SB 622 (Hernandez), Optometry
AB 1418 (Lara), Clinical Laboratory Testing
AB 1774 (Bonilla), Clinical Laboratories: Facilities Licensing
AB 757 (Gomez), Healing Arts: Clinical Laboratories
AB 940 (Ridley-Thomas and Waldron), Clinical Laboratories
SB 75 (CDPH), Clinical Laboratories: EQC and IQCP
Membership Involvement is the Key
Start here to find your legislators: http://www.legislature.ca.gov/
CAMLT Political Update
Public Policy Advocates, LLC, Fall 2016
The California Legislature’s final day and night of the 2015-2016 two-year legislative session ended August 31. The final gavel fell sine die on the session after the introduction of over 5000 proposed laws, resolutions and constitutional amendments. In the last month of the session, the legislature sent over 700 bills to the Governor. He had until September 30 to sign or veto. The PPA/CAMLT agenda was dominated by optometrists wanting to expand their scope of practice to, among other things, order and perform waived lab tests without a lab director; Theranos wanting to allow anyone to obtain any test and test result without physician’s order; a key legislator wanting to dismantle Lab Field Services (with the unintended consequence to water down or eliminate lab personnel standards) because, while LFS is sitting on $12 M in licensing fees, according to the State Auditor General, it is not carrying out its inspection mandates; and Grifols and plasma centers wanting non-qualified personnel to do moderate complexity testing on plasma using the Reichert Protein Analyzer. PPA thwarted these attempts. Without CAMLT, there could/would have been different outcomes. In addition, PPA monitored a cross-section of bills from nursing to HIV; from bioanalysts to clinical laboratories to reciprocity.
This session was not unlike every other over the 20 plus years that we have represented CAMLT. Though California requires higher laboratory personnel standards and requires licensing, every legislative session is marked by other allied health professions trying to expand their scope of practice to perform laboratory tests without the requisite education or lab director—pharmacists, primary care clinics, naturopaths, optometrists and chiropractors for starters. Without CAMLT, these many attempts to dilute or repeal laboratory and laboratory personnel licensing law would have succeeded.
The new era of term limits began to take shape. In 2012, voters agreed to relax term limits to allow up to 12 years in either house of the legislature. These new lawmakers have become a major force. The longer terms mean that legislators can stay engaged in driving how policy turns out. Assembly Speaker Rendon (D-Paramount) has the potential of serving longer than any speaker in the last 20 years—since Willie Brown who served as Speaker for 14 years. However, with this being an election year, at least 14 Assembly Members and six Senators are termed out. With the election of new legislators, we always see new legislation carried to dilute California laboratory law. And we can well assume that the optometrists will be back next year.
What does this all mean for CAMLT? For more than 50 years, CAMLT has successfully defended laboratory standards to protect patients as others have tried to convince legislators to dilute licensing and personnel standards. CAMLT membership is critical. CAMLT must be strong financially and in membership numbers to effectively execute a legislative program and to educate key legislators and government officials. CAMLT is the only professional organization that exclusively protects the legislative interests of CLSs, MLTs, CPTs and other laboratory personnel in the best interest of the patient and in the best interest of the laboratory profession. It is the only professional association representing clinical laboratory science personnel that retains a lobbying firm in Sacramento to be the voice for clinical laboratory personnel in Sacramento before the legislature and state government. If CAMLT does not grow its membership or raise the necessary revenue to support its legislative program, there will be no legislative program to protect the profession and the patients it serves.
Organized labor has been extremely helpful in the past. But labor unions also represent chiropractors, optometrists, and pharmacists in addition to CLSs---the very professions at the forefront of diluting California laboratory law. So Labor has not been in a position to take these other professions head on when they want to expand their scopes into clinical laboratory science. This has now fallen almost exclusively to CAMLT to protect. Other laboratory personnel professional associations may provide continuing education, certification, or fellowship—but none have a Sacramento presence or help to underwrite CAMLT’s governmental representation on behalf of the entire profession. The clinical laboratory profession must come together to unify and shore up its efforts to support CAMLT’s legislative and political agenda if it wants to preserve its profession—not tomorrow, but now.
