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 SAN JOSE DISTRICT HOSPITAL

Laboratory name SAN JOSE DISTRICT HOSPITAL-LABORATORY
Laboratory manager/Supervisor NERILIZA P. RAMOS, RMT II
Project titles/Relevant standard operating procedures SOPs FOR ANTIGEN COLLECTION AND TESTING
(SOPs) SOPs FOR OPS/ NPS COLLECTION
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 COVID-19 VIRUS/ SARS COV 2
(for example, transmission, infectious dose,
treatment/preventive measures, pathogenicity).
Mode of transmission: Human to human direct contact
Via respiratory droplets from cough and sneezes
Maybe airborne as well with aerosol potentially being able to transfer
virus
Indirect contact vi a contaminated surfaces
Pathogenicity: disease severity classification with probable and
confirmed cases
a. Mild: symptomatic presenting with fever, cough, fatigue,
anorexia, myalgias; other non-specific symptoms such as sore
throat, nasal congestion, headache, diarrhea, nausea and
vomiting; loss of smell *anosmia) or loss of taste (ageusia)
preceding the onset of respiratory symptoms with no signs of
pneumonia or hypoxia
b. Moderate: adult with clinical signs of non-severe (e.g. fever,
cough, dyspnea, respiratory rate = 221-30 breaths/minute,
peripheral capillary oxygen saturation >92% on room air
Child with signs of non severe pneumonia (e.g. cough or
difficulty breathing and fast breathing <2 months: >60; 2-11
months>50; 1-5 years: >40; and chest in drawing
c. Severe: adult with clinical signs of sever pneumonia or severe
acute respiratory infection as follows: fever, cough, dyspnea,
RR>30 breaths/ minute, severe respiratory distress <92% on
room air
Child with clinical signs of pneumonia plus at least one of the
ff: central cyanosis < 90%; severe respiratory distress (e.g. fast
breathing, grunting, very severe chest in drawing); general
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Describe the laboratory procedures to be used (for
example, culturing, centrifugation, work with sharps, waste
handling, frequency of performing the laboratory
activity).
Frequency of performing lab activity: 24 hours’ daily
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 a.
is conducted.
b.
Describe relevant human factors (for example, a.
competency, training, experience and attitude of
personnel). b.
c.
danger sign: inability to breastfeed or drink, lethargy or
unconsciousness, or convulsions.
Fast breathing: <2 months: >60 in breaths/ min; 2-11 months:
>50; 1-5 yr: >40
d. Critical: acute respiratory distress syndrome patient with onset
within 1 week of known clinical insult (pneumonia) or new or
worsening respi. Symptoms, progressing infiltrates on chest x-
ray or ct scan, with respiratory failure not fully explained by
cardiac failure
Sepsis: adults with life threathening organ dysfunction caused
by a dysregulated host response to suspected or proven
infection. Signs of organ dysfunction include altered mental
status, difficult or fast breathing, low oxygen saturation,
reduced urine output, fast heart rate, weak pulse, cold
extremities or low blood pressure, skin mottling, or laboratory
evidence of coagulopathy, thrombocytopenia, acidosis, high
lactate or hyperbilirubinemia
Children with suspected or proven infection and >2 age-based
systemic inflammatory response syndrome criteria (abnormal
temp > 38.5 or <36 OC; tachycardia for age or bradycardia for
age if <1 yr; tachypnea for age or need for mechanical
ventilation; abnormal wbc count for age or > 10% bands, of
which one must be abnormal temperature or wbc count
Septic shock: adults with persistent hypotension despite volume
resuscitation, requiring vasopressor to maintain MAP> 65
mmHg abd serum lactate >2 mmol/ L
Children with any hypotension (SBP <5 th centile or > 2 SD
below normal for age) or two or three of the following: altered
mental status; bradycardia or tachycardia (HR <90bpm or >
160 bpm in infants and heart rate <70 bpm or 150 bpm in
children); prolonged capillary refill >2 sec or weak pulse; fast
breathing; mottled or cool skin or petechiae or purpuric rash;
high lactate; reduced urine output; hyperthermia or
hypothermia.
1. packing of complete PPEs
2. antigen testing
3. Ops/nps collection
4. Proper waste handling and disposal
5. Triple packaging
6. Linelist encoding
7. Sorting and transporting of samples
8. Decontamination of equipment
1. PPE
2. OPS/ NPS KIT
3. ANTIGEN KIT
4. Cool dogs
5. Waste bags
6. VTM
7. Lysol, 70% alcohol, 10% bleach
8. Refrigerator
9. Ice box container
10. Sharps bin
Hospital-based facility. It has own waiting area for swabbing and
antigen testing. The collection of samples is done on a swab booth
located on Covid Fastlane for close contact, probable and suspected,
which is isolated from the main building and out-patient
department.
OPS/ NPS samples are properly packaged and stored in refrigerator
prior transportation to OMPH for RT-PCR testing.
The swabber is a licensed medical personnel preferably medical
technologist with training in OPS/ NPS collection
The swabber must have basic handling of infectious waste in
accordance to biorisk management training
The person for the job must be competent, skilled, knowledgeable,
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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flexible, good listener and follower.
Describe any other factors that may affect laboratory a. Inadequate supplies of PPEs’ and antigen kits
operations (for example, legal, cultural, b. Increased number od Covid-19 cases.
socioeconomic). c. Decreasing number of personnel due to Covid-19 infection.
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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STEP 2. Evaluate the risks

