214.452 Blood establishments to be federally licensed -- Inspection fees --
506 words·~2 min read·
/ky/214-452A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.