Bill > S1490

This bill modernizes the regulation of clinical laboratories by updating definitions and operational guidelines in Massachusetts law. The bill expands and clarifies definitions for key terms like "clinical laboratory," "person," and "ownership interest," and introduces specific terminology related to laboratory testing, such as "CLIA-waived test" (a test qualifying for a Certificate of Waiver under federal Clinical Laboratory Improvement Amendments) and "exempt test" (simple laboratory examinations with minimal error risk). The legislation modifies existing regulations to allow the Department of Public Health to classify laboratory tests as exempt with advice from an advisory committee, and updates rules about specimen examination, specifying that tests can only be conducted upon written request from licensed healthcare practitioners or authorized entities like substance abuse programs. Additionally, the bill revises provisions regarding laboratory director qualifications, requiring that directors be employed only as authorized by department regulations. These changes aim to standardize and enhance oversight of clinical laboratory operations, ensuring more precise and consistent regulatory standards while maintaining patient safety and test accuracy.

Budget and Finance, Health and Social Services

https://malegislature.gov/Bills/194/S1490