Amendment #134 to H4617

Clinical Lab Technical Fix

Mr. Cahill of Lynn moves to amend the bill by inserting after section 65 the following sections:

“SECTION XA. Section 1 of chapter 111D of the General Laws, as appearing in the 2016 Official Edition, is hereby amended by adding the following definition:-

(9) “CLIA-Waived Test”, a test system, assay, or examination that the federal department of health and human services has determined meets the statutory criteria as specified for waiver under section 353(d)(3) of the Public Health Service Act.

SECTION XB. Said section 1 of said chapter 111D, as so appearing, is hereby further amended by striking out the definitions of “Complex Laboratory Test” and “Simple Laboratory Test”.

SECTION XC. Said section 1 of said chapter 111D, as so appearing, is hereby further amended by striking out the definition of “Exempt Test” and inserting in place thereof the following definition:-

(6) ''Exempt test'', a test designated by the department as having a low risk of error, including, but not limited to, CLIA-waived tests and provider-performed microscopy.

SECTION XD. Clause (9) of section 2 of said chapter 111D, as so appearing, is hereby amended by striking out, in line 30, the words “simple or complex,”.

SECTION XE. Said section 2 of said chapter 111D, as so appearing, is hereby further amended by adding the following clause:-

(10) to establish minimum qualifications of clinical laboratory directors.

SECTION XF. Said chapter 111D  is hereby further amended by striking out section 7.

SECTION XG. Section 8 of said chapter 111D, as appearing in the 2016 Official Edition, is hereby amended by striking out clauses (7) and (8).

SECTION XH. Clause (11) of said section 8 of said chapter 111D, as so appearing, is hereby amended by striking out the words “except as provided in section seven;” and inserting in place thereof the following words:- who does not meet the department’s minimum qualifications for a laboratory director;”.