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Purpose

The purpose of the UK Biosafety Laboratory Inspection program is to ensure compliance with all federal, state, and local regulations, review biosafety practices outlined in relevant Institutional Biosafety Committee (IBC) protocols, identify biosafety gaps, and offer real-time, practical solutions to biosafety challenges in the research community.

What to expect?

There are 4 different types of biosafety laboratory inspection.

  1. Biosafety Inspection (Annual) - These inspections must be completed prior to approval of any full IBC protocol registration (New or Renewal), annually thereafter, any time there is a change of laboratory locations, or any changes in work with biohazardous materials that significantly alter the risk assessment. These inspections are scheduled in advance with the PI or their designee and focus on work with biohazardous materials as described in the corresponding IBC protocol(s).
  2. Biosafety Walkthrough (Annual) - These inspections are completed annually by building and are unannounced. These inspections are based on visual findings observed at the time of inspection. Biosafety walkthrough inspections are scheduled by the Office of Biological Safety in coordination with other departments within UK EH&S. Biosafety Walkthrough inspections are not intended to disturb research laboratory work.
  3. Clinical Biosafety Inspection - These inspections must be completed prior to approval of any full IBC protocol registration (New or Renewal) and annually thereafter for those UK Healthcare Clinical locations associated with UK IBC protocol registrations. Clinical Biosafety Inspections should never interfere with patient care.
  4. FSAP Select Toxin Inspection - These inspections are completed annually for all laboratories possessing exempt quantities of Select Toxins as designated by the Federal Select Agent Program (FSAP).

How to prepare?

Biosafety laboratory inspections are not intended to be punitive, but rather an opportunity to identify safety gaps and solutions with the Biosafety Team. 

Tips & Tricks

  1. Review your laboratory's profile in SciShield, our research management platform. Ensure the lab spaces, personnel, and hazards are listed correctly.
  2. Ensure all lab personnel are reflected in the Lab Safety Manual's Chemical Hygiene Plan (CHP) personnel page.
  3. Ensure all lab personnel have completed and documented Laboratory Specific Training.
  4. Update all required online training.
  5. Review and update lab door signage, if needed.
  6. Review the Biosafety Inspection checklist.

Biosafety Inspection Checklist

Please refer to the following checklist to familiarize yourself with what our Biosafety Team looks for during inspections, as well as the corrective action to fix any potential issues.

Click HERE to view the full Biosafety Inspection Checklist document.

NOTE - Not every item listed here will apply to your laboratory. Reach out to UK Biosafety at biosafety@uky.edu with questions.

Prior to Entering Laboratory

Information on Laboratory Door Sign is incomplete, outdated, or incorrect. 

Corrective Action: Door signs must be placed on ALL entry doors to laboratory spaces. Door sign information must be reviewed & signed at least annually. 

Compliant door signage must display the following: 

  • PI and/or responsible individual and emergency contact information 
  • Symbols for materials stored or used within laboratory. Ex. universal biological or radiological hazard symbols, GHS pictograms for chemicals and compressed gas cylinders. 
  • Text or symbols indicating any other present hazards. Ex. electrical hazards, strong magnetic hazards, noise, etc. 
  • Require PPE and additional precautions required for entry. 

Instructions for generating laboratory door signage is available in SciShield -> Research Tools -> Document Library.

Area doors open to non-research space.

Corrective Action: Area doors must remain closed to non-research space or shared hallways.

Area doors unlocked when space unoccupied.

Corrective Action: Area doors shall be locked when the space is unoccupied.

Inside Laboratory: General

CHP/Lab Safety binder not available to personnel.

Corrective Action: Make CHP/Lab Safety binder available to personnel.

CHP ID page is not current and/or dated.

Corrective Action: Update and sign the ID page. A template is available in SciShield -> Research Tools -> Document Library.

Lab does not have a Chemical Hygiene Plan and/or Lab Safety Binder.

Corrective Action: Email labsafety@uky.edu for CHP.

Unable to locate Lab Specific Training documentation and/or lab personnel unaware of this requirement.

Corrective Action: Principal Investigator and/or Lab Manager must complete Lab Specific Training documentation for all lab members. Laboratory-Specific Training Checklist available online here.

Applying cosmetics (including lip balm) or handling contact lenses in the lab.

