FDA Adopts Expedited Blood Donation Screening Standard

Posted 10 May 2013 | By Alexander GaffneyRF News Editor

The US Food and Drug Administration (FDA) has released a final guidance document that it says is intended to expedite the donation of blood and plasma for frequent donors.

Background

The final guidance, "Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components," recognizes a standard maintained by the American Association of Blood Banks (AABB) known as the abbreviated donor history questionnaire (aDHQ) version 1.3.

As least as far back as 2000, AABB said it wanted to support an abbreviated questionnaire for frequent donors as a means to expedite the donation process and make it less burdensome on donors. As anyone who has ever given blood can attest, the process of going through screening is exponentially longer than is the process of giving blood, which could potentially discourage people from donating blood as frequently.

"Such redundant questioning may discourage some frequent donors from returning for future donations," FDA explained in its 2013 guidance. "Streamlining of the donor screening process may enhance the availability of safe blood products from frequent donors."

But that raises an issue: How can you expedite the process while still being certain that someone is eligible to donate blood? Less thorough screening procedures represent something of a higher-risk, higher-reward paradigm in this respect. While donors might be more likely to give blood if a survey is shorter, they might also be more susceptible to omitting important information, thereby increasing the chance of a disease being transmitted through the blood product.

FDA has long recognized the potential benefits of an expedited donor history collection process. In July 2003, it issued a guidance document entitled, "Streamlining the Donor Interview Process:  Recommendations for Self-Administered Questionnaires," which allowed blood establishments to permit "certain donors"-frequent ones-to undergo a simplified screening process.

New Standard

Now FDA is implementing an updated version of the AABB's standard and outlining its appropriate use in its new final guidance document. "We find the AABB aDHQ documents (version 1.3) to be acceptable for use in screening frequent blood donors," FDA observed.

In it, the agency explains that any abbreviated questionnaire should be administered in conjunction with the full-length (FL) questionnaire. For example, if a company adopts the abbreviated questionnaire standard, it should also administer the FL questionnaire, and not a proprietary or other questionnaire that might not use the same wording as the abbreviated questionnaire.

The abbreviated documents in the aDHQ standard include the:

  • abbreviated Donor History Questionnaire
  • abbreviated Donor History Questionnaire User Brochure - includes glossary and references; describes which donors may complete the questionnaire and how questions can be administered
  • abbreviated Donor History Questionnaire Flow Charts - contain follow-up questions as a method to obtain additional information to further evaluate a potential donor's response to capture questions  ("Capture" questions ask a general question about a donor's history or behavior and are followed up by obtaining additional information about the donor if needed.)
  • medication Deferral List - contains a list of medications that may serve as a basis for donor deferral
  • blood Donor Educational Materials - educates the donor about risks and conditions that are a basis for deferral

The new standard also differs from previous standards in that it eliminates several questions that AABB officials determined "would not need to be asked in future interviews" involving the donor.

Sponsors that choose to implement the aDHQ standard will be required to report its use to FDA under 21 CFR 601.12, typically under an annual report so long as they are implemented without modifications or without modifications that would be determined "important to the safety… of screening procedures." If such changes are made, the facility must submit FDA Form 356H to FDA, along with a cover letter explaining the changes and the new questionnaire containing highlighted changes.

In addition, if the questionnaire is administered to patients using a computer-assisted procedure, facilities need to submit a changes being effected 30-day (CBE-30) notice to FDA indicating how that system functions.

FDA's guidance also contains one caveat: The AABB questionnaire contains questions regarding the pregnancy status of the donor. FDA does not require this question to be asked under its regulations, and the agency said sponsors who omit the question will not be penalized or be found to be out of compliance with FDA requirements.

The guidance document may be found here, and its Federal Register notification may be found here.


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