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Based on staff interviews and review of administrative records, policies and procedures, and infection control and quality assurance documentation, the hospital's governing body failed to assume full responsibility for determining, implementing, and monitoring policies governing the facility's total operation.

The governing body failed to ensure that a comprehensive quality assurance program was in place (cross-refer A-0263); failed to ensure that surgical services were well organized and provided in accordance with acceptable standards (cross-refer A-0940); and failed to ensure that an effective infection control program was established and maintained (cross-refer A-0747).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality healthcare in a safe environment.

Based on interview and record review, the facility failed to ensure performance improvement activities included identifying opportunities for improvement and changes that will lead to improvement when actions were not initiated to mitigate risks and promote better outcomes after data collected in the neonatal intensive care unit (NICU, specialty care area for newborns who are seriously ill or born prematurely), and concerns identified in the surgical services department and gastroenterology (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) unit, including the use of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body), indicated potential infection control issues (A 0283).

The cumulative effect of these failures resulted in the facility's failure to identify areas of needed improvement in infection control and prevention practices which may have contributed to the development of Methicillin Resistant Staphylococcus Infection (MRSA, infection with staphylococcus aureus bacteria which does not respond to some antibiotics) in the NICU, and increased the risk of spreading infections to the patients receiving care in the facility. These failures had the potential to result in cross-contamination (spread of infection to other patients), other outbreaks, and prolonged hospitalization and possible death of the patients.

Based on interview and record review, the facility failed to ensure performance improvement activities included identifying opportunities for improvement and changes that will lead to improvement when actions were not initiated to mitigate risks and promote better outcomes after data collected in the neonatal intensive care unit (NICU, specialty care area for newborns who are seriously ill or born prematurely), and concerns identified in the surgical services department and gastroenterology (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) unit, including the use of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body), indicated potential infection control issues.

This failure had the potential for increased risk of avoidable disease transmission for patients in the facility.

Findings:

1. Review of a facility memo sent from Hospital Administration to Department Managers, dated December 4, 2023, at 8:05 p.m., indicated, "...Important Policy Update: MRSA Patient Isolation and Testing Procedures...after thorough research and deliberation with our physician and nursing leaders, Infection Prevention and Control, and other community hospitals, [Name of Facility] will no longer place Methicillin-resistant Staphylococcus aureus (MRSA, a type of bacteria not easily treated due to its resistance to many antibiotics) colonized patients in Contact Isolation effective December 4, 2023...With this policy change, only patients with active MRSA infections will be placed in Contact Precautions...In lieu of Contact Isolation, it is crucial to focus on strict adherence to decolonization practices. Every adult patient must receive a daily: 1) Chlorhexidine gluconate (CHG, a cleaning product which kills germs) bath; and (2) nasal decolonization with [Name of medication] twice a day..."

The document did not indicate additional precautions to be taken for non-adult patients hospitalized at the facility (e.g. NICU patients) in lieu of contact isolation.

Review of the facility document titled, "Medical Executive Committee (MEC) Meeting Minutes," dated December 14, 2023, indicated, "...MRSA Colonization Contact Isolation process has changed...Infection Control observed increase in MRSA colonization with our change in PCR testing...Recommendation to discontinue contact isolation for MRSA colonization were discussed...the committee determined agreed with [sic] discontinuing contact isolation practices for patients with MRSA colonization..."

Review of an untitled facility document indicating patients in the NICU who tested positive for MRSA, from June 2023, through December 2023, was conducted. The document indicated there were 17 patients (Patients 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18) who acquired MRSA while hospitalized at the facility from June 8, 2023, to December 4, 2023. The document also indicated the following:

- In June 2023, two patients (Patient 2 and 18) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility;

- In July 2023, two patients (Patient 3 and 4) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility;

- In August 2023, two patients (Patient 5 and 6) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility;

- In September 2023, one patient (Patient 7) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility;

- In October 2023, three patients (Patient 8, 9, and 10) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility;

- In November 2023, five patients (Patient 11, 12, 13, 14, and 15) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility; and

- In December 2023, preliminary monthly data indicated two patients (Patients 16 and 17) who tested negative for MRSA on admission had tested positive for MRSA on discharge from the facility.

An observation on December 20, 2023, at 9:24 a.m., was conducted with the NICU Assistant Director (AD-1) and the Infection Control Manager (ICM) in the NICU. There were two isolation rooms. One isolation room was observed as designed for a single patient occupancy, and the other isolation room was observed as designed for a double patient occupancy.

During an interview on December 20, 2023, at 10:15 a.m., conducted with the AD-1 in the NICU, AD-1 stated starting on December 4, 2023, they stopped placing NICU patients who were colonized (person carries the organism [MRSA] in the nose or on the skin but are not sick with an infection) with MRSA in isolation. When asked what guidelines were used to make the determination to not isolate NICU patients colonized with MRSA, AD-1 and the ICM did not give a specific answer. AD-1 stated the last baby who tested positive for MRSA was admitted to the NICU on December 11, 2023, and was not placed in isolation. AD-1 further stated NICU patients colonized with MRSA can be placed with other patients, and no additional infection control and prevention precautions were necessary.

During an interview on December 20, 2023, at 1:31 p.m., conducted with the ICM, in the conference room, the ICM stated the facility made changes to the isolation policy for MRSA. The ICM stated the facility made the decision to no longer isolate patients colonized with MRSA. The ICM stated the facility stopped isolating patients colonized with MRSA on December 4, 2023. The ICM stated with the change in the type of testing used for MRSA, the facility anticipated an increase in patients testing positive for MRSA. The ICM further stated the increased MRSA cases in the NICU was not reported to the local public health department and the California Department of Public Health (CDPH) since it was an anticipated increase. Therefore, with the anticipated increase in positive MRSA cases, the ICM stated no additional precautions were taken nor changes were made to the facility's infection control practices.

2. During an observation of the scope's storage clean room with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:34 a.m., Scope Cabinet 1's was observed with its door missing. Seven scopes were observed hanging freely in the cabinet and were labeled "Clean." Thick grey fuzzy matter, black particles, and debris was observed scattered throughout the scope storage room's floor, along the baseboards, and around the edges of the cabinet where the scopes were stored.

During an interview conducted with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:34 a.m., NC 1 stated "I knew you would ask about the missing scope door. I was hoping that you did not see the scopes." NC 1 stated Scope Cabinet 1's door was removed May 2023 (seven months prior) and the GI department did not stop using Scope Cabinet 1 for scope storage after the door had been removed. NC 1 stated the hospital's IPCP (Infection Prevention and Control Program) was aware of the missing door and approved Scope Cabinet 1 without a door for storing scopes for patient use. NC 1 stated Infection Preventionist 1 instructed the GI department to keep the scope storage room's door closed as much as possible until the scope cabinet was repaired or replaced. NC 1 stated the thick grey fuzzy matter was dust and she could not identify the black particles. NC 1 stated she did not know if the scope storage room or the scope sterile processing room were terminally cleaned. NC 1 stated the scope sterile processing room should have been terminally cleaned because the room was used to clean and decontaminate (High Level Disinfect) re-usable patient scopes. NC 1 stated she was aware that contaminated scopes could adversely affect the health and safety of the patients being cared for in the GI department.

An interview was conducted with the Chief Integration Officer (CCIO) on December 21, 2023, at 2:45 p.m., in the conference room. The CCIO was made aware of the findings in the scope's storage room and the scope's sterile processing room. The CCIO did not provide an explanation as to why Scope Cabinet 1's door had been missing and the hospital continued to use Scope Cabinet 1 without a door for storing scopes for patient use for seven months (May 2023).

A concurrent record review and interview was conducted with the Infection Control Manager (ICM), on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. The IPCP minutes did not mention Scope Cabinet 1. The ICM stated the IPCP had identified that the removal of the scope cabinet's door increased the risk for cross-contamination (the physical movement or transfer of harmful bacteria from one person, object or place to another) and could pose a risk of disease transmission (harmful germs move from a source to a susceptible person) to patients receiving care in the GI department. The ICM confirmed the IPCP did not ensure the affected scope cabinet was taken out of service or ensured other methods were implemented to prevent the risk of cross-contamination. The ICM did not explain why the IPCP had approved Scope Cabinet 1 (without a door) for storing endoscopes for patient use. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the quality assessment and performance improvement (QAPI) program related to clean endoscopes exposed to environmental contaminates and/or accidental contact and were being used for GI procedures.

3. A tour of the Labor and Delivery Unit was conducted on December 22, 2023, at 11:36 a.m., with Charge Nurse (CN) 3 and Executive Director of Maternal Child Health (EXD) 1. The following were observed:

-For Operating Room (OR) B, the double doors were observed broken and did not close completely; and

-For OR A, a surgical procedure was observed being performed on Patient 33 and the double doors were were observed to be not completely closed.

An interview was conducted with CN 3 and EXD 2 on December 22, 2023, at 11:40 a.m., in OR B. CN 3 stated the double doors of OR A and OR B had been broken for a while and she could not recall how long the doors had been broken. CN 3 stated the hospital continued to perform surgical procedures in OR A and OR B while waiting for the OR doors to be repaired. CN 3 stated she did not know if the hospital implemented an infection prevention plan to minimized air turbulence (chaotic changes in pressure and air flow) and cross-contamination of the surgical sterile field while waiting on the OR doors to be repaired or replaced. CN 3 or EXD 2 did not explain why the OR doors should be kept closed during Patient 33's surgical procedure.

A concurrent observation and interview was conducted with Plant Operations (PO) Supervisor 2, on December 22, 2023, at 12:01 p.m., in the corridor, outside of OR A and OR B. PO Supervisor 2 was observed measuring the openings between the double doors and the door's frame of OR B. PO Supervisor stated OR B's measurements were about two inches wide and one inch long. PO Supervisor 2 proceded to OR A and was observed measuring the opening between the double doors and the door's frame of OR A. PO Supervisor 2 stated OR A's measurements were three inches wide and three inches long. PO Supervisor 2 stated the OR doors should be closed completely to prevent cross-contamination.

A concurrent record review and interview was conducted with the ICM, on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. There was no mention of OR A nor OR B's broken doors related to infection prevention practices. The ICM confirmed the IPCP was aware that OR A and OR B's double doors were broken and did not close completely. The ICM stated the IPCP did not perform an infection control risk assessment nor did the IPCP implement an infection control plan to minimized cross-contamination while waiting on the OR doors to be replaced. The ICM stated the doors were ordered for the ORs. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the QAPI program on surgical procedures being performed in ORs when the doors did not close completely.

During an interview on December 27, 2023, at 2:42 p.m., conducted with the QAPI committee members, the facility's current QAPI projects were discussed. In regard to QAPI activities related to infection control and prevention, the ICM stated they were tracking and conducting root cause analysis for MRSA bloodstream infections. The ICM stated they were following guidelines/evidence for MRSA infections from the Centers for Disease Control and Prevention (CDC, the national public health agency of the United States) and the American Society of Microbiology (a professional organization for scientists). The ICM stated they currently had no baseline for establishing what constitutes an outbreak and planned to gather data with the new testing for MRSA for about three months. The ICM further stated they had not conducted any formal root cause analyses for patients who tested positive for MRSA in the NICU since they anticipated the increase in cases. Per ICM, the facility started using the new PCR test (PCR, nasal swab test that provides rapid, direct detection of nasal colonization by MRSA) for MRSA in September, 2023.

A follow up interview on December 28, 2023, at 5:05 p.m., was conducted with the Chief Clinical Integration Officer (CCIO). The CCIO stated neither she nor the facility's Quality Department was made aware about the broken gastrointestinal (GI, pertaining to the digestive system) cabinet door for storage of endoscopes. The CCIO further stated this issue had not been brought up in QAPI or governing body meetings.

The CCIO also stated the broken doors for the two cesarean section (C-section, surgical delivery of a baby tough an incision in the abdomen) OR rooms were ordered as soon as they found out the doors were not closing properly. The CCIO stated she signed off on the purchase of the doors which did not need to go through the governing board, therefore the governing body was not made aware of the issue. The CCIO stated the C-section OR doors were not discussed in QAPI or governing body because it was not considered an issue since they had ordered the new doors and were monitoring the doors.

The facility did not have a system in place to mitigate risks of transmission of infection while waiting for the GI cabinet door and OR doors to be replaced.

There was no documented evidence the facility addressed these issues in the QAPI, Medical Executive Committee, and Board of Supervisors (BOS, governing body) meeting minutes, from July 2023, through December 2023.

Review of the facility document titled, "Performance Improvement and Patient Safety Plan," dated July 2023 to June 2024, indicated, "...[Name of Facility] is committed to fostering an environment that encourages performance assessment and improvement of patient care processes and outcomes...Provides high quality clinical services and a safe environment by encouraging recognition and prompt reporting of risks to quality and safety so that actions can be initiated to mitigate risks and promote better outcomes...The goals of the plan include: Encourage leadership in prioritizing, planning, and providing strong direction for the implementation of performance improvement and patient safety standards...Integrate medical staff and all disciplines' involvement in performance improvement and patient safety activities...Identify and implement evidence-based best practice...Act as a central repository for quality information responsible for reporting data to appropriate committees, groups, and individuals...Identify high risk processes in order to focus action through, but not limited to, root cause analysis and failure mode and effects analysis...Performance Measurement and Monitoring...Performance measurement and monitoring is accomplished in a systematic approach. Data will be used to: Establish a performance baseline...Describe a process performance or ability...Describe the dimensions of performance relevant to the functions, processes and outcomes...Identify areas for more focused data collection to sustain improvement. At a minimum, but not limited to, the organization collects data to monitor its performance on measures as outlined by the Joint Commission Standards, CMS, state regulations and priorities identified by hospital leadership. Measured data is aggregated and referred to the responsible department for analysis and action planning. The analyzed data is reported to the PIPSC, and then reported to the Medical Executive Committee and the Governing Board..."

