(a) As used in this chapter, “histocompatibility laboratory director” means a physician and surgeon licensed to practice medicine pursuant to Chapter 5 (commencing with Section 2000) who is qualified pursuant to Section 1209, a bioanalyst licensed pursuant to Section 1260 who is qualified pursuant to Sections 1203 and 1209, or a person who has earned a doctoral degree in a biological science, who has completed, subsequent to graduation, four years of experience in immunology, two of which have been in histocompatibility testing.

(b) On and after January 1, 2007, in order to be eligible for licensure as a histocompatibility laboratory director, an applicant who is not a duly licensed physician and surgeon or a duly licensed bioanalyst shall provide evidence of satisfactory performance on a written examination in histocompatibility administered by the American Board of Histocompatibility and Immunogenetics, and have demonstrated satisfactory performance on an oral examination administered by the department regarding this chapter and Part 493 (commencing with Section 493.1) of Subchapter G of Chapter IV of Title 42 of the Code of Federal Regulations.

Terms Used In California Business and Professions Code 1209.1

  • bioanalyst: means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory. See California Business and Professions Code 1203
  • board: means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or registration authorizing a person to engage in a business or profession. See California Business and Professions Code 31
  • department: means the State Department of Public Health. See California Business and Professions Code 1202
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • histocompatibility laboratory director: means a physician and surgeon licensed to practice medicine pursuant to Chapter 5 (commencing with Section 2000) who is qualified pursuant to Section 1209, a bioanalyst licensed pursuant to Section 1260 who is qualified pursuant to Sections 1203 and 1209, or a person who has earned a doctoral degree in a biological science, who has completed, subsequent to graduation, four years of experience in immunology, two of which have been in histocompatibility testing. See California Business and Professions Code 1209.1
  • laboratory director: means any person who is any of the following:

    California Business and Professions Code 1209

  • person: includes firm, association, partnership, individual, limited liability company, and corporation. See California Business and Professions Code 1201

(c) A person licensed under Section 1260.1 as a histocompatibility laboratory director and 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, in the specialty of histocompatibility, immunology, or other specialty or subspecialty specified by regulation adopted by the department. A person licensed as a “histocompatibility laboratory director” may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.

(Amended by Stats. 2006, Ch. 319, Sec. 1. Effective January 1, 2007.)

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