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 MUNICIPAL HEALTH OFFICE

Laboratory name ITOGON MUNICIPAL HEALTH SERVICES OFFICE-
LABORATORY ANNEX
Laboratory manager/Supervisor GLORIA DEPAYSO/ CLAUDETTE CARIÑO
Project titles/Relevant standard operating procedures SOPSs FOR NPS & OPS COLLECTION
(SOPs) SOPSs FOR ANTIGEN AND ANTIBODY COLLECTION AND
TESTING
Date 1/18/2022

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 Biological Agent: SARS-COV2
(for example, transmission, infectious dose, Mode of Transmission: Direct Contact, Respiratory Droplets, Fomites
treatment/preventive measures, pathogenicity). Preventive Measures: Good Microbiological Practices and Procedures,
Proper Donning and Doffing, Level 3 PPE
Pathogenecity: Most common initial symptoms include a fever greater
than 38°C, accompanied by malaise, chills, myalgia, headache, non-
productive cough, diarrhea, shortness of breath and rigor. Severe
symptoms on patient require oxygen support and mechanical ventilation.
Chest examinations typically show ground-glass opacities and focal
consolidations. Diarrhea is the most common extrapulmonary
manifestation, followed by hepatic dysfunction, dizziness, abnormal
urinalysis, myositis, petechiae, epileptic fits. The case fatality is 9.6%
however, in patients over 65 years of age, the rate exceeds 50%.

Predisposing Factors: Pregnant women and those 65 years of age, the

rate exceeds 50%.
Communicability: It is at its greatest in severely ill patients or those
experiencing rapid clinical deterioration. Transmission usually occurs
after onset of clinical signs and symptoms (on or after the 5th day of
illness on average), which coincides with peak viral load in
nasopharyngeal secretions around day 10 of illness.
Infectious Dose: The precise infectious dose remains unknown.
Incubation Period: It ranges from 2-16 days, with maximum of 10 days.
Describe the laboratory procedures to be used (for 1. Logistics/Packing of complete PPEs
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
example, culturing, centrifugation, work with sharps, waste 2. Filling out of CIFs (Direct interview with patients)
handling, frequency of performing the laboratory 3. Swab collection (NPS/OPS)
activity). 4. Antigen testing
5. Antibody testing-working with sharps
6. Waste handling and disposal
7. Encoding of linelists
8. Sorting of samples
9. Triple Packaging
10.Transporting of samples
11.Decontamination of used equipments (transport bag, scissors,
collection site/booth, cold packs and specimen racks)
*Frequency of performing lab activity: DAILY
Describe the types of equipment to be used (personal 1. PPE
protective equipment [PPE], centrifuges, autoclaves, 2. Waste bins/Waste bags
biological safety cabinets [BSCs]). 3. NPS/OPS kits
4. Antigen and Antibody Kits
5. Cold packs
6. VTMs/SSRs
7. Disinfectants (3-5% Lysol/Bleach, 70% alcohol)
8. Sharps Bin
9. Lancets
10. Refrigerator
Describe the type and condition of the facility where work The collection site for COVID-19 amongst close contacts, probable,
is conducted. suspected and random patients is separated from the clinical laboratory.
The collection site in the Municipal Health Office (MHO) is a swabbing
booth and is located outside the MHO. It has its own waiting area for
swabbing and antigen/antibody testing that is separated from those
patients for checkups. An interview area is placed beside the swabbing
booth and is fully covered to protect the interviewers from possible
transmission amongst patients.

Itogon MHSO Laboratory is a free standing secondary laboratory that

performs routine tests with TB DOTS. An annex office is assigned for the
purpose of COVID related procedures. It is the office of all
swabbers/contact tracers and it is where all the equipment is stored.
Procedures like encoding of linelists, logistics, following up on positive
patients (via phone), conducting reports on COVID cases, packaging of
PPEs, disinfection of used materials and donning of PPEs are being
conducted here. On the other hand, sorting of samples (alphabetizing of
samples prior to submission), filling out of CIFs, encoding of linelists and
doffing of PPEs are conducted outside the Municipal Health Office.
Swab testing is conducted at the swabbing booth.

