Laboratory biosafety guidance related to

coronavirus disease (COVID-19)

Interim
guidance 28
January 2021

Background LBM4.

The purpose of this document is to provide interim guidance

on laboratory biosafety related to the testing of clinical
specimens of patients.

Highlights of SARS-CoV-2 laboratory biosafety

 All procedures must be performed based on risk
assessment and only by personnel with demonstrated
capability, in strict observance of any relevant
protocols at all times.
 Initial processing (before inactivation) of specimens
should take place in a validated biological safety
cabinet (BSC) or primary containment device.
 Non-propagative diagnostic laboratory work (for
example, sequencing, nucleic acid amplification test
[NAAT]) should be conducted at a facility using
heightened control measures similar to Biosafety Level
2 (BSL-2).
 Point of care (POC), near-POC assays and antigen-
detecting rapid diagnostic tests (Ag-RDTs) can be
performed on a bench without employing a BSC, when
the local risk assessment so dictates and proper
precautions are in place.
 Propagative work (for example, virus culture or
neutralization assays) should be conducted in a
containment laboratory with inward directional airflow
(heightened control measures/BSL-3).
 Appropriate disinfectants with proven activity against
enveloped viruses should be used (for example,
hypochlorite [bleach], alcohol, povidone‐iodine,
chloroxylenol, chlorhexidine, benzalkonium chloride).
Patient specimens from suspected or confirmed cases
should be transported as UN3373, “Biological Substance
Category B”. Viral cultures or isolates should be
transported as Category A, UN2814, “infectious
substance, affecting humans”.

In this updated version of the Laboratory biosafety guidance

related to SARS-CoV-2, the virus that causes coronavirus
disease (COVID-19), the following topics were added: biosafety
aspects for working with antigen-detecting rapid diagnostic tests,
handling new variants of SARS-CoV-2 in the laboratory,
updated assay decontamination before disposal, personal
protective equipment (PPE) for specimen collection and, even
though not directly a biosafety issue, this version of the guidance
addresses chemical hazards and their safe disposal. Furthermore,
the fourth edition of the WHO (World Health Organization)
Laboratory biosafety manual (LBM4) (1) is now available
and the terminology in this guidance was aligned with the
1
Laboratory biosafety
It is essential to ensure that health laboratories adhere to
appropriate biosafety practices. Any testing for the
presence of SARS-CoV-2 or of clinical specimens from
patients meeting the suspected case definition (2) should
be performed in appropriately equipped laboratories, by
staff trained in the relevant technical and safety
procedures. National guidelines on laboratory biosafety
should be followed in all circumstances. For general
information on laboratory biosafety guidelines, see the
WHO Laboratory biosafety manual: fourth edition (1).

Key points
 Each laboratory should conduct a local (that is,
institutional) risk assessment to ensure it is
competent to safely perform the intended testing
with appropriate risk control measures in place
as exemplified in Annex II.
 Appropriate PPE for droplet or airborne
precaution, as determined by a detailed local risk
assessment, should be worn when laboratory
personnel collect patient samples. Droplet
precautions are necessary for most of the
commonly performed sample collection
procedures such as oropharyngeal and
nasopharyngeal swabs. Airborne precautions,
may be necessary, for example, for collection of
nasopharyngeal wash/aspirate, sputum, tracheal
aspirate, bronchioalveolar lavage fluid and
pleural fluid (3,4). The minimum PPE for
droplet precautions should include medical
mask, eye protection (goggles, face shield etc.),
disposable gloves and solid-front or wrap-
around or back- fastening gown. Minimum PPE
for airborne precautions should include gloves,
long-sleeved gowns, eye protection, and fit-
tested particulate respirators. A local risk
assessment should also specify the PPE worn by
all laboratory personnel handling these
specimens.
 When handling and processing specimens,
including blood for serological testing,
laboratory practices and procedures that are
basic to good microbiological practice and
procedure (GMPP) (refer to Annex I) should be
followed.
 The handling and processing of specimens from
cases with suspected or confirmed SARS-CoV-2
infection that are intended for additional
laboratory tests, such as haematology or blood
gas analysis, should follow standard guidelines
without additional measures.