Longer term limits afford CAMLT grass roots the opportunity to build champions in the legislature who know and understand the importance of California’s patient protections in California law. But legislators and their staff must be educated. The clinical laboratory profession must come together to unify and shore up its efforts to support CAMLT’s legislative and political agenda if it wants to preserve its profession and protect patients. This includes building a strong grass roots network that meets with legislators and a strong LAB-PAC.
RECRUIT NEW CAMLT MEMBERS! CONTRIBUTE TO LAB-PAC!
Recent legislative sessions have been very rigorous and active in terms of bills legislating a frontal attack on the CLS, MLT and CPT professions, depleting CAMLT resources. Only you can ensure the growth and vibrancy of a strong, well organized CAMLT. Rise to the challenge. Recruit members to your professional organization —CAMLT. Contribute to your LAB-PAC. Meet with your legislators. Ensure the best possible patient safety in laboratory testing, and preserve your important profession.
The following is key legislation that PPA tracked or lobbied on behalf of CAMLT for the 2015-2016 session. Check below for updates on bill status, Legislator lists, and Committee assignments.
AB 1774 (Bonilla), Clinical Laboratories: Facilities, as amended 5/11/16 - OPPOSE UNLESS AMENDED
- This bill repeals the requirements for a clinical laboratory to be licensed or registered by LFS, including the licensing fee
- If lab facilities are not licensed by the state, LFS cannot effectively hold the owners and lab directors responsible for violations of California lab laws including the hiring of unlicensed personnel to perform laboratory testing
Current law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. AB 1774 would repeal the laws regarding requiring a clinical laboratory to be licensed and inspected by laboratory field services, including the licensing fee. PPA worked with the Author and staff seeking three specific amendments, viewing this measure as “throwing the baby out with the bath water.” The Author took two of the three amendments. We remained opposed unless amended, while we continued to address the third desired amendment. AB 1774 passed its policy committee hearing and was referred to the Assembly Appropriations committee, where it was sent to the Appropriations Suspense File. The bill did not advance out of committee .
AB 599 (Bonilla), Clinical Laboratories: Cytotechnologists, as amended 8/24/15 – NEUTRAL/WATCH
This bill, co-sponsored by the California Association of Cytotechnologists and the California Society of Pathologists, authorized a licensed cytotechnologist to perform all tests and procedures pertaining to cytology, including, but not limited to, microscopic and nonmicroscopic methodologies and tests and procedures that utilize molecular or genetic methodologies as well as other methodologies and diagnosis, under the overall operation and administration of a laboratory director “who shall be a qualified pathologist.” This bill also requires that tests or procedures performed by a licensed cytotechnologist shall be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology. The Governor signed this measure.
AB 757 (Gomez), Healing Arts: Clinical Laboratories, as amended 6/22/15 — OPPOSE
AB 757 is sponsored by Grifols, Inc., the laboratory instrument manufacturer of the Reichert Protein analyzer and the plasma centers and would let non-qualified personnel do moderate complexity testing with regard to plasma. AB 757 would allow lesser trained and educated persons than currently permitted by law to perform a total protein refractometer analysis, categorized as a moderately complex test by the Food and Drug Administration, in a licensed plasma collection facility. If the protein refractometer test and/or calibration is done incorrectly there is potential to cause donor harm. While AB 757 passed both Houses of the Legislature, the Governor vetoed this measure due to concerns that the standards outlined in the bill for persons to perform this test does not ensure the health and safety of plasma donors.