Based on observation, interview, and record review, the facililty failed to ensure an effective and active system-wide infection control program for the prevention, control, and investigation of infections and communicable diseases, including meeting the needs of all patients requiring gastroenterology services (the study, diagnosis, and treatment of disorders that deal with the digestive system) and the use of flexible endoscopes (a reusable instrument used to inspect and treat interior portions of the body) was implemented when,

1. For the GI (gastrointestinal, pertaining to the digestive system) unit, the IPCP failed to ensure the scope storage room's floor did not contain thick grey fuzzy matter, black particles, and debris scattered throughout the endoscope storage room's floor and the endoscopes were protected from environmental contaminants (Refer to A0951);

2. For the labor and delivery unit (a unit in the hospital where babies are delivered), the IPCP failed to implement an infection control plan to minimized cross-contamination while waiting on the operating room doors to be replaced (Refer to A0951);

3. For surgical services, the IPCP failed to ensure the bloodborne pathogen exposure control plan was implemented to ensure that biohazardous containers were closed in between cases (Refer to A0951);

4. For the GI unit, the IPCP failed to ensure the manufacturer's instruction for use (IFU) on the endoscope reprocessing steps were followed and there was no thick grey fuzzy matter, black particles, and debris, observed throughout the sterile processing room (the area in a hospital where cleaning and sterilization (process to make equipment germ free) of devices used in medical procedures takes place) (Refer to A0951);

5. For the medical surgical center (MSC), the IPCP failed to ensure the manufacturer's guidelines on the endoscope reprocessing steps were followed (Refer to A0951);

6. For the GI unit, the IPCP failed to ensure preventative maintenance was performed on scope storage cabinets and HEPA (a medical grade air filter) filters were changed in accordance with the manufacturer's IFU (Refer to A0951);

7. For the GI unit, the IPCP failed to ensure the manufacturer's IFU on scope storage was followed and staff did not access the scope cabinet without performing hand hygiene or putting on gloves (Refer to A0951);

8. For surgical services, the IPCP failed to ensure the policy and procedure on cleaning between surgical cases was implemented and there were no red stains on the surgical table's frame (Refer to A0951);

9. For the Neonatal Intensive Care Unit (NICU, unit for critically ill infants), the IPCP failed to ensure the facility reported an increase in cases of a multiple drug resistant organism (MDRO, bacteria that do not respond to three or more classes of antimicrobial drugs) methicillin resistant staphylococcus aureus (MRSA, germs that no longer responds to the medicine designed to kill them) in the NICU to the California Department of Public Health (CDPH) and the Local Health Officer (LHO), for 29 of 52 sampled patients (Patients 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28, 29, 30, and 32, (Refer to A0750);

10. For the NICU, the IPCP failed to ensure the facility had a system in place to minimize the spread of MRSA for one of 52 sampled patients (Patient 32) (Refer to A0750);

11. For the NICU, the IPCP failed to ensure visitors were compliant with hand hygiene in the (Refer to A0749);

12. For the NICU, the IPCP failed to ensure staff personal belongings were not placed in the patient care areas (Refer to A0749);

13. For the NICU, the IPCP failed to ensure the computer keyboard used in the patient care areas did not have dried residue stuck to the keyboard keys and fuzzy grayish white particles observed lodged between the keys of the computer keyboard which did not have a protective cover, and the posters on the NICU wall were cleaned in accordance with the facility's policies and procedures (Refer to A0749);

14. For the NICU, the IPCP failed to ensure the representatives of the patients who were admitted in the NICU and acquired MRSA were notified the patients acquired MRSA, for 15 patients of 52 sampled patients (Patients 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17) (Refer to A0749);

15. For Patient 34, who had an indwelling urinary catheter, the facility failed to ensure a dependent loop (formed by poorly positioned drainage tubing falling below the level of the collection device which may contribute to urinary tract infections) was not formed, and the IPCP failed to ensure the assessment for the daily indication for the indwelling urinary catheter was performed from December 19, 2023, through December 22, 2023 (Refer to A0749);

16. For Patient 51, the IPCP failed to ensure that the facility's 24-hour urine collection procedure was followed, when the 24-hour urine collection container was observed under Patient 51's bed instead of in the bathroom (Refer to A0749);

17. For Patients 35, 36, 37, 39, 40, 41, and 44, the IPCP failed to ensure the patients were provided a Chlorhexidine Gluconate (CHG, bathing product that kills germs and reduces the spread if infections in the facility) bath, in accordance with the facility's policy and procedure (P&P), for eight of 52 sampled patients (Refer to A0749);

18. For Patients 36, 41, 42, and 44, the IPCP failed to ensure patients were provided nasal decolonization (use antibacterial agent to eliminate MRSA), in accordance with the facility's P&P (Refer to A0749);

19. For Patients 36, 37, 42, and 43, the IPCP failed to ensure patients were provided indwelling urinary catheter care and assessment, in accordance with the facility's P&P (Refer to A0749); and

20. For the Infection Control Professional, the IPCP failed to ensure the Infection Control Manager (ICM) was qualified by education, training, experience or certification to identify, investigate, and control infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations (Refer to A0748).

The cumulative effects of these systemic problems resulted in the facility's inability to provide an effective hospital wide infection control program and to provide patient care in a safe and effective manner.

On December 20, 2023, at 5:06 p.m., the survey team identified significant concerns in the facility's NICU. Due to the seriousness of the situation, an immediate jeopardy (IJ, a situation with the potential to cause harm to the health and safety of the patients) was called in the presence of the hospital's Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Operating Officer (COO), Chief Medical Officer (CMO), Infection Control Manager (ICM), Chief Clinical Integration Officer (CCIO), Chief of Infectious Disease (CID), Medical Director Inpatient Services (MDIPS) and Medical Director of Quality (MDQ). The facility's Administrators were verbally notified regarding the concerns of the facility's failure to ensure an active system was in place to prevent the spread of infection and cross-contamination between patient to patient in the NICU and the failure to minimize the risk of cross-contamination between patients and staff, the contaminated environment, and patient equipment due to contact precautions not being implemented. These failures had the potential to result in poor health outcomes thereby increasing the risk of death for patients receiving NICU services in the facility.

On Dec 22, 2023, at 7:31 p.m., the facility provided a Corrective Action Plan (CAP).

On December 26, 2023, at 11:02 a.m., the CAP was reviewed and accepted.

On December 27, 2023, at 1:45 p.m., the immediate jeopardy was removed in the presence of the CCIO, ICM, and CEO, after the CAP implementation was verified through observation, interviews, and record reviews. The CAP included the following components:

1. On December 20, 2023, the leadership team met to conduct a review of current isolation practices. The practice of conducting a MRSA PCR (Polymerase Chain Reaction, laboratory test) screen for every infant admitted to the NICU will continue as mandated by Senate Bill 1058 (a legislation requiring hospitals to implement certain procedures for the screening, prevention, and reporting of specified health-care-associated infections). If the screen result is positive, the patient will be placed in contact isolation. The facility policies IC-4-7 Contact Precautions and IC-2-9 Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA) were reviewed;

2. On December 20, 2023, the Executive Director of Women's Services and the Assistant Director of the NICU immediately began education with all NICU registered nurses, nurse practitioners, and physician staff to place NICU infants with a positive PCR screening for MRSA in contact isolation;

3. On December 21, 2023, the facility leadership and the Infection Control Department met to conduct an additional review of the facility policy IC-2-9 Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA) to ensure NICU adherence to current recommendations and nationally recognized infection prevention and control guidelines as referenced by the Centers for Disease Control and Prevention (CDC, the national public health agency of the United States). As a result of this review, a revision was made to implement contact isolation for all infants admitted to the NICU with a positive MRSA screening result; and

4. A tip sheet was developed which will be used during shift huddles and the department meeting until all staff have received the training. It will also be posted on huddle boards and will be accessible to nursing staff on the facility intranet.

Based on observation, interview, and record review, the hospital failed to ensure the Infection Control Manager (ICM) was qualified by education, training, experience or certification to identify, investigate, and control infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations when:

1. The ICM did not ensure that appropriate control measures for a multiple drug resistant organism (MDRO) methicillin resistant staphylococcus aureus (MRSA, germs that no longer responds to the medicine designed to kill them) outbreak in the neonatal intensive care unit (NICU, a unit for critically ill newborn patients) were implemented for 29 of 52 sampled Patients (Patients 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28, 29, 30, and 32);

2. The ICM did not ensure NICU families were notified about the need to be evaluated for the hospital acquired MRSA for 15 of 52 sampled patients (Patients 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17);

3. The ICM did not ensure a system was in place for preventing the spread of MRSA in the NICU after the facility changed the policy and no longer placed MRSA colonized patients into contact precautions for one of 52 sampled patients (Patient 32);

4. The ICM did not ensure endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were protected from environmental contaminants in accordance with nationally recognized infection control practice recommendations and the manufacturer's IFU;

5. The ICM did not ensure an infection control plan was implemented in the labor and delivery unit to minimized cross-contamination (the transfer of harmful germs from one person, object, or place to another) while waiting on the operating room doors to be replaced;

6. The ICM did not ensure the manufacturer's instruction for use (IFU) on the endoscope reprocessing were implemented in the medical surgical center;

7. The ICM did not ensure Infection Control Preventionist (ICP) 1 provided education on sterile water for irrigation in accordance with the manufacturer's IFU for the sterile processing department; and

8. The ICM did not ensure that bleach germicidal wipes were used on food contact surfaces in accordance with the manufacturer's IFU.

These failures increased the risk for the spread of communicable diseases and cross-contamination thereby adversely affecting the health and safety of patients being cared for in the hospital.

Findings:

An interview was conducted with the Infection Control Manager (ICM), on December 20, 2023, at 9:15 a.m., in the conference room, the ICM stated the hospital followed the following nationally recognized guidelines for disease outbreaks:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. The Society for Healthcare Epidemiology of America (SHEA, a professional society that improves public health by establishing infection-prevention measures and supporting antibiotic stewardship among healthcare providers);

C. Association for Professionals in Infection Control and Epidemiology (APIC, professional association for infection prevention);

D. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

E. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); and

F. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.

1. A concurrent interview and record review was conducted with the ICM, on December 20, 2023, at 11:30 a.m., in the conference room. The undated facility document titled "[Name of the Facility] NICU Summary," indicated 31 NICU patients were diagnosed with MRSA colonization. The ICM confirmed there were no identified MRSA cases in the NICU from March 2023 to May 2023. The ICM stated on June 8, 2023, to December 4, 2023, there were 31 NICU patients diagnosed with MRSA.

An interview was conducted with the ICM, on December 20, 2023, at 1:30 p.m., in the conference room. The ICM stated the infection prevention and control program (IPCP) defined a disease outbreak or an unusual occurrence of two or more cases of a disease not usually common to a unit. The ICM stated she did not think the infection control department needed to:

-Conduct a root cause analysis and/or investigation;

-Ensure NICU staff adherence to the IPCP's transmission-based precautions;

-Implement environmental cleaning and disinfection; and/or

-Report the increase in MRSA cases to the California Department of Public Health and the Local Health Officer.

The ICM stated the facility had implemented a more sensitive testing method and the increase in hospital acquired MRSA cases were expected.

A concurrent interview and record review was conducted with the Clinical Laboratory Director (DOL) and the Laboratory Analysis (PHD), on December 21, 2023, at 1:10 p.m., in the conference room. The DOL stated the MRSA testing methods were changed in the hospital's clinical laboratory on September 26, 2023. The DOL stated after September 26, 2023, patients in the NICU were tested under the new testing method on admission to the NICU and upon discharge from the NICU. The following clinical laboratory reports titled, "MRSA PCR," dated September 30, 2023, to December 11, 2023, for NICU patients were reviewed with the DOL. The DOL confirmed the tests were conducted under the new testing method on admission and upon discharge for the following patients, Patients 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 25, 26, 28, 29, 30, and 32. The PHD stated she was not aware that patients were admitted to the NICU and tested negative for MRSA and tested again upon discharge and were positive for MRSA. The PHD stated there should have been some type of follow-up or investigation because the test results should not have been negative on admission and positive upon discharge unless the patients had encountered MRSA in the NICU. The PHD stated, if the patient tested negative for MRSA on admission to the NICU, the increase in positive MRSA cases upon discharge was not related to the new testing method. The PHD stated the increase in the hospital acquired MRSA cases should not have been expected or anticipated.

The hospital policy and procedure (P&P) titled, "Outbreak Investigation," dated July 21, 2023, indicated, "...Policy...The policy of [Name of Facility] is to control and prevent the further spread of infection/disease, characterized the cases that contributed to a cluster or outbreak, and to identify factors that may have contributed to a cluster or outbreak in order to develop and implement measure to prevent similar clusters and outbreaks from occurring in the future...

Definitions: 2.1 Cluster is defined: a. an unexpected or an unusual increase in the number of cases of given organism on a given unit or households...

Outbreak is defined as: a. An excess level of endemic disease or statically significant disease or clinical symptom. C. Two or more cases of certain disease within a specified time period...

...Procedure...The infection Prevention and Control Department shall have responsibility for investigating epidemics, aka cluster and outbreaks...and developing policies aimed at prevention and control of healthcare associated infections..." (cross-ref A-0750).

2. A concurrent interview and record review was conducted with the ICM on September 26, 2023, at 2:55 p.m., in the conference room. The ICM stated NICU patients that were colonized with MRSA could potentially spread MRSA to their family members. The ICM stated the IPCP had implemented a system to notify patients who tests positive for MRSA and have been discharged prior to the results being available. The hospital document titled, "Infection Prevention and Control: Methicillin-Resistant Staphylococcus Aureus (MRSA)," was reviewed. The document indicated, " ...Having MRSA in the nose does not indicate an infection nor does it usually require treatment, but each patient needs to be evaluated individually in order to determine if treatment is necessary ...Please call your primary care provider to discuss these results..." The ICM confirmed the document advised patients to be evaluated in order to determine if medical treatment was necessary. The ICM stated the facility notified NICU families via the United States postal service. The notification system was reviewed with the ICM and there was no documented evidence that showed the hospital's physician had advised medical evaluations for Patients 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17. The ICM stated the hospital had not notified patients of their positive MRSA results which were not completed prior to discharge since June 2023. The ICM stated she could not explain why the documents were not mailed to the affected families.

The review of the facility P&P titled, "Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA)," effective date December 2, 2020, indicated, "...The policy of [Name of the Facility] is...To identify patients in designated high-risk groups who may be colonized with Methicillin Resistant Staphylococcus Aureus (MRSA)...To prevent transmission of MRSA in the community...A patient colonized with MRSA may spread this organism...Patient Notification...Patients who have been discharged prior to results being available will be notified via U.S. mail by an attending physician..."

