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Based on observation, interview and record review, the Condition of Participation (COP) Compliance with Federal, State, and Local laws and regulations related to the health and safety of patients was determined to be NOT MET when the hospital assigned and utilized an unlicensed area to reprocess (process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) in the Endoscopy (procedure used in medicine to look inside the body) department.

The cumulative effect of this systemic failure resulted in the facility's substantial noncompliance with federal, state and local laws. (Refer A022)

Based on observation, interview, and record review, the hospital failed to ensure compliance with federal, state and local laws when staff assigned and utilized an unlicensed area of the building to reprocess (a special process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) in the Endoscopy (procedure used in medicine to look inside the body) department. Facility staff and leadership were aware the room assigned to reprocess endoscopes was not licensed and located in the part of the building that is unlicensed.

This failure had the potential to permit the reprocessing of endoscopes in a room/area not in compliance with building codes and requirements meant to ensure a sanitary environment.

Findings:

During a concurrent observation and interview on 7/6/22, at 1:35 p.m., in Operating Room (OR) 9, with Endoscopy Technician (ET) 1 and the Flexible Scope Coordinator (FSC), ET 1 pre-cleaned an endoscope with an enzymatic detergent in a plastic container. ET 1 stated the endoscope was used in an endoscopic retrograde cholangiopancreatography (ERCP- a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas) procedure and "point of use pre-cleaning" was required prior to the scope being transported to the sterile processing department (SPD- area where cleaning and sterilization of devices used in medical procedures takes place) for reprocessing. ET 1 completed the "pre-clean" process and suctioned all the remaining fluid from the container. ET 1 applied a transparent red disposable biohazard cap over the container and carried the container through the patient and visitor lobby, across the hallway, and to the SPD reprocessing room for endoscopes. The outside of the container was not cleaned and disinfected before leaving OR 9. The FSC stated this process was in place since 2018. The FSC stated endoscope reprocessing was centralized to an unlicensed area outside the endoscopy department due to space constraints. The FSC stated he did not know who had made the decision to move the endoscope reprocessing to the particular room. The FSC stated the area had been either an office space or a patient's room before. The room was spacious and clean with machines inside the area.

During an interview on 7/8/22, at 8:02 a.m., with Registered Nurse (RN) 10, RN 10 stated he used an endoscope "transport tower" to transport the contaminated endoscopes to the SPD reprocessing department. RN 10 stated he did not carry or use an open metal cart to transport the "dirty" endoscopes because the endoscope had the potential to fall. RN 10 stated it was an infection control and patient safety issue which he tried to minimize as much as he could. RN 10 stated staff hand carried endoscopes to the reprocessing department "all the time."

During an interview on 7/8/22, at 8:30 a.m., with RN 9, RN 9 stated she was not comfortable carrying "dirty" endoscopes to SPD through patient and visitor common areas. RN 9 stated the process risked scope integrity and had the potential to expose patients or visitors to infectious materials if there was an unforeseen accident during transport.

During an interview on 7/8/22, 9:05 a.m., with ET 1, ET 1 stated she was not comfortable with carrying endoscopes to SPD scope reprocessing room through patient and visitor areas of the facility. ET 1 stated she tried not to touch or open doors while carrying the contaminated endoscopes but the risk for cross contamination remained high during transport.

During concurrent interviews on 7/11/22, at 4:45 p.m., with the Medical Director of Gastroenterology Services (MDGI), the MDGI stated the scope cabinets were stored in procedure rooms B and C due to the department's space constraints. The MDGI stated the way the endoscopes were stored posed minimal infection control risk to patients because the cabinets stayed closed and were reprocessed and tested for bacteria (germs). The MDGI stated the scope that required special attention, most difficult to reprocess, and had a higher risk to spread infection were the "EUS" scopes (long flexible scopes with ultrasound capabilities that can be inserted through the mouth or rectum; also referred to as duodenoscopes) because of their small mechanical components and use in "ERCP" procedures. The MDGI stated the "EUS" scopes were stored elsewhere in the department to minimize contamination and risk of infection to patients. The MDGI stated he was not aware the temperature and humidity in scope storage areas were not monitored and that scopes were reprocessed in "unlicensed" area of the hospital.

During an interview on 7/13/22, at 3 p.m., with the Quality Assurance and Performance Improvement team consisting of the Administrator (ADM), Chief Nursing Executive/Chief Operations Officer (CNE/COO), Interim Area Quality Leader & Patient Safety Officer (IAQLPSO), Perioperative Director (PD), Support Services Administrator (SSA), Patient Care Director (PCD), Nursing Operations Director (NOD), Chief of Medical Staff (CMS), the CNE stated the scopes were placed in the Endoscopy procedure rooms due to the fact that the hospital was making plans to expand the space needed to have a centralized location for reprocessing and storing endoscopes. The PD stated there had been a discussion about storing and reprocessing scopes in a centralized area, and that scopes had been stored and reprocessed in other areas. The PD stated the Endoscopy department had evolved into having more complex scopes that drove the need for centralizing the sterile processing of all scopes. The PD stated he knew of the need to standardize the reprocessing of endoscopes so that there could be specific staff that were trained and to track universal standards for reprocessing the scopes, but had not been implemented until 7/6/22 when the state agency discovered the infection control breaches.

During a review of the hospital's "2021 and 2022 Quality and Patient Safety Work Plan and Annual Evaluation", dated 2021 to 2022, there was no indication of the hospital initiating performance improvement projects to address reprocessing endoscopes in an unlicensed area of the Endoscopy department.

During a review of the hospital license (HL) and facility map (FM), the HL indicated the hospital was licensed for 169 general acute care beds and included approved services of Basic Emergency services and Endoscopy. The FM indicated the hospital was on a campus that included outpatient clinics space that was not licensed and is not under the jurisdiction of the Department. The facility map indicated the clinic and hospital were configured on four floors with contiguous access from one part of the campus to the other. The hospital portion of the building complex was clearly demarcated on the facility map and the configuration is an upside down "L" with the shorter arm being the clinic space.

During a concurrent interview and record review on 7/21/22, at 3 p.m., with the Health Care Access and Information Compliance Officer (HCAI), the HCAI stated the hospital needed to ensure it was complying with the California Building Code 1224.15 for surgical services areas. The HCAI stated the hospital could not have endoscopes stored in one place and cross over to another area of the hospital for reprocessing. The HCAI stated the area for reprocessing endoscopes needed to have the space adequate to store and reprocess in the same area to ensure codes were met. The "CALIFORNIA BUILDING CODE CHAPTER 12 - INTERIOR ENVIRONMENT", dated 2016, indicated, " ...1224.15 Surgical Service Space ...1224.15.1 General ...The surgical service space shall be divided into two designated areas: 1) semi-restricted areas (e.g. storage areas for clean and sterile supplies, sterile processing rooms, scrub stations, and corridors leading to restricted areas of the surgical suite, etc.); and 2) restricted areas (e.g. operating rooms, hybrid operating rooms, sterile procedure rooms, cardiac catheterization labs, etc.) that can be reached only through a semi-restricted area. The surgical service space shall be located and arranged to provide direct support from the anesthesia/recovery service space with a common door to prevent nonrelated traffic through the surgical service space. An operating room suite design with a sterile core shall provide for no cross traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas. The use of facilities outside the operating room for soiled/decontaminated processing and clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean/sterile without compromising universal precautions or aseptic techniques in either department ... 1224.15.2.2 Surgical Cystoscopic and Other Endo-Uro-Logic Procedures ...Each room shall have a minimum clear floor area of 250 square feet (23.23 m2) with a minimum of 15 feet (4572 mm) clear dimension between fixed cabinets and built-in shelves. X-ray viewing and/or other imaging modality capabilities shall be provided ...1224.39.3 Gastrointestinal Endoscopy...If gastrointestinal endoscopy is performed in the outpatient service area, the endoscopy suite shall be divided into a minimum of three major functional areas: the procedure room(s), instrument processing room(s), and patient holding/preparation and recovery room or area and the following shall be provided: 1224.39.3.1 Procedure Room(s)...1224.39.3.1.1 Space Requirements...Procedure room shall have a minimum clear floor area of 200 square feet (18.6 m2). Room arrangement shall permit a minimum clearance of 3 feet, 6 inches (1067 mm) at each side, head, and foot of the gurney/table...1224.39.3.1.2 Handwashing Stations...A separate dedicated handwashing station with hands-free controls shall be provided in the procedure room...1224.39.3.2 Processing Room...1224.39.3.2.1 Dedicated processing room(s) for cleaning and decontaminating instruments shall be provided. The cleaning area shall allow for flow of instruments from the contaminated area to the clean assembly area and then to storage...1224.39.3.2.2...The decontamination area shall be equipped with the following: Utility sink(s) shall be provided as appropriate to the method of decontamination used. One freestanding handwashing station. Work counter space(s)."

During a review of a professional reference titled "Storage and Transport of Flexible Endoscopes", dated May/June 2019, the article indicated, " ... Soiled endoscopes must be handled in a manner that minimizes the risk of cross- contamination of the environment. This is accomplished by containing the endoscope in a solid transport container ... Containment of the soiled instrument must be performed correctly to prevent exposure to staff and other patients to that biohazardous device ... an OSHA- complaint transport container ... Since endoscopes are sharp in the respect that they have metal prongs that stick out ... they should be treated as sharp metal devices ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes ... SGNA ...Society of Gastroenterology Nurses and Associates", dated 2018, the manual indicated, "Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that prevents exposing staff, patients, or the environment to potentially infectious organisms ..."

Based on observation, interview and record review, the hospital failed to have an effective Governing Body which was held legally responsible for the conduct of the hospital when:

1. Resources were not allocated to address the age and unsanitary condition of storage cabinets for endoscopes in the Endoscopy Department and storage cabinets for sterile supplies in Obstetrics.

2. Quality Improvement projects were not prioritized to address adherence to accreditation and licensing requirements. An unlicensed area was assigned and utilized to reprocess endoscopes from the Endoscopy Department. Staff were unaware and did not follow CDC and CDPH standards for Covid 19 screening at all entries of the hospital.

3. There was a systemic failure to adhere to professional standards of practice and CDC standards for Infection Control hospital-wide.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner. (Refer A063)

Based on observation, interview and record review, the hospital failed to have an effective Governing Body which was held legally responsible for the conduct of the hospital when:

1. Resources were not allocated to address the age and unsanitary condition of storage cabinets for endoscopes in the Endoscopy Department and storage cabinets for sterile supplies in Obstetrics.

2. Quality Improvement projects were not prioritized to address adherence to accreditation and licensing requirements. An unlicensed area was assigned and utilized to reprocess endoscopes from the Endoscopy Department. Staff were unaware and did not follow CDC and CDPH standards for Covid 19 screening at all entries of the hospital.

3. There was a systemic failure to adhere to professional standards of practice and CDC standards for Infection Control hospital-wide.

These failures resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Findings:

1. During concurrent observation and interview on 7/6/22, at 11:18 a.m., in the endoscopy department, with the Flexible Scope Coordinator (FSC) and Medical Assistant (MA1), procedure rooms B and C had one endoscope cabinet in each room. Fourteen reprocessed endoscopes hung vertically in each of the storage cabinets. The cabinets were chipped and had gray particles outside the collection bins on the cabinet floors. Adjacent to the procedure rooms was a "clean storage" room with three endoscope cabinets. Cabinet "One" (C1) stored 16 reprocessed scopes, cabinet "Two" (C2) stored eight scopes, and cabinet "Three" (C3) stored seven scopes. The cabinets (C1, C2, and C3) were chipped and had gray particles on the cabinet floors. C2 had a reddish-brown staining on the cabinet floor trim. MA1 wiped the reddish- brown stain with a disinfectant wipe and stated, "It doesn't come off ... looks like rust." The FSC stated the endoscopy department followed manufacturer's guidelines and AAMI standards for scope storage and reprocessing. The FSC acknowledged the five cabinets were not cleaned and maintained in sanitary condition in accordance with AAMI standards. The FSC stated the unsanitary conditions were identified six months ago and the facility was in the process of replacing the cabinets. The FSC stated the cabinets were stored in procedure rooms B and C due to a lack of space and there was no plan in place to move the cabinets out of the procedure rooms. The FSC stated unused endoscopes were reprocessed every 30 days. The FSC stated all scopes were reprocessed by SPD in an "unlicensed" area of the facility.

During an interview on 7/6/22, at 11:30 a.m., with the Director of Engineering and Plant Operations (DPO), the DPO stated endoscopy procedure rooms were not monitored for temperature and humidity. The DPO stated the "clean storage" room was a "positive pressure" room (room that contains a higher pressure than the external environment to prevent air from leaving the room and circulating back inside) that was not monitored for temperature and humidity.

During an interview on 7/11/22, at 12:45 p.m., with the Endoscopy Manager (EM), the EM stated endoscopes were stored in procedure rooms B and C since before she was hired over two years ago. The EM stated the unsanitary condition of the cabinets were identified six months ago and department leadership determined that the cabinets needed to be replaced, however there was no discussion about moving the cabinets out of the procedure rooms. The EM stated she was not aware staff entered procedure rooms to retrieve scopes during endoscopy procedures. The EM stated staff were expected to prepare scopes prior to each procedure to avoid entering the rooms during procedures and potentially contaminating the reprocessed scopes. The EM acknowledged this practice compromised the safety of the procedures and patients.

During a concurrent observation and interview on 7/7/22, at 9:28 a.m., with Obstetrics Tech (OBT 1), in storage room 1LD-88, operating room (OR) sterile instrument kits for C-sections (surgical procedure by which a baby is delivered through an incision in the mother's abdomen, often performed because vaginal deliver would put the baby or mother at risk) were stored on an open metal rack, and on the opposite rack there were the following non-sterile supplies: baby diapers, baby wipes, an opened box of [brand name] foot/finger print pads, an opened box of [brand name] pulse oximeter probe wraps (tapeless wrap used on baby) and additional non-sterile unit supplies were observed. OBT 1 stated, the storage room was used to store ready-to-use sterile instruments that had been picked up from the sterile processing department after they were sterilized. OBT 1 stated, that additional unit supplies were stored in the same space. OBT 1 stated, her process is to remove the stored sterilized C-section instrument kits from the rack in the storage room and place them in the OR for the next surgery.

During a concurrent observation and interview on 7/8/22, at 9:45 a.m., with Obstetrics Tech (OBT 2), in 1LD-88, no badge access was observed when entering. In 1LD-88, a chain link fence padlocked with a computer behind the fence was observed, the chain link fence ran across the back of one supply storage rack. OBT 2 stated, the storage area "may be considered a clean environment". OBT 2 stated, the OR sterile C-section instrument kits had "always" been stored in there. OBT 2 stated, no badge access was required for entrance to room and all staff had access to room.

During an interview on 7/11/22, at 3 p.m., with IP 1, IP 1 stated she was aware of the endoscopes being stored in procedure rooms. IP 1 stated the endoscopes were stored in procedure rooms B and C for "a long time" and recognized there was a problem with the cabinets "2-3 years ago." IP 1 stated there was a plan to have them replaced once the project to replace the cabinets was approved. IP 1 stated the cabinets in the procedure rooms posed minimal risks to patients since "our cabinet is tightly closed." IP 1 stated staff were expected to prepare supplies and scopes before each procedure and was unaware of any "breaches" in infection control. IP 1 stated she expected scopes to be reprocessed when breaches in infection control occurred. IP 1 also stated she thought plant operations monitored the temperature and humidity in the procedure rooms. IP 1 stated, she was aware that 1LD-88 was used to store sterile obstetrics OR C-section instrument kits, clean storage and an IT tower which included a computer. IP 1 stated there was temperature, humidity and pressure parameters followed. IP 1 stated, if the IT tower is cleaned from top to bottom from an IP perspective it was appropriate for OR sterile C-section instrument kits, IT equipment and clean storage to be stored together. IP 1 stated, the facility follows Association for the Advancement of Medical Instrumentation (AMMI) standards of practice.

During concurrent interviews on 7/11/22, at 4:45 p.m., with the Medical Director of Gastroenterology Services (MDGI), the MDGI stated the scope cabinets were stored in procedure rooms B and C due to the department's space constraints. The MDGI stated the way the endoscopes were stored posed minimal infection control risk to patients because the cabinets stayed closed and were reprocessed and tested for bacteria (germs). The MDGI stated the scope that required special attention, most difficult to reprocess, and had a higher risk to spread infection were the "EUS" scopes (long flexible scopes with ultrasound capabilities that can be inserted through the mouth or rectum; also referred to as duodenoscopes) because of their small mechanical components and use in Endoscopic Retrograde Cholangiopancreatography (ERCP-procedure to diagnose and treat problems in the liver, gallbladder, and pancreas using imaging and a long flexible lighted tube) procedures . The MDGI stated the "EUS" scopes were stored elsewhere in the department to minimize contamination and risk of infection to patients. The MDGI stated he was not aware the temperature and humidity in scope storage areas were not monitored and that scopes were reprocessed in "unlicensed" area of the hospital.

During an interview on 7/12/22, at 7:52 a.m., with Plant Operations Director (POD), POD stated, in 1LD-88 thirty-six square feet (measurement of area) was used for IT equipment. POD stated, a fan is on at all times for the IT equipment and that the fan picks up dust in the room. POD stated, storage room 1LD-88 is currently (7/12/22) being monitored for humidity.

During a review of a handwritten document provided by the facility's endoscopy department, dated 7/6/22, the document listed the type, number, and storage location of the reprocessed endoscopes. The "EUS" scopes were stored in C2, the cabinet with reddish-brown staining.

During an interview on 7/13/22, at 3 p.m., with the Quality Assurance and Performance Improvement team consisting of the Administrator (ADM), Chief Nursing Executive/Chief Operations Officer (CNE/COO), Interim Area Quality Leader & Patient Safety Officer (IAQLPSO), Perioperative Director (PD), Support Services Administrator (SSA), Patient Care Director (PCD), Nursing Operations Director (NOD), Chief of Medical Staff (CMS), the CNE stated the scopes stored in the Endoscopy procedure rooms were not the original location in where scopes should have been stored. The CNE stated the decision to place the scopes in the cabinets preceded all members with oversight of those scopes. The CNE stated she was not aware of those scopes being stored in those cabinets in the Endoscopy cabinets. The CNE stated the scopes were placed there due to the fact that the hospital was making plans to expand the space needed to have a centralized location for reprocessing and storing endoscopes. The PD stated the decision to store scopes in the cabinets had predated him. The PD stated there had been a discussion about storing and reprocessing scopes in a centralized area, and that scopes had been stored and reprocessed in other areas of the hospital. The ADM stated the hospital had identified the need to replace the cabinets and were looking to fund the new installments back in October 2021. The ADM stated the hospital was awaiting for approval for the funding as it had already been planned to invest in new cabinets. The ADM stated because it was going through a Space Committee approval, it was not an urgent matter to address and was delayed. The ADM stated the Infection Control Committee involving the IP were responsible for tracking any infection control issues with storing of endoscopes in the cabinets in the Endoscopy procedure rooms. The ADM stated there was also intent to move the endoscopes out of the Endoscopy procedure rooms, but had not expedited the project as it was not an urgent matter. The CNE stated the current hospital staff overseeing the storage of endoscopes in the Endoscopy rooms had not made the decision to be placed there, but there had been complacency on the part of the hospital and there was no sense of urgency to remove the endoscopes from the Endoscopy rooms. The CNE stated the hospital did have funds to initiate projects to replace cabinets and take them to a more centralized location for reprocessing. The CNE stated she understood the importance of having endoscopes sanitary before patient use. The CNE stated she was bothered by the fact that staff were using scopes located in unsanitary locations to be used on patients for procedures. The NOD stated storage of scopes in OB had also been occurring for years. The NOD stated anesthesiologists (doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) needed more space and the storage room in OB could serve to keep equipment such as scopes. The NOD stated the hospital believed they were meeting regulations regarding storage of items in the OB due to Plan Operations department stating they had met the regulations for storage of equipment in the OB.

