(a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the department, as part of its routine, fee-supported inspection of the licensed plasma collection center, including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all center positions for a licensed plasma collection center, determines that all of the following conditions are met: (1) (A) The person has earned a high school diploma or equivalent, as determined by the federal Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a). (B) The person has training sufficient to demonstrate that the individual has the skills and abilities described in paragraph (2) of subdivision (a) of Section 1269. (2) (A) In addition to the education and training requirements specified in paragraph (1), the person has received five hours of training in the proper procedures to be employed when performing a total protein test using a digital refractometer, including evaluation of specimen acceptability and criteria for rejection of inadequate specimens, and the procedures for recording the test results pursuant to paragraph (9). (B) Their training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a moderate complexity laboratory technical consultant as specified in Section 1036.2 of Title 17 of the California Code of Regulations, 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 center. (C) The instructor documents, and the plasma collection center maintains the documentation of, the individualâs successful completion of training in the performance of the total protein test using a digital refractometer. This documentation shall be made available to the department upon request. (3) The person performs the total protein test using a digital refractometer under the supervision of one of the following individuals: (A) A moderate complexity laboratory technical consultant as specified in Section 1036.2 of Title 17 of the California Code of Regulations. (B) A registered nurse licensed pursuant to Chapter 6 of Division 2. (C) A physician or surgeon licensed pursuant to Chapter 5 of Division 2. (D) A clinical laboratory director licensed pursuant to this chapter. (E) A clinical laboratory scientist licensed pursuant to this chapter. (4) The supervisor is physically onsite in the licensed plasma collection center and available for consultation during the entire time that the person is processing specimens and performing the test. (5) The licensed plasma collection centerâs supervising physician and surgeon or licensed clinical laboratory director provides a written job description for each employee who performs a total protein test using a digital refractometer that specifies the responsibilities and supervision requirements as specified in this section. (6) The person performs the total protein test using a digital refractometer in accordance with both of the following: (A) Standardized operating procedures required by the licensed plasma collection centerâs license. (B) Standardized procedures approved by the licensed plasma collection centerâs supervising physician and surgeon or licensed clinical laboratory director for administration of the total protein test by the persons authorized to perform the total protein test pursuant to this section. These standardized procedures shall be made available to the department upon request. (7) The person does not draw the blood sample required for the test using a procedure that requires a registration, certification, or license under state law unless they are properly registered, certified, or licensed to perform the procedure.
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