(a) You, an establishment that collects human blood or blood components, must defer donors testing reactive by a screening test for evidence of infection due to a communicable disease agent(s) listed in Sec. 610.40(a) or reactive for a serological test for syphilis under Sec. 610.40(i), from future donations of human blood and blood components, except:
(1) You are not required to defer a donor who tests reactive for anti-HBc or anti-HTLV, types I or II, on only one occasion. When a supplemental (additional, more specific) test for anti-HBc or anti-HTLV, types I and II, has been approved for use under Sec. 610.40(e) by FDA, such a donor must be deferred;
(2) A deferred donor who tests reactive for evidence of infection due to a communicable disease agent(s) listed in Sec. 610.40(a) may serve as a donor for blood or blood components shipped or used under Sec. 610.40(h)(2)(ii);
(3) A deferred donor who showed evidence of infection due to hepatitis B surface antigen (HBsAg) when previously tested under Sec. 610.40(a), (b), and (e) subsequently may donate Source Plasma for use in the preparation of Hepatitis B Immune Globulin (Human) provided the current donation tests nonreactive for HBsAg and the donor is otherwise determined to be suitable;
(4) A deferred donor, who otherwise is determined to be suitable for donation and tests reactive for anti-HBc or for evidence of infection due to HTLV, types I and II, may serve as a donor of Source Plasma;
(5) A deferred donor who tests reactive for a communicable disease agent(s) described under Sec. 610.40(a) or reactive with a serological test for syphilis under Sec. 610.40(i), may serve as an autologous donor under Sec. 610.40(d).
(b) A deferred donor subsequently may be found to be suitable as a donor of blood or blood components by a requalification method or process found acceptable for such purposes by FDA. Such a donor is considered no longer deferred.
(c) You must comply with the requirements under Sec. Sec. 610.46 and 610.47 when a donor tests reactive by a screening test for HIV or HCV required under Sec. 610.40(a) and (b), or when you are aware of other reliable test results or information indicating evidence of HIV or HCV infection. [66 FR 31164, June 11, 2001, as amended at 72 FR 48798, Aug. 24, 2007]