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

1. The hospital did not have an active and effective quality assurance and performance improvement (QAPI) program that selected and analyzed data and used the data and analyses for the reduction of risk of medical errors. (Refer to A 283 and A286)

2. The hospital did not have an effective Infection Control Program that ensured autoclaves and the Sterile Processing Department processed surgical instruments to the quality standards per nationally recognized standards; and did not track and monitor infection control practices throughout the hospital to reduce the risk of disease transmission. (refer to A749 and A750)

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were inspected, cleaned, processed and sterilized according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI an organization for advancing the development, and safe and effective use for medical technology) and AORN, an Immediate Jeopardy (IJ) situation was called with the Director of Perioperative Services (DPS), Director of Infection Prevention (DIP), Director of Regulatory and Compliance (DRC) and Medical Director (MD) on 11/30/22 at 2:35 p.m. under A-0749 CFR 482.42(a)(2). The DRC was provided the IJ template which documented the immediate actions necessary to address the IJ situation. The DRC was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 2 of the Action Plan was acceptable on 12/1/22 at 5:02 p.m. The following items were listed on the Action Plan and validated by the survey team: 1. All elective surgeries were stopped effective November 30, 2022 at 2:27 p.m. The Chief Medical Officer verbally communicated with affected surgeons at the time the decision was made to cancel all surgeries. A memo was sent on 12/1/22 to all surgery, emergency medicine, and inpatient medicine providers outlining: Only emergent surgeries can be performed, Emergent case criteria to be established by following clinical decision making and supported by appropriate documentation, and the surgeons were instructed to inspect the surgical trays and approve which instruments are acceptable for use in the surgery. 2. The Director of Surgical Services contacted the vendor and initial cleaning of the affected autoclaves began on 12/1/22 at 7 a.m. A second vendor was contracted for industrial cleaning which started on 12/1/22 at 2 p.m. with an expected completion time on 12/1/22 at 6 p.m. A certified sterile processing technician will validate the integrity of the sterilization process. 3. On 12/1/22 at 2 p.m., a multidisciplinary team consisting of the Program Specialist Educator for Perioperative Services, a certified SPD technician and Infection Preventionist conducted re-educations for all available Sterile Processing Technicians on the following: AAMI ST79, AORN Guidelines 2022, Infection Prevention, Decontamination, Inspection of Surgical Instruments, Tray Assembly & Management, Sterilization, Monitoring/Quality Assurance, Indicators, Integrators, Biologicals, Monitoring/Documentation, Policies & Procedures, Equipment, Sterilizers, Washer/Sterilizer, Ultrasonic. 4. Any associates not available 12/1/22 at 2 p.m. will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. 5. All Sterile Processing technicians, Surgical technicians and OB technicians will receive reeducation on how to properly inspect sterile instruments prior to use to ensure the integrity is intact on 12/2/22 at 7 a.m. The education will include a physical tray observation by the team to identify compromises to sterility. Any associates not available will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. Any associate that does not meet the required demonstration at 100% compliance will not be assigned to clean or handle instruments until successful remediation is completed. 6. Except for emergent cases, all sterile instruments have been removed from service effective 11/30/22. The removed instruments will be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects. All others Instruments in disrepair will be labeled and taken out of service until properly repaired or replaced. 7. A memo was provided on 12/1/22 , to all nursing leaders to conduct instrument integrity visual inspection prior to use in any bedside procedure. 8. Sterile Processing technicians began manual cleaning and polishing of the affected instruments on 11/30/22 after identification using Surgistain cleaning solution that was found to be effective in removing water marks and discoloration. Any marking tape and/or residue is also being removed from affected instruments. 9. The Director of Surgical Services contacted the vendor to be onsite on 12/6/22 to 12/8/22 to begin servicing instruments in need of repair and/or replacement. Subsequent onsite visits will be scheduled to complete additional instruments as needed. 10. The Director of Surgical services or designee, effective 12/2/22, will audit the cleanliness of the interior of autoclaves weekly for 90 days and monthly thereafter. If any areas of concern are found, a vendor will be scheduled for professional service cleaning at time of finding. Daily audits of instrument integrity will occur until professional cleaning is complete and instrument integrity is in compliance. 11. Professional cleaning service of the autoclaves will be conducted biannually or as recommended by the manufacturer (manual has been ordered and expected to arrive on 12/2/22) and professional cleaning service beginning on 12/1/22. 12. The Director of Surgical Services or designee will audit the integrity of one major tray and one random tray daily when operational for 30 days, weekly for 90 days, and then monthly thereafter beginning 12/2/22. If any tray is found to be out of compliance, an additional five trays will be inspected for any necessary corrections to include reprocessing and/or replacement. 13. The Infection Prevention team will conduct monthly audits beginning 12/22, of the SPD department with focus on instrument integrity and autoclave cleanliness and log verification. In addition, the Environment of Care Committee (EOC) conducts monthly EOC rounds and will inspect instruments in areas that maintain sterile instruments for use using a newly developed rounding tool. 14. A multidisciplinary team consisting of the Director of Surgical Services, Manager of Sterile Processing, Infection Preventionist, and the Program Specialist Educator for Perioperative Services will conduct a comprehensive audit created by a consultative Sterile Processing Specialist annually. 15. The Director of Surgical Services or designee will present data collected from monitoring activities to the Quality Committee of the Medical Staff monthly with the exception of July and December. 16. The Patient Care Executive (PCE) will update the balanced score cards for the Director of Surgical Services, Director of Infection Prevention and Director of Regulatory Compliance on 12/2/22, to include elements specific to the monitoring and compliance of audits pertaining to autoclave maintenance and sterile instrument integrity to be reviewed during monthly 1:1 with PCE. This will ensure the oversight and monitoring is occurring and any areas of concerns are addressed.

All items listed on the Action Plan were validated through observations, interview, and record review and the IJ was removed with the Chief Nursing Officer (CNO), DRC, DPS, and the DIP on 12/2/22 at 7:45 p.m.

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

Based on observation, interview and record review, the hospital failed to ensure three of three patients (Pt - Pt 25, Pt 26, and Pt 27) who were admitted to the Emergency Department for mental health symptoms were appropriately provided the level of observation for the risk of suicide. One staff was assigned to provide direct observation for the three patients instead of 1:1 observation for each patient.

These failures put patients and staff at risk for harm.

Findings:

During a concurrent observation and interview on 11/28/22 at 3:05 p.m., with the Director of the Emergency Department (DED), in the Emergency Department (ED) two patients (Patient [Pt] 25 and Pt 26) were observed on gurneys on opposite sides of a hallway with approximately 10 feet between the ends of the gurneys. On Pt 25's side of the hallway there was a patient room with the door closed and the curtain pulled back and a patient (Pt 27) could be observed through the window. In the hallway outside Pt 27's room next to the window was a hospital employee sitting in a chair which faced the direction of Pt 25 and 26. The DED stated these three patients are in ED on a 5150 hold (refers to the California Welfare and Institutions Code number [5150] -an involuntary psychiatric hold placed by law enforcement or a mental health professional for a person determined to pose a danger to themselves [DTS] or others [DTO], or if they are "gravely disabled" [GD] for the purpose of evaluation and treatment) and are awaiting placement at a different facility, and stated the employee was a Safety Attendant (SA) 1. On the table in front of SA 1 were three forms titled SAFETY ATTENDANT DIRECT OBSERVATION RECORD, one for each patient. The SA stated she was assigned to observe Pt 25, pt 26, and Pt 27 and document on the form every fifteen minutes. The DED stated one employee could observe all three patients as long as they were within their "line of sight."


