Risk Management in Medical Laboratories

Risk management in medical
laboratories
Ana Stavljenic-Rukavina
Zagreb, Croatia
Kornati Islands,
Croatia
The annual rate of illness and

injury reported for hospital
workers is 10% - about the
The most frequent occupationrelated illnesses among hc personel

respiratory
problems
infections
dermatitis
drug
or medication reactions
Reasons for the lack of emphasis

on employers health:
common notion that health

professionals are capable of
maintaining their health without
assistance
availability of informal consultation
with hospital physician
hospitals are oriented toward treating
disease rather than maintaining health
Accidents do not happen, they

are caused
Safety should be taught and implemented

on every level in the health care sector
Within health care environment, both
workers and patients are daily
confronted with various health and
safety hazards
Therefore, implementation of general
safety and risk reduction system is
mandatory
LABORATORY HAZARDS
Non-infectious
dusts
physical agents
chemical agents
mutagenic and
teratogenic
agents
skin irritants
stress (!)
Infectious
hepatitis
AIDS
Material Safety Data

Sheets (MSDS)
It is obligatory that the vendors supply

MSDS for the chemicals
Vendor should make sure that the facility
receives the MSDS before or along the
shipment of chemical product
MSDS must be available for each chemical
used in an operation
Emergency and first aid procedures and
handling precautions should be given in
writen form to professionals
Infectious occupational health

hazards
Hepatitis B: a model for transmission

of blood-borne patogens (10-40% of
health care workers have serologic
evidence of past or present infection)
Infection risk after needle puncture:
HBV: 5-40%
HCV: 1-10%
HIV: <0.5%
An individual is at risk for

HBV or HIV infection in
proportion to the extent at
which he/she is exposed to
blood and body fluids
Therefore, effective
protection against bloodborne diseases requires
universal observation of
common barrier precautions
....which simply means: within

healthcare environment, all
body fluids and tissues
should be treated as
infectious.
Equally important: waste
disposal!
COMPONENTS OF
MEDICAL SAFETY
Employee safety
Patient safety
Environment safety
ELEMENTS OF EMPLOYEE
SAFETY
Blood and body fluid exposures

Allergies
Communicable disease exposures
Musculoskeletal injuries
Immunization program
Systematic review, follow-up, and
reporting of employee incidents
Levels of Biosafety
BSL 1: Material not known to consistently cause

disease in healthy adults.
BSL 2: Associated with human disease. Hazard
is from percutaneous injury, ingestion, or
mucous membrane exposure.
BSL 3: Indigenous or exotic agents with
potential for aerosol transmission; disease may
have serious or lethal consequences.
BSL 4: Dangerous/exotic agents which pose a
high risk of life-threatening disease, aerosoltransmitted lab infections or related agents
with unknown risk of transmission.
Risk Assessment
Pathogenicity of material disease incidence and

severity
Routes of Transmission parenteral, airborne or
ingestion
Agent Stability ease of decontamination
Infectious Dose LD50
Concentration infectious organisms/vol. & working
volume
Origin of material - Wild Type, primary cells
Availability of effective prophylaxis Hep. B
vaccine
Medical surveillance exposure management
Skill level of staff
Risk Assessment
Risk of Activity same agent can have

different containment levels at different
stages of protocol:
Procedures that produce aerosols have
higher risk
Procedures using needles or other sharps
have higher risk
Handling blood, serum or tissue samples
may have lower risk
Purified cultures or cell concentrates may
have higher risk
Larger volumes (10 L) have higher risk
Primary Containment
Lab practices SOP regulating access,

biohazard warning sign, sharps/needle
precautions, SOPs for decontamination and
waste.
Safety equipment biosafety cabinets
(BSC), sharps containers, sealed rotors.
Personal protective equipment (PPE) : coat,
gloves, goggles.
Host-vector for rDNA
Aerosol Precautions
Use BSC for all procedures that may

generate aerosols.
Use centrifuges with biosafety covers.
Do not use a syringe for mixing infectious
fluids.
Cultures, tissues, specimens of body fluids,
etc., are placed in a container with a cover
that prevents leakage during collection,
handling, processing, storage, transport or
shipping.
Needle and Sharps

Precautions
Precautions are for any

contaminated sharp item,
including needles and syringes,
slides, pipettes, capillary tubes,
and scalpels.
Plasticware should be substituted
for glassware whenever possible.
Needle and Sharps

Precautions
Used disposable needles must not be bent,

sheared, broken, recapped, removed from
disposable syringes, or otherwise manipulated
by hand before disposal. Dispose in punctureresistant containers which must be located
near work.
Non-disposable sharps must be placed in a
hard-walled container for transport to a
processing area for decontamination,
preferably by autoclaving.
Broken glassware must not be handled directly
by hand.Pick up by mechanical means such as a
brush and dustpan, tongs, or forceps.
Human Blood, Tissue and Fluid

Occupational Exposure to Bloodborne Pathogens
Use BSL 2 work practices and procedures.

