Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Review of VA Use of Animals in 

Research Activities 

Report No. 07-01148-109 April 15, 2009

VA Office of Inspector General 

Washington, DC 20420 
 

 

 

To Report Suspected Wrongdoing in VA Programs and Operations 

Telephone: 1-800-488-8244 between 8:30AM and 4PM Eastern Time,

 Monday through Friday, excluding Federal holidays

 E-Mail: vaoighotline@va.gov 
Review of VA Use of Animals in Research Activities 

VA Office of Inspector General i 

Executive Summary 

The Veterans Health Administration (VHA) actively supports the use of animals in 

research, teaching and testing. The VHA animal research program provides hope for 

veterans suffering from diseases that currently lack cures or effective treatments. In 

2007, there were 824 active animal research projects at 71 VA facilities nationwide. 

VHA adheres to the Public Health Service (PHS) Policy on Humane Care and Use of 

Laboratory Animals policy. These guidelines require facilities conducting 

PHS-sponsored research to provide a written assurance of compliance with this policy to 

the PHS. The Office of Laboratory Animal Welfare at the National Institutes of Health 

monitors compliance with PHS Policy to ensure the humane care and use of animals. 

The VHA developed its own policies and procedures – VHA Handbook 1200.7, Use of 

Animals in Research, issued May 27, 2005 – to ensure compliance with both PHS policy 

and the Animal Welfare Act of 1985. 

The Office of Inspector General conducted a national review of VHA animal research to 

assess compliance with certain Handbook requirements, focusing on Institutional Animal 

Care and Use Committee (IACUC) minutes, semi-annual self assessments of the animal 

research program (SARS), and veterinary qualifications. 

Our review disclosed overall good compliance with the documentation requirements for 

IACUC minutes, yet we found a wide variety in how the minutes were documented. The 

highest area of non-compliance was in the facilities’ performance of the SARs. We 

found significantly lower compliance when the animal research program had an affiliate 

IACUC as the IACUC of record. We found most of the Animal Research Facilities 

(ARFs) to be clean, in good repair and adequately secured. We did not identify any 

instances of animal abuse or neglect. Sites we visited identified a lack of funding and the 

way funding is allocated as their greatest difficulties in maintaining active, robust animal 

research programs. 

We recommended that VHA animal research programs require university affiliates’ 

compliance with the requirements of the Handbook and that all VA animal research 

programs have an active occupational health program. We also recommended 

improvements in security at one facility and full implementation of Handbook 

requirements at another facility. Finally, we recommended that minimum qualification 

standards for Veterinary Medical Officers and Veterinary Medical Consultants. The 

Under Secretary for Health agreed with the findings and recommendations and provided 

acceptable improvement plans. We will follow-up on the planned actions until they are 

completed. 
 

 

DEPARTMENT OF VETERANS AFFAIRS
 

Office of Inspector General 

Washington, DC 20420 

TO: Under Secretary for Health (10) 

SUBJECT: Review of VA Use of Animals in Research Activities 

Introduction 

Animal research contributes immeasurably to advancements in medical science. As 

recognized by principle number 3 of the Nuremberg Code of 1947, it is often a moral 

imperative to perform research or testing on animals before subjecting humans to new 

procedures, pharmacologics, or devices. Most research and testing involving human 

patients continues to be based on the results of animal experimentation. To provide hope 

for veterans suffering from diseases that currently lack cures or effective treatments, VA 

actively supports the use of animals in research, teaching, and testing. However, the use 

of animals in VA research is a privilege granted with the understanding and expectation 

that such research be conducted according to the highest ethical and legal standards.1

 In 

2007, there were 824 active animal research projects at 71 VA facilities nationwide. The 

total fiscal year (FY) 2007 animal research budget was $118 million, which included 

funding to support the animal research facilities.2 

While societal concerns regarding the humane treatment of animals prompted many of 

the advances in animal care and use programs, “animal welfare is also of importance 

because of the link between healthy, well-cared for animals and sound science.”3 All 

VA-funded animal research must comply with Federal and VA regulations. Compliance 

with all VA and Federal regulations requires a significant investment of resources. 

Professional staff must perform necessary, labor-intensive activities associated with 

animal research, including educating and training clinician investigators and research 

staff, ensuring compliance with applicable regulations, maintaining the animal facilities, 

and participating in or operating the Institutional Animal Care and Use Committee 

(IACUC). IACUCs are committees constituted at the level of the medical center or 

1

 Veterans Health Administration Handbook 1200.7, Use of Animals in Research, May 27, 2005. 2

 Research and Development Information Systems Part II report for VA-funded projects plus animal facility support 

dollars. 

3

 Gilles Demers, et al., “Harmonization of Animal Care and Use Guidance,” Science, Vol. 312, May 5, 2006. 

VA Office of Inspector General 1 
 

 

 

Review of VA Use of Animals in Research Activities 

institution conducting animal research that provide the oversight and assurance that the 

institution will comply with regulations. 

Background 

Legislative efforts to protect animals used in research activities essentially began with the 

Laboratory Animal Welfare Act of 1966. Enforced by the U.S. Department of 

Agriculture (USDA), this law describes the minimal standards for the care and use of 

animals in research activities. In accordance with this act, the Secretary of Agriculture 

announced regulations permitting USDA inspectors to conduct unannounced inspections 

and to require maintenance of certain records. The act was amended and renamed the 

Animal Welfare Act in 1970 and was subsequently amended in 1976 and 1985 to clarify 

the types of animals regulated and to provide additional standards for their care and use 

in research activities. The 1985 amendment resulted in regulations that required 

institutions conducting animal research to form IACUCs to oversee animal research 

activities. 

