Pre-audit Preparation Auditing Contract Research Organizations (CROs) and Vendor Facilities

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Marianna Jenkins
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1 Pre-audit Preparation Auditing Contract Research Organizations (CROs) and Vendor Facilities Amber Lange Novartis Institutes for Biomedical Research East Hanover, NJ

2 Pre-Audit Preparation Introduction to Audit Preparation Initial Contact Pre-audit Questionnaires/Document Requests Onsite Audit vs Virtual Audit Pre-audit Conference Call Auditor Requirements Travel Preparations Summary 2

3 Preventable Audit Issues Possible Audit Issues Too little time allotted for the audit Audit team does not have proper clearances medical; legal Facility does not have the appropriate people available Facility does not have the documentation ready Stressful audit due to lack of preparation by one or the other party Auditors not qualified to audit the facility, or are not clear on what is required to be audited This presentation serves as a Guide to prevent some of these possible experiences; allowing for an efficient and comprehensive facility audit 3

4 Introduction Facility Selection Risk Mitigation Preapproved Facility list Audit Frequency considerations Initial evaluation Periodic scheduled re-assessment Unannounced or interim assessment Efficiency - Top Priority in Audit Planning 4

5 Initial Contact Who makes the initial contact? Scientist Animal Welfare Procurement Facility Manager Other Who is contacted at the facility? Scientist Facility Manager Attending Veterinarian Animal Welfare/IACUC Customer Service/Business Representative Timing of Initial Contact Recommend as much lead time as possible 5

6 Initial Communication - Content Introduction - Audit Request - Describe the purpose and extent of the audit One species or every species housed at the facility Specific facilities or entire campuses Representative areas/rooms or every area Example» Standard room for each species» Standard room for each housing type Request confirmation of facility representative coordinating audit Request verification of exact facility location Introduce pre-audit documents - Requested time line for completion - Submission electronically or hard copy 6

7 Initial Communication (cont d) 7 Introduce Audit Team Names and Titles - Animal Welfare - Laboratory Animal Science - Scientist - Other Health Safety, Security, Quality Assurance Suggest Length of Audit - Based on previous audit, sq. footage, different species, number of campuses, facility complexity, etc. - Based on AAALAC site visit length - Other Propose Dates - CRO In-life activity review can be extremely beneficial; confirm scheduled events - Vendor facility confirm heavy shipping days - Monday start - if Facility exposure must be minimized; downside Weekend or Sunday Travel Request Airport/Hotel Recommendations

8 Pre-Audit Questionnaire or Checklist Extremely beneficial in enhancing efficiency of audit Facility to summarize or provide specific information on: - IACUC, Animal Care, Veterinary Care, Security, Facilities, etc. - Form can be re-utilized in subsequent site audits Allows for preliminary review of many areas prior to audit, and in some cases will assist in prioritization of areas/programs during the onsite review Request electronic submission for ease of continued use by audit team; provides a starting place for data collection Clarify information during the pre-audit conference call Some facilities may not fill the form out, or the form may be filled out poorly Some facilities may charge a fee for documents to be filled out or for certain aspects of audit participation 8

9 Onsite vs Virtual Audit Possible Evaluation Criteria for determining if a Virtual Audit may be acceptable Rodent studies vs AWA covered species AAALAC Accreditation Status OLAW Assurance Status Study Load - One time study vs ongoing studies Complexity of Study Low or High Severity of anticipated Pain and Distress level Regulatory aspect - USDA prior non-compliances - Potential for FDA inspection Issues identified during the virtual audit may still necessitate an onsite audit 9

10 Pre-Audit Teleconference Conduct 1-2 or more weeks prior to Audit start Opportunity to make contact with audit participants on both sides Introduce and confirm Audit Team Clarify any pre-audit requirements for auditors Confirm facility address and location to arrive Confirm distance between sites/buildings/farms to be audited Offer contact information in the event of an emergency Cell phone Hotel if not recommended by facility Clarify any questions regarding requested documents 10

