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Based on document review and interview, the facility failed to ensure staff followed their policy related to flexible scope cleaning and implementation of manufacturers procedure for delay in reprocessing for 13 of 13 medical records reviewed. (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13) See tag 0749


The cumulative effects of the above resulted in the facility inability to provide services in a safe manner.

Based on document review and interview, the facility failed to ensure staff followed their policy related to flexible scope cleaning and implementation of manufacturers procedure for delay in reprocessing for 13 of 13 medical records reviewed. (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13)

Findings include:

1. A review of policy titled "Flexible Scope Cleaning 2020-1" Visiting Policy" last reviewed/revised on 1/1/20 indicated the following: "...POLICY...will ensure that endoscopes are reprocessed in accordance with regulatory and expert guidelines. PURPOSE: Provide guidance for reprocessing of all types of reusable flexible endoscopes and accessories...III. A. Precleaning at the point of use. Precleaning should be performed at the point of use. Manual cleaning is performed at the bedside after each case to remove debris before bioburden can form before transport to cleaning area. Record of the procedure's end time and start time of manual cleaning will be marked on the patient's sticker. Recording these times will ascertain the reprocessing personnel how long the endoscope has been awaiting reprocessing to determine whether routine reprocessing according to manufacturer's recommendations is achievable, and if not, to implement the manufacturer's procedure for delayed processing. D. Manual Cleaning & Inspection: If the manual cleaning is not performed within the timeframe of the manufacturer's IFU (Instructions for Use), the scope cleaner will implement the manufacturer's procedure for delayed processing."

2. A review of an article provided by N3 (Manager of Endoscopy/Registered Nurse) on 12/19/23 that was written by the Infection Control Manager of Olympus titled "Delays in Endoscope Reprocessing...and the Biofilms Within", last updated on 9/22/23 indicated the following: "Introduction: In addition to the time commitment required by staff, there are time constraints that need to be adhered to in order to reprocess devices effectively. One such time constraint is the maximum time delay allowed by endoscope manufacturers between precleaning of the endoscope at bedside after the procedure has been completed and the start of leak testing and manual cleaning. Olympus mandates a maximum dwell time between precleaning and manual cleaning of 60 minutes. If the endoscope sits awaiting manual cleaning for over 60 minutes, then a delayed reprocessing or presoaking protocol must be performed in order for the device to be reprocessed effectively. Why does Olympus require a maximum of 60 minutes between steps and not 30 minutes, 90 minutes, or any other amount of time? The answer is multifaceted and includes input from the FDA (Food and Drug Administration), the process of reprocessing instruction validation, and the science behind biofilm formation. Studies show that patient infections have occurred when reprocessing was delayed. It is important to understand that reprocessing endoscopes as soon as possible after procedural use is essential. Endoscope reprocessing begins with precleaning at the bedside. Precleaning should be performed immediately after the end of the procedure. Transport to the reprocessing area and manual cleaning should begin as soon as possible once the endoscope has been precleaned. Failure to adhere to the endoscope manufacturer's reprocessing protocol and delaying the cleaning of endoscopes may compromise patient safety and lead to an infection control risk. Ideally, endoscope reprocessing should begin with precleaning immediately after removal of the endoscope from the patient cavity and continue with minimal disruptions throughout manual cleaning, high-level disinfection/sterilization and into storage. When reprocessing is delayed beyond 60 minutes, Olympus recommends performing an extended soaking procedure, often referred to as "presoaking" or "delayed reprocessing". Conclusion: Failing to keep accurate records of the time between precleaning and manual cleaning is not only a lapse in following reprocessing instructions but also a patient safety issue. The drying of organic debris and bioburden, even in the smallest amounts, can result in ineffective cleaning and disinfection of the endoscope and encourage growth of biofilms. Each facility should develop a method of documenting the time when reprocessing steps occur. In addition to documentation, communication needs to occur between staff members within the facility."

