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(D) Apply to the department for certification as a Limited Phlebotomy Technician pursuant to Section 1031.4(c).
(2) For a person with no on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:
(A) Be a high school graduate, or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and
(B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and
(C) Have completed a minimum of 40 hours practical instruction from a phlebotomy training program approved by the department pursuant to Section 1035.1(f), which instruction shall include completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and
(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and
(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).
(3) For a person who has less than 1040 hours on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:
(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and
(B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and
(C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years, which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and
(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and
(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).
(4) For a person who has 1040 hours or more of on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:
(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and
(B) Have completed a minimum of 20 hours advanced didactic instruction pursuant to Section 1035.1(e)(2) from a phlebotomy training program approved by the department; and
(C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and
(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and
(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).
(5) For a person to be eligible for certification as a Certified Phlebotomy Technician II, he or she shall:
(A) Be a Certified Phlebotomy Technician I who holds a current, valid certificate from the department or who meets certification requirements as a Certified Phlebotomy Technician I pursuant to Section 1034(a)(4)(A)-(D) and who has at least 1040 hours on-the-job experience in phlebotomy in the previous 5 years as certified in writing by the director(s) of the laboratory(ies) employing the person; and
(B) Have completed a minimum of 20 arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and performed under the general overall responsibility of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, respiratory care practitioner or a licensed clinical laboratory scientist, who will certify in writing that this person has completed this practical instruction; and
(C) Apply to the department for certification as a Certified Phlebotomy Technician II pursuant to Section 1031.4(c).
(b) Performance of phlebotomy by a person certified by the department shall be limited as follows:
(1) A Limited Phlebotomy Technician shall perform skin punctures only when he or she:
(A) Maintains a current, valid certification with the department as a Limited Phlebotomy Technician; and
(B) Performs skin punctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures and other duties related to blood collection performed by the Limited Phlebotomy Technician. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation when blood is being collected; and
(C) Is shown to be competent to perform skin punctures after employment without direct and constant supervision before being allowed to perform skin puncture on patients. Documentation of competency shall be done at least annually; and
(D) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and
(E) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Limited Phlebotomy Technician. When performing skin punctures away from the posted location, the Limited Phlebotomy Technician shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Limited Phlebotomy Technician.
(2) A Certified Phlebotomy Technician I shall perform skin punctures and venipunctures only when he or she:
(A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician I; and
(B) Performs skin punctures and venipunctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be a person licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures, venipunctures and other duties related to blood collection performed by the Certified Phlebotomy Technician I. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation as needed; and
(C) Is shown to be competent to perform skin puncture and venipuncture after employment without direct and constant supervision before being allowed to perform skin punctures or venipunctures on patients. Documentation of competency shall be done at least annually; and
(D) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and
(E) Has posted at the work location of the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician I. When performing skin punctures or venipunctures away from the posted location, the Certified Phlebotomy Technician I shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician I.
(3) A Certified Phlebotomy Technician II shall perform skin punctures and venipunctures only under conditions pursuant to Section 1034(b)(2), and shall be limited to performing arterial punctures only when a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner is present at the location during performance of an arterial puncture, and when he or she:
(A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician II; and
(B) Is shown to be competent to perform arterial punctures after employment by direct, personal observation and documentation of his or her expertise in arterial punctures by a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner. Documentation of competency shall be done at least annually; and
(C) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and
(D) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician II. When performing arterial punctures, skin punctures, or venipunctures away from the posted location, the Certified Phlebotomy Technician II shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician II.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1220, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.


s 1034.1. Unlicensed Personnel, Laboratory Aides.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code.


s 1034.2. Unlicensed Personnel, Cytotechnologist.


Note: Authority cited: Section 1224, Business and Professions Code; Section 208, Health and Safety Code. Reference: Section 1270, Business and Professions Code; Section 1002, Health and Safety Code.