During a review of the hospital's "2021 and 2022 Quality and Patient Safety Work Plan and Annual Evaluation", dated 2021 to 2022, there was no indication of the hospital addressing infection control practices of endoscopes being stored in unclean areas in the Endoscopy procedure rooms, nor in the OB storage rooms. There were no improvement projects initiated by the QAPI team to improve any breaches in infection control as it pertained to the endoscopes in the endoscopy department or scopes in the OB department.

During a review of the hospital's "Medical Executive Committee Minutes" (MEC), dated July 2021 to June 2022, the MEC indicated no meetings to discuss any oversight of endoscopes being stored in unsanitary conditions in the endoscopy department.

During a review of the hospitals "Project Schedule", dated 7/13/22, indicated, " ...2021 FRS MC (Fresno MC) Cabinet Endoscopes ...Duration 21.35 months ...Planning ...Start 10/28/21 ...Finish 1/19/22 ...Design ...Start 1/20/22 ...Finish ...5/19/22 ...Permitting ...Start 5/20/22 ...Finish 8/11/22...Field Construction ...Start 9/22/22 ...Finish 11/3/22 ...Facility utilization ...Start 12/20/22 ..."

During a review of Chapter 8 of the manufacturer's guidelines for duodenovideoscopes, gastrointestinal videoscope, and colonovideoscopes titled "Reprocessing Manual", undated, the manuals indicated " ... Precautions of storage ... maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/ or operators who touch them ... Establish a local policy regarding method and frequency of cleaning and disinfecting the endoscope storage cabinet ... Improper storage practices ... will lead to an infection control risk ... To prevent damage, do not store the endoscope ... at high temperatures, in high humidity ... Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated ... Microorganisms proliferate in wet/moist environments. Keep cabinet doors closed to protect the equipment from environmental contaminants and accidental contact ... Store the sterilized endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices ..."

During a review of the document from the Association for the Advancement of Medical Instrumentation (AAMI-primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals) "Drying and Storage of Flexible Endoscopes: An Area of Growing Concern" dated 2020, the document indicated," ... Healthcare Infection Control Practices ... A risk assessment should be performed for storage of endoscopes, as appropriate. Store endoscopes and accessories in a manner that prevents recontamination ... Recommendation ... Society of Gastroenterology Nurses and Associates ... Storage areas should be suitable for clean endoscopes (clean, well ventilated, and dust free) ... Seven-day storage if scopes were reprocessed and stored according to professional guidelines and manufacturer's instructions ... the key drivers of endoscope contamination are inadequate disinfection and/ or poor storage practices ..."

During a review of the facility's policy and procedure (P&P) titled "Temperature and Humidity Monitoring in the Operating Rooms, Sterile Processing and Procedure Rooms NCAL Regional Policy" dated 7/28/21, the P&P indicated, " ... Critical environments where invasive surgical procedures are performed and sterile instruments are processed and stored require optimum environmental conditions such as temperature and humidity to ... regulate the environment for the safety and comfort of patients and care providers ... decrease potential for microbial growth, such as mold and mildew in the case of high humidity conditions ... preserve shelf life and integrity of sterile supplies and equipment calibration ... Manual daily monitoring can be done by individual departments if the facility has no automated remote monitoring capacity ... Daily logging is required for non-continuous, periodic monitoring ... The temperature and humidity shall be maintained in the following ranges (ASHRAE & AAMI Standard ST79, 2017) ...location: sterile storage Temperature Range [less than] 75 [Fahrenheit (unit of measure for temperature)] Relative Humidity Range Max [imum] 60 [percent] ..."

A review of the professional reference at https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13563 titled "Management and Mitigation of Temperature and Humidity ... Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ..."

During a review of professional reference titled "AAMI Sterility Assurance", dated 3/13/19, the reference indicated, " ...Objectives ... To provide an overview of the relevant AAMI standards that direct processing practices ... ST-79 ... General work areas - 68-73 deg. [degrees] F [Fahrenheit] (20-23 deg. C [Celsius]) ... Decontam [decontamination] - 60-65deg F (16-18 deg. C.) ... Sterilization access room -75-85 def. F (24-29 deg. C.) (or as recommended by equipment mfr [manufacturer]) ... Sterile storage/support areas - 75 deg. (maximum -24deg.C.) ..."

During a professional reference reviewed retrieved from https://www.aami.org/standards/ansi-aami-st79, titled, "ANSI [American National Standards Institute]/AAMI [Association for the Advancement of Medical Instrumentation] ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" indicated, "Sterile storage ... Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry ... Access to the sterile storage area should be restricted to authorized personnel ... Closed or covered cabinets are recommended for sterile storage. Open shelving may be used, but requires special attention to traffic control, area ventilation, and environmental services ..."

During a professional reference reviewed retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf, titled, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008", dated May 2019, the professional reference indicated, " ...Storage of Sterile Items ...Ensure the sterile storage area is a well-ventilated area that provides protection against dust, moisture, insects, and temperature and humidity extremes ..."

During a professional reference reviewed retrieved from https://aornguidelines.org/guidelines/content?sectionid=173737535&view=book#229141984, titled, "AORN eGuidelines", dated September 2018, the professional reference indicated, " ...Storage of Sterile Items ... Store sterile items in a controlled environment ... Limiting exposure to moisture, dust, direct sunlight, handling, and temperature and humidity extremes decreases the potential for contamination and degradation of sterilized items. Factors that contribute to contamination include handling, air movement, humidity, temperature, location of storage, dust, presence of vermin, whether shelving is open or closed, and properties of the sterile barrier system ... Store sterile items under controlled conditions. Controlled conditions reduce the risk of contaminating sterile items ... Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts ... Store sterile items in a manner that protects the integrity of the sterile barrier system ...sterile items should be ...stored under environmentally controlled conditions, which include a maximum temperature of 75° F (24° C), a maximum relative humidity of 60%, positive air pressure in relation to adjacent areas ..."

During a review of the job description for "Scope Oversight Coordinator", undated, the job description indicated, " ... Provides support to clinic managers responsible for endoscope/endocavity reprocessing areas ... staff training ... performing audits ... Collaborates with sterile processing/ and/ or department managers for employee and department safety, and risk management issues ..."

During a review of the job description for "Infection Prevention Program Manager", undated, the job description indicated, " ...Manages the medical center Infection Prevention Program to ensure activities are directed toward preventing and decreasing healthcare associated infections and improving patient safety across the continuum of care ... Collaborates with leadership team to ensure compliance with regulatory and accrediting agency requirements ... ensure surveillance activities and improvement plans are analyzed, implemented and reported to leadership ...Collaborates with Facility Services to ensure an integrated Environment of Care Program ..."

2. During a concurrent observation and interview on 7/6/22, at 1:35 p.m., in OR 9, with ET 1 and the FSC, ET 1 pre-cleaned an endoscope with an enzymatic detergent in a plastic container. ET 1 stated the endoscope was used in an ERCP procedure and "point of use pre-cleaning" was required prior to the scope being transported to Sterile Processing Department (SPD-area in the hospital where cleaning and sterilization of devices used in medical procedures takes place)for reprocessing. ET 1 completed the "pre-clean" process and suctioned all the remaining fluid from the container. ET 1 applied a transparent red disposable biohazard cap over the container and carried the container through the patient and visitor lobby, across the hallway, and to the SPD reprocessing room for endoscopes. The outside of the container was not cleaned and disinfected before leaving OR 9. The FSC stated this process was in place since 2018. The FSC stated endoscope reprocessing was centralized to an unlicensed area outside the endoscopy department due to space constraints. The FSC stated he did not know who had made the decision to move the endoscope reprocessing to the particular room. The FSC stated the area had been either an office space or a patient's room before. The room was spacious and clean with machines inside the area.

During an interview on 7/13/22, at 3 p.m., with the Quality Assurance and Performance Improvement team consisting of the Administrator (ADM), Chief Nursing Executive/Chief Operations Officer (CNE/COO), Interim Area Quality Leader & Patient Safety Officer (IAQLPSO), Perioperative Director (PD), Support Services Administrator (SSA), Patient Care Director (PCD), Nursing Operations Director (NOD), Chief of Medical Staff (CMS), the CNE stated the scopes were placed in the Endoscopy procedure rooms due to the fact that the hospital was making plans to expand the space needed to have a centralized location for reprocessing and storing endoscopes. The PD stated there had been a discussion about storing and reprocessing scopes in a centralized area, and that scopes had been stored and reprocessed in other areas. The PD stated the Endoscopy department had evolved into having more complex scopes that drove the need for centralizing the sterile processing of all scopes. The PD stated he knew of the need to standardize the reprocessing of endoscopes so that there could be specific staff that were trained and to track universal standards for reprocessing the scopes, but had not been implemented until 7/6/22 when the state agency discovered the infection control breaches.

During a review of the hospital license (HL) and facility map (FM), the HL indicated the hospital was licensed for 169 general acute care beds and included approved services of Basic Emergency services and Endoscopy. The FM indicated the hospital was on a campus that included outpatient clinics space that was not licensed and is not under the jurisdiction of the Department. The facility map indicated the clinic and hospital were configured on four floors with contiguous access from one part of the campus to the other. The hospital portion of the building complex was clearly demarcated on the facility map and the configuration is an upside down "L" with the shorter arm being the clinic space.

During a review of the hospital's "2021 and 2022 Quality and Patient Safety Work Plan and Annual Evaluation", dated 2021 to 2022, there was no indication of the hospital initiating performance improvement projects to address reprocessing endoscopes in an unlicensed area of the Endoscopy department.

During a review of the hospital's "Medical Executive Committee Minutes" (MEC), dated July 2021 to June 2022, the MEC indicated no meeting to discuss use of an unlicensed area in the SPD to reprocess endoscopes.

During a review of a professional reference titled "Storage and Transport of Flexible Endoscopes", dated May/ June 2019, the article indicated, " ... Soiled endoscopes must be handled in a manner that minimizes the risk of cross- contamination of the environment. This is accomplished by containing the endoscope in a solid transport container ... Containment of the soiled instrument must be performed correctly to prevent exposure to staff and other patients to that biohazardous device ... an OSHA- complaint transport container ... Since endoscopes are sharp in the respect that they have metal prongs that stick out ... they should be treated as sharp metal devices ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes ... SGNA ...Society of Gastroenterology Nurses and Associates", dated 2018, the manual indicated, "Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that prevents exposing staff, patients, or the environment to potentially infectious organisms ..."

During a concurrent interview and record review on 7/21/22, at 3 p.m., with the Health Care Access and Information Compliance Officer (HCAI), the HCAI stated the hospital needed to ensure it was complying with the California Building Code 1224.15 for surgical services areas. The HCAI stated the hospital could not have endoscopes stored in one place and cross over to another area of the hospital for reprocessing. The HCAI stated the area for reprocessing endoscopes needed to have the space adequate to store and reprocess in the same area to ensure codes were met. The "CALIFORNIA BUILDING CODE CHAPTER 12 - INTERIOR ENVIRONMENT", dated 2016, indicated, " ...1224.15 Surgical Service Space ...1224.15.1 General ...The surgical service space shall be divided into two designated areas: 1) semi-restricted areas (e.g. storage areas for clean and sterile supplies, sterile processing rooms, scrub stations, and corridors leading to restricted areas of the surgical suite, etc.); and 2) restricted areas (e.g. operating rooms, hybrid operating rooms, sterile procedure rooms, cardiac catheterization labs, etc.) that can be reached only through a semi-restricted area. The surgical service space shall be located and arranged to provide direct support from the anesthesia/recovery service space with a common door to prevent nonrelated traffic through the surgical service space. An operating room suite design with a sterile core shall provide for no cross traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas. The use of facilities outside the operating room for soiled/decontaminated processing and clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean/sterile without compromising universal precautions or aseptic techniques in either department ... 1224.15.2.2 Surgical Cystoscopic and Other Endo-Uro-Logic Procedures ...Each room shall have a minimum clear floor area of 250 square feet (23.23 m2) with a minimum of 15 feet (4572 mm) clear dimension between fixed cabinets and built-in shelves. X-ray viewing and/or other imaging modality capabilities shall be provided ...1224.39.3 Gastrointestinal Endoscopy...If gastrointestinal endoscopy is performed in the outpatient service area, the endoscopy suite shall be divided into a minimum of three major functional areas: the procedure room(s), instrument processing room(s), and patient holding/preparation and recovery room or area and the following shall be provided: 1224.39.3.1 Procedure Room(s)...1224.39.3.1.1 Space Requirements...Procedure room shall have a minimum clear floor area of 200 square feet (18.6 m2). Room arrangement shall permit a minimum clearance of 3 feet, 6 inches (1067 mm) at each side, head, and foot of the gurney/table...1224.39.3.1.2 Handwashing Stations...A separate dedicated handwashing station with hands-free controls shall be provided in the procedure room...1224.39.3.2 Processing Room...1224.39.3.2.1 Dedicated processing room(s) for cleaning and decontaminating instruments shall be provided. The cleaning area shall allow for flow of instruments from the contaminated area to the clean assembly area and then to storage...1224.39.3.2.2...The decontamination area shall be equipped with the following: Utility sink(s) shall be provided as appropriate to the method of decontamination used. One freestanding handwashing station. Work counter space(s)."

3. During an observation on 7/6/22, at 8:29 a.m., at the facility's clinic entrance surgical masks and hand sanitizer was observed on a table. No security personnel or staff were at entrance. Individuals were observed to walk past pharmacy to the welcome desk at the elevators and into patient care areas without screening for signs and symptoms of COVID-19.

During an observation and interview on 7/7/22, at 7:00 a.m. at the facility entrance near birthing center, with Transporter (TR) 1, Inpatient Pharmacy Technician (IPT), and the Director of Risk Management and Patient Safety (DRM), TR 1 asked surveyor questions to validate their vaccination status. TR 1 stated he did not ask visitors if visitors have signs and symptoms for COVID-19. TR 1 stated he would only ask if visitors are vaccinated. TR 1 stated if visitors are not vaccinated are given instructions to go in a room and get a nasal swab for the COVID-19 antigen (a toxin which detects COVID-19). IPT stated the sign outside entrance addressed visitors. The English sign located on the outside entrance indicated, "no visitors with COVID-19 symptoms or suspected COVID-19 allowed". IPT stated visitors are expected to know what the symptoms of COVID 19. DRM stated, "after two years I don't believe that people don't know what symptoms of COVID are".

During an observation on 7/7/22, at 1:10 p.m., at the birthing center entrance to facility, three screeners were observed sitting at a table. Surgical masks, hand sanitizer, armbands and stickers were observed on the table. The screeners (personnel who screen individuals entering the facility) did not ask any questions related to signs and symptoms of COVID 19.

During an observation on 7/8/22, at 7:05 a.m., at the facility's clinic entrance, hand sanitizer, a box half full of child masks and empty box for adult masks were on the table. No hospital personnel were located at the table to screen any visitors, staff or patients entering the facility and no COVID-19 signs and symptoms screening was being performed.

During a concurrent interview and record review on 7/11/22, at 3 p.m., with IP 1, CNE, IAQLPSO, DRM, CCIPP, Endoscopy Manager (EM), Regional Director of Infection Prevention (RDIP), IP 1 stated the screeners are responsible for stocking masks and hand sanitizer. IP stated any staff member can check if masks or hand sanitizer are available, as "infection prevention is everybody's business". IP 1 reviewed the document titled, "Recommended Approach for Compliance (RAD)". IP 1 stated the RAD guided staff on how to manage visitors that may have symptoms of COVID-19 coming into the Emergency Department (ED) and inpatient areas. IP stated a poster outside the entrances prompted visitors if they were symptomatic to not en

Based on observation interview and record review the facility failed to protect and promote each patient's rights when;

1. The facility failed to inform patients in advance of furnishing care in accordance with hospital policy and procedure for two of three patients (Patients 27 and 33) when Patients 27 and 33 staff was aware of their non-English language preference and an interpreter was not utilized to interpret documents explaining conditions of admission. Forms in English were provided for signature when the non-English preference forms were available for use. (Refer to A117)

2. The facility failed to ensure patients' right to privacy when staff routinely entered endoscopy (procedure used to examine a person's digestive tract) department procedure rooms while the patient was undergoing a procedure. The staff entered the procedure room in order to retrieve endoscopes (a flexible instrument used to view internal parts of the body) and supplies stored in cabinets located in the procedure room. The retrieved endoscopes and supplies were to be used in a separate and different procedure room. (Refer to A143)

3. Five of five cabinets storing reprocessed (a special process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) were not maintained in a manner that assured they were clean, safe, and functional. (Refer to A144 Finding 1)

4.. One of one endoscope used for an endoscopic retrograde cholangiopancreatography (ERCP- a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas) was carried by staff in a plastic container through patient, visitor, and staff seating areas and walkways. (Refer to 144 Finding 2)

5. The facility failed to ensure one of five sampled patients (Patient 29) was free from restraints, when the facility placed Patient 29 in restraints without attempting alternative and less restrictive interventions per the facility's policy and procedure titled, "Restraints NCAL(Northern California) Regional Policy". (Refer to A164)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on observation, interview and record review, the hospital failed to inform patients in advance of furnishing care in accordance with hospital policy and procedure for two of three patients (Patients 27 and 33) when Patients 27 and 33 staff was aware of their non-English language preference and an interpreter was not utilized to interpret documents explaining conditions of admission. Forms in English were provided for signature when the non-English preference forms were available for use.

These failures resulted in not protecting the patients' rights to be informed in a language of their preference, possible medical services for which the patients were unaware and could result in negatively affecting quality of care.
Findings:

During a review of Patient 27's "Face sheet" (a document with patient demographics), dated 7/8/22, the "Face sheet" indicated, " ...Spoken Language Spanish ...Written Language Spanish ..."

During an observation on 7/8/22, at 6:12 a.m., in the labor delivery unit, Patient 27 was seen signing the "Hospital Conditions of Admission (Inpatient/Outpatient Services) in English after a brief explanation by Unit Assistant (UA) 1 of the form.

During an interview on 7/8/22, at 7:20 a.m., with Patient 27, Patient 27 stated she preferred speaking and writing in Spanish.

During a concurrent interview and record review, on 7/12/22, at 8:10 a.m., with Registered Nurse (RN 17), Patient 27 "Hospital Conditions of Admission (Inpatient/Outpatient Services)", dated 7/8/22 was reviewed. The "Hospital Conditions of Admission (Inpatient/Outpatient Services)" indicated, Patient 27 "Signature [signature] ...Name [blank] ...Relationship [blank] ...Witness [blank] ...Date [date] Time [time] ...Sight Translated via (if applicable) [blank] ...Print Interpreter's Name and Identification Number [blank]." RN 17 stated, she usually asks patients if they need interpreter services, and does not go by what is indicated as a patient preferred language. RN 17 stated, an interpreter name and number should be on the form if an interpreter was used. RN 17 stated, she would not know if an interpreter was used because one is not indicated on the "Hospital Conditions of Admission (Inpatient/Outpatient Services)". RN 17 stated, she has only seen "Hospital Conditions of Admission (Inpatient/Outpatient Services)" available electronically in English. RN 17 stated all the non-English speaking patients she has had sign the form in English.