During a concurrent interview and record review on 12/2/22 at 2 p.m., Pt 25's medical record was reviewed. The record indicated Pt 25 had been brought to the ED on 11/28/22 at 11:12 on a hold for suicidal ideation (SI- thinking about, considering, or planning suicide). Pt 25 was triaged as Emergency Severity Index level 2 (ESI- a five level scale used by triage nurses to indicate the seriousness of the patient's condition and the resources needed, ESI level 1 being the most serious). Review of medical record document titled "C-SSRS [The Columbia Suicide Severity Rating Scale, a tool to evaluate suicide risk] Lifetime/Recent-Adult" dated 11/28/22 at 11:45 a.m., indicated the assessment was completed on 11/28/22 at 11:45 a.m. but was not documented in the record until 11/29/22 at 10:09 a.m. The C-SSRS indicated Pt 25 had non-specific active suicidal thoughts two to five times a week lasting one to four hours and had a suicide attempt within the last three months. The C-SSRS did not indicate what the suicide risk level was, only that the risk level had not changed. The SAFETY ATTENDANT DIRECT OBSERVATION RECORD indicated on 11/28/22 starting at 12 p.m. until 7:15 p.m., SA 1 was responsible for observation of Pt 25. The record indicated on 11/30/22 at 10:09 a.m., Pt 25 was transferred to a facility for inpatient psychiatric care.


During a concurrent interview and record review on 12/2/22 at 2:05 p.m., Pt 26's medical record was reviewed. The record indicated Pt 26 had been brought to the ED on 11/28/22 at 10:36 am on a hold for SI. Pt 26 was triaged as ESI level 2. Review of medical record document titled "C-SSRS dated 11/28/22 at 10:50 a.m., indicated the assessment was completed on 11/28/22 at 10:50 a.m. and documented in the record on 11/28/22 at 2:39 p.m. The C-SSRS indicated Pt 26 had attempted suicide on 11/28/22 by cutting himself and was stopped by a friend. The C-SSRS indicated Pt 26 had active suicidal thoughts with intent to act once a week and had another previous suicide attempt by drowning one year ago. The C-SSRS did not indicate what the suicide risk level was. The SAFETY ATTENDANT DIRECT OBSERVATION RECORD indicated on 11/28/22 starting at 11:30 p.m. until 7:15 p.m., SA 1 was responsible for observation of Pt 26. The record indicated on 11/30/22 at 10:52 a.m., Pt 26 was transferred to a facility for inpatient psychiatric care.


During a concurrent interview and record review on 11/28/22 at 3 p.m., Pt 27's medical record was reviewed. The record indicated Pt 27 had been brought to the ED from a skilled nursing facility on 11/4/22 at 8:59 p.m. due to "out of control behavior." Pt 27 was triaged as ESI level 3. The record indicated Pt 27 had a history of mental illness and was also physically disabled. Review of the triage assessment dated 11/04/22 at 9 p.m. indicated the registered nurse was unable to complete the C-SSRS assessment because Pt 27 being "unable to answer or refused." The record indicated on 11/7/22 at 11 a.m. a social worker (SW 1) met with Pt 27 at bedside for a consult and to complete the C-SSRS. The SW was unable to complete the C-SSRS assessment because Pt 27 had "disorganized thoughts, speech was slurred and mumbled" and SW 1 provided Pt 27 with telephone numbers of a suicide prevention hotline. The record indicated on 11/7/22 at 3 p.m. SW 1 made a second attempt to complete the C-SSRS assessment, but Pt 27 was asleep and did not wake up when SW 1 attempted to wake Pt 27 up. The SAFETY ATTENDANT DIRECT OBSERVATION RECORD indicated on 11/28/22 starting at 7:15 a.m. until 7:15 p.m., SA 1 was responsible for observation of Pt 27. The record indicated the hospital was looking for placement for Pt 27 who was considered gravely disabled and unable to care for herself.


During an interview on 12/5/22 at 4:30 p.m. with the DED, the DED stated Pt 27 is on a hold because she is unable to care for herself. The DED stated Pt 27 also needs to be closely watched so she doesn't hurt herself because she has a medical condition causing her to have fragile bones. The DED stated she reviewed the medical record and stated the staff have not been doing regular risk assessments of Pt 27. The DED stated she is aware there is a C-SSRS tool available to be used on patients who are cognitively impaired. The DED stated she reviewed Pt 25's and Pt 26's records and stated the C-SSRS assessments do not indicate what the risk level was and their policy on suicide prevention indicated patients determined to be at high risk for suicide must have 1:1 observation, not just Line of Sight. The DED stated the electronic tool used to indicate the level of risk at the end of the assessment but now it does not for some reason. The DED stated there is not documentation by the RN to indicate the patient was not at high risk.


During a review of the hospital's policy and procedure (P&P) titled SUICIDE PREVENTION, dated 4/22/20, the P&P indicated, "The [C-SSRS] scale identifies specific behaviors which may be indicative of an individual's intent to complete suicide. An individual exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide...Interventions for High Risk: Patient Safety Attendant for constant 1:1 observation of the patient...For patients who are unable to answer or refuse, the patient shall be considered high risk until the screen can be completed..."

Based on interview and record review, the hospital failed to provide evidence of documentation of completed background checks (an investigation of a person to identify criminal history) for two of fifteen sampled staff members (Emergency Room Registered Nurse (RNED) 3 and Sterile Processing Technician (SPT) 2.

These failures had the potential to allow persons with a criminal history to work in the hospital and not provide a safe environment for care. and not ensure patients the right to be free from all forms of abuse or harassment.

Findings:

During a concurrent interview and record review on 12/1/22, at 10:13 a.m., with the Human Resource Partner (HR 1), RNED 3 and SPT 2's personnel files were reviewed. RNED 3's date of hire was 1/1/98, and SPT 2's date of hire was 9/11/86. When HR 1 was asked to provide clearance documentation of the background check on RNED 3 and SPT 2, HR 1 stated, there was no documentation of the background check on RNED 3 and SPT 2. HR 1 stated the hospital transitioned to electronic (digital records) and all background checks conducted prior to 2013 were done differently. HR 1 stated the hospital was unable to locate the background check paper format documents for RNED 3 and SPT 2. HR 1 stated a complete personnel file should include documentation of a cleared background check on all staff members, but did not for RNED and SPT 2.

During an interview on 12/5/22, at 5:00 p.m., with the Chief Nursing Executive (CNO), CNO stated, the purpose of conducting background checks was to make sure the hospital did not hire individuals with felonies (a serious crime that can be punished by more than one year in prison) or anyone with a drug abuse history in order to provide a safe working environment for staff and patients. CNO stated the Human Performance Department (HD) was responsible to ensure background checks were completed and obtained on all employees hired. CNO stated HD should have notified RNED 3 and SPT 2 and/or any staff member without documentation of a cleared background check that a background check was to be conducted electronically in order to complete their personnel file.

