Bill > H2395

This bill updates Massachusetts law regarding clinical laboratories by making several key changes. It expands the Department of Public Health's authority to establish and enforce requirements for clinical laboratories, including performance standards, proficiency testing, and personnel training. The bill creates a new 13-member advisory committee to provide guidance on clinical laboratory administration, composed of healthcare professionals, laboratory experts, and non-provider representatives. The legislation introduces more detailed licensing procedures for clinical laboratories, including requirements for license applications, renewals, and transfers. It mandates that each clinical laboratory must have a designated director responsible for technical and scientific operations, and establishes strict regulations about laboratory practices, such as prohibiting misrepresentation, false advertising, and conflicts of interest in specimen testing and referrals. The bill also requires laboratories to disclose ownership interests to the Attorney General's office every two years and gives the department expanded powers to inspect laboratories, modify licenses, and impose sanctions for non-compliance. These changes aim to enhance the quality, transparency, and accountability of clinical laboratories in Massachusetts by strengthening regulatory oversight and professional standards.

Budget and Finance, Health and Social Services

https://malegislature.gov/Bills/194/H2395