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Abbreviated Donor History Questionnaire: Blood Systems Experience

Abbreviated Donor History Questionnaire: Blood Systems Experience. FDA Blood Products Advisory Committee March 18, 2005 Mary Beth Bassett Vice President of Quality Management & Regulatory Affairs . 2003 Presentation to BPAC included…. Why Blood Systems implemented ADHQ Policy/Criteria

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Abbreviated Donor History Questionnaire: Blood Systems Experience

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  1. Abbreviated Donor History Questionnaire:Blood Systems Experience FDA Blood Products Advisory Committee March 18, 2005 Mary Beth Bassett Vice President of Quality Management & Regulatory Affairs

  2. 2003 Presentation to BPAC included… • Why Blood Systems implemented ADHQ • Policy/Criteria • Comparison of ADHQ and FDHQ • Monitoring Introduction of ADHQ • Donor Survey Results

  3. Today’s Presentation • Donor Survey Results • Comparison of ADHQ and FDHQ • New Data

  4. Donor Satisfaction Survey

  5. March 2005 Survey of Donors Eligible for ADHQ • Survey objective was to determine if donors are more satisfied and more likely to donate in the future if they receive the abbreviated questionnaire. • 250 interviews were completed with donors who were eligible for and received ADHQ, and 250 with donors who were eligible for ADHQ but received the FDHQ interview. • Both groups were administered the same interview. • Results are statistically significant to the 95% confidence level. • Research conducted by WestGroup Research, Phoenix AZ.

  6. Survey Results

  7. Commitment to Future DonationsDo you plan to donate blood in the coming 12 months? • Even though respondents were eligible for ADHQ (and therefore repeat donors), 5% of those receiving FDHQ were unsure that they would donate during the coming 12 months. • Among ADHQ recipients, only 1% of the sample were unsure that they would donate during the coming year (99% stated they would donate).

  8. ADHQ Implementation

  9. Eligible vs. Non-eligible Donors * P<0.001

  10. Results for ADHQ Eligible Donors * p=0.024 † p=<0.001

  11. Donors whose last donation was < 8 weeks from current donation * p=0.02

  12. Post Donation InformationNovember 1-20, 2004

  13. Post Donation Information Known at time of donation (N = 37)

  14. How many times can a donor withhold deferring information? • Information not provided on ONE occasion: 24 donors • On Full Questionnaire (FQ) = 21 • On Abbreviated Questionnaire (ADHQ) = 3 • Information not provided on TWO occasions: 4 donors • On 2 FQ = 3 • On 1 FQ & 1 ADHQ = 1 • Information not provided on THREE occasions: 4 donors • On 3 FQ = 3 • On 2 FQ & 1 ADHQ = 1

  15. How many times can a donor withhold deferring information? • Information not provided on FIVE occasions: 2 donors • On 5 FQ = 1 • On 3 FQ & 2 ADHQ = 1 • Information not provided on SIX occasions: 1 donor • On 5 FQ & 1 ADHQ = 1

  16. Errors from ADHQ Interviews3rd Quarter 2003 to 4th Quarter 2004

  17. Experience to Date… • Donors want a shorter process and like ADHQ. • 1/3 of donors are eligible for ADHQ. • ¾ of those received ADHQ in recent months. • There are no data indicating ADHQ increases risk. • Platelet donors are probably not biasing our analyses. • Analysis of PDI shows that donors withhold information during both the FQ and the ADHQ. • Analysis of root cause and implementation of corrective action has reduced ADHQ application errors.

  18. Collaborators • Chris Paden • Hany Kamel , MD • Michael Rangel • Brian Custer Ph.D. • Michael Busch, MD, Ph.D • Dennis Harpool • Peter Tomasulo, MD

  19. Comparison of ADHQ and FDHQ *23 questions linked to period since donor’s last donation

  20. Donors whose last donation was > 8 weeks from current donation * p=0.02

  21. Eligible for ADHQ Ineligible for ADHQ Received ADHQ Received Full HQ Repeat Donors First Time Donors Number Presenting 24,040 44,090 75,010 39,243 Medical History Deferral 0.38% 0.43% 1.42% 3.03% Temporary Deferral 7.86% 9.02% 14.95% 19.08% Units Collected* 87.05% 86.07% 78.70% 71.94% Repeat Reactive 0.35% 0.29% 0.45% 1.23% Confirmed Positive 0.01% 0.03% 0.25% 1.88% Post Donation Illness 0.16% 0.18% 0.25% 0.31% Comparison of Donation Outcomes:ADHQ versus Full HQTime Period: August 4 – October 15, 2003 N=182,383 * Percentage excludes unsuccessful collections

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