During a review of the hospital's employee handbook section titled, "Employment Screening Policy," undated, the section indicated, "Human Performance (HP) coordinates all pre- and post-employment screening for [BRAND NAME] Health ... These processes commence after the contingent offer of employment is extended to an applicant. Employment will not commence until satisfactory drug screening, background checks ... Multi County Criminal: Performs run on counties applicants listed on the release form, including counties of past residence for a period of up to seven years. Federal Criminal History: Checks district courts for any crimes committed in violation of federal law in district of current residence ... "

Based on observation, interview and record review, the hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when there was no effective oversight or monitoring for the cleanliness of autoclaves or surgical instruments (refer to A283 and A749)

These failures placed all surgical patients at risk for infection and serious harm.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for QAPI.

Based on observation, interview and record review, the hospital failed to set priorities for its performance improvement activities that included high-risk, high volume, or problem-prone areas when the Quality Improvement program did not collect and analyze data or perform monitoring activities in the Sterile Processing Department (SPD) to ensure professional standards of practice were followed.

These failures resulted in a situation where two of two autoclaves were not cleaned, sanitized and deep-cleaned in accordance with professional standards of practice and hospital policies and procedures; the inspection, cleaning, processing and sterilization of surgical instruments did not adhere to standards of practice and processed surgical instruments failed to meet quality standards; Sterile Processing Technicians were not provided training and inservices to ensure competency; managers and leadership staff provided no oversight and did not monitor the processing of surgical instruments and equipment in SPD. (cross reference A749)


Findings:

During a concurrent observation and interview on 11/29/22 at 3:15 p.m., with the Sterile Processing Manager (SPMG), in the pre- pack (clean area) of the SPD, the SPMG stated the hospital has two industrial autoclaves. Autoclave 1 and Autoclave 2 were inspected with SPMG in attendance. SPMG confirmed Autoclave 1 and Autoclave 2 had rust and black colored stains around the door frames, inside door surfaces, and sanitizing chambers. The sterilizer carts was positioned next to the autoclaves and was observed to have rust colored stains on the upper panels. SPMG stated the autoclaves and sterilizer cart should have no stains. The SPMG stated the autoclaves were 12 years old, and the last preventative maintenance was performed on 10/25/22, but she was not aware if the autoclave chamber was inspected and cleaned. The SPMG stated the SPTs' were responsible to clean the autoclaves and sterilizer carts.

During a concurrent observation and interview on 11/30/22 at 9 a.m., with the Director of Perioperative Services (DPS), and the Director of Infection Prevention (DIP) in the clean area of SPD, Autoclave 1 and Autoclave 2 were observed to have rust and black colored stains around the door frames, inside door surfaces, and sanitizing chambers. The DPS stated the autoclaves should have no stains, and she was not aware of the condition of Autoclave 1 and Autoclave 2 until this inspection. The DPS stated she did not do a Quality Assurance (QA- a systematic process to determine whether a product or services meets specified requirements) on the autoclave. The DPS stated it was difficult to have the time to check the autoclaves. The DPS stated "We have not performed deep cleaning for the autoclaves for a long time." The DPS stated the hospital followed AAMI and AORN standards. The DIP stated she conducted her audit in 3/2022 in preparation for the accreditation survey by an outside agency, and she did not inspect the inside of the autoclaves because they were in use. The DIP stated the dirty and unsanitary condition of the two autoclaves was a concern.

During a concurrent observation and interview, on 11/19/22, at 3:15 p.m., with SPT 3, in the pre and pack area of SPD (clean area where surgical instruments are inspected prior to autoclave), one thyroidectomy (is surgical removal of the thyroid gland) set (set of instruments used for thyroid surgical procedure) sterilization container filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the SPMG. SPT 3 was observed inspecting surgical instruments. SPT 3 was not able to verbalize what he was inspecting on the surgical instruments and did not check the sharpness of the scissors until he was prompted by the SPMG. SPT 3 stated he was inspecting for stains, defects, cleanliness, and should have check the scissors for sharpness, but did not. SPT 3 was not able to identify surgical instruments with rust colored stains, and stated it was acceptable, not until the rust colored stains was pointed out to him by Health Facilities Evaluator Nurse (HFEN). The following concerns were identified upon observation of the surgical instruments: in the thyroidectomy tray 23 of 70 instruments contained the following: 11 instruments had rust colored stain, 8 were discolored, one had an adhesive tape, one had adhesive residue, one scissor not aligned, and one did not open properly. The SPMG stated the previously cleaned and sterilized surgical instruments should be free from stains and discoloration. The SPMG stated the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During a concurrent observation and interview, on 11/29/22, at 4:49 p.m., with the DPS, the 11 instruments with rust colored stain, 8 discolored, one had an adhesive tape, one had adhesive residue, and two not properly functioning was presented to the DPS. The DPS stated the identified instruments were not acceptable and would be disposed.

During a concurrent observation and interview on 11/30/22, at 11:14 a.m., with SPT 3, in the pre pack area of SPD, one minor (set of instruments used for short surgical procedure) sterilization container filled with multiple previously cleaned and sterilized surgical instruments was inspected, in the presence of DPS. SPT 3 was observed inspecting surgical instruments. The following concerns were identified upon observation of the surgical instruments: in the minor tray 20 of 54 instruments contained the following: 20 instruments had rust colored stains, one was discolored, three with nicks, two with adhesive, and one scissor squeaked and needed lubrication. The DPS stated the previously cleaned and sterilized surgical instruments should be free from stains and discoloration. The CST stated the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During a concurrent observation and interview, on 11/30/22, at 11:20 a.m., with SPT 3, in the pre and pack area of SPD, one major sterilization tray (collection of reusable surgical instrument used during complex surgery) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the DPS. SPT 3 was observed inspecting the surgical instruments. The following concerns were identified upon observation of the surgical instruments: in the major tray 39 of 77 instruments contained the following: 34 instruments had rust colored stains, two instruments were discolored, and one with indentation. The DPS stated the previously cleaned and sterilized surgical instruments should be free from stain and discoloration and the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.


During an interview on 12/1/22 at 4:30 p.m., with the Sterile Processing Manager (SPMG), the SPMG stated she did not inspect the autoclaves for cleanliness and did not have a process to monitor the condition of the autoclaves per manufacturer's instructions. The SPMG stated the SPTs did not receive appropriate step by step training on how to clean the autoclaves. The SPMG stated the hospital policy and procedure on the autoclave maintenance did not indicate the process on how to clean the autoclaves.

During an interview on 12/2/22, at 1:10 p.m., with the Director of Infection Prevention (DIP), the DIP stated the rust and black colored stains discovered on the two autoclaves in the SPD clean area were her responsibility, and it was a lack of oversight from her and the SPD management that allowed the stains to go undiscovered. The DIP stated the autoclaves should have been clean to prevent infection.

During an interview on 12/5/22, at 3:13 p.m., with the Director of Perioperative Services (DPS), the DPS stated it was the lack of oversight from management and the lack of training for the SPTs' that led to the issues of the autoclave, the sterilizer carts, and the surgical instruments. The DPS stated the Sterile Processing Technicians (SPTs) did not identify the issues, and she did not inspect and did not have a process to monitor the condition of the autoclave, sterilizer carts and surgical instruments.