The Department of Health and Human Services formulated an important policy in 1971, 

which further defined and clarified the appropriate use of animals in research activities. 

Entitled the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory 

Animals (PHS policy), this policy became the basis for National Institutes of Health 

guidelines required under the Health Research Extension Act of 1985. These guidelines 

required facilities conducting PHS-sponsored research to provide a written assurance of 

compliance (hereafter termed PHS Assurance) with this policy to the PHS. The Office of 

Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) monitors 

compliance with PHS Policy to ensure the humane care and use of animals in 

PHS-supported research.4 

The Veterans Health Administration (VHA) developed its own policies and procedures to 

ensure compliance with both PHS policy and the Animal Welfare Act. VHA Handbook 

1200.7, Use of Animals in Research, issued May 27, 2005, describes VHA policy. It 

specifically requires compliance with both the Animal Welfare Act and PHS policy, 

regardless of whether or not the facility receives funding from PHS. A facility may 

execute its own PHS Assurance or be covered under an affiliated university’s PHS 

Assurance, provided that the assurance specifies that the VA program is covered under 

that assurance. The term “animal” is defined in VHA policy as “any live vertebrate 

animal used or intended for use in research, research training, experimentation, or 

biological testing, or for a related purpose.” 

VHA policy also requires VA facilities conducting animal research to be accredited by 

the Association for Assessment and Accreditation of Laboratory Animal Care 

International (AAALAC), although they may also be accredited as a component of their 

4

 OLAW Mission Statement. 

VA Office of Inspector General 2 
Review of VA Use of Animals in Research Activities 

affiliate’s program. The facility director is the institutional official responsible for 

correspondence with the AAALAC and the PHS, unless the institution is covered by the 

affiliate’s AAALAC accreditation or PHS Assurance. 

While VHA Handbook 1200.7 covers many aspects of the appropriate care and use of 

laboratory animals, this review focuses on four major areas: 

1. IACUC operations. 

2. Semi-annual self-assessments of the animal research program. 

3. Certification and availability of veterinarians used in animal research activities. 

4. Certain aspects of animal macro-environments and occupational health and safety 

issues which surfaced during onsite inspections. 

We discuss the regulatory background of each of these areas below. 

General IACUC Operations 

IACUCs are the institutional committees that review and approve all research protocols 

using animals. VA facilities must either maintain their own IACUC or use the affiliate’s 

IACUC. If the affiliate’s IACUC is used, the affiliate must agree to provide documents 

pertaining to IACUC review and AAALAC correspondence or USDA correspondence to 

the VA if requested. The VA’s Veterinary Medical Officer (VMO) or Veterinary 

Medical Consultant (VMC) must sit on the affiliate’s IACUC, and the facility director 

must officially appoint all members of the affiliate’s IACUC. 

IACUCs are required to approve all protocols involving animals and to review these 

projects at least annually. Facility Research and Development (R&D) Committees must 

also approve all animal research protocols. IACUCs also ensure that animal research 

staff receive necessary education and training to perform their duties. They prepare 

written minutes of their meetings and publish these within 3 weeks of the meeting date. 

These minutes must record the presence or absence of all voting members of the IACUC; 

whether a quorum is present; and deliberations relative to specific protocols, with 

identification of the protocol by title and principal investigator. Minutes must be signed 

by the IACUC Chairperson following approval at the next convened meeting. 

IACUCs must also report serious and continuing noncompliance with PHS policy. 

Further, Animal Welfare Act regulations state that failure to correct any significant 

deficiency within 15 business days of an IACUC-imposed deadline must be reported to 

the USDA and any other Federal agency funding the research. IACUCs also have the 

authority to suspend research projects and to investigate allegations of noncompliance. 

Semi-Annual Program and Facility Self-Assessment Reviews 

A key responsibility of the IACUC is to perform a self-assessment review (SAR) of the 

animal care and use program every 6 months. This review is required to include all 

VA Office of Inspector General 3 
 

 

Review of VA Use of Animals in Research Activities 

facilities and areas where animals purchased with local VA funds are used in research or 

housed for longer than 12 hours; a random review of 5 percent of total active projects or a 

minimum of five total projects; any minority views relative to the findings; information 

regarding the IACUC members present during the review; and a number of specific data 

elements, which are more fully described in the text of this report. The IACUC members 

must also distinguish between major deficiencies, which are those which may threaten 

the health or welfare of the animals, and minor deficiencies, which are any findings not 

meeting the definition of major deficiency. The IACUC Chairperson, the veterinarian, 

and one or more research administrators must then discuss the report with the facility 

director, who ultimately is required to sign the report. The R&D Committee also receives 

a copy of the report. 

Use of Veterinarians 

Veterinary medical services must be provided by facilities conducting animal research 

activities but may be in the form of a full- or part-time VMO, a VMC, or a clinical 

veterinarian. VMOs and VMCs have many responsibilities, including directing the 

animal research programs, serving on the IACUCs, and participating in SARs. Clinical 

veterinarians who are not experienced in the care of laboratory animals may supplement 

but not replace VMOs or VMCs if appropriate care cannot be provided otherwise. A 

clinical veterinarian, however, can only provide care under a written plan developed by a 

VMO or VMC. When using a VMC, a schedule of visits must be arranged for provision 

of routine care, and such visits must be documented in writing. These visits cannot occur 

less often than once a month. 