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
 Non-propagative diagnostic laboratory work, an integral part of, laboratory biosafety. These measures reflect international
standards and best practice in biosafety that are necessary to work safely with
including sequencing and NAAT, on clinical biological agents, even where the associated risks are minimal.
specimens from patients who are suspected or
confirmed to be infected with SARS-CoV-2, should
be conducted adopting the practices and procedures
of “core requirements”,1 as detailed in Annex I, and
an appropriate selection of “heightened control
measures”,2 as informed by the local risk assessment.
 Handling of material with high concentrations of
live virus (such as when performing virus
propagation, virus isolation or neutralization
assays) or large volumes of infectious materials
should be performed only by properly trained
and competent personnel in laboratories
meeting additional essential containment
requirements and practices, that is, heightened
control measures (BSL-3).
 Initial processing other than POC/near-POC and Ag-
RDTs of specimens that need RNA extraction, such
as sequencing and NAAT, should take place in an
appropriately maintained and validated BSC
(biological safety cabinet) or primary containment
device.
 The external lysis buffer of the listed common
RNA extraction kits is effective in inactivating the
SARS- CoV-2 virus without heat or other
additional means (5).
 Appropriate disinfectants with proven activity
against enveloped viruses should be used for the
recommended contact time, at the correct dilution
and within the expiry date after the working
solution is prepared.
 All technical procedures should be performed in a
way that minimizes the generation of aerosols and
droplets (6).
 Patient specimens from suspected or confirmed
cases should be transported as UN3373,
“Biological Substance Category B”. Viral cultures
or isolates should be transported as Category A
UN2814, “infectious substance, affecting humans”
(7).

Recommendations addressing
minimal/essential working conditions
associated with specific manipulations in
laboratory settings
The additional recommendations provided in this section
address the minimal/essential working conditions associated
with specific manipulations in laboratory settings.

1. Risk assessment
Risk assessment is a systematic process of gathering
information and evaluating the likelihood and impact of
exposure to or release of workplace hazard(s), and
determining the appropriate risk control measures to reduce
the risk to an acceptable level. Hazards alone do not pose a
risk to humans

1
Core requirements: A set of minimum requirements defined in the 4th
edition of the WHO Laboratory biosafety manual to describe a
combination of risk control measures that are both the foundation for, and
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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
or animals. The types of equipment used and guidance the risk assessment indicates that the biological agents being handled and/or
the activities to be performed with them are associated with a relatively
procedure(s) performed with the biological agent also play high risk that cannot be acceptable solely with the core requirements.
a role.
It is highly recommended to start by conducting a local risk
assessment for each process step, that is, from sample
collection, sample reception, clinical testing, polymerase
chain reaction (PCR), antigen detection (such as lateral
flow assays or automated high throughput immunoassays)
to virus isolation (only when and where applicable).
Specific hazards will be identified for each process step,
such as aerosol exposure during sample processing; eye
splash during sample processing; infectious culture material
spill; chemical hazards associated with reagents and leaking
sample receptacles. Each process step has its own assessed
risk. For each identified risk, appropriate risk control
measures, including the following recommendations,
should be selected and implemented, to mitigate the
residual risks to an acceptable level.
New knowledge about SARS-CoV-2 including the
emergence of new mutations and variants, may require a
risk re- assessment that may necessitate additional risk
control measures.

Particular consideration should be given to risks related to

human factors. The likelihood of errors and incidents are
higher when staff training is insufficient and staff members
are under pressure to produce rapid results.
A risk assessment template is provided in Annex II; this is
intended to serve as an example and to facilitate the
process.

2. Routine laboratory procedures, including non-

propagative diagnostic work, and PCR analysis
Non-culture-based diagnostic laboratory work and PCR
analysis on clinical specimens from patients who are
suspected or confirmed to be infected with SARS-CoV-2
should be conducted adopting practices and procedures
described for conventional clinical and microbiology
laboratories as described in the “core requirements” (see
Annex I).
However, all manipulations of potentially infectious
materials, including those that may cause splashes, droplets,
or aerosols of infectious materials (for example, loading
and unloading of sealed centrifuge cups, grinding, blending,
vigorous shaking or mixing, sonic disruption, opening of
containers of infectious materials whose internal pressure
may be different from the ambient pressure) should be
performed in appropriately maintained and validated BSCs
or primary containment devices, by personnel with
demonstrated capability.
Examples of routine laboratory procedures include:

 diagnostic testing of serum; blood (including

haematology and clinical chemistry); respiratory
specimens such as nasopharyngeal and
oropharyngeal swabs, saliva, sputum and/or
endotracheal aspirate or bronchoalveolar lavage;
stool; or other specimens;

2
Heightened control measures: A set of risk control measures that
may need to be applied in a laboratory facility because the outcome of a
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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
 routine examination of mycotic and bacterial Not only does the biological agent contained in patient
cultures developed from respiratory tract specimens. samples pose a risk, but certain test reagents might also be
When handling and processing specimens, “core hazardous and require specific waste management practices
requirements” (see Annex I), including GMPP, for safe disposal. For example, guanidinium thiocyanate
should be followed at all times, including but not (reagent used in RNA extraction kits, including some
limited to those under the following subheadings. POC/near-POC) produces toxic gas in the presence of bleach
More details are explained and demonstrated in the (sodium hypochlorite) so contact of these two chemicals
WHO Biosafety video series (8). must be avoided. Sodium azide, an ingredient of some
immunoassays and Ag-RDTs, should not be poured down
3. Point of care (POC), near-POC assay and the drain or autoclaved. It is toxic to aquatic life and chelates
Antigen-detecting rapid diagnostic tests to some metals in drainpipes and autoclaves to produce
(Ag- RDTs) explosive metal azides (14).
Point of care or near-POC assays, including those using
polyvalent platforms such as GeneXpert, were recently If the existing GeneXpert or similar platform of the
released for SARS-CoV-2 testing of samples such as tuberculosis programme is to be temporarily shared for
nasopharyngeal swab, nasal wash and aspirate (9). Each POC SARS- CoV-2 testing, the equipment should be already
molecular platform uses different procedures to process installed in a suitable area with sufficient ventilation (15). In
samples and it is difficult to generalise the safety this case, there is no particular need to relocate it. Should the
recommendations. Antigen-detecting rapid diagnostic tests equipment have been in use for non-respiratory disease
are increasingly used for diagnostic purposes and include programmes, such as HIV/AIDS, it is important to ensure
similar procedures (10). proper ventilation before starting the test for SARS-CoV-2.