The annex office is not accessible to anyone working in the Municipality

of Itogon offices besides the Health Officers and swabbers themselves.
The swabbers/contact tracers have their own vehicular service so as to
avoid being infected and infecting other personnels working in the
Municipality.
Describe relevant human factors (for example, 1. A swabber must have a medical background. Preferably a nurse
competency, training, experience and attitude of or a medical technologist. Training on NPS & OPS collection is
personnel). an advantage.
2. For antigen and antibody testing, a registered medical
technologist must be the sole performer. Experience is an
advantage but not a requirement.
3. For waste handling, personnels must have basic knowledge
and/or training on Biosafety, Biosecurity and Biorisk
Management Training.
4. The personnels must possess a positive attitude, skilled,
knowledgeable, a fast learner and a team player.
Describe any other factors that may affect laboratory 1. Scarcity of PPEs and testing kits (OPS/NPS)
operations (for example, legal, cultural, 2. Scarcity of Antigen and Antibody test kits.
socioeconomic). 3. Increased number of COVID-19 cases in the municipality.
4. The number of infected personnels would also impose a higher
risk for the remaining individuals performing the procedures.
 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: not very possible to occur in the
near future.
● 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
exposure/release (negligible, moderate, severe)?
1. Improper doffing of PPEs.
2. Not decontaminating the area of the collection site/swabbing
booth.
3. Not donning proper PPEs or not donning any PPEs at all.
4. Interviewing with possible carriers in a close space area.
5. Lack of knowledge on Good Microbiological Procedures and
Practices (GMPP) among swabbers/personnels.
6. Accidental pricks while conducting antibody testing.
7. Biological spill while collecting OPS/NPS samples.
8. Wearing of masks only when a patient possibly carrying
SARS-COV2 coughs thus producing droplets.
9. Sorting of samples with bare hands.
10. Not decontaminating the equipment used.
11. Working with sharps during collection of blood samples for
antibody testing.
1. Improper doffing of PPEs. =Possible
2. Not decontaminating the area of the collection site/swabbing
booth.=Likely
3. Improper donning of PPEs or not donning any PPEs at
all.=Unlikely
4. Interviewing with possible carriers in a close space
area.=Likely
5. Lack of knowledge on Good Microbiological Procedures and
Practices (GMPP) among swabbers/personnels.=Possible
6. Accidental pricks while conducting antibody testing.=Possible
7. Biological spill while collecting OPS/NPS samples.=Possible
8. Wearing of masks only when a patient possibly carrying
SARS-COV2 coughs thus producing droplets.=Likely
9. Sorting of samples with bare hands.=Unlikely
10. Failure to decontaminate the equipment used.=Unlikely
11. Working with sharps during collection of blood sample for
antibody testing.=Possible
Moderate to 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
*Improper doffing of PPEs. =Possible
* Not decontaminating the area of the collection ✔️
site/swabbing booth.=Likely ✔️
*Improper donning of PPEs or not donning any PPEs
at all.=Unlikely ✔️
* Interviewing with possible carriers in a close space
area.=Likely ✔️
* Lack of knowledge on Good Microbiological ✔️
Procedures and Practices (GMPP) among
swabbers/personnels.=Possible
* Accidental pricks while conducting antibody ✔️
testing.=Possible
* Biological spill while collecting OPS/NPS
✔️
samples.=Possible
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
* Wearing of masks only when a patient possibly
carrying SARS-COV2 coughs thus producing
droplets.=Likely ✔️ ✔️
* Sorting of samples with bare hands.=Unlikely ✔️
* Failure to decontaminate the equipment
used.=Unlikely
* Working with sharps during collection of blood ✔️
samples for antibody testing.
Consequence of exposure/release Severe ✔Medium High Very high
Moderate Low Medium ✔Hig
h
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)
Logistics/Packing of complete PPEs Very Low No Low
Filling out of CIFs (Direct interview with Low No Medium
