2024 Risk Assessment - Revised

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MEDLEX

Alfonso Medical Building


DIAGNOSTIC
335 Malvar St., Puerto Princesa City
DOH License No. 4B-0032-22-CL-2
LABORATOR
Y
2024 ANNUAL RISK ASSESSMENT
Institution Name/ name of Facility MEDLEX DIAGNOSTIC LABORATORY
Laboratory Name MEDLEX DIAGNOSTIC LABORATORY
Head of Laboratory PERLA E. PALAO, MD, DPSP
Project Title RISK ASSESSMENT – Serology & Blood Chemistry
Date January 4, 2024

HAZARD IDENTIFICATION:
Instructions: Provide a brief Overview of the Laboratory work and summarize the laboratory activities to be conducted that are
included in the risk assessment
Describe the biological agents and other HEPATITIS B VIRUS INFECTION – TO BE TRANSMITTED
potential hazards (for example, transmission, THRU NEEDLE PRICK ACCIDENTS, AND SOMETIMES VIA
infectious dose, treatment/preventive PARENTERAL ROUTE OF TRANSMISSION.
measures, pathogenicity)
Describe the laboratory procedures to be used BLOOD EXTRACTION, CENTRIFUGATION, WORKING WITH
( for example: culturing, centrifugation, work SHARPS
with sharps, waste handling, frequency of
performing the laboratory activity. FREQUENCY IS DAILY
Describe the type of equipment to be used PERSONAL PROTECTIVE EQUIPMENT LIKE GLOVES,
(PPE, centrifuges, autoclaves, Biological GOGGLES, FACE MASKS, COVER-ALL CLOTHING, AND LAB
Safety Cabinets) GOWNS.

CENTRIFUGE AND LABORATORY GLASSWARE..


Describe the type and condition of the facility THE LABORATORY IS HOUSED IN A PERMANENT
where work is conducted. STRUCTURE.
AIR-CONDITIONED ROOM.
LOCATED IN A COMMERCIAL AREA.
NEAR A PUBLIC HOSPITAL AND ADJACENT TO A BIRTHING
HOME FACILITY.
. LABORATORY WORKERS ARE TRAINED AND EXPERIENCED
MEDICAL TECHNOLOGISTS AND LABORATORY AIDES.
BIOSAFETY TRAINING OF LAB WORKERS.
Describe any other factors that may affect AFFECTED BY THE DOG ISSUANCES ON LABORATORY AS
laboratory operations ( Ex: legal, cultural, MANDATORY REQUIREMENT.
socio-economic. ) LOCAL IATF AND LOCAL IMT ISSUANCES FOR THE
LABORATORY TO ADHERE TO, PERTAINING TO THE COVID-
19 PANDEMIC ISSUES.

RISK EVALUATION:
INSTRUCTION: Describe how exposure and release could occur
What potential situations are there in which MISHANDLING OF SPECIMENS, GROSS NEGLIGENCE, AND
exposure or release could occur? POOR LABORATORY SAFETY PRACTICES.
What is the likelihood of an exposure/ release
occurring? POSSIBLE TO OCCUR IN THE NEAR 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
exposure/release (negligible, moderate, severe MINOR TO MODERATE

Instruction: valuate the risk and prioritize the implementation of risk control measures. Circle the initial (Inherent) risk of the laboratory
activities before additional risk control measure have been put in place.
Noter:
 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
Consequences of Severe Medium High Very High
Exposure/Release
Moderate Low Medium High

Negligible Very Low Low Medium


Initial Risk Is the initial risk Priority
(Very low, low, above the tolerance (High/Medium/Low)
medium, High, Very level
High) (YES/NO?)
CENTRIFUGATION LOW NO LOW
BLOOD COLLECTION LOW NO LOW
SAMPLE TESTING VERY LOW NO LOW
MICROSCOPY 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

DEVELOP A RISK CONTROL STRATEGY


Instruction: List any requirements that have been prescribed by international and national regulations, legislation, guidelines, policies
and strategies on biosafety and biosecurity.
Describe measures required by national DOH, IATF Guideline issued by the Government on Biological
legislation or regulations (if any) Wastes, Handling, Storage and Disposals.
Describe the measures advised by CREATION OF LABORATORY STANDARD OPERATING
guidelines, policies and strategies PROCEDURES, OUTLINING AND DEFININF THE POLICIES AND
STRATEGIES.

Instruction: 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 IT IS SUFFICIENT, FUNDS ARE APPROPRIATED AND
maintain potential risk control measures AVAILABLE.
What Factors exists that may limit or POSSIBLE LACK OF SUPPLIES LIKE PPE’s FROM THE
restrict any of the risk control measures? SUPPLIER, AND THE PROMPTNESS OF SUPPLY DELIVERY
DUE TO TRAVEL RESTRICTION, ALTHOUGH GIVEN PRIORITY
WHEN IT COME TO MEDICAL SUPPLIES.
Will work be able to proceed without any
of the risk control measures; are the YES, IT MAY CONTINUE
there alternatives?
SELECTION AND IMPLEMENTATION OF RISK CONTROL MEASURES:
INSTRUCTION: 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.
LABORATORY
ACTIVITIES/PROCEDURES Selected risk control Residual risk Is the residual risk Are risk control
measures (very low, low, above the measures available,
medium, very tolerance level? effective, and
high) (yes/No?) sustainable
BLOOD SAMPLE COLLECTION Wearing of
required PPE’s Very low No Yes
such as gloves
and gowns
CENTRIFUGATION Wearing of safety
goggles/ face Very low No yes
shields

Instruction: Evaluate the residual risk that remains after the 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


Consequences of Moderate Low Medium High
exposure/release Negligible Very Low Low Medium

Overall residual risk Very low √ Medium High Very High


Low
If the residual risk is still above the risk tolerance level, further action is necessary, such 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 control
measures. YES
Approved by: (Name and title) JOSEPH JOJO D. DAJAY, RMT, LLB.
Approved by: (Signature

Date: JANUARY 3, 2024

Instruction: Describe how to communicate risk 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 SOP’s and trainings
have been completed before starting the laboratory work.
Communication of the hazards, risks and control Through the use of laboratory signages, and alarms
measures.
Operational and maintenance procedure Through the availability of the Laboratory SOP’s
Purchase (and budgeting) of risk control measures To be done by personal communication to the top
management, ensuring that sufficient budget is in place.
Training of personnel Through announcements in bulletin boards that trainings
are available, identifying who the participant shall be.

REVIEW RISKS AND RISK CONTROL MEASURES


Instruction: 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, feedback, incidents, or near
misses.
Frequency of the review Annually or as the need arises.
Person to conduct the review Biosafety Officer
Describe updates/changes Should be done as the need arises, such as when the
pandemic once again spike/surge. Or when new changes in
the structure and protocols in the laboratory are being
undertaken.
Personnel/procedures to implement the changes Biosafety Officer and Laboratory Analyst
Reviewed by: (Name and Title) JOSEPH JOJO D. DAJAY, RMT, LLB.
Reviewed by: (Signature)

Date: JANUARY 4, 2024

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