Legislative Information
Legislation Changes
The following bills were signed into law in 2022.
Amends Section 1246.7 of the Business and Profession Code to allow an unlicensed person to perform a total protein test using a digital refractometer in a licensed plasma collection center, under specified conditions, including that the person performs the test in accordance with standardized procedures developed and approved by the centerās supervising physician and surgeon or licensed clinical laboratory director.
Effective January 1, 2023.
Amends Section 1246 of the Business and Profession Code to authorize a certified phlebotomy technician to collect blood through a peripheral venous catheter in a facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code under specified conditions, under specified conditions, including training by the supervising physician and surgeon or their delegate in the proper procedures to be employed when collecting blood through a peripheral venous catheter, and performance of blood collection under the supervision of a physician and surgeon or a delegated registered nurse using a device or devices approved by the United States Food and Drug Administration. This does not authorize a certified phlebotomy technician to manage, stop, or restart a patientās active intravenous infusion or insert or remove a peripheral intravenous catheter.
A physician and surgeon or a registered nurse may restrict or limit a certified phlebotomy technicianās ability to collect blood from a patientās peripheral venous catheter.
AB 1120 does not authorize a certified phlebotomy technician to manage, stop, or restart a patientās active intravenous infusion or insert or remove a peripheral intravenous catheter.
AB 1120 does not affect the content requirements for phlebotomy training programs, as the supervising physician and surgeon of the licensed facility is responsible for training of the individual phlebotomy technician in the technique.
Effective January 1, 2023.
Amends Section 1210 of the Business and professions Code to allow 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.
Effective September 30, 2022, as an urgency statute.
Amends Sections 1209, 2544, and 3041 of the Business and Professions Code.
Amends Section 1209 to correct a reference to the Optometry Practice Act that was rendered obsolete by AB 691 in 2021.
Amends Section 3041 to authorize an optometrist certified pursuant to Section 3041.3 to utilize laboratory tests or examinations performed in a laboratory with a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), for detecting indicators of possible systemic disease that manifests in the eye for the purpose of facilitating appropriate referral to or consultation with a physician and surgeon, and for detecting the presence of SARS-CoV-2 virus.
AB 2574 also makes other changes to the optometry scope of practice.
Effective January 1, 2023.
Amends Sections 1203, 1204, 1205, 1206, 1207, 1210, 1261, 1261.5, 1264, and 1300 of the Business and Professions Code to create a new licensure specialty of clinical reproductive biology and a new licensure subspecialty of clinical laboratory genetics. It adds licensure for trainees, limited clinical laboratory scientists, and masterās and doctoral specialists (directors) in clinical laboratory genetics and clinical reproductive biology to the types of clinical laboratory personnel licensed and regulated by the department and defines their subspecialities and duties. It also allows the Department to charge fees for licensure in the new specialty and subspecialty.
Prior to the adoption of implementing regulations, SB 1267 allows the department to issue licenses to clinical reproductive biologist scientists, clinical laboratory geneticist scientists, clinical reproductive biologists, and clinical laboratory geneticists who meet specified requirements.
Effective January 1, 2023.
Note that AB 2107 and SB 1267 both amend Section 1210 of the Business and Professions Code. The underlined changes in AB 2107 took effect on September 30, 2022, as an urgency statute. Section 1210 as amended by AB 2107 will remain operative until January 1, 2023, when Section 1210 as amended by SB 1267 will become operative. SB 1267 includes the changes made in AB 2107, so those changes will continue in effect, and further changes will also become effective. In the table below, changes are indicated by underline.
ā1210.
(a) As used in this chapter, āclinical chemist scientist,ā āclinical microbiologist scientist,ā āclinical toxicologist scientist,ā āclinical immunohematologist scientist,ā āclinical genetic molecular biologist scientist,ā āclinical cytogeneticist scientist,ā and āclinical histocompatibility scientistā 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 āclinical chemist scientist,ā āclinical microbiologist scientist,ā āclinical toxicologist scientist,ā āclinical immunohematologist scientist,ā āclinical genetic molecular biologist scientist,ā āclinical cytogeneticist scientist,ā or a āclinical histocompatibility scientistā may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
|
ā1210.
(a) As used in this chapter, āclinical chemist scientist,ā āclinical microbiologist scientist,ā āclinical toxicologist scientist,ā āclinical immunohematologist scientist,ā āclinical genetic molecular biologist scientist,ā āclinical cytogeneticist scientist,ā āclinical laboratory geneticist scientist,ā āclinical reproductive biologist scientist,ā and āclinical histocompatibility scientistā 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 āclinical chemist scientist,ā āclinical microbiologist scientist,ā āclinical toxicologist scientist,ā āclinical immunohematologist scientist,ā āclinical genetic molecular biologist scientist,ā āclinical cytogeneticist scientist,ā āclinical laboratory geneticist scientist,ā āclinical reproductive biologist scientist,ā or a āclinical histocompatibility scientistā may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
|
ā(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.
|
ā(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.
|
ā(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.
|
ā(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.
|
ā(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.
|
ā(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.
|
Amends Section 1607 of the Health and Safety Code to authorize blood collection at a blood bank when a physician or surgeon is not physically present if the medical director and their medical advisory committee approve and if the employee placed in charge is a registered nurse. The bill authorizes the registered nurse placed in charge to be physically present or available via telehealth.
SB 1475 requires a blood bank to report annually to the department on any adverse donor events requiring emergency medical intervention, including whether a registered nurse was physically present on the premises, and to provide, at the request of the department, written procedures for managing adverse donor reactions.
Effective January 1, 2023, until January 1, 2028.
Amends Sections 1602.5, 1609, 1635.1 and 111656.1 of the Health and Safety Code to exempt from CDPH tissue bank and biologics licensure requirements a clinical trial site storing or preparing for patient administration human whole blood and blood derivatives, biologics other than human whole blood and blood derivatives, and human tissue if the products are intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices, and the investigation is conducted in accordance with specified provisions of the federal Food, Drug, and Cosmetic Act.
Effective January 1, 2023.