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					Occupational Health
and Safety Programs:
  An AAALAC Perspective
Section 1


Elements of an
Occupational Health Program:
Deficiencies identified by AAALAC.


David DeLong, D.V.M.
Chief, Veterinary Medical Unit
VAMC, Minneapolis, Minnesota
                                  Elements of an OHS program:
                            Deficiencies identified by AAALAC




Why does AAALAC assess
occupational health and safety programs?
                                      Elements of an OHS program:
                                Deficiencies identified by AAALAC




According to the Guide -

“An occupational health and safety
 program must be part of the overall
 animal care and use program."
                                          Elements of an OHS program:
                                    Deficiencies identified by AAALAC



Working with animals
can be dangerous business!
   Physical and chemical hazards
   Protocol related hazards
   Allergens
   Zoonotic diseases
                                                     Elements of an OHS program:
                                               Deficiencies identified by AAALAC


How does
AAALAC assess an OHS program?
   Prior to the site visit, review the
    Program Description.

   During the site visit, review facilities
    and documents; interview personnel.
                                    Elements of an OHS program:
                              Deficiencies identified by AAALAC




The Guide is the basis for the review.
                                             Elements of an OHS program:
                                       Deficiencies identified by AAALAC


Other documents:
   Occupational Health and Safety in the Care and
    Use of Research Animals. 1997. NRC, National
   Academy of Sciences.

   Biosafety in Microbiological and Biomedical
    Laboratories. 1999. HHS Pub. No.
    (CDC) 93-8395.

   Miscellaneous AAALAC resource documents.
                                               Elements of an OHS program:
                                         Deficiencies identified by AAALAC


What are the required
components of an OHS program?
   Risk assessment and hazard identification.
   Training.
   Personal hygiene and personal
    protective equipment.
   Facilities, procedures, and monitoring.
   Medical evaluation and preventive medicine.
                                             Elements of an OHS program:
                                       Deficiencies identified by AAALAC




What are the hallmarks
of a successful program?
   Strong administrative support.
   Sound implementation strategies.
   Effective coordination of program components.
                                 Elements of an OHS program:
                           Deficiencies identified by AAALAC




What trends in OHS Program deficiencies
have been identified by AAALAC?
                                                      Elements of an OHS program:
                                                Deficiencies identified by AAALAC


Occupational Health and Safety of Personnel

120

100

 80

 60                                                            Mandatory
                                                               Suggestion
 40

 20

  0
      1993   1994   1995   1996   1997   1998   1999*
                                                    Elements of an OHS program:
                                              Deficiencies identified by AAALAC


Hazard Identification and Risk Assessment
60

50

40

30                                                         Mandatory
                                                           Suggestion
20

10

 0
     1993   1994   1995   1996   1997   1998 1999*
                                                     Elements of an OHS program:
                                               Deficiencies identified by AAALAC

              Personnel Training
60

50

40

30                                                         Mandatory
                                                           Suggestion
20

10

 0
     1993   1994   1995   1996   1997   1998 1999*
                                                     Elements of an OHS program:
                                               Deficiencies identified by AAALAC


        Personal Hygiene/Protection
60

50

40

30                                                         Mandatory
                                                           Suggestion
20

10

 0
     1993   1994   1995   1996   1997   1998 1999*
                                                      Elements of an OHS program:
                                                Deficiencies identified by AAALAC


     Facilities, Procedures, and Monitoring
60

50

40

30                                                          Mandatory
                                                            Suggestion
20

10

 0
      1993   1994   1995   1996   1997   1998 1999*
                                                      Elements of an OHS program:
                                                Deficiencies identified by AAALAC

             Medical Evaluation/
     Preventative Medicine for Personnel
60

50

40

30                                                          Mandatory
                                                            Suggestion
20

10

 0
      1993   1994   1995   1996   1997   1998 1999*
                                               Elements of an OHS program:
                                         Deficiencies identified by AAALAC




More common deficiencies:
   Hazard identification/risk assessment.

   Personal hygiene/protection.
                                               Elements of an OHS program:
                                         Deficiencies identified by AAALAC




Less common deficiencies:
   Personnel training.

   Facilities, procedures and monitoring.

