WHO Risk Assessment Template - Annex2

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RISK ASSESSMENT

Institution/Facility name Anonas Diagnostic Clinic


Laboratory name
Laboratory manager/Supervisor Jasmine Sampan, RMT, Laboratory Manager
Project titles/Relevant standard operating procedures Biological Spill Response
(SOPs)
Date March 31, 2022

STEP 1. HAZARD IDENTIFICATION

Describe the biological agents and other potential hazards Bloodborne pathogens: human immunodeficiency virus (HIV), and
(for example, transmission, infectious dose, hepatitis A, B, C and D viruses. Unknown bloodborne pathogens
treatment/preventive measures, pathogenicity). (rarer). The most dangerous of the bloodborne pathogens is hepatitis
B since it can survive outside the body (on surfaces) for up to 7 days
and it is a common sexually transmitted infection. Hepatitis C can
also survive outside the body on surfaces but only up to 4 days.
Although Hepatitis A can survive on surfaces for long periods, this
infection is always acute, is transmitted by the fecal/oral route and
can be easily detected. • Hepatitis A: vaccine-preventable, post-
exposure prophylaxis available, acute and recovery is spontaneous •
Hepatitis B: vaccine-preventable, post-exposure prophylaxis
available, acute and chronic forms • Hepatitis C: no vaccine, chronic,
now treatable • HIV: no vaccine, post-exposure prophylaxis available,
incurable, lifelong treatment with antiretroviral drugs All are
transmissible; all can be prevented using good microbiological
practice and procedure, and the specified risk control measures.
Describe the laboratory procedures to be used (for We will be testing blood specimens.
example, culturing, centrifugation, work with sharps, waste Blood sample collection, Centrifugation, Handling sharps, Processing
handling, frequency of performing the laboratory of blood samples, wastes handling.
activity).
Describe the types of equipment to be used (personal  PPE will be worn, including disposable gloves and an open-front
protective equipment [PPE], centrifuges, autoclaves, laboratory coat. Pipettes, centrifuges, Hematology analyzers,
biological safety cabinets [BSCs]). Chemistry analyzers • Mitigation measures: Staff training, PPE, SOP`s
Describe the type and condition of the facility where work The facility is old but physical plants are regularly maintained.
is conducted.
Describe relevant human factors (for example, We have training on Biosafety/Biosecurity conducted by RITM.
competency, training, experience and attitude of
personnel).
Describe any other factors that may affect laboratory Both hepatitis and HIV infection are culturally unacceptable in the
operations (for example, legal, cultural, community. All specimens will have identification removed by the
socioeconomic). personnel receiving the specimens before being forwarded to
laboratory personnel. The clinic physicians will inform patients of
their disease.
STEP 2. EVALUATE THE RISK

What potential situations are there in which exposure or Potential situations in which exposure or release could occur if there
release could occur? is improper handling of specimens and not wearing of PPE.

What is the likelihood of an exposure/release occurring? The likelihood of an exposure/release is: Possible- feasible to occur
● Unlikely: not very possible to occur in the in the near future.
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 The severity of the consequences of an exposure/release is
exposure/release (negligible, moderate, severe)? negligible.

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)
Use of PPE Very low No Low
Handling of specimens Very low No Low

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

Are resources sufficient to secure and maintain potential We have a complete sets of PPE for employee`s protection and we have
risk control measures? Spill kits if accidental biological spills take place.
What factors exist that may limit or restrict any of the risk Improper use of PPE and poor precautionary measures like improper
control measures? handling of specimens
Will work be able to proceed without any of the risk Proper and strict precautionary measures should be observed
control measures; are there alternatives?

STEP 4. Select and implement 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)
Handling of Specimens like blood Proper use of PPEVery low No yes
samples
Vaccination of
Staffs
Responding to biological spills Availability and Very low No yes
accessibility of
Spill Kits
Biosafety and
Biosecurity
training for staffs
Contamination of work surfaces Decontamination Very Low No Yes
of surfaces after
completing work
and at the end of
the day

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) Jasmine Sampan, RMT
Approved by (signature)
Date March 31, 2022
Communication of the hazards, risks, and risk control measures Prepare an SOP specific to our laboratory that will include
biosafety equipment to be used and practices that must be
followed.
Purchase (and budgeting) of risk control measures Risk control measures will be included in the annual budget.
The laboratory manger will be responsible for inventory and
usage records, and inform of expenditures so that budget
adjustments can be made accordingly.
Operational and maintenance procedures Included in annual budget
Training of personnel All personnel will have a Biosafety/Biosecurity training

STEP 5. Review risks and risk control measures

Frequency of the review This procedure will be reviewed in one year from the start date of this
risk assessment but sooner if needed because of personnel, equipment
and/or protocol changes. The procedure will be reviewed before the
one-year date if a laboratory incident occurs.
Person to conduct the review Laboratory Manager
Describe updates/changes Minor updates or changes to the SOP may be implemented to: 1)
ensure accuracy of testing, or 2) improve workflow. These will be done
on a case-by-case basis without review of the entire process
Personnel/procedures to implement the changes Laboratory Manager
Reviewed by (name and title) Jasmine Sampan, RMT – Laboratory Manager
Reviewed by (signature)
Date March 31, 2022

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