Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-3 - MAINE REQUIREMENTS AND LABORATORY LICENSE EXEMPTIONS

Current through 2024-29, July 17, 2024
STATE STANDARDS
3.1
Laboratories operating in Maine.
The Maine Medical Laboratory Act applies to medical laboratories
				  operating in the State, except as otherwise stated in these rules. See
				   22 M.R.S.A.
				  §2013-A.
3.2
Requirements.
All medical
				  laboratories whether licensed or exempt from state licensure, must comply with
				  state standard set out in Sections 3.3 and 3.4 of these rules.
3.3
Public health reporting
				  requirements.
Medicallaboratories whether licensed or exempt from state
				  licensure, regardless of location, must comply with the public health reporting
				  requirements in Title 22, chapter 250 of the Maine Revised Statutes (notifiable
				  diseases, communicable diseases). This applies to laboratories that receive,
				  forward or analyze specimens of material from the human body or referred
				  cultures of specimens from the human body and report the results to health care
				  providers who use the data for purposes of patient care. See
				   22 M.R.S.A.
				  §2013-A(3).
3.4
Employee drug testing.
Medical laboratories testing employees and applicants for substances of
				  abuse for employment related purposes must be licensed in accordance with the
				  laws and rules governing Maine Drug Testing Laboratories. See
				   26 M.R.S.A.
				  §§681 -
				  690 and 10 -
				  144 C. M.R. Chapter 265.
3.5
Maternal serum alpha-fetoprotein (AFP) testing.
Medical
				  laboratories are subject to Section 6.8 of these rules that governs the
				  performance of maternal serum alpha-fetoprotein (AFP) testing.See
				   22 M.R.S.A.
				  §2013-A(2).
EXEMPT LABORATORIES
3.6
No state license required.
Medical laboratories exempt from state licensure must have the required
				  CLIA certification. The following medical laboratories are exempt from state
				  licensure.
3.6.1
Government operated
				  laboratories.
Medical laboratories operated by the United State
				  Government, the State or municipalities of the State.
3.6.2
Hospital laboratories.
Laboratory facilities and laboratory services operated in a hospital
				  licensed by the State.
3.6.3
Laboratories for exclusive testing of their own patients.
Medical
				  laboratories operated by the following entities are exempt from state licensure
				  if they perform only tests that are within the scope of their CLIA certificate
				  exclusively for the examination of their own patients.
3.6.3.1 Physicians;
3.6.3.2 Physician assistants;
3.6.3.3 Family nurse practitioners;
3.6.3.4 Medicare-certified rural health
				  clinics; or
3.6.3.5 Group
				  practices
.
3.6.4
School and business laboratories.
Medical laboratories operated in a school, industrial plant or business
				  are exempt from state licensure if they are under the direct supervision of,
				  and services are performed exclusively by, a duly licensed physician, physician
				  assistant, or nurse practitioner.
3.6.4.1 The
				  laboratory must only provide services to students and employees of the school,
				  industrial plant or business.
3.6.4.2 The laboratory is authorized to
				  perform only those tests that are within the scope of the laboratory's CLIA
				  certificate.
3.6.5
				  Research and teaching laboratories. Laboratories operated and maintained for
				  research and teaching purposes that are recognized by the department are exempt
				  from state licensure.
3.6.5.1 The laboratory
				  must not provide any patient or public health service.
3.6.5.2 The laboratory is authorized to act
				  only within the scope of the laboratory's CLIA certificate
3.6.6
Radiology.
The practice of
				  radiology by a radiologist; and
3.6.7
Health screening laboratories.
Health screening laboratories (HSLs) performing health screening tests
				  are exempt from state licensure, if the required permit has been issued to the
				  HSL in accordance with PART TWO, Sections 12-19, of these rules. See
				   22 M.R.S.A.
				  §2013-A(1).
NONEXEMPT LABORATORIES