Guidance for Industry 

 
 
 
 
 
 
 
Streamlining the Donor Interview 

Process: Recommendations for 
 
Self-Administered Questionnaires 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Training and 
Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by 
calling 1-800-835-4709 or 301-827-1800, or from the Internet at 
http://www.fda.gov/cber/guidelines.htm.  
 
For questions on the content of the guidance contact the Division of Blood Applications, Office 
of Blood Research and Review, CBER, at 301-827-3543, or by fax at 301-827-3534.  
 
 
 
 
 
 
 
 
 
   
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Biologics Evaluation and Research (CBER)  
July 2003  
    Contains Nonbinding Recommendations  

 
TABLE OF CONTENTS 
 
 
 
 
I.  	 INTRODUCTION............................................................................................................... 1
  
II.  	 BACKGROUND ................................................................................................................. 1
  
III. 	  RECOMMENDATIONS FOR IMPLEMENTING SELF-ADMINISTERED DONOR 

QUESTIONNAIRES .......................................................................................................... 3
  
A. 	  Recommendations for All Self-Administered Procedures.................................... 3
  
B.	   Additional Recommendations for the Use of Audio/Visual Tools ........................ 5
  
C. 	  Additional Recommendations for Computer-Assisted Interactive Procedures.. 5
  
IV. 	  PROCEDURES FOR SUPPLEMENTING THE BIOLOGICS LICENSE 

APPLICATION TO INCLUDE THE USE OF SELF-ADMINISTERED DONOR 

QUESTIONNAIRES .......................................................................................................... 6
  
A. 	  General Submission Information ............................................................................ 6
  
B.	   Submission Content for All Self-Administered Procedures.................................. 7
  
C. 	  Additional Submission Content for Computer-Assisted Interactive Procedures7  
V. 	  FOR MORE INFORMATION .......................................................................................... 8
  
VI. 	  REFERENCES .................................................................................................................... 9
  
 
 
i   Contains Nonbinding Recommendations  
 
GUIDANCE FOR INDUSTRY
  
 
Streamlining the Donor Interview Process:
  
Recommendations for Self-Administered Questionnaires 
 
 
This guidance represents the Food and Drug Administrations (FDAs) 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.  
 
 
I.   INTRODUCTION  
 
Blood and plasma establishments (hereafter referred to as blood establishments) that collect 
blood and blood components intended for transfusion or for further manufacture may present 
donor screening questions to the donor by several methods.  The blood establishment should 
choose the method that works best within its donor screening procedures.  This guidance is 
intended for those blood establishments that wish to implement self-administered donor 
questionnaires, which allow donors to answer the pre-donation questions on their own; however, 
you (the blood establishment) may elect to continue to administer the donor questions by direct 
oral questioning.  The guidance provides the recommendations of the Food and Drug 
Administration (FDA) for implementing self-administered donor questionnaires.   In addition, 
the guidance describes the information the licensed blood establishments should include in a 
biologics license application supplement or annual report when they intend to implement self-
administered questionnaires.  This guidance finalizes the draft guidance of the same title dated 
April 2002.  It also supersedes Section I.A of FDAs memorandum dated April 23, 1992, entitled 
Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) 
Transmission by Blood and Blood Products.   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs 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 FDAs guidances means that something is suggested or 
recommended, but not required.  
 
II.   BACKGROUND  
 
A donors suitability to donate blood and blood components is determined in part by a 
medical/health history/high-risk behavior interview (21 CFR 640.3 and 640.63).  Blood 
establishments began formal questioning of blood donors about their health in the 1950s with the 
1    Contains Nonbinding Recommendations  

development of the first donor screening questionnaire.  Since then, the number of questions and 
the amount of information captured during the questioning process has increased due to FDA 
requirements and recommendations and voluntary standards, resulting in an increasingly 
complex and time-consuming process.  For example, we have recommended that you ask the 
high-risk behavior questions by direct oral questioning (Ref. 1).  This guidance updates those 
recommendations to allow blood donors to self-administer the high-risk behavior questions.  
 
