BILL ANALYSIS Ó AB 757 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 757 (Gomez) As Amended June 22, 2015 Majority vote -------------------------------------------------------------------- |ASSEMBLY: | 74-0 | (May 22, |SENATE: |39-0 | (August 24, | | | |2015) | | |2015) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: B. & P. SUMMARY: Authorizes a person, who meets specified criteria, to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state. Specifically, this bill: 1)Authorizes a person whose qualifications are at least the equivalent of those specified in Code of Federal Regulations Title 42, Section 493.1423(b)(4) to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state if all of the following conditions are met: a) The person has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1998 (CLIA) (42 United AB 757 Page 2 States Code Section 263a); b) The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility; c) The person's training in the proper procedure to be employed when performing a total protein refractometer test using an automatic, button-operated refractometer with a digital readout has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor must document, and the plasma collection facility must maintain the documentation of, the individual's successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout; d) The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director; and, e) The person submits the test results for interpretation to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout. 2)States that no reimbursement is required pursuant to California Constitution Article XIII B, Section 6, as specified. The Senate amendments increase the required qualifications to perform the test (a moderate complexity test) from a medical assistant to a person qualified to perform the test under federal law. AB 757 Page 3 FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. COMMENTS: Purpose. This bill is sponsored by Grifols, Inc. According to the author, "Plasma donation centers are critical to ensuring the availability of therapies that treat rate, chronic, and sometimes life-threatening diseases. AB 757 would authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis - a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility - in state licensed plasma collection facility in California. This will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety." Background. In California, only licensed or certified individuals may perform moderate complexity tests. This bill would create an exception to the requirement under state law for a total protein refractometer test, which is a moderate complexity test. However, it will still require the person to meet the qualifications required under federal law to perform a moderate complexity test, including having earned a high school diploma or equivalent and having documentation of training appropriate for the testing performed prior to analyzing patient specimens. The training must ensure that the individual has: 1)The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; AB 757 Page 4 2)The skills required for implementing all standard laboratory procedures; 3)The skills required for performing each test method and for proper instrument use; 4)The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; 5)A working knowledge of reagent stability and storage; 6)The skills required to implement the quality control policies and procedures of the laboratory; 7)An awareness of the factors that influence test results; and, 8)The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. Total Protein Refractometer Test. The measurement of total protein uses an instrument called a refractometer. A refractometer is a device that shines a beam of light through a sample of liquid. The device measures the amount of light that is refracted (bent) due to the solids in the sample. In blood, protein causes light to bend. The greater the amount of protein, the more light is bent from the light path. According to the sponsors, Grifols measures a potential plasma donor's total protein levels as part of the initial screening process. Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001303 AB 757 Page 5