PPTA Donor History Questionnaire

The PPTA Donor History Questionnaire (DHQ) represents nearly a decade of work on the part of PPTA staff and member companies, that worked in conjunction with AABB (an international organization of blood banks) and the U.S. Food and Drug Administration (FDA).  This collaborative effort produced a set of standardized tools that will assist source plasma collection centers with meeting acceptable donor eligibility requirements. To provide education about these tools, PPTA is hosting an implementation workshop on June 14, 2010 in Reston, Virginia in connection with the Plasma Protein Forum.

PPTA Donor History Questionnaire Version 1.0* October 2009

Full-length DHQ 1
Full-length DHQ 2
Full-length Directions for Use
Abbreviated DHQ
Abbreviated Directions for Use
Medication List
Risk Poster 1
Risk Poster 2
Travel Poster 1
Travel Poster 2

The U.S. Food and Drug Administration (FDA) maintains all officially recognized versions of the Donor History Questionnaire (DHQ).  At this time, FDA has not officially accepted the PPTA DHQ, but indicated that FDA reviewers currently do not have questions regarding the documents. The documents will not be officially recognized until publication of final guidance by the FDA.  FDA currently is developing draft guidance, which will be issued for public comment.  Companies that implement the PPTA DHQ materials, before issuance of FDA final guidance, must submit materials to FDA for review and approval as a Prior Approval Supplement (PAS).   Those companies that do submit the materials in a PAS will need to review the FDA final guidance to ensure that they are in compliance with the final guidance as changes may have occurred following the public comment period.  Once final guidance has been issued, companies will be able to implement the PPTA DHQ as presented in the final guidance and report the change to FDA in their annual reports.

 *This version has NOT been officially recognized by the FDA.