1. David M. Pinson, DVM, PhD, DACVP, DACLAM Copyright 2012 Masterware Corporation All rights Reserved WHAT THE SOFTWARE CAN DO FOR PAM

2. ABSTRACT The recent adoption of the 2010 version of the Guide for the Care and Use of Laboratory Animals has indicated program requirements in post approval monitoring (PAM). Problem : Many institutions are struggling with methods of implementing such programs and tracking the numerous details of an active monitoring process. Animal care committees define problems and solutions and track those mandated corrections to completion. The current range of problems includes facility repairs, expired medical materials, procedural inconsistencies, and noncompliance with approved protocols. These issues must be defined for supporting data, remediation methods, deadlines, and completion. There are very few software packages that focus on post approval monitoring and drug inventories or that provide in depth documentation behind these programs. Approach : We describe here a software program developed to track dated inventories and events in detail with associated documentation. The program has subroutines that keep approaching expiring inventory and deadlines in the forefront of the IACUC and monitoring staff. The program automatically notifies administrators and target personnel responsible for corrections and deadlines to complete tasks. The program has in depth reporting capabilities and filtering capabilities for events. Observations : The software package effectively tracks any dated inventory, and provides a mechanism for distribution of materials and documented audits of controlled substances required every two years by the Drug Enforcement Administration. The Quality Assurance Module tracks events for location, species, problem description, correction, trending, and justification for missed deadlines. In addition, supporting images or files can be associated with an event. Conclusions : Versatile software has been designed to track in detail inventories and post approval monitoring events. The trending capabilities provide information that can support requests for allocation of compliance resources.

3. THE SCOPE OF POST APPROVAL MONITORING The IACUC is charged with the responsibility of post approval monitoring. The scope of IACUC monitoring includes many aspects of research and facility function. All animal activities must be monitored by IACUC. From a USDA perspective, animal activities include all aspects of care and use (USDA definition). Active monitoring of large programs will create a complicated data matrix that presents challenges for tracking myriad deadlines, compliance details, and outcomes. All of these monitoring activities must be focused into the IACUC review paradigm. IACUC Drug Inventories Dispensing Monitoring Facilities Animal Care Procedures Approved Protocol Compliance Documentation Compliance Resources Allocation, Funding, and Strategic Planning

4. DRUG INVENTORY Controlled drugs and dated inventory present complex challenges in small and large institutions. For controlled drugs, the license holder is liable for records, audits, and storage. Complete audits are required by DEA at least once every two years. For any dated drugs or materials, the animal care program is liable in the context of USDA regulations. Monitoring for expiration dates can be most challenging in large complex institutions with numerous sites where drugs cannot be centrally monitored on a daily basis. Drug Inventory and Dispensing Prescription Documents Usage Records Where and How Stored Federally Required Audits Materials Returned Long term Records

5. FACILITIES INSPECTIONS AND PROBLEMS Monitoring facilities issues detected on routine inspections or semiannual inspections requires tracking detailed information on the problem, the proposed resolution, and the deadlines. Responsible personnel have to be notified and reminded of deadlines. IACUC has to be able to track status easily and to completion with a document trail. Failure to complete a correction by deadline requires a USDA report for regulated institutions. The tracking of deadlines and communications are best if automated. Facilities Issues (Details) Where is the problem? What is the problem? Who is responsible? Communication and reminders Assigning and Tracking Deadlines and Completion Recording Failed Deadlines and Explanations

6. ANIMAL CARE PROCEDURES Daily husbandry and animal health management is a complex daily routine that involves personnel, operating procedures, equipment, daily work processes and flow, and significantly, records. In such complex operations, failures do occur. Some of these may warrant additional training, counseling, and occasionally revised operating procedures or work processes. All of these are under the purview of IACUC monitoring or veterinary oversight. Animal Care Procedures Who failed? What is the cause? What correction required? Long term solutions or prevention Documentation Trending to argue for resources

7. PROTOCOL COMPLIANCE MONITORING The IACUC is charged with assuring the research is conducted as approved. Active research programs tend to change over time and often result in protocol drift or the gradual implementation of procedures that are not reviewed and approved by IACUC. The post approval monitoring program is directed at detecting these deviations and correcting them. In cases of noncompliance resulting in animal pain or distress, careful documentation is required since funded programs are at stake and noncompliance must be reported to regulatory agencies. Protocol Compliance Monitoring Who failed? When, where, how? What protocol? What grant? DocumentationRemediation Deadlines for correction

