(a) To be licensed as a medical laboratory technician (MLT), a person must satisfy each of the following requirements:
- (1) Apply for an MLT license and meet the requirements as specified in section 1031; and
- (2) Document successful completion of an associate degree, or equivalent education of at least 60 semester or equivalent quarter credit hours of coursework, from an accredited college or university with courses pertinent to clinical laboratory science as specified in Section 1032; and
(3) Complete at least 36 semester or equivalent quarter credit hours in chemical and biological sciences with an emphasis on applied clinical laboratory science, medical laboratory science, or medical laboratory technology, including at least:
- (A) 6 semester or equivalent quarter credit hours in chemistry; and
- (B) 6 semester or equivalent quarter credit hours in biology; and
(4) Complete one of the following training or experience requirements in a clinical laboratory certified under CLIA, or a laboratory accredited by the College of American Pathologists (CAP), COLA, or Joint Commission International (JCI) or certified to meet International Organization for Standardization (ISO) 15189 and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC 17011 standards or later standards, at the time the applicant obtained the training and/or experience:
- (A) Six months of MLT training from an approved NAACLS-accredited training program as specified in section 1029 and section 1035.1; or
- (B) Six months of MLT training in a program approved by the Department pursuant to section 1035.1 while licensed as an MLT trainee; or
- (C) Two years of training and experience in any branch of the Armed Forces of the United States as a military laboratory specialist that include one year of basic (Phase 1) and advanced (Phase 2) training as a clinical laboratory technician or medical laboratory technician; or
- (D) The education and training requirements for clinical laboratory scientist (CLS) licensure pursuant to section 1030.7; or
(E) Three years of on-the-job practical experience as an MLT or a CLS within the ten years immediately prior to application in a clinical laboratory located outside California that meets the requirements specified in section 1032.5 and includes the performance of tests or examinations categorized as moderate complexity under CLIA in the specialties of chemistry, microbiology, diagnostic immunology, hematology, and immunohematology, and fulfills the following requirements:
- 1. Achieve satisfactory performance on an examination for MLTs or CLSs provided by a Department-approved certifying organization pursuant to section 1031.8; and
- 2. Complete 640 hours of practical experience that includes performing at least 60 hours of moderate complexity testing in each of the specialties of chemistry, microbiology, and hematology, and at least 160 hours of testing in immunology and immunohematology that includes at least 80 hours of blood typing of moderate complexity such as automated ABO/Rh testing and antibody screen testing; and
- 3. Provide documentation of all practical experience signed by the laboratory director of each laboratory employing the applicant pursuant to section 1031; or
(F) Three years of on-the-job practical experience as an MLT or a CLS within the ten years immediately prior to application in a licensed physician's office laboratory located in California or a laboratory owned and operated by the government of the United States that includes the performance of tests or examinations categorized as moderate complexity under CLIA in the specialties of chemistry, microbiology, diagnostic immunology, hematology and immunohematology, and fulfills the following requirements:
- 1. Achieve satisfactory performance on an examination for MLTs or CLSs provided by a Department-approved certifying organization pursuant to section 1031.8; and
- 2. Complete 640 hours of practical experience that includes performing at least 160 hours of moderate complexity testing in each of the specialties of chemistry, microbiology, and hematology, and at least 160 hours of testing in immunology and immunohematology that includes at least 80 hours of blood typing of moderate complexity such as automated ABO/Rh testing and antibody screen testing; and
- 3. Provide documentation of all practical experience signed by the laboratory director of each laboratory employing the applicant pursuant to section 1031; and
(5) Meet the following examination requirements:
- (A) Document satisfactory performance on an MLT 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 MLT 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 complexity under CLIA in the following specialties:
- (A) Chemistry, including routine chemistry, urinalysis, endocrinology, and toxicology; and
- (B) Microbiology, including bacteriology, mycobacteriology, mycology, parasitology, and virology; and
- (C) Diagnostic immunology, including syphilis serology and general immunology, including microscopic urinalysis; and
- (D) Hematology, including coagulation and blood smear reviews other than manual leukocyte differentials; and
- (3) Perform blood typing of moderate complexity, such as automated ABO/Rh testing and antibody screen testing; and
- (4) Report test results and perform phlebotomy only after competency has been documented and signed by the laboratory director, or by a person who qualifies as a designee under Section 1209 of the Business and Professions Code; and
- (5) Supervise a limited phlebotomy technician or a certified phlebotomy technician I.
(c) A licensed MLT must perform clinical laboratory tests or examinations under the supervision of a licensed physician and surgeon or a clinical laboratory bioanalyst, master's or doctoral degree specialist, CLS, or CLS limited to a specialty or subspecialty licensed under Chapter 3, under the following conditions:
- (1) Supervision must be available onsite during the entire time the MLT performs clinical laboratory tests or examinations categorized as moderate complexity under CLIA; and
- (2) The ratio of licensed supervisors to MLTs for moderate complexity testing is one supervisor for no more than eight MLTs.
(d) A licensed MLT must maintain current licensure with the Department as an MLT during the entire period the MLT is performing tests or examinations in a clinical laboratory located in California.
- (1) The MLT must possess a current license issued by the Department attesting to the MLT's name, license type, and effective dates of licensure as an MLT.
(2) The MLT's current MLT license issued by the Department must be posted in the clinical laboratory in which the MLT performs clinical laboratory tests or examinations.
- (A) If an MLT performs clinical laboratory tests or examinations at one or more locations of a single employer under the same clinical laboratory license, the current MLT license issued by the Department must be posted at the MLT's primary work location.
- (B) If an MLT performs clinical laboratory tests or examinations for more than one employer, or at multiple laboratories not under the same clinical laboratory license, the current MLT license issued by the Department must be posted at the MLT's primary work location at each address of employment.
(3) To renew licensure, the MLT 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.
- (e) The non-refundable license application fee and license renewal fee for an MLT license, pursuant to section 1300, subdivision (q), of the Business and Professions Code, is the same as the license application fee and license renewal fee for a CLS license pursuant to section 1300, subdivisions (c) and (e), 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 1206.5, 1242, 1260.3, 1275 and 1300, 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 subsections (b)(1)(B) and (b)(2)(B), transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).
5. Change without regulatory effect renumbering former section 1030.6 to section 1030.25 and renumbering former section 1032.5 to new section 1030.6 filed 10-3-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 40).
6. Amendment of section heading, repealer and new section and amendment of Note filed 11-13-2024; operative 1-1-2025 (Register 2024, No. 46).