UNOFFICIAL COPY 24 RS BR 1223
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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 214.450 is amended to read as follows: 3
As used in KRS 214.452 to 214.466, unless the context otherwise requires: 4
(1) "Blood" means any blood, blood product, blood component, or blood derivative 5
including plasma;[.] 6
(2) "Blood establishment" means a place of business under one (1) management at one 7
(1) general physical location which engages in the collection, preparation, 8
processing, labeling, packaging, and dispensing of blood to any health care facility, 9
health service, or health care provider and which is licensed by the United States 10
Food and Drug Administration. Blood establishment does not include autologous 11
blood donation programs permitted under KRS 214.456;[.] 12
(3) "Blood-borne communicable disease" means any of those diseases which are 13
specifically so defined and set forth in administrative regulation promulgated by the 14
United States Food and Drug Administration;[.] 15
(4) "COVID-19 vaccine" or "mRNA vaccine" means any COVID-19 vaccination or 16
any other messenger ribonucleic acid (mRNA) vaccine components, including 17
evidence of lipid nanoparticles and spike protein from a vaccine for COVID-19 18
and COVID-19 antibodies; 19
(5) "Donor" means either a paid or volunteer donor of blood; 20
[ "Health facility" means any health facility set forth under KRS 216B.015 which 21
provides for the transfusion of blood into a living human body.] 22
(6)[(5)] "Health care provider" means any person licensed or certified under the laws 23
of the Commonwealth as a dentist, physician, osteopath, registered nurse, practical 24
nurse, paramedic, emergency medical technician, or physician assistant;[.] 25
(7) "Health facility" means any health facility set forth under KRS 216B.015 which 26
provides for the transfusion of blood into a living human body; 27 UNOFFICIAL COPY 24 RS BR 1223
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(8)[(6)] "Health service" means any health service as set forth under KRS 216B.015 1
and which provides for the transfusion of blood into a living human body;[.] 2
(9)[(7)] "Transfuse" means to transfer blood from one (1) person to another; and[.] 3
[(8) "Donor" means either a paid or volunteer donor of blood.] 4
(10)[(9)] "Untested blood" means blood that has not been tested or blood for which test 5
results have not yet been returned. 6
Section 2. KRS 214.452 is amended to read as follows: 7
The following policies shall apply to blood establishments and to donors of blood: 8
(1) All blood establishments within the Commonwealth shall be licensed by the United 9
States Food and Drug Administration and remain in compliance with all applicable 10
federal regulations. The Cabinet for Health and Family Services shall, under 11
administrative regulations promulgated pursuant to KRS Chapter 13A, establish 12
fees necessary to cover the cost of and adhere to a schedule for regular inspection, 13
by the Office of the Inspector General of the Cabinet for Health and Family 14
Services, of all blood establishments within the Commonwealth to ascertain 15
whether each blood establishment is licensed and in compliance with KRS 214.450 16
to 214.464 and KRS 214.468;[. The Office of the Inspector General shall 17
commence its inspection program of blood establishments no later than September 18
1, 1994.] 19
(2) All blood establishments shall test blood for: 20
(a) The human immunodeficiency virus and for any known causative agent for 21
any blood-borne communicable disease, using tests approved and required, 22
for purposes of blood donation, by the United States Food and Drug 23
Administration; and 24
(b) COVID-19 antibodies, evidence of lipid nanoparticles, and spike protein;[.] 25
(3) It shall be the duty of the administrator of any blood establishment which collects 26
blood for the purpose of distributing to another health service, health facility, or 27 UNOFFICIAL COPY 24 RS BR 1223
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health-care provider the blood for transfusion to: 1
(a) Secure donor consent and a signed written risk factor history and donor 2
consent form for each potential paid or volunteer donor for the purpose of 3
determining if the potential donor is at high risk for infection with the human 4
immunodeficiency virus, or has tested confirmatory positive for infection with 5
the human immunodeficiency virus; or has acquired immune deficiency 6
syndrome; or has tested confirmatory positive for infection with any causative 7
agent for acquired immune deficiency syndrome recognized by the United 8
States Centers for Disease Control; or has a blood-borne communicable 9
disease; 10
(b) 1. Inquire on the donor history questionnaire whether a potential donor 11
has received a COVID-19 vaccine or any other mRNA vaccine during 12
the donor's lifetime; and 13
2. If the donor has received a COVID-19 vaccine, the donor shall 14
provide the manufacturer name of the COVID-19 vaccine the donor 15
received. If the donor fails to provide the manufacturer name of the 16
