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June 24, 2002

Dockets Management Branch (HFA-305)

Docket No. 02D-0080

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

> RE: Draft Guidance for Industry: Streamlining the Donor Interview
> Process: Recommendations for Self-Administered Questionnaires (67 FR
> 19578; April 22, 2002) \[Docket No. 02D-0080\].

Dear Docket Officer:

This letter is to provide public comments on behalf of the American Red
Cross (ARC or Red Cross) concerning the Food and Drug Administration's
(FDA or Agency) *Draft Guidance for Industry: Streamlining the Donor
Interview Process: Recommendations for Self-Administered Questionnaires*
(draft guidance).

The Red Cross, through its 36 Blood Services regions and nine testing
laboratories, supplies approximately half of the nation's blood for
transfusion needs. Blood donated by Red Cross volunteers is also
processed or fractionated into plasma derivatives.

Donor screening is a critical step in the effort to acquire the safest
blood possible and the Red Cross recognizes the importance of having a
donation process that is clear, simplified and as precise as possible.

Thus, we fully support the draft guidance's intent. The Red Cross
provides the attached comments in the hope that they will be
constructive in aiding the development of a final guidance. Our key
points are as follows:

-   In the absence of data to demonstrate differences between the
    comprehension of first time and repeat donors, ARC requests that FDA
    revise the draft guidance to assure a uniform screening process by
    allowing all donors to use a self-administered questionnaire.

-   ARC requests that FDA reconsider the requirement to include use of
    an audio component for first time donors using Computer-Assisted
    Interactive Procedures.

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-   ARC requests that FDA modify areas in the draft guidance where
    volunteer donors may misconstrue the blood center's efforts to
    comply with the requirements for donor health history
    administration.

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-   ARC recommends that FDA streamline the draft guidance especially in
    identified sections that overlap with other regulations and/or
    guidances as well as requirements that we believe are unnecessarily
    detailed. Specific examples are included in the attached comments.

Thank you again for the opportunity to comment. If you have any
questions, please contact Anita Ducca at 703-312-5601.

Sincerely,

Gary D. Dolch, Ph.D.

Senior Vice President

Quality and Regulatory Affairs

Biomedical Services

Attachment

**Comments by**

### **The American Red Cross**

**On the**

**Draft Guidance for Industry:**

Streamlining the Donor Interview Process:

Recommendations for Self-Administered Questionnaires

67 FR 19578; April 22, 2002

Docket No. 02D-0080

The American Red Cross (ARC or Red Cross) is pleased to provide these
comments to the Food and Drug Administration (FDA) on the *Draft
Guidance for Industry:*

*Streamlining the Donor Interview Process: Recommendations for
Self-Administered Questionnaires* (draft guidance). Our views are
identified by the draft guidance's section containing the
recommendation.

# ii. Background

Under the background section, FDA defines the options available for
self-administering the donor questionnaire. Options #1 and \# 3 contain
brief descriptions of the media and how the donor might use it. However,
Option #2 does not. Rather, it states that such an option exists:

> Audio and/or visual presentation of the questions. The donor reviews
> the media and documents the answers on a printed form. Your personnel
> review the answers.

This does not actually contain a description of "Audio." For example,
there is no indication of the type of equipment that may be used by a
donor. ARC recommends that FDA clarify this option. The description
might be revised to read:

> Audio and/or visual 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.

**III. A. Recommendations for Manual Procedures**

**Title** - ARC believes that FDA intended to make the requirements of
this section applicable to all forms of self-administered
questionnaires, including the audio and computer-assisted interactive
interview. To clarify the applicability, ARC recommends changing the
title of this section from "Recommendations for Manual Procedures" to
"Recommendations for *All Self-Administered Procedures.*"

**Introductory Paragraph** - To be consistent with the intention of
making this section apply to all media, we recommend the following
changes in the first paragraph of this section:

-   Delete the term "manual" in the first sentence, since the guidance's
    recommendations for this section will apply equally to audio and
    computer assisted self-administration.

-   Insert the phrase *"listens to and/or sees"* in the first sentence
    directly after the phrase "as one in which the donor reads\..." This
    change is to explicitly define the broader applicability.

