21cfr1271

§ 1271.47

21 CFR Ch. I (4–1–06 Edition)

has been determined to be eligible, except as provided under §§ 1271.60(d),
1271.65(b), and 1271.90 of this subpart.
(d) Applicability of requirements. If you
are an establishment that performs
any function described in this subpart,
you must comply with the requirements contained in this subpart that
are applicable to that function.
[69 FR 29830, May 25, 2004, as amended at 69
FR 68681, Nov. 24, 2004]

§ 1271.47 What procedures must I establish and maintain?
(a) General. You must establish and
maintain procedures for all steps that
you perform in testing, screening, determining donor eligibility, and complying with all other requirements of
this subpart. Establish and maintain
means define, document (in writing or
electronically), and implement; then
follow, review, and as needed, revise on
an ongoing basis. You must design
these procedures to ensure compliance
with the requirements of this subpart.
(b) Review and approval. Before implementation, a responsible person must
review and approve all procedures.
(c) Availability. Procedures must be
readily available to the personnel in
the area where the operations to which
they relate are performed, or in a nearby area if such availability is impractical.
(d) Departures from procedures. You
must record and justify any departure
from a procedure relevant to preventing risks of communicable disease
transmission at the time of its occurrence. You must not make available for
distribution any HCT/P from a donor
whose eligibility is determined under
such a departure unless a responsible
person has determined that the departure does not increase the risks of communicable
disease
transmission
through the use of the HCT/P.
(e) Standard procedures. You may
adopt current standard procedures,
such as those in a technical manual
prepared by another organization, provided that you have verified that the
procedures are consistent with and at
least as stringent as the requirements
of this part and appropriate for your
operations.

§ 1271.50 How do I determine whether
a donor is eligible?
(a) Determination based on screening
and testing. If you are the establishment responsible for making the donoreligibility determination, you must determine whether a donor is eligible
based upon the results of donor screening in accordance with § 1271.75 and
donor testing in accordance with
§§ 1271.80 and 1271.85. A responsible person, as defined in § 1271.3(t), must determine and document the eligibility of a
cell or tissue donor.
(b) Eligible donor. A donor is eligible
under these provisions only if:
(1) Donor screening in accordance
with § 1271.75 indicates that the donor:
(i) Is free from risk factors for, and
clinical evidence of, infection due to
relevant communicable disease agents
and diseases; and
(ii) Is free from communicable disease
risks
associated
with
xenotransplantation; and
(2) The results of donor testing for
relevant communicable disease agents
in accordance with §§ 1271.80 and 1271.85
are negative or nonreactive, except as
provided in § 1271.80(d)(1).
§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete;
and what records must I retain?
(a) Accompanying records. Once a
donor-eligibility determination has
been made, the following must accompany the HCT/P at all times:
(1) A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to
the donor and to all records pertaining
to the HCT/P and, except in the case of
autologous donations, directed reproductive donations, or donations made
by first-degree or second-degree blood
relatives, does not include an individual’s name, social security number, or
medical record number;
(2) A statement whether, based on
the results of screening and testing,
the donor has been determined to be eligible or ineligible; and
(3) A summary of the records used to
make the donor-eligibility determination.
(b) Summary of records. The summary
of records required by paragraph (a)(3)

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Food and Drug Administration, HHS

§ 1271.60

of this section must contain the following information:
(1) A statement that the communicable disease testing was performed
by a laboratory:
(i) Certified to perform such testing
on human specimens under the Clinical
Laboratory Improvement Amendments
of 1988 (42 U.S.C. 263a) and 42 CFR part
493; or
(ii) That has met equivalent requirements as determined by the Centers for
Medicare and Medicaid Services in accordance with those provisions;
(2) A listing and interpretation of the
results of all communicable disease
tests performed;
(3) The name and address of the establishment that made the donor-eligibility determination; and
(4) In the case of an HCT/P from a
donor who is ineligible based on screening and released under paragraph (b) of
§ 1271.65, a statement noting the reason(s) for the determination of ineligibility.
(c) Deletion of personal information.
The accompanying records required by
this section must not contain the donor’s name or other personal information that might identify the donor.
(d) Record retention requirements. (1)
You must maintain documentation of:
(i) Results and interpretation of all
testing for relevant communicable disease agents in compliance with
§§ 1271.80 and 1271.85, as well as the
name and address of the testing laboratory or laboratories;
(ii) Results and interpretation of all
donor screening for communicable diseases in compliance with § 1271.75; and
(iii) The donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination.
(2) All records must be accurate, indelible, and legible. Information on the
identity and relevant medical records
of the donor, as defined in § 1271.3(s),
must be in English or, if in another
language, must be retained and translated to English and accompanied by a
statement of authenticity by the translator that specifically identifies the
translated document.
(3) You must retain required records
and make them available for authorized inspection by or upon request from

FDA. Records that can be readily retrieved from another location by electronic means are considered ‘‘retained.’’
(4) You must retain the records pertaining to a particular HCT/P at least
10 years after the date of its administration, or if the date of administration is not known, then at least 10
years after the date of the HCT/P’s distribution, disposition, or expiration,
whichever is latest.
[69 FR 29830, May 25, 2004, as amended at 70
FR 29952, May 25, 2005]

§ 1271.60 What quarantine and other
requirements apply before the
donor-eligibility determination is
complete?
(a) Quarantine. You must keep an
HCT/P in quarantine, as defined in
§ 1271.3(q), until completion of the
donor-eligibility
determination
required by § 1271.50. You must quarantine semen from anonymous donors
until the retesting required under
§ 1271.85(d) is complete.
(b) Identification of HCT/Ps in quarantine. You must clearly identify as
quarantined an HCT/P that is in quarantine pending completion of a donoreligibility determination. The quarantined HCT/P must be easily distinguishable from HCT/Ps that are available for release and distribution.
(c) Shipping of HCT/Ps in quarantine.
If you ship an HCT/P before completion
of the donor-eligibility determination,
you must keep it in quarantine during
shipment. The HCT/P must be accompanied by records:
(1) Identifying the donor (e.g., by a
distinct identification code affixed to
the HCT/P container);
(2) Stating that the donor-eligibility
determination has not been completed;
and
(3) Stating that the product must not
be implanted, transplanted, infused, or
transferred until completion of the
donor-eligibility determination, except
under the terms of paragraph (d) of this
section.
(d) Use in cases of urgent medical need.
(1) This subpart C does not prohibit the
implantation, transplantation, infusion, or transfer of an HCT/P from a
donor for whom the donor-eligibility
determination is not complete if there

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