Sec.19a-36-D35. Responsibilities of licensee and director

(a) The licensee shall ensure that the laboratory is at all times under the direction of a director who meets the qualification standards identified in Section 19a-13-D33 of the regulations of Connecticut State Agencies. Whenever the designated director is to be on leave for more than thirty (30) calendar days, the licensee shall so notify the department in advance and shall designate an interim supervisor of the laboratory who meets the qualifications identified in subsection (c) of this section. The licensee shall notify the department at least thirty (30) days in advance of any proposed change of ownership or major expansion or alteration in quarters. At such time that the director severs connection with the laboratory, the department may grant permission for the continued operation of the laboratory under an interim supervisor for not more than six (6) weeks. In extenuating circumstances, permission to operate longer without a permanent director may be granted subject to conditions specified in writing by the department.

(b) The licensee and director, if different persons, shall be jointly and severally responsible for the operation of the laboratory in compliance with sections 19a-36-D20 through 19a-36-D38 of the regulations of Connecticut State Agencies, and with other pertinent regulatory and statutory requirements. They shall advise the department within seven (7) days of changes in operations or personnel. They shall submit to the department an annual report on forms provided for the purpose which shall relate to the numbers and types of laboratory examinations performed during the preceding year.

(c) The director shall be responsible for the work of subordinates, the proper management of patient test specimens and records, the proper performance of all tests in the laboratory, and the continual application of quality control procedures to the work in accordance with recommendations and directives of the department. In the absence of the director for any cause, the interim supervisor shall assume the director's responsibilities. Such interim supervisor shall meet the qualification requirements identified in Section 19a-36-D34 of the regulations of Connecticut State Agencies.

(d) Except for illness, vacation or other justifiable leave, the director shall be responsible for the overall operation of the laboratory. No person shall act as director of more than five (5) laboratories.

(Adopted effective June 4, 1996)