CMS SOM App. C, Tag D6079

The laboratory director is responsible for the overall operation and administration

of the laboratory, including the employment of personnel who are competent to

perform test procedures, record and report test results promptly, accurately and

proficiently, and for assuring compliance with the applicable regulations.

Interpretive Guidelines §493.1445

The requirement that a laboratory must be under the direction of a qualified person is not

automatically met simply because the director meets the education and experience

requirements. It must be demonstrated that the individual is, in fact, providing effective

direction over the operation of the laboratory.

In determining whether the director responsibilities are met, consider deficiencies found

in other conditions, e.g., facility administration, general laboratory systems, preanalytic

systems, analytic systems, postanalytic systems, and proficiency testing.

If the laboratory has more than one person qualifying as a director, one individual must

be designated as accepting ultimate responsibility for the overall operation and

administration of the laboratory. These responsibilities must be delegated in writing.

(a) The laboratory director, if qualified, may perform the duties of the technical

supervisor, clinical consultant, general supervisor, and testing personnel, or delegate

these responsibilities to personnel meeting the qualifications under §§493.1447,

493.1453, 493.1459, and 493.1487, respectively.

Interpretive Guidelines §493.1445(a)

An individual qualified as laboratory director under §493.1443 may not qualify as

technical supervisor in a particular specialty or subspecialty unless he or she has the

required training or experience. If the director of high complexity testing is not qualified

to perform the duties of the technical supervisor or clinical consultant, he or she must

employ individual(s) meeting the respective qualifications.

(b) If the laboratory director reapportions performance of his or her

responsibilities, he or she remains responsible for ensuring that all duties are

properly performed.

Interpretive Guidelines §493.1445(b)

The laboratory director may reapportion to a technical supervisor, in writing, the

responsibilities in: §§493.1445(e)(3), (4), (5), (6), (7), (12), (13), and (14).

The laboratory director may reapportion to a clinical consultant, in writing, the

responsibilities in: §§493.1445(e)(8) and (9).

The only responsibilities that may be delegated to the general supervisor are listed at

§§493.1463(b)(1)-(4).