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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components

Guidance for Industry

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Contents

Reference Information:

May 2013


I . Introduction

This guidance recognizes the abbreviated donor history questionnaire (aDHQ) and accompanying materials, version 1.3 dated December 2012, prepared by the AABB Donor History Task Force (referred to as “task force”), as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with the FDA requirements and recommendations.  In the future, we may recognize other aDHQ and accompanying materials as acceptable.  We intend to make the current recognized versions of the aDHQ and accompanying materials (referred to as “aDHQ documents”) available on the FDA website.

The aDHQ documents will provide blood establishments that collect blood and blood components (referred to as “manufacturers” or “you”) with a specific process for administering questions to frequent donors of blood and blood components1 (referred to as “frequent blood donors”) to determine their eligibility to donate.  (In this guidance, the term “eligibility” refers to the donor suitability requirements described in Title 21 Code of Federal Regulations 640.3 (21 CFR 640.3)).   Acceptable aDHQ documents are those documents that FDA has determined will provide manufacturers with one means of obtaining donor history information from a frequent blood donor to determine if the donor is eligible, consistent with the requirements in 21 CFR 640.3.

This guidance also advises licensed manufacturers who choose to implement the acceptable aDHQ documents on how to report the manufacturing change consisting of the implementation of the aDHQ documents under 21 CFR 601.12 (§ 601.12).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.

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II. BACKGROUND

Section 640.3(a) requires the eligibility of all blood donors to be determined on the day of collection.  (We interpret “day of collection” to permit clarifying a donor’s response to the donor history questionnaire or obtaining omitted responses to questions within 24 hours of the time of collection.)2  Such determination is intended to ensure a donor’s overall good health and prevent transmission of diseases transmissible by blood and blood components (21 CFR 640.3(a) through (d)).  A donor’s eligibility to donate blood and blood components is determined in part by a physical assessment and the donor’s answers to questions concerning medical history and risk factors for diseases transmissible by blood and blood components.  The donor screening interview is especially important in identifying risks for diseases and conditions for which there are no adequate laboratory tests or for which tests are unable to identify early stage or window period infection.

The first formal uniform questionnaire developed for the purpose of blood donor screening was implemented nearly 60 years ago (Ref. 1).  Though the donor interview process is helpful in excluding ineligible donors, errors in this process do occur because some information may not be understood or captured during the screening process (Ref. 2).  As noted during workshops sponsored by FDA to discuss this issue, the blood donor screening process should consider such factors as question complexity, donor recall ability, donor health and safety, donor satisfaction and willingness to return, any further processing which a product may undergo prior to use, and risk to the end user/recipient of blood and blood components (Refs. 3 and 4).  Strategies such as using self-administered computer-assisted and abbreviated questionnaires have been suggested as approaches to improve donor understanding and satisfaction over what some view as a lengthy and time-consuming process, particularly for frequent donors (Refs. 3 through 5).  FDA issued a guidance document entitled “Guidance for Industry:  Streamlining the Donor Interview Process:  Recommendations for Self-Administered Questionnaires,” dated July 2003 (Streamlining Donor Interview guidance) which explains how blood and plasma establishments may simplify the donor screening process by allowing certain donors to use self-administered donor history questionnaires (Ref. 6). 

In October 2006, FDA published a guidance document entitled “Guidance for Industry:  Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components” which recognized the task force’s full-length donor history questionnaire (AABB FL-DHQ) and accompanying materials (version no. 1.1 dated June 2005) as an acceptable mechanism that is consistent with FDA requirements and recommendations for collecting blood donor history information (Ref. 7).  FDA recognized the AABB FL-DHQ version 1.3 dated May 2008, in a guidance document entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated May 2010 (Ref. 8).

Donors of blood and blood components can donate certain blood components on a frequent basis.  The most common example of a frequent blood donor is one who donates platelets and/or plasma by automated apheresis methods as frequently as twice per week.  Most frequent blood donors are currently administered the AABB FL-DHQ at each donation.  Such redundant questioning may discourage some frequent donors from returning for future donations.  Streamlining of the donor screening process may enhance the availability of safe blood products from frequent donors.

