An Act relative to clinical laboratories

This bill (HD 2079) updates Massachusetts regulations for clinical laboratories. It requires labs to meet new construction/maintenance standards, participate in proficiency testing, and have qualified directors with specified education/certifications. The bill also establishes an advisory committee with 13 members (including physicians, technologists, and industry representatives) and revises licensing rules, including new application requirements, provisional licensing terms (up to 6 months), and restrictions on transferring licenses without department approval. These changes directly affect all clinical laboratories operating in Massachusetts seeking or holding a license under Chapter 111D.