Blood establishments are concerned that the current donor questionnaire process is burdensome 
for the following reasons:  (a) the donor questionnaire is complicated, (b) the donor interview 
process makes increasing demands upon limited resources at the blood collection facilities (e.g., 
time and personnel), and (c) many donors are concerned about answering personal questions in 
front of a stranger.  We are committed to improving the efficiency and effectiveness of the 
donation process.  Consequently, we are evaluating methods to streamline the interview process 
while maintaining and improving the accuracy and completeness of the information in order to 
better protect the health of donors and ensure the safety, purity, and potency of blood products.  
 
You must determine the donors suitability on the day of each donation ( 640.3(a) and 
640.63(a)).  Collection personnel use pre-donation screening questions to assist them in 
determining donor suitability.  The questions are an integral part of the donation process to help 
personnel assess risks to the donor from the donation process.  In addition, the questions help to 
ensure product safety by addressing hazards that may not be detectable by laboratory testing and 
help to ensure product purity and potency (Ref. 2).   
 
We define the self-administered, pre-donation questionnaire as one in which the donor reads or 
listens to the medical/health history questions and/or high-risk questions and documents his/her  
answers. A self-administered questionnaire process allows a donor to answer the pre-donation 
screening questions without direct oral questioning by collection personnel.  We are not 
including donor identification or demographic questions (e.g., name, address, social security 
number) in this definition.  You may elect to allow donors to self-administer only the 
medical/health history questions, only the high-risk behavior questions, or both, as long as you 
do not jeopardize donor safety and product safety, purity, and potency.  There are several options 
available for self-administering the donor questionnaire.  These include, but are not limited to:  
 
1.	   Questions presented on printed forms.  The donor reads the questions and documents the 
answers on the form.  Your personnel review the answers.   
 
2.	   Audio and/or video presentation of the questions.  The donor reviews the questions by 
listening to a recording or watching a video and documents the answers.  Your personnel 
review the answers.  
 
3.	   Computer-assisted interactive interview.  The donor reviews the questions on a computer 
screen and enters the answers electronically.  Your personnel review the answers. 
Published studies have shown that computer-assisted interactive questionnaires that have 
an audio component provide an effective method to elicit sensitive information from the 
donors (Ref. 3, 4).  [Note:  Some blood collection facilities use computer programs to 
display the questions to personnel, who question the donor and enter the responses into 
2    Contains Nonbinding Recommendations  

the computer.  We do not address this process in this guidance because it is not a self-
administered process.]  
 
The recommendation in our draft guidance entitled Streamlining the Donor Interview Process: 
Recommendations for Self-Administered Questionnaires, dated April 2002, to not allow new 
donors to self-administer the donor questionnaire was discussed at the Blood Products Advisory 
Committee meeting on September 12, 2002.  The committee pointed out that all the methods for 
administering the donor questionnaires were comparable for eliciting information from new 
donors, but stated that additional studies were needed to determine the efficacy of the various 
methods to provide a safe blood product.  Because the methods are comparable, we have 
removed that recommendation from this final guidance.  Consistent with the final guidance, new 
donors may self-administer the donor questionnaire.     
 
This guidance does not address the informed consent process.  We also do not address specific 
screening questions, a specific questionnaire, or, for licensed blood establishments, how to 
submit changes to the questions on your currently approved questionnaire.  Instead, this guidance 
describes how you may change your current pre-donation donor screening interview procedure to 
a self-administered format.   
 
This guidance also advises licensed blood establishments how to report the change to a self-
administered questionnaire format to FDA under  601.12, Changes to an Approved 
Application, and what information they should submit.  Licensed blood establishments that are 
already approved to implement a self-administered donor questionnaire do not need to report this 
change again to FDA.  Unlicensed registered blood establishments implementing self-
administered donor questionnaire procedures do not need FDA approval for this change.  Both 
licensed and unlicensed registered blood establishments are subject to the Current Good 
Manufacturing Practice (CGMP) regulations in 21 CFR Parts 210, 211, and 606, as well as all 
other applicable regulations, including product standards in Part 640 and the computer record 
keeping requirements of 21 CFR Part 11.  
 