There still are chances of spills, especially when staff are not 4. Use of appropriate disinfectants
adequately trained and at the same time are under immense
SARS-CoV-2 is susceptible to disinfectants with proven
pressure to deliver rapid results.
activity against enveloped viruses, including sodium
Current evidence suggests, however, that sample hypochlorite (bleach; for example, 1 000 parts per million
manipulation and the level of aerosol generation would be [ppm] (0.1%) for general surface disinfection and 10 000
minimal (11). The United States Food and Drug ppm (1%) for disinfection of sample spills); 70% ethanol;
Administration has authorized the use of the GeneXpert tests povidone‐iodine (7.5%), chloroxylenol (0.05%),
outside of heightened control measures (BSL-2) laboratories chlorhexidine (0.05%), benzalkonium chloride (0.1%), if
and patient care settings (9). used according to the manufacturer’s recommendations (13).

Thus, POC assays can be performed on a bench without Particular attention should be paid not only to the selection of
employing a BSC, when the local risk assessment so dictates the disinfectant but also the contact time (for example, 10
and the following conditions are fully met: minutes), dilution (that is, concentration of the active
ingredient), shelf-life and expiry date after the working
 performed on a diaper or large paper towel in a solution is prepared.
well- ventilated area free of clutter, where there are
no documents, computers or personal stuff SARS-CoV-2 and human coronaviruses in general are known
to persist on inanimate surfaces such as metal, glass or plastic
 appropriate PPE worn similar to other manual
for up to 7 and 9 days, respectively (16).
testing, such as but not limited to a full-length long
(elastic) sleeved lab coat, safety goggles or glasses, 5. Viral isolation
and suitable disposable gloves
 in circumstances where ventilation is insufficient, Unless the country decides otherwise, viral isolation on
the use of respirators is encouraged (12) clinical specimens from patients who are suspected or
 risk assessment should inform the use of respiratory confirmed to be infected with SARS-CoV-2 should be
protection as a supplementary precaution performed only in laboratories capable of meeting the
 staff well trained in GMPP following additional containment criteria:
 no rush or increased pressure for test turnaround time
 a validated infectious waste management including  a controlled ventilation system maintains inward
excess specimens directional airflow into the laboratory room;
 exhaust air from the laboratory room is not
It has not been conclusively proven whether the used recirculated to other areas within the building. Air
cartridges of Ag-RDTs are deemed as non-infectious. After must be HEPA (high-efficiency particulate air)
a careful assessment, chemical decontamination may be filtered, if reconditioned and recirculated within the
needed for Ag-RDTs cartridges before they are disposed of, laboratory. When exhaust air from the laboratory is
for example, 1 000 ppm = 0.1% sodium hypochlorite for a discharged to the outdoors, it must be dispersed
minimum contact time of 5 minutes (13). Autoclaving of away from occupied buildings and air intakes. This
Ag-RDT cartridges is not recommended because of the air should be discharged through HEPA filters;
formation of toxic vapours.  a dedicated hand-wash sink is available in the
On the contrary, the used cartridges of point of care or near- laboratory;
point of care assays may need to be properly  all manipulations of infectious or potentially
decontaminated before disposal (e.g. autoclaving). infectious materials must be performed in
appropriately maintained and validated BSCs;
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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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 laboratory workers should wear protective transport of dangerous goods by air (Doc 9284) of the
equipment, including disposable gloves; solid-front International Civil Aviation Organization (17), for airlifted
or wrap- around gowns, scrub suits, or coveralls with transport, and any other applicable regulations depending on
sleeves that fully cover the forearms; head coverings; the mode of transport being used. More information may be
shoe covers or dedicated shoes; and eye protection found in the WHO Guidance on regulations for the transport
(goggles or face shield). Risk assessment should of infectious substances 2019-2020 (applicable as from 1
inform the use of respiratory protection (fit-tested January 2019) (7). A summary on transport of infectious
particulate respirator, for example, EU FFP2, US 6 substances can also be found in Tool box 4 of the WHO
NIOSH-certified N95 or equivalent, or higher handbook, Managing epidemics: key facts about deadly
protection); diseases (18).
 centrifugation of specimens should be performed using
sealed centrifuge rotors or sample cups. These rotors Patient specimens from suspected or confirmed cases should
or cups should be loaded and unloaded in a BSC. be transported as UN3373, “Biological Substance Category
B”, when they are transported for diagnostic or investigational
6. Additional risks associated with virus isolation purposes. Viral cultures or isolates should be transported as
studies Category A UN2814, “infectious substance, affecting humans”
(7). All specimens being transported (whether UN3373 or
Certain experimental procedures may carry additional risks of
UN2814) should have appropriate packaging, labelling, and
virus mutations with possible increased pathogenicity and/or
documentation, as described in the documents mentioned
transmissibility, or viruses with altered antigenicity or drug
earlier.
susceptibility. Specific risk assessments should be conducted,
and specific risk-reduction measures adopted, before any of
the following procedures are conducted:

