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Based on observation, interview and record review, the facility failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The facility 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.

a. Surgical instruments, endoscopes, and essential perioperative equipment were not cleaned, transported, or stored in accordance with policies and procedures, manufacturer's guidelines, and standards established by nationally recognized organizations for perioperative practices and for the safe use and management of surgical instrumentation and medical devices. These failures had the potential to cause equipment or instrument failure and transmission of infectious diseases resulting in serious harm to patients. (Refer to A 750 findings 1, 2, 3, 5, 6, and 7)

b. Safe temperature and humidity ranges were not maintained in the sterile processing department which increased the risk for microbial growth and equipment or device failure. (Refer to A 750 finding 4)

c. Staff did not perform hand hygiene and utilize PPE in accordance with policies and procedures and nationally recognized infection prevention and control guidelines, which had the potential to compromise the health and safety of patients, staff, and visitors. (Refer to A 750 finding 8 and 9)

As a result of the hospital not having a system in place to monitor practices to reduce the risk of infections and a system-wide failure of staff not following Infection Control principles and the serious risk of infections or cross contamination to all patients an Immediate Jeopardy (IJ) situation was identified on 8/31/22 at 5:47 p.m., under Code of Federal A-0750 §482.42(a)(3) in the presence of the Chief Operating Officer, Chief Nursing Officer, Director Quality and Risk, Manager Quality and Accreditation, Vice President Performance Excellence, Director of Perioperative Services, and the Director of Sterile Processing.

The serious issues identified included: surgical instruments and endoscopes were not cleaned and/or transported per professional standards to prevent cross contamination; reusable operating room equipment was air dried in the decontamination room and transported to a clean storage room for use in surgical procedures; autoclaves and critical equipment used to sterilize instruments and equipment were not cleaned and maintained in sanitary condition; endoscopes were not cleaned per manufacturer's guidelines and professional standards of practice; sterile supplies were not stored in accordance with professional standards; and staff were not wearing appropriate PPE in sterile processing and operating room.

The hospital submitted an Acceptable Action Plan to address the IJ situation. Survey team's observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 9/2/22 at 4:05 p.m. in the presence of the facility the Director Quality and Risk and the Manager of Quality and Accreditation.

2. First Assist Registered Nurses performed duties in surgical procedures without the benefit of being assigned a physician supervisor, without having experiences and qualifications vetted appropriately through medical staff office and without having evaluations on an ongoing basis. (refer to A945)

3. Staff did not follow policies and procedures to prevent retained foreign objects for Patient 2 and Patient 36. (refer to A951)

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.

Based on interview and record review, the facility failed to protect and promote patient's rights when:

1. Patients did not receive care in a safe setting (Refer to A-0144, Findings 1, 2, and 3)

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

Based on interview and record review, the hospital failed to follow their grievance process for two of 56 patients (Patients 34 and 35) when the response letters to the grievances submitted by Patients 34 and 35 were not sent by the 7th day in accordance with hospital policy and procedure.

These failures resulted in not ensuring Patients 34 and 35's right to a prompt resolution of their grievance and could negatively affect the quality of healthcare provided to them.

Findings:

During a review of the hospital's grievances log titled, "Grievances June - August 2022", the log indicated, on 7/18/22, Patient 34 filed a grievance. The log indicated a resolution letter was sent to Patient 34 on 7/28/22, 10 days after submission of the grievance. The log indicated, on 7/26/22, Patient 35 filed a grievance. The log indicated, a resolution letter was sent to Patient 35 on 8/3/22, eight days following the grievance.

During a concurrent interview and record review on 9/2/22, at 10:39 a.m., with Director of Quality and Accreditation (DQA) and Interim Risk Manager (IRM), the "Grievances June - August 2022" log was reviewed. IRM stated, Patient 34 filed the grievance by phone on 7/18/22. A letter of resolution was sent to Patient 34 on 7/28/22. DQA stated, the hospital missed the seven-day mark. IRM stated, Patient 35 filed the grievance by phone on 7/26/22. A letter of resolution was sent to Patient 35 on 8/3/22. DQA stated, the hospital missed the seven-day mark. DQA stated, there was no attempt to contact Patient 34 and Patient 35 for the delay.

During an interview on 9/2/22, at 10:45 a.m., DQA stated, CMS (Centers for Medicare and Medicaid Services - part of the Department of Health and Human Services which provide guidance and regulation to health care facilities) wants to resolve grievances as soon as possible. DQA stated, the Risk Department (unit that address issues and concern) was short on staff. DQA stated, a resolution letter should have been sent out within seven days. DQA stated, "Patients want to be heard, patients want to know their concerns are addressed. Facility also wants to know if there are any patient safety concerns that we need to address as a facility."

During a review of the hospital's policy and procedure (P&P), titled "Patient Grievance Policy," dated 1/22, the P&P indicated, "Purpose: To provide guidelines and prompt resolution of patient and/or family complaints and grievances and to support our efforts to continuously improve quality of care at [name of hospital], and to treat patients and visitors with courtesy and respect ... Procedure: B. All grievances will be responded to in writing and every attempt will be made to resolve the grievance as promptly as possible. i. The hospital will notify the patient or patient's representative if there will be a delay beyond the 7 days to provide a written response ..."

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

1. Surgical instruments, endoscopes, and essential perioperative equipment were not cleaned, transported, or stored in accordance with policies and procedures, manufacturer's guidelines, and standards established by nationally recognized organizations for perioperative practices and for the safe use and management of surgical instrumentation and medical devices. These failures had the potential to cause equipment or instrument failure and transmission of infectious diseases resulting in serious harm to patients.

2.Temperature and humidity were not maintained in Outpatient Surgery North (OPSN) Sterile Processing Department (SPD- performs sterilization and other actions on medical devices and equipment) prepack areas in accordance with hospital policy and procedure. This failure had the potential to cause the transmission of infectious diseases, electrostatic charges, and compromised the integrity of biological/ chemical indicators (used in the sterilization process) and EKG (electrocardiogram) electrodes (sticky patches with wires that connect to a monitor used to check electrical activity of the heart).

3. Three of three sampled crash carts (a set of tray/drawers/shelves on wheels used in hospitals for transportations and dispensing of emergency medication/equipment at site of medical/surgical emergency for life support protocols to potentially save someone's life) were not checked daily and documented as required in accordance with their policy to ensure quick access to emergency medications and supplies in life-threatening situations. This failure had the potential to result in a delay of life saving treatment to patients during emergent situations.

Findings:

1. During concurrent observation and interview on 8/30/22, at 9:25 a.m., in Outpatient Surgery North (OPSN) decontamination room, with Sterile Processing Technician (SPT) 1, SPT 1 demonstrated her process for manually cleaned surgical instruments before sterilization (process of making something free from germs). SPT 1 removed the soiled instruments that were placed on top of the towel and set them in a metal basin. SPT 1 stated the basin was filled with one gallon of water and one-half ounce of enzymatic solution. The remaining instruments were left in the dry sink that had pockets of water pooled near the sink's backsplash and handle. SPT 1 stated unused instruments, divided by the dry towel, did not have to be manually scrubbed since they were not used during the procedure. SPT 1 scrubbed the used instruments in the metal basin with a reusable brush and stated there was no "soak time" in the enzymatic solution required. SPT 1 used a scrub brush with notable frayed bristles. SPT 1 stated the reusable brush was "washed" at the end of each shift and was good for up to 3-5 days. Contaminated water from the metal basin splattered on the sink, SPT 1, and floor of the room during the cleaning process. The surgical instruments left in the dry sink were then placed on an instrument stringer (adjustable tool designed to keep hinged instruments in an open position during sterilization) and set aside to be sterilized.

During an interview on 8/31/22, at 10:55 p.m., with Manager of Sterile Processing (MGR) 4, MGR 4 stated SPT 1 had to be retrained on the "entire" process of reprocessing sterile instruments. MGR 4 stated he expected staff to manually clean and inspect all instruments in opened procedure trays, regardless of not being used in the procedure. MGR 4 stated cleaning brushes could be reused but had to be discarded if visibly soiled or damaged. MGR 4 stated, "[SPT 1] should have known."

During an observation on 8/30/22, at 9:40 a.m., reusable suction cannisters (storage container for secretions or fluids removed from the body) were cleaned, disinfected, and hung to dry in the decontamination area (separate "dirty" room of sterile processing where soiled surgical instrumentation and devices go to be cleaned) prior to storage in the sterile supply room and then used in the operating room (OR).

During concurrent interviews on 8/30/22, at 9:50 a.m., with OPSN Patient Coordinator (PC) 2 and MGR 4, PC 2 acknowledged the process of air-drying suction cannisters reused for procedures in the decontamination room, then directly storing them in the OR's clean supply room, increased the risks for transmission of infection and cross contamination of clean and/ or sterile supplies and compromised the OR environment. MGR 4 stated he was aware the clean suction cannisters were air dried in the decontamination room but failed to identify potential risks for transmission and cross contamination of infectious disease to patients.

During concurrent observation and interview on 8/30/22, at 4:30 p.m., in the endoscopy department (a designated area where medical procedures are performed to visually examine structures inside the body using a camera), with Lead Endoscopy Technician (ET) 1 in the presence of Patient Coordinator (PC) 5 and the Director of Surgical Services (DSS), department staff carried an endoscope in a biohazard bag (plastic bag used to collect, compile, pack, and dispose harmful and infectious wastes) from the procedure room to the endoscope reprocessing room. The tip of the endoscope had poked through the bag as the staff person carried the bag across the department's main walkway. ET 1 stated it was the department's practice to transport endoscopes to be reprocessed in a biohazard bag.

During an interview on 8/31/22, at 9:50 a.m., in OPSN, with SPT 1, SPDT 1 stated she does not perform daily cleaning of the autoclave and the SPD clean area.
During a concurrent observation and interview, on 8/31/22, at 9:53 a.m., in OPSN, with MGR 4, in the clean area of the SPD two autoclaves had a rust-colored deposits within the sanitizing compartment. MGR 4 stated the autoclave chamber should have no rust-colored deposits and should have been clean. The MGR 4 stated he was not aware of the rust-colored deposits in the autoclave.

During a concurrent interview and record review, on 9/1/22, at 9:30 a.m., with the MGR 4, the autoclave manufacturer's instructions for use (IFU) "AMSCO Steam Sterilization Cleaning Procedure," dated 2017 was reviewed. The AMSCO Steam Sterilization Cleaning Procedure indicated, " ...Chamber Cleaning Frequency ... Due to difference in water quality, steam quality, frequency of use and boiler additives, no specific frequency interval is recommended for chamber cleaning. Operators must determine the appropriate cleaning interval based on the local water conditions and chamber appearance. In general, chamber cleaning should be performed under the following circumstances: 1. when spills or other soiling have occurred, 2. periodically to maintain sterilizer cleanliness and appearance ..." MGR 4 stated brown colored deposits on the autoclave chamber should have been clean, and "it falls on me." The MGR stated it was his oversight responsibility.

During an interview on 9/1/22, at 9:50 a.m., with the Infection Preventionist (IP), the deficient infection prevention and control practices that were observed in the various departments were discussed with the IP. The IP acknowledged the deficient practices placed patients at risk for infections and compromised the safety of the hospital's high- risk environments (i.e., SPD, endoscopy, and OR). The IP stated these practices were not identified by the hospital's infection control team during surveillance rounds. The IP stated she was on leave and had not conducted an infection control surveillance in OPSN.

During a review of the professional reference titled "ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities", dated 2017, the professional reference indicated, " ... The first and most important step in reprocessing reusable medical devices is thorough cleaning and rinsing. Cleaning removes microorganisms and other organic and inorganic materials ... All microorganisms in health care facilities should be considered potentially pathogenic ... Medical devices, instruments, and equipment used in patient care become contaminated with microorganisms and should be decontaminated ... To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized ..."

During a review of the manufacturer's information for use (IFU) "General Instrument Cleaning Brushes", undated, " ... Clean brushes after each use and disinfect between cases or daily, at minimum ... Inspect between uses and replace when worn, frayed, bent, otherwise damaged. Damaged brushes cannot be cleaned effectively. Worn or damaged bristles and handles are ineffective in cleaning, and may damage the device ..."

During a review of professional reference titled "Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes... Society of Gastroenterology Nurses and Associates [SGNA- a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing]", 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 review of the hospital's policy and procedure (P&P) titled "Patient Rights" dated 10/20, the P&P indicated, " ...[Hospital] will provide to all patients a copy of the Patient's Bill of Rights ... Bill of Rights and Responsibilities ... We at [hospital] believe that quality health care is about more than providing the finest treatment. It involves caring for each patient's personal well- being. That is why we've developed the following list of patient rights ... Receive care in safe setting ..."

2. During concurrent interviews and record review on 9/1/22, at 10:00 a.m., with the Facilities Maintenance Manager (MGR) 8 and the Heating Ventilation and Air Conditioning Technician (HVACT), MGR 8 stated the temperature and humidity in OPSN-SPD were remotely monitored and recorded on the hour, 24 hours per day, via the hospital's computer monitoring system. MGR 8 stated the temperature and humidity in OPSN-SPD were preset to temperature ranges between 68 degrees F and 73 degrees F and humidity ranges between 20 and 60 percent (%). MGR 8 stated the system documented and "alarmed" maintenance if temperatures and humidity readings registered outside the preset ranges. The temperature and humidity logs for 6/2022, 7/2022, and 8/2022 were reviewed. Findings were as follows:

The OPSN-SPD temperature and humidity logs for June 2022, "alarmed" out of range temperatures on 6/10/22, 6/24/22, 6/25/22, 6/26/22, 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The temperatures ranged between 75.3 degrees F and 86.3 degrees F for two to 17 consecutive hours. Out of range humidity readings were registered on 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The humidity ranges that "alarmed" were between 12.66% and 18.73% for three to eight consecutive hours.

The OPSN-SPD temperature and humidity logs for July 2022 registered out of range temperatures on 7/3/22, 7/17/22, 7/18/22, 7/19/22, 7/20/22, 7/21/22, 7/22/22, 7/23/22, 7/24/22, 7/25/22, 7/26/22, 7/27/22, 7/28/22, 7/29/22, 7/30/22, and 7/31/22. The temperatures ranged between 75.1 degrees F and 88.4 degrees F for seven to 15 consecutive hours. Out of range humidity readings that "alarmed" registered on 7/20/22, 7/21/22, and 7/22/22. The humidity ranged between 15.47% and 18.62% for three to nine consecutive hours.

The OPSN-SPD temperature and humidity logs for August 2022 registered out of range temperatures on 8/14/22, 8/15/22, 8/16/22, 8/17/22, 8/18/22, 8/19/22, 8/20/22, 8/21/22, 8/22/22, 8/23/22, 8/24/22, 8/25/22, 8/26/22, 8/27/22, 8/28/22, 8/29/22, and 8/30/22. The temperatures ranged between 75.2 degrees F and 88.2 degrees F for four to 14 consecutive hours. There were no out of range humidity ranges that "alarmed" for August 2022.
HVACT stated the HVAC system could not keep up with demands during "summertime" months because the system "pulled [hot] air from the outside and [the HVAC] was old." MGR 8 stated maintenance personnel were sent to OPSN-SPD to check the HVAC and thermostat each time the system alarmed but there was not much that could be done. MGR 8 stated the temperature and humidity were difficult to maintain within safe ranges and the system needed replacement.

During an interview on 9/2/22, at 12:30 p.m., with the Director of Facilities (DFM), DFM stated the HVAC system in OPSN-SPD did not have the capacity to maintain safe temperature and humidity ranges. DFM stated equipment used in SPD generated lots of heat and the HVAC system utilized 100% of outside air which, on summer days, increased the room's temperatures. DFM stated the current system required upgrading.

During a review of the hospital's P&P titled, "Humidity/ Temperature Monitoring, Surgical/ Procedural Units" dated May 2020, the P&P indicated, " ...To ensure patient safety in terms of prevention of electrostatic charges and infection control ... and to reduce the potential for bacterial growth ... A relative humidity will be maintained between 30% and 60% in all surgical and procedural suites and sterile storage areas ... Temperature will be maintained at 68 degrees F to 75 degrees F ... humidity and temperature are manually monitored and recorded daily by each department in designated sterile storage in SPD ..."

Review of the hospital's policy and procedures for Humidity and Temperature monitoring, the preset ranges for humidity should have been set between 30% and 60%, not 20% as MGR 8 previously indicated. For the month of June 2022, there were a total of 216 occurrences for which the humidity in OPSN-SPD registered below 30% and did not "alarm." In July 2022, there were 148 occurrences and in August 2022, there were 19 occurrences. The humidity levels stayed below 30% for up to 65 consecutive hours (7/21/22 through 7/24/22).

