COMPREHENSIVE MEDICAL SAFETY PROGRAM

1
Risk management in medical laboratories Ana
Stavljenic-Rukavina Zagreb, Croatia
Kornati Islands, Croatia
2
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)
3
The most frequent occupation-related illnesses
among hc personel

• respiratory problems
• infections
• dermatitis
• drug or medication reactions

4
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

5
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

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LABORATORY HAZARDSNon-infectious Infectious

• dusts
• physical agents
• chemical agents
• mutagenic and teratogenic agents
• skin irritants
• stress (!)

• hepatitis
• AIDS

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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

8
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 lt0.5

9
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
10
Therefore, effective protection against
blood-borne diseases requires universal
observation of common barrier precautions
11
....which simply means within healthcare
environment, all body fluids and tissues should
be treated as infectious. Equally important
waste disposal!
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COMPONENTS OF MEDICAL SAFETY

• Employee safety
• Patient safety
• Environment safety

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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

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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,
  aerosol-transmitted lab infections or related
  agents with unknown risk of transmission.

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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

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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

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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

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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.

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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.

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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
  puncture-resistant 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.

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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.

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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.

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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.

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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.

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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

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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 EHS red bag/box (material is
  incinerated).

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CRITICAL ELEMENTSCREATING 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

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Role of management

• The scope identifying problem areas and exerting
  specific actions to correct them

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Development of Safety Program

• Recognition of hazards
• Determination (evaluation) of hazards
• Baseline health and safety survey
• Sampling strategy
• Health and safety plan

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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
• l
• EXAMINE CAUSES AND CONSEQUENCE
• HARMLESS HARMFUL
• IGNORE ELIMINATE OR CONTROL

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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/guidelin
  es.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/

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Resources

• CDC Biosafety in Microbiological and Biomedical
  Laboratories
• http//www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.h
  tm
• ABSA Risk Groups
• http//www.absa.org/riskgroups/index.htm
• Canadian MSDSs
• http//www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index
  .html
• Environmental Health Safety Lab Safety
• http//www.ehs.sunysb.edu or 2-9672