Section 45 Clinical Laboratories Statute 1

Chapter 111D of the General Laws is hereby amended by striking out sections 1 through 5 and inserting in place thereof the following 5 sections:-

Section 1. As used in this chapter, the following words shall, unless the context requires otherwise, have the following meaning:-

(1) "CLIA-Waived Test", a test that the federal Centers for Medicare and Medicaid Services has determined qualifies for a Certificate of Waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).

(2) ''Clinical Laboratory'', a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; provided, that these examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. For the purposes of this chapter, facilities only collecting or preparing specimens, or both, or only serving as a mailing service and not performing testing are not considered laboratories.

(3) ''Commissioner'', the commissioner of public health.

(4) ''Company'', a corporation, partnership, limited liability company, limited liability partnership, an association, a trust or an organized group of persons, whether incorporated or not.

(5) ''Department'', the department of public health in the executive office of health and human services.

(6) ''Exempt test'', a test designated by the department as a simple laboratory examination or a procedure that has an insignificant risk of error, including but not limited to, CLIA-waived tests; provided, that exempt tests also may include tests designated by the department that the federal Centers for Medicare and Medicaid Services has determined qualify for a Certificate of Provider Performed Microscopy under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).

(7) ''Ownership interest'', interests including, but not limited to, any membership, proprietary interest, shares of stock in a corporation, units or other interest in a partnership, bonds, debentures, notes or other equity interest or debt instrument or co-ownership in any form.

(8) ''Person'', corporations, societies, associations, partnerships, limited liability companies, limited liability partnerships, trusts, organized group of persons, whether incorporated or not, an individual or the individual's estate upon death, any other entity including, but not limited to, medical practice, medical office, clinic, counseling center, substance use disorder treatment program or sober house or a political subdivision of the commonwealth.

Section 2. The department shall have authority:

(1) to establish and to enforce, requirements in addition to any prescribed in this chapter for the construction, maintenance and utilization of clinical laboratories, including standards of performance in the examination of specimens;

(2) to require evidence of successful participation by clinical laboratories licensed by the department in proficiency testing programs, and by laboratory personnel in training programs, covering all or specific laboratory specialties and approved by the department;

(3) to establish appropriate fees for the issuance and renewal of licenses;

(4) to make such reasonable classification of clinical laboratories, by category of laboratory procedures performed or nature and scope of services provided, as the department may find necessary or appropriate in the public interest;

(5) to inspect at any time any clinical laboratory and any records maintained in connection with such laboratory; provided, that a license has been issued or an application for a license has been filed pursuant to section 5;

(6) to conduct investigations and adjudicatory proceedings;

(7) to conduct research and studies, to sponsor or hold educational programs, to make informational materials available to the public, and to engage in such other activities as may be necessary or appropriate for the administration or enforcement of this chapter;

(8) to make such rules, regulations, as may be necessary or appropriate for the administration or enforcement of this chapter;

(9) to classify laboratory tests as exempt; and

(10) to establish minimum qualifications of laboratory personnel.

Section 3. The department may from time to time convene an advisory committee on clinical laboratories, to advise the department on the administration of this chapter. The advisory committee shall serve solely in an advisory capacity and shall not have authority to make binding decisions. Such committee shall consist of 13 members, to be appointed by the commissioner, as follows: 5 persons, 3 physicians and 2 nonphysicians, who meet the requirements for a clinical laboratory director as defined in regulation by the department; 1 other physician not a clinical laboratory director; 1 medical laboratory technologist; 1 chief executive officer of a hospital licensed by the department; and 5 non-providers of health services, 1 of whom shall be a member of the Massachusetts Bar and 1 a representative of manufacturers of clinical laboratory technology. Each member of the committee shall serve without compensation for a term of 3 years, or until a successor is appointed; provided, that no member shall serve more than 2 consecutive terms.

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 such person holds, and there is in effect, a license issued by the department except that the licensing requirement of this section shall not apply to: (a) a clinical laboratory operated by not more than 2 licensed physicians exclusively in connection with the diagnosis and treatment of their own patients; provided, however, that (i) the physician or the physician's assistant under the direct supervision of such physician performs all testing; and (ii) the clinical laboratory performs only exempt tests; or (b) a clinical laboratory operated by 3 or more licensed physicians exclusively in connection with the diagnosis and treatment of their own patients; provided, however, that (i) the physician or the physician's assistant under the direct supervision of such physician performs all testing; and (ii) the clinical laboratory performs only exempt tests; or (c) a clinical laboratory performing only CLIA-waived tests, provided that clinical laboratories performing non-CLIA waived tests in addition to CLIA-waived tests must obtain a clinical laboratory license; or (d) in the case of a clinical laboratory operated exclusively for research that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; or (e) any laboratory with respect to tests or other procedures made by it for any person engaged in the business of insurance if made for purposes of determining whether to write an insurance contract or determining eligibility or continued eligibility thereunder, or for the examination of its employees or officers; or (f) any laboratory maintained exclusively for a health promotion screening program, as defined in regulations of the department, which does not provide reports for diagnosis or treatment of patients and which meets standards for such program established by the department; or (g) a clinical laboratory operated by a college or university exclusively in connection with the diagnosis and treatment of the college or university's own students, staff, or faculty and that meets the requirements in section 7 and department regulations for clinical laboratory director; provided, however, that (i) tests are performed under the direct supervision of the clinical laboratory director; and (ii) the clinical laboratory performs only exempt tests. No provision of this chapter other than section 6 shall apply to any agency of the commonwealth; nor shall any provision of this chapter relative to licensing apply to any hospital or clinic licensed under section 51 of chapter 111.

Section 5. Any person seeking a license to maintain a clinical laboratory apart from a hospital or clinic licensed under section 51 of chapter 111 shall file with the department a license application containing such information as the department may reasonably require, including but not limited to: the identity of the applicant and any parent or associated company, including respective ownership interests, the identity and qualifications of the proposed laboratory director; and the procedures or categories of procedures for which the license is sought.

Upon receipt and review of an application for license and upon payment of the appropriate fee, the department shall issue a license if it finds that the applicant is responsible and suitable to maintain a clinical laboratory and meets such requirements as the department has established by regulation for a license. In the case of renewal application, the department may, subject to such regulations as it shall make, issue a provisional license to an applicant who does not meet every requirement for a license; provided, that the applicant has demonstrated to the department's satisfaction a good faith intention to correct deficiencies, and provided further, that the department finds that the licensee provides reliable reports of examinations of specimens and presents satisfactory evidence that the requirements for full licensure can and will be met within a period of time not to exceed 6 months. The department shall in no case issue a person more than 2 consecutive provisional licenses for the same clinical laboratory.

The department shall set forth in every license issued under this section the name and address of the licensee; the name by which the clinical laboratory shall be known; the address of the licensed premises; the period which such license is issued; the classification, if any, for which such license is issued; the conditions as to transfer and assignment prescribed by law; and such other terms of issuance as the department may reasonably prescribe. The period of a license shall be not more than 2 years and the period of a provisional license shall be for not more than 6 months.

This section, along with two others, aligns the DPH clinical laboratories statute with federal Clinical Laboratory Improvement Amendments (CLIA) testing classifications, exempts laboratories performing only CLIA-waived tests from clinical licensure requirements, permits DPH to set qualifications for clinical laboratory directors in regulation, and updates disclosure of ownership interest requirements for clinical laboratories.