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The 189th General Court of the Commonwealth of Massachusetts

Section 8: Prohibited activities

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, bar, or otherwise interfere with an inspection undertaken under the authority of section two;

(3) make any false statement in or to omit a material fact from an application or other paper filed with the department;

(4) offer or give a commission, rebate, or other fee, directly or indirectly to any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory;

(5) solicit or accept a commission, rebate, or other fee, directly or indirectly, from any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory;

(6) lend the use of the name of a licensed clinical laboratory or of a licensed hospital or clinic, or of any employee of any such laboratory or institution, to an unlicensed clinical laboratory;

(7) to examine any specimen derived from a human body except upon the written request of a licensed physician, licensed dentist, licensed chiropractor, licensed surgeon, licensed podiatrist, licensed osteopath or, for the sole purpose of requesting urine drug screening, department of public health-licensed substance abuse programs, state agencies or those vendors that contract with state agencies and are designated by the contracting agency to request such screenings, or other person authorized to use the report of such examination by provision of chapter one hundred twelve, unless such examination is for the sole purpose of testing the accuracy or sufficiency of the procedures or equipment of a clinical laboratory and is by instruction of the director of such laboratory, or unless such examination is for the purpose of providing a health promotion screening program and is not used for diagnosis or treatment of patients;

(8) report an examination of any specimen derived from a human body except to or as directed by the licensed physician, licensed chiropractor, licensed surgeon, licensed podiatrist, licensed osteopath or, for the sole purpose of requesting urine drug screening, department of public health-licensed substance abuse programs, state agencies or those vendors that contract with state agencies and are designated by the contracting agency to request such screenings, or other authorized person who requested such examination in writing, unless such examination was made for the sole purpose of testing the accuracy or sufficiency of the procedures or equipment of a clinical laboratory and by instruction of the director of such laboratory, or unless such examination is for the purpose of providing a health promotion screening program and is not used for diagnosis or treatment of patients;

(9) make a report of an examination of any specimen derived from the human body without designating the name and address, and the name of the director, of the clinical laboratory in which such examination was actually performed;

(10) represent, or to maintain a specimen collection station on behalf of, any clinical laboratory, unless such laboratory, if in the commonwealth, is licensed under section five, or unless such laboratory, if not in the commonwealth, has been accredited or is licensed in accordance with federal law;

(11) employ a person as a director of a clinical laboratory, or to serve as a director of a clinical laboratory, except as provided in section seven;

(12) fail to report evidence of infectious disease in violation of section six or of any rule, regulation, or order made to implement section six;

(13) violate or fail to observe any requirement of this chapter or of a rule, regulation, or order made pursuant to this chapter, which the department has made subject to this section by regulation;

(14) knowingly and willfully make fraudulent representations regarding the results of any laboratory test or service. Any laboratory employee, clinical laboratory director, or owner of a clinical laboratory as defined in this chapter who knowingly and willfully makes fraudulent representation regarding the results of any laboratory test or service or who should have known of the fraudulent representation of laboratory test results shall be subject to the penalties set forth in this chapter;

(15) engage in any misrepresentation or false advertising of the nature, quality or cost of such services or of the terms and conditions on which such services are provided;

(16) enter into any agreement or act in concert with any purchaser of or third party payor for laboratory services to commit any act which would be deemed to be a violation of section three of chapter one hundred and seventy-six D; provided further that for purposes of this subsection, all purchasers and third party payors entering into arrangements with clinical laboratories shall be deemed to be engaged in the business of insurance.

(17) knowingly solicit, accept or test any specimen derived from the human body that is received from, ordered, requested or referred by: (a) any person or company in which the clinical laboratory or its directors, owners, partners, employees or family members thereof have any direct or indirect ownership interest; or (b) any person or company or its directors, owners, partners, employees or family members thereof having any direct or indirect ownership interest in the clinical laboratory; provided, however, that this clause shall not apply to: (i) a clinical laboratory owned by a licensed physician or group of licensed physicians used exclusively in connection with the diagnosis and treatment of the physician's or group of physicians' own patients and where all testing is performed by or under the direct supervision of the physician or group of physicians; (ii) a hospital or clinic licensed under section 51 of chapter 111 used exclusively in connection with the diagnosis or treatment of the hospital's or clinic's own patients; or (iii) any case exempted under subsection (b) to (d), inclusive, of 42 U.S.C. section 1395nn, or specifically permitted by regulations or rules of the United States Secretary of Health and Human Services, the federal Centers for Medicare or Medicaid Services, the executive office of health and human services or the executive office for administration and finance.