Legislative Update: As of 8/23/23
AB 269 (Berman) COVID-19 Testing and Treatment
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 codified two waivers granted by the Governor during the COVID-19 State of Emergency. This bill was requested by the Governor. One of those emergency orders (EO) suspended certification and licensure requirements for the performance of clinical laboratory tests for SARS-CoV-2. Any person who meets the requirements under federal CLIA for high complexity testing may perform analysis of samples to test for SARS-CoV-2. This bill would continue to allow any person who meets federal CLIA for high complexity laboratory testing to perform COVID-19 testing indefinitely. CAMLT opposed AB 269 as it was no longer necessary or appropriate.
Lowering testing personnel requirements from the more stringent CA standards had many negative consequences. Since March 2020, there have been numerous complaints at the local, state, and national levels against laboratories who employed unlicensed testing personnel to perform COVID-19 testing. CDPH laboratory inspectors found deficiencies in some labs that employed mostly unlicensed personnel that posed an immediate jeopardy to patient health and safety that could lead to serious harm or death.
Assembly Member Berman heard CAMLT’s concern and offered to limit the extension of the EO to suspend certification and licensure requirements for the performance of COVID-19 testing to five years in exchange for CAMLT’s removal of its opposition to the bill. CAMLT agreed and AB 269 was chaptered, and AB 1341 was introduced by Assembly Member Berman that places a 5-year sunset clause onto AB 269.
AB 1341 (Berman) COVID-19 Testing and Therapeutics Dispensing Sites
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.
AB 1741 (Waldron) Healing arts: clinical laboratories: personnel
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.
Although the April 27, 2023, amendments remove 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, the amendments still inappropriately expand some tasks unlicensed personnel should perform in a clinical laboratory.
Quantitative measurement of the specimen or test reagent and performance of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation require a thorough understanding not only of the actual performance of the task but also the reasons for performing in the designated manor as well as the potential repercussions of errors that could be made.
In addition, the ability to make any judgement calls such as those needed for manual quantitative measurements or performance of any phase of laboratory tests or examinations in the specialty of immunohematology requires significant training and experience not accounted for in AB 1741.
SB 667 (Dodd) Healing arts: pregnancy and childbirth
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.
Laboratory directors remain ultimately responsible for all phases of testing and must ensure that all the duties of the laboratory director, supervisors and testing personnel are properly performed and applicable CA and CLIA regulations are adhered to. Laboratory directors must ensure that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate, reliable, and timely patient test results. Without education and training in the clinical laboratory sciences, laboratory director responsibilities to ensure quality testing results cannot be achieved by CNMs.
A New Threat to Our Profession!
Update as of February 27, 2023: AB 269 (Berman-D) passed the Assembly easily with a compromise of a sunset date of five years and now goes to the Senate. This will probably become law as soon as February 28th.
A new threat looms for us now: AB 1741 (Waldron-R) is sponsored by Quest Diagnostics and seeks to expand the number of tests unlicensed personnel can do. This new bill will take time to be introduced. At that time CAMLT will respond with letter writing accordingly. Read here about it...
Although AB 1741 does not appear to eliminate the degree requirement for CLS and limited licensure categories, it does expand those activities that an unlicensed person may perform. Expanding the tasks an unlicensed person may perform could jeopardize the health and safety of patients in California.
Expanded activities mentioned in the bill include:
Collection of biological specimens. But, without certification as a phlebotomist, this poses potential problems with test results as analysis is dependent on an adequate specimen.
Performance of preventative maintenance. This is critical to accurate, reliable test results.
Preparation and storage of reagents is vital to test performance.
The above activities require a thorough understanding not only of the actual performance of the task but also the reasons for performing in the designated manner as well as the potential repercussions of errors that could be made.
Additionally, AB 1741 does not indicate a requirement for:
Knowledge of pre and post analytic contributions to the outcome of a test.
Ability to make any judgement calls such as those needed for manual quantitative measurements.
Capability to select or program an instrument, select temperatures, or set timers especially during the analytical phase of testing.
And, unlicensed personnel would still not be able to evaluate whether the Quality Control is acceptable, allowing results to be reported.
All of these examples require judgement calls by the unlicensed person and requires significant training and experience not accounted for in AB 1741.
AB 1741 expands the qualifications to take an exam for licensure as a CLS or limited license scientist to include 18 months experience as an unlicensed person, performing the expanded duties described, in place of 1 year in a formal training program. 18 months performing the expanded tasks listed in AB 1741 is not equivalent to 12 months training in a CA licensed training program and should not qualify a person to take a licensure exam – too much vital knowledge is missing.
Finally, it appears as if some of the expanded tasks related to high complexity testing are not allowed according to requirements specified in CLIA 88, the federal clinical laboratory standard.
STOP AB 269!
Protect Our Profession!
