KRS 214.452: Blood establishments to be federally licensed -- Inspection fees --

Donor conditions -- Forms -- Sign posting.

The following policies shall apply to blood establishments and to donors of blood:

(1) All blood establishments within the Commonwealth shall be licensed by the

United States Food and Drug Administration and remain in compliance with all

applicable federal regulations. The Cabinet for Health and Family Services

shall, under administrative regulations promulgated pursuant to KRS Chapter

13A, establish fees necessary to cover the cost of and adhere to a schedule for

regular inspection, by the Office of the Inspector General of the Cabinet for

Health and Family Services, of all blood establishments within the

Commonwealth to ascertain whether each blood establishment is licensed and

in compliance with KRS 214.450 to 214.464 and KRS 214.468. The Office of

the Inspector General shall commence its inspection program of blood

establishments no later than September 1, 1994.

(2) All blood establishments shall test blood for the human immunodeficiency virus

and for any known causative agent for any blood-borne communicable

disease, using tests approved and required, for purposes of blood donation, by

the United States Food and Drug Administration.

(3) It shall be the duty of the administrator of any blood establishment which

collects blood for the purpose of distributing to another health service, health

facility, or health-care provider the blood for transfusion to:

(a) Secure donor consent and a signed written risk factor history and donor

consent form for each potential paid or volunteer donor for the purpose of

determining if the potential donor is at high risk for infection with the

human immunodeficiency virus, or has tested confirmatory positive for

infection with the human immunodeficiency virus; or has acquired immune

deficiency syndrome; or has tested confirmatory positive for infection with

any causative agent for acquired immune deficiency syndrome

recognized by the United States Centers for Disease Control; or has a

blood-borne communicable disease;

(b) Provide a means for a potential donor to self-elect not to donate blood;

(c) Refuse donation or sale of blood by persons at high risk for infection with

the human immunodeficiency virus, or who have been medically

diagnosed as having acquired immune deficiency syndrome, or who have

tested confirmatory positive for infection with the human

immunodeficiency virus, or who have a blood-borne communicable

disease;

(d) Post a sign in the blood establishment which is visible to all potential

donors and which states: "Persons with acquired immune deficiency

syndrome (AIDS), or who have tested confirmatory positive for infection

with the human immunodeficiency virus (HIV), or who have a blood-borne

communicable disease or who have one (1) or more risk factors for the

human immunodeficiency virus as determined by the United States

Centers for Disease Control, are prohibited by law from donating or

selling blood. Persons violating the law are guilty of a Class D felony. ASK

STAFF OF THIS BLOOD ESTABLISHMENT."

(4) The provisions of this section shall not be construed to impose requirements

which are in conflict with donor eligibility requirements set out in United States

Food and Drug Administration or American Association of Blood Banks

standards.