December 11, 2003 Mary Townsend, MD Chair, AABB Task Force to Redesign the Blood Donor Screening Questionnaire

1. The Redesigned Donor History Questionnaire: The Abbreviated Donor QuestionnaireReport of the Task Force to the FDA Blood Products Advisory Committee December 11, 2003 Mary Townsend, MD Chair, AABB Task Force to Redesign the Blood Donor Screening Questionnaire

2. Abbreviated Donor History Questionnaire--aDHQ • Brief history of DHQ and aDHQ project • Rationale for aDHQ • What did the TF hope to accomplish with the aDHQ? • Development of aDHQ • Use of aDHQ • Issues and concerns • Proposed monitoring strategies

3. Introduction • 3 year process to redesign the blood donor screening questionnaire • Initiated by FDA • Extensive collaborative effort by numerous stakeholders • Commitment for all parties • Groundbreaking approach to design queries • First time a blood screening document has been systematically evaluated

4. Donor History Questionnaire: Project Chronology Launch 6/00 Survey design expert and TF Subcommittees 6/00 – 5/01 Entire Task Force 5/01 Focus Groups 9/01 CBER Task Force 9/01- 1/02 Cognitive Evaluation (NCHS) • Ed Mats • aDHQ • User Broch Task Force 1/02- 3/02 Finalized Wording, Documents THE DELIVERY March, 2002

5. Donor History Questionnaire: Project Chronology CBER (March, 2002) Blood Products Advisory Committee, June 2002 Question to BPAC: “Does the committee believe that the revised Uniform Donor History Questionnaire proposed by the Task Force is suitable to screen donors of allogeneic whole blood and blood components for transfusion?” Vote: Unanimously “Yes” CBER for more discussion FDA response delivered at the October 2002 AABB Annual Meeting

6. Donor History Questionnaire: Project Chronology FDA response delivered at the October 2002 AABB Annual Meeting Revisions by Task Force • Addressed FDA issues •Added new • New glossary Smallpox questions • • Updated Medication Deferral List CBER for more discussion Released documents for pre-implementation review by centers July 2003 • FL DHQ and User Brochure •Medication Deferral List • Educational Materials

7. Abbreviated Donor History Questionnaire (aDHQ)

8. aDHQ –Rationale Donor Request

9. aDHQ—Rationale ”National Study of Blood Donation Decision-Making: Current and Lapsed Donors” Efficiency of the collection and convenience of the collection are perceived as important variables to facilitate or impede blood donation and should be integrated into center recruitment and retention strategies for donors. 2002 AABB Abstract Gillespie, Newman, Bellamy, et. Al.

10. Donor & Lapsed Donor Data:Mail Surveys of Donors Identified Through ARC & ABC Blood CentersN=5143 Gillespie TW, Newman JL, Bellamy M, Hillyer KL, Strong M, Hillyer CD. National Study of Blood Donation Decision-Making: Current and Lapsed Donors, Transfusion, 42 (9 Supplement), 122S, 2002.

11. Lapsed Donors: Reasons Why Have Not Given Blood in Past 3 Years –Top Reasons by Ranking Mean Rank Assigned (Range of Ranks: 1-12; 1.0 = Most Important)

12. aDHQ—Rationale ”National Study of Blood Donation Decision-Making by Non-Donors” Primary factors described as impeding the donation of blood by this group were ranked as 1). Perceived inefficiency 2). Fear of needles ASH Abstract 2001 Gillespie, Steeh, Strong, Hillyer

13. Non-Donor Data:Random Digit Dial National Telephone InterviewN=1673 Gillespie TW, Steeh CG, Hillyer KL, Strong M, Hillyer CD:  National Study of Blood Donation Decision-Making by Non-Donors. Blood 98: 61a, 2001.

14. Non-Donor Responses:Top Reasons Given Why Decide Notto Donate Blood

15. aDHQ—Rationale 2000 AABB Survey of Blood Center Screening Materials and Issues • 34 Blood Centers surveyed • Goal • Review questionnaires and educational materials • Identify problematic donor screening questions • Identify other concerns of blood donors and AABB members • Findings Comments most frequently noted by donors was repetitiveness of the questions and personal nature of questions

16. aDHQ—Rationale FDA sponsored AIR study 1994-95 • American Institutes of Research (AIR) • Determine if safety of the blood supply could be improved by using a more effective process to screen donors, specifically an abridged questionnaire and computer assisted screening • Report presented to BPAC in 1994 • Subcommittee of BPAC reported back in 1995 • Supported the use of an abbreviated history for repeat donors

