CMS SOM App. C, Tag D6143

(a) The general supervisor must possess a current license issued by the State in

which the laboratory is located, if such licensing is required; and

(b) The general supervisor must be qualified as a--

(b)(1) Laboratory director under §493.1443; or

(b)(2) Technical supervisor under §493.1449.

(c) If the requirements of paragraph (b)(1) or (2) of this section are not met, the

individual functioning as the general supervisor must--

(c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric

medicine licensed to practice medicine, osteopathy, or podiatry in the State in which

the laboratory is located or have earned a doctoral, master’s, or bachelor’s degree

in a chemical, biological, clinical or medical laboratory science, or medical

technology from an accredited institution; and

(c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high

complexity testing; or

(c)(2)(i) Qualify as testing personnel under §493.1489(b)(3); and

(c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high

complexity testing; or

(c)(3) Meet the requirements at § 493.1443(b)(3) or § 493.1449(c)(4) or (5); or

(c)(4) Notwithstanding any other provision of this section, an individual is

considered qualified as a general supervisor under this section if they were qualified

and serving as a general supervisor in a CLIA-certified laboratory as of December

28, 2024, and have done so continuously since December 28, 2024.

Interpretive Guidelines §493.1461(c)(4)

The grandfathering provision will allow individuals already qualified and employed as a

general supervisor of high complexity as of the effective date of the final rule December

28, 2024, to continue to be qualified under the new provisions provided the individuals

remain continuously employed in their position after the effective date of December 28,

2024. The individual may have no more than 6 months of break in employment in their

position in a two-year period.

(d) For blood gas analysis, the individual providing general supervision must--

(d)(1) Be qualified under §§493.1461(b)(1) or (2), or 493.1461(c); or

(d)(2)(i) Have earned a bachelor’s degree in respiratory therapy or cardiovascular

technology from an accredited institution; and

(d)(2)(ii) Have at least one year of laboratory training or experience, or both, in

blood gas analysis; or

(d)(3)(i) Have earned an associate degree related to pulmonary function from an

accredited institution; and

Interpretive Guidelines §493.1461(d)(3)(i)

NOTE: Many blood gas systems are categorized as moderate complexity tests;

therefore, only moderate complexity personnel requirements are applicable. To

determine which tests are categorized as waived or nonwaived (i.e., moderate or high

complexity tests), refer to the “FDA CLIA Complexity Database” at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.

Test systems, assays, and examinations not yet classified are considered high complexity.

(d)(3)(ii) Have at least two years of training or experience, or both in blood gas

analysis.

(e) The general supervisor requirement is met in histopathology, oral pathology,

dermatopathology, and ophthalmic pathology because all tests and examinations,

must be performed:

(e)(1) In histopathology, by an individual who is qualified as a technical supervisor

under § 493.1449(b) or (f)(1);

(e)(2) In dermatopathology, by an individual who is qualified as a technical

supervisor under § 493.1449(b) or § 493.1449(f)(2);

(e)(3) In ophthalmic pathology, by an individual who is qualified as a technical

supervisor under § 493.1449(b) or § 493.1449(f)(3); and

(e)(4) In oral pathology, by an individual who is qualified as a technical supervisor

under § 493.1449(b) or (g).

Interpretive Guidelines §493.1461(e)

In the case of gross examinations, the technical supervisor may delegate to individuals

qualified under §493.1489 the responsibility for the physical examination/description,

including color, weight, measurement and other characteristics of the tissue; or other

mechanical procedures for which a specific written protocol has been developed. The

delegation should be in writing.

The technical supervisor is ultimately responsible for the diagnosis related to the gross

examination and must sign the examination report. The technical supervisor is not

required to provide direct on-site supervision but is responsible for the accuracy of all test

results reported. All physical examinations/descriptions of tissue including color, weight,

measurement and other characteristics of the tissue; or other mechanical procedures

including dissection, inking, marking, and specific orientation for diagnostic

interpretation performed in the absence of the technical supervisor by individuals

qualified under §493.1489 should be reviewed within 24 hours by the technical

supervisor. All microscopic tissue examinations must be performed by individuals

qualified under §493.1449(b), (f) or (g), as appropriate.

There should be documentation of the identity of the personnel performing the grossing

portion of the test. The name does not necessarily need to be included in the final report

because the final report is under the responsibility of the technical supervisor. The

decision to include the name/initials of the person grossing in the final report is a

laboratory decision, and does not fall under the CLIA requirements. The grossing

information should be recorded and maintained to show who performed the test,

somewhere in the test record. During a Mohs procedure the surgical test requisition may

be the surgical report. D5787 §493.1283(a)(4)