UNOFFICIAL COPY 25 RS BR 1766
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AN ACT relating to blood donation. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 214.452 is amended to read as follows: 3
The following policies shall apply to blood establishments and to donors of blood: 4
(1) All blood establishments within the Commonwealth shall be licensed by the United 5
States Food and Drug Administration and remain in compliance with all applicable 6
federal regulations. The Cabinet for Health and Family Services shall, under 7
administrative regulations promulgated pursuant to KRS Chapter 13A, establish 8
fees necessary to cover the cost of and adhere to a schedule for regular inspection, 9
by the Office of the Inspector General of the Cabinet for Health and Family 10
Services, of all blood establishments within the Commonwealth to ascertain 11
whether each blood establishment is licensed and in compliance with KRS 214.450 12
to 214.464 and KRS 214.468. The Office of the Inspector General shall commence 13
its inspection program of blood establishments no later than September 1, 1994. 14
(2) All blood establishments shall test blood for the human immunodeficiency virus 15
and for any known causative agent for any blood-borne communicable disease, 16
using tests approved and required, for purposes of blood donation, by the United 17
States Food and Drug Administration. 18
(3) It shall be the duty of the administrator of any blood establishment which collects 19
blood for the purpose of distributing to another health service, health facility, or 20
health-care provider the blood for transfusion to: 21
(a) Secure donor consent and a signed written risk factor history and donor 22
consent form for each potential paid or volunteer donor for the purpose of 23
determining if the potential donor: 24
1. Is at high risk for infection with the human immunodeficiency virus;[, or 25
] 26
2. Has tested confirmatory positive for infection with the human 27 UNOFFICIAL COPY 25 RS BR 1766
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immunodeficiency virus;[ or ] 1
3. Has acquired immune deficiency syndrome;[ or ] 2
4. Has tested confirmatory positive for infection with any causative agent 3
for acquired immune deficiency syndrome recognized by the United 4
States Centers for Disease Control;[ or ] 5
5. Has a blood-borne communicable disease; or 6
6. Has received a COVID-19 vaccine; 7
(b) Provide a means for a potential donor to self-elect not to donate blood; 8
(c) Refuse donation or sale of blood by persons at high risk for infection with the 9
human immunodeficiency virus, or who have been medically diagnosed as 10
having acquired immune deficiency syndrome, or who have tested 11
confirmatory positive for infection with the human immunodeficiency virus, 12
or who have a blood-borne communicable disease; and 13
(d) Post a sign in the blood establishment which is visible to all potential donors 14
and which states: "Persons with acquired immune deficiency syndrome 15
(AIDS), or who have tested confirmatory positive for infection with the 16
human immunodeficiency virus (HIV), or who have a blood-borne 17
communicable disease or who have one (1) or more risk factors for the human 18
immunodeficiency virus as determined by the United States Centers for 19
Disease Control, are prohibited by law from donating or selling blood. 20
Persons violating the law are guilty of a Class D felony. ASK STAFF OF 21
THIS BLOOD ESTABLISHMENT." 22
(4) The provisions of this section shall not be construed to impose requirements which 23
are in conflict with donor eligibility requirements set out in United States Food and 24
Drug Administration or American Association of Blood Banks standards. 25
Section 2. KRS 214.458 is amended to read as follows: 26
(1) Each unit of blood collected by a blood establishment for transfusion shall be 27 UNOFFICIAL COPY 25 RS BR 1766
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affixed with the United States Food and Drug Administration required label 1
and[which includes] a donor identification number through which the following 2
information can be obtained: 3
(a) The date the blood was collected; 4
(b) The name of the blood establishment; 5
(c) A nonidentifying code representing the name of the blood donor; 6
(d) A blood establishment serial number for the blood; 7
(e) The date of laboratory testing of the blood; 8
(f) The name of the person and laboratory testing the blood; 9
(g) The laboratory test results; and 10
(h) Notice that the blood donor signed a statement that he or she had received a 11
COVID-19 vaccine. 12
(2) Each unit of blood received by a blood establishment or health facility within the 13
Commonwealth from an out-of-state blood establishment shall contain a label in 14
accordance with the provisions of subsection (1) of this section and the blood 15
establishment or health facility shall either test the blood in accordance with the 16
requirements for blood establishments within the Commonwealth under the 17
provisions of KRS 214.452(2) or may accept documented evidence of the test 18
results as are required under subsection (1) of this section for blood collected within 19
the Commonwealth. 20
(3) Each laboratory testing blood for transfusion shall maintain for ten (10) years from 21
the date of testing, and each blood establishment shall maintain for ten (10) years 22
from the date of collection, a list containing the information set forth in subsection 23
(1) of this section. 24
(4) No blood may be transfused into any patient in any health facility or health service 25
or by any health care provider unless the unit of blood has affixed to it the label as 26
required under this section and the blood has tested negative for the human 27 UNOFFICIAL COPY 25 RS BR 1766
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immunodeficiency virus or any causative agent of AIDS and[, or] any blood-borne 1
communicable disease as provided under KRS 214.452. 2
(5) Except in an emergency, before blood is transfused into any patient, a health 3
facility, health service, or a health care provider shall inform the patient if the 4
blood donor signed a statement that he or she had received a COVID-19 vaccine. 5
(6) When a unit of blood is transfused, a label containing the donor identification 6
number required under this section shall be removed from the unit and affixed to 7
the patient's medical chart or the blood donor identification number for the unit of 8
blood shall be recorded in the patient's medical chart. 9
(7)[(5)] Any unit of blood not containing the label required under this section shall be 10
destroyed by the health facility, health service, or health care provider. 11
(8)[(6)] Any unit of blood testing confirmatory positive for an agent of a blood-borne 12
communicable disease and in the possession of a health facility, health service, or 13
health care provider may be donated to educational or scientific research 14
institutions for the purpose of scientific research only and not for transfusion. 15