[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 730-731]
 
                        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.  1271.75  How do I screen a donor?

    (a) All donors. Except as provided under Sec.  1271.90, if you are 
the establishment that performs donor screening, you must screen a donor 
of cells or tissue by reviewing the donor's relevant medical records 
for:
    (1) Risk factors for, and clinical evidence of, relevant 
communicable disease agents and diseases, including:
    (i) Human immunodeficiency virus;
    (ii) Hepatitis B virus;
    (iii) Hepatitis C virus;
    (iv) Human transmissible spongiform encephalopathy, including 
Creutzfeldt-Jakob disease;
    (v) Treponema pallidum; and
    (2) Communicable disease risks associated with xenotransplantation.

[[Page 731]]

    (b) Donors of viable, leukocyte-rich cells or tissue. In addition to 
the relevant communicable disease agents and diseases for which 
screening is required under paragraph (a) of this section, and except as 
provided under Sec.  1271.90, you must screen the donor of viable, 
leukocyte-rich cells or tissue by reviewing the donor's relevant medical 
records for risk factors for and clinical evidence of relevant cell-
associated communicable disease agents and diseases, including Human T-
lymphotropic virus.
    (c) Donors of reproductive cells or tissue. In addition to the 
relevant communicable disease agents and diseases for which screening is 
required under paragraphs (a) and (b) of this section, as applicable, 
and except as provided under Sec.  1271.90, you must screen the donor of 
reproductive cells or tissue by reviewing the donor's relevant medical 
records for risk factors for and clinical evidence of infection due to 
relevant communicable diseases of the genitourinary tract. Such 
screening must include screening for the communicable disease agents 
listed in paragraphs (c)(1) and (c)(2) of this section. However, if the 
reproductive cells or tissues are recovered by a method that ensures 
freedom from contamination of the cells or tissue by infectious disease 
organisms that may be present in the genitourinary tract, then screening 
for the communicable disease agents listed in paragraphs (c)(1) and 
(c)(2) of this section is not required. Communicable disease agents of 
the genitourinary tract for which you must screen include:
    (1) Chlamydia trachomatis; and
    (2) Neisseria gonorrhea.
    (d) Ineligible donors. You must determine ineligible a donor who is 
identified as having either of the following:
    (1) A risk factor for or clinical evidence of any of the relevant 
communicable disease agents or diseases for which screening is required 
under paragraphs (a)(1), (b), or (c) of this section; or
    (2) Any communicable disease risk associated with 
xenotransplantation.
    (e) Abbreviated procedure for repeat donors. If you have performed a 
complete donor screening procedure on a living donor within the previous 
6 months, you may use an abbreviated donor screening procedure on repeat 
donations. The abbreviated procedure must determine and document any 
changes in the donor's medical history since the previous donation that 
would make the donor ineligible, including relevant social behavior.

[66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006]