correct these findings. During a concurrent interview and record review on May 21, 2025, at 9:25 AM, with the COO, the facility’s “Board of Quality Committee Minutes,” dated March 24, 2025, was reviewed. The “Board of Quality Committee Minutes” did not show any data regarding the cleanliness of the sterilizers in the sterile processing department, the tracking of reusable surgical instruments, and the used of wrong cleaning cloth material. The COO acknowledged and stated, the facility should have identified these issues with the tracking system. During a follow-up concurrent interview and record review on May 21, 2025, at 9:27 AM, with the COO, the facility’s “Infection Control Committee Meeting Minutes,” dated February 12, 2025, was reviewed. The “Infection Control Committee Meeting Minutes” did not show any data regarding the tracking of Endoscopes and monitoring of the cleanliness of patient care rooms and the Obstetrics unit. The COO verified and stated, the facility was not tracking the issues. During a review of the facility’s document titled “Infection control Committee meeting minutes” dated February 12, 2025, the “Infection control Committee meeting minutes” indicated, “EVS Room Cleaning q4 [quarter 4] 2024: Surfaces that fell below 95% were :Chair arms, paper towel dispenser, soap dispenser, IV pole, IV pump, Door knob, Light switch, telephone, bathroom handrail, bathroom doorknob, bathroom light switch, bathroom sink, bathroom faucet, soap dispenser, toilet flush handle, heal wall switches.” During a concurrent interview and record review on May 21, 2025, at 9:30 AM, with the COO, the facility’s “Quality management Plan,” dated 2025 indicated, “ II. Hospital and medical staff leaders have the authority and responsibility for ensuring high quality, safe patient care services ... They are responsible for ensuring that there is a planned, systemic hospital wide approach for designing, measuring, assessing and improving patient care, patient safety and services. III. The goal of the Quality Management program is the provide a framework for improving performance, which is collaborative and systematic ...IV. The Quality management program monitors the performance of important functions/ processes and significant issues which are linked to and integrated with the QM Program though reporting processes, committee participation or oversight including: Clinical pertinence, Pharmacy and therapeutic function, Operative and other procedures, medication usage, patient safety, environmental safety, infection prevention, efficiency of clinical practice patterns, monitoring of significant departures from establish clinical patterns.” The COO stated, the quality team has the overall responsibility for evaluating the problems, and making plans to improve, the hospital has things we need to improve on.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 46696 Based on interview, and record review, the hospital failed to maintain an effective and an ongoing hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15, 2025, when the facility failed to identify the collected data of the facility’s issues and work on the opportunities for improvement when: 1. the sterile processing department clean (Pre & Pack) areas floor contained tape, stickers and scattered black spots. 2. the infection preventionist did not implement surveillance activities when there were allegations of mold in the obstetric (area of medicine that deals with pregnancy and the birth of babies) patient care rooms in accordance with the policy and procedure. These failures resulted in the hospital’s inability to focus and improve the problem prone areas to ensure the provision of quality care and patient safety and had the potential to cause adverse health outcomes which could interfere with the patient’s medical care and may jeopardize the health and safety. Findings: 1. During an interview on May 21, 2025, at 9:23 AM with the Chief Operations Officer (COO), the findings regarding the tape, stickers and black spots on the floor of the sterile processing department was discussed. The COO confirmed that the floor of the sterile processing room was not cleaned to infection prevention control standard. During a concurrent interview and record review on May 21, 2025, at 9:25 AM with the COO, the facility’s, “Infection control Committee meeting minutes” dated February 12, 2025, indicated, “Sterile Processing Department Monitoring and Evaluation 4th Quarter 2024 no positive spore tests (a biological indicator used to assess the effectiveness of a sterilization process, specifically by testing the ability of the process to kill highly resistant microbial spores) on steam sterilization and no positive spore tests on the Hydrogen Peroxide sterilization process.” There was no further data presented regarding the Sterile processing department. The COO stated, the facility’s environmental rounds should have been more detailed, this issue was not identified prior. 