During concurrent interview and record review, on 7/12/22 at 8:57 a.m., with RN 17, Patient 33 "Face Sheet" was reviewed. The "Face Sheet" indicated, "Patient Languages Interpreter Needed Yes ...Spoken Language Spanish ...Written Language Spanish ..." RN 17 indicated, an interpreter was needed for Patient 33.

During a concurrent interview and record review, on 7/12/22, at 9:04 a.m., with RN 17, Patient 33 "Hospital Conditions of Admission (Inpatient/Outpatient Services)", dated 7/6/22 was reviewed. The Patient 33's "Hospital Conditions of Admission (Inpatient/Outpatient Services)" indicated, "Signature [signature], Relationship Self ...Witness [signature] RN, Date [date] Time [time] ...Sight Translated via (if applicable) [blank] ...Print Interpreter's Name and Identification Number [blank]." RN 17 verified, there was no indication that an interpreter was used.

During an interview on 7/13/22, at 10:09 a.m., with Coordinator Care Services Director (CCSD), CCSD stated, the expectation for staff is that they communicate in a manner that an alert and oriented patient would understand. CCSD stated, she encourages the use of a professional interpreter when the patient communicates with the medical team and the preference is non-English language. CCSD stated, her expectation is that if the medical record indicates a need for an interpreter, then one should be used. CCSD stated if an interpreter is not used, she would expect documentation indicating why. CCSD stated, her expectation is that the patients understand what they are signing. CCSD stated, she was not sure staff assigned to conduct admitting services had a Spanish version of the "Hospital Conditions of Admission (Inpatient/Outpatient Services)".

During an interview on 7/13/22, at 10:15 a.m., with Interim Area Quality Leader and Patient Safety Officer (IAQLPSO), IAQLPSO stated, the electronic "Hospital Conditions of Admission (Inpatient/Outpatient Services)" form was available in Spanish.

During an interview on 7/13/22, at 10:16 a.m., with Revenue Cycle Manager (RCM), RCM stated, she expected the nurse or admitting staff to read through every line on the "Hospital Conditions of Admission (Inpatient/Outpatient Services)" with the use of interpreter services for patients who indicate non-English preference. RCM stated, the patient would be expected to sign the consent in English and documentation of the interpreter to be indicated on the form.

During an interview on 7/13/22, at 2:15 p.m., with Chief Nursing Executive/ Chief Operations Officer (CNE/COO), CNE/COO stated, Patient 27 should have signed the "Hospital Conditions of Admission (Inpatient/Outpatient Services)" in Spanish. CNE/COO stated, signing a consent in English for a non-English speaking patient was a patient rights issue. CNE/COO stated that "key documents" are available in core (non-English) languages.

During a review of hospital document titled, "PRF03: Language Preference of Members by PARFU (Population at Risk for Utilization) Facility" for Fresno, dated 4/30/22, the "PRF03: Language Preference of Members by PARFU (Population at Risk for Utilization) Facility" indicated, 5,815 total members had indicated a preferred spoken language other than English. "PRF03: Language Preference of Members by PARFU (Population at Risk for Utilization) Facility" indicated, 2,728 required the use of an interpreter and 5,553 preferred a different written language other than English.

During a review of the facility's policy and procedure titled, "Qualified Interpreter Services for Limited English Proficient Persons", dated November 2021, indicated, " ...Members/patients are informed of their right to receive interpreter services ...how to access interpreter services ...Any member/patient who express a preference for non-English language, including Sign language or demonstrates a need for interpreter services is offered the use of qualified interpreter services at all administrative and clinical points of contact during all hours of operation ...The use of interpreter services in such encounters must be documented in the patients chart ...In a situation where a member or patient refuses the offer of interpreter ...the offer of interpreter services and refusal by the member/patient is be documented ..."

During a review of the facility's policy and procedure titled, "RI-014 Consent Policy", dated November 2021, indicated. " ...Interpreters ...Patients and decision-makers must be able to understand why they are being asked to authorize, whether it is agreement to the general terms and conditions of the hospitalization ...Documentation of the Interpreter ...The person providing the interpretation shall complete documentation and sign the consent form, indicating the date and time the interpretation services were provided and the general nature of the conversation ..."

Based on interviews and record review, the facility failed to ensure a safe environment for patients when three of eleven sampled personnel records (Environmental Service Aide [EVSA] 1, Sterile Processing Technician [SPDT] 5, and Registered Nurse [RN] 2) did not have mandatory annual education for confidentially and abuse reporting completed within the past year.

This failure placed patients at risk for confidentially breaches and unreported abuse.

Findings:

During a concurrent interview and record review on 7/8/22, at 10:40 a.m., with the Northern California Risk Management Human Resources Director (NCRMHRD), personnel education records were reviewed for education titled "NCAL Human Resources Review and Attestations" (NCALHRRA).dated 2022. The NCRMHRD stated the NCALHRRA contained annual education for confidentially and abuse reporting. The NCRRMHRD stated there was no record of completion of NCALHRRA for EVSA 1, nor for SPDT 5.

During a concurrent interview and record review on 7/11/22, at 10:22 a.m., with the NCRMHRD, the NCRMHRD reviewed education record for RN 2. NCRMHRD stated there was no record of RN 2's completion of NCALHRRA for 2022.

During an interview on 7/13/22, at 10:47 a.m., with the NCRMHRD, the NCRMHRD stated department managers have electronic reporting tools for managers to view, but some managers struggle with the platform for the tool. The NCRMHRD stated it was important for this training to be completed each year because the training contained elements for staff to identify and report abuse. The NCRMHRD stated there were regulatory elements for completing the NCALHRRA and if employees did not get educated, abuse might not get reported and that would have been unfortunate.

During an interview on 7/13/22, at 1:47 p.m., with the Compliance Officer, Northern California Human Resources (CONCHR), the CONCHR stated the NCALHRRA are completed by all employees upon hire and annually thereafter. The CONCHR stated the NCALHRRA was due to be completed by May 31 in 2022. The CONCHR stated the NCALHRRA is important to complete annually, as regulations change and the NCALHRRA, dated 2022, would have the most updated information. The CONCHR stated if employees did not complete the NCALHRRA, the employee may do something incorrectly or not report abuse and cause harm to patients. The CONCHR stated the employee's supervisor was responsible for monitoring the completion of the NCALHRRA and Human Resources sent out email reminders. The CONCHR stated consequences for non-completion of the NCALHRRA should have been suspension of the employee. The CONCHR stated Human Resources was responsible to follow up on the completion of the NCALHRRA and a global follow up did not occur.

During a record review of the NCALHRRA, the NCALHRRA indicated, " ...We periodically set aside to review [sic] and refresh our commitment to confidentiality and identifying our reporting requirements. In this review we will cover the following annual requirements ..." The NCALHRRA included education and attestations for a Confidentiality Agreement, Child Abuse Reporting Requirements, Domestic Violence Reporting Requirements, and Elder & Dependent Abuse Reporting Requirements.

Based on observation, interview and record review, the facility failed to ensure patients' right to privacy when staff routinely entered endoscopy (procedure used to examine a person's digestive tract) department procedure rooms while the patient was undergoing a procedure. The staff entered the procedure room in order to retrieve endoscopes (a flexible instrument used to view internal parts of the body) and supplies stored in cabinets located in the procedure room. The retrieved endoscopes and supplies were to be used in a separate and different procedure room.

This failure denied patients who received care in the endoscopy department the right to personal privacy and respect and preservation of personal dignity.

Findings:

During concurrent observation and interview on 7/6/22, at 11:18 a.m., in the endoscopy department, with the Flexible Scope Coordinator (FSC), reprocessed endoscopes were stored in storage cabinets in procedure rooms B and C. The FSC stated the cabinets were stored in procedure rooms B and C due to a lack of space and there was no plan in place to move the cabinets out of the procedure rooms.

During an interview on 7/8/22, at 8:45 a.m., with Endoscopy Technician (ET) 3, ET 3 stated ETs interrupted patient procedures to retrieve scopes from the storage cabinets for upcoming cases. ET 3 stated ETs tried to prepare supplies and scopes prior to scheduled procedures in other rooms but, because certain scopes were stored in procedure rooms B and C, ETs had to interrupt the procedures already in progress to obtain their scopes. ET 3 stated staff that entered the rooms during procedures would see the exposed bodies of the patients having the procedure. ET 3 stated staff that entered the room were not assigned to the procedure in progress. ET 3 stated, "I wouldn't like that if it was me ... I'd be embarrassed ... not right."

During an interview on 7/11/22, at 12:45 p.m., with the Endoscopy Manager (EM), the EM stated endoscopes were stored in procedure rooms B and C since before she was hired over two years ago. The EM stated there was no discussion amongst leadership to move the cabinets out of the procedure rooms. The EM stated she was not aware staff entered procedure rooms to retrieve scopes during endoscopy procedures. The EM acknowledged this practice compromised the safety of the procedures and patients.

During a review of the facility's policy and procedure (P&P) titled ""Patient Rights and Responsibilities", dated 11/18/20, the P&P indicated, " ...staff assures that the rights of all patients are preserved during illnesses ... The patient has the right to considerate, respectful care at all times and under all circumstances, with preservation of their personal dignity ..."

Based on observation, interview, and record review, the facility failed to ensure the rights of patients to receive care in a safe environment when:

1. Five of five cabinets storing reprocessed (a special process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) were not maintained in a manner that assured they were clean, safe, and functional.

2. One of one endoscope used for an endoscopic retrograde cholangiopancreatography (ERCP- a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas) was carried by staff in a plastic container through patient, visitor, and staff seating areas and walkways.

These failures resulted in an unsafe environment for patients, visitors, and staff.

Findings:

1. During concurrent observation and interviews on 7/6/22, at 11:18 a.m., with the Flexible Scope Coordinator (FSC) and Medical Assistant (MA1), in the endoscopy department, procedure rooms B and C were observed ha one endoscope cabinet in each room. Fourteen reprocessed endoscopes (scopes) hung vertically in each of the storage cabinets. The cabinets were chipped and had gray particles outside the collection bins on the cabinet floors. Adjacent to the procedure rooms was a "clean storage" room with three endoscope cabinets. Cabinet "One" (C1) stored 16 reprocessed scopes, cabinet "Two" (C2) stored eight scopes, and cabinet "Three" (C3) stored seven scopes. The cabinets (C1, C2, and C3) were chipped and had gray particles on the cabinet floors. C2 had a reddish-brown staining on the cabinet floor trim. MA1 wiped the reddish- brown stain with a disinfectant wipe and stated, "It doesn't come off ... looks like rust." The FSC stated the endoscopy department followed manufacturer's guidelines and AAMI standards for scope storage and reprocessing. The FSC acknowledged the five cabinets were not cleaned and maintained in sanitary condition in accordance with AAMI standards. The FSC stated the unsanitary conditions were identified six months ago and the facility was in the process of replacing the cabinets. The FSC stated the cabinets were stored in procedure rooms B and C due to a lack of space and there was no plan in place to move the cabinets out of the procedure rooms. The FSC stated unused endoscopes were reprocessed every 30 days. The FSC stated all scopes were reprocessed by SPD in an "unlicensed" area of the facility.

During an interview on 7/6/22, at 11:30 a.m., with the Director of Engineering and Plant Operations (DPO), the DPO stated endoscopy procedure rooms were not monitored for temperature and humidity. The DPO stated the "clean storage" room was a "positive pressure" room (room that contains a higher pressure than the external environment to prevent air from leaving the room and circulating back inside) that was not monitored for temperature and humidity.

During an interview on 7/8/22, at 8:02 a.m., with Registered Nurse (RN) 10, RN 10 stated he was "not too familiar" with AAMI standards but had worked at other endoscopy clinics in the past. RN 10 stated he questioned the facility's practice of storing scopes in rooms used for "GI" (gastrointestinal- esophagus, stomach, and intestines) procedures and staff not checking the temperature and humidity of those rooms. RN 10 stated he reported concerns to "other nurses" and was told "It's always been like that." RN 10 stated "So, I just let it go."

During an interview on 7/8/22, at 8:30 a.m., with RN 9, RN 9 stated scope cabinets in the procedure rooms increased the risk of infection for the patients. RN 9 stated the cabinets were stored in a "dirty" area with high risk for cross contamination (transfer of germs from area to another) and the cabinets were opened multiple times a day exposing the scopes to the contaminated environment. RN 9 stated staff did not monitor the temperature and humidity in the rooms.

During an interview on 7/8/22, at 8:45 a.m., with Endoscopy Technician (ET) 3, ET 3 stated ETs interrupted patient procedures to retrieve scopes for upcoming cases. ET 3 stated ETs tried to prepare supplies and retrieve the scopes prior to scheduled procedures in other rooms but, because certain scopes were stored in procedure rooms B and C, ETs had to interrupt the procedures already in progress to obtain their scopes. ET 3 validated their practice of opening the cabinets during procedures increased the risk for cross contamination and infection and compromised the safety of the patients.

During an interview on 7/11/22, at 12:45 p.m., with the Endoscopy Manager (EM), the EM stated endoscopes were stored in procedure rooms B and C since before she was hired over two years ago. The EM stated the unsanitary condition of the cabinets were identified six months ago and department leadership determined that the cabinets needed to be replaced, however there was no discussion about moving the cabinets out of the procedure rooms. The EM stated she was not aware staff entered procedure rooms to retrieve scopes during endoscopy procedures. The EM stated staff were expected to prepare scopes prior to each procedure to avoid entering the rooms during procedures and potentially contaminating the reprocessed scopes. The EM validatedthis practice compromised the safety of the procedures and patients. The EM could not explain why the procedure rooms were not monitored for temperature and humidity.

During a review of the facility's document titled "Hospital Acquired Infections" dated 6/1/22 through 6/20/22, the document indicated Patient (Pt) 15 resulted positive for Clostridioides difficile (C. diff- an infectious germ that causes diarrhea and inflammation of the intestine and spread through contact with surfaces contaminated with feces).

During a concurrent interview and record review of Pt 15's electronic health record (EHR- patient medical record in electronic form) on 7/11/22, at 2:05 p.m., with the Clinical Consultant Infection Control Program (CCIPC), the CCIPC stated Pt 15 was admitted to the facility from a nursing home on 6/18/22, with a diagnosis of sepsis (life threatening infection in the body) and pyelonephritis (urinary infection in which both kidneys are infected). The CCIPC stated Pt 15 had an Esophagogastroduodenoscopy (EGD- internal examination of the esophagus, stomach, and small intestine), on 6/20/22, in the endoscopy department. On 6/23/22, Pt 15 exhibited C. diff symptoms (loose watery and mucoid like stools) and resulted positive for C. diff on 6/25/22. The CCIPC stated the likelihood of Pt 15 acquiring C. diff during the EGD procedure was minimal and potential causes of the C. diff infection was multifactorial. However, it was possible for Pt 15 to acquire C. diff during the EGD procedure because of the way endoscopes were managed in the endoscopy department. The CCIP stated temperature and humidity had to be regulated to prevent bacteria from growing.

A review of the professional reference at https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13563 titled "Management and Mitigation of Temperature and Humidity ... Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ..."

During an interview on 7/11/22, at 3 p.m., with IP 1, IP 1 stated she was aware of the endoscopes being stored in procedure rooms. IP 1 stated the endoscopes were stored in procedure rooms B and C for "a long time" and "we" recognized there was a problem with the cabinets "2-3 years ago." IP 1 stated there was a plan to have them replaced once the project to replace the cabinets was approved. IP 1 stated the cabinets in the procedure rooms posed minimal risks to patients since "our cabinet is tightly closed." IP 1 stated staff were expected to prepare supplies and scopes before each procedure and was unaware of any "breaches" in infection control. IP 1 stated she expected scopes to be reprocessed when breaches in infection control occurred. IP 1 also stated she thought plant operations monitored the temperature and humidity in the procedure rooms.

During concurrent interviews on 7/11/22, at 4:45 p.m., with the Medical Director of Gastroenterology Services (MDGI), the MDGI stated the scope cabinets were stored in procedure rooms B and C due to the department's space constraints. The MDGI stated the way the endoscopes were stored posed minimal infection control risk to patients because the cabinets stayed closed and were reprocessed and tested for bacteria (germs). The MDGI stated the scope that required special attention, most difficult to reprocess, and had a higher risk to spread infection were the "EUS" scopes (long flexible scopes with ultrasound capabilities that can be inserted through the mouth or rectum; also referred to as duodenoscopes) because of their small mechanical components and use in "ERCP" procedures. The MDGI stated the "EUS" scopes were stored elsewhere in the department to minimize contamination and risk of infection to patients. The MDGI stated he was not aware the temperature and humidity in scope storage areas were not monitored and that scopes were reprocessed in "unlicensed" area of the hospital.

During a review of a handwritten document provided by the facility's endoscopy department, dated 7/6/22, the document listed the type, number, and storage location of the reprocessed endoscopes. The "EUS" scopes were stored in C2, the cabinet with reddish-brown staining.

During a review of Chapter 8 of the manufacturer's guidelines for duodenovideoscopes (hollow, flexible, lighted tubes that allow doctors to see the top of a patient's small intestine), gastrointestinal videoscope (a flexible tube with a camera to see the lining of the intestines), and colonovideoscopes(A long flexible endoscope, often equipped with a device for obtaining tissue samples, that is used for visual examination of the colon) titled "Reprocessing Manual", undated, the manuals indicated " ... Precautions of storage ... maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/ or operators who touch them ... Establish a local policy regarding method and frequency of cleaning and disinfecting the endoscope storage cabinet ... Improper storage practices ... will lead to an infection control risk ... To prevent damage, do not store the endoscope ... at high temperatures, in high humidity ... Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated ... Microorganisms proliferate in wet/ moist environments. Keep cabinet doors closed to protect the equipment from environmental contaminants and accidental contact ... Store the sterilized endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices ..."

During a review of the document from the Association for the Advancement of Medical Instrumentation (AAMI- primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals) "Drying and Storage of Flexible Endoscopes: An Area of Growing Concern" dated 2020, the document indicated, " ... Healthcare Infection Control Practices ... A risk assessment should be performed for storage of endoscopes, as appropriate. Store endoscopes and accessories in a manner that prevents recontamination ... Recommendation ... Society of Gastroenterology Nurses and Associates ... Storage areas should be suitable for clean endoscopes (clean, well ventilated, and dust free) ... Seven-day storage if scopes were reprocessed and stored according to professional guidelines and manufacturer's instructions ... the key drivers of endoscope contamination are inadequate disinfection and/ or poor storage practices ..."

During a review of the facility's policy and procedure (P&P) titled "Temperature and Humidity Monitoring in the Operating Rooms, Sterile Processing and Procedure Rooms NCAL Regional Policy" dated 7/28/21, the P&P indicated, " ... Critical environments where invasive surgical procedures are performed and sterile instruments are processed and stored require optimum environmental conditions such as temperature and humidity to ... regulate the environment for the safety and comfort of patients and care providers ... decrease potential for microbial growth, such as mold and mildew in the case of high humidity conditions ... preserve shelf life and integrity of sterile supplies and equipment calibration ... Manual daily monitoring can be done by individual departments if the facility has no automated remote monitoring capacity ... Daily logging is required for non-continuous, periodic monitoring ... The temperature and humidity shall be maintained in the following ranges (ASHRAE & AAMI Standard ST79, 2017) ..."

During a review of professional reference titled "AAMI Sterility Assurance", dated 3/13/19, the reference indicated, " ...Objectives ... To provide an overview of the relevant AAMI standards that direct processing practices ... ST-79 ... General work areas - 68-73 deg. [degrees] F [Fahrenheit] (20-23 deg. C [Celsius] ) ... Decontam [decontamination] - 60-65deg F(16-18 deg. C.) ... Sterilization access room -75-85 deg.F. (24-29 deg.C.) (or as recommended by equipment mfr [manufacturer]) ... Sterile storage/support areas - 75 deg. (maximum -24deg.C.) ..."