COVID-19 vaccine, the donor may be required to wait before donating 17
blood; 18
(c) Provide a means for a potential donor to self-elect not to donate blood; 19
(d)[(c)] Refuse donation or sale of blood by persons at high risk for infection 20
with the human immunodeficiency virus, or who have been medically 21
diagnosed as having acquired immune deficiency syndrome, or who have 22
tested confirmatory positive for infection with the human immunodeficiency 23
virus, or who have a blood-borne communicable disease; and 24
(e)[(d)] Post a sign in the blood establishment which is visible to all potential 25
donors and which states: "Persons with acquired immune deficiency 26
syndrome (AIDS), or who have tested confirmatory positive for infection with 27 UNOFFICIAL COPY 24 RS BR 1223
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the human immunodeficiency virus (HIV), or who have a blood-borne 1
communicable disease or who have one (1) or more risk factors for the human 2
immunodeficiency virus as determined by the United States Centers for 3
Disease Control, are prohibited by law from donating or selling blood. 4
Persons violating the law are guilty of a Class D felony. ASK STAFF OF 5
THIS BLOOD ESTABLISHMENT."; 6
(4) (a) A donor shall wait at least two (2) weeks after having received a live 7
attenuated COVID-19 vaccine before the donor may donate blood. If the 8
donor does not know the manufacturer of the COVID-19 vaccine the donor 9
received, the donor shall wait at least two (2) weeks from the day the donor 10
received the vaccine before the donor may donate blood; 11
(b) A donor shall wait ten (10) days following a diagnosis of COVID-19 or 12
displaying any signs and symptoms of COVID-19 before the donor may 13
donate blood; and 14
(c) A donor who received an inactivated or mRNA based COVID-19 vaccine 15
shall have no deferral requirements unless otherwise required by law; and 16
(5) The provisions of this section shall not be construed to impose requirements which 17
are in conflict with donor eligibility requirements set out in United States Food and 18
Drug Administration or American Association of Blood Banks standards. 19
Section 3. KRS 214.458 is amended to read as follows: 20
(1) Each unit of blood collected by a blood establishment for transfusion shall be 21
affixed with the United States Food and Drug Administration required label which 22
includes a donor identification number through which the following information 23
can be obtained: 24
(a) Date the blood was collected; 25
(b) Name of blood establishment; 26
(c) Nonidentifying code representing the name of the blood donor; 27 UNOFFICIAL COPY 24 RS BR 1223
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(d) A blood establishment serial number for the blood; 1
(e) The date of laboratory testing of the blood; 2
(f) The name of the person and laboratory testing the blood; 3
(g) The laboratory test results of testing required pursuant to subsection (2) of 4
Section 2 of this Act. 5
(2) Each unit of blood received by a blood establishment or health facility within the 6
Commonwealth from an out-of-state blood establishment shall contain a label in 7
accordance with the provisions of subsection (1) of this section and the blood 8
establishment or health facility shall either test the blood in accordance with the 9
requirements for blood establishments within the Commonwealth under the 10
provisions of KRS 214.452(2) or may accept documented evidence of the test 11
results as are required under subsection (1) of this section for blood collected within 12
the Commonwealth. 13
(3) Each laboratory testing blood for transfusion shall maintain for ten (10) years from 14
the date of testing, and each blood establishment shall maintain for ten (10) years 15
from the date of collection, a list containing the information set forth in subsection 16
(1) of this section. 17
(4) No blood may be transfused into any patient in any health facility or health service 18
or by any health care provider unless the unit of blood has affixed to it the label as 19
required under this section and the blood has tested negative for the human 20
immunodeficiency virus or any causative agent of AIDS, or any blood-borne 21
communicable disease as provided under KRS 214.452. When a unit of blood is 22
transfused, a label containing the donor identification number required under this 23
section shall be removed from the unit and affixed to the patient's medical chart or 24
the blood donor identification number for the unit of blood shall be recorded in the 25
patient's medical chart. 26
(5) Any unit of blood not containing the label required under this section shall be 27 UNOFFICIAL COPY 24 RS BR 1223
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destroyed by the health facility, health service, or health care provider. 1
(6) Any unit of blood testing confirmatory positive for an agent of a blood-borne 2
communicable disease and in the possession of a health facility, health service, or 3
health care provider may be donated to educational or scientific research 4
institutions for the purpose of scientific research only and not for transfusion. 5