Section 47 Clinical Laboratories Statute 3

Said chapter 111D is hereby further amended by striking out section 14 and inserting in place thereof the following section:-

All clinical laboratories shall disclose ownership interests in writing to the attorney general upon initial licensure and thereafter every 2 years. The disclosure shall contain the name and ownership interest of the disclosing person or company, as well as the names and ownership interests of all other parties with an ownership interest in the clinical laboratory.

This section, along with two others, aligns the DPH clinical laboratories statute with federal Clinical Laboratory Improvement Amendments (CLIA) testing classifications, exempts laboratories performing only CLIA-waived tests from clinical licensure requirements, permits DPH to set qualifications for clinical laboratory directors in regulation, and updates disclosure of ownership interest requirements for clinical laboratories.