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If the retest confirms a positive spore growth, then the sterilizer must remain out of service and all instruments that were sterilized by that machine must be recalled from use and re-sterilized through a different sterilizer to confirm that they are safe for patient care. Remember to document both the failed test and the passing retest in this scenario. Most failed spore tests are due to operator error, so a passed retest confirms that the sterilizer is safe to use. The sterilizer must be removed from service until you get a passing result from the retest. If a positive test is reported on a sterilizer, immediately retest the sterilizer using the same cycle that produced the positive result. Remove any sterilizer with a positive test During a QA review, the examiner reviews records related to spore testing, so be sure to have them on hand for at least the past 12 months. With mail-in services, recordkeeping is done by the monitoring service. Retain records of spore testing for at least a year In addition, the Centers for Disease Control and Prevention and the American Dental Association both recommend sterilizers be monitored at least weekly with biological indicators. Test results shall be documented and maintained for 12 months.” Spore test at least once a weekĬalifornia Code of Regulations states: “Proper functioning of the sterilization cycle of all sterilization devices shall be verified at least weekly through the use of a biological indicator (such as a spore test). To remain in compliance, store out of use or broken sterilizers away from the sterilization space in your practice if you are not conducting weekly spore testing on them. If a sterilizer is not currently being used, or is considered a back-up, it still must be spore tested at least weekly. You must test all sterilizers present in your sterilization area. Here’s a checklist of important points to keep in mind to make sure your practice is safe and compliant when it comes to spore testing sterilizers. Inactivation of these microorganisms strongly implies that other potential pathogens in the load have been eliminated. Spore testing assesses the killing of highly resistant Geobacillus and Bacillus spores. Spore testing, or biological monitoring, remains the best assurance that sterilization equipment is functioning and that your office is performing instrument processing procedures correctly. Improperly sterilized equipment is one of the most common reasons for QA non-compliance. If your California-based practice has a quality assessment (QA) review coming up, you’ll want to be absolutely certain that you’re properly spore testing all sterilizers on a weekly basis. Monitoring sterilizer functionality is crucial for every office.