Assessing the Quality of VA Animal Care and Use Programs

QI 12. IACUC chair and members’ animal care and use education and training requirements was chosen because of the important role of the IACUC chair and members in the institution’s ACUP. To appropriately evaluate and approve/disapprove animal research protocols, the chair and members of IACUC must maintain sufficient knowledge of federal regulations and VA policies regarding animal protections.

QI 13. Veterinarian and veterinary medical unit staff qualification was chosen because of the important role of veterinarian and veterinary medical unit staff in the day-to-day care of research animals and the specialized knowledge and qualification they need to maintain the animal research facilities. The number of veterinarians and nonveterinary animal care staff with appropriate board certifications reflects the strength of an institution’s ACUP.

Results

Recognizing the importance of assessing the quality of VA ACUPs, the authors started to collect some QI data of VA ACUPs parallel to those of VA HRPPs before the aforementioned proposed QIs for VA ACUPs were fully developed. These preliminary data are included here to demonstrate the feasibility of implementing these proposed VA ACUP QIs.

IACUC and R&DC Approvals (QI 2)

VA policies require that all animal research protocols be reviewed and approved first by the IACUC and then by the R&DC.^13,14 The IACUC is a subcommittee of the R&DC. No animal research activities in VA may be initiated before receiving both IACUC and R&DC approval.^13,14

Between June 1, 2011, and May 31, 2012, regulatory audits were conducted on 1,286 animal research protocols. Among them, 1 (0.08%) protocol was conducted and completed without the required IACUC approval, 1 (0.08%) was conducted and completed without the required R&DC approval, 1 (0.08%) was initiated prior to IACUC approval, and 2 (0.16%) were initiated prior to R&DC approval.

For-Cause Suspension or Termination (QI 3)

Among the 1,286 animal research protocols audited, 14 (1.09%) protocols were suspended or terminated for cause; 10 (0.78%) protocols were suspended or terminated due to animal safety concerns; and 4 (0.31%) protocols were suspended or terminated due to investigator-related concerns.

Lapse in Continuing Reviews (QI 5)

Federal regulations and VA policies require that IACUC conduct continuing review of all animal research protocols annually.^2,13 Of the 1,286 animal research protocols audited, 1,159 protocols required IACUC continuing reviews during the auditing period. Fifty-three protocols (4.57%) lapsed in IACUC annual reviews, and in 25 of these 53 protocols, investigators continued research activities during the lapse.

Scope of Practice (QI 9)                                                                   

VA policies require all research personnel to have an approved research scope of practice or functional statement that defines the duties that the individual is qualified and allowed to perform for research purposes.¹⁴

A total of 4,604 research personnel records were reviewed from the 1,286 animal research protocols audited. Of these, 276 (5.99%) did not have an approved research scope of practice; 1 (0.02%) had an approved research scope of practice but was working outside the approved research scope of practice.

Training Requirements (QI 11)

VA policies require that all research personnel who participate in animal research complete initial and annual training to ensure that they can competently and humanely perform their duties related to animal research.¹⁴

Among the 4,604 animal research personnel records reviewed, 186 (4.04%) did not maintain their training requirements, including 26 (0.56%) without required initial training and 160 (3.48%) with lapses in required continuing training.

Discussion

Collectively, these proposed QIs should provide useful information about the overall quality of an ACUP. This allows semiquantitative assessment of the quality and performance of VA facilities’ ACUPs over time and comparison of the performance of ACUPs across research facilities in the VAHCS. The information obtained may also help administrators identify program vulnerabilities and make management decisions regarding where improvements are most needed. Specifically, QI data will be collected from all VA research facilities’ ACUPs annually. National averages for all QIs will be calculated. Each facility will then be provided with the results of its own ACUP QI data as well as the national averages, allowing the facility to compare its QI data with the national averages and determine how its ACUP performs compared with the overall VA ACUP performance.

These QIs were designed for use in assessing the quality of ACUPs at VA research facilities annually or at least once every other year. With the recent requirement that a full-time RCO at each VA research facility conduct regulatory audits of all animal research protocols once every 3 years, it is feasible that an assessment of the VA ACUPs using these QIs could be conducted annually as demonstrated by the preliminary data for QIs 2, 3, 5, 9, and 11 reported here.^15,16 These preliminary data also showed high rates of lapses in IACUC continuing review (4.57%), lack of research personnel scopes of practice (5.99%), and noncompliance with training requirements (4.04%). These are areas that need improvements.