The Peer Review Process: What Happens After the Exit Briefing? Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB, Senior Director and Director of Pacific Rim Activities, AAALAC International - PowerPoint PPT Presentation

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Title: The Peer Review Process: What Happens After the Exit Briefing? Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB, Senior Director and Director of Pacific Rim Activities, AAALAC International


1
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2
Welcome!
Moderator James R. Swearengen, DVM, DACLAM,
DACVPM Senior Director, AAALAC International
  • The Peer Review Process What Happens After the
    Exit Briefing?Kathryn Bayne, MS, PhD, DVM,
    DACLAM, CAAB, Senior Director and Director of
    Pacific Rim Activities, AAALAC International
  • Animal Environment, Housing and Management Dale
    G. Martin, DVM, PhD, DACLAM, DACVPM, DECLAM,
    Senior Director, Laboratory Animal Science and
    Welfare, sanofi-aventis
  • Training and OHS ProgramsDennis M. Stark, DVM,
    PhD, DACLAM, Executive Director, Veterinary
    Sciences, Pharmaceutical Research Institute,
    Bristol-Myers Squibb
  • PPE and HVAC IssuesJames J. Elliott, DVM,
    DACLAM, Director, Department of Laboratory Animal
    Resources, University of Texas Health Science
    Center at San Antonio

3
The Peer Review Process What Happens After the
Exit Briefing?
Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB Senior
Director and Director of Pacific Rim Activities
4
The Accreditation Program
  • is a peer-review process
  • is performance-based
  • is completely confidential

5
What is Peer Review?
  • a process of subjecting an author's scholarly
    work or ideas to the scrutiny of others who are
    experts in the field (Wikipedia)
  • a process by which something proposed (as for
    research or publication) is evaluated by a group
    of experts in the appropriate field
    (Merriam-Webster)

6
Reasons for Peer Review
  • showing work to others increases the probability
    that weaknesses will be identified, and with
    advice and encouragement, fixed.
  • since the reviewers are normally selected from
    experts in the fields discussed the process of
    peer review is considered critical to
    establishing a reliable body of research and
    knowledge.

7
Criticism of Peer Review
  • Reviewers tend to be especially critical of
    conclusions that contradict their own views, and
    lenient towards those that accord with them

8
The AAALAC International process is one of
layersof peer review
  • i.e., there is peer review of the peer review

9
The First Step in the Peer Review Process
  • AAALAC International Rules of Accreditation
  • All accreditable units shall be initially
    evaluated by a team of not less than two site
    visitors chosen by AAALAC International from
    among the members of and consultants to the
    Council

10
Methods to Ensure High Quality Peer Review
  • Composition of the site visit team
  • Tailored to the institution Senior Director
    makes site visit assignments
  • Avoidance of conflict of interest
  • Annual declaration
  • Site visit specific declaration
  • Both real and perceived taken into account
  • Limit to the number of times a Council member may
    take out a particular ad hoc Consultant
  • Avoids cronyism
  • Office assigns ad hoc Consultants

11
Who is the Council on Accreditation?
  • Veterinarians
  • 10 DVMs 24 DVM plus graduate degree
  • Researchers
  • Research administrators
  • From 8 countries (including U.S.)
  • Represent academia, industry, government, private
    sector
  • Experience on Council ranges from 1-12 years

12
Quality Assuranceof the Peer Reviewers
  • New Council members undergo an orientation
    program and are assigned a mentor
  • Council members receive ongoing feedback from
    institutions, other Council members, and Council
    Officers
  • Council members receive site visit specific
    continuing education

13
Who are the ad hoc Consultants/Specialists?
  • Formal application and selection/election process
  • More than 200 ad hocs on the roster
  • Consultants and Specialists from 23 countries and
    36 of the 50 states
  • Expertise includes barrier operations, biosafety,
    toxicology, agricultural animals and other
    species-specific knowledge (e.g., nonhuman
    primates, aquatics, transgenic rodents), surgery,
    infectious disease, IACUC function, etc.

