Short answer: A laboratory biosafety checklist should follow a documented risk assessment and cover biosafety cabinets, PPE, sharps and waste, spill response, staff vaccination and exposure records, disinfectants, access control, chemical safety, incident reporting and specimen transport. Audit it quarterly, record findings, assign corrective actions and retrain staff where gaps appear.
- Start with a risk assessment, as the WHO Laboratory Biosafety Manual 4th edition recommends.
- Check daily and monthly items routinely, and audit the full checklist every quarter.
- Specimens shipped as UN3373 need P650 triple packaging and trained staff.
- Every finding needs an owner, a deadline and a check that the fix worked.
Why should a biosafety checklist start with a risk assessment?
A biosafety checklist is only useful if it reflects the real hazards in your laboratory, and a risk assessment is how you find them. The WHO Laboratory Biosafety Manual, 4th edition (2020) moved away from relying on fixed biosafety levels alone towards a risk-based approach: identify the agents, procedures, equipment and people involved, judge the likelihood and consequence of exposure or release, then choose control measures proportionate to that risk.
ISO 35001:2019, the biorisk management standard for laboratories and other related organisations, puts the same idea into a management system: policy, risk assessment, controls, competence, monitoring and continual improvement. Under ISO 15189:2022, the laboratory’s facilities and safety arrangements are also part of what assessors review.
Practically, review your biosafety risk assessment at least annually and whenever you introduce a new test, agent, piece of equipment or procedure. Then build the checklist from the controls it identifies.
What should a laboratory biosafety checklist include?
A laboratory biosafety checklist should include engineering controls, personal protection, waste, emergency response, health surveillance, decontamination, biosecurity, chemical safety, incident reporting and specimen transport. The table below is a practical starting point; adapt the frequencies to your risk assessment and national requirements.
| Checklist item | What to check | How often |
|---|---|---|
| Biosafety cabinet (BSC) certification | Valid certification label and report from a qualified engineer; recertification after relocation, filter change or major repair | At least annually; label checked quarterly |
| BSC daily checks | Airflow alarm or indicator working, sash at correct height, grilles unobstructed, work surface decontaminated, log completed | Daily (log reviewed quarterly) |
| Personal protective equipment | Correct PPE available in all sizes, worn as the risk assessment requires, removed before leaving work areas, stock levels adequate | Spot checks weekly; full review quarterly |
| Sharps and waste segregation | Puncture-resistant sharps containers not overfilled, colour-coded bins used correctly, infectious waste autoclaved or collected by a licensed handler, records kept | Monthly; quarterly audit |
| Spill response | Spill kits complete and in date, written procedure posted, staff can describe the steps, last drill recorded | Kit check monthly; drill at least annually |
| Staff vaccination and exposure records | Hepatitis B vaccination status recorded, other vaccines as risk assessment requires, needlestick and exposure incidents logged with follow-up | Quarterly review; on recruitment |
| Decontamination and disinfectants | Correct disinfectant for the agents handled, dilutions labelled with preparation and expiry date, contact times followed, autoclave validation records | Daily preparation where required; quarterly audit |
| Signage, access control and biosecurity | Biohazard signs on doors, restricted access to work areas, inventory of high-risk materials, visitor log, freezers and stocks secured | Quarterly |
| Chemical safety | Safety data sheets accessible, chemicals labelled and stored by compatibility, fume hood working, eyewash and shower tested | Eyewash weekly; quarterly audit |
| Incident reporting | Incidents and near misses reported, investigated, and closed with corrective action; trends reviewed | Quarterly review |
| Specimen packaging and transport | UN3373 specimens packed to P650 triple packaging, correct marks and labels, documentation complete, packers trained and training records current | Every shipment; quarterly audit |
| Staff biosafety training | Induction and refresher training recorded, competence assessed for BSC use, spill response and waste handling | Quarterly review; refresher at least annually |
How do you run a quarterly biosafety audit?
Run a quarterly biosafety audit as a planned internal audit: use a fixed checklist, observe work in progress, check records, and turn every gap into a tracked corrective action.
- Plan the audit. Agree the date, scope and auditor with the laboratory manager. Use someone who does not work in the area being audited where possible.
- Prepare the checklist. Use the table above, adjusted for your risk assessment, and pull the previous quarter’s findings so you can check that actions were closed.
- Observe live work. Watch BSC use, PPE practice, waste handling and specimen packing as they happen, not only the records.
- Review records. BSC logs and certificates, disinfectant preparation logs, autoclave records, vaccination and exposure files, training records and incident reports.
- Talk to staff. Ask how they would respond to a spill or a needlestick injury. Their answers show whether procedures are understood.
- Grade and record findings. Separate nonconformities from observations, and note the evidence for each.
- Agree corrective actions. Use root cause analysis for significant findings and assign an owner and deadline to each action.
- Report and follow up. Share results with management, feed them into management review, and verify effectiveness at the next audit.