 coinfection of cell cultures with different References

coronaviruses, or any procedures that may result in a 1. Laboratory biosafety manual: fourth edition. Geneva:
coinfection and potential viral recombination; World Health Organization; 2020
 culture of viruses in the presence of antiviral drugs; (https://apps.who.int/iris/handle/10665/337956,
 deliberate genetic modification of viruses. accessed 19 January 2021).

7. Work with animals infected with SARS-CoV-2 2. Coronavirus disease (COVID-19) technical guidance:
surveillance and case definitions. Geneva: World
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 any protocol involving animal inoculation for 3. Klompas M, Baker M, Rhee C. What Is an Aerosol-
confirmation and/or characterization of SARS-CoV- Generating Procedure? JAMA Surg. Published online
2. December 15, 2020.
(https://jamanetwork.com/journals/jamasurgery/fullarti
8. Referral of specimens to laboratories with cle/2774161#:~:text=The%20World%20Health%20Or
appropriate risk control measures in place ganization%20stipulates,greater%20risk%20for%20he
alth%20care, accessed 9 January 2021)
Laboratories that are not able to meet the above biosafety
recommendations should consider transferring specimens to 4. SARS Laboratory case definition. Australian
national, regional, or international referral laboratories with Government, Department of Health; 2021.
SARS-CoV-2-detection capacity that can meet the biosafety (https://www1.health.gov.au/internet/main/publishing.
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Packaging and shipment
All materials transported within and between laboratories 5. CDC 2019-Novel Coronavirus (2019-nCoV) Real-
should be placed in a secondary packaging, to minimize the Time RT-PCR Diagnostic Panel. Atlanta: Centers for
potential for breakage or a spill. Specimens leaving the BSC Disease Control and Prevention; 2020
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provided in the WHO Biosafety video series (8), in particular, accessed 22 April 2020).
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6. van Doremalen N, Bushmaker T, Morris DH,
transport.
Holbrook MG, Gamble A, Williamson BN, et al.
Transport of specimens within national borders should Aerosol and surface stability of SARS-CoV-2 as
comply with national regulations. Cross-boundary transport compared with SARS-CoV-1. N Engl J Med. 2020
of specimens of SARS-CoV-2 should follow the United Mar17(https://www.nejm.org/doi/full/10.1056/NEJMc
Nations model regulations, Technical instructions for 2004973, accessed 7 April 2020).
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7. Guidance on regulations for the transport of infectious 16. Chin A, Chu J, Perera M, Hui K, Yen HL, Chan M, et
substances 2019–2020. Geneva: World Health al. Stability of SARS-CoV-2 in different environmental
Organization; 2019 conditions. The Lancet Microbe 2020
(https://apps.who.int/iris/bitstream/handle/10665/3258 (https://www.medrxiv.org/node/74521.external-
84/WHO-WHE-CPI-2019.20- links.html, accessed 7 April 2020).15.
eng.pdf?sequence=1&isAllowed=y, accessed 16
January 2021). 17. International Civil Aviation Organization (ICAO).
Safety. Technical instructions for the safe transport of
8. Strengthening health security by implementing the dangerous goods by air (Doc 9284)
International Health Regulations (2005). Biosafety (https://www.icao.int/safety/DangerousGoods/Pages/te
video series. Geneva: World Health Organization; chnical-instructions.aspx, accessed 6 April 2020).
(year) (https://www.who.int/ihr/publications/biosafety-
video-series/en/, accessed 6 April 2020). 18. Managing epidemics: key facts about deadly diseases.
Geneva: World Health Organization; 2018
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Use Authorization (EUA) information, and list of all accessed 6 April 2020).
current EUAs. (https://www.fda.gov/emergency-
preparedness-and-response/mcm-legal-regulatory-and- 19. How to handrub? With alcohol-based formulation.
policy-framework/emergency-use-authorization, How to handwash? With soap and water. Geneva:
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Acknowledgements
11. Banada PP, Sivasubramani SK, Blakemore R, Boehme The following people contributed to this guidance:
C, Perkins MD, Fennelly K, Alland D. Containment of
bioaerosol infection risk by the Xpert MTB/RIF assay Stuart Blacksell, Mahidol Oxford Tropical Medicine
and its applicability to point-of-care settings. J Clin Research Unit, Thailand; Christina Scheel, Centers for
Microbiol. 2010 Oct; 48(10):3551-7. Disease Control and Prevention, United States of America;
(https://jcm.asm.org/content/jcm/48/10/3551.full.pdf, Kathrin Summermatter, Institute for Infectious Diseases,
accessed 6 April 2020). University of Bern, Switzerland.
Declarations of interest were collected and reviewed and no
12. World Health Organization. Ensuring a safe conflict of interest was identified.
environment for patients and staff in COVID-19
health-care facilities 2020 [updated 20 October 2020. WHO Health Emergencies Programme: Kazunobu Kojima,
Available from: Rica Zinsky, Karin von Eije, Mark Perkins, Céline
https://apps.who.int/iris/bitstream/handle/10665/33625 Barnadas, Sébastien Cognat, Maria Van Kerkhove.
7/WHO-2019-nCoV-HCF_assessment-
Safe_environment-2020.1- eng.pdf?
sequence=1&isAllowed=].