3. An interview was conducted with the ICM on December 20, 2023, at 1:30 p.m., in the conference room. The ICM confirmed that she was aware Patient 32 was diagnosed with MRSA and Patient 32 was not placed into contact precautions. The ICM stated the IPCP did not implement a system or implement additional preventative measures to prevent the spread of MRSA cases in the NICU after the hospital implemented the policy change and no longer placed MRSA colonized patients into contact precautions. The ICM stated an infection control risk assessment was not performed for the NICU before or after the hospital no longer required patients with MRSA colonization to be placed into contact precautions. The ICM stated she did not think additional infection control measures were necessary because the increase in NICU MRSA cases were anticipated due to the new MRSA testing method. The ICM repeatedly stated that the policy change was based on evidence-based practice. A request was made for the following documents:

- A copy of the evidenced-based practice guidelines;

- A copy of the hospital's nationally recognized infection prevention and control guidelines that were implemented with the policy change; and

- A copy of the revised policy.

The ICM did not provide a copy of the hospital's nationally recognized infection prevention and control guidelines that were implemented with the policy change and could not demonstrate that a system was in place to prevent the spread of MRSA.

The review of the acility P&P titled, "Isolation Precautions Defined," effective date December 10, 2020, indicated, "...Policy...preventing the transmission of infectious agents [Name of Facility] are designed to meet the following objectives...Provide infection prevention and control recommendations for all components of the healthcare delivery system...Provide epidemiologically sound, and whenever possible, evidenced-based infection control standards of care...Provide a unified infection prevention and control approach to multi-drug resistant organisms (MDROs)...How microorganisms are spread...Contact Transmission...indirect-contact transmission:...involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, such as unwashed hands, a contaminated surface, or patient care devices. Note this is the most frequent mode of transmission..." (cross-ref A-0750).

4. During an observation of the scope's storage clean room with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:34 a.m., Scope Cabinet 1's was observed with its door missing. Seven scopes were observed hanging freely in the cabinet and were labeled "Clean." Thick grey fuzzy matter, black particles, and debris was observed scattered throughout the scope storage room's floor, along the baseboards, and around the edges of the cabinet where the scopes were stored.

A concurrent record review and interview was conducted with the Infection Control Manager (ICM), on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. The Infection Prevention and Control Program (IPCP) minutes did not mention Scope Cabinet 1. The ICM stated the IPCP had identified that the removal of the scope cabinet's door increased the risk for cross-contamination and could pose a risk of disease transmission (harmful germs move from a source to a susceptible person) to patients receiving care in the GI department. The ICM confirmed the IPCP did not ensure the affected scope cabinet was taken out of service or ensured other methods were implemented to prevent the risk of cross-contamination. The ICM did not explain why the IPCP had approved Scope Cabinet 1 (without a door) for storing endoscopes for patient use. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the quality assessment and performance improvement (QAPI) program related to clean endoscopes exposed to environmental contaminants and/or accidental contact and were being used for GI procedures.

The review of the facility P&P titled, "Cleaning and Processing of Flexible Endoscopes and Endoscope Accessories," dated March 19, 2021, indicated the following: "...2.9 Storing...b. Store clean flexible endoscopes in a closed cabinet..."

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2018, indicated the following instructions for use, "...8.2 Storing the disinfected 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...Keep the cabinet doors closed to protect the equipment from environmental contaminates and accidental contact..."

The review of the AORN's Guidelines for Perioperative Practice: "Guidelines for Flexible Endoscopes," dated September 15, 2022, the AORN guidelines indicated the following, "...13. Storage...13.2. Flexible endoscopes and accessories should be stored in a manner that minimizes contamination and protects the device or item from damage in accordance with the manufacturer's IFU...13.4.1. Storage cabinets should have doors that are kept closed..." (cross-ref A-0951).

5. A tour of the Labor and Delivery Unit was conducted on December 22, 2023, at 11:36 a.m., with Charge Nurse (CN) 3 and Executive Director of Maternal Child Health (EXD) 1. The following were observed:

- For OR B, the double doors were observed broken and did not close completely; and

- For OR A, a surgical procedure was observed being performed on Patient 33 and the double doors were not completely closed.

A concurrent record review and interview was conducted with the ICM, on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. There was no mention of OR A nor OR B's broken doors related to infection prevention practices. The ICM confirmed the IPCP was aware that OR A and OR B's double doors were broken and did not close completely. The ICM stated the IPCP did not perform an infection control risk assessment nor did the IPCP implement an infection control plan to minimized cross-contamination while waiting on the OR doors to be replaced. The ICM stated the doors were ordered for the ORs. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the QAPI program on surgical procedures being performed in ORs when the doors did not close completely.

The review of the facility P&P titled, "Surgical Services/Procedures Areas," effective date March 15, 2021, indicated the following "...4. Personal Traffic...4.3 During a surgical procedure, traffic should be controlled in and out of the room to minimize air turbulence. The door should be kept closed except for passage of personnel, equipment, etc..."

The review of the AORN's Guidelines for Perioperative Practice: "Sterile Technique," dated November 1, 2018, the AORN guideline indicated the following, "...7. Moving Around a Sterile Field...7.5. Keep doors to the operative or invasive procedure room closed as much as possible except during the entry and exit of patients, required personnel, and necessary equipment..." (cross-ref A-0951).

6. A tour was conducted of the MSC, with the Director of Operations (DOMSC) and Nurse Coordinator (NC) 2, on December 26, 2023, at 11:15 a.m., in the MSC's endoscope sterile processing room. Gastroenterology (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) Technician (GI Tech) 2 was observed removing the endoscope from a disposal transport box and placing the endoscope into the endoscope's sterilizer (a machine used to kill germs on a specific surface or object).

GI Tech 1 stated the Infection Control Manager (ICM) and Infection Preventionist (ICP) 1 made changes to the process for cleaning endoscopes and instructed the GI department staff to skip Step 1 to Step 5 if the endoscope had not encountered a patient's skin or mucous membranes. GI Tech 1 confirmed she followed the new endoscope process and skipped Step 1 to Step 5 for endoscopes that were either expired or had been potentially cross-contaminated (the transfer of harmful bacteria from one person, object, or place to another). GI Tech 1 stated the ICM did not provide the department with written instructions, competencies (measurable or observable knowledge and skills), or a revised P&P on the new scope process. GI Tech 1 stated she could not recall the date that the ICM changed the endoscope cleaning process.

During an interview with the ICM, on December 27, 2023, at 11:50 a.m., in the conference room, the ICM stated she did not realize that staff were skipping Step 1 to Step 5. The ICM stated, "It was a misunderstanding." The ICM stated staff must perform all endoscope processing steps in accordance with the manufacturer's IFU.

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2018, indicated the following instructions for use, "...1.2 Importance of Cleaning, Disinfection, and Sterilization: The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals for all ancillary equipment, and have a thorough understanding of the following items: Instruction manuals for the endoscope, accessories, and all the other reprocessing equipment..."

The review of the facility's P&P titled, "Cleaning and Processing of Flexible Endoscopes and Endoscope Accessories," dated March 19, 2021, indicated, "...2. Procedures: 2.1 The manufacturer's written instructions for flexible endoscopes and all accessories will be followed regarding: a. Cleaning process..." (cross-ref A-0951).

7. A tour was conducted with the Sterile Processing Department (an area in the hospital used to clean, disinfect, sterilize, store, and maintain the reusable and surgical medical instruments) Manager (SPDM), and the Executive Director of Perioperative Services on December 21, 2023, at 10:30 a.m., in the SPD 's clean work area. A plastic pour bottle of sterile water for irrigation was stored on the counter. The bottle had been opened and the label indicated the container had been opened on December 12, 2023.

A concurrent observation and interview was conducted with the SPDM, on December 21, 2023, at 10:41 a.m., in the SPD's clean work area. The SPDM stated the sterile water was used for flushing small surgical instruments. The SPDM stated she did not know the time that the bottle was opened, and the bottle should have been labeled to indicate the time that the bottle had been opened. SPDM was observed reading the manufacturer's IFU on the sterile water pour bottle's label and stated the IFU did not indicate the sterile water was for single use. The SPDM stated Infection Preventionist (ICP) 1 had provided education to the staff and ICP 1 stated after the pour bottle had been opened, the pour bottle of sterile water was good for 24 hours. The SPDM stated the bottle must be dated to indicate when the pour bottle of sterile water would expire.

An interview was conducted with the ICM and ICP 1 on December 21, 2023, at 12:30 p.m., in the conference room. ICP 1 stated upon hire to the hospital, the hospital staff were using the sterile water for multiple activities. ICP 1 stated, "I held them to their standard by ensuring the bottle was dated and discarded after 24 hours." ICP 1 stated she did not know the sterile water was for single use until this survey. ICP 1 stated she had received multiple calls from staff, and she telephoned the manufacturer, and the manufacturer stated the pour bottle of sterile water is for single use. The ICM stated she was responsible for the competency-based training and education of hospital personnel on the practical applications of infection prevention and control guidelines, policies, and procedures.

A request was made for the manufacturer's IFU for Sterile Water for Irrigation, USP.

The review of the manufacturer's IFU titled, "Sterile Water for Irrigation, USP," dated 2018, indicated "...The contents of the opened bottle container should be used immediately to minimize potential for bacterial growth and pyrogen formation, and the unused contents of opened containers must be discarded, since Sterile Water for Irrigation, USP does not contain an antimicrobial agent. Sterile Water for Irrigation, USP is for single use only..."

8. During an observation conducted with ICM and the Assistant Director of the NICU (AD-1), on December 20, 2023, at 9:40 a.m., in the formula preparation room, Charge Nurse (CN) 2 was observed to don (put-on) the personal protective equipment (PPEs, specialized clothing or equipment, worn by an employee for protection against infectious materials) and wipe the food counter's surface with a bleach germicidal wipe. CN 2 allowed the counter to remain wet for one minute and proceeded to place a blue pad over the treated food contact surface.

During an interview conducted with CN 2, AD-1, and the ICM, on December 20, 2023, at 9:53 a.m., in the formula preparation room, CN 2 confirmed she did not rinse the counter with potable water prior to preparing the formula. CN 2 was observed reading the manufacturer's IFU on the bleach germicidal wipes container's label and stated the IFU indicated a potable rinse is required for food contact surfaces. CN 2 and AD-1 stated they were not aware the food contact surface should be rinsed prior to preparing the formula. CN 2 stated the food contact surface should be disinfected with the bleach germicidal wipes and rinsed with potable water before preparing the formula. The ICM stated, "But CN 2 added the pad, shouldn't that count?" AD-1 stated the food contact surface should have been rinsed before adding the pad. CN 2 stated she did not follow the manufacturer's direction for sanitizing and disinfecting the counter.

The review of the manufacturer's IFU titled, "Bleach Germicidal Wipes," undated, indicated, "... a potable rinse is required for food contact surfaces..."

Based on observation, interview, and record review, the facility failed to ensure the facility's infection control program was maintained or methods to prevent the transmission of infections were implemented within the facility when:

1. Staff did not ensure visitors were compliant with hand hygiene in the neonatal intensive care unit (NICU, specialty care area for criticall ill newborns), in accordance with the visitor handwashing procedure at the NICU;

2. Staff personal belongings were observed in the patient care area in the NICU;

3. Dried white residue was observed stuck to the keyboard keys of the computer used in a patient care area and fuzzy grayish white particles were observed lodged between the keys of the computer keyboard which did not have a protective cover, and the posters on the NICU wall were not cleaned in accordance with the facility's policies and procedures (P&P);

4. The representatives of the patients who were admitted in the NICU and acquired methicillin-resistant staphylococcus aureus (MRSA, a type of bacteria not easily treated due to its resistance to many antibiotics) were not notified the patients acquired MRSA, for 15 patients of 52 sampled patients (Patients 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17);

5. A dependent loop (formed by poorly positioned drainage tubing falling below the level of the collection device which may contribute to urinary tract infections) was observed on Patient 34, who had an indwelling urinary catheter and there was no documented evidence the assessments for the daily indication for the indwelling urinary catheter from December 19,2023, through December 22,2023, were performed;

6. The facility's 24-hour urine collection procedure was not followed, for one of 52 sampled patients (Patient 51), when the 24-hour urine collection container was observed under Patient 51's bed instead of the bathroom;

7. Patients were not provided a Chlorhexidine Gluconate (CHG, bathing product that kills germs and reduces the spread if infections in hospitals) bath, in accordance with the facility's P&P, for eight of 52 sampled patients (Patient 35, 36, 37, 39, 40, 41, 42, and 44);

8. Patients were not provided a nasal decolonization (use antibacterial agent to remove MRSA), in accordance with the facility's P&P, for four of 52 sampled patients (Patient 36, 41, 42, and 44);

9. Patients were not provided indwelling urinary catheter care and assessment, in accordance with the facility's P&P, for four of 52 sampled patients (Patients 36, 37, 42, and 43 ).

These failures had the potential to result in the transmission and spread of pathogens (bacteria, virus, or other microorganism) which could cause disease/s to the patients receiving care in the facility.

Findings:

1. A concurrent observation and interview on December 20, 2023, at 9:30 a.m., was conducted with the NICU Assistant Director (AD-1) in the NICU. A visitor was observed entering the visitor handwashing station. There was no NICU staff observed present. The AD-1 stated the normal process is for staff to observe and ensure visitors perform hand hygiene before entering the patient care area. The AD-1 stated staff did not verify the visitor performed hand hygiene through observation because there was not enough staff.

During an interview on December 20, 2023, at 10 a.m., conducted with Patient 54's visitor in the NICU patient care area, Patient 54's visitor stated staff do not observe her washing her hands when she comes to visit.

During an interview on December 20, 2023, at 10:10 a.m., conducted with Patient 53's visitor in the NICU patient care area, Patient 53's visitor stated staff do not watch while she washes her hands when visiting.

During a follow up interview on December 28, 2023, at 10:32 a.m., conducted with AD-1 in the conference room, AD-1 stated when a visitor calls in for a visit, staff should verify the visitor's arm band and observe the visitor performing hand washing for three minutes.