During a review of the job description for "Scope Oversight Coordinator", undated, the job description indicated, " ... Provides support to clinic managers responsible for endoscope/ endocavity reprocessing areas ... staff training ... performing audits ... Collaborates with sterile processing/ and/ or department managers for employee and department safety, and risk management issues ..."

During a review of the job description for "Infection Prevention Program Manager", undated, the job description indicated, " ...Manages the medical center Infection Prevention Program to ensure activities are directed toward preventing and decreasing healthcare associated infections and improving patient safety across the continuum of care ... Collaborates with leadership team to ensure compliance with regulatory and accrediting agency requirements ... ensure surveillance activities and improvement plans are analyzed, implemented and reported to leadership ...Collaborates with Facility Services to ensure an integrated Environment of Care Program ..."


2. During interview on 7/6/22, at 11:00 a.m., in the operative department, with the Perioperative Director (PD), the PD stated operating room (OR) 9 was reserved for endoscopy procedures that required general anesthesia (drug-induced depression of consciousness and ventilatory function).

During a concurrent observation and interview on 7/6/22, at 1:35 p.m., in OR 9, with ET 1 and the FSC, ET 1 pre-cleaned an endoscope with an enzymatic detergent in a plastic container. ET 1 stated the endoscope was used in an ERCP procedure and "point of use pre-cleaning" was required prior to the scope being transported to SPD for reprocessing. ET 1 completed the "pre-clean" process and suctioned all the remaining fluid from the container. ET 1 applied a transparent red disposable biohazard cap over the container and carried the container through the patient and visitor lobby, across the hallway, and to the SPD reprocessing room for endoscopes. The outside of the container was not cleaned and disinfected before leaving OR 9. The FSC stated this process was in place since 2018. The FSC stated endoscope reprocessing was centralized to an unlicensed area outside the endoscopy department due to space constraints.

During an interview on 7/8/22, at 8:02 a.m., with RN 10, RN 10 stated he used an endoscope "transport tower" to transport the contaminated endoscopes to the SPD reprocessing department. RN 10 stated he did not carry or use an open metal cart to transport the "dirty" endoscopes because the endoscope had the potential to fall. RN 10 stated it was an infection control and patient safety issue which he tried to minimize as much as he could. RN 10 stated staff hand carried endoscopes to the reprocessing department "all the time."

During an interview on 7/8/22, at 8:30 a.m., with RN 9, RN 9 stated she was not comfortable carrying "dirty" endoscopes to SPD through patient and visitor common areas. RN 9 stated the process risked scope integrity and had the potential to expose patients or visitors to infectious materials if there was an unforeseen accident during transport.

During an interview on 7/8/22, 9:05 a.m., with ET 1, ET 1 stated she was not comfortable with carrying endoscopes to SPD scope reprocessing room through patient and visitor areas of the facility. ET 1 stated she tried not to touch or open doors while carrying the contaminated endoscopes but the risk for cross contamination remained high during transport.

During a review of a professional reference titled "Storage and Transport of Flexible Endoscopes", dated May/ June 2019, the article indicated, " ... Soiled endoscopes must be handled in a manner that minimizes the risk of cross- contamination of the environment. This is accomplished by containing the endoscope in a solid transport container ... Containment of the soiled instrument must be performed correctly to prevent exposure to staff and other patients to that biohazardous device ... an OSHA- complaint transport container ... Since endoscopes are sharp in the respect that they have metal prongs that stick out ... they should be treated as sharp metal devices ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes ... SGNA ...Society of Gastroenterology Nurses and Associates", dated 2018, the manual indicated, "Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that prevents exposing staff, patients, or the environment to potentially infectious organisms ..."

During a professional reference reviewed retrieved from https://www.aami.org/standards/ansi-aami-st79, titled, "ANSI [American National Standards Institute]/AAMI [Association for the Advancement of Medical Instrumentation] ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" indicated, " ...Transportation scheduling and routes ... Transport routes should ...avoid areas of high traffic ... Transportation equipment ...To help prevent damage to reusable items and avoid contamination of the environment, transport carts or other system should ...be designed to prevent items from falling over or off during transport ...be large enough to maintain the security and package integrity of the items being transported ...be covered or closed ..."

During a professional reference reviewed retrieved from https://aornguidelines.org/guidelines/content?sectionid=173737535&view=book#229141984, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines", dated September 2018, the professional reference indicated, " ...Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart ...The container or cart must be leak proof ...puncture resistant ...large enough to contain all contents ...Transporting items in leak-proof, puncture-resistant containers and in a manner that prevents exposing personnel to blood, body fluids, and other potentially infectious materials is a regulatory requirement ..."

During a review of the facility's policy and procedure (P&P) titled "Patient Rights and Responsibilities", dated 11/18/20, the P&P indicated, " ...staff assures that the rights of all patients are preserved during illnesses ... The patient has the right to expect reasonable safety insofar as the Medical Center's practices and environment are concerned ..."

Based on observations, interviews, and record review, the facility failed to ensure the confidentiality for one of three sampled patients (Patient [PT]) 5 when the PT 5's electronic medical record (EMR) was displayed on an unattended computer screen in a busy hallway.

This failure had the potential for unauthorized individuals to have access to protected health and sensitive information for PT 5.

Findings:

During an observation on 7/6/22, at 10:00 a.m., in the Emergency Department (ED), the EMR for PT 5 was displayed on a mobile computer screen in the hallway with no staff attending to the medical record. In the hallway there were patients, visitors, security guards, and staff.

During an interview on 7/13/22, at 10:47 a.m., with Emergency Department Manager (EDM) 1, EDM 1 stated, she validated on 7/6/22 when PT 5's EMR was open on a computer screen in the hallway, unattended by staff. EDM 1 stated there was a lot of traffic in the hall at that time consisting of staff, patients, visitors, and security personnel. EDM 1 stated Personal Health Information (PHI) is always to be confidential and the expectation was that the screen should have been minimized to prevent the PHI from being seen. EDM 1 stated PT 5's record was open for anyone to see. EDM 1 stated it was the facility staff's responsibility to protect the health information of their patients.

During a record review of the facility's policy and procedure (P&P), "Obligations Regarding Confidentiality (ORC)," dated 1/24/2021, the ORC indicated, "Employees are required to protect confidential patient, member, personnel and business information from unauthorized access, use or disclosure."

During a review of the facility's P&P titled, "Patient Rights & Responsibilities," dated 11/18/20., the P&P indicated, " ...Confidentiality ... The patient has the right to have the medical information/medical record read only by individuals who have legitimate and authorized access to the information/ medical record only after the patient or the patient's personal representative provided authorization in writing...The patient has the right to expect all communications and other records pertaining to their care, including the source of payment, to be treated as confidential."

Based on observation, interview, and record review, the facility failed to ensure one of five sampled patients (Patient 29) was free from restraints, when the facility placed Patient 29 in restraints without attempting alternative and less restrictive interventions per the facility's policy and procedure titled, "Restraints NCAL(Northern California) Regional Policy".

This failure violated Patient 29's rights and placed Patient 29 at risk of developing a negative physiological outcome and continued decline in health after the application of the restraints.

Findings:

During a review of Patient 29's "History and Physical Note (H&P)", dated 7/3/22, the H&P indicated, " ...Assessment and Plan: Active Hospital Problems Diagnosis ...(Principal) CONFUSION (lack of understanding) ...[history] OF CHOLNGIOCARCINOMA (rare cancer that forms in the ducts between the liver and gallbladder) ...CAD (disease in which there is a narrowing or blockage of the blood vessels that carry blood and oxygen to the heart). ...COPD STAGE 1 MILD (chronic obstructive pulmonary disease refers to a group of diseases that cause airflow blockage and breathing-related problems) ...well controlled ... NONTRAUMATIC ACUTE KIDNEY INJURY (when the kidneys suddenly stop working correctly) ...DELIRIUM (serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment) ...GERD (Gastroesophageal reflux disease-occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach) ... HYPERLIPIDEMIA (abnormally high levels of fats in the blood) ..."

During a review of Patient 29's "ED [Emergency Department] Nursing (ED note)", dated 7/3/22 at 3:06 p.m., the ED note indicated, Patient 29 was " ...confused but easily reoriented and follows commands ..."

During a review of Patient 29's "Plan of Care" note, dated 7/3/22 at 6:28 p.m., the "Plan of Care" note indicated, "SUMMARY OF PATIENT PROGRESS: STATUS: Progress not as expected ...Primary Problem: Confusion ...[Patient 29] with increased agitation and confusion throughout shift. [Patient 29] attempts to get out bed, shakes side rails. Attempted to have spouse re-direct. Unable to do safely. [Patient 29] attempted to get out of bed between side rails so restrains initiated ..."

During a review of Patient 29's "Plan of Care" note, dated 7/3/22 at 10:59 p.m., the "Plan of Care" note indicated, "[7:30 p.m.] Received [Patient 29] with [blood pressure greater] 180's. [Patient 29] agitated getting out from bed and pulling out lines on Bilateral (both) wrist restraints ..."

During a concurrent observation and interview on 7/6/22, at 10:20 a.m., with Registered Nurse/Assistant Nurse Manager 4E and 4W (RN) 2, 4th floor East unit, Patient 29 was observed with a sitter for himself and Patient 28. RN 2 stated, Patient 29 also had wrist restraints.

During an interview on 7/11/22, at 10:30 a.m., with Clinical Nurse Specialist (CNS) 1, CNS stated, that the facility's alternative safety interventions before bilateral wrist restraints were placed for Patient 29 on 7/3/22 was primarily having Patient 29's wife help redirect. CNS 1 verified, that the sitter was placed after the restraints were initiated for Patient 29 on 7/3/22. CNS 1 stated, no additional alternate interventions were used before placement of restraints. CNS 1 validated that the initial restraint order for Patient 29 was ordered on 7/3/22 at 4:28 p.m.

During an interview on 7/13/22, at 9:15 a.m., with Clinical Nurse Educator for Critical Care Unit and post-anesthesia (medical treatment that prevents patients from feeling pain during procedures like surgery, certain screening and diagnostic tests) care unit (CNE) 2, CNE 2 stated, nurses are expected to assess the need for restraints and follow the hospital policy. CNE 2 stated, restraints should be the last option tried after all other safety measures have failed for patients.

During an interview on 7/13/22, at 2:05p.m., with the Chief Nursing Executive/ Chief Operations Officer (CNE/COO), CNE/COO stated, there is an "opportunity" for the facility to better use sitters as an alternative intervention before restraints are applied to a patient.

During a review of the facility's policy titled, "Restraints NCAL (Northern California) Regional Policy", dated November 2020, the policy indicated, " ...The use of restraint must be discontinued as soon as possible based on an individualized patient assessment and re-evaluation. Restraints may only be used when less restrictive interventions have been determined to be ineffective ...Restraint: A restraint is any manual method, physical or mechanical device, material or equipment that immobilized or reduces the ability of a patient to move his or her arms, legs, body or head freely ...It is the policy [name of facility] that restraints are used when it can be clinically justified or when warranted by patient behavior that threatens the physical safety of the patient, staff, or others ...A restraint can only be used if less restrictive interventions have been determined to be ineffective ...The minimum level of restraint needed to accomplish the desired goal will be used ...Restraint may only be employed while the unsafe situation continues and must be discontinued at the earliest possible time ...Preform (and document) an initial assessment at the initiation of restraint: The choice of safe, effective and least restrictive method of restraint is determined by registered nurse assessment, in collaboration with the physician and other healthcare team members, based upon the patient's needs and behavior. Assessment includes a description of the patient's behavior, condition or symptom that warranted the use of the restraint and the intervention used ...Alternatives or other less restrictive interventions attempted ...Use Least Restrictive Means: When an assessment has indicated the need for restraint, the least restrictive form of restraint that protects the physical safety of the patient ...Alternative interventions attempted or the rationale for not using alternatives ...Less restrictive interventions attempted or determined by staff to be ineffective to protect the patient or to pose a greater risk than the risk of using the restraint ...The patent's response to the interventions used, including the rational for continued use of the intervention ...Appendix A ...Situation ...The patient was observed constantly removing the BIPAP (a device that helps with breathing) with desaturation of pO2 (saturation of oxygen in the body) noted ...Examples of Devices Used ...Mittens[,] Soft writs restraints ...What Is It?...Non-violent non-self-destructive restraint ...Appendix C ...EXAMPLES OF ALTERNATIVE INTERVENTIONS AND LESS RESTRICTIVE DEVICES ...Behavior Exhibited ...Pulling tubes ...Remove unnecessary tubes as soon as possible ...Hide or camouflage tubing ...Provide alternative tubing or diversionary activities to keep patient occupied ...Consider alternatives for nasogastric tubes Medicate for pain ...Supervise confused patients carefully ...Less Restrictive Devices ...Mittens ...Elbow extenders before limb holders ..."

Based on observation, interview and record review, the hospital failed to implement and maintain an on-going, comprehensive, Quality Assurance and Performance Improvement (QAPI) program to improve quality and safety when:

1. Data was not collected, analyzed and evaluated and quality improvement projects not prioritized regarding the age and condition of storage cabinets in Endoscopy (procedure used to look inside the body) processing area and the storage area in obstetrics (branch of medicine and surgery concerned with childbirth and the care of women giving birth). (refer to A283, finding 1)

2. QAPI did not evaluate data and follow internal accreditation and licensing procedure prior to the decision to assign and utilize an unlicensed area for reprocessing (a special process used to prepare the product for reuse) of endoscopes (a flexible instrument used to view internal parts of the body) in the Endoscopy department. (refer to A283, Finding 2)

3. Data was not collected, analyzed and evaluated prior to the decision to not follow infection control practices for Coronavirus disease (COVID-19, a disease, caused by a novel (new) corona virus spread primarily through droplets of saliva or discharge from the nose when an infected person talks, coughs, or sneezes) screening of patients and visitors in the Emergency Department (ED), and points of entry in the hospital. (Refer to A283, Finding 3)

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

Based on observation, interview and record review, the hospital's Quality Assurance and Performance Improvement (QAPI - program to improve quality and safety) program activities failed to focus and set priorities in high-volume and problem-prone areas when no data was collected, analyzed and evaluated to address:

1. The age, safety and sanitary condition of storage cabinets in the endoscopy (procedure used in to look inside the body) procedure room and storage room for sterile supplies in Obstetric (OB, branch of medicine and surgery concerned with childbirth and the care of women giving birth) department.

2. The decision to assign and utilize an unlicensed area of the hospital as the reprocessing room for endoscopes.

3. The decision to not conduct Coronavirus disease (COVID-19, a disease, caused by a novel (new) corona virus spread primarily through droplets of saliva or discharge from the nose when an infected person talks, coughs, or sneezes) screening of staff, visitors and patients at points of entry to the Emergency Department and main hospital.

These failures resulted in lost opportunities to improve safety and quality of care to patients; and the potential harm of increasing the risk of infections to patients and visitors.

Findings:

1. During concurrent observation and interview on 7/6/22, at 11:18 a.m., in the endoscopy department, with the Flexible Scope Coordinator (FSC) and Medical Assistant (MA 1), procedure rooms B and C had one endoscope cabinet in each room. Fourteen reprocessed endoscopes hung vertically in each of the storage cabinets. The cabinets were chipped and had gray particles outside the collection bins on the cabinet floors. Adjacent to the procedure rooms was a "clean storage" room with three endoscope cabinets. Cabinet "One" (C1) stored 16 reprocessed scopes, cabinet "Two" (C2) stored eight scopes, and cabinet "Three" (C3) stored seven scopes. The cabinets (C1, C2, and C3) were chipped and had gray particles on the cabinet floors. C2 had a reddish-brown staining on the cabinet floor trim. MA 1 wiped the reddish- brown stain with a disinfectant wipe and stated, "It doesn't come off ... looks like rust." The FSC stated the endoscopy department followed manufacturer's guidelines and Association for the Advancement of Medical Instrumentation (AAMI- primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals) for scope storage and reprocessing. The FSC acknowledged the five cabinets were not cleaned and maintained in sanitary condition in accordance with AAMI standards. The FSC stated the unsanitary conditions were identified six months ago and the facility was in the process of replacing the cabinets. The FSC stated the cabinets were stored in procedure rooms B and C due to a lack of space and there was no plan in place to move the cabinets out of the procedure rooms. The FSC stated unused endoscopes were reprocessed every 30 days. The FSC stated all scopes were reprocessed by sterile processing department (SPD- area where cleaning and sterilization of devices used in medical procedures takes place) in an "unlicensed" area of the facility.

During an interview on 7/6/22, at 11:30 a.m., with the Director of Engineering and Plant Operations (DPO), the DPO stated endoscopy procedure rooms were not monitored for temperature and humidity. The DPO stated the "clean storage" room was a "positive pressure" room (room that contains a higher pressure than the external environment to prevent air from leaving the room and circulating back inside) that was not monitored for temperature and humidity.

During an interview on 7/11/22, at 12:45 p.m., with the Endoscopy Manager (EM), the EM stated endoscopes were stored in procedure rooms B and C since before she was hired over two years ago. The EM stated the unsanitary condition of the cabinets were identified six months ago and department leadership determined that the cabinets needed to be replaced, however there was no discussion about moving the cabinets out of the procedure rooms. The EM stated she was not aware staff entered procedure rooms to retrieve scopes during endoscopy procedures. The EM stated staff were expected to prepare scopes prior to each procedure to avoid entering the rooms during procedures and potentially contaminating the reprocessed scopes. The EM acknowledged this practice compromised the safety of the procedures and patients.

During a concurrent observation and interview on 7/7/22, at 9:28 a.m., with Obstetrics Tech (OBT 1), in storage room 1LD-88, operating room (OR) sterile instrument kits for C-sections (surgical procedure by which a baby is delivered through an incision in the mother's abdomen, often performed because vaginal deliver would put the baby or mother at risk) were stored on an open metal rack, and on the opposite rack there were the following non-sterile supplies: baby diapers, baby wipes, an opened box of [brand name] foot/finger print pads, an opened box of [brand name] pulse oximeter probe wraps (tapeless wrap used on baby) and additional non-sterile unit supplies were observed. OBT 1 stated, the storage room was used to store ready-to-use sterile instruments that had been picked up from the sterile processing department after they were sterilized. OBT 1 stated, that additional unit supplies were stored in the same space. OBT 1 stated, her process is to remove the stored sterilized C-section instrument kits from the rack in the storage room and place them in the OR for the next surgery.

During a concurrent observation and interview on 7/8/22, at 9:45 a.m., with OBT 2, in 1LD-88, no badge access was observed when entering. In 1LD-88, a chain link fence padlocked with a computer behind the fence was observed, the chain link fence ran across the back of one supply storage rack. OBT 2 stated, the storage area "may be considered a clean environment". OBT 2 stated, the OR sterile C-section instrument kits had "always" been stored in there. OBT 2 stated, no badge access was required for entrance to room and all staff had access to room.

