HospitalInspections.org

Based on review of the Association of Perioperative Registered Nurses' (AORN), manufacturer's recommendations, hospital policies and procedures, hospital documents, observation and staff interviews, it was determined the CAH failed to require that:

1. immediate use sterilization was properly implemented in the surgery department according to nationally recognized standards of practice;

2. CIDEX Plus and CIDEX OPA solution was properly monitored for temperature, time and concentration when soaking the radiology transesophageal echocardiogram (TEE) probe and the vaginal probe prior to each patient's use for the ultrasound; and

3. reusable equipment used during outpatient Physical Therapy was disinfected between each patient use according to manufacturer's recommendations and hospital policy.

Findings include:

1. AORN Perioperative Standards and Recommended Practices 2010 Edition; Recommendation IV. a pg. 461 requires: "...Flash sterilization should not be used as a substitute for sufficient instrument inventory...."

Review of Immediate Use Sterilization Record for autoclave located in sub sterile room "A," dated 04/01/13 through 04/24/13, revealed the following:

04/01/13: Load contents: Pterygium instruments, reason for flashing: only one set with two cases.
04/01/13: Load contents: eye instruments; reason for flashing: only two sets with several cases.
04/01/13: Load contents: big gray needle, aspirating irrigation handle, reason for flashing: not enough for the day.
04/11/13: Load contents: Maryland, reason for flashing: not enough Maryland instruments on hand.
04/18/13: Load contents: Myringotomy tray, reason for flashing: only have 2 sets and have 3 cases.
04/22/13: Load contents: Eye instruments, reason for flashing: have 2 sets with 5 cases.
04/23/13: Load contents: Eye instruments, reason for flashing: have 2 sets with 5 cases.
04/24/13: Load contents: Eye instruments, reason for flashing: have 2 sets with 5 cases.

The Sterile Processing Lead Surgical Instrument Technician confirmed during an interview conducted on 04/24/13, the facility uses the immediate use sterilization when there are not enough sterile instruments for the scheduled cases.

The Co-Interim Director of Surgical Services confirmed the above immediate use sterilization findings during an interview conducted 04/24/13.

2. Manufacturer's recommendations for Cidex OPA revealed: "...Cidex OPA solution be tested before each usage with the CIDEX OPA Solution test strips in order to guard against dilution...." Cidex OPA directions for use revealed: immerse for minimum of 12 minutes at 20 degrees C (68 degrees F).

Hospital policy titled "Disinfection of endovaginal probes are disinfected before each use...soaking in Cidex OPA...minimum of 12 minutes...with test strip...results will be recorded...solution...changed out every 14 days...."

Cidex OPA Log from Radiology, dated 03/04/13 through 04/26/13, revealed three columns titled: Date, pass and failed. The Log revealed a check mark under the "pass" column for all dates. The log did not contain a patient name, time or temperature.

Observation of the Cidex solution located in the Surgical Suite; operating room #4; and storage room revealed: a large blue bin labeled "CIDEX" with an expiration date 04/26/13, hand written in pen on the top cover. In a closed cabinet located in the room was a bottle of CIDEX Plus test strips with an expiration date of 04/20/12. The solution could not be verified as CIDEX Plus or CIDEX OPA.

The Co-Interim Director of Surgical Services confirmed during an interview conducted 04/24/13, that the operating room does not use any CIDEX solution. The CIDEX solution in the storage room is used and monitored by Ultrasound Radiology department for any TEE procedure.

The Ultrasound Technician confirmed, during an interview conducted 04/26/13, he thought the surgery department changed and monitored the CIDEX solution.

The Director of Radiology provided the CIDEX calendar log for January 2013. The log contained the following: testing was performed on 01/23/13, "...start CIDEX activated PASS STrip...." The calendar log for February contained on 02/20/13, "END of CIDEX...." No calendar logs for March or April were provided.

The Director of Radiology confirmed during an interview conducted 04/24/13, the above findings.

3. Hospital policy titled "General Infection Control Policy" requires: " ...reusable equipment is not used...care of another patient until...properly cleaned with...disinfectant...with manufacturer's recommendation...."

Manufacturer's recommendations for SaniMaster 4 disinfectant revealed: " ...Solution must remain on the surface for 10 minutes, then wipe off or allow to air dry."

The Interim Director of Rehabilitation confirmed during an interview conducted 04/24/13, that the department disinfects the large physical therapy equipment such as treadmills, however they do not routinely disinfect the small equipment such as weights, balls and bands. The Interim Director confirmed the SaniMaster 4 disinfectant is sprayed on the equipment and wiped off without allowing a ten minute contact time.

The Director of Quality/Risk/Education/Infection Control confirmed during an interview conducted 04/25/13, that the Rehabilitation Department was not following the manufacturer's recommendations or hospital policy.