During an interview on 12/5/22, at 4:56 p.m., with the Chief Nursing Officer (CNO), the CNO stated the SPT, the Sterile Processing Manager, the DPS, the Director of Infection Prevention, and CNO were all responsible to keep the autoclave clean according to manufacturer's recommendations. The CNO stated they did not perform quality audits on the autoclave and surgical instruments, as expected.

Based on observation, interview and record review, the hospital failed to have an active hospital-wide Infection Control and Prevention program that demonstrated adherence to nationally recognized infection prevention and control guidelines when:

1. The inspection, cleaning, processing and sterilization of surgical instruments did not adhere to Association of the Advancement of Medical Instruments (AAMI) and Association of periOperative Registered Nurses (AORN) guidelines and hospital policies and procedures. Two of two autoclaves in the Sterile Processing Department were visibly dirty and were not cleaned and deep cleaned per manufacturer's instructions. Processed sterile surgical trays were opened to observe quality and 65 of 201 surgical instruments were observed to be stained, have nicks and debris and not pass quality standards. The hospital did not employ a system of quality assurance and quality monitoring for the autoclaves and for the processing of surgical instruments. (refer to A749, Findings 1 and 3)

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were inspected, cleaned, processed and sterilized according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI an organization for advancing the development, and safe and effective use for medical technology) and AORN, an Immediate Jeopardy (IJ) situation was called with the Director of Perioperative Services (DPS), Director of Infection Prevention (DIP), Director of Regulatory and Compliance (DRC) and Medical Director (MD) on 11/30/22 at 2:35 p.m. under A-0749 CFR 482.42(a)(2). The DRC was provided the IJ template which documented the immediate actions necessary to address the IJ situation. The DRC was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 2 of the Action Plan was acceptable on 12/1/22 at 5:02 p.m. The following items were listed on the Action Plan and validated by the survey team: 1. All elective surgeries were stopped effective November 30, 2022 at 2:27 p.m. The Chief Medical Officer verbally communicated with affected surgeons at the time the decision was made to cancel all surgeries. A memo was sent on 12/1/22 to all surgery, emergency medicine, and inpatient medicine providers outlining: Only emergent surgeries can be performed, Emergent case criteria to be established by following clinical decision making and supported by appropriate documentation, and the surgeons were instructed to inspect the surgical trays and approve which instruments are acceptable for use in the surgery. 2. The Director of Surgical Services contacted the vendor and initial cleaning of the affected autoclaves began on 12/1/22 at 7 a.m. A second vendor was contracted for industrial cleaning which started on 12/1/22 at 2 p.m. with an expected completion time on 12/1/22 at 6 p.m. A certified sterile processing technician will validate the integrity of the sterilization process. 3. On 12/1/22 at 2 p.m., a multidisciplinary team consisting of the Program Specialist Educator for Perioperative Services, a certified SPD technician and Infection Preventionist conducted re-educations for all available Sterile Processing Technicians on the following: AAMI ST79, AORN Guidelines 2022, Infection Prevention, Decontamination, Inspection of Surgical Instruments, Tray Assembly & Management, Sterilization, Monitoring/Quality Assurance, Indicators, Integrators, Biologicals, Monitoring/Documentation, Policies & Procedures, Equipment, Sterilizers, Washer/Sterilizer, Ultrasonic. 4. Any associates not available 12/1/22 at 2 p.m. will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. 5. All Sterile Processing technicians, Surgical technicians and OB technicians will receive reeducation on how to properly inspect sterile instruments prior to use to ensure the integrity is intact on 12/2/22 at 7 a.m. The education will include a physical tray observation by the team to identify compromises to sterility. Any associates not available will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. Any associate that does not meet the required demonstration at 100% compliance will not be assigned to clean or handle instruments until successful remediation is completed. 6. Except for emergent cases, all sterile instruments have been removed from service effective 11/30/22. The removed instruments will be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects. All others Instruments in disrepair will be labeled and taken out of service until properly repaired or replaced. 7. A memo was provided on 12/1/22 , to all nursing leaders to conduct instrument integrity visual inspection prior to use in any bedside procedure. 8. Sterile Processing technicians began manual cleaning and polishing of the affected instruments on 11/30/22 after identification using Surgistain cleaning solution that was found to be effective in removing water marks and discoloration. Any marking tape and/or residue is also being removed from affected instruments. 9. The Director of Surgical Services contacted the vendor to be onsite on 12/6/22 to 12/8/22 to begin servicing instruments in need of repair and/or replacement. Subsequent onsite visits will be scheduled to complete additional instruments as needed. 10. The Director of Surgical services or designee, effective 12/2/22, will audit the cleanliness of the interior of autoclaves weekly for 90 days and monthly thereafter. If any areas of concern are found, a vendor will be scheduled for professional service cleaning at time of finding. Daily audits of instrument integrity will occur until professional cleaning is complete and instrument integrity is in compliance. 11. Professional cleaning service of the autoclaves will be conducted biannually or as recommended by the manufacturer (manual has been ordered and expected to arrive on 12/2/22) and professional cleaning service beginning on 12/1/22. 12. The Director of Surgical Services or designee will audit the integrity of one major tray and one random tray daily when operational for 30 days, weekly for 90 days, and then monthly thereafter beginning 12/2/22. If any tray is found to be out of compliance, an additional five trays will be inspected for any necessary corrections to include reprocessing and/or replacement. 13. The Infection Prevention team will conduct monthly audits beginning 12/22, of the SPD department with focus on instrument integrity and autoclave cleanliness and log verification. In addition, the Environment of Care Committee (EOC) conducts monthly EOC rounds and will inspect instruments in areas that maintain sterile instruments for use using a newly developed rounding tool. 14. A multidisciplinary team consisting of the Director of Surgical Services, Manager of Sterile Processing, Infection Preventionist, and the Program Specialist Educator for Perioperative Services will conduct a comprehensive audit created by a consultative Sterile Processing Specialist annually. 15. The Director of Surgical Services or designee will present data collected from monitoring activities to the Quality Committee of the Medical Staff monthly with the exception of July and December. 16. The Patient Care Executive (PCE) will update the balanced score cards for the Director of Surgical Services, Director of Infection Prevention and Director of Regulatory Compliance on 12/2/22, to include elements specific to the monitoring and compliance of audits pertaining to autoclave maintenance and sterile instrument integrity to be reviewed during monthly 1:1 with PCE. This will ensure the oversight and monitoring is occurring and any areas of concerns are addressed.

All items listed on the Action Plan were validated through observations, interview, and record review and the IJ was removed with the Chief Nursing Officer (CNO), DRC, DPS, and the DIP on 12/2/22 at 7:45 p.m.

2. Systems were not in place to maintain a sterile environment in the Surgical Suite located at Hospital 2. Staff transported decontaminated, but not yet sterile, surgical instruments, out of the decontamination room through the sterile surgical corridor to the Sterile Processing Department where the autoclaves were located. (refer to A750)

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

Based on observation, interview and record review, the hospital's infection control and prevention program failed to employ methods for preventing and controlling the transmission of infections in accordance with policies and procedures, professional standards of practice and manufacturer's instructions in the Sterile Processing Department (SPD - the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place) when:

1. Six of Six Sterile Processing Technicians (SPT 1, SPT 2, SPT 3, SPT 4, SPT 5 and SPT 6) did not clean, sanitize and maintain two of two autoclaves (Autoclave 1 and Autoclave 2-is a machine that provides physical method of sterilization by killing bacteria, viruses, and spores) according to manufacturer's instructions for use (IFUs), standards as described by Association of Perioperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and hospital's policies and procedures; the hospital's policies and procedures reference AAMI and AORN standards. The condition of Autoclaves 1 and 2 were visibly dirty; door frames, inside door surfaces, and sanitizing chambers had rust and black colored stains. The SPTs did not have training and annual competencies for cleaning and maintaining the autoclaves per IFUs. There was no system in place to ensure quality assurance audits were performed to monitor the cleanliness of the autoclaves in accordance with manufacturer's instructions and AAMI and AORN standards.

