2021 Florida Statutes (Including 2021B Session)
Donation and transfer of human tissue; testing requirements.
Donation and transfer of human tissue; testing requirements.
381.0041 Donation and transfer of human tissue; testing requirements.—
(1) Every donation of blood, plasma, organs, skin, or other human tissue for transfusion or transplantation to another shall be tested prior to transfusion or other use for human immunodeficiency virus infection and other communicable diseases specified by rule of the Department of Health. Tests for the human immunodeficiency virus infection shall be performed only after obtaining written, informed consent from the potential donor or the donor’s legal representative. Such consent may be given by a minor pursuant to s. 743.06. Obtaining consent shall include a fair explanation of the procedures to be followed and the meaning and use of the test results. Such explanation shall include a description of the confidential nature of the test as described in s. 381.004(2). If consent for testing is not given, then the person shall not be accepted as a donor except as otherwise provided in subsection (3).
(2) Notwithstanding the provisions of subsection (1), written, informed consent to perform testing shall not be required:
(a) When the blood, plasma, organ, skin, or other human tissue is received for processing or testing from an out-of-state blood bank;
(b) When blood or tissue is received from a health care facility or health care provider for reference testing or processing and the results of such test are reported back to the facility or provider; or
(c) When an unrevoked anatomical gift has been made pursuant to s. 765.514, by will or other written instrument, and the donor is deceased or incompetent.
(3) No person shall collect any blood, organ, skin, or other human tissue from one human being and hold it for, or actually perform, any implantation, transplantation, transfusion, grafting, or any other method of transfer to another human being without first testing such tissue for the human immunodeficiency virus and other communicable diseases specified by rule of the Department of Health, or without performing another process approved by rule of the Department of Health capable of killing the causative agent of those diseases specified by rule. Such testing shall not be required:
(a) When there is insufficient time to perform testing because of a life-threatening emergency circumstance and the blood is transferred with the recipient’s informed consent.
(b) For a donation of semen made by the spouse of a recipient for the purposes of artificial insemination or other reproductive procedure.
(c) When there is insufficient time to obtain the results of a confirmatory test for any tissue or organ which is to be transplanted, notwithstanding the provisions of s. 381.004(2)(d). In such circumstances, the results of preliminary screening tests may be released to the potential recipient’s treating physician for use in determining organ or tissue suitability.
(4) All human blood, organs, skin, or other human tissue which is to be transfused or transplanted to another and is found positive for human immunodeficiency virus or other communicable disease specified by rule of the Department of Health shall be rendered noncommunicable by the person holding the tissue or shall be destroyed, unless the human tissue is specifically labeled to identify the human immunodeficiency virus and:
(a) Is used for research purposes; or
(b) Is used to save the life of another and is transferred with the recipient’s informed consent.
(5) Each person who collects human blood, organs, skin, or other human tissue who finds evidence after confirmatory testing of human immunodeficiency virus in the donor shall notify the donor of the presence of the virus. When notifying the donor pursuant to this requirement, the donor shall be provided the following information:
(a) The meaning of the test results;
(b) Measures for the prevention of the transmission of the human immunodeficiency virus;
(c) The availability in the geographic area of any appropriate health care services, including mental health care, and appropriate social and support services;
(d) The benefits of locating and counseling any individual by whom the infected individual may have been exposed to human immunodeficiency virus and any individual whom the infected individual may have exposed to the virus; and
(e) The availability, if any, of the services of public health authorities with respect to locating and counseling any individual described in paragraph (d).
(6) Human immunodeficiency virus tests performed pursuant to autologous blood donations which have not been confirmed as positive by confirmatory testing may be revealed to the donor’s treating physician when such test results may be necessary for the diagnosis, treatment, or care of the donor.
(7) Any blood donor who tests positive for human immunodeficiency virus based upon confirmatory testing shall be notified in the following manner:
(a) The donor shall be sent written notification by certified mail that abnormal test results exist with respect to his or her blood donation, and the blood bank shall offer the opportunity to discuss the nature and significance of the findings by telephone or in person.
(b) If the blood bank does not receive a response from the donor within 30 days, it shall send the actual test results and the information required by subsection (5) to the donor by certified mail.
(8) The Department of Health shall develop, in conjunction with persons who collect human tissue, a model protocol for providing the information required in subsection (5).
(9) All blood banks shall be governed by the confidentiality provisions of s. 381.004(2).
(10) The Department of Health is authorized to adopt rules to implement this section. In adopting rules pertaining to this section, the department shall consider the rules of the United States Food and Drug Administration and shall conform to those rules to the extent feasible without jeopardizing the public health.
(11)(a) Any person who fails to test blood, plasma, organs, skin, or other human tissue which is to be transfused or transplanted, or violates the confidentiality provisions required by this section, is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(b) Any person who has human immunodeficiency virus infection, who knows he or she is infected with human immunodeficiency virus, and who has been informed that he or she may communicate this disease by donating blood, plasma, organs, skin, or other human tissue who donates blood, plasma, organs, skin, or other human tissue is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(12) Prior to the transplant of an organ or artificial insemination, the institution or physician responsible for overseeing the procedure must provide the prospective recipient a warning as to the risks of contracting human immunodeficiency virus.
(13) The department shall develop and publish on its website an educational pamphlet relating to the risks and benefits of human cell, tissue, and cellular and tissue-based product transplants. The department shall electronically notify physicians of the availability of the pamphlet. At a minimum, the pamphlet shall include:
(a) An overview of the risk of infectious disease transmission.
(b) An overview of the standards for donor testing and screening.
(c) An overview of processing methods intended to reduce the risk of disease or bacterial transmission in donated human cells, tissue, or cellular or tissue-based products.
(d) The importance of providing limited recipient transplant information to the supplier of the human cells, tissue, or cellular or tissue-based products.
(e) The generosity of the human donor who provided the human cells, tissue, or cellular or tissue-based products.
History.—s. 22, ch. 88-380; s. 7, ch. 89-350; s. 4, ch. 90-292; s. 4, ch. 90-344; s. 17, ch. 91-297; s. 67, ch. 95-143; s. 650, ch. 95-148; s. 186, ch. 96-406; s. 177, ch. 97-101; s. 77, ch. 2001-226; s. 118, ch. 2012-184; s. 1, ch. 2018-36.
Note.—Former s. 381.6105.