11 Pre-audit Teleconference (Cont d) Review proposed Agenda Audit start and expected exit debriefing times Recommend Company/Site Overview be provided to audit team by Facility Representative Identify personnel expected to participate and/or be available for questions for example: IACUC Chair (& Committee), Attending Veterinarian, Facility Manager, Health & Safety Officer, Study Director, Maintenance Manager, Security Head, etc. Estimate time required for tour, document review, meeting with specific individuals - IACUC Chair, Training or Enrichment Coordinator, for example Lunch and/or snacks - Do not assume these will be provided; if provided indicate diet restrictions Dinner -The evening is a great time to catch up on and/or work on the audit report and prepare for the next day do not feel awkward declining a dinner invitation Explain that any areas not covered during the audit may require follow up after the visit Explain the process for communicating comments/findings after the audit 11

12 Documentation Request Be Very Specific IACUC Documentation 12-3 Months of IACUC Meeting Minutes - 2 Most recent semi-annual Inspection reports - IACUC Membership specifying, title, term and membership type AAALAC Accreditation - Accreditation Letter vs - Letter from the AAALAC Council regarding the most recent site visit Standard Operating Procedures - SOP Table of Contents - Facilities with Extensive SOP listing request specific SOPs ahead of visit - SOPs available in Conference Room Electronic SOPs will require someone to assist in navigation Regulatory Inspection Reports - Previous 3 vs previous 3 years of USDA Inspection reports - USDA/APHIS Annual Report

13 Other Suggested Documentation 13 AAALAC Program Description and Appendices OLAW Assurance Documentation Disaster/Business Continuity Plan Floor Plans Organizational Charts Documentation in support of SOPs (examples) - Pest control reports - Feed analysis - Sanitation effectiveness testing results - Water analysis - Air flow or environmental reports and/or excursion for the rooms utilized for sponsor studies - Training Records - Sentinel or other Health Monitoring Data - Environmental Data & Alarm Testing Documentation List of Suppliers and Supplier audits, including last audit date and next scheduled date - Research models, feed, bedding, microbial, environmental or contamination screening laboratories

14 Auditor Requirements Request audit team requirements in writing Identification with photograph; Proof of TB test, measles titer or nonhuman primate area clearance Period required outside of animal facilities - 24, 36 hours or longer - What species rodent areas only, or all species Signed Confidentiality Agreement (CDA) or any other legal documents which should be reviewed by a lawyer Respiratory Protection provided by facility or required to be brought - Proof of fit testing & pulmonary function test - N95 or other respirator 14

15 Travel Preparations Hotel recommended by facility; discounted pricing Restaurant Recommendations Transportation requirement Walking distance Public transportation subway or Taxi Facility provided transportation - Although offered it is often best not to take personnel out of their way Rental Car Apparel Comfortable walking shoes Is clothing change or shower required for facility/barrier tour 15

16 Recommended Supplies Supplies - Business Cards - Post-it notes - Small Note book or pad - Flashlight - Measuring tape - Camera (some facilities do allow photos...) - Copies of pre-audit questionnaire/checklists - The Guide; - AWA; - GLP regulations (if applicable) - Breath Mints/Snacks, especially if long day touring, document review 16

17 Additional Travel Preparations Search for facility hits on the Internet; Have they been in the news? Request Security review and Animal Rights status Review prior internal audits, and associated documentation Inquire of your Animal Facility staff - receipt or ordering issues Inquire of your scientists/monitors - ongoing study issues/processes to assess Review documents available by FOIA; USDA Inspections, Annual Report Obtain copy of proposed protocol, if available, to cross reference with staff training files It is important that the Audit Team have prior agreement on primary responsibilities during the audit rather than everyone reviewing all processes and documents Get a good night sleep ahead of the audit 17

18 Pre-Audit Preparation - Summary Guide to those items sometimes missed during audit preparation Prepare to test the system...do not offer, but wait to see what the facility does - Does the facility request Identification - Are audit team members left unescorted - Is required auditor documentation reviewed (TB test, etc.) - Are phones and recording devices retrieved from team or are security methods employed such as security tape over lenses - Are pens provided Audits do not always go as planned make the best of what you have to work with Weather issues; flight delays; illness Facility staff pulled away by USDA, FDA, etc Pre-Audit Preparation is key to an efficient, stress-free comprehensive audit 18

19 Questions? 19

Initial Reporting of Animal Welfare Concern to the Institution

Initial Reporting of Animal Welfare Concern to the Institution IACUC POLICY INVESTIGATING ANIMAL WELFARE CONCERNS & NONCOMPLIANT ACTIVITIES To ensure the humane care and treatment of animals used in research, teaching, and testing, the Drexel University Institutional