s 1035. Training Schools.
(a) Any person operating a school or conducting any course for the purpose of training or preparing individuals for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code shall submit, on forms provided by the department and subject to periodic renewal, such information as may be required by the department to satisfactorily evaluate the personnel, equipment, quality of instruction, and scope of activities of said schools.
(b) Persons providing instruction in general or specialized technic shall provide training which when successfully completed will fully qualify individuals to meet the minimum requirements for licensure under the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code.
(c) A training school shall accept a person licensed for training in clinical laboratory procedures only if there are on active duty in the laboratory a minimum of two full-time actively employed persons who possess any of the following licenses: clinical laboratory technologist, clinical laboratory bioanalyst, physician and surgeon, or appropriate laboratory specialty.
(d) The ratio of licensed clinical laboratory personnel to trainees shall be no less than 2:1.
(e) The following shall be minimum requirements for approval of laboratories to employ clinical laboratory technologist trainees as provided for in Article 2 of Chapter 3, Division 2 of the Business and Professions Code:
(1) There shall be adequate space and necessary equipment as defined by the department to carry out the procedures of the laboratory and to provide training for the clinical laboratory technologist trainees.
(2) The workload of the laboratory training clinical laboratory technologist trainees shall meet minimum standards set by the department and shall include at least the following: routine chemical determinations commonly required on blood, spinal fluid, and other body fluids; morphological, cultural, chemical and immunological tests for microbial pathogens; tests for helminths and protozoa; examinations for normal and abnormal blood cells; sedimentation rates, bleeding and coagulation time determinations and other commonly employed tests in hematology; precipitation, flocculation, agglutination or complement fixation tests; blood typing, Rh factor determinations and pretransfusion procedures; commonly employed serological tests; routine and microscopic urinalyses and such other technics as may be required to properly instruct clinical laboratory technologist trainees in current clinical laboratory procedures.
(3) The amount of practical training required by each clinical laboratory technologist trainee in order to fulfill the minimum requirements for admission to the licensing examinations shall be in accordance with the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code. When one year of practical training in all subjects is necessary, the minimum time devoted to each shall be as follows:
Biochemistry................. 12 Weeks
Hematology................... 8 Weeks
Pretransfusion Procedures.... 4 Weeks
Urinalysis................... 4 Weeks
Bacteriology................. 9 Weeks
Serology..................... 4 Weeks
Parasitology................. 3 Weeks
Miscellaneous and review..... 8 Weeks

(4) When less than one or more than one year of practical training is required toward admission to the clinical laboratory technologists' examination, the above time devoted to the various subjects shall be decreased or increased proportionately after the laboratory director has secured approval from the department for the modification.
(5) However, when one or more years of practical training in any one basic science or specialty is necessary, the laboratory director shall modify this schedule, subject to prior approval by the department, so that the area of concentration is in one or more subjects.
(6) Unless a trainee is a college graduate, he must receive during the course of his training program a minimum of 40 clock hours of recitation or instruction in the subjects covered in clinical laboratory work other than that received as practical training in the laboratory. Any laboratory school approved for specialist or limited technologist training must provide the department with adequately documented workload and program information and must comply with the minimum requirements heretofore stated in that special field of training.
(7) The requirements for the members of the teaching staff must be those considered minimum for licensure, and in addition, persons with an advanced degree in one or more of the fields covered in the curriculum may be included on the teaching staff.
(8) The director of any school shall supply sufficient information to the department to satisfy the department that adequate specimen material will be made available for training purposes.
(9) There shall be available to persons receiving training a technical library adequate in the number of copies of each text book.
(10) The names and addresses of persons receiving training are to be reported to the department at the time of entrance to course and again at completion of course.
(11) The department may require such other information as may be necessary to satisfactorily evaluate the application for approval including periodic on-site reviews.
(12) Approval for training granted by the department pursuant to requirements of this section may be denied or withdrawn if the school is unable to meet or maintain these requirements.
(f) Colleges or universities accredited by the Western College Association or the Northwest Association of Secondary and Higher Schools or an essentially equivalent accrediting agency, as determined by the department, conducting courses for the purpose of training or preparing persons for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code, shall be considered approved by the department. Provided, however, that when such training is carried out in cooperation with other laboratories than those of said institutions, specific approval shall be obtained.