17. aDHQ—Rationale October 16, 2000 Workshop, “Streamlining the Blood Donor History Questionnaire” sponsored by FDA, CBER, ABRA and AABB • Charge to Task Force by Dr. Epstein: • “challenge to FDA and the blood community to devise a donor selection process which optimizes bothblood safety and availability” • “donor selection process should contribute significantly toward preventing disease transmission YET IT SHOULD NOT discourage volunteer donors nor result in unnecessary donor deferral”

18. October 16, 2000 Workshop, “Streamlining the Blood Donor History Questionnaire” sponsored by FDA, CBER, ABRA and AABB Charge to Task Force by Dr. Epstein: • “We have questions whether we maintain valid screening when we keep asking the same questions over and over and over again of repeat donors.” • “Certainly, one modification, which I suppose could be a standard modification, is that of the abbreviated questionnaire for the repeat donor.”

19. aDHQ--Rationale • Precedent • Abbreviated screening document approved for Blood Center of Iowa in 1999 • Abbreviated screening document approved for Blood Systems in 2002

20. What did we hope to accomplish?

21. aDHQ-What did we hope to accomplish? • Safety Safety efficacy equivalent to DHQ • Satisfaction Increase donor satisfaction • Availability Increase availability of safe blood

22. aDHQ-What did we hope to accomplish? • Equivalent safety to DHQ • Validated questions • Testing of aDHQ capture approach for recent changes in health status “Since your last donation have you had any new medical problems or diagnoses?” “Since your last donation have you had any new medical treatments?” • One-on-one cognitive evaluation

23. aDHQ-What did we hope to accomplish? • Equivalent safety to DHQ • Increased donor focus on recent risk behaviors and activities “behavioral risk screening needs to be optimized to query donors about factors that best predict recent infection.” from Blood Safety in the New Millennium, 2001 Alan Williams, PhD and Sharyn Orton, MSPH, PhD

24. aDHQ-What did we hope to accomplish? • Equivalent safety to DHQ • Increased donor attention by reducing time required to complete screening

25. aDHQ-What did we hope to accomplish? • Increased availability of blood • Increased donor satisfaction • Decrease phenomenon of “lapsed donors” • Increased frequency of donation

26. Development of aDHQ • Subcommittee • Validated DHQ basis for aDHQ • Question-by-question consideration • Delete questions for single risk in past “From 1980 through 1996, were you a member of the U.S. military, a civilian military employee, or a dependent of a member of the U.S. military?” • Consolidate travel into a single capture question about recent travel • Consolidate medical questions by use of 2 capture questions • HIV and Hepatitis risk questions remain intact

27. Development of aDHQ • Definition of Frequent Donor • Successfully complete full-length DHQ (DHQ) at least twice • At least one donation within previous 6 month period Rationale: The donor will answer all of the newvalidated screening questions at least twice. Anecdotal evidence indicates that donors may remember information at the second donation that they did not remember at the first donation. However, this is less likely to occur after a second experience with the questions.

28. “Nut and Bolts” Comparison of DHQ and aDHQ Use of aDHQ Addressing questions and concerns

29. DHQ -48 questions 5 current 6 specified time 2 distant (1980-1996) 17 direct questions about risk activity 14 direct health related questions 4 travel aDHQ -29 questions 2 current 6 specified time 17 direct questions about changes in risk activity since last donation 3 questions about changes in health, medications or new treatments 1 travel since last donation Comparison of DHQ to aDHQ

30. DHQ In the past 12 months have you had sexual contact with anyone who has HIV/AIDS or has had a positive test for the HIV/AIDS virus? Have you ever used needles to take drugs, steroids, or anything not prescribed by your doctor? Have you ever had babesiosis? aDHQ Since your last donation have you had sexual contact with anyone who has HIV/AIDS or has had a positive test for the HIV/AIDS virus? Since your last donation have you used needles to take drugs, steroids, or anything not prescribed by your doctor? Since your last donation have you had any new medical problems or diagnoses? Comparison of DHQ to aDHQ

36. Questions and Concerns

37. Questions and Concerns about Use of the aDHQ • Many questions/concerns about use • October 16, 2000 Workshop: “Streamlining the Blood Donor History Questionnaire” sponsored by FDA, CBER, ABRA and AABB • 2003, AABB Annual Meeting: Donor History Questionnaires: FDA Perspective ; Judy Ellen Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ) Division of Blood Applications, OBRR • Answers to most of these have been addressed in the User Brochure accompanying the aDHQ

38. Concern: Omits asking direct questions to get required information • DHQ From 1977 to the present, have you (male donors) had sexual contact with another male, even once? • aDHQ Since your last donation have you (male donors) had sexual contact with another male, even once?

