§2013-A. Applicability

In general, this Act applies to all medical laboratories and directors of medical laboratories operating in the State.   [PL 1989, c. 72, §2 (NEW).]

1.  Exemptions.  Subject to the limitations set forth in subsections 2 and 3, the following entities are exempted from the provisions of this Act under the following circumstances:

A. Medical laboratories operated by the United States Government, the State or municipalities of the State;   [PL 1989, c. 72, §2 (NEW).]

B. Laboratory facilities and laboratory services operated in a hospital licensed by the State;   [PL 1989, c. 72, §2 (NEW).]

C. Physicians and medical staff pursuant to this paragraph:

(1) Physicians, physician assistants, family nurse practitioners, Medicare-certified rural health clinics, professional associations or group practices performing only tests acceptable to the department, as defined by rule, exclusively for the examination of their own patients; and

(2) Physicians, physician assistants, family nurse practitioners, Medicare-certified rural health clinics, professional associations or group practices performing tests, other than those listed in subparagraph (1), exclusively for the examination of their own patients are subject only to sections 2024, 2025 and 2039.

Notwithstanding subparagraphs (1) and (2), laboratories incorporated for the mutual use of physician or group practice owners are subject to all provisions of this Act;   [PL 2005, c. 383, §21 (AMD).]

D. Medical laboratories in a school, college, university or industrial plant that are under the direct supervision of, and whose services are used exclusively by, a duly licensed physician and that perform only tests acceptable to the department; otherwise, only sections 2024, 2025 and 2039 apply;   [PL 2005, c. 383, §21 (AMD).]

E. Laboratories operated and maintained for research and teaching purposes that are recognized by the department or involve no patient or public health service;   [PL 2005, c. 383, §21 (AMD).]

F. The practice of radiology by a radiologist; and   [PL 1989, c. 72, §2 (NEW); PL 1989, c. 456, §1 (AMD).]

G. Laboratory services performing health screening tests as defined and regulated by rule adopted by the department. Services exempted under this paragraph include, but are not limited to, the performance of screening tests for cholesterol and colon cancer.   [PL 1993, c. 600, Pt. B, §4 (AMD).]

[PL 2005, c. 383, §21 (AMD).]

2.  Maternal serum alpha-fetoprotein testing.  Notwithstanding subsection 1, all medical laboratories and directors of medical laboratories shall be subject to all provisions of this Act, and rules promulgated under it, which govern the performance of maternal serum alpha-fetoprotein testing.

[PL 1989, c. 72, §2 (NEW).]

3.  Public health reporting requirements.  Notwithstanding subsection 1, any facility, regardless of location, that receives, forwards or analyzes specimens of material from the human body or referred cultures of specimens from the human body and reports the results to health care providers who use the data for purposes of patient care must comply with chapter 250.

[PL 2005, c. 383, §22 (NEW).]

SECTION HISTORY

PL 1989, c. 72, §2 (NEW). PL 1989, c. 456, §§1,2 (AMD). PL 1989, c. 665, §1 (AMD). PL 1993, c. 600, §§B2-4 (AMD). PL 2005, c. 383, §§21,22 (AMD).