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", dated 11/30/21, indicated, "... Temperature or relative humidity variations that fall outside the recommended parameters for the perioperative environment can have serious implications for patient safety ... 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. Other negative effects include ... decreased patient satisfaction stemming from delays or rescheduled procedures ..."

During a review of the professional reference titled, "ANSI [American National Standards Institute- national organization supporting the development of technology standards]/ ASHRAE [American Society of Heating, Refrigerating and Air-Conditioning Engineers]/ASHE [American Society for Health Care Engineering] Standard," dated 2017, the professional reference indicated, " ...Standard 170 will be included in the Hospitals and Outpatient
Facilities books ... The purpose of this standard is to define ventilation system design requirements that provide environmental control for comfort, asepsis, and odor in health care facilities ... Sterile Processing Department ...Clean workroom ...humidity Max 60% ...temperature 68-73 degrees F ... Decontamination room ... humidity NR ... temperature 60-73 degrees F ... Sterile Storage ... humidity Max 60%... temperature Max 75 degrees F ..."

A review of the professional reference at https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/ASTGuidelinesHumidityintheOR.pdf titled "Guidelines for Best Practices for Humidity in the Operating Room", dated 6/17, indicated, " ... RH [relative humidity] level is important to the shelf life of sterile supplies that are stored in the surgery department and the levels established by manufacturers of electromedical devices ... Therefore, shelf life and product integrity can be even more greatly affected if the IFU [information for use] calls for 30-60% RH, but the HDO [healthcare delivery organization] lowers the RH to 20%. Examples of products that are sensitive to humidity include biological and chemical indicators, and EKG [electrocardiogram] electrodes [sticky patches with wires that connect to a monitor used to check electrical activity of the heart]. Manufacturer's test products at a specific RH, of which it can be assumed the testing level has been at 30%... The manufacturers of electro-medical devices (EMD) and healthcare technology management (HTM) have communicated concerns about lower RH levels. Problems with EMDs not working properly at lower RH levels have been reported by HTM technicians, and the lower levels causing problems with calibration ..."

3. During a concurrent observation, record review, and interview, on 8/30/22, at 7:30 a.m., with DSS and PRERN1, on the second floor in the Pre-operative unit (area where patients are prepared for surgery), the crash cart (a mobile unit which contains emergency medication and equipment) logs were observed. The crash cart had a plastic lock that was intact. The crash cart had a clipboard with a record to document that the crash cart had been checked for supplies and medications once a day. The "Crash Cart Checklist - Preop (CCCP)", dated August 2022, July 2022, June 2022, May 2022, and April 2022 were reviewed. The CCCP for August 2022 indicated no daily crash cart checks were done on 8/6/22, 8/7/22, 8/10/22, 8/11/22, 8/13/22, 8/14/22, 8/17/22, 8/16/22, and 8/17/22. The CCCP for July 2022 indicated no daily crash cart checks were done on 7/1/22, 7/2/22, 7/3/22, 7/4/22, 7/9/22, 7/10/22, 7/23/22, 7/24/22, 7/25/22, 7/30/22, and 7/31/22. The CCCP for June 2022 indicated no daily crash cart checks were done on 6/3/22, 6/6/22, 6/8/22, and 6/17/22. The CCCP for May 2022 indicated no daily crash cart checks were done on 5/1/22, 5/2/22, 5/13/22, 5/21/22, 5/22/22, and 5/29/22. The CCCP for April 2022 indicated no daily crash cart checks was done on 4/27/22. PRERN 1 stated the crash carts should be checked daily. PRERN 1 stated the crash carts have not been checked daily as per policy. DSS stated the crash carts should be checked daily as per policy. DSS stated if the crash carts are not checked daily, the staff are not prepared for emergencies, and it puts patients at risk.

During an observation on 8/30/22, at 10:00 a.m., on the fifth floor in the Telemetry Unit (area where patients are under constant cardiac monitoring), the defibrillator (device that send an electric pulse or shock to the heart to restore a normal heartbeat) on the unit's crash cart was observed with no ECG (electrocardiogram) paper (a strip of paper with grids to record the rhythm of the heart).

During a concurrent observation and interview on 8/30/22, at 10:35 a.m., with Manager (MGR) 6, MGR 6 stated, MGR 6 was the charge nurse of the unit. MGR 6 validated there was no ECG paper installed in the defibrillator. MGR 6 stated, contents on the crash cart were checked once a day and the manual shock test of the defibrillator was checked once a week by the charge nurse to ensure contents and functionality were ready for use in emergency situations. MGR 6 stated, MGR 6 checked the contents of the crash cart and performed the defibrillator shock test on 8/30/22. MGR 6 stated, MGR 6 used the last of the ECG paper and did not replace it. MGR 6 stated, when a red ribbon appears on the ECG paper, it was time to replace the ECG paper. MGR 6, stated the ECG paper should have been replaced following the previous performance check when the red ribbon first appeared. MGR 6, stated the purpose of checking the crash cart and defibrillator was to be prepared in case of emergency.

During an interview on 8/30/22, at 10:50 a.m., with Director of Clinical Operations (DOC) 2, DOC 2 stated, making sure there was ECG paper in the defibrillator was part of the routine checking process. DOC 2 stated, DOC 2 expected there was ECG paper in the defibrillator and to be replaced when the red ribbon appeared on the ECG paper. DOC 2 stated, the red ribbon indicated the ECG paper was low and staff should have replaced it. DOC 2 stated, the defibrillator was checked routinely to be prepared for emergency use.

During an observation and record review on 8/31/22, at 10:00 a.m., in the Out-Patient Infusion Unit (area where patients receive intravenous medication), the crash cart was observed. On the crash cart was a clipboard with log sheets titled, "Crash Cart Checklist - [brand name of the defibrillator] indicating items to be checked. Each sheet indicated the month the crash cart items were checked with no year written next to the month.

During a concurrent interview and record review on 8/31/22, at 10:05 a.m., with Registered Nurse (RN) 7, the "Crash Cart Checklist - [brand name of the defibrillator]," dated June, July, August ... was reviewed. RN 7 stated, there should have been a year written next to the month on the crash cart check list to indicate the accurate date.

A review of the hospital's policy and procedure (P&P) titled, "Crash Cart/Defibrillators", dated March 2021, indicated " ...Policy 1. Crash Carts will be check daily ...Procedure 1. Check the crash cart number, the defibrillator, the O2 tank amount and the medication lock daily ....4. Check the defibrillators for: A. ECG paper ...Documentation: Crash Cart Checklist: 1. Staff checking the crash cart sign their name on the 'Crash Cart Checklist' indicating: A. Crash cart number B. Oxygen tank >1/2 full C. Defibrillator has been checked ..."

Based on interview and record review, the hospital failed to take action aimed at performance improvement when the quality assurance and performance improvement (QAPI) committee did not identify high-risk, high-volume, problem-prone areas and did not consider the incidence and severity of problems affecting patient safety and quality of care in Outpatient Surgery North (OPSN).

This failure led to a delay in the implementation of necessary corrective measures resulting in continued risk of infections and injury to patients that had surgical procedures in OPSN.

Findings:

During an observation on 8/30/22, at 9:40 a.m., reusable suction cannisters (storage container for secretions or fluids removed from the body) were cleaned, disinfected, and hung to dry in the decontamination area (separate "dirty" room of sterile processing where soiled surgical instrumentation and devices go to be cleaned) prior to storage in the sterile supply room and then used in the operating room (OR).

During concurrent interviews on 8/30/22, at 9:50 a.m., with OPSN Patient Coordinator (PC) 2 and Manager of Sterile Processing (MGR) 4, PC 2 acknowledged the process of air-drying suction cannisters reused for procedures in the decontamination room, then directly storing them in the OR's clean supply room, increased the risks for transmission of infection and cross contamination of clean and/ or sterile supplies and compromised the OR environment. PC 2 stated the cannisters were stored in the decontamination room due to a lack of space in the sterile reprocessing department (SPD- performs sterilization and other actions on medical devices and equipment) which hospital administration was aware of the issue "for some time." MGR 4 stated the limited space and configuration of the OPSN SPD department had "some challenges" and department expansion was necessary.

During a concurrent observation and interview, on 8/31/22, at 9:42 a.m., in OPSN- SPD, with sterile processing technician (SPT) 1 and MGR 4, Temperature range (T) and humidity ranges (H) were not maintained in OPSN SPD prepack areas. MGR 4 stated a work order was placed "two days ago." SPT 1 stated staff did not document the temperature and humidity in the log. SPT 1 stated temperature and humidity in SPD was last documented by staff "like a month ago." MGR 4 stated the system for recording temperature and humidity in SPD was changed and staff had not documented the temperature and humidity in SPD since June 2022. MGR 4 stated he was not certain if maintenance staff monitored and had oversight of the temperature and humidity in OPSN-SPD.

During a review of the OPSN's sterile processing department (OPSN-SPD) temperature and humidity logs for June 2022, "alarmed" out of range temperatures on 6/10/22, 6/24/22, 6/25/22, 6/26/22, 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The temperatures ranged between 75.3 degrees F and 86.3 degrees F for two to 17 consecutive hours. Out of range humidity readings were registered on 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The humidity ranges that "alarmed" were between 12.66% and 18.73% for three to eight consecutive hours.

During a review of the OPSN-SPD temperature and humidity logs for July 2022 registered out of range temperatures on 7/3/22, 7/17/22, 7/18/22, 7/19/22, 7/20/22, 7/21/22, 7/22/22, 7/23/22, 7/24/22, 7/25/22, 7/26/22, 7/27/22, 7/28/22, 7/29/22, 7/30/22, and 7/31/22. The temperatures ranged between 75.1 degrees F and 88.4 degrees F for seven to 15 consecutive hours. Out of range humidity readings that "alarmed" registered on 7/20/22, 7/21/22, and 7/22/22. The humidity ranged between 15.47% and 18.62% for three to nine consecutive hours.

During a review of the OPSN-SPD temperature and humidity logs for August 2022 registered out of range temperatures on 8/14/22, 8/15/22, 8/16/22, 8/17/22, 8/18/22, 8/19/22, 8/20/22, 8/21/22, 8/22/22, 8/23/22, 8/24/22, 8/25/22, 8/26/22, 8/27/22, 8/28/22, 8/29/22, and 8/30/22. The temperatures ranged between 75.2 degrees F and 88.2 degrees F for four to 14 consecutive hours. There were no out of range humidity ranges that "alarmed" for August 2022.

During concurrent interviews and record review on 9/1/22, at 10:00 a.m., with the Facilities Maintenance Manager (MGR) 8 and the Heating Ventilation and Air Conditioning Technician (HVACT), HVACT stated the HVAC system could not keep up with demands during "summertime" months because the system "pulled [hot] air from the outside and [the HVAC] was old." MGR 8 stated maintenance personnel were sent to OPSN-SPD to check the HVAC and thermostat each time the system alarmed but there was not much that could be done. MGR 8 stated the temperature and humidity were difficult to maintain within safe ranges and the system needed replacement. MGR 8 stated, "this has been a problem for years," and hospital administration were aware of the ongoing issues.

During a concurrent interview and administrative document review on 9/1/22, at 3:24 p.m., with the Manager Quality Accreditation (MQA), MQA stated a representative from the Quality Department participated in routine monthly rounds in the hospital. MQA stated each area was visited one to two times a year to evaluate compliance and identify potential patient safety concerns. MQA stated the administrative documents reflected dates and areas inspected during rounds which were last conducted, on 10/22/20, in OPSN. The administrative document "OPSN 10/22/20," did not include department specific items to be inspected (i.e., the sterile reprocessing department).

During an interview on 9/2/22, at 2:04 p.m., with the Director of Quality and Accreditation (DQA) and MQA, DQA stated quality data reported to Quality included recurring issues which were discussed with Quality council and reported to leadership. MQA stated this "normal" practice was disrupted by COVID-19 (a highly contagious respiratory disease caused by the SARS-CoV-2 virus) pandemic and hospital rounding did not happen as usual. MQA stated staff were working from home and processes that monitored and provided oversight of the hospital's environment and infection prevention practices did not happen. MQA also stated the workload increased and resources decreased, and the volume of procedures were down.

During a review of the hospital's "Quality, Patient Safety & Performance Improvement Plan FY 2022", the plan indicated, " ... The Quality Council, compromised of physicians, administrators, clinical and ancillary department leaders, is responsible for monitoring, evaluating trends, and taking action on patient safety and quality issues in the organization ... Potential projects for performance improvement are evaluated to determine their alignment with the organization's PSAs [priority strategic aims] and are selected based upon risk and severity level, impact to patient safety and operations ..."

During a review of the professional reference titled "ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities", dated 2017, the professional reference indicated, " ... a continuous quality improvement (CQI) program encompasses the entire process of decontamination, preparation and packaging, sterilization, quality control, sterile storage, and product distribution ... There should be a planned, systematic, and ongoing process for verifying compliance with procedures. Quality processes can be enhanced by audits that are conducted on a regular basis ... Measurements of process performance allow the steam sterilization process to be monitored against a predetermined level of quality. Evaluation of findings provides a method of identifying problems or shifts in activities and facilitates informed decision-making on policies and procedures. Ongoing auditing provides data essential to assess the effectiveness of the processes and to make improvements in performance..."

During a review of the hospital's policy and procedure (P&P) titled "SPD Department- Outpatient Surgery North" dated 6/17, the P&P indicated, " ... To ensure practices and processes performed in OPSN SPD department mirror the practices and processes being performed in the main Hospital SPD Department ... Audits are to be performed on the first Monday in July, October, January, and April ... include a comprehensive assessment of a) Decontamination process b) Inspection, assembly, and packaging of surgical instrumentation, equipment and utensils c) Process point scanning in SPM [computer system] d)Sterilization practices and record keeping e) Transport and storage of sterile items ... Summary worksheets are to contain a comprehensive list of focal points ... Sterilization practices ... Temperature and humidity controls ... Transport and storage of sterile items ... Temperature and humidity of storage areas ... storage practices ... At conclusion of all quarterly audits, SPD leadership will document all outcomes and findings ... Copies of the worksheet will be provided to OPSN, OR, and SPD leadership ..."

Based on interview and record review, the hospital failed to have a medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital when:

First Assist Registered Nurses were scheduled and performed surgical procedures without the benefit of being assigned a physician supervisor, without having experiences and qualifications vetted appropriately through medical staff office and without having evaluations on an ongoing basis. (refer to A339)

The cumulative effect of these systemic concerns resulted in the hospital's inability to provide quality healthcare in a safe setting.

Based on interview and record review, the hospital failed to follow privileging processes according to hospital Bylaws, standardized procedures and policy and procedures, and granted surgical privileges for nine of nine Surgical First Assistant (FA), non-physician allied healthcare providers (AHP) without first vetting and evaluating experience, training, professional education, competence, and/or ability.

The failure of the hospital Interdisciplinary Patient (IPC) and Medical Staff (MEC) committees to properly credential and assess APHs' qualifications and allow nine of nine unqualified Surgical First Assistant to furnish surgical care to patients potentially endangered the health and safety of patients.

Findings:

During concurrent interview and record review, with the Medical Staff Service Manager (MSS) during the following dates: 8/29/2022 at 3:22 p.m., 8/30/2022 at 9:14 a.m. and 4:15 p.m., and 9/1/2022 at 8:23 a.m., the medical staff files and documents were provided by the MSS were reviewed and discussed: "Standardized Procedures for RN First Assistant", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", "Ongoing Professional Performance Evaluation Allied Health Professional (AHP) form", "To be Agreed Upon by the Supervising Physician(s)" form indicated that the signing physician(s)", [Hospital] for a refence letter form letter, "Bylaws of the Medical Staff of[Hospital]", "Allied Health Professional Policies and Procedures", "[Hospital] Orthopedic Surgery Clinical Privileges", "[Hospital] General Surgery Clinical Privileges", "[Hospital] Allied Health Professional Policies and Procedures", "Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant", "[Hospital] Nurse Practitioner Task List", "[Hospital] Physician Assistant Task List", "Surgical Assistant Focused Professional Performance Evaluation", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", Requirements for Service Authorization and Criteria for Approval of Tasks Non-Physician Assistant", "Nursing Department, 'Position Description, Title: RN First assistant, department of surgery, Reports to: Practice Coordinator, surgery", DCA State of California Department of Consumer Affairs, "The RN as First Assistant to the Surgeon". The MSS stated AHPs, included non-physician First Assistants (FA) and Physician Assistants (PA), Nurse Practitioners (NP) and Registered Nurses (RN), could be privileged (ability furnish medical and surgical services to patients) by MEC as non-physician Surgical First Assistants (FA). The MSS stated, if the AHP is an employee of the hospital, he/she must meet the Human Resources nursing requirements to apply for medical staff privileges as a surgical First Assistant. The MSS stated FA applications were reviewed for completeness first by ICP, then by MEC, and the Board of Directors (GB) approves the final clinical privileges. The MSS stated during review of the credentialing files, primary verification of education, professional experience and certification is "sometimes" done. The MSS acknowledged 9 of 9 RNFA credential files were deficient, and the privileging process was not followed. The MSS stated the FAs' clinical privileges to furnish surgical services were approved without the required vetting and documents by ICP, MEC and GB. The following items were verified by MSS during record review:

1. 9 of 9 FAs (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1, NPFA2 and NPFA3) did not have documentation of competency for surgical cases, peer review evaluation, [Hospital] surgical activity logs, ongoing evaluations, continuous monitoring, or signed Standard Procedure agreements.