14
Quality Assuranceof the Peer Reviewers
  • Annual ad hoc orientation program offered at
    national AALAS meeting and other venues
  • Performance is evaluated by Council member after
    each site visit by use of a standardized form
  • Contribution to the site visit, inclusive of
    ability to elicit, assess and communicate
    information and understand issues and their
    significance

15
The Second Step in the Peer Review Process
  • Review of the Site Visit Report (including the
    post site visit communication from the
    institution)
  • Pre-meeting electronic review and
    comment/discussion
  • Minimum of two Council Officers and two other
    Council members, initially
  • Site visit team members can respond to queries
    and provide clarifications, additional detail

16
The Second Step in the Peer Review Process
  • Review of the Site Visit Report (including the
    post site visit communication from the
    institution)
  • Council meeting deliberations
  • Face-to-face, real-time
  • Discussion by Council section (10-11 members)
  • Any Revoke or Withhold actions discussed by full
    Council

17
Council Structure
  • Full Council 43 members
  • North American Section (32)
  • European Section (10)
  • Council Officers
  • President (belongs to both NA and EU Sections)
  • Vice President
  • Leads one section
  • Section Leader (3)
  • Each leads a section
  • Assistant Section Leaders (4)
  • Official record keeper of the deliberation results

18
Council Officers Meetings
  • Meetings held immediately prior to the Council
    meetings (Jan, May, Sept)
  • Evaluate Council operations to ensure sound
    functioning of the peer review process
  • Identify topics of more intense discussion in
    each section
  • Work to establish an approach to resolve
  • Perhaps establish a committee to evaluate further

19
Council Committees
  • Convened in response to an identified need
    examples include
  • Special topics
  • Use of alcohol as a disinfectant
    (http//www.aaalac.org/publications/newsletter.cfm
    )
  • Quality control through assurance of appropriate
    degrees of flexibility and consistency in the
    application of standards
  • Consideration of new Reference Resources or
    deletion of existing Reference Resources

20
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21
Council Deliberations
  • Guide and AAALAC Reference Resources available to
    each Council Section
  • A staff member is available as an administrative
    resource in each Council Section
  • The President of Council moves among Sections to
    ensure consistency in the review process
  • A formal vote is taken for each accreditation
    status recommendation records are maintained of
    the votes

22
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23
The Third Step in the Peer Review Process
  • Review of the letter to the institution
  • Post Council meeting review by Section Leader or
    Vice President
  • Content, clarity
  • Post Council meeting review by President
  • Content, clarity, consistency
  • Post Council meeting review by Senior Director
    and other staff
  • Content, clarity, consistency, grammatical,
    matches records from Section

24
Institutional Responses
  • Correspondence from institutions that had a
    mandatory item for correction identified in the
    animal care and use program
  • Undergoes similar process as a site visit report
  • Review by site visit team
  • Pre Council meeting electronic discussion
  • Council meeting deliberations in assigned section
  • Post Council review by Officers and AAALAC staff

25
Definitions of Peer
  • 1 one that is of equal standing with another
    EQUAL especially one belonging to the same
    societal group (Merriam-Webster)
  • Colleagues who share the same experiences you do
    in your animal care and use programs

26
Animal Environment, Housing and Management
  • Dale G. Martin, DVM, PhD, DACLAM, DACVPM,
  • DECLAM, Senior Director, Laboratory Animal
    Science
  • and Welfare, sanofi-aventis

27
The content of the Exit Briefing coupled with how
you respond in the post site visit communication
(PSVC) may result in vast differences in
programmatic outcomes to the same observation.
28
Example..Site Visitors Observations
  • Rats were singly housed on wire-bottom caging.
    Some mice had nestlets, however, some mice on
    similar studies did not

29
Exit Briefing Discussion
  • Site visitors suggested that the Unit evaluate
    the environmental enrichment program for all
    species

30
The Guide States
  • some evidence suggests that solid-bottom caging
    is preferred by rodents. Solid bottom caging,
    with bedding, is therefore recommended for
    rodents IACUC review of this aspect of the
    animal care program should ensure that caging
    enhances animal well-being consistent with good
    sanitation and the requirements of the research
    project.
  • Wherever it is appropriate, social animals
    should be housed in pairs or groups, rather than
    individually,
  • Depending on the species and use, the structural
    environment should include..

31
Post site visit communication (PSVC)States
binding commitment by the Unit to AAALAC
International
32
Unit Response
  • No response submitted

33
Unit Response in PSVC
  • The IACUC convened a committee of investigators
    and the attending veterinarian. A comprehensive
    environmental enrichment program for all species
    was developed and a policy was developed rodent
    housing consistent with the Guide.