2. During a concurrent interview and record review on May 21,2025, at 9:30 AM, with the COO, the facility’s “Quality management Plan,” dated 2025,was reviewed. The “Quality management Plan,” indicated, “ II. Hospital and medical staff leaders have the authority and responsibility for ensuring high quality, safe patient care services ... They are responsible for ensuring that there is a planned, systemic hospital wide approach for designing, measuring, assessing and improving patient care, patient safety and services. III. The goal of the Quality Management program is the provide a framework for improving performance, which is collaborative and systematic ...IV. The Quality management program monitors the performance of important functions/ processes and significant issues which are linked to and integrated with the QM Program though reporting processes, committee participation or oversight including: Clinical pertinence, Pharmacy and therapeutic function, Operative and other procedures, medication usage, patient safety, environmental safety, infection prevention, efficiency of clinical practice patterns, monitoring of significant departures from establish clinical patterns.” The COO stated, the quality team has the overall responsibility for evaluating the problems, and making plans to improve, the hospital has things to improve on. During an interview on May 21, 2025, at 9:45 AM with the COO and Chief Executive Officer (CEO) regarding the findings that the infection preventionist did not implement surveillance activities when there were allegations of mold on April 22,2025 in the obstetric patient care rooms in accordance with policy. The COO stated that the infection preventionist were told by Environment Services (EVS) there was no infection problem, Infection control should have checked for them self, Infection control needed to evaluate it so it could be brought to the quality committee and this was not done. The CEO stated that the hospital should trust what EVS told them, but they should also validate the report. During a review of the facility policy and procedure (P&P) titled, “Infection prevention and control Admi Manual, Environmental cultures”, dated May 2023, the P&P indicated, “” ...c. Outbreak [higher than usual number of cases of a disease] investigations 1 appropriate environmental culture will be collected if the environment is implicated as a source of nosocomial infection outbreak conditions. 2. the environment should be tested only after establishing, i. A common microbial agent ii. Role of the person-to- person transmission via patients or personnel has been ruled out epidemiologically. iii. mode of transmission is not apparent. iv. Epidemiologic investigation implicates a specific environmental source as a risk factor. 3 Environmental culturing will be conducted when recommended by the infection prevention committee chair (designee) and in coordination with the microbiology department.””

“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: 46696 Based on observation, interview, and record review, the facility failed to ensure the Obstetrics (OB- a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period (time after childbirth)) Operating room was cleaned according to the policy between surgical procedures. This failure had the potential to expose patients to unsafe operating conditions with increased risk of hospital acquiring the infection, surgical complication and prolonged hospitalization. Findings: During a concurrent observation and interview on May 15,2025, at 11:25 AM, with the Infection Control Preventionist Manager (ICPM), the OB Unit Operating room (OR) was observed. The OB OR was observed to be ready for use, the operating table base was covered with a white blanket, when lifted the operating room table base was observed to have streaks on it, when wiped with a facility provided cleaning wipe, the wipe had brown residue on it after being wiped on the OR table base. The ICPM stated “I don’t believe the table base was cleaned as well as it should have.” During a concurrent observation and interview on May 15,2025, at 11:27 AM, with the ICPM, the OB Operating room was observed. The air conditioning vent located in the ceiling above the Operating room table, was observed to be dirty and dusty. The ICPM stated, this would be a concern for infection especially in the operating room. During a review of the facility’s “Operating room terminal cleaning [a thorugh cleaning process after a patient is moved out to ensure a clean and safe healthcare environment to prevent the spread of infections] log- Labor and Delivery May 2025” the “Operating room terminal cleaning log- Labor and Delivery May 2025” indicated, “ EVS [Environmental Service] staff please date time and initial that the daily OR terminal cleaning has been performed as follows: Clean and disinfect all surfaces (overhead lights/switches, ceiling vents, hoses, walls ... OR bed/ attachments positioning/ transfers devices, mobile/ fixed equipment ...” A further review of the record indicated the log was last dated and signed on May 14, 2025 at 8:30AM. During a review of the facility’s policy and procedure (P&P) titled “Area cleaning- Surgical areas- Terminal cleaning 8440.40000.12” undated, the P&P indicated, “This procedure covers the terminal or end of day cleaning instructions for surgical/invasive areas and delivery rooms and meets AORN [Association of Perioperative (around the time of surgery) Nursing] requirements. Guidelines I. Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily when the areas are being used ...Procedure ...5. After the last case, a more thorough cleaning may be needed. The table should be disassembled and cleaned with a disinfectant. 6. Spot wash walls and wall vents with hospital approved disinfectant.” During an interview on May 20,2025, at 3:00 PM, with Obstetrician-Gynecologist (OBGYN1) (a medical doctor who focuses on the health and care of women), OBGYN 1 stated, if dust or debris from a vent entered the sterile field during a procedure, it would contaminate the sterile field (area created and maintained as free from microorganisms as possible to reduce the risk of infection during surgery) which is an infection risk.