2. SPTs did not clean, sanitize and maintain two of two sterilizer carts (Cart 1 and Cart 2 - medical equipment used to hold and transport surgical instruments for sterilization) in accordance with the hospital's policy and procedure. Carts 1 and 2 were visibly dirty and had rust colored stains on the upper panels.

3. SPT 3 did not inspect, clean and sterilize surgical instruments in accordance with the standards of practice as described in AAMI, AORN and hospital policies and procedures. Three of three processed surgical trays were opened and inspected for quality. Sixty-five of 201 surgical instruments had brown stains, nicks and other visible markings that did not pass quality standards. There was no system in place to ensure quality assurance audits were performed to monitor the quality of the processed and sterilized surgical instruments.

4. SPT 1 did not remove her dirty gloves, perform hand hygiene, and don new pair of gloves prior to moving from the sink area to the storage area.

These failures resulted in the potential for transmission of infections for patients undergoing surgical procedures in the hospital.

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were inspected, cleaned, processed and sterilized according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI an organization for advancing the development, and safe and effective use for medical technology) and AORN, an Immediate Jeopardy (IJ) situation was called with the Director of Perioperative Services (DPS), Director of Infection Prevention (DIP), Director of Regulatory and Compliance (DRC) and Medical Director (MD) on 11/30/22 at 2:35 p.m. under A-0749 CFR 482.42(a)(2). The DRC was provided the IJ template which documented the immediate actions necessary to address the IJ situation. The DRC was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 2 of the Action Plan was acceptable on 12/1/22 at 5:02 p.m. The following items were listed on the Action Plan and validated by the survey team: 1. All elective surgeries were stopped effective November 30, 2022 at 2:27 p.m. The Chief Medical Officer verbally communicated with affected surgeons at the time the decision was made to cancel all surgeries. A memo was sent on 12/1/22 to all surgery, emergency medicine, and inpatient medicine providers outlining: Only emergent surgeries can be performed, Emergent case criteria to be established by following clinical decision making and supported by appropriate documentation, and the surgeons were instructed to inspect the surgical trays and approve which instruments are acceptable for use in the surgery. 2. The Director of Surgical Services contacted the vendor and initial cleaning of the affected autoclaves began on 12/1/22 at 7 a.m. A second vendor was contracted for industrial cleaning which started on 12/1/22 at 2 p.m. with an expected completion time on 12/1/11 at 6 p.m. A certified sterile processing technician will validate the integrity of the sterilization process. 3. On 12/1/22 at 2 p.m., a multidisciplinary team consisting of the Program Specialist Educator for Perioperative Services, a certified SPD technician and Infection Preventionist conducted re-educations for all available Sterile Processing Technicians on the following: AAMI ST79, AORN Guidelines 2022, Infection Prevention, Decontamination, Inspection of Surgical Instruments, Tray Assembly & Management, Sterilization, Monitoring/Quality Assurance, Indicators, Integrators, Biologicals, Monitoring/Documentation, Policies & Procedures, Equipment, Sterilizers, Washer/Sterilizer, Ultrasonic. 4. Any associates not available 12/1/22 at 2 p.m. will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. 5. All Sterile Processing technicians, Surgical technicians and OB technicians will receive reeducation on how to properly inspect sterile instruments prior to use to ensure the integrity is intact on 12/2/22 at 7 a.m. The education will include a physical tray observation by the team to identify compromises to sterility. Any associates not available will complete just in time training provided by a certified SPD technician prior to the beginning of their shift. Any associate that does not meet the required demonstration at 100% compliance will not be assigned to clean or handle instruments until successful remediation is completed. 6. Except for emergent cases, all sterile instruments have been removed from service effective 11/30/22. The removed instruments will be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects. All others Instruments in disrepair will be labeled and taken out of service until properly repaired or replaced. 7. A memo was provided on 12/1/22 , to all nursing leaders to conduct instrument integrity visual inspection prior to use in any bedside procedure. 8. Sterile Processing technicians began manual cleaning and polishing of the affected instruments on 11/30/22 after identification using Surgistain cleaning solution that was found to be effective in removing water marks and discoloration. Any marking tape and/or residue is also being removed from affected instruments. 9. The Director of Surgical Services contacted the vendor to be onsite on 12/6/22 to 12/8/22 to begin servicing instruments in need of repair and/or replacement. Subsequent onsite visits will be scheduled to complete additional instruments as needed. 10. The Director of Surgical services or designee, effective 12/2/22, will audit the cleanliness of the interior of autoclaves weekly for 90 days and monthly thereafter. If any areas of concern are found, a vendor will be scheduled for professional service cleaning at time of finding. Daily audits of instrument integrity will occur until professional cleaning is complete and instrument integrity is in compliance. 11. Professional cleaning service of the autoclaves will be conducted biannually or as recommended by the manufacturer (manual has been ordered and expected to arrive on 12/2/22) and professional cleaning service beginning on 12/1/22. 12. The Director of Surgical Services or designee will audit the integrity of one major tray and one random tray daily when operational for 30 days, weekly for 90 days, and then monthly thereafter beginning 12/2/22. If any tray is found to be out of compliance, an additional five trays will be inspected for any necessary corrections to include reprocessing and/or replacement. 13. The Infection Prevention team will conduct monthly audits beginning 12/22, of the SPD department with focus on instrument integrity and autoclave cleanliness and log verification. In addition, the Environment of Care Committee (EOC) conducts monthly EOC rounds and will inspect instruments in areas that maintain sterile instruments for use using a newly developed rounding tool. 14. A multidisciplinary team consisting of the Director of Surgical Services, Manager of Sterile Processing, Infection Preventionist, and the Program Specialist Educator for Perioperative Services will conduct a comprehensive audit created by a consultative Sterile Processing Specialist annually. 15. The Director of Surgical Services or designee will present data collected from monitoring activities to the Quality Committee of the Medical Staff monthly with the exception of July and December. 16. The Patient Care Executive (PCE) will update the balanced score cards for the Director of Surgical Services, Director of Infection Prevention and Director of Regulatory Compliance on 12/2/22, to include elements specific to the monitoring and compliance of audits pertaining to autoclave maintenance and sterile instrument integrity to be reviewed during monthly 1:1 with PCE. This will ensure the oversight and monitoring is occurring and any areas of concerns are addressed.

All items listed on the Action Plan were validated through observations, interview, and record review and the IJ was removed with the Chief Nursing Officer (CNO), DRC, DPS, and the DIP on 12/2/22 at 7:45 p.m.

