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Donor History Questionnaire
User Brochure

Purpose: The User Brochure was designed to aid the donor historian in determining if a
prospective donor is eligible to donate. Each blood center must have a standard operating
procedure (SOP) related to donor suitability to be used in conjunction with the User
Brochure. The User Brochure does not replace an SOP for determining donor suitability.
Both the User Brochure and the SOP must be available to staff performing health
histories. Alternately, the User Brochure contents may be transcribed into the SOP.
Introduction: The Donor History Questionnaire (DHQ) must be administered on the
date of donation. All prospective donors, including those that meet criteria for screening
using the abbreviated DHQ, must read the Donor Educational Materials prior to
completing the DHQ. They also must be given the Medication Deferral List, and a list of
BSE countries to be used with the DHQ. As an alternative, one or all of the lists can be
prominently displayed at the donation site for the donors’ use while they are completing
the DHQ. The DHQ was designed for self-administration by the donor, with follow-up
review by a trained donor historian. All donors, including those that meet criteria for
screening using the abbreviated DHQ, should be instructed to complete all questions on
the questionnaire. A knowledgeable donor historian should be available to the
prospective donor to answer any questions concerning eligibility or the donation process.
Alternatively, the DHQ may be administered by a donor historian. The method of
administration of the DHQ should be in accordance with the blood center’s SOP.
Collection facilities using these screening materials should be aware that these materials
were tested in English-speaking donor and non-donor groups and due to practical
limitations could not be tested in all possible settings, including with non-English
speaking donors.
DHQ Format: The DHQ questions were composed for ease of understanding by the
prospective donor. The DHQ was evaluated in its current form for comprehension;
therefore, the wording and the order of the questions should not be changed. Blood
centers may choose to add local questions to the beginning or the end of the DHQ. The
Educational Material and Medication Deferral List also must be used unabridged except
for local additions. The questions are grouped by time period beginning with a question
about “today” and ending with questions relating to “have you ever.” The entire DHQ
must be completed before eligibility is determined.
The DHQ uses capture questions that may require donor historian intervention or
follow-up. Capture questions are questions that cover a broad topic, and when an
affirmative answer is given, additional follow-up questions to elicit additional
information are asked by the donor historian. Some follow-up questions are included in
the User Brochure, but since specific donor eligibility criteria may vary from one blood
center to another, an affirmative response to some questions may require consultation
with the blood center's SOP. Blood centers may implement more restrictive deferral
policies than described in the User Brochure per their local SOP. If a donor is determined
to be eligible despite an affirmative response to a question(s), a detailed explanation for
each question must be documented in sufficient detail in a designated area on the DHQ.
Additionally, DHQ has several “attention” questions. An example of one of the
attention questions is listed below.
In the past 6 weeks, have you been pregnant or are you pregnant now? (Males check “I am male”)
An inappropriate answer to the question would be a male answering “yes” or “no.” Each
blood center must define the action of the donor historian when a donor inappropriately
answers the attention questions.
Abbreviated Donor History Questionnaire: An abbreviated version of the DHQ
(aDHQ) that is intended to be used by repeat blood donors.
When is a donor considered to be a repeat blood donor?
A blood donor is eligible to use the aDHQ if certain defined donor criteria are met and if
the blood collection facility has a system in place that can determine when it is
appropriate to use the aDHQ.
Repeat Donor Criteria: A donor who has previously donated two times, one donation of
which occurred within the previous six months. Both donations must have been screened
using the full-length DHQ.
Is it necessary to administer the full-length questionnaire once a donor is classified
as a repeat donor?
Once the donor qualifies for the aDHQ, there is no need to administer the full-length
questionnaire as long as the donor continues to qualify for the abbreviated version.
However, if the donor does not qualify,  for example, if the last donation was greater
than 6 months  the full-length DHQ MUST be administered.
From time to time, new donor history questions will be added. The new questions must
be added to the full-length and the abbreviated DHQ. The new questions will remain on
the aDHQ for one year from the date the question was added. If the question must be
asked at each donation, the question will remain indefinitely on both DHQs.
How will the blood collection facility track whether the full-length questionnaire or
the abbreviated questionnaire should be administered, especially at mobile
collection units?
The blood collection facility must have a system to determine when it is appropriate to
administer the abbreviated questionnaire and when the full-length questionnaire must be
administered. Some of the items that the system must be able to determine are: how many
times the donor has donated, the time interval since their last donation, which
questionnaire was utilized at each donation, the full-length questionnaire or the
abbreviated questionnaire. If the donor was deferred at the last donation, the full-length
questionnaire will be administered.

