(a)
Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria:
(1)
Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.
(2)
Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:
(A)
The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
(B)
The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
(C)
The skills required for performing preventive maintenance, and troubleshooting.
(D)
A working knowledge of reagent stability and storage.
(E)
The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.
(F)
An awareness of the factors that influence test results.
(b)
The activities that may be performed are:
(1)
Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
(2)
Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
(3)
Assisting in preventive maintenance, and troubleshooting.
(4)
Preparation and storage of reagents and culture media.
(5)
Assisting in the performance of quality control procedures.
(c)
Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a).
(d)
Unlicensed laboratory personnel shall not do any of the following:
(1)
Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument.
(2)
Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure.
(3)
Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.
(e)
When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:
(1)
In the case of qualitative and semi-quantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.
(2)
In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.
(f)
When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities:
(1)
Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control.
(2)
Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument.
(3)
Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers.