0302 21cfr1270 33

§ 1270.31

21 CFR Ch. I (4–1–06 Edition)

(f) Determination by the responsible
person that a donor of human tissue intended for transplantation is suitable
shall include ascertainment of the donor’s identity, and accurately recorded
relevant medical records (as defined in
§ 1270.3(t)) which documents freedom
from risk factors for and clinical evidence of hepatitis B, hepatitis C, and
HIV infection.
(g) For corneal tissue procured under
legislative consent where a donor medical history screening interview has
not occurred, a physical assessment of
the donor is required and other available information shall be reviewed. The
corneal tissue shall be accompanied by
the summary of records documenting
that the corneal tissue was determined
to be suitable for transplantation in
the absence of the donor medical history interview. Corneal tissue procured
under legislative consent shall be documented as such in the summary of
records.
(h) Human tissue shall be determined
to be not suitable for transplantation if
from:
(1) A donor whose specimen has tested repeatedly reactive on a screening
test for HIV, hepatitis B, or hepatitis
C;
(2) A donor where blood loss is known
or suspected to have occurred and
transfusion/infusion of more than 2,000
milliliters (mL) of blood (i.e., whole
blood, reconstituted blood, or red blood
cells), or colloids within 48 hours; or
more than 2,000 mL of crystalloids
within 1 hour; or any combination
thereof prior to the collection of a
blood specimen from the tissue donor
for testing, unless:
(i) A pretransfusion or preinfusion
blood specimen from the tissue donor is
available for infectious disease testing;
or
(ii) An algorithm is utilized that
evaluates the volumes administered in
the 48 hours prior to collecting the
blood specimen from the tissue donor
to ensure that there has not been plasma dilution sufficient to affect test results; or
(3) A donor who is 12 years of age or
less and has been transfused or infused
at all, unless:
(i) A pretransfusion or preinfusion
blood specimen from the tissue donor is

available for infectious disease testing;
or
(ii) An algorithm is utilized that
evaluates the volumes administered in
the 48 hours prior to collecting the
blood specimen from the tissue donor
to ensure that there has not been plasma dilution sufficient to affect test results.

Subpart C—Procedures and
Records
§ 1270.31 Written procedures.
(a) There shall be written procedures
prepared and followed for all significant steps in the infectious disease
testing process under § 1270.21 which
shall conform to the manufacturers’ instructions for use contained in the
package inserts for the required tests.
These procedures shall be readily available to the personnel in the area where
the procedures are performed unless
impractical. Any deviation from the
written procedures shall be recorded
and justified.
(b) There shall be written procedures
prepared and followed for all significant steps for obtaining, reviewing, and
assessing the relevant medical records
of the donor as provided in § 1270.21.
Such procedures shall be readily available to personnel who may perform the
procedures. Any deviation from the
written procedures shall be recorded
and justified.
(c) There shall be written procedures
prepared and followed for designating
and identifying quarantined tissue.
(d) There shall be written procedures
prepared, validated, and followed for
prevention of infectious disease contamination or cross-contamination by
tissue during processing.
(e) In conformity with this section,
any facility may use current standard
written procedures such as those in a
technical manual prepared by another
organization, provided the procedures
are consistent with and at least as
stringent as the requirements of this
part.
§ 1270.33 Records, general requirements.
(a) Records shall be maintained concurrently with the performance of each
significant step required in this part in

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Food and Drug Administration, HHS

§ 1270.41

the performance of infectious disease
screening and testing of donors of
human tissue. All records shall be accurate, indelible, and legible. The
records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as
necessary to provide a complete history of the work performed and to relate the records to the particular tissue
involved.
(b) All human tissue shall be quarantined until the following criteria for
donor suitability are satisfied:
(1) All infectious disease testing
under § 1270.21 has been completed, reviewed by the responsible person, and
found to be negative; and
(2) Donor screening has been completed, reviewed by the responsible person, and determined to assure freedom
from risk factors for and clinical evidence of HIV infection, hepatitis B, and
hepatitis C.
(c) All human tissue processed or
shipped prior to determination of donor
suitability must be under quarantine,
accompanied by records assuring identification of the donor and indicating
that the tissue has not been determined to be suitable for transplantation.
(d) All human tissue determined to
be suitable for transplantation must be
accompanied by a summary of records,
or copies of such original records, documenting that all infectious disease
testing and screening under § 1270.21
has been completed, reviewed by the
responsible person, and found to be
negative, and that the tissue has been
determined to be suitable for transplantation.
(e) Human tissue shall be quarantined until the tissue is either determined to be suitable for transplantation or appropriate disposition is accomplished.
(f) All persons or establishments that
generate records used in determining
the suitability of the donor shall retain
such records and make them available
for authorized inspection or upon request by FDA. The person(s) or establishment(s) making the determination
regarding the suitability of the donor
shall retain all records, or true copies
of such records required under § 1270.21,
including all testing and screening

records, and shall make them available
for authorized inspection or upon request from FDA. Records that can be
retrieved from another location by
electronic means meet the requirements of this paragraph.
(g) Records required under this part
may be retained electronically, or as
original paper records, or as true copies
such as photocopies, microfiche, or
microfilm, in which case suitable reader and photocopying equipment shall
be readily available.
(h) Records shall be retained at least
10 years beyond the date of transplantation if known, distribution, disposition, or expiration, of the tissue,
whichever is latest.
[62 FR 40444, July 29, 1997, as amended at 63
FR 16685, Apr. 6, 1998]

§ 1270.35

Specific records.

Records shall be maintained that include, but are not limited to:
(a) Documentation of results and interpretation of all required infectious
disease tests;
(b) Information on the identity and
relevant medical records of the donor,
as required by § 1270.21(e) in English or,
if in another language translated to
English and accompanied by a statement of authenticity by the translator
which specifically identifies the translated document;
(c) Documentation of the receipt and/
or distribution of human tissue; and
(d) Documentation of the destruction
or other disposition of human tissue.

Subpart D—Inspection of Tissue
Establishments
§ 1270.41

Inspections.

(a) An establishment covered by
these regulations in this part, including any location performing contract
services, shall permit an authorized inspector of the Food and Drug Administration (FDA) to make at any reasonable time and in a reasonable manner
such inspection of the establishment,
its facilities, equipment, processes,
products, and records as may be necessary to determine compliance with
the provisions of this part. Such inspections may be made with or without

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