A review of the facility policy and procedure (P&P) titled, "Hand and Nail Hygiene," dated April 1, 2021, was conducted. The P&P indicated, "...BACKGROUND...Hand hygiene is one of the most important measures for prevention of health-care-associated infections...PROCEDURE...Handwashing/ hand antisepsis shall be performed using warm water and agency approved liquid soap...Neonatal Intensive Care Unit (NICU) requires 3 (three)-minute scrub...Before and after entering a patient care area that involves touching anything within a patient's immediate environment..."

A review of the facility P&P titled, "Visitation," dated March 1, 2023, was conducted. The P&P indicated, "...PURPOSE...To promote family centered care while maintaining a safe environment that promotes privacy, recovery and maternal infant bonding...GUIDELINE...All Perinatal Areas...All visitors are asked to wash their hands before handling the newborn infant..."

2. A concurrent observation and interview on December 20, 2023, at 11 a.m., was conducted with AD-1 in the NICU patient care area. A sweater was observed at the bottom of a computer workstation on wheels (WOW, mobile computer used for charting patient records) cart located next to a patient. A backpack with black-brown stains was also observed hanging on the back of the computer workstation chair which was also in close proximity to the patient. The AD-1 stated the sweater belonged to a respiratory therapist (RT) working on the unit and the backpack should have been placed in a locker.

An interview on December 20, 2023, at 11:16 a.m., was conducted with the Respiratory Care Practitioner Supervisor (RCPS) in the NICU. The RCPS stated there are lockers for RTs to store their personal belongings and the RT should have placed the backpack and personal belongings in the locker.

On December 21, 2023, at 4:51 p.m., the Chief Clinical Integration Officer (CCIO) stated the facility did not have a policy for staff personal belongings in the patient care area.

A review of the facility P&P titled, "Isolation Precautions Defined," dated December 10, 2020, was conducted. The P&P indicated, "...Policy...Preventing the transmission of infectious agents at [Name of Facility]...Microorganisms are transmitted in healthcare facilities by five main routes: contact, droplet, airborne, common vehicle and vector borne...Indirect-contact transmission involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, such as unwashed hands, a contaminated surface, or patient care devices...How Transmission Is Prevented...Standard Precautions...A transmission-based approach that is to be used in the provision of all patient care and are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in the healthcare environment..."

3a. A concurrent observation and interview on December 20, 2023, at 9:41 a.m., was conducted with AD-1 and Registered Nurse (RN) 1 in the NICU. On close inspection of the computer keyboard, there was dried, white residue stuck to the keys, fuzzy grayish white particles were observed lodged between the keys of the computer keyboard, and the keyboard did not have a protective cover. RN 1 stated she wipes down the computer keyboard using the bleach wipes.

During a follow up interview on December 28, 2023, at 10:32 a.m., conducted with AD-1 in the conference room, AD-1 stated the process for cleaning the computer and keyboard was using bleach wipes to wipe the surfaces of the screen, keyboard, and mouse. AD-1 stated staff were not routinely cleaning between the keyboard keys.

A review of the facility P&P titled, "Cleaning and Disinfection Patient Care Equipment," dated December 28, 2020, was conducted. The P&P indicated, "...Policy...to establish guidelines for the cleaning and disinfection of shared equipment...Cleaning is the removal of organic and inorganic material from objects and surfaces...Thorough cleaning is necessary before disinfection and sterilization because organic and inorganic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes...Disinfection is a process that reduces the number of microorganisms...on inanimate objects. This is done most often by use of a hospital approved detergent/disinfectant or chemical sterilant...Soiled environmental surfaces can be a source of contamination to hands or other objects which may have contact with the patient. Use a hospital-approved detergent-disinfectant regularly to clean and disinfect surfaces...High-touch surfaces and equipment in patient rooms in acute and critical care areas are cleaned at regular intervals, at least daily...Computers, Computer Peripherals and Workstations on Wheels (WOWs): Every computer user is responsible for ensuring the computers and their peripheral equipment are kept clean...Clean keyboard cover and the mouse of multi-user computer workstations daily, when visibly soiled or if contaminated with blood, using a hospital-approved detergent/disinfectant...Wipe the keyboard cover and mouse with germicidal wipes. Use moistened cotton-tipped applicators to clean the keyboard cover creases if necessary...WOWs...Clean surfaces of WOW carts daily with a hospital approved detergent/disinfectant..."

3b. A concurrent observation and interview on December 20, 2023, at 9:45 a.m., was conducted with the AD-1, Infection Control Manager (ICM), and Environmental Services (EVS) Housekeeper (EVSH-1, housekeeping staff assigned to the NICU) in the NICU. A wall near the patient care area was observed to have several postings (workplace information on paper) with some in plastic inserts and a large posterboard (paper or cardboard material) without a plastic cover. When asked if the walls were routinely cleaned, the ICM stated the walls can be wiped clean since the paper postings are in plastic. The ICM and AD-1 stated the posterboard with paper postings could not be wiped clean. EVSH-1 stated EVS does not sanitize the walls, and they do not touch the boards (referring to the posted signs/posters on the wall). If needed, EVSH-1 stated she would use bleach to clean and sanitize the walls. EVSH-1 further stated she has not cleaned the posterboard.

A review of the Environmental Services cleaning logs for the NICU, dated November 27, 2023, through December 27, 2023, indicated, "...Clean all Areas/Cubicles Thoroughly and Daily...Clean and High Dust all Surfaces...Sweep and Mop all Hallways to include where the babies are at least Twice a day..."

A review of the facility P&P titled, "Critical Care Areas Cleaning," dated October 30, 2023, indicated, "...POLICY...EVS staff will identify the proper steps to be followed when cleaning critical or intensive care units...Procedure for cleaning Critical Care Areas...Spot clean the walls, windows..."

A review of the facility P&P titled, "Ten Step Cleaning Procedure," dated October 20, 2020, indicated, "...POLICY...EVS staff will adhere to the approved methods when cleaning occupied patient rooms...Spot clean Vertical Surfaces...Use hospital approved germicide solution...Let surfaces air dry in compliance with product approved dwell time...Vertical surfaces include but are not limited to light switches, walls, privacy curtains, mirror, TV screens, etc..."

4. A concurrent interview and record review on December 28, 2023, at 11:13 a.m., was conducted with the ICM in the conference room.

Review of an untitled facility document which listed the patients in the NICU who tested positive for MRSA, from June 2023, through December 2023, indicated there were 17 patients who acquired MRSA while admitted in the NICU.

Review of the medical records for each patient indicated the following:

1. Patient 3's Face Sheet indicated Patient 3 was admitted on April 18, 2023, and was discharged on July 26, 2023.

The "NICU Admission History and Physical," dated April 18, 2023, indicated Patient 3 was born at the facility and was admitted to the NICU for prematurity (born before the expected date of delivery).

The untitled facility document, dated April 20, 2023, at 9 a.m., indicated, "...MRSA ...per protocol: Patient Communication ...Results ...Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated July 27, 2023, at 12:44 p.m., indicated, "...MRSA ...per protocol: Patient Communication ...Results ...Culture Report...MRSA ISOLATED!!..."

2. Patient 4's Face Sheet indicated Patient 4 was admitted to the NICU on April 5, 2023, and was discharged on July 5, 2023.

The "NICU Admission History and Physical," dated April 5, 2023, indicated Patient 4 was born outside the facility and admitted for prematurity and low birth weight.

The untitled facility document, dated April 7, 2023, at 6:44 a.m., indicated, "...MRSA ...per protocol: Patient Communication ...Results ......Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated July 6, 2023, at 4:26 p.m., indicated, "...Culture Report...MRSA ISOLATED!!..."

3. Patient 5's Face Sheet indicated Patient 5 was admitted on May 26, 2023, and was discharged on August 23, 2023.

The "NICU Admission History and Physical,", dated May 27, 2023, indicated Patient 5 was born at the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated May 28, 2023, at 9:54 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated August 25, 2023, at 8:32 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...MRSA ISOLATED!!..."

4. Patient 6's Face Sheet indicated Patient 6 was admitted to the NICU on May 7, 2023, and was discharged on August 25, 2023.

The "NICU Admission History and Physical," dated May 7, 2023, indicated Patient 6 was born at the facility and admitted for prematurity.

The untitled facility document, dated May 9, 2023, at 7:32 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated August 26, 2023, at 12:11 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...MRSA ISOLATED!!..."

5. Patient 7's Face Sheet indicated Patient 7 was admitted to the NICU on September 25, 2023, and was discharged on September 29, 2023.

The "NICU Admission History and Physical," dated September 25, 2023, indicated Patient 7 was born at the facility and was admitted to the NICU for weight loss and dehydration due to feeding issues.

The untitled facility document, dated September 27, 2023, at 4:23 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR (Polymerase Chain Reaction, a highly sensitive laboratory test)...NOT DETECTED...Comment: INCONCLUSIVE: Poorly collected specimen. Recollection required ..."

The untitled facility document, dated September 30, 2023, at 3:09 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

6. Patient 8's Face Sheet indicated Patient 8 was admitted to the NICU on October 10, 2023, and was discharged on October 22, 2023.

The "NICU Admission History and Physical," dated October 10, 2023, indicated Patient 8 was born outside the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated October 11, 2023, at 11:31 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated October 23, 2023, at 2:01 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

7. Patient 9's Face Sheet indicated Patient 9 was admitted to the NICU on June 3, 2023, and was discharged on October 15, 2023.

The "NICU Admission History and Physical," dated June 3, 2023, indicated Patient 9 was born at the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated June 4, 2023, at 9:44 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated October 16, 2023, at 11:51 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

8. Patient 10's Face Sheet indicated Patient 10 was admitted to the NICU on October 7, 2023, and was discharged on October 12, 2023.

The "NICU Admission History and Physical," dated October 7, 2023, indicated Patient 10 was born at the facility and was admitted to the NICU for prematurity and low birth weight.

The untitled facility document, dated October 8, 2023, at 1:46 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated October 13, 2023, at 2:22 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

9. Patient 11's Face Sheet indicated Patient 11 was admitted on September 22, 2023, and was discharged on November 27, 2023.

The "NICU Admission History and Physical," dated September 22, 2023, indicated Patient 11 was born at the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated September 23, 2023, at 11:33 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...Culture Report...NO MRSA ISOLATED..."

The untitled facility document, dated November 28, 2023, at 11:37 a.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

10. Patient 12's Face Sheet indicated Patient 12 was admitted to the NICU on October 6, 2023, and discharged on November 16, 2023.

The "NICU Admission History and Physical," dated October 6, 2023, indicated Patient 12 was born at the facility and was admitted to the NICU for respiratory failure (inefficient breathing) in a newborn.

The untitled facility document, dated October 7, 2023, at 2:56 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated November 17, 2023, at 2:48 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

11. Patient 13's Face Sheet indicated Patient 13 was admitted to the NICU on October 22, 2023 and was discharged on November 11, 2023.

The "NICU Admission History and Physical," dated October 22, 2023, indicated Patient 13 was born at the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated October 23, 2023, at 2:07 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated November 12, 2023, at 12:27 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

12. Patient 14's "NICU Admission History and Physical," dated October 24, 2023, indicated Patient 14 was born on October 23, 2023, at 10:39 p.m. at the facility and admitted to the NICU for respiratory failure in a newborn.

Review of Patient 14's "NICU Discharge Summary," dated November 2, 2023, indicated Patient 14 was discharged on November 2, 2023.

The untitled facility document, dated October 24, 2023, at 3:15 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated November 3, 2023, at 1:12 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

13. Patient 15's "NICU Admission History and Physical," dated October 30, 2023, indicated Patient 15 was born on October 30, 2023, at 6:33 p.m. at the facility and was admitted to the NICU for prematurity.

The "NICU Discharge Summary," dated November 13, 2023, indicated Patient 15 was discharged on November 13, 2023.

The untitled facility document, dated October 31, 2023, at 12:55 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated November 14, 2023, at 12:04 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

14. Patient 16's Face Sheet indicated Patient 16 was admitted on October 29, 2023, and was discharged on December 4, 2023.

The "NICU Admission History and Physical," dated October 30, 2023, indicated Patient 16 was born on October 29, 2023, at 11:52 a.m. at the facility and was admitted to the NICU for neonatal abstinence syndrome (withdrawal symptoms from certain drugs newborn was exposed to in the womb before birth).

The untitled facility document, dated October 31, 2023, at 12:57 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document dated December 5, 2023, at 12:09 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

15. Patient 17's Face Sheet indicated Patient 17 was admitted on November 3, 2023 and was discharged on December 1, 2023.

The "NICU Admission History and Physical," dated November 3, 2023, indicated Patient 17 was born at the facility and was admitted to the NICU for prematurity.

The untitled facility document, dated November 4, 2023, at 3:07 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...NOT DETECTED..."

The untitled facility document, dated December 2, 2023, at 1:25 p.m., indicated, "... MRSA ...per protocol: Patient Communication ...Results ...MRSA PCR...DETECTED !..."

The ICM stated there was no documented evidence the facility sent a letter and education to Patients 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17's family members notifying the families of the positive MRSA result in accordance with facility policy and procedure.

The facility policy and procedure (P&P) titled, "Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA)," dated December 2, 2020, was reviewed. The P&P indicated, "...The policy of [Name of Facility] is...To identify patients in designated high-risk groups who may be colonized with Methicillin Resistant Staphylococcus Aureus (MRSA)...To isolate in strict Contact Precautions those patients whose surveillance cultures are positive for MRSA...To prevent healthcare associated transmission of MRSA from one patient to another...To prevent transmission of MRSA in the community...Colonization is the presence of organisms in or on a host with growth or multiplication of the organism...A patient colonized with MRSA may spread this organism to other patients...Patient Notification...If a patient tests positive for MRSA, the attending physician shall inform the patient or the patient's representative immediately or as soon as practically possible...Patients who have been discharged prior to results being available will be notified via U.S. mail by an attending physician, including written educational material...A patient who tests positive for MRSA shall, prior to discharge, receive oral and written instruction regarding aftercare and precautions to prevent the spread of MRSA to others..."

5a. During an observation on December 20,2023 at 10:31 a.m., a dependent loop was observed on the Patient 34's right thigh on the patient's indwelling urinary catheter.

During an interview on December 20,2023 at 10:33 a.m., conducted with Executive Director (Exec Dir 3), Exec Dir 3 stated the expectation is for indwelling urinary catheters to have no dependent loops.