3. Review of patient #1's medical record indicated the following:
(A) The patient was admitted on 11/25/23
(B) The patient had a Bronchoscopy and bronchial washing on 12/3/23 with a start time of 12:45 p.m.
(C) The instrument used in the procedure was an Olympus BF-P190 Bronchovideoscope/ICU (Intensive Care Unit) with scope number #2752.
(D) The medical record lacked documentation of the procedure stop date and time. The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

A review of the endoscopy reprocessing log for Patient #1 indicated that the (AER) Automated Endoscope Reprocessor was started on 12/3/23 at 6:37 p.m. for the endoscope used for Patient #1.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing scopes and/or the manufacturer's IFU's.

4. Review of patient #2's medical record indicated the following:
(A) The patient was admitted on 12/1/23
(B) The patient had a Bronchoscopy and bronchial washing on 12/3/23 with a start time of 11:00 a.m.
(C) The instrument used in the procedure was an Olympus BF-1TH190 Bronchovideoscope/OR (Operating Room) with scope number #3387.
(D) The medical record lacked documentation of the procedure stop date and time. The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #2 indicated that the (AER) was started on 12/3/23 at 6:50 p.m. for the endoscope used for Patient #2.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing scopes and/or the manufacturer's IFU's.

5. Review of patient #3's medical record indicated the following:
(A) The patient was admitted on 12/1/23
(B) The patient had an ERCP (Endoscopic Retrograde Cholangiopancreatography) on 12/11/23 with a start time of 9:09 p.m. and a stop time of 9:45 p.m.
(C) The instrument used in the procedure was an Olympus TJF-Q190 Duodenovideoscope with scope number #2226548.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #3 indicated that the AER was started on 12/12/23 at 4:48 p.m. for the endoscope used for Patient #3. A time lapse of approximately 19 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

6. Review of patient #4's medical record indicated the following:
(A) The patient was admitted on 12/1/23.
(B) The patient had a Bronchoscopy with Endobronchial ultrasound with biopsy on 12/11/23 with a start time of 12:50 p.m. and a stop time of 3:08 p.m.
(C) The following instruments were used in the procedure which included: 1.) An Olympus BF-1TH190 Bronchovideoscope with scope number #2723430, 2.) An Olympus BF-P190 with scope number #2711687 and 3.) An Olympus UC180F with scope number #3930.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #4 indicated the following:
1.) Olympus BF-1TH190 scope number #2723430 the (AER) was started on 12/12/23 at 4:50 p.m., which indicated a time lapse of approximately 1.50 hours from end of procedure to start of AER.
2.) Olympus BF-P190 scope number #2711687 the (AER) was started on 12/13/23 at 10:11 a.m., which indicated a time lapse of approximately 44 hours from end of procedure to start of AER.
3.) Olympus UC180F scope number #3930 the (AER) was started on 12/13/23 at 10:12 a.m. A time lapse of approximately 44 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

7. Review of patient #5's medical record indicated the following:
(A) The patient was admitted on 12/12/23.
(B) The patient had a colonoscopy on 12/12/23 with a start time of 12:35 p.m. and a stop time of 1:10 p.m.
(C) The instrument used in the procedure was an Olympus CF-HQ190L Colonovideoscope with scope number #2874058.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #5 indicated that the AER was started on 12/12/23 at 5:03 p.m. for the endoscope used for Patient #5. A time lapse of approximately 4 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

8. Review of patient #6's medical record indicated the following:
(A) The patient was admitted on 12/12/23.
(B) The patient had a EGD (Esophagogastroduodenoscopy) with PEG (Percutaneous endoscopic gastrostomy) tube insertion on 12/12/23 with a start time of 11:17 a.m. and a stop time of 11:22 a.m.
(C) The instrument used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2858230.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #6 indicated that the AER was started on 12/12/23 at 5:13 p.m. for the endoscope used for Patient #6. A time lapse of approximately 6 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