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 39723 Based on observation, interview, and record review, the facility failed to ensure the infection prevention and control needs of all patients requiring surgical services and gastroenterology services (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) including the storage of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were met when: 1. The steam sterilizer (autoclave, a machine used to kill germs on surgical instruments) was not maintained in accordance with the manufacturer’s instruction for use (IFU) and brown staining, black matter, and whitish/grey residue were observed throughout the chamber (the internal portion of the sterilizer) for one of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 2). 2. Previously reprocessed instruments were observed with black spots, brown staining, discoloration, scratches, etching (an engraving on the surface of the instrument), flawed (defected), and white residue for two of three sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2). 3. Hand-held cleaning cloths were not made of lint-free material and were used to clean reusable surgical instruments for seven of seven sampled surgical patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36). 4. The facility’s policy and procedure (P&P) on the manual cleaning process (the physical removal of visible soil and debris from instruments using hand-held cloth, hand-held brushes, detergents, and water) did not clearly outline the critical steps on cleaning reusable surgical instruments for one of two sampled surgical cases (Surgical Case 1). 5. Terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were not implemented in accordance with the hospital protocol and black spots, adhesive labels (stickers), and pieces of medical plastic tape were observed throughout the floor for one of two sampled reprocessing workrooms (Sterile Processing Department Workroom-SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment). 6. The facility’s P&P was not implemented on cleaning and brushing soiled (potentially infectious) instruments submerged (underwater) in the enzymatic solution (a cleaning detergent used to help prepare instruments for cleaning) for one of four sampled Sterile Processing Technicians (SPDT 1). 7. Thick grey fuzzy matter, debris, and a brown bug were observed under the endoscope’s drip tray (a removable tray designed to collect residual moisture that may drip during the storage process), and the endoscope cabinet’s drip tray contained black matter and debris for one of two sampled endoscope storage cabinets (Scope Cabinet 2). 8. Terminal cleaning procedures were not implemented in the surgical scrub area (a designated area for surgeons and other operating room staff to scrub their hands and arms before a surgical procedure) and the water did not drain from the sink properly (water drained slowly) for one of two sampled surgical scrub stations (Scrub Station 2). 9. Hand hygiene (the practice of cleaning one’s hand to remove dirt and germs to prevent the spread of infections) was not performed after handling soiled surgical instruments in accordance with the hospital’s P&P, for one of four sampled Sterile Processing Technicians (SPDT 4). These failures had the potential for cross-contamination (the unintentional transfer of harmful germs or other from one surface or object to another), injury, and prolonged hospitalization, for seven of seven sampled surgical patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36), and jeopardize the health and welfare of other patients experiencing surgical procedures. Findings: On May 19, 2025, at 4:47 PM, an immediate jeopardy (IJ- a situation that had threatened or was likely to threaten the health and safety of a patient) situation was called in the presence of the Chief Operating Officer (COO). The COO was verbally notified of failure of the facility not implementing safe infection prevention and control practices when the steam sterilizer was not clean and maintained in accordance with the manufacturer’s IFU; Multiple reusable surgical instruments were not clean and/or damaged and were available for patient use; there was no written policy and procedure that clearly outlined the critical (important) steps in instrument cleaning; and hand-held cleaning cloths used to clean reusable surgical instruments were not made of non-linting material in accordance with the Association for the Advancement of Medical Instrument (AAMI, nationally recognized infection prevention and control standards). These failures had the potential for cross-contamination, injury, and prolonged hospitalization, for seven of seven sampled patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36), and jeopardize the health and welfare of other patients experiencing surgical procedures. On May 20, 2025, at 1:44 PM, the facility provided a corrective action plan (CAP). The CAP included the following components: “1. Sterilizer 2 not clean and the routine cleaning procedures were not performed per manufacturer’s guidelines. CAP: -Phenix (an equipment cleaning vendor) performed a deep clean (a process used to clean the steam sterilizer machine which involves removing persistent stains and other chemical material that regular cleaning may not address). Date completed: 5/18/25. -All trays (containers that hold a variety of surgical instruments) processed in Sterilizer 2 prior to it being deep cleaned by the Vendor, were reprocessed. Date completed: 5/18/25. -Staff re-education on routine cleaning of Sterilizer per manufactures guidelines started on 5/17/25. Education will be completed for all staff as they come to work by: 6/2/25. -Log created to document the cleaning (chamber, door/gasket, clean drain, printer, and external wipe down). Date completed: 5/17/25. -SPD