Corrective Action: Applying cosmetics (include lip balm) or handling contact lenses is prohibited in the lab.

Eating and/or drinking in the lab.

Corrective Action: Food and drink are prohibited in all research wet labs. Please view policy and instructions for obtaining exemption online here.

Foodstuffs utilized for research not labeled for intended use.

Corrective Action: Label all foodstuffs as "Not for Human Consumption" or similar.

Handwashing sink lacking liquid hand soap and/or paper towels.

Corrective Action: Liquid hand soap and/or paper towels must be made available to allow for handwashing after removal of gloves, when visibly contaminated, and before leaving the lab.

Lab personnel wearing improper lab attire (e.g. shorts, open-toed shoes).

Corrective Action: Lab personnel must wear proper attire in the lab. 

*Research Safety Tip - In summer months, store a pair of scrub pants and tennis shoes for lab use.

Personal items/electronics used with PPE or in active work areas. 

Corrective Action: Personal items, such as electronics, are not to be handled with PPE (gloves) or in active work areas (viral vector use areas, BSCs).

Personnel do not wash hands after removing gloves, working with potentially hazardous material, and before leaving the lab. 

Corrective Action: Personnel must be instructed to wash hands after removing gloves, after work with potentially hazardous materials, and prior to leaving the lab.

Poor housekeeping of lab space. 

Corrective Action: Appropriate housekeeping of lab surfaces (e.g., floors, walls, and other “housekeeping surfaces”) to facilitate cleaning and minimize the accumulation of debris and/or fomites is required.

Personnel are not aware of IBC protocol and/or regulatory resources (e.g. CDC BMBL, NIH Guidelines, etc.).

Corrective Action: Personnel must be made aware of IBC protocol and appropriate regulatory resources. 

*Research Safety Tip – 

Access to equipment used for storage of biohazardous materials is not controlled.

 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

Corrective Action: Through the use of locks or other control methods, access shall be restricted to equipment used for storage of or potentially contaminated with biohazardous materials (e.g. human pathogens and OPIM.)

Unauthorized individuals in the lab. 

Corrective Action: Only authorized personnel are permitted in the lab.

Inside Laboratory: Emergency Procedures

Emergency numbers are not posted in the laboratory. 

Corrective Action: Emergency numbers must be posted in the lab. Provide Research Safety Contact Info magnet, if available.

First-aid kit not readily available. 

Corrective Action: Make first-aid kit readily available in lab.

Lab personnel are not aware of emergency procedures. 

Corrective Action: Train all lab personnel regarding their responsibilities in an emergency. These responsibilities may range from notify and evacuate to cleaning up a small spill if the personnel are properly trained and comfortable in completing these tasks.

Occupational Injury & Exposure Protocol for Laboratories is not posted or made available to personnel.

 Corrective Action: Ensure Occupational Injury and Exposure Protocol for Laboratories available to personnel.

Biohazard spill kit not available. 

Corrective Action: Ensure biohazard spill supplies are available. Email biosafety@uky.edu to request spill kit.

Inside Laboratory: Personal Protective Equipment (PPE)

Appropriate PPE not available. 

Corrective Action: PPE for the work conducted shall be made available to personnel at all times.

Lab coats laundered at home. 

Corrective Action: Lab coats must be laundered on site or through an approved vendor.

Lab coats not laundered when visibly soiled. 

Corrective Action: Lab coats must be laundered when visibly soiled.

Lab personnel not wearing PPE according to hazard assessment OR PPE improperly utilized. 

Corrective Action: Lab personnel must wear appropriate PPE in the lab, according to SOPs and risk assessments.

Lab personnel reusing single use items (e.g. gloves). 

Corrective Action: Disposable, single-use PPE must be decontaminated and disposed of after use.

PPE worn outside of laboratory area. 

Corrective Action: All PPE, including lab coats and disposable gloves, shall be removed before exiting the lab and entering public corridors and non-laboratory spaces.

Inside Laboratory: Biohazardous Waste

Laboratory Waste Guidelines

Appropriate disposal procedures for Regulated Medical Waste (RMW) not followed. 

Corrective Action: Use appropriate disposal procedures for RMW. At the University of Kentucky, medical waste is not autoclaved and instead is sent to a licensed vendor; therefore, lab disposal of this waste requires special designation by the use of a red bag.

