---
kind: "section"
citation: "42 C.F.R. § 493.1423"
title: "42"
number: "493.1423"
heading: "Standard; Testing personnel qualifications."
url: "https://uscodex.org/cfr/42/493.1423"
---

# §493.1423. Standard; Testing personnel qualifications.


Each individual performing moderate 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 or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or
  - (2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or
  - (3) Meet the requirements in § [493.1405(b)(3)(i)(B)](/cfr/42/493.1405.md?p=b-3-i-B), [(b)(4)(i)(B)](/cfr/42/493.1405.md?p=b-4-i-B) or [(C)](/cfr/42/493.1405.md?p=b-4-i-C), or [(b)(5)(i)(B)](/cfr/42/493.1405.md?p=b-5-i-B); or
  - (4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or
  - (5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
  - (6)
    - (i) Have earned a high school diploma or equivalent; and
    - (ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has—
      - (A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens;
      - (B) The skills required for implementing all standard laboratory procedures;
      - (C) The skills required for performing each test method and for proper instrument use;
      - (D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed;
      - (E) A working knowledge of reagent stability and storage;
      - (F) The skills required to implement the quality control policies and procedures of the laboratory;
      - (G) An awareness of the factors that influence test results; and
      - (H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.
  - (7) **For blood gas analysis, the individual must—**
    - (i) Be qualified under paragraph [(b)(1)](#b-1), [(2)](#b-2), [(3)](#b-3), [(4)](#b-4), [(5)](#b-5), or [(6)](#b-6) of this section; or
    - (ii)
      - (A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and
      - (B) Have at least 1 year of laboratory training or experience, or both, in blood gas analysis; or
    - (iii)
      - (A) Have earned an associate degree related to pulmonary function from an accredited institution; and
      - (B) **Have at least 2 years of laboratory training or experience, or both, in blood gas analysis.**
  - (8) Notwithstanding any other provision of this section, an individual is considered qualified as a testing personnel under this section if they were qualified and serving as a testing personnel for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.

## Notes

### Amendments

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 88 FR 90040, Dec. 28, 2023; 89 FR 6431, Feb. 1, 2024]

### Source

Source: 57 FR 7172, Feb. 28, 1992, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 88 FR 90040, Dec. 28, 2023; 89 FR 6431, Feb. 1, 2024]