39. Must a full length questionnaire be administered periodically? • Once the donor qualifies for the abbreviated questionnaire, there is no need to re-administer the full length questionnaire as long as the donor continues to qualify for the abbreviated questionnaire (donated within 6 months) • If the donor is deferred, at the end of the deferral period he/she must then be screened using the full length questionnaire and must re-qualify for aDHQ

40. How will the blood collection facility track whether the full length questionnaire or the aDHQ should be administered, especially at mobile collection units? • The blood collection facility must have a system to determine when it is appropriate to administer the aDHQ. Some of the factors include • Number of donations • Time since last donation • Which questionnaire was used at last donation • Whether donor was deferred at last donation Rationale: It is essential that the correct questionnaire be used in order to maintain the safety of the blood supply. Only those facilities that can track this information should use both a full length and abbreviated questionnaire.

41. How will the addition of new questions be handled? Must the full length questionnaire be re-administered with new questions? • The new question will be added to both the full length and aDHQ at the same time. A new question will be retained on the aDHQ for one full year from the date the question is adopted. If the question must be asked at each donation, it will be retained indefinitely on both questionnaires. This determination should be made by FDA at the time new questions are recommended.

42. How will the addition of new questions be handled? Must the full length questionnaire be re-administered with new questions? Rationale: In order to continue qualifying for the aDHQ, donors must come in at least twice a year and would be exposed to the new question at least twice before the question could be removed from the aDHQ. Furthermore, it is not practical to “reset the clock” and revert to the full length questionnaire for all donors each time a new question is asked. New questions are added so frequently that this approach would, in effect, negate the value of the aDHQ in encouraging donors to return frequently.

43. What action should be taken when it is determined that an incorrect questionnaire was administered? • The blood collection facility must have a SOP describing actions in this circumstance. If the DHQ was administered, no action is indicated. If the aDHQ was administered in error the SOP must insure the unit is not made available for distribution until donor suitability is determined in compliance with regulations. If the unit has already been distributed then it should be treated as an error including submission of a biological product deviation report to the FDA.

44. If a donor presents new information during the abbreviated screening process which is not necessarily included in the shortened procedure how will that information be acted on? (Elizabeth Callaghan, October 16, 2000 workshop; Questions to Consider) • Any information presented during donor screening (whether using full length or abbreviated questionnaire) which impacts donor suitability will be considered in determination of acceptability. A unit should not be collected from a donor until suitability has been conclusively determined on the day of donation.

45. Is it mandatory that a blood collection facility use the aDHQ? • It is NEVER mandatory that any given blood center use a specific donor screening tool • If a blood collection facility opts to use the uniform DHQ, it is NOT mandatory that they use the abbreviated questionnaire • Even for blood collection facilities that opt to use an aDHQ, either an individual donor or a donor screener may choose to use the full length questionnaire if there is an issue of donor comprehension

46. Post Implementation Monitoring

47. Post-Implementation Monitoring • July 2003 FDA Guidance, “Streamlining the Donor Interview Process: Recommendation for Self-Administered Questionnaires – recommendation to monitor effectiveness by evaluating: • Post Donation Information-PDI • Infectious disease marker rates • Specific deferral trends • Biological product deviation reports • Post-transfusion infectious disease reports

48. Post-Implementation Monitoring • Post Donation Information-PDI • Represents largest group (61% in 1998) of reportable errors • One impetus for redesigning the DHQ • ARC focus group study confirmed that the chief contributor to post donation reports was poor comprehension of questions Orton SL, Virvos VJ, Williams AE. Validation of selected donor screening questions: Structure, content, and comprehension. Transfusion 2000; 40: 1407-13. • Another contributor to high rates of PDI is imperfect recall of past information

49. Post-Implementation Monitoring • Post Donation Information-PDI • Current PDI rates apply ONLY to current donor screening documents— obsolete with confusing and complex questions that were never tested • With implementation of new, validated DHQ it is likely PDI rates will actually increase temporarily due to increased simplicity and clarity of the questions and more structured time frame format, resulting in more effective detection of deferrable risk • Appropriate comparison: PDI rates in donors screened with new DHQ vs. aDHQ

50. Post-Implementation Monitoring • Infectious disease marker rates • Current marker rates apply ONLY to donors screened with current donor screening documents • Any comparison of marker rates would have to compare rates of donors screened with NEW full length DHQ to new aDHQ • Marker rates are currently so low that any comparison unlikely to be useful