2. 8 of 9 FAs (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1 and NPFA3) did not have documentation of a supervising physician.

3. 8 of 9 FAs (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1 and NPFA2) did not have professional /surgeon performance evaluation.

4. 7 of 9 FAs (RNFA1, RNFA4, RNFA6, RNFA7, NPFA1, NPFA2 and NPFA3) did not have OPPE documentation.

5. 5 of 9 FAs (RNFA2, RNFA4, RNFA5, RNFA7 and NPFA3) did not have verification 120 completed hours of supervised surgical procedures by a surgeon sponsor/supervisor.

6. 5 of 9 FAs (RNFA2, RNFA5, RNFA6, NPFA1 and NPFA3) did not have verification of completing a required Surgical First Assistant 40 hours of classroom education

7. Unknown employment status of 5 of 9 First Surgical Assistants, (RNFA2, RNFA4, RNFA7, NPFA1 and NPFA3).

8. 4 of 9 FAs (RNFA6, RNFA7, NPFA2 and NPFA3) did not have documentation of the medical staffing "Professional Liability insurance" as required by the hospital Bylaws.

9. 3 of 9 FAs (RNFA1, RNFA6, RNFA7 and NPFA2) did not have the required Basic Life Support (CPR) certification

10. 3 of 9 FAs (RNFA1, RNFA6, NPFA2) First Surgical Assistants did not have the required Advanced Cardiac Life Support, (advanced measures to save a person's life)

11. 3 of 9 FAs (RNFA2, NPFA1 and NPFA3), did not have an up-to date National Provider Data Base (NPDB) report.

12. The MSS stated she could not determine the status of employment for 5 of 9 FAs (RNFA2, RNFA4, RNFA7, NPFA1 and NPFA3). The MSS stated the FAs could be hospital employees, contracted, self-employed or private physician employees.

13. 4 of 9 FAs, (RNFA1, RNFA5, RNFA6, and NPFA2), were employees of the hospital, and hired by Human Resources (HR), Nursing Department.

The MSS stated RN employees had additional requirements that needed to be met which included 5 years of perioperative experience, physician surgeon sponsor, completion of an AORN (Association of Perioperative Registered Nurses) approved RNFA program, yearly nursing evaluation and education, and ACLS certification. The MSS stated she did not have verification from the hospital HR nursing department that RNFA1, RNFA5, RNFA6, and NPFA have completed these requirements. The MSS stated HR nursing department does not provide any documentation, education, training or evaluations about RNFA or NPFA employees.

During a concurrent interview and record review, with the Chief Medical Officer (CMO) on 9/2/2022 at 10:58 a.m., the following documents were reviewed: "Bylaws of the Medical Staff of [Hospital]", "[Hospital] Surgical Assistant Focused Professional Performance Evaluation" form, Hospital "Task List for Non-Physician First Assistants", "Department of Surgery Rules and Regulations", "[Hospital] Procedural Evaluation Focused Professional Performance Evaluation (FPPE)" form, "To be Agreed Upon by the Supervising Physician(s)" form, "Standardized Procedures for RN First Assistant", "Orthopedic Surgery Clinical Privileges", "General Surgery Clinical Privileges",]", and "Allied Health Professional Policies and Procedures", "Position Description, Title: RN First assistant, department of surgery, State of California Department of Consumer Affairs (DCA), "The RN as First Assistant to the Surgeon". The CMO was provided with the above forms, Bylaws, SPs and policy and procedures and was asked to explain the credentialling process for APH, including FAs. The CMO stated he could "not figure-out" what the requirements were and what constituted a complete application for FAs. The CMO stated he was "not involved" with processing FAs' privileging applications. The CMO stated the policy and procedures, Bylaws and Standardized Procedures (SP) "must be followed." The CMO stated medical staff "forms need to be completed." The CMO stated that the ICP, CNO and MEC are responsible for vetting and verifying APH's qualifications, training, competence, and experience. The CMO was unable to explain why the IPC, MEC and GB approved incomplete applications for clinical privileges and allowed 9 of 9 FAs to furnish surgical services to patients. The CMO stated the GB makes the final decision and granted privileges for APH, including FAs.

During concurrent interview and record review, with the Chief Nursing Officer (CNO) on 9/2/2022, at 9:38 a.m., the following records were reviewed and discussed: "Standardized Procedures for RN First Assistant", "Surgical Assistant Focused Professional Performance Evaluation", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", "Ongoing Professional Performance Evaluation Allied Health Professional (AHP)" form, "To be Agreed Upon by the Supervising Physician(s)" form, Bylaws of the Medical Staff of [Hospital]", "Allied Health Professional Policies and Procedures", Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant", " Bylaws of the Medical Staff of[Hospital]", Nursing Department, "Position Description, Title: RN First assistant, department of surgery, Reports to: Practice Coordinator, surgery", DCA State of California Department of Consumer Affairs, "The RN as First Assistant to the Surgeon." The CNO stated the nursing department and medical staffing privileges were different for RNFA. The CNO stated she was "familiar" with SP, policy and procedures and Nursing hiring and Human Resources (HR) requirements, interdisciplinary patient committee (IPC). The CNO stated she was a member of the IPC. The CNO stated she was involved in developing the Allied Health Professional Policy and Procedures, and RNFA SP. The CNO stated Licensed Nurses must meet the HR requirements for nursing staff. The CNO indicated nursing credentials, education and experience were verified by the nursing administration. The CNO stated after the nurse has been hired and met RNFA requirements, the RNFA can apply for Medical Staff privileges. The CNO stated the RN may also work as a hospital nurse and the completed application moves to the IPC for approval and afterwards the application is passed on to the MEC. The CNO stated she did not know what information was in the RNFA employee files or if the RNFAs were meeting mandatory nursing staff requirements. The CNO was unable to explain why the IPC approved applications for 9 of 9 Allied Health First Surgical Assistant files that were incomplete. The CNO stated the RNFA incomplete files were approved by the ICP, MEC and GB.

During a review of the facility documents titled, "Bylaws of the Medical Staff of [Hospital]", revised on 7/27/2018, and "Processing initial application for Allied Health Professional applicant qualifications", the hospital documents indicated "Once application is determined complete, it will be forwarded to the IPC for consideration. The IPC retains the authority to make all recommendations to the Medical Executive Committee ....the application is forwarded to the department chair to which the supervising physician is assigned ... ....If the APH does not have a supervising physician, the application will be forwarded to the department to which the APH is assigned ...Thereafter the application shall be processed by the Medical Executive Committee and the Board of Trustees". The section titled "Allied Health Professionals Renewal of Service Authorization" indicated "APHs shall be granted service authorization for no more than 24 months ...The completed application will be reviewed by the IPC ...Focused Professional Practice Evaluation of Allied Health Professionals at the time of reappointment ...provide activity data (number only) on all procedures beyond basic scope of practice for previous two years ...Ongoing Professional Evaluations of Allied Health Professionals ... Competency will be evaluated annually ...review occurrence reports involving AHP for past twelve months ...evaluation as clinical practice and competence by Departmental Director or designee knowledgeable of the practitioner's skill and competence ....Occurrence Reports Involving Allied Health Professionals ...the Chair of the ICP will review all Occurrence Reports involving AHPs ... Responsibilities of the Supervising Physician ..."

During a review of the facility documents titled, "Department of Surgery Rules and Regulations", approved March 27, 2020, signed by President of the Medical Staff, Chief Medical Officer (CMO) and Board of Trustees and "Requirements for Surgical Assistants" the hospital documents indicated, "Prior to granting surgical assistant privileges, physicians who are not surgeons will be required to provide documentation of experience or a statement from another surgeon attesting to his/her ability, including training in sterile technique ..."

During a review of the facility's document Hospital Human Resources Nursing Department titled, "Position Description, Title: RN Surgical First Assistant (RNFA), Department of Surgery, Reports to: Practice Coordinator, Surgery", updated June 20, 2011, the facility document indicated "the RN First Assistants is responsible for coordinating and delivering patient care utilizing the nursing process ...Requirements licensure as a Registered Nurse ...Healthcare provider CPR (cardiopulmonary resuscitation, basic life support) card ...ACLS (Advance Cardiac Life Support) certification ...Minimum of five years' experience as a perioperative [care of patient before, during and after surgery] nurse with successful completion of an AORN [Association of Perioperative Registered Nurses] RNFA program including supervised clinical component is required ...annual review performed by the surgeon sponsor is required to maintain privileges ...special skills ...Demonstrate competency ...Actively participate in Performance Improvement and risk management by collecting data and patriating in performance improvement efforts ..."

During a review of the facility document titled "Standardized Procedures for RN First Assistant", approved 3/2020 and signed by Interdisciplinary Practice Committee (IPC),Department of Surgery Medical Executive Committee (MEC), Chief Nursing Officer (CNO) and Board of directors (GB), the facility document indicated the RN First Assistant "renders direct patient care as part of the perioperative role assisting the surgeon ...supervising physician and who is authorized to supervise the Allied Health Professional ....Direct supervision will not be necessary once competency is determined ....Provide additional surgical support( exposure, hemostasis, suturing in the Operating Room and Nursing Units ...Performance procedures ...retraction ...provide hemostasis ...perform know tying ....closure of layers ....clamp and sever tissue ...rasp. Ad fixate screws, staples, and other devices...drill, ream and modify tissue ...cauterize and approximate tissues ...Affixing and stabilizing all drains ...applying casts, plaster splints or other devices ...written record reflects the presence and role of APH in the operating room by the Attending Surgeon ...Initial Competence ... BLS certification ...ACLS certification optional ...Training in the processes of RN First Assistant duties in an accredited graduate nursing program ...Completion of an approved RNFA course ....Completion of 120 hours of proctored instruction with a qualified surgeon ...perform the procedure six times under direct supervision prior to completing the procedure without direct supervision ... Continued proficiency ...must perform the procedure at least three times per year ....will be signed-off after demonstrating 100% accuracy in completing the procedure ...Demonstration of continued proficiency shall be monitored through the annual evaluation ...clinical practice outcomes logs to be submitted with each renewal of credentials ..."

During a review of the facility document titled "Orthopedic Surgery Clinical Privileges" undated, the facility document did not indicate any "special Non-core Privileges" for supervising RNs First Assistants, self-employed RNs, or RNs employed by another entity.

During a review of the facility document titled, "General Surgery Clinical Privileges" undated, the facility document did not indicate any "special Non-core Privileges" for supervising RNs First Assistants, self-employed RNs, or RNs employed by another entity.

During a review of the facility's Policy and Procedure titled, "Allied Health Professional Policies and Procedures", revised July 20, 2019, signed by Interdisciplinary Practice Committee (IPC), Medical Executive Committee (MEC), Chief Nursing Officer (CNO) and Board of directors (GB), the policy and procedure indicated Advanced Practice Professionals (APP) " ...Are permitted to render services according to the services offered and needs of the Hospital" and include Non-physician First Assist ...All applications require professional training, current license, demonstrated ability and judgment, three personal references, liability insurance ...Once the application is determined complete, it is forwarded to the IPC ...The application shall processed by the Medical Executive Committee and the Board of directors in a manner parallel to processing of Medical Staff applications" ...establish a method for initial evaluation of the competence ...method of maintaining a written record of those persons authorized to perform ...Specify the nature and scope of review and/or supervision ...communicate with patient's physician ...limitations on settings or department ...record keeping. Requirements ... reviewed at the time of renewal of service authorization". The section titled "Allied Health Professional Practice Evaluation", indicated at the time of re-appointment to Provisional Allied Health Professional Staff ...will be required to provide activity data (numbers only) on all procedures beyond the basic scope of practice for the previous two years". The section titled, "Ongoing professional Practice Evaluation" indicated ... competency will be evaluated annually ...[and] shall include review of occurrence reports ....Evaluation of clinical practice and competence". The section titled, "Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant "qualifications indicated " ...Recommendation letters are required from the O.R. [operating room] supervisors at all facilities at which they have worked ...Present a certificate of successful completion at an approved non-physician First Assistant course with a minimum of 40 hours didactic training ...AND clinically supervised surgical assisting activities of 120 hours. If less than 120 hours ...be precepted by surgeon employer to total of 120 hours ...OR provide documentation of three-year active experience as an OR staff member and at least two years active scrub experience with documentation of assisting in 100 cases". The section titled, Scope of Practice includes "positioning, prepping, and draping ...observing the operative field ...retaining manually controlled retractors ...managing instruments ...knot tying ...provide hemostasis ...apply suture ligatures in the muscle, subcutaneous, and skin layers ...provide close of layers ...Perform CPR". The responsibility of the "the primary surgeon is responsible for direct supervision of the non-physician first assistant's performance ...Renewal of Service Authorization and Tasks ...the non-physician First Assistant will undergo performance -based recredentialing every two years ..."

During a professional reference review retrieved from the State of California Department of Consumer Affairs (DCA) undated, the professional reference indicated, "The RN as First Assistant to the Surgeon" was provided by Medical Staff Service Manager (MSS) as the foundation of the RNFA hospital policy and procedure. The document indicated, the "RN First Assistant directly assists the surgeon by controlling bleeding, providing wound exposure, suturing and other surgical tasks. The RN first assistant may provide other advanced assistance, such as mobilization of tissue, patient positioning and directing other surgical team members with specific individual tasks. The RN first assistant, practices perioperative nursing and must have acquired the necessary specific knowledge, skills, and judgment. The RN first assistant practices under the supervision of the surgeon during the intraoperative phase of the perioperative experience. To perform those functions considered to be first assistant to the surgeon, the RN must adhere to standardized procedures ...additional safeguard for the consumer is that the nurse be currently capable to perform the procedure ... Specify any experience, training and/or education requirements for performance of standardized procedure functions ...Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions ...The registered nurse who undertakes a procedure without the competence to do so is grossly negligent and subject to discipline by the Board of Registered Nursing".

During a review of the facility document titled, "Task List for Non-Physician First Assistants", reviewed 7/2005, indicated the scope of practice for First Assistants (FA) ... included "assists with patient positions ...draping ...retract ...cut/tie sutures ...hand suction and/or sponge in surgical field ...assist surgeon in utilizing specialized equipment ...suture drains ...remove sutures under direct supervisions ...apply electro-cautery to instrument held by surgeon ...remove and/or apply dressings, packing or casts ..." The form required "documentation of proficiency in use of specialized tools". The form had signature lines for the FA, Chairman of the Interdisciplinary Committee (IDC), Department Chairman, Medical Executive Committee (MEC) and Board of Directors (GB). There was no signature line for supervising physician or responsible physician.

During a review of the facility document titled, "Nurse Practitioner Task List", revised 1/2009, indicated the "Tasks which require additional documentation of training/experience: Assist in Surgery ...3 years of experience as an operating room staff member and at least two years active scrub experience with documentation of assisting in 100 cases OR completion of an approved Non-Physician First Assistant courses with documentation of 120 hours of assisting activities. If fewer than 120 hours, your b precepted by your physician employer ..." There is a line for the name and signature for the Nurse Practitioner. There were no other signature lines.

During a review of the facility document titled, "Surgical Assistant Focused Professional Performance Evaluation" undated, the document indicated it had a designated space for the evaluating surgeon, surgical assistant, procedure type, date, and patient medical record number. The evaluation sections included "tissue handling ...use of instruments ...providing exposure ...general [skills).." The completed form was to be returned to Medical Staff Services.

