(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:

Terms Used In California Business and Professions Code 1207

  • department: means the State Department of Public Health. See California Business and Professions Code 1202
  • laboratory director: means any person who is any of the following:

    California Business and Professions Code 1209

  • license: means license, certificate, registration, or other means to engage in a business or profession regulated by this code or referred to in Section 1000 or 3600. See California Business and Professions Code 23.7
  • 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. See California Business and Professions Code 1207
  • person: includes firm, association, partnership, individual, limited liability company, and corporation. See California Business and Professions Code 1201
  • Subdivision: means a subdivision of the section in which that term occurs, unless some other section is expressly mentioned. See California Business and Professions Code 15

(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.

(Amended by Stats. 2022, Ch. 473, Sec. 5. (SB 1267) Effective January 1, 2023.)