Findings:

1. During a concurrent observation and interview on 11/29/22 at 3:15 p.m., with the Sterile Processing Manager (SPMG), in the pre- pack (clean area) of the SPD, the SPMG stated the hospital has two industrial autoclaves. Autoclave 1 and Autoclave 2 were inspected with SPMG in attendance. SPMG confirmed Autoclave 1 and Autoclave 2 had rust and black colored stains around the door frames, inside door surfaces, and sanitizing chambers. The sterilizer carts was positioned next to the autoclaves and was observed to have rust colored stains on the upper panels. SPMG stated the autoclaves and sterilizer cart should have no stains. The SPMG stated the autoclaves were 12 years old, and the last preventative maintenance was performed on 10/25/22, but she was not aware if the autoclave chamber was inspected and cleaned. The SPMG stated the SPTs' were responsible to clean the autoclaves and sterilizer carts.

During a concurrent observation and interview on 11/30/22 at 9 a.m., with the Director of Perioperative Services (DPS), and the Director of Infection Prevention (DIP) in the clean area of SPD, Autoclave 1 and Autoclave 2 were observed to have rust and black colored stains around the door frames, inside door surfaces, and sanitizing chambers. The DPS stated the autoclaves should have no stains, and she was not aware of the condition of Autoclave 1 and Autoclave 2 until this inspection. The DPS stated she did not do a Quality Assurance (QA- a systematic process to determine whether a product or services meets specified requirements) on the autoclave. The DPS stated it was difficult to have the time to check the autoclaves. The DPS stated "We have not performed deep cleaning for the autoclaves for a long time." The DPS stated the hospital followed AAMI and AORN standards. The DIP stated she conducted her audit in 3/2022 in preparation for the accreditation survey by an outside agency, and she did not inspect the inside of the autoclaves because they were in use. The DIP stated the dirty and unsanitary condition of the two autoclaves was a concern.

During an interview on 12/1/22 at 10:31 a.m., with SPT 6, SPT 6 stated she had been an SPT in the hospital for 11 years. SPT 6 stated the autoclaves were cleaned once per week, and should have no stains. SPT 6 stated she verbally reported the rust and black colored stains on the autoclaves to SPT 2 (lead SPT). SPT 6 stated the problem in the SPD department was the lack of training, and no annual competencies were done for the SPTs' to improve their practice.

During an interview on 12/1/22 at 11:40 a.m., with SPT 2, SPT 2 stated she had been an SPT in the hospital for 30 years. SPT 2 stated she was aware of the rust and black colored stains on the autoclaves, and had notified SPD management numerous times, but nothing was done. SPT 2 stated the autoclaves should have been cleaned, and she was frustrated the SPD management did not take actions to clean the autoclaves. SPT 2 stated she did not receive training for her role as a Lead SPT, and did not have annual competencies done.

During an interview on 12/1/22 at 4:30 p.m., with the SPMG, the SPMG stated she did not inspect the autoclaves for cleanliness and did not have a process to monitor the condition of the autoclaves per manufacturer's instructions. The SPMG stated the SPTs' did not receive appropriate step by step training on how to clean the autoclaves. The SPMG stated the hospital policy and procedure on the autoclave maintenance did not indicate the process on how to clean the autoclaves. The SPMG stated it was her responsibility, the SPT, and the DPS to monitor the cleanliness of the autoclaves and the sterilizer carts. The SPMG stated the poor condition of the autoclaves could have damaged the surgical instruments. The SPMG stated if the surgical instruments were not sterilized according to quality standards, patients undergoing surgical procedures would be at risk of infection.

During an interview on 12/2 /22, 9:45 a.m., with SPT 5, SPT 5 stated he had been an SPT in the hospital for 12 years. SPT 5 stated it was his responsibility to clean the autoclaves weekly, but admitted he did not clean the autoclaves consistently each week. SPT 5 stated he did not receive appropriate training on how to clean the autoclaves, and did not identify the rust and black colored stains on the autoclaves.

During an interview on 12/2/22, at 1:10 p.m., with the DIP, the DIP stated the rust and black colored stains discovered on the two autoclaves in the SPD clean area was her responsibility, and it was a lack of oversight from her and the SPD management. The DIP stated the autoclaves should had been clean to prevent infection.

During an interview on 12/5/22, at 3:13 p.m., with the DPS, the DPS stated it was the lack of oversight from her, and the lack of training for the SPTs' that led to the issues of the autoclave, the sterilizer carts, and the surgical instruments. The DPS stated the SPTs' did not identify the issues, and she did not inspect and did not have a process to monitor the condition of the autoclave, sterilizer carts and surgical instruments.

During an interview on 12/5/22, at 4:56 p.m., with the CNO, the CNO stated she expected the cleaning of the autoclaves were included during the preventative maintenance according to manufacturer's instructions for use but it was not. The CNO stated "you don't know what you don't know." The CNO stated the SPT, the SPMG, the DPS, the DIP, and herself were responsible to keep the autoclave clean according to manufacturer's recommendations. The CNO stated the hospital staff did not perform quality audits on the autoclave and surgical instruments, and should have.

During review of the facility policy and procedure (P&P), dated 6/8/22, the "P&P" indicated, "To maintain an efficient and effective Department Specific Management Program ...The following sterile processing safety procedures apply to employees working in the Sterile Processing Department. Autoclaves and other high-pressure equipment will be operated only by authorized personnel who are properly trained ... Inspect all equipment returned to Sterile Processing for proper functioning. If proper operation is in question, notify facilities and/or Biomed ...

During a record review of the "Manufacturer's IFU for the autoclave [brand name]", undated was reviewed. The "Manufacturer's IFU for the autoclave" indicated, "Routine Maintenance ... Cleaning the chamber, Interior ...The Chamber interior is constructed of stainless steel and should be cleaned with nonchloric cleaner ... all surfaces have been designed for ease of cleaning, access and compatibility ... Stainless steel accessories (including loading [sterilizer] carts, transfer carriages, rack shelves, and trays) must be cleaned and maintained properly to ensure long life expected of this materials. Failure to maintain the stainless surfaces properly may result in discoloration and deterioration of those surfaces ...Preventative maintenance performed by factory-trained service representatives, using authorized parts and service techniques, is recommended ..."

During a review of the professional reference from https://www.aami.org/standards/ansi-aami-st79 the professional reference indicated, " ... 12.2 instructions manuals. The purchaser should require the sterilizer manufacturer provided a comprehensive instruction manual. The care and maintenance section of the manual should include, at a minimum, all information necessary to carry out the procedures recommended ... and should specify the frequency with which these procedures should be performed ... Routine care. Sterilizer should be inspected and cleaned daily according to the manufacturer's written IFU. Examples of item requiring daily care and/or cleaning are ... door gasket, the chamber drain screen, the internal chamber and external surfaces. Weekly or other prescribed inspection and cleaning should be performed as specified in the manufacturer's written IFU ...The manufacturer of the sterilizer should provide written IFU for preventive maintenance of the equipment. This maintenance should be carried out by a qualified individual. Particular attention should be given to the inspection, maintenance, and replacement of components subject to wear, such as recording devices (as applicable), filters, steam traps, drain pipes, valves, and door gaskets ... The maintenance program may be in-house or contracted with the equipment manufacturer or other qualified service company. Preventive maintenance and repair records should be retained ... Rationale: Malfunction of critical components can cause sterilization failures or failures of the sterilization parameter recording system. Sterilizer manufacturers generally recommend that preventive maintenance and repair records be maintained for the life of the equipment ..."

