Autoclave Daily Biological Indicator Test Log [FREE PDF]

Daily biological indicator (BI) testing of autoclaves is required by AAMI ST79:2017 and Joint Commission EC.02.04.01 to verify that sterilization cycles achieve the minimum 10⁻⁶ sterility assurance level (SAL) necessary for patient safety. The Centers for Medicare & Medicaid Services (CMS) Conditions of Participation mandate documented BI testing as part of hospital infection control programs. This checklist provides a structured daily log for Sterile Processing Managers to record autoclave perf

Industry: Sterile Processing
Frequency: Daily
Estimated Time: 15-25 minutes
Role: Sterile Processing Manager
Total Items: 41
Compliance: AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance, Joint Commission EC.02.04.01 Medical Equipment Maintenance Standards, FDA 21 CFR 820.70 Production and Process Controls QSR, OSHA 29 CFR 1910.1030 Bloodborne Pathogens Standard, ANSI/AAMI ST19:2017 Sterilization of Health Care Products

Autoclave Startup and Pre-Operational Check

Verify autoclave readiness and environmental conditions before initiating the daily BI test cycle.

Has the autoclave completed its warm-up cycle and reached operational standby?
Is the autoclave chamber door gasket free from visible damage, cracks, or debris?
Are the chamber drain strainer and filter free from blockage or residue?
Is the autoclave's display or printout showing no active fault or error codes?
Has the autoclave been cleaned per the scheduled maintenance log for today?

Biological Indicator Selection and Preparation

Document the BI product used and verify it is within specification prior to placing it in the test load.

Is the biological indicator product approved for use with this autoclave type (gravity or pre-vacuum)?
Is the BI product within its manufacturer-stated expiration date?
BI product lot number recorded?
BI product expiration date recorded?
Has a positive control BI (unsterilized, same lot) been set aside for comparison incubation?

Test Load Configuration and Placement

Confirm correct placement of the BI within a test load or PCD to represent the most challenging sterilization location.

Has the BI been placed in a process challenge device (PCD) or approved test pack?
Is the PCD or test pack placed in the front-bottom rack position of the autoclave chamber?
Is the test load loaded consistent with routine sterilization load configurations?
Has the selected sterilization cycle type been recorded for this BI test?
Load number assigned to the BI test cycle?

Sterilization Cycle Parameter Recording

Document the actual cycle parameters achieved during the BI test run for compliance records.

Sterilization temperature achieved during cycle?
Exposure time recorded from cycle printout?
Chamber pressure achieved during sterilization phase?
Did the cycle printout or display indicate a successful, uninterrupted cycle completion?
Cycle printout attached or archived to this test record?
Photo of cycle printout or display reading captured?

Biological Indicator Incubation

Document BI and positive control placement in the incubator and confirm incubation conditions meet specifications.

Has the processed BI been placed in the incubator immediately following cycle completion?
Incubator temperature confirmed at the required 55-60°C for Geobacillus stearothermophilus?
Has the positive control (unsterilized) BI been placed in the incubator simultaneously?
BI incubation start time recorded?
Scheduled BI read time (24 or 48 hours per manufacturer IFU) recorded?

Biological Indicator Results and Interpretation

Record final BI and positive control results and confirm result interpretation per manufacturer and AAMI criteria.

Did the positive control BI show growth (color change or turbidity) confirming BI viability?
Test BI result?
BI read time and date recorded at result documentation?
For self-contained BIs, was the fluorescence or color change method used per manufacturer IFU?
Photo documentation of both test and positive control BI results captured?

Corrective Action for BI Failure

Complete this section only if the BI test result was positive (growth detected). Document all corrective actions taken.

Has the autoclave been taken out of service immediately following a positive BI result?
Have all loads processed since the last negative BI test been quarantined or recalled?
Has the infection control and/or risk management department been notified of the positive BI result?
Has a retest been conducted after corrective maintenance on the autoclave?
Has a CAPA (Corrective and Preventive Action) report been initiated for this failure event?
Corrective actions taken and responsible person noted?

Record Completion and Retention

Confirm this test log is complete, signed, and filed per regulatory record retention requirements.

Has all required information on this log been completed before filing?
Has the supervisor or manager reviewed and countersigned this BI test log?
Has this record been filed in the designated sterilization log binder or CMMS system?
Additional observations or notes regarding autoclave performance today?

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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 41 critical inspection points across 8 sections. Recommended frequency: daily.

Ensures compliance with AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance, Joint Commission EC.02.04.01 Medical Equipment Maintenance Standards, FDA 21 CFR 820.70 Production and Process Controls QSR, OSHA 29 CFR 1910.1030 Bloodborne Pathogens Standard, ANSI/AAMI ST19:2017 Sterilization of Health Care Products. 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 41 inspection items across 8 sections: Autoclave Startup and Pre-Operational Check, Biological Indicator Selection and Preparation, Test Load Configuration and Placement, Sterilization Cycle Parameter Recording, Biological Indicator Incubation, Biological Indicator Results and Interpretation, Corrective Action for BI Failure, Record Completion and Retention. 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.