February 12, 2023
Dear fellow CLS and supporter of the profession,
My name is Valerie Trenev and I am the president of CAMLT. Recently our organization became aware of a dire threat to our profession. I am writing to you, now, to ask that you help us protect our license and help ensure quality laboratory testing for all Californians.
In March 2020, Governor Newsom established Emergency Executive Order N-25-20. This action temporarily reduced California personnel requirements with regard to high complexity Covid testing to CLIA ‘88 standards (i.e. Bachelor’s degree and on-the-job training).
There have been many issues concerning “pop-up labs” and testing at the CDPH Valencia Branch Lab over the past several years. Despite this, the Governor feels that higher CA lab personnel requirements for high-complexity testing COVID testing are not necessary.
In the last few weeks, a bill called AB 269 (Berman-D) has come up and will soon be in the Assembly Business & Professions Committee on February 14, 2023. It will then go to the Assembly Health Committee on February 15th, 2023. This bill seeks to codify or “make permanent” the Emergency Executive Order N-25-20 that allowed high complexity COVID testing to be performed by unlicensed personnel.
Even worse, special interest groups have now approached Mr. Berman, the author of the bill, to ask him to extend the bill to ALL CLINICAL LAB TESTING! This would repeal ALL California laboratory law and default to CLIA ‘88 standards. Fortunately, there is a Committee Consultant that is against this move, however, if the legislators do not hear from other concerned parties - like us - this nightmare could become reality and there possibly be a time where California no longer requires a CLS/MLT/PHM license to perform laboratory tests!
Please act now. Use the “finder” link below to look up your legislator. Then click on the link to both the Assembly Business & Professions Committee list of members and the Assembly Health Committee list of members. Do you see your legislator on either list? If yes - you are like “gold” because your legislator can help us greatly. Even if your legislator is not on one of the committees, please write to him or her and ask them to approach someone on the committee to share our concerns. You must do this as soon as possible. On the committee member lists for both committees is a link you can click to share your contact information and write an email. This is a very easy process. Feel free to use my sample letter and modify it to suit you. We desperately need everyone to act. Be aware of the deadlines! Please help us protect the profession.
1. Find your legislator:
2. Assembly Business & Professions Committee Member List:
3. Assembly Health Committee
4. Sample Letter - Editable - Make your changes and paste into the email for your legislator.
I am a Clinical Laboratory Professional. I work or have worked in a Clinical Laboratory. My job involves analyzing blood and other body fluids for the presence of illness. AB 269 (Berman) will come before the B&P committee on 2/14/23. This bill seeks to dilute standards for our profession by allowing persons without a license to perform laboratory testing of high complexity. Current California law requires a person to have a license to perform testing of that nature. I attended four years of college and participated in a one year training program in an accredited teaching lab and then sat for a state exam and passed it to earn my license. Due to the pandemic, an emergency order was issued to sidestep the requirement and allow persons with only a Bachelor's degree to do this testing. Only ten states and Puerto Rico require a license now.
California is a leader in healthcare and many other states follow what we do. Other states must only follow CLIA '88 lab law. This is inferior to what we now have in place. The Governor now seeks to codify this emergency, temporary status. I cannot overemphasize the complexity of what we do in a clinical laboratory. Doctors depend upon accurate lab results to treat patients. During the pandemic, many inconclusive results were reported necessitating people to needlessly miss work or school. This happened in labs staffed by personnel without adequate training.
I would like to meet with you in person to further discuss this challenge. Please let me know when I could meet with you or your staff. I realize you are not on the B&P Committee or Assembly Health Committee, but knowing that you are aware of this issue, and perhaps can tell some of your colleagues on the Assembly B&P or Assembly Health Committee, our concerns is very helpful. Please help us protect Californian’s health by ensuring continued, good, quality laboratory testing in our great state. Thank you for your service to our community.
Very sincerely yours,
Just click on your legislator and write your email! Thank you in advance for your help. Share with a friend.
President - CAMLT
CAMLT Expand To Excel Update
CAMLT’s Expand to Excel effort to expand training program seats is still alive and well. Originally introduced in late 2020, this effort is a budget item and will add 200 seats to existing training programs.
It is making slow progress, but it will be under consideration in January as part of the new budget. One setback was that it was said that our sector (healthcare) already receives adequate funding. Another angle is to present it as a women’s rights issue. Key people in high places within the legislature are dedicated to this coming to be.
At an upcoming CLTAC meeting (Clinical Laboratory Technology Advisory Committee), the Workforce Subcommittee will present a white paper (explanation and recommendation) on the workforce shortage, to CLTAC. If adopted, it will be presented.
PPA is jockeying to bring the budget item to the forefront of what Governor Newsom will consider. Several key people in Sacramento have been working tirelessly to help further the effort. Let’s hope this important budget item can be realized soon.