During a review of the professional reference from https://www.aorn.org/outpatient-surgery/articles/outpatient-surgery-magazine/2007/September/keys-to-maintaining-your-steam-autoclave, dated 10/2008, the professional reference indicated, " ...Steam sterilizers are the most prevalent sterilization devices in use today. They're also the most likely to be affected by errors of familiarity. Think about it. Your staff activates the steam autoclave, hears the reassuring whoosh of steam entering its chamber and moves on to prepare the next set of instrument packs. But do they really know what makes the device tick? Can they recognize potential problems before they jeopardize instrument sterilization and patient safety? Routine observation is key to keeping autoclaves running effectively, day after day, load after load. They require regular attention and constant maintenance. They'll provide years of quality service if you take the time to match your steam sterilizer's performance against the manufacturer's maintenance guidelines as well as universal ones ... Specific upkeep requirements vary based on the manufacturer's instructions and the sterilizer's type and age. There are, however, six basic maintenance tasks your staff should always perform ... a daily back flush and thorough cleaning of the chamber drain screens ... a cleaning of the inside of chamber according to the manufacturer's recommendation ... Establish your own policies and procedures for steam sterilizer maintenance. They should be driven by manufacturers' guidelines for service, preventative maintenance, inspection and quality controls, and AAMI standards. Sterilizer records must be kept according to your state's regulations. Document the personnel who maintain your autoclaves, how often they perform that upkeep and the methods they use ... Stay in tune with your staff's performance of autoclave maintenance. Constant monitoring can be as simple as firsthand observations made during regular passes through sterile processing or as involved as designing random audits to measure adherence to your facility's policy and procedures ... Above all, make sure staff is well trained and experienced ... Educate your sterile processing team on core competencies, re-demonstrate required skills, monitor their progress and test their steam sterilizer maintenance knowledge with random audits ..."

2. During a concurrent observation and interview on 11/29/22 at 3:15 p.m., with the Sterile Processing Manager (SPMG), in the pre-pack (clean area) of the SPD, Two sterilizer cart was positioned next to the autoclaves and was observed to have rust colored stains on the upper panels. SPMG stated the sterilizer carts should have no rust colored stains.

During an interview on 12/1/22 at 4:30 p.m., with the SPMG, the SPMG stated she did not inspect the autoclaves and sterilizer carts for cleanliness, and it was her responsibility, the SPT, and the DPS to monitor the cleanliness of the autoclaves and the sterilizer carts, and it was not done.

During an interview on 12/2/22 at 10:20 a.m., SPT 3 stated the autoclaves and sterilizer carts had rust colored stains. SPT 3 stated the autoclave and sterilizer cart should have been clean, and it was not done.

During a record review of the "Manufacturer's IFU", undated was reviewed. The "Manufacturer's IFU" indicated, "Routine Maintenance ...Stainless steel accessories (including loading [sterilizer] carts, transfer carriages, rack shelves, and trays) must be cleaned and maintained properly to ensure long life expected of this materials. Failure to maintain the stainless surfaces properly may result in discoloration and deterioration of those surfaces ..."

3. During a concurrent observation and interview, on 11/19/22, at 3:15 p.m., with SPT 3, in the pre and pack area of SPD (clean area where surgical instruments are inspected prior to autoclave), one thyroidectomy (is surgical removal of the thyroid gland) set (set of instruments used for thyroid surgical procedure) sterilization container filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the SPMG. SPT 3 was observed inspecting surgical instruments. SPT 3 was not able to verbalize what he was inspecting on the surgical instruments and did not check the sharpness of the scissors until he was prompted by the SPMG. SPT 3 stated he was inspecting for stains, defects, cleanliness, and should have check the scissors for sharpness, but did not. SPT 3 was not able to identify surgical instruments with rust colored stains, and stated it was acceptable, not until the rust colored stains was pointed out to him by Health Facilities Evaluator Nurse (HFEN). The following concerns were identified upon observation of the surgical instruments: in the thyroidectomy tray 23 of 70 instruments contained the following: 11 instruments had rust colored stain, 8 were discolored, one had an adhesive tape, one had adhesive residue, one scissor not aligned, and one did not open properly. The SPMG stated the previously cleaned and sterilized surgical instruments should be free from stains and discoloration. The SPMG stated the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During a concurrent observation and interview, on 11/29/22, at 4:49 p.m., with the DPS, the 11 instruments with rust colored stain, 8 discolored, one had an adhesive tape, one had adhesive residue, and two not properly functioning was presented to the DPS. The DPS stated the identified instruments were not acceptable and would be disposed.

During a concurrent observation and interview on 11/30/22, at 11:14 a.m., with SPT 3, in the pre pack area of SPD, one minor (set of instruments used for short surgical procedure) sterilization container filled with multiple previously cleaned and sterilized surgical instruments was inspected, in the presence of DPS. SPT 3 was observed inspecting surgical instruments. The following concerns were identified upon observation of the surgical instruments: in the minor tray 20 of 54 instruments contained the following: 20 instruments had rust colored stains, one was discolored, three with nicks, two with adhesive, and one scissor squeaked and needed lubrication. The DPS stated the previously cleaned and sterilized surgical instruments should be free from stains and discoloration. The CST stated the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During a concurrent observation and interview, on 11/30/22, at 11:20 a.m., with SPT 3, in the pre pack area of SPD, one major sterilization tray (collection of reusable surgical instrument used during complex surgery) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the DPS. SPT 3 was observed inspecting the surgical instruments. The following concerns were identified upon observation of the surgical instruments: in the major tray 39 of 77 instruments contained the following: 34 instruments had rust colored stains, two instruments were discolored, and one with indentation. The DPS stated the previously cleaned and sterilized surgical instruments should be free from stain and discoloration and the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During an interview on 11/30/22, at 9 a.m., with the DPS, the DPS stated "historically we did not do quality audits on surgical instruments. It was just the SPT doing the daily checking and packing of instruments."

During an interview on 11/30/22 at 11:10 a.m., with the DPS, the DPS stated the stain, adhesive and damage instruments should have been identified during washing, cleaning and inspecting the surgical instruments prior to sterilization to prevent the risk of infection to patients undergoing surgery.

During an interview on 12/1/22, at 10:31 a.m., with SPT 6, SPT 6 stated the surgical instruments should be inspected for stains, adhesive tapes, and defects during washing and cleaning, and prior to sterilization. SPT 6 stated the adhesive tape should have been removed prior to sterilization because bioburden (the number of bacteria living on a surface that has not been sterilized) would stay underneath the tape, and not get sterilized. SPT 6 stated the surgical instruments should have no stains or nicks ... SPT 6 stated the problem in the SPD department was the lack of training. SPT 6 stated annual competencies for the SPTs to improve their practice had not been done.

During an interview on 12/1/22 at 11:40 a.m., with SPT 2, SPT 2 stated the surgical instruments with rust colored stains, adhesive tape, and nicks, was not identified and were not acceptable. The surgical instruments with rust colored stains, adhesive tapes could harbor microorganism which increased the risk of infection to patients undergoing surgery. SPT 2 stated yearly training and competencies on inspecting surgical instruments for proper function and cleanliness had not been done.

