Be it enacted by the Senate and House of Representatives
in General Court assembled, and by the authority of the same,
SECTION 1. Chapter 111D of the General Laws is hereby amended by striking out section 1, as appearing in the 1984 Official Edition, and inserting in place thereof the following section:-
Section 1. As used in this chapter, the following words shall, unless the context requires otherwise, have the following meaning:-
(1) "Clinical Laboratory", a facility or place, however named, the purpose of which is to make biological, serological, chemical, immuno-hematological, cytological, pathological, or other examinations of materials derived from a human body.
(2) "Commissioner", the commissioner of public health.
(3) "Company", a corporation, a partnership, an association, or an organized group of persons, whether incorporated or not.
(4) "Complex laboratory test", a test which requires sophisticated technique, interpretation of multiple signals or proven technical skill. Such test shall require, but not be limited to, one or more of the following steps:- (a) highly skilled physical manipulation; (b) technique dependent steps in the testing, sampling or reading of results; (c) user programming of the device or devices; (d) detailed calculation of the results; (e) dilution of samples with chemically reactive substances; or (f) preparation of reagents.
(5) "Department", the department of public health in the executive office of human services.
(6) "Exempt test", a test which is generally noninstrumental in nature, and the results of which are determined by observation of a visual signal.
(7) "Person" and "whoever" shall include corporations, societies, associations, partnership, an individual or his estate upon his death, and a political subdivision of the commonwealth, but not an agency of the commonwealth.
(8) "Simple laboratory test", a test which may require a series of steps, reagent additions or instrumentation, and the results of which are generally determined by a visual signal, but which is not a complex laboratory test as defined in clause (4).
SECTION 2. Section 2 of said chapter 111D, as so appearing, is hereby amended by adding the following clause:-
(9) to classify, with the advice of the advisory committee on clinical laboratories, laboratory tests as exempt, simple or complex, for purposes of licensing physician clinical laboratories.
SECTION 3. Said chapter 111D is hereby further amended by striking out sections 3 and 4, as so appearing, and inserting in place thereof the following two sections:-
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 follows: four persons, two physicians and two nonphysicians, who meet the requirements for confirmation as a clinical laboratory director; one other physician not a clinical laboratory director; one medical laboratory technologist; one chief executive officer of a hospital licensed by the department; and five non-providers of health services, one of whom shall be a member of the Massachusetts Bar and one a representative of manufacturers of clinical laboratory technology. Each member of the committee shall serve without compensation for a term of three years, or until his successor is appointed; provided, that no member shall serve more than two consecutive terms. A chairman of the committee shall be elected annually from the membership.
Section 4. No person shall maintain a clinical laboratory in the commonwealth apart from a hospital or clinic licensed under section fifty-one of chapter one hundred and eleven, unless he holds, and there is in effect, a license issued under section five except that the licensing requirement of this section shall not apply to: (a) a clinical laboratory maintained by not more than two licensed physicians exclusively in connection with the diagnosis and treatment of his own patients; (b) a clinical laboratory maintained by three or more licensed physicians exclusively in connection with the diagnosis and treatment of his own patients; provided, however, that (i) the physician or his assistant under the direct supervision of such physician performs all testing; and (ii) the clinical laboratory performs only laboratory tests which the commissioner, with the advice of the advisory committee on clinical laboratories, has determined to be exempt from licensure; or (c) in the case of a clinical laboratory maintained exclusively for research and teaching purposes and not providing reports for diagnosis and treatment of patients or for a public health purpose; or (d) 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. No provision of this chapter other than section six 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 fifty-one of chapter one hundred and eleven.