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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

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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


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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


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The Accreditation Program

  • is a peer-review process

  • is performance-based

  • is completely confidential


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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)


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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.”


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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


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The AAALAC International process is one of layersof peer review

i.e., there is peer review of the peer review…


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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


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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


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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


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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


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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.


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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Animal Environment, Housing and Management

Dale G. Martin, DVM, PhD, DACLAM, DACVPM,

DECLAM, Senior Director, Laboratory Animal Science

and Welfare, sanofi-aventis


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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.


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Example…..Site Visitor’s Observations:

  • Rats were singly housed on wire-bottom caging. Some mice had nestlets, however, some mice on similar studies did not


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Exit Briefing Discussion:

  • Site visitors: suggested that the Unit evaluate the environmental enrichment program for all species


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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…..”


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Post site visit communication (PSVC)=States binding commitment by the Unit to AAALAC International:


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Unit Response:

  • No response submitted


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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.


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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.


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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 damaged”Obviously, 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.


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AAALAC, International’s Response:

  • No responsesubmitted

    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.


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Programmatic result from PSVC:

  • no change in housing arrangement to………………all rats group housed in solid bottom cages with nestlets being used (perhaps overused)..and because AAALAC International required it??!!!


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Animal Environment, Housing and Management (Example 2)


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Example…..Site Visitor’s 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.


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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.


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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.”


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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.”


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Post site visit communication (PSVC)=States binding commitment by the Unit to AAALAC International:


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Unit Response:

  • No response submitted


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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.


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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.


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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.”


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AAALAC International’s 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.


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AAALAC International’s 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,Z>. 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.


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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.”


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Training and Occupational Health and Safety Programs

Dennis M. Stark, DVM, PhD, DACLAM

Executive Director, Veterinary Sciences,

Pharmaceutical Research Institute, Bristol-Myers Squibb


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Risk Assessment of TB


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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.


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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.


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The Unit’s 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.


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Council’s 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.


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The Unit’s 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 institution’s 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.


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Council’s 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.


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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…


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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.


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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.


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Animal Transport and Safety / Occupational Health Concerns


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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.


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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.


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The Unit’s Post Site Visit Communication

  • Issue not addressed in the PSVC


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Council’s 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.


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The Unit’s 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.


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Council’s 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, …


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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.


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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.


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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).


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Rabbit Post-Surgical Care


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The Observation

  • While evaluating a rabbit holding room colony, two investigative group’s post-surgical rabbits were found with ingrown and infected surgical staples. One investigator’s animals had received surgery 13 days earlier and the other investigator’s animals 22 days earlier. No notices of post surgical monitoring, nor request for veterinary consultations, were on record.


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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.


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The Unit’s Post Site Visit Communication

  • We have contacted the two research technicians who performed the rabbit surgery and both have removed the offending staples.


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Council’s 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....


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The Unit’s 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.


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Council’s 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….


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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.


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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.


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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 …


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An IACUC in Need of Information


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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.


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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.


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The Unit’s Post Site Visit Communication

  • No PSVC was submitted by the unit to AAALAC International.


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Council’s 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 institution’s 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.


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The Unit’s Post Site Visit Communication

  • The IACUC has discussed their protocol review procedures and form. The committee agrees that the additional information on the study investigator’s 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.


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Council’s Response

  • Council recognizes the prompt action taken to enhance the IACUC review of proposed study protocols. It is also the institution’s 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.


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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.


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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.


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PPE and HVAC Issues

James J. Elliott, DVM, DACLAM

Director, Department of Laboratory Animal ResourcesUniversity of Texas Health Science Center at San Antonio


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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?


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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


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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.


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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


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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.


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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?


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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”


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Positive Flow Work Stations

  • What can the facility do about it?

    • Evaluate allergen exposure from animal procedures (OH&S 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


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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


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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


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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.”


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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


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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.


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Humidity Control

  • SFI

    • “The facility HVAC data indicated low humidity (<30%) 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.


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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)


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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 didn’t 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.


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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.


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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


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