During an interview on 7/11/22, at 3 p.m., with Infection Preventionist (IP) 1, IP 1 stated she was aware of the endoscopes being stored in procedure rooms. IP 1 stated the endoscopes were stored in procedure rooms B and C for "a long time" and recognized there was a problem with the cabinets "2-3 years ago." IP 1 stated there was a plan to have them replaced once the project to replace the cabinets was approved. IP 1 stated the cabinets in the procedure rooms posed minimal risks to patients since "our cabinet is tightly closed." IP 1 stated staff were expected to prepare supplies and scopes before each procedure and was unaware of any "breaches" in infection control. IP 1 stated she expected scopes to be reprocessed when breaches in infection control occurred. IP 1 also stated she thought plant operations monitored the temperature and humidity in the procedure rooms. IP 1 stated, she was aware that 1LD-88 was used to store sterile obstetrics OR C-section instrument kits, clean storage and an IT (information technology, use of computers to create, process, store, retrieve, and exchange all kinds of data and information) tower which included a computer. IP 1 stated there was temperature, humidity and pressure parameters followed. IP 1 stated, if the IT tower is cleaned from top to bottom from an IP perspective it was appropriate for OR sterile C-section instrument kits, IT equipment and clean storage to be stored together. IP 1 stated, the facility follows Association for the Advancement of Medical Instrumentation (AMMI) standards of practice.

During concurrent interviews on 7/11/22, at 4:45 p.m., with the Medical Director of Gastroenterology Services (MDGI), the MDGI stated the scope cabinets were stored in procedure rooms B and C due to the department's space constraints. The MDGI stated the way the endoscopes were stored posed minimal infection control risk to patients because the cabinets stayed closed and were reprocessed and tested for bacteria (germs). The MDGI stated the scope that required special attention, most difficult to reprocess, and had a higher risk to spread infection were the "EUS" scopes (long flexible scopes with ultrasound capabilities that can be inserted through the mouth or rectum; also referred to as duodenoscopes) because of their small mechanical components and use in Endoscopic Retrograde Cholangiopancreatography (ERCP-procedure to diagnose and treat problems in the liver, gallbladder, and pancreas using imaging and a long flexible lighted tube) procedures . The MDGI stated the "EUS" scopes were stored elsewhere in the department to minimize contamination and risk of infection to patients. The MDGI stated he was not aware the temperature and humidity in scope storage areas were not monitored and that scopes were reprocessed in "unlicensed" area of the hospital.

During an interview on 7/12/22, at 7:52 a.m., with Plant Operations Director (POD), POD stated, in 1LD-88 thirty-six square feet (measurement of area) was used for IT equipment. POD stated, a fan is on at all times for the IT equipment and that the fan picks up dust in the room. POD stated, storage room 1LD-88 is currently (7/12/22) being monitored for humidity.

During a review of a handwritten document provided by the facility's endoscopy department, dated 7/6/22, the document listed the type, number, and storage location of the reprocessed endoscopes. The "EUS" scopes were stored in C2, the cabinet with reddish-brown staining.

During an interview on 7/13/22, at 3 p.m., with the Quality Assurance and Performance Improvement team consisting of the Administrator (ADM), Chief Nursing Executive/Chief Operations Officer (CNE/COO), Interim Area Quality Leader & Patient Safety Officer (IAQLPSO), Perioperative Director (PD), Support Services Administrator (SSA), Patient Care Director (PCD), Nursing Operations Director (NOD), Chief of Medical Staff (CMS), the CNE stated the scopes stored in the Endoscopy procedure rooms were not the original location in where scopes should have been stored. The CNE stated the decision to place the scopes in the cabinets preceded all members with oversight of those scopes. The CNE stated she was not aware of those scopes being stored in those cabinets in the Endoscopy cabinets. The CNE stated the scopes were placed there due to the fact that the hospital was making plans to expand the space needed to have a centralized location for reprocessing and storing endoscopes. The PD stated the decision to store scopes in the cabinets had predated him. The PD stated there had been a discussion about storing and reprocessing scopes in a centralized area, and that scopes had been stored and reprocessed in other areas of the hospital. The ADM stated the hospital had identified the need to replace the cabinets and were looking to fund the new installments back in October 2021. The ADM stated the hospital was awaiting for approval for the funding as it had already been planned to invest in new cabinets. The ADM stated because it was going through a Space Committee approval, it was not an urgent matter to address and was delayed. The ADM stated the Infection Control Committee involving the IP were responsible for tracking any infection control issues with storing of endoscopes in the cabinets in the Endoscopy procedure rooms. The ADM stated there was also intent to move the endoscopes out of the Endoscopy procedure rooms, but had not expedited the project as it was not an urgent matter. The CNE stated the current hospital staff overseeing the storage of endoscopes in the Endoscopy rooms had not made the decision to be placed there, but there had been complacency on the part of the hospital and there was no sense of urgency to remove the endoscopes from the Endoscopy rooms. The CNE stated the hospital did have funds to initiate projects to replace cabinets and take them to a more centralized location for reprocessing. The CNE stated she understood the importance of having endoscopes sanitary before patient use. The CNE stated she was bothered by the fact that staff were using scopes located in unsanitary locations to be used on patients for procedures. The NOD stated storage of scopes in OB had also been occurring for years. The NOD stated anesthesiologists (doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) needed more space and the storage room in OB could serve to keep equipment such as scopes. The NOD stated the hospital believed they were meeting regulations regarding storage of items in the OB due to Plan Operations department stating they had met the regulations for storage of equipment in the OB.

During a review of the hospital's "2021 and 2022 Quality and Patient Safety Work Plan and Annual Evaluation", dated 2021 to 2022, there was no indication of the hospital addressing infection control practices of endoscopes being stored in unclean areas in the Endoscopy procedure rooms, nor in the OB storage rooms. There were no improvement projects initiated by the QAPI team to improve any breaches in infection control as it pertained to the endoscopes in the endoscopy department or scopes in the OB department.

During a review of the hospitals "Project Schedule", dated 7/13/22, indicated, " ...2021 FRS MC (Fresno MC) Cabinet Endoscopes ...Duration 21.35 months ...Planning ...Start 10/28/21 ...Finish 1/19/22 ...Design ...Start 1/20/22 ...Finish ...5/19/22 ...Permitting ...Start 5/20/22 ...Finish 8/11/22...Field Construction ...Start 9/22/22 ...Finish 11/3/22 ...Facility utilization ...Start 12/20/22 ..."

During a review of Chapter 8 of the manufacturer's guidelines for duodenovideoscopes, gastrointestinal videoscope, and colonovideoscopes titled "Reprocessing Manual", undated, the manuals indicated " ... Precautions of storage ... maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/ or operators who touch them ... Establish a local policy regarding method and frequency of cleaning and disinfecting the endoscope storage cabinet ... Improper storage practices ... will lead to an infection control risk ... To prevent damage, do not store the endoscope ... at high temperatures, in high humidity ... Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated ... Microorganisms proliferate in wet/moist environments. Keep cabinet doors closed to protect the equipment from environmental contaminants and accidental contact ... Store the sterilized endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices ..."

During a review of the document from the Association for the Advancement of Medical Instrumentation (AAMI-primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals) "Drying and Storage of Flexible Endoscopes: An Area of Growing Concern" dated 2020, the document indicated," ... Healthcare Infection Control Practices ... A risk assessment should be performed for storage of endoscopes, as appropriate. Store endoscopes and accessories in a manner that prevents recontamination ... Recommendation ... Society of Gastroenterology Nurses and Associates ... Storage areas should be suitable for clean endoscopes (clean, well ventilated, and dust free) ... Seven-day storage if scopes were reprocessed and stored according to professional guidelines and manufacturer's instructions ... the key drivers of endoscope contamination are inadequate disinfection and/ or poor storage practices ..."

During a review of the facility's policy and procedure (P&P) titled "Temperature and Humidity Monitoring in the Operating Rooms, Sterile Processing and Procedure Rooms NCAL Regional Policy" dated 7/28/21, the P&P indicated, " ... Critical environments where invasive surgical procedures are performed and sterile instruments are processed and stored require optimum environmental conditions such as temperature and humidity to ... regulate the environment for the safety and comfort of patients and care providers ... decrease potential for microbial growth, such as mold and mildew in the case of high humidity conditions ... preserve shelf life and integrity of sterile supplies and equipment calibration ... Manual daily monitoring can be done by individual departments if the facility has no automated remote monitoring capacity ... Daily logging is required for non-continuous, periodic monitoring ... The temperature and humidity shall be maintained in the following ranges (ASHRAE & AAMI Standard ST79, 2017) ...location: sterile storage Temperature Range [less than] 75 [Fahrenheit (unit of measure for temperature)] Relative Humidity Range Max [imum] 60 [percent] ..."

A review of the professional reference at https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13563 titled "Management and Mitigation of Temperature and Humidity ... Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ..."

During a review of professional reference titled "AAMI Sterility Assurance", dated 3/13/19, the reference indicated, " ...Objectives ... To provide an overview of the relevant AAMI standards that direct processing practices ... ST-79 ... General work areas - 68-73 deg. [degrees] F [Fahrenheit] (20-23 deg. C [Celsius]) ... Decontam [decontamination] - 60-65deg F (16-18 deg. C.) ... Sterilization access room -75-85 def. F (24-29 deg. C.) (or as recommended by equipment mfr [manufacturer]) ... Sterile storage/support areas - 75 deg. (maximum -24deg.C.) ..."

During a professional reference reviewed retrieved from https://www.aami.org/standards/ansi-aami-st79, titled, "ANSI [American National Standards Institute]/AAMI [Association for the Advancement of Medical Instrumentation] ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" indicated, "Sterile storage ... Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry ... Access to the sterile storage area should be restricted to authorized personnel ... Closed or covered cabinets are recommended for sterile storage. Open shelving may be used, but requires special attention to traffic control, area ventilation, and environmental services ..."

During a professional reference reviewed retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf, titled, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008", dated May 2019, the professional reference indicated, " ...Storage of Sterile Items ...Ensure the sterile storage area is a well-ventilated area that provides protection against dust, moisture, insects, and temperature and humidity extremes ..."

During a professional reference reviewed retrieved from https://aornguidelines.org/guidelines/content?sectionid=173737535&view=book#229141984, titled, "AORN eGuidelines", dated September 2018, the professional reference indicated, " ...Storage of Sterile Items ... Store sterile items in a controlled environment ... Limiting exposure to moisture, dust, direct sunlight, handling, and temperature and humidity extremes decreases the potential for contamination and degradation of sterilized items. Factors that contribute to contamination include handling, air movement, humidity, temperature, location of storage, dust, presence of vermin, whether shelving is open or closed, and properties of the sterile barrier system ... Store sterile items under controlled conditions. Controlled conditions reduce the risk of contaminating sterile items ... Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts ... Store sterile items in a manner that protects the integrity of the sterile barrier system ...sterile items should be ...stored under environmentally controlled conditions, which include a maximum temperature of 75° F (24° C), a maximum relative humidity of 60%, positive air pressure in relation to adjacent areas ..."

During a review of the job description for "Scope Oversight Coordinator", undated, the job description indicated, " ... Provides support to clinic managers responsible for endoscope/endocavity reprocessing areas ... staff training ... performing audits ... Collaborates with sterile processing/ and/ or department managers for employee and department safety, and risk management issues ..."

During a review of the job description for "Infection Prevention Program Manager", undated, the job description indicated, " ...Manages the medical center Infection Prevention Program to ensure activities are directed toward preventing and decreasing healthcare associated infections and improving patient safety across the continuum of care ... Collaborates with leadership team to ensure compliance with regulatory and accrediting agency requirements ... ensure surveillance activities and improvement plans are analyzed, implemented and reported to leadership ...Collaborates with Facility Services to ensure an integrated Environment of Care Program ..."

2. During a concurrent observation and interview on 7/6/22, at 1:35 p.m., in OR 9, with ET 1 and the FSC, ET 1 pre-cleaned an endoscope with an enzymatic detergent in a plastic container. ET 1 stated the endoscope was used in an ERCP procedure and "point of use pre-cleaning" was required prior to the scope being transported to SPD for reprocessing. ET 1 completed the "pre-clean" process and suctioned all the remaining fluid from the container. ET 1 applied a transparent red disposable biohazard cap over the container and carried the container through the patient and visitor lobby, across the hallway, and to the SPD reprocessing room for endoscopes. The outside of the container was not cleaned and disinfected before leaving OR 9. The FSC stated this process was in place since 2018. The FSC stated endoscope reprocessing was centralized to an unlicensed area outside the endoscopy department due to space constraints. The FSC stated he did not know who had made the decision to move the endoscope reprocessing to the particular room. The FSC stated the area had been either an office space or a patient's room before. The room was spacious and clean with machines inside the area.

During an interview on 7/13/22, at 3 p.m., with the Quality Assurance and Performance Improvement team consisting of the ADM, CNE/COO, IAQLPSO, PD, Support Services SSA, PCD, NOD, CMS, the CNE stated the scopes were placed in the Endoscopy procedure rooms due to the fact that the hospital was making plans to expand the space needed to have a centralized location for reprocessing and storing endoscopes. The PD stated there had been a discussion about storing and reprocessing scopes in a centralized area, and that scopes had been stored and reprocessed in other areas. The PD stated the Endoscopy department had evolved into having more complex scopes that drove the need for centralizing the sterile processing of all scopes. The PD stated he knew of the need to standardize the reprocessing of endoscopes so that there could be specific staff that were trained and to track universal standards for reprocessing the scopes, but had not been implemented until 7/6/22 when the state agency discovered the infection control breaches.

During a review of the hospital license (HL) and facility map (FM), the HL indicated the hospital was licensed for 169 general acute care beds and included approved services of Basic Emergency services and Endoscopy. The FM indicated the hospital was on a campus that included outpatient clinics space that was not licensed and is not under the jurisdiction of the Department. The facility map indicated the clinic and hospital were configured on four floors with contiguous access from one part of the campus to the other. The hospital portion of the building complex was clearly demarcated on the facility map and the configuration is an upside down "L" with the shorter arm being the clinic space.

During a review of the hospital's "2021 and 2022 Quality and Patient Safety Work Plan and Annual Evaluation", dated 2021 to 2022, there was no indication of the hospital initiating performance improvement projects to address reprocessing endoscopes in an unlicensed area of the Endoscopy department.

During a review of a professional reference titled "Storage and Transport of Flexible Endoscopes", dated May/ June 2019, the article indicated, " ... Soiled endoscopes must be handled in a manner that minimizes the risk of cross- contamination of the environment. This is accomplished by containing the endoscope in a solid transport container ... Containment of the soiled instrument must be performed correctly to prevent exposure to staff and other patients to that biohazardous device ... an OSHA- complaint transport container ... Since endoscopes are sharp in the respect that they have metal prongs that stick out ... they should be treated as sharp metal devices ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes ... SGNA ...Society of Gastroenterology Nurses and Associates", dated 2018, the manual indicated, "Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that prevents exposing staff, patients, or the environment to potentially infectious organisms ..."

During a concurrent interview and record review on 7/21/22, at 3 p.m., with the Health Care Access and Information Compliance Officer (HCAI), the HCAI stated the hospital needed to ensure it was complying with the California Building Code 1224.15 for surgical services areas. The HCAI stated the hospital could not have endoscopes stored in one place and cross over to another area of the hospital for reprocessing. The HCAI stated the area for reprocessing endoscopes needed to have the space adequate to store and reprocess in the same area to ensure codes were met. The "CALIFORNIA BUILDING CODE CHAPTER 12 - INTERIOR ENVIRONMENT", dated 2016, indicated, " ...1224.15 Surgical Service Space ...1224.15.1 General ...The surgical service space shall be divided into two designated areas: 1) semi-restricted areas (e.g. storage areas for clean and sterile supplies, sterile processing rooms, scrub stations, and corridors leading to restricted areas of the surgical suite, etc.); and 2) restricted areas (e.g. operating rooms, hybrid operating rooms, sterile procedure rooms, cardiac catheterization labs, etc.) that can be reached only through a semi-restricted area. The surgical service space shall be located and arranged to provide direct support from the anesthesia/recovery service space with a common door to prevent nonrelated traffic through the surgical service space. An operating room suite design with a sterile core shall provide for no cross traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas. The use of facilities outside the operating room for soiled/decontaminated processing and clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean/sterile without compromising universal precautions or aseptic techniques in either department ... 1224.15.2.2 Surgical Cystoscopic and Other Endo-Uro-Logic Procedures ...Each room shall have a minimum clear floor area of 250 square feet (23.23 m2) with a minimum of 15 feet (4572 mm) clear dimension between fixed cabinets and built-in shelves. X-ray viewing and/or other imaging modality capabilities shall be provided ...1224.39.3 Gastrointestinal Endoscopy...If gastrointestinal endoscopy is performed in the outpatient service area, the endoscopy suite shall be divided into a minimum of three major functional areas: the procedure room(s), instrument processing room(s), and patient holding/preparation and recovery room or area and the following shall be provided: 1224.39.3.1 Procedure Room(s)...1224.39.3.1.1 Space Requirements...Procedure room shall have a minimum clear floor area of 200 square feet (18.6 m2). Room arrangement shall permit a minimum clearance of 3 feet, 6 inches (1067 mm) at each side, head, and foot of the gurney/table...1224.39.3.1.2 Handwashing Stations...A separate dedicated handwashing station with hands-free controls shall be provided in the procedure room...1224.39.3.2 Processing Room...1224.39.3.2.1 Dedicated processing room(s) for cleaning and decontaminating instruments shall be provided. The cleaning area shall allow for flow of instruments from the contaminated area to the clean assembly area and then to storage...1224.39.3.2.2...The decontamination area shall be equipped with the following: Utility sink(s) shall be provided as appropriate to the method of decontamination used. One freestanding handwashing station. Work counter space(s)."

3. During an observation on 7/6/22, at 8:29 a.m., at the facility's clinic entrance surgical masks and hand sanitizer was observed on a table. No security personnel or staff were at entrance. Individuals were observed to walk past pharmacy to the welcome desk at the elevators and into patient care areas without screening for signs and symptoms of COVID-19.

During an observation and interview on 7/7/22, at 7:00 a.m. at the facility entrance near birthing center, with Transporter (TR) 1, Inpatient Pharmacy Technician (IPT), and the Director of Risk Management and Patient Safety (DRM), TR 1 asked surveyor questions to validate their vaccination status. TR 1 stated he did not ask visitors if visitors have signs and symptoms for COVID-19. TR 1 stated he would only ask if visitors are vaccinated. TR 1 stated if visitors are not vaccinated are given instructions to go in a room and get a nasal swab for the COVID-19 antigen (a toxin which detects COVID-19). IPT stated the sign outside entrance addressed visitors. The English sign located on the outside entrance indicated, "no visitors with COVID-19 symptoms or suspected COVID-19 allowed". IPT stated visitors are expected to know what the symptoms of COVID 19. DRM stated, "after two years I don't believe that people don't know what symptoms of COVID are".

During an observation on 7/7/22, at 1:10 p.m., at the birthing center entrance to facility, three screeners were observed sitting at a table. Surgical masks, hand sanitizer, armbands and stickers were observed on the table. The screeners (personnel who screen individuals entering the facility) did not ask any questions related to signs and symptoms of COVID 19.

During an observation on 7/8/22, at 7:05 a.m., at the facility's clinic entrance, hand sanitizer, a box half full of child masks and empty box for adult masks were on the table. No hospital personnel were located at the table to screen any visitors, staff or patients entering the facility and no COVID-19 signs and symptoms screening was being performed.

