1. The Art of Auditing: An academic perspective
Jennifer Davis, DVM, DACLAM
Compliance Liaison Veterinarian
Office of Animal Welfare
University of Pennsylvania

2. Partners in Research Compliance: An academic perspective
Jennifer Davis, DVM, DACLAM
Compliance Liaison Veterinarian
Office of Animal Welfare
University of Pennsylvania

3. My road to compliance DVM PAM Background:
BS in Biology from University of SC
DVM from UGA
2 years in CV Research Lab at MUSC
Internship in Small Animal Medicine and Surgery
2 year residency in LAM at Emory University
CL Veterinarian at the University of Pennsylvania
ACLAM boards (2014) – WHEW!
16 years in Small Animal Private Practice

4. Goals of PAM Ensure animal well-being Protect the institution
Resource to research community
Facilitate science
Ensure regulatory compliance
What is the overarching goal of post-approval monitoring? Why do we all do ?
Ensuring animal well-being – happier healthier animals = better science, builds public trust
Protect the institution by avoiding reportable issues
Providing a resource to the research community – keep researchers aware of guidelines and policies determined by the IACUC
Facilitate science – advancement of of scientific knowledge to benefit the lives of humans and potential animals as well
And when all 4 of these occur, then regulatory compliance happens on its own.

5. USDA – United States Department of Agriculture
What do the regs say?
USDA – United States Department of Agriculture
OLAW– Office of Laboratory Animal Welfare
AAALACi– Association for the Assessment and Accreditation of Laboratory Care International
All 3 of these agency’s have recognized the value and benefit of a well-engaged PAM process. However, none of them give any specific guidance as to how post-approval monitoring is best achieved.
The USDA does not require it.
The Public Health Service does not require it, however OLAW endorses the Guide, which does provide further input on post-approval monitoring.
AAALAC also endorses the Guide and FAQ A.5. states that AAALAC interprets the Guide recommendation for a PAM program in the broadest sense for the international community, namely that there will be a system for ensuring animal procedures conform with the approved protocol or study plan.

6. PAM and the “Guide”
“Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Post-approval monitoring (PAM) … [consists] of all types of protocol monitoring after the IACUC’s initial protocol approval.” (Guide)
“PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory visits inspections…; veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.” (Guide)
What does the Guide say?

7. What PAM is not… Not policing mechanism
Not a replacement for IACUC or AV
Not required by USDA or PHS
Not a ‘must’ of AAALAC
Not a funded mandate
Not any easier at large or small institutions
Not new ground or new regulation
Not policing mechanism – that’s why it is beneficial to avoid terms like “Compliance Officer” or “monitor”.

8. What pam is… A conduit for information to researchers
Disseminate information
Answer questions
A liaison between the IACUC/laboratories
Advocate for the PI
Serve as the “eyes and ears” of the IACUC
A process to assure program integrity
Encourage collegial dialogue
Acknowledge compliance
Assist to maintain compliance
Fosters a culture change
Be personal
Be nonjudgmental
Be consistent
Although PAM functions as the “eyes and ears” of the IACUC, it is important to avoid statements like “I have a right to be here” or “I am here on behalf of the IACUC”. If you consider yourself a visitor, then odds are in your favor you will be welcomed.
Fostering a culture change is ultimately about providing good customer service.

9. What it sometimes feels like…
PI/
Research Staff
IACUC
Veterinary Staff
For anyone affiliated with a large program or institution, this illustration may seem kind of familiar – all are independent offices with often little overlap. They can function independent of each other, which creates a problem for the researcher in trying to understand which office handles what. Although all of these impart their own contribution to a program, if they they don’t work together, then the program suffers.

10. What it sometimes feels like…
It sort of like having parts of a car. What good are all of these parts unless [new slide]

11. …when instead,
They are put together and function as one. This is what you want! Anyone remember the Disney movie “Herbie the Love Bug”?

12. …when instead, PI/ Research Staff PAM Compliance Liaisons Veterinary
IACUC
Veterinary
Staff
As Compliance Liaisons, our role is actually help bridge these programmatic areas, assisting how to navigate across all 3. So how has Penn done this?

