Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

POLICY ON RISK ASSESSMENT

PURPOSE

Effective control of risks is the cornerstone of laboratory safety. The laboratory

has a responsibility to their personnel and the community to ensure that work is done in

a way that brings Risk Assessment identify, monitor, and review the dangers in a working

environment. It focuses on prevention and reduce injury, damages and costs. Also, it

functions as an opportunity to promulgate and revise policies and procedures to improve

safety measures based on the findings.

POLICY

The risk assessment process includes the identification of threats and

vulnerabilities having to do with the laboratory.

PROCEDURE:

ACTIVITY FLOW RESPONSIBLE DETAILS

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

 Date and Agenda for meeting will

HOL be set. Relevant personnel will
START and CMT be tasked with preparing their
own reports
 Inputs would include but not
limited to:
INITIATE MANAGEMENT 1. Review of Quality Policy
2. Review of Quality Objectives
REVIEW
3. Result of Audits
4. Customer and other feedback
and complaints
5. Status of corrective/
preventive action
6. Process, performance and
service conformity
7. Changes that could affect the
management system
8. Follow up actions from
previous reviews
9. Recommendations for
improvement

CMT Notification is done thru verba,

NOTIFY PARTICIPANTS electronic mail, and/or memorandum

CONDUCT All personnel The minutes of the previous

MANAGEMENT REVIEW management review meeting will be
read. It will serve as a review of what
were discussed before.

DISCUSS ALL INPUT Concerned Current situation with respect to noted

Personnel opportunities for improvements and
results of audits are reviewed and
actions for improvement are discusse,
including conclusion as to the status
and effectiveness of the system. The
A appointed secretary take minutes of the
meeting

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

A HOL Outputs of the review may include

and/or action items (specifying responsible
Top persons and target dates) related to:
Management  Changes to policy, objectives
(Board and targets
DETERMINE ACTION Members)  Business requirements
POINTS NEEDED  Improving effectivess of the
quality management system
 Resources needed (funds and
budgets included)

Note decisions and actions required

including responsible person and
timetable on the minutes for all areas
discussed

DOCUMENT AND The review of findings and plan of

MAINTAIN RECORD OF actions are fully documented and filed.
THE REVIEW

COMMUNICATE RESULTS
OF THE REVIEW Disseminated management review
report to all relevant personnel

Follow up actions to ensure effective

IMPLEMENT ACTION implementation of committed actions
PLAN AS AGREED

END

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

Institution/Facility name HC MEDICAL CLINIC AND LABORATORY

Laboratory name HC MEDICAL CLINIC AND LABORATORY
Laboratory manager/Supervisor
Project titles/Relevant standard operating RISK ASSESSMENT PROGRAM OF HC
procedures (SOPs) MEDICAL CLINIC AND LABORATORY
Date

STEP 1. 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 Biological agents that may be identified within the
hazards (for example, transmission, infectious laboratory facilities are non-virulent, minimal
dose, treatment/preventive measures, pathogenicity if not non-pathogenic microbes
pathogenicity). which can be transmitted through poor handling
of specimens and cross-contamination. Also
direct contamination through droplets of aerosol
or airborne microbes from patients while
performing blood collection. These modes of
microbes transmission can be prevented through
implementation of GLP or Good Laboratory
Practice; wearing the complete PPE while
working in the lab., The use cellular phones are
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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

prohibited inside the lab. Strictly no eating and

drinking inside the lab and the most important
is by following the prescribed Standard
Operating Procedure ( SOP ) of the lab for
proper guidance and orderly in the laboratory.
Describe the laboratory procedures to be used The following procedures are being performed
(for example, culturing, centrifugation, work with in the laboratory
sharps, waste handling, frequency of performing 1) Centrifugation of bodily specimens such
the laboratory activity). urine and stool
2) Blood collection using needles, blood
lancet
3) Waste disposal of biological and non-
biological matters which is done on a
daily basis
4) Microscopy for urine and stool analysis.
Blood smear for differential count after
staining is read microscopically.
Centrifugation is done using a table-top
centrifuge machine. There is a separate
centrifuge machines for blood and urine and
other body fluids Urine samples are spin for 5
minutes using 2500 while blood sample for 10
minutes using a digital high-speed centrifuge.

