HospitalInspections.org

Based on observation, document review, and interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the surgery staff changed the sterile water flush bottle after endoscopy procedures for each patient, in accordance with the manufacturer's directions in 1 of 1 minor operating room. Failure to change the flush bottle of sterile water after each patient could potentially result in cross contamination of the sterile water with bacteria or other microorganisms, potentially causing an infection in the next patient. The CAH Administrative staff identified the surgery staff performed approximately 72 endoscopy procedures from 07/01/2019 to 06/30/2020.

Findings include:

1. Observations during a tour of the surgery department on 10/27/2020 at approximately 9:20 AM in the Minor Operating Room (used to perform endoscopy procedures) revealed 1 of 1 ICU Medical 1000 ml bottles of sterile water for irrigation, unopened and sitting adjacent to the endoscopy equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract). Review of the manufacturer's instructions indicated in part, "Sterile Water for irrigation, USP ... is intended for use only as a single-dose ... when smaller volumes are required the unused portion should be discarded." The sterile water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water once the hospital staff opened the bottles of sterile water for irrigation.

2. During an interview at the time of the tour, the Specialty Clinic and OR Supervisor indicated the surgery staff opened the bottles of sterile water for irrigation each day endoscopy procedures are scheduled and connected it to the equipment. The equipment contained a one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery staff changed the flush tubing between the patient and the one-way valve after each endoscopy procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscopy procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscopy procedures for the day or if the bottle ran empty.

3. During an interview on 10/28/2020 at approximately 1:30 PM, the Operating Room/Outpatient Services Manager stated she reviewed and confirmed the manufacturer's directions for ICU Medical 1000 ml of sterile water for irrigation. The Operating Room/Outpatient Services Manager acknowledged the manufacturer's product information did not support using the bottles of sterile water for irrigation for more than one patient.

4. During an interview on 10/28/2020 at approximately 2:00 PM, the CEO acknowledged the ICU Medical product information and ICU Medical 1000 ml bottle of sterile water for irrigation label indicated the product is for single patient use only.