34
Other Unit Response(s) in PSVC
  • A. Rats are now housed on wire only when the
    investigator requests and the IACUC approves
    housing rats on wire. B. The Attending
    Veterinarian recommended and the IACUC endorsed
    that all breeding mice will be provided nestlets.
    C. Environmental enrichment is encouraged, a
    policy is in development which should address
    species specific needs for all rodents.

35
Unit Response in PSVC
  • As AAALAC demanded all rats will be group housed
    in solid bottom caging. All rodents will be
    provided nestlets. Nestlets will be changed as
    soon as they become damagedObviously, there
    was a failure to communicate, what was observed
    by the site visitors, and discussed, was not
    interpreted or communicated effectively to the
    unit. An undesirable outcome may result.

36
AAALAC, Internationals Response
  • No response submitted
  • AAALAC may say in a Suggestion for Improvement
    (SFI) Many of the rodents were housed on
    wire-bottom cages for both short and long term
    studies. While wire-bottom caging may enhance
    sanitation, there is evidence that suggests
    rodents prefer bedded solid-bottom cages. In
    addition, pressure neuropathy may result when
    animals are housed on wire-bottom cages for
    extended periods of time. The IACUC should
    review the use of wire-bottom caging for rodents
    and ensure that caging enhances animal well-being
    consistent with good sanitation and the
    requirements of each research project.The
    structural environment for rodents did not
    include items that increase the opportunity for
    expression of species-typical postures and
    activities and enhance the animals well being.
    These behavioral management needs should be
    reviewed to conform with recommendations of the
    Guide.

37
Programmatic result from PSVC
  • no change in housing arrangement toall rats
    group housed in solid bottom cages with nestlets
    being used (perhaps overused)..and because AAALAC
    International required it??!!!

38
Animal Environment, Housing and Management
(Example 2)
39
Example..Site Visitors Observations
  • Animal facility had many rabbits, Guinea Pigs and
    dogs.
  • The facility did not have a rack washer.
  • Rabbit cages, Guinea Pig cages and all racks were
    sprayed with hot water and soap in a wash-down
    area of the cagewash.
  • There was excess mineral deposits on the Rabbit
    and GP caging.
  • Dog runs were washed down in place on a routine
    basis, however, there was visible dirt and grime
    build-up in several of the dog runs.
  • There was no monitoring of the effectiveness of
    the sanitation practices.

40
Exit Briefing Discussion
  • Site visitors
  • expressed concern about the effectiveness of
    sanitation of the dog runs.
  • noted that an optimal washing regiment may not be
    in place for GP and Rabbit caging.\
  • Suggested that the Unit implement a
    program/procedures to effectively sanitize dog
    runs and all caging.
  • Suggested the Unit monitor the effectiveness of
    their sanitation program/ procedures.

41
The Guide States
  • For pens and runs, frequent flushing with water
    and periodic use of detergents or disinfectants
    are usually appropriate to maintain sufficiently
    clean surfaces.
  • Rabbits and some rodents, such as GP and
    hamsters, produce urine with high concentrations
    of proteins and minerals. Minerals and organic
    compounds in the urine from these animals often
    adhere to cage surfaces and necessitate treatment
    with acid solutions before washing.

42
The Guide States
  • Washing and disinfection of cages and equipment
    by hand with hot water and detergents can be
    effective but require attention to detail. It is
    particularly important to ensure that surfaces
    are free of residual chemicals and that personnel
    have appropriate equipment to protect themselves
    from exposure to hot water or chemical agents
    used in the process.
  • Monitoring of sanitation practices should be
    appropriate to the process and materials being
    cleaned it can include visual inspection of the
    materials, monitoring of water temperatures, or
    microbiologic monitoring.

43
Post site visit communication (PSVC)States
binding commitment by the Unit to AAALAC
International
44
Unit Response
  • No response submitted

45
Unit Response in PSVC
  • The facility manager and attending veterinarian
    stated that they would evaluate their overall
    sanitation program and would implement a program
    to monitor the effectiveness of sanitation.

