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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Question and Answer on FDA Guidance Entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS"

Are there alternative procedures to inclusion of specific questions on SARS in the donor questionnaire that would meet the intent of the guidance?

Section III.A. of the above guidance provides examples of questions that may be used to ask donors (either orally or in writing) about history of SARS, suspected SARS or treatment for SARS within the previous 28 days; close contact within the previous 14 days with persons with SARS or suspected SARS; and travel or residence in areas affected by SARS within the previous 14 days. The guidance also recommends that blood establishments show donors a list of affected areas as updated by CDC.

FDA recognizes that the rapid introduction of several new questions to the donor questionnaire instrument introduces practical challenges to blood establishments seeking to follow these recommendations. The key elements that the guidance recommends are that the donor receive written or oral questions to address the information defined in Section III.A. The administration of questions and the donor responses must be documented in accordance with 21 CFR 606.100 and 606.165.

Although introduction of new questions into the donor questionnaire instrument is the standard mechanism for implementation of donor deferral criteria based on donor history, FDA believes that, during this transition period, alternative interim measures can satisfy the applicable statutes and regulations in this circumstance.

For example, it has been suggested that a blood establishment could provide to every donor a printed information sheet that contains a description of SARS risk factors and the three questions described in our SARS guidance document. The information sheet would instruct a potential donor who responds "Yes" (either in writing, or orally to the donor screener, in accordance with donor screener procedures) to any of the questions to self-defer for the time period indicated in the guidance. A single question would be added to the donor history questionnaire: "Have you read the SARS information and answered "No" to all questions?" A donor who responded affirmatively would not be deferred for SARS or SARS exposure. A donor who said "No" or needed clarification would be asked the three questions orally and deferred for the time(s) specified in the guidance, if appropriate.

We believe that blood collection facilities may implement this procedure, provided that blood collection facilities document the donor's responses to these questions. We also remind blood establishments that they will need to update the information sheet to reflect updates by the Centers for Disease Control and Prevention. Each blood establishment should have a process in place to ensure that only the most current version is available at all donation sites, include bloodmobiles.

We further note that licensed blood establishments should report implementation of these procedures to FDA in their Annual Report under 21 CFR 601.12(d). Additionally, licensed blood establishments should report the date that the specific donor questions related to SARS were fully incorporated and implemented as part of the donor history questionnaire in their Annual Report. Unlicensed blood establishments are not required to report this change to FDA.

Unlicensed blood establishments may either incorporate the questions described in our SARS guidance document directly into the donor history questionnaire, or may use the procedures described above. In addition, if an unlicensed blood establishment wishes to use a mechanism different from those described in our SARS guidance document or in this document, we encourage them to discuss the plan with FDA.

FDA recommendations may be modified as appropriate depending upon progress of the SARS epidemic or the availability of new scientific information.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448