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, without excluding the possibility of developing
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, where appropriate and applicable.

Institution/Facility name City of General Trias Doctors Medical Center

Laboratory name cGTDMC Laboratory
Laboratory manager/Supervisor Ethylwolda Asinas
Project titles/Relevant standard operating Cgtdmc LABORATORY- RISK ASSESSMENT
procedures (SOPs)
Date 3/29/2022

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 containers for sharps and specimens.
activity).
Describe the types of equipment to be used (personal
protective equipment [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).
These are pathogens that are produced by organisms that are harmful
especially to humans.
Used of decontamination devices for containment of samples for proper
waste disposals. Use of disinfectants to the workplace. Use of proper
PPE’s should be disposable. Calibrated and certified machines/devices.
Laboratory should always observe biosafety and biosecurity of the
personnel
Every personnel that are going to be assigned in a specific section in the
laboratory should have a proper training and experience for them to be
able to do their work properly.
Factors that may affect laboratory operations are untrained personnel,
lack of budget, environmental disasters, pandemic

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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 Example is the proper collection and proper handling of specimens.
or release could occur?
What is the likelihood of an exposure/release
occurring?
• Unlikely: not very possible to occur in the
near future. Possible.
• Possible: feasible to occur in the near future
• Likely: very possible to occur in the near
future.
What is the severity of the consequences of an Severe
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 risk Priority
(very low, low, medium, above the tolerance (high/medium/lo
high, very high) level? w)
(yes/no)
Collection and handling of specimen Med NO Med
Waste Management Med No Med
Use of BSC in Performing Tests Med NO Med

Select the overall initial risk. ☐

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

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 Lab Staff’s shall have the appropriate training and have a proficiency in
and strategies (if any). special sections. Should have a clear SOP’s policies and guidelines.

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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 Resources are limited; however, lab staff can improvise resources.
potential risk control measures? Resources that are readily available in the lab, examples are disinfecting
solutions and using of empty reagent container as sharps and glass
container.
What factors exist that may limit or restrict any of the Limited resources may be one factor and Personnel Proficiency especially
risk control measures? when dealing in spillage/leakage hazards.
Will work be able to proceed without any of the risk Work may be able to proceed but risks are not reduced. I propose training
control measures; are there alternatives? of personnels.

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 cont rol
measures.
Is the residual
Residual risk risk above the Are risk control measures
Selected risk (very low, low, tolerance available, effective, and
control medium, high, level? sustainable?
Laboratory activity/procedure measure(s) very high) (yes/no) (yes/no)
Collection and Sample Handling Use of PPE in Medium NO YES
extraction and
collection of other
hazardous specimens.
Training of personnel is
included.
Waste Management SOP’s should be strictly Medium NO YES
implemented.
Orientation of Staff that
is related to work. Use
of containment devices
/machines.

Use of BSC in Performing Test/s Use of PPE. Special Medium NO YES

training of personnel
should be provided.

Instructions: Evaluate the residual risk that remains after risk control measures have been selected, to determine whether that
level of risk is now below the tolerance level 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
▪ ☐
High
☐
Very high
Medium
If the residual risk is still above the risk tolerance level, further action is necessary, such as additional risk control measu res,
based on the initial risk evaluated in STEP 2, redefining the scope of work such that it falls below the risk tolerance level with
existing risk control measures in place, or identifying an alternative laboratory with appropriate risk control strategies al ready
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) Imma Conception B. Sanchez Medical Technologist
Approved by (signature)
Date 3/29/2022
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 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim guidance

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 Orientation should be appropriate to help lab personnel fully understood
measures the SOP’s, Policies and guidelines for the hazards and risk in the lab.
Proper training for biosafety and biosecurity for personnel’s is a must.
Purchase (and budgeting) of risk control measures Lab and management should set a budget for risk control measures this
includes Personnel Trainings.
Operational and maintenance procedures Maintenance and calibration of machines and devices should be done
monthly or when machines/devices need to be checked. Also, SOP’s for
this must be strictly followed.
Training of personnel Training of personnel is a requirement in putting up a lab. It must
have an appropriate training from a recommended training center.

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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 As often as needed.
Person to conduct the review Lab Personnel, Biosafety Officer, Lab Supervisor
Describe updates/changes It should depend on Risk Assessment.
Personnel/procedures to implement the changes Biosafety Officer/Lab Personnel. SOP’s must be provided.
Reviewed by (name and title) Imma Conception B. Sanchez Medical Technologist
Reviewed by (signature)
Date 3/29/2022

© World Health Organization 2020. Some rights reserved. This work is available under the CC BY-NC-SA
3.0 IGO licence.

WHO reference number: WHO/WPE/GIH/2020.2

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