October 28, 2003

Division of Dockets Management (HFA-305)\
Food and Drug Administration\
5630 Fishers Lane, Room 1061

Rockville, MD 20852

RE: Docket No. 2003N-0211: Revisions to Labeling and Storage Requirments
for Blood and Blood Components, Including Source Plasma

To: FDA Dockets Manager

Long Beach Memorial Medical Center Blood Bank is a hospital based Blood
Bank in a 700+ bed community medical center. We collect 4 -- 5,000 units
of whole blood and 400 plateletpheresis products annually. Over 12,000
units of red cells are transfused at our facility annually.

Long Beach Memorial Medical Center (LBMMC) Blood Bank (BB) appreciates
the opportunity to comment on the Food and Drug Administration's (FDA)
proposed rule concerning revisions to the labeling and storage
requirements for blood and blood components. Simplifying, updating and
consolidation of regulations into one section of the CFR is a welcome
change. However, we would like to comment on some of the proposed rules
and the significant impact we expect these changes will have on our
processes and the resultant increased cost of compliance.

A.  *Proposed change in FFP expiration date based on storage
    temperatures:*\
    All of the blood centers who currently supply our facility with
    products use the AABB\
    Standards for Blood Banks and Transfusion Services storage
    requirement/expiration date of\
    1 year for FFP and cryoprecipitate stored at --18C or colder. This
    allows our computer system to have one product code each for FFP and
    cryoprecipitate. BB staff clearly know the expiration date (1 yr) of
    these products because there is no choice other than 1 yr. However,
    alteration of the storage/expiration date to either 2 yrs if --25C
    or 3 mo if --18 to --35 complicates the processes of handling these
    products. Specifically, a Transfusion Service or BB will need to
    have two types of computer product codes for FFP and two for
    cryoprecipitate to accommodate products that may have either of the
    expiration dates and to assure the correct expiration date is
    utilized. Staff will not easily be able to determine the correct
    product code to use for incoming products because the products would
    both be labeled FFP (or cryoprecipitate). The determination as to
    whether the product is a --25 FFP or a --18 FFP will have to be made
    by closely reading the storage temperature on the product labels.
    While we agree that BB staff should always be reading labels, it
    seems to us to be counterproductive to all the current medical
    safety goals to develop a system that inherently opens the
    possibility for errors by having two products with the same name and
    only different storage temperatures.\
    \
    We believe that the development and validation of new computer
    codes, designing a process to\
    decrease the possibility of computer entry errors between the --18
    and the --25 products, revising related procedures and training
    staff will require significant time (4 to 6 weeks) for our facility.
    Additionally we will have to develop on-going monitoring of the
    correctness of product entries in a more detailed manner than what
    we currently utilize. Labels with the proper storage temperatures
    will need to be designed, ordered and a supply maintained.
    Significant "compliance costs" will be associated with these
    implementation and on-going activities required by the proposed
    storage/expiration date changes.

B.  *Proposed requirement to label blood products with results of
    communicable tests:*\
    Currently blood and components we receive from our blood suppliers
    are not labeled with the\
    results of all the communicable disease tests done on blood units.
    Industry practice for\
    several years has been to include the communicable test results
    information in the\
    Circular of Information that is made available to all interested
    transfusionists.

To accomplish these new labeling requirements will require printing of
new labels not only initially, but every time a new test is added to the
donor communicable disease test panel, a not infrequent occurrence in
recent years.

We believe that this additional labeling information will further
clutter the current, already "full" blood product labels. "Busy" labels
seem to be counterproductive to a very important goal of blood product
labeling -- that of assuring the correct product is transfused to the
correct patient. While, in an ideal world, the transfusionists would
read and evaluate every word on a\
blood product label, our experience tells us that this does not occur
and, to best assure the correctness of patient identification at the
bedside by the transfusionist and thus better assure patient safety, we
need continue our basic philosophy of "keep it simple" as related to
blood product labels.

In summary, we believe the aspects of the proposed rule changes
discussed above do not reflect "current industy practice", will result
in significant compliance costs for our facility both immediately and on
an on-going basis and will complicate systems and process that we feel
need to be kept as\
simple and straightforward as possible.

Thank you for the opportunity to comment on the proposed rules.

Sincerely,

Emanuel Ferro, MD Janet Kay Wilson, MT(ASCP)SBB

Medical Director Quality Assurance Supervisor, Blood Bank\
Long Beach Memorial Medical Center and Department of Pathology

2801 Atlantic Ave (562)933-0814

Long Beach, CA 90806 <jwilson@memorialcare.org>\
(562)933-0829\
eferro@memorialcare.org