   Medical evaluation/preventive medicine.
                                              Elements of an OHS program:
                                        Deficiencies identified by AAALAC




Animal experimentation involving hazards
  This category reflects how OHSP components are
  implemented and coordinated to ensure safety in the
  face of a particular hazard.
                                                     Elements of an OHS program:
                                               Deficiencies identified by AAALAC

            Animal Experimentation
               Involving Hazards
60

50

40

30                                                         Mandatory
                                                           Suggestion
20

10

 0
     1993   1994   1995   1996   1997   1998 1999*
                                              Elements of an OHS program:
                                        Deficiencies identified by AAALAC




OHSP expectations:
   Individual components that are appropriate
    for the facility.

   Evidence that the components work effectively
    together.
Section 2


Issues in OHSP
Implementation and Participation


Christian E. Newcomer, V.M.D., DACLAM
Research Professor and Director
Pathology and Laboratory Medicine
The University of North Carolina at Chapel Hill
                                                       Issues in OHSP
                                       implementation and participation


OHSP implementation: first steps

   What mandates the creation of an OHSP?

   Who authorizes the OHSP?

   Who funds the OHSP?

   Who designs the OHSP?

   Who coordinates the OHSP?
                                                           Issues in OHSP
                                           implementation and participation


OHSP implementation issues:
  What mandates the creation of an OHSP?

     • PHS Policy: “The Guide”

     • OSHA: CFR 29

     • ILAR: “Occupational Health and Safety
              in the Care and Use of Research
              Animals”
                                                            Issues in OHSP
                                            implementation and participation


OHSP implementation issues:
  Who authorizes the OHSP?

     The senior official must:
        • Understand the issues.
        • Provide guidance.
        • Establish and support policies.
        • Have resource authority.
        • Assemble the team.
                                                            Issues in OHSP
                                            implementation and participation


OHSP implementation issues:

  Who funds the OHSP?
    • The Senior Official is accountable.

  By what funding mechanism?
     • The funding mechanism is not of concern
       to the AAALAC peer review process!
                                                           Issues in OHSP
                                           implementation and participation


OHSP implementation issues:
   Who designs the OHSP?

   Who or what qualifies the OHSP designers?

   Does one design fit all or are there
    various successful models?

   Opportunities for cost containment?
                                                      Issues in OHSP
                                      implementation and participation


OHSP design team members:
   Animal Care and Use Staff

   Research Staff

   Environmental Health and Safety

   Occupational Health/Medicine

   Administration and Management
                                                                Issues in OHSP
                                                implementation and participation


OHSP implementation issues:
   Who coordinates the OHSP?
     • Single point coordination of OHSP.

     • Team management of OHSP.

     • Interaction and communication among team
       members to refine approach, measure results and
       improve outcomes.

   Are participants clear on the available
    OHSP services?
                                                           Issues in OHSP
                                           implementation and participation

OHSP participation issues:
   What is participation in the OHSP?

   Who participates in the OHSP?

   Can personnel waive OHSP participation?

   How are participants identified/enrolled?

   Who tracks OHSP enrollment?

   What are the enrollment recall provisions?
     • Periodic? Status change?
                                                       Issues in OHSP
                                       implementation and participation


Issues in OHSP
implementation and participation:
   Who reviews OHSP scope and participation?

     •   IACUC
     •   OHSP Coordinator
     •   Senior Official
     •   AAALAC International
Section 3


Hazard Control
and Risk Assessment


Ron E. Banks, D.V.M.
University Veterinarian & Director
Office of Laboratory Animal Resources
University of Colorado Health Sciences Center
                                                        Hazard control
                                                    and risk assessment


What is the principal
objective of an OHSP?
   To reduce to an acceptable level, the risk associated
    with using materials or systems that have
    inherent danger by controlling or eliminating hazards.
                                                          Hazard control
                                                      and risk assessment



How does risk assessment
relate to the greater OHSP?
   Risk Assessment is the foundation for progressive OH&S

   Risk Assessment is prerequisite to selecting an appropriate
    health-care service for employees!
                                           Hazard control
                                       and risk assessment




What is risk?

   The likelihood of a consequence.
                                                          Hazard control
                                                      and risk assessment




What is risk assessment?
     A measure of the likelihood of a consequence.

     Defining and quantifying a hazard.
                                                          Hazard control
                                                      and risk assessment


What „issues‟ enter into risk assessment?

Known /         Work            Species          Facility
unknown         Assignment                       Engineering
Experimental    Duration of     Specific Agent   Current Health
Conditions      Study           Properties       Status
Outside Work / Frequency of     Intensity of     Required
Play           Exposure         Exposure         Equipment
Facility History Regulatory     Prevalence       Personnel
                 Requirements                    Experience
                                              Hazard control
                                          and risk assessment




When can I stop defining and quantifying hazards?
   Dynamic process – never completed!
                                                      Hazard control
                                                  and risk assessment




How important is risk assessment?
   Undetected / undefined hazards pose the
    most significant problem to research staff…

   Undetected and unrelated hazards are the
    most worrisome.

