HospitalInspections.org

Based on document review and staff interview it was determined the facility failed to perform the Center for Disease recommendation requiring the weekly use of a biological indicator to monitor the effectiveness of their steam sterilizer. Failure to perform a weekly biological indicator test can result in a failure to recognize a steam sterilizer that is not working properly leading to items not being effectively resterilized. Findings include:

1. The Center for Disease Control in the 2008 Recommendations for Disinfection and Sterilization states in part the following for the Monitoring of Sterilizers:

a. Use mechanical, chemical, and biologic monitors to ensure the effectiveness of the sterilization process.

b. Monitor each load with mechanical (e.g., time, temperature, pressure) and chemical (internal and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed.

d. Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDA-cleared commercial preparation of spores (e.g., Geobacillus stearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer.

2. On 2/9/11 in the afternoon observations were made in the sterile reprocessing area which contains one steam sterilizer. The load records and monitor logs were reviewed. There was no log or documentation indicating the use of a weekly biological to monitor the effectiveness of the sterilizer.

3. The Director of Inpatient Services was interviewed on 2/10/11 at 0900 hours concerning the lack of biological monitoring in the steam sterilizer. She presented evidence of chemical and mechanical monitors and stated they are currently not using a biological monitor. She stated she thought the chemical and mechanical monitors they were using was adequate to assure proper sterilization.