HospitalInspections.org

Based on observation, record review and interview, facility staff failed to validate endoscope cleaning prior to high level disinfection in 1 of 1 endoscope cleaning observed (Patient #7), in a total sample of 1 high level disinfection procedure observed.

Findings include:

Review of facility policy "Cleaning and High Level Disinfection of Flexible and Rigid Endoscopic Equipment and Accessories Procedure" dated 4/11/2022 revealed "3.5. Validation of cleaning procedure: Perform and document validation of cleaning procedure on all GI [gastrointestinal] endoscopes. Use facility approved product (i.e. ChannelCheck, Endocheck, Protein Check)."

Review of "Instructions for Use: ChannelCheck" dated 6/2021 revealed "Steps for Use of Product: ...4. Dip Test Strip into Water: Dip the test strip into the recaptured water ensuring all 3 pads are completely immersed. Keep test strip immersed for 5 seconds. 5. Dab Side of Test Strip: Remove test strip from water. ...6. Wait 90 seconds. The reagents in the test pads require time to interact with the residual soil. Wait a complete 90 seconds before reading the results."

Review of the facility's "Endoscopy Competency GI Unit," used to evaluate staff competency in endoscopic procedures and tasks, revealed "Channel Check Procedure: ...5. Dip and swish test strip in water for 10 seconds. 6. Wait 90 seconds before reading results. 7. Compare to color chart..."

During observation of endoscope high level disinfection on 4/12/2022 at 10:00 AM, Surgical Technician D used a ChannelCheck strip after performing scope cleaning and flushing, prior to placing the endoscope into the Medivator [automated machine] for high level disinfection. Technician D flushed water through the endoscope channel into a small bag, swished the ChannelCheck strip in the water for 30 seconds, removed the strip and immediately read the results before throwing the strip in the garbage bin. Technician D did not immerse the strip for 5 seconds then wait 90 seconds before reading the results per manufacturer instructions. Technician D did not compare the strip to a color chart to interpret the results of the test.

During an interview at the time of the observation, Technician D stated "we swish the strip for 30 seconds." When asked how the results of the test were determined, D stated "it's good if it looks the same. It looks the same, just wet."

During an interview on 4/12/2022 at 10:25 AM, Logistics Coordinator F stated Technician D "didn't wait 90 seconds... staff sometimes will do other things while they wait the 90 seconds, but [Technician D] threw the strip away, it shouldn't be thrown away" before the results can be read after the 90 seconds.

Based on record review and interview, facility staff failed to develop and implement a process for monitoring high level disinfection (HLD) quality assurance documentation and failed to perform audits of HLD practices in 4 of 4 departments (Surgical Services, Outpatient Cardiology, Radiology, Women's Health), in a total sample of 4 departments performing HLD of semi-critical equipment.

Findings include:

Review of facility policy "Cleaning and High Level Disinfection of Flexible and Rigid Endoscopic Equipment and Accessories Procedure" dated 4/11/2022 revealed "3.7. Scopes that are not able to be put in an AER [Automated Endoscope Reprocessor] should be manually HLD per manufacturer's instructions... a. Ensure quality testing of the disinfectant and the disinfectant test strips is done per manufacturer's instructions."

During an interview on 4/12/2022 at 9:05 AM, Director of Patient Care Services A stated "There was one day in February that the temperature of the Cidex [HLD solution] was recorded 3 degrees below what it was supposed to be. It's supposed to be 68 degrees and it was 65... it was not noted on the log sheet, how [the out of range temperature] was handled wasn't addressed." Per Director A, the HLD was performed on a TEE (transesophageal echocardiogram) scope in the outpatient cardiology clinic and the discrepancy was identified on 4/8/2022. Director A was unable to state what the process was for reviewing the quality assurance logs.

During an interview on 4/12/2022 at 10:45 AM, Cardiac Echo Technician G stated the TEE scopes were cleaned manually and the temperature and chemical test strip results of the disinfectant were logged with each use. When asked about oversight of the logs, Technician G stated "we [the technicians] would make sure" the log books were saved. Per G, the department has 7 technicians and Lead Technician H but "I'm not sure who was reviewing the logs." During an interview at the time of the observation, Director of Patient Care Services A stated "I would guess [Manager of Clinical Operations L] would be looking at the logs" but could not state who was responsible for oversight of the HLD process in the outpatient cardiology clinic.

The endoscopy suite and HLD processes in the surgical services department were observed on 4/12/2022 at 10:00 AM and HLD quality assurance log books were reviewed. During an interview on 4/12/2022 at 12:40 PM, when asked about the manager's role in reviewing logs and other quality control data related to HLD, Surgical Services Manager E stated the log books in endoscopy are "reviewed by the team."

The Trophon [HLD] machines for ultrasound probes (2 in Radiology, 1 in Women's Health) were observed on 4/12/2022 at 10:55 AM and HLD quality assurance log books were reviewed. During an interview at the time of the observations, Director A stated "we had some issues with the chemical strip lot numbers and expiration dates not being documented, we are looking at creating a log sheet for the Trophons instead of the books to make it easier for documenting and tracking." During an interview on 4/12/2022 at 12:50 PM, Quality Director I stated "we're implementing changes to the Trophon logs. The managers are expected to review the logs weekly and the Infection Preventionist will review them quarterly."

During an interview on 4/12/2022 at 12:30 PM, Infection Preventionist J stated if discrepancies on HLD quality assurance logs "are not caught in real time, it should be caught by the person doing it, or the manager, or when I look at the logs. It's a group effort, I would check them, but I would hope the manager and technicians would be involved." Infection Preventionist J stated that J had not completed audits of HLD since starting in the role of Infection Preventionist in October 2021.

Review of the facility's 2021 and 2022 Infection Prevention Plan revealed a risk priority for "Patient Safety: High Level Disinfection of Semi-Critical Medical Equipment" for the acute setting with an objective to "reduce rates of healthcare associated infections through appropriate use of high level disinfection for all semi-critical items used on non-intact skin or mucous membranes." Strategies include "4. Incorporate rounding on high-level disinfection records into normal infection prevention rounding." Those responsible for this risk priority measure include "direct patient care staff, patient care managers, infection prevention." The plan for oversight of HLD included the inpatient setting only, and did not include the outpatient clinic.