**Blood Bank of Delmarva, Inc. (BBD), FDA License# 1707, comments are as
follows:**

**#1** pg 63420, Section III.C (Records), 606.160(e) (2) (Shared Donor
Deferral Registry)

**FDA's proposal:** That all donor screening locations of a collecting
establishment operating under a common organization use a collective
master list of donors determined at each location to be ineligible to
donate. Under proposed 606.160(e)(2), we are proposing to limit entry
into the shared donor deferral registry to those donors who are
determined to be ineligible to donate due to a possible exposure to a
relevant transfusion-transmitted infection.

**BBD's Comments:**

BBD's comments on feasibility of sharing donor deferral lists between
licensed establishments for deferrals required by the FDA are:

-   Ineffective attempts in the past

-   No unique donor identifier available, donor SSN is not currently
    being captured.

-   Donor confidentiality may not be protected.

-   Overall consensus: will be an inefficient system

**#2** pg 63421, Section D. 3, (Testing for Bacterial Contamination for
Platelets and Other Transfusible Blood Components), 630.30(a) (5)

**FDA's proposal:** That a platelet component would not be suitable
until tests for bacterial contamination are found negative.

**BBD's Comments:**

At what point do you consider the bacterial detection test to be
negative? BBD (like many other blood centers) utilizes the BacTAlert
system which continually monitors culture bottles inoculated with a
sample product for the entire lifespan of the product. A final culture
result of "Negative" is not truly obtained until the platelet product
actually expires.

**#3** pg 63422 and 63423, Section G, 630.5 (a) and (b) (Medical
Supervision)

**FDA's proposal:** Would require an establishment to have a responsible
physician present during the determination of eligibility of a donor,
the collection of blood and blood components.

**BBD's Comments:**

BBD agrees that the responsible physician would direct and control the
physician substitutes and trained personnel and would permit collecting
establishments to authorize trained personnel, including physician
substitutes, to determine the donor's eligibility and collect blood and
blood components in the absence of a responsible physician.

**#4** pg 63423, Section G (Medical Supervision), 630.5(e)

**FDA's proposal:** The collecting establishment would be required to
have SOPs for providing emergency medical services to a donor within 15
minutes when necessary.

**BBD's Comments:**

BBD would require blood collection personnel to:

-   Be trained in CPR / AED

-   Call 911 and transport donors to a medical facility for emergency
    care as soon as possible.

**#5** pg 63423, Section H.1 (General Donor Eligibility Requirements)
630.10(b) **FDA's proposal:** Educational Material to be provided to all
donors, before donation, with information about the relationship among
behaviors that increase risks of relevant transfusion-transmitted
infections, signs an symptoms of such infections, and the consequent
risk to the safety of the blood and blood component. When screening for
behavioral risk factors is required for a relevant
transfusion-transmitted infection (for example, HIV, HBV, or HCV), the
material would instruct the donors to self-defer if they determine that
they have participated in an increased --risk behavior, or show signs or
symptoms of that relevant transfusion-transmitted infection.

**BBD's Comments:**

BBD supports UDHQ's recommended educational material (AABB to drive the
changes).

**\# 6** pg 63425, (Signs and symptoms of relevant
transfusion-transmitted infections) 630.10(f) (3)

**FDA's proposal:** We would require blood establishments to assess
donors for signs or symptoms of relevant transfusion-transmitted
infections; donors exhibiting such signs or symptoms would be ineligible
to donate blood and blood components.

**BBD's Comments:**

BBD's current method of donor screening and future implementation of
UDHQ requires checking donor's temperature, blood pressure, pulse and
hemoglobin and a visual assessment of donor's condition; no further
assessment of donor's signs and symptoms of relevant
transfusion-transmitted infections is performed.

**\# 7** pg 63425, (Percutaneous exposure) 630.10(f) (6)

**FDA's proposal:** Require collecting establishments to assess whether
a donor had a nonsterile percutaneous inoculation within the past year.

**BBD's Comments:**

BBD suggests that deferral period for percutaneous inoculations be for
four months instead of 12 months based on current testing for infectious
diseases.

**\# 8** pg 63426 (Major surgical procedure) 630.10 (g) (3)

**FDA's proposal:** Would require establishments to defer donors who
have experienced major surgery within the past 12 months.

**BBD's Comments:**

BBD requests clarification on major verses minor surgical procedure.
Such conditions to be evaluated by Medical Director and if released from
care with no complications, should be eligible to donate.

**#9** pg 63426 (Xenotransplantation product recipient and intimate
contact) 630.10 (g) (5)

**FDA's proposal:** The potential for infectious disease transmission
and public health risks associated with xenotransplantation products.

**BBD's Comments:**

Need more details regarding the types of xenotransplantation products
that may have the potential for infectious disease transmission and may
cause any public health risks.

**#10** pg 63426 (Unreliable answers) 630.10 (g) (8), Section 640.63 (d)

**FDA's proposal:** Requires plasma establishments to defer a donor of
blood and blood components from donating if, in the opinion of the
interviewer, the individual appears to be under the influence of drugs
or alcohol, or does not appear to be providing credible answers to
medical history questions.

**BBD's Comments:**

BBD's assessment of a donor for impairment due to the influence of drugs
or alcohol beyond a visual and auditory assessment would be
unreasonable.

**#11** pg 63427 (Pulse) 630.10 (h) (4)

**FDA's proposal:** Irregular pulse to be below 50 beats per minute or
above 100 beats per minute.

**BBD's Comments:**

Any unexplained irregular pulse should be assessed by the donor's
physician prior to donation and further evaluated by the collecting
establishment's Medical Director.