During an interview on 12/1/22 at 4:30 p.m., with the SPMG, the SPMG stated the identified surgical instruments with stains, adhesive tape, nicks, and pitting were not acceptable to prevent compromising the sterility of the surgical instruments in the tray and to prevent infection. The SPMG stated the hospital did not have a standard process for surgical instrument inspection and did not provide annual competencies for SPTs'.

During an interview on 12/5/22, at 4:56 p.m., with the CNO, the CNO stated she expected the cleaning of the autoclave was included during the preventative maintenance according to manufacturer's recommendation but it was not. The CNO stated "you don't know what you don't know." The CNO stated the SPT, the SPMG, the DPS, the DIP, and herself were responsible to keep the autoclave clean according to manufacturer's recommendations. The CNO stated we did not perform quality audits on the autoclave and surgical instruments.

During a review of the facility's policy and procedure (P&P) titled, "Instruments, cleaning and disinfecting of," dated 6/8/22, the P&P indicated, "To explain the proper procedure for the cleaning of instruments ... Instruments are maintained clean as possible during the procedure. The cleaning of instruments shall begin during the surgical procedure to prevent drying of blood, soil, debris on the surfaces and within the lumens. The Perioperative team member in the scrub role should keep the instruments free of debris and blood during the surgical procedure ... Instruments should be wiped clean using sterile water ... Instruments recommended for manual cleaning are submerged ... in an appropriate detergent, cleaned beneath the surface of the water and rinsed ... Instruments are inspected for defects, proper function, and cleanliness after decontamination ...Instruments that contain moveable parts are lubricated with water-soluble lubricant as appropriate ..."

During a professional reference review from AAMI titled, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC Guidelines, and AORN guidelines, their recommendations, stipulated the following: "Instruments should undergo an inspection for proper function and cleanliness ...1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects. 2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

During a professional reference review from AORN Guidelines for "Perioperative Practice (2015), Recommendation X (p629) dated indicated, "Surgical instruments should be inspected and correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired. Items that are not clean or do not function correctly put a patient at risk for Injury or SSI (surgical site infection)..."

During a review of the facility document titled, "Sterile Processing Technician
(SPT)," dated 2022, the "SPT" indicated, "Job Summary. Process and sterilizes surgical and hospital instruments and equipment. Assembles surgical instrument sets and trays. Distributes patient care supplies and equipment ... Essential Functions ... Decontaminates and process instruments. Maintains a clean and orderly environment in the department ... Cleans the autoclave chambers on a weekly basis ... Evaluates instruments for function and safety when processing ..."

During a review of the facility documents titled, "Manager, Sterile Processing (MSP)," dated 2022, the "MSP" indicated, "Job Summary. Manages the Sterile Processing Department which provides services for Perioperative Services as well as the entire facility ... Develops and implements policies, procedures and, maintains quality assurance initiatives as required by external review agencies to ensure that established standards are maintained ... Essential Functions ... Monitors and coordinates all activities related to the production and distribution of case carts, Plans, directs, and coordinates activities involved in the acquisition, decontamination, storage, assembly, cleaning and sterilization of medical surgical and related supplies, materials, and equipment utilized in the care and treatment of patients and the operation of Sterile Processing ... Establishes and maintain ongoing in-service education program in the department ..."

During a review of the facility documents titled, "Director, RN (DRN)," dated 2022, the "DRN" indicated, "Job Summary. Provides overall supervision of nursing for patients care units. Maintains direct accountability for the financial, operational and mission performanc

Based on observation, interview and record review, the hospital failed to ensure systems were in place to maintain a sterile environment in the Surgical Suite located at Hospital 2. Staff transported decontaminated, but not yet sterile, surgical instruments, out of the decontamination room through the sterile surgical corridor to the Sterile Processing Department where the autoclaves were located.

This configuration resulted in the transport of non-sterile surgical instruments through an area meant to be sterile. This resulted in the potential transmission of infections to all patients undergoing surgical procedures in the operating room (OR).

Findings:

During a concurrent observation and interview on 11/30/22, at 10:15 a.m., in Hospital 2, Surgery Suite, with Chief Nursing Officer 2 (CNO 2), Infection Preventionist (IP 2) and Sterile Processing Technician 5 (SPT 5), SPT 5 stated a room across from operating room 1is used as a decontamination room for surgical instruments. A surgical corridor (an area of a surgical facility designated primarily for surgical cases and surgical support staff) separates the operating rooms and the decontamination room. SPT 5 stated sink and washer in the decontamination room is used to wash and clean instruments delivered from the operating rooms via the surgical corridor. SPT 5 stated clean instruments then are covered with towels, loaded into metal cart in the surgical corridor outside the room. SPT 5 stated the instruments are then transported outside the surgical suite to the clean processing room to be sterilized. CNO 2 stated the decontamination room located in the surgical suite is the only decontamination room in Hospital 2. CNO 2 stated potential for cross contamination exists as clean instruments are transported through surgical corridor to the clean processing room. IP 2 stated decontamination needs to be separate from sterile environment.

During a review of the Hospital 2's license (HL) and facility map (FM), dated 2018, the HL indicated the hospital was licensed for 3 operating rooms in a surgical suite. The FM indicated "Soiled Utility, 118" was the decontamination room across from "OR #1, 109". The facility map indicated "Corridor B" between the two rooms was part of the "Surgery Suite" and exited to "Corridor C Staff Entry". The facility map showed double doors between the two corridors showing the entrance to the "Surgery Suite." The facility map indicated next to "Corridor C ...", "Clean Supply" and "Autoclave 100."

During a concurrent interview and record review on 12/5/22, at 4:05 p.m., with the Health Care Access and Information Compliance Officer (HCAI), the HCAI stated the hospital needed to ensure it was complying with the California Building Code 1224.15 for surgical services areas. The HCAI stated the hospital could not have surgical instruments cleaned and decontaminated in one place and cross over a surgical corridor to another area of the hospital for reprocessing. The HCAI stated the area for reprocessing surgical needed to have the space adequate to store and reprocess in the same area to ensure codes were met. The "CALIFORNIA BUILDING CODE CHAPTER 12 - INTERIOR ENVIRONMENT", dated 2016, indicated, " ...1224.15 Surgical Service Space ...1224.15.1 General ...The surgical service space shall be divided into two designated areas: 1) semi-restricted areas (e.g. storage areas for clean and sterile supplies, sterile processing rooms, scrub stations, and corridors leading to restricted areas of the surgical suite, etc.); and 2) restricted areas (e.g. operating rooms, hybrid operating rooms, sterile procedure rooms, cardiac catheterization labs, etc.) that can be reached only through a semi-restricted area ... An operating room suite design with a sterile core shall provide for no cross traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas. The use of facilities outside the operating room for soiled/decontaminated processing and clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean/sterile without compromising universal precautions or aseptic techniques in either department ... 1224.39.3.2 Processing Room...1224.39.3.2.1 Dedicated processing room(s) for cleaning and decontaminating instruments shall be provided. The cleaning area shall allow for flow of instruments from the contaminated area to the clean assembly area and then to storage..."

During a concurrent interview and record review on 12/5/22, at 5:00 p.m., with the CNO, the FM was reviewed. The CNO stated the washing and cleaning the surgical instruments in the surgical suite and then transporting the instruments through the sterile surgical corridor to the sterile processing room resulted in potential contamination. CNO stated this could potentially result in infections and harm to patients.

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..."