Other Requirements 

VHA policy concerning the appropriate care and use of animals in research also regulates 

certain components of facilities’ physical plants and of their occupational health 

programs. 

Animal research facilities require that facility heating, ventilation, and air conditioning 

(HVAC) systems have special features. For example, reheat coils in heating systems 

must fail in the “off” or “safe” position to prevent excessive temperatures, which could 

result in animal loss.5

 Exposure of unadapted animals to excessive temperatures could 

also result in behavioral, physical, or morphological changes that could affect protocol 

outcomes. 

In addition to physical plant safeguards, VHA policy mandates special safeguards for 

personnel engaged in the handling of research animals. While an evaluation of the full 

scope of the occupational health programs is beyond the scope of this review, VA 

facilities are required to develop guidelines for personal hygiene, eating and drinking 

5

 VHA Handbook 1200.7, Appendix. E, 3b(7). 

VA Office of Inspector General 4 
 

 

Review of VA Use of Animals in Research Activities 

practices in laboratory areas, and the provision of clean uniforms and laundry services. 

Further, the facilities are required to offer a rabies vaccine to all personnel who have 

significant contact with dogs, cats, bats, or wild carnivores. 

Scope and Methodology 

This review examines only the specific requirements of VHA Handbook 1200.7. It is not 

a comprehensive compliance review of all applicable animal research regulations or of all 

the provisions of VHA Handbook 1200.7. This review focuses on IACUC minutes, 

SARs, and veterinary qualifications, as well as other items found during the site visits. 

We conducted the inspection in accordance with Quality Standards for Inspections 

published by the President’s Council on Integrity and Efficiency. 

Sample Selection 

Prior to beginning this review, we obtained a list of all active VA animal research 

programs from the VA Central Office. We then sent the list of 77 programs to the Chief 

VMO for the VA for validation that these programs were still active. He told us that five 

of the programs were inactive. In January 2007, we requested that facilities with active 

animal research programs send us the following FY 2006 documentation: 

• IACUC minutes. 

• SARs. 

• Memorandums of Understanding (MOUs) with affiliates. 

• Veterinarian licenses and curriculum vitas. 

• A list of all active protocols and the locations where the animals were housed. 

We reviewed the submitted documentation for compliance with VHA Handbook 1200.7. 

If a facility did not provide all requested documentation, it was given a lower overall 

score even if the submitted documentation met handbook requirements. At the 

completion of the data review, we stratified the facilities based on 29 possible “no” 

answers (“no” equals noncompliance). We then divided the 29 into quintiles. Facilities 

that fell in the bottom two quintiles were selected for site visits. Twelve facilities met 

these criteria. However, prior to starting the site visits, we learned that two of the sites no 

longer had active animal research programs, and we canceled our planned visits to those 

two sites. In addition, we visited two other sites for the following reasons. One facility 

had a hotline complaint, which had resulted in multiple visits from Office of Research 

Oversight (ORO). The other facility was visited due to the poor quality of the IACUC 

minutes and the lack of documentation regarding the occupational health program. 

We conducted site visits from February–August 2008. During the site visits, we 

reviewed FY 2007–2008 documentation, reviewed 5 percent of the active protocols, 

interviewed IACUC and animal research facility (ARF) personnel, and conducted ARF 

VA Office of Inspector General 5 
 

Review of VA Use of Animals in Research Activities 

inspections. The purpose of the ARF inspections was to identify any issues with 

cleanliness, temperature and humidity control, proper storage of food, and the general 

physical condition of the facility. 

Results 

Seventy-two active animal research programs submitted documentation from FY 2006 

for review. Of these 72 programs, 12 were affiliated with a university IACUC. All 12 of 

these had MOUs with the affiliated university detailing the responsibilities of each 

institution. All 12 VA programs were covered under the affiliated institution’s AAALAC 

accreditation and the affiliate’s PHS policy. One of the other VA programs had an 

IACUC and was AAALAC accredited but came under the affiliate’s PHS policy. No 

programs were 100 percent compliant with the requirements of VHA Handbook 1200.7. 

I. IACUCs 

A. Members. 

All 72 sites we reviewed had the required five members on the IACUC; however, only 

9 of the 72 sites had the required memorandum from the Institutional Official (IO) 

appointing the five members to the IACUC with the terms of the appointment described. 

All sites had a VMO or VMC on the IACUC. 

B. IACUC Minutes. 

IACUCs are required to approve all protocols involving animals and to review these 

protocols at least annually. In the IACUC minutes submitted for review, 64 sites met the 

requirement and had documentation to show that they reviewed all protocols involving 

animals. In addition, they documented the presence or absence of a quorum, the presence 

or absence of members, and any education and training completed during the meetings. 

There was documentary evidence that 56 of the IACUCs reviewed and investigated 

internal or external concerns or allegations about animal care and use. A lack of 

standardization of the minutes made it difficult to determine if the remaining IACUCs 

met all the requirements in the handbook. Only 12 sites submitted evidence that the 

R&D Committee reviewed the IACUC minutes. There was no distinction between the 

affiliate and the VA IACUCs in whether the minutes were submitted for review by the 

R&D Committee. 

II. Semi-Annual Program and Facility Self-Assessment Reviews 

The semi-annual program and facility SARs are performed by members of the IACUC. 