In the blood extraction area, there is biohazard

equipment to dispose materials used in blood
extraction. There is a separate biohazard
equipment for sharps where needles are bend
prior to disposal.

Wastes are disposed according to DOH and

DENR regulations. The waste holding area is
found outside the laboratory however, wastes
from daily processing are withhold in small,
color coded trash bins which are transferred
after work. These trash bins are provided with
cover that swing when open through its foot
pedal. Color coding are black, yellow and green.
Med Techs do not touch the cover of each
trash bin all the time.

Microscopic examination of specimen is done in

microscopy and hematology area. There are two
available microscopes for the purpose. The
“clean” microscope for reading differential
count, and manual cell count while the “dirty”
microscope is found in the microscopy station
used for urine sediment and stool examinations.

All the above techniques are performed on a

daily basis and are part of the routine
processing in the laboratory.
Describe the types of equipment to be used All equipment found within the lab facilities are
(personal protective equipment (PPE), of standard, high quality instruments. These
centrifuges, autoclaves, biological safety cabinets equipment are FDA approved supported by CPR.
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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

(BSCs)). Complete PPE are disposable including the head

cover and footwear. All lab personnel are
requested to wear the prescribed PPE before
starting to work in the lab. Table- top centrifuge
machines are calibrated periodically. Centrifuge
machine for urinalysis is a 6-placer, non-digital
while the centrifuge used for blood is a 24-
placer, digital and fully automatic. The autoclave
is 36 liter capacity that can hold tubes, petri
dishes, cotton and gauze pads.
Describe the type and condition of the facility HC medical clinic and laboratory is spacious
where work is conducted. with ___ sq mm space allocation. The blood
extraction area is found outside the main. It is
enclosed and private space between the med
tech and the patient. The main laboratory is
clean, organize, well-ventilated and being
sanitize everyday. The wall is painted white as
well as the counter top tables. There are three
sinks with 8 mm depth found inside the lab.
Each sink is provided with handwashing
technique slogan on the wall to remind the lab
workers to perform handwashing as often as
possible. The floor is non-slippery, tiled and
always clean. It is maintained dry, no spillage of
any fluid all the time.
Air-conditioner is a split-type run with 2.5 hp
hence, the room is well-ventilated and conducive
to work more than 8 hours a day. However, the
lab strictly operates 8 hours a day. No overtime
being required to med techs by the
management of the company. Air-conditioner is
clean and calibrated periodically to maintain
good functionality and as part of the sanitation
program of the company.
Describe relevant human factors (for example, There is assigned Biosafety and Biosecurity
competency, training, experience and attitude of Officer in the lab who is certified by RITM-
personnel). BRMO. The HOL and the Biosafety and
Biosecurity Officer conducts training and
orientation for the staff periodically. Other staff
underwent relevant trainings on COVID
transmission while others on laboratory
processing and quality control programs. The lab
personnel consists of a pathologist who is the
HOL , 4 fulltime med techs and 1 reliever.
Describe any other factors that may affect The number of laboratory personnel matches
laboratory operations (for example, legal, with the service capability of the lab as primary
cultural, socioeconomic). laboratory. No lab personnel are allowed to
work more than the expected workload.
Minimum requirements are met and all services
are available. Prices of services are affordable to
the people around the area however, discounts
are given to senior citizens, PWD and
underprivileged individuals in San Mateo in order
to get ideal census of tests per month. All
employees in Vayos medical services are assured
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Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

of acceptable salaries with benefits like hazard

pay and meal allowance. Uniform is given free
to all staff. This is to make sure that all
employees are satisfied and the expectation has
met for them.

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

STEP 2. Evaluation of the risks

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

What potential situations are there in which Cross contamination of potential microbe
exposure or release could occur?
What is the likelihood of an exposure/release Unlikely; not very possible to occur in the near
occurring? future
 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 negligible
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/rel Moderate Low Medium High
ease
Negligible Very low Low Medium

Laboratory Initial risk Is the initial risk Priority

activity/procedure (very low, low, above the tolerance (high/medium/lo
medium, high, very level? w)
high) (yes/no)
centrifugation Very low low medium
blood collection Very low low medium
microscopy Very low low medium
waste disposal / handling Very low low medium
Specimen processing Very low low medium
Select the overall initial ☐√ ☐ ☐ ☐ ☐
risk. Very low Low Medium High Very high
Should work proceed
without additional risk √Yes ☐No
control measures?

