Local AccountabilityCommon Problems, Solutions

“History never looks like history when you are living through it.”

John W. Gardner (1912 - 2002),

Animal Facility Monitoring Systems

• Both ethical and regulatory mandates require adequate environmental monitoring to protect animals.

• Rodents are extremely intolerant of temps greater than 78F, and will die if temps persist over 90F for 30-60 min.

• "Real-time" monitoring of animal room temperatures required- after business hours, animal facility and engineering staff must be able to respond quickly to high temps in animal facility rooms

Environmental Monitoring- Animal Facilities

Animal Room

Temp, humidity, light cycle data

Boiler Room

Animal Facility Office

Alarm Procedures

Animal Room

Temp, humidity, light cycle data

Boiler Room

Animal Facility Office

Autodialer

Animal Fac /Eng

Staff

Offsite Animal

Fac Staff

Internet

Internet

Importance of Computer Access to Internet

• Animal care staff must be able to monitor temp/humidity/security remotely

• Vendor software updates and troubleshooting done via internet

• Remote data backup is an attractive option (non-sensitive) Animal

Facility Office

Offsite Animal Fac

Staff

Vendor Staff

Internet

Importance of Computer Access to Internet

Animal Facility Office

Offsite Animal Fac

Staff

Vendor Staff

?

VA Network

Solution

Training Deficiencies

• Per AAALAC: “…majority of deficiencies identified (during site visits) are related to training problems.”

• Common problems include failure to:– Train all personnel who use animals.– Provide training for IACUC members.– Document training, including one-on-one and

OJT.

IACUC-Based Solutions– Capture names of all personnel on animal protocol forms,

including students, residents, WOCs.– Make protocol approval contingent upon documentation of

training.**– Make access to animal facility contingent upon training.

**Mandated by Handbook 1200.7

Failure to train all personnel who use animals:

Solutions– Utilize VA web-based training for IACUC members.**– IACUC can spend a few minutes at each meeting on

discussion of a pertinent regulation or topic.– Distribute copies of regulatory documents to members.– Use issues related to agenda items as training opportunities.

**Mandated by Handbook 1200.7

Failure to provide training for IACUC members:

Solutions– Place researcher web training completion certificates in IACUC

files, or use software that tracks such information automatically; documentation is CRITICAL.

– Ask vet and husbandry staff to submit summaries of their own training for IACUC files.

– Document training of IACUC during meetings in the minutes.

Failure to document training, including one-on-one and OJT:

Semi-Annual IACUC Self-Review

• Self-reviews are extremely important yet very labor intensive and tedious to document

• Common problems include failure to:– Formulate both a clear plan for correction and a

timetable for correction for each deficiency.– Follow up on deficiencies and document

corrections.– Document communication of results to Institutional

Official (VAMC Director).

Solutions– Use VA IACUC Semi-Annual Review items or other compliant

forms to document process (VA Form #2 prompts a plan and timetable for each deficiency; integration with ORO list impending).

– IACUC should not approve forms until such information is present for all identified deficiencies (incomplete forms lead to “loose ends”).

Failure to formulate both a clear plan and timetable for correction of each

deficiency:

Solutions– Assign responsibility for addressing each deficiency to a specific

individual, as appropriate.– Use VA Form #2 to carry over past deficiencies onto successive semi-

annual forms until corrections are documented and item is “closed out.”– IACUC: Routinely monitor progress in correcting deficiencies as an

item on the agenda, and document progress in the minutes.

Failure to follow up on deficiencies and document corrections:

Solution– Use Form 3 of VA IACUC Semi-Annual Self-Review (or

equivalent) to document a meeting between the IO and IACUC to discuss review results**

– Create paper trail of communication to update IO on progress between semi-annual review meetings. The meeting minutes can be used for this purpose.

Failure to document communication of results to Institutional Official (VAMC Director) :

**Mandated by Handbook 1200.7

Documentation of Medical/Postoperative Care

• Expectations have evolved now to the point that written documentation of rodent care is necessary (individual rodent records not needed).

