COMPREHENSIVE MEDICAL SAFETY PROGRAM

Report
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
same as for sheet metal
workers, auto mechanics and
paper mill workers
(Am J of Nursing, 1992)
The most frequent occupationrelated illnesses among hc personel
 respiratory
problems
 infections
 dermatitis
 drug
or medication reactions
Reasons for the lack of emphasis
on employer’s health:
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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
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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
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dusts
physical agents
chemical agents
mutagenic and
teratogenic
agents
skin irritants
stress (!)
Infectious
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hepatitis
AIDS
Material Safety Data
Sheets (MSDS)
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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
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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:
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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
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Employee safety
Patient safety
Environment safety
ELEMENTS OF EMPLOYEE
SAFETY
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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:
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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
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Recognition of hazards
Determination (evaluation) of
hazards
Baseline health and safety survey
Sampling strategy
Health and safety plan
Risk management
RISK ASSESSMENT (GENERIC)
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TAKE THE DESIGN INTENTION
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CHANGE IT BY "GUIDE WORDS"
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CREATE HYPOTHETICAL DEVIATIONS
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CREATE IMAGES
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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
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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
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CDC Biosafety in Microbiological and Biomedical Laboratories
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
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ABSA Risk Groups
http://www.absa.org/riskgroups/index.htm
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Canadian MSDSs
http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.html
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Environmental Health & Safety – Lab Safety
http://www.ehs.sunysb.edu or 2-9672

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