9. Review of patient #7's medical record indicated the following:
(A) The patient was admitted on 12/6/23.
(B) The patient had an EGD with banding and EUS (endoscopic ultrasound) on 12/7/23 with a start time of 2:04 p.m. and a stop time of 3:49 p.m.
(C) An instrument that was used in the procedure was an Olympus GF-UCT180 Ultrasound Gastrovideoscope with scope number #7511192.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #7 indicated that the AER was started on 12/8/23 at 10:02 a.m. for the endoscope used for Patient #7. A time lapse of approximately 6 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

10. Review of patient #8's medical record indicated the following:
(A) The patient was admitted on 12/7/23.
(B) The patient had an EGD with stent removal on 12/7/23 with a start time of 4:51 p.m. and a stop time of 5:16 p.m.
(C) The instrument that was used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2511249.
(D) The bedside cleaning of the scope was completed on 12/7/23 at 5:20 p.m.
(E) The medical record lacked documentation of the date and time when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #8 indicated that the AER was started on 12/8/23 at 9:40 a.m. for the endoscope used for Patient #8. A time lapse of approximately 16.50 hours from completion of the bedside cleaning of the scope to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

11. Review of patient #9's medical record indicated the following:
(A) The patient was admitted on 10/16/23.
(B) The patient had an EGD/EUS on 10/16/23 at 2:44 p.m. and a stop time of 3:20 p.m.
(C) The instrument that was used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2858230.
(D) The bedside cleaning of the scope was completed on 10/16/23 at 2:58 p.m.
(E) The medical record lacked documentation of the date and time when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #9 indicated that the AER was started on 10/17/23 at 9:38 a.m. for the endoscope used for Patient #9. A time lapse of approximately 18 hours from completion of the bedside cleaning of the scope to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

12. Review of patient #10's medical record indicated the following:
(A) The patient was admitted on 10/16/23.
(B) The patient had an EGD/EUS/ERCP on 10/16/23 at 4:14 p.m. and a stop time of 5:33 p.m.
(C) One of the instruments that was used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2858271.
(D) The bedside cleaning of the scope was completed on 10/16/23 at 4:35 p.m.
(E) The medical record lacked documentation of the date and time when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #10 indicated that the AER was started on 10/17/23 at 9:53 a.m. for the endoscope used for Patient #10. A time lapse of approximately 17 hours from completion of the bedside cleaning of the scope to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

13. Review of patient #11's medical record indicated the following:
(A) The patient was admitted on 10/16/23.
(B) The patient had an EGD/colonoscopy on 10/16/23 at 1:22 p.m. and a stop time of 2:17 p.m.
(C) One of the instruments that was used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2611453.
(D) The bedside cleaning of the scope was completed on 10/16/23 at 1:42 p.m.
(E) The medical record lacked documentation of the date and time when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #11 indicated that the AER was started on 10/17/23 at 10:17 a.m. for the endoscope used for Patient #11. A time lapse of approximately 20 hours from completion of the bedside cleaning of the scope to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

14. Review of patient #12's medical record indicated the following:
(A) The patient was admitted on 11/2/23.
(B) The patient had an EGD/colonoscopy/ERCP on 11/2/23 at 3:09 p.m. and a stop time of 4:42 p.m.
(C) One of the instruments that was used in the procedure was an Olympus GIF-HQ190 Gastrointestinal videoscope with scope number #2611453.
(D) The medical record lacked documentation of the dates and times of the bedside cleaning of the endoscope along with when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #12 indicated that foam was applied to the scope on 11/2/23 at 4:15 p.m. and the AER was started on 11/3/23 at 10:20 a.m. for the endoscope used for Patient #12. A time lapse of approximately 18 hours from application of foam to the scope to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived at the decontamination area, how long the foam stayed on the scope, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

15. Review of patient #13's medical record indicated the following:
(A) The patient was admitted on 10/30/23.
(B) The patient had an EGD/EUS/colonoscopy on 10/30/23 at 6:17 p.m. and a stop time of 7:21 p.m.
(C) One of the instruments that was used in the procedure was an Olympus GF-UCT180 Ultrasound Gastrovideoscope with scope number #7511192.
(D) The medical record lacked documentation of the date and time when the endoscope was taken to the decontamination area.

