Preparing for Animal Facility Inspections: USDA-regulated species

1. Preparing for Animal Facility Inspections: USDA-regulated species David Lyons and Colleen Bennett

2. WHO has your back? DEAN US ARP YOU

3. WHO inspects and WHEN? • IACUC • Every six months in spring and fall • USDA • Whenever they want! • Standard has been: Late Oct, Early Nov – BGC, DTC, RC campuses; February – FC • For cause - ? • AAALAC • Every 3 years • Next is early 2008

4. WHERE are inspections done? Depends on the inspector • IACUC • All housing, procedural and support areas, including labs • Animal Resources Program & Investigators • USDA, APHIS • USDA regulated species only • AAALAC • All housing, procedural and support areas, including some labs

5. HOW are inspections done? • IACUC Semi-annual Inspections • announced by email • Various teams inspect over about one month • Findings sent to PI or ARP • Include correction date • PI/ARP replies with plan within 2 weeks • PI/ARP corrects finding by correction date • Final report provided to IO and filed

6. HOW are inspections done? • Post-Approval Review • Conducted by Research Oversight Specialist • Review of compliance with protocol • One-on-one meeting with PI • Observation of animal activity • Final report to PI and IACUC

7. How are inspections done? • USDA, APHIS • VMO arrives unannounced at WFUHS Office of Research or ARP office • VMO tells us what she wants to see • VMO escorted by veterinary and other staff at all times • Focus is on regulatory compliance with AWA/R. • Inspection Report provided at end of inspection that is part of public record.

8. HOW are inspections done? • AAALAC • Scheduled in advance • Two or three external site visitors escorted by veterinary and other staff at all times • Focus is programmatic • Final report drafted by school, then edited by site visitors. Full response to criticisms expected prior to re-accreditation.

9. WHAT's in it for you? • You join the team – Go Deacs! • Effective self-assessment and self-governance • You know where you stand • Increased confidence in compliance • You know what is expected • Increased understanding of standards • You know who to ask • Access to your local experts • You are not alone • Research is a team sport, and so is regulatory compliance.

10. Best ways to interact with inspectors… • Be friendly • Answer questions concisely • Don’t offer more than is asked • Say ‘I don’t know’ if you don’t • ‘but I know who to ask!’ • ‘but I know where to find it!’ • Smile

11. Common Don’ts and how to fix them…

12. Housing and Husbandry

13. Animals not checked daily • Check all animals daily, including holidays and weekends, and keep records. • Record room temperature in housing areas daily.

14. Inadequate facility maintenance • Repair damage to facilities e.g. flaking paint, holes, broken lights, leaking faucets, blocked sinks, promptly. • Certifications instrumentation, such as hoods, biosafety cabinets, vaporizers.

15. Incomplete animal identification • Identify all animals with • protocol number, • source, • species, • investigators, • contact information, • and pertinent dates. • Some require individual identification • Dogs and cats, linked to USDA number • Exotics, e.g., nonhuman primates

16. Improper feed and bedding storage • Store bedding and feed on pallets away from the wall. Store opened bags of feed and bedding in vermin proof containers. • Label containers with feed mill dates. Discard expired feed. • Store feed or bedding away from chemicals and other contaminants.

17. Surgery and Procedures

18. Dirty surgical areas • Keep surgery areas clean, clutter free and disinfected. It is best practice to post a cleaning/sanitation schedule and record dates done. • Rodent surgical can be multi-use area that is prepared and used for surgery intermittently. • USDA-regulated animal surgeries must be done in dedicated surgical suite.

19. Inadequate Autoclave monitoring • During regular use, autoclaves must be tested weekly with a biological monitor. Biological control tests must be conducted monthly. • For intermittent use, test with bio monitor before reinitiating use. • Temperature-sensitive tape must be applied to all packs. • Sterile instruments must be dated at autoclaving and can be used for one year from the date.

20. Improper sharps disposal • Dispose sharps in proper sharps containers. • Containers should not be overfilled.

21. Unsecured gas tanks • Secure all gas tanks to prevent injury to people and animals.

22. Vaporizers not serviced • Service vaporizers annually and record the dates on the machine.

23. Waste anesthetic gases not scavenged • Scavenge anesthetic gases using a dedicated system or through building exhaust. • Record weights of canisters regularly. Mark initial weight. Best practice is to re-weigh at each use or at established intervals based on usage.

24. Insufficient post procedural monitoring • Monitor animals closely after procedures until they are fully recovered from anesthesia and the effects of the procedure. Keep records. • WFU Policy: • Stage 4, un- or semi-conscious, monitor every 30 minutes; • Stage 3, sternal recumbant, monitor every 6-10 hours; • Stage 2, ambulatory but residual effects of procedure, monitor daily; • Stage 1, Sutures in place, monitor daily, Remove wound clips or skin sutures after 10-14 days; • Stage 0, Normal, close-out post-op surgical record with final statement about animals disposition. • WFU Policy: Pain score must be recorded at monitoring point at stages 3 to 1.

25. Inadequate record keeping • Records should be complete, legible and accessible. Keep records for • Surgery/procedures: intra-operative, post-procedural monitoring and care • Regulation/restriction of food/fluid • Record of drug use: drug, time, dose in a form that is understandable. DO NOT BACKLOG OR FORELOG. • All animals must be monitored every 15 minutes during the operative procedures (intra-operative). • Exception if minor procedures of less than one hour.

26. Unacceptable euthanasia method • Method must conform to AVMA report of 2000 or be approved alternative by IACUC

27. General Concepts

28. Expired protocols • Protocols cannot be used once expired. Replace expired protocols. Cage cards must have current protocol number. • NIH grant dollars cannot be used to support animals on an expired protocol.

29. Personal protective equipment (PPE) use • PPE is your last defense against work place hazards. Wear uniforms, scrubs or laboratory coats as indicated. • These clothes should not be worn in public places. Do not wear gloves in elevators. • Eye protection is required for nonhuman primates users. Eye glasses are not acceptable as PPE.

30. Poor Sanitation • Clean and sanitize animal housing areas, surgeries, surfaces and equipment regularly. • For satellite housing, it is a best practice to post a cleaning/sanitation schedule and record dates done.

31. Clutter • Maintain all animal use areas neat and free of clutter.

32. Controlled drug • Store behind at least two locks, e.g., room door and lock box. • Disposal • often must be done in the presence of DEA. Contact DEA office for guidance at each occurrence. • ARP cannot dispense controlled drugs, e.g., ketamine, pentobarbital. • Records of use must be complete, including Drug name, Lot/ID number, amount, personnel.

33. Expired drugs and supplies • Identify and properly dispose of outdated drugs, fluids and supplies, including suture material and gloves. • Expired materials can be used for terminal procedures, except anesthetic agents and analgesics. • Expired materials must be labeled as expired and stored separately. • NOTE: If just one lab in the entire school is found with an expired drug it is a violation. A repeat violation carries a stiffer penalty, even if it occurs in a different lab.

34. Unapproved satellite housing • House animals only in ARP Facilities or IACUC approved locations and for approved purposes and times. • Greater than 12 consecutive hours is considered housing. • Advantage of approved housing is environmental controls (temp, humidity, lighting, air exchanges) and infection/contamination/vermin controls.

35. Environmental Enrichment • Expected for all species • Special care for singly house animals, as documented in protocol • Written SOPs for nonhuman primates