13. Chin AWH, Chu JTS, Perera MRA, et al. Stability of

SARS-CoV-2 in different environmental conditions.
Lancet Microbe. 2020;1(1):e10.
(https://www.thelancet.com/journals/lanmic/article/PII
S2666-5247(20)30003-3/fulltext, accessed 9 January
2021)

14. Laboratory Safety Guideline: Sodium Azide [CAS No.

26628-22-8]. Harvard Campus Services Environmental
Health and Safety; 2019
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ety_guideline_sodium_azide.pdf, accessed 9 December
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15. Tuberculosis laboratory biosafety manual. Geneva:

World Health Organization; 2012
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result=true&query=Tuberculosis+laboratory+biosafety
+manual&scope=&rpp=10&sort_by=score&order=des
c, accessed 20 April 2020).

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guidance

Annex I: Core requirements transmit infection. Where close proximity of such devices
to biological agents is unavoidable, ensure the devices are
1. Good microbiological practice and
either protected by a physical barrier or decontaminated
procedure (GMPP)
before leaving the laboratory.
Best practice
Technical procedures
• Never store food or drink, or personal items such as
• Avoid inhalation of biological agents. Use GMPP
coats and bags in the laboratory. Activities such as
techniques to minimize the formation of aerosols and
eating, drinking, smoking, and applying cosmetics are
droplets when manipulating specimens.
only to be performed outside the laboratory.
• Avoid ingestion of biological agents and their contact
• Never put materials, such as pens, pencils or gum in
with the skin and eyes.
the mouth while inside the laboratory, regardless of
having gloved hands or not. • Always wear disposable gloves when handling specimens.
• Wash hands thoroughly (19), preferably with warm • Avoid gloved hands coming into contact with the face.
running water and soap, after handling biological
material and/or animals, before leaving the laboratory or • Shield or otherwise protect the mouth, eyes and face
when hands are known or believed to be contaminated. during procedures where splashes may occur.
• Ensure open flames or heat sources are never placed • Wherever possible, replace any glassware with
near flammable supplies and are never left unattended. plasticware.
• Ensure that cuts or broken skin are covered before • If required, use scissors with blunt or rounded ends
entering the laboratory. rather than pointed ends.
• Before entering the laboratory, ensure that there are • Handle any sharps, syringes or needles with care in
adequate supplies of laboratory equipment and order to prevent injury and injection of biological agents.
consumables, including reagents, PPE and disinfectants,
and that these items are suitable for the activities • Use ampoule openers for safe handling of ampoules.
envisaged.
• Never re-cap, clip or remove needles from disposable
• Ensure that supplies are stored safely and according to syringes.
storage instructions to reduce accidents and incidents
such as spills, trips and falls. • Dispose of any sharps materials (for example, needles,
needles combined with syringes, blades, broken glass) in
• Ensure proper labelling of all biological agents and
puncture-proof or puncture-resistant containers fitted with
chemical and radioactive material.
sealed covers.
• Protect written documents from contamination using
• Preventing dispersal of biological agents:
barriers (such as plastic coverings), particularly those that
– discard specimens and cultures for disposal in
may need to be removed from the laboratory.
leak- proof containers with the tops appropriately
• Ensure that the work is performed with care and without secured before disposal in dedicated waste
hurrying. Avoid working when fatigued. containers;
– consider opening tubes with disinfectant-soaked
• Keep the work area tidy, clean and free of non-essential pad/gauze;
objects and materials. – decontaminate work surfaces with a suitable
disinfectant at the end of the work procedures and
• Prohibit the use of earphones, which can distract if any material is spilled or obviously
personnel and prevent equipment or facility alarms from contaminated;
being heard. – ensure that the disinfectant is efficacious against
the pathogen being handled and is left in contact
• Cover or remove any jewellery that could tear gloves, with infectious waste materials long enough for
easily become contaminated or become fomites. Cleaning complete inactivation.
and decontamination of jewellery or spectacles should be
considered, if such items are worn regularly. 2. Personnel competence and training

