C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 493—LABORATORY REQUIREMENTS › Subpart M—Personnel for Nonwaived Testing

42 C.F.R. § 493.1489

Standard; Testing personnel qualifications

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Each individual performing high complexity testing must—

(a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and

(b) Meet one of the following requirements:

(1) 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

(2)(i) 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;

(ii) Be qualified under the requirements of § 493.1443(b)(3) or § 493.1449(c)(4) or (5); or

(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or—

(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes—

(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—

(1) Twenty-four (24) semester hours of medical laboratory technology courses; or

(2) Twenty-four (24) semester hours of science courses that include—

(i) Six (6) semester hours of chemistry;

(ii) Six (6) semester hours of biology; and

(iii) Twelve (12) semester hours of chemistry, biology, or medical laboratory technology in any combination; and

(B) Have laboratory training that includes:

(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or

(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or

(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or

(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.

(6) For blood gas analysis—

(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or

(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or

(iii) Have earned an associate degree related to pulmonary function from an accredited institution.

(7) For histopathology, meet the qualifications of § 493.1449(b) or (f) to perform tissue examinations.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 58 FR 39155, July 22, 1993; 60 FR 20050, Apr. 24, 1995; 88 FR 90044, Dec. 28, 2023]
Notes of Decisions
Cited in 1 case, 1998–1998 · leading case: Bd. of Clin. Lab. v. Ass'n of Blood Banks, 721 So. 2d 317 (Fla. 1st DCA 1998).
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Bd. of Clin. Lab. v. Ass'n of Blood Banks, 721 So. 2d 317 (Fla. 1st DCA 1998). “" 42 C.F.R. § 493.1489 . As Florida licensure requirements must, at a minimum, satisfy federal licensure requirements, the ALJ erred in holding that the proposed rules, adopted to meet the minimum federal requirements, are invalid as arbitrary, capricious, or unsupported by the…”
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