During a review of the facility document titled, "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)" undated, the document indicated it had a designated space for the healthcare professional, supervising physician, procedure type, method of FPPE, patient medical record number. The form evaluation sections included "communication with supervising physician ...technical proficiency ...post-op orders/medications ...procedural judgment ...procedure note ...complications managed appropriately ...patient outcome ..." The completed form was to be returned to Medical Staff Services.

During a review of the facility document titled, "To be Agreed Upon by the Supervising Physician(s)" form indicated that the signing physician(s) "agree with the above designated tasks", and the "applicant being my direct employee ..."

A Hospital refence letter form with Medical Staff credentialing application requested the applicant to complete it "at your institution privileging Professional Reference form for service authorization on the Allied House Staff.

During a professional reference review retrieved from The Business Professional Code (BPC) section 2732.05 indicated, "(a) Every employer of a registered nurse, every employer of a registered nurse required to hold any board-issued certification, and every person acting as an agent for such a nurse in obtaining employment, shall ascertain that the nurse is currently authorized to practice as a registered nurse... BPC section 2726. Except as otherwise provided herein, this chapter confers no authority to practice medicine or surgery..."

During a professional reference review retrieved from the Department of Consumer Affairs (DCA) Board of Registered Nursing (BRN) titled, "AN EXPLANATION OF THE SCOPE OF RN PRACTICE INCLUDING STANDARDIZED PROCEDURES. Scope Of Registered Nursing Practice", undated, indicated, "Each standardized procedure shall establish a method for initial and continuing evaluation of the competence ...Provide for a method of maintaining a written record of those persons authorized to perform standardized procedure functions ...scope of supervision ...limitations on settings ...patient record-keeping requirements ...method of periodic review ...the nurse be currently capable to perform the procedure ..."

Based on observations, interviews, and record review, the facility failed to follow their policies and procedures titled "Crash Cart Defibrillators" when three of three sampled crash carts (a set of tray/drawers/shelves on wheels used in hospitals for transportations and dispensing of emergency medication/equipment at site of medical/surgical emergency for life support protocols to potentially save someone's life) were not checked daily and documented as required in accordance with their policy to ensure quick access to emergency medications and supplies in life-threatening situations.

This failure had the potential to result in a delay of life saving treatment to patients during emergent situations and was not the standard of practice according to the hospital's policy and procedure.

Findings:

During a concurrent observation, record review, and interview, on 8/30/22, at 7:30 a.m., with DSS and PRERN1, on the second floor in the Pre-operative unit (area where patients are prepared for surgery), the crash cart (a mobile unit which contains emergency medication and equipment) logs were observed. The crash cart had a plastic lock that was intact. The crash cart had a clipboard with a record to document that the crash cart had been checked for supplies and medications once a day. The "Crash Cart Checklist - Preop (CCCP)", dated August 2022, July 2022, June 2022, May 2022, and April 2022 were reviewed. The CCCP for August 2022 indicated no daily crash cart checks were done on 8/6/22, 8/7/22, 8/10/22, 8/11/22, 8/13/22, 8/14/22, 8/17/22, 8/16/22, and 8/17/22. The CCCP for July 2022 indicated no daily crash cart checks were done on 7/1/22, 7/2/22, 7/3/22, 7/4/22, 7/9/22, 7/10/22, 7/23/22, 7/24/22, 7/25/22, 7/30/22, and 7/31/22. The CCCP for June 2022 indicated no daily crash cart checks were done on 6/3/22, 6/6/22, 6/8/22, and 6/17/22. The CCCP for May 2022 indicated no daily crash cart checks were done on 5/1/22, 5/2/22, 5/13/22, 5/21/22, 5/22/22, and 5/29/22. The CCCP for April 2022 indicated no daily crash cart checks was done on 4/27/22. PRERN 1 stated the crash carts should be checked daily. PRERN 1 stated the crash carts have not been checked daily as per policy. DSS stated the crash carts should be checked daily as per policy. DSS stated if the crash carts are not checked daily, the staff are not prepared for emergencies, and it puts patients at risk.

During an observation on 8/30/22, at 10:00 a.m., on the fifth floor in the Telemetry Unit (area where patients are under constant cardiac monitoring), the defibrillator (device that send an electric pulse or shock to the heart to restore a normal heartbeat) on the unit's crash cart was observed with no ECG (electrocardiogram) paper (a strip of paper with grids to record the rhythm of the heart).

During a concurrent observation and interview on 8/30/22, at 10:35 a.m., with Manager (MGR) 6, MGR 6 stated, MGR 6 was the charge nurse of the unit. MGR 6 validated there was no ECG paper installed in the defibrillator. MGR 6 stated, contents on the crash cart were checked once a day and the manual shock test of the defibrillator was checked once a week by the charge nurse to ensure contents and functionality were ready for use in emergency situations. MGR 6 stated, MGR 6 checked the contents of the crash cart and performed the defibrillator shock test on 8/30/22. MGR 6 stated, MGR 6 used the last of the ECG paper and did not replace it. MGR 6 stated, when a red ribbon appears on the ECG paper, it was time to replace the ECG paper. MGR 6, stated the ECG paper should have been replaced following the previous performance check when the red ribbon first appeared. MGR 6, stated the purpose of checking the crash cart and defibrillator was to be prepared in case of emergency.

During an interview on 8/30/22, at 10:50 a.m., with Director of Clinical Operations (DOC) 2, DOC 2 stated, making sure there was ECG paper in the defibrillator was part of the routine checking process. DOC 2 stated, DOC 2 expected there was ECG paper in the defibrillator and to be replaced when the red ribbon appeared on the ECG paper. DOC 2 stated, the red ribbon indicated the ECG paper was low and staff should have replaced it. DOC 2 stated, the defibrillator was checked routinely to be prepared for emergency use.

During an observation and record review on 8/31/22, at 10:00 a.m., in the Out-Patient Infusion Unit (area where patients receive intravenous medication), the crash cart was observed. On the crash cart was a clipboard with log sheets titled, "Crash Cart Checklist - [brand name of the defibrillator] indicating items to be checked. Each sheet indicated the month the crash cart items were checked with no year written next to the month.

During a concurrent interview and record review on 8/31/22, at 10:05 a.m., with Registered Nurse (RN) 7, the "Crash Cart Checklist - [brand name of the defibrillator]," dated June, July, August ... was reviewed. RN 7 stated, there should have been a year written next to the month on the crash cart check list to indicate the accurate date.

A review of the hospital's policy and procedure (P&P) titled, "Crash Cart/Defibrillators", dated March 2021, indicated " ...Policy 1. Crash Carts will be check daily ...Procedure 1. Check the crash cart number, the defibrillator, the O2 tank amount and the medication lock daily ....4. Check the defibrillators for: A. ECG paper ...Documentation: Crash Cart Checklist: 1. Staff checking the crash cart sign their name on the 'Crash Cart Checklist' indicating: A. Crash cart number B. Oxygen tank >1/2 full C. Defibrillator has been checked ..."

Based on interview and record review, the hospital failed to keep accurate medical records for two of 56 sampled patients (Patients 31 and 51) when the discharge instructions were not completed and signed.

These failures resulted in the potential harm of Patients 31 and 51 not being provided adequate information and counseling for after hospital care services and could negatively affect the quality of their health.

Findings:

During a concurrent interview and record review on 8/30/22, at 4:00 p.m., with Quality Registered Nurse (QRN) 1 and Registered Nurse Manager (MGR) 3 of the OB ED (Obstetric Emergency Department; an area that provides emergency care to pregnant patients), Patient 31's "Electronic Health Record" (EHR - systematized collection of patient health information in a digital format), was reviewed. The "EHR" indicated, Patient 31 was admitted on 8/29/22 at 11:47 a.m. with Gestational Hypertension (high blood pressure during pregnancy) for observation in the OB ED and discharged on 8/29/22 at 4:27 p.m. MGR 3 stated, Patient 31 should have received discharge instructions upon discharge.

During a review of patient 31's discharge instructions (DI), dated 8/31/22, the "DI" indicated, Patient signature was blank (no signature). The Provider Signature was blank.

During a concurrent interview and record review on 9/2/22, at 11:45 a.m., with Quality Registered Nurse (QRN) 1, Patient 51's "Electronic Health Record" (EHR), was reviewed. The "EHR" indicated, Patient 51 was admitted on 8/22/22 at 7:17 p.m. following a fall fracturing (breaking) the right humerus (upper arm bone) and right knee sprain (twisted ligament) and discharged on 8/30/22 at 7:10 p.m. QRN 1 stated, Patient 51 should have received discharge instructions upon discharge.

During a review of Patient 51's discharge instructions (DI), dated 8/31/22, the "DI" Patient Signature was blank. Responsible Party was blank. Relationship to Patient was blank. Clinician Signature was blank.

During an interview with QRN 1 on 9/2/22, at 3:00 p.m., QRN 1 stated a copy of Patient 31's and Patient 51's discharge instructions with signatures could not be located in the hospital's EHR and not obtained as required. QRN 1 stated, signatures on discharge instructions indicated acknowledgement that discharge information was given and received.

During a review of the hospitals policy and procedure (P&P) titled, "Patient Rights," dated 10/20, the P&P indicated, "Purpose: [name of hospital], as part of its Mission, will endeavor to assure that the basic right of human beings for independence of expression, decision, and action and concern for personal dignity and human relationship while they are a patient/client of any of services preserved ... Policy: Patient Rights - See attached Patient Bill of Right and Responsibilities ... As a patient you have the right to: 19. Be informed by the physician, or delegate of the physician, of continuing health care requirements and options following discharge from the hospital. You have the right to be involved in the development and implementation of your discharge plan. Upon your request, a friend or family member may be provided this information also ..."

Based on interview and record review, the hospital failed to ensure physician (MD) verbal orders for medications were promptly co-signed for two of 56 patients (Patients 33 and 55) when medication orders for each patient were verbally given by the ordering MD and not co-signed within 48 hours in accordance with Medical Staff Bylaws and state regulatory requirements.

These failures increased the potential for medication errors and possibly adverse medication reactions and negatively affect the quality of care to Patients 33 and 55.

Findings:

During a review of Patient 33's "History and Physical" (H&P), dated 8/11/22, the "H&P" indicated, Patient 33 was admitted for infected hardware (prosthetic device invaded by microorganisms such as bacteria, virus, fungi, and parasites causing disease) in the right knee on 8/11/22.

During a review of Patient 33's "Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments" (consent), dated 8/26/22, the "consent" indicated, "Right Total Knee Explantation (removal of hardware), irrigation and debridement (cleaning and removal of debris), Antibiotic Spacer Placement (a material filled with medication to destroy disease causing microorganisms left inside the body over a period of time to deliver the medication to the infected area), Possible Muscle Flap (tissue taken from one area of the body and transplanted to another), Possible Complex Wound Closure (repair of a wound requiring more than a layered closure), Possible Wound Vac (suction device), Possible Skin Graft" (skin taken from one area of the body and transplanted to another).

During a review of Patient 33's "Medication Orders" (MO), dated 8/25/22, the "MO" indicated, Cefazolin (antibiotic) 2 g (gram - unit of measurement) IVPB (intravenous piggyback) one time one dose. Ordering Physician [name of MD 1] Verbal Order received by [name of RN 10] on 8/25/22 at 12:47 p.m."

During a review of Patient 33's "Medication Orders" (MO), dated 8/26/22, the "MO" indicated, "Heparin (blood thinner) drip infusion bolus per protocol. Ordering Physician [name of MD 2] Telephone Order received by [name of RN 9] on 8/26/22 at 4:01 p.m."

During a concurrent interview and record review on 8/31/22, at 11:00 a.m., with the Medical Safety Pharmacist (MSP) and Medical Educator Registered Nurse (MERN), Patient 33's Medication Orders were reviewed. MSP and MERN validated there was no MD signature for the verbal and telephone orders received by RN 9 and RN 10 on 8/25/22 and 8/26/22 for Patient 33. MERN stated, the Cefazolin verbal order was routed (sent to) to MD 1 and the Heparin telephone order was routed to MD 2 at the time the orders were entered for verification. MERN stated, signature for verification has not been obtained from MD 1 and MD 2 as of 8/31/22. MSP stated, MD verbal and MD telephone orders required MD verification for authentication within 48 hours.

During a review of Patient 55's "History and Physical" (H&P), dated 8/23/22, the "H&P" indicated, Patient 55 was admitted for right upper arm DVT (deep vein thrombosis; a blood clot inside a blood vessel) on 8/23/22.

During a review of Patient 55's "Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments" (consent), dated 8/26/22, the "consent" indicated, "Thrombectomy venous Right" (surgical removal of a blood clot from inside a vein or artery).

During a review of Patient 55's "Procedure Log" (PL), dated 8/26/22, the "PL" indicated, "Procedure - Thrombectomy Venous - RT (right) ... Case Synopsis IR (interventional radiology; a medical specialty that performs minimally-invasive procedures using medical imaging guidance, such as x-ray, fluoroscopy, computed tomography, and magnetic resonance imaging, or ultrasound) Medications 8/26/22 14:45:05 (2:45 p.m.) IR Intra-Op (during surgery)/Verbal Orders (Entered By: [name of RN 8]). 8/26/22 14:45:15 (2:45 p.m.) Oxygen (air) 8 L/min (liters - unit of measurement per minute) via (by) venti mask (medical device used to deliver Oxygen to assist with breathing) ... 8/26/22 14:54:58 (2:54 p.m.) Lidocaine (numbing medication) 1 % (percent - unit of measurement) 20 ml (milliliters - unit of measurement) added to the table ... 8/26/22 14:55:29 (2:55 p.m.) Heparin (blood thinner) gtt (drip) continued from floor new bag hung by pharmacy ... 8/26/22 15:04:14 (3:04 p.m.) Fentanyl (pain medication) 50 mcg (micrograms - unit of measurement) IV (intravenous) ... 8/26/22 15:27:23 (3:27 p.m.) Fentanyl 50 mcg IV ... 8/26/22 15:33:14 (3:33 p.m.) Versed (sedation medication) 0.5 mg (milligrams - unit of measurement) IV ..."

During a concurrent interview and record review on 9/2/22, at 3:00 p.m., with Quality Registered Nurse (QRN) 1, Patient 55's "PL", dated 8/26/22, was reviewed. QRN 1 stated, the "PL" was documented in a program application separate from the hospital's Electronic Health Record (EHR - systematized collection of patient health information in a digital format). QRN 1 stated, the "PL" was printed and scanned into Patient 55's EHR. QRN 1 stated, the MD verbal order verification for the procedure could not be located and not obtained in Patient 55's EHR.

During a review of the hospital's Medical Staff Bylaws, undated, page 106 indicated, "Section 3. General Conduct of Care. E. All physician verbal orders should be electronically signed within fourteen (14) days, except medication orders, which must be electronically signed within 48 hours ..."

22 CCR § 70263 Pharmaceutical Service General Requirements (g) No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish. This shall not preclude the administration of aerosol drugs by respiratory care practitioners. The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber or furnisher. Orders for drugs should be written or transmitted by the prescriber or furnisher. Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours.

Based on interview and record review, the facility failed to properly execute informed consents for two of 56 sampled patients (Patients 1 and 2) when Patient 1's primary language was Spanish and a written consent in the Spanish language was not provided; and Patient 2's consent was verbally obtained from the spouse of Patient 2 and the spouse's name was not included on the consent.

These failures resulted in Patients 1 and 2's right to be properly informed prior to making a decision for a procedure and could possibly negatively affect the quality of care.

Findings:

During a review of Patient 1's "Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments" (consent), dated 6/27/22, the "consent" indicated, "Sigmoid Colectomy, Colostomy" (surgical resection of the large intestine and diversion to an artificial opening in the abdomen). The "consent" indicated Patient 1 received the information using an interpreter from Language Line Solutions (Spanish interpreter). The "consent" form was written in English.

During a review of Patient 1's "Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments" (consent), dated 7/1/22, the "consent" indicated, "Exploratory Laparotomy" (a minimally invasive surgical procedure to examine the abdomen). The "consent" form indicated no interpreter was used. The "consent" form was written in English.

During a concurrent interview and record review on 9/2/22, at 10:10 a.m., with Director of Surgical Services (DSS), DSS stated, informed consent was important that patients have a clear understanding and agreed that the physician is providing the correct procedure. DSS stated, patients have the right to refuse surgery, right to have consent explained to them in their language. DSS stated, the hospital had consent forms available in Spanish. DSS stated, Patient 1 should have been given a copy of the consent form in Spanish.

During a review of Patient 2's "Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments" (consent), dated 6/7/22, the "consent" indicated, "Removal of Left Patella Protector s/p (status post; after) Total Knee Replacement" (surgical procedure to remove a synthetic device to protect the knee during surgery). The signature on the "consent" form indicated, "Verbal Consent obtained via telephone from spouse."

