Section 1: Definitions
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 under the federal Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a.
''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.
''Commissioner'', the commissioner of public health.
''Company'', a corporation, partnership, limited liability company, limited liability partnership, an association, a trust or an organized group of persons, whether incorporated or not.
''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, 1 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.
''Department'', the department of public health in the executive office of health and human services.
''Exempt test'', a test which is generally noninstrumental in nature and the results of which are determined by observation of a visual signal.
''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.
''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.
''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.