Occupational Healthand Safety Programs:
An AAALAC Perspective
Elements of anOccupational Health Program:
Deficiencies identified by AAALAC.
David DeLong, D.V.M.Chief, Veterinary Medical UnitVAMC, Minneapolis, Minnesota
Section 1
Why does AAALAC assessoccupational 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 animalscan 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 deficiencieshave been identified by AAALAC?
Elements of an OHS program:Deficiencies identified by AAALAC
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20
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1993 1994 1995 1996 1997 1998 1999*
Mandatory
Suggestion
Occupational Health and Safety of Personnel
Elements of an OHS program:Deficiencies identified by AAALAC
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1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
Hazard Identification and Risk Assessment
Elements of an OHS program:Deficiencies identified by AAALAC
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1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
Personnel Training
Elements of an OHS program:Deficiencies identified by AAALAC
Personal Hygiene/Protection
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10
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30
40
50
60
1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
Elements of an OHS program:Deficiencies identified by AAALAC
Facilities, Procedures, and Monitoring
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1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
Elements of an OHS program:Deficiencies identified by AAALAC
Medical Evaluation/Preventative Medicine for Personnel
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10
20
30
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1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
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 ExperimentationInvolving Hazards
0
10
20
30
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1993 1994 1995 1996 1997 1998 1999*
MandatorySuggestion
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.
Elements of an OHS program:Deficiencies identified by AAALAC
Issues in OHSPImplementation and Participation
Christian E. Newcomer, V.M.D., DACLAMResearch Professor and DirectorPathology and Laboratory MedicineThe University of North Carolina at Chapel Hill
Section 2
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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation 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 OHSPimplementation and participation
Issues in OHSP implementation and participation:
Who reviews OHSP scope and participation?
• IACUC
• OHSP Coordinator
• Senior Official
• AAALAC International
Issues in OHSPimplementation and participation
Hazard Controland Risk Assessment
Ron E. Banks, D.V.M.University Veterinarian & DirectorOffice of Laboratory Animal ResourcesUniversity of Colorado Health Sciences Center
Section 3
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 controland 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 controland risk assessment
What is risk?
The likelihood of a consequence.
Hazard controland risk assessment
What is risk assessment?
A measure of the likelihood of a consequence.
Defining and quantifying a hazard.
Hazard controland risk assessment
What ‘issues’ enter into risk assessment?
Known / unknown
Work Assignment
Species Facility Engineering
Experimental Conditions
Duration of Study
Specific Agent Properties
Current Health Status
Outside Work / Play
Frequency of Exposure
Intensity of Exposure
Required Equipment
Facility History Regulatory Requirements
Prevalence Personnel Experience
Hazard controland risk assessment
When can I stop defining and quantifying hazards?
Dynamic process – never completed!
Hazard controland 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 controland risk assessment
Whose responsibility is it to identify hazards?
The researcher
The facility management team
The care provider
In short …. EVERYONE!
Hazard controland risk assessment
How should risk assessmentbe used in the laboratory?
To manage the hazard
To avoid / control exposure
To provide therapy when exposure occurs
Hazard controland 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 controland 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 controland 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 controland risk assessment
Where can you find informationto assist in risk assessment?
Scientific literature Other scientists MSDS The researchers themselves Your own staff!
Hazard controland risk assessment
Risk assessment providesa 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 controland risk assessment
Hazard controland 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).
Training andInformation Management
Barbara Garibaldi, D.V.M., ACLAMDirector, Animal Research FacilityBeth Israel Deaconess Medical CenterBoston, Massachusetts
Section 4
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 andinformation management
Information provided to employees should bedeveloped through the interaction of several key people:
A veterinarian
A health and safety professional
A research scientist
Training andinformation management
What types of occupational health and safety training should be provided?
Training andinformation 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 andinformation 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 andinformation 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 andinformation management
What type of documentation does AAALAC look at?
Training andinformation management
Training andinformation management
Training logs
Informational Newsletters
Written Guidelines
Websites
How do you ensure that all individuals have received OHS training?
Training andinformation 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 andinformation management
Approaches to achieving investigator/scientist participation?
Training andinformation 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 andinformation 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 andinformation 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 andinformation management
What would lead AAALAC to conclude that training is inadequate?
Training andinformation management
Have you been offered participation in the OHS program?
Training andinformation 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 andinformation 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 andinformation management
How are oversight mechanisms reviewed?
Training andinformation management
An effective education and trainingprogram requires:
Resources Administrative record keeping A mechanism for monitoring its efficiency
Training andinformation 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 andinformation management
How is information managed?
Training andinformation 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 andinformation 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 andinformation 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 andinformation 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
Training andinformation management
Medical Evaluationand Preventative Medicine
Dale G. Martin, D.V.M., Ph.D., ACLAM, ACVPMDirector, Laboratory Animal Science and WelfareAventis PharmaceuticalsBridgewater, New Jersey
Section 5
Martin’s Observation #1:
Physicians should not practice veterinary medicine.
Martin’s Rule #1:
Veterinarians must not practice human medicine.
Medical evaluationand 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 evaluationand preventative medicine
Who is the appropriate health professional?
Occupational health physician Occupational health nurse? General practitioner? Contract nurse? Attending veterinarian? Senior animal caretaker?
Medical evaluationand 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 evaluationand 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 evaluationand 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 evaluationand preventative medicine
For pre-employment or periodic evaluations,
should it include a questionnaire and/or
a physical?
Ideal- questionnaire + physical
Medical evaluationand 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 evaluationand preventative medicine
Symptoms of allergy and asthma:
Allergy-• Sneezing• Nasal congestion• Itchy eyes• Cough
Medical evaluationand preventative medicine
Asthma• Coughing• Wheezing• Chest tightness• Shortness of breath
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 evaluationand preventative medicine
Components of one “allergy” program:
Screening
Questionnaire- family/personal history
Testing
• Skin• RAST- IgE• ELISA- IgE
Medical evaluationand 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 evaluationand 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 evaluationand preventative medicine
What immunizations or screening programs should be included?
Tetanus (Guide) Rabies? Hepatitis B? Other immunizations? TB testing? Serum banking?
Medical evaluationand 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 Safetyin the Care and Use of Research Animals.
Medical evaluationand preventative medicine
Special precautions for primates:
TB testing
Herpes B program
• Pre-arrangement with health professionals• Bite/scratch kits
• SOPs for sampling/testing
Medical evaluationand 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.
Medical evaluationand preventative medicine
Occupational Healthand Safety Programs:
An AAALAC Perspective