• Refrain from using portable electronic devices (for General familiarization and awareness training
example, mobile telephones, tablets, laptops, flash drives, General training should include an introduction to
memory sticks, cameras, or other portable devices, laboratory layout, codes of practice, local guidelines, safety
including those used for DNA/RNA sequencing) when manuals, risk assessments, legislative requirements, and
not specifically required for the laboratory procedures emergency response procedures.
being performed.
Job-specific training
• Keep portable electronic devices in areas where they • Training requirements may vary depending on the job
cannot easily become contaminated or act as fomites that functions.

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
• However, in general, all personnel involved in the guidance
handling of biological agents must be trained on
GMPP.

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
• Competency and proficiency assessment must be used handle broken or leaking containers; and how to handle
and verified before working independently, followed by spills and use disinfectants to manage any contamination.
regular review and refresher training.
• Specimens must be stored in containers with adequate
• Relevant information such as new procedures must be strength, integrity, and volume to contain the specimen,
updated and communicated to applicable personnel. and that are leakproof when the cap or stopper is correctly
applied. Use plastic containers whenever possible that are
Safety and security training
free of any biological material on the outside of the
• All personnel must be aware of the hazards present in
packaging. In addition, containers should be correctly
the laboratory and their associated risks as well as safe
labelled, marked and recorded to facilitate identification,
working procedures, security measures, and emergency
and made of an appropriate material for the type of
preparedness and response.
storage required
3. Facility design
• Inactivation methods must be properly validated
• Ample space and a designated hand-washing basin must whenever an inactivation step is used, before transferring
be provided, with appropriate restriction of access. the specimens to other areas for further manipulation,
such as PCR analysis.
• Doors must be properly labelled, and laboratory walls,
floors, and furniture must be smooth, easy to clean, 5. Decontamination and waste management
impermeable to liquids and resistant to the chemicals and
• Any surface or material known to be, or potentially be,
disinfectants normally used in the laboratory.
contaminated by biological agents during laboratory
• Laboratory ventilation, where provided (including operations must be correctly disinfected to control
heating/cooling systems and especially fans/local cooling infectious risks.
split-system air-conditioning units – specifically when
• Proper processes for the identification and segregation
retrofitted) should ensure airflows do not compromise
of contaminated materials must be adopted before
safe working. Consideration must be made for resultant
decontamination or disposal.
airflow speeds and directions, and turbulent airflows
should be avoided; this applies also to natural ventilation. • Where decontamination is not possible in the laboratory
area, or onsite, contaminated waste must be packaged in a
• Laboratory space and facilities must be adequate and
leakproof fashion, for transfer to another facility with
appropriate for safe handling and storage of infectious and
decontamination capacity.
other hazardous materials, such as chemicals and solvents.
6. Personal protective equipment
• Facilities for eating and drinking must be provided
outside the laboratory, and first-aid-facilities must be • Laboratory coats must be used in laboratories to prevent
accessible. personal clothing from getting splashed or contaminated
by biological agents. Laboratory coats must have long
• Appropriate methods for decontamination of waste, for
sleeves, preferably with elasticated or fitted cuffs, and
example disinfectants and autoclaves, must be available
must be fastened when worn in the laboratory. Sleeves
close to the laboratory.
should never be rolled up. Coats must be long enough to
• The management of waste must be considered in the cover the knees, but not trail on the floor. Where possible,
laboratory design. Safety systems must cover fire, the fabric of the laboratory coat should be splash-resistant.
electrical emergencies, and emergency/incident response Laboratory coats must only be worn in designated areas.
facilities, based on risk assessment. When not in use, they should be stored properly; they
should not be hung on top of other laboratory coats or
• There must be a reliable and adequate electricity supply kept in lockers or on hooks with personal items.
and lighting to permit safe exit.
• Appropriate disposable gloves must be worn for all
• Emergency situations must be considered in the design, procedures that may involve planned or inadvertent
as indicated in the local risk assessment, and should contact with blood, body fluids or other potentially
include the geographical/meteorological context. infectious materials. They must not be disinfected or
reused, as exposure to disinfectants and prolonged wear
4. Specimen receipt and storage reduces the integrity of the glove and decreases protection
to the user. Gloves should always be inspected before use,
• A specimen received by the laboratory must be to check that they are intact.
accompanied by sufficient information to identify what it
is, when and where it was taken or prepared, and which • Safety glasses or goggles, face shields (visors) or other
tests and/or procedures (if any) are to be performed. protective devices must be worn whenever necessary to
protect the eyes and face from splashes, impacting objects
• Consider unpacking the items in the BSC. Personnel or artificial ultraviolet radiation. Eye protection devices
unpacking and receiving specimens must be adequately can be re-used but must be cleaned each time after use. If
trained on the hazards involved; how to adopt necessary splashed, devices must be decontaminated with an
precautions according to GMPP described earlier; how to appropriate disinfectant.

