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 Programs
Dennis M. Stark, DVM, PhD, DACLAM, Executive Director, Veterinary
Sciences, Pharmaceutical Research Institute, Bristol-Myers Squibb
 PPE and HVAC Issues
James J. Elliott, DVM, DACLAM, Director, Department of Laboratory
Animal Resources, University of Texas Health Science Center at San
Antonio
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
The Accreditation Program
 is a peer-review process
 is performance-based
 is completely confidential
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)
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.”
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
The AAALAC International
process is one of layers
of peer review
i.e., there is peer review of the
peer review…
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
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
Who is the Council on
Accreditation?
 Veterinarians
 10 DVMs; 24 DVM plus graduate degree
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Researchers
Research administrators
From 8 countries (including U.S.)
Represent academia, industry, government,
private sector
 Experience on Council ranges from 1-12 years
Quality Assurance
of 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
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.
Quality Assurance
of 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
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
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
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
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
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
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
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
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
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Review by site visit team
Pre Council meeting electronic discussion
Council meeting deliberations in assigned section
Post Council review by Officers and AAALAC staff
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
Animal Environment,
Housing and Management
Dale G. Martin, DVM, PhD, DACLAM, DACVPM,
DECLAM, Senior Director, Laboratory Animal Science
and Welfare, sanofi-aventis
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.
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
Exit Briefing Discussion:
 Site visitors: suggested that the Unit
evaluate the environmental enrichment
program for all species
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…..”
Post site visit communication
(PSVC)=States binding
commitment by the Unit to AAALAC
International:
Unit Response:
1. No response submitted
Unit Response in PSVC:
2. 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.
Other Unit Response(s) in PSVC:
3. 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.
Unit Response in PSVC:
4. “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.
AAALAC, International’s Response:
1. 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 solidbottom 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.
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??!!!
Animal Environment,
Housing and Management
(Example 2)
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.
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.
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.”
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.”
Post site visit communication
(PSVC)=States binding
commitment by the Unit to AAALAC
International:
Unit Response:
1. No response submitted
Unit Response in PSVC:
2. 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.
Other Unit Response(s) in PSVC:
3.
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 resanitized and retested.
Unit Response in PSVC:
4. “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.”
AAALAC International’s Response:
1. 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.
AAALAC International’s Response:
1. 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.
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.”
Training and Occupational
Health and Safety Programs
Dennis M. Stark, DVM, PhD, DACLAM
Executive Director, Veterinary Sciences,
Pharmaceutical Research Institute, Bristol-Myers Squibb
Risk Assessment of TB
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.
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.
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.
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.
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.
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.
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…
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.
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.
Animal Transport and Safety /
Occupational Health Concerns
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.
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.
The Unit’s Post Site Visit
Communication
 Issue not addressed in the PSVC
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.
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.
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, …
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.
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 hazardssuch 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.
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).
Rabbit Post-Surgical Care
The Observation
 While evaluating a rabbit holding room
colony, two investigative group’s postsurgical 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.
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.
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.
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....
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.
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….
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.
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.
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 …
An IACUC in Need of Information
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.
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.
The Unit’s Post Site Visit
Communication
 No PSVC was submitted by the unit to
AAALAC International.
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.
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.
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.
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.
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.
PPE and HVAC Issues
James J. Elliott, DVM, DACLAM
Director, Department of Laboratory Animal Resources
University of Texas Health Science Center at San Antonio
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?
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
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.
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
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.
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?
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”
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
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
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
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.”
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
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.
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 wellbeing of animals and to preserve the integrity
of animal studies.
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)
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.
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.
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