Problem statement: There is an expectation that institutions using animals in research, teaching, and testing will have a PAM program of some sort. The Guide for the Care and Use of Laboratory Animals states “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. PAM is considered here in the broadest sense, consisting of all potential types of protocol monitoring following initial protocol approval by the IACUC. PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory inspections (as part of regular facilities inspections or conducted separately); veterinary or IACUC observation of select procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments. The IACUC, veterinary, animal care, and compliance staff may all conduct PAM, which may also be used as an educational tool.” And, if an institution is US Public Health Service (PHS)-Assured, there is also an expectation for PAM. Although PHS Policy does not explicitly require a comparison between procedures described in the approved protocol against the manner in which they are conducted, according to OLAW’s FAQ G6, there is an expectation that the IACUC is responsible for program evaluations, review of protocols, reporting noncompliance, ensuring that personnel are appropriately trained, and addressing concerns involving the care and use of animals at the institution, all part of monitoring animal care and use. Finally, in keeping with its emphasis on performance standards, AAALAC also notes that PAM programs may vary from reliance on existing activities already performed by the IACUC to very extensive supplemental audits of protocols and the entire program conducted by compliance staff. “Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement.” In fact, many institutions do not have the resources necessary to have dedicated PAM personnel or a formal PAM program. For example, while Pfizer, Inc. is committed to complying with all laws, regulations and accrediting standards related to the use of animals in research, we do not have dedicated PAM personnel. However, we maintain a robust PAM program using, a “hybrid” PAM approach with a team made up of animal technicians, IACUC members, and regulatory compliance personnel. At least two IACUC members perform the procedure review part of the PAM program, while related components of the entire animal care and use program are monitored by a multi-disciplinary team of individuals, including animal and veterinary technicians, as well as regulatory compliance personnel.
Methods/Approach: As part of the hybrid PAM program, the Readiness team conducts weekly “Readiness Rounds” during which all areas in the vivarium are inspected on a rotating basis, ensuring that all animal holding and procedure rooms, storage space, cage wash areas, and halls are inspected monthly. The standards used for the assessment include the Animal Welfare Act & Regulations, the Guide for the Care & Use of Laboratory Animals (2011), AVMA Guidelines for the Euthanasia of Animals, Pfizer Corporate Policy #901, CM Standard Operating Procedures, Pfizer La Jolla IACUC Guidelines, Pfizer Global IACUC Guidelines, and our Environmental Health & Safety (EH&S) Laboratory Safety Inspection Checklist. After each inspection, a Readiness Rounds form is completed; any findings are assigned to the responsible individuals to be completed by a reasonable due date based on task.
Results/Observations: “Readiness Rounds” is an effective and efficient process to enhance our PAM program by proactively self-inspecting our facilities with limited resources and no additional staff. We have identified issues that could impact the results of formal inspections and ways to improve our program. Since initiating this hybrid PAM approach, the overall number of weekly inspection findings has steadily decreased and there has been a concomitant reduction in findings on both the IACUC semiannual inspections and quarterly EH&S inspections. This has also provided an opportunity for our animal care technicians to learn more about the assessment/inspection process with the added benefit of increased colleague engagement regarding compliance and inspection-readiness.
Conclusion: PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Our hybrid PAM approach engages the IACUC, veterinary, animal care, and compliance staff, and is an effective and efficient process to meet the expectation for a PAM program with limited resources and no additional staff.