\-\--

Specific concerns:

Combined requirements

-This may not be productive from the standpoint of the users of the
regulations. Source Plasma establishments collect Whole Blood for very
different uses, and community blood banks rarely collect Source Plasma.
Adding information about rules which do not apply is more likely to
confuse the reader.

§1271 rules

-The definition for blood in the revised §606.3 includes several
products which are also HCT/Ps covered under §1271. Do establishments
that handle these products follow these rules or the HCT/P rules?
21CFR1271.3 includes a definition of HCT/P which excludes blood and
blood components, and it would make sense to have an equivalent
statement which excludes HCT/Ps from the §606.3 definition.

List content

-For §606.160(e)(2), consider including §630.10(g)(7), postpartum
deferrals, on the distributed deferred donor lists.

Bacterial detection and notification

-Limit notification requirements to deferral, anything further is
probably practice of medicine.

Plasma industry practice

-§630.5 (medical supervision) refers to §630.15(b) (physical exams of
donors) for exceptions, but there are no exceptions to medical
supervision in those sections. These tasks are routinely performed by
physician substitutes for the plasmapheresis industry as discussed in
§630.5(c). The eligibility for the program is by "responsible
physician", but eligibility for a donation is by staff.

Exemptions

-§630.10 gives exemptions where the physician may allow a donor to
donate when criteria are not met. Many blood banks allow specific
subsets of donors (e.g. donors who are fit and have a low pulse) outside
of these ranges by procedure without approval.

§630.10(h)(5) gives a minimum weight. Autologous donors are sometimes at
less than this weight and collections are adjusted by established
procedures. Do these now require a specific approval from the physician
(§630.20) or a variance?

Similarly, the exception for autologous donations as written would
require a specific approval from the responsible physician for
conditions that are irrelevant to autologous donors. The ordering
physician is almost never a blood bank physician, and in many cases is a
specialist who is unfamiliar with the patient's overall medical history.

Weight loss tracking

-§630.10(h)(5) has a separate requirement regarding weight losses. This
is a symptom of HIV, but it is a nonspecific symptom. Weight losses were
never numerically tracked in Whole Blood donors. Plasma donors were
previously screened for ten pound weight losses over specific time
periods. The "ten percent over six months" standard is new.

Apheresis

-The revised §630.15 talks about "double unit collection programs."
These procedures often have additional and different donor suitability
requirements. A requirement to follow the manufacturer's directions
would be consistent with §606.65(e). The rules also do not capture
apheresis procedures for the purposes of producing transfusable
components other than platelets.

Availability of the "collective list"

-The requirement for using deferral lists solely for subchapter F of 21
CFR chapter 1 should be broadened slightly so that deferral information
from blood donation can be used to determine the eligibility of HCT/P
donors. This is especially important for cadaveric tissue, where medical
history cannot be obtained from the donor directly and information from
prior blood donations may identify potential donors whose tissue is not
suitable.

HIPAA and lists

-A large number of registered facilities are subject to HIPAA (i.e.
hospital blood banks) but they tend to have relatively limited
collection operations. In our area, the only hospitals that collect
blood for transfusion do so for autologous use. Limiting distributed
lists of deferred donors to allogeneics would remove them.

\-\--

Minor issues:

The revised §606.100 begins "Establishments must establish..." The term
"Establishment" is not defined, and this section could probably be
written more clearly in a question and answer plain language format.

The line "for all steps in the investigation of product deviations
related to §606.171" should probably be moved to a new section
§606.100(b)(22). Procedures for reporting donor and recipient fatalities
are also generally expected, and they could also be explicitly addressed
in this section.

The revised §606.160(e)(2) refers to a "collective list." While
technically correct, the word "collective" is unnecessary and not plain
language. Compare: "Establishments must provide to appropriate personnel
at all locations operating under the same license or common management a
list of ineligible donors with sufficient information..." (Two commas
were also removed).

§630.5(e) should probably read "...operating procedures for providing,
within 15 minutes, emergency medical services for donor when..." or
"...operating procedures for providing emergency medical services within
15 minutes for donors when..." Since this is a requirement for
procedures, it would probably make more sense to put it in §606.100 with
the list of required procedures.

In §630.10(c), "one day" probably means "the previous calendar day" and
not exactly 24 hours. This could be clearer.

§630.10(g)(1) and (g)(3) appear to be redundant.