View all text of Subjgrp 43 [§ 493.1403 - § 493.1425]
§ 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), (b)(4)(i)(B) or (C), or (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), (2), (3), (4), (5), or (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.