(a)As used in this chapter, “clinical chemist,” “clinical microbiologist,” “clinical toxicologist,” “clinical genetic molecular biologist,” “clinical cytogeneticist,” “clinical laboratory geneticist,” “clinical reproductive biologist,” or “oral and maxillofacial pathologist” means a person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to the person’s area of specialization or to direct a clinical laboratory, or portion thereof, limited to their area of specialization. A licensed person who is qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities
of a laboratory director, technical consultant, clinical
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(a)
As used in this chapter, “clinical chemist,” “clinical microbiologist,” “clinical toxicologist,” “clinical genetic molecular biologist,” “clinical cytogeneticist,” “clinical laboratory geneticist,” “clinical reproductive biologist,” or “oral and maxillofacial pathologist” means a person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to the person’s area of specialization or to direct a clinical laboratory, or portion thereof, limited to their area of specialization. A licensed person who is qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities
of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, limited to their area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties. A person licensed as a “clinical chemist,” “clinical microbiologist,” “clinical toxicologist,” “clinical genetic molecular biologist,” “clinical cytogeneticist,” “clinical laboratory geneticist,” “clinical reproductive biologist,” or “oral and maxillofacial pathologist” may perform any clinical laboratory test or examination classified as waived or of moderate complexity under
CLIA.
(b)
The specialty or subspecialty for each of the limited license categories identified in subdivision (a), and the clinical laboratories that may be directed by persons licensed in each of those categories, are the following:
(1)
For a person licensed under this chapter as a clinical chemist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)
For a person licensed under this chapter as a clinical microbiologist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)
For a person licensed under this chapter as a clinical toxicologist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)
For a person licensed under this chapter as a clinical genetic molecular biologist, the subspecialty of molecular biology related to diagnosis of human genetic abnormalities within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(5)
For a person licensed under this chapter as a
clinical cytogeneticist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)
For a person licensed under this chapter as a clinical laboratory geneticist, the subspecialties of molecular biology related to diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or laboratory genetics within the specialty of genetics, or other specialty or subspecialty specified by
regulation adopted by the department.
(7)
For a person licensed under this chapter as a clinical reproductive biologist, the specialty of reproductive biology and the subspecialties of andrology and embryology related to diagnostic testing for management of primary and secondary infertility, fertility assessment, and fertility preservation, as well as the evaluation and assessment of gametes, embryos, and their associated fluids and tissues, or other specialty or subspecialty specified by regulation adopted by the department.
(8)
For a person licensed under this chapter as an oral and maxillofacial pathologist, the subspecialty of oral pathology within the specialty of pathology or other specialty or subspecialty specified by regulation adopted by the
department.