Leadership will audit Logs on a daily basis for compliance. - IP (infection prevention) Environment rounds (a systematic assessment of a healthcare facility’s environment to ensure it’s safe and sanitary, preventing the spread of infections) to include checking (monitoring) for compliance. -Responsible Person: Chief Nursing Office/Director for SPD. 2. Surgical instruments were found to be contaminated with brown/black spots, white residue, and stains after sterilization (a process used to kill germs) and ready for patient use. CAP: -SPD water source connected to soft water so that the Sterilization is fed with soft steam, upon investigation found out that it was bypassed and hooked up directly to city water. Date completed: 5/19/25 -Steris (manufacturer/vendor) will proactively verify the drain on the cool can (a reservoir used to cool down the hot water produced during sterilization) is functioning properly. -Steris will conduct an inspection bi-monthly to verify proper drain function to prevent any water or steam from backing up into the sterilizer. -Water source tested on 5/19/25. -Plant Operations will continue to test water on a daily basis. -Water will continue to be tested by Vendor on a monthly basis. -Steris will continue to monitor for stains, spots, and white residue after sterilization three times a month. -Any instruments found with stains, spots and white residue after sterilization will be re-processed, refurbished or taken out of service by the SPD staff. -Responsible person: Chief Nursing Officer/Director for SPD. 3. Cleaning cloths used to clean reusable patient surgical instruments, were not non-linting in accordance with AAMI Standards. CAP: -Non Linting (lint-free) cloths ordered, delivered, and implemented in SPD. Date: 5/19/25. -Staff re-education started for the use of Lint Free cloths to be used in SPD on 5/19/25. -Education will be completed for all SPD staff as they come to work by 6/2/25. -SPD leadership will monitor on a weekly basis to ensure that only non-linting cloth is used for cleaning instruments. -IP Environment rounds to include checking for compliance. -Responsible person: Chief Nursing Officer/Director for SPD. 4. Policies and procedure did not clearly outline critical steps for instrument cleaning. CAP: -Instrument cleaning policy for SPD # 8380.50800 (policy reference number) updated to include critical steps for instrument cleaning based on AAMI guidelines. Policy approved by Medical Chair of Surgery and Medical Director of Infection Prevention Committee on 5/20/25. -Staff re-education for the updated policy started on 5/20/25. -Education will be completed for all SPD staff as they come to work by 6/2/25. -Responsible person: Chief Nursing Officer/Director for SPD.” On May 20, 2025, at 3:01 PM, the CAP for the IJ was reviewed and was found acceptable. On May 21, 2025, at 11:34 AM, the immediate jeopardy situation was removed onsite in the presence of the COO, after the CAP was verified onsite as implemented through observation, interviews, and record reviews, as evidenced by the cleanliness of the sterilizer, cleanliness and integrity of the surgical instruments, implementation of the lint-free cleaning cloth, staff knowledge of the critical steps for instrument cleaning, and a tracking system to prevent future reprocessing breeches. 1. An interview was conducted with the Infection Control Preventionist Manager (ICPM) and the Infection Control Preventionist (ICP), on May 15, 2025, at 10:55 AM, in the conference room. The ICP stated the hospital followed the following nationally recognized guidelines: A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States); B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas); C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); D. ANSI/AAMI ST79 (2017) American National Standards/Association for the Advancement of Medical Instrument: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and E. The Association for Professionals in Infection Control (APIC, a professional association for individuals working in the field of infection prevention). A concurrent observation and interview were conducted with the Sterile Processing Manager (SPDM) and the Infection Control Preventionist (ICP) on May 16, 2025, at 8:17 AM, in the SPD clean workroom. Two sterilizer machines were observed. There was brown staining, black matter, and whitish/grey residue observed throughout Sterilizer 2’s chamber wall (internal portion of the sterilizer). The SPDM stated, Sterilizer 2 “have some discoloration and needs a deep cleaning.” An interview and record review were conducted with the SPDM on May 19, 2025, at 10:16 AM, in the conference room. The facility’s document titled, “AMSCO 400 Series Medium Steam Sterilizers: Operator Manual,” dated 2019, indicated, “...8.3.1 Clean Chamber Drain Strainer: Recommended Frequency: The chamber drain strainer must be cleaned at least once a day...8.3.2 Flush Chamber Drain...The chamber drain should be cleaned once a week...Drain Cleaning Method...6. Rinse the bottom of the chamber with a small amount of water to prevent detergent residue from baking onto the surface...” The SPDM stated she had reviewed the manufacturer’s IFU, and the facility performs daily cleaning of the sterilizer’s chamber drain filter. The SPDM stated the staff did not clean the sterilizer’s internal chamber daily and the facility did not have documentation to show that staff had provided daily inspection or cleaning of the sterilizer’s door gasket, the internal chamber, or the machine’s external surfaces. The SPDM stated there was room for additional education on routine cleaning of the steam sterilizers. The review of the facility’s P&P titled, “Sterilization and Disinfection Methods,” reviewed June 2023, was conducted. The P&P indicated, “...Procedure I. Steam Sterilization: A. Sterilizers will be inspected and cleaned daily according to the manufacturer’s IFU. Examples of items requiring daily inspection and cleaning are door gaskets, chamber drain screens (filters), the internal chamber, and external surfaces ...” 