During a concurrent interview and record review on 9/2/22 10:15 a.m., with Director of Surgical Services (DSS), Patient 2's "consent" form was reviewed. DSS stated, the "consent" which indicated "Verbal Consent obtained via telephone from spouse" was unacceptable. DSS stated, the name of the spouse should have been documented on the form according to the hospital's policy and procedure if the patient was unable to consent.

During a review of the hospital's policy and procedure (P&P) titled, "Informed Consent/Consent Forms," dated 10/19, the P&P indicated, "Purpose: To provide information to the patient regarding their health status, diagnosis, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms ... General Information: 1. Give the patient or responsible person a duplicate copy of the signed consent form ... 3. If the patient is unable to speak, read or understand English, interpreter services must be available to explain the consent form to the patient ... 4. If a patient is unable to sign the consent, the responsible party may give consent by telephone provided two hospital employees (e.g., RN, Technologist), whose signatures are on the consent form, listen to the phone consent ... A. Names of responsible party, date and time must be fully documented ..."

22 CCR §70707 Patients' Rights (a) Hospitals and medical staffs shall adopt a written policy on patients' rights. (b) A list of these patients' rights shall be posted in both Spanish and English in appropriate places within the hospital so that such rights may be read by patients. This list shall include but not be limited to the patients' rights to: (1) Exercise these rights without regard to sex, economic. (5) Receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment. Except in emergencies, this information shall include a description of the procedure or treatment, the medically significant risks involved in this treatment, alternate courses of treatment or nontreatment and the risks involved in each and to know the name of the person who will carry out the procedure or treatment.

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.Surgical instruments, endoscopes, and essential perioperative equipment were not cleaned, transported, or stored in accordance with policies and procedures, manufacturer's guidelines, and standards established by nationally recognized organizations for perioperative practices and for the safe use and management of surgical instrumentation and medical devices. These failures had the potential to cause equipment or instrument failure and transmission of infectious diseases resulting in serious harm to patients. (Refer to A 750 findings 1, 2, 3, 5, 6, and 7)

2. Safe temperature and humidity ranges were not maintained in the sterile processing department which increased the risk for microbial growth and equipment or device failure. (Refer to A 750 finding 4)

3. Staff did not perform hand hygiene and utilize PPE in accordance with policies and procedures and nationally recognized infection prevention and control guidelines, which had the potential to compromise the health and safety of patients, staff, and visitors. (Refer to A 750 finding 8 and 9)

4. Expired intravenous supplies were stored with routine supplies which had the potential of being used and result in adverse health effects for patients. (Refer to A 750 finding 10)

As a result of the hospital not having a system in place to monitor practices to reduce the risk of infections and a system-wide failure of staff not following Infection Control principles and the serious risk of infections or cross contamination to all patients an Immediate Jeopardy (IJ) situation was identified on 8/31/22 at 5:47 p.m., under Code of Federal A-0750 §482.42(a)(3) in the presence of the Chief Operating Officer, Chief Nursing Officer, Director Quality and Risk, Manager Quality and Accreditation, Vice President Performance Excellence, Director of Perioperative Services, and the Director of Sterile Processing.

The serious issues identified included: surgical instruments and endoscopes were not cleaned and/or transported per professional standards to prevent cross contamination; reusable operating room equipment was air dried in the decontamination room and transported to a clean storage room for use in surgical procedures; autoclaves and critical equipment used to sterilize instruments and equipment were not cleaned and maintained in sanitary condition; endoscopes were not cleaned per manufacturer's guidelines and professional standards of practice; sterile supplies were not stored in accordance with professional standards; and staff were not wearing appropriate PPE in sterile processing and operating room.

The hospital submitted an Acceptable Action Plan to address the IJ situation. Survey team's observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 9/2/22 at 4:05 p.m. in the presence of the facility the Director Quality and Risk and the Manager of Quality and Accreditation.

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.

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. Surgical instruments were not cleaned in accordance with hospital policy and standards published by the Association of Peri-Operative Registered Nurses (AORN- is the leader in advocating for excellence in peri-operative practice and healthcare) and the Association for the Advancement of Medical Instrumentation (AAMI- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals). Surgical Technician (ST) 2 did not spray surgical instruments with enzymatic solution after a surgical procedure and prior to transport to the decontamination area of the sterile processing department. Sterile Processing Technician (SPT) 1 used a brush with frayed bristles and did not pre-soak dirty surgical instruments in accordance with hospital P&P, AAMI and AORN standards.

2. Endoscopes (a flexible instrument used to view internal parts of the body) were not transported and cleaned in accordance with manufacturer's guidelines, hospital policy and standards published by AORN and the Society of Gastroenterology Nurses and Associates (SGNA- a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing). Lead Endoscopic Technician (ET) 1 did not fully immerse the endoscopes during manual cleaning and transport of the endoscopes did not utilize a closed, puncture-resistant container.

3. Reusable suction cannisters (storage container for secretions or fluids removed from the body) utilized in the Operating Rooms (OR) were cleaned, disinfected and hung to dry in the decontamination area prior to storage in the sterile supply room and then used in the OR, not in accordance with AAMI standards of separating clean and dirty supplies.

4.Temperature range (T) and humidity range (H) were not maintained in Outpatient Surgery North (OPSN) Sterile Processing Department (SPD- performs sterilization and other actions on medical devices and equipment) prepack areas in accordance with hospital policy and procedure and AORN standards. Staff did not implement effective actions to address temperatures and humidity levels when the computer monitoring system "alarmed" outside of range.

5. Staff in OPSN stored one of one major surgical instrument tray in OPSN prepack area on a rack 6 inches from the floor, not in accordance AAMI guidelines for storage of sterile supplies.

6. Two of three autoclaves (used in medical and laboratory setting to sterilize instruments) used in OPSN-SPD to sterilize instruments were not cleaned and maintained daily per manufacturer's instructions for use (IFUs). Autoclave 1 and 2 were observed to have rust-colored deposits within the sanitizing compartment.

7. The air gap (prevent cross-connections and contamination by discharging water and waste across an unobstructed space) in the SPD prepack (clean room) area had rust- colored deposits.

8. Eight of eight staff (Surgical Technician [ST 2], Registered Nurse [ORN 7], Registered Nurse- Quality [QRN], Surgical Technician [ST 6], Physician Assistant [PA 1], Emergency Medical Services Visitor [EMS], RN trainee [RNT], and Certified Nurse Anesthesia [CRNA 2]) did not wear appropriate operating room (OR) attire and/or personal protective equipment (PPE- gown, mask, eye protection, gloves, shoe covers) per hospital policy and procedure in the OPSN decontamination room, Main operating room, and Endoscopy (unit where medical procedures are performed with endoscopes).

9.One of three housekeepers (EVS 2) did not perform the daily cleaning in occupied isolation room in accordance with hospital policy for cleaning occupied rooms and hand hygiene and recommendations published by the Centers for Disease Control and Prevention (CDC- a national public health agency of the United States).

10. Three of three 21- gauge (size of needle) vacutainer kits (used for blood sampling), four of four liter-bags of Dextrose 5% Solution (D5W- used to treat low blood sugar, insulin shock, or fluid loss), and one of one Swan-Ganz catheter (device inserted in the body to measure the overall function of the heart) were expired and stored for use in the Nuclear Medicine (specialized area of radiology), Medical Surgical (area of hospital provides care to adults for a variety of medical conditions including pneumonia, stroke and fractures) and Cardiac Catheterization Lab (specialized area that performs advanced cardiac procedures) supply storage areas.

11. There was no system in place to document and validate the daily routine cleaning and disinfection of essential equipment used in OPSN-SPD and Endoscopy.

These failures resulted in not maintaining a sanitary environment in OPSN area and the possibility of cross contamination to all surgical patients in this area of the hospital.

Because of the potential of serious harm of cross contamination of infections to all surgical patients provided services in the OPSN 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 8/31/22 at 5:47 p.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Operating Officer, Chief Nursing Officer, Director Quality and Risk, Manager Quality and Accreditation, Vice President Performance Excellence, Director of Perioperative Services, and the Director of Sterile Processing. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2) on 9/2/22 at 9:05 a.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) Developed and implemented processes to safely transport endoscopes 2) Immediately cleaned the autoclaves and air gap in Outpatient sterile processing department 3) Created logs to document and monitor cleaning and disinfection of the sterile processing department (SPD) and equipment 4) Purchased HVAC equipment and scheduled replacement of said equipment in Outpatient SPD's prepack areas 5) Developed and implemented processes to reprocess and store sterile supplies during SPD downtimes 6) Trained staff in appropriate operating room attire, cleaning of surgical instrumentation, new processes in endoscopy, and use of new equipment 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 9/2/22 at 4:05 p.m. with the facility the Director Quality and Risk and the Manager of Quality and Accreditation.

Findings:

1. During concurrent observation and interview on 8/30/22, at 9:20 a.m., in OPSN OR 2, with ST 2, Surgeon (SX 1) completed the Open Umbilical Hernia (weakness that develops in the abdominal wall through and around the belly button) Repair procedure for patient (PT) 19. ST 1 removed sharps (devices that can puncture or cut skin), segregated the surgical instruments used in the procedure from the unused instruments, and left the instruments on the back table (holds most of the surgical instruments and other equipment used during surgery). ST 2 gathered the surgical instruments from the back table and placed them in the metal sterilization tray (metal cases with insert trays used to hold surgical instruments). The instruments not used during the procedure were placed at the bottom of the tray, then covered with a dry towel. The instruments used during the procedure were placed on top of the towel and secured with a metal top. ST 2 transported the tray to the decontamination room (place where soiled surgical instrumentation and devices go to be cleaned). ST 2 acknowledged she did not spray the instruments with an enzymatic solution (solution used as part of the first step of the cleaning process to remove or prevent organic material [i.e., tissue or blood] from adhering to the instrument) and stated her process was to spray surgical instruments in the decontamination room, not in the OR. When asked if this was the hospital's process for all surgical instrumentation, ST 2 stated, "I just work per diem [as needed]," and could not articulate the standard processes used at OPSN. ST 2 placed, what she called the "minor tray," on a metal rack in the decontamination room and did not spray the instruments with enzymatic solution.

During concurrent observation and interview on 8/30/22, at 9:25 a.m., in OPSN decontamination room, with Sterile Processing Technician (SPT) 1, SPT 1 demonstrated her process for manually cleaned surgical instruments before sterilization (process of making something free from germs). SPT 1 pulled the same "minor tray" used in the open umbilical hernia repair procedure off the metal shelf and placed it in a dry sink. SPT 1 removed the soiled instruments that were placed on top of the towel and set them in a metal basin. SPT 1 stated the basin was filled with one gallon of water and one-half ounce of enzymatic solution. The remaining instruments were left in the dry sink that had pockets of water pooled near the sink's backsplash and handle. SPT 1 stated unused instruments, divided by the dry towel, did not have to be manually scrubbed since they were not used during the procedure. SPT 1 scrubbed the used instruments in the metal basin with a reusable brush and stated there was no "soak time" in the enzymatic solution required. SPT 1 used a scrub brush with notable frayed bristles. SPT 1 stated the reusable brush was "washed" at the end of each shift and was good for up to 3-5 days. Contaminated water from the metal basin splattered on the sink, SPT 1, and floor of the room during the cleaning process. The surgical instruments left in the dry sink were then placed on an instrument stringer (adjustable tool designed to keep hinged instruments in an open position during sterilization) and set aside to be sterilized.

During an interview on 8/31/22, at 10:55 p.m., with MGR 4, MGR 4 stated SPT 1 had to be retrained on the "entire" process of reprocessing sterile instruments. MGR 4 stated he expected staff to manually clean and inspect all instruments in opened procedure trays, regardless of not being used in the procedure. MGR 4 stated cleaning brushes could be reused but had to be discarded if visibly soiled or damaged. MGR 4 stated, "[SPT 1] should have known."

A review of the professional reference at https://www.aorn.org/outpatient-surgery/articles/special-editions/2015/may-infection-control/decontamination-begins-in-the-or titled "Decontamination Begins in the OR", dated 4/27/15, the reference indicated, " ... Surgical instruments that aren't clean can't be sterilized ... decontamination begins in the operating room, at the point of use ... Keep instruments moist until they're cleaned to prevent bioburden [germs living on a surface] from drying and adhering ... This will prevent blood, organic materials and debris from drying and forming biofilm [thin, slimy film created by germs] ... pre-soak them [instruments] with an instrument spray or gel designed for pretreatment (enzymatic solution, for example) ... be sure to consult the manufacturer's written recommendations for the correct dilution, temperature and soak time ..."

During a review of the professional reference titled "ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities", dated 2017, the professional reference indicated, " ... The first and most important step in reprocessing reusable medical devices is thorough cleaning and rinsing. Cleaning removes microorganisms and other organic and inorganic materials ... All microorganisms in health care facilities should be considered potentially pathogenic ... Medical devices, instruments, and equipment used in patient care become contaminated with microorganisms and should be decontaminated ... To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized ... begin decontamination as soon as possible after the items have been used ... Because effective sterilization depends on minimizing the contamination present on items before the sterilization cycle, thorough cleaning procedures are essential during pre-sterilization processing ... Brushes used for decontamination need to be cleaned themselves and disinfected or sterilized. Brushes that show wear will not clean thoroughly. Prompt cleaning of brushes and other cleaning implements reduces or eliminates biofilm-forming microorganisms and thus minimizes the formation of biofilm ... instruments should be presoaked as soon as possible after use with a product intended to loosen soil ... Presoaking instruments moistens and loosens the soil, thus making the cleaning step more effective and efficient. Thorough rinsing removes potentially harmful residues and blood and other potentially infectious material..."

During a review of the facility's policy and procedure (P&P) titled, "Staging, Handling & Decontamination of Reusable Medical Devices," dated 1/2020, the P&P indicated, " ... Soiled instruments are to be kept moist during transport using a presoak spray and/ or moist towel ... Work surfaces must be cleaned and disinfected ... whenever visibly soiled ... Any reusable brushes must be inspected for cleanliness, wear, and damage. If any soil, wear, or damage is identified, the brushes must be discarded ... Pre-cleaning ... [enzymatic product] require a minimum soak time of 1 minute ... Cleaning and decontamination ... General instrument trays: Soak in enzymatic detergent for a minimum of 5 minutes ... All cleaning of instruments should be performed below the surface of the solution to prevent aerosolization of pathogenic substances ..."

During a review of the manufacturer's information for use (IFU) "General Instrument Cleaning Brushes", undated, " ... Clean brushes after each use and disinfect between cases or daily, at minimum ... Inspect between uses and replace when worn, frayed, bent, otherwise damaged. Damaged brushes cannot be cleaned effectively. Worn or damaged bristles and handles are ineffective in cleaning, and may damage the device ..."

2. During concurrent observation and interview on 8/30/22, at 4:00 p.m., in the endoscopy reprocessing room (designated area used to clean and prepare the endoscope for reuse), with Lead Endoscopy Technician (ET) 1, ET 1 demonstrated how he manually cleaned endoscopes before they were disinfected. ET 1 submerged an endoscope in the sink filled with an enzymatic detergent solution. He pulled the suction valve and insertion tube portions of the scope out of the detergent solution and manually scrubbed the external surfaces of the scope with a lint- free cloth. ET 1 followed the same process for scrubbing the scope's inner channels with a channel cleaning brush. The brush was pulled out while portions of the endoscope was above the surface of the solution. ET 1 stated this was his standard procedure for cleaning endoscopes. ET 1 stated endoscopes were precleaned with an enzymatic cleaner in the procedure room therefore did not have to be completely submerged during manual cleaning.

During concurrent observation and interview on 8/30/22, at 4:30 p.m., in the endoscopy department (a designated area where medical procedures are performed to visually examine structures inside the body using a camera), with ET 1 and Patient Coordinator (PC) 5 and in the presence of the Director of Surgical Services (DSS), department staff carried an endoscope in a biohazard bag (plastic bag used to collect, compile, pack, and dispose harmful and infectious wastes) from the procedure room to the endoscope reprocessing room. The tip of the endoscope had poked through the bag as the staff person carried the bag across the department's main walkway. ET 1 stated it was the department's practice to transport endoscopes to be reprocessed in a biohazard bag. ET 1 stated transporting endoscopes in plastic biohazard bags was okay since the distance between the procedure rooms and the reprocessing room "was short" and the likelihood of the bag tearing was minimal. ET 1 acknowledged the endoscope had poked through the plastic bag and stated, "that never happened before." PC 5 stated the department followed SGNA professional standards and was not aware of any literature that indicated hard puncture resistant containers were the preferred method for transporting endoscopes.