46
Other Unit Response(s) in PSVC
  • A. Rabbit caging is now treated with Urid for 15
    minutes, then sanitized with hot water and
    quatricide. B. Dog runs are scrubbed every 3
    months to eliminate all visible dirt. A program
    of microbiological monitoring is now in place to
    monitor the effectiveness of sanitation of the
    dog runs. C. RODAC plate testing is performed
    on 10 of dog runs after sanitation, if 50 or
    more colonies grow on more that 2 of the plates,
    then the entire room is re- sanitized and
    retested.

47
Unit Response in PSVC
  • As the Site Visitors recommended, the University
    spent 200,000 on a new rack washer. This brought
    great hardship on the investigators as the per
    diems were increased four-fold.Obviously,
    there was a failure to communicate.Or perhaps
    the Unit wanted to use the AAALAC Club.

48
AAALAC Internationals Response
  • No response submitted
  • AAALAC may say in a Suggestion for Improvement
    (SFI) Hand washing of animal runs and cages
    can provide effective sanitation but requires
    attention to detail. Uniform procedures and
    practices should be implemented for ensuring
    consistent sanitation of animal cages and
    equipment. It is particularly important to
    ensure that surfaces are rinsed free or residual
    chemicals and that personnel have appropriate
    equipment to protect themselves from exposure to
    hot water or chemical agents used in the process.
    If hand washing is used, monitoring should be
    instituted to ensure effective sanitation.

49
AAALAC Internationals Response
  • No response submitted
  • AAALAC may say in a Suggestion for Improvement
    (SFI) Although the dog runs were flushed twice
    a day with water, they were only cleaned with
    detergent once per year. Consequently, many runs
    had algae growth on the concrete. The runs
    should be cleaned and disinfected regularly.
    The timing of pen or run cleaning should take
    into account normal behavioral and physiological
    processes of the animals. Mineral deposits were
    present on many of the cages in Rooms X,Y,Zgt.
    Minerals and organic compounds in the urine from
    animals often adhere to cage surfaces and
    necessitate treatment with acid solutions before
    washing. Cage washing practices should be
    improved to minimize animal waste accumulations
    and provide proper sanitation.

50
Programmatic result from PSVC
  • Implementing slight changes in procedures, to
    spending hundreds of thousands of dollars.
  • At times units may use AAALAC International
    inappropriately as a Club.

51
Training and Occupational Health and Safety
Programs
Dennis M. Stark, DVM, PhD, DACLAM Executive
Director, Veterinary Sciences, Pharmaceutical
Research Institute, Bristol-Myers Squibb
52
Risk Assessment of TB
53
The Observation
  • Review of the institution OHSP pointed to the
    standard procedures of radiographic evaluation
    annually for all employees to address concerns
    about endemic tuberculosis in the community.

54
The Exit Dialogue
  • The site visitors noted that annual evaluation
    for TB using radiographic testing could be
    dangerous for the employees. Also, no special or
    additional evaluations were in place for several
    husbandry and scientific staff at possible
    greater risk as they were working with a colony
    of 200 wild caught rhesus monkeys.

55
The Units Post Site Visit Communication
  • The LAF Manager and DVM evaluated the program and
    believe, based on the past history, it is
    sufficient to ensure the safety and health of
    our employees working with NHP.

56
Councils Response
  • The extent and level of participation of
    personnel in the program should be based on the
    hazards posed by the animals and materials used
    on the exposure intensity, duration, and
    frequency on the susceptibility of the personnel
    in the particular workplace. The occupational
    health program for monitoring tuberculosis
    requires yearly chest radiographs. Council is
    concerned that personnel are unnecessarily
    exposed to ionizing radiation when tuberculin
    skin testing is much safer and generally
    reliable. Yearly radiographs are contrary to
    DHHS (FDA) occupational guidelines. Council
    requires that the tuberculosis diagnosis program
    be re-evaluated by trained health professionals
    in the light of current recommendations. Council
    must be informed of the tuberculosis screening
    program and given justification for your
    practices.

57
The Units Post Site Visit Communication
  • The EHS and Occupational Health Departments have
    reviewed our current procedures and
    evaluated the additional risks of staff employed
    in the NHP colony. The institutions staff
    working with NHP will now be evaluated semi
    annually by PPD for the presence of TB. Annual TB
    screening for all our staff will be based on the
    PPD test results rather than annual radiological
    chest screening.

58
Councils Response
  • Council acknowledges receipt of your
    correspondence received May 16, 2006 indicating
    prompt actions taken relative to concerns
    expressed by site visitors during the exit
    briefing. Specifically, the items included
    enhanced health screening for employees with risk
    of NHP exposure and the elimination of
    radiographic chest monitoring as a screening tool.

