HospitalInspections.org

Based on observation, review of facility policy, review of facility documentation, and interviews the facility failed to conduct biological indicator testing (a test system that monitors and measures the sterilization of medical instruments by using a specific organism known to be resistant to specific sterilization processes) as part of monitoring the efficacy of the sterilization process for colonoscopes (a flexible, lighted instrument used to view the inside of the colon) and gastroscopes (a flexible, lighted instrument that is put through the mouth and throat to view the stomach) in accordance with national infection control standards. This deficient practice had the ability to affect the 14 patients undergoing procedures with the equipment on 06/13/18.

Findings Include:

Review of the facility outpatient "Operating Room Schedule," dated 06/13/18, identified 14 patients who were scheduled for colonoscopy procedures.

Observation of the colonoscope reprocessing procedure with the Operating Room (OR) Technician, (no identifier only one OR Technician), on 06/13/18 at 11:35 AM, identified the OR technician conducted a manual cleaning of the gastroscope using an enzymatic (compounds that are produced by living organisms) cleaning solution. The OR Technician completed the manual cleaning and placed the gastroscope in the Steris sterilization machine that uses a liquid chemical sterilization process.

Review of the "Steris Record Book," on 06/13/18 at 12:00 PM, identified printouts and documentation that reflected chemical indicator and mechanical indicator monitoring of colonoscopes and gastroscopes was conducted as part of the sterilization process. The "Steris Record Book" failed to identify biological indicator testing was being conducted by the facility.

The OR Technician in an interview on 06/13/18 at 12:00 PM stated, "The facility used to conduct biological indicator testing with the old Steris machine, but stopped the testing when the current Steris machine was put into service." The OR Technician could not recall the exact date but indicated the current Steris machine has been in use for at least 3 years at the facility.

Review of the "Infection Prevention and Control Colonoscope Surveillance for Outpatients," dated January-May 2018, identified zero (0) number of hospital acquired infections from the outpatient colonoscope and gastroscope procedures.

Registered Nurse (RN) 1 (OR Manager) in an interview on 06/14/18 at 8:30 AM stated, "The facility thought because the Steris machine used peracetic acid (a liquid acid used as a disinfectant) as sterilant (free from living organisms), biological indicator testing was not necessary." RN1 was unable to identify the exact date the Steris 1E was put into service but thought it was at least 3 years. RN1's attempts to contact the Steris manufacturer's representative to provide information were unsuccessful.

The facility policy "Care of Colonoscope and Gastroscope," unsigned and revised January 2004, identified "The Steris System 1 will be used for disinfecting scopes. The scope will be placed in the Steris according to the manufacturers guidelines. . . The data regarding diagnostic and sterile process is printed out by the Steris. Printouts will be kept in a record book, with the type of scope and if chemical monitoring is safe. (Will change from a color to white for safe) . . ." The policy did not identify biological indicator sterilization monitoring procedures.

The "Centers for Disease Control and Prevention (CDC) website" indicated, "The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. The mechanical monitors for steam sterilization include the daily assessment of cycle time and temperature by examining the temperature record chart (or computer printout) and an assessment of pressure via the pressure gauge . . . 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. Since the Bacillus spores used in biological indicators are more resistant and present in greater numbers than are the common microbial contaminants found on patient-care equipment, the demonstration that the biological indicator has been inactivated strongly implies that other potential pathogens in the load have been killed ... Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process . . . 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. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of equipment malfunctions or procedural errors and thus minimizes the extent of patient surveillance and product recall needed in the event of a positive biological indicator . . . "

The "Steris Life Science" website indicated, "Biological indicators are test systems that contain viable microorganisms with a defined resistance to a specific sterilization process. They help monitor whether the necessary conditions were met to kill a specified number of microorganisms for a given sterilization process. Bacterial spores are some of the toughest microorganisms to kill . . . A passing result for the Biological indicators demonstrates that the sterilizer is effective in killing a large number of highly resistant bacterial spores, providing users with a level of assurance in their sterilization process."