s 1035.1. Phlebotomy Training Program Requirements.
(a) In order to be eligible for approval by the department to provide didactic and/or practical phlebotomy instruction leading to certification of phlebotomists, a phlebotomy training program shall meet the requirements of this section and be offered by either a:
(1) National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) approved program for training phlebotomists; or
(2) Accredited college or university; or
(3) Private, post-secondary program or occupational program registered or approved by the Bureau for Private Postsecondary and Vocational Education; or
(4) California Adult Education or Regional Occupational Program (ROP); or
(5) United States of America military medical laboratory specialist program; or
(6) California licensed clinical laboratory.
(b) A phlebotomy training program shall be directed by a licensed physician and surgeon, licensed physician assistant, registered nurse, or person licensed under Chapter 3, who shall be responsible for:
(1) Overall operation and administration of the phlebotomy training program; and
(2) Ensuring the quality of the technical, scientific and clinical instruction; and
(3) Ensuring that the person(s) providing instruction meets the qualifications of this section; and
(4) Ensuring that the person(s) providing instruction is competent and that his or her work performance is periodically evaluated, monitored and documented.
(c) The person(s) providing instruction shall be a:
(1) Licensed physician and surgeon; or
(2) Licensed physician assistant; or
(3) Registered nurse; or
(4) Person licensed under Chapter 3; or
(5) Respiratory care practitioner with a minimum of 2 years experience in the previous 5 years; or
(6) Certified phlebotomy technician with a minimum of 3 years of experience in the previous 5 years or a phlebotomist with 3 years of experience in the previous 5 years and employed as a phlebotomy instructor, who shall meet certification requirements pursuant to Section 1034(a)(4) on or before December 31, 2003.
(d) Person(s) specified in Subsection (c)(1) through (5) shall pass a written examination in phlebotomy, administered by a certifying organization approved by the department pursuant to Section 1031.7 either:
(1) Prior to employment by a phlebotomy training program approved by the department pursuant to this section; or
(2) No later than December 31, 2003, if employed as a phlebotomy instructor on or before April 9, 2003.
(e) An approved phlebotomy training program shall provide the following didactic instruction to its students:
(1) A basic phlebotomy curriculum consisting of a minimum of 20 hours lecture and testing for knowledge of:
(A) Basic infection control, universal precautions and safety; and
(B) Basic anatomy and physiology of body systems with emphasis on the circulatory system, the appropriate medical terminology; and
(C) Proper identification of patient and specimens, the importance of accuracy in overall patient care; and
(D) Proper selection and preparation of skin puncture site, including selection of antiseptic; and
(E) Blood collection equipment, types of tubes and additives, proper order of draw when additives are required, special precautions; and
(F) Post-puncture care; and
(G) Appropriate disposal of sharps, needles and waste.
(2) An advanced phlebotomy curriculum consisting of a minimum of 20 hours of lecture and testing for knowledge of:
(A) Advanced infectious disease control and biohazards; and
(B) Anti-coagulation theory; and
(C) Knowledge of pre-analytical sources of error in specimen collection, transport, processing and storage; and
(D) Anatomical site selection and patient preparation; and
(E) Risk factors and appropriate responses to complications which may arise from phlebotomy; and
(F) Recognition of, and corrective actions to take, with problems in test requisitions, specimen transport and processing; and
(G) Applications of basic concepts of communication, interpersonal relations, stress management, professional behavior, ethics and legal implications of phlebotomy; and
(H) Quality assurance in phlebotomy necessary to provide accurate and reliable laboratory test results; and
(I) Legal issues related to blood collection.
(f) An approved phlebotomy training program shall provide a clinical setting for a minimum of 40 hours of practical instruction in phlebotomy. This setting shall provide access to patients whose blood is being tested by a clinical laboratory. In order for a program to be eligible for approval by the department, it shall provide documentation of a training curriculum that includes:
(1) Selection of blood collection equipment appropriate to test requisitions; and
(2) Preparation of the patient and infection control; and
(3) Skin punctures for testing purposes from patients of varying ages, including pediatric and geriatric, and of varying health and obesity status; and
(4) Venipunctures from patients of varying ages, health and obesity status; and
(5) Post-puncture care; and
(6) Processing of blood containers after collection, including centrifugation; and
(7) Proper disposal of needles, sharps and medical waste; and
(8) Observation of arterial punctures; and
(9) A practical examination showing evidence of successful completion of Subsections (f)(1) through (7).
(g) A phlebotomy training program shall be responsible for assuring that a student completes a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations during or after his or her practical instruction.
(h) A phlebotomy 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 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.
(i) A phlebotomy training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section. Verification may include an on-site inspection of the program.
(j) A complete application for phlebotomy training program approval shall include the following:
(1) Name and address of the training program; and
(2) Location(s) of all sites where didactic and practical instruction occur; and
(3) Name(s) and license number(s) of the physician and surgeon, physician assistant, registered nurse, or person licensed under Chapter 3 who is directing the program; and
(4) Name(s), license number(s) or certificate number(s), experience in phlebotomy, and evidence of satisfactory performance on a phlebotomy certification examination administered by a certifying organization with departmental approval in effect at the time the examination was administered, of every physician and surgeon, physician assistant, registered nurse, person licensed under Chapter 3, respiratory care practitioner, certified phlebotomy technician, or phlebotomist pursuant to Subsection (c)(6) who is supervising or providing instruction; and
(5) List of equipment, supplies and educational materials used for instruction; and
(6) Curriculum and instructional objectives, including hours spent at each activity.
(k) Timeframes for approval of training programs shall be as follows:
(1) Submission of an application for approval shall be deemed to occur on the date the complete application is received by the department.
(2) Written notification by the department to the applicant shall be considered to occur on the date the documents are postmarked.
(3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following:
(A) That the application is complete and acceptable for processing by the department; or
(B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or
(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.
(4) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.1(k)(3)(B).
(5) The department's time periods for processing an application, from the date the initial application is received to the date the final decision is made regarding approval, are as follows:
(A) The median time for processing an application is 90 days.
(B) The minimum time for processing is 30 days.
(C) The maximum time for processing is 150 days.
(l) Approval shall be valid for a two-year period.
(m) To apply for renewal, a training program shall file a renewal application at least 60 days prior to the end of the approval period and provide the following:
(1) The name and address of the training program; and
(2) The name and license number of all directors; and
(3) The name, license or certificate number of all instructors; and
(4) The name(s) and location(s) of all didactic and practical instruction; and
(5) The curriculum and instructional objectives, including hours spent at each activity; and
(6) The schedule of didactic and practical instruction for the next 24 months; and
(7) The listing of students who completed its program and the total number of students who enrolled in its program in the previous approval period; and
(8) The signature of the director(s) and date of the application for renewal.
(n) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.
(o) The training program shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (h) within 30 days after the change(s) has occurred.