During a concurrent interview and record review on 7/11/22, at 3 p.m., with IP 1, CNE, IAQLPSO, DRM, CCIPP, Endoscopy Manager (EM), Regional Director of Infection Prevention (RDIP), IP 1 stated the screeners are responsible for stocking masks and hand sanitizer. IP stated any staff member can check if masks or hand sanitizer are available, as "infection prevention is everybody's business". IP 1 reviewed the document titled, "Recommended Approach for Compliance (RAD)". IP 1 stated the RAD guided staff on how to manage visitors that may have symptoms of COVID-19 coming into the Emergency Department (ED) and inpatient areas. IP stated a poster outside the entrances prompted visitors if they were symptomatic to not enter. IP 1 stated at the entrances to the facility a screener asks the visitor about symptoms of CO

Based on observation, interview and record review, the hospital failed to ensure all licensed nurses in the hospital were able to perform daily crash cart (a wheeled container carrying medicine and equipment for the use in emergency life support situations) maintenance ...when four out of four staff (RN 19, RN 2, RN 15 and RN 20) were unable to perform daily crash cart maintenance per facility policy and procedure titled, "Adult/Pediatric Crash cart maintenance".

Based on observation, interview and record review, the hospital failed to ensure four of four registered nurses ( RN 19, RN 2, RN 15, and RN 20) were unable to perform daily crash cart maintenance per hospital policy and procedure titled., "Adult/Pediatric Crash cart maintenance."

This failure had the potential to result in patients not receiving lifesaving treatment in case of an emergency.

Findings:

During a concurrent observation and interview on 7/6/22, at 10:45 a.m., with Registered Nurse (RN) 19 and Patient Care Services Director (PCSD), in the 4 East unit, RN 19 demonstrated how to perform the daily crash cart maintenance check. RN 19 looked at the oxygen tank on the crash cart but did not open it. RN 19 looked at the suction canister but did not turn it on. RN 19 received a prompt from PSCD to perform a manual [brand name] cardiac (heart) monitor (a machine used to shock the heart and monitor after) test for the [brand name] cardiac (heart) monitor. RN 19 did not check t the [brand name] cardiac monitor to ensure the battery was fully charged. RN 19 stated night shift staff are the ones that check the crash cart. RN 19 stated she was not sure when she last received education on how to properly check the crash cart.

During a concurrent observation and interview on 7/6/22, at 10:50 a.m., with Registered Nurse/Assistant Nurse Manager (RN) 2, in the 4 East unit, RN 2 demonstrated how to perform the daily crash cart maintenance check. RN 2 looked at the oxygen tank but did not turn it on. RN 2 looked at the suction canister but did not turn it on. RN 2 preformed a manual a defibrillator test for the [brand name] cardiac monitor. RN 2 did not check to if the [brand name] cardiac monitor had a fully charge battery pack in it. RN 2 stated it is important to make sure that the crash cart is completely functioning properly.

During a concurrent observation and interview on 7/6/22, at 11:10 a.m., with RN 15, in the 4 West unit, RN 15 demonstrated how to perform the daily crash cart maintenance check. RN 15 was observed making sure the cart was plugged into the wall. RN 15 was observed looking at the oxygen tank but did not open it. RN 15 looked at the suction canister but did not turn it on. RN 15 stated, he was looking for the "dummy plug" to check the [brand name] cardiac monitor and he was not able to locate them. RN 15 did check if the [brand name] cardiac monitor had a fully charge battery pack in it. RN 15 stated, he "should know how to check the crash cart it should be like double checking a glucometer (a machine used to check blood sugar for patients that is calibrated daily)."

During an interview on 7/6/22, at 11:23 a.m., with PCSD, PCSD stated, the expectation is that all nurses know how to use and check the crash cart to make sure the equipment is ready to use. PSCD stated, the nurses on P.M. shift are the ones that check the crash carts.

During a concurrent observation and interview on 7/6/22, at 11:47 a.m., with RN 20, in the obstetrics department, RN 20 demonstrated how to perform the daily crash cart maintenance check. RN 20 was observed to turning on the suction monitor, occluding it with her finger but did not measure or verbalize checking the PSI (pounds per square inch-unit of measurement). RN 20 did not check if the [brand name] cardiac monitor had a fully charge battery pack in it. RN 20 stated, it is important to check the battery on the [brand name] cardiac monitor to make sure it is working. RN 20 stated, the crash cart can be needed in a room for an emergency and cannot be plugged in.

During an interview on 7/13/22, at 1:57 p.m., with the Chief Nursing Executive/Chief Operations Officer (CNE/COO), CNE/COO stated her expectation for staff is to know how to use and check equipment in the crash cart because staff do not know who may need to "revive a patient".

During a review of the facility's policy titled, "Adult/Pediatric Crash cart maintenance", dated September 2021, indicated, " ...To ensure appropriate Adult and pediatric crash cart supplies are available for immediate, emergent use ...Routine Inspections for Adult/Pediatric Crash ...Daily crash cart checks will be done to ensure the seal is intact, all external equipment is present and functional, an the contents are within date ...A defibrillator test check is performed according to the manufacturer's instructions ...Turn on the suction machine, occlude the tubing an assure that the machine register 500 [millimetre of mercury-unit of measurement] within 5 seconds ...Open the [oxygen] tank to assure minimum pressure of 1500 [pounds per square inch-unit of measurement] ...Confirm the presence of all other outside contents ..."

During a review of "[brand name cardiac monitor] Operator's Guide", dated June 2019, " ...Defibrillator equipment must be maintained to be ready for immediate use. The defibrillator should be tested daily ...Inspect all cables, cords, and connectors for good condition ...Batteries/External Power Supply ...Check that a fully charged battery pack is installed in the unit ...Operational checks ...use Energy Select arrows to select 30 joules (measurement of energy), press CHARGE button, then SHOCK button. '30J TEST OK" message displayed ..."

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when:

1. Five of five cabinets storing reprocessed (a special process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) were not maintained in a manner that assured they were clean, safe, and functional; established "hang-time" (which is the amount of time a scope can be stored before it should be reprocessed) limits for the scopes were 30 days; and two of five cabinets were stored in procedure rooms that were not monitored for temperature and humidity which were not in accordance with hospital policy and standards published by the Association for the Advancement of Medical Instrumentation (AAMI- primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals). (Refer to A0750, Finding 1)

2. One of one endoscope used for an endoscopic retrograde cholangiopancreatography (ERCP- a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas) was carried by staff in a plastic container through patient, visitor, and staff seating areas and walkways not in accordance with Association for the Advancement of Medical Instrumentation (AAMI(AAMI-a professional organization) and Association of periOperative Registered Nurses (AORN- a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety). (Refer to A0750, Finding 2)

3. Two of eight operating rooms (OR 6 and OR 8) were not cleaned and maintained in accordance with hospital policy and standards published by the Association of Perioperative Registered Nurses (AORN- a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety). (Refer to A0750, Finding 3)

4. One of one storage room located in the obstetrics department was used to store sterile instrument kits for Cesarean sections (C-sections a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) together with 513 various sterile and non-sterile supply items. Computer equipment was stored in the same room and was enclosed by a chain link fence. The storage room was not secure and not controlled for humidity in accordance with Association for the Advancement of Medical Instrumentation (AAMI-professional organization) and AORN. (Refer to A0750, Finding 4)

6. Patients and visitors were not screened at the entry of the hospital for COVID-19 (a disease, caused by a novel (new) corona virus spread primarily through droplets of saliva or discharge from the nose when an infected person talks, coughs, or sneezes) in accordance with CDC's nationally recognized infection and communicable disease control guidelines. (Refer to A0749, Finding 1)

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

Because of the potential of serious harm and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 7/6/22 at 5:30 p.m., under Code of Federal A-0750 §482.42(a)(3) with the Director Risk Management & Patient Safety (DRM), Patient Care Services Director (PCSD), Chief Executive Officer Area Manager (ADM), Quality Nurse Consultant (QRN), Chief Nursing Executive/ Chief Operations Officer (CNE/COO) and Assistant Medical Group Administrator 2 (AMGA 2). The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 7) on 7/9/22 at 12:41 p.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Removed endoscope storage cabinets from endoscopy procedure rooms 2) Endoscope storage cabinets were cleaned and refurbished 3) Developed processes to reprocess endoscopes immediately prior to use and transport safely through common areas 4) Installed thermometers and hygrometers (device used to measure humidity) in procedure rooms 5 ) Created logs to document temperature and humidity readings and report outliers 4) Trained staff in disinfectant use and environmental cleaning 6) Created a space for sterile storage that is monitored for temperature and humidity 7) Process for monitoring compliance was established. Training and competencies of staff were validated. The components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 7/9/22 at 2:45 p.m. with the facility ADM, CNE/COO, Perioperative Director (PD), QRN, PCSD, and Labor Delivery Recovery Manager (LDRM).

Based on observation, interview, and record review, the hospital failed to ensure staff followed hospital policies and procedures and the Centers for Disease Control and Prevention (CDC, a national health protection agency) guidelines for infection prevention and control when:

1. Patients and visitors were not screened at the entry of the hospital for COVID-19 (a disease, caused by a novel (new) corona virus spread primarily through droplets of saliva or discharge from the nose when an infected person talks, coughs, or sneezes) in accordance with CDC's nationally recognized infection and communicable disease control guidelines.

2. Unvaccinated staff were not required to wear N95 respirators in accordance with state/federal guidelines.

3. Three of 11 sampled staff (Environmental Services Aide [EVSA] 1, Sterile Processing Department Technician [SPDT] 5, Surgical Technician [ST] 2) did not adhere to the policy and procedure (P&P) "Influenza Vaccination".

4. Three of three Registered Nurses (RN 12, RN 17, and RN 18) did not adhere to the facility P&P titled, "PCS-ADM-007 Dress and Appearance Standards",

5. One of one registered nurse (RN 19) did not adhere to the P&P titled ""Hand Hygiene NCAL (Northern California) Regional Policy."

6. Three of three staff members (Endoscope Technician License Vocational Nurse [ET 2, ET 4] and Pharmacy Technician [PT]) did not follow the hospital's policy and procedures for hand hygiene and standard transmission-based precautions (germs spread by air, drops of liquid, or contact with dry skin or contaminated surfaces).

These failures placed patients, visitors, and staff at risk for the transmission of COVID-19, influenza, and cross contamination ( transfer of bacteria from on person to another) of infectious diseases.

1. During an observation on 7/6/22, at 8:29 a.m., at the facility's clinic entrance surgical masks and hand sanitizer was observed on a table. No security personnel or staff were at entrance. Individuals were able to walk past pharmacy to the welcome desk at the elevators and into patient care areas without screening of signs and symptoms of COVID-19.

During an observation and interview on 7/7/22, at 7:00 a.m. at the facility entrance near birthing center, with Transporter (TR) 1, Inpatient Pharmacy Technician (IPT), and the Director of Risk Management and Patient Safety (DRM), TR 1 asked surveyor questions to validate their vaccination status. TR 1 stated he did not ask visitors if visitors have signs and symptoms for COVID-19. TR 1 stated he would only ask if visitors were vaccinated. TR 1 stated if visitors are not vaccinated are given instructions to go in a room and get a nasal swab for the COVID-19 antigen (a toxin which detects COVID-19). IPT stated the sign outside entrance addressed visitors. The English sign located on the outside entrance indicated, "no visitors with COVID-19 symptoms or suspected COVID-19 allowed". IPT stated visitors are expected to know what the symptoms of COVID 19. DRM stated, "after two years I don't believe that people don't know what symptoms of COVID are".

During an observation on 7/7/22, at 1:10 p.m., at the birthing center entrance to facility, three screeners were observed sitting at a table. Surgical masks, hand sanitizer, armbands and stickers were observed on the table. The screeners (personnel who screen individuals entering the facility) did not ask any questions related to signs and symptoms of Covid 19.

During an observation on 7/8/22, at 7:05 a.m., at the facility's clinic entrance, hand sanitizer, a box half full of child masks and empty box for adult masks were on the table was observed. No personnel at table to screen any visitors, staff or patients entering the facility and no COVID-19 signs and symptoms screening was being performed.

During an interview on 7/11/22, at 3:02 p.m., with Infection Preventionist (IP) 1, IP 1 stated the screeners are responsible for stocking masks and hand sanitizer. IP stated any staff member can check if masks or hand sanitizer are available, as "infection prevention is everybody's business".

During an interview and record review on 7/11/22, at 3:02 p.m., with IP 1, the Interim Area Quality Leaders & Patient Safety Officer (IAQLPSO), and the DRM, IP 1 reviewed the document titled, "Recommended Approach for Compliance (RAD)". IP 1 stated the RAD guides staff on how to manage visitors that may have symptoms of COVID-19 coming into the Emergency Department (ED) and inpatient areas. IP stated a poster outside the entrances prompts visitors if they are symptomatic to not enter. IP 1 stated at the entrances to the facility a screener asks the visitor about symptoms of COVID-19 and their COVID-19 vaccination status. IP 1 stated if visitor has symptoms they cannot enter. IP 1 stated the expectation is that the visitor reads poster outside, and the screener reinforces questions about COVID-19 symptoms and universal (everyone) masking. The IP stated the screener would give a green armband if a visitor were COVID-19 vaccinated and a white armband if visitor is unvaccinated for COVID-19 with a negative COVID-19 test. IP 1 read the RAD, which indicated, "For all visitors entering acute care space, follow this workflow. Note: This workflow does not apply to lab, radiology, or pharmacy ...". IP 1 stated for that area if the visitor has no symptoms they can come in, we have a screener and a poster at that entrance. IP 1 stated she was at the entrance lab, pharmacy, radiology (clinic entrance) the previous Wednesday (7/6/22) and there was a screener there before 9 a.m. The IAQLPSO stated facility leadership did a risk assessment and the clinic entrance does not allow access to acute care. The IAQLPSO stated the facility receives all their guidance for infection control from the Centers for Disease Control & Prevention (CDC) and the California Department of Public Health (CDPH). The DRM stated, the expectation is that if the visitor does come into acute care unit, any staff would redirect the visitor if the visitor does not have an armband. DRM stated we have managers reinforcing this expectation every day.

During an interview and record review on 7/11/22, at 3:49 p.m., with IP 1, DRM, IAQLPSO, and Regional Director of Infection Prevention (RDIP), IP 1 stated white armbands for visitors that are unvaccinated against COVID-19 and tested negative for COVID-19 are good for 72 hours. IAQLPSO stated white armbands are good for 24 hours.

During an observation and interview on 7/11/22, at 4:41p.m., with the CCIPP, the CCIPP stated that there should be a screener outside the ED entrance. Emergency Department Manager (EDM) 2 stated patient flow from outside enters door to security desk had hand sanitizer and masks. EDM 2 stated security screens for weapons and patients/visitors go through a metal detector into waiting room. After the security screening the patient/visitor will wait in the lobby for the receptionist for registration. EDM 2 stated the receptionist registered and screened patient for COVID-19 symptoms. One reception desk was visible behind glass window. EDM 2 stated symptomatic patients were taken to one of two triage rooms or to an empty room away from others.

During an observation and interview on 7/11/22, at 5:15 p.m., with the CCIPP, at the clinic entrance to facility, the CCIPP stated there is no partition between clinic entrance and acute care entrance. No screener was observed at the entrance.

During a concurrent observation and interview on 7/12/22, at 4:05 p.m., with the Lobby Officer (LO) 1 in the front part of the Emergency Department (ED), the LO was observed to have a surgical mask on. The LO 1 stated he does not screen patients for COVID symptoms. The LO 1 stated he asked patients the reason for their visit, asked them to put on a mask, provides hand sanitizer and asked them to go through the metal detector to make sure they have no weapons on them. The LO 1 stated if a patient came in with obvious symptoms of Covid 19 he would ask them to place a mask on right away.

During an interview on 7/13/22, at 8:36 a.m., with the Quality Nurse Consultant (QRN), the QRN stated she was unable to provide information when the screening process changed and when the ED stopped screening patients and visitors outside before entrance into the facility.

During a concurrent interview and document review on 7/13/22, at 10:24 a.m., with the Emergency Department Manager (EDM) 1, the "Emergency Department Visitor Log (ED Visitor Log)" was reviewed. The EDM 1 stated when visitors come into the ED he checks for proof of vaccination. If they cannot prove vaccination status a rapid COVID test is offered. The EDM 1 stated the ED Visitor Log is what they use to track and monitor visitor vaccination and EDM 1 validated the log does not track for screening of signs and symptoms of COVID.

During an interview on 7/13/22, at 11:12 a.m., with the Administrative Services Manager (ASM), the ASM stated he supervised the ED Unit Clerks and is responsible for their education. The ASM stated the expectation for ED Unit Clerks is to screen patients and visitors for COVID-19 vaccination status only. The ASM stated if the patient or visitor is vaccinated, they get a green armband and if not vaccinated, the clerks will have them tested for the COVID-19 antigen. The ASM stated the antigen test is performed in the waiting room or the bathroom. The ASM stated the ED clerks will ask the patient why they are coming to the ED to get a chief complaint entered in the medical record. The ASM stated the ED Unit Clerks do not ask patients about COVID-19 symptoms. The ASM stated the clerks are not clinical staff and it is the responsibility of the triage nurse to screen for s/s of COVID 19. The ASM stated if the patient is positive, the ED Unit Clerks notify the Charge Nurse, and the patient waits in the waiting room until they are moved. The ASM stated if the visitor is positive the ED clerk asks them to leave.

During a concurrent observation and interview on 7/13/22, at 12:00 p.m., with TR 2, near the south entrance of the facility, TR 2 stated his responsibility was to screen any visitors for COVID-19 vaccination status and have them show proof of vaccination before entering to visit a patient. TR 2 stated visitors who did not have proof of vaccination needed to be tested with a COVID-19 antigen test. TR 2 stated he did not stop visitors to ask about COVID-19 symptoms and did not have a tool that listed COVID-19 symptoms to ask visitors.

During an interview on 7/13/22, at 2:33 p.m., with the CNE/COO, the CNE/COO stated that she oversees the Infection Prevention Department. The CNE/COO stated screening for vaccination is a component of screening process and testing if not vaccinated. The CNE/COO stated, "I think we do more than other facilities". The CNE/COO stated that the facility has signage listing COVID-19 symptoms.

During a professional reference review retrieved from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, titled, "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic" dated 2/2/2022, the professional reference indicated, " ... 1. Recommended routine infection prevention and control (IPC) practices during the COVID-19 pandemic ... Establish a process to identify anyone entering the facility, regardless of their vaccination status, who has any of the following three criteria so that they can be properly managed: 1) a positive viral test for SARS-CoV-2, 2) symptoms of COVID-19, or 3) close contact with someone with SARS-CoV-2 infection (for patients and visitors) or a higher-risk exposure (for healthcare personnel (HCP) ...Options could include (but are not limited to): individual screening on arrival at the facility; or implementing an electronic monitoring system in which individuals can self-report any of the above before entering the facility ...."

During a professional reference review retrieved from https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms, titled, "Symptoms of COVID-19" dated 3/22/22, indicated, " ...Watch for Symptoms People with COVID-19 have had a wide range of symptoms reported - ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. Anyone can have mild to severe symptoms. People with these symptoms may have COVID-19: Fever or chills, Cough, Shortness of breath or difficulty breathing, Fatigue, Muscle or body aches, Headache, New loss of taste or smell, Sore throat, Congestion or runny nose, Nausea or vomiting, Diarrhea, This list does not include all possible symptoms. CDC will continue to update this list as we learn more about COVID-19. Older adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness..."

During a professional reference titled "CDC Facilities COVID-19 Screening", undated, the document indicated, " ... please read each question carefully ... 1. Have you experienced any of the following symptoms in the last 48 hours? ... fever or chills ... cough ... shortness of breath or difficulty breathing ... fatigue ... muscle or body aches ... headache ... new loss of taste or smell ... sore throat ... congestion or runny nose ... nausea or vomiting ... diarrhea ... 2. Are you isolating or quarantining [separation of a person who has been exposed to a communicable disease] because you tested positive for COVID-19 or are worried that you may be sick with COVID-19?... 3. Are you fully vaccinated OR have you recovered from a documented COVID-19 infection in the last 3 months?... 4. Have you been in close physical contact in the last 14 days with: Anyone who is known to have laboratory-confirmed COVID-19? Or Anyone who has symptoms consistent with COVID-19?... 5. Are you currently waiting on the results of a COVID-19 test?... 6. Have you traveled in the past 10 days?..."