2. A concurrent interview and inspection of surgical trays were conducted with SPDT 2 and the SPDM, on May 16, 2025, at 8:25 AM, in the SPD clean workroom. Two surgical tray sets were inspected. SPDT 2 stated the surgical tray sets contained reusable surgical instruments that had been “previously reprocessed and were ready for patient use.” The following were observed: -Tray Set 1 contained 24 surgical instruments, dated May 15, 2025. 11 of 24 sampled instruments were of concern upon inspection of the surgical tray set. Two instruments had multiple scratches; three instruments were discolored; four instruments had brown staining, and two instruments contained etchings; and -Tray Set 2 contained 78 surgical instruments, dated May 8, 2025. 19 of 78 sampled instruments were of concern upon inspection of the tray set. Two instruments were damaged; six instruments had brown staining; three instruments had multiple scratches; one instrument had white residue; one instrument had black spots; two instruments had etchings; two instruments had orange/red matter; and two instruments were flawed. The SPDM stated the facility has been discarding all instruments containing etching. The SPDM stated the instruments with etchings should have been removed from the tray set prior to the sterilization process. SPDT 2 stated the orange/red matter was “rust” and the rust was “missed” during the inspection process. SPDT 2 nor the SPDM did not provide an explanation for the multiple brown stained instruments. SPDT 2 stated if one reprocessed instrument in a tray set was potentially contaminated, the entire tray set would not be acceptable for patient use and the surgical tray set would have to be returned to the SPD’s decontamination (the process of removing or neutralizing germs) workroom for reprocessing. SPDT 2 did not provide an explanation for the identified damaged and/or stained instruments. An interview and record review were conducted with the Director of Perioperative (the care provided to patients before, during, and after a surgical procedure) Services (DSS) on May 21, 2025, at 9:30 AM, in the conference room. The DSS stated, “During the instrumentation inspection process, all damaged instruments should have been removed from the tray set prior to the sterilization process.” The facility’s document titled, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,” dated 2017, was reviewed. The document indicated, 7.6 Cleaning: 7.6.1 General Considerations ...g) Instruments should be carefully inspected for flaws, damage, debris, detergent residue, and completeness, then dried ...” The facility’s P&P was requested on the instrumentation inspection process. The DSS stated the facility did not have a P&P on inspecting surgical instruments and the facility followed the infection control national standards from ANSI/AAMI on inspecting instruments. 3. The review of surgical procedures performed for Patients 3, 6, 7, 31, 34, 35, and 36 was conducted. The findings were as follows: -For Patient 3, Patient 3’s “Discharge Summary” (a document that summarizes patient care events during hospitalization) dated May 16, 2025, indicated Patient 3 was admitted to the facility on May 12, 2025, and a C-section (cesarean birth, a surgical procedure used to deliver a baby) was performed on May 14, 2025. -For Patient 6, Patient 6’s “Discharge Summary” dated May 15, 2025, indicated Patient 6 was admitted to the facility on May 12, 2025, and a C-section was performed on May 12, 2025. -For Patient 7, Patient 7’s “Discharge Summary” dated May 16, 2025, indicated Patient 7 was admitted to the facility on May 13, 2025, and a C-section was performed on May 14, 2025. -For Patient 31, Patient 31’s “Discharge Summary” dated May 4, 2025, indicated Patient 31 was admitted to the facility on May 1, 2025, and a C-section was performed on May 1, 2025. -For Patient 34, Patient 34’s “Progress Note-Physician” dated May 17, 2025, indicated Patient 34 was admitted to the facility on May 16, 2025, and a C-section was performed on May 17, 2025. -For Patient 35, Patient 35’s “Discharge Summary” dated May 2, 2025, indicated Patient 35 was admitted to the facility on April 30, 2025, and a repeat C-section and a bilateral salpingectomy (a surgical procedure used to prevent pregnancy) were performed on May 1, 2025. -For Patient 36, Patient 36’s “Discharge Summary” dated April 26, 2025, indicated Patient 36 was admitted to the facility on April 19, 2025, and a C-section was performed on April 22, 2025. An observation was conducted with the ICPM and the SPDM on May 19, 2025, at 10:37 AM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 1 was observed standing at the decontamination sink and wiping debris off the surface of the surgical instrument with the hand-held cleaning cloth. A concurrent interview and observation were conducted with SPDT 1 and the SPDM on May 19, 2025, at 10:43 AM, in the SPD decontamination workroom. SPDT 1 stated she was performing manual instrument cleaning, and she did not know if the cleaning cloth was made of non-linting material. The cleaning cloth label was viewed, and the label indicated the cleaning cloth was made of 100 percent (unit of measurement) cotton material. The SPDM stated cleaning supplies were supplied by the