Note: Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220, 1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code; and Section 120580, Health and Safety Code.


s 1035.3. 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 1035.1(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 1035.3(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 1035.3(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 1035.3(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 1035.3(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 1035.3(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.


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.


s 1035.4. Timeframes for Approval of Training Programs.
(a) Timeframes for approval of training programs to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows:
(1) Submission of an application for approval shall be deemed to occur on the date the application is received by the department.
(2) Written notification by the department to the applicant program shall be considered to occur on the date the documents are postmarked.
(3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following:
(A) That the application is complete and acceptable for processing by the department; or
(B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or
(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.
(4) The department shall consider an application to have been abandoned by any applicant program which fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.4(a)(3)(B).
(b) Timeframes for processing applications for renewal of approval to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows:
(1) The training program shall submit a renewal application at least 120 days prior to the end of the approval period.
(2) Within 30 days of receipt of a renewal application, the department shall inform the training program in writing that the application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application.
(3) Within 30 days of submitting a completed renewal application, the department shall inform the training program in writing whether its application has been approved or denied.
(4) The department may authorize a training program to extend its approval during the time its application is being reviewed when that training program is in good standing and its application was submitted at least 120 days prior to the end of the approval period.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1261.5, 1263, 1264, 1286 and 1302, Business and Professions Code.


s 1036. Clinical Consultant.
(a) Every clinical laboratory director, under whom moderate or high complexity tests or examinations are performed, shall either perform the duties of a clinical consultant or employ a clinical consultant who can provide consultation about the appropriateness of testing ordered and interpretation of test results, as specified in Section 1209, chapter 3 of the Business and Professions Code.
(b) The clinical consultant shall possess a current, valid license issued by the State to direct a clinical laboratory pursuant to chapter 3, Business and Professions Code, or to practice medicine, osteopathy or podiatry pursuant to chapter 5, Business and Professions Code appropriate to the specialties and subspecialties for which he or she is consulting.
(c) The clinical consultant shall:
(1) Provide clinical consultation to the clients of the laboratory; and
(2) Assist in ordering tests appropriate to meet clinical expectations; and
(3) Ensure that test results include pertinent information required for interpretation; and
(4) Communicate matters about quality of test results reported and interpretation in relation to specific patient conditions.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.


s 1036.1. General Supervisor.
(a) Every clinical laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a general supervisor or employ a general supervisor who shall be responsible for day-to-day supervision of laboratory operation and personnel performing and reporting high complexity tests, pursuant to Section 1209, chapter 3 of Business and Professions Code.
(b) A general supervisor shall:
(1) Possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and
(2) Have a minimum of two years' experience in high complexity testing in the specialty or specialties they are supervising.
(c) The general supervisor shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems.
(d) The general supervisor shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.


