§ 5.22. Responsibilities of owner and director.
(a) The owner and director, jointly and severally, shall be responsible for the proper maintenance and ethical operation of the clinical laboratory and for any violations of these and other existing provisions. The Department will be notified in writing within a 30-day period of changes in the directors or general supervisor, and of all other technical personnel changes on a 6-month basis. Significant changes in physical facilities shall be reported to the Department within 30 days after initiation of the changes.
(b) The owner shall be responsible that the clinical laboratory is at all times under the direction of a director acceptable to the Department as set forth in this section. Whenever the designated director is to be on leave from his duties for more than 30-calendar days, the registrant shall so notify the Department in advance and shall designate, subject to approval of the Department, an interim director of the laboratory.
(c) The owner shall notify the Department in advance whenever the designated director is expected to terminate his services with the laboratory. Permission may be granted to continue operation of a clinical laboratory for not more than 6-calendar weeks under a general supervisor who does not meet the qualifications of a director. In extenuating circumstances, permission to operate longer without a permanent director may be granted subject to conditions specified in writing by the Department.
(d) The owner and director shall, if different persons, be jointly and severally responsible for the operation of the clinical laboratory in compliance with this section and with other pertinent regulatory and statutory requirements. They shall be responsible for the employment of personnel meeting qualifications specified in this chapter. They shall submit to the Department, on forms provided by the Department, an annual report of the number and types of laboratory examinations performed during the preceding year.
(e) The director shall be responsible for the proper performance of all tests in the laboratory. He shall direct and supervise such tests and be responsible for the work of subordinates. He shall be responsible for the continuous application of quality control procedures to the work in accordance with recommendations and directives of the Department. Laboratory records of all work performed shall indicate the name of the director, and be signed by or otherwise indicate the person who actually performed the test.
(f) No person may act as a director of more than two clinical laboratories.
(g) A director shall be present for a reasonable period of each working day in each laboratory for which he is director.
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