A concurrent interview and policy and record reviews were conducted with the Infection Control Manager (ICM), on December 20, 2023, at 2:20 p.m. The facility policy and procedure titled, "Indwelling Urinary Catheter," dated March 30, 2021, was reviewed. The P&P indicated, "...Assessment ...assess every four hours and PRN for...drainage bag maintained below the level of the bladder no dependent looping of catheter tubing..." The ICM stated the policy was not followed because the expectation is indwelling urinary catheters should not have a dependent loop.

5b. During an observation on December 22, 2023, at 10:50 a.m., in Patient 34's room, Patient 34 was observed to have an indwelling urinary catheter.

A concurrent interview and record review, on December 22, 2023, at 3:30 p.m., was conducted with the Critical Care Unit Director (CCU Dir). There was no documented evidence the assessment for the daily indication for the indwelling urinary catheter from December 19, 2023, through December 22, 2023, was performed. The CCU Dir stated there was no documentation of the daily indication for the indwelling urinary catheter for Patient 34 by the phyician, from December 19, 2023, to December 22, 2023.

The facility P&P titled, "Indwelling Urinary Catheter," dated March 30, 2021 was reviewed. The P & P indicated, "...indications for indwelling catheter will be assessed daily and documented in the progress notes by physicians..."

6. During an observation on December 20, 2023, at 10:45 a.m., a 24-hour urine collection container was observed in a grey bucket filled with watered ice beside the foley catheter under Patient 51's bed.

During a concurrent interview and record review, on December 22,2023, at 12;30 p.m., conducted with the Infection Control Manager (ICM), the Critical Care Unit Director (CCU Dir), and the 2500 Director (2500 Dir), the ICM stated the undated facility document titled, "Skills: Specimen Collection: Timed Urine Specimen," is the protocol the facility uses for 24-hour urine collection. The document was reviewed and indicated, "...Timed urine collection...Each specimen is transferred immediately to a large collection container kept in the patient's bathroom." The ICM, the CCU Dir, and 2500 Dir all stated the 24-hour urine collection container should have been placed in the bathroom as indicated on their protocol instead of being placed under the patient's bed.

7. A concurrent interview and policy and record reviews were conducted with the RNS-1 on December 21, 2023, at 1:13 p.m. The following records were reviewed:

a. Patient 35's face sheet and History and Physical (H&P) indicated he was admitted to the facility on December 19, 2023, currently an inpatient, and was admitted for left fore arm pain after a motorcycle accident. There was no documented evidence Patient 35 was allergic to CHG.

The Activity of daily living (ADL) flow sheets, from December 19, 2023, to December 21, 2023, were reviewed.

There was no documented evidence Patient 35 was provided CHG bath on December 19, 2023.

b. Patient 36's face sheet and H&P indicated he was admitted to the facility on December 18, 2023, currently for colovesical fistula (abnormal connection between the colon and urinary bladder), diverticulitis (a condition which occurs when outpouches in the colon tear and result in inflammation). There was no documented evidence Patient 36 was allergic to CHG.

The ADL flow sheets, from December 18, 2023, to December 21, 2023, were reviewed.

There was no documented evidence Patient 36 was provided a CHG bath on the following dates: December 19, 2023, December 20, 2023, and December 21, 2023.

c. Patient 37's face sheet and H&P indicated he was admitted on December 2, 2023, for intracranial hemorrhage (brain bleed) and multiple fractures (broken bones) after a fall. There was no documented evidence Patient 37 was allergic to CHG.

The ADL flow sheets, from December 2, 2023, to December 21, 2023, were reviewed.

There was no documented evidence Patient 37 was provided a CHG bath on the following dates: December 7, 2023, December 8, 2023, and December 18, 2023.

d. Patient 39's face sheet and H&P indicated he was admitted on December 18, 2023, for atrial flutter (type of abnormal heart rhythm), end stage renal disease (kidney disease) on hemodialysis (procedure using a machine to filter and clean the blood). There was no documented evidence Patient 39 was allergic to CHG.

The ADL flow sheets, from December 18, 2023, to December 21, 2023, were reviewed.

There was no documented evidence Patient 39 was provided a CHG bath on the following dates: December 18, 2023, December 19, 2023, and December 20, 2023.

e. Patient 40's face sheet and H&P indicated the patient was admitted on December 12, 2023,for nausea, pulmonary embolism (blood clot in the lungs), and prolonged Q-T interval on electrocardiogram (irregular heart rhythm).There was no documented evidence Patient 40 was allergic to CHG.

The ADL flow sheets, from December 12, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 40 was provided a CHG bath on the following dates: December 14, 2023, December 15, 2023, December 16, 2023, December 17, 2023, December 18, 2023, and December 19, 2023.

f. Patient 41's face sheet and H&P indicated he was admitted on December 2, 2023, for sepsis (a life threateing infection in the blood), cardiac arrest (heart suddenly stops bating), and hypotension (lower than normal blood pressure). There was no documented evidene Patient 41 was allergic to CHG.

The ADL flow sheets, from December 2, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 41 was provided CHG bath on the following dates: December 4, 2023, December 6, 2023, December 9, 2023, December 14, 2023, and December 17, 2023.

g. Patient 42's face sheet and H&P indicated he was admitted on December 15, 2023, for gross hematuria (blood in the urine) and ruptured bladder. There was no documented evidence Patient 42 was allergic to CHG.

The ADL flow sheets, from December 2, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 42 was provided a CHG bath on the following dates: December 4, 2023, December 6, 2023, December 9, 2023, December 14, 2023, and December 17, 2023.

h. Patient 44's face sheet and H&P indicated he was admitted on December 15, 2023, for cellulitis (deep bacterial infection of the skin) of right lower extremity (leg). There was no documented evidence Patient 44 was allergic to CHG.

The ADL flow sheets, from December 18, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 44 was provided a CHG bath on the following dates: December 19, 2023.

During an interview on December 22, 2023, at 10:20 a.m., RNS-1 stated there was no documentation Patients 35, 36, 37, 39, 40, 41, 42, and 44 were provided CHG baths on the dates mentioned above. RNS-1 stated the facility's policy was not implemented.

A review of the facility P&P titled, "Chlorhexidine Gluconate (CHG) Bathing and Surgical preparation in the Inpatient Settings," dated July 6, 2021, indicated, "...policy applies to all patients admitted in the [Name of Facility], ages 18 and above...all patients in the inpatient areas ages 18 and above are bathed with CHG daily, unless the patient is allergic to CHG..."

8. A concurrent interview and policy and record reviews were conducted with the RN Supervisor (RNS) 1 on December 21, 2023, at 1:13 p.m. The following records were reviewed:

a. Patient 36's face sheet and History and Physical (H&P) indicated he was admitted on December 18, 2023, for colovesical fistula and diverticulitis.

The Activity of Daily Living (ADL) flow sheets, from December 18, 2023, to December 21, 2023, were reviewed.

There was no documented evidence Patient 36 was provided nasal decolonization twice per day, on the following dates: December 18, 2023, December 19, 2023, December 20, 2023, and December 21, 2023.

b. Patient 41's face sheet and H&P indicated the patient was admitted on December 2, 2023, for sepsis, cardiac arrest, and hypotension.

The ADL flow sheets, from December 2, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 40 was provided nasal decolonization twice per day on the following dates: December 5, 2023, a.m. and p.m., December 6, 2023, p.m. (evening), December 7, 2023, a.m. (morning), December 8, 2023, p.m., December 9, 2023, p.m., December 11, 2023, a.m., December 12, 2023, p.m., and December 21, 2023, p.m.

c. Patient 42's face sheet and H&P indicated he was admitted on December 15, 2023, for gross hematuria and ruptured bladder.

The ADL flow sheets, from December 18, 2023, and December 22, 2023, were reviewed.

There was no documented evidence Patient 42 was provided nasal decolonization twice per day on the following dates: December 15, 2023, a.m., December 16, 2023, a.m., December 17

Based on observation, interview, and record review, the facility failed to ensure the infection prevention and control program (IPCP) included a facility-wide program for the surveillance, prevention, and control of healthcare-associated infections (HAIs, infections acquired during the process of receiving health care that was not present during the time of admission) and other infectious diseases for 29 of 52 sampled Patients (Patients 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28, 29, 30, and 32) when:

1. For Patients 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28, 29, 30, and 32, the hospital did not report an increase in cases of a multiple drug resistant organism (MDRO) methicillin resistant staphylococcus aureus (MRSA, germs that no longer responds to the medicine designed to kill them) in the neonatal intensive care unit (NICU, a unit for critically ill newborn patients) to the California Department of Public Health (CDPH) and the Local Health Officer (LHO); and

2. For Patient 32, the hospital did not have a system in place to minimize the spread of MRSA in the NICU and contact precautions (measures that are intended to prevent transmission of infectious germs which are spread by direct or indirect contact with the patient or the patient's environment) were discontinued.

These failures resulted in unsafe healthcare practices and had the potential to cause further harm and prolonged hospitalization thereby increasing the risk of death to patients being cared for in the hospital.

Finding:

1. An interview was conducted with the Infection Control Manager (ICM), on December 20, 2023, at 9:15 a.m., in the conference room, the ICM stated the hospital followed the following nationally recognized guidelines for disease outbreaks:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. The Society for Healthcare Epidemiology of America (SHEA, a professional society that improves public health by establishing infection-prevention measures and supporting antibiotic stewardship among healthcare providers); and

C. Association for Professionals in Infection Control and Epidemiology (APIC, professional association for infection prevention).

A concurrent interview and record review was conducted with the ICM, on December 20, 2023, at 11:30 a.m., in the conference room. The undated facility document titled "[Name of the Facility] NICU Summary," indicated 31 NICU patients were diagnosed with MRSA colonization. The ICM confirmed there were no identified MRSA cases in the NICU from March 2023 to May 2023. The ICM stated on June 8, 2023, to December 4, 2023, there were 29 NICU patients diagnosed with MRSA. The ICM stated she did not report the increase in MRSA cases to the CDPH nor to the LHO because the hospital had changed the testing method for MRSA on September 4, 2023, and the facility expected to have an increase of positive MRSA results due to the sensitivity (a laboratory test's ability to designate an individual with disease as positive) of the test.

The NICU Summary document indicated the following:

- For March 2023, there were no identified MRSA cases;

- For April 2023, there were no identified MRSA cases;

- For May 2023, there were no identified MRSA cases;

- For June 2023, there were four new identified positive MRSA cases;

- For July 2023, there were four new identified positive MRSA cases;

- For August 2023, there were three new identified positive MRSA cases;

- For September 2023, there were three new identified positive MRSA cases;

- For October 2023, there were six new identified positive MRSA cases;

- For November 2023, there were eight new identified MRSA cases; and

- For December 2023, there were three new identified positive MRSA cases.

A record review was conducted of all patients in the NICU that were diagnosed with MRSA from June 8, 2023, to December 4, 2023. The findings were as follow:

- For Patient 2, the "Face Sheet" (contains medical and demographic information) indicated Patient 2 was admitted to the NICU on May 15, 2023, with the diagnosis of prematurity (infants born alive before 37 weeks of pregnancy are completed).

Patient 2's clinical laboratory report titled, "Culture, MRSA Surveillance," dated June 12, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 3, the "Face Sheet" indicated Patient 3 was admitted to the NICU, on April 18, 2023, with the diagnosis of prematurity.

Patient 3's clinical laboratory report titled, "Culture, MRSA Surveillance," dated July 27, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 4, the "Face Sheet" indicated Patient 4 was admitted to the NICU, on April 5, 2023, with diagnoses of apnea (a serious breathing disorder), COVID (an infectious disease), and acute hypoxemic respiratory failure (low oxygen in the blood).

Patient 4's clinical laboratory report titled, "Culture, MRSA Surveillance," dated July 6, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 5, the "Face Sheet" indicated Patient 5 was admitted to the NICU, on May 26, 2023, with diagnoses of retinopathy of prematurity (an eye disease related to use of oxygen in premature infants).

Patient 5's clinical laboratory report titled, "Culture, MRSA Surveillance," dated August 25, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 6, the "Face Sheet," indicated Patient 6 was admitted to the NICU, on May 7, 2023, with diagnosis of prematurity.

Patient 6's clinical laboratory report titled, "Culture, MRSA Surveillance," dated August 26, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 7, the "Face Sheet" indicated Patient 7 was admitted to the NICU, on September 25, 2023, with diagnoses of weight loss and dehydration due to feeding disorder.

Patient 7's clinical laboratory report titled, "MRSA PCR Colonization," dated September 30, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 8, the "Face Sheet" indicated Patient 8 was admitted to the NICU, on October 10, 2023, with diagnosis of prematurity.

Patient 8's clinical laboratory report titled, "MRSA PCR Colonization," dated October 23, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 9, the "Face Sheet" indicated Patient 9 was admitted to the NICU, on June 3, 2023, with diagnosis of prematurity.

Patient 9's clinical laboratory report titled, "MRSA PCR Colonization," dated October 16, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 10, the "Face Sheet" indicated Patient 10 was admitted to the NICU, on October 7, 2023, with diagnosis of prematurity.

Patient 10's clinical laboratory report titled, "MRSA PCR Colonization," dated October 12, 2023, indicated "...MRSA PCR... DETECTED..."

- For Patient 11, the "Face Sheet" indicated Patient 11 was admitted to the NICU, on September 22, 2023, with diagnosis of prematurity.

Patient 11's clinical laboratory report titled, "MRSA PCR," dated November 28, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 12, the "Face Sheet" indicated Patient 12 was admitted to the NICU, on October 6, 2023, with diagnosis of respiratory failure (when not enough oxygen passes from your lungs to the blood).

Patient 12's clinical laboratory report titled, "MRSA PCR," dated November 16, 2023, indicated "...MRSA PCR... DETECTED..."

- For Patient 13, the "Face Sheet" indicated Patient 13 was admitted to the NICU, on October 22, with diagnosis of prematurity.

Patient 13's clinical laboratory report titled, "MRSA PCR," dated November 12, 2023, indicated "...MRSA PCR... DETECTED..."

- For Patient 14, the "Face Sheet" indicated Patient 14 was admitted to the NICU, on October 23, 2023, with diagnosis of prematurity.