   You can‟t protect staff from the unknown …
                                       Hazard control
                                   and risk assessment


Whose responsibility is it
to identify hazards?
   The researcher

   The facility management team

   The care provider

   In short …. EVERYONE!
                                                  Hazard control
                                              and risk assessment



How should risk assessment
be used in the laboratory?
   To manage the hazard

   To avoid / control exposure

   To provide therapy when exposure occurs
                                                            Hazard control
                                                        and risk assessment


What must you know to perform
risk assessment for chemical agents?
     Toxic doses
     Stability
     Form (gas/liquid/solid)
     Type of toxicity (irrit/corrosion/carcin/narcosis/lethality)
     Severity of reaction
     Mode of action
     Metabolic products
                                                  Hazard control
                                              and risk assessment

What must you know to perform risk
assessment for infectious diseases?
     Dose-response relationship
     Virulence
     Communicability
     Prevalence
     Route of exposure
     Shedding patterns
     Stability
     Availability of prophylaxis / therapy
                                                       Hazard control
                                                   and risk assessment


Does the IACUC have a role
to play in risk assessment?
   Yes!

   Protocol review can (and should) include requests
    for information on the potential hazards
    of a particular study.

   Hazard review can be performed by:
     • A committee member
     • A H&S committee or board
     • The IACUC
                                       Hazard control
                                   and risk assessment



Where can you find information
to assist in risk assessment?
     Scientific literature
     Other scientists
     MSDS
     The researchers themselves
     Your own staff!
                                                             Hazard control
                                                         and risk assessment
Risk assessment provides
a touch of reality to life!
     The likelihood of occupationally acquired zoonoses
      is MUCH lower than is popularly perceived.

     The likelihood of occupationally acquired immune
      response to chemical is MUCH higher than
      is popularly perceived.

     „Substantial animal contact‟ IS NOT a sufficient
      indicator of the need for enrollment in OH&SP!
                                                                      Hazard control
                                                                  and risk assessment

How can I assure AAALAC site visitors
we have a risk assessment based OHSP?
     OHS „Committee‟ minutes showing program formation / review.
     Note in semiannual review of OHSP assessment (program review).
     Occasional changes in OHSP process (dynamic process).
     Common sense subtle differences (consistent inconsistencies)
      in the OHSP between care facilities.
     A suggestion process involving employees
      (program enhancements).
      Ready explanations (consistent between employees) to site visitor
      inquiry of why they do something a certain way (PPE / process).
Section 4


Training and
Information Management


Barbara Garibaldi, D.V.M., ACLAM
Director, Animal Research Facility
Beth Israel Deaconess Medical Center
Boston, Massachusetts
                                                             Training and
                                                 information management



An institution‟s approach for providing
education and training depends on its:
     Size

     Resources

     Animal species used

     Research activities

     Staff experience and technical expertise
                                                     Training and
                                         information management


Information provided to employees should be
developed through the interaction of several
key people:
     A veterinarian

     A health and safety professional

     A research scientist
                                                    Training and
                                        information management




What types of occupational health and
safety training should be provided?
                                                                     Training and
                                                         information management



   The use of personnel protective equipment (PPE).

   Good hygiene practices and universal precautions.

   Laboratory animal allergies.

   Zoonotic agents.

   Ergonomics; Physical Hazards; Noise.

   Training sessions in chemical, radiation, biohazardous
    material safety, and bloodborne pathogens may be
    provided by experts in the appropriate department.
                                                               Training and
                                                   information management


   Personnel who have contact with
    experimental animals should receive training
    in the proper handling of the animals that
    they will work with.

   Personnel should be instructed to avoid
    unnecessary risk when working with
    animals, and to seek expert assistance when
    in doubt.
                                                               Training and
                                                   information management


   Most animal inflicted injuries occur because
    of inadequate training and experience, or
    because of carelessness.

   Training should be provided that injuries,
    splashes, animal bites and/or scratches, and
    cuts sustained while working with animals
    should be promptly reported and the employee
    referred to employee health service.
                                         Training and
                             information management




What type of documentation
does AAALAC look at?
                                            Training and
                                information management




   Training logs
   Informational Newsletters
   Written Guidelines
   Websites
                                                 Training and
                                     information management




How do you ensure that all individuals
have received OHS training?
                                                                   Training and
                                                       information management

   Utilize human resources (HR) to obtain a list
    of graduate students, and new employees.