59
Information
  • The Guide - Nonhuman-primate diseases that are
    transmissible to humans can be serious hazards.
    Animal technicians, clinicians, investigators,
    predoctoral and postdoctoral trainees, research
    technicians, consultants, maintenance workers,
    security personnel, and others who have contact
    with nonhuman primates or have duties in
    nonhuman-primate housing areas should be
    routinely screened for tuberculosis

60
Information (Cont.)
  • The Guide - Development and implementation of a
    program of medical evaluation and preventive
    medicine should involve input from trained health
    professionals, such as occupational-health
    physicians and nurses. Confidentiality and other
    medical and legal factors must be considered in
    the context of appropriate federal, state, and
    local regulations.

61
Information (Cont.)
  • OLAW Assurance - Where appropriate describe
    special precautions for personnel working with
    nonhuman primates (e.g. tuberculosis screening,
    training and procedures for bites and scratches,
    and education regarding Cercopithecine
    herpesvirus 1.

62
Animal Transport and Safety / Occupational Health
Concerns
63
The Observation
  • While visiting scientists laboratories, where
    animals are used in the adjoining hospital, the
    site visitors shared a public elevator with
    research technicians transporting rats in a
    standard shoe box cage and a cat in a pet
    transport box.

64
The Exit Dialogue
  • The site visitors have concerns that hospital
    patients, staff and visitors could be unknowingly
    exposed to animal allergens, study hazards or
    zoonotic organisms. This practice should be
    evaluated in the context of the occupational
    health and safety standards of the institution.

65
The Units Post Site Visit Communication
  • Issue not addressed in the PSVC

66
Councils Response
  • An effective occupational health and safety
    program ensures that the risks associated with
    the experimental use of animals are reduced to
    acceptable levels. Council requires that the
    current practice of transporting animals in
    public places within unfiltered caging be
    evaluated by a trained safety specialist to
    assess potential risk of allergen and hazard
    exposure to personnel and others not using
    laboratory animals. . In accordance with the
    Guide, Council must be assured that all personnel
    at risk are appropriately considered under your
    occupational health and safety program.

67
The Units Post Site Visit Communication
  • The Environmental Health and Safety Officer has
    reviewed this practice and at her recommendation,
    we have purchased filtered transport boxes which
    now must be used when transporting laboratory
    animals outside of the vivarium.

68
Councils Response
  • Council acknowledges receipt of your
    correspondence received October 2, 2006
    indicating prompt actions taken relative to
    concerns expressed by site visitors during the
    exit briefing. Specifically, the items included
    enhanced protective filtering for animal
    transport caging,

69
Information
  • The Guide - Professional staff who conduct and
    support research programs that involve hazardous
    biologic, chemical, or physical agents (including
    ionizing and nonionizing radiation) should be
    qualified to assess dangers associated with the
    programs and to select safeguards appropriate to
    the risks.

70
Information (Cont.)
  • The Guide - An effective occupational health and
    safety program ensures that the risks associated
    with the experimental use of animals are reduced
    to acceptable levels. Potential hazards-such as
    animal bites, chemical cleaning agents,
    allergens, and zoonoses-that are inherent in or
    intrinsic to animal use should also be identified
    and evaluated. Health and safety specialists with
    knowledge in appropriate disciplines should be
    involved in the assessment of risks associated
    with hazardous activities and in the development
    of procedures to manage such risks.

71
Information (Cont.)
  • OLAW Assurance - Include a description of covered
    personnel procedures for hazard and risk
    assessment and training of personnel (e.g. on
    zoonoses, allergies, hazards, special precautions
    for pregnancy, illness, immune suppression).

72
Rabbit Post-Surgical Care
73
The Observation
  • While evaluating a rabbit holding room colony,
    two investigative groups post-surgical rabbits
    were found with ingrown and infected surgical
    staples. One investigators animals had received
    surgery 13 days earlier and the other
    investigators animals 22 days earlier. No
    notices of post surgical monitoring, nor request
    for veterinary consultations, were on record.

