Fla. Admin. Code Ann. R. 64D-2.005 - Blood and Human Tissue Donations

(1) No blood, plasma, organ, skin, semen, or other human tissue from donors whose blood is reactive to HIV shall be released for transfusion or transplantation to another. Such blood shall be retested using a confirmatory test prior to release of test results outside the facility. Test results may be released immediately to the physician of an organ donation recipient, prior to confirmatory testing. Donated blood, organs and tissue must also be tested for infectious diseases identified by the federal government in 21 CFR s. 610.40 (2013) (donated blood), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03426; 21 CFR s. 1270.21 (2013) (donated tissue), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03427; and in the Federal Health Resources and Services Administration's Organ Procurement and Transplantation Network Policy 2.2, as revised 9-1-2012 (donated organs), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03428.

(2) The recipient's physician shall be notified of HIV confirmatory test results within 24 hours by the medical director of the facility in the event that blood, plasma, organ, skin, semen, or other tissue is transferred and is subsequently reported positive on confirmatory test. The donor or their legal representative shall also be notified in accordance with the Model Protocol for Counseling Blood, Organ or Tissue Donors.

(3) The Model Protocol for Counseling Blood, Organ or Tissue Donors, effective December 2012, developed pursuant to Section 381.0041(8), F.S., and incorporated herein by reference provides a list of the information that shall be included in the letter of notification to donors who test positive for HIV based on confirmatory testing. The Model Protocol for Counseling Blood, Organ or Tissue Donors is available through the Department of Health, HIV/AIDS and Hepatitis Section, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03429.

(4) The blood of any human tissue donor testing negative for HIV or hepatitis at the time of donation shall not require retesting by the collecting facility when such tissue is collected for transplantation, implantation, transfusion, grafting, or any other method of transfer to another human.

Notes

Fla. Admin. Code Ann. R. 64D-2.005

Rulemaking Authority 381.0041(10) FS. Law Implemented 381.0041 FS.

New 7-12-89, Amended 5-1-96, Formerly 10D-93.073, Amended 1-9-14.

New 7-12-89, Amended 5-1-96, Formerly 10D-93.073, Amended 1-9-14.