If VA-funded research is performed at the affiliate, areas housing the animals for more 

than 12 hours must be inspected in conjunction with this review. The IACUC of record 

VA Office of Inspector General 6 
 

Review of VA Use of Animals in Research Activities 

completes the review. One site did not submit any SARs. Six sites only submitted one 

SAR for FY 2006, and all six of these sites had affiliated IACUCs. 

VHA Handbook 1200.7 requires that the front page of the SAR contain the name of the 

facility, the station number, the address, and the date of the review. Thirty-one SARs did 

not contain the station number, 17 did not contain the address, 12 did not have the name 

of the facility, and 9 did not have the date. Of these 31 SARS, 6 SARS were completed 

by the affiliates, using their own forms. 

During the SAR, the IACUC must perform an audit of at least 5 percent or a minimum of 

five protocols. The purpose of the audit is to ascertain that the initial and annual reviews 

contain the required documentation and that the annual reviews are performed within the 

required timeframe. Twenty sites did not document completion of these audits at the 

time of the SARs. In addition 1 of the 20 sites did not submit any documentation. At the 

completion of the SAR, the IACUC documents the individuals who participated in the 

SAR. Twenty-five sites failed to record this information. Additionally, 16 sites failed to 

list the educational degrees of the individuals participating, and 6 of those 16 sites failed 

to document the roles of the IACUC participants. The VMO or VMC is required to 

participate in SARs, and 46 sites had no documentation that the VMO or VMC 

participated. 

At the completion of the SAR, the participants compile a report, detailing the deficiencies 

identified, and a plan for correction including the timeframe for estimated completion, 

and any actions taken during the SAR to correct the deficiency. All the SARs we 

reviewed had this plan of correction documented. At the completion of the SAR, all the 

participants are required to review the findings and sign a document stating whether or 

not they agree with the findings. The participants then meet with the IO to discuss their 

findings and the plans for correction. We identified 12 SARs that did not have the IO’s 

signature indicating that he/she had met with the IACUC members and discussed the 

SAR. Of these, eight had affiliate IACUCs. 

VHA Handbook 1200.7 requires that the IACUC send the signed documentation of the 

completed SAR to the VA VMO within 60 days of the completion of the SAR. 

Thirty-five sites submitted documentation that this was completed. 

III. Veterinarians 

All sites conducting animal research are required by VHA Handbook 1200.7 to provide 

veterinary medical services. These services may be provided through appointment of a 

full- or part-time VMO, appointment of a qualified VMC, or a combination of a qualified 

consultant and a clinical veterinarian. Only 37 of the 72 sites we reviewed submitted 

documentation that the veterinarian had current license. Currently, all 50 states and the 

District of Columbia require veterinarians to be licensed when caring for animals. In 

February 2009, all positions listed for veterinarians in the Federal government required 

VA Office of Inspector General 7 
Review of VA Use of Animals in Research Activities 

licensure as a condition of employment. VHA policy, however, does not explicitly state 

that licensure is a requirement for employment. 

In addition to licensure, individuals providing veterinary services to research programs 

must be qualified to care for laboratory animals. However, nothing in PHS policy or the 

Animal Welfare Act defines what is considered to be the minimum additional training or 

experience required to qualify a veterinarian in laboratory animal science. While VA 

policy defines some minimum experience requirements for veterinarians on the General 

Schedule (GS), it does not define standards for veterinarians who do not have a GS 

appointment. 

The American College of Laboratory Animal Medicine (ACLAM) offers a certification 

examination for the purpose of establishing an individual’s qualification to practice in the 

area of laboratory animal medicine. To take this examination, applicants must have, 

among other requirements, a minimum of 2 years in a post-doctoral training or residency 

program or at least 6 years’ experience (previously 4 years) in laboratory animal 

medicine. Of the 72 sites we reviewed, 57 had VMOs or VMCs that were either 

ACLAM diplomates or had a minimum of 4 years’ experience in laboratory animal 

medicine at an institution with a biomedical research program. 

IV. Other Findings 

During our review of the minutes and the SARs, we noted that 19 sites reported problems 

with their HVAC systems. Exposure of unadapted animals to excessive temperatures can 

result in behavioral, physical, or morphological changes that could affect protocol 

outcomes or cause the death of the animals. Of these 19 sites, 3 had complete failures of 

their HVAC systems, endangering all the animals in their program. Other deficiencies 

noted were difficulties maintaining temperature and humidity and HVAC systems that 

were not connected to emergency power systems in case of power failure at the facility. 

During our review, we interviewed the Chief VMO for VHA. He indicated that VHA 

recognized that many facilities had HVAC problems and planned to send a team of 

engineers out to each VHA site by the end of FY 2009 to document the current HVAC 

systems in use and to identify any problems the sites have with these systems. Once this 

is completed, the plan is to seek funding to replace or repair any problematic systems. 

In addition to physical plant safeguards, VHA policy mandates special safeguards for 

personnel engaged in the handling of research animals. For example, if the site conducts 

research using dogs, cats, bats, or wild carnivores, the site is required to offer all 

personnel who have significant contact with these animals the opportunity to receive a 

rabies vaccination. In addition, all personnel engaged in the handling of research animals 

are to have an annual occupational health assessment. In the SARs and minutes we 

reviewed, we noted the lack of an occupational health program in at least three facilities. 

At one site with a vervet monkey colony, which increases the occupational health 

requirements, the IACUC minutes discussed the lack of an occupational health program. 

