Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use Summary of a Workshop (2015) / Chapter Skim
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5 Detailed Steps in the Development and Implementation of Performance Standards
5 Detailed Steps in the Development and Implementation of Performance Standards
Pages 53-64
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From page 53... ...
CRL, he said, has developed a standardized process for creating performance standards, including a proposal process and a dedicated form that proceeds step by step, creates consistency, and provides value in the future when reevaluations are conducted. He noted the company started performance approach evaluations in 1997, and when he joined the company a decade ago he was able to go through the company files to review the history of each performance evaluation, which included the data sets the company used to make its decisions at each evaluation along the way.
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From page 54... ...
The key stakeholders in this process, explained Mulder, include the IACUC, which is involved from the very beginning; the attending veterinarian; the researchers who will be using the animals; any specialists with unique expertise in areas of study design, equipment, or interpretation of the study results; and the vivarium management, including the husbandry personnel, who often have an intimate knowledge and unique insights that he might not have as the veterinarian. Mulder said that CRL has created a dedicated Request for Exception to ILAR 2011 Guide Recommendations form, which he characterized as a research proposal, complete with hypothesis and proposed statistical analysis.
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From page 55... ...
Examples of variances or exceptions to the Guide for which CRL has used a performance approach include cage density for mice and rats, cage change frequency, housing multiple rodent species in the same room, and the frequency of water bottle sanitation. For each of these, Mulder's team developed evaluation criteria unique to the question they were asking.
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From page 56... ...
If the performance standard was about cage change frequency, the appropriate measures might involve humidity in the cage, ammonia levels, and other gas production from waste products, Mulder explained. For reproductive performance, Mulder's team started with a list including the number of pups weaned per female breeder per week, known as the production index; litter size at birth; survival to weaning; sex ratio; weaning weight; interͲlitter interval; time to first plug; and time to vaginal opening in female pups.
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From page 57... ...
The CRL team developed a scoring system for each parameter, most of which could be measured in the barrier room by standard husbandry technicians who received some additional training from the company's behavioral staff. Assessments of space utilization, however, were performed in a behavioral lab, which Mulder characterized as a quiet room outfitted with video equipment that could simultaneously record 24 hours a day from 48 mouse cages and 32 rat cages, spanning both light and dark cycles and multiple litters of breeding groups.
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From page 58... ...
Veterinary care definitely required; consider treatment or euthanasia. FIGURE 5Ͳ1 Charles River Laboratory's behavioral assessment scoring for fighting and aggression SOURCE: Mulder slide 22 0 = full pelage No hair loss observed (to include vibrissae)
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From page 59... ...
FIGURE 5Ͳ3 Charles River Laboratory's behavioral assessment scoring for stereotypic behaviors SOURCE: Mulder slide 23 (adapted from Würbel and Stauffacher 1996) After careful consideration of which stocks and strains, or genotypes, to evaluate the CRL team picked the C57B/6, the most common inbred mouse strain used in research and common background strain for genetically engineered mice; CDͲ1, or Swiss mouse, the most common outbred mouse; the SpragueͲDawley or CD rat, an outbred strain; and the brown Norway rat, an inbred strain.
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From page 60... ...
The experimental design for the cage density evaluation consisted of a Latin square factorial design, with cage type or size, breeding condition, and strain of animal being the three variables. For mice, the breeding conditions consisted of breeding the female and then removing the male so the female is alone with the pups; a matched male and female pair kept together, including when the litter is present; and a trio of two females and one male.
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From page 61... ...
: x 580 cm2, the smallest cage available x 758 cm2, the standard CRL cage C x 903 cm2, a GuideͲcomp pliant cage x 1355 cm2, the largest ca available age FIGURE 5Ͳ5 Th smallest and largest rat ca he d ages SOURCE: Muld slide 33 der
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From page 62... ...
For postͲapproval monitoring the IACUC will conduct an annual review of key performance indicators for the variance for two consecutive years and then do a de novo review at the end of year three with a complete literature review to determine if new or additional studies are warranted. There is also regular ongoing review of production indices that is outside of direct IACUC involvement.
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From page 63... ...
He did note that "perhaps there should be a more common approach to evaluating questions such as housing density so that the results of those studies are more comparable, but at some point we need to be able to say ‘this seems reasonable,' and groups such as AAALAC should be ready to agree that individual studies don't need to be performed at every single institution." Paul Locke asked how another facility might go about generalizing from the publications resulting from the studies Mulder described. The first thing to do, Mulder replied, is to look at the performance measures in the publication and see if they fit the proposed study.
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From page 64... ...
Another question from an online participant asked Mulder about the time and resources required to develop and complete this project. He replied that CRL made a significant investment in both time and resources.
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