BILL NUMBER: AB 1557 CHAPTERED 10/10/99 CHAPTER 695 FILED WITH SECRETARY OF STATE OCTOBER 10, 1999 APPROVED BY GOVERNOR OCTOBER 6, 1999 PASSED THE ASSEMBLY AUGUST 26, 1999 PASSED THE SENATE AUGUST 24, 1999 AMENDED IN SENATE AUGUST 19, 1999 AMENDED IN SENATE JULY 14, 1999 AMENDED IN SENATE JUNE 23, 1999 AMENDED IN ASSEMBLY MAY 28, 1999 AMENDED IN ASSEMBLY MAY 17, 1999 INTRODUCED BY Assembly Member Migden (Principal coauthor: Assembly Member Bock) (Coauthors: Assembly Members Aroner and Shelley) FEBRUARY 26, 1999 An act to amend Sections 1242, 1242.5, 1246, and 1269 of the Business and Professions Code, and to amend Section 120580 of the Health and Safety Code, relating to clinical laboratories. LEGISLATIVE COUNSEL'S DIGEST AB 1557, Migden. Clinical laboratories: unlicensed personnel. Existing law regulates clinical laboratories. These provisions require, among other things, that individuals be licensed to perform various laboratory tests. However, certain provisions specifically authorize an unlicensed person employed by a licensed clinical laboratory to perform venipuncture or skin puncture for the purpose of withdrawing blood for test purposes, upon specific authorization from a licensed physician and surgeon, if that unlicensed person meets specified requirements. Existing law also authorizes the State Department of Health Services to authorize by regulation unlicensed laboratory personnel to perform skin tests for specific diseases, venipuncture, arterial puncture, or skin puncture for the purposes of withdrawing blood or for test purposes, as specified. Existing law authorizes an unlicensed person employed by a public health department as a venereal disease case investigator to perform venipuncture or skin puncture for the purpose of withdrawing blood for test purposes, as specified. This bill would require the department to adopt regulations by January 1, 2001, for becoming a "certified phlebotomy technician," would require unlicensed persons employed by a clinical laboratory or by a public health department who perform venipuncture or skin puncture to obtain certification pursuant to these regulations to perform the above-specified acts on and after the effective date of those regulations, and would authorize the department to charge fees not to exceed $25 for application and renewal of these certificates. The bill would not require unlicensed persons employed by a clinical laboratory who are performing these duties on the effective date of these regulations to be certified pursuant to these regulations until 3 years after the effective date of those regulations. The bill would also provide that the department may adopt regulations to issue a separate certificate to unlicensed persons employed by a clinical laboratory who only perform skin puncture tests. The bill would also make related changes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 1242 of the Business and Professions Code is amended to read: 1242. Any person duly licensed under the provisions of this chapter to perform tests called for in a clinical laboratory may perform skin tests for specific diseases, arterial puncture, venipuncture, or skin puncture for purposes of withdrawing blood or for clinical laboratory test purposes as defined by regulations established by the department and upon specific authorization from any person in accordance with the authority granted under any provisions of law relating to the healing arts. SEC. 2. Section 1242.5 of the Business and Professions Code is amended to read: 1242.5. Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant to Section 1246 to perform venipuncture, arterial puncture, or skin puncture for the purposes of withdrawing blood or for clinical laboratory test purposes, as defined by regulations established by the department. SEC. 3. Section 1246 of the Business and Professions Code is amended to read: 1246. (a) Except as provided in subdivision (b), and in Section 23158 of the Vehicle Code, an unlicensed person employed by a licensed clinical laboratory may perform venipuncture or skin puncture for the purpose of withdrawing blood or for clinical laboratory test purposes upon specific authorization from a licensed physician and surgeon provided that he or she meets both of the following requirements: (1) He or she works under the supervision of a person licensed under this chapter or of a licensed physician or surgeon or of a licensed registered nurse. A person licensed under this chapter, a licensed physician or surgeon, or a registered nurse shall be physically available to be summoned to the scene of the venipuncture within five minutes during the performance of those procedures. (2) He or she has been trained by a licensed physician and surgeon or by a clinical laboratory bioanalyst in the proper procedure to be employed when withdrawing blood in accordance with training requirements established by the State Department of Health Services and has a statement signed by the instructing physician and surgeon or by the instructing clinical laboratory bioanalyst that such training has been successfully completed. (b) (1) On and after the effective date of the regulations specified in paragraph (2), any unlicensed person employed by a clinical laboratory performing the duties described in this section shall possess a valid and current certification as a "certified phlebotomy technician" issued by the department. However, an unlicensed person employed by a clinical laboratory to perform these duties pursuant to subdivision (a) on that date shall comply with this requirement within three years after the effective date of those regulations. (2) The department shall adopt regulations for certification by January 1, 2001, as a "certified phlebotomy technician" that shall include all of the following: (A) The applicant shall hold a valid, current certification as a phlebotomist issued by a national accreditation agency approved by the department, and shall submit proof of that certification when applying for certification pursuant to this section. (B) The applicant shall complete education, training, and experience requirements as specified by regulations that shall include, but not be limited to, the following: (i) At least 40 hours of didactic instruction. (ii) At least 40 hours of practical instruction. (iii) At least 50 successful venipunctures. However, an applicant who has been performing these duties pursuant to subdivision (a) may be exempted from the requirements specified in clauses (ii) and (iii), and from 20 hours of the 40 hours of didactic instruction as specified in clause (i), if he or she has at least 1,040 hours of work experience, as specified in regulations adopted by the department. It is the intent of the Legislature to permit persons performing these duties pursuant to subdivision (a) to use educational leave provided by their employers for purposes of meeting the requirements of this section. (3) Each "certified phlebotomy technician" shall complete at least three hours per year or six hours every two years of continuing education or training. The department shall consider a variety of programs in determining the programs that meet the continuing education or training requirement. (4) He or she has been found to be competent in phlebotomy by a licensed physician and surgeon or person licensed pursuant to this chapter. (5) He or she works under the supervision of a licensed physician and surgeon, licensed registered nurse, or person licensed under this chapter, or the designee of a licensed physician and surgeon or the designee of a person licensed under this chapter. (6) The department shall adopt regulations establishing standards for approving training programs designed to prepare applicants for certification pursuant to this section. The standards shall ensure that these programs meet the state's minimum education and training requirements for comparable programs. (7) The department shall adopt regulations establishing standards for approving national accreditation agencies to administer certification examinations and tests pursuant to this section. (8) The department shall charge fees for application for and renewal of the certificate authorized by this section of no more than twenty-five dollars ($25). (c) The department may adopt regulations providing for the issuance of a certificate to an unlicensed person employed by a clinical laboratory authorizing only the performance of skin punctures for test purposes. SEC. 4. Section 1269 of the Business and Professions Code is amended to read: 1269. (a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria: (1) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA. (2) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities: (A) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (B) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (C) The skills required for performing preventive maintenance, and troubleshooting. (D) A working knowledge of reagent stability and storage. (E) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory. (F) An awareness of the factors that influence test results. (b) The activities that may be performed are: (1) Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (2) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (3) Assisting in preventive maintenance, and troubleshooting. (4) Preparation and storage of reagents and culture media. (5) Assisting in the performance of quality control procedures. (c) Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a). (d) Unlicensed laboratory personnel shall not do any of the following: (1) Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument. (2) Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure. (3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation. (e) When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows: (1) In the case of qualitative and semi-quantitative "spot, tablet, or stick" tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter. (2) In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. (f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities: (1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control. (2) Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. (3) Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers. SEC. 5. Section 120580 of the Health and Safety Code is amended to read: 120580. Notwithstanding any other provision of law, a person employed by a public health department may perform venipuncture or skin puncture for the purpose of withdrawing blood for test purposes, upon specific authorization from a licensed physician and surgeon, even though he or she is not otherwise licensed to withdraw blood; provided that the person meets all of the following requirements: (1) He or she works under the direction of a licensed physician and surgeon. (2) He or she has been trained by a licensed physician and surgeon or by a licensed clinical laboratory scientist or bioanalyst in the proper procedures to be employed when withdrawing blood, in accordance with training requirements established by the department, and has a statement signed by the instructing physician and surgeon that the training has been successfully completed. (b) Any person employed by a public health department to perform venipuncture or skin puncture shall hold a valid and current certification after the effective date of the regulations adopted pursuant to Section 1246 of the Business and Professions Code.