21 C.F.R. PART 630—GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
Title 21 - Food and Drugs
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264.
Source: 66 FR 31176, June 11, 2001, unless otherwise noted.
(a) Notification of donors. You, an establishment that collects blood or blood components, must make reasonable attempts to notify any donor, including an autologous donor, who has been deferred based on the results of tests for evidence of infection with a communicable disease agent(s) as required by §610.41 of this chapter; or who has been determined not to be suitable as a donor based on suitability criteria under §640.3 or §640.63 of this chapter. You must attempt to obtain the results of supplemental testing required under §610.40(e) of this chapter prior to notifying a donor of the deferral. If notification occurs prior to receipt of such results, you must also notify a deferred donor of the results of the supplemental testing. You must notify a donor as described in paragraph (b) of this section. (b) Content of notification. You must provide the following information to a donor deferred or determined not to be suitable as a donor as described in paragraph (a) of this section: (1) That the donor is deferred or determined not to be suitable for donation and the reason for that decision; (2) Where appropriate, the types of donation of blood or blood components that the donor should not donate in the future; (3) Where applicable, the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral under §610.41 of this chapter, including results of supplemental (i.e., additional, more specific) tests as required in §610.40(e) of this chapter; and, (4) Where appropriate, information concerning medical followup and counseling. (c) Time period for notification. You must make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation as described in paragraph (a) of this section. You must document that you have successfully notified the donor or when you are unsuccessful that you have made reasonable attempts to notify the donor. (d) Autologous donors. (1) You also must provide the following information to the referring physician of an autologous donor who is deferred based on the results of tests for evidence of infection with a communicable disease agent(s) as described in paragraph (a) of this section: (i) Information that the autologous donor is deferred based on the results of tests for evidence of infection due to communicable disease agent(s), as required under §610.41 of this chapter, and the reason for that decision; (ii) Where appropriate, the types of donation of blood or blood components that the autologous donor should not donate in the future; and (iii) The results of tests for evidence of infection due to communicable disease agent(s), that were a basis for deferral under §610.41 of this chapter, including results of supplemental (i.e., additional, more specific) tests as required in §610.40(e) of this chapter. (2) You must make reasonable attempts to notify the autologous donor's referring physician within 8 weeks after determining that the autologous donor is deferred as described in paragraph (a) of this section. You must document that you have successfully notified the autologous donor's referring physician or when you are unsuccessful that you have made reasonable attempts to notify the physician.
Title 21: Food and Drugs
PART 630—GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
Section Contents
§ 630.6 Donor notification.
§ 630.6 Donor notification.
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