Revised on
04/13/17 12:35pm

Laboratory Audit Guidance

Contact information

The following laboratory audit form screenshots and comments are provided so that you will know what to expect during your annual BUA laboratory audit.

Laboratory information:

  • The top section of the audit form is completed by the auditor prior to beginning the laboratory audit.

BUA documentation:

  • The auditor will ask you if the current BUA and amendments are available for users to reference when needed and they will check the training sheet to confirm that all authorized users have been trained on these documents annually.
  • The auditor will ask the laboratory representative to verify that there are no changes to the BUA. Depending on the changes to the BUA, the principal investigator may have to submit an amendment to update the BUA.

Training and safety documentation available:

Documents and records which are not applicable to your work will be marked "N/A" or designated by strikethrough. If you are unsure which documents apply to your work, contact the Biosafety office or your auditor for clarification.

Below is a brief description of each document listed on the audit checklist and the expectations for record keeping:

  • Laboratory-specific training: Each employee listed on the BUA should have documented initial and annual training applicable to the work they perform. The auditor will review the most recent training records.

Minimum training documents and topics should include:

  • Your Biological Use Authorization (BUA)
  • Safety features of the laboratory or facility (location of eyewash/showers, location of spill kits, evacuation route, etc.)
  • Available laboratory-specific plans (such as the Medical Waste Management Plan, Bloodborne Pathogen Exposure Control Plan, Aerosol Transmissible Disease Plan)
  • Spill training (biological spills – SafetyNet #127) including reporting requirements
  • Any agency permits required for the research – for example, if your work is covered by permits from the California Department of Food and Agriculture or USDA-Animal Plant Health Inspection Service (APHIS), laboratory auditors will verify that copies of the permits are available and included in annual training

Specific training that may be required depending on the type of research and materials used include:

  • Safe Use of Biological Safety Cabinets: Any employee who uses a biological safety cabinet must complete this online training. Copies of training certificates or a record of the training date for each employee should be available for review in the laboratory.
  • Biological Safety and Medical Waste Management or School of Medicine Laboratory Safety training: All Principal Investigators, employees, and students who work in BSL2 laboratories must complete one of these classes. Copies of training certificates or a record of the training date for each employee should be available for review in the laboratory.
  • NIH Guidelines training (recombinant DNA research): The NIH Office of Biotechnology Activities requires Principal Investigators to understand their obligations under the NIH Guidelines for Research Involving Recombinant DNA Molecules and how the Guidelines apply to their work. To ensure that this expectation is met and communicated to PIs a NIH brochure outlining their responsibilities is also provided.
  • Greenhouse safety training: This training is required for greenhouse users. If laboratory users have taken this training, a copy of their training checklist or a record of the training date for each employee should be available for review in the laboratory.
  • Bloodborne Pathogen Exposure Control Plan (BBPECP). This plan is required by the California Code of Regulation, Title 8, Section 5193 covering occupational exposure to human source materials (including established human cell lines). UC Davis also requires a BBP Exposure Control Plan and training for work with non-human primate materials. An important feature of the regulatory standard is that employees working with human materials must be offered the Hepatitis B vaccine series free of charge through the UC Davis Occupational Health Services (530-752-6051) as part of a health surveillance program. This offer is to be documented as part of the BBPECP.
    • This plan must be reviewed annually to document that all the information is current. This review date must be documented.
    • All employees handling human or non-human primate source materials must receive documented annual refresher training on this plan.
  • Aerosol Transmissible Diseases (ATD) Plan: This plan is required by California Code of Regulation, Title 8, Section 5199 covering occupational exposure to aerosol transmissible disease agents. If you are working with any of the agents listed in the standard complete the document with laboratory-specific information.
    • This plan must be reviewed annually to document that all the information is current. This review date must be documented.
    • All employees working with ATD agents must receive documented refresher training on this plan annually.
  • Medical Waste Management Plan (MWMP): This plan describes waste handling and disposal practices for red bag waste, un-fixed human and non-human primate materials (including established cell lines) and human infectious agents.
    • This plan must be reviewed annually to document that all the information is current. This review date must be documented.
    • All employees working in the laboratory must receive annual documented training on this plan.