The endoscopy reprocessing log for Patient #13 indicated that foam was applied to the scope but lacked documentation of the date and time the foam was applied. The log also indicated that the AER was started on 11/1/23 at 9:03 a.m. for the endoscope used for Patient #13. A time lapse of approximately 39 hours from end of procedure to the start of the AER.

The endoscopy reprocessing log lacked documentation of the date and time the endoscope arrived to the decontamination area, how long the Intercept foam stayed on the scope, whether the endoscope was soaked along with start and end times and the start time of the manual cleaning, therefore unable to determine if the facility followed their policy related to delay in reprocessing of endoscopy scopes and/or the manufacturer's IFU's.

16. During an interview with N1 (Endoscopy Reprocessing Technician) on 12/18/23 at approximately 11:37 a.m., N1 verified that the AERs were used after the manual cleaning of the endoscopes was completed. N1 verified that the endoscopes can only wait to be reprocessed up to 60 minutes per the manufacturer's guidelines.

17. During an interview with N3 on 12/18/23 at 11:45 a.m., he/she verified that the facility uses Olympus endoscopes and that if there was a delay in reprocessing endoscopes, then they would follow the manufacturer's guidelines based on the endoscope type.

18. During an interview with N3 on 12/19/23 at 11:30 a.m., N3 verified that there was no policy and procedure for the use of Intercept foam.

19. During an interview with N3 on 12/19/23 at 1:15 p.m., N3 verified that there was no log/record of dates/times when endoscopes arrived from bedside to the decontamination area and/or the manual clean date/time of endoscopes. N3 also verified that there was not always a date/time of bedside point of use cleaning of the endoscopes documented. N3 verified that there was no log/record of "Intercept" foam application/removal date/time and/or soak times of the endoscopes if there was a delay in reprocessing the endoscopes.

20. During an interview with N3 on 12/19/23 at approximately 2:30 p.m., N3 verified that the "Intercept Foam" usage on endoscopes trial started on 8/22/23 through 11/6/23. N3 verified that the trial of "Intercept" foam on endoscopes was stopped due to the facility running out of the foam. N3 verified that they would use the "Intercept" foam on those endoscopes that would have been over an hour before they would be reprocessed. After the use of the foam and when the endoscope was ready to be reprocessed the endoscope would be soaked based on the manufacturer's guidelines.

21. During an interview with N3 on 12/19/23 at 2:55 p.m., N3 verified the maximum soak times were based on the manufacturer's IFU's for the different types of endoscopes that were used. N3 verified the manufacturer's IFU's for the maximum soak time for the following endoscopes:

(a.) Olympus BF-1TH190 has a one hour maximum soak time and was used in the procedures for Patient's #1, 2 and 4.
(b.) Olympus BF-P190 has a one hour maximum soak time and was used in the procedure for Patient #4.
(c.) Olympus TJF-Q190V has a ten hour maximum soak time and was used in the procedure for Patient #3.
(d.) Olympus BF-UC180F has a one hour maximum soak time and was in the procedure for Patient #4.
(e.) Olympus CF-HQ190L/l has a ten hour maximum soak time and was used in the procedure for Patient #5.
(f.) Olympus GIF-HQ190 has a ten hour maximum soak time and was used in the procedures for Patient #6, 7, 8, 9, 10, 11 and 12.
(g.) Olympus GF-UE160-AL5 has a ten hour maximum soak time and was used in the procedure for Patient #7.
(h.) Olympus GF-UCT180 has a ten hour maximum soak time and was used in the procedure for Patient #7 and #
13.

22. During an interview with A1 and N3 on 12/19/23 at 3:25 p.m., they verified the medical record and endoscopy reprocessing log information for Patients #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13.