2. During an interview on 7/11/22, at 3:49 p.m., with IP 1, DRM, IAQLPSO, the Clinical Consultant Infection Prevention Program (CCIPP), and the Regional Director of Infection Prevention (RDIP), IP 1 stated that the facility uses universal masking (everyone should wear a mask) and a surgical mask (loose-fitting, disposable device that creates a physical barrier between the mouth and nose) is appropriate. IP 1 stated staff are to wear eye protection and either a N95 (a particulate-filtering facepiece respirator mask), Powered Air Purifying Respirator (PAPR, a respirator that blows air through a filter to remove a contaminant and supplies purified air to a face piece) define ), or a Controlled Air Purifying Respirator (CAPR, a version of a PAPR with a slightly different arrangement that is more comfortable define) when caring for COVID-19 positive or a suspected positive patient, no matter where in the facility the staff works. The RDIP stated there is no difference in the required masks for COVID-19 vaccinated staff versus unvaccinated staff. The IAQLPSO stated all facility infection control standards come from the CDC and the California Department of Public Health (CDPH).

During an interview on 7/12/22, at 1:50 p.m., with the Respiratory Care Manager (RCM), the RCM stated unvaccinated staff wear the same procedure mask as other vaccinated staff. RCM stated the Safety Department performs N95 fit tests (a respirator test that determines if a tight-fitting respirator can be worn without having leaks) annually.

During an interview on 7/12/22. At 2:15 p.m., with the Safety Operations Practice Leader (SOPL), the SOPL stated Safety Operations tracks for which size N95 mask each employee is fit tested. The SOPL stated the facility follows CDC guidelines. The SOPL stated N95 are used with Tuberculosis (TB, an airborne disease) and aerosol generating procedures and COIVD-19 but did not know all the times when staff should wear or not wear a N95.

During a concurrent observation and interview on 7/12/22, at 4:15 p.m., in the ED, with Registered Nurse (RN) 12, RN 12 was observed wearing a surgical mask. RN 12 stated she has a medical exemption for the COVID-19 booster. RN 12 stated she wears an N95 respirator when she is working with patients with COVID-19 symptoms or working in triage (an area where patients are assessed and prioritized) or high traffic areas when she does not know who she will encounter. RN 12 stated she was not required to wear a N95 unless she was in those areas.

During a concurrent observation and interview on 7/12/22, at 4:20 p.m., in the ED, with RN 13, RN 13 is wearing an N95 mask. RN 13 stated he is unvaccinated against COVID-19. RN 13 stated he wears a N95 all the time. RN 13 stated he chooses to wear a N95 for better protection than a surgical mask. RN 13 stated, "sometimes the state requires us to wear a N95, but right now they require just a surgical mask".

During a record review of "Quality & Safety Oversight (QSO)-22-07, Attachment D" (QSO-22-07), dated 12/28/21, "QSO-22-07" indicated, "The hospital policies and procedures must be implemented within 30 days after the issuance of this memorandum and address the following components ...Requiring staff who have not completed their primary vaccination series to use a [National Institute for Occupational Safety & Health] NIOSH-approved N95 or equivalent or higher-level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients ..."

During a review of the facility document titled, "Personal Protective Equipment (PPE) Use for Patient Care Delivery During COVID-19 Pandemic (PPECOVID)", dated January 2022, PPECOVID indicated, " ...N95 respirators are available for any employee who are required to wear a N95 for the job they are performing but would like to wear one because they meet the following criteria: they are unvaccinated healthcare worker in a clinical area where patient and visitors may be present ..."

3. During a concurrent interview and record review on 7/11/22, at 11:04 a.m., with the Director of Occupational Medicine & Employee Health (DOMEHS) and, Assistant Medical Group Administrator (AMGA) 1, the DOMEHS reviewed personnel files for eleven sampled staff. The DOMEHS validated the personnel files of Environmental Services Aide (EVSA) 1, Sterile Processing Department Technician (SPDT) 5, and Surgical Technician (ST) 2 did not have evidence of influenza vaccination for the current 2021-2022 influenza season. The DOMEHS stated that EVSA 1, SPDT 5, and ST 2 should all have evidence of an influenza vaccination or a signed influenza vaccination declination.

During a review of policy & procedure (P&P) "Influenza Vaccination", dated 12/14/2020, the P&P indicated, "All employees must either obtain seasonal and [sic] novel (e.g., H1N1) influenza vaccinations ...proof of employees' seasonal and novel influenza vaccinations is maintained in EHS ...Employees who decline the vaccine must also complete and sign an Influenza Vaccine Declination Form ...those who decline the influenza vaccination ...will also sign ...documentation that he/she will wear a mask at all times ...for the duration of the influenza season ..."

4. During a concurrent observation and interview on 7/11/22, at 10:45 am, with the Emergency Department Manager (EDM) 1, Registered Nurse (RN) 12 was observed with her hair half up and half down falling approximately 2-3 inches below her shoulders. The EDM 1 stated RN 12 could just pull it back if needed but she was not sure what the hospital hair policy said about staff who perform direct patient care.

During a concurrent observation and interview on 7/11/22, at 11:12 a.m., with the Assistant Nurse Manager (ANM) 3 for 3 East, RN 17 was observed to have her hair down and extend 2 inches below her shoulders and RN 18 was observed to have her hair down and extended more than 4-6 inches below her shoulder. The ANM 3 stated the expectation for staffs' hair is that it should be shoulder length or be pulled back.

During an interview on 7/12/22, at 11 a.m., with the Infection Control Program Manager (IP) 1, the IP 1 stated the hospital has a policy to address hair, hair should not fall below shoulder length and should be kept away from your face; it could contaminate the patient or the staff member.

During a review of the hospital's policy and procedure titled, "PCS-ADM-007 Dress and Appearance Standards", dated 10/21/20, it indicated " ... 4.0 Procedure 4.1 Attire ... 4.4 Hair 4.4.1 Hair should be clean, neat, and tidy. If length presents any safety or health hazards, it should be secured above shoulder or tied back ..."

5. During a concurrent observation and interview on 7/11/22, at 11:30 a.m., with the ANM 3, on floor 3 East, RN 19 was observed having long nails that extended past the tips of her fingers and her nail polish was chipped in multiple places. The ANM 3 stated the expectation for staff who participate in direct patient care was no fake nails, no long nails, no cracked nail polish or chips. The ANM 3 stated that this can be an infection control issue for staff and patients.

During an interview on 7/12/22, at 11 a.m., with IP 1, the IP 1 stated the hospital has a policy to address hand hygiene. IP 1 stated the policy addresses no chipped nail polish, no artificial nails, and no long nails they could harbor bacteria. IP 1 stated the hospital uses the five moments of hand hygiene to address when staff should wash their hand or use hand sanitizer and it should be done before and after removing gloves. IP 1 stated it is important to perform hand hygiene to prevent transmitting multi drug resistant organisms to patients.

During a review of the hospital's P&P titled, "Hand Hygiene NCAL (Northern California) Regional Policy," dated 3/19/20, it indicated, "1.0 Policy Statement 1.1 All healthcare workers will follow hand hygiene provisions established in this policy based on World Health Organization across the continuum of care in the hospital, medical offices and ambulatory settings. 2.0 Purpose 2.1 To prevent the transmission of microorganisms from patient to patient and from inanimate surfaces to patients by the hands of all healthcare providers ... 5.0 Provisions ... 5.2 Indications for hand hygiene include the WHO [World Health Organization] Moments of Hand Hygiene and other instances as indicated below: 1. Before or upon entry to patient's room; before contact or donning personal protective equipment (PPE). 2. Before performing clean and/or aseptic procedures. 3. After body fluid exposure/risk or after removal of PPE. 4. After contact with patient and patient's environment. 5. After or upon exiting the patient's room ... 5.7 Fingernails 5.7.1 Artificial fingernails, wraps, overlays, extenders, or nail jewelry cannot be worn if duties include direct contact with patients, patient's supplies, food, or environment. 5.7.2 Nails must be clean and should not extend beyond fingertips. 5.7.3 Nail polish if worn, should be free of cracks and chips. 5.7.4. Staff, vendors, volunteers and students assigned in the operating rooms and sterile processing must not wear nail polish ..."

6. During a concurrent observation and interview on 7/7/22, at 8:48 a.m., with Pharmacy Technician (PT), with PT in the third-floor hallway, PT was observed walking with gloves on and a blue bag over her shoulder. PT stated, she needed to wear gloves if she was touching the bag because of the medication in it.

During a concurrent observation and interview on 7/7/22, at 8:55 a.m., in procedure room C, with ET 2, ET 2 stated ETs were responsible for cleaning and disinfecting patient care equipment after procedures. ET 2 was observed with gloved hands ET 2 pulled a disinfectant wipe from a pop-up container of germicidal disposable wipes to clean reusable patient care equipment in the room. ET 2 wiped the suction canister (system used to collect body fluids), discarded the wipe and returned to the pop-up container to get a second wipe. ET 2 handled and cleaned the surfaces of the room's computer, additional patient care equipment, and disinfectant pop-up container while she wore the same pair of contaminated gloves. After the room was cleaned, ET 2 stated she should have removed her gloves and perform hand hygiene between tasks. ET 2 stated she contaminated the disinfectant container and clean items in the room when she did not remove the gloves and perform hand hygiene. ET 2 stated hand hygiene was important to avoid cross contamination and transmission of infection.

During a concurrent observation and interview on 7/8/22, at 9:43 a.m., with PT, in the third-floor hallway, PT was observed walking with gloves on and a yellow bag over her shoulder. PT stated, she needed to wear the gloves for the medication in the bag.

During an interview on 7/11/22, at 4 p.m., with Infection Preventionist (IP), IP stated she would need to reeducate staff on wearing gloves in a clean area. IP stated, gloves would be unnecessary for transport of medication.

During a concurrent observation and interview on 7/11/22, at 4 p.m., with the Quality Nurse Consultant (QNC), while in the endoscope procedure room, the Endoscope Technician Licensed Vocational Nurse (ET 4) was seen removing her gown and dirty gloves and placing on new clean gloves and removed the endoscope tray from the procedure room. The QNC stated no she did not see the ET 4 clean her hands in between removing her dirty gloves and putting on clean ones.

During a review of the hospital's P&P titled, "Hand Hygiene NCAL (Northern California) Regional Policy," dated 3/19/20, it indicated, "1.0 Policy Statement 1.1 All healthcare workers will follow hand hygiene provisions established in this policy based on World Health Organization across the continuum of care in the hospital, medical offices and ambulatory settings. 2.0 Purpose 2.1 To prevent the transmission of microorganisms from patient to patient and from inanimate surfaces to patients by the hands of all healthcare providers ... 5.0 Provisions ... 5.2 Indications for hand hygiene include the WHO [World Health Organization] Moments of Hand Hygiene and other instances as indicated below: 1. Before or upon entry to patient's room; before contact or donning personal protective equipment (PPE). 2. Before performing clean and/or aseptic procedures. 3. After body fluid exposure/risk or after removal of PPE. 4. After contact with patient and patient's environment. 5. After or upon exiting the patient's room ... 5.7 Fingernails 5.7.1 Artificial fingernails, wraps, overlays, extenders, or nail jewelry cannot be worn if duties include direct contact with patients, patient's supplies, food, or environment. 5.7.2 Nails must be clean and should not extend beyond fingertips. 5.7.3 Nail polish if worn, should be free of cracks and chips. 5.7.4. Staff, vendors, volunteers and students assigned in the operating rooms and sterile processing must not wear nail polish ..."

During a professional reference retrieved from https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html/isolation2007.pdf, titled "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings", dated May 2022, the professional reference indicated, "Gloves ...Wear gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, nonintact skin, or potentially contaminated intact skin (e.g., of a patient incontinent of stool or urine) could occur ...Wear gloves with fit and durability appropriate to the task ...Wear disposable medical examination gloves for providing direct patient care ...Wear disposable medical examination gloves or reusable utility gloves for cleaning the environment or medical equipment ...Remove gloves after contact with a patient and/or the surrounding environment (including medical equipment) using proper technique to prevent hand contamination (see Figure). Do not wear the same pair of gloves for the care of more than one patient. Do not wash gloves for the purpose of reuse since this practice has been associated with transmission of pathogens ..."

Based on observation, interview and record review, the hospital failed to maintain a clean and sanitary environment for all patients, visitors, and staff when:

1. Five of five cabinets storing reprocessed (a special process used to prepare the product for reuse) endoscopes (a flexible instrument used to view internal parts of the body) were not maintained in a manner that assured they were clean, safe, and functional; established "hang-time" (which is the amount of time a scope can be stored before it should be reprocessed) limits for the scopes were 30 days; and two of five cabinets were stored in procedure rooms that were not monitored for temperature and humidity which were not in accordance with hospital policy and standards published by the Association for the Advancement of Medical Instrumentation (AAMI- primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals).

2. One of one endoscope used for an endoscopic retrograde cholangiopancreatography (ERCP- a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas) was carried by staff in a plastic container through patient, visitor, and staff seating areas and walkways not in accordance with Association for the Advancement of Medical Instrumentation (AAMI and Association of periOperative Registered Nurses (AORN- a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety).

3. Two of eight operating rooms (OR 6 and OR 8) were not cleaned and maintained in accordance with hospital policy and standards published by the Association of Perioperative Registered Nurses (AORN- a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety).

4. One of one storage room located in the obstetrics department was used to store sterile instrument kits for Cesarean sections (C-sections a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) together with 513 various sterile and non-sterile supply items. Computer equipment was stored in the same room and was enclosed by a chain link fence. The storage room was not secure and not controlled for humidity in accordance with Association for the Advancement of Medical Instrumentation (AAMI-professional organization) and AORN.

5. Environmental Services (EVS) did not document the environmental cleaning and disinfection of sterile storage areas and procedure rooms in the endoscopy department in accordance with hospital policy and procedure.

6. Two of two staff Medical Assistant (MA) 1 and Endoscopy Technician/ Licensed Vocational Nurse (ET) 2 assigned to clean the endoscopy storage cabinets and reusable equipment were not trained in disinfectant products and manufacturer wet times (how long disinfectant need to stay wet on a surface to be effective) to assure cabinets and equipment were thoroughly clean and disinfected.

7. One of one vent in the sterile processing department (SPD- area where cleaning and sterilization of devices used in medical procedures takes place) was covered with gray matter and appeared dirty.

8. One of two hospital Environmental Services Aides, (EVSA) 3, did not monitor contact times (measurement of the length of time it takes for a disinfectant to kill germs on a surface or inanimate object) for disinfectant solution and did not dispose of gloves during daily cleaning of an occupied room for Patient 18 in accordance with hospital policy and procedure.

9. Daily cleaning of one of one occupied patient isolation room by EVSA 1 was not performed in accordance with hospital policy and professional guidelines.

As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses.

Because of the potential of serious harm and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice, an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 7/6/22 at 5:30 p.m., under Code of Federal A-0750 §482.42(a)(3) with the Director Risk Management and Patient Safety (DRM), Patient Care Services Director (PCSD), Chief Executive Officer Area Manager (ADM), Quality Nurse Consultant (QRN), Chief Nursing Executive/ Chief Operations Officer (CNE/COO) and Assistant Medical Group Administrator 2 (AMGA 2). The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 7) on 7/9/22 at 12:41 p.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Removed endoscope storage cabinets from endoscopy procedure rooms 2) Endoscope storage cabinets were cleaned and refurbished 3) Developed processes to reprocess endoscopes immediately prior to use and transport safely through common areas 4) Installed thermometers and hygrometers (device used to measure humidity) in procedure rooms 5 ) Created logs to document temperature and humidity readings and report outliers 4) Trained staff in disinfectant use and environmental cleaning 6) Created a space for sterile storage that is monitored for temperature and humidity 7) Process for monitoring compliance was established. Training and competencies of staff were validated. The components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 7/9/22 at 2:45 p.m. with the facility ADM, CNE/COO, Perioperative Director (PD), QRN, PCSD, and Labor Delivery Recovery Manager (LDRM).

Findings:

1. During concurrent observation and interviews on 7/6/22, at 11:18 a.m., with the Flexible Scope Coordinator (FSC) and Medical Assistant (MA1), in the endoscopy department, procedure rooms B and C were observed to have one endoscope cabinet in each room. Fourteen reprocessed endoscopes (scopes) hung vertically in each of the storage cabinets. The cabinets were chipped and had gray particles outside the collection bins on the cabinet floors. Adjacent to the procedure rooms was a "clean storage" room with three endoscope cabinets. Cabinet "One" (C1) stored 16 reprocessed scopes, cabinet "Two" (C2) stored eight scopes, and cabinet "Three" (C3) stored seven scopes. The cabinets (C1, C2, and C3) were chipped and had gray particles on the cabinet floors. C2 had a reddish-brown staining on the cabinet floor trim. MA1 wiped the reddish- brown stain with a disinfectant wipe and stated, "It doesn't come off ... looks like rust." The FSC stated the endoscopy department followed manufacturer's guidelines and AAMI standards for scope storage and reprocessing. The FSC acknowledged the five cabinets were not cleaned and maintained in sanitary condition in accordance with AAMI standards. The FSC stated the unsanitary conditions were identified six months ago and the facility was in the process of replacing the cabinets. The FSC stated the cabinets were stored in procedure rooms B and C due to a lack of space and there was no plan in place to move the cabinets out of the procedure rooms. The FSC stated unused endoscopes were reprocessed every 30 days. The FSC stated all scopes were reprocessed by SPD in an "unlicensed" area of the facility.

During an interview on 7/6/22, at 11:30 a.m., with the Director of Engineering and Plant Operations (DPO), the DPO stated endoscopy procedure rooms were not monitored for temperature and humidity. The DPO stated the "clean storage" room was a "positive pressure" room (room that contains a higher pressure than the external environment to prevent air from leaving the room and circulating back inside) that was not monitored for temperature and humidity.

During an interview on 7/8/22, at 8:02 a.m., with Registered Nurse (RN) 10, RN 10 stated he was "not too familiar" with AAMI standards but had worked at other endoscopy clinics in the past. RN 10 stated he questioned the facility's practice of storing scopes in rooms used for "GI" (gastrointestinal- esophagus, stomach, and intestines) procedures and staff not checking the temperature and humidity of those rooms. RN 10 stated he reported concerns to "other nurses" and was told "It's always been like that." RN 10 stated "So, I just let it go."

During an interview on 7/8/22, at 8:30 a.m., with RN 9, RN 9 stated scope cabinets in the procedure rooms increased the risk of infection for the patients. RN 9 stated the cabinets were stored in a "dirty" area with high risk for cross contamination (transfer of germs from area to another) and the cabinets were opened multiple times a day exposing the scopes to the contaminated environment. RN 9 stated staff did not monitor the temperature and humidity in the rooms.

During an interview on 7/8/22, at 8:45 a.m., with Endoscopy Technician (ET) 3, ET 3 stated ETs interrupted patient procedures to retrieve scopes for upcoming cases. ET 3 stated ETs tried to prepare supplies and retrieve the scopes prior to scheduled procedures in other rooms but, because certain scopes were stored in procedure rooms B and C, ETs had to interrupt the procedures already in progress to obtain their scopes. ET 3 validated their practice of opening the cabinets during procedures increased the risk for cross contamination and infection and compromised the safety of the patients.

