[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.80]

[Page 726-727]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
                       Subpart C_Donor Eligibility
 
Sec. 1271.80  What are the general requirements for donor testing?

    (a) Testing for relevant communicable diseases is required. To 
adequately and appropriately reduce the risk of transmission of relevant 
communicable diseases, and except as provided under Sec. 1271.90, if 
you are the establishment that performs donor testing, you must test a 
donor specimen for evidence of infection due to communicable disease 
agents in accordance with paragraph (c) of this section. You must test 
for those communicable disease agents specified in Sec. 1271.85. In the 
case of a donor 1 month of age or younger, you must test a specimen from 
the birth mother instead of a specimen from the donor.
    (b) Timing of specimen collection. You must collect the donor 
specimen at the time of recovery of cells or tissue from the donor. 
However, if collection at the time of recovery is not feasible, then you 
may collect the donor specimen up to 7 days before or after recovery or, 
for donors of peripheral blood stem/progenitor cells only, up to 30 days 
before recovery. In the case of a repeat semen donor from whom a 
specimen has already been collected and tested, and for

[[Page 727]]

whom retesting is required under Sec. 1271.85(d), you are not required 
to collect a donor specimen at the time of each donation.
    (c) Tests. You must test using appropriate FDA-licensed, approved, 
or cleared donor screening tests, in accordance with the manufacturer's 
instructions, to adequately and appropriately reduce the risk of 
transmission of relevant communicable disease agents or diseases; 
however, until such time as appropriate FDA-licensed, approved, or 
cleared donor screening tests for Chlamydia trachomatis and for 
Neisseria gonorrhea are available, you must use FDA-licensed, approved, 
or cleared tests labeled for the detection of those organisms in an 
asymptomatic, low-prevalence population. You must use a test 
specifically labeled for cadaveric specimens instead of a more generally 
labeled test when applicable and when available. Required testing under 
this section must be performed by a laboratory that either is 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 
has met equivalent requirements as determined by the Centers for 
Medicare and Medicaid Services.
    (d) Ineligible donors. You must determine the following donors to be 
ineligible:
    (1) A donor whose specimen tests reactive on a screening test for a 
communicable disease agent in accordance with Sec. 1271.85, except for 
a donor whose specimen tests reactive on a non-treponemal screening test 
for syphilis and negative on a specific treponemal confirmatory test;
    (2)(i) A donor in whom plasma dilution sufficient to affect the 
results of communicable disease testing is suspected, unless:
    (A) You test a specimen taken from the donor before transfusion or 
infusion and up to 7 days before recovery of cells or tissue; or
    (B) You use an appropriate algorithm designed to evaluate volumes 
administered in the 48 hours before specimen collection, and the 
algorithm shows that plasma dilution sufficient to affect the results of 
communicable disease testing has not occurred.
    (ii) Clinical situations in which you must suspect plasma dilution 
sufficient to affect the results of communicable disease testing include 
but are not limited to the following:
    (A) Blood loss is known or suspected in a donor over 12 years of 
age, and the donor has received a transfusion or infusion of any of the 
following, alone or in combination:
    (1) More than 2,000 milliliters (mL) of blood (e.g., whole blood, 
red blood cells) or colloids within 48 hours before death or specimen 
collection, whichever occurred earlier, or
    (2) More than 2,000 mL of crystalloids within 1 hour before death or 
specimen collection, whichever occurred earlier.
    (B) Regardless of the presence or absence of blood loss, the donor 
is 12 years of age or younger and has received a transfusion or infusion 
of any amount of any of the following, alone or in combination:
    (1) Blood (e.g., whole blood, red blood cells) or colloids within 48 
hours before death or specimen collection, whichever occurred earlier, 
or
    (2) Crystalloids within 1 hour before death or specimen collection, 
whichever occurred earlier.