Autoclave Daily Biological Indicator Test Log [FREE PDF]

Daily biological indicator (BI) testing of autoclaves is mandated by AAMI ST79:2017, Joint Commission EC.02.04.01, and CDC Guidelines for Disinfection and Sterilization as the highest-level assurance of sterilization efficacy. Geobacillus stearothermophilus spore strips or self-contained BIs must be processed daily in each sterilizer and incubated per manufacturer specifications to confirm kill of the most resistant organisms. Failure to perform and document daily BI testing is a leading cause o

  • Industry: Sterile Processing
  • Frequency: Daily
  • Estimated Time: 15-25 minutes
  • Role: Sterile Processing Manager
  • Total Items: 35
  • Compliance: AAMI ST79:2017 Section 10.5 Biological Indicators, FDA 21 CFR Part 820.70 Production and Process Controls, Joint Commission Standard EC.02.04.01 Equipment Maintenance, CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities 2008, OSHA 29 CFR 1910.1030 Bloodborne Pathogens Standard

Sterilizer Pre-Test Status Verification

Confirm the autoclave is in proper operating condition before initiating the daily biological indicator test cycle.

  • Has the autoclave passed the daily Bowie-Dick or vacuum leak test before the BI test cycle was initiated?
  • Is the sterilizer free of visible error codes, alarm indicators, or fault messages on the control panel?
  • Are the sterilizer door gaskets and seals visually inspected and found to be intact with no visible cracks or deformation?
  • Is the sterilizer chamber and drain strainer clean and free of debris, soil, or mineral buildup?
  • Is the water supply (where applicable) confirmed as purified or distilled per sterilizer manufacturer requirements?

Biological Indicator Preparation and Placement

Document the specific BI product used, verify lot numbers, and confirm correct placement within the test load.

  • Is the biological indicator (BI) product from an approved and validated manufacturer meeting AAMI ST79 requirements?
  • Has the BI lot number been verified and recorded, and is the product within its manufacturer-stated expiration date?
  • Was the BI placed in the most challenging location within the test load (e.g., geometric center or per manufacturer IFU)?
  • Was a control BI from the same lot incubated without sterilization processing to serve as a positive control?
  • Is the BI lot number, expiration date, and placement location documented in this test record?

Sterilization Cycle Parameter Recording

Record all critical sterilization cycle parameters to confirm the BI was exposed to a properly executed sterilization cycle.

  • Was the sterilization cycle type used for the BI test (gravity, pre-vacuum, flash) the same as the facility's standard cycle?
  • Did the sterilization temperature reach and maintain the required set point throughout the exposure phase?
  • Was the sterilization exposure time within the validated range for the selected cycle type?
  • Did the sterilizer pressure reach and hold within acceptable range throughout the sterilization phase?
  • Was the cycle printout or digital cycle record reviewed for anomalies and attached to this log?

Biological Indicator Incubation Monitoring

Document incubator conditions, incubation start time, and monitoring throughout the incubation period.

  • Was the incubator temperature verified and documented at the start of incubation?
  • Was the incubation start time recorded immediately after placing the BI and control in the incubator?
  • Is the incubator functioning correctly with a current calibration verification date within the required interval?
  • Was the incubation period completed for the full manufacturer-required duration without premature reading?
  • Is the BI type used a rapid readout (enzymatic) BI or a traditional (spore growth) BI?

Biological Indicator Result Interpretation

Record and interpret the final BI and control results, and confirm pass/fail determination.

  • Did the processed BI show a negative result (no growth, no color change, or no fluorescence) indicating sterilization success?
  • Did the positive control BI (unprocessed) show a positive result (growth, color change, or fluorescence) confirming BI viability?
  • Is the result (Negative/Positive) and reading time documented in the official sterilization log?
  • Was a photograph of the BI result (processed and control) captured for the quality record?
  • If the BI result was positive (indicating sterilization failure), was the sterilizer immediately taken out of service?

Sterilization Failure Response Protocol

Document corrective actions taken in the event of a positive BI result, including load recall and sterilizer quarantine.

  • If a positive BI was confirmed, were all items from the implicated load recalled and reprocessed?
  • Was the physician, infection control officer, and risk management notified of the positive BI result per facility protocol?
  • Was a formal CAPA (Corrective and Preventive Action) report initiated for the positive BI event?
  • Was a biomedical engineering work order generated for sterilizer inspection and repair before return to service?
  • Were three consecutive negative BI test results obtained before returning the sterilizer to routine service after a failure?

Record Keeping and Compliance Documentation

Confirm all required documentation is complete, retained in the appropriate system, and accessible for regulatory review.

  • Is this completed BI test log stored in the sterilization records management system with the associated cycle printout?
  • Are the BI lot number, expiration date, incubation temperature, start time, read time, and result all recorded on this log?
  • Has the supervising sterile processing manager or quality officer reviewed and signed this BI test log?
  • Is the sterilizer's preventive maintenance current and within the scheduled interval per the biomedical engineering department?
  • Are any additional observations, equipment concerns, or quality notes entered in the comments field of this record?

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Why Use This Autoclave Daily Biological Indicator Test Log [FREE PDF]?

This autoclave daily biological indicator test log [free pdf] helps sterile processing teams maintain compliance and operational excellence. Designed for sterile processing manager professionals, this checklist covers 35 critical inspection points across 7 sections. Recommended frequency: daily.

Ensures compliance with AAMI ST79:2017 Section 10.5 Biological Indicators, FDA 21 CFR Part 820.70 Production and Process Controls, Joint Commission Standard EC.02.04.01 Equipment Maintenance, CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities 2008, OSHA 29 CFR 1910.1030 Bloodborne Pathogens Standard. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Autoclave Daily Biological Indicator Test Log [FREE PDF] cover?

This checklist covers 35 inspection items across 7 sections: Sterilizer Pre-Test Status Verification, Biological Indicator Preparation and Placement, Sterilization Cycle Parameter Recording, Biological Indicator Incubation Monitoring, Biological Indicator Result Interpretation, Sterilization Failure Response Protocol, Record Keeping and Compliance Documentation. It is designed for sterile processing operations and compliance.

How often should this checklist be completed?

This checklist should be completed daily. Each completion takes approximately 15-25 minutes.

Who should use this Autoclave Daily Biological Indicator Test Log [FREE PDF]?

This checklist is designed for Sterile Processing Manager professionals in the sterile processing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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