During an interview on 9/1/22, at 9:50 a.m., with the Infection Preventionist, the IP stated the infection prevention team did not identify endoscopes being transported in plastic biohazard bags as a potential risk for cross contamination during routine hospital surveillance rounds. The IP stated endoscopes should have been transported by staff using both hands to better secure the scope and avoid the scope from poking through the plastic biohazard bags. The IP acknowledged the exposed tip of the endoscope increased the risk of cross contamination and transmission of infection for staff and patients when it was transported through the endoscopy department in the torn bag.

During a review of the "Manufacturer's Reprocessing Manual for [brand name endoscopes]," undated, the manual indicated, " ...Clean the external surface ... Fill a clean, large basin with the detergent solution at the temperature and concentration recommended by the detergent manufacturer. Immerse the endoscope in the detergent solution. Thoroughly brush or wipe all external surfaces ... To avoid splashing the detergent solution when the brush is pulled out from the endoscope, keep the endoscope immersed in the detergent solution while brushing ... Warning ...Make sure that the disinfectant solution contacts all external surfaces of the endoscope and accessories ... If the endoscope and accessories are not completely immersed, any protruding section(s) of the device(s) will not be adequately disinfected. Always confirm that the endoscope and accessories are completely below the surface of the disinfectant ... Leave the endoscope, channel plug, the injection tube, and the auxiliary water tube immersed in the disinfectant solution ... Confirm the recommended contact time, temperature, and concentration. Use a clock or timer to accurately measure the contact time ..."

During a review of the hospital's P&P titled, "Endoscope Cleaning", undated, the P&P indicated, " ... Manual cleaning ... Keeping scope submerged in detergent solution as much as possible ..."

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 review of the hospital's job description titled "Endoscopy Technician", dated 9/19/19, the job description indicated, " ... Role Specific Accountabilities ... Clean, process and store the various endoscopes according to manufacturer's recommendations in conjunction with the standards of Society of Gastroenterology Nurses and Associates (SGNA) ..."

3. During concurrent observation and interview on 8/30/22, at 9:40 a.m., in OPSN decontamination room, with SPT 1, reusable suction cannisters used in the operating room (OR) hung on a roller stand next to the washer. SPT 1 stated the reusable cannisters were cleaned and disinfected then left to air dry in the decontamination room (separate "dirty" room of SPD where surgical instruments are first manually cleaned, sorted, inspected and if necessary, disassembled) The SPT 1 stated once dry, the cannisters were transferred to the clean supply room to be used in OR procedures.

During an interview on 8/30/22, at 9:50 a.m., with OPSN- PC 2 and Manager of Sterile Processing (MGR) 4, PC 2 acknowledged the process of air-drying suction cannisters in the decontamination room, then directly storing them in the OR's clean supply room, increased the risks for transmission of infection and cross contamination of clean and/ or sterile supplies. PC 2 stated the cannisters were stored in the decontamination room due to a lack of space in the sterile reprocessing department (SPD-performs sterilization and other actions on medical devices and equipment) which hospital administration was aware of the issue "for some time." MGR 4 stated the limited space and configuration of the OPSN SPD department had "some challenges" and department expansion was necessary. MGR 4 stated he was aware the clean suction cannisters were air dried in the decontamination room but failed to identify potential risks for transmission and cross contamination of infectious disease to staff and patients.

During an interview on 9/1/22, at 9:50 a.m., with the IP, the IP stated the practice of air-drying suction cannisters in the decontamination room, then using the potentially contaminated cannisters during procedures compromised the OR sterile environment and placed patients at risk for infections. The IP stated this practice was not identified by the hospital's infection control team during surveillance rounds.

During a review of the professional reference titled "ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities", dated 2017, the professional reference indicated, " ...Separating "clean" and "dirty" areas limits environmental contamination ... Adherence to these functional design recommendations helps contain potential contaminants within a particular portion of the decontamination area and thus helps prevent cross-contamination or recontamination. Segregation of contaminated items from items being removed from mechanical processing equipment is necessary to protect the processed items... Similarly, there is a significant risk of recontamination if receiving areas for items requiring different methods of reprocessing are not separated..."

4. During a concurrent observation and interview, on 8/31/22, at 9:42 a.m., in OPSN- SPD, with SPT 1 and MGR 4, the SPD prepack clean area temperature registered between 74 degrees Fahrenheit (F) and 75 degrees F. MGR 4 stated the temperature registered one degree above the requirement. MGR 4 stated a work order was placed "two days ago." SPT 1 stated staff did not document the temperature and humidity in the log but "we used to." SPT 1 stated temperature and humidity in SPD was last documented by staff "like a month ago." MGR 4 stated the system for recording temperature and humidity in SPD was changed and staff had not documented the temperature and humidity in SPD since June 2022. MGR 4 stated he was not certain if maintenance staff monitored and had oversight of the temperature and humidity in OPSN-SPD.

During concurrent interviews and record review on 9/1/22, at 10:00 a.m., with the Facilities Maintenance Manager (MGR) 8 and the Heating Ventilation and Air Conditioning Technician (HVACT), MGR 8 stated the temperature and humidity in OPSN-SPD were remotely monitored and recorded on the hour, 24 hours per day, via the hospital's computer monitoring system. MGR 8 stated the temperature and humidity in OPSN-SPD were preset to temperature ranges between 68 degrees F and 73 degrees F and humidity ranges between 20 and 60 percent (%). MGR 8 stated the system documented and "alarmed" maintenance if temperatures and humidity readings registered outside the preset ranges. The temperature and humidity logs for 6/2022, 7/2022, and 8/2022 were reviewed. Findings were as follows:

The OPSN-SPD temperature and humidity logs for June 2022, "alarmed" out of range temperatures on 6/10/22, 6/24/22, 6/25/22, 6/26/22, 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The temperatures ranged between 75.3 degrees F and 86.3 degrees F for two to 17 consecutive hours. Out of range humidity readings were registered on 6/27/22, 6/28/22, 6/29/22, and 6/30/22. The humidity ranges that "alarmed" were between 12.66% and 18.73% for three to eight consecutive hours.

The OPSN-SPD temperature and humidity logs for July 2022 registered out of range temperatures on 7/3/22, 7/17/22, 7/18/22, 7/19/22, 7/20/22, 7/21/22, 7/22/22, 7/23/22, 7/24/22, 7/25/22, 7/26/22, 7/27/22, 7/28/22, 7/29/22, 7/30/22, and 7/31/22. The temperatures ranged between 75.1 degrees F and 88.4 degrees F for seven to 15 consecutive hours. Out of range humidity readings that "alarmed" registered on 7/20/22, 7/21/22, and 7/22/22. The humidity ranged between 15.47% and 18.62% for three to nine consecutive hours.

The OPSN-SPD temperature and humidity logs for August 2022 registered out of range temperatures on 8/14/22, 8/15/22, 8/16/22, 8/17/22, 8/18/22, 8/19/22, 8/20/22, 8/21/22, 8/22/22, 8/23/22, 8/24/22, 8/25/22, 8/26/22, 8/27/22, 8/28/22, 8/29/22, and 8/30/22. The temperatures ranged between 75.2 degrees F and 88.2 degrees F for four to 14 consecutive hours. There were no out of range humidity ranges that "alarmed" for August 2022.

HVACT stated the HVAC system could not keep up with demands during "summertime" months because the system "pulled [hot] air from the outside and [the HVAC] was old." MGR 8 stated maintenance personnel were sent to OPSN-SPD to check the HVAC and thermostat each time the system alarmed but there was not much that could be done. MGR 8 stated the temperature and humidity were difficult to maintain within safe ranges and the system needed replacement. MGR 8 stated, "this has been a problem for years," and hospital administration were aware of the ongoing issues.

During an interview on 9/2/22, at 12:30 p.m., with the Director of Facilities (DFM), DFM stated the HVAC system in OPSN-SPD did not have the capacity to maintain safe temperature and humidity ranges. DFM stated equipment used in SPD generated lots of heat and the HVAC system utilized 100% of outside air which, on summer days, increased the room's temperatures. DFM stated the current system required upgrading.

During a review of [name of vendor] invoice, dated 8/31/22, the invoice indicated, " ... It was determined that the existing [name of HVAC] system cannot keep up and additional capacity is needed ... Install (1) 45,000 BTU [British thermal unit- the number of heat the unit can remove from the air in a specific area per hour] [name] Multi (2) head heat pump assembly ... Install one 230V [volt] electrical circuit including breaker, EMT [conduit pipe], and cabling from the nearest panel to the unit ..."

During a review of the hospital's P&P titled, "Humidity/ Temperature Monitoring, Surgical/ Procedural Units" dated May 2020, the P&P indicated, " ...To ensure patient safety in terms of prevention of electrostatic charges and infection control ... and to reduce the potential for bacterial growth ... A relative humidity will be maintained between 30% and 60% in all surgical and procedural suites and sterile storage areas ... Temperature will be maintained at 68 degrees F to 75 degrees F ... humidity and temperature are manually monitored and recorded daily by each department in designated sterile storage in SPD ..."

Review of the hospital's policy and procedures for Humidity and Temperature monitoring, the preset ranges for humidity should have been set between 30% and 60%, not 20% as MGR 8 previously indicated. For the month of June 2022, there were a total of 216 occurrences for which the humidity in OPSN-SPD registered below 30% and did not "alarm." In July 2022, there were 148 occurrences and in August 2022, there were 19 occurrences. The humidity levels stayed below 30% for up to 65 consecutive hours (7/21/22 through 7/24/22).

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", dated 11/30/21, indicated, "... Temperature or relative humidity variations that fall outside the recommended parameters for the perioperative environment can have serious implications for patient safety ... 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. Other negative effects include ... decreased patient satisfaction stemming from delays or rescheduled procedures ..."

During a review of the professional reference titled, "ANSI [American National Standards Institute- national organization supporting the development of technology standards]/ ASHRAE [American Society of Heating, Refrigerating and Air-Conditioning Engineers]/ASHE [American Society for Health Care Engineering] Standard," dated 2017, the professional reference indicated, " ...Standard 170 will be included in the Hospitals and Outpatient Facilities books ... The purpose of this standard is to define ventilation system design requirements that provide environmental control for comfort, asepsis, and odor in health care facilities ... Sterile Processing Department ...Clean workroom ...humidity Max 60% ...temperature 68-73 degrees F ... Decontamination room ... humidity NR ... temperature 60-73 degrees F ... Sterile Storage ... humidity Max 60%... temperature Max 75 degrees F ..."

A review of the professional reference at https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/ASTGuidelinesHumidityintheOR.pdf titled "Guidelines for Best Practices for Humidity in the Operating Room", dated 6/17, indicated, " ... RH [relative humidity] level is important to the shelf life of sterile supplies that are stored in the surgery department and the levels established by manufacturers of electromedical devices ... Therefore, shelf life and product integrity can be even more greatly affected if the IFU [information for use] calls for 30-60% RH, but the HDO [healthcare delivery organization] lowers the RH to 20%. Examples of products that are sensitive to humidity include biological and chemical indicators, and EKG [electrocardiogram] electrodes [sticky patches with wires that connect to a monitor used to check electrical activity of the heart]. Manufacturer's test products at a specific RH, of which it can be assumed the testing level has been at 30%... The manufacturers of electro-medical devices (EMD) and healthcare technology management (HTM) have communicated concerns about lower RH levels. Problems with EMDs not working properly at lower RH levels have been reported by HTM technicians, and the lower levels causing problems with calibration ..."

5. During a concurrent observation and interview, on 8/31/22, at 10:10 a.m., with MGR 4, in the OPSN SPD clean area, a large surgical instrument tray was stored in a storage rack 6 inches from the floor. MGR 4 stated the instrument tray stored in the storage rack 6 inches from the floor was a Laparoscopic Instrument Set (surgical instruments used for abdominal surgery). The MGR 4 stated clean surgical instruments should not be stored below 8 inches per AAMI guidelines to prevent cross contamination from environmental contaminants.

During an interview on 8/31/22, at 10:04 a.m. with the SDPT, the SPDT stated she was the one who stored the Laparoscopic Instrument tray in the storage rack 6 inches from the floor and should have been stored 8 inches from the floor to prevent cross contamination.

During a review of the professional reference titled, "Association for the Advancement of Medical Instrumentation (AAMI)," dated 2017, the professional reference indicated, " ... Storage facilities ... Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry. Sterile items should be 1) stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air c

Based on observation, interview and record review, the hospital failed to provide surgical services in accordance with acceptable standards of practice when:

1. First Assist Registered Nurses performed duties in surgical procedures without the benefit of being assigned a physician supervisor, without having experiences and qualifications vetted appropriately through medical staff office and without having evaluations on an ongoing basis. (refer to A945)

2. Staff did not follow policies and procedures to prevent retained foreign objects for Patient 2 and Patient 36. (refer to A951)

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.

Based on interview and record review, the Medical Staff and Nursing departments did not verify or monitor the competencies, training, education, experience and/or or performance for 9 of 9 non-physician surgical First Assistants (FA - a healthcare professional who acts as a lead assistant to the surgeon) performing surgical procedures and ensure each FA was under a MD/DO surgeon "supervision."

This failure placed surgical patients at risk for subquality care which could endanger the health and safety of surgical patients.

Findings:


During a record review on 9/2/2022, at 9:38 a.m., with Chief Nursing Officer (CNO), hospital documents were reviewed. The CNO reviewed the "Standardized Procedures for RN [Registered Nurse] First Assistant", "Surgical Assistant Focused Professional Performance Evaluation", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", "Ongoing Professional Performance Evaluation Allied Health Professional (AHP)" form, "To be Agreed Upon by the Supervising Physician(s)" form, "Bylaws of the Medical Staff of [Hospital]", "Allied Health Professional Policies and Procedures", "Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant", " Bylaws of the Medical Staff of[Hospital]", Nursing Department, "Position Description, Title: RN First assistant, department of surgery, Reports to: Practice Coordinator, surgery", DCA State of California Department of Consumer Affairs, and "The RN as First Assistant to the Surgeon".

During an interview on 9/2/2022, at 9:42 a.m., CNO stated, she was "familiar" with the standardized procedures (SP), hospital policy and procedures, Nursing hiring and Human Resources (HR) requirements, Interdisciplinary Patient Committee (IPC) and medical staff requirements. CNO stated, she was involved in developing the Allied Health Professional (AHP) Policy and Procedures and SP. CNO stated, she was a member of the IPC and participated in the approval process of AHP Surgical First Assistant (FA) applications. CNO stated, "all RNs must go through the HR [hiring] process ... unless hired by a physician." CNO stated, a RN can be hired under "two job descriptions", RNFA and hospital nurse. CNO stated, hospital-employed nurse FAs (RNFA) must meet the requirements as described in: Nursing Department's, "Position Description, Title: RN First assistant, department of surgery, Reports to: Practice Coordinator, surgery", "Allied Health Professional Policies and Procedures", "Standardized Procedures for RN First Assistant", and State of California Department of Consumer Affairs (DCA), "The RN as First Assistant to the Surgeon." CNO stated, nursing employees had "mandatory" yearly evaluations, education, and training. CNO stated, the hospital nursing department did not communicate or provide documentation to the Medical Staff Office about RNFA nursing employees. CNO stated, after being hired by the hospital, the FAs were required to meet the medical staff Bylaw requirements. CNO stated, IPC approved the applications that will be moved forward to the medical staff Committee (MEC) for review and final approval by Board of Directors.

During an interview on 9/2/2022, at 9:45 a.m., CNO stated, physician supervision involved being in the room the entire time the RNFA was doing First assist." CNO stated, the FA also acted as the circulating nurse. CNO stated, according to the "SP", the RNFA was able to perform the surgical procedures of "exposure of layers" and "sever tissue." CNO stated, the RNFA was able to "cut, resect, any tissue ... remove any tissue ...even bowel". CNO described surgical procedures performed by a surgeon. CNO stated, the hospital allowed the nurse to do "any procedure as directed" by the surgeon.