The full-length and abbreviated donor history questionnaires are designed to be administered together.  For example, if you choose to implement the AABB Abbreviated Donor History Questionnaire, you should also implement the AABB Full-Length Donor History Questionnaire as described in the User Brochure.  The aDHQ documents are designed to be administered by blood establishment personnel or self-administered with follow-up by establishment personnel.  The aDHQ documents include the following materials and are intended to be used in their entirety in conjunction with the AABB FL-DHQ, with the exceptions noted in section IV.A.2. of this document (Ref. 9): 

  • 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 aDHQ documents were developed by the task force to identify recent changes in medical, behavior and travel information since the donor’s previous donation.  It eliminates questions about events or behaviors that, if a donor had previously answered “no” on the AABB FL-DHQ, would not need to be asked in future interviews of that donor.  The aDHQ documents allow frequent blood donors for whom a record of their medical, behavior and travel history has been established, to be interviewed using an aDHQ.  The User Brochure describes those donors who would be eligible to be administered the aDHQ documents.

We discussed the use of an abbreviated questionnaire during several Blood Products Advisory Committee (BPAC) meetings.  Informational presentations describing the task force’s activities and the new abbreviated questionnaire developed by the task force were given during the BPAC meeting held on December 11, 2003 (Ref. 5).  BPAC supported the task force’s efforts to define an acceptable process for using an aDHQ but stated that the aDHQ documents should be studied post-implementation to assess its effectiveness in identifying ineligible donors compared to the current AABB FL-DHQ and to evaluate the capability of blood establishments to accurately and reliably determine the eligibility of donors who complete the aDHQ documents.

The task force developed a plan to evaluate the performance and appropriate use of the new process by summarizing post-donation information about donor eligibility received by blood establishments.  During the BPAC meeting held on March 18, 2005, the task force presented a study design for evaluating the abbreviated questionnaire post-implementation (Ref. 10).  The task force also proposed to assess inappropriate use of the aDHQ documents instead of the AABB FL-DHQ for donor screening.  This study will include a review of post-donation information and data about inappropriate use of the aDHQ documents.  The task force has agreed to submit the summary data to FDA once the study has been completed.  Based on the outcome of the post-implementation evaluation, FDA may revise its recommendations for the use of the aDHQ. 

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III. RECOGNITION of aDHQ DOCUMENTS

We find the AABB aDHQ documents (version 1.3) to be acceptable for use in screening frequent blood donors.  These documents are consistent with FDA requirements and recommendations related to donor eligibility interviews, subject to the following exception.  The aDHQ documents contain questions related to pregnancy.  By recognizing the acceptable aDHQ documents as one way to satisfy FDA’s regulatory requirements, we are not requiring or recommending that donors be screened or deferred for this issue.  If you choose to implement the acceptable aDHQ documents and omit these questions, you would still be in compliance with FDA requirements. 

While we recognize that the acceptable aDHQ documents provide an effective tool for screening frequent blood donors, we do not require that you implement the acceptable aDHQ documents.  You may continue to use any abbreviated donor history questionnaires and accompanying materials developed by your establishment that were previously approved by FDA.  These materials may include procedures and wording that are different from those in the AABB aDHQ documents.  In the future, you may implement, consistent with § 601.12, new procedures and materials that differ from those in AABB aDHQ documents (Ref. 11).

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IV. REPORTING TO FDA THE IMPLEMENTATION OF ACCEPTABLE ABBREVIATED DONOR HISTORY QUESTIONNAIRE AND ACCOMPANYING MATERIALS

As discussed in section II. of this document, we recommend that the full-length and abbreviated questionnaires be used together.  For example, if you choose to implement the AABB Abbreviated Donor History Questionnaire, we recommend that you also implement the AABB Full-Length Donor History Questionnaire.

A. Implementation of Acceptable aDHQ Documents

Licensed manufacturers must report the implementation of the acceptable aDHQ documents to FDA under § 601.12 as follows:

