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
(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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or
(2)
Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or
(3)
Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
(ii)
Have documentation of 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;
(D)
The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;
(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.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]