**#12** pg 63427 (Weight) 630.10 (h) (5) and 606.160 (b) (1) (i)

**FDA's proposal:** Requires minimum weight of 110 lbs and collecting
establishments would be required to retain documentation of donor's
response if the donor experienced an unexplained weight loss greater
than 10% of body weight within past 6 months.

**BBD's Comments:**

The current FDA approved UDHQ (AABB version 1.1), does not require this
as a donor eligibility/suitability criteria.

**#13** pg 63428 (Proof of identity and mailing address) 630.10 (i) (1)
and 606.160 (b) (1) (x)

**FDA's proposal:** Would require collecting establishments to obtain
photographic identification with current address.

**BBD's Comments:**

It is not always possible to obtain photographic identification, Amish
community is an example, procedure should allow for other means of
identifying the donor.

**#14** pg 63428 Section I. 1 (Donor Eligibility Requirement Specific to
Whole Blood and Plasma Collected by Plasmapheresis) - Whole Blood
Donation Frequency 630.15 (a) (1)

**FDA's proposal:** A donor may donate sooner than the proposed required
time period if the collecting establishment's responsible physician
examines and certifies the donor to be in good health and one of the
following three conditions exists:

-   Donor presents a physician's prescription for a therapeutic
    phlebotomy.

-   The donation is an autogolous donation.

-   Donation dedicated to a specific recipient based on documented
    medical need.

-   **BBD's Comments:**

BBD suggests that the decision should be based on the following
criteria:

-   A treating physician's order to draw the donor

-   Donor History

-   Mini physical prior to donation ( B/P, Temp., Pulse, Hgb, and Arm
    check)

-   Review by Medical Director / Designee

-   Complying with BBD's procedures that address donor safety, along
    with product safety, purity and potency.

**#15** pg 63429 2.a. (Plasma Collected by Plasmapheresis -- Examination
by a responsible physician) 630.10, 630.15 (b) (1)

**FDA's proposal:** Would require initial and annual examination by a
responsible physician.

**BBD's Comments:**

Requiring a responsible physician to examine donor is restrictive,
plasmapheresis collection has taken place for years without risk to
donor. Annual and initial exam is unnecessary for infrequent donors and
donors not participating in immunization program.

**#16** pg 63429 Section 2. b. (Weight) 630.15 (b) (2)

**FDA's proposal:** FDA is soliciting comments with supporting data on
the usefulness of measuring weight loss at the time of donation by
apheresis as an indicator to identify health problems with the donor.

**BBD's Comments:**

We do not believe this is useful , however, we have no supporting data.

**#17** pg 63430 Section K (Exceptions from Certain Donor Eligibility
Requirements for Infrequent Plasmapheresis) 630.25 (3^rd^ bullet point)

**FDA's proposal:** To reduce the medical examination and laboratory
testing burden on collecting establishments when donors are
participating in plasma collection programs at intervals of 4 weeks or
more providing the donor is determined by the responsible physician to
be in good health.

**BBD's Comments:**

BBD suggests that the interval should be more than 4 weeks, if the
responsible physician is the donor's physician who determines the donor
to be in good health.

**#18** pg 63431, Section O (Eligibility Requirements Specific for
Platelet Donors) 640.21

**FDA's proposal:** Plateletpheresis donation at intervals less than 8
weeks provided: (2^nd^ bullet) The pre-donation count is greater than
150,000/uL; and the donor's post-donation count is no less than
100,000/uL

**BBD's Comment:**

Our current practice is as follows:

In the event, the donor's post count is less than 100,000/uL it should
be reviewed by the Medical Director, it should not be a reason for
deferral for subsequent donations. Pre-count, in some instances, may not
be able to be performed, however, the blood bank should be allowed to
use a post count from a previous donation to qualify donor provided

( #18 BBD's comment continued)

the post count from previous donation is 150,000/uL or higher. If
platelet count falls below 100,000/uL it will be reviewed by blood bank
Medical Director and, based on donor history, Medical Director may deem
donor eligible for future donations.

**#18A** pg 63431, Section O (Eligibility Requirements Specific for
Platelet Donors) 640.21(e)

**FDA's proposal:** If, over an 8-week period, a donor cumulatively
loses 450 mL or more of whole blood or 200 mL or more of red blood
cells, or donates a unit of Whole Blood, the collecting establishment
must defer the donor for 8 weeks; or if the donor participates in a
double Red Blood Cells unit collection program, the collecting
establishment must defer the donor for 16 weeks. An exception to this
proposed requirement would be permitted when:

-   The donor waits 2 calendar days for plateletpheresis after donating
    Whole Blood or sustaining a blood loss and

-   The extracorporeal red blood cell volume during the plateletpheresis
    procedure is 100ml or less.

    **BBD's Comments:**

BBD disagrees with the exception that the donor waits 2 calendar days
for plateletpheresis after donating Whole Blood or sustaining a blood
loss and the extracorporeal Red Blood Cell volume during the
plateletpheresis procedure is 100ml or less. There is a potential for
plateletpheresis donors to lose more than 100 ml of Red Blood cells
based on the type of machine used and the donor's hematocrit. For
example, Fenwal's Amicus has an extracorporeal blood volume of 209 or
205 based on kit type. Considering that the acceptable hematocrit range
for the donor is 38% - 55%, the donor could potentially lose greater
than 100 ml of red blood cells. Therefore, we believe that a Whole Blood
donor should have to wait 8 weeks before donating Plateletpheresis,
unless the instrument used is designed to collect less than 100ml of Red
Blood Cells, regardless of the donor's hematocrit, when the donor is not
fully re-infused.