0302 21cfr1270 31

§ 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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