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§ 1035.1. Medical Laboratory Technician Training Program Standards.

17 CA ADC § 1035.1Barclays 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 2. Training
17 CCR § 1035.1
§ 1035.1. Medical Laboratory Technician Training Program Standards.
(a) In order to be eligible for approval by the department, a medical laboratory technician training program shall be offered by either a:
(1) California licensed clinical laboratory; or
(2) Accredited college or university in the United States of America; or
(3) United States of America military medical laboratory specialist program of at least 26 weeks duration; or
(4) Laboratory owned and operated by the United States of America.
(b) The program director of a medical laboratory technician training program shall be a physician and surgeon licensed under Chapter 5, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist or clinical laboratory specialist licensed under Chapter 3. The program director shall be responsible for the content, quality and conduct of the training program and shall:
(1) Employ instructors who are physicians and surgeons licensed under chapter 5; doctoral scientists, clinical laboratory bioanalysts, clinical laboratory scientists, or clinical laboratory specialists licensed under chapter 3; medical laboratory technicians with five years practical experience licensed under Chapter 3; or public health microbiologists certified pursuant to Health and Safety Code Section 101160.
(2) Assure that training includes at least 26 weeks, consisting of at least 1040 hours, of instruction and practical experience in moderate complexity testing in chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology. The training shall include at least 160 hours each in chemistry, hematology, microbiology and immunology.
(3) Provide didactic training in:
(A) Pre-analytical skills including phlebotomy, specimen processing, reagent preparation, and infection control, as specified in Section 1035.1(e) and (f); and
(B) Analytical skills required for performing tests of waived or moderate complexity, including quality control, test calibration, quality assurance, legal requirements for documentation of testing, data storage and retrieval, safety and standard precautions, troubleshooting, preventive maintenance, reagent preparation and storage; and
(C) Post-analytical skills such as 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
(D) Test methods commonly used in chemistry, hematology, microbiology and immunology, including clinical significance of test results, how the tests interrelate and how the tests impact diagnosis and treatment, quality assessment of test results, information processing and regulatory compliance in state and federal law.
(4) Provide practical training in:
(A) Phlebotomy that shall include 40 hours instruction and successful completion of a minimum of 10 skin punctures and 50 venipunctures, as specified in Section 1035(f); and
(B) Instruction and practical experience in the use of instruments; and
(C) Preventive maintenance and problem solving malfunctions of instruments; and
(D) Knowledge of instrument and test parameters to assess reasonableness of results; and
(E) Validation of moderate complexity test methods and clinical correlation of test results.
(c) A medical laboratory technician training program shall provide a certificate of completion to its students upon satisfactory completion of the program. The program shall maintain a copy of this certificate for at least five years. This certificate shall be signed by the director of the program and shall include:
(1) Name and address of the training program; and
(2) Name of the student; and
(3) Statement of satisfactory completion of the program; and
(4) Dates that training began and ended.
(d) A program approved to train medical laboratory technicians shall maintain records of its students for at least five years and shall make available to the department documentation of the students successfully completing their training.
(e) A medical laboratory technician training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section.
(f) A medical laboratory technician training program shall be allowed to document program compliance with the requirements of this section for a period dating up to four years prior to their initial application, after the date of implementation of these standards. The program shall document that, during the time preceding initial approval, the training program met the standards pursuant to Section 1035.1(a) and (b).
(g) A complete application for a medical laboratory technician training program shall include the following:
(1) The name and address of the primary training program, including city, state, county and zip code; telephone number, FAX number and e-mail address; and
(2) The location(s) of all sites where training will be conducted, including city, state and zip code; and
(3) The name(s) and qualifications of the person(s) directing and instructing in the program including a copy of current licensure for each person. Training programs in the United States of America but outside California shall provide evidence that the director(s) and instructor(s) substantially meet this licensure requirement by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards; and
(4) Dates the training program was conducted if prior approval is requested as specified in Section 1035.1(f); and
(5) The didactic curriculum listing each class or topic with instructional objectives, the instructor(s) and the amount of time allocated for each class or topic, pursuant to Section 1035.1(b)(3); and
(6) Documentation of practical training in pre-analytical, analytical and post-analytical skills, including instructor(s) and hours spent at each activity, list of equipment, supplies and materials used pursuant to Section 1035.1(b)(4); and
(7) The signature(s) of the program director(s), telephone number(s) and date of application.
(h) A medical laboratory technician training program approval shall be valid for a four-year period. To apply for renewal, the training program shall file an application at least 120 days prior to the end of the approval period providing the following:
(1) The name and address of the primary training program, including city, state, county and zip code, telephone number, FAX number and e-mail address; and
(2) The name, address, and telephone number(s) of the director(s) and instructor(s), providing documentation of their current licensure; and
(3) Any changes in training locations, didactic and practical instruction, course objectives, equipment, supplies and materials, that shall be made to the program from that approved in the previous application; and
(4) A listing of all students who completed its program and the total number of students who enrolled in its program during the previous approval period; and
(5) The signature(s) of the program director(s) and the date of application for renewal.
(i) The training program shall notify the department in writing of any change(s) in the information and materials required by Section 1035.1(b) through (d) within 30 days after the change(s) has occurred.
(j) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department.

Credits

Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1222, 1222.5, 1242, 1246, 1260.3, 1269,1286 and 1300, 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).
This database is current through 7/5/24 Register 2024, No. 27.
Cal. Admin. Code tit. 17, § 1035.1, 17 CA ADC § 1035.1
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