During an interview on 7/11/22, at 12:45 p.m., with the Endoscopy Manager (EM), the EM stated endoscopes were stored in procedure rooms B and C since before she was hired over two years ago. The EM stated the unsanitary condition of the cabinets were identified six months ago and department leadership determined that the cabinets needed to be replaced, however there was no discussion about moving the cabinets out of the procedure rooms. The EM stated she was not aware staff entered procedure rooms to retrieve scopes during endoscopy procedures. The EM stated staff were expected to prepare scopes prior to each procedure to avoid entering the rooms during procedures and potentially contaminating the reprocessed scopes. The EM validated this practice compromised the safety of the procedures and patients. The EM could not explain why the procedure rooms were not monitored for temperature and humidity.

During a review of the facility's document titled "Hospital Acquired Infections" dated 6/1/22 through 6/20/22, the document indicated Patient (Pt) 15 resulted positive for Clostridioides difficile (C. diff- an infectious germ that causes diarrhea and inflammation of the intestine and spread through contact with surfaces contaminated with feces).

During a concurrent interview and record review of Pt 15's electronic health record (EHR- patient medical record in electronic form) on 7/11/22, at 2:05 p.m., with the Clinical Consultant Infection Control Program (CCIPC), the CCIPC stated Pt 15 was admitted to the facility from a nursing home on 6/18/22, with a diagnosis of sepsis (life threatening infection in the body) and pyelonephritis (urinary infection in which both kidneys are infected). The CCIPC stated Pt 15 had an Esophagogastroduodenoscopy (EGD- internal examination of the esophagus, stomach, and small intestine), on 6/20/22, in the endoscopy department. On 6/23/22, Pt 15 exhibited C. diff symptoms (loose watery and mucoid like stools) and resulted positive for C. diff on 6/25/22. The CCIPC stated the likelihood of Pt 15 acquiring C. diff during the EGD procedure was minimal and potential causes of the C. diff infection was multifactorial. However, it was possible for Pt 15 to acquire C. diff during the EGD procedure because of the way endoscopes were managed in the endoscopy department. The CCIP stated temperature and humidity had to be regulated to prevent bacteria from growing.

A review of the professional reference at https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13563 titled "Management and Mitigation of Temperature and Humidity Events in the Perioperative Setting", " ... Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ..."

During an interview on 7/11/22, at 3 p.m., with IP 1, IP 1 stated she was aware of the endoscopes being stored in procedure rooms. IP 1 stated the endoscopes were stored in procedure rooms B and C for "a long time" and "we" recognized there was a problem with the cabinets "2-3 years ago." IP 1 stated there was a plan to have them replaced once the project to replace the cabinets was approved. IP 1 stated the cabinets in the procedure rooms posed minimal risks to patients since "our cabinet is tightly closed." IP 1 stated staff were expected to prepare supplies and scopes before each procedure and was unaware of any "breaches" in infection control. IP 1 stated she expected scopes to be reprocessed when breaches in infection control occurred. IP 1 also stated she thought plant operations monitored the temperature and humidity in the procedure rooms.

During concurrent interviews on 7/11/22, at 4:45 p.m., with the Medical Director of Gastroenterology Services (MDGI), the MDGI stated the scope cabinets were stored in procedure rooms B and C due to the department's space constraints. The MDGI stated the way the endoscopes were stored posed minimal infection control risk to patients because the cabinets stayed closed and were reprocessed and tested for bacteria (germs). The MDGI stated the scope that required special attention, most difficult to reprocess, and had a higher risk to spread infection were the "EUS" scopes (long flexible scopes with ultrasound capabilities that can be inserted through the mouth or rectum; also referred to as duodenoscopes) because of their small mechanical components and use in "ERCP" procedures. The MDGI stated the "EUS" scopes were stored elsewhere in the department to minimize contamination and risk of infection to patients. The MDGI stated he was not aware the temperature and humidity in scope storage areas were not monitored and that scopes were reprocessed in "unlicensed" area of the hospital.

During a review of a handwritten document provided by the facility's endoscopy department, dated 7/6/22, the document listed the type, number, and storage location of the reprocessed endoscopes. The "EUS" scopes were stored in C2, the cabinet with reddish-brown staining.

During a review of Chapter 8 of the manufacturer's guidelines for duodenovideoscopes (hollow, flexible, lighted tubes that allow doctors to see the top of a patient's small intestine), gastrointestinal videoscope (a flexible tube with a camera to see the lining of the intestines), and colonovideoscopes (A long flexible endoscope, often equipped with a device for obtaining tissue samples, that is used for visual examination of the colon) titled "Reprocessing Manual", undated, the manuals indicated " ... Precautions of storage ... maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/ or operators who touch them ... Establish a local policy regarding method and frequency of cleaning and disinfecting the endoscope storage cabinet ... Improper storage practices ... will lead to an infection control risk ... To prevent damage, do not store the endoscope ... at high temperatures, in high humidity ... Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated ... Microorganisms proliferate in wet/ moist environments. Keep cabinet doors closed to protect the equipment from environmental contaminants and accidental contact ... Store the sterilized endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices ..."

During a review of the document from AAMI, "Drying and Storage of Flexible Endoscopes: An Area of Growing Concern" dated 2020, the document indicated, " ... Healthcare Infection Control Practices ... A risk assessment should be performed for storage of endoscopes, as appropriate. Store endoscopes and accessories in a manner that prevents recontamination ... Recommendation ... Society of Gastroenterology Nurses and Associates ... Storage areas should be suitable for clean endoscopes (clean, well ventilated, and dust free) ... Seven-day storage if scopes were reprocessed and stored according to professional guidelines and manufacturer's instructions ... the key drivers of endoscope contamination are inadequate disinfection and/ or poor storage practices ..."

During a review of the facility's policy and procedure (P&P) titled "Temperature and Humidity Monitoring in the Operating Rooms, Sterile Processing and Procedure Rooms NCAL Regional Policy" dated 7/28/21, the P&P indicated, " ... Critical environments where invasive surgical procedures are performed and sterile instruments are processed and stored require optimum environmental conditions such as temperature and humidity to ... regulate the environment for the safety and comfort of patients and care providers ... decrease potential for microbial growth, such as mold and mildew in the case of high humidity conditions ... preserve shelf life and integrity of sterile supplies and equipment calibration ... Manual daily monitoring can be done by individual departments if the facility has no automated remote monitoring capacity ... Daily logging is required for non-continuous, periodic monitoring ... The temperature and humidity shall be maintained in the following ranges (ASHRAE & AAMI Standard ST79, 2017) ..."

During a review of professional reference titled "AAMI Sterility Assurance", dated 3/13/19, the reference indicated, " ...Objectives ... To provide an overview of the relevant AAMI standards that direct processing practices ... ST-79 ... General work areas - 68-73 deg. [degrees] F [Fahrenheit] (20-23 deg. C [Celsius] ) ... Decontam [decontamination] - 60-65deg F(16-18 deg. C.) ... Sterilization access room -75-85 deg.F. (24-29 deg.C.) (or as recommended by equipment mfr [manufacturer]) ... Sterile storage/support areas - 75 deg. (maximum -24deg.C.) ..."

During a review of the job description for "Scope Oversight Coordinator", undated, the job description indicated, " ... Provides support to clinic managers responsible for endoscope/ endocavity reprocessing areas ... staff training ... performing audits ... Collaborates with sterile processing/ and/ or department managers for employee and department safety, and risk management issues ..."

During a review of the job description for "Infection Prevention Program Manager", undated, the job description indicated, " ...Manages the medical center Infection Prevention Program to ensure activities are directed toward preventing and decreasing healthcare associated infections and improving patient safety across the continuum of care ... Collaborates with leadership team to ensure compliance with regulatory and accrediting agency requirements ... ensure surveillance activities and improvement plans are analyzed, implemented and reported to leadership ...Collaborates with Facility Services to ensure an integrated Environment of Care Program ..."

2. During an interview on 7/6/22, at 11:00 a.m., in the operative department, with the Perioperative Director (PD), the PD stated operating room (OR) 9 was reserved for endoscopy procedures that required general anesthesia (drug-induced depression of consciousness and ventilatory function).

During a concurrent observation and interview on 7/6/22, at 1:35 p.m., in OR 9, with ET 1 and the FSC, ET 1 pre-cleaned an endoscope with an enzymatic detergent in a plastic container. ET 1 stated the endoscope was used in an ERCP procedure and "point of use pre-cleaning" was required prior to the scope being transported to SPD for reprocessing. ET 1 completed the "pre-clean" process and suctioned all the remaining fluid from the container. ET 1 applied a transparent red disposable biohazard cap over the container and carried the container through the patient and visitor lobby, across the hallway, and to the SPD reprocessing room for endoscopes. The outside of the container was not cleaned and disinfected before leaving OR 9. The FSC stated this process was in place since 2018. The FSC stated endoscope reprocessing was centralized to an unlicensed area outside the endoscopy department due to space constraints.

During an interview on 7/8/22, at 8:02 a.m., with RN 10, RN 10 stated he used an endoscope "transport tower" to transport the contaminated endoscopes to the SPD reprocessing department. RN 10 stated he did not carry or use an open metal cart to transport the "dirty" endoscopes because the endoscope had the potential to fall. RN 10 stated it was an infection control and patient safety issue which he tried to minimize as much as he could. RN 10 stated staff hand carried endoscopes to the reprocessing department "all the time."

During an interview on 7/8/22, at 8:30 a.m., with RN 9, RN 9 stated she was not comfortable carrying "dirty" endoscopes to SPD through patient and visitor common areas. RN 9 stated the process risked scope integrity and had the potential to expose patients or visitors to infectious materials if there was an unforeseen accident during transport.

During an interview on 7/8/22, 9:05 a.m., with ET 1, ET 1 stated she was not comfortable with carrying endoscopes to SPD scope reprocessing room through patient and visitor areas of the facility. ET 1 stated she tried not to touch or open doors while carrying the contaminated endoscopes but the risk for cross contamination remained high during transport.

During a review of a professional reference titled "Storage and Transport of Flexible Endoscopes", dated May/ June 2019, the article indicated, " ... Soiled endoscopes must be handled in a manner that minimizes the risk of cross- contamination of the environment. This is accomplished by containing the endoscope in a solid transport container ... Containment of the soiled instrument must be performed correctly to prevent exposure to staff and other patients to that biohazardous device ... an OSHA- complaint transport container ... Since endoscopes are sharp in the respect that they have metal prongs that stick out ... they should be treated as sharp metal devices ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes ... SGNA ...Society of Gastroenterology Nurses and Associates", dated 2018, the manual indicated, "Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that prevents exposing staff, patients, or the environment to potentially infectious organisms ..."

During a professional reference review retrieved from https://www.aami.org/standards/ansi-aami-st79, titled, "ANSI [American National Standards Institute]/AAMI [Association for the Advancement of Medical Instrumentation] ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" indicated, " ...Transportation scheduling and routes ... Transport routes should ...avoid areas of high traffic ... Transportation equipment ...To help prevent damage to reusable items and avoid contamination of the environment, transport carts or other system should ...be designed to prevent items from falling over or off during transport ...be large enough to maintain the security and package integrity of the items being transported ...be covered or closed ..."

During a professional reference review retrieved from https://aornguidelines.org/guidelines/content?sectionid=173737535&view=book#229141984, titled, "AORN (Association of periOperative Registered Nurses) eGuidelines", dated September 2018, the professional reference indicated, " ...Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart ...The container or cart must be leak proof ...puncture resistant ...large enough to contain all contents ...Transporting items in leak-proof, puncture-resistant containers and in a manner that prevents exposing personnel to blood, body fluids, and other potentially infectious materials is a regulatory requirement ..."

3.During a concurrent observation and interview on 7/7/22, at 1:30 p.m., in OR 6, with the PD, the PD stated the facility's OR floors were aged and made of linoleum (smooth-surfaced floor covering made from a mixture of oxidized linseed oil, gums and resins, and other substances). The PD stated the smudges and stains seen on the floor were old and difficult to clean. The PD stated EVS was responsible for the cleaning and maintenance of the floors.

During concurrent observation and interviews on 7/7/22, at 2:02 p.m., in OR 6, with Environmental Services Aide (EVSA) 2, the Environmental Services Manager (EVSM), and PD, EVSA 2 performed the cleaning and disinfection of OR 6. EVSA 2 wiped the OR equipment with a disinfectant wipe from top to bottom and worked her way into the middle of the room. EVSA 2 stated she used [disinfectant name] to clean and disinfect the OR which had a "wet time" of five minutes. EVSA 2 stated she did not monitor how long the OR equipment stayed "wet" but thought allowing the disinfectant product to air dry was adequate. EVSA 2 returned to her clean housekeeping cart outside the room twice during the cleaning process to return and retrieve cleaning supplies. EVSA 2 did not remove gloves nor perform hand hygiene both times. After EVSA 2 finished cleaning the room, a strip of gray sticky residue remained on the floor in the center of the room. The floor's periphery had smudges and grime. Notable were gouges (a groove, hole, or indentation) found in the flooring with black and gray grime in the grooves. The EVSM stated EVSA 2 did not follow facility policy and good infection control practices when she did not perform hand hygiene and clean equipment prior to returning to her clean cart. The EVSM stated EVSA 2's practice had the potential for cross contamination of infectious material from room to room. The EVSM inspected the floor and validated the strip of sticky residue, grime along the periphery, and gouges in the flooring. The EVSM stated the floor was a linoleum product that was difficult to maintain free from gouges and smudges. The EVSM stated the gray sticky residue was the remnant of tape used during OR procedures and EVS staff were expected to remove the residue during the "turnover" of the room. The EVSM stated floors in the OR were "deep cleaned" weekly to remove the grime along the periphery and corners of the OR floor. The EVSM validated the grime along the periphery and inside the gouges appeared to be longstanding and validated adequate disinfection could not occur if the grime and residue was not removed.

During a concurrent observation and interview on 7/7/22, at 2:32 p.m., in the OR department, with the PD, the flooring in OR 8 had nicks and gouges with grime on the linoleum floor. The PD validated the condition of the floor and stated, "it probably needs to be replaced too."

During a review of the facility's P&P titled, "Transmission Based Precautions ... and Special and Protective Precautions", dated 8/18/21, the P&P indicated, " ... To prevent transmission of infection between patients, medical center staff and visitors ... Transmission Based precautions ... They may be used singularly or in combination, and always in conjunction with Standard precautions ... Hand Hygiene ... Before or upon entry to patient's room ... After body fluid exposure/ risk or after removal of PPE ... After contact with patient and patient's environment ..."

During a review of professional reference by AORN titled "Environmental Cleaning ... Cleaning Basics Module 1", dated 2014, the reference indicated, " ... definitions ... clean ... the absence of visible dust, soil, debris, blood, or other potentially infectious material ... disinfection ... a process that kills most forms of microorganisms on inanimate surfaces ... dwell time [wet time] ... the amount of time required for contact of a chemical agent with a surface ... turnover clean ... cleaning and disinfecting done to a room between patients throughout the day ... There is a high risk for spreading germs in the perioperative environment ... Clean and disinfect the floor surfaces at the edge of the room first moving toward the center of the room. The center of the room is where most patient care happens the center is likely to be dirtier ... always follow ... the manufacturer's instructions for use ..."

During a review of the [disinfectant name- oxycide] manufacturer's instructions for use (IFU), undated, the IFU indicated, " ... is for use on hard, nonporous hospital or medical surfaces ... environmental surfaces, high touch surfaces ... Apply solution with mop, cloth, sponge, brush, scrubber, or coarse spray device or by soaking so as to wet all surfaces thoroughly ... Allow to remain wet for required contact of 3, 5 or 10 minutes ..."

During a review of the facility's P&P titled, "OR Structure and Standards", dated 11/18/20, the P&P indicated, " ... To provide safe, appropriate, and effective nursing care for all surgical patients ... Statement of accountability and responsibility for the Service Director of Perioperative Services ... Appropriate budgets are prepared for the operating room ... and projected needs for personnel, operating plant renovation and maintenance ..."

4. During a concurrent observation and interview on 7/7/22, at 9:28 a.m., with Obstetrics Tech (OBT 1), in storage room 1LD-88, operating room (OR) sterile instrument kits for c-sections were stored on an open metal rack, on the opposite rack baby diapers, baby wipes, an opened box of [brand name] foot/finger print pads, an opened box of [brand name] pulse oximeter probe wraps (tapeless wrap used on baby) and additional unit supplies were observed. OBT 1 stated, the storage room was used to keep clean sterile instruments that had been picked up from the sterile processing department after they were sterilized. OBT 1 stated, that additional unit supplies were stored in the same space. OBT 1 stated, her process is to remove the stored sterilized c-section instrument kit from the rack in the storage room and place them in the OR for the next surgery.

During a concurrent observation and interview on 7/8/22, at 9:45 a.m., with Obstetrics Tech (OBT 2), in 1LD-88, no badge access was observed when entering. OBT 2 validated while in storage room 1LD-88, OR sterile instrument kit for c-sections were stored on an open metal rack, on the opposite rack baby diapers, baby wipes, an opened box of [brand name] foot/finger print pads, an open box of [brand name] pulse oximeter probe wraps was observed. In 1LD-88, a chain link fence padlocked with a computer behind the fence was observed, the chain link fence ran across the back of one supply storage rack. OBT 2 stated, the storage area "may be considered a clean environment". OBT 2 stated, the OR sterile c-section instrument kits had "always" been stored in there. OBT 2 stated, no badge access was required for entrance to room and all staff had access to room.

During a concurrent observation and interview on 7/8/22, at 9:50 a.m., with LDR Educator (LDRE), in 1LD-88, LDRE was observed checking the outside entrance door for badge access. LDRE stated, she thought badge a

Based on interview and record review, the facility failed to develop a policy and procedure for SARS-CoV-2 (COVID 19- a highly contagious respiratory illness that is transmitted through the air, which is the cause of current worldwide pandemic [prevalent over a whole country or the world]) testing for unvaccinated staff in accordance with accordance with nationally recognized Centers of Disease Control and Prevention (CDC) guidelines and nationally recognized standards.

This failure had the potential to result in facility staff to be unaware of the testing requirements and staff to go untested.

Findings:

During an interview on 7/7/22, at 8:00 a.m., with the Director Risk Management and Patient Safety (DRM), requested policy for COVID-19 testing for unvaccinated staff. The policy was not received.

On 7/8/22 at 7:20 a.m., with the Requested policy for COVID-19 testing of unvaccinated staff on an email list to the DRM on 7/8/22, at 7:20 a.m. The policy was not received.

During an interview on 7/8/22, at 3:05 p.m., with the Quality Nurse Consultant (QRN), requested policy for COVID-19 testing of unvaccinated staff. The policy was not received.

During an interview on 7/11/22, at 3:49 p.m., with Infection Preventionist (IP) 1, the Regional Director of Infection Prevention (RDIP), and the DRM, IP 1 stated unvaccinated staff get tested for COVID-19 twice a week. The Clinical Consultant Infection Control Program (CCIPP) stated they are tested when they report to work. The RDIP stated the facility follows CDC guidelines. The DRM stated they did not have a policy for COVID-19 testing for unvaccinated employees.

During a record review of "Quality & Safety Oversight (QSO)-22-07, Attachment D" (QSO-22-07), dated 12/28/21, "QSO-22-07" indicated, "The hospital policies and procedures must be implemented within 30 days after the issuance of this memorandum and address the following components ...Requiring at least weekly testing for exempted staff and staff who have not completed their primary vaccination series ..."