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Based on observation, review of policy and procedure, Gastroscope/Colonoscope Cleaning Record, Cidex OPA solution log sheet and interview, it was determined the Facility failed to: store five of five endoscopes to prevent contamination; store biopsy forceps to prevent contamination; have storage for endoscopes that prevented contamination; follow their policy for processing of endoscopes and failed to monitor the efficacy of the Cidex OPA per policy and manufacturer's recommendations. The failed practice affected 57 patients listed on the Gastroscope/Colonscope cleaning record from 09/01/15 - 09/21/15. The findings were:

A. Observation on 09/22/15 at 0914 revealed five of five endoscopes (Colonscope #2152, #4701 and #1864 and Gastroscope #0909 and #1089) were stacked one upon another. The endoscopes were coiled on themselves and each scope had a cloth towel loosely wrapped around them. The towels were damp. The Nurse Manager stated at the time of observation the endoscopes had been high level disinfected on 09/21/15 and stated "they should have been hung up".
1) Review of the Log for Gastrointestinal Procedures (GI) and Manual Gastroscope/Colonoscope Cleaning documentation record revealed scope #2152, #4701 and #0909 were high level disinfected on 09/21/15. Scope # 1089 was high level disinfected on 09/16/15 and #1864 was high level disinfected on 09/18/15.
2) The Nurse Manager stated on 09/22/15 at 1530 the Facility adopted CDC (Center for Disease Control and Prevention) standards for endoscope reprocessing.
3) Review of the CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008", Reprocessing of Endoscopes, revealed: "Store the endoscope in a way that prevents recontamination and promotes drying (e.g. hung vertically). "

B. Observation on 09/22/15 at 0930 revealed five endoscope biopsy forceps coiled and in unsealed peel packages in a storage room adjacent to the Endoscope Procedure Room. The Nurse Manager stated at the time of observation that the forceps were placed in the peel packs after processing and confirmed the forceps were not sealed in the peel package.
1) The Nurse Manager provided manufacturer's label information 09/22/15 at 1530 for the autoclavable and reusable hot biopsy forceps used at the Facility. The Hot Biopsy Forceps label listed reusable and autoclavable in the description. The stored reusable forceps were not maintained to assure sterility in that the peel packages were not sealed after processing.
2) Review of the CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed: sterilization, "Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps and implanted medical devices."

C. Observation on 09/22/15 at 0930 with the Nurse Manager revealed a cabinet in the Endoscopy Procedure Room with a door that was broken and not in use. A portion of the door was noted with cloth type tape on each end and stored in the bottom of the cabinet. The bottom of the cabinet had an accumulation of dust and one area of a drip splash. The Nurse Manager confirmed at the time of observation the cabinet door was broken and stated at the time of observation the cabinet was used for hanging endoscopes after high level disinfection. There were no endoscopes in the storage cabinet at the time of observation.

D. Registered Nurse #2, stated in an interview on 09/22/15 at 1015 that tap water was used to rinse the endoscopes. Review of the Gastroscope/Colonscope Cleaning Record revealed there were 57 patients who had procedures from 09/01/15 - 09/21/15.

1) Review of the Facility policy "Infection Prevention: High-Level Disinfection for Reusable Instruments" on 09/22/15 revealed, "following removal from Cidex OPA, rinse the device by immersing it in a large volume (e.g. two gallons) of water. Repeat the rinse process at least twice, for a total of three rinses. Each rinse should be done using a fresh bottle of sterile water. Flush all lumens with large volumes - not less than 100 ml. Disinfected instruments should be used immediately or stored in a manner to minimize recontamination."

E. Review of the Cidex OPA Solution Log Sheet for 09/19/14 through 09/09/15 on 09/22/15 revealed no documentation of MEC (Minimum Effective Concentration) testing for the Cidex OPA solution prior to each use. There was no documentation of testing positive and negative controls to verify the efficacy of the test strips.
1) Review of Facility policy "Infection Prevention: High-level Disinfection for Reusable Instruments" revealed section "Testing the Cidex OPA Solution" "Record the date that the bottle of Cidex OPA Test Strips expires on the container label. The bottle must always be kept tightly closed. Prepare the control solutions to perform the Quality Control (QC) test: Verify the expiration date on the Cidex OPA solution; Full strength Cidex OPA solution may be used as the positive control; Dilute one part full strength Cidex OPA solution with one part water for the negative control; and label each solution. Positive and negative controls are required to verify the efficacy of the test strips. If the results of the QC test indicate that the test strip is not functioning properly, discard the remaining strips. Cidex OPA solution will be tested prior to each use. "
2) Review of Manufacturer's Guidelines for Cidex OPA revealed the statement, "During reuse, it is recommended that the Cidex OPA Solution be tested with the Cidex OPA test strips prior to each usage. This is to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present."
3) The Nurse Manager confirmed the lack of MEC prior to each use of the Cidex OPA and the lack of QC on 09/22/15 at 1540.