Preparing for Animal Facility Inspections: USDA-regulated species

David Lyons and Colleen Bennett

WHO has your back?

YOU

US

DEAN

ARP

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

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

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

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

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.

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.

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.

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

Common Don’ts and how to fix them…

Housing and Husbandry

Animals not checked daily

Check all animals daily, including holidays and weekends, and keep records.

Record room temperature in housing areas daily.

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.

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

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.

Surgery and Procedures

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.

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.

Improper sharps disposal

Dispose sharps in proper sharps containers. Containers should not be overfilled.

Unsecured gas tanks

Secure all gas tanks to prevent injury to people and animals.

Vaporizers not serviced

Service vaporizers annually and record the dates on the machine.

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.

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.

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.

Unacceptable euthanasia method Method must conform to AVMA report of

2000 or be approved alternative by IACUC

General Concepts

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.

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.

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.

Clutter

Maintain all animal use areas neat and free of clutter.

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.

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.

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.

Environmental Enrichment

Expected for all species Special care for singly house animals, as

documented in protocol Written SOPs for nonhuman primates