PARRIS N. GLENDENING, Governor                             Ch. 465

Article - Health - General

17-201.

(a)     In this subtitle the following words have the meanings indicated.

(b)     (1) "Medical laboratory" means any [laboratory] FACILITY, ENTITY, OR
SITE that OFFERS OR PERFORMS TESTS OR [makes] examinations in connection with
the diagnosis and control of human diseases or the assessment of human health,
nutritional, or medical conditions OR IN CONNECTION WITH JOB-RELATED DRUG AND
ALCOHOL TESTING.

(2)     "MEDICAL LABORATORY" INCLUDES ANY LABORATORY OWNED OR
OPERATED BY THE STATE OR OWNED OR OPERATED BY A COUNTY OR MUNICIPAL
CORPORATION IN THE STATE.

[(2) "Medical laboratory" does not include tests or examinations that:

(i) Are performed by a health care practitioner who is licensed under
the Health Occupations Article, with the exception of a physician, if the tests or
examinations:

1.       Are performed on the patients of the practitioner; and

2.       Are within the practitioner's lawful scope of practice; or
(ii) Concern pregnancy screening.]

(c)      ["Permit"] "LICENSE" means a permit, LETTER OF EXCEPTION,
CERTIFICATE, OR OTHER DOCUMENT issued by the Secretary GRANTING APPROVAL
OR AUTHORITY TO:

(1)     [To operate a] OFFER OR PERFORM medical laboratory TESTS OR
EXAMINATIONS in this State;

[(2) To represent or service in this State a medical laboratory that is outside
this State; or

(3)     To perform tests or examinations pertaining to individuals in this State
at a medical laboratory located outside this State.]

(2)     OFFER OR PERFORM MEDICAL LABORATORY TESTS OR
EXAMINATIONS ON SPECIMENS ACQUIRED FROM HEALTH CARE PROVIDERS IN THIS
STATE AT A MEDICAL LABORATORY LOCATED OUTSIDE THIS STATE; OR

(3)     REPRESENT OR SERVICE IN THIS STATE A MEDICAL LABORATORY
REGARDLESS OF THE LABORATORY'S LOCATION.

17-202.

(a) (1) The Secretary shall adopt [rules and] regulations that set standards
AND REQUIREMENTS for medical laboratories.

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