Sec. 1030.6 - Licensure of Clinical Cytogeneticists

ยง 1030.6. Licensure of Clinical Cytogeneticists

(a) Except for a clinical laboratory bioanalyst licensed by the department who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, or a pathologist who meets the laboratory director qualifications in Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of clinical cytogenetics within the specialty of genetics shall possess a valid clinical cytogeneticist license issued by the department.

(b) In order to be eligible for licensure as a clinical cytogeneticist, an applicant shall:

(1) Be a physician and surgeon licensed by the State to practice medicine pursuant to Chapter 5 of the Business and Professions Code, and have:

(A) Two years' training in clinical cytogenetics in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Business and Professions Code, Chapter 3, and

(B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and

(C) Evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and

(D) Demonstrated satisfactory performance on an oral examination regarding Business and Professions Code, Chapter 3, and Title 42, CFR, Part 493, as published October 1, 1994; or

(2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with thirty semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and

(A) Have two years' training in clinical cytogenetics in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3, of Business and Professions Code; and

(B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical cytogenetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and

(C) Provide evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and

(D) Have demonstrated satisfactory performance on the oral examination administered by the Department regarding Business and Professions Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as published October 1, 1994; or

(3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of cytogenetics on or before December 31, 1997 and either;

(A) Meet the laboratory director qualifications of Section 493.1443(b)(2) or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or

(B) Hold an earned doctoral degree, have four years' clinical cytogenetics training or experience in a clinical laboratory certified by HCFA in clinical cytogenetics, and provide evidence of satisfactory performance on a written certifying examination in cytogenetics administered by the ABMG or the CCMG.

(1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day. 2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day. 3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day. 4. Certificate of Compliance as to 10-19-2000 order, including amendment of subsections (b)(1)(B) and (b)(2)(B), transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).)

Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209,1264, 1265 and 1282, Business and Professions Code.

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