What action should be taken when it is determined that an incorrect questionnaire
has been administered?
The blood collection facility must have a standard operating procedure describing actions
in this circumstance. If a full-length questionnaire has been administered when a donor
qualified for an abbreviated questionnaire, no additional action is required with regard to
donor or product suitability. If an abbreviated questionnaire was administered when a
full-length questionnaire should have been administered, the SOP must ensure that the
donor unit is not made available for distribution (quarantined) until donor suitability
issues have been resolved. If the unit has already been distributed, then it should be
treated as post-donation information, including submission of a biological product
deviation report to the FDA if appropriate.
User Brochure Format: The User Brochure is modular and uses flow-charting to guide
the donor historian through the donor questionnaire process. Each question is a complete
section that begins on a new page, so that changes to the DHQ and the aDHQ can be
easily modified in the User Brochure. Each section contains the following information:
Question: Question number and the question.
Donor Eligibility: This section provides additional information to the donor
historian on donor eligibility requirements for each question.
Note: Optional field; additional relevant information relating to the donor
question.
Flow Chart: Each question is flow-charted using standard flow-charting symbols.
Square -- Statement
Diamond -- Question/decision point
Oval -- Action
Arrow -- Move to the next question
Each question ends with an ARROW that indicates to “move to the next question;”
however, blood centers must follow their established policies concerning whether or not
the donor suitability process is terminated when it is known that the donor will be
deferred.
Donor Deferrals: For some questions, a “yes” answer calls for a required deferral, either
indefinitely or for a specified period of time. A required deferral is designated in the flow
chart by the Action “Defer donor.” The donor historian may need to refer to the blood
center’s SOP to determine if and when the donor may be eligible to return.
For other questions, a “yes” answer may not require a deferral; rather, it may trigger a
line of questioning to determine if the donor is eligible. The donor historian will need to
refer to the blood center’s SOP for follow-up questions to determine suitability. This type
of deferral is designated in the flow chart by the Action “ Defer donor per SOP.” For
example, if a donor answers “yes” to the question “In the past 12 months, have you had a
blood transfusion?,” certain blood centers may ask further questions regarding the kind of
blood. Some blood centers may allow donors with confirmed receipt of autologous blood
only to donate. Other centers may simply defer all donors who received blood in the last
12 months, regardless of whether the blood was allogeneic or autologous.
Each blood center’s SOP must define how the donor responses to the follow-up questions
will be documented on the DHQ. Responses should be documented with sufficient detail
to determine the reason for donor acceptance or deferral.
References: A list of references concerning donor eligibility is included at the end of the
questions.
GLOSSARY
The following terms are defined in the context of their use in the Donor History
Questionnaire.

QUESTIONNAIRE TERMS

Attention Question – Questions in the Donor History Questionnaire that are designed to
test if the donor is paying attention. EXAMPLE: In the past six weeks, have you been
pregnant or are you pregnant now? (Males check: “I am Male”)
Capture Question – A question that covers a broad topic. When an affirmative answer
is given, additional follow-up questions to elicit additional information are asked by the
donor historian. EXAMPLE: Have you ever been to Africa? If the donor answers yes,
additional questions must be asked.

