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AB-2107 Clinical laboratory testing.(2021-2022)

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Date Published: 10/03/2022 09:00 PM
AB2107:v92#DOCUMENT

Assembly Bill No. 2107
CHAPTER 956

An act to amend Section 1210 of the Business and Professions Code, relating to clinical laboratories, and declaring the urgency thereof, to take effect immediately.

[ Approved by Governor  September 30, 2022. Filed with Secretary of State  September 30, 2022. ]

LEGISLATIVE COUNSEL'S DIGEST


AB 2107, Flora. Clinical laboratory testing.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law also specifies what duties the clinical laboratory personnel can engage in, or supervise others engaged in, including for a person licensed as a clinical genetic molecular biologist scientist. Violation of these provisions is a crime.
This bill would authorize a person licensed as a clinical genetic molecular biologist scientist to use molecular biology techniques to perform a clinical laboratory test or examination for the detection of any disease affecting humans.
This bill would incorporate additional changes to Section 1210 of the Business and Professions Code proposed by SB 1267 to be operative only if this bill and SB 1267 are enacted and this bill is enacted last.
This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


SECTION 1.

 Section 1210 of the Business and Professions Code is amended to read:

1210.
 (a) As used in this chapter, “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist scientist,” “clinical genetic molecular biologist scientist,” “clinical cytogeneticist scientist,” and “clinical histocompatibility scientist” means a person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. The licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which the person is licensed by the department. A person licensed as a “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist scientist,” “clinical genetic molecular biologist scientist,” “clinical cytogeneticist scientist,” or a “clinical histocompatibility scientist” may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b) The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1) For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2) For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3) For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4) For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5) For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6) For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(7) For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c) Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
(d) A person licensed under this chapter as a clinical genetic molecular biologist scientist may use molecular biology techniques to perform a clinical laboratory test or examination for the detection of any disease affecting humans.

SEC. 1.5.

 Section 1210 of the Business and Professions Code is amended to read:

1210.
 (a) As used in this chapter, “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist scientist,” “clinical genetic molecular biologist scientist,” “clinical cytogeneticist scientist,” “clinical laboratory geneticist scientist,” “clinical reproductive biologist scientist,” and “clinical histocompatibility scientist” means a person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. The licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which the person is licensed by the department. A person licensed as a “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist scientist,” “clinical genetic molecular biologist scientist,” “clinical cytogeneticist scientist,” “clinical laboratory geneticist scientist,” “clinical reproductive biologist scientist,” or a “clinical histocompatibility scientist” may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b) The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1) For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2) For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3) For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4) For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5) For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6) For a person licensed under this chapter as a clinical laboratory geneticist scientist, the subspecialties of molecular biology related to diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or laboratory genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7) For a person licensed under this chapter as a clinical reproductive biologist scientist, the specialty of reproductive biology and the subspecialties of andrology and embryology related to diagnostic testing for management of primary and secondary infertility, fertility assessment, and fertility preservation, as well as the evaluation and assessment of gametes, embryos, and their associated fluids and tissues, or other specialty or subspecialty specified by regulation adopted by the department.
(8) For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(9) For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c) Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, clinical laboratory geneticist scientists, clinical reproductive biologist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
(d) A person licensed under this chapter as a clinical genetic molecular biologist scientist may use molecular biology techniques to perform a clinical laboratory test or examination for the detection of any disease affecting humans.

SEC. 2.

 Section 1.5 of this bill incorporates amendments to Section 1210 of the Business and Professions Code proposed by both this bill and Senate Bill 1267. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2023, but this bill becomes operative first, (2) each bill amends Section 1210 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 1267, in which case Section 1210 of the Business and Professions Code, as amended by Section 1 of this bill, shall remain operative only until the operative date of Senate Bill 1267, at which time Section 1.5 of this bill shall become operative.

SEC. 3.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to maintain the health care workforce necessary to continue to administer and process tests for the COVID-19 virus if the Governor’s emergency order relating to the COVID-19 global pandemic expires or is rescinded, it is necessary for this act to take effect immediately.