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§ 1030.10. Licensure of Clinical Laboratory Specialists.

17 CA ADC § 1030.10Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 2. Laboratories (Refs & Annos)
Subchapter 1. Service Laboratories
Group 2. Clinical Laboratory Regulations
Article 1.5. Licensure of Clinical Laboratory Personnel
17 CCR § 1030.10
§ 1030.10. Licensure of Clinical Laboratory Specialists.
(a) The minimum requirements for admission to the limited scientist examinations shall be as follows:
(1) An applicant for admission to the examination for a clinical chemist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including courses in analytical chemistry and instrumentation. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of chemistry, as listed in (b)(1) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of chemistry.
(2) An applicant for admission to the examination for a clinical microbiologist scientist shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in microbiology or an equivalent major which shall include at least 25 semester or 38 quarter units in microbiology including courses in medical or pathogenic microbiology or bacteriology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of microbiology, as listed in (b)(2) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology.
(3) An applicant for admission to the examination for a clinical immunohematologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in biology, clinical laboratory science or equivalent major which shall include at least 25 semester or 38 quarter units in biology, including genetics and immunology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of immunohematology, as listed in (b)(3) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of immunohematology.
(4) An applicant for admission to the examination for clinical toxicologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including analytical chemistry or quantitative analysis. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by a college or university from an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in the specialty of toxicology, as specified in (b)(4) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of toxicology.
(5) An applicant for admission to the examination for a clinical hematologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate degree from an accredited college or university in biology, clinical laboratory science or an equivalent major which shall include at least 25 semester or 38 quarter units in biology, including hematology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have one year of post-baccalaureate training or experience in all areas of the specialty of hematology, as specified in (b)(5) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of hematology.
(b) Any license issued under this section shall specify the particular specialty or subspecialty in which the licentiate may perform tests under such license. A license issued for:
(1) A clinical chemist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of chemistry, including routine chemistry, clinical microscopy, endocrinology and toxicology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.
(2) A clinical microbiologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of microbiology including bacteriology, mycobacteriology, mycology, parasitology, and virology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.
(3) A clinical immunohematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of immunohematology including ABO/Rh Type or Group, unexpected antibody detection, compatibility testing and antibody identification.
(4) A clinical toxicologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the subspecialty of toxicology.
(5) A clinical hematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of hematology including routine hematology and coagulation.

Credits

Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code.
History
1. Change without regulatory effect renumbering former section 1031 to new section 1030.10 filed 10-3-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 40).
This database is current through 5/17/24 Register 2024, No. 20.
Cal. Admin. Code tit. 17, § 1030.10, 17 CA ADC § 1030.10
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