Self-administered Questionnaire – A questionnaire that the donor completes on his/her
own, followed by donor health historian review.
Abbreviated Questionnaire – An abbreviated version of the Donor History
Questionnaire that is intended to be used by repeat blood donors.
Repeat blood donor – A donor who has previously donated two times, one donation of
which occurred within the previous six months. Both donations must have been screened
using the full-length Donor History Questionnaire.


TYPES OF CONTACT

Contact with Blood – (1) a needlestick or other sharps injury from an instrument that has
been used on any individual or patient; (2) exposure to non-intact skin (e.g., skin that is
chapped, abraded, or afflicted with dermatitis); (3) a human bite that breaks the skin; (4)
exposure to eye, nose, or mouth i.e., the mucous membranes.
Sexual Contact – The meaning of the words “sexual contact with” and “sex” are
identical, and apply to any of the following activities, whether or not a condom or other
protection was used: (1) Vaginal sex (contact between penis and vagina); (2) Oral sex
(mouth or tongue on someone’s vagina, penis, or anus); (3) Anal sex (contact between
penis and anus).


Close Contact with Smallpox Vaccination Site – Touching the vaccination site,
including the bandages covering the vaccination site; touching/handling materials that
might have come into contact with an unbandaged vaccination site including clothing,
towels, and bedding.
Lived With – Residing in the same dwelling. EXAMPLES: house, dormitory,
apartment.
TYPES OF DEFERRAL

Indefinite Deferral – Prospective donor is unable to donate blood for someone else for
an unspecified period of time due to current regulatory requirements. EXAMPLE: A
prospective donor who states that they lived in England for 1 year in 1989 would be
deferred indefinitely. This donor would not be able to donate blood until the current
requirement changes. These donors may be eligible to donate autologous blood.

Permanent Deferral – Prospective donor will never be eligible to donate blood for
someone else. EXAMPLE: A prospective donor states that he/she has Hepatitis C.
Additionally, some permanent deferrals may result from the testing performed on a
previous donation. These donors may be eligible to donate autologous blood.

Temporary Deferral – Prospective donor is unable to donate blood for a limited period
of time. EXAMPLE: A prospective donor who discloses that he/she received a tattoo is
temporarily deferred for 12 months after he/she received the tattoo.

