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 TIGLAO MEDICAL CENTER

Laboratory name TIGLAO MEDICAL CENTER LABORATORY DEPARTMENT
Laboratory manager/Supervisor IMELDA MANUSIG, RMT
Project titles/Relevant standard operating procedures COVID-19 ANTIGEN TEST RISK ASSESSMENT
(SOPs)
Date 6/22/22

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 Biological Agent: SARS-COV 2 is a virus responsible for the
(for example, transmission, infectious dose, 2019 Coronavirus disease(COVID-19).It is a disease-causing
treatment/preventive measures, pathogenicity).
human pathogen.
Transmission: Inhalation of virus, deposition of virus on exposed
mucous membranes, and touching mucous membranes with soiled
hands contaminated with virus
Infectious dose: According to CDC the infectious dose of SARS-
CoV-2 needed to transmit infection has not been established.
Treatment/Preventive Measures:
● Promoting Vaccination
● Use of appropriate Personal Protective Equipment
● Use of Biosafety Cabinet Class 2 when performing the
test
● Perform proper hand hygiene.
● Perform proper cleaning, disinfection and
decontamination.
● Availability of Biological Spill Kit in the laboratory
Describe the laboratory procedures to be used (for Nasopharyngeal/ Oropharyngeal sample collection:
example, culturing, centrifugation, work with sharps, waste ● It is a procedure done to collect samples for the diagnosis
handling, frequency of performing the laboratory of Covid-19 in adults and children.
activity).
● It is the method we used for the collection of samples for
Antigen Testing of our patients.
Waste Handling:
● All potentially contaminated laboratory wastes must be
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
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 Capas Medical Center laboratory is a secondary laboratory
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).
autoclaved at 121℃, 15 psi for 30 mins prior disposal.
Monitoring the performance of autoclave is essential and must
be documented.
● Working with a certified waste disposal company to prevent
improper waste disposal of infectious materials
● Proper segregation of infectious waste shall be observed.
Personal Protective Equipment: equipment worn to minimize
exposure to hazards that cause serious workplace injuries and
illnesses.
● Gloves
● Face shield/Goggles
● Hair cap
● Cover-all
● Shoe cover
● Fit tested Respirator
Biosafety Cabinet Class 2: it uses HEPA filters to provide
containment and a sterile environment when performing
hazardous materials. It is calibrated and functional.
located inside the building of Capas Medical Center which is
located at MacArthur Highway, Sto. Domingo 2nd, Capas, Tarlac.
The facility is designed and installed as a Biosafety Level 2 based
on the standards of DOH.
-It is well ventilated and well lighted. There is also adequate space
for working.
-It has a sink located at the exit door of the working area.
-Only authorized personnel are allowed inside.
-There is a designated area for swabbing of patients.
Competency:
To perform every task safely, all laboratory staff must have completed In-
House Biosafety training conducted by the Biosafety Officer and the
Pathologist.
All staff must have completed training required by the Department of
Health.
Experience:
A Pathologist, who also underwent such training, is assigned to authorize
and responsible to the organization and the operations of all Laboratory
Services. Administrative and Technical supervision are also delegated to
the Pathologist.
Certain administrative functions are delegated to the Chief Medical
Technologist with necessary training. Also, supervises and directs the
work of laboratory staff.
Medical Technologist staff underwent training such as Swabbing training
conducted by the Department of Health and currently having their
training on Biosafety, Biosecurity and Biorisk Assessment conducted by
RITM.
Attitude:
All laboratory staff shall have a good working attitude, should be open
minded and open for new learnings.
The laboratory is under a Memorandum of Agreement with Marilao
Medical & Diagnostic Clinic, Inc. and Philippine Red Cross Clark for
RT-PCR testing.
 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 ● Leakage or spillage of OPS/NPS sample
release could occur? ● Lack of PPE
● Lack of Kits
What is the likelihood of an exposure/release occurring? Leakage or spillage of OPS/NPS sample-unlikely; Double checking of
● Unlikely: not very possible to occur in the caps or nozzle in the sample bottle is observed and the staffs have
near future. undergone proper training in sample collection
● Possible: feasible to occur in the near future Lack of PPE and Lack of Kits-unlikely; Due to continuous supply and
● Likely: very possible to occur in the near funding of hospital.
future.