VA Office of Inspector General 8 
Review of VA Use of Animals in Research Activities 

V. Site Visits 

We visited 10 sites that were deemed to be low performers after the initial document 

review. Nine sites had agreements with the affiliated IACUC. Two other sites were 

visited for reasons listed in the Scope and Methodology section of this report. 

The research program at the Facility #1 was suspended by ORO in August 2006, due to 

multiple deficiencies in the animal care and use program. In addition, the OIG received a 

complaint detailing problems with this program. The animal care and use program is 

supported by an affiliate agreement with a local university. The purpose of our site visit 

in February 2008 was to monitor the progress of action plans this site submitted to ORO 

for the correction of identified deficiencies. 

During the site visit, we interviewed IACUC, ARF, and engineering personnel from the 

facility and members from the affiliate IACUC. In addition, we toured the ARF and 

reviewed IACUC and SAR documentation from all of FY 2007–February 29, 2008. 

Since program suspension, the facility has made major improvements to their animal 

research program. A new animal research compliance officer is in place to ensure that 

the program meets all Federal and VA requirements. In addition, there is a new 

chairperson on the IACUC. Also, the facility’s safety officer is now a member of the 

R&D Committee, enabling him to understand ARF issues and helping the site to quickly 

correct any ARF issues that occur. The facility is building a new ARF and replacing the 

HVAC in the old ARF. New standard operating procedures are in effect for the ARF and 

the IACUC. Animal husbandry staff make rounds twice a day every day to ensure the 

safety and health of the animals. 

The suspension was lifted in January 2007. The chairman of the R&D Committee stated 

that in FY 2007 they had a funding deficit of approximately $750,000. According to the 

chairman, the lack of funding contributed to not getting and maintaining staff, training, 

and ARF maintenance. Our review of the IACUC minutes, the protocols, and current 

SARs revealed no major problems. We toured the ARF. It was clean, and security was 

maintained. We did not find any major deficiencies during our site visit case, and this 

hotline was administratively closed. 

When we started our review, Facility #2 had vervet monkeys. During our review of the 

submitted 2006 IACUC documentation, the IACUC minutes contained documentation of 

a discussion regarding the lack of an adequate occupational health program for the 

surveillance of personnel working with the monkeys. In addition, the 2006 IACUC 

minutes were very poorly documented. When we conducted a site visit at the facility, we 

discovered that the monkeys had been relocated to a non-VA facility in 2007. Also, at 

the time of our site visit, the facility had a functional occupational health program. We 

toured the ARF and found it to be clean, well maintained, and tightly secured. Our 

review of the documentation did not reveal any major deficiencies, and the 

documentation had greatly improved since our initial review. 

VA Office of Inspector General 9 
 

Review of VA Use of Animals in Research Activities 

Facility #3 is addressed in this report individually due to the deficiencies we found during 

our site visit. The animal research program is located on two campuses. During our site 

visit to campus A, we noted that temperatures in the animal rooms were not monitored 

during the night shift or at other times when ARF personnel were absent from the 

building. The IACUC and the health care system engineer had discussed purchasing a 

new central temperature monitoring system, but at the time of our visit, it was uncertain 

when this would occur due to the expense. If the HVAC system were to fail during one 

of the times it was not being monitored, no one would be aware, and repairs would be 

delayed, which could lead to changes in behavior or physical harm to the animals. 

In addition, we noted that visitors to the ARF at campus A were not required to sign in 

and that there were no security cameras at the door to monitor who was entering. Also, 

there are many entrances into the ARF. During our site visit, we noted that there were 

workmen in the ARF doing repairs. They did not sign in, and they had no escort. If a 

security incident occurred, there would be no record of who was in the building at the 

time of the incident. In addition there were delays in completing work orders for this 

ARF. Also, we noted that the personnel working with the animals had not been offered 

routine vaccines or the annual health questionnaire. We spoke with the Director of 

Occupational Health who stated that he thought it was the responsibility of the IACUC 

and ARF personnel to monitor the Occupational Health program. 

In July 2008, the ARF instituted a program to monitor the temperatures off shift, 

developed an occupational health program, and instituted improved security measures at 

the campus A ARF. 

We toured campus B, which has an older ARF and a new ARF. The new ARF has not 

yet opened due to the difficulty in recruiting a qualified ARF supervisor. This campus 

had delays in work order completion. During our tour of the ARF we found an outside 

dishwasher with a patch of cement that was disintegrating and very rough, with visible 

mold on the cement in front and under the dishwasher. A work order to replace the 

cement and remove the mold was submitted a year ago. The most recent AAALAC 

accreditation noted the delay in processing work orders at both campuses as well. 

We visited nine other sites. In the documentation we reviewed, we found that five of the 

nine sites had not sent the completed SARs to the VA VMO, five had not documented 

completion of the protocol audits during the SARs, and four were missing various parts 

of the heading on the first page of the SARs. The IACUC chairmen from the university 

affiliates reported good working relationships with the VA programs. Three of nine sites 

had modified their university protocol submission forms so that the new format met both 

the VA and university requirements. 

When we visited Facility #4, we found that the animal research program continued to 

have significant deficiencies. In 2000, the facility shut down all research due to damage 

sustained in an earthquake. At the time of our visit, they had just finished restoring the 

VA Office of Inspector General 10 
 

Review of VA Use of Animals in Research Activities 

human research program and were now focusing on the animal research program. Most 

of the research involving animals takes place at the affiliate ARF under the approval of 

their IACUC. Our visit revealed problems with IACUC minutes and SARs, which the 

health care system was in the process of improving. 