-   Delete the phrase *"*printed answer form" after the phrase
    "documents his/her answers" since the donor may be assisted by an
    alternative form of documentation such as a computer.

After the changes noted above, the first sentence would read:

> We define the self-administered pre-donation questionnaire as one in
> which the donor reads, listens to and/or sees the medical health
> history questions and/or high-risk questions and documents his/her
> answers.

FDA may find that this change leaves the guidance without a complete
definition of the manual self-administered questionnaire. If this is the
case, we recommend that FDA include the definitions of each form of the
self-administration questionnaire in the previous section, i.e., Section
II. Background.

**Point #4 --** ARC requests that FDA reconsider the recommendation
that: "You should not allow new donors to self-administer the donor
questionnaire\..."

To our knowledge, there are no data demonstrating that a first-time
donor is less likely to understand a self-administered questionnaire
than repeat donors. Further, many donor centers are examining new
technologies and the efforts to simplify the Donor Health History have
made considerable progress. Donor centers may have or may be able to
develop self-administered questionnaires that are equally comprehensible
to first time and repeat donors. Thus, ARC requests that FDA modify this
requirement to allow the option for first time donors to use a
self-administered questionnaire.

Should the FDA feel that further direction is needed, the Agency could
recommend that blood collection centers determine, through pilot testing
or other means, that the comprehension of first-time donors is
equivalent to that of repeat donors prior to implementation.

**Point #5** - Also of major concern is the requirement to "include an
evaluation of the donor's ability to read and understand the language of
self-administered questionnaire\..."

This requirement is very subjective. It will be interpreted and
conducted in a highly variable manner among the blood collection
facilities, and similarly be subject to highly variable interpretations
by FDA investigators. Is merely asking the donor if they can read the
questionnaire sufficient for an "evaluation"? Or, does FDA intend
something more rigorous?

Regardless of how carefully donor center staff fulfill this requirement,
some donors may misconstrue this form of evaluation. We particularly
risk offending qualified donors for whom English is a second language.

ARC also believes this requirement is unnecessary given the full support
for donors before, during, and after the questionnaire answering process
as required throughout the draft guidance. For example, as defined in
Point #6, donor centers must provide options for donors who request
assistance, including direct oral questioning.

We believe these activities and all the other practices for aiding
donors at the blood donation sites will ensure the donor's
comprehension, or provide other means to complete the questionnaire if
uncertainties exist. ARC recommends eliminating this "evaluation"
requirement.

**Point #7** - This point states that "The instructions and
questionnaire must be in a language the donor readily understands." ARC
is uncertain whether FDA believes that all donors must be provided with
a translation if English is a second language, or whether the guidance
was referring to the donor's reading/educational level as an indication
of their ability to understand the questionnaire.

ARC has translated the donor materials into Spanish. However, having
translations available for any possible language that a donor may be
more familiar with is unrealistic, and we request that FDA delete this
specification. As noted in other sections of this attachment, there are
many other provisions for overseeing the donor, providing assistance,
and verifying answers so that a translation for each and every language
would not be necessary.

**Point #9** - This provision requires donor center staff to "administer
the new or modified questions to all donors by direct oral questioning
or provide all donors with a detailed description of the changes\..."
How this requirement would be carried out in actual practice and whether
it is intended for all forms of self-administered questionnaires is
unclear to ARC.

For example, if it has been a year or more since a repeat donor has
donated, would we be expected to identify records of previous donations
and questionnaires, cross compare them for questions that may have
changed since that date, then verbally ask the new or revised questions?
Once we've asked the new questions, or provided the required detailed
information, would we then ask the donor to switch to filling out the
rest of the questionnaire through the manual, audio/visual, or the
computer-assisted method?

If this is the intent, ARC's concern is that carrying out this directive
will not occur without a significant slow-down in the donation process.
Additionally, the potential for the donor to fail to recall the date and
location of the last donation exists, so that there would be limited
ability to fulfil this requirement if the previous donation was made at
a non-ARC donation center.

Job aids might ease some of this activity, but they will not completely
eliminate delays. Automation could be considered, but such software will
require substantial time to develop, test, and implement. It may be
particularly cumbersome to work with automation at a mobile collection
site. Moreover, if incorporated into a computer-assisted interactive
procedure, automation will not alleviate all delays such as those that
may be associated with switching from answering some questions orally to
answering others through the computer-assisted procedure.

