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Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the cleaning and disinfection of flexible endoscopes.

These failures created the potential for transmission of health care acquired infections (HAIs) to patients receiving care in the facility.

FINDINGS

REFERENCE

According to the Association of periOperative Nurse's (AORN) Guidelines for Perioperative Practice (2015):

Recommendation I (page 589) flexible endoscopes should be cleaned and stored in accordance to the manufacturer's written instructions. Failure to follow the manufacturer's written instructions could result in ineffective cleaning that interferes with high-level disinfection or sterilization, creating a risk of infection for the patient.

According to the manufacturer's instructions for the Medivator Advantage Plus Endoscope Reprocessing System, the complete reprocessing cycle is comprised of a number of specific steps designed to ensure proper endoscope disinfection. These steps include startup, washing, disinfectant, rinse, alcohol and air phases. All steps must be properly followed and should not be modified beyond manufacturer recommendations. At the end of a cycle, the system will prompt to collect a disinfectant sample to measure the minimum recommended concentration (MRC). If the test strips indicates a fail, rerun the cycle and retest. If the test strip indicates a fail again, open a new bottle of test strips and test the concentration again with a new test strip.

According to the instructions for use for Medivator Rapicide PA High-Level Disinfectant (HLD) Test Strips, the test strips provide a convenient way to directly test for peracetic acid (the active ingredient) from the Rapicide PA solution. Rapicide PA is a disinfectant solution used for endoscope reprocessing. The minimum recommended concentration (MRC) has been established at 850 ppm of peracetic acid. Results that do not match the "PASS" color block indicate the Rapicide PA use solution is not suitable for high-level disinfection.

Keep the strip in the original container. Do not use the strip after the expiration date (opened or unopened). Test strips have a four months open bottle shelf life.

1. The facility failed to maintain infection control processes in the cleaning of flexible endoscopes.

a) On 10/04/17 at 12:16 p.m., the reprocessing of a flexible endoscope was observed. Registered Nurse (RN) #1 completed the initial manual cleaning process prior to transport of the endoscope to the GI (gastrointestinal) utility room where s/he completed two additional manual cleaning processes. RN #1 then placed the endoscope into the right compartment of the Medivator Endoscope Reprocessing System for its final cleaning and high-level disinfection. S/he explained the process upon completion of the run cycle was to check the concentration of high-level disinfectant solution to make sure it had not become diluted.

At 12:33 p.m., RN #2 entered the GI utility room to remove an endoscope from the left compartment of the Medivator Endoscope Reprocessing System. RN #2 stated the endoscope had completed the processing cycle and s/he was going to check the MRC of the Rapicide PA use solution to ensure the endoscope had been properly disinfected.

Observation of the Rapicide PA (HLD) test strips revealed the bottle had been opened and not dated as instructed by the manufacturer. RN #2 stated the bottle of test strips were used up so quickly that they never reached the opened expiry date. When questioned why the manufacturer instructions required the dating of the opened test strip bottle, RN #1 confirmed the use of test strips past the expiration date could provide an inaccurate result, which could lead to improperly cleaned endoscopes being used on patients.

b) An interview was conducted with the GI Lab Manager (#3) on 10/05/17 at 1:31 p.m. According to Manager #3, s/he expected all staff performing the reprocessing of endoscopes to adhere to the manufacturer's instructions for cleaning and testing procedures. The Rapicide PA HLD test strips should be dated with the new expiration date when the bottle was opened and if there was no expiration date marked on an opened bottle of test strips, they should not be used at all. S/he confirmed the use of expired Rapicide HLD test strips my cause the "test results to be off and you wouldn't know if the endoscope has been disinfected".