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Based on facility policies and procedures, observations and interviews it was determined the facility failed to ensure surgical instruments were inspected and safe for patient when reprocessed and sterilized.

This deficient practice had the potential to affect all patients requiring sterilized surgical instruments.

Refer to A 0951 for findings.

Based on facility policies and procedures, observations and interviews it was determined the facility failed to ensure surgical instruments were inspected for oxidation, damage, tape/tape residue, water spotting, and pitting which resulted in unsafe instruments available for patient use.

This deficient practice had the potential to affect all patients requiring surgical instruments processed in the central sterile department.

Findings include:

Facility Policy: Processing of Instrument and Procedure Trays, 02-757-0030
Policy #: 10716540
Date Last Revised: 03/2017

Purpose:

To outline proper method for cleaning, packaging and processing of sterile trays.

Procedure:

All objects to be sterilized must first be thoroughly cleaned to remove all organic matter (blood and tissue) and other residue...

Inspect instruments to make sure that they are clean, dry and functioning properly...Soiled objects shall be returned for decontamination. Objects that do not function properly shall be removed and replaced with properly functioning items.

Use a mesh-bottom or perforated tray or equivalent. Instrument trays shall be designed for effective sterilization, drying and orderly arrangement of instruments.

Facility Policy: Disposables Vs Non-Disposables, 02-757-0018
Policy #: 10716811
Date Last Revised: 08/2019

Any item designated in writing with the description "disposable" or "single use only" is intended for a single use only and then discarded as trash when finished with use. The item is usually designated as disposable on the outer wrapper...and sometimes on the item itself. These items are never reprocessed for use again...

Most stainless-steel surgical instruments are intended for reuse and may be processed for sterility...

When in doubt, consult with your supervisor, the manufacturer and/or the infection control nurse.

A. Disposable items are not to be reprocessed, resterilized or reissued at any time. All used disposable items returned to Central Sterile are to be discarded...

1. Inspection of a sterile laparotomy (lap) tray was conducted on 12/1/21 at 8:30 AM with Employee Identifier (EI) # 2, Director of Quality/Acting Director of Surgical Services and EI # 3, Registered Nurse (RN) Operating Room (OR) Lead. The lap tray, which had been processed on 11/30/21, was pulled from the instrument room located in the OR department. The following unsafe instruments were identified:

a. One knife handle with oxidation.

b. One Allis clamp which had a colored rubber-like substance on the ring handles which was dry, cracked and peeling.

c. One towel clip with tape residue on the shaft.

EI # 2 and EI # 3 confirmed on 12/1/21 at 8:45 AM the instruments were not safe for patient use and should have been discarded.

2. An inspection of a vaginal delivery tray pulled from the Labor and Delivery set-up room was conducted on 12/1/21 at 8:50 AM with EI # 4, RN Director of Women's and Children's Services. The vaginal delivery tray was processed on 11/29/21. The following unsafe instruments were identified:

a. One small forceps with rust and water spots.

b. One sponge stick with colored rubber-like substance on the ring handles which was dry, cracked and peeling.

c. One sponge stick with no identification marking as surgical grade.

d. One Allis clamp with dipped handles and no identification marking as surgical grade.

e. One straight scissors with reddish colored spots on the shaft.

f. One needle holder with gold-colored handles in which the gold color was wearing off and rough edges.

g. One Kocker's forceps with dipped ring handles with approximately 1 inch of the rubber like substance remaining on the handles (most had peeled off), areas of pitting and there was no identification marking as a surgical grade instrument.

h. One Kocker's forceps with black tape, approximately 1 inch wide, on the shaft.

EI # 4 confirmed on 12/1/21 at 9:00 AM the instruments described above were not safe for patient use and should have been discarded.

3. An inspection of a sterile C-section (cesarean) tray pulled from the substerile room in Labor and Delivery was conducted 12/1/21 at 9:00 AM with EI # 4. The following unsafe instruments were identified:

a. One long forceps with water spots.

b. One Medium Dubakey forceps with red spots in the groves.

c. One short clamp with black spots and a rough area on the shaft.

d. One Adson forceps with oxidation.

e. One bowel blade with water spots.

f. One Richardson Retractor with dried tape material that flaked off.

g. One towel clip with rubber-like material peeling off of dipped handles.

h. One Allis clamp with reddish oxidation and no identification marking as surgical grade.

i. One Babcock forceps with tape, approximately 1//2 inch wide that was peeling.

j. One Kelly clamp with approximately 1/2 inch of tape around each ring handle.

k. One Kelly clamp with no identification marking as surgical grade and a crack at the hinge.

l. One Kelly clamp with approximately 1/2 inch of tape on one ring handle.

m. One hemostat with dipped handle peeling off and no identification marking as surgical grade.

n. One needle carrier with no identification marking as surgical grade.

o. One Mitzenbaum scissors with water spots.

p. One Mayo scissors with water spots.

q. One Straight Mayo scissors with removable reddish discoloration on blade.

r. The instrument casket had dark colored, sticky residue on the inside of the basket.

EI # 4 confirmed on 12/1/21 at 9:15 AM the instruments described above were not safe for patient use and should not be in the sterile instrument tray.

An interview was conducted on 12/1/21 at 10:00 AM with EI # 1 who confirmed the above instruments identified during inspection were not safe for patient use and would be discarded and replaced.