facility, and she was not aware the “washcloth” needed to be made of lint-free material. An interview and record review were conducted with the ICPM on May 19, 2025, at 11:50 AM, in the conference room. The ICPM stated she had contacted the linen/washcloth vendor, and the following document was provided by the linen vendor. The facility’s document titled, “Washcloths” dated May 19, 2025, indicated the washcloths used in the facility were “100% (percent, unit of measurement) cotton white. They (linen/washcloth) are designed to be very low-linting.” The ICPM stated the “washcloths” used to clean Patients 3, 6, 7, 31, 34, and 35’s surgical instruments were not lint-free. The ICPM stated lint-free cloths were designed to help minimize the spread of germs on surgical instruments during the cleaning process and the cleaning cloth should have been lint-free in accordance with AAMI standards. The review of the ANSI/AAMI ST79: 2017, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” was conducted. The standard indicated the following, “7.4 Decontamination: 7.6.1 General considerations ...d) Cloths and towels used in decontamination should be clean and nonlinting (e.g., microfiber cloth or cellulose sponge) and should be changed at regular established intervals and when they are soiled or wet ...” 4. An observation was conducted with the SPDM and the ICP on May 16, 2025, at 10:25 AM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 1 was observed standing at the decontamination sink. SPDT 1 placed an instrument tray into the enzymatic solution and proceeded to clean the instrument. An interview was conducted with SPDT 1 and the SPDM on May 16, 2025, at 10:30 AM, in the SPD decontamination room. SPDT 1 stated she was not sure of the manual cleaning steps, and she could not recall the steps. The SPDM stated the surgical instruments should have been rinsed in water prior to placing the instruments into the enzymatic solution. The SPDM stated she was not sure if instruments should have been soaked in the enzymatic solution. A follow up interview was conducted with the SPDM on May 16, 2025, at 4:20 PM, in the conference room. The SPDM stated the facility did not have a P&P which clearly outlined the manual cleaning process. A request was made for the facility’s surgical instrument cleaning competency-based performance checklist (a specific set of skills, knowledge, abilities, and behaviors an employee must possess to perform instrument cleaning effectively) which outlined the manual cleaning process. The SPDM stated the facility did not have a competency-based checklist which clearly outlined the steps of the manual cleaning process. The review of the ANSI/AAMI ST79: 2017, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” was conducted. The standard indicated the following, “M.3 Resources and training: Facility-specific written policies and procedures that are both general and instrument-specific should clearly outline the important steps in instrument cleaning and sterilization ...” 5. A concurrent observation and interview were conducted on May 16, 2025, at 8:15 AM, with the ICP and SPDM, in the SPD clean workroom. Black and dark brown spots were observed scattered throughout the floor; multiple black and grey adhesive labels were observed attached to the floor; and pieces of medical tape was covered with grey fuzzy matter were observed throughout the floor. The ICP stated the tape, and stickers should have been removed during the terminal cleaning process. The SPDM confirmed the floor should have been cleaned each day the SPD workroom was used. An interview and review of the facility’s document titled, “Sterile Processing Cleaning Logs,” dated May 2025, was conducted with the Director of Environmental Service (EVSD) on May 16, 2025, at 3:20 PM, in the conference room. The terminal cleaning log indicated the SPD workrooms were cleaned daily from May 1, 2025, to May 15, 2025. The EVSD stated the facility’s expected the EVS staff to perform terminal cleaning in accordance with the terminal cleaning procedure. The EVSD stated the SPD’s clean workroom and the SPD’s decontamination workroom should have been terminally cleaned. The review of the facility’s P&P titled “Area Cleaning-Sterile Processing Department,” reviewed June 2023, was conducted. The P&P indicated “I. Terminal Cleaning: A. Perform terminal cleaning and disinfection of sterile processing areas daily when the areas are used ...F. Disinfect all floors with a single-use mop, including areas under mobile equipment, starting with the perimeter and working around the room toward the center ...” 6. A concurrent interview and observation of the manual cleaning process was conducted with the SPDM and the ICP on May 16, 2025, at 10:35 AM, in the SPD’s decontamination workroom. SPDT 1 was observed performing manual cleaning on a reusable surgical instrument. SPDT 1 was observed using a hand-held brush to scrub debris from the surfaces of the instrument. During the brushing process, the instrument was not completely submerged in the enzymatic solution water. SPDT 1 confirmed the instrument was not completely submerged in the cleaning solution when she had scrubbed the instrument surfaces to remove the excess debris. SPDT 1 stated, “I understand, I should have scrubbed the instrument under water to remove the debris.” The SPDM stated instruments should be completely submerged in the cleaning solution during the brushing process to prevent splashing and the risk of aerosolization (turning into a fine mist or spray containing minute [very small] particles) of chemicals and contaminates (harmful germs). The review of the facility’s P&P titled, “General