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§ 1030.7. Licensure of Clinical Genetic Molecular Biologists.

17 CA ADC § 1030.7BARCLAYS OFFICIAL CALIFORNIA CODE OF REGULATIONS

Barclays Official California Code of Regulations Currentness
Title 17. Public Health
Division 1. State Department of Health Services
Chapter 2. Laboratories
Subchapter 1. Service Laboratories
Group 2. Clinical Laboratory Regulations
Article 1.5. Licensure of Clinical Laboratory Personnel (Refs & Annos)
17 CCR § 1030.7
§ 1030.7. Licensure of Clinical Genetic Molecular Biologists.
(a) Except for a clinical laboratory bioanalyst licensed by the department pursuant to Business and Professions Code, Chapter 3, 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, and a pathologist who meets the laboratory director qualifications in Section 493.1443 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 molecular biology related to the diagnosis of abnormalities related to human genetic disorders shall possess a valid clinical genetic molecular biologist license issued by the department.
(b) In order to be eligible for licensure as a clinical genetic molecular biologist, an applicant shall:
(1) Be a physician and surgeon licensed by the State, pursuant to Chapter 5 of the Business and Professions Code, to practice medicine and have:
(A) Two years of training in clinical genetic molecular biology 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, Chapter 3 of the Business and Professions Code; 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 genetic molecular biology administered by the ABMG or CCMG or the department; and
(D) Demonstrated satisfactory performance on an oral examination administered by the department regarding Chapter 3 of the Business and Professions Code and Part 493 of Title 42, Code of Federal Regulations, 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 30 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 genetic molecular biology 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 genetic molecular biology 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 certifying examination in genetic molecular biology administered by the ABMG or CCMG or the department; and
(D) Have demonstrated satisfactory performance in the oral examination regarding Chapter 3 of Business and Professions Code and Part 493 of Title 42 Code of Federal Regulations 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 molecular biology related to the diagnosis of human genetic abnormalities on or before December 31, 1997, and either:
(A) Meet the qualifications of Section 493.1443(a), (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 genetic molecular biology training or experience in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of molecular biology, and provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG.
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.
HISTORY
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 section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).
This database is current through 2/12/21 Register 2021, No. 7
17 CCR § 1030.7, 17 CA ADC § 1030.7
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