   Name a designee from each approved protocol responsible
    for listing new employees on the protocol and contacting the
    IACUC coordinator to set up training.

   This individual can serve as a source of information,
    guidance, and instruction for their colleagues.

   Some institutions choose to link training to facility access.
                                                    Training and
                                        information management




Approaches to achieving investigator/
scientist participation?
                                                        Training and
                                            information management



Occupational health and safety goals and how
they will be achieved must be clearly
communicated to all employees through:
     Formal orientation.

     Distribution of written guidelines.

     And periodic refresher training.
                                                                Training and
                                                    information management


One option is a mandatory course offered
several times during the year:
     “Live" organized class.

     Distance learning i.e. teleconferencing or video.

     Online training/Web site.

     Individual may be asked to take a test verifying
      that the information was understood.
                                                                 Training and
                                                     information management


   Training may be conducted in individual investigator
    laboratories, instead of organized classes.

   One-on-one training offered by a veterinarian,
    occupational health professional, or designee
    (smaller institutions).

   Written guidelines appropriately designed to the scope
    of the institution's animal care and use program.

   Brochures/pamphlets.
                                            Training and
                                information management




What would lead AAALAC to conclude
that training is inadequate?
                                                  Training and
                                      information management




Have you been offered participation
in the OHS program?
                                                                Training and
                                                    information management




   "Details of OHS training program were not provided
    to employees and did not include foreseeable hazards such
    as exposure to animal allergens."

   "Several procedures described in the occupational health
    and safety program (OHSP) brochure, used to train
    employees, were not being practiced."
                                                                 Training and
                                                     information management


   “Training provided to researchers using animals consisted
    of general print-outs and dated booklets and was not
    well-matched to the scope of the program of animal care and
    use … a training program covering subjects relevant to the
    needs of the institution must be developed and
    implemented."

   “The communication of the potential hazards of working
    with macaques had been done verbally between the
    veterinarian and the investigator but had not been formally
    documented."
                                              Training and
                                  information management




How are oversight mechanisms reviewed?
                                                            Training and
                                                information management




An effective education and training
program requires:
   Resources
   Administrative record keeping
   A mechanism for monitoring its efficiency
                                                    Training and
                                        information management


A wide variety of mechanisms exist for
evaluating the success of the education
and training program.
     Site inspections
     Personnel reviews
     Injury and illness records
     Regulatory-compliance citations
     Periodic questionnaires
                                          Training and
                              information management




How is information managed?
                                                                   Training and
                                                       information management



Record keeping is essential.
 Training records are necessary to satisfy specific
    requirements of federal and state environmental health and
    safety regulations.

   Establish a simple system with minimal administrative
    burden.

   A computer based system may facilitate such an approach.
                                                               Training and
                                                   information management



Rapid access to employee-specific
exposure information is vital.
The following documentation should be available:

    Occupational exposures
    Safety training
    Medical surveillance
    Work-related injury and illness
                                                                            Training and
                                                                information management
On-line access to health
and safety information could:
 Improve the management and performance of an occupational health
  and safety program.

   Make it practical to develop records that are specific for each research
    protocol.

    Computer links with other institutions through external networks, such
    as electronic mail, are useful for obtaining current health and safety
    information.

   Safety bulletin boards should be available for communicating
    with other health professionals.
                                                                Training and
                                                    information management


Training should be a continuing process
A well-informed staff with safe work habits will:

      Minimize injuries and illnesses
      Reduce costs related to:
            •   Labor time
            •   Insurance
            •   Health care
            •   And legal actions
Section 5


Medical Evaluation
and Preventative Medicine


Dale G. Martin, D.V.M., Ph.D., ACLAM, ACVPM
Director, Laboratory Animal Science and Welfare
Aventis Pharmaceuticals
Bridgewater, New Jersey
                                             Medical evaluation
                                      and preventative medicine


Martin’s Observation #1:

    Physicians should not practice
    veterinary medicine.

