AAALAC Perspectives on Performance-based Standards. John Bradfield, DVM, PhD, DACLAM Senior Director, AAALAC International

Transcription

1 AAALAC Perspectives on Performance-based Standards John Bradfield, DVM, PhD, DACLAM Senior Director, AAALAC International

2 Performance Standards A commonly used term...with a less common understanding

3 Dictionary.com Performance the execution or accomplishment of work, acts, feats, etc. the manner in which or the efficiency with which something reacts or fulfills its intended purpose.

4 Dictionary.com Standard A rule or principle that is used as a basis for judgment -ora grade of beef immediately below good

5 AAALAC s use of performance-based standards

6 An example of the added performancebased concept in the 8 th edition. Solid-bottom caging, bottles, and sipper tubes usually require sanitation at least once a week. Some types of cages and housing systems may require less frequent cleaning or disinfection; such housing may include large cages with very low animal density and frequent bedding changes, cages containing animals in gnotobiotic conditions with frequent bedding changes, individually ventilated cages, and cages used for special situations. Guide 8 th edition, page 70

7 AAALAC s performance-based assessment. IVC cages - Assuming no issues with animal health and wellbeing: 1 week or less - no comment at all 1-2 week change interval (longer than one week but not longer than 2 weeks) the IACUC should be aware of and considered the interval and its impact on the microenvironment and animals. The level of review/ consideration by the IACUC need not necessarily be rigorous (i.e., citing relevant literature or IVC manufacture information alone, might be adequate). Longer than 2 week change interval the IACUC should have conducted a more rigorous evaluation of the practice with validation that cage microenvironment is satisfactory (i.e., preferable that there be some objective analysis [with data] to show why the practice does not negatively impact animal health or wellbeing). The longer the interval the more rigorous the evaluation that is required.

8 The Guide & Critical Concepts Guidance is written in general terms Clear on what is expected Silent on how to achieve the standards Room for interpretation

9 Interpretation an example. Requirements for cage washers? The point The IACUC, AV & IO must be expert in understanding the standards of the Guide

10 The Guide & Critical Concepts Professional Judgment The collective judgment of a profession., not the judgment of one professional - or - Dr. Nelson Garnett Good judgment is based on experience And most of that, is based on bad judgment Will Rodgers

11 AAALAC s Interpretation Three components: - A Performance Standard - 1) Precise, detailed, definition of the goal 2) Assessment criteria to determine that the goal is met (what to measure ) 3) How to evaluate that the goal is met (methods of how to measure )

12 An Example Conventional rodent cage sanitation 1) Precise definition: (any benchmarks?) Guide (pgs 70-1) solid bottom, static cages washed 1x/wk. IVC s longer interval..? Washing times and conditions should be sufficient to reduce or eliminate vegetative forms of opportunistic and pathogenic bacteria, adventitious viruses, and other organisms

13 Conventional rodent cage sanitation 1) Precise definition - an example - (ƒ) - Static cages 1x/wk, IVC s 1x/2wk Mechanical washer (preferred) hot water + detergent (180⁰F) + defined cycle times Manual (hand) washing when necessary sink/ soak/ detergent, etc. or - pressure washer Remove debris/ biological material, etc. Significantly reduce or eliminate vegetative bacteria

14 Conventional rodent cage sanitation - an example - 2) Assessment criteria: (what do we measure?) Husbandry/ sanitation logs/ records Visual inspection of cages (ƒ) Examine/retain cage washer function records (ƒ) Use & retention of T ⁰ sensitive tapes (ƒ) Bioluminescence &/or microbiologic (RODAC, swab) assays - w/ established pass/ fail criteria (ƒ)

15 Conventional rodent cage sanitation - an example - 3) Methods of evaluation:(how do we know we are meeting the defined standard?) SOP for day-to-day monitoring by personnel (+contingencies if problems arise) Supervisor check of cages, logs, cage wash &T⁰-tape records (ƒ) Periodic review of microbiologic monitoring records to see if pass/fail criteria are met (managers/ vet staff) (ƒ) Preventative maintenance of machinery (ƒ)

16 Global (program-wide) Exceptions to Guide Standards When an institution implements a program-wide standard that is different from that described in the Guide. AAALAC expects specific criteria for IACUC consideration: Thorough, complete, documented, IACUC review that includes site-specific, data-driven, objective analysis which demonstrates the practice promotes animal health and well-being and meets scientific needs.

17 An Example of Success Large institution many dogs, bred in-house Housing - social grouping of compatible animals in pens Pen size was such that, according to Guide recommendations, there was ~ 0.5 too many dogs in many of the enclosure(s). The nature of the studies benefited from having dogs grouped in this manner (litters).

18 Their strategy. Option 1 engineering approach: remove one dog from each pen according to Guide standards. Option 2 a performance-based approach what housing method works best for the dogs and the science.?

19 Their Strategy. Define the goal: Group size & age were important scientific factors in the housing strategy. Priorities: o Have as many dogs as possible socially housed o Animal well-being (compatibility, males, litter-groups) o Guide standards

20 Their Strategy Assessment criteria (what to measure) Study: (site-specific, data-driven, objective analysis) Grouped according to the defined goal vs grouped according to Guide recommendations Measures: o # in compatible groups, # single-housed, stereotypies/ aberrant behaviors, impact on science?

21 Their Strategy Methods to evaluate: Enrichment technicians + PI s Collected data for 1 year IACUC, AV and PI s analyzed data made a determination

22 What They Found Guide Strategy Greater # of single-housed dogs Fewer compatible groups Greater # stereotypies Fewer litter-groups Scientific data more variable, studies took longer & required more dogs Performance-based Strategy Greater # of socially compatible groups Fewer # stereotypies More litter-groups Scientific data less variable & used fewer dogs

23 Summary Performance Standard Three components: 1) Precise, detailed, definition of the goal 2) Assessment criteria to determine that the goal is met (what to measure ) 3) How to evaluate that the goal is met (methods of how to measure ) When necessary site-specific, data-driven, objective analysis

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