III. 	  RECOMMENDATIONS FOR IMPLEMENTING SELF-ADMINISTERED 
DONOR QUESTIONNAIRES  
 
A. 	  Recommendations for All Self-Administered Procedures  
 
1.	   You must describe the self-administered procedures in your written 
standard operating procedures (SOPs) ( 606.100(b)).  You must 
adequately train your personnel in these procedures ( 600.10(b) and 
606.20(b)).  
 
2.	   The donor must complete the self-administered questionnaire on the day 
of donation ( 640.3(a) and 640.63(a)) before blood collection at the 
donation site.  
 
3    Contains Nonbinding Recommendations  

3. 	  You must provide an appropriate environment for individuals to complete 
their donor questionnaire in a private setting ( 606.40(a)(1)).  You should 
ensure that the donor is answering the questions in a confidential setting.  
 
4. 	  You should have a method at each donation to ensure that the donor 
understands the questions (e.g., additional verbal or written questions). 
This should include an evaluation of the donors ability to read and 
understand the language of the self-administered questionnaire, regardless 
of its medium (written, audio, or visual).  Published studies have shown 
that individuals with low medical literacy may not reliably complete self-
administered questionnaires (Ref. 5).  You must defer donors who do not 
appear to be providing reliable answers to the questions ( 640.63(d)).  
 
5. 	  You should provide options for donors who prefer direct oral questioning 
or who would like or need assistance in completing the questionnaire.  
 
6. 	  You should provide the donor with written or verbal instructions on how 
to properly complete the questionnaire, including how to request 
assistance, if needed.  The instructions and questionnaire should be in a 
language that the donor readily understands.  You should instruct the 
donor to read and/or listen to the full question before answering and leave 
the answer blank if he or she does not understand a question.  Your 
personnel should be available to answer questions.  
 
7. 	  The donor should answer all applicable questions on the questionnaire, as 
defined by your SOP.  The donor does not need to complete the 
questionnaire if he or she is deferred early in the questioning process.  
 
8. 	  You should have a method to review the questionnaire for completeness 
and accuracy before allowing the donor to donate and to question the 
donor further, when necessary to determine the donors suitability.  If you 
modify answers or document the donors answer to blank questions after 
clarification from the donor, you should annotate the entries (e.g., 
reviewers initials, further explanation of comments).  If there are multiple 
reasons to defer the donor, you must document all reasons for deferral on 
the donor record ( 606.160(b)(1)(ii)).  
 
9. 	  If you revise your questionnaire to include new or modified questions, you 
should highlight, or otherwise draw attention to, the new or modified 
questions for one year so that all donors (new donors and donors who have 
previously donated at your facility) will be aware of the change.  You 
should have a method to ensure consistent implementation of revised 
questionnaires.  
 
10. 	  You should monitor the effectiveness of the self-administered 
questionnaire in identifying unsuitable donors (e.g., by evaluating post
4    Contains Nonbinding Recommendations  

donation information reports, infectious disease marker rates, specific 
deferral trends, biological product deviation reports, post-transfusion 
infectious disease reports).   
 
B.	   Additional Recommendations for the Use of Audio/Visual Tools  
 
Current audio/visual (AV) technology may encompass electronic media such as 
audiocassette tapes and compact discs, videotape (e.g., VHS), digital videodisks, and 
digitized recordings played on a computer.  You may use these media to present the 
medical/health history and/or high-risk behavior questions as well as AIDS/HIV 
educational materials to the donors.  The donors may play these recordings and document 
their answers to the questions.   
 
In addition to the recommendations in section III.A, you should consider the following 
item when implementing the self-administered questionnaire using audio and visual 
media:  
 
1.	   Before implementation and periodically thereafter, you should verify and 
document that the audio portion is understandable, in accordance with a 
written SOP.  You should have a written SOP for administering the 
questionnaire when the audio/visual tools are not available.  
  
