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AB-613 Healing arts: clinical laboratories.(2017-2018)

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Date Published: 08/29/2017 09:00 PM
AB613:v95#DOCUMENT

Amended  IN  Senate  August 29, 2017
Amended  IN  Senate  August 23, 2017
Amended  IN  Assembly  April 25, 2017
Amended  IN  Assembly  March 27, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 613


Introduced by Assembly Member Nazarian
(Principal coauthors: Assembly Members Cristina Garcia and Gomez)

February 14, 2017


An act to add and repeal Section 1246.7 of the Business and Professions Code, relating to clinical laboratories.


LEGISLATIVE COUNSEL'S DIGEST


AB 613, as amended, Nazarian. Healing arts: clinical laboratories.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.
This bill, until January 1, 2020, would authorize a person with specified qualifications to perform a total protein test using a digital refractometer that creates an electronic record of the test results in a licensed plasma collection center in this state if specified circumstances are met, as determined by the department, including that the person meets certain education and training requirements. The bill would require the digital refractometer used to perform a total protein test pursuant to these provisions to meet specific criteria, including that it be used within 30 feet of the donor for whom the test is being conducted and the refractometer performs total protein tests on plasma samples from the waived spun hematocrit test. The bill would require a licensed plasma collection center to maintain specified records and provide specified information to the department upon request, as well as provide an annual report of protein test results below the required lower limit, as specified. Because a violation of those provisions would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection center in this state.

SEC. 2.

 Section 1246.7 is added to the Business and Professions Code, to read:

1246.7.
 (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer that creates an electronic record of the test results 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) He or she 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).
(2) (A) In addition to the training requirements specified in paragraph (1), he or she has received five hours of training in the proper procedures to be employed when performing a total protein test using a digital refractometer.
(B) His or her 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 individual’s 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) He or she performs the total protein test using a digital refractometer while one of the following individuals is physically onsite in the licensed plasma collection center and is available for consultation and direction while the person is processing specimens and performing the test:
(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.
(4) He or she 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 center’s license.
(B) Standardized procedures developed and approved by the licensed plasma collection center’s 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.
(5) He or she does not draw the blood sample required for the test using a procedure that requires a registration, certification, or license under state law unless he or she is properly registered, certified, or licensed to perform the procedure.
(6) His or her competency in performing total protein tests using a digital refractometer is evaluated before testing on donors, and every six months thereafter, by a person providing supervision pursuant to paragraph (3) of subdivision (a), who will review a random sampling of the tests performed. A licensed plasma collection center shall maintain documentation of the competency evaluation, which shall be made available to the department upon request.
(b) The digital refractometer used to perform a total protein test pursuant to this section shall meet all of the following criteria:
(1) Is used within 30 feet of the donor for whom the test is being conducted.
(2) Is used in accordance with the donor test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220, if applicable to the licensed plasma collection center under federal law.
(3) Performs total protein tests classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(4) Performs total protein tests using a digital refractometer on plasma samples only obtained from the waived spun hematocrit test.
(5) Provides total protein test results without calculation or discretionary intervention by the testing personnel.
(6) Performs total protein tests without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturer’s instructions or basic cleaning.
(c) To assess persons authorized to perform the total protein test pursuant to this section, licensed plasma collection centers shall report the name of the facility, the date the test was provided, and the total protein test result for each total protein test result below the required lower limit of 6.0 gm/dl to the department annually by electronic mail in a data spreadsheet.
(d) Electronic records of digital refractometer test results shall be maintained for three years and made available to the department upon request.
(e) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.

SEC. 3.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.