333.040 Medical laboratories not subject to law.
197 words·~1 min read·
/ky/chapter-333/333-040A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
This chapter applies to all medical laboratories within the State of Kentucky, except:
(1)Medical laboratories operated by the United States government;
(2)Medical laboratories operated by a licensed physician, or a group of licensed
physicians, solely and exclusively in connection with the diagnosis and treatment of
their own patients; if any referred work is received or performed by such medical
laboratories, all provisions of this chapter shall apply;
(3)Medical laboratories operated by hospitals licensed by the secretary for health and
family services;
(4)Medical laboratories operated and maintained exclusively for research purposes,
involving no patient or public health service whatsoever; and
(5)Medical laboratories operated by facilities holding a permit pursuant to KRS
315.035 and holding a valid certification issued pursuant to the Clinical Laboratory
Improvement Act of 1988 (CLIA), as amended, solely and exclusively in
connection with assisting a patient with the use of CLIA-waived tests available
from the facility's stock or inventory, and in connection with testing and treatment
of patients covered under collaborative care agreements established under KRS
315.010 and other applicable laws. If any referred work is received or performed by
these medical laboratories, all provisions of this chapter shall apply.