Cleaning and Decontamination Policy,” reviewed June 2023, was conducted. The P&P indicated, “ ...Procedure: I. Instruments: D. ...Submerge instruments when cleaning to reduce aerosolized particles in the air.” 7. An observation was conducted on May 16, 2025, at 8:05 AM, of the endoscope storage workroom with the Gastroenterology Technician (GI Tech) and the ICP. Scope Cabinet 2’s drip tray contained black matter and debris. The GI Tech wiped the drip tray with a wet cloth and the black matter and debris were easily removed. The GI Tech proceeded to remove the drip tray from the cabinet and thick grey fuzzy matter, debris, and a brown insect were observed. Twelve endoscopes were observed hanging freely in the cabinet and were labeled “Clean.” An interview was conducted with the GI Tech, the ICP, and the SPDM on May 16, 2025, at 8:14 AM, in the endoscope storage workroom. The SPDM stated the endoscopes had been cleaned and were ready for patient use. The GI Tech stated the grey fuzzy matter was dust and the black matter was dirt and debris. The GI Tech confirmed the brown insect was “a dead bug.” The GI Tech stated he did not clean under the drip tray and did not know who was responsible for cleaning under the scope’s drip tray. The SPDM confirmed the endoscopes were potentially contaminated. The ICP stated the scopes needed to be reprocessed and the scope cabinet and storage room needed to be clean to prevent cross-contamination. The review of the manufacturer’s manual titled, “Olympus Reprocessing Manual,” dated 2014, was conducted. The manual indicated the following instructions for use, “...8.2 Storing the disinfected (to cleanse or treat something to destroy or prevent the growth of harmful germs) endoscope and accessories: Warning: Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices...Be sure the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated...” 8. An observation was conducted with the ICPM and the Maternal Child Health (MCH, mother and baby care unit) Director on May 15, 2025, at 12:25 PM, in the scrub area. Scrub Station 2 was observed discolored and contained brownish/yellow residue. The MCH Director was observed using a leg handle to turn the faucet on, and the running water was observed to flow into the scrub sink. The MCH Director turned the water valve off and the water was observed to slowly drain from the scrub sink. An interview was conducted with the ICPM and the MCH Director, on May 15, 2025, at 12:33PM, in the scrub area. The MCH Director stated she did not know when Scrub Station 2 had been cleaned but the sink should have been cleaned when the operating room was terminally cleaned. The MCH Director stated she did not know why the water was draining slow from the sink and she was not aware if a work order had been created to repair the sink. The ICPM stated the sink should be cleaned and Scrub Station 2’s drain should be cleaned to prevent cross-contamination of potential waterborne germs from the sink, faucet, or drain to the surrounding environment including the hands and clothing of the perioperative personnel. The review of the facility’s P&P titled “Area Cleaning-Surgical Areas-Terminal Cleaning,” reviewed June 2023, was conducted. The P&P indicated, “ ...Guidelines: I. Surgical and invasive procedures room and scrub/utility areas should be terminally cleaned daily when the areas are being used ...” 9. An observation was conducted with the SPDM and ICPM on May 20, 2025, at 3:40 PM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 4 was observed standing at the decontamination sink and brushing debris off the surface of the surgical instrument. SPDT 4 was observed to be wearing two pairs of gloves. SPDT 4 walked toward the SPD’s clean supply shelf and was observed removing his blue gloves. SPDT 4 was not observed to remove his off-white gloves or perform hand hygiene. SPDT 4 gathered the supplies and was observed walking back to the decontamination sink. An interview was conducted with SPDT 4 on May 20, 2025, at 3:45 PM, in the SPD decontamination workroom. SPDT 4 stated he was performing manual instrument cleaning, and the red soil on the instrument was blood. SPDT 4 confirmed he did not perform hand hygiene after handling the soiled instrument. SPDT 4 stated he did not know that he should have removed the second pair of gloves or perform hand hygiene after removing his first pair of gloves. SPDT 4 stated he thought the second pair of gloves were considered clean. An interview was conducted with the ICPM on May 20, 2025, at 3:50 PM, in the SPD decontamination workroom. The ICPM stated SPDT 4 should have removed both pairs of gloves and perform hand hygiene to prevent cross-contamination to the clean supplies. The review of the hospital’s P&P titled, “Handling of Contaminated Items,” reviewed June 2023, was conducted. The P&P indicated, “ ...Procedure: Hands should always be washed between glove changes or before donning (to put on) and upon removal of gloves ...” The review of the facility’s P&P titled, “Hand Hygiene,” reviewed May 2023, was conducted. The P&P indicated, “...111. Hand Decontamination using an alcohol-based hand rub is indicated: ...C. After contact with bloody fluids or excretions ...Note: If hands are visibly soiled, use soap and water ...H. After removing gloves or other personal protective equipment. Note: Gloves do not replace handwashing/hand decontamination ...””

