Operator means the individual or group of individuals who oversee all facets of the operation of a laboratory and who bear primary responsibility for the safety and reliability of the results of all specimen testing performed in that laboratory. The term includes -
(1) A director of the laboratory if he or she meets the stated criteria; and
(2) The members of the board of directors and the officers of a laboratory that is a small corporation under subchapter S of the Internal Revenue Code.
42 CFR § 493.2
As used in this part, unless the context indicates otherwise -