[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.21]

[Page 666-667]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
                 Subpart B--Donor Screening and Testing
 
Sec. 1270.21  Determination of donor suitability for human tissue intended for transplantation.


    (a) Donor specimens shall be tested for the following communicable 
viruses, using Food and Drug Administration (FDA) licensed donor 
screening tests in accordance with manufacturers' instructions:
    (1) Human immunodeficiency virus, Type 1 (e.g., FDA licensed 
screening test for anti-HIV-1);
    (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed 
screening test for anti-HIV-2);
    (3) Hepatitis B (e.g., FDA licensed screening test for HBsAg); and
    (4) Hepatitis C (e.g., FDA licensed screening test for anti-HCV).
    (b) In the case of a neonate, the mother's specimen is acceptable 
for testing.
    (c) Such infectious disease testing shall be performed by a 
laboratory certified under the Clinical Laboratories Improvement 
Amendments of 1988 (CLIA).
    (d) Human tissue shall be accompanied by records indicating that the 
donor's specimen has been tested and found negative using FDA licensed 
screening tests for HIV-1, HIV-2, hepatitis B, and hepatitis C. FDA 
licensed screening tests labeled for cadaveric specimens must be used 
when available.
    (e) Human tissue for transplantation shall be accompanied by a 
summary of records or copies of the original records of the donor's 
relevant medical records as defined in Sec. 1270.3(t) which documents 
freedom from risk factors for and clinical evidence of hepatitis B, 
hepatitis C, or HIV infection. There shall be a responsible person 
designated and identified in the original record and summary of records 
as having made the determination that the human tissue is suitable for 
transplantation.
    (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 Sec. 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

[[Page 667]]

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.