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Based on observation, hospital policies and procedures, and interviews, it was determined the hospital failed to ensure sterilized instrument trays and peel pouches were stored in a clean, dry environment, in a manner that ensures sterility.

This deficient practice had the potential to affect all patients having surgery served by this hospital.

Findings include:

Hospital Policy: Instrument Care (Decontamination, Sterilization, Storage)
Policy Number: None
Review Date: February 2021

Policy:
It is the policy of Clay County Healthcare Authority to provide instruction on the proper care of reusable surgical instruments

Procedure:
After sterilization, devices should remain in sterilization packages and be stored in a clean dry environment.

Hospital Policy: Storage of Sterile Supplies
Policy Number: None
Review Date: February 2021

Policy:
It is the policy of Clay County Healthcare Authority to outline proper storage of sterile supplies.

Procedure:
A. All sterile supplies shall be stored in a secure location which maintains the integrity of the sterile item...
1. All storage area shall be clean, dry, protected from moisture...
B. All cloth sterile and paper wrapped items are stored in the Central Service sterile area...
K. Storage of sterile supplies shall be done under conditions which tend to preserve not threaten the integrity of the packaging...
5. No sterile packages of any type shall be placed next to or below any sink...

Hospital Policy: Sterile Storage-Event Related Shelf Life
Policy Number: None
Review Date: January 2017

Policy:
...B. All items sterilized by Sterile Processing will be considered sterile unless the package/pack/tray/container is damaged or wet.
Damage includes:
...5. Exposure to a contaminated or unsafe environment.
6. Exposure to any type of moisture.

Procedure:
A. All items packaged for sterilization...
H. ...will be stored in an environment free from moisture, excessive heat or contamination...

A tour of the surgical unit was conducted on 4/29/25 at 11:30 AM with Employee Identifier # 2, Chief Nursing Officer and EI # 4, Chief Executive Officer/Administrator.

In the decontamination/dirty area, which contained the sink for washing dirty instruments, the surveyor observed sterile, wrapped, packaged supplies stored in cabinets on both sides of the room including:
a). Six sterile, peel pouched microscope knobs for eye surgery cases.
b). Six sterile eye instrument trays.
c). One pterygium eye tray.
d). Twenty three peel pouched packages of miscellaneous instruments.
e). One small fragment instrument set.
f). Seven wrapped instruments including an amputation knife and various saws.

The sterilized instrument trays and peel pouches were not stored in a clean, dry environment in a manner that ensures sterility.

An interview was conducted at the time of the observation with EI # 2, who confirmed the above observations.