What is the severity of the consequences of an Moderate;

exposure/release (negligible, moderate, severe)?
Exposure from the OPS/NPS sample leakage or spillage during sample
collection and testing may result in the inhalation of virus and
deposition of virus on exposed mucous membranes.
The risk of disease transmission is relatively high with direct
contact, droplet transmission or airborne transmission of the virus.

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 exposure/release Severe Medium High Very high

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)
Sample collection(Nasopharyngeal and Medium Yes High
Oropharyngeal)
Sample processing Medium Yes High
Decontamination of work area Low Yes Medium
Waste Disposal Medium Yes High
Select the overall initial risk. ☐ ☐ ☐ ☐ ☐
Very low Low Medium High Very
high
Should work proceed without additional risk control
measures? ☐ Yes ☐No

STEP 3. Develop a risk control strategy

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

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 CDC: Interim Laboratory Biosafety Guidelines for Handling
regulations (if any). and Processing Specimens Associated with COVID-19
Procedures with a high likelihood of generating aerosols or droplets
should be conducted using either a certified Class II BSC or
additional precautions to provide a barrier between the specimen
and personnel. Examples of these additional precautions include
centrifuge safety cups, sealed centrifuge rotors to reduce the risk of
exposure to laboratory personnel, and additional PPE, such as an
N95 respirator or disposable mask with a face shield.
WHO: Laboratory Biosafety Guidance Related to Coronavirus
Disease(COVID-19)
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 detection 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).
Describe the measures advised by guidelines, policies and Guidelines set by RITM are also based on WHO and CDC guidelines for
strategies (if any). Handling and Processing Specimens associated with COVID-19.
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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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 Yes, resources are sufficient to secure and maintain potential risk control
risk control measures? measures.
What factors exist that may limit or restrict any of the risk Low stocks due to global demands of kits and PPEs
control measures? Staff are not well trained in handling Covid-19 Antigen samples.
Will work be able to proceed without any of the risk Yes, work will be able to proceed without any of the risk control measures.
control measures; are there alternatives? ● There are other available FDA approved testing kits. Our supplier
informs us beforehand that the kits that we use are not available
at the moment and suggest other alternatives.
● We have MOA with other laboratories
● Training is provided by accredited institutions.

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.
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)
Decontamination of work area Use of UV light Low Yes Yes
for
decontamination
Waste Disposal Double bagging, Low Yes Yes
labeling bins with
“COVID-19
BIOMEDICAL
WASTE”and
disinfection of
inner and outer
part of the bin with
10% sodium
hypochlorite

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 Medium High Very high
If the residual risk is still above the risk tolerance level, 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 falls below the risk tolerance level 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) IMELDA V. MANUSIG, RMT (CHIEF MEDICAL TECHNOLOGIST)
Approved by (signature)
Date 6/22/22
 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 Laboratory staff meetings are conducted in every risk assessment.
measures The Laboratory SOP, MSDS and Spill Kit are readily available.
Laboratory signages and posters of safety practices that should be followed
are observed.
Purchase (and budgeting) of risk control measures Purchase orders are made by the Chief Medical Technologist then
approved by the Head of the Hospital. There is enough budget allocated for
the Laboratory risk control measures.
Operational and maintenance procedures Regular updating and review of the Laboratory Standard Operating
Procedures is necessary whenever there is a change of Guidelines
set by the Department of Health and change for Laboratory
procedures and practices.
Training of personnel Laboratory staff are given a chance to undergo training that will help them
for their professional growth and clinical laboratory experiences.
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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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 Chief MedTech/Pathologist/Biosafety Offcier
Describe updates/changes After every update/change
Personnel/procedures to implement the changes Chief MedTech/Pathologist/Biosafety Officer
Reviewed by (name and title) IMELDA V. MANUSIG, RMT (Chief Medical Technologist)
Reviewed by (signature)
Date 6/22/22

© 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