s 1036.2. Moderate Complexity Laboratory Technical Consultant.
(a) Every laboratory director, under whom moderate complexity tests or examinations are performed, shall either perform the duties of a moderate complexity laboratory technical consultant or employ a moderate complexity laboratory technical consultant who is responsible for providing technical and scientific consultation for each of the specialties and subspecialties performed.
(b) A moderate complexity laboratory technical consultant of a laboratory performing moderate complexity testing shall:
(1) Possess an active, valid license issued by the State pursuant to chapter 3 of the Business and Professions Code to perform high complexity testing, or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which he or she is consulting; and
(2) Have a minimum of two years' experience in moderate or high complexity testing in the specialty or specialties for which he or she is consulting.
(c) A moderate complexity laboratory technical consultant shall be responsible for the technical and scientific oversight of the laboratory as specified in Section 493.1413, Title 42, Code of Federal Regulations, as published October 1, 1994.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.


s 1036.3. Waived Laboratory Supervisor.
(a) A laboratory director of a clinical laboratory performing waived tests may delegate or reapportion his or her responsibilities, as allowed by Section 1209 of the Business and Professions Code, by utilizing a waived laboratory supervisor. Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code and pursuant to subsection (c) and (d), a waived laboratory supervisor shall:
(1) Be listed in Section 1206.5 of the Business and Professions Code; and
(2) Possess at least a baccalaureate degree from an accredited college or university; and
(3) Have at least one year of training or experience in clinical laboratory testing in those tests or examinations that he or she will be supervising; and
(4) Document competency in those tests he or she will be supervising to the laboratory director at least semiannually during the first year and annually, or whenever new instrumentation is added, thereafter.
(b) Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code, a waived laboratory supervisor shall be responsible for:
(1) Selecting, in consultation with the laboratory director, the test methodology appropriate for clinical use of test results; and
(2) Establishing a quality control program appropriate for the tests performed, which follows the test manufacturer's parameters for acceptable levels of analytical performance and ensures that these levels are maintained throughout the entire testing process from initial receipt of the specimen through sample analysis and test result reporting; and
(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications; and
(4) Ensuring patient test results are not reported until all corrective actions have been taken and the test system is performing properly; and
(5) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for waived testing; and
(6) Evaluating and documenting that the staff maintain their competency to perform test procedures and report tests promptly, accurately and proficiently by:
(A) Directly observing routine test performance, including patient preparations (if applicable), specimen handling, processing and testing; and
(B) Monitoring the recording and reporting of test results; and
(C) Reviewing quality control records and preventive maintenance records; and
(D) Directly observing performance of instrument maintenance and function checks; and
(E) Assessing problem solving skills; and
(F) Evaluating and documenting the performance of individuals responsible for waived testing at least semiannually during the first year the individual tests patient specimens. Thereafter evaluations shall be performed at least annually unless test methodology or instrumentation changes (in which case and prior to reporting patient test results, the individual's performance shall be re-evaluated to include the use of the new test methodology or test instrumentation).
(c) A waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code shall:
(1) Hold a current, active license as an Emergency Medical Technician-Paramedic pursuant to Health and Safety Code Section 1797.194, as a registered nurse pursuant to Chapter 6 (commencing with Section 2700) or as a person under Chapter 3 (commencing with Section 1200) authorized to engage in clinical laboratory practice or to direct a clinical laboratory; and
(2) Have at least one year training or experience in blood glucose testing in the method or procedure that he or she will be supervising.
(d) The waived laboratory supervisor of a laboratory performing blood glucose testing as specified in subsection (c) shall be responsible for:
(1) Documenting that each individual performing blood glucose is competent to perform the test before he or she starts testing and whenever new methodologies or technologies are added; and
(2) Ensuring that manufacturer's instructions for test performance, equipment maintenance and quality control are followed; and
(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications.
(e) A waived laboratory technical supervisor shall be accessible to the laboratory testing personnel to provide onsite, telephone or electronic consultation. The laboratory director of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code may designate a licensed physician and surgeon or an authorized registered nurse at the hospital serving as the base hospital to provide such consultation.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.


s 1036.4. Technical Supervisor. (continued)