1. (a) A person operating a school or conducting a program to train persons for medical laboratory technician (MLT) licensure under 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 for MLT 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 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 complexity under CLIA; or
   3. (3) A program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) with affiliated clinical laboratories that provide at least six months of instruction in the performance of tests or examinations categorized as moderate complexity under CLIA; or
   4. (4) A United States military medical laboratory specialist program of at least 26 weeks duration; or
   5. (5) A laboratory owned and operated by the United States government performing tests or examinations categorized as moderate 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 clinical laboratory scientist (CLS) or CLS limited to a specialty or subspecialty licensed under Chapter 3; or
   5. (5) For training programs located outside California, a person with equivalent qualifications as specified in section 1039.2.

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 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 or, for training programs located outside California, ensure that each person providing supervision has licensure or qualifications equivalent to those specified in Chapter 3, pursuant to section 1039.2; 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 MLT 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, if the training program is located in California, or a physician and surgeon with equivalent qualifications as specified in section 1039.2, if the training program is located in the United States outside California; 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, if the training program is located in California, or a person with equivalent qualifications as specified in section 1039.2, if the training program is located in the United States outside California, 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, if the training program is located in California, or a person with equivalent qualifications as specified in section 1039.2, if the training program is located in the United States outside California, 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, if the training program is located in California, or a physician and surgeon with equivalent qualifications as specified in section 1039.2, if the training program is located in the United States outside California; 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, if the training program is located in California, or a person with equivalent qualifications as specified in section 1039.2, if the training program is located in the United States outside California, who is limited to the work scope of the person's license category.
   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) Pre-analytical skills including phlebotomy, specimen processing, reagent preparation, and infection control, as specified in section 1035; and
      2. (B) Analytical skills required for performing tests of moderate complexity, including quality control, test calibration, test validation, quality assurance, legal requirements for documentation of testing, data storage and retrieval, safety, and standard precautions, troubleshooting, preventive maintenance, reagent preparation and storage; and
      3. (C) Post-analytical skills, including knowledge of factors that influence test results and the ability to access and verify the validity of patient test results through review of quality control values prior to reporting patient test results; and
      4. (D) Test methods commonly used in the specialties of chemistry, microbiology, diagnostic immunology, hematology, and immunohematology, including clinical significance of test results, how clinical tests interrelate, the impact of tests on diagnosis and treatment, quality assessment of test results, information processing, and regulatory compliance with state and federal law; and
      5. (E) Didactic instruction may also be given in performance of tests categorized as waived under CLIA; and
      6. (F) 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
      7. (G) Test reporting, data handling, and patient confidentiality requirements; and
      8. (H) Professional standards and ethics.

   2. (2) Practical training must be obtained in a clinical laboratory certified under CLIA and must consist of at least 160 hours of practical training in each of the specialties of chemistry, microbiology, and hematology, and at least 160 hours of practical training in immunology and immunohematology, for a total of at least 640 hours. Practical training must include each of the following subjects:

      1. (A) At least 80 hours of training in blood typing of moderate complexity, such as automated ABO/Rh testing and antibody screen testing; and
      2. (B) Practical training in phlebotomy that must include 40 hours instruction and successful completion of at least 10 skin punctures and 50 venipunctures, as specified in section 1035; and
      3. (C) Instruction and practical training in the use of instruments; and
      4. (D) Preventive maintenance and problem-solving malfunctions of instruments; and
      5. (E) Knowledge of instrument and test parameters to assess test results; and
      6. (F) Validation of moderate complexity test methods and clinical correlation of test results.
      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, 1260.3 and 1286, Business and Professions Code.

History

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

2. Change without regulatory effect renumbering section 1035.1 to section 1035 and renumbering former section 1035.3 to section 1035.1, including amendment of subsections (b)(4)(A), (f), (g)(4)-(6) and (i), filed 10-6-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 40).

3. Amendment of article 2 heading and section heading, repealer and new section and amendment of Note filed 11-13-2024; operative 1-1-2025 (Register 2024, No. 46).