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June 20, 2002

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 02D-0080, Draft "Guidance for Industry: Streamlining the
Donor Interview Process: Recommendations for Self-Administered
Questionnaires;" Availability

Dear Docket Officer:

The American Association of Blood Banks (AABB) is the professional
society for over 8,000 individuals involved in blood banking and
transfusion medicine and represents approximately 2,000 institutional
members, including blood collection centers, hospital-based blood banks,
and transfusion services as they collect, process, distribute, and
transfuse blood and blood components and hematopoietic stem cells. Our
members are responsible for virtually all of the blood collected and
more than 80 percent of the blood transfused in this country. For over
50 years, the AABB\'s highest priority has been to maintain and enhance
the safety and availability of the nation\'s blood supply.

The AABB interorganizational Task Force for Redesigning the Uniform
Donor History Questionnaire (UDHQ) consists of representatives from the
American Association of Blood Banks (AABB), America's Blood Centers
(ABC), Plasma Protein Therapeutics Association (PPTA), Armed Services
Blood Program Office (ASBPO), and liaisons from the Food and Drug
Administration (FDA), the Centers for Disease Control and Prevention
(CDC), and the Canadian Blood Services. The Task Force also comprises
survey design experts, statisticians and an ethicist who is representing
the public. The UDHQ Task Force is engaged in an extensive process to
redesign and simplify the donor questions.

The AABB Uniform Donor History Questionnaire Task Force is pleased to
comment on the "Draft Guidance for Industry: Streamlining the Donor
Interview Process: Recommendations for Self Administered
Questionnaires." The Task Force members unanimously support the concept
of self-administered questionnaires (SAQs). The concept of a
self-administered format was one of several that were fundamental for
development of the new questionnaires recently submitted to FDA. The
Task Force recommends that the questionnaires be self-administered by
ALL blood donors without the use of direct questioning by donor
collection staff. We also recommend that blood center staff make it
clear that they are readily available to assist donors and provide
clarification when needed.

Although we support self-administered questionnaires, the Task Force has
concerns about the draft guidance as written. In general, the guidance
is extremely proscriptive. Many of the recommendations impose new
burdens on the pre-donation screening process, thus undermining the
stated intent of the guidance to streamline the donor interview process.
We anticipate that these burdens may discourage some blood centers from
choosing to utilize self-administered questionnaires, and that the
increased time that would be required for donor screening could
discourage prospective blood donors. Some of the recommendations in the
draft guidance are "good practice" and are already in place for current
screening procedures, but exact details may not coincide with this
guidance. However, other recommendations, such as Section III A 10, to
assess the effectiveness of the \[self-administered\] questionnaire, are
not in place for current screening procedures and would be difficult to
implement.

Specific concerns are as follows:

1\. Section III A 4 states that "You should not allow new donors to
self-administer the donor questionnaire. **The Task Force disagrees with
this approach and requests that ALL donors be permitted to
self-administer the questionnaire**. There is no evidence that new
donors should be treated differently from repeat donors. In fact, in a
study by Mayo, et al, it was observed that in general, first time and
occasional donors were more likely than frequent donors to pay attention
to SAQs.^1^ All donors should be educated about their responsibilities
in donating blood products, not just new donors, and this information
can be provided in many ways -- not just during completion of the donor
questionnaire. Barriers of limited literacy, attention and comprehension
could exist for *any* donor and must be dealt with for all donors.
Finally, the basis for the exception to permit new donors to use
computer-assisted interactive procedures that include an audio component
is not supported by a considerable body of data. In contrast, there is a
considerable body of survey design literature that supports the use of
SAQs over face-to-face interviews. The fact that a computer is asking
the questions provides no more human interaction in which the donor can
comment or ask questions than does a carefully constructed protocol for
self-administration.

A precedent for allowing donor self-administration of a written
questionnaire was established when the American Red Cross received FDA
approval for such an approach, provided that the donors are given an
opportunity to ask additional questions or seek clarification. This
FDA-approved ARC method, which showed no apparent increase in infectious
disease incidence or prevalence rates^2^ has been in general use since
1998. To date, incidence and prevalence data have not shown a compromise
in blood safety as a result of utilizing this alternative screening
methodology.

In other blood centers, it is common practice for both first time and
repeat donors to self-administer the questionnaire, with the exception
of the high-risk questions. This practice has been in place for many
years, and there is no evidence that prohibiting self-administration of
the questionnaire by first time donors would contribute to an improved
donor qualification process.

It is also widely known that the interviewing process itself can
inadvertently serve as a vehicle for introducing error into data
collection. Interviewers may inject such errors, for example, by reading
questions too quickly or with little discussion and voice inflection,
thereby resulting in failure to trigger an appropriate or accurate
response. This can be avoided by having individuals read the questions
themselves, an approach that has been shown to improve respondent focus
and accuracy. Other observed problems are that even well trained
interviewers can start to anticipate responses to questions that have
little response variation, and may also introduce variety into question
administration.

