HospitalInspections.org

Based on observation, review of sterilizer documentation, staff interview, and review of manufacturer's instructions, the facility failed to ensure biological indicators were used for each sterilizer in 1 of 2 areas reviewed (off-site clinic). The findings were:

1. Observation on 8/25/17 at 1:18 PM at MHSC Family and Occupational Medicine (off-site clinic under the hospital's provider number) revealed the facility had a small autoclave (sterilizer). Review of documentation for the sterilizer showed no evidence biological indicators were used. During an interview on 8/25/17 at 1:18 PM registered nurse (RN) #1 stated most loads contained scissors and needle drivers. She stated chemical indicators were used for each item, but stated they did not use biological indicators.

2. Review of the manufacturer's instructions for the autoclave (Ritter M9) showed "...All items must be processed in accordance with Centers for Disease Control and Prevention (CDC), ..."Guidelines for Disinfection and Sterilization in Healthcare Facilities-2008..."

3. Review of the CDC "Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008" showed "Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacillus spores), and not by merely testing the physical and chemical conditions necessary for sterilization...Steam and low temperature sterilizers (e.g., hydrogen peroxide gas plasma, peracetic acid) should be monitored at least weekly with the appropriate commercial preparation of spores...Each load should be monitored if it contains implantable objects."

4. According to "ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" by the Association for the Advancement of Medical Instrumentation (AAMI), 2013, "...Biological indicators should be used within PCDs [Process Challenge Devices] for routine sterilizer efficacy and monitoring at least weekly, but preferably every day that the sterilizer is in use. Additionally, BIs [biological indicators] within PCDs should be used to monitor every load containing implants."