The AABB DHTF has committed to studying postimplementation use of the aDHQ. Summary results of the study will be provided to the FDA. All questions should be directed to aDHQ@aabb.org.

The AABB aDHQ should be used only in the circumstances described in the aDHQ User Brochure. Participation in the study is not required, however all establishments that implement the aDHQ are invited to participate. The postimplementation study protocol available below provides background on the purpose of the study as well as instructions for participation. Data element sheets to be used by participating blood collection establishments are available to be downloaded and returned via email to aDHQ@aabb.org.

The AABB DHTF will review the returned data, on a monthly basis, and provide a summary report to the FDA on a quarterly basis. Reports to the FDA will not contain identifying information. Providing data to the postimplementation study does not alleviate any establishment from submitting relevant Biological Product Deviation reports to the FDA.

aDHQ Postimplementation Study (PDF)

aDHQ Study Data Element Sheets (MS Excel)