Bagged biohazard waste containers > 2/3 full. 

Corrective Action: Close and process biohazardous waste containers when no greater than 2/3 full to allow for adequate space for steam penetration and proper fit inside the autoclave chamber.

Bagged biohazard waste directly on floor, not in leak-proof container. 

Corrective Action: Biohazardous waste, if not to be immediately autoclaved, should set within a leak proof container to prevent puncture and/or leakage.

Improper biohazard waste container. 

Corrective Action: Utilize correct container for UK disposal procedures. Containers must be sturdy enough to withstand load. 

Improper pipette disposal in mixed bagged waste. 

Corrective Action: Pipettes and pipette tips contaminated with biohazardous materials may be collected in a plastic-lined box, sealed shut, and enclosed in an autoclave bag for processing as solid biohazardous waste. Loose pipettes or tips in bagged trash are strictly prohibited.

Improper use of autoclave. 

Corrective Action: Use autoclave in accordance with SOPs and UK policy.

Inappropriate autoclave bags used. 

Corrective Action: Autoclave bags should be clear/opaque or orange and marked with the universal biohazard symbol. Red bags are designated for RMW only and must never be autoclaved.

Lab does not maintain control of unautoclaved waste until cycle has begun. 

Corrective Action: Maintain control of unautoclaved waste until the cycle has begun. Biohazard waste must never be left unattended/unsecured.

Lack of proper sharps containment.

Corrective Action: Sharps potentially contaminated with biohazardous material must be placed in a sealed, hard plastic, medical sharps container marked with the universal biohazard symbol OR is red in color. Medical sharps containers must be no greater than 2/3 full and closed shut for pickup. Sharps not used in conjunction with biohazardous materials may be placed in a hard plastic or metal container with a screw-on lid. When full, lid must be reinforced with heavy-duty tape, marked “Not Recyclable Trash, and placed with regular trash for pickup.

Leak-proof container not utilized for transport of waste to autoclave facility. 

Corrective Action: Use a leak-proof container suitable for transport of waste to autoclave facility.

Potentially biohazardous materials NOT properly decontaminated prior to disposal. 

Corrective Action: Potentially biohazardous materials must be properly decontaminated prior to disposal per SOPs.

Potentially contaminated glassware not disposed of properly. 

Corrective Action: Contaminated glassware may be disposed of as biohazardous sharps waste. Alternatively, contaminated glassware may be collected in a plastic-lined box, sealed shut, and enclosed in an autoclave bag for processing as solid biohazardous waste.

Unprocessed biohazard waste stockpiled. 

Corrective Action: Biohazard waste should be autoclaved and disposed of in a timely fashion.

Sharps containers > 2/3 full. 

Corrective Action: Sharps containers must never be filled greater than 2/3 full.

Inside Laboratory: Vacuum

Liquid biowaste not emptied regularly. 

Corrective Action: Liquid biowaste must be decontaminated and emptied at the end of each workday OR when 2/3 full, whichever comes first.

Liquid biowaste pH not tested prior to sink disposal. 

Corrective Action: Once appropriate concentration and contact time have been met for decontamination, test the pH using a pH meter or pH test strip (available upon request - biosafety@uky.edu) to ensure it is within acceptable drain disposal limits (5.5-11.5 SU) PRIOR to sink disposal. 

*Research Safety Tip – email biosafety@uky.edu to request pH test strips.

No disinfectant in trap flask for vacuum line. 

Corrective Action: Trap flask for vacuum line should be primed with an appropriate disinfectant for the work performed. Microorganisms such as mold should not be observed growing in the traps.

No double flask on BSC vacuum line trap set-up. 

Corrective Action: BSC vacuum line trap set-up requires a double catch flask.

No secondary container for trap flasks. 

Corrective Action: Trap flasks not housed in BSCs should be placed in secondary containers and placed in a safe location to prevent spillage and breakage. 

*Research Safety Tip - Email biosafety@uky.edu to request secondary container for trap flasks.

Trap flask for vacuum line >2/3 full.

Corrective Action: Liquid biowaste must be decontaminated and emptied at the end of each workday OR when 2/3 full, whichever comes first.

Vacuum line set-up lacks protection with filtration device. 

Corrective Action: Proper vacuum line set-up requires protection of vacuum lines with filtration device. 