Outside the blood donor screening arena, there is considerable evidence
that people disclose less information of a personal nature, such as use
of alcohol and illicit drugs, sexual behaviors, and mental health, in
the presence of an interviewer. Examples include studies by Aquilino
demonstrating greater likelihood to discuss a history of depression^3^
and admit to use of illegal drugs and alcohol in self administered
questionnaires (SAQs) compared to other modalities,^4^ and Tourangeau et
al, showing a significantly increased likelihood to report a number of
sexual partners, sexually transmitted diseases, and condom use in SAQs
vs. face-to-face interviews .^5^

Viewed alone or in concert, survey design literature and the experience
of survey design experts suggest that any perceived advantage of direct
questioning over SAQs in identifying risks among *blood donors* may no
longer be as great as originally perceived. Much of this literature
compares the use of computer-assisted questioning with the traditional
face-to-face interview, and clearly shows the benefit of
computer-assisted systems. Of the literature that compares self-
administered questionnaires to face-to-face interviews, there is
considerable support for self-administered questionnaires.^3,4,5^

*It is particularly relevant to this discussion to note that the
cognitive interviews performed by the National Center for Health
Statistics as part of the Task Force development of a streamlined
questionnaire assumed a self-administered survey. This offers
reassurance that a SAQ would "work" in a blood donor screening milieu.*
Conversely, there is no guarantee that an interviewer-administered
questionnaire would be as effective.

2\. Section III A 5 requires a method to ensure the donor understands
the questions and requires an evaluation of the donor's ability to read
and understand the language of the self-administered questionnaire. This
is an unrealistic requirement. Task Force experts state that it is not
possible to verify comprehension within the limited context of the donor
screening interview. Survey design experts who work with the Task Force
have indicated that a procedure akin to cognitive evaluation -- and
requiring a questionnaire as long as the donor screening instrument --
would be needed in order to evaluate a donor's comprehension. However,
it is possible to detect whether someone is not paying attention or does
not appear to be reading the questionnaire. The Task Force took the
approach of designing the new questionnaires to detect when someone was
simply checking boxes, by making the "correct" answer vary. Simple
observation can also determine that someone does not appear to be
reading the questions or is inattentive. The Task Force reminds FDA that
blood donation is not done in a vacuum, and that the donor receives
careful attention. We suggest that a better means of evaluating the
donor is to encourage the donor to ask questions and to ensure that
early in the process, he or she is reminded that "blood center staff
want to make sure that you understand the questions. If you have any
questions, please ask the staff." Staff who are readily available to
discuss any questions, and show interest in the donor are far more
likely to recognize donor confusion than any method of asking additional
written or verbal questions.

3\. Section III A 7 recommends that you instruct the donor not to sign
the questionnaire until personnel have reviewed it. The Task Force
points out that not all blood centers have procedures requiring the
donor to sign the actual questionnaire. In most centers, the donor signs
an informed consent only. The guidance should clarify this
recommendation.

4\. Section III A 9 recommends that all new or modified questions be
administered to all donors by direct oral questioning. ***Due to
frequent addition of new donor screening questions, this recommendation
would preclude practical use of a self-administered questionnaire.***
The Task Force recommends that a better approach would be to emphasize
in donor instructions that questions change frequently and that they
should read all questions carefully. This will also avoid undue emphasis
on a change to a question that might be less significant than many other
questions that have not been changed.

5\. Section III B 4 recommends monitoring the donor's attentiveness and
intervening if the donor appears confused or inattentive. While this is
a good suggestion, it is difficult to reconcile with Section III A 3 to
ensure that the donor is answering the questions in a private setting.

6\. Section III C Additional Recommendations for Computer-Assisted
Interactive Procedures is unnecessarily proscriptive and may serve as a
disincentive to adoption of this exciting new technology. For example,
it assumes that personnel will print the electronically captured
questions and review them with the donor. While this is one way to
review the donor's answers, it presents logistical problems for mobiles
where space for printers may be limited. Further, it is also quite
possible to obtain signatures electronically, so a paper document is not
always necessary. Finally, the requirement for an audio component, if
CASI is to be used with new donors, is excessive.

It also is somewhat confusing to find validation requirements detailed
in this guidance. While it may be appropriate to include a statement
that all aspects of the computer system should be validated, these
requirements are not significantly different from validation required
for any computerized or other system.

Finally, the Task Force requests clarification of the intent of the
document. If a blood center has already received approval for
self-administered questionnaires, must they resubmit a request to use
self-administered questionnaires? Must they stop permitting first time
donors to complete a self-administered questionnaire?

The Task Force appreciates this opportunity to comment. If you have
questions or would like additional clarification, please contact Kay
Gregory, director, AABB Regulatory Affairs at <kayg@aabb.org> or
910-842-2790.

Sincerely,

Joy L. Fridey, MD

Chair, AABB Task Force to Redesign the Blood Donor Screening
Questionnaire

References:

1.  Mayo DJ, Rose AM, Matchett SE, et al. Screening potential blood
    donors at risk for human immunodeficiency virus. Transfusion.
    1991;31:466-477

2.  Letter from Brian McDonough (American Red Cross) to Katheryn Zoon,
    PhD, (FDA). February 10, 1998 (FDA code number 98-0921)

3.  Aquilino WS. Effects of interview mode on measuring depression in
    younger adults. Journal of Official Statistics. 1998;14(1):15-29.

4.  Aquilino WS. Interview mode effects in surveys of drug and alcohol
    use: A field experiment. Public Opinion Quarterly. 1994;58:210-240.

5.  Tourangeau R, Rasinski K, Jobe JB, et al. Sources of error in a
    survey on sexual behavior. Journal of Official Statistics.
    1997;13(4):341-365.