MA H2395

Amends Chapter 111D of Massachusetts General Laws to update licensing requirements for clinical laboratories operating outside of licensed hospitals or clinics, including requirements for applicant identity, ownership interests, director qualifications, and procedures sought for licensure

Establishes a 13-member advisory committee appointed by the commissioner to advise on clinical laboratory administration, including physicians, laboratory directors, a medical technologist, a hospital CEO, and non-providers including a Massachusetts Bar member

Prohibits clinical laboratories from accepting specimens referred by persons or companies with direct or indirect ownership interests in the laboratory, with exceptions for physician-owned labs treating their own patients, licensed hospitals/clinics, and college/university health services

Requires all clinical laboratories to disclose ownership interests in writing to the Attorney General's office upon initial licensure and every 2 years thereafter

Authorizes the Department of Public Health to inspect laboratories, issue correction orders with minimum 30-day compliance periods, modify or revoke licenses for violations, and suspend licenses immediately when public health or safety is in jeopardy