General Laws

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).