21 CFR 1271.55: What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?

(a)Accompanying records. Once a donor-eligibility determination has been made, the following must accompany the HCT/P at all times:

(1)A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to the donor and to all records pertaining to the HCT/P and, except in the case of autologous donations, directed reproductive donations, or donations made by first-degree or second-degree blood relatives, does not include an individual's name, social security number, or medical record number;

(2)A statement whether, based on the results of screening and testing, the donor has been determined to be eligible or ineligible; and

(3)A summary of the records used to make the donor-eligibility determination.

(b)Summary of records. The summary of records required by paragraph (a)(3) of this section must contain the following information:

(1)A statement that the communicable disease testing was performed by a laboratory:

(i)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

(ii)That has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services in accordance with those provisions;

(2)A listing and interpretation of the results of all communicable disease tests performed;

(3)The name and address of the establishment that made the donor-eligibility determination; and

(4)In the case of an HCT/P from a donor who is ineligible based on screening and released under paragraph (b) of § 1271.65, a statement noting the reason(s) for the determination of ineligibility.

(c)Deletion of personal information. The accompanying records required by this section must not contain the donor's name or other personal information that might identify the donor.

(d)Record retention requirements. (1) You must maintain documentation of:

(i)Results and interpretation of all testing for relevant communicable disease agents in compliance with §§ 1271.80 and 1271.85, as well as the name and address of the testing laboratory or laboratories;

(ii)Results and interpretation of all donor screening for communicable diseases in compliance with § 1271.75; and

(iii)The donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination.

(2)All records must be accurate, indelible, and legible. Information on the identity and relevant medical records of the donor, as defined in § 1271.3(s), must be in English or, if in another language, must be retained and translated to English and accompanied by a statement of authenticity by the translator that specifically identifies the translated document.

(3)You must retain required records and make them available for authorized inspection by or upon request from FDA. Records that can be readily retrieved from another location by electronic means are considered “retained.”

(4)You must retain the records pertaining to a particular HCT/P at least 10 years after the date of its administration, or if the date of administration is not known, then at least 10 years after the date of the HCT/P's distribution, disposition, or expiration, whichever is latest.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]