• Common problems include failure to document:– Visits by consultant veterinarians.– Injection of analgesics postoperatively according to

schedule approved by IACUC. – Clinical problems in rodents and medical care

provided thereafter.

Solutions– Provide sign-in book or clipboard for veterinary

consultant.– Ask veterinary consultant to sign and date active

medical records to document veterinary attention.

Failure to document visits by veterinary consultants:

Solutions (IMPORTANT ISSUE!)– IACUC: in approval letter to PI, emphasize that records of postoperative

injections (according to the schedule approved) must be maintained by research staff if veterinary staff are not tasked.

– IACUC: during semi-annual review of laboratories, review postop analgesic records maintained by research staff, compare to ACORP.

– To improve quality of records, assign all postoperative care to veterinary care staff.

Failure to document injection of analgesics postop according to schedule approved by IACUC:

Solutions– For rodents, maintain a ledger of clinical problems and actions taken to treat

them (in lieu of individual medical records). – Focus on training husbandry staff to identify and report clinical problems to

veterinary care staff (VERY IMPORTANT); AALAS– Ask veterinary care staff to develop a system of visually identifying cages

with rodent clinical cases (e.g. colorful paper strips, clear tinted plastic cage card overlays).

Failure to document clinical problems in rodents and medical care provided thereafter:

Occupational Health and Safety (OHS) Program

• Intense emphasis by AAALAC and an area of focus by OLAW in PHS Assurance reviews.

• Common problems include failure to:– Include all personnel with significant animal contact

in program.– Conduct routine annual follow-ups.– Educate personnel on hazards of lab

animal allergies and strategies toreduce exposure.

Solutions– Make IACUC approval and facility access contingent upon proof of enrollment.– Set up effective communication and confirmation staff participation in program with

OHS staff.– Create policies to decide if IACUC members and engineering, housekeeping, and

maintenance staff should be enrolled, and if so, what services they need..– When appropriate, include enrollment of new staff in OHSP as part of new employee

orientation.

Failure to include all personnel with significant animal contact in program:

Note:

1200.7 10c(1) VA employees, without compensation (WOC) personnel, VA research and education corporation employees, and students with significant animal contact must be given the opportunity to participate equally in the Occupational Health and Safety Program, unless the IACUC determines that such personnel are enrolled in an alternate program (e.g., affiliate's program) that complies with PHS policy. NOTE: Consistent with PHS policy, OLAW will be the final arbiter if questions regarding the suitability of an alternate program are raised.

Solutions– Make IACUC annual renewals contingent upon proof of

visit by all personnel to occupational health physician or nurse in past year.

– Inactivate access to animal facility if personnel do not visit occupational health professional.

Failure to conduct routine annual follow-ups:

Solutions (IMPORTANT!!)– Hand out animal OHS brochure available from CVMO's office.– Include discussion of topic in new employee orientation for those

who will handle animals.– Utilize sample annual OHS questionnaire provided in Appendix C of

1200.7, section 5.– Utilize species-specific VA web-based training.

Failure to educate personnel on hazards of lab animal allergies and strategies to reduce

exposure:

Reducing Cost/ Enhancing Effectivenessof OHS Program

Researcher fills out questionnaire

Screening by nurse/ PA

Physician review /appointment

Review by Biosafety Committee (IBC)/ IACUC

Animal facility access

IACUC protocol approval

IBC project approval

(as needed)

PHI section

Non-PHI risk assessment session

Reducing Cost/ Enhancing Effectivenessof OHS Program

Researcher fills out questionnaire

Screening by nurse/ PA

Physician review /appointment

Review by Biosafety Committee (IBC)/ IACUC

Animal facility access

IACUC protocol approval

IBC project approval

(as needed)

PHI section

Non-PHI risk assessment session

IACUC Protocol Review Documentation

• Another area of increasing emphasis by AAALAC• Common problem is failure to maintain complete

IACUC files, to include:– Annual renewal letters– Amendments– Correspondence between IACUC and PI– Most recent approved ACORP or other animal

protocol form

Solutions– IACUC or compliance officer should audit at least 5%

(minimum of 5) of IACUC files each 6 months to find and correct problems quickly.**

– Utilize an audit check list and attach the audit sheets to the semi-annual report (an audit form is available from the CVMO).

