Chapter 111D

Section 1. As used in this chapter, the following words shall, unless the context clearly requires otherwise, have the following meanings: ''CLIA-waived test'', a test that the federal Centers for Medicare and Medicaid Services has determined qualifies for a Certificate of Waiver…

Section 10. Whenever the department finds upon inspection, or through information in its possession, that a clinical laboratory, licensed under this chapter is not able to provide or is not providing reliable reports of examinations pursuant to the terms of such license, it may b…

Section 11. The department may revoke the license issued under section five or impose other appropriate administrative sanction upon a license, or both, for conduct by or chargeable to him as follows: (1) failure to observe any term of such license; (2) failure to meet any requir…

Section 12. The department, in its own name, may bring a complaint in the superior court or supreme judicial court to enforce compliance with this chapter or any rule, regulation, or order made under this chapter, whenever it shall appear that any person has engaged in, is engagi…

Section 13. (a) No individual shall: (i) maintain a clinical laboratory in the commonwealth without a license in violation of section 4; (ii) maintain a clinical laboratory in violation of the terms of a license issued under section 5; (iii) engage in, aid, abet, cause or permit …

Section 14. The department shall require all clinical laboratories to disclose any ownership interests in writing to the department every 2 years. The disclosure shall contain the name and ownership interest of the disclosing person or company, as well as the names and all owners…

Section 2. The department shall have authority: (1) to establish, with the advice of the advisory committee on clinical laboratories, and to enforce, requirements in addition to any prescribed in this chapter for the construction, maintenance, and utilization of clinical laborato…

Section 3. There shall be within the department an advisory committee on clinical laboratories, to advise the department, as provided in section two, on the administration of this chapter. Such committee shall consist of twelve members, to be appointed by the commissioner, as fol…

Section 4. No person shall maintain a clinical laboratory in the commonwealth apart from a hospital or clinic licensed under section 51 of chapter 111, unless the person holds, and there is in effect, a license issued under section 5; provided, however, that the licensing require…

Section 5. Any person seeking a license to maintain a clinical laboratory apart from a hospital or clinic licensed under section fifty-one of chapter one hundred and eleven shall file with the department a license application containing such information as the department may reas…

Section 6. The department may require the reporting of any infectious disease found in the examination of specimens at clinical laboratories if, in its opinion, reporting of such disease is necessary to protect or promote the public health. Every person who and every agency which…

Section 7. Every person licensed to maintain a clinical laboratory under this chapter shall appoint an individual, who shall bear the title ''clinical laboratory director'', with responsibility for the direction of the technical and scientific operation of such laboratory, includ…

Section 8. A clinical laboratory shall not: (1) misrepresent, by false statement, by omission of a material fact, or by scheme, trick, or device, the category or categories of procedures performed at, or the service or services available at, a clinical laboratory; (2) obstruct, b…

Section 8A. No person or company shall knowingly refer, request, order or send any specimen derived from the human body for examination to a clinical laboratory in which the person or company, or any of its owners, directors, partners, employees or family members thereof have a d…

Section 9. Whenever the department finds upon inspection, or through information in its possession, that a clinical laboratory licensed under this chapter is not in compliance with a requirement prescribed in or established under this chapter, it may by order require the licensee…