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Based on observation, interview, record review, policy review and hospital job description review, the hospital failed to ensure the Supervisor of the central sterile processing department (CSPD, area designated to clean, prepare, sterilize [process that eliminates viruses and bacteria], store and track reusable medical and surgical instruments or equipment) had the certification required for that position and ensure the CSPD staff followed hospital policy regarding proper surgical instrument decontamination.

These failed practices had the potential to compromise the safety and health of all patients undergoing surgeries at the hospital. The hospital performed approximately 867 surgeries per month. The average number of trays processed in the CSPD per month was 10,043. The hospital census was 23.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 482.51 Condition of Participation: Surgical Services.

Based on observation, interview and review of the job description, the hospital failed to ensure that the Supervisor of the central sterile processing department (CSPD, area designated to clean, prepare, sterilize [process that eliminates viruses and bacteria], store and track reusable medical and surgical instruments or equipment) had the certification required for that position.

This failure had the potential to affect the quality of care and safety of all patients in the hospital. The hospital census was 23. The average number of trays processed in the CSPD for the past six months was 10,043.

Findings included:

Review of the hospital's document titled, "Supv, Sterile Processing Job Description," dated 04/17/23, showed that a Certified Registered Central Service Technician (CRCST, introductory certification for sterile processing professionals) certification was required for the position.

Review of Staff G's, Supervisor of CSPD, personnel file showed that Staff G did not have a CRCST certification.

During an interview on 04/19/23 at 10:55 AM, Staff G, Supervisor of CSPD, stated that he had been the supervisor for the day shift for one year and six months. He took the CRCST exam in 2015, but did not pass. He planned at some point to attend the class and retake the examination to get his certification, but did not know when he was going to do that.

During an interview on 04/19/23 at 2:43 PM, Staff GGG, Director of Peri-Operative (the time period of a patient's surgical procedure) Services, stated that Staff G, Supervisor of CSPD, had been studying and working on taking his test for his CRCST certification for several months. Her expectation was that Staff G would get his certification, but there was no time line set for completion.

During an interview on 04/20/23 at 8:20 AM, Staff M, Operating Room and CSPD Manager, stated that there was a class at the local community college for employees to prepare them to take the CRCST exam and become certified. The class included labs, was two days a week and lasted four months. At the end of the classes an exam was given, and if the student passed that exam they could take the CRCST exam and become certified. Staff needed to attend the classes and take the exam to ensure they had a good basic background in central sterilization processing to effectively perform their job, and understand how important it was for instruments to be sterilized and cleaned. Staff G, Supervisor of CSPD, did not have his CRCST certification.

During an interview on 04/19/23 at 1:30 PM, Staff III, Human Resources Business Partner, stated that Staff G, Supervisor of CSPD, did not have his CRCST certification.

Based on observation, interview, record review and policy review, the hospital failed to ensure Central Sterile Processing Department (CSPD, area designated to clean, prepare, sterilize [process that eliminates viruses and bacteria], store and track reusable medical and surgical instruments or equipment) staff followed hospital policy regarding proper surgical instrument decontamination.

This failure had the potential to affect the quality of care and safety of all patients in the hospital. The average number of instrument trays processed in the CSPD for the past six months was 10,043. The hospital census was 23.

Findings included:

Review of the hospital's undated policy titled, "Barnes Jewish West County Hospital - Central Sterile - Decontamination Area Procedures - Category/Central Sterile Processing Department," showed that the manufacturers' written recommendations for the cleaning and handling of the device will be followed. Every cannulated (thin hollow tube) instrument must be handled in the same manner: enzymatic solution (cleaning agent) must be applied directly to the inside of the cannulated instrument, allowed to soak for the recommended time, and a pipe cleaner ran completely through cannulation. Manufacturer's instructions for the correct soak time should be followed. After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil.

Review of the hospital's undated policy titled, "Barnes Jewish West County Hospital - Central Sterile - Assembly, Wrapping, and Packaging - Category/Central Sterile Processing Department," showed that staff were to remove damaged instruments for repair and document in the tracking system. There were no instructions on what staff were to do if they found an instrument with bioburden (the presence of disease causing organisms on a surface or item, inside a device, or in a portion of liquid before sterilization) while assembling or wrapping instrument trays.