13. Penn OAW Organization Director of Animal Welfare (VMD)
IACUC Administration
Compliance
Associate Director of Administration
(DVM)
Compliance
Liaison
(DVM)
2 yr ago the University formed a committee to determine how the program could improve. The OAW brought addtl staff, including 3 veterinarians. Broken into 2 sides of office. The administrative or Prereview side and compliance or post-review.
This may not be achievable for every program but this became easier to do at a large institution bc there is enough work, as Penn has about 1700 active protocols, spanning 6 schools, and a variety of species from mice and rats to guinea pigs to sheep and pigs to non-human primates.
Office Manager/ IACUC Administrator
IACUC Administrator
Protocol Specialist
(DVM)
Protocol Specialist
(PhD)
Senior Compliance Liaison
Compliance Liaisons
N=2

14. Penn’s compliance liaisons
(DVM)
Senior Compliance Liaison
(MLAS, RLATg)
(RLATg)
(MLAS, LAT)
So on the Compliance side of the office, there is myself, and my background I’ve already mentioned. Additionally,
Senior Compliance Liaison – she has RLATg certification and MLAS degree from Drexel. She spent several years in research, gaining experience in rodent survival surgery. She recently was promoted to the Sr level and not only is she responsible for performing PAM, but she coordinates both our SA visits (no small feat) and the LARC program, which I will discuss a little later.
With regards to our 2 other Compliance Liaisons: 1 is a RLATg with several years experience as an Animal Care Tech and was an acting husbandry trainer prior to joining our office. With her husbandry experience, she helps oversee our satellite housing areas, which currently is about 18 areas. The other CL is an LAT with a MLAS degree. She was a veterinary technician in private practice for a few years, then joined a CV research lab at Penn. After a few years working in research, she became a veterinary technician with ULAR.
All CLs also participate in SAs, again not as an IACUC member, but more as a friendly, recognizable face. Clarification is often needed during SAs and CLs familiar with particular labs or procedures will be able to facilitate discussion between the IACUC members and lab personnel. If an issue is noted, CLs then also verify that measures have been taken to correct deficiency.

15. Penn “reboot” OAW Compliance LIAISONS Risk-based prioritization of PAM
OAW CLs are here to help the PIs and staff maintain compliance
NOT IACUC members – no conflict of interest
Focus on high-risk models
USDA species
Surgery
TBI
Unrelieved pain/distress
Risk-based prioritization of PAM
USDA species – 1-2x per year
Rodent “E” protocols – 2x per year
Satellite housing – 2x per year
LARC 3rd bullet – the LARC fosters a situation where the PI see their role in being compliant. Builds bridge between the research and good animal care.
----- Meeting Notes (1/30/15 15:16) -----
CSC slide by itself.
LARC slide and reference RS.

16. Penn “reboot” IACUC Compliance Subcommittee
Three scientists, 2 veterinarians
Ad hoc members: 4 OAW Compliance Liaisons
Operates under clearly defined policies
Review all PAM findings
Determine actions following non-compliance
Contentious situations
Meets regularly (3-4x/mo.)
----- Meeting Notes (1/30/15 15:16) -----
Check font. Put CL here
Policy not SOP

17. Laboratory Animal Research Coordinator
LARC
Laboratory Animal Research Coordinator
University of Pennsylvania
Laboratory Animal Research Coordinator
Voluntary formal education program
Supplement ULAR training
Covers regs, policies, Penn’s who’s who
Learn to navigate the system
Protocol review process
Improved submission quality = quick approval
1st class – 24 participants, 9 mo. curriculum
Lectures, AALAS modules, mock site visits, meetings, recordkeeping
Laboratory Liaison
Coordinate lab for SAs, others if applicable (e.g. AAALAC)
Manage lab’s compliant practices and make corrections
Mentor junior lab members
Builds rapport btw OAW/research staff/IACUC
Provide feedback for policy and training development
Coordination of LARC program responsibility of Senior Compliance Liaison.
The program consists of Face-to face lectures, AALAS modules, learn how to educate lab members, mock site visits, attend monthly IACUC meetings or post-SA programmatic IACUC meetings, learn importance of recordkeeping (examples: lab SOPs, intra-/post-op documentation, controlled substances).

