Cal. Code Regs. tit. 17, § 1030.8
Licensure and Work Scope of a Clinical Laboratory Scientist Who Meets Requirements for Medical Laboratory Technician Licensure.
Effective Jan 1, 2025Register 2024, No. 46Authority cited: Section 1224, Business and Professions Code; and Sections 100275 and 131200, Health and Safety Code. Reference: Sections 1208, 1261 and 1275, Business and Profession Code.State of California
(a) To be licensed as a clinical laboratory scientist (CLS), a person who is licensed as a medical laboratory technician (MLT) or who meets requirements for licensure as an MLT must satisfy each of the following requirements:
- (1) Apply for a CLS license and meet the requirements as specified in section 1031; and
- (2) Hold a current license, or meet the requirements for licensure, as an MLT pursuant to Chapter 3; and
- (3) Document successful completion of a baccalaureate, or an equivalent degree as defined in section 1029, from an accredited college or university with courses pertinent to clinical laboratory science as specified in Section 1032; and
(4) Complete at least:
(A) 16 semester or equivalent quarter credit hours in chemistry, including:
- 1. Quantitative analysis or analytical chemistry; and
- 2. Clinical chemistry or biochemistry; and
- (B) 16 semester or equivalent quarter credit hours in biology, including medical, clinical, or pathogenic microbiology, hematology, and immunology; and
- (C) 3 semester or equivalent quarter credit hours of physics, mathematics, or statistics.
- (5) Complete training in a six-month CLS training program approved by the Department as specified in section 1035.3 while licensed as a CLS trainee as specified in section 1030; and
(6) Meet the following examination requirements:
- (A) Document satisfactory performance on a CLS licensure examination pursuant to section 1031 provided by a Department-approved certifying organization as specified in section 1031.8, completed on or after the date of examination approval by the Department; and
- (B) Achieve satisfactory performance on an examination on California clinical laboratory law pursuant to section 1034.
(b) A licensed CLS is authorized to:
- (1) Engage in clinical laboratory practices as defined in section 1029 related to the scope of this category; and
- (2) Perform clinical laboratory tests or examinations categorized as waived and tests or examinations categorized as moderate or high complexity under CLIA in the specialties of chemistry, microbiology, diagnostic immunology, immunohematology, hematology, histocompatibility, and genetics; and
(3) Perform any of the following duties:
- (A) Serve as general supervisor if the CLS meets the requirements as specified in sections 1029 and 1036.1, and CLIA; and
- (B) Serve as moderate complexity laboratory technical consultant if the CLS meets the requirements as specified in sections 1029 and 1036.2, and CLIA; and
- (C) Serve as waived laboratory supervisor if the CLS meets the requirements as specified in sections 1029 and 1036.3; and
- (D) Serve as technical supervisor if the CLS meets the requirements as specified in sections 1029 and 1036.4, and CLIA.
(c) A licensed CLS must maintain current licensure with the Department as a CLS during the entire period the CLS is performing tests or examinations in a clinical laboratory located in California.
- (1) The CLS must possess a current license issued by the Department attesting to the CLS's name, license type, and effective dates of licensure as a CLS.
(2) The CLS's current CLS license issued by the Department must be posted in the clinical laboratory in which the CLS performs clinical laboratory tests or examinations.
- (A) If a CLS performs clinical laboratory tests or examinations at one or more locations of a single employer under the same clinical laboratory license, the current CLS license issued by the Department must be posted at the CLS's primary work location.
- (B) If a CLS performs clinical laboratory tests or examinations for more than one employer or at multiple laboratories not under the same clinical laboratory license, the current CLS license issued by the Department must be posted at the CLS's primary work location at each address of employment.
(3) To renew licensure, the CLS must:
- (A) Complete at least twelve hours per year, or twenty-four hours every two years, of continuing education in clinical laboratory related courses from an approved provider of continuing education pursuant to Article 2.5; and
- (B) Renew the license pursuant to sections 1275 and 1300 of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Sections 100275 and 131200, Health and Safety Code. Reference: Sections 1208, 1261 and 1275, Business and Profession Code.
History
1. New section filed 11-13-2024; operative 1-1-2025 (Register 2024, No. 46). For prior history, see Register 2022, No. 40