2.	   The content of the audio recording should match the information displayed 
in the video.  When you revise your written materials or questionnaire, 
you should also change the video and audio recording to match the written 
materials.  If you provide the donor with written AIDS/HIV educational 
materials, they should correlate with the video and/or audio recording.   
 
3.	   If more than one donor will be listening to the audio and/or watching the 
audio/visual display at one time, your SOP should include provisions 
regarding the appropriate number of donors for joint listening or viewing 
to ensure privacy when answering the questions.  
 
C. 	  Additional Recommendations for Computer-Assisted Interactive Procedures  
 
In the self-administered computer-assisted interactive interview procedure, the donor 
reviews the questions on a computer screen and enters the answers electronically into the 
software program managing the interview process.  The computer software may or may 
not make decisions on the suitability of the donors depending on the responses to the 
questions.  Under Section 510 of the Federal Food, Drug, and Cosmetic Act, your 
computer systems functionality may require 510(k) clearance (Ref. 6).  
 
The computer system used in the computer-assisted interactive interview procedure 
includes any hardware and software needed to perform the process.  It may be a stand
alone system, used solely to conduct the donor interview, or it may interface with other 
computer systems at the same or other locations.  It may be a desktop or laptop computer 
5    Contains Nonbinding Recommendations  

or a handheld device.  The software may have data storage capabilities or may send data 
to a printer for hardcopy printout.  In addition, the computer system may be accessible 
from a remote location.  The user interface may present both video and audio data to the 
user via monitors, headphones, etc.  Donors and collection personnel may input data or 
responses via keyboard, microphone, or a pointing device such as a mouse, touch screen, 
or stylus.  The system may use pictures or drawings to illustrate the topic of the displayed 
questions.  
 
In addition to the recommendations in sections III.A and III.B, you should consider the 
following items when implementing the self-administered computer-assisted interactive  
questionnaire:  
 
1. 	  You should validate all aspects of your computer system for its intended 
use.  You should perform this validation consistent with the provisions 
contained in FDA guidance documents (Refs. 7-8) and in  820.100.  
 
2. 	  The computer system record keeping functions, including electronic 
signatures and records, must comply with the requirements in Part 11 
(Refs. 9-10).   
 
3. 	  You should have a written SOP for administering the questionnaire when 
your computer system is not available.  
 
IV. 	  PROCEDURES FOR SUPPLEMENTING THE BIOLOGICS LICENSE 
APPLICATION TO INCLUDE THE USE OF SELF-ADMINISTERED DONOR 
QUESTIONNAIRES  
 
A. 	  General Submission Information  
 
If you change your donor interview process to include self-administering the high-risk 
behavior questions, as described in this guidance, using your currently approved 
questionnaire, you should supplement your license application and report this change to 
us as a Changes Being Effective in 30 Days (CBE30) supplement under  601.12(c) (Ref. 
11).  
 
If you change your donor interview process to include self-administering only the 
medical/health history questions from your currently approved donor questionnaire (e.g., 
you are not changing the process for administering the high-risk behavior questions), you 
may report this change to us in your Annual Report under  601.12(d).   
 
Licensed blood establishments that are already approved to implement a self-
administered donor questionnaire do not need to report this change to FDA.  However, 
you may wish to review your procedures to ensure that they are consistent with this 
guidance.  If you revise your procedures to be consistent with this guidance, you may 
report this to us in your Annual Report under  CFR 601.12(d).   
 
6    Contains Nonbinding Recommendations  

B.	   Submission Content for All Self-Administered Procedures  
 
For assistance in preparing your supplement, see our 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 (Ref. 12). You 
should include the following items in your supplement:    
 
1. 	  FDA Form 356h, Application to Market a New Drug, Biologic or an 
Antibiotic Drug for Human Use.   
 
2. 	  A cover letter describing your request and the contents of your 
submission.  
 
3. 	  A written SOP incorporating the self-administered questionnaire process.  
Include a copy of the instructions to prospective donors on how to 
complete the donor questionnaire and your procedures for determining and 
documenting each donors ability to provide reliable answers. The SOP 
should also include alternate procedures for when you cannot use your 
self-administered process.  
 