During a concurrent interview and record review on 9/2/2022, at 9:47 a.m., CNO stated, FAs medical staff and nursing privileges were based on training, education, experience, certifications, demonstrated competencies, ongoing evalautions, monitoring, and direct physician supervision/sponsor. Nine FAs medical staff files were reviewed:
" 9 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1, NPFA2, and NPFA3) did not have documentation of competency for surgical cases, peer review evaluation, [Hospital] surgical activity logs, ongoing evaluations, or monitoring, signed Standard Procedure agreements.
" 8 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1, and NPFA3) did not have documentation of supervising physician.
" 8 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1 and NPFA2) did not have professional/surgeon performance evaluation.
" 5 of 9 First Surgical Assistants, (RNFA2, RNFA4, RNFA5, RNFA7 and NPFA3) completion of 120 hours of supervised surgical procedures by a surgeon sponsor.
" 5 of 9 First Surgical Assistants (RNFA2, RNFA5, RNFA6, NPFA1, and NPFA3) of completing a required Surgical First Assistant 40 of classroom education
" 5 of 9 First Surgical Assistants (RNFA2, RNFA4, RNFA7, NPFA1 and NPFA3) employment status was unknown.
" 4 of 9 First Surgical Assistants (RNFA1, RNFA6, RNFA7, NPFA2) did not have the required Basic Life Support (CPR) certification, and
" 3 of 9 First Surgical Assistants (RNFA1, RNFA6, NPFA2) did not have the required Advanced Cardiac Life Support (advanced measures to save a person's life) certification.
During an interview with the CNO on 9/2/2022 at 9:50 a.m., CNO stated she did not know what information was in RNFA employee files or if the RNFAs were meeting mandatory nursing staff requirements. CNO stated, she was unable to explain why the IPC approved applications for 9 of 9 Allied Health First Surgical Assistant files were incomplete. CNO stated, the RNFA medical staff files were incomplete.

During a concurrent interview and record review with Medical Staff Service Manager (MSS) during the dates of 8/29/2022 at 3:22 p.m., 8/30/2022 at 9:14 a.m. and 4:15 p.m., and 9/1/2022 at 8:23 a.m., the medical staff files were reviewed, and the following documents that MSS provided: : "Standardized Procedures for RN First Assistant", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", "Ongoing Professional Performance Evaluation Allied Health Professional (AHP) form", "To be Agreed Upon by the Supervising Physician(s)" form indicated that the signing physician(s)", [Hosptal] for a refence letter form letter, "Bylaws of the Medical Staff of[Hospital]", "Allied Health Professional Policies and Procedures", "[Hosptal] Orthopedic Surgery Clinical Privileges", "[Hospital] General Surgery Clinical Privileges", "[Hospital] "Allied Health Professional Policies and Procedures", "Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant", "[Hospital] Nurse Practioner Task List", "[Hospital] Physician Assistant Task List", "Surgical Assistant Focused Professional Performance Evaluation", "Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", Requirements for Service Authorization and Criteria for Approval of Tasks Non-Physician Assistant", "Nursing Department, 'Position Description, Title: RN First assistant, department of surgery, Reports to: Practice Coordinator, surgery", DCA State of California Department of Consumer Affairs, "The RN as First Assistant to the Surgeon".

MSS stated 4 of 9 First Surgical Assistants, RNFA1, RNFA5, RNFA6, and NPFA2, were employees of the hospital, and hired by Human Resources (HR), Nursing Department. MSS stated RN employees had additional requirements that also needed to be met-- 5 years of perioperative experience, physician surgeon sponsor, completion of an AORN (Association of periOperative Registered Nurses) approved RNFA program, yearly nursing evaluation and education, and ACLS certification. MSS stated she does not have verification from HR nursing department that RNFA1, RNFA5, RNFA6, and NPFA completed these requirements. MSS stated HR nursing department does not provide any documentation, education, training or evalautions about RNFA or NPFA employees.

The medical staff files of nine surgical First Assistant (HA) were reviewed with MSS. MSS acknowledged nine of nine RNFA re-credential files were deficient and did not follow, policy and procedure, completion of forms, By laws and/or standardized procedures and credentialing requirements. Nonetheless, MSS stated the files were approved without the required documents and vetting ICP, MEC and the Board of Directors. MSS acknowledged for the most current APH credentialing period:
" 9 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1, NPFA2, and NPFA3) did not have documentation of competency for surgical cases, peer review evaluation, [Hospital] surgical activity log, signed Standard Procedure agreements, ongoing evaluations, or monitoring.
" 8 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1, and NPFA3) did not have documentation of supervising physician
" 8 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA5, RNFA 6, RNFA7, NPFA1 and NPFA2) did not have professional /surgeon performance evaluation.
" 8 of 9 First Surgical Assistants (RNFA1, RNFA2, RNFA4, RNFA6, RNFA7, NPFA1, NPFA2 and NPFA3 did not have OPPE.
" 5 of 9 First Surgical Assistants, (RNFA2, RNFA4, RNFA5, RNFA7, NPF1, and NPFA3) verification of the completing the required of 120 hours of supervised surgical procedures by a surgeon sponsor.
" 5 of 9 First Surgical Assistants (RNFA2, RNFA5, RNFA6, NPFA1, and NPFA3) verification of completing the required First Assistant 40 of classroom education.
" 5 of 9 First Surgical Assistants (RNFA2, RNFA4, RNFA7, NPFA1 and NPFA3
" 4 of 9 First Surgical Assistants (RNFA6, RNFA7, NPFA2 and NPFA3) did not have documentation of the medical staffing "Professional Liability insurance" as required by the hospital Bylaws.
" 3 of 9 First Surgical Assistants, (RNFA2, NPFA1 and NPFA3), did not have an up-to date National Provider Data Base (NPDB) report.
" 3 of 9 First Surgical Assistants (RNFA1, RNFA6, RNFA7 NPFA2) did not have the required Basic Life Support ( CPR) certification, and
" MSS acknowledged for the current recredentialing period for 3 of 9 (RNFA1, RNFA6, NPFA2) First Surgical Assistants did not have the required Advanced Cardiac Life Support, (advanced measures to save a person's life).

During an interview with Director Quality and Accreditation (DQA) on 8/31/2022 at 8:06 a.m., DQA stated that even though arrangements had been made the day before to observe cardiovascular cases with RNFA, the team would not be able to observe the cases. DQA stated the cardiac surgeon, SMD 1 would "not allow the survey team to observe his case unless we were present at the start of the case", and since the case had started, we could not enter the OR. A request was submitted to observe another case. DQA stated that the survey team could only enter at the end of cases when final instrument and sponge counts were being done. Otherwise, the CDPH team was "not allowed in" cardiovascular, pulmonary, and other surgical cases. An explanation was provided the hospital the need to observe different aspects of the surgical cases in which Surgical First Assistants (FAs) provided surgical services. DQA was requested to reconfirm the observation restrictions with the surigal team and administration. At 8:53 a.m., DQA stated, "no cardiovascular or physician would allow the survey team to observe".

During an interview on 8/31/2022 at 9:04 a.m. in Main OR area with DSS, DSS stated surveyors were only allowed to observe final surgical counts at the end of a case. An explanation was provided the hospital the survey team needed to observe different aspects and processes of the surgical cases in which FAs provided surgical services.

During an interview on 8/31/2022 at 11:20 a.m. in OR10 with Registered Nurse-Quality (QRN), QRN stated that cardiovascular surgeons would only allow surveyors to observe counts at the end of the case and would not allow any other observations. An explanation was provided the QRN the survey team needed to observe during different aspects of the surgical cases in which FAs provided surgical services.

During a phone interview with Registered Nurse Surgical First Assistant (RNFA6), also present DSS and DQA, on 9/2/2022 at 12:11 p.m., RNFA6 stated she had been working at the hospital for over 16 years and as an RNFA more recently. RNFA6 stated there are "no formal evaluations" for the RNFA by the surgeons. RNFA6 stated RNFA are not evaluated by peers or other RNFAs.

RNFA6 stated RNFA "physician supervision updated every two years" during the credentialing process. RNFA6 did not have an official supervising surgeon. RNFA6 stated surgeons "request" an RFA ahead of time". RNFA6 stated OR case logs are forwarded to medical staffing office. RNFA6 stated she does not have a copy of her RNFA OR case logs. RNFA6 acknowledged she does not know how many or what type of cases she has participated in on the past six months. RNFA6 stated she works a "majority" of the time as an OR RN preceptor and hospital "charge nurse".

Hospital "Department of Surgery Rules and Regulations", approved March 27, 2020, signed by President of the Medical Staff, Chief Medical Officer (CMO) and Board of Trustees, section titled "Requirements for Surgical Assistants" indicated, "prior to granting surgical assistant privileges, physicians who are not surgeons will be required to provide documentation of experience or a statement from another surgeon attesting to his/her ability, including training in sterile technique".

Hospital Human Resources Nursing Department, "Position Description, Title: RN Surgical First Assistant (RNFA), Department of Surgery, Reports to: Practice Coordinator, Surgery", updated June 20, 2011, indicated "the RN First Assistants is responsible for coordinating and delivering patient care utilizing the nursing process ...Requirements licensure as a Registered Nurse ...Healthcare provider CPR (cardiopulmonary resuscitation, basic life support) card ...ACLS (Advance Cardiac Life Support) certification ...Minimum of five years' experience as a perioperative [care of patient before, during and after surgery] nurse with successful completion of an ARON [Association of periOperative Registered Nurses] RNFA program including supervised clinical component is required ...annual review performed by the surgeon sponsor is required to maintain privileges ...special skills ...Demonstrate competency ...Actively participate in Performance Improvement and risk management by collecting data and patriating in performance improvement efforts ..."

Hospital "Nurse Practioner Task List", revised 1/2009, indicated the "tasks which require additional documentation of training/experience: Assist in Surgery ...3 years of experience as an operating room staff member and at least two years active scrub experience with documentation of assisting in 100 cases OR completion of an approved Non-Physician First Assistant courses with documentation of 120 hours of assisting activities. If fewer than 120 hours, your b precepted by your physician employer ..." There is a line for the name and signature for the Nurse Practioner. There are no other signature lines.

Hospital "Task List for Non-Physician First Assistants", reviewed 7/2005, indicated the scope of practice for First Assistants (FA). The list headings included "assists with patient positions ...draping ...retract ...cut/tie sutures ...hand suction and/or sponge in surgical field ...assist surgeon in utilizing specialized equipment ...suture drains ...remove sutures under direct supervisions ...apply electro-cautery to instrument held by surgeon ...remove and/or apply dressings, packing or casts ..." The form required "documentation of proficiency in use of specialized tools". The form had signature lines for the FA, Chairman of the Interdisciplinary Committee (IDC), Department Chairman, Medical Executive Committee (MEC) and Board of Directors (GB). There was no signature line for supervising physician or responsible physician.

Hospital form: "[Hospital] Surgical Assistant Focused Professional Performance Evaluation", had a designated space for the evaluating surgeon, surgical assistant, procedure type, date, and patient medical record number. The evaluation sections included "tissue handling ...use of instruments ...providing exposure ...general [skills).." The completed form was to be returned to Medical Staff Services.

Hospital form: "[Hosptal] Procedural Evaluation Focused Professional Performance Evaluation (FPPE)", had a designated space for the healthcare professional, supervising physician, procedure type, method of FPPE, patient medical record number. The form evaluation sections included "communication with supervising physician ...technical proficiency ...post-op orders/medications ...procedural judgment ...procedure note ...complications managed appropriately ...patient outcome ..." The completed form was to be returned to Medical Staff Services.

Hospital form: "To be Agreed Upon by the Supervising Physician(s)" form indicated that the signing physician(s) "agree with the above designated tasks", and the "applicant being my direct employee ..."

Hospital "Standardized Procedures for RN First Assistant", approved 3/2020 and signed by Interdisciplinary Practice Committee (IPC),Department of Surgery Medical Executive Committee (MEC), Chief Nursing Officer (CNO) and Board of directors (GB), indicated the RN First Assistant "renders direct patient care as part of the perioperative role assisting the surgeon ...supervising physician and who is authorized to supervise the Allied Health Professional ....Direct supervision will not be necessary once competency is determined ....Provide additional surgical support( exposure, hemostasis, suturing in the Operating Room and Nursing Units ...Performance procedures ...retraction ...provide hemostasis ...perform know tying ....closure of layers ....clamp and sever tissue ...rasp. Ad fixate screws, staples, and other devices...drill, ream and modify tissue ...cauterize and approximate tissues ...Affixing and stabilizing all drains ...applying casts, plaster splints or other devices ...written record reflects the presence and role of APH in the operating room by the Attending Surgeon ...Initial Competence ... BLS certification ...ACLS certification optional ...Training in the processes of RN First Assistant duties in an accredited graduate nursing program ...Completion of an approved RNFA course ....Completion of 120 hours of proctored instruction with a qualified surgeon ...perform the procedure six times under direct supervision prior to completing the procedure without direct supervision ... Continued proficiency ...must perform the procedure at least three times per year ....will be signed-off after demonstrating 100% accuracy in completing the procedure ...Demonstration of continued proficiency shall be monitored through the annual evaluation ...clinical practice outcomes logs to be submitted with each renewal of credentials".

Hospital "Bylaws of the Medical Staff of [Hospital]", revised 7/27/2018, section titled "Processing initial application for Allied Health Professional applicant qualifications indicated, "once application is determined complete , it will be forwarded to the IPC for consideration. The IPC retains the authority to make all recommendations to the Medical Executive Committee ....the application is forwarded to the department chair to which the supervising physician is assigned ... ....If the APH does not have a supervising physician, the application will be forwarded to the department to which the APH is assigned ...Thereafter the application shall be processed by the Medical Executive Committee and the Board of Trustees". The section titled "Allied Health Professionals Renewal of Service Authorization" indicated "APHs shall be granted service authorization for no more than 24 months ...The completed application will be reviewed by the IPC ...Focused Professional Practice Evaluation of Allied Health Professionals at the time of reappointment ...provide activity data (number only) on all procedures beyond basic scope of practice for previous two years ...Ongoing Professional Evaluations of Allied Health Professionals ... Competency will be evaluated annually ...review occurrence reports involving AHP for past twelve months ...evaluation as clinical practice and competence by Departmental Director or designee knowledgeable of the practitioner's skill and competence ....Occurrence Reports Involving Allied Health Professionals ...the Chair of the ICP will review all Occurrence Reports involving AHPs ... Responsibilities of the Supervising Physician".

[Hospital] "Allied Health Professional Policies and Procedures", revised July 20, 2019, signed by Interdisciplinary Practice Committee (IPC), Medical Executive Committee (MEC), Chief Nursing Officer (CNO) and Board of directors (GB), indicated Advanced Practice Professionals (APP) "are permitted to render services according to the services offered and needs of the Hospital" and include Non-physician First Assist ...All applications require professional training, current license, demonstrated ability and judgment, three personal references, liability insurance ...Once the application is determined complete, it is forwarded to the IPC ...The application shall processed by the Medical Executive Committee and the Board of directors in a manner parallel to processing of Medical Staff applications" ...establish a method for initial evaluation of the competence ...method of maintaining a written record of those persons authorized to perform ...Specify the nature and scope of review and/or supervision ...communicate with patient's physician ...limitations on settings or department ...record keeping. Requirements ... reviewed at the time of renewal of service authorization". The section titled "Allied Health Professional Practice Evaluation", indicated at the "time of reappointment to Provisional Allied Health Professional Staff ...will be required to provide activity data (numbers only) on all procedures beyond the basic scope of practice for the previous two years". The section titled, "Ongoing professional Practice Evaluation" indicated "competency will be evaluated annually ...[and] shall include review of occurrence reports ....Evaluation of clinical practice and competence". The section titled, "Requirements for Service Authorization and Criteria for Approval of Tasks Non- Physician Assistant "qualifications indicated "recommendation letters are required from the O.R. [operating room] supervisors at all facilities at which they have worked ...Present a certificate of successful completion at an approved non-physician First Assistant course with a minimum of 40 hours didactic training ...AND clinically supervised surgical assisting activities of 120 hours. If less than 120 hours ...be precepted by surgeon employer to total of 120 hours ...OR provide documentation of three-year active experience as an OR staff member and at least two years active scrub experience with documentation of assisting in 100 cases". The section titled, Scope of Practice includes "positioning, prepping, and draping ...observing the operative field ...retaining manually controlled retractors ...managing instruments ...knot tying ...provide hemostasis ...apply suture ligatures in the muscle, subcutaneous, and skin layers ...provide close of layers ...Perform CPR". The responsibility of the "the primary surgeon is responsible for direct supervision of the non-physician first assistant's performance ...Renewal of Service Authorization and Tasks ...the non-physician First Assistant will undergo performance -based recredentialing every two years".