74
The Exit Dialogue
  • The site visitors are concerned that there has
    been inadequate training provided to both
    investigative staff conducting rabbit surgery and
    the vivarium husbandry staff who routinely assess
    the health of animals under their care. The
    institution should evaluate both their standard
    post surgical care procedures and the training
    offered to staff involved with post surgical
    animals.

75
The Units Post Site Visit Communication
  • We have contacted the two research technicians
    who performed the rabbit surgery and both have
    removed the offending staples.

76
Councils Response
  • Council recognizes the actions taken to improve
    the health of the post surgical rabbits observed
    in the two investigative studies during the site
    visit. Postoperative infections in animals may
    be inapparent and cause distress to animals and
    confound research results. The IACUC must
    establish standards and training for survival
    surgery on animals in accord with Guide
    recommendations. Council also requires education
    of animal care personnel. Such training would
    enhance effective animal care. Council must be
    assured that all personnel....

77
The Units Post Site Visit Communication
  • The animals in question were immediately treated
    and the responsible surgery groups were included
    in a special IACUC training workshop to ensure
    their skills and post surgical care are improved.
    The investigator surgical training program has
    been revised to include additional training
    related to their appropriate post surgical care
    and monitoring of healing incisions in compliance
    with recommendations in the Guide. An outline of
    our revised training program is attached.

78
Councils Response
  • Council recognizes the actions taken by the IACUC
    to establish standards and training for staff
    conducting survival rodent surgery in accord with
    Guide recommendations. Council also requires
    education of animal care personnel related to
    monitor procedures or the post surgical care.
    Post surgical care and observation must be
    strengthened. Council requires.

79
Information
  • The Guide - It is important that persons have had
    appropriate training to ensure that good surgical
    technique is practiced, that is, asepsis, gentle
    tissue handling, minimal dissection of tissue,
    appropriate use of instruments, effective
    homeostasis, and correct use of suture materials
    and patterns. People performing and assisting in
    surgical procedures in a research setting often
    have a wide range of educational backgrounds and
    might require various levels and kinds of
    training before they participate in surgical
    procedures on animals. For example, persons
    trained in human surgery might need training in
    inter species variations in anatomy, physiology,
    and the effects of anesthetic and analgesic
    drugs, or in postoperative requirements.

80
Information (Cont.)
  • Animal Welfare Regulations - It shall be the
    responsibility of the research facility to ensure
    that all scientists, research technicians, animal
    technicians, and other personnel involved in
    animal care, treatment, and use are qualified to
    perform their duties. This responsibility shall
    be fulfilled in part through the provision of
    training and instruction to those personnel.

81
Information (Cont.)
  • Animal Welfare Regulations - Training and
    instruction shall be made available, and the
    qualifications of personnel reviewed, with
    sufficient frequency to fulfill the research
    facility's responsibilities under this section
    and Sec. 2.31.
  • Training and instruction of personnel must
    include guidance in at least the following areas
  • Humane methods of animal maintenance and
    experimentation, including
  • The basic needs of each species of animal
  • Proper handling and care for the various species
    of animals used by the facility
  • Proper pre-procedural and post-procedural care of
    animals
  • Aseptic surgical methods and procedures

82
An IACUC in Need of Information
83
The Observation
  • The IACUC review of proposed protocols as
    reflected in meeting minutes, nor the protocol
    review form, documented the justification for
    either the species proposed or the numbers of
    animals to be involved in proposed studies.

84
The Exit Dialogue
  • The site visitors, while reviewing IACUC records,
    could not identify any committee evaluation of
    the scientific justification for the species, nor
    number of animals, in any proposed protocol, or
    in the minutes of IACUC deliberations. The IACUC
    chair indicated that she did not realize these
    factors should be evaluated during protocol
    reviews.

85
The Units Post Site Visit Communication
  • No PSVC was submitted by the unit to AAALAC
    International.

86
Councils Response
  • Although the Institutional Animal Care and Use
    Committee (IACUC) was structured appropriately,
    the activities of the IACUC deviated
    significantly from requirements for review of
    proposed protocol review. Scientific
    justification for the species, nor number of
    animals in any proposed protocol, was considered.
    It is the institutions responsibility to
    provide suitable orientation and specific
    training to assist IACUC members in understanding
    the requirements of the regulations and in
    carrying out their responsibilities in accord
    with the Guide requirements related to protocol
    review. Council must be assured that IACUC
    members have been provided adequate training
    opportunities to ensure understanding of the
    requirements of the Guide and that Protocol
    review procedures also meet Guide requirements.

