21 CFR 606.160 - Records.
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(1) Records shall be maintained concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced. All records shall be legible and indelible, and shall identify the person performing the work, include dates of the various entries, show test results as well as the interpretation of the results, show the expiration date assigned to specific products, and be as detailed as necessary to provide a complete history of the work performed.
(2) Appropriate records shall be available from which to determine lot numbers of supplies and reagents used for specific lots or units of the final product.
(b) Records shall be maintained that include, but are not limited to, the following when applicable:
(i) Donor selection, including medical interview and examination and where applicable, informed consent.
(iii) Donor adverse reaction complaints and reports, including results of all investigations and followup.
(iv) Therapeutic bleedings, including signed requests from attending physicians, the donor's disease and disposition of units.
(v) Immunization, including informed consent, identification of the antigen, dosage and route of administration.
(vi) Blood collection, including identification of the phlebotomist.
(vii) Records to relate the donor with the unit number of each previous donation from that donor.
(viii) Records concerning the following activities performed under §§ 610.46, 610.47, and 610.48 of this chapter: Quarantine; consignee notification; testing; notification of a transfusion recipient, the recipient's physician of record, or the recipient's legal representative; and disposition.
(ix) Records of notification of donors deferred or determined not to be suitable for donation, including appropriate followup if the initial attempt at notification fails, performed under § 630.6 of this chapter.
(x) The donor's address provided at the time of donation where the donor may be contacted within 8 weeks after donation.
(xi) Records of notification of the referring physician of a deferred autologous donor, including appropriate followup if the initial notification attempt fails, performed under § 630.6 of this chapter.
(2) Processing records:
(ii) Component preparation, including all relevant dates and times.
(ii) Visual inspection of whole blood and red blood cells during storage and immediately before distribution.
(v) Emergency release of blood, including signature of requesting physician obtained before or after release.
(i) Results of all compatibility tests, including crossmatching, testing of patient samples, antibody screening and identification.
(5) Quality control records:
(i) Sterilization of supplies and reagents prepared within the facility, including date, time interval, temperature and mode.
(iii) Biological product deviations.
(v) Supplies and reagents, including name of manufacturer or supplier, lot numbers, expiration date and date of receipt.
(vi) Disposition of rejected supplies and reagents used in the collection, processing and compatibility testing of blood and blood components.
(c) A donor number shall be assigned to each accepted donor, which relates the unit of blood collected to that donor, to his medical record, to any component or blood product from that donor's unit of blood, and to all records describing the history and ultimate disposition of these products.
(d) Records shall be retained for such interval beyond the expiration date for the blood or blood component as necessary to facilitate the reporting of any unfavorable clinical reactions. You must retain individual product records no less than 10 years after the records of processing are completed or 6 months after the latest expiration date for the individual product, whichever is the later date. When there is no expiration date, records shall be retained indefinitely.
(e) A record shall be available from which unsuitable donors may be identified so that products from such individuals will not be distributed.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.