Additional requirements for HIV work.
Everyone needs to be offered the Hepatitis B
vaccine.
Develop specific exposure plan SOPs.
Specific training is required.
Review needle/syringe use and replace with
safe devices.
Exposure incidents must be followed up.
Toxins
Use BSL 2 work practices and

procedures.
Develop a Chemical Hygiene Plan
specific to the toxin used.
Include containment (hoods,
biosafety cabinets).
Some toxins are Select Agents
and require registration.
Select Agents
Possession, use and transfer of

specific biological agents requires
registration.
Restricted Persons are not allowed
to have access to these agents.
High security and containment must
be maintained.
Security
Control access to areas where biological

agents or toxins are used and stored.
Keep biological agents and toxins in
locked containers.
Know who is in the laboratory, what
materials are being brought and what
materials are being removed from the
laboratory.
Have a protocol for reporting incidents.
Have an emergency plan.
Emergencies
Develop and practice plans for:
Spills: large spills, spills inside BSC

Accidental exposures: needlesticks,
eye/mucous membrane splash, breathing
aerosols
Power/Utility failures: BSC, freezers,
ventilation, lights, water
Fires
Medical emergencies
Waste Disposal
Red bag or Regulated Medical Waste:
All mammalian cells or anything that came

in contact with mammalian cells
All BSL 2 material or anything that came
in contact with BSL 2 material
All needles/syringes regardless of use
No need to autoclave this waste prior to
disposal in EH&S red bag/box (material is
incinerated).
CRITICAL ELEMENTS
CREATING A SAFETY CULTURE
Demonstrate top leadership commitment to

safety
Swift and visible correction of unsafe
conditions
Established procedures for reporting
unsafe conditions
Reward workers for following procedures
Involve frontline healthcare workers in
identifying problems and solutions
Role of management
The scope: identifying problem
areas and exerting specific
actions to correct them
Development of Safety
Program
Recognition of hazards
Determination (evaluation) of
hazards
Baseline health and safety survey
Sampling strategy
Health and safety plan
Risk management
RISK ASSESSMENT (GENERIC)
|
TAKE THE DESIGN INTENTION
l
CHANGE IT BY "GUIDE WORDS"
l
CREATE HYPOTHETICAL DEVIATIONS
l
CREATE IMAGES
l
STIMULATE IMAGINATIONS OF THE TEAM TO SEARCH DATA FOR REAL
DEVIATIONS
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EXAMINE CAUSES AND CONSEQUENCE
HARMLESS
IGNORE
HARMFUL
ELIMINATE OR CONTROL
Regulations
OSHA Bloodborne Pathogens

http://www.osha.gov/SLTC/bloodbornepathogens/index.html
CDC Select Agents
http://www.cdc.gov/od/ohs/lrsat.htm
NIH Guidelines for Research Involving Recombinant DNA
Molecules
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
DOT/CDC Shipping
http://www.cdc.gov/od/ohs/biosfty/shipregs.htm
CDC Import Permits
http://www.cdc.gov/od/ohs/biosfty/imprtper.htm
USDA/APHIS Permits
http://www.aphis.usda.gov/vs/ncie/
Resources
CDC Biosafety in Microbiological and

Biomedical Laboratories
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.ht
m
ABSA Risk Groups
http://www.absa.org/riskgroups/index.htm
Canadian MSDSs
http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.h
tml
Environmental Health & Safety Lab

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Risk management in medical

The annual rate of illness and

The most frequent occupationrelated illnesses among hc personel

Reasons for the lack of emphasis

common notion that health

Accidents do not happen, they

Safety should be taught and implemented

Material Safety Data

It is obligatory that the vendors supply

Infectious occupational health

Hepatitis B: a model for transmission

An individual is at risk for

....which simply means: within

Blood and body fluid exposures

BSL 1: Material not known to consistently cause

Pathogenicity of material disease incidence and

Risk of Activity same agent can have

Lab practices SOP regulating access,

Use BSC for all procedures that may

Needle and Sharps

Precautions are for any

Needle and Sharps

Used disposable needles must not be bent,

Human Blood, Tissue and Fluid

Use BSL 2 work practices and procedures.

Use BSL 2 work practices and

Possession, use and transfer of

Control access to areas where biological

Spills: large spills, spills inside BSC

All mammalian cells or anything that came

Demonstrate top leadership commitment to

OSHA Bloodborne Pathogens

CDC Biosafety in Microbiological and

ABSA Risk Groups

Environmental Health & Safety Lab

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