Patient 14's clinical laboratory report titled, "MRSA PCR," dated November 3, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 15, the "Face Sheet" indicated Patient 15 was admitted to the NICU, on October 30, with diagnosis of prematurity.

Patient 15's clinical laboratory report titled, "MRSA PCR," dated November 14, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 16, the "Face Sheet" indicated Patient 16 was admitted to the NICU, on October 29, 2023, with diagnosis of neonatal abstinence syndrome.

Patient 16's clinical laboratory report titled, "MRSA PCR Colonization," dated December 5, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 17, the "Face Sheet" indicated Patient 17 was admitted to the NICU, on November 3, 2023, with diagnosis of prematurity.

Patient 17's clinical laboratory report titled, "MRSA PCR Colonization," dated December 2, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 18, the "Face Sheet" indicated Patient 18 was admitted to the NICU, on June 4, 2023, with diagnosis of neonatal abstinence syndrome (a group of problems a baby experiences when withdrawing from exposure to narcotics before birth.

Patient 18's clinical laboratory report titled, "Culture, MRSA Surveillance," dated June 21, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 19, the "Face Sheet" indicated Patient 19 was admitted to the NICU, on June 12, 2023, with diagnosis of hyperbilirubinemia (a life-threatening disorder in newborns).

Patient 19's clinical laboratory report titled, "Culture, MRSA Surveillance," dated June 14, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 20, the "Face Sheet" indicated Patient 20 was admitted to the NICU, on June 6, 2023, with diagnoses of neonatal abstinence syndrome and opioid withdrawal.

Patient 20's clinical laboratory report titled, "Culture, MRSA Surveillance," dated June 6, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 22, the "Face Sheet" indicated Patient 22 was admitted to the NICU, on July 22, 2023, with diagnosis of a brief resolved unexplained event (BRUE, a life-threatening event in infant).

Patient 22's clinical laboratory report titled, "Culture, MRSA Surveillance," dated July 22, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 23, the "Face Sheet" indicated Patient 23 was admitted to the NICU, on August 18, 2023, with diagnosis of fever of unknown origin.

Patient 23's clinical laboratory report titled, "Culture, MRSA Surveillance," dated August 18, 2023, indicated "...Culture Report...MRSA ISOLATED..."

- For Patient 24, the "Face Sheet" indicated Patient 24 was admitted to the NICU, on September 27, 2023, with diagnosis of prematurity.

Patient 24's clinical laboratory report titled, "MRSA PCR," dated September 27, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 25, the "Face Sheet" indicated Patient 25 was admitted to the NICU, on September 29, 2023, with diagnosis of hyperbilirubinemia.

Patient 25's clinical laboratory report titled, "MRSA PCR," dated September 29, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 26, the "Face Sheet" indicated Patient 26 was admitted to the NICU, on October 15, 2023, with diagnosis of prematurity.

Patient 26's clinical laboratory report titled, "MRSA PCR," dated October 15, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 27, the "Face Sheet" indicated Patient 27 was admitted to the NICU, on October 31, 2023, with diagnosis of hyperbilirubinemia.

Patient 27's clinical laboratory report titled, "MRSA PCR," dated October 31, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 28, the "Face Sheet" indicated Patient 28 was admitted to the NICU, on October 14, 2023, with diagnosis of prematurity.

Patient 28's clinical laboratory report titled, "MRSA PCR," dated October 14, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 29, the "Face Sheet" indicated Patient 29 was admitted to the NICU, on November 10, 2023, with diagnosis of brief resolved uexplained event (BRUE, when an infant younger than one year stops breathing, has a change in muscle tone, turns pale or blue in color, or is unresponsive).

Patient 29's clinical laboratory report titled, "MRSA PCR," dated November 19, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 30, the "Face Sheet" indicated Patient 30 was admitted to the NICU, on November 21, 2023, with diagnosis of hyperbilirubinemia (increased level of bilirubin [a yellowish pigment that is made during the breakdown of red blood cells] in the blood).

Patient 30's clinical laboratory report titled, "MRSA PCR," dated November 21, 2023, indicated "...MRSA PCR...DETECTED..."

- For Patient 32, the "Face Sheet" indicated Patient 32 was admitted to the NICU, on December 11, 2023, with diagnosis of poor feeding of newborn.

Patient 32's clinical laboratory report titled, "MRSA PCR," dated December 11, 2023, indicated "...MRSA PCR...DETECTED..."

An interview was conducted with the ICM, on December 20, 2023, at 1:30 p.m., in the conference room. The ICM stated the infection prevention and control program (IPCP) defined a disease outbreak or an unusual occurrence of two or more cases of a disease not usually common to a unit. The ICM stated the increase in cases were not reported to the California CDPH nor to the LHO because the hospital had implemented a new MRSA testing method and the IPCP expected the number of cases to increase. The ICM did not provide an explanation for the increase in the number of cases that were diagnosed in the NICU population prior to implementing the new testing methods on September 4, 2023, which showed the following:

-For June 2023, there were four new identified cases;

-For July 2023, there were four new identified cases; and

-For August 2023, there were three new identified cases.

The ICM stated the IPCP received infection prevention and control updates from CDPH and communicates the alerts to different departments in the hospital. The ICM stated she had recently received updated information on the requirements to report outbreaks and unusual infectious disease occurrences. The ICM stated the document from CDPH titled, "All Facilities Letter Summary," dated August 2023, indicated outbreaks and increased cases of MRSA colonization or infection in the NICU should be reported to the CDPH and to the LHO.

The ICM stated she did not think the increase of MRSA cases needed to be reported because the hospital had implemented a more sensitive testing method and the IPCP expected the increase in new MRSA cases. The ICM stated neither the LHO nor the CDPH were notified of the increase in newly identified MRSA cases.

A review of the hospital's policy and procedure (P&P) titled, "Outbreak Investigation," effective date July 21, 2023, indicated, "...3.3 Components of a Cluster/Outbreak Investigation:...p. Notify [Name of County Public Health Department], Disease control division as appropriate..."

A review of the hospital's P&P titled, "Infection Prevention and Control Plan," effective date April 19, 2023, indicated, "...13. Public Health Department Reports: Specified disease and conditions are mandated by state law and regulations to be reported by healthcare providers and laboratories to the local health officer. Infection Prevention and Control Department is performing surveillance, monitoring trends, detecting outbreaks, investigating outbreaks, eliminating sources...and reporting to Public Health all reportable diseases and conditions. This is very important for controlling outbreaks of communicable diseases in the community...From Public Health Department: Infection Prevention and Control Department receives updates from CDPH and communicates the alerts to different departments and clinicians..."

2. An observation of the NICU isolation rooms was conducted with Assistant Director (AD) 1, Charge Nurse (CN) 1, and the Infection Control Manager (ICM), on December 20, 2023, at 10:15 a.m., in the NICU. There were two isolation rooms. One isolation room was designed for a single patient occupancy and the other isolation room was designed for a double patient occupancy.

An interview was conducted with AD-1 on December 20, 2023, at 10:15 a.m., in the NICU. AD-1 stated the NICU no longer placed patients colonized with MRSA into contact precautions. AD-1 stated the staff received a memo about the new changes two week ago and the new workflow started on December 4, 2023. The ICM stated the policy and procedure had been revised but was not available to staff at this time. AD-1 stated babies diagnosed with MRSA colonization can now be paired on a nurse assignment list with babies that have not been diagnosed with MRSA. AD-1 stated Patient 32 was admitted after December 4, 2023, and was diagnosed with MRSA colonization. AD-1 stated Patient 32 received care in the NICU for four days and was paired on an assignment list with two other babies that had not been diagnosed with MRSA. AD-1 stated Patient 32 was not placed into contact precautions. The ICM stated the policy change was based on evidence-based practice. A request was made for the following documents:

- A copy of the evidenced-based practice guidelines;

- A copy of the hospital's nationally recognized infection prevention and control guidelines that were implemented with the policy change; and

- A copy of the revised policy.

A review of Patient 32's "Face Sheet" indicated Patient 32 was admitted to the NICU, on December 11, 2023, with diagnosis of poor feeding of newborn.

A review of Patient 32's clinical laboratory report titled, "MRSA PCR," dated December 11, 2023, indicated "...MRSA PCR...DETECTED..."

A review of Patient 32's physician order titled "Contact Isolation," dated December 11, 2023, indicated the physician ordered Contact Isolation on December 11, 2023, at 1:25 p.m., and the order for Contact isolation was cancelled on December 11, 2023, at 1:26 p.m. (one minute later).

An interview was conducted with the ICM on December 20, 2023, at 1:30 p.m., in the conference room. The ICM confirmed that she was aware of Patient 32's diagnosis and Patient 32 was not placed into contact precautions.

During an interview with the Medical Director, Quality (MDQ), on December 20, 2023, at 5:10 p.m., the MDQ stated if the Centers for Disease Control and Prevention (CDC) recommends contact precautions for MRSA cases the hospital did not need to follow CDC recommendations. The MDQ did not provide a copy of the hospital's nationally recognized infection prevention and control guidelines that were implemented with the policy change.

The review of the facility's P&P titled, "Isolation Precautions Defined," effective date December 10, 2020, indicated, "...Policy...preventing the transmission of infectious agents [Name of Facility] are designed to meet the following objectives...Provide infection prevention and control recommendations for all components of the healthcare delivery system...Provide epidemiologically sound, and whenever possible, evidenced-based infection control standards of care...Provide a unified infection prevention and control approach to multi-drug resistant organisms (MDROs)...How microorganisms are spread...Contact Transmission...indirect-contact transmission:...involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, such as unwashed hands, a contaminated surface, or patient care devices. Note this is the most frequent mode of transmission..."

On December 20, 2023, at 5:06 p.m., the survey team identified significant concerns in the facility's Neonatal Intensive Care Unit (NICU). Due to the seriousness of the situation, an immediate jeopardy (IJ, a situation with the potential to harm the health and safety of the patients) was called in the presence of the hospital's Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Operating Officer (COO), Chief Medical Officer (CMO), Infection Control Manager (ICM), Chief Clinical Integration Officer (CCIO), Chief of Infectious Disease (CID), Medical Director Inpatient Services (MDIPS) and Medical Director of Quality (MDQ). The facility's Administrators were verbally notified regarding the concerns, of the hospital's failure to ensure an active system was in place to prevent the spread of infection and cross-contamination between patient to patient in the NICU, and the failure to minimize the risk of cross-contamination between patients and staff, the contaminated environment, and patient equipment due to not implementing contact precautions. These failures had the potential to result in poor health outcomes thereby increasing the risk of death for patients receiving NICU services in the facility.

On Dec 22, 2023, at 7:31 p.m., the hospital provided a Corrective Action Plan (CAP).

On December 26, 2023, at 11:02 a.m., the CAP was reviewed and accepted.

On December 27, 2023, at 1:45 p.m., the immediate jeopardy was removed in the presence of the CCIO, ICM, and CEO, after the implementation of the CAP was verified through observation, interviews, and record reviews. The Corrective Action Plan included the following components:

1. On December 20, 2023, the leadership team met to conduct a review of current isolation practices. The practice of conducting a MRSA PCR screen for every infant admitted to the NICU will continue as mandated by Senate Bill 1058 (a legislation requiring hospitals to implement certain procedures for the screening, prevention, and reporting of specified health-care-associated infections). If the screen result is positive, the patient will be placed in contact isolation. The facility policies IC-4-7 Contact Precautions and IC-2-9 Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA) were reviewed;

2. On December 20, 2023, the Executive Director of Women's Services and the Assistant Director of the NICU immediately began education with all NICU registered nurses, nurse practitioners, and physician staff to place NICU infants with a positive PCR screening for MRSA in contact isolation;

3. On December 21, 2023, the facility leadership and the Infection Control Department met to conduct an additional review of the facility policy IC-2-9 Active Surveillance Testing (AST) for Methicillin Resistant Staphylococcus Aureus (MRSA) to ensure NICU adherence to current recommendations and nationally recognized infection prevention and control guidelines as referenced by the Centers for Disease Control and Prevention (CDC, the national public health agency of the United States). As a result of this review, a revision was made to implement contact isolation for all infants admitted to the NICU with a positive MRSA screening result; and

4. A tip sheet was developed which will be used during shift huddles and the department meeting until all staff have received the training. It will also be posted on huddle boards and will be accessible to nursing staff on the facility intranet.

Based on observation, interview, and document review, the facility failed to ensure they had active surgical services that was well organized and provided in accordance with acceptable standards of practice including meeting the needs of all patients requiring gastroenterology services (the study, diagnosis, and treatment of disorders that deal with the digestive system) and the use of flexible endoscopes (a reusable instrument used to inspect and treat interior portions of the body) when:

1. For the GI unit, the surgical services failed to ensure the scope storage room's floor did not contain thick grey fuzzy matter, black particles, and debris scattered throughout the endoscope (a reusable instrument used to inspect and treat interior portions of the body) storage room's floor and the scopes were protected from environmental contaminants (Refer to A0951);

2. For the labor and delivery unit (L&D, a unit in the hospital where babies are delivered), the surgical services failed to implement an infection control plan to minimized cross-contamination while waiting on the L&D operating room doors to be replaced (Refer to A0951);

3. For surgical services, the surgical services failed to ensure the bloodborne pathogen exposure control plan was implemented to ensure that biohazardous containers were closed in between cases (Refer to A0951);

4. For the GI unit, the surgical services failed to ensure the manufacturer's instruction for use (IFU) on the endoscope reprocessing steps were followed and there was no thick grey fuzzy matter, black particles, and debris, observed throughout the sterile processing room (the area in a hospital where cleaning and sterilization (process to render equipments germ free) of devices used in medical procedures takes place) (Refer to A0951);

5. For the medical surgical center (MSC), the surgical services failed to ensure the manufacturer's guidelines on the endoscope reprocessing steps were followed (Refer to A0951);

6. For the GI unit, the surgical services failed to ensure preventative maintenance was performed on scope storage cabinets and HEPA (a medical grade air filter) filters were changed in accordance with the manufacturer's IFU (Refer to A0951);

7. For the GI unit, the surgical services failed to ensure the manufacturer's IFU on scope storage was followed and staff did not access the scope cabinet without performing hand hygiene or putting on gloves (Refer to A0951); and

8. For the perioperative unit, the surgical services failed to ensure the policy and procedure on between surgical case cleaning was implemented and red stains were not observed on the surgical table's frame (Refer to A0951).

