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Laws and regulations
2023 Year End Political Update Summary
 

LEGISLATURE

The California State Legislature has now adjourned, which completes the first year of the 2023-2024 legislative session. The COVID-19 pandemic continues to be used as an avenue to expand scope of practice. As in previous legislative sessions, bills were introduced with that goal in mind. This legislative session the midwives joined dentists, optometrists, and pharmacists in wanting to expand their scope of practice into clinical laboratory medicine. Despite California requiring stringent laboratory personnel standards and licensing we continue to see, year after year, attempts to dilute those standards through legislation or regulations.
 

HOW YOU CAN HELP
For decades, CAMLT has continued to defend laboratory standards to protect patients as others
continue to try and convince legislators to dilute licensing and personnel standards. Only you can help
keep our advocacy strong by joining CAMLT as a member and maintaining your membership throughout
your career. A financially strong association coupled with sustainable membership growth is vital to
effectively execute a comprehensive legislative program in California to protect your profession and
patients. To date, CAMLT continues to be at the forefront exclusively protecting the legislative interests
of CLS’s, MLT’s and other laboratory personnel. CAMLT continues to be the only professional association
solely representing clinical laboratory science personnel that retains a lobbying firm in Sacramento.
CAMLT is typically the last Association holding the line against onerous legislative and regulatory
changes. No other laboratory personnel professional associations have a Sacramento presence or help
financially underwrite CAMLT’s governmental program on behalf of the entire profession.


LEGISLATION
CAMLT actively opposed several pieces of legislation and amended/watched others. The following is
report on legislation for the first year of the 2023-2024 legislative session.


AB 269 (Berman D) Public health: COVID-19 testing and dispensing sites.  POSITION-NEUTRAL

  • Authorizes any person who meets the requirements under federal CLIA for high complexity laboratory testing to perform COVID-19 testing without meeting CA licensure requirements. AB 269’s intent was to codify the Governor’s Executive Order with regard to COVID-19 that would allow any holder of a Bachelor of biological, chemical or physical science degree to perform high complexity COVID 19 testing without a California CLS license. After push back and opposition from CAMLT, the author agreed to place a 5-year sunset in another piece of legislation. As a result, CAMLT went to a neutral position.

Status: Signed into law by the Governor on 3/2/23.


AB 1341 (Berman D) Public health: COVID-19: testing and dispensing sites. POSITION-WATCH 

  • Repeals the authorization of persons without a CA license who meets the requirement under federal 
    CLIA for high complexity laboratory testing to perform COVID-19 testing on July 1, 2028. 
    When Governor Newsom announced that California’s State of Emergency would be terminated on 
    February 28, 2023, he requested statutory changes to ensure “the continued ability of laboratory workers to solely process COVID-19 tests.” Subsequently, Assembly Bill 269 (Berman) was enacted to 
    continue the waiver of state requirements for individuals analyzing COVID-19 tests who meet the 
    federal requirements for high complexity testing. During the expedited legislative process for that bill,
    the author made commitments to CAMLT and other stakeholders that he would add a sunset date to
    this provision in another vehicle introduced following enactment of the urgency legislation. AB 1341 will 
    fulfill that promise by adding a July 1, 2028, sunset date to the relevant provision of AB 269.

Status: Signed into law by the Governor on 9/30/23.


AB 1741 (Waldron R) Healing arts: clinical laboratories: personnel. POSITION-OPPOSED

  • Expands the activities of unlicensed laboratory personnel to include:

    • Performance of any test or part thereof that involves the quantitative measurement of the
      specimen or test reagent, or any mathematical calculation relative to determining the
      results or the validity of a test procedure when assisting a physician and surgeon or licensed
      personnel (CLS or MLT), other than trainees, in a licensed clinical laboratory.

    • Performance of any phase of clinical laboratory tests or examinations in the specialty of
      immunohematology when assisting a physician and surgeon or licensed personnel licensed (CLS or MLT), other than trainees, in a licensed clinical laboratory.
      Sponsored by Quest, AB 1741 in its introduced form, would reshape the scope of practice regime for 
      unlicensed laboratory personnel. AB 1741 would allow unlicensed personnel to perform a range of tasks 
      that may affect patient results not limited to but including performing waived testing. While CAMLT 
      opposed outright, we also joined labor in their opposition. 


Although the April 27, 2023, amendments removed the expansion of qualifications to an exam for 
licensure as a CLS or limited license scientist to include 18 months experience as an unlicensed person 
performing expanded duties and serve as testing personnel, CAMLT felt that the amendments still 
inappropriately expand some tasks unlicensed personnel should perform in a clinical laboratory.
Satisfied with these amendments, labor removed their opposition. 


Therefore, CAMLT was left as the sole opponent as the bill reached Governor Newsom’s desk. We are 
pleased to report that the Governor vetoed the bill. The attached Veto Message includes clear and

explicit language that “… this bill contains a provision that could enable unlicensed personnel to perform
tasks that exceed their level of training, posing a danger to the health and safety of Californians. As a
result, this bill could conflict with the Clinical Laboratory Improvement Act, a federal law that prohibits
individuals from who do not meet the specified education and training requirements from performing
any aspect of the analytical phase of testing.” A victory for CAMLT, but we anticipate the sponsors will
return with a new bill again next year.


Status: VETOED by the Governor on 10/8/23.


SB 667 (Dodd D) Healing arts: pregnancy and childbirth. Enrolled: 9/15/2023. POSITION-OPPOSE

  • Would authorize Certified nurse-midwife (CNM) to serve as waived and Provider Performed 
    Microscopy Procedures (PPMP) lab directors without requisite education, experience, or training in
    clinical laboratory sciences.

SB 667 seeks to authorize Certified nurse-midwife (CNM) to serve as waived and Provider Performed
Microscopy Procedures (PPMP) lab directors without education, experience, or training in clinical

laboratory sciences. Under current law, CNMs are authorized to order and perform CLIA waived tests
and PPMP within their scope under the overall supervision of a qualified laboratory director. However,
there is nothing in their education, experience, or training that would qualify CNMs to be identified as
laboratory directors. Simply stating that it is cost prohibitive for an independent CNM to retain a
laboratory director for their clinical laboratory is not a valid reason to qualify CNMs as laboratory
directors.


Senator Dodd and the sponsors set forth CNMs’ education, training and experience credentials within
the scope of their practice to properly perform these tests and convinced the California Medical
Association that since CNMs had achieved independence from MDs, the lab director requirement only
added additional cost to the practice. After a series of meetings with the sponsors and an indication that
Governor Newsom was inclined to sign the measure, CAMLT obtained narrowing amendments to limit
the laboratory tests to waived or PPMP tests within the scope of their practice.

Status: Signed into law by the Governor on 10/8/23.

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