(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.

(a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue. All records shall be accurate, indelible, and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved.

(b) All human tissue shall be quarantined until the following criteria for donor suitability are satisfied:

(1) All infectious disease testing under § 1270.21 has been completed, reviewed by the responsible person, and found to be negative; and

(2) Donor screening has been completed, reviewed by the responsible person, and determined to assure freedom from risk factors for and clinical evidence of HIV infection, hepatitis B, and hepatitis C.

(c) All human tissue processed or shipped prior to determination of donor suitability must be under quarantine, accompanied by records assuring identification of the donor and indicating that the tissue has not been determined to be suitable for transplantation.

(d) All human tissue determined to be suitable for transplantation must be accompanied by a summary of records, or copies of such original records, documenting that all infectious disease testing and screening under § 1270.21 has been completed, reviewed by the responsible person, and found to be negative, and that the tissue has been determined to be suitable for transplantation.

(e) Human tissue shall be quarantined until the tissue is either determined to be suitable for transplantation or appropriate disposition is accomplished.

(f) All persons or establishments that generate records used in determining the suitability of the donor shall retain such records and make them available for authorized inspection or upon request by FDA. The person(s) or establishment(s) making the determination regarding the suitability of the donor shall retain all records, or true copies of such records required under § 1270.21, including all testing and screening records, and shall make them available for authorized inspection or upon request from FDA. Records that can be retrieved from another location by electronic means meet the requirements of this paragraph.

(g) Records required under this part may be retained electronically, or as original paper records, or as true copies such as photocopies, microfiche, or microfilm, in which case suitable reader and photocopying equipment shall be readily available.

(h) Records shall be retained at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration, of the tissue, whichever is latest.

Records shall be maintained that include, but are not limited to:

(a) Documentation of results and interpretation of all required infectious disease tests;

(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;

(c) Documentation of the receipt and/or distribution of human tissue; and

(d) Documentation of the destruction or other disposition of human tissue.