1 / 21

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

brie
Download Presentation

Abbreviated Donor History Questionnaire: Blood Systems Experience

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related