Martin’s Rule #1:

    Veterinarians must not practice
    human medicine.
                                                       Medical evaluation
                                                and preventative medicine



The Guide states –
     Input from trained health professionals
     Pre-employment risk assessment
     Periodic medical evaluations
     Appropriate immunizations
     Zoonoses surveillance
     Incident reporting
     Primates (special considerations)
                                             Medical evaluation
                                      and preventative medicine



Who is the appropriate health professional?
     Occupational health physician
     Occupational health nurse?
     General practitioner?
     Contract nurse?
     Attending veterinarian?
     Senior animal caretaker?
                                                             Medical evaluation
                                                      and preventative medicine



What services should be provided?
  “The occupational health services are often the most
  difficult for an institution to plan or carry out because
  consensus on what needs to be done has not yet been
  established.”
                             ILAR, NRC Occupational Health and Safety
                                        in Research Animal Facilities.
                                                    Medical evaluation
                                             and preventative medicine



What services can be provided?
     Pre-employment medical evaluation
     Periodic health evaluations
     Episodic health evaluations
     Analysis of adverse outcomes
     Medical management of worker compensation cases
                                                    Medical evaluation
                                             and preventative medicine



What services can be provided?        (continued)

     Immunizations/serum banking
     Hearing conservation program
     Ergonomic program
     Allergy program
     Respiratory protection program
     Reproductive counseling
     Non-human primate exposure program
                                              Medical evaluation
                                       and preventative medicine




For pre-employment or periodic evaluations,
should it include a questionnaire and/or
a physical?
     Ideal- questionnaire + physical
                                                       Medical evaluation
                                                and preventative medicine




What questions should be asked?
     Do you have any allergies?
     Are you allergic to animals?
     What hazards were you/will you be exposed to?
     What animals do you/you work with?
     Have you had illnesses associated with working
      with animals (zoonoses)?
     Do you have back problems, etc.?
                                                      Medical evaluation
                                               and preventative medicine




Symptoms of allergy and asthma:

  Allergy-                 Asthma
     •   Sneezing              •   Coughing
     •   Nasal congestion      •   Wheezing
     •   Itchy eyes            •   Chest tightness
     •   Cough                 •   Shortness of breath
                                                      Medical evaluation
                                               and preventative medicine



Components of one
“allergy” program:
   Screening
   Management of the sensitized patient
   Management of the allergic and/or asthmatic patient
   Management of the anaphylactic patient
                                                         Medical evaluation
                                                  and preventative medicine



Components of one “allergy” program:
  Screening

        Questionnaire- family/personal history

        Testing
              •    Skin
              •    RAST- IgE
              •    ELISA- IgE
                                                                 Medical evaluation
                                                          and preventative medicine



Components of one “allergy” program:
     Screening

     Management of the sensitized patient
           •   Avoid exposure (PPE, procedures)
           •   Questionnaire (symptom progression)
           •   Enrollment in respiratory protection program
           •   Pulmonary function testing
                                                            Medical evaluation
                                                     and preventative medicine



Components of one “allergy” program:
     Screening

     Management of the sensitized patient

     Management of the allergic and or asthmatic patient
           •   Periodic pulmonary function testing
           •   Emmunotherapy?

     Management of the anaphylactic patient
           •   Emergency (Epi)
                                         Medical evaluation
                                  and preventative medicine



What immunizations or screening
programs should be included?
     Tetanus (Guide)
     Rabies?
     Hepatitis B?
     Other immunizations?
     TB testing?
     Serum banking?
                                                                 Medical evaluation
                                                          and preventative medicine



Should serum banking be a part
of an Occupational Health program?
  “Only when there is a clear reason for obtaining the specimens
  AND there is a plan to analyze the data as a part of a risk assessment
  strategy. …..substantial issues should be considered in advance of
  instituting a serum banking program including chain of custody,
  confidentiality, identification and handling of samples, retention,
  potential deterioration of sample quality over time, and cost.”

                                 ILAR, NRC Occupational Health and Safety
                                   in the Care and Use of Research Animals.
                                                                  Medical evaluation
                                                           and preventative medicine



Special precautions for primates:
     TB testing

     Herpes B program
           •   Pre-arrangement with health professionals
           •   Bite/scratch kits
           •   SOPs for sampling/testing
                                                          Medical evaluation
                                                   and preventative medicine

Martin’s Observation #1:
    Physicians should not practice Veterinary Medicine.

Martin’s Rule #1:
    Veterinarians must not practice Human Medicine.

Martin’s Advice #1:
    Obtain and retain appropriate health professionals to set up
    and administer the Medical Evaluation and Preventive
    Medicine aspects of your Occupational Health and Safety
    program.
Occupational Health
and Safety Programs:
  An AAALAC Perspective