Incomplete IACUC files:

**Mandated by Handbook 1200.7

Oversight of Procedures in Investigator Labs

• Intense emphasis by AAALAC.• Common problems include:

– Research technicians/postdocs unaware of procedures approved in ACORP.

– Inappropriate euthanasia, handling, and surgical procedures being conducted.

Solutions– Ask each lab to keep a copy of approved animal protocol

forms in a notebook accessible by lab personnel.– Emphasize in IACUC approval letters that personnel

conducting studies must be aware of which procedures are approved by the IACUC.

Research technicians/postdocs unaware of procedures approved in ACORP:

Solutions– Utilize VA web-based species-specific courses (or equivalent) so that

personnel are familiar with acceptable procedures for each species.– Compliance officer: conduct regular visits to labs to interact with personnel

and become familiar with their projects.– IACUC: during semi-annual review, ask open-ended questions about

procedures to see if responses are consistent with procedures approved by IACUC.

Inappropriate euthanasia, handling, and surgical procedures being conducted:

Test Your Knowledge #1

The IACUC has 9 voting members but due to bad weather, only 5 make it to the meeting. Being careful to properly manage conflicts of interest, Dr. Smith recuses herself when her own protocol comes up for review. After the IACUC deliberates and votes to approve the protocol, she comes back into the room. The meeting ends and the minutes are prepared by the IACUC coordinator thereafter without incident.

At the next IACUC meeting, the previous minutes are reviewed and one of the IACUC members expresses concern about the minutes.

What might her concern be?

Test Your Knowledge #2

Mrs. Jones served with great integrity and energy on the Hometown VA IACUC as the non-affiliated member (NAM) for 5 years. She was now moving permanently to another state to be with her family. The IACUC had a going away luncheon and presented her with a plague expressing gratitude for her service. Mrs. Jones left the next week.

At the next monthly IACUC meeting, the Chair announced that several new candidates for the NAM position were under discussion, and that IACUC members would be asked to meet with each of them. At the end of the meeting, one IACUC member raised his hand and expressed serious concern.

What do you think his concern might have been?

Test Your Knowledge #3Friday afternoon the IACUC Chair answers the phone and receives

an anonymous allegation that Dr. Green is not using proper sterile technique during survival surgery. A surgery is underway, so the IACUC Chair and veterinarian go to the lab. They observe several possible lapses in technique, and they suggest that some improvements might be necessary. They also decide suspension of the work is unnecessary, but ask Dr. Green to delay her work 2 days until the IACUC can meet to review it more completely.

At the IACUC meeting the IACUC decides that the suggestions made by the Chair and veterinarian are adequate and that no further delay in Dr. Green's work is warranted. The Chair expresses satisfaction that the matter was handled efficiently and diplomatically without the need to report to outside agencies.

Should the IACUC be commended?

Test Your Knowledge #4Dr. Brown, an eminent researcher and future Nobel laureate, is

due for a 3-year review on her approved animal protocol. As the deadline approaches, the IACUC sends multiple letters reminding Dr. Brown of the deadline. Finally, the deadline passes and at the next meeting, the IACUC decides to give Dr. Brown one more chance. The IACUC sends a diplomatic yet sharply worded letter to Dr. Brown suspending all new animal orders until her protocol receives approval.

Unable to order new animals, Dr. Brown submits a new protocol and after IACUC approval, she orders additional animals.

A later audit of Dr. Brown's IACUC file by an oversight agency raises a concern.

What is the most likely concern?