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.
PPTA Donor History Questionnaire Version 1.0.1* December 2010
The 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 has provided “preliminary” approval. FDA has termed this as "preliminary" approval due to the guidance development process, which may result in changes to the questionnaires and/or accompanying materials before final publication. FDA is currently developing draft guidance, which will be published for public comment over the next several months. Companies that implement the PPTA DHQ materials before issuance of FDA final guidance must submit materials as a Prior Approval Supplement (PAS). Additionally, it will be necessary to review the FDA final guidance once published to ensure that companies are in compliance. Once final guidance has been issued, companies will be able to implement the PPTA DHQ and report the change to FDA in their annual reports.
* This version has NOT been officially recognized by the FDA
** Several clerical changes have been made to the DHQ since PPTA’s October 2009 DHQ submission, including adding Jayln to the Medication list.