Question: 1. Are you feeling healthy and well today?
Donor Eligibility: A donor should be free of infectious diseases and colds on the day of donation. Donors who
are not in good health should not donate until it is determined that the underlying condition is not cause for
deferral.
Question: 2. Have you read the educational materials and had your questions answered?
Donor Eligibility: Donors must read the educational materials prior to donating and have an opportunity to have
their questions answered.
·Have donor read
·Answer all donor
Question: 3. In the past 48 hours have you taken aspirin or anything that has aspirin in it?
Donor Eligibility: Aspirin irreversibly inactivates platelet function. Donors who are taking aspirin or any aspirin
containing medication should not be the sole source of platelets.
Question: 4. (Female Donors) In the past 6 weeks, have you been pregnant or are you pregnant now? (Males:
check “I am male.”)
Donor Eligibility: A female with a known pregnancy or who has been pregnant in the last 6 weeks should not
donate blood.
(Female Donors)
Question: 5. In the past 8 weeks have you donated blood, platelets or plasma?
Donor Eligibility: Frequency of whole blood donation is a minimum of every 8 weeks; plasma, platelets or
leukapheresis is a minimum of every 48 hours.
·Determine type of donation(s)
·Determine date of
·Consult SOP for eligibility.
Question: 6. In the past 8 weeks, have you had any vaccinations or other shots?
Donor Eligibility: Certain vaccinations may contain live viruses. A donor who has been exposed to a live virus
via vaccination should not serve as a donor. For other shots, refer to SOP.
Question: 7. In the past 8 weeks, have you had close contact with the smallpox vaccination site of someone
else?
Donor Eligibility: Certain vaccinations may contain live viruses. A donor who has had close contact with the
vaccination site, bandages covering the vaccination site or materials that might have come into contact with an
unbandaged vaccination site, including clothing, may be exposed to the live virus and should not serve as a donor.
Question: 8. In the past 16 weeks have you donated a double unit of red cells using an apheresis machine?
Donor Eligibility: A donor should not donate double red cells by apheresis more frequently than every 16
weeks.
Question: 9. Since your last donation, have you had any new medical problems or diagnoses?
Donor Eligibility: Certain medical conditions may be cause for the donor to be ineligible to donate.
Question: 10. Since your last donation, have you had any new medical treatments?
Donor Eligibility: Certain medical treatments might indicate an underlying medical condition that would be
cause for the donor to be ineligible to donate.
Question: 11. Since your last donation, have you taken any of the medications on the Medication Deferral List?
Donor Eligibility: Donors taking certain designated medications, currently or in the past, must not donate
blood.
·medication(s) and
·when last dose was
·Tegison
·human GH
·Beef insulin from
No, the donor took another medication on the list.
Yes, over 3 years ago.
orNever taken it.
Yes, over 6 months ago.
orNever taken it.
·Propecia
·Accutane?
Yes, but over a month ago.
orNever taken it.
Yes, within the last yearfor exposure to HepatitisB.
Yes, but over a year ago,orNever taken it.
Question: 12. Since your last donation, have you been outside the U.S. or Canada?
Donor Eligibility: Donors who have been outside the U.S. or Canada should be evaluated for eligibility. Travel
to certain areas may constitute reason for deferral. (See additional flow charts.)
·African country--refer to flow chart #8a
·European country--refer to European country
·UK--refer to UK country list and flow chart #8c
·Malarial country--refer to flow chart #8d
12a. Flow chart for Africa travel, residence or place of birth
Donor Eligibility: Donors who have lived in certain countries in Africa since 1977 (see list below) are
indefinitely deferred. Donors who have received a blood transfusion or any other medical treatment in Africa are
indefinitely deferred. Donors may have been exposed to rare strains of HIV that are not detected by current test
methods.
·Consult SOP to determine if
·Apply deferral as indicated or
12b. Flow chart for time spent in Europe.
Donor Eligibility: Donors who have spent time that adds up to five (5) years or more in Europe from 1980 to
the present are indefinitely deferred. Donors may be at theoretical risk of developing vCJD from eating beef in
Europe. There may be a theoretical risk of transmitting vCJD through blood transfusion.
time that adds up to five (5) years or more 12c. Flow chart for time spent in the United Kingdom. (Review list of countries in the UK.)
Donor Eligibility: Donors who have spent time that adds up to three (3) months or more in the United Kingdom
from 1980 through 1996 are indefinitely deferred. Donors may be at theoretical risk of developing vCJD from
eating beef from the UK. There may be a theoretical risk of transmitting vCJD through blood transfusion.
12d. Flow chart for time spent outside U.S. or Canada in the past three years.
Donor Eligibility: Immigrants, refugees, or citizens coming from a country in which malaria is considered