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services.

On December 22, 2023, at 3:22 p.m., the survey team identified significant concerns in the facility's Gastrointestinal (GI, the digestive system) Unit and the Labor and Delivery (L&D, a unit where babies are delivered) Unit. Due to the seriousness of the situation, an immediate jeopardy was called in the presence of the facility's CEO, CNO, COO, CMO, ICM, CCIO, Medical Center Internal Medicine (GME/IM), and MDQ. The facility's Administrators were verbally notified regarding the concerns of the facility's failure to ensure endoscopes were not exposed to environmental contaminants, contaminated scopes were not being used for GI procedures, and the facility's failure to ensure a system was in place to minimize contaminates from penetrating the surgical zone in the L&D ORs, while waiting for OR doors to be replaced. These failures created the increased risk of transmission of infections and further compromised the patients' clinical conditions.

On December 22, 2023, at 7:31 p.m., the facility provided a Corrective Action Plan (CAP).

On December 26, 2023, at 12:15 p.m., the CAP for the immediate jeopardy was reviewed and accepted.

On December 27, 2023, at 1:46 p.m., the immediate jeopardy was removed in the presence of the CCIO, ICM, and CEO, after the CAP implementation was verified through observation, interviews, and record reviews.

The CAP included the following components:

- The labor and delivery unit educational plan was developed to include:

1. Pharmacy stocking medications in the Main OR for the change in workflow.

2. Patients will be called the day before their scheduled surgery to remind them they MUST be on time. Patients who are not taken to the OR during their schedule block will be bumped until the next available time on the schedule.

3. L&D Charge Nurse will assess all high-risk patient admissions and assign those patients to laboring rooms that are closest to the emergency elevator as available.

4. Plan for emergency C-sections (caesarian section, delivery of newborn through a surgical incision in the abdomen)that must be done in the main OR.

5. Supply, equipment carts, fetal monitors (medical equipment used to monitor the baby's heart rate), and infant warmers delivered to main OR. Plan for maintenance and restocking of supplies.

6. Post-delivery and stabilization plan.

7. Elevator considerations.

8. Environmental Services considerations.

9. EPIC EHR (electronic health record) considerations.

-The GI Unit education plan was developed to include:

1. Reprocessing of scopes for any reason (e.g., expired, contaminated, used in a procedure) must follow the original processing steps in their entirety.

2. The location of new scope cabinet in the Medical Surgical Center (MSC).

3. The process of keeping the scope room door secure.

4. Proper transport procedures of the clean scopes to the new location in the MSC as well as the equipment needed for transport.

Based on observation, interview, and record review, the hospital failed to ensure the needs of all patients requiring surgical services and gastroenterology (GI) services (the study, diagnosis and treatment of disorders that deal with the digestive system) including the use of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were met when:

1. For the GI unit, thick grey fuzzy matter, black particles, and debris were observed scattered throughout the endoscope (a reusable instrument used to inspect and treat interior portions of the body) storage room's floor and the scope cabinet's door was observed missing for one of four scope storge cabinets (Scope Cabinet 1);

2. For the labor and delivery unit (L&D, a unit in the hospital where babies are delivered), the operating room (OR) doors were observed to be broken and would not close completely, for two of two sampled ORs (OR A and OR B);

3. For surgical services, the bloodborne pathogen exposure control plan was not implemented to ensure that biohazardous containers were closed in between cases for three of four sampled ORs (OR B, OR 9, and OR 10);

4. For the GI unit, the manufacturer's IFU on the endoscope reprocessing steps were not followed and there was thick grey fuzzy matter, black particles, and debris, observed throughout the sterile processing room (the area in a hospital where cleaning and sterilization (process to render equipment germ free) of devices used in medical procedures takes place);

5. For the medical surgical center (MSC), the manufacturer's guidelines on the endoscope reprocessing steps were not followed;

6. For the GI unit, preventative maintenance was not performed on scope storage cabinets and HEPA (high efficiency particulate air, a medical grade air filter) filters were not changed in accordance with the manufacturer's IFU, for one of two sampled scope storage cabinets (Scope Cabinet 2);

7. For the GI unit, the manufacturer's IFU on scope storage was not followed and staff were observed accessing the scope cabinet without performing hand hygiene or putting on gloves, for one of four sampled scope cabinets (Scope Cabinet 4); and

8. For surgical services, the policy and procedure (P&P) on between surgical case cleaning was not implemented and red stains were observed on the surgical table's frame, for one of four sampled ORs (OR 9).

These failures had the potential to result in poor health outcomes to the patients receiving surgical services and GI services in the hospital.

Findings:

On December 22, 2023, at 3:22 p.m., the survey team identified significant concerns in the hospital's GI Unit and the Labor and Delivery Unit. Due to the seriousness of the situation, an Immediate Jeopardy (IJ-a situation with the potential to harm the health and safety of the patients) was called in the presence of the hospital's Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Operating Officer (COO)Chief Medical Officer (CMO), Infection Control Manager (ICM), Chief Clinical Integration Officer (CCIO), Medical Center Internal Medicine (GME/IM), Medical Director, Quality (MDQ). The hospital's Administrators were verbally notified regarding the concerns, of the hospital's failure to ensure endoscopes were not exposed to environmental contaminates, contaminated scopes were not being used for GI procedures, and the hospital's failure to ensure a system was in place to minimize contaminates from penetrating the surgical zone in the labor and delivery ORs, while waiting for OR doors to be replaced. These failures created the increased risk of transmission of infections and further compromised the patients' clinical conditions.

On December 26, 2023, at 12:15 p.m., a Corrective Action Plan (CAP) was reviewed and accepted.

On December 27, 2023, at 1:46 p.m., the Immediate Jeopardy was removed in the presence of the CCICO, ICM, and CEO, after the implementation of the CAP was verified through observation, interviews, and record reviews.

The CAP included the following components:

- The labor and delivery unit educational plan was developed to include:

1. Pharmacy stocking medications in the Main OR for the change in workflow.

2. Patients will be called the day before their scheduled surgery to remind them they MUST be on time. Patients who are not taken to the OR during their schedule block will be bumped until the next available time on the schedule.

3. L&D Charge Nurse will assess all high-risk patient admissions and assign those patients to laboring rooms that are closest to the emergency elevator as available.

4. Plan for emergency C-sections (caesarian section, delivery of newborn through a surgical incision in the abdomen)that must be done in the main OR.

5. Supply, equipment carts, fetal monitors (medical equipment used to monitor the baby's heart rate), and infant warmers delivered to main OR. Plan for maintenance and restocking of supplies.

6. Post-delivery and stabilization plan.

7. Elevator considerations.

8. Environmental Services considerations.

9. EPIC EHR (electronic health record) considerations.

-The GI Unit education plan was developed to include:

1. Reprocessing of scopes for any reason (e.g., expired, contaminated, used in a procedure) must follow the original processing steps in their entirety.

2. The location of new scope cabinet in the Medical Surgical Center (MSC).

3. The process of keeping the scope room door secure.

4. Proper transport procedures of the clean scopes to the new location in the MSC as well as the equipment needed for transport.

During an interview with the Infection Control Manager (ICM), on December 20, 2023, at 9:20 a.m., in the conference room (CR), the ICM stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and

E. Association for Professionals in Infection Control and Epidemiology (APIC, a professional association for infection prevention).

1. During a record review of the hospital's document titled "Work Order," dated March 17, 2023, the document indicated the work order was placed for Scope Cabinet 1's door. The work order request indicated the following: "The scope cabinet broken; we can't access our scopes. We need fixed (sic) immediately." The action performed on March 17, 2023, indicated, "Cannot repair roll up door, advised requester to contact outside vendors for repair."

During a record review of the hospital's document titled, "Work Order," dated May 10, 2023, the document indicated the work order was placed for Scope Cabinet 1's door. The work order request indicated, "The cabinet cover in the scope room needs to be removed ASAP [as soon as possible] as it interferes with storing and removing scopes." The action performed on May 12, 2023, indicated, "Assignment completed."

During an observation of the scope's storage clean room with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:34 a.m., Scope Cabinet 1's was observed with its door missing. Seven scopes were observed hanging freely in the cabinet and were labeled "Clean." Thick grey fuzzy matter, black particles, and debris was observed scattered throughout the scope storage room's floor, along the baseboards, and around the edges of the cabinet where the scopes were stored.

During an interview conducted with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:34 a.m., NC 1 stated "I knew you would ask about the missing scope door. I was hoping that you did not see the scopes." NC 1 stated Scope Cabinet 1's door was removed May 2023 (seven months ago) and the GI department did not stop using Scope Cabinet 1 for scope storage after the door had been removed. NC 1 stated the hospital's IPCP was aware of the missing door and approved Scope Cabinet 1 without a door for storing scopes for patient use. NC 1 stated Infection Preventionist 1 instructed the GI department to keep the scope storage room's door closed as much as possible until the scope cabinet was repaired or replaced. NC 1 stated the thick grey fuzzy matter was dust and she could not identify the black particles. NC 1 stated she did not know if the scope storage room or the scope sterile processing room were terminally cleaned. NC 1 stated the scope sterile processing room should have been terminally cleaned because the room was used to clean and decontaminate (High Level Disinfection, complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores) re-usable patient scopes. The Terminal cleaning logs for the scope's sterile processing room and the scope's storage room were requested.

NC 1 stated she was aware that contaminated scopes could adversely affect the health and safety of the patients being cared for in the GI department.

An interview was conducted with the Chief Integration Officer (CCIO) on December 21, 2023, at 2:45 p.m., in the conference room. The CCIO stated he was made aware of the findings in the scope's storage room and the scope's sterile processing room. The CCIO did not provide an explanation as to why Scope Cabinet 1's door had been missing for seven months (May 2023) and the hospital continued to use Scope Cabinet 1 without a door for storing scopes for patient use.

The following documents were requested:

1. Terminal cleaning logs for the scope's sterile processing room and the scope's storage room.

2. The hospital's P/P specific to terminally cleaning the scope sterile processing room and the scope storage room.

The facility did not provide logs to demonstrate that terminal cleaning was performed in the scope's sterile processing room or the scope's storage room on a regular basis and the facility did not have a policy in place to provide guidance to staff specific to terminally cleaning the scope's sterile processing room or the scope's storage room (a restricted area).

A concurrent record review and interview was conducted with the Infection Control Manager (ICM), on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. The Infection Prevention and Control Program (IPCP) minutes did not mention Scope Cabinet 1. The ICM stated the IPCP had identified that the removal of the scope cabinet's door increased the risk for cross-contamination (the physical movement or transfer of harmful bacteria from one person, object or place to another) and could pose a risk of disease transmission (harmful germs move from a source to a susceptible person) to patients receiving care in the GI department. The ICM confirmed the IPCP did not ensure the affected scope cabinet was taken out of service or ensured other methods were implemented to prevent the risk of cross-contamination. The ICM did not explain why the IPCP had approved Scope Cabinet 1 (without a door) for storing endoscopes for patient use. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the quality assessment and performance improvement (QAPI) program related to clean endoscopes exposed to environmental contaminates and/or accidental contact and were being used for GI procedures.

The review of the facility's P&P titled, "Cleaning and Processing of Flexible Endoscopes and Endoscope Accessories," dated March 19, 2021, indicated the following: "...2.9 Storing...b. Store clean flexible endoscopes in a closed cabinet..."

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2018, indicated the following instructions for use, "...8.2 Storing the disinfected 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...Keep the cabinet doors closed to protect the equipment from environmental contaminates and accidental contact..."

The review of the AORN's Guidelines for Perioperative Practice: "Guidelines for Flexible Endoscopes," dated September 15, 2022, the AORN guidelines indicated the following, "...13. Storage...13.2. Flexible endoscopes and accessories should be stored in a manner that minimizes contamination and protects the device or item from damage in accordance with the manufacturer's IFU...13.4.1. Storage cabinets should have doors that are kept closed..."

The review of the AORN's Guidelines for Practice "Guidelines for Perioperative Practice: Environmental Cleaning", dated January 13, 2020, the AORN guideline indicated, "...6. Sterile Processing Areas: 6.2 Terminally clean sterile processing areas each day the areas are used. 6.3 Clean and disinfect the clean work areas, such as the packaging area and sterile storage area, before the dirty work areas, such as the decontamination area, to reduce the possibility of contaminating the clean areas... 6.7 Clean and disinfect all floors in sterile processing areas each day the areas are used..."

2. During a record review of the facility's document titled "Work Order," dated December 4, 2022, the document indicated the work order was placed for Operating Rooms A and B. The work order request indicated the following: "Operating room double doors need repair: Doors [OR A] and [OR B]." The work order indicated the assignment was completed and closed on January 25, 2023 (52 days later).

During a record review of the facility's document titled, "Work Order," dated January 3, 2023, showed the work order was placed for OR B. The work order request indicated the OR door in OR B is missing the hinge and need to be fixed. On January 3, 2023, the work order indicated "Missing parts, need access control to go tomorrow morning to complete job." On June 15, 2023, the work order indicated "Work order has been completed; closing out work order." The work order was completed and closed on June 15, 2023 (five months later days later).

A tour of the Labor and Delivery Unit was conducted on December 22, 2023, at 11:36 a.m., with Charge Nurse (CN) 3 and Executive Director of Maternal Child Health (EXD) 1. The following were observed:

- For OR B, the double doors were observed broken and did not close completely; and

- For OR A, a surgical procedure was observed being performed on Patient 33 and the double doors were not completely closed.

An interview was conducted with CN 3 and EXD 2 on December 22, 2023, at 11:40 a.m., in OR B. CN 3 stated the double doors of OR A and OR B had been broken for a while and she could not recall how long the doors had been broken. CN 3 stated the hospital continued to perform surgical procedures in OR A and OR B while waiting for the OR doors to be repaired. CN 3 stated she did not know if the hospital implemented an infection prevention plan to minimized air turbulence (chaotic changes in pressure and air flow) and cross-contamination of the surgical sterile field while waiting on the OR doors to be repaired or replaced. CN 3 or EXD 2 did not explain why the OR doors should be kept closed during Patient 33's surgical procedure.