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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• Footwear must be worn in the laboratory and must be of provides specific standard operating procedures (SOPs) to
a design that minimizes slips and trips and reduces the be followed in possible emergency scenarios that apply to
likelihood of injury from falling objects and exposure to the work and local environment. Personnel must be
biological agents. trained on these procedures and have periodic refresher
training to maintain competency.
• Respiratory protection is generally not among the core
requirements. In the present COVID-19 context, however, • First-aid kits, including medical supplies, such as bottled
a local risk assessment should be conducted to determine eye washes and bandages, must be available and easily
whether the use of respiratory protection is needed, accessible to personnel. These products must be checked
especially when procedures that may create aerosols and routinely to ensure that they are within their use-by dates
droplets will be performed outside the BSC, for example, and are in sufficient supply.
centrifugation and handling leaking samples. These also
include procedures that can cause splashes, such as: • All incidents must be reported to the appropriate
loading and unloading of sealed centrifuge cups, grinding, personnel promptly. Accidents and incidents must be
blending, vigorous shaking or mixing, sonic disruption, documented, in line with national regulations where
opening of containers of infectious materials whose applicable. Any incident must be reported and
internal pressure may be different from the ambient investigated in a timely manner and taken into
pressure. consideration when updating laboratory procedures and
emergency response plans.
7. Laboratory equipment
• Laboratory staff should have immediate access to spill
When used effectively together with GMPP, the safe use kits, including those containing disinfectant. Depending
of laboratory equipment will help to minimize the on the size, location, concentration or volume of the spill,
likelihood of exposure of personnel when handling or different protocols may be necessary. Written procedures
manipulating biological agents. for cleaning and decontaminating spills must be
developed for the laboratory and followed by adequate
• To effectively reduce any associated risks with using
training of personnel.
laboratory equipment, the laboratory management must
ensure that ample space is provided for its use. An 9. Occupational health
adequate budget must also be available to operate and
maintain the equipment. All staff working in the • The employer, through the laboratory director, must take
laboratory or who are responsible for maintaining responsibility for ensuring that the health of laboratory
equipment must be adequately trained and be able to personnel is adequately monitored.
demonstrate proficiency.
• Medical examination or health status information of the
8. Emergency/incident response plan laboratory personnel may be required to verify whether it
is safe for them to work in the laboratory.
• Even when carrying out low-risk work and following all
core requirements for biosafety, incidents can still occur.
To reduce the likelihood of exposure to/release of a
biological agent, or to reduce the consequences of such
incidents, a contingency plan must be developed that

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
Annex II: Risk assessment template
Although a qualitative approach to combining likelihood and severity parameters in a risk matrix is provided as a method for
risk evaluation here, it is important to note that quantitative (for example, from simple numerical scoring schemes to complex
mathematical models) and hybrid (semi-quantitative) methods can also be used for risk evaluation. Laboratories should use a
risk-evaluation/assessment method that best meets their unique needs, including customized evaluation approaches, scoring
methods and definitions of the parameters.

Although this template was primarily developed for biosafety risk assessment, it can also be used for general safety risk
assessment of laboratory activities, especially when the biosafety and general safety risks are interlinked, for example, sample
collection and transport.

Personnel on the risk assessment team may include but are not limited to, principal investigators, laboratory and quality
managers, laboratory technicians and biosafety officers. Active involvement of the laboratory and/or organizational leadership
is important in the risk assessment process.

Institution/Facility name FREE-STANDING CLINICAL LABORATORY

Laboratory name JOSON-LIZARONDO IMAGING AND DIAGNOSTIC CENTER
Laboratory manager/Supervisor NICK R. FERNANDEZ. M.D., DPSP
Project titles/Relevant standard operating LOCAL RISK ASSESSMENT POLICY AND PROCEDURES
procedures (SOPs)
Date OCTOBER 2, 2024

If using this template, complete all sections following the instructions in the grey boxes. The instructions and bullet points in
the grey boxes can be copied into the text boxes beneath the instructions and used as prompts to gather and record the
necessary site-specific information. The grey instruction boxes can then be deleted, and the text remaining will form a risk
assessment draft. This draft must be carefully reviewed, edited as necessary, and approved by the members of the risk
assessment team.