Review of the hospital's untitled and undated document showed CSPD key performance indicators. The indicators measured were bioburden or condensate (liquid) in the instrument trays. There were five out of 29,160 trays identified as containing bioburden or condensate from 01/2023 through 03/2023. In 03/2023, the goal of 0.03% bioburden or condensate was not met. Five out of 9,416 instrument trays, (0.05% of their trays) had bioburden or condensate.

Review of the hospital's document titled, "Class Registration/Sign-In Sheet," dated 03/28/23 showed that 15 of 29 CSPD staff attended an in-service (training) by Stryker Mako on cleaning the Mako instruments.

Review of the hospital's document titled, "Stryker Mako THA Instrument Cleaning and Sterilization Guide," dated 04/2018, showed that during the instrument cleaning process, Mako Total Hip Application (Mako THA, set of surgical instruments designed for total hip replacement surgeries) instruments were fully immersed in an enzymatic solution and allowed to soak for a minimum of five minutes.

Observation on 04/18/23 at 9:20 AM, in the Decontamination Area of the CSPD showed Staff GG, Sterile Processing Technician, decontaminating two trays of Striker Mako THA instruments. She did not wash or soak the instruments in an enzymatic solution prior to placing them in the washer tray.

During an interview on 04/18/23 at 10:35 AM, Staff GG, Sterile Processing Technician, stated that everything was supposed to be touched by the enzymatic solution, whether the instruments were hand washed, soaked, or briefly dunked in the enzymatic solution.

Review of the hospital's document titled, "Karl Storz Endoscopy-America, Inc. Clickline and MiniClick Instruments Assembly Guide," dated 2014, showed that during the cleaning process, the Clickline and Miniclick (set of surgical instruments designed for endoscopic surgeries) instruments were completely immersed in an enzymatic cleaning solution. A syringe filled with the enzymatic solution was used to thoroughly clean the inner mechanisms of the instrument.

Observation on 04/18/23 at 9:50 AM, in the Decontamination Area of the CSPD, showed Staff HH, Sterile Processing Technician, decontaminating a tray of Karl Storz Endoscopy-America, Inc. Clickline instruments. She did not rinse or submerge all parts of the endoscopic instruments in enzymatic solution. She did not use a syringe filled with enzymatic solution or a pipe cleaner brush to clean the interior of the instruments.

Observation on 04/18/23 at 9:45 AM, in the Decontamination Area of the CSPD, showed Staff HH, Sterile Processing Technician, went over where the washer racks came from the assembly, wrapping, and packaging (clean) side of CSPD back to the decontamination area. There was a single pair of scissors that had been part of a tray of instruments and had a white substance on both blades of the scissors. The scissors had been sent back from the clean side of CSPD alone, there was no tray of instruments sent back with the scissors.

During an interview on 04/18/23 at 9:30 AM, Staff HH, Sterile Processing Technician, stated that she used the enzymatic solution like a detergent to help get "the hard stuff unstuck." If a dirty instrument was found on the clean side of CSPD, it would be sent back to the decontamination area to be cleaned.

Observation on 04/17/23 at 3:00 PM and on 04/18/23 at 9:35 AM, in the Decontamination Area of the CSPD, showed a clock with the time showing as 2:40.

Observation on 04/18/23 at 2:03 PM, in the Decontamination Area of the CSPD, showed Staff II, Sterile Processing Technician, placed a tray of clamps in enzymatic solution. Nine of the 15 clamps were not fully submerged in the enzymatic solution.

Observation on 04/18/23 at 2:15 PM, in the Decontamination Area of the CSPD, showed Staff II, Sterile Processing Technician, placed a tray of clamps in enzymatic solution. Nine of nine clamps were not fully submerged in the enzymatic solution.

During an interview on 04/18/23 at 2:30 PM, Staff II, Sterile Processing Technician, stated that she should have fully submerged the clamps in the enzymatic solution.

During an interview on 04/19/23 at 9:39 AM, Staff H, CSPD Lead Technician, stated that all pieces of instruments that could have been soaked in the enzymatic solution were soaked and totally submerged for up to five minutes. There was a clock in the decontamination area that staff could use to time the soaks. If an item was identified as dirty or contaminated on the clean side of CSPD, the whole instrument tray would have been sent back to the decontamination area. The whole tray should have been sent back to the decontamination area instead of just the single pair of scissors. She did not know how they were processing so many instrument trays with as few staff as they had. She did not know any way to shorten or have a short cut for the instrument cleaning or sterilization process. Any time an instrument tray was in the Operating Room (OR) and staff found anything that would compromise its sterility (e.g. a hole in the wrapper, bioburden on an instrument, condensate in the tray, etc.), the entire tray would be rejected and sent back to the decontamination area to be cleaned. CSPD received a tray every day from the OR with something wrong or compromised sterility. There was no set guideline for OR staff on what to do to assist CSPD staff in identifying what compromised the instrument tray, so CSPD staff had to "waste time trying to find what the issue was." There was no quality tracking in place for what caused a tray to be rejected by the OR. Staff H felt that tracking what caused the tray to have been rejected would have helped CSPD staff to quickly identify trends and fix the problems.

