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I. Based on observation, document review, and interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the surgery staff changed the sterile water flush bottles after endoscopy procedures for each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in bacteria growing in the sterile water and potentially causing an infection in the next patient. The hospital's administrative staff identified that an average of 10 endoscopy procedures per month perform per fiscal year from 07/01/2021to 06/30/2022.

Findings include:

1. Observations during a tour of the surgery department on 02/23/2023 at approximately 07:45AM with the Director of Surgical Services and Certified Surgical Technician (CST) A revealed 1 of 1 bottle ICUMedical 1,500 mL bottle of sterile water for irrigation connected to the endoscopy equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract).

2. Review of the manufacturer's instructions indicated in part... "Sterile Water of Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded."

3. During an interview at the time of the tour, Director of Surgical Services and CST A stated the surgery staff opened the bottles of sterile water for irrigation each day for endoscopy procedures that 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.

4. During an interview on 02/23/2023 at approximately 9:00 AM, the Director of Surgical Services and CST A stated they were unaware reviewed and confirmed the manufacturer's directions for the ICUMedical bottles of sterile water for irrigation. The Director of Surgical Services and CST A acknowledged the manufacturer did not support using the bottles of sterile water for irrigation for more than one patient.

II. Based on observation, document review, and interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the surgery staff secure used medication from a procedure was returned to Pyxis, in accordance with the CAH's policies. Failure to secure medication could result in an opportunity for drug diversion. The hospital's administrative staff identified that an average of 319 procedures per month perform per fiscal year from 07/01/2021to 06/30/2022.

1. Observation during a tour of the surgery department on 2/23/2023 at approximately 9:00 AM with the Director of Surgical Services revealed the follow found in a drawer in the Certified Registered Nurse Anesthetist (CRNA) room:

a. 1 ampoule of 0.9% Sodium Chloride Injection 10 mL Lot 10809A Expiration 8/2024

b. 1 ampoule of Lidocaine HCI 1% Injection 50 mg/5 mL Lot AE0018 Expiration 9/2023

c. 1 ampoule of Lidocaine HCI 1% Injection 50 mg/5 mL Lot 11025F Expiration 10/2023

d. 1 ampoule of Marcaine Spinal Injection 2 mL Lot 1228 Expiration 7/1/2024

e. 1 ampoule of Lidocaine HCI 1% Injection 50 mg/5 mL Lot FG8254 Expiration 7/1/2024


2. Review of policy "Drug Tracking- Procedure", approved 10/2022, revealed in part, " ...Noncontrolled medications should be disposed of in the black hazardous waste box."

3. During an interview on 02/23/2023 at 5:01 PM with CRNA C revealed these medications were part of kits used during minor procedures. CRNA C acknowledged she did not follow the policy on the disposal of noncontrolled medications, by placing these medications in a black box located in each procedure room. CRNA C stated she was used to saving these medications due to a shortage.

4. During an interview on 02/23/2023 at 3:42 PM with Pharmacist B revealed, medication a and c was part of an epidural kit; medication b was part of a PICC line kit; medication d and e were part of a spinal kit. Pharmacist B verified these medications came from those complete kits that are used for minor procedures. Pharmacist B also acknowledged if these medications were not going to be utilized after the kit was opened the medication should have been disposed of per policy.

Based on review of policies and procedures, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure policies and procedures implemented were enforced. Surgical services policies must be in accordance with acceptable standards of medical practice and surgical patient care. The CAH Administrative Staff identified a total of 319 procedures performed during fiscal year July 1, 2021-June 20, 2022.

1. The CAH Administrative staff failed to ensure a qualified practitioner reassess a patient and update the patient's history and physical (H&P) prior to a surgical procedure.

2. The CAH Administrative staff failure to ensure if an H&P was conducted no more than 30 days and no less than the day before the surgery the H&P should be updated by a qualified practitioner prior to surgical services for a CAH patient.

The cumulative effect of the systemic failure and deficient practices resulted in the facility's inability to ensure quality and safe health care provided to patients.

Findings include:

1. Review of the CAH's Rules and Regulations policy reveals in part, " ...Any change in physical condition in the interim will be noted in the progress notes ..."

2. Review of the CAH's medical records revealed 1 of 5 charts that did not have an updated H&P present prior to Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5's procedures.

4. During interview on 02/22/2023 at approximately 07:20 PM Director of Quality and Patient Advocate verified there was no update to the H&P that was performed by a qualified provider found in the medical record.