Additionally, if donor centers highlight new questions, it may appear
that the new questions are more important than the previously existing
ones. Donors may erroneously believe that if they focus on the new
questions, the accuracy of the others is of lesser consequence. We want
to be sure that donors treat all questions with an equal level of care
and attention.

ARC urges FDA to reconsider and eliminate this requirement.

**Point \# 10** --ARC believes that quality assurance practices should
extend to the self-administered questionnaire. However, this point
emphasizes one aspect of quality assurance, i.e., an effectiveness check
of the self-administered questionnaire. As a result:

-   Donor centers may spend efforts checking the effectiveness of the
    self-administered questionnaire, when quality assurance of other
    processes might be more beneficial.

-   It appears that the draft guidance requires blood collection centers
    to continue quality assurance effectiveness checks, even if the
    effectiveness checks produce satisfactory results. Blood centers may
    find that they must continue an unnecessary task.

-   This point may be unnecessary given validation requirements. Many of
    the concerns that might be found after implementation, would be
    identified and resolved before implementation.

Blood Establishments do not object to following quality assurance
requirements, but these are fully discussed in other regulations and
guidances including the July 11, 1995 *Guideline for Quality Assurance
in Blood Establishments* and CFR 820.20, 820.22, and 211.22.

We believe these existing regulations and guidances provide full
direction on quality assurance practices, and pertain to the
self-administered questionnaire. Thus, there would be no detrimental
public health consequence by deleting this point, and we encourage the
FDA to do so.

If the Agency still believes a reminder to perform quality assurance
steps is needed, point #10 could be amended to do so, but we urge
referring to the quality assurance regulations and guidance noted above
rather than effectiveness checks. Noting quality assurance
specifications within a document designed for a different purpose adds
to the difficulty of monitoring all regulatory requirements.

If effectiveness checks are of particular concern to FDA, it would be
more appropriate to discuss them in a revision to the 1995 *Guideline
for Quality Assurance in Blood Establishments,* so that all the Quality
Assurance requirements for blood establishments are retained in one
guidance.

**III.B. Additional Recommendations for the Use of Audio/Visual Tools**

ARC agrees in concept with the goals of this section. However, we note
that some requirements tend to be subjective, are unnecessarily
detailed, or risk offending the donors who may regard the required form
of oversight as intrusive. ARC recommends revision of these points, so
that the donor center has greater flexibility to implement the
audio/visual tools and establish a more congenial environment for the
donors.

**Point #3** -- This point states that blood collection facilities
should:

> "Instruct new donors to immediately document answers to
> questions\...and not answer before the recording finishes\... instruct
> the donor to listen to or read the whole question before
> responding\..."

This point comes across as a somewhat heavy-handed approach to guiding
donors. Blood donors are volunteers, many make great sacrifices of time
and comfort in order to give blood. Donors will be reluctant to return
if they do not feel they are treated with a high degree of respect. A
more affable approach will help make the donation experience as pleasant
as possible for them.

Also, the main concern is that the donors understand the question,
regardless of whether they are reading or listening. We recommend the
following revised version:

> To help the donor hear or read the questions, including any new or
> revised versions, provide information appropriate for assuring the
> donor's comprehension prior to response to questions delivered through
> an audio medium. Such information would include being sure to
> understand the question before responding, and documenting answers as
> soon as the question is completely understood.

**Point #4** - Similarly, ARC understands FDA's objective, but finds
that this point's specificity may be problematic during implementation.
For example, if the recording does not pause, the donor may be able to
follow along with a written copy of the questions rather than discussing
it with the donor center staff.

ARC recommends revising this point to read as follows:

> Your system may allow the donor to pause the recording to replay the
> question, or to ask for clarification. If the donor is not able to
> pause the recording, make provisions for clarifying the question for
> the donor prior to recording a response.

**Point #5** -- This point states that donor centers "should monitor the
donor's attentiveness and be ready to intervene if the donor appears
confused or inattentive." This directive is very subjective, and will be
difficult to implement without appearing overly intrusive to some
donors.

