Computer Assisted Self Interview (CASI) Donor Questionnaires

1. Computer Assisted Self Interview (CASI) Donor Questionnaires Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009

2. Outline • CASI Software Applications Overview • Web-based systems • Non-web-based systems • SOP content • Submissions: Information to include • Submissions: Documents to include • Submissions: Print Screens • Submissions: Reporting categories • References

3. CASI Software Applications Overview • Donors review questions via a computer and respond electronically • Medical/health history questions • High-risk behavior questions • Non-web-based Applications: • Accessed on-site (fixed locations & mobiles) • Web-based Applications: • Remote donor access via the Internet

4. SOP Content: Web-based & Non-web-based CASI • Steps describing the self-administered questionnaire process including use of the software program [21 CFR 606.100(b)] • Donor must complete questionnaire on the day of donation [21 CFR 640.3] • Web-based: How to determine if questionnaire was completed on day of donation • Web-based: What actions to take if donor appears the day after

5. SOP Content: Web-based & Non-web-based CASI(cont.) • Non-web-based: Describe how donor privacy is assured at fixed locations and mobile sites, when applicable [21 CFR 606.40(a)(1)] • Web-based: Describe steps for determining if questionnaire was completed in a private setting [21 CFR 606.40(a)(1)]

6. SOP Content:Web-based & Non-web-based CASI (cont.) Additionally we recommend you include: • How donor comprehension of questions is assessed and documented • Alternate procedures if computer system is unavailable • Alternative methods for donor screening • Donor does not wish to use CASI • Donor unable to use CASI

7. SOP Content:Web-based & Non-web-based CASI (cont.) • Additionally we recommend you include (cont.): • Availability of staff to respond to a user’s questions • How changes to donor responses or interviewer’s comments are documented • How questionnaire revisions are managed • Revisions should be made obvious to donors in some manner for at least one year

8. Additional SOP Content: Web-based CASI • How donor identity is confirmed upon arrival at center [21 CFR 640.3] • How donor responses are documented when donor is at the center (electronic or hard copy) [21 CFR 606.160]

9. What To Include in Your Submission

10. Submission: Information to Include • Software manufacturer’s name • Software name • Software version or release number • Software capabilities and functions • 510(k) number • Who can modify the software

11. Submission: Information to Include (cont.) • Usage on mobile operations, if applicable • CASI wireless connectivity on mobile operations, if applicable • Is wireless functionality 510(k) cleared? • Software interfaces with other regulated devices such as BECS, if applicable • List of fixed locations with addresses where software will be used/installed

12. Submission: Information to Include (cont.) • Does system interface with other locations where program is installed or is it stand-alone (independent) • Who can modify the donor health history questionnaire (DHQ) • Are medical history and/or AIDS high risk questions computer administered

13. Submission: Information to Include (cont.) • Are donor suitability decisions made by the software and/or center personnel

14. Submission: Additional Information Typically Requested • Who is authorized to access the system and enter or change data • Example: changing software applied donor suitability decisions, if applicable • How system access is managed • Authorization and deauthorization

15. Submission: Documents to Include • SOPs • Donor instructions for completing the questionnaire • Copy of DHQ • Validation protocol • Pre-defined written plan that was used for on-site validation prior to implementation • Do not include actual validation data • Print screens

16. Submission: Documents to Include Print Screens All print screens • New non-web-based CASI • New DHQ used with CASI not previously: • Approved by FDA, or • Accepted by FDA in a guidance document • New web-based CASI: non-web-based CASI not previously approved

17. Submission: Documents to Include Print Screens (cont.) Only print screens for web-based CASI • New web-based CASI: non-web-based CASI previously approved

18. Submission Reporting Categories • CBE-30 – Web-based CASI if already approved for non-web-based CASI • CBE-30 – CASI or web-based CASI – firm’s DHQ previously approved by FDA • CBE-30 – CASI or web-based CASI- DHQ has been accepted by FDA in a guidance document • PAS – CASI or web-based CASI - new DHQnot previously approved or accepted by FDA

19. References • 21 CFR 601.12 • Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (7/3/2003) • Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components  (10/27/2006) 

20. References (cont.) • Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (8/07/2001) • Guidance Link: FDA website A to Z Subject Index - G Page; Click Guidance Documents – Biologics: http://www.fda.gov/SiteIndex/ucm148505.htm