  1. If the acceptable aDHQ documents are implemented without modifications and in their entirety, except as described below, as a complete process for administering questions to frequent blood donors, the change is considered to be minor, with a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.  You must report such changes to FDA in your annual report under § 601.12(d), noting the date the process was implemented.  If donors will be allowed to self-administer acceptable aDHQ documents, see section IV.B.
  2. If the acceptable aDHQ documents are implemented in their entirety, but modified by:  (a) adding additional, more restrictive selection criteria that are specific to your establishment; or (b) omitting questions that FDA has not required or recommended for determining donor eligibility, the changes are considered to be minor.  Report such changes to FDA in your annual report under § 601.12(d), noting the date the process was implemented and describing the additional criteria or questions that were omitted from your questionnaire.
  3. If you make changes to the format or wording in the aDHQ flow charts but the content remains consistent with the FDA required/recommended donor deferral criteria, or you adopt stricter donor deferral criteria, the changes are considered minor.  You must report such changes to FDA in your annual report under § 601.12(d), noting the date the process was implemented and describing how you modified the acceptable aDHQ documents.
  4. If the acceptable aDHQ documents are implemented in their entirety, but modified by reformatting any of the acceptable aDHQ documents (other than the flow charts) to be consistent with your current process, the changes are considered to be minor provided you do not change the wording and the order of content in the acceptable aDHQ documents.  Report such changes to FDA in your annual report under § 601.12(d), noting the date the process was implemented and describing how you modified the acceptable aDHQ documents.
  5. Donor screening is important to the safety of blood and blood components and screening procedures have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of blood and blood components, as they may relate to the safety or effectiveness of the product.  Therefore, the implementation of the acceptable aDHQ documents that have been modified other than as specifically described in sections IV.A. 2 through 4, will be a major change.  If you wish to implement the acceptable aDHQ documents modified in a manner other than as described in sections IV.A. 2 through 4, you must report such changes as a Prior Approval Supplement (PAS) under § 601.12(b).  We recommend that you include the following in the submission:
    1. FDA Form 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use” which may be obtained at http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.
    2. A cover letter describing the request and the contents of the submission.
    3. A written standard operating procedure (SOP) describing the donor questions and questionnaire process. 
    4. The donor history questionnaires and accompanying document(s).  Please highlight the modifications.

For assistance in preparing the supplement, please refer to FDA’s guidance entitled “Guidance for Industry:  For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h ‘Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use’” dated May 1999 (Ref. 12).

B. Implementation of Self-Administered Acceptable aDHQ Documents

In July 2003, we issued the Streamlining Donor Interview guidance (Ref. 6) advising licensed blood establishments to submit procedures for self-administering the donor history questionnaire to FDA as a Changes Being Effected in 30 Days supplement (CBE30) under § 601.12(c).  We determined in the Streamlining Donor Interview guidance that a CBE30 was an appropriate supplement to ensure that controls were in place to manage this process.  However, we have since determined that when acceptable aDHQ documents include instructions for controlling the self-administration process, such as in the User Brochure, this change may be reported in an annual report or as a CBE30 in some situations, as described in sections IV.B.1. and IV.B.2. of this document. 

Note that the recommendations set forth in this section modify the recommendation set forth in the Streamlining Donor Interview guidance at section IV.A.  Licensed manufacturers planning to implement self-administration of a questionnaire other than the acceptable aDHQ documents should continue to consult the Streamlining Donor Interview guidance (Ref. 6).

Licensed manufacturers must report implementation of self-administered acceptable aDHQ documents under § 601.12 as follows:

  1. If you choose to implement self-administration of the acceptable aDHQ documents using the written form or audio/visual presentation methods described in the acceptable aDHQ documents, this is considered a minor change.  Report such a change to FDA in your annual report under § 601.12(d), noting the date the process was implemented.
  2. If you choose to implement the acceptable aDHQ documents using a computer-assisted interactive interview procedure, report this change to FDA as a CBE30 under § 601.12(c).  This change presents a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of blood and blood components, as they may relate to the safety or effectiveness of the product, because of concerns that the presentation of the questions and information may not be easily readable in all conditions and by all potential users.  Additionally, implementation for the first time of a computer-assisted interactive interview procedure may raise new issues that should be evaluated, such as the management of electronic records.  Therefore, we cannot conclude at this time that the implementation of a computer-assisted interactive interview procedure will be a minor change.

For assistance in implementing and reporting the use of self-administered questionnaires other than as described above, and for preparing the CBE30 for the computer-assisted interactive interview procedure, see the Streamlining Donor Interview guidance (Ref. 6).

Unlicensed blood establishments do not need to report implementation of the aDHQ documents (as described in sections IV.A. and IV.B. of this document) to FDA.