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations

STEP 3. Developing 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 Training on Biosafety and Biosecurity
legislation or regulations (if any). Proper Waste Management Program - appoint
Pollution Control Officer / Biohazardous Waste
Collection
Describe the measures advised by guidelines, To hire Biosafety and Biosecurity Officer and
policies and strategies (if any). Pollution Control Officer
MOA to DENR Waste Hauler to collect biological /
hazardous samples, follow color coding or proper
segregation of wastes
Conduct regular trainings on biosafety measures
among the lab personnel

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 Yes.
potential risk control measures?
What factors exist that may limit or restrict any Inability of other personnel to follow strictly the
of the risk control measures? SOP of the laboratory
Will work be able to proceed without any of the Yes. Posting of notices and warnings / regular staff
risk control measures; are there alternatives? meeting to remind ALL lab staff to comply on risk
control measures

STEP 4. Selection and implementation of 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.
Laboratory activity/procedure Selected risk Residual risk Is the Are risk
control (very low, residual risk control
measure(s) low, above the measures
medium, tolerance available,
high, very level? effective and
high) (yes/no) sustainable?
(yes/no)
centrifugation Wearing of Very low no yes
complete PPE
including goggles
blood extraction Wearing of Very low no yes
complete PPE
during
phlebotomy /
needle sticks
Waste disposal / handling Proper waste low no yes
disposal, Wearing
of PPE with
double gloves,
Wearing of N95
to prevent
inhalation of
possible pathogens

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 Laboratory biosafety guidance for novel coronavirus (2019-nCoV): Interim Recommendations
microscopy Use separate low No Yes
microscope units
for blood and
urine and stool to
prevent cross
contamination,
wear complete
PPE
Specimen processing Wear complete low No yes
PPE including
goggles, avoid
spillage of fluids,
Ready Spill Kit at
all times

Instructions: Evaluate the residual risk that remains after risk control measures have been
selected to determine if 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

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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
√Yes ☐No
risk control measures?
Approved by (Name and title) JENNIFER CHAVEZ
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
that all identified risk control measures are purchased, have associated SOPs and training has been
completed before starting the laboratory work.
Communication of the hazards, risks and risk Through regular meetings of all lab personnel,
control measures orientation of new personnel and re-orientation among
regular staff every 6 months. Memorandum is issued
to those who are found non-compliant to regulations
pertaining to Risk and Hazards Prevention
Purchase (and budgeting) of risk control Spill Kit is ensured complete and other items such
measures as disinfectant and antiseptics, calibration of
autoclave is done every 6 months. There is a regular
budget allotted for materials / instruments approved
by the finance officer of the company
Operational and maintenance procedures Preventive measures are done in the lab two-folds;
preventive maintenance for the equipment and the physical
plant / facility. All equipment are calibrated regularly to
check for functionality and maintenance. Instruments and
equipment are ensured operational and safe to use.
Room Temperature is being checked daily to ensure proper
ventilation, building structure is check for cracks , faucets
and water supply are being checked. Overall, the laboratory
is safe, organized and well maintained.
Training of personnel Staff development is part of the Continuing Professional
Education ( CPE ) of all lab personnel. Attendance of
personnel on trainings, seminars, conventions is subsidize by
the company. Training on Biosafety and Biosecurity is part
of the requirements for regular staff.

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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 and/or near misses.
Frequency of the review Once a year
Person to conduct the review Head of the laboratory
Describe updates/changes Updating of SOP particularly on procedure of specimen
processing whenever possible when equipment and reagent
system are changed,
Personnel/procedures to implement the changes The Head of the Laboratory shall regular meeting among
all the lab personnel to implement new procedures . A
memorandum is also issued to all lab staff to comply on
the changes
Reviewed by (Name and title) JENNIFER CHAVEZ
Reviewed by (Signature)
Date