Preparing for Animal Facility Inspections: USDAregulated species

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Preparing for Animal Facility Inspections
USDA-regulated species

• David Lyons and Colleen Bennett

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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

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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

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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

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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

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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.

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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.

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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.

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Best ways to interact with inspectors

• Be friendly
• Answer questions concisely
• Dont offer more than is asked
• Say I dont know if you dont
• but I know who to ask!
• but I know where to find it!
• Smile

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Common Donts and how
to fix them
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Housing and Husbandry
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Animals not checked daily

• Check all animals daily, including holidays and
  weekends, and keep records.
• Record room temperature in housing areas daily.

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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.

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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

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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.

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Surgery and Procedures
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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.

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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.

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Improper sharps disposal

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

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Unsecured gas tanks

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

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Vaporizers not serviced

• Service vaporizers annually and record the dates
  on the machine.

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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.

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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.

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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.

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Unacceptable euthanasia method

• Method must conform to AVMA report of 2000 or be
  approved alternative by IACUC

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General Concepts
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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.

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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.

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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.

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Clutter

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

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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.

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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.

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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.

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Environmental Enrichment

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