VI. Best Practices 

During our site visits, we noted several best practices. Facility #5 has one of the largest 

animal research budgets in the VA. It houses more than 15,000 animals in four 

buildings—the oldest one built in the 1850s—covering 20,000 total square feet. We 

found the entire program to be exceptional. When we toured the ARFs, we found them 

clean and well maintained with good security. Researcher compliance with the rules and 

regulations of the animal research program is strictly enforced. If a researcher fails to 

maintain compliance, his/her key to the ARF is de-activated until the issue is resolved. 

Many of the researchers are from other countries, so to increase compliance, cage signs 

are frequently in English and the language of the researcher. 

We reviewed the facility’s IACUC minutes for all of FY 2007 and through July 31, 2008, 

and SARs. Also, we reviewed protocol documentation for 5 percent of the active 

protocols and found only one discrepancy—the lack of documentation that the protocol 

audit was performed during the semi-annual review. The occupational health program is 

also a best practice. It encompasses an extensive training program that researchers and 

their staff are required to complete online. The occupational health nurse who supervises 

the program is an active participant in the IACUC and is well versed on the vaccinations, 

health assessments, and tests that are required for each species studied at the site. 

Another best practice comes from Facility #6. Animal husbandry personnel at the facility 

ARF are required to complete an associate’s degree in animal technology and must be 

certified prior to working in the ARF. The increased level of education improves the care 

of the animals by providing staff that are able to identify animals in the beginning stages 

of decline. This identification allows early intervention by veterinary staff. In addition, 

staff have the ability to take care of minor problems as they occur without the delay of 

contacting the veterinarian. 

Conclusions 

Overall the 72 sites we reviewed were compliant with the documentation requirements 

for IACUC minutes. There was a wide variety in how the minutes were documented. 

Cases of non-compliance were generally due to the format of the minutes. The highest 

area of non-compliance was with the SARs. We found significantly lower compliance 

when the animal research program had an affiliate IACUC as the IACUC of record. 

During our site visits, we found most of the ARFs to be clean, in good repair and 

adequately secured. We did not identify any instances of animal abuse or neglect. We 

found that the ARF staff we met were genuinely interested in the welfare of the animals 

VA Office of Inspector General 11 
 

Review of VA Use of Animals in Research Activities 

they cared for. Sites we visited identified a lack of funding and the way funding is 

allocated as their greatest difficulties in maintaining active, robust animal research 

programs. 

Recommendations 

Recommendation 1. We recommended that the Under Secretary for 

Health work with all VA animal research programs require university 

affiliates’ compliance with the requirements of VHA Handbook 1200.7. 

Recommendation 2. We recommended that the Under Secretary for 

Health ensure that all VA animal research programs have an active 

occupational health program. 

Recommendation 3. We recommended that the Under Secretary for 

Health ensure that Facility #3 improve the security at the main campus 

ARF. 

Recommendation 4. We recommended that the Under Secretary for 

Health ensure that the VHA ensure that work orders submitted for repairs to 

ARFs are completed in a timely fashion. 

Recommendation 5. We recommended that the Under Secretary for 

Health ensure that the VA ensure that the Facility #4 Animal Care and Use 

Committee comply with all requirements of VHA Handbook 1200.7. 

Recommendation 6. We recommended that the Under Secretary for 

Health define minimum qualification standards for VMOs and VMCs 

performing duties described in VHA Handbook 1200.7. 

Comments 

The Under Secretary agreed with the findings and recommendations and provided an 

acceptable improvement plan. See Appendix A (pages 13–19) for the full text of his 

comments. We will follow up on all recommendations until they are completed.

 (original signed by:)

JOHN D. DAIGH, JR., M.D.

Assistant Inspector General for

Healthcare Inspections 

VA Office of Inspector General 12 
 

Review of VA Use of Animals in Research Activities 

Appendix A 

Under Secretary for Health Comments 

Department of 

Veterans Affairs Memorandum 

Date: March 30, 2009 

From: Under Secretary for Health 

Subject: Healthcare Inspection – Review of VA Use of Animals in 

Research Activities 

To: Assistant Inspector General for Healthcare Inspections (54) 

1. I have reviewed the draft report, and I concur with the report and the 

recommendations. Your report highlights the tremendous commitment of 

VA animal care staff across the Nation to care for laboratory animals 

involved in research activities. Although the review found best practices 

already implemented at several VA animal research programs, VHA’s 

Office of Research and Development (ORD) will take several actions to 

implement the report recommendations for enhanced compliance with 

VHA Handbook 1200.7, Use of Animals in Research, dated May 27, 2005. 

2. To ensure that VA animal research programs require affiliates to comply 

with VHA Handbook 1200.7 requirements, ORD will develop a specific 

monitoring checklist for all VA animal research programs that utilize an 

affiliate Institutional Animal Care and Use Committee (IACUC) for the VA 

IACUC. This checklist will be used to identify any changes in affiliate 

IACUC procedures that must be made to ensure compliance with 

Handbook 1200.7. VA’s contract with the Association for Assessment and 

Accreditation of Laboratory Animal Care will be changed to add 

compliance with Handbook 1200.7 policies as part of site review criteria. 

Evaluation of IACUCs compliance with the Handbook during on-site 

reviews of affected Animal Care and Use Programs will also be 

emphasized. To further ensure compliance with all requirements of VHA 

Handbook 1200.7, the Chief Veterinary Medical Officer will work with 

Facility #4 research administrators to bring their animal research program 

into full compliance with VA policies, including the format of IACUC 

minutes and self-assessment reviews (SARs). 