A concurrent interview and record review was conducted with Plant Operation Supervisor (PO Supervisor) 2 on December 22, 2023, at 11:50 a.m., in OR B. PO Supervisor 2 stated OR A and OR B's double door could not be repaired, and the facility ordered new doors. The facility's document titled, "Purchase Order," dated August 10, 2023, was reviewed. The purchase order included a due date for the extended payment amount to be paid by October 9, 2023. The purchase order was not signed and PO Supervisor 2 stated he did not have the receipt to show that the hospital had rendered payment for the doors.

A concurrent observation and interview was conducted with PO Supervisor 2, on December 22, 2023, at 12:01 p.m., in the corridor, outside of OR A and OR B. PO Supervisor 2 was observed measuring the openings between the double doors and the door's frame of OR B. PO Supervisor stated OR B's measurements were about two inches wide and one inch long. PO Supervisor 2 proceded to OR A and was observed measuring the opening between the double doors and the door's frame of OR A. PO Supervisor 2 stated OR A's measurements were three inches wide and three inches long. PO Supervisor 2 stated the OR doors should be closed completely to prevent cross-contamination.

A concurrent record review and interview was conducted with the ICM, on December 26, 2023, at 2:55 p.m., in the conference room. The IPCP minutes were reviewed for the following dates: February 22, 2023, May 18, 20203, August 17, 2023, and November 30, 2023. There was no mention of OR A nor OR B's broken doors related to infection prevention practices. The ICM confirmed the IPCP was aware that OR A and OR B's double doors were broken and did not close completely. The ICM stated the IPCP did not perform an infection control risk assessment nor did the IPCP implement an infection control plan to minimized cross-contamination while waiting on the OR doors to be replaced. The ICM stated the doors were ordered for the ORs. The ICM stated the IPCP did not address the potential for patient harm in collaboration with the QAPI program on surgical procedures being performed in ORs when the doors did not close completely.

The review of the hospital's P&P titled, "Surgical Services/Procedures Areas," effective date March 15, 2021, indicated the following "...4. Personal Traffic...4.3 During a surgical procedure, traffic should be controlled in and out of the room to minimize air turbulence. The door should be kept closed except for passage of personnel, equipment, etc..."

The review of the AORN's Guidelines for Perioperative Practice: "Sterile Technique," dated November 1, 2018, the AORN guideline indicated the following, "...7. Moving Around a Sterile Field...7.5. Keep doors to the operative or invasive procedure room closed as much as possible except during the entry and exit of patients, required personnel, and necessary equipment..."

3a. A tour of the surgical service department was conducted on December 21, 2023, at 9:30 a.m., with the Director of Perioperative Services (DOR) and the Executive Director of Perioperative Services (EXD 2). One biohazard sharp container (containers that are used for the disposal of waste that may be soiled with germs that present a danger to people) on a medical trolley cart was observed stored in OR 9 and one biohazard sharp container on a medical trolley cart was observed stored in OR 10. The containers were observed to be filled with sharp objects, needles, and broken glass. The containers were not closed and were not in use. The containers were labeled, "Biohazard."

An interview was conducted with the DOR and EXD 2, on December 21, 2023, at 9:45 a.m., outside of OR 9. EXD 2 confirmed the containers were not closed and were filled with sharp objects, needles, and broken glass. EXD 2 stated biohazard waste was regulated waste and the hospital followed OSHA regulatory requirements for bloodborne pathogens (infectious germs in human blood that can cause disease in humans). The DOR stated the biohazard sharp containers should have been closed when the containers were not in use.

An interview was conducted with the ICM and the CCIO, on December 21, 2023, at 1:05 p.m., in the conference room (CR). The CCIO stated she was not aware biohazard waste containers required lid covers in the perioperative areas (areas used immediately before, during, and immediately after a surgery).

A request was made for the hospital's documents on OSHA regulatory requirements and/or the hospital's bloodborne pathogen exposure plan.

3b. A tour of the Labor and Delivery Unit was conducted on December 22, 2023, at 11:36 a.m., with Charge Nurse (CN) 3 and Executive Director of Maternal Child Health (EXD) 1, in OR B. One biohazard sharp container (containers that are used for the disposal of waste that may be soiled with germs that present a danger to people) on a medical trolley cart was observed stored in OR B. The container was observed to be filled with sharp objects; needles; two used intravenous (into the vein) fluid bags; one opened and used fentanyl medication vial (medication used for pain); one opened and used rocuronium medication vial (medication used to relax the muscles during surgery); one opened and used versed medication vial (medication used for relaxation and to reduce anxiety); one opened and used Marcaine medication vial(medication used to numb an area of the body during surgical procedures); several glass bottles; and broken glass. The container was not closed and was not in use. The container was labeled, "Biohazard."

A concurrent record review and interview was conducted with the ICM and the CCIO, on December 22, 2023, at 1:05 p.m., in the CR. The following facility documents titled, "OSHA Fact Sheet," dated January 2011, and the P&P titled "Bloodborne Pathogen Exposure Plan-Hospital," effective date December 23, 2020, were reviewed. The ICM confirmed the hospital followed OSHA standards on bloodborne pathogens. The CCIO stated the document titled, OSHA Fact Sheet was vague, and it would depend on how the document was interpreted. The CCIO stated the document did not indicate that biohazardous regulated waste had to be covered when the containers were not in use. The ICM did not provide an explanation or clarification on the hospital's document titled OSHA Fact Sheet or the hospital's document titled Bloodborne Pathogen Exposure Plan.

A review of OSHA's regulatory requirement indicated the following, "...29 CFR 1910.1030(d)(4)(iii)(B)(1)(i), dated 08/09/2007 (August 9, 2007), requires that...Regulated waste shall be placed in containers which are...Closable..."

A review of the facility's P&P titled, "Biohazardous Waste Management and Sharps Disposal," effective December 28, 2020, indicated, "...Policy: The policy of [Name of the Hospital] is to decrease the potential of exposure to hazardous waste by appropriate management and disposal...4. Guideline...4.1...a. Place biohazardous waste in identified puncture resistant covered trash containers..."

A review of the facility's P&P titled, "Bloodborne Pathogen Exposure Control Plan-Hospital" effective date December 23, 2020, indicated, "...Requirements for Handling Contaminated Sharps...2. Disposable sharps shall not be reused and shall be placed into containers that are closeable, puncture resistant and leak-proof on the sides and bottom..."

4. During a tour of the GI department conducted with Nurse Coordinator (NC) 1, on December 21, 2023, at 11:17 a.m., the scope's sterile processing room was observed. Thick grey fuzzy matter, black particles, and debris was observed scattered throughout the scope storage room's floor, and along the baseboards. Sterile Processing Technician (SPT) 1 was observed removing the lid cover from a contaminated scope transport box and placing the scope into the scope's sterilizer (a machine used to kill germs on a specific surface or object). The lid cover was observed to contain the following information:

The physician's name;

The patient's room number; and

Pre-cleaned at 9:05 a.m.

An interview was conducted with SPT 1 and NC 1, on December 21, 2023, at 11:24 a.m., in the scope's sterile processing room. SPT 1 confirmed the transport box was used to transport the contaminated scope from the patient's room to the sterile processing area. SPT 1 stated he had performed the enzymatic cleaning process and placed the scope back into the contaminated box because the department was short staffed, and the scope sterilizers were in use after he had completed the enzymatic cleaning for the scope. NC 1 stated SPT 1 should have requested assistance and should not have reused the transport box. NC 1 stated she agreed that the department was short staffed, but staff must accurately perform all scope processing steps in accordance with the manufacturer's IFU. NC 1 stated the scope must be reprocessed in accordance with the manufacturer's instructions and acceptable standards of practice. NC 1 stated the thick grey fuzzy matter was dust and she could not identify the black particles. NC 1 stated she did not know if the scope's sterile processing room was terminally cleaned. NC 1 stated the scope sterile processing room should have been terminally cleaned because the room was used to clean and decontaminate (High Level Disinfect) re-usable patient scopes. The Terminal cleaning logs for the scope's sterile processing room was requested.

The facility did not provide logs to demonstrate that terminal cleaning was performed in the scope's sterile processing room.

The review of the AORN's Guidelines for Practice "Guidelines for Perioperative Practice: Environmental Cleaning," dated January 13, 2020, was conducted and the AORN guideline indicated, "...6. Sterile Processing Areas: 6.2 Terminally clean sterile processing areas each day the areas are used..."

5. A tour was conducted of the MSC, with the Director of Operations (DOMSC) and Nurse Coordinator (NC) 2, on December 26, 2023, at 11:15 a.m., in the MSC's endoscope sterile processing room. GI Technician (GI Tech) 2 was observed removing the endoscope from a disposal transport box and placing the endoscope into the endoscope's sterilizer (a machine used to kill germs on a specific surface or object).

An interview was conducted with GI Tech 1 and GI Tech 2, on December 26, 2023, at 11:40 a.m., in the MSC's endoscope processing room. GI Tech 1 stated the following steps should be followed for processing flexible endoscopes in accordance with the manufacturer's instruction for use (IFU).

Step 1. Pre-cleaning (a point-of-use treatment to prevent soils from drying on the endoscope).

Step 2. Leak testing (to detect damage to the endoscopes);

Step 3. Manual cleaning (to remove germs from an endoscope);

Step 4. Rinse after cleaning (to remove residual debris and detergent);

Step 5. Visual inspection (to make sure the endoscope is visibly clean);

Step 6. High-level disinfection (a process to kill all germs except for bacterial spores);

Step 7. Rinse after high level disinfection (to prevent exposure and potential injury to the patient's skin and mucous membranes from the chemical residue);

Step 8. Drying the endoscope thoroughly before storage (to prevent germs form surviving and multiplying); and

Step 9. Storage (the area must be clean and dust free to keep the endoscopes free from microbial contamination).

GI Tech 1 stated the Infection Control Manager (ICM) and Infection Preventionist (ICP) 1 made changes to the process for cleaning endoscopes and instructed the GI department staff to skip Step 1 to Step 5 if the endoscope had not encountered a patient's skin or mucous membranes. GI Tech 1 confirmed she followed the new endoscope process and skipped Step 1 to Step 5 for endoscopes that were either expired or had been potentially cross-contaminated (the transfer of harmful bacteria from one person, object, or place to another). GI Tech 1 stated the ICM did not provide the department with written instructions, competencies (measurable or observable knowledge and skills), or a revised P&P on the new scope process. GI Tech 1 stated she could not recall the date that the ICM changed the endoscope cleaning process.

During an interview with the ICM, on December 27, 2023, at 11:50 a.m., in the conference room, the ICM stated she did not realize that staff were skipping Step 1 to Step 5. The ICM stated, "It was a misunderstanding." The ICM stated staff must perform all endoscope processing steps in accordance with the manufacturer's IFU.

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2018, indicated the following instructions for use, "...1.2 Importance of Cleaning, Disinfection, and Sterilization: The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals for all ancillary equipment, and have a thorough understanding of the following items: Instruction manuals for the endoscope, accessories, and all the other reprocessing equipment..."

The review of the facility P&P titled, "Cleaning and Processing of Flexible Endoscopes and Endoscope Accessories," dated March 19, 2021, indicated, "...2. Procedures: 2.1 The manufacturer's written instructions for flexible endoscopes and all accessories will be followed regarding: a. Cleaning process..."

6. A concurrent interview and observation of Scope Cabinet 2 was conducted with Charge Nurse (CN) 2, on December 26, 2023, at 2:00 p.m., in the endoscope's storage room. CN 2 stated he did not know if Scope Cabinet 2 had a HEPA filter. CN 2 was observed opening Scope Cabinet 2's rolled-top door and the HEPA filter was observed behind the endoscopes and attached to the surface of the cabinet. There was no preventative maintenance sticker observed attached to Scope Cabinet 2. CN 2 stated he did not know who was responsible for providing preventative maintenance for the scope storage cabinets or who was responsible for changing the scope cabinet's filter. CN 2 stated, "Probably, the biomedical department is responsible for changing the scope cabinet's filter."

An interview was conducted with Plant Operation Staff (POS) 1 and the Director of Plant Operations (DOPO) on December 26, 2023, at 2:25 p.m., in the GI department. POS 1 stated the scope cabinet's fan or HEPA filter had never been scheduled on the preventative maintenance program and there were no preventative maintenance records for the storage cabinets. The DOPO stated the biomedical department has never changed the scope cabinet's HEPA filters because the cabinets do not have preventative maintenance stickers.

During an interview conducted with Registered Nurse Manager (RNM) 1 on December 26, 2023, at 4:30 p.m., in the CR, RNM 1 stated she was employed as the manager for the GI department two years ago. RNM 1 stated the scope cabinet's HEPA filters should have been changed every six months and she had ensured the scope cabinet's HEPA filters had been changed before she left the department. RNM 1 stated she did not know if the facility had documentation that showed the scope storage cabinets and filters were on a regular schedule for the preventative maintenance program.

A concurrent interview and observation of Scope Cabinet 2 was conducted with RNM 1 on December 26, 2023, at 4:40 p.m., in the endoscope's storage room. RNM 1 was observed accessing Scope Cabinet 2 and removing the cabinet's HEPA filter. The HEPA filter was observed dated to be changed on January 16, 2022 (23 months ago). RNM 1 viewed the front and back surfaces of the HEPA filter and proceded to read the date that was written on the side of the HEPA filter. RNM 1 stated, "This filter is very dirty and should have been changed on January 16, 2022." RNM 1 stated the filter must be replaced and Scope Cabinet 2 should be cleaned and all the scopes in the cabinet should be removed and reprocessed before patient use.

The review of the manufacturer's instructions, titled "InnerSpace: Care and Maintenance," dated 2018, indicated the following, "...To maintain your Fan Unit: Change Fan Unit HEPA filter every 6 months..."

The review of the manufacturer's instructions, titled "Mass Medical Storage," version 4.2, indicated the following, "...Cabinets with HEPA Filters: HEPA filters should be replaced every six months..."

The review of the AORN's Guidelines for Perioperative Practice: "Flexible Endoscopes," dated November 1, 2018, the AORN guideline indicated the following, "...18. Processing Records...8.10. Maintain records of all repairs and maintenance for all endoscopes and endoscope accessories, processing equipment, water filtration systems (e.g., filter changes), and storage cabinets (e.g., filter changes) including records of when the devic