87
The Units Post Site Visit Communication
  • The IACUC has discussed their protocol review
    procedures and form. The committee agrees that
    the additional information on the study
    investigators rationale for species and numbers
    needs to be evaluated. We have modified our
    review forms (see attached ) to require the
    investigators to include such information for
    IACUC evaluation.

88
Councils Response
  • Council recognizes the prompt action taken to
    enhance the IACUC review of proposed study
    protocols. It is also the institutions
    responsibility to provide suitable orientation
    and training to assist IACUC members in
    understanding the requirements of the regulations
    and in carrying out their responsibilities in
    accord with the Guide. Council must be assured
    that IACUC members have been provided adequate
    training opportunities to ensure understanding of
    the requirements of the Guide.

89
Information
  • The Guide - It is the institution's
    responsibility to provide suitable orientation,
    background materials, access to appropriate
    resources, and, if necessary, specific training
    to assist IACUC members in understanding and
    evaluating issues brought before the committee.
  • The following topics should be considered in the
    preparation and review of animal care and use
    protocols
  • Rationale and purpose of the proposed use of
    animals.
  • Justification of the species and number of
    animals requested. Whenever possible, the number
    of animals requested should be justified
    statistically.

90
Information (Cont.)
  • OLAW Assurance - Describe frequency and
    documentation of training.
  • Animal Welfare Regulations - It shall be the
    responsibility of the research facility to ensure
    that all scientists, research technicians, animal
    technicians, and other personnel involved in
    animal care, treatment, and use are qualified to
    perform their duties. This responsibility shall
    be fulfilled in part through the provision of
    training and instruction to those personnel.

91
PPE and HVAC Issues
James J. Elliott, DVM, DACLAM Director,
Department of Laboratory Animal
ResourcesUniversity of Texas Health Science
Center at San Antonio
92
PPE Discussions
  • Site Visit Finding
  • During a site visit you notice dirty bedding was
    being dumped into open hoppers
  • Employees were in scrub suits and rubber boots
    but no other PPE was being worn
  • Is there a problem here?

93
Bedding Dump Stations
  • Things to Consider
  • Are employees exposed to unnecessarily high
    levels of allergens or aerosols?
  • How are chemical carcinogens handled?
  • Infectious waste?
  • Radiological waste?
  • Are there any other procedures in place to avoid
    employee exposure
  • Increased airflow, directional airflow, PPE
    available

94
Bedding Dump Stations
  • SFI
  • Personnel were seen dumping dirty bedding into
    open containers without appropriate PPE or
    negative flow dump stations. Emptying dirty
    bedding into open containers can create aerosols
    and expose personnel to high levels of allergens,
    dust and other contaminants. The institution
    should review its bedding removal procedures and
    evaluate employee exposure risk.

95
Bedding Dump Stations
  • Possible Institutional Responses
  • Have personnel where PPE gloves, masks, tyveks
  • Install negative flow bedding dump stations
  • w/ or w/o PPE?
  • Install automatic bedding exhaust system
  • Perform Occupational Health surveillance to
    determine risk and response

96
Positive Flow Work Stations
  • Site Visit Finding
  • Positive flow benches were being used for animal
    procedures and changing cages.
  • Why is this a problem?
  • May expose employees to increase levels of
    allergens or other contaminants during changing
    cages or manipulating animals due to air flow out
    of the work station.

97
Positive Flow Work Stations
  • Considerations
  • Laminar Flow work stations
  • Positive or negative flow?
  • Certification requirements?
  • What is/are the issues if any with these
    stations
  • Designed for product protection
  • NOT BSC
  • Air flow directly at worker
  • Increased allergens in room?

