Section 144-256-ONE-3 - MAINE REQUIREMENTS AND LABORATORY LICENSE EXEMPTIONSSTATE STANDARDS
3.1Laboratories 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. 3.2Requirements. 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.3.3Public 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).3.4Employee 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 265.3.5Maternal 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
3.6No state license required. Medical laboratories exempt from state licensure must have the required CLIA certification. The following medical laboratories are exempt from state licensure. 3.6.1Government operated laboratories. Medical laboratories operated by the United State Government, the State or municipalities of the State.3.6.2Hospital laboratories. Laboratory facilities and laboratory services operated in a hospital licensed by the State.3.6.3Laboratories 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. 3.6.3.2 Physician assistants;3.6.3.3 Family nurse practitioners;3.6.3.4 Medicare-certified rural health clinics; or3.6.4School 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 certificate3.6.6Radiology. The practice of radiology by a radiologist; and3.6.7Health 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
3.7State-issued license required. Except as provided in Section 3.6 of these rules, medical laboratories must secure a department-issued state medical laboratory license. 3.7.1CLIA certification required. Laboratories that are required to secure a state license must have the required CLIA certification.3.7.2Compliance with state standards. Laboratories that are required to secure a state license must comply with state standards in accordance with Section 3.2 of these rules.3.7.3Scope of certification. Laboratories that are required to secure a state license are authorized to perform only those tests that are within the scope of their CLIA certificate.3.7.4Each location licensed. A separate license must be obtained for each nonexempt laboratory location. The license is not valid for any premises other than the location for which the license was issued.3.7.5License displayed. The license must be displayed in a prominent place in the nonexempt medical laboratory where it may be seen by the public. 3.7.5.1 A medical laboratory must not in any advertisement, announcement, letter, circular, poster, sign, or any other manner include any statement expressly or by implication to the effect that it is approved or endorsed by the department. See 22 M.R.S.A. §2019. 3.7.6License not transferable. No license issued pursuant to these rules may be sold, assigned or transferred.3.7.7Valid license. A license is valid only for the person(s) to whom it is issued. See 22 M.R.S.A. §2018. 3.7.8Unlicensed nonexempt laboratories. No person, firm, partnership, association, corporation or other entity shall establish, operate, maintain, or direct or engage in the business of operating a nonexempt medical laboratory, without a state-issued license. See 22 M.R.S.A. §2037(1).3.7.9License required: incorporated laboratories for mutual use of owners. Medical laboratories incorporated for the mutual use of physician or group practice owners must secure a state-issued license and are subject to the provisions of these rules. An incorporated mutual use laboratory is a reference laboratory. See 22 M.R.S.A. §2013-A(C).10-144 C.M.R. ch. 256, § ONE-3