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 39723 Based on observation, interview, and record review the facility failed to investigate an allegation of mold infestation on the Maternal Child Health Unit (a unit for mother and baby care) for one of 37 sampled Patients (Patient 36). This failure resulted in no infection prevention activities thereby increasing the risk of harm for six of six sampled Patients (Patients 3, 31, 32, 34, 36, and 37) and jeopardized the health and welfare of other patients admitted to one of four sampled rooms (Room A). An observation was conducted with the Maternal Child Health Director (MCH Director) and the Infection Preventionist Manager (ICPM) on May 15, 2025, at 11:37 AM, in Room A. The findings were as follows: There was black/greyish fuzzy matter observed along the shower door; there was black fuzzy matter observed in the hinges of the shower door; multiple tiles were observed broken, cracked, or missing; the grout around the shower’s door was observed broken and discolored. The shower’s handrail was observed covered with an orange/brownish substance; the wall was observed with scattered black circular spots; and the tile that surrounded the upper portion of the shower area was observed to have layers of thick black matter. An interview was conducted with the ICPM and the MCH Director on May 15, 2025, at 11:47 AM, in Room A. The MCH Director stated she could not identify the orange/brownish substance, the black fuzzy matter, the black/greyish fuzzy matter, or the black spots. The ICPM stated Room A needed to be cleaned. The review of Patient 36’s clinical record was conducted. The findings were as follows: Patient 36’s “Discharge Summary,” dated April 26, 2025, indicated Patient 36 developed a febrile illness (fever/elevated body temperature) and a rash on the abdomen (the front part of the body between the chest and the pelvis) during the hospital course that did not resolve with medication. Patient 36’s physician indicated Patient 36 had body aches, lethargy (tiredness/sleepiness), and severe headaches while in Room A and Patient 36 symptoms did not resolve until after Patient 36 was moved out of the “moldy (germ) room of [room number].” Significant Findings: “Mold in Room A likely Toxic Mold (highly dangerous germ) which affected patient’s care.” The review of the “Laboratory Preliminary Report” dated May 19, 2025, was conducted. The findings were as follows: Procedure: Environmental Culture (a sample of the black fuzzy matter) Collected: May 15, 2025 Preliminary Report: Possible rare fungus (mold/germ) identification to follow. Moderated bacteria (germ) present to date. An interview was conducted with the ICPM on May 19, 2025, at 9:45 AM, in the conference room. The ICPM stated she was not aware of the condition of Room A until the survey team arrived at the facility on May 15, 2025. The ICPM stated someone (she could not recall) had informed her that “the mold issue had been resolved.” The ICPM stated she did not observe Room A or investigate the allegation of potential for mold infestation. On May 19, 2025, 11:20 AM, an interview with the Infection Preventionist Manager (ICPM) and a concurrent telephone interview were conducted with the Infectious Disease Medical Doctor (MD 1), in the conference room. MD 1 stated the final culture results were needed before he could make an informed diagnoses of the germs that were obtained from Room A. MD 1 viewed the photographs of Room A restroom and stated the shower, wall, floor, grout, and the tile needed to be “fixed” and were not cleanable.” MD 1 stated the tile surfaces and wall surfaces should not have been cracked or damaged. MD 1 stated the surfaces should have been durable, smooth, and cleanable to prevent cross-contamination (the unintentional transfer of harmful germs or other from one surface or object to another). The review of the facility’s “Admission List,” dated April 27, 2025, to May 19, 2025, was conducted. The findings were as follows: -For Patient 31, Patient 31 was admitted to Room A on May 1, 2025. -For Patient 32, Patient 32 was admitted to Room A on May 5, 2025. -For Patient 37, Patient 37 was admitted to Room A on May 8, 2025. -For Patient 3, Patient 3 was admitted to Room A on May 12, 2025. -For Patient 34, Patient 34 was admitted to Room A on May 16, 2025. An interview was conducted with the Chief Nursing Officer (CNO) on May 20, 2025, at 8:15 AM, in the conference room. The CNO stated the allegation of mold in Room A was reported to her the following morning after the patient had been moved to another room. The CNO stated she did not observe the room. The CNO stated “the mold allegation was resolved when the patient was moved to another room.” A follow-up interview was conducted with the ICPM, on May 20, 2025, at 8:55 AM, in the conference room. The policy and procedure (P&P) on the facility’s infection prevention program was requested. The ICPM stated if she had been involved in the allegation process, the outcome would have looked a lot different. The ICPM stated she should have been included in the investigation process. The review of the facility’s P&P titled, “Infection Prevention Program Elements,” reviewed May 2023, was conducted. The P&P indicated, “ ...Policy: I. The hospital develops, implements and maintains an active, hospital wide program for the prevention, control and investigation of infections and communicable disease .... III The infection prevention program includes essential elements designed to identify and reduce risks of patients, staff, and visitors acquiring and/or transmitting infections. V. Elements on the infection prevention program include: A. A hospital wide active surveillance system that covers both hospital patients and staff working in the hospital which includes documentation of infection detection, data collection and analysis, monitoring, implementing evaluation of preventions and reporting findings/results ...””