Section 37 Clinical Laboratories Statute 1

Section 1. Chapter 111D of the General Laws is hereby amended by striking out section 1 and inserting in place thereof the following section:-

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 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.

(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 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. Exempt test 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.

This section, along with four others, aligns the DPH clinical laboratories statute with federal Clinical Laboratory Improvement Amendments (CLIA) testing classifications.