18. Conducting of Pam Communication, communication, communication!
Before, during, and after
Remember purpose of visit
Good performance
“Find it/fix it”
Various PAM types at Penn
General protocol review
Clarify ambiguities
Update for major changes in policies and guidance
Correct inconsistencies
Specific procedure review
Procedural/surgical observation
Site visit follow up (SAs, AAALAC, USDA)
For cause (Adverse event, WB)

19. Conducting of Pam PAM procedure Schedule in advance
“Dropping by” likely not successful
Be professional – be prepared
Exit briefing
Encourage PI resolution input
Acknowledge “Gold Star” labs
Post-visit correspondence
Recordkeeping
ID’s trends for improvement
Chronic NCs may need CSC input

20. Scheduling a visit Typical request for PAM:
Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. As such our IACUC has instructed the compliance staff to perform post-approval monitoring of any animal care activities on campus. Our goal is to visit all laboratories throughout the year and your group has been randomly chosen. These visits can last about 1 hour and the purpose is to simply document evidence of good performance.
The PAM visit is intended to be collegial and supportive of animal-based research on our campus. The objective is not to be obstructive but rather to help maintain compliance so that the scientific work may continue without disruption.
As an aside, this meeting is open to anyone in the lab; some investigators have used this meeting as an opportunity to educate new lab personnel to federal and university regulations.

21. Post-approval monitoring policy
----- Meeting Notes (1/30/15 15:16) -----
Policy not SOP
(Available on Penn
IACUC website)

22. Compliance checklist Develop standardized checklist*
Send with “PAM Request”
The protocol and personnel
Read protocol?
Study procedures
Procedures consistent?
Anesthesia/analgesia
Surgery, other procedures
Post-operative care
Euthanasia
Consistent with 2013 AVMA GLs
General recordkeeping
CS records
General lab management
Approved satellite housing
Safety concerns
(*Available on Penn
IACUC website)

23. Post-visit correspondence
Typical highlights in post-PAM
Thank you for meeting with me today to discuss your animal use procedures. I appreciated the time you took to explain some of the procedures, which gave me a better idea of the overall study needs. Our discussion reaffirms the OAW’s mission to work openly and cooperatively with scientific staff so the research continues.
Acknowledge compliant and non-compliant activities
Itemize resolution plan discussed
Advise all PAM are reviewed by the IACUC CSC
Warn of potential additional action items
Hopefully you found today’s visit helpful and our office is open to any feedback. Please feel free to contact with any future questions or concerns.
----- Meeting Notes (1/30/15 15:16) -----
Same thing
Bert and Ernie instead

24. Compliance Concern reports
Develop internal recordkeeping
PI/protocol number
Species/# of animals
Funding source
Issue or incident/date
Date of CSC review
Immediate actions by PI
Amendment
SOP
Voluntarily stopped NC
Retraining
CL summary
Further actions
Further meetings, follow-up
Although full discussion of these CC reports occur with the IACUC Compliance SC, they are also provided to IACUC members for review prior to each monthly full IACUC meeting. This also give the IACUC members to ask additional questions or to request further actions for NCs.

25. Acknowledgements Drs. Julie Sharp and Troy Hallman
My co-CLs: Alli Czarnecki, Amanda O’Hara, Rebecca Spangenberg
The OAW administrative staff
Dr. James Wilson – the inspiration behind my title slide
Animal Care Training Services for the opportunity
Julie and Troy for all their help and guidance putting this presentation together.

26. References http://www.aaalac.org/accreditation/faq
Banks RE, Norton JN A Sample Postapproval Monitoring Program in Academia.
ILAR 49(4):
Banks, RE Post-Approval Monitoring. In: Silverman J, Suckow MA,
Murthy S, eds. The IACUC Handbook, 3rd ed. Boca Raton, London, New
York: CRC Press, p 719 – 750.
National Research Council Guide for the Care and Use of Laboratory
Animals, 8th ed. Washington DC: The National Academies Press.
Get the references correctly noted…
NIH, Office of Laboratory Animal Welfare FAQ G.6, Is post approval monitoring
Required?

27. Contact info
Feel free to contact me:
Jennifer Davis, DVM, DACLAM
Office of Animal Welfare
University of Pennsylvania