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V. RECOGNITION AND IMPLEMENTATION OF FUTURE ACCEPTABLE aDHQ DOCUMENTS

In the future, we may issue regulations or guidance documents concerning donor deferrals when we identify new infectious diseases, medical conditions, behaviors, geographic exposures or medications that have the potential to affect the donor’s safety or the safety, purity, and potency of blood and blood components.  Implementation of new safeguards would change your donor interview SOPs, and involve amending the accepted aDHQ documents (typically by adding a question at the end of the questionnaire in the area designated for additional questions or by implementing new or revised aDHQ documents).  We note that the User Brochure describes how to add and administer revised aDHQ documents.  If you do not use the acceptable aDHQ documents, this would involve amending your own donor history questionnaire.  We anticipate that in the event we recommend a new donor deferral criterion, we will, in the same guidance, provide recommendations concerning implementing and reporting to FDA the manufacturing changes associated with this change in procedure.  If the aDHQ documents are revised to reflect this new donor deferral criterion and found acceptable, we also intend to recognize those aDHQ documents as acceptable in the guidance document addressing this new criterion.  We intend to make all acceptable aDHQ documents available on the FDA website.

We recommend that you have a procedure in place for implementing updated acceptable aDHQ documents in all of your facilities.

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VI. FOR MORE INFORMATION

If you have questions regarding this guidance and FDA policies for implementing acceptable aDHQ documents, contact OCOD at the phone numbers or e-mail address provided on the cover page of this document.

If you have questions regarding the aDHQ documents, contact AABB by phone at 301-907-6977, by fax at 301-907-6895 or by e-mail at aabb@aabb.org to the attention of the AABB Donor History Task Force.

You may view the aDHQ documents described in this guidance on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/
BloodDonorScreening/ucm164185.htm
.

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VII. References

  1. American Association of Blood Banks, Technical Methods and Procedures of the American Association of Blood Banks, pp. 3-5, Minneapolis: Burgess Publishing Co., 1953.
  2. Biological Product Deviation Reports Annual Summaries, CBER.  Available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/default.htm
  3. FDA/AABB Workshop on “Streamlining the Blood Donor History Questionnaire” Transcript - October 16, 2000.  Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/
    TranscriptsMinutes/UCM055357.pdf.
     
  4. Orton S, Virvos V, Williams A. Validation of selected donor-screening questions: structure, content and comprehension. Transfusion 2000; 40:1407-1413.  
  5. Blood Products Advisory Committee Meeting Transcript, December 11, 2003.  Available at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4014t1.htm.   
  6. Guidance for Industry:  Streamlining the Donor Interview Process:  Recommendations for Self-Administered Questionnaires, July 2003.  Available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm075086.htm.
  7. Guidance for Industry:  Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components, October 2006.  Available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073445.htm.  
  8. Guidance for Industry:  Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, May 2010.  Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/
    UCM213415.pdf
    .  
  9. American Association of Blood Banks:  Association Bulletin #04-05: Uniform Donor History Questionnaire, June 29, 2004.  
  10. Blood Products Advisory Committee Meeting Transcript, March 18, 2005.  Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4096t2.htm.   
  11. Guidance for Industry:  Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture, July 2001.  Available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm076729.htm

Guidance for Industry:  For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use,” May 1999.  Available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm077087.htm

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Footnotes

1. In the Abbreviated Donor History Questionnaire User Brochure (User Brochure), AABB defines a frequent donor as "[a] donor who has previously donated two times using the full-length Donor History Questionnaire, one donation of which occurred within the previous 6 months." The User Brochure contains additional instructions that delineate when the aDHQ documents and full-length donor history questionnaire should be administered.

2. See FDA’s “Guidance for Industry:  Recommendations for Blood Establishments:  Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application,” dated November 2010, for additional information on donor suitability procedures.  Available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm235785.htm.

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About This Guidance Document

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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To obtain copies of this document

Additional copies of this guidance are available from:

Office of Communication, Outreach and Development (OCOD), (HFM-40),
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,
or by calling 1-800-835-4709 or 301-827-1800,
or e-mail ocod@fda.hhs.gov, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

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For questions regarding this document

If you have questions regarding this guidance and FDA policies for implementing acceptable aDHQ documents, contact OCOD at the phone numbers or e-mail address listed above.

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FDA office that authored this guidance

U.S. Department of Health and Human Services
Food and Drug Administration

  • Center for Biologics Evaluation and Research

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