C. 	  Additional Submission Content for Computer-Assisted Interactive 
Procedures  
 
In addition to the submission content described in section IV.B, you should include the 
following items when supplementing your biologics license application to include the use 
of the self-administered, computer-assisted interactive  questionnaire:  
 
1. 	  The name of the software manufacturer, program name, and version or 
release number.  
 
2. 	  A description of the capabilities and functions of the computer system 
used by the blood establishment.  
 
3. 	  The addresses of any blood collection facilities where you will install the 
computer system and a description of the interface between facilities, if 
applicable.  
 
4. 	  The computer system user on-site validation protocol.  If applicable, the 
validation should include any interfaces with other computer systems. 
You should not submit the actual validation data.  Your validation data 
should be readily available for review at the time of FDA inspections.  
 
7    Contains Nonbinding Recommendations  

5. 	  An SOP that accurately incorporates the computer system manufacturer's 
instructions for use.  The SOP should include alternate procedures for 
when your computer system is not available.  
 
6. 	  A copy of the printed questionnaire.  
 
7. 	  A printout of all screens.  
 
 
V. 	  FOR MORE INFORMATION  
 
If you have questions regarding the self-administered questionnaire or about computer system 
requirements, call the Division of Blood Applications, Center for Biologics Evaluation and 
Research, at 301-827-3543 or fax 301-827-3534.  
 
 
8    Contains Nonbinding Recommendations  

REFERENCES  
 
1.  FDA memorandum, Revised Recommendations for the Prevention of Human 
Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products, April 23, 1992. 
(http://www.fda.gov/cber/memo.htm)  
 
2.  FDA memorandum, Revised Guideline for the Collection of Platelets, Pheresis, October 7, 
1988. (http://www.fda.gov/cber/memo.htm)  
 
3.  Cooley PC, Rogers SM, Turner CF, et al.  Using touch screen audio-CASI to obtain data on 
sensitive topics.  Computers in Human Behavior, 2001; 17:285-93.  
 
4.  Turner CF, Ku L, Rogers SM, et al.  Adolescent sexual behavior, drug use, and violence: 
Increased reporting with computer survey technology.  Science 1998; 280:867-73.  
 
5. Al-Tayyib AA, Rogers SM, Gibble, JN, et al.  Effect of low medical literacy on health survey 
measurements.  American Journal of Public Health, 2002; 92(9); 1478-81.  
 
6.  FDA Correspondence, Letter to Blood Establishment Computer Software Manufacturers, 
March 31, 1994.  
 
7.  FDA, Draft Guideline for the Validation of Blood Establishment Computer Systems, 
September 28, 1993.  (http://www.fda.gov/cber/guidelines.htm)*  
 
8.  FDA, Guidance for Industry:  General Principles of Software Validation; Final Guidance for 
Industry and FDA Staff,  January 11, 2002.  (http://www.fda.gov/cber/guidelines.htm)  
 
9.  FDA Final Rule, Electronic Records; Electronic Signatures, March 20, 1997 (62 FR 13430
13467) (http://www.access.gpo.gov/su_docs/aces/aces140.html)  
 
10.  FDA, Draft Guidance for Industry:  21 CFR Part 11; Electronic Records; Electronic 
Signatures, Scope and Application, February 20, 2003. 
(http://www.fda.gov/cber/guidelines.htm)*  
 
11.  FDA, Guidance for Industry:  Changes to an Approved Application: Biological Products: 
Human Blood and Blood Components Intended for Transfusion or for Further Manufacture, 
August 7, 2001.  (http://www.fda.gov/cber/guidelines.htm)  
 
12.  FDA, 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 10, 
1999. (http://www.fda.gov/cber/guidelines.htm)  
 
* These draft guidance documents have been issued but are not for implementation.  Once 
finalized, they will represent the Agencys current thinking on that topic.  
9