STEP 1. Gather information (hazard identification)

Instructions: Provide a brief overview of the laboratory work and summarize the laboratory activities to be conducted that
are included in the scope of this risk assessment.
Describe the biological agents and other potential
hazards (for example, transmission, infectious dose,
treatment/preventive measures, pathogenicity).
Describe the laboratory procedures to be used (for
example, culturing, centrifugation, work with sharps,
waste handling, frequency of performing the laboratory
activity).
Describe the types of equipment to be used (PPE,
centrifuges, autoclaves, biological safety cabinets
[BSCs]).
Describe the type and condition of the facility where
work is conducted.
Describe relevant human factors (for example,
competency, training, experience and attitude of
personnel).
Describe any other factors that may affect laboratory
operations (for example, legal, cultural,
socioeconomic).

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance

STEP 2. Evaluate the risks

Instructions: Describe how exposure and/or release could occur.

What potential situations are there in which exposure
or release could occur?
What is the likelihood of an exposure/release
occurring?
 Unlikely: to occur in the near future
 Possible: to occur in the near future
 Very likely: to occur in the near future
What is the severity of the consequences of an
exposure/release (negligible, moderate, severe)?

Instructions: Evaluate the risk and prioritize the implementation of risk control measures. Circle the initial (inherent) risk of
the laboratory activities before additional risk control measures have been put in place.
Note:
 When assigning priority, other factors may need to be considered, for example, urgency, feasibility/sustainability
of risk control measures, delivery and installation time and training availability.
 To estimate the overall risk, take into consideration the risk ratings for the individual
laboratory activities/procedures, separately or collectively as appropriate for the laboratory.
Likelihood of exposure/release
Unlikely Possible Likely
Consequence of Severe Medium High Very high
exposure/release Moderate Low Medium High
Negligible Very low Low Medium
Laboratory activity/procedure Initial risk Is the initial Priority
(very low, low, medium, risk acceptable? (high/medium/low)
high, very high) (yes/no)

Select the overall initial risk. ☐ ☐ ☐ ☐ ☐

Very low Low Medium High Very
high
Should work proceed without additional risk ☐ Yes ☐No
control measures?

STEP 3. Develop a risk control strategy

Instructions: List any requirements that have been prescribed by international and national regulations, legislation,
guidelines, policies, and strategies on biosafety and biosecurity.
Describe the measures required by national legislation
or regulations (if any).
Describe the measures advised by guidelines, policies
and strategies (if any).

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
Instructions: Describe the resources available for risk control and consider their applicability, availability, and sustainability
in the local context, including management support.
Are resources sufficient to secure and maintain
potential risk control measures?
What factors exist that may limit or restrict any of the
risk control measures?
Will work be able to proceed without any of the risk
control measures; are there alternatives?

STEP 4. Select and implement risk control measures

Instructions: Describe where and when risk control measures are needed, the level of residual (remaining) risk when these
risk control measures are in place, and an assessment of the availability, effectiveness, and sustainability of the risk control
measures.
Residual risk Is the residual Are risk control measures
Selected risk (very low, low, risk available, effective, and
control medium, high, acceptable? sustainable?
Laboratory activity/procedure measure(s) very high) (yes/no) (yes/no)

Instructions: Evaluate the residual risk that remains after risk control measures have been selected, to determine whether that
level of risk is now acceptable and whether work should proceed.
Circle the residual risk of the laboratory activities after risk control measures are in place.
Likelihood of exposure/release
Unlikely Possible Likely
Severe Medium High Very high
Consequence of Moderate Low Medium High
exposure/release
Negligible Very low Low Medium

Overall residual risk: ☐ ☐ ☐ ☐ ☐

Very low Low Medium High Very high
If the residual risk is still unacceptable, further action is necessary, such as additional risk control measures, based on the
initial risk evaluated in STEP 2, redefining the scope of work such that it is acceptable with existing risk control measures in
place, or identifying an alternative laboratory with appropriate risk control strategies already in place that is capable of
conducting the work as planned.
Should work proceed with selected risk ☐ Yes ☐No
control measures?
Approved by (name and title)
Approved by (signature)
Date

Instructions: Describe how to communicate risks and risk mitigation strategies to personnel. Provide a mechanism of
communication within the laboratory. Describe the process and timeline for ensuring all identified risk control measures and
that associated SOPs and training have been completed before starting the laboratory work.
Communication of the hazards, risks and risk control
measures
Implementation of risk control measures
Training of personnel
Operational and maintenance procedures

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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance

STEP 5. Review risks and risk control measures

Instructions: Establish a periodic review cycle to identify: changes in laboratory activities, biological agents, personnel,
equipment or facilities; changes in knowledge of biological agents or processes; and lessons learnt from audits/inspections,
personnel feedback, incidents, or near misses.
Frequency of the review
Person to conduct the review
Describe updates/changes
Personnel/procedures to implement the changes
Reviewed by (name and title)
Reviewed by (signature)
Date

WHO continues to monitor the situation closely for any changes that may affect this interim guidance. Should any factors change,
WHO will issue a further update. Otherwise, this interim guidance document will expire 2 years after the date of publication.

© World Health Organization 2021. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.

WHO reference number: WHO/WPE/GIH/2020.3

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