*Research Safety Tip - Email biosafety@uky.edu to request hydrophobic/HEPA vacuum line filter.

Inside Laboratory: Biological Safety Cabinet (BSC)

Evidence that BSC is not properly cleaned on a routine basis. 

Corrective Action: BSC must be properly cleaned and decontaminated on a routine basis according to SOPs.

Improper material storage in BSC. 

Corrective Action: Remove materials stored in BSC. Grills in the front and back of BSC must never be blocked to ensure proper airflow and containment.

Procedures which generate infectious aerosols NOT contained per SOP. 

Corrective Action: Work which requires use of a BSC cannot be performed in the fume hood, animal changing station, or other exposure control device.

Prohibited source of flame in BSC. 

Corrective Action: Use of open flame (ex. Bunsen burner) in a BSC is strictly prohibited. Please contact biosafety@uky.edu for flame alternatives.

BSC certification is expired. 

Corrective Action: BSCs in use with biohazardous materials must maintain annual certification from an approved vendor. BSCs not in active use must be marked by Biosafety Office.

UV lights in BSC used improperly. 

Corrective Action: UV lights in BSC must not be used as the primary means of decontamination or with open sash.

Inside Laboratory: Decontamination

Bench paper not changed regularly. 

Corrective Action: Surfaces where work with viable microorganisms or cultures is done must be decontaminated regularly (and particularly after any spill or splash of viable material) with disinfectants that are effective against the agents of concern. Bench paper when used on such surfaces must be disposed of (placed with the biohazard trash) daily.

Equipment is not properly cleaned and decontaminated. 

Corrective Action: Laboratory equipment must be decontaminated with an effective disinfectant on a routine basis, after working with infectious materials, and especially after overt spills, splashes, or other contamination by infectious materials. Contaminated equipment must be decontaminated before it is sent for repair or maintenance.

Potentially infectious materials not centrifuged according to SOP. 

Corrective Action: When centrifuging biohazardous or potentially infectious materials, use aerosol-tight safety rotors/buckets/cups. Centrifuge rotors/buckets/cups must be loaded/unloaded in the BSC and wiped down with appropriate disinfectant prior to removal from BSC. Centrifuge tubes must be sealed (i.e. plates sealed with Parafilm) or capped.

Proper disinfectant not available for use. 

Corrective Action: Proper disinfectant must be available for use. 

*Research Safety Tip - Approved disinfectant(s) will be listed on corresponding IBC protocol(s).

Work surfaces not decontaminated after procedures OR when work is completed for the day. 

Corrective Action: Decontaminate all work surfaces in between experiments and when work is completed for the day.

Inside Laboratory: Equipment

Eyewash access is obstructed. 

Corrective Action: Keep area around eyewash clear of obstructions.

Safety shower access is obstructed. 

Corrective Action: Keep area around safety shower clear of obstructions.

Appropriate containment for transport and/or storage of potentially infectious materials unavailable. 

Corrective Action: Utilize leak-proof, shatter-proof, secure-lidded, secondary container for transport of biohazardous or potentially infectious materials between UK campus locations.

Lab chairs covered with non-porous material. 

Corrective Action: Lab chairs and other lab furniture must be covered with non-porous material. 

*Research Safety Tip – Check out Surplus for non-porous lab chairs or get crafty with duct tape.

Plasticware is NOT substituted for glassware whenever possible. 

Corrective Action: Whenever possible, substitute plasticware for glassware when working with potentially biohazardous materials. 

*Research Safety Tip – Try plastic “plasteur” pipettes in lieu of Pasteur pipettes.

Potentially contaminated equipment NOT marked with the universal biohazard symbol. 

Corrective Action: Label potentially contaminated equipment with the universal biohazard symbol.

Compressed gas cylinders are not restrained. 

Corrective Action: Secure all compressed gas cylinders with appropriate restraint.

Inside Laboratory: Facilities

Handwashing sink not available. 

Corrective Action: Handwashing sink is required.

Lab surfaces not easily cleaned and decontaminated. 

Corrective Action: Lab surfaces must be easily cleaned and decontaminated.

Mold growing in cold room.

Corrective Action: Moldy items must be removed and all surfaces wiped down with a cleaning/disinfecting solution. Cardboard and other cellulose-based items must not be stored long term in cold rooms.

