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2401 W MAIN

HENRYETTA, OK 74437

OPERATING ROOM POLICIES

Tag No.: A0951

Based on record review and interview, the hospital failed to ensure:
1. Staff followed the manufacturer IFU for one (Prolystica HP Enzymatic Manual Cleaner Dye & Fragrance) of one enzymatic solutions.
2. A policy was in place for one (Hillcrest Hospital Henryetta) of one surgical departments.

This failed practice has the likelihood to place surgical patients at risk of infection from surgeries and procedures being performed with contaminated instruments.

Review of the manufacturer IFU titled "Prolystica HP Enzymatic Manual Cleaner Dye & Fragrance Technical Data" read in part, "Soak for a minimum of 1-5 minutes. Cleaning times may be longer with dried on soil."

During a tour of the decontamination room on 09/14/21 at approximately 2:15 PM, no method to monitor the duration of soak time for contaminated surgical instruments placed in the Prolystica HP Enzymatic Manual Cleaner Dye & Fragrance solution was described by staff. An enzymatic log was not available for review.

On 09/14/21 at approximately 2:15 PM, Staff H stated the following:
1. Contaminated surgical instruments were placed in the enzymatic solution for one to three minutes.
2. No timer was used and no documentation was completed to show the length of soak time.

On 09/15/21 at 1:48 PM, Staff G stated policy related to surgical instrument decontamination could not be found.