More information regarding training requirements and examples of annual training documentation can be found on the Biosafety FAQ page.

Containment and equipment:

Auditors will check the equipment and containment features of the laboratory based on BSL1 and BSL2 containment criteria outlined in the most current edition of the CDC publication: Biosafety for Microbiological and Biomedical Laboratories (BMBL).

Containment and equipment

  • Door signage: entry doors to the laboratory should be posted with hazard warnings for emergency responders, and 24-hour emergency contact information for the Principal Investigator, laboratory manager (if applicable), and departmental or building safety coordinator. A biohazard symbol at all laboratory entrances is required for all BSL2 laboratories that generate medical waste. Other required laboratory door signage includes appropriate notification of other hazards present in the laboratory (e.g., radioactive materials, carcinogens) and personal protective equipment (PPE) requirements for entry (if applicable).
  • Appropriate PPE is available (laboratory coat, gloves, and eye protection for splashes) and is consistent with door signage. Gloves must be provided in multiple sizes. If latex gloves are provided, nitrile or other protective gloves must also be provided for individuals who may be sensitive to latex.
  • The auditor will verify that the directional air flow is appropriate for the work being performed.
  • All laboratory furniture and work surfaces used with human or non-human primate materials or infectious agents must be impermeable to liquids (such as use of vinyl-upholstered chairs or use of an impermeable chair cover over cloth surfaces).
  • All house vacuums must be protected with in-line filters. If the vacuum is used to aspirate liquids the auditor will verify that an in-line filter and secondary flask are used.
  • Waste collection flasks must be in a leak-proof secondary container that can contain the contents of the flasks in case of a spill. The liquid in the flask should be inactivated by chemicalb disinfectant (e.g. adding enough bleach so that it is 10% of the final volume).
  • Signage within the BSL2 laboratory: All equipment used for biohazardous material handling, manipulation, containment, or storage must be labeled with the universal biohazard symbol (e.g, biological safety cabinets, incubators, water baths, shakers, vortexers, refrigerators, freezers, centrifuges, open bench work areas, liquid and dry biohazardous waste containers and transport containers).
  • Biohazardous materials must be transported in appropriately-labeled containers or equipment. For transport this means that the container must prevent release to the environment or exposure to people if it is dropped or tipped during transport and it should accommodate the volume of the liquid and contain enough absorbent material in the secondary container to absorb the entire volume in case of a spill.
  • It is the responsibility of the Principal Investigator to ensure that biological safety cabinets in their laboratories are certified annually – (UC Davis PPM 290-55, UC Davis Biosafety Cabinet Policy). The auditor will verify that BSCs have been certified within the past year.

Sanitation, disinfection, and waste:

Auditors will check your equipment and practices related to disposal and spill cleanup.

Sanitation, disinfection, and waste

  • Auditors will review your eyewash testing records to verify that eyewash or eye flush stations within the laboratory are being flushed monthly (see Cal-OSHA requirement).
  • Biological spill SafetyNet and spill kit: Auditors will verify that you have posted SafetyNet #127 and that you have a spill kit stocked with supplies to clean up biological spills.

Disinfection practices:

  • The auditor will review your practices for disinfecting waste generated in your laboratory and will check the boxes indicating which practices you are using.
    • "Mixed biohazardous waste" is any mixture of viable biohazardous waste mixed with chemical or radiological waste.

  • Auditors will review your sharps disposal practices and will check your sharps container to ensure it is appropriately maintained, labeled, and not overfilled.
    • Serological pipets used for handling biohazardous materials can be disposed into a sharps container or can be bundled and disposed as solid medical waste in a red medical waste bag.
    • Sharps contaminated with human biohazards should be disposed in a sharps waste container labeled with a biohazard symbol.
    • Sharps waste which does not contain human biohazards should be disposed in a sharps container with no biohazard or medical waste caution signs. If the sharps container was supplied with a biohazard symbol, remove or deface the symbol and write "non-infectious" on the container.

Medical waste:

  • The lid should be secure enough to prevent spillage of contents if the secondary container is tipped over.
  • The auditor will verify that the waste is appropriately labeled before it is removed from the laboratory.
  • If you are disposing serological pipettes in red bag waste the auditor will verify that the pipettes are bundled to prevent from tearing the bag.