VA Office of Inspector General 13 
Review of VA Use of Animals in Research Activities 

3. VHA also agrees that defined minimum qualification standards for 

Veterinary Medical Officers (VMO) and Veterinary Medical Consultants 

(VMC) performance duties are needed. Since the current qualification 

standards do not require licensure, VHA will work with the Office of 

Human Resource Management (OHRM) to define the minimum 

qualification standards for VMOs and VMCs performing duties. In fact, 

ORD has already contacted a Human Resources Specialist in the Office of 

Human Resource Management, Recruitment and Placement Office (059), 

regarding the issue of adding licensure as one of the qualifications for a 

VMO. 

4. Thank you for the opportunity to review the draft report and for 

incorporating our technical comments and a revised recommendation 6 in 

the final report. An action plan to implement all report recommendations is 

attached. If you have any questions, please contact Margaret M. Seleski, 

Director, Management Review Service (10B5) at (202) 461-8470. 

(original signed by:) 

Michael J. Kussman, MD, MS, MACP 

Attachment 

VA Office of Inspector General 14 
Review of VA Use of Animals in Research Activities 

Under Secretary for Health’s Comments 

to Office of Inspector General’s Report 

The following comments are submitted in response to the recommendations 

in the Office of Inspector General’s report: 

OIG Recommendations 

Recommendation 1. We recommended that the Under Secretary for 

Health work with all VA animal research programs require university 

affiliates’ compliance with the requirements of VHA Handbook 1200.7. 

Concur 

The Office of Research and Development (ORD) will develop a specific 

monitoring checklist for all VA animal research programs that utilize the 

affiliate Institutional Animal Care and Use Committee (IACUC) for the VA 

IACUC. This checklist will be constructed with input from the Office of 

Research Oversight (ORO) and sent out to be completed by VA animal 

research programs that utilize the affiliate’s IACUC by May 1, 2009 

(requested return date will be June 1, 2009). The individual checklists will 

be used to identify any changes in affiliate IACUC procedures that must be 

made to ensure compliance with VHA Handbook 1200.7. Correction of 

any deficiencies will be requested with a completion date of August 1, 

2009. Changes in affiliate IACUC policies require changes in VA-affiliate 

Memorandums of Understanding (MOUs), and could delay implementation 

past August 1, 2009; these delays will be evaluated on a case-by-case basis. 

ORD will change the VA accreditation contract with AAALAC to add 

compliance with Handbook 1200.7 policies as site review criteria. 

AAALAC has already been contacted, and they are amenable to this 

change. Specific review criteria based upon Handbook 1200.7 will be 

developed by ORD with assistance from ORO for the use of AAALAC site 

visitors by July 1, 2009. A formal change order will be made in the 

AAALAC contract to reflect this additional review criterion for VA 

programs with a completion date of June 1, 2009. 

ORO agrees to place increased emphasis on evaluating the compliance of 

affiliate IACUCs with Handbook 1200.7 during its on-site reviews of 

affected Animal Care and Use Programs. 

VA Office of Inspector General 15 
Review of VA Use of Animals in Research Activities 

During reviews of VA-affiliate animal research MOUs, ORD and ORO will 

continue to ensure that MOUs make clear that affiliate IACUCs must 

comply with Handbook 1200.7 if the affiliate IACUC serves as the VA 

IACUC. 

In process - August 1, 2009 

Recommendation 2. We recommended that the Under Secretary for 

Health ensure that all VA animal research programs have an active 

occupational health program 

Concur 

The presence of an animal research occupational health and safety program 

(OHSP) is required for all VA animal research programs per VHA 

Handbook 1200.7, and the OHSP for each animal research program is 

evaluated at least every 3 years by AAALAC, which is the accrediting body 

for VA animal research. However, complete implementation of field 

OHSP is challenging due to the resources required to provide continuing 

services and track personnel on a regular basis. 

ORD, with assistance from ORO, will develop a survey of all field animal 

research programs so that the need for specific improvements in OHSPs 

can be identified and targeted guidance to field programs developed. This 

survey will be developed and distributed by May 1, 2009 (required return 

date will be June 1, 2009). Data tabulation and development of individual 

station corrective action plans will be completed by July 1, 2009. Due to 

the complexity of making major changes in OHSPs, stations will be given 

until October 1, 2009, to make corrections. 

In process - October 1, 2009. 

Recommendation 3. We recommended that the Under Secretary for 

Health ensure that VHA Facility #3 improve the security at the main 

campus ARF. 

Concur 

Security requirements for VA animal research facilities are found in VA 

Handbook 0730, Security and Law Enforcement, dated August 11, 2000, 

Appendix B. This Appendix is the primary source of security feature 

mandates for animal research facilities and lists closed circuit TV 

surveillance with central monitoring as an optional feature. 

VA Office of Inspector General 16 
Review of VA Use of Animals in Research Activities 

Regardless, given the particularly challenging security environment for 

animal research in its locale, Facility #3 Veterinary Medical Unit (VMU) 

will further improve security for its animal facility by adding video camera 

surveillance to the two external doors not already covered by video 

surveillance. 