State of California Department of Consumer Affairs (DCA), "The RN as First Assistant to the Surgeon" was provided by Medical Staff Service Manager (MSS) as the foundation of the RNFA hospital policy and procedure. The document indicated, the "RN First Assistant directly assists the surgeon by controlling bleeding, providing wound exposure, suturing and other surgical tasks. The RN first assistant may provide other advanced assistance, such as mobilization of tissue, patient positioning and directing other surgical team members with specific individual tasks. The RN first assistant, practices perioperative nursing and must have acquired the necessary specific knowledge, skills, and judgment. The RN first assistant practices under the supervision of the surgeon during the intraoperative phase of the perioperative experience. To perform those functions considered to be first assistant to the surgeon, the RN must adhere to standardized procedures ...additional safeguard for the consumer is that the nurse be currently capable to perform the procedure ... Specify any experience, training and/or education requirements for performance of standardized procedure functions ...Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions ...The registered nurse who undertakes a procedure without the competence to do so is grossly negligent and subject to discipline by the Board of Registered Nursing".

Business Professional Code (BPC) 2732.05. "(a) Every employer of a registered nurse, every employer of a registered nurse required to hold any board-issued certification, and every person acting as an agent for such a nurse in obtaining employment, shall ascertain that the nurse is currently authorized to practice as a registered nurse".

BCP 2726. Except as otherwise provided herein, this chapter confers no authority to practice medicine or surgery.

Department of Consumer Affairs (DCA) Board of Registered Nursing (BRN) "AN EXPLANATION OF THE SCOPE OF RN PRACTICE INCLUDING STANDARDIZED PROCEDURES. Scope Of Registered Nursing Practice", indicated each standardized procedure shall: "Establish a method for initial and continuing evaluation of the competence ...Provide for a method of maintaining a written record of those persons authorized to perform standardized procedure functions ...scope of supervision ...limitations on settings ...patient record-keeping requirements ...method of periodic review ...the nurse be currently capable to perform the procedure."

Based on observation, interview, and record review, the facility failed to implement interventions meant to support the effectiveness of the policy and procedure titled, "Counts: Prevention of Retained Surgical Items" for two out of three patients (Patient 2 and Patient 36) when:
Patient (Pt) 2 underwent a robotic (robot-assisted) left total knee arthroscopy (surgery performed on patients with severe arthritis [serious, painful disease that gets worse with age] using a smaller incision) on 6/7/21, and surgical staff in the operating room at the time of the surgery, including the surgeon, did not count the patellar protector (an object used to protect the kneecap). Pt 36 underwent a right total knee arthroplasty (surgical reconstruction or replacement of the worn surfaces of the knee joint to reduce pain and improve stability) on 8/31/22, and surgical staff in the operating room at the time of the surgery, allowed Vendor (VEN- sales representative who are responsible for ensuring that all the instruments and components needed for each surgery on their schedule are on hand and ready for use) 1 to write on the white board, did not perform surgical instrument counts, or use the "Perioperative Count Sheet".

These failures resulted in Pt 2 to undergo an avoidable second surgery on 6/7/21 to remove the patellar protector (device placed over the kneecap to protect it during surgery) left under Pt 2's knee muscle (stretchy fibers responsible for starting and controlling movement of the knee), and placed Pt. 36 at a potential risk to sustain a retained foreign object.

Findings:

During a review of Pt 2's "History and Physical (H&P)," dated 6/7/21, the H&P indicated, Pt 2 was a 66-year-old who elected to have a left total knee arthroplasty (after a consult with the surgeon) after non-surgical measures were unsuccessful. Pt 2 elected to have surgery to help correct the problem.

During a review of Pt 2's "Operative/Procedure Reports," dated 6/7/21, the "Operative/Procedure Reports" indicated, Pt 2 had a left total knee arthroplasty on 6/7/21. Pt 2 was in the PACU when Medical Doctor (MD) 3 obtained an x-ray (digital image of a part of the body) of Pt 2's knee. Pt 2's x ray revealed an oval object over the patella. Pt 2 returned to surgery two hours later and was found to have a retained patellar protector which was removed. Pt. 2 was discharged home on 6/8/21.

During a review of Pt 2's "Postoperative Radiograph Report," dated 6/7/21, the "Postoperative Radiograph Report" indicated, "... an oval 3.5 centimeters (cm- unit of measure) overlying the superolateral (situated above and towards the side) join space (space between the bones that make up the joint) ... No obvious radiopaque (does not allow radiation to pass through) foreign bodies (an object or substance that is not supposed to be in the body) ..."

During an interview on 6/17/21, at 12:30 p.m., with Medical Doctor (MD) 3, MD 3 stated, the patellar protector was missed (not accounted for) during Pt 2's surgery on 6/7/21 because it was not part of the surgical count. MD 3 stated, the robotic surgery started two to three months prior to Pt 2's surgery on 6/7/21. MD 3 stated, "Usually, thorough irrigation would reveal anything remaining in the surgical field, but in this case, the protector floated up too high and could not be seen." MD 3 stated, an x-ray was not done in the operating room since there was no indication of having a retained surgical object.

During an interview on 6/17/21, at 1:13 p.m., with Operating Room Circulating Nurse (ORN- a nurse who assists in managing the nursing care of a patient during surgery) 3, ORN 3 stated, sponge, needles and (cautery [used to stop bleeding] brand name) tips (a cover to cover the tip of a surgical cautery device) were counted in Pt 2's surgery. ORN 3 stated, MD 3 was responsible to ensure Pt 2 did not have a retained foreign object.

During a record review Pt 2's "Operative/Procedure Reports," dated 6/7/21, the "Operative/Procedure Reports" indicated, ORN 3 entered the OR on 6/7/21, at 2:23 p.m. and exited at 3:28 p.m. ORN 3 reentered the OR at 3:46 p.m. and exited at 4:31 p.m. ORN 5 entered the OR at 3:27 p.m. and exited the OR at 3:48 p.m. ORN 3 documented "n/a" (not applicable) in the section where initial instrument counts should be, indicating counts were not done before Pt 2's surgery. There was no documentation of counts done when ORN 5 entered the OR and ORN 3 left the OR.

During an observation on 8/31/22, at 10:04 a.m. in Operating Room one, Pt 36's surgery was observed for a surgical tracer (are designed to follow the care experiences that a patient had while receiving services from the organization). ORN 4 performed counts of softs (sponges) and needles with Surgical Technician (ST- an allied health professional who assists the surgeon during surgical procedures) 5. ORN 4 and ST 5 did not count surgical instruments before, during or after the surgery. VEN 1 wrote measurements (sizes of femur [thigh bone], tibia [larger of the two bones between the knee and ankle] and patella [kneecap-small triangular bone that is in the front of the knee]) on the white board (a wipeable board for nonpermanent markings used to track items used during surgery, visible to all staff in the OR room) .

During a concurrent interview and record review on 8/31/22, at 1:20 p.m., with ORN 4, Quality Registered Nurse (QRN) 2, Director of Surgical Services (DSS), and Nurse Manger Outpatient Surgery Center (MGR) 5, the facility's policy and procedures (P&P) titled "General Perioperative Count Sheet", "Counts: Prevention of Retained Surgical Items", and "Circulating Team Member Responsibilities" were reviewed. ORN 4 stated, he primarily worked with orthopedic surgeries (procedure concerned with the correction or prevention of deformities, disorders, or injuries of the skeleton). ORN 4 stated, his responsibility in the operating room (OR) was to be a patient advocate, document in the patient's Electronic Health Record (EHR), and to maintain flow of room. ORN 4 stated, the EHR, and white board was used to document counts during a surgery. ORN 4 stated, the "General Perioperative Count Sheet" was not used to document surgical instruments in orthopedic surgeries. ORN 4 validated that the "Perioperative count sheet" was not used in Pt. 36' surgery procedure. ORN 4 stated, vendors were present in most orthopedic surgeries. ORN 4 stated, vendors brought in prepackaged hardware for the surgeon to utilize in their surgeries. ORN 4 stated, VEN 1 was the vendor expert during Pt 36's surgery. ORN 4 stated, the nurses did not count or document the instruments or items from vendors. ORN 4 stated, he did not count what the vendor had brought in for the surgery because that was not what their facility did. ORN 4 stated, he allowed the vendors to write on the white board to keep track of what size of artificial patella was used on the patient. ORN 4 stated, the information on the white board was erased after the surgery. ORN 4 stated, there were three surgical counts in a surgical case. ORN 4 stated. the initial count was the count that was done before the surgery started. ORN 4 stated, the second surgical count was called first count which occurred when a patient's cavity was being closed. ORN 4 stated, the third surgical count was called the final count which was done when the skin was closed. ORN 4 stated, the hospital EHR did not have a place to document the quantity (amount) of surgical instruments. ORN 4 stated, the EHR only allowed an entry of yes, no, or not applicable (n/a-not available, not assessed, or no answer).

During a review of Pt 36's "Operative/Procedure Reports," dated 8/31/22, the "Operative/Procedure Reports" indicated, Pt 36 had no x-ray after the implant was placed, and "n/a" was documented under instrument counts for the initial count, first count and final count.

During a review of the facility's policy and procedure (P&P) titled, "Circulating Team Member Responsibilities," dated 4/20, the P&P indicated, the responsibility of the circulating nurse was to ensure all instruments, sharps and sponge counts are correct, to keep traffic to a minimum, to remain in room during the procedure, and to perform necessary counts and to write count on white board.

During an interview on 8/31/22, at 1:30 p.m., with Director of Surgical Services (DSS), the DSS stated, it was up to each circulating nurse if the vendor used the white board in the OR. DSS stated, after the retained patella protector incident on 6/7/22, the vendor kept track of information on the white board before it was erased. DSS stated, staff did not count everything in the trays. DSS stated, staff only counted certain items depending on the type of surgery performed. DSS stated, the facility followed Association of PeriOperative Registered Nurses (AORN- leader in advocating for excellence in perioperative practice and healthcare) guidelines for the OR (operating room) standards of care. DSS stated, there were gaps in surgical counts.

During an interview on 8/31/22, at 2:43 p.m., with MD 3, MD 3 stated, surgical counts were completed by the ST and the ORN at the beginning of the surgical case, closing of a cavity and suturing of the skin. MD 3 stated, the ORN informed the surgeon (MD 3) of the count result. MD 3 stated, he would not leave the OR if the count was not correct, .

During an interview on 8/31/22, at 2:55 p.m., with Patient Coordinator (PC) 3, PC 3 stated, surgical counts were not be done for orthopedic, extremity, laparoscopic (an operation performed in the abdomen or pelvis using small incisions (usually 0.5-1.5 cm) with the aid of a camera), head and neck surgeries. PC 3 stated, vendors brought in trays with surgical instruments for procedures. PC 3 stated, the contents of the trays were unknown to OR staff. PC 3 stated, the ORN used the "General Perioperative Count Sheet" during a case for the instruments on the table. PC 3 stated, the "General Perioperative Count Sheet" was discarded after the patient had left the OR.

During a concurrent interview and record review on 9/1/22, at 1:00 p.m., with ST 3, Pt 2's "Operative/Procedure Report," dated 6/7/21 was reviewed. The "Operative/Procedure Report" indicated, Pt 2's first surgery had nine people in the OR, including two vendors. ST 3 stated, there were two vendors during Pt 2's surgery on 6/7/21 because the patella protector was new to the hospital. ST 3 stated, one vendor oversaw the instrumentation and one vendor oversaw the robot system. ST 3 stated, the order of the surgery was for the surgeon to open the femur, tibia, and lastly the patella. ST 3 stated, the patella was opened first for Pt 2's surgery which was a different order. ST 3, stated her role was to maintain sterile technique and performing surgical counts with the circulating nurse. ST 3 stated the counts were done before the patient enters the room, before the surgical incision and final count which was upon closure of the patient's skin. ST 3 stated, sponges, needles, and softs were the only items counted in an orthopedic surgery. ST 3 stated, the circulating nurse was responsible to write on the white board, to document in the computer and on the paper what sponges, needles, and softs were used in a surgery. ST 3 stated, vendors were not allowed to write on the white board. ST 3 stated, she had not witnessed a vendor write on the white board.

During a review of the facility's P&P titled, "Scrub Team Member Responsibilities," dated 4/20, the P&P indicated, "... Special care is taken during total joint procedures to ensure all team members be aware of the components that are on the field and placed in the patient. This may be accomplished by using the count board to write the components opened ..."

During a concurrent interview and record review on 9/1/22, at 2:35 p.m., with Quality Registered Nurse (QRN) 1, Pt. 2's "Root Cause Analysis (RCA) Delta," dated 6/14/21 was reviewed. The "RCA Delta" indicated, "... Design flaw of the patellar protector, and the OR team still getting accustomed to [Specialized Robotic Surgery] cases, along with the fact that the protector was not include in the count process, contributed to the item being retained and causing potential harm to the patient ...ACTIONS: 1. Discontinue use of patella protector ... 5. If ever the patellar protector is requested in the future, it will automatically be a countable instrument ..." QRN 1 stated, the facility used RCA Delta to investigate Pt 2's retained patellar protector on 6/7/21. QRN 1 stated, this type of root cause analysis was done using staff that was not involved with Pt 2's surgery for an impartial investigation and plan of action based on the investigation outcome.

During a concurrent interview and record review on 9/1/22, at 6:30 p.m., with Manager of Quality & Accreditation (MQA), MQA stated, ORN 3 no longer worked at the facility and was not available for a reinterview. The facility's P&P for Vendors was requested for review. MQA provided an eleven-page document titled, "Facility Required Credentials," dated 9/1/22. The document was a report that was generated the day that a policy was requested. MQA stated, there was no other P&P regarding vendors in the OR.

During an interview on 9/2/22, at 10:58 a.m., with Chief Medical Officer (CMO), CMO stated he was aware of the RFOs (retained foreign object). CMO stated, staff were to follow all hospital policies and procedures and complete all hospital forms.

During a review of the facility's P&P titled, "Counts: Prevention of Retained Surgical Items," dated 7/18, the P&P indicated, "... Instruments will be counted on any case in which any major body cavity will be entered Counts are completed audibly and viewed concurrently by two individuals, one of whom is an RN. The counting should not be interrupted ... Instruments will be counted on any case in which any major body cavity will be entered ... All items that could conceivably be left in the body." The policy indicated the procedure for "... official counts are taken: Initially before the case starts ... Document on the instrument count sheet both initial sponges, sharp and instrument count ... At closures of a major body cavity ... At skin closure ... Extra counts may be taken at change of personnel for relief ... At least one of the original team must count with the relief person ... each time a cavity within a cavity is closed ... ALWAYS keep a running total ... Documentation : initial counts are recorded on the perioperative record and on the count board and instrument count sheet ... Any permanent change in staff requires a count. This was documented in the count section of the chart with staff names and time of counts ... Incorrect counts ... take another count immediately ... Notify the surgeon ..."

During a professional reference review retrieved from https://www.infectioncontroltoday.com/view/preventing-retained-surgical-items-team-effort titled, "Preventing Retained Surgical Items is a Team Effort," dated 3/31/17, the professional reference indicated, "... A retained surgical instrument is considered to be any item inadvertently left behind in a patient's body in the course of surgery. A Sentinel Event Alert from the Joint Commission in 2013 warned clinicians about the dangers of unintended retention of foreign objects (URFOs) - also called retained surgical items (RSIs) - after invasive procedures. Depending on the type of object retained and the length of time it is retained, these RSIs can cause infections and death, and surviving patients may sustain both physical and emotional harm ... advised that perioperative personnel document the results of counts of surgical items, instruments ..."

During a professional reference review retrieved from https://aornguidelines.org/tool/content?gbosid=394149 titled, "Key Takeaways," dated 9/22, the professional reference indicated, all members of the surgical team are responsible for the prevention of unintentionally retained surgical items, minimize distractions, using a standardized process for surgical counts, using adjunct technology devices to supplement manual counting procedures for soft goods, such as the use of x-rays or adjunct technology to verify there are no unintended items in the operative field, and use a systems approach to performance improvement for prevention of unintentionally retained surgical items.

During a professional reference review retrieved from https://ortoday.com/seamless-making-vendors-part-of-the-perioperative-team-to-ensure-positive-outcomes/ titled, "Seamless: Making Vendors Part of the Perioperative Team to Ensure Positive Outcomes," dated 2/1/13, the professional reference indicated, "... that it recognizes the need for a structured process for education, training and introduction of procedures, techniques, technology and equipment to health care professionals practicing within the perioperative setting ... Operating room nurses have ultimate responsibility for patient care, they are responsible for the safety of the patient and are the patient's advocate at all times ... it's critical that OR nurses make sure that health care industry representatives understand operating room protocol to ensure that patient safety is never compromised ..."