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

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Date Published: 04/25/2017 09:00 PM
AB613:v97#DOCUMENT

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 in a licensed plasma collection facility in this state if specified circumstances are met, as determined by the department. 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 the proximity of the donor for whom the test or examination is being conducted and the refractometer performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection. 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 facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.

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 in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), the licensed plasma collection facility, including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, 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 Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a). meets the education and training requirements for unlicensed laboratory personnel specified in Section 1269.
(2) (A) In addition to the training requirements specified in paragraph (1), he or she is trained in the proper procedures to be employed when performing a total protein test using a digital refractometer.

(2)

(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 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
(C) The instructor shall document, documents, and the plasma collection facility shall maintain maintains the documentation of, the individual’s successful completion of training in the performance of the total protein test using a digital refractometer.
(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director. in accordance with both of the following:
(A) Standardized operating procedures required by the licensed plasma collection facility’s license.
(B) Standardized procedures developed and approved by the licensed plasma collection facility’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.
(4) 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.
(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 the proximity of the donor for whom the test or examination 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 facility under federal law.
(3) Performs clinical laboratory tests or examinations 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 clinical laboratory tests or examinations on biological specimens that require no preparation after collection. For purposes of this paragraph, “preparation” means any step beyond those required for the collection and transfer of a sample between a donor and a testing device or between the digital refractometer and a waived testing device, including, but not limited to, staining, use of test reagents, quantitative measurement without an automatic or calibrated pipette or dispenser, or slide mounting.
(5) Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(6) Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturer’s instructions or basic cleaning.

(b)

(c) 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.