patients)
Swab collection (NPS/OPS) Medium Yes High
Antigen testing Medium Yes Low
Antibody testing-working with sharps Medium No Low
Waste handling and disposal High Yes High
Encoding of linelists Low No Low
Sorting of samples High Yes Medium
Triple Packaging High Yes Medium
Transporting of samples Low No Low
Decontamination of used equipments Medium No Low
(transport bag, scissors, collection site/booth,
cold packs and specimen racks)
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 Executive No. 430 of October 1990
regulations (if any). “National Committee on Biosafety in the Philippines”
Describe the measures advised by guidelines, policies and 1. Laboratory Biosafety Guidance to COVID-19 Interim Guidelines
strategies (if any). 2. Biosafety Guidelines for Laboratories Handling and Testing
Respiratory Specimen for Laboratory Diagnosis of COVID-19
using Rapid Antigen Detection Kit.
3. Interim Guidelines for Sample Collection, Handling, Storage and
Transportation of Clinical Specimens from Persons Suspected of
Coronavirus Disease 2019.
4. Interim Guidelines for Specimen Collection and Laboratory
Testing for Case Finding and Investigation of Severe Respiratory
Disease Associated with Novel Coronavirus.
5. Department Memorandum No. 2020-0436
“Minimum Data Requirements of COVID-19 Related
Information Systems”
6. Interim Guidelines for Biosafety and COVID-19 (CDC).
7. Interim Biosafety Guidelines for Laboratories Handling &
Testing SARS-COV2 (COVID 19) Specimen
 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 No
risk control measures?
What factors exist that may limit or restrict any of the risk 1. Lack of PPEs
control measures? 2. Lack of knowledge on dealing with biohazard materials and on
biosafety.
3. Availability of budget
Will work be able to proceed without any of the risk No; yes.
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.
Is the residual
Residual risk risk above the Are risk control
Selected risk (very low, low, tolerance level? measures available,
control medium, high, (yes/no) effective, and
Laboratory activity/procedure measure(s) very high) sustainable?
(yes/no)
Logistics/Packing of complete PPEs Engineering Very low No Yes
Filling out of CIFs Engineering, Very Low No Yes
(Direct interview with patients) Practices, PPE
Swab collection (NPS/OPS) Administrative Low No Yes
Practices, PPE
Antigen testing Administrative Low No Yes
Practices, PPE
Antibody testing-working with sharps Administrative Low No Yes
Practices, PPE
Waste handling and disposal Elimination Low No Yes
Engineering
Encoding of linelists Engineering Very Low No Yes
Sorting of samples Engineering Very Low No Yes
Practices, PPE
Administrative
Triple Packaging Practices, PPE Low No Yes
Transporting of samples Practices, PPE Very Low No Yes
Decontamination of used equipments Engineering Very Low No Yes
(transport bag, scissors, Administrative
collection site/booth, cold packs Practices
and specimen racks) PPE

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
exposure/release
Moderate ✔L Medium High
ow
Negligible Very low Low ✔Medium
Overall residual risk: ✔ ☐ ☐ ☐ ☐
Very low Low Medium High Very high
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
guidance
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) GITTEL GRACE O. GANO, RMT
Approved by (signature) gittelgrace
Date 1/18/2021

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 Through updating of Standard Operating Procedures, meetings and
measures trainings.
Purchase (and budgeting) of risk control measures Through the Office of Budget Management in the Municipality.
Operational and maintenance procedures Through the Office of Budget Management in the Municipality.
Training of personnel Careof the LGU.
 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 Monthly or as frequent as needed.
Person to conduct the review Biosafety Officer/Supervisor
Describe updates/changes 1. Check updates on PPEs used, practices and trainings of the
personnel involved.
Personnel/procedures to implement the changes Supervisors
Reviewed by (name and title) GITTEL GRACE O. GANO, RMT
Reviewed by (signature) gittelgrace
Date 1/18/2021

© 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