endemic will be deferred for 3 years after departure from the area if they have been free from unexplained
symptoms suggestive of malaria. Donors who have traveled to a country where malaria is considered endemic
will be deferred for 12 months after returning from that area regardless of whether or not they took anti-malaria
prophylaxis. Malaria may be transmitted through blood transfusion. The donors shall be accepted or deferred
based on the Malaria Risk Countries as designated by your institution.
have you been outside the United States or Question: 13. Since your last donation, have you come into contact with someone else's blood?
Donor Eligibility: A donor who has been exposed to someone else's blood should not donate blood for 12
months following exposure, due to possible transmissibility of infectious disease. (See Glossary for definition of
“contact with blood.”)
Question: 14. Since your last donation, have you had an accidental needle-stick?
Donor Eligibility: A donor who has been exposed to someone else's blood through a needle-stick should not
donate blood for 12 months following exposure, due to possible transmissibility of infectious disease.
Question: 15. Since your last donation, have you had sexual contact with anyone who has HIV/AIDS or has
had a positive test for the HIV/AIDS virus?
Donor Eligibility: Persons who have had sexual contact with persons with clinical or laboratory evidence of
HIV infection are deferred for 12 months from the date of last contact. HIV may be transmitted through sexual
contact with an infected person.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Question: 16. Since your last donation, have you had sexual contact with a prostitute or anyone else who takes
money or drugs or other payment for sex?
Donor Eligibility: Persons who have given money or drugs in exchange for sex (sexual contact) are deferred
for 12 months from the date of the last sexual contact. HIV and other diseases may be transmitted through
sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Question: 17. Since your last donation, have you had sexual contact with anyone who has ever used needles
to take drugs or steroids, or anything not prescribed by their doctor?
Donor Eligibility: Persons who have had sexual contact with persons who, in the past or present, have used
needles to take drugs, steroids, or anything not prescribed by their doctor are deferred for 12 months from the
date of the last sexual contact. HIV and other diseases may be transmitted through sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Note: The phrase "use of a needle" includes intravenous use, "skin popping" (injection under the skin),
"mainlining" (arterial injection) and any other use of a needle to administer drugs, steroids or anything else not
prescribed by their doctor.
Question: 18. Since your last donation, have you had sexual contact with anyone who has hemophilia or has
used clotting factor concentrates?
Donor Eligibility: Persons who have had sexual contact with one of the following: 1) any person with
hemophilia or related clotting disorders; or 2) any person who has received clotting factor concentrates is
deferred for 12 months. HIV and other diseases may be transmitted through sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Question: 19. Female donors: Since your last donation, have you had sexual contact with a male who has ever
had sexual contact with another male? (Males: check “I am male.”)
Donor Eligibility: Women who have had sexual contact with men who have had sexual contact with another
man even one time since 1977 are deferred for 12 months from the date of last sexual contact. HIV and other
diseases may be transmitted through sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
(Female Donors)
sexual contact with a male who has ever had sexual contact with another male? (Males: Question: 20. Since your last donation, have you had sexual contact with anyone who was born in or lived in
Africa?
Donor Eligibility: If the donor had a sex partner who was born in or lived in certain countries in Africa (see list
below) after 1977, the donor is indefinitely deferred. Donors who have had sexual contact may have been
exposed to rare strains of HIV that are not detected by current test methods.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Question: 21. Since your last donation, have you come into contact with blood from a person who has
hepatitis?
Donor Eligibility: Persons who have had one of the following during the preceding 12 months: 1) contact of an
open wound, non-intact skin or mucous membrane with the blood of a person with hepatitis, or 2) a needle-stick
or other sharps injury from an instrument that has been used on a person with hepatitis, are deferred for 12
months from the date of exposure. Hepatitis may be spread through contact with blood.
Question: 22. Since your last donation, have you had sexual contact with a person who has hepatitis?
Donor Eligibility: Persons who report having had sexual contact with a person who has hepatitis are to be
deferred for 12 months from the time of last exposure. Hepatitis, particularly hepatitis A and B, may be spread
through sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Hepatitis A or B,Symptomatic Hepatitis C,or unknown Question: 23. Since your last donation, have you lived with a person who has hepatitis?
Donor Eligibility: In certain cases, living with a person with hepatitis puts the donor at risk for acquiring
hepatitis as well.
Hepatitis A or B,Symptomatic Hepatitis C,or unknown Question: 24. Since your last donation, have you received money, drugs, or other payment for sex?
Donor Eligibility: Donors who received money, drugs, or other payment for sex are permanently deferred. HIV
and other diseases may be transmitted by sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
Question: 25. (Male Donors) Since your last donation, have you had sexual contact with another male, even
once? (Females: Check “I am female.”)
Donor Eligibility: Male donors who have had sexual contact with another male, even once, since 1977 are
permanently deferred. Males who have had sex, even once, with males may be at risk of transmitting infectious
diseases. HIV and other diseases may be transmitted through sexual contact.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read the educational
materials provided.
(Male Donors) Since your last donation,
have you had sexual contact with another male, Question: 26. Since your last donation, have you had a tattoo?
Donor Eligibility: Persons who have had a tattoo in the previous 12 months are deferred for 12 months from
the date of the tattoo application. Unless tattoos have been applied using single-use needles and single-use ink,
there may be a risk of transmission of infectious diseases.
Note: Tattoos include tattoo "touch ups", tattoos applied by oneself, and those applied by others.
Question: 27. Since your last donation, have you had ear or body piercing?
Donor Eligibility: Persons who have had ear or body piercing during the previous 12 months are usually
deferred for 12 months from the date of procedure. Unless ear or body piercing has been done using single-use
equipment, there may be a risk of transmission of infectious diseases.
Question: 28. Since your last donation, have you been in juvenile detention, lockup, jail, or prison for more than
72 hours?
Donor Eligibility: Persons who have been detained or incarcerated in a facility (juvenile detention, lockup, jail,
or prison) for more than 72 consecutive hours (3 days) are deferred for 12 months from the date of occurrence.
These persons are at higher risk for exposure to infectious diseases.
Note: The reason for incarceration (e.g. white-collar crimes, child support) does not change the deferral.
Question: 29. Since your last donation, have you used needles to take drugs, steroids, or anything not
prescribed by your doctor?
Donor Eligibility: Donors who are past or present needle-using drug users are indefinitely deferred due to
potential transmission of infectious diseases.
Question: 30. Have any of your relatives had Creutzfeldt-Jakob disease?
Donor Eligibility: Donors with a blood relative with Creutzfeldt-Jakob disease are indefinitely deferred.
Note: If laboratory testing (gene sequencing) shows that the donor does not have a mutation associated with
familial CJD, the donor is eligible.
Donor qualification requirements are located in 21 CFR 640.3 and AABB Standards for Blood Banks and Transfusion Services (Standard 5.4; 5.5; and 5.4.1A in the 21st Edition). Additional donor qualification requirements may be found in FDA memoranda and guidance: FDA Memorandum October 7, 1988: Revised Guidelines for the Collection of Platelets, Pheresis. FDA Memorandum, December 12, 1991: Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing. FDA Memorandum, April 23, 1992: Revised Recommendations for the Prevention of HIV Transmission by Blood and Blood Products. FDA Memorandum, April 23, 1992: Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti HCV) in Blood Establishments. FDA Memorandum, July 28, 1993: Deferral of Blood and Plasma Donors Based on Medications. FDA Memorandum December 22, 1993: Donor Suitability Related to Laboratory Testing For Viral Hepatitis and a History of Viral Hepatitis. FDA Memorandum July 26, 1994: Recommendation for Deferral of Donors for Malaria Risk. FDA Memorandum, June 8, 1995: Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma. FDA Memorandum, March 10, 1995: Revision of FDA Memorandum of August 27, 1982: Requirements for Infrequent Plasma Donors. FDA Memorandum, December 14, 1995: Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma. FDA Memorandum December 11, 1996: Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infections. Blood Products Advisory Committee Meeting June 16, 2000: Update on Sexual Transmission of HCV. FDA Guidance, February 2001: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods. FDA Guidance, January 9, 2002: Revised Preventive Measures to Reduce the Possible Risk of Recent Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products. Avodart Consumer Information, January 14, 2003: www.fda.gov/cder/consumerinfo/druginfo/avodart.htm. AABB Pulse Points No. 555, January 14, 2003: Association Bulletin #30-02: Donor Deferral Related to Use of AVODART (dutasteride). FDA Guidance, December 2002: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients.

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