The VMU supervisor will now maintain a log of visits by workers and 

arrange for escorts when workers must be in the facility, as determined by a 

security risk assessment of the individuals involved. 

a. The Facility #3 VMU will request installation of additional security 

cameras for two building entrances by April 15, 2009, with an installation 

deadline of September 15, 2009. 

b. By May 1, 2009, the Facility #3 IACUC will review updated relevant 

standard operating procedures (SOPs) listing the procedures to be followed 

when workers must enter the animal facility. The SOPs will include 

requirements for an entry log, and guidelines regarding the need for escort 

when work is performed. Final IACUC approval of these updated SOPs 

will be by June 1, 2009. 

c. The ORD Chief Veterinary Medical Officer (CVMO) will assist Facility 

#3 as needed, and monitor progress toward meeting action plan items 1 and 

2. 

d. ORO will monitor these security items whenever it conducts on-site 

Animal Care and Use Program reviews at Facility #3. 

In process - September 15, 2009 

Recommendation 4. We recommended that the Under Secretary for 

Health ensure that the VHA ensure that work orders submitted for repairs to 

ARFs are completed in a timely fashion. 

The CVMO, with assistance from ORO, will modify the standard semiannual IACUC self-review forms to include specific items addressing 

delays in work order completion. This will ensure that each VA IACUC 

can report the delays and readily bring the problems to the attention of the 

medical center Director. The CVMO will also be notified. As needed, the 

CVMO will make ORO aware of persistent problems in work order 

completions for further action on a station-by-station basis. If consistent 

barriers to completing animal facility work orders in a timely fashion are 

identified, a Directive will be issued to highlight problem(s), provide 

relevant solutions, and express expectations for timely corrections. 

VA Office of Inspector General 17 
Review of VA Use of Animals in Research Activities 

In process - June 1, 2009 (modification of semi-annual IACUC form) 

Recommendation 5. We recommended that the Under Secretary 

for Health ensure that the VA ensure that the Facility #4 Animal 

Care and Use Committee comply with all requirements of VHA 

Handbook 1200.7. 

Concur 

The CVMO has contacted Facility #4 research administrators to 

determine what assistance may be needed to bring their IACUC 

minutes and self-assessment reviews (SARs) into compliance. 

ORO will perform a targeted review of the deficiencies referenced 

by OIG, and conduct a comprehensive on-site Animal Care and Use 

Program review at the facility no later than July 1, 2009. Standard 

ORO on-site review procedures will be followed in following up to 

make sure appropriate corrections are made. 

In process - July 1, 2009 

Recommendation 6. We recommended that the Deputy Assistant 

Secretary for Human Resource Management in collaboration with 

the Under Secretary for Health define and revise the minimum 

qualification standards for Veterinary Medical Officers (VMO) and 

Veterinary Medical Consultants (VMC) performing duties described 

in VA Handbook 5005 “Staffing” Appendix F32 “Qualification 

Standards” dated April 15, 2002, and VHA Handbook 1200.7. 

Concur 

VHA will work with the Office of Human Resource Management (OHRM) 

to define the minimum qualification standards for VMOs and VMCs 

performing duties. ORD has already contacted a Human Resources 

Specialist in the OHRM’s Recruitment and Placement Office (059) 

regarding the issue of adding licensure as one of the qualifications for a 

VMO. It is our understanding, as discussed with OHI that the 

qualifications for a VMO (Laboratory Animal Medicine) as listed in VA 

Handbook 5005 “Staffing” Appendix F32 “Qualification Standards” dated 

April 15, 2002, would need to be revised first, in order for ORD to require 

that all veterinarians obtain a license. The current qualification standards 

do not require licensure. ORD will work with the Recruitment and 

Placement Office to redraft this appendix. 

VA Office of Inspector General 18 
Review of VA Use of Animals in Research Activities 

Until the qualification standards are changed to require licensure, ORD will 

strongly encourage all current VMOs and VMCs to obtain a license in one 

of the 50 states, the District of Columbia, the Commonwealth of Puerto 

Rico, or a U.S. territory. In addition, ORD will give preference in hiring to 

new applicants who hold such licenses for the position of VMO. 

For veterinarians who do not hold a General Schedule (GS) appointment, 

ORD will develop policy that would require them to have the same 

qualifications as veterinarians holding a GS appointment. 

ORD will encourage all current VMOs and VMCs to obtain American 

College of Laboratory Animal Medicine certification as soon as they are 

eligible to obtain it. In addition, ORD will use this criteria to differentiate 

between best qualified candidates who hold such certifications for the 

position of VMO. 

In process - November 2009 

Note: A timeline for changing the qualification standards in Appendix F32 

can not be provided because the processes to accomplish this are not under 

the authority of VHA. 

VA Office of Inspector General 19 
 

Review of VA Use of Animals in Research Activities 

Appendix B 

OIG Contact and Staff Acknowledgments 

OIG Contact Andrea Buck, M.D., J.D. 

Senior Physician 

Office of Healthcare Inspections 

202-461-4705 

Acknowledgments Donna Giroux, RN, BSN, CPHQ ,Project Manager 

Gail Bozzelli, RN 

Nelson Miranda, LCSW 

Randall Snow, J.D. 

Carol Torczon, RN, MSN, ACNP 

VA Office of Inspector General 20 
 

Review of VA Use of Animals in Research Activities 

Appendix C 

Report Distribution 

VA Distribution 

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Veterans Integrated Service Network Directors (1–23) 

Non-VA Distribution 

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

This report is available at http://www.va.gov/oig/publications/reports-list.asp. 

VA Office of Inspector General 21