In addition, the goal of the questionnaire is to obtain the most
accurate answers possible. Pilot testing prior to use is likely to
identify alternative measures to help ensure the donor is attentive,
understands the questions, and answers accurately. Pilot testing may
also reveal that the monitoring described in this point may be either
unnecessary or of little use in actual practice. Further, Section III.A.
provides full guidance on giving the donors adequate instructions and
opportunities for questions.

ARC recommends eliminating this point. If there is some lingering
concern, the draft guidance could be amended to recommend that the donor
center staff remain ready to assist the donor whenever needed.

**Point #6** -- This point discusses working with multiple donors
listening to an audio questionnaire. The main concern is whether the
donor can confidentially answer the questions. Thus, the goal is to give
all donors adequate privacy when they are answering the questions,
regardless of whether there are other donors listening at the same time.

We recommend revising this point to read as follows:

> The donor center's SOP should include provisions for
> self-administration if more than one donor will be listening and/or
> watching the visual display at one time. The provisions should include
> determining an appropriate number of donors for joint listening and
> ensuring privacy when answering the questions.

**III.C. Additional Recommendations for Computer-Assisted Interactive
Procedures**

**Point #1 --** The draft guidance states that a "New donor may use the
computer-assisted interactive procedures provided there is an audio
component with the system."

Similar to our comments on Section III.A., Point #4, ARC requests that
FDA reconsider this requirement. In the absence of data to demonstrate
there is a reason to differentiate, we ask FDA to revise this
recommendation to allow blood collection centers to use the
self-administered questionnaire, without an audio component, on all
donors.

We would like to point out that this revision would be particularly
important for those new donors who may be hearing impaired.

**Point #2** -- This recommendation contains several provisions,
including where to place the printers, review of the answers by the
donor and the donor center staff, and signature requirements.

We do not believe that specifying a printer location is needed as long
as the donor's responses are kept confidential. ARC recommends that FDA
revise the guidance to remind donor centers to ensure the
confidentiality of the donor's answers throughout the process rather
than include a statement about printer placement.

ARC understands the goal of requiring the donor center staff to review
the answers. However, we believe this requirement may not be necessary
in the future as technology advances.

ARC recommends allowing greater flexibility by revising the draft
guidance to specify that the SOPs should define, using fully tested
procedures or technology, how the donor center will ensure that the
answers are complete and as accurate as possible prior to signature.
Further, we urge establishing this requirement without specifying that
the donor center staff must perform the review. This will provide the
flexibility to have either the donor center staff review the answers, or
take advantage of technology that may be developed in the future to do
so.

We also strongly urge FDA to eliminate the requirement to have the donor
sign a paper copy. In the future, donor centers would like to have the
flexibility to use new technologies that might allow use of electronic
signatures, as long as they follow the specifications of CFR Part 11. If
a requirement for a signed paper copy remains in this draft guidance,
donor centers may not be able to use such technological advances.

**Point #3** -- This point contains several validation provisions.
However, there are numerous validation provisions already existing in
other regulations and guidances, including medical device regulations,
and we do not believe there is a need for establishing overlapping
requirements in the draft guidance. Thus, we request a revision to avoid
the potential for conflicting efforts if an additional set of
requirements, terminology definitions, and other specifications result
from the duplication.

ARC recommends specifying only that validation should take place, and
citing the applicable regulations and guidances. ARC recommends revising
this point to read:

> You should validate all aspects of your computer system for its
> intended use. You should perform this validation based on the
> provisions contained in: References 7 and 10, CFR 820.100, the August
> 1999 *Guide to Inspections of Quality Systems*, and the Jan. 11, 2002
> *Guidance on General Principles of Software Validation: Final Guidance
> for Industry and FDA Staff*.

**Additional Point** - Although not mentioned in the draft guidance,
Computer Assisted Interactive Procedures are likely to be using computer
software that would be defined as Medical Devices. ARC recommends adding
a reminder for blood collection centers, where appropriate, to submit
such software under Section 510(k) for FDA review prior to use.

**Closing**

Again, the Red Cross appreciates the opportunity to provide these
comments. If there are any questions, please contact Anita Ducca at
703-312-5601