610.41—Donor deferral.
(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 § 610.40(a) or reactive for a serological test for syphilis under § 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 § 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 § 610.40(a) may serve as a donor for blood or blood components shipped or used under § 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 § 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 § 610.40(a) or reactive with a serological test for syphilis under § 610.40(i), may serve as an autologous donor under § 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 §§ 610.46 and 610.47 when a donor tests reactive by a screening test for HIV or HCV required under § 610.40(a) and (b), or when you are aware of other reliable test results or information indicating evidence of HIV or HCV infection.