Current through Register 1533, October 25, 2024
Section 180.041 - Standard - Responsibility of Owners(A) The owner shall be responsible for the proper maintenance and ethical operation of the clinical laboratory and for any violations of 105 CMR 180.000 and other regulations. The Department shall be notified in writing within a 30-day period of changes in Director, General Supervisor, and Technical Supervisor. Significant changes in the physical facilities shall be reported to the Department within 30 days after initiation of such changes.(B) The owner shall notify the Department 15 days in advance of any change in the location or ownership of a laboratory.(C) The owner shall be responsible that the clinical laboratory is at all times under the direction of a Director acceptable to the Department. In the case where the Director is to be absent for more to the approval of the Department, and shall so notify the Department in advance.(D) The owner shall notify the Department in advance whenever the designated Director is expected to terminate his employment. Permission may be granted to continue operation of the laboratory for a time period not to exceed six calendar weeks after the termination of the Director and prior to the appointment of a new Director.(E) The owner and director shall, if different persons, be jointly and severally responsible for the operation of the laboratory in compliance with the provisions set forth in 105 CMR 180.000 and with other pertinent regulatory and statutory requirements.