8. DOCUMENTATION FOR RECORDS The documentation and tracking of compliance events is challenging under conditions of limited staffing and resources. Documents may include room check sheets, photographs, research records (or lack thereof), medical records (or lack thereof), or drug records. These can be maintained in print or electronically. Either way, documentation showing that IACUC is doing its required work is prudent. This is best done in detailed monthly reports included in the IACUC minutes. These reports should include notification trails of when responsible personnel were notified DocumentationDeadlinesDocumentsPhotographs Counseling records Failed Deadlines and Explanations Querying and Reporting Data

9. ARGUING FOR PROGRAM RESOURCES Almost all institutions operate on budgets with some restriction of resources. Arguing for resources is best done with data. Trending is a means of categorizing compliance data to determine what area of compliance is most needy. Trending events into categories generates data that can show frequency of events. Noting common compliance events (high frequency) would provide a tangible argument for resources to correct the problem. Compliance and Program Resources Allocation MonitoringTrainingDocumentationFunding Regulatory Interface Strategic Planning

10. THE CONCEPT OF TRENDING Compliance Events Equipment10 EventsFacilities5 EventsIACUC Issues0 Events Investigator Noncompliance 20 Events Operating Procedures 5 Events Performance Standards 1 Event Research Procedures 5 Events Training – Animal Care 25 Events Training – Investigator 25 EventsVeterinary Care4 Events Unclassified Event 0 Events Trending of compliance events and inspection results permits collection of frequency data. These data can be used to argue for resources needed to correct problems. In the example at right, one could strategically argue for resources directed at managing investigator compliance and training and animal care training as distinct programmatic needs.

11. PINTRACKWARE DOES IT ALL PinTrackWare manages all of complexities of monitoring data Drugs Records Expiration dates Prescriptions Required audits Facilities Protocol Compliance SOP Compliance Trending Documentation Reporting Communications Automation

12. DRUG INVENTORY SOLUTIONS PinTrackWare tracks all drug inventories for expiration dates and lot numbers. There are dispensing modules to track who received the drugs. Controlled drugs that are dispensed should be accompanied by prescriptions and usage records.

13. DRUG INVENTORY SOLUTIONS Many institutions dispense controlled drugs for research. Software should provide for records of dispensing and tracking use. The program should also retain those records as recallable PDF documents after consumption and return of the empty containers.

14. DRUG INVENTORY SOLUTIONS DEA regulations currently call for drug inventories or audits at a minimum of 2 year intervals. Managing software should prompt for those audits and retain the data as recallable PDF documents.

15. DRUG INVENTORY SOLUTIONS One of the most common USDA violations is expired drugs. A useful paradigm is a focused alert routine that notifies the user of expiring materials and sends reminder emails to address the expiring inventory. Expired inventory that is not addressed should be automatically converted to an item for IACUC review. PinTrackWare does this.

16. COMPLIANCE EVENT SOLUTIONS Compliance events encompass a range of possible data types including a description of the event and where it occurred, who detected the event, and any relevant governing policies. There are often documents that reflect the events and these must be recorded. Resolutions and deadlines must be established and tracked.

17. COMPLIANCE EVENT SOLUTIONS Resolutions should define a target person responsible for the correction (along with all contact information), what the resolution is, and when it is due. It is also important to track who required the correction (IACUC? USDA? Attending Veterinarian?) and information on resolution or missed deadlines.

18. IACUC DOCUMENTATION Software should enable storage of all kinds of documentation, including photographs, PDF documents, reports, drugs, logs, etc. These documents support the IACUC investigation of events and their resolution. This is tangible evidence that IACUC is doing its job.

19. IACUC DOCUMENTATION Detailed reporting for individual events should provide a history of the event, including the findings, resolution, assigned deadlines, when target individuals were notified, and any associated documentation.

20. NEVER EVER MISS A DEADLINE The opening screen of PinTrackWare tells you what deadlines are approaching and provides a quick link to the issue. You should never miss a deadline.

21. TRENDING ARGUING FOR RESOURCES Trending of compliance events is useful for determining where compliance management is failing or needy. Software that trends compliance should be adaptable to the institution (ie., trending categories appropriate for the program)

22. TRENDING ARGUING FOR RESOURCES Data generated in trending events over time can be used to argue for additional resources in specific areas of compliance, based on the overall number of events in any given category.

23. CONCLUSIONS Post-approval monitoring generates a complex data cluster that is challenging to manage in a single paradigm. Well designed software can enable tracking of these types of data. Software can provide additional functionality to meet compliance monitoring goals and record keeping.