During an interview on 04/19/23, Staff G, Supervisor of the CSPD, stated that during the decontamination process, instruments were to be soaked in an enzymatic solution for three to five minutes. Instruments were inspected on the clean side of CSPD. If the OR found a problem with the instrument tray, they would call Staff G and send the tray to the decontamination area to be cleaned and reprocessed. Staff were required to fill out a Safety Event Management System (SEMS) report if they found a problem, take a picture and document the problem. The SEMS system did not differentiate between problems (hole in the wrap, missing instrument, etc.), but lumped all the rejected trays together. CSPD received rejected trays on average "a couple times a month." His main concern was "the turnover of trays." His expectation was that if staff found a dirty instrument while assembling or wrapping an instrument tray, they would send the whole tray back to the decontamination area, not just the single dirty instrument.

During an interview on 04/17/23 at 3:50 PM, Staff F, OR Assistant Nurse Manager, stated that they occasionally received dirty instruments. The tray with the dirty instrument would have been sent to CSPD to be reprocessed.

During an interview on 04/19/23 at 2:20 PM, Staff FFF, RN, stated that when OR staff found a tray with compromised sterility or dirty instruments, they called the CSPD and talked with Staff G, Supervisor of the CSPD, and they sent the whole tray to the decontamination area. She did not usually report unsterile/contaminated trays in SEMS if the issue was identified before the patient was present in the OR. She would have reported an unsterile/contaminated tray in SEMS if it was found after the patient was brought into the OR, or if it was discovered during the surgery. She did recall there was education in the daily huddles for OR staff to start the decontamination process prior to sending instruments to CSPD. Staff M, Manager of the OR and CSPD, went to CSPD to help with process improvement. Staff FFF stated that she did not have many issues with CSPD, but she heard that orthopedics had more issues with CSPD.

During an interview on 04/20/23 at 8:20 AM, Staff M, Manager of the OR and CSPD, stated that at the end of a surgery, OR staff would rinse and soak the instruments in an enzymatic solution and send the instruments to the decontamination area of the CSPD. Once there, instruments would be disassembled and cleaned. If instruments were cannulated, staff were to use a brush to clean the instrument's interior. If the manufacturers' instructions allowed, instruments were submerged in the enzymatic solution. There was a clock in the decontamination area to make sure staff were soaking the instruments for the required period of time. Bioburden could have been anything; tissue, bone, surgical cement, paper, hair, etc. Condensate was a tray that was found to be wet after being run through the sterilizer. Upon discovering a wet tray, the OR called down to CSPD, and CSPD staff opened several other trays from the load the wet tray was in. The wet tray and any other trays opened were reprocessed. Sometimes the whole load of trays were reprocessed if multiple wet trays or issues were found. If bioburden was found on an instrument during the assembly process in CSPD, the whole instrument tray, not just the dirty instrument, would have been sent back to the decontamination area to be cleaned again. In 03/2023, a vender from Stryker did an in-service on the Mako instrument cleaning. The Mako instruments were used in total hip replacements and total knee replacements. Some "stuff" was found in several instruments prior to the instruments being used on a patient. Staff M did not recall if the "stuff" was bioburden or cement.

During an interview on 04/19/23 at 2:45 PM, Staff GGG, Director of Peri-Operative Services, stated that if a dirty instrument was found on the clean side of CSPD, the instrument and the whole instrument tray would have been sent back to the decontamination area for cleaning and processing. If the dirty instrument was discovered in the OR, the nurse would contact Staff OO, Sterile Processing Technician, who was also in charge of Quality Assurance in CSPD. Staff OO would then start an investigation. In 03/2023, there was an uptick in Mako orthopedic instrument issue reports, so the vender was brought in to do an in-service with staff in the OR and CSPD on proper cleaning of the instruments. The most common type of bioburden was surgical cement that had dried on the instruments. She encouraged staff to report any problems with equipment or instruments in SEMS.


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