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

What potential situations are there in which exposure or 1. Improper Donning and Doffing of PPEs’.
release could occur? 2. Biological spill while collecting NPS/OPS samples.
3. Lack of knowledge on Proper Good Microbiological Procedures and
Practices (GMPP) among swabbers/personnel.
4. Not decontaminating the equipment used and the working area
(collection area and swabbing booth)
5. Sorting of samples with barehands

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.
1. Improper Donning and Doffing of PPEs’. =Possible
2. Biological spill while collecting NPS/OPS samples. =Possible
3. Lack of knowledge on Proper Good Microbiological Procedures and
Practices (GMPP) among swabbers/personnel. =Possible
4. Not decontaminating the equipment used and the working area
(collection area and swabbing booth)= Likely
5. Sorting of samples with barehands = Unlikely

What is the severity of the consequences of an Moderate to 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
1. Improper Donning and Doffing of PPEs’.
=Possible
2. Biological spill while collecting NPS/OPS samples.
=Possible
3. Lack of knowledge on Proper Good
Microbiological Procedures and Practices (GMPP)
among swabbers/personnel. =Possible
4. Not decontaminating the equipment used and the
working area (collection area and swabbing
booth)= Likely
5. Sorting of samples with barehands = Unlikely
✔️

✔️
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)
Swab collection Medium Yes High
Antigen testing Medium Yes Medium
Waste handling and disposal High Yes High
Transporting of samples Low No Low
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Decontamination of used equipments Medium No Low

(transport bag, scissors, collection site/booth cold
packs and specimen rack)

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

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. Interim Biosafety Guidelines for Laboratories Handling and
Testing SARS-COVS (COVID 19) Specimens
6. Interim Guidelines for Biosafety and COVID-19 (CDC)
7. Department Memorandum No. 2020-0436
“Minimum Data Requirements of COVID-19 Related
Information Systems”.
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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 No
risk control measures?
What factors exist that may limit or restrict any of the risk 1. Lack of PPEs’
control measures? 2. Inadequate supplies of decontaminants.

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)
Swab collection Administrative, Low No Yes
Practices, PPE
Antigen testing Administrative, Low No Yes
Practices, PPE
Waste handling and disposal Elimination, Low No Yes
Engineering
Transporting of samples Practices, PPE
Decontamination of used equipments Administrative, Very Low No Yes
(transport bag, scissors, collection site/booth Engineering
cold packs and specimen rack) Practices, 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 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) NERILIZA P. RAMOS, RMT II
Approved by (signature) Neriliza Ramos
Date 1/18/2022

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.
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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Communication of the hazards, risks, and risk control Attending trainings, meetings and updating SOP (Standard Operating
measures Procedure)
Purchase (and budgeting) of risk control measures Provincial Health Office – Budget Department
Operational and maintenance procedures Provincial Health Office – Budget Department
Training of personnel Provincial Health Office
 Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim
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STEP 5. Review risks and risk control measures

© 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

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