1. (a) A person operating a school or conducting a program to train persons who are licensed as a medical laboratory technician (MLT) or who meet requirements for licensure as an MLT, pursuant to Chapter 3, for clinical laboratory scientist (CLS) licensure pursuant to Chapter 3 must submit an application for approval of the school or program as specified in section 1035.10 and is subject to renewal of approval as specified in section 1035.10.

2. (b) To be approved, a program to train persons who are licensed as an MLT or who meet requirements for licensure as an MLT, pursuant to Chapter 3, for CLS licensure must meet the requirements of this section and be offered by one of the following programs or institutions:

   1. (1) A California-licensed clinical laboratory performing tests or examinations categorized as moderate and high complexity under CLIA; or
   2. (2) An accredited college or university in the United States with affiliated clinical laboratories performing tests or examinations categorized as moderate and high complexity under CLIA.

3. (c) A training program must be directed by a training program director who is:

   1. (1) A physician and surgeon licensed under chapter 5 of the Business and Professions Code; or
   2. (2) A master's or doctoral degree specialist licensed under Chapter 3; or
   3. (3) A clinical laboratory bioanalyst licensed under Chapter 3; or
   4. (4) A CLS or CLS limited to a specialty or subspecialty licensed under Chapter 3.

4. (d) A training program director must fulfill each of the following duties:

   1. (1) Be responsible for the content, quality, and administration of the training program; and
   2. (2) Provide for didactic instruction and clinical practical training in the analytical techniques required to perform clinical laboratory tests or examinations categorized as moderate and high complexity under CLIA; and
   3. (3) Ensure that each licensed person providing direct and responsible supervision to a trainee pursuant to section 1206 of the Business and Professions Code is competent in the clinical laboratory tests or examinations the person supervises; and
   4. (4) Maintain a staffing level that ensures that a licensed person provides direct and responsible supervision pursuant to section 1206 of the Business and Professions Code to no more than two trainees at one time; and
   5. (5) Notify the Department in writing within 30 days of the date of initiation, completion, extension, or interruption of training for each trainee; and
   6. (6) Notify the Department in writing of any change in the information and material provided on the application and obtain approval for any change at least 30 days prior to making the change; and
   7. (7) Notify the Department in writing of a change of director or change of instructor and obtain approval within 30 days of the change; and
   8. (8) Ensure that all trainees in a training program are licensed as CLS trainees as specified in section 1030.5 prior to the start of training; and
   9. (9) Require that all persons providing didactic instruction, practical training, or direct and responsible supervision meet qualifications as specified in this section; and
   10. (10) Require through measurable criteria that all trainees master training and instruction objectives; and
   11. (11) Maintain trainee records for at least five years; and
   12. (12) Ensure that documentation of the students successfully completing their training is made available to the Department.

5. (e) A person providing didactic instruction to program trainees must be:

   1. (1) A physician and surgeon licensed under chapter 5 of the Business and Professions Code; or
   2. (2) A master's or doctoral degree specialist, clinical laboratory bioanalyst, CLS, CLS limited to a specialty or subspecialty, or MLT licensed under Chapter 3, who is limited to the work scope of the person's license category; or
   3. (3) A certified phlebotomy technician certified under Chapter 3 with at least three years of experience in the previous five years, who is limited to providing instruction in phlebotomy; or
   4. (4) A public health microbiologist certified pursuant to section 101160 of the Health and Safety Code, who is limited to providing instruction in microbiology or immunology; or
   5. (5) Additional instructors designated by the program director, whose total instruction time may not exceed 10 percent of total training time; or
   6. (6) A person with an earned baccalaureate, master's, or doctoral degree appropriate to the specialty or subspecialty of instruction.
6. (f) A person providing instruction to program trainees during practical training must be any of the persons listed in subdivisions (e)(1) through (5).