Positive or static airflow relative to uncontaminated areas. 

Corrective Action: Lab airflow must be negative relative to uncontaminated areas. UK OHS will be notified of ventilation issue.

Separate desk space/break area not available. 

Corrective Action: Designate separate desk and break space apart from wet lab work area.

Inside Laboratory: Animal Work

Animals not associated with lab work present. 

https://www.cdc.gov/labs/BMBL.html

Corrective Action: Animals unassociated with lab work must be removed from lab area.

Use of live research animals in conjunction with biohazards deviates from lab SOPs. 

Corrective Action: Use live research animals in conjunction with biohazards as outlined in lab SOPs.

Inside Laboratory: Select Toxins

Lab possesses unreported Select Toxins. 

Corrective Action: Select Toxins of biological origin must be registered with the Biological Safety Office. 

https://www.selectagents.gov/sat/list.htm

 

Inside Laboratory: Plant Work

Biohazardous/Transgenic plant materials handled outside confined space or without containment measures in place. 

Corrective Action: Biohazardous/Transgenic seeds, tissue culture, plant materials etc. must be handled in confined space or with containment measures in place. Ex. includes the replacement of worn sticky pads.

Biohazardous/Transgenic plant materials not secured. 

Corrective Action: Biohazardous/Transgenic plant materials must be secured with controlled access.

Biohazardous/Transgenic seeds and/or plants improperly labeled or lack labeling. 

Corrective Action: Biohazardous/Transgenic seeds and/or plants must be labeled. Racks, trays, growth chambers, etc. must be labelled with PI/contact information.

Biohazardous/Transgenic seeds, tissue culture, plant materials, etc. not transported appropriately in secondary containment. 

Corrective Action: Biohazardous/Transgenic seeds, tissue culture, plant materials etc. must be transported appropriately (i.e. secondary containment).

Deviation from disposal methods/devitalization of collected seeds/material outlined in SOP. 

Corrective Action: Disposal methods and devitalization of collected seeds or plant material must be performed as outlined in SOPs and/or permits.

Growth area contains cracks, irregular surfaces, or obvious places where seeds may become trapped or lost. 

Corrective Action: Growth area must be free of cracks, irregular surfaces, or obvious places where seeds may become trapped or lost.

Plants unassociated with lab work are present. 

Corrective Action: Plants unassociated with lab work must be removed from lab area.

Release of biohazardous/transgenic plant materials or seed. 

Corrective Action: May require additional regulatory reporting. Contact UK Biosafety Officer.

Water drainage in growth area not properly contained. 

Corrective Action: Water drainage in growth area must be properly contained. (Ex. absent, screened, or trapped).

Inside Laboratory: Hazardous Waste

Containers uncapped or with funnels in them. 

Corrective Action: All containers must be closed with a tight-fitting lid unless contents are being added to them. Place a compatible lid on the container or, if an HPLC effluent container, install a cap with holes drilled in it for the tubing.

Hazardous waste containers not marked with the hazard warning information for the waste being accumulated.

Corrective Action: All hazardous waste containers must have the primary hazards of the material being accumulated indicated on the label (for example: flammable liquid, explosive, organic peroxide, corrosive, etc.). Premade labels may be obtained by request: Environmental Quality Management, Maridely Loyselle: mmloys2@uky.edu.

Hazardous waste container is not labeled with constituents and their approximate percentages/volumes. 

Corrective Action: The contents of the container and their approximate percentages/volumes should be clearly written and affixed to the container. This list should be kept up to date as waste is added.

Hazardous waste containers not labeled with the words “Hazardous Waste”. 

Corrective Action: A waste accumulation container must be labeled with the words 'HAZARDOUS WASTE' as soon as waste is introduced into the container unless the waste is Ethidium Bromide or Formalin. These 2 wastes should be labeled as 'NON-RCRA REGULATED WASTE.' Premade labels may be obtained by request: Environmental Quality Management, Maridely Loyselle: mmloys2@uky.edu.

Waste containers are not in a secure area or under control of waste generator. 

Corrective Action: All Hazardous Waste containers must be under the control of the generator. This may be accomplished by having the containers in direct line of sight or having the containers behind a locked door, such as the lab door being locked when personnel are not present in the lab.