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Tag No.: A0940
Based on document review and interviews, the facility failed to ensure that surgical instruments were monitored for temperature and humidity during transportation, following sterilization at a sister facility. Additionally, the facility did not adhere to its policy titled "Transporting Soiled Instruments Outside of Surgery Department-SS-MKT," Policy number 48490.1.
Findings:
An observation tour was conducted on 9/18/2024 at 10:00 AM with Staff #4, the Director of Surgical Services, and Chief Nursing Officer (CNO) Staff #3.
An interview was conducted with the Sterile Processing Technicians, Staff #5, and Staff #6 on 9/18/2024 after 10:00 AM. Staff #5 and Staff #6 were asked if the temperature and humidity were monitored when sterile instruments were transported back to the facility from an outside facility. Staff #5 stated, "Yes, we do monitor temperature and humidity when we transport sterilized instruments". Staff #5 and #6 were asked how the instruments were transported. Staff #6 stated, "We wash the instruments here after the procedure is complete and then place them in a transport cart and take them to the main hospital in a transport van. We process the instruments ourselves and bring them back, but we don't do this all the time."
An interview was conducted on 9/18/2024 at 10:30 AM with Staff #4, Director of Surgical Services. Staff #4 was asked how the temperature and humidity were monitored when sterile instruments were transported from an outside facility. Staff #4 stated, "Instruments are cleaned and taken out of the operating room (OR) to the sterile processing department (SPD). The SPD staff then continued to clean the instruments to make sure there is no human tissue or blood on the instruments before placing them in the enclosed transportation cart and taking them to the van for transport. The SPD staff get a portable temperature and humidity device from plant operations before they leave the hospital with the instruments. Our SPD staff wash and process the instruments at the sister hospital and when they are complete, the instruments get covered and placed in a clean transport cart and brought back to our hospital. The temperature and humidity are monitored during the transport back to our hospital".
A review of the blank document titled, "Sterile Instrument Transportation Log for Temp/Humidity" revealed a place to document the date the instruments left the facility, the date the instruments returned to the facility, the name of the instruments that were transported, the temperature and humidity in the transport van when the instruments were loaded, the temperature humidity in the van when the instruments were unloaded, and the SPD personal signature.
Staff #4 was asked how the surgical department would know which surgical procedures the transported instruments were used on. Staff # 4 confirmed there was no way to know which patient or surgical procedure the transported instruments were used on.
After multiple requests for the temperature and humidity logs for the transported instruments, none were provided for review.
An interview was conducted with the Infection Control Preventionist (ICP), Staff #11 on 9/18/2024 before noon via video call. Staff #11 was asked if she monitored surgical site infections (SSI). Staff #11 confirmed that all surgical site infections were monitored through her department. Staff #11 confirmed there was only one return to surgery from 8/21/2024 to 9/18/2024 and the surgical procedure was not related to an infection.
During an interview with Staff #4 on 9/18/2024 after 10:30 AM, Staff #4 confirmed there was no return to surgery procedures for post-operative infections from 8/21/2024 to 9/18/2024.
A review of the policy titled "Transporting Soiled Instruments Outside of Surgery Department-SS-MKT" Policy number 48490.1, approval date 09/27/2023, stated:
" ...Policy: Contaminated instruments will be transported to SPD for reprocessing.
Procedure:
1 ...
8. Temperature and Humidity log will be kept for the transportation of sterile instruments. See Attachment A. If the temperature and/or humidity goes out of range, the instruments will need to be re-processed prior to use ..."
In a final interview on 9/18/2024 after 11:30 AM, Staff #4 confirmed that the facility had failed to follow its policy by not documenting temperature and humidity during the transport of sterilized instruments, thus failing to ensure their sterility.