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Based on record review, interview, and observation, the hospital failed to collect data and monitor the effectiveness of its post-operative surgical instrument cleaning procedures. Unaware that the hospital's nonfunctional surgical instrument washer had been replaced by staff's manual and mechanical cleaning procedures, the facility quality management failed to evaluate the effectiveness of its manual instrument reprocessing with objective measures and identify and address a potential lack of contaminant removal in quality and executive leadership committees between 02/12/2025 and survey initiation on 07/02/2025.



Findings included:

Observations on the hospital's surgical unit on 07/02/2025 between 1330 and 1400 was conducted with Personnel A, B, D, E, and F in the hospital's surgical suite. There were no surgeries at that time.

The sterile processing department, identified by Personnel A as the post-operative cleaning and decontamination area for used surgical instruments, reflected three sinks with instructions for cleaning with enzymatic and detergent solutions. Additional instructions for cleaning parts of the endoscope (a tubular optical instrument used for examining, biopsy, or surgical procedures) and emergency eye wash procedures were also provided as pictorials on the wall. A gallon-sized plastic container identified by Personnel A as a cleaning chemical for surgical instruments had an opening date of 07/01/2025. The thermometer on one sink reflected a water temperature of 112.5-degree Fahrenheit.

A surgical washer located in the area was identified by Personnel A as nonfunctional. A document titled "All Clean Test Washer Indicator Log Form" was dated 02/12/2025 and reflected Washer #1 had gone through the "All Clean Test" with "pass." Personnel E stated at that time that quotes to repair the washer had been requested.

Interviews

Personnel A stated on 07/02/2025 at 1315 during an interview the instrument washer had been out of service for "four to five months" and instruments were "washed by hand ...two surgical cases ... 50 instruments just today." When washing the instruments, staff followed the 3-sink-method.

Personnel M stated during a telephone interview on 07/02/2025 at approximately 1325 that they notified administration in a February email that the washer had been broken.

Quality Personnel C acknowledged during an interview on 07/02/2025 at 1545 that the last washer indicator test strip date was 02/12/2025, close to five months ago; Personnel C was asked how quality and administration were sure the washing and removal of contaminants on the surgical instruments was done correctly and effectively. There was no response.

During an interview on 07/17/2026 approximately 1230, Quality Personnel C stated being unaware of the non-functional washer until survey initiation [07/02/2025]; action items after survey initiation included staff ordered test strips for the water, but " ...I am not sure whether they had come in ...water temp logs have been created ...trying to find a vendor that sells the test strips."

Administrative Personnel E stated during a phone interview on 07/17/2025 at 1615 they created a purchase order in May 2025 after operating room staff notification.

Administrative Personnel G was phone contacted on 07/17/2025 at 1610 and stated unawareness of the nonfunctional surgical washer until survey initiation on 07/02/2025.

Record Review

The latest hospital's Quality Meeting minutes dated 03/18/2025 and Medical Executive Committee (MEC) minutes dated 04/17/2025 provided by hospital staff on 07/02/2025 did not reflect quality monitoring data of manual and mechanical cleaning due to a nonfunctional surgical instrument washer.

MEC Committee minutes dated 04/17/2025 did not address a nonfunctional surgical instrument washer.

Hospital provided email correspondence dated 05/23/2025 at 1140 reflected a purchase order was sent to a commercial supplier of sterilization and surgical products; three additional emails dated 05/28/2025, 06/09/2025, and 07/02/2025 (timed after survey initiation) requested updates on the original email.

Temperature logs provided by the quality director on 07/18/2025 per email reflected temperature logs were initiated on 07/02/2025.

Hospital Policy titled Surgical Instruments, Care and Cleaning - All Types, dated 12/2024, reflected the policy that "the cleaning, decontamination, and care of instruments will be evaluated in a quality management program ...will include monitoring of manual and mechanical cleaning ..." (p. 1).