98
Positive Flow Work Stations
  • SFI
  • In rooms XXX positive flow work stations were
    used for animal procedures and cage changing.
    This practice may expose employees to increased
    allergens due to the air flow directed across the
    work surface. The facility should evaluate the
    use of positive flow work stations and implement
    procedures to minimize allergen exposure to
    employees

99
Positive Flow Work Stations
  • What can the facility do about it?
  • Evaluate allergen exposure from animal procedures
    (OHS testing, manufacturers data)
  • Require use of PPE during animal manipulations
    (mask, gloves, coat)
  • PAPRs?
  • Turn off bench when changing cages
  • Replace with negative or vertical flow benches

100
HVAC Issues
  • Site Visit Finding
  • HVAC data shows animal rooms were positive to the
    corridor including the rodent quarantine room.
  • What else needs to be considered?
  • How are animals housed?
  • Conventional caging
  • Microisolators
  • Negative flow racks
  • Flexible film isolators
  • Other animal rooms on corridor?
  • Rodent clean rooms
  • Other species
  • Health status of facility

101
Low Air Changes Per Hour
  • Site Visit Finding
  • Upon entry into some rodent housing you notice a
    strong ammonia odor. The mice were in
    conventional static microisolator caging. HVAC
    data shows animal rooms with 6-8 air changes per
    hour.
  • Why is this a problem?
  • The Guide and AWA recommend 10-15 ACH to
    provide adequate ventilation to remove odors,
    allergens and excess humidity from animal rooms

102
ACH Issues
  • SFI
  • Animal rooms XXX had increased ammonia odor and
    only 6-8 ACH reported in the most recent HVAC
    data. This is less than Guide recommended 10-15
    ACHs. Increased ammonia levels and allergen
    build up within a room can be irritating to
    employees and expose them to increased allergen
    loads. The institution should evaluate the air
    flow within these rooms to verify adequate
    ventilation and/or increase air flow to satisfy
    The Guide recommendations.

103
ACH Issues
  • Possible Institutional Responses
  • Adjust air flow to increase ACHs within the room
  • Decrease cage densities to decrease odor and
    allergen load
  • Increase cage changing frequencies
  • Switch to ventilated racks using house or hepa
    filtered exhaust

104
Humidity Control
  • Site Visit Finding
  • During the site visit and evaluation of the HVAC
    data, you notice humidity levels below 30
    throughout the facility.
  • Why is this a problem?
  • The Guide recommends humidity be controllable
    within a range of 30-70 throughout the year.
    Humidity control should be provided for all
    animal rooms to ensure the health and
    well-being of animals and to preserve the
    integrity of animal studies.

105
Humidity Control
  • SFI
  • The facility HVAC data indicated low humidity
    (lt30) throughout the facility. The facility
    does not have humidification capability. The
    Guide recommends humidity be controllable within
    a range of 30-70 throughout the year. The
    institution should evaluate humidity levels
    and/or controls to ensure the health and
    well-being of animals and to preserve the
    integrity of animal studies.

106
Humidity Control
  • Possible Facility Response
  • Install humidifiers in animal rooms
  • Monitor humidity levels to determine how often
    humidity drops below the 30
  • Check humidity within the cage to determine if
    the humidity at the cage level drops below 30
  • Performance standards (i.e. rodent health status)

107
Adequate ACH but Increased Humidity
  • Site Visit Findings
  • The dog and nonhuman primate rooms were hosed
    down twice daily but never seemed to dry out.
    There didnt seem to be adequate air movement
    and floors were wet all day. The HVAC data
    showed 12 ACHs in each room but humidity was
    consistently over 75.
  • Why is this a problem?
  • Although the ventilation was reported to be
    adequate, many of the rooms had little air
    movement. The successful operation of any
    heating, ventilation, and air conditioning system
    requires regular maintenance and evaluation,
    including measurement of its function at the
    level of the secondary enclosure. Such
    measurements should include supply and exhaust
    air volumes, as well as static pressure
    differentials.

108
Adequate ACH but Increased Humidity
  • SFI
  • Although the ventilation in Rooms XXX were
    reported to be adequate, the rooms had little air
    movement, and the rooms did not dry out after
    cleaning. This could be indicative of poor air
    circulation within the room. The successful
    operation of any heating, ventilation, and air
    conditioning system requires regular maintenance
    and evaluation, including measurement of its
    function at the level of the secondary enclosure
    (cage/run). Such measurements should include
    supply and exhaust air volumes, as well as static
    pressure differentials, where applicable. The
    institution should evaluate these rooms for
    adequate air ventilation and circulation.

109
Adequate ACH but Increased Humidity
  • Possible Institutional Responses
  • Increase ACHs to increase air flow into the rooms
  • Change air diffusers to achieve better air
    circulation
  • Change rack/run layout to get better airflow
  • Install dehumidifiers
  • Switch to dry bedding systems

110
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