What are the most common biosafety audit findings?
Common biosafety audit findings tend to involve everyday controls that slip when the laboratory is busy, rather than rare or complex failures.
- Biosafety cabinet certification overdue, or daily checks not recorded.
- Gloves and gowns worn outside the work area, including at desks and phones.
- Sharps containers filled beyond the fill line, or mixed waste in the wrong bins.
- Spill kits incomplete, expired or locked away, and no record of a drill.
- Disinfectant dilutions unlabelled, past their use-by time or wrong for the agents handled.
- Missing Hepatitis B vaccination records for new staff, and exposure incidents not followed up.
- Near misses not reported, so trends are invisible.
- Specimens sent in improvised packaging, without UN3373 marking, or prepared by untrained staff.
- Risk assessment not updated after a new test or analyser was introduced.
Many of these are occurrence management problems as much as safety problems. Our guide to building a laboratory quality management system explains how facilities and safety fit alongside the other quality system essentials.
How do you ship biological specimens under UN3373?
Specimens classified as UN3373 “Biological Substance, Category B” are shipped by air under IATA Packing Instruction 650, using triple packaging and the UN3373 diamond mark. The three layers are:
- A leak-proof primary receptacle containing the specimen.
- Leak-proof secondary packaging enclosing the primary receptacle, with enough absorbent material for liquids.
- Rigid outer packaging of adequate strength, marked with UN3373 and the proper shipping name.
Category A infectious substances (UN2814 and UN2900) follow stricter rules, including specific packaging, documentation and training requirements. Classification is the shipper’s responsibility, so staff must be able to tell the categories apart. Requirements are updated regularly and road transport rules can differ by country, so always check the current IATA Dangerous Goods Regulations and your national requirements before shipping.
Why does biosafety and biosecurity training matter?
Biosafety and biosecurity training matters because most checklist controls depend on people doing the right thing every day, and audits only find gaps after they appear. Trained staff understand why a control exists, so they keep using it when no one is watching.
Training is also a specific requirement for anyone who prepares infectious substances for transport. Staff who classify, pack, mark or document shipments need appropriate dangerous goods training, with refreshers at intervals set by the regulation and the operator. In Kenya, biosafety competence also supports SLIPTA and ISO 15189 assessments, where facilities and safety are reviewed.
Biosafety sits within the laboratory’s wider approach to risk. Tools such as FMEA, root cause analysis and CAPA help you prioritise hazards and make corrective actions stick, which is the focus of the Risk Management in the Clinical Laboratory course. Laboratory managers who need to resource safety, staffing and equipment can build those skills in the Clinical Laboratory Management course. For training choices across the team, see our guide to laboratory staff training options.
How can your team build biosafety skills with Elmenta?
The Biorisk, Biosafety and Biosecurity course is a 5-day, in-person programme run once a year in September in Nairobi. It is aligned to ISO 35001 and the WHO Laboratory Biosafety Manual, is taught by an IATA-certified trainer, and covers packaging and transporting infectious substances. The fee is USD 3,000, including accommodation and airport transfer where applicable. Participants receive a certificate of completion from Elmenta.
Places are limited to cohorts of 5 to 30, and the course can also be delivered in-house for a laboratory team. See dates on the training calendar.
Make your biosafety checklist work in practice. Join the annual September cohort in Nairobi and learn risk assessment, biosecurity and specimen transport from an IATA-certified trainer.
Frequently asked questions
How often should a biosafety cabinet be certified?
Biosafety cabinets are normally certified at least once a year by a qualified engineer, and again after they are moved, after a HEPA filter change or after major repair. Users should also check the airflow indicator and alarm before each use and keep a daily log. Follow the manufacturer's instructions and any national requirements.
Who should carry out a laboratory biosafety audit?
A trained internal auditor or the laboratory's biosafety officer usually leads the audit, ideally someone who does not work in the area being audited. They should understand the risk assessment, the relevant procedures and audit technique. Findings go to the laboratory manager, who assigns corrective actions and reviews progress at management review.
What is the difference between biosafety and biosecurity?
Biosafety protects people and the environment from accidental exposure to biological agents, through containment, PPE, safe practice and waste management. Biosecurity protects biological materials from loss, theft, misuse or intentional release, through access control, inventory, secure storage and personnel reliability. ISO 35001 treats both together as biorisk management.
Is Hepatitis B vaccination required for laboratory staff?
Hepatitis B vaccination is widely recommended for laboratory staff who handle blood or body fluids, and many employers and national guidelines require it. The laboratory should offer vaccination, record each person's status, and check immunity where policy requires. Other vaccines depend on the agents handled, as identified in the risk assessment.
Does a certificate of completion qualify me to ship infectious substances?
Not automatically. Shipping infectious substances requires training that meets the applicable dangerous goods regulations, such as IATA for air transport, and your employer must confirm you are competent for the tasks you perform. Check which training records your airline, courier and national authority accept before you prepare shipments.