7. (g) A person providing direct and responsible supervision pursuant to section 1206 of the Business and Professions Code to program trainees during practical training must be competent in the clinical laboratory tests or examinations the person supervises and must be:

   1. (1) A physician and surgeon licensed under chapter 5 of the Business and Professions Code; or
   2. (2) A master's or doctoral degree specialist, clinical laboratory bioanalyst, CLS, or CLS limited to a specialty or subspecialty licensed under Chapter 3, who is limited to the work scope of the person's license category; and
   3. (3) A person providing direct and responsible supervision to program trainees during practical training may provide direct and responsible supervision to no more than two trainees at one time.

8. (h) A training program must establish and provide to the Department a training schedule for at least six months of activities that include didactic instruction and practical training. The program must address pre-analytical, analytical, and post-analytical components of clinical laboratory science.

   1. (1) Didactic instruction must include instruction and testing in each of the following subjects:

      1. (A) Principles and theory underlying clinical laboratory tests or examinations performed during practical training in clinical laboratory practice; and
      2. (B) Clinical significance and application of clinical laboratory tests or examinations; and
      3. (C) An understanding of laboratory test results or examinations and the factors that influence their accuracy, precision, and clinical correlation with other test results; and
      4. (D) Principles and practices of quality assurance, quality control, and laboratory statistics that ensure test accuracy; and
      5. (E) Problem solving of pre-analytical, analytical, and post-analytical procedures, taking corrective action for test failure, avoiding adverse events, and assuring continuous test improvement; and
      6. (F) Laboratory safety and hygiene, infection control, standard precautions, and waste disposal; and
      7. (G) Principles of laboratory management; and
      8. (H) Compliance with laws affecting clinical laboratories including California clinical laboratory law, CLIA, the federal Health Insurance Portability and Accountability Act, regulations of the California Division of the Occupational Safety and Health Administration of the Department of Industrial Relations, and local ordinances; and
      9. (I) Test reporting, data handling, and patient confidentiality requirements; and
      10. (J) Laboratory computer applications and information security; and
      11. (K) Professional standards and ethics.

   2. (2) Practical training must be obtained in a clinical laboratory certified under CLIA and must consist of at least four weeks of practical training in each of the following subjects, for a total of at least 24 weeks:

      1. (A) Chemistry, including routine chemistry, urinalysis, clinical microscopy, endocrinology, and toxicology; and
      2. (B) Microbiology, including bacteriology, mycobacteriology, mycology, parasitology, virology, and infectious disease testing; and
      3. (C) Diagnostic immunology, including syphilis serology and general immunology; and
      4. (D) Immunohematology, including ABO group and Rh type, unexpected antibody detection, compatibility testing, and antibody identification; and
      5. (E) Hematology, including routine hematology and coagulation; and

      6. (F) One or more of the following subjects:

         1. 1. One or more other areas, such as histocompatibility, cytogenetics, genetic molecular biology; or
         2. 2. Phlebotomy and clinical laboratory practice; or
         3. 3. Laboratory administration including practical training in quality control, quality assurance, performance improvement, safety, standard precautions, and reagent control and storage, the use of laboratory instruments and information technology systems; and the assessment of instruments and test parameters for clinical correlation of test results; or
         4. 4. Review, as determined by the program director.
      7. (G) No more than 20 percent of training may be performance of clinical laboratory tests or examinations categorized as waived under CLIA and/or training in phlebotomy.

9. (i) A training program must provide a certificate of completion to its trainees upon successful completion of the program.

   1. (1) The certificate must be signed by the program director and must include:

      1. (A) Name and address of the training program; and
      2. (B) Name and trainee license number of the trainee; and
      3. (C) A statement documenting that the trainee completed and met all requirements of the training program; and
      4. (D) Dates training began and ended; and
   2. (2) The program must maintain a copy of the certificate for at least five years.
10. (j) A training program must maintain records of its trainees for at least five years and must make available to the Department documentation of the students successfully completing their training.

Note: Authority cited: Section 1224, Business and Professions Code; and Sections 100275 and 131200, Health and Safety Code. Reference: Sections 1222, 1222.5, 1242, 1261 and 1286, Business and Professions 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