Transcript Records

Preparing for Animal Facility
Inspections: USDA-regulated
species
David Lyons and Colleen Bennett
WHO has your back?
DEAN
US
ARP
YOU
WHO inspects and WHEN?
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IACUC
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Every six months in spring and fall
USDA
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Whenever they want!
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Standard has been: Late Oct, Early Nov – BGC, DTC,
RC campuses; February – FC
For cause - ?
AAALAC
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Every 3 years
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Next is early 2008
WHERE are inspections done?
Depends on the inspector
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IACUC
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USDA, APHIS
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All housing, procedural and support areas, including labs
Animal Resources Program & Investigators
USDA regulated species only
AAALAC
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All housing, procedural and support areas, including some
labs
HOW are inspections done?
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IACUC Semi-annual Inspections
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announced by email
Various teams inspect over about one month
Findings sent to PI or ARP
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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?
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Post-Approval Review
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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?
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USDA, APHIS
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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?
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AAALAC
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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?
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You join the team – Go Deacs!
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You know where you stand
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Increased understanding of standards
You know who to ask
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Increased confidence in compliance
You know what is expected
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Effective self-assessment and self-governance
Access to your local experts
You are not alone
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Research is a team sport, and so is regulatory compliance.
Best ways to interact with inspectors…
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Be friendly
Answer questions concisely
Don’t offer more than is asked
Say ‘I don’t know’ if you don’t
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‘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
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Check all animals daily, including holidays
and weekends, and keep records.
Record room temperature in housing areas
daily.
Inadequate facility maintenance
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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
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Identify all animals with
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protocol number,
source,
species,
investigators,
contact information,
and pertinent dates.
Some require individual identification
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Dogs and cats, linked to USDA number
Exotics, e.g., nonhuman primates
Improper feed and bedding storage
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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
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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
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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
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Dispose sharps in proper sharps containers.
Containers should not be overfilled.
Unsecured gas tanks
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Secure all gas tanks to prevent injury to
people and animals.
Vaporizers not serviced
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Service vaporizers annually and record the
dates on the machine.
Waste anesthetic gases not scavenged
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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
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Monitor animals closely after procedures until they
are fully recovered from anesthesia and the effects
of the procedure. Keep records.
WFU Policy:
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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
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Records should be complete, legible and accessible.
Keep records for
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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).
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Exception if minor procedures of less than one hour.
Unacceptable euthanasia method
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Method must conform to AVMA report of 2000
or be approved alternative by IACUC
General Concepts
Expired protocols
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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
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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
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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
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Maintain all animal use areas neat and free of
clutter.
Controlled drug
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Store behind at least two locks, e.g., room door and
lock box.
Disposal
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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
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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
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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
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Expected for all species
Special care for singly house animals, as
documented in protocol
Written SOPs for nonhuman primates