AB 940 (Ridley-Thomas and Waldron), Clinical Laboratories, as amended 8/20/2015—WATCH
According to the sponsor, the California Clinical Laboratory Association, AB 940 is intended to allow for Co-Directors of high complexity laboratories, an applicant for bioanalyst, to obtain out of state training, create embryology and biochemical genetics licensure categories, allow the Department of Public Health to issue licenses for clinical embryologist and clinical biochemical geneticist, and allow the Department of Public Health to charge a fee for the licensing of clinical embryologist, clinical biochemical geneticist, clinical cytogeneticist or clinical molecular biologist. AB 940 amends the definition of laboratory director to clarify that the laboratory director on the laboratory’s CLIA certificate meets the qualifications under CLIA for the type and complexity of tests being offered by the laboratory and also amends the definition of laboratory director to allow a scientist, licensed under state law to direct a laboratory performing high complexity tests, such as a bioanalyst, to become a co-director of a laboratory performing high complexity tests without having to meet the CLIA requirements. A licensed bioanalyst, if qualified under CLIA, may act as a CLIA laboratory director or as a co-laboratory director, deletes the two new license categories of reproductive biology and biochemical genetics, renames the license for clinical molecular biologist to the license for clinical genetic molecular biologist, and makes other conforming changes. According to the sponsor “this bill will reestablish a true career ladder in the California clinical laboratory field.” The Governor signed this measure.
SB 75 (CDPH), Clinical Laboratories: EQC and IQCP, as amended 6/16/15 – SUPPORT
California Clinical Laboratories are regulated under federal law, CLIA and CDPH pursuant to Business and Professions Code Section 1200 et. seq. For more than a decade, CDPH has allowed California laboratories to utilize federally approved alternative QC programs such as Equivalent Quality Control (EQC) and Individualized Quality Control Plan (IQCP) in lieu of default QC to meet certain quality standards when performing laboratory tests. However, CDPH recently conducted a review of federal regulations and state statutes and determined that EQC and IQCP may not be authorized under California law. Stakeholders have requested state law be amended to allow for EQC to be used until December 31, 2015 and begin use of IQCP as of January 1, 2016. This proposed CDPH Budget Item is part of the May Revise of the state budget and was heard May 21 in the Senate Budget and Fiscal Review Subcommittee #3 on Health and Human Services. Governor Brown signed the budget and this related bill on June 24, effective date was January 1, 2015.
AB 1939 (Patterson), Licensing Requirements, as amended 4/12/16 – WATCH/MONITOR FOR AMENDMENTS
AB 1939 while not directed at licensed laboratory personnel, it gets at the principle that reciprocity from other states should be allowed. While this may be acceptable for other licensed entities, it is not for CLSs, MLTs or CPTs. This measure initially would have required the Director of the Department of Consumer Affairs (DCA) to conduct a study on whether occupational licensing requirements create an unnecessary barrier to labor entry and labor mobility, particularly for dislocated workers, service members and military spouses, but the author agreed to take an amendment putting the Legislative Analyst’s Office in charge of the study. The study would then be submitted to the Legislature as well as the DCA. Since there is movement in this area, AB 1939 was monitored closely. AB 1939 was sponsored by its author. AB 1939 was held in Assembly Appropriations, did not advance out of committee.
SB 622 (Hernandez), Optometry, as amended 6/22/16 – NEUTRAL
- Amends the current language with regard to diabetes testing to allow optometrists to collect blood specimen by the finger prick method
SB 622 was initially introduced as a vocational nursing bill, and was amended to deal with optometry and scope of practice expansion. Similar to SB 492 (Hernandez) which died on the Assembly Floor last session, SB 622, if passed, would expand the scope of practice for optometrists to include expanded ability to order and perform the Clinical Laboratory Improvement Amendments (CLIA) waived tests, use noninvasive, nonsurgical technology to treat a condition authorized by the Optometric Act, perform laser and minor procedures, and administer certain vaccines. This bill was amended on June 22, 2016 to return it to existing law with regard to clinical laboratory testing. At which time, CAMLT removed its opposition and changed its position to neutral. SB 622 was scheduled to be heard in the Assembly Business and Professions Committee on June 28 but was canceled at the request of the author and subsequently died.
AB 1418 (Lara), Clinical Laboratory Testing, as amended 4/13/16 – OPPOSE
- Would allow persons to order any laboratory test on themselves without a health care provider’s request on a direct access basis
- Test results will not be interpreted by a health care provider or considered along with clinical history that may lead to misinterpretation, misdiagnosis or even death
Existing law authorizes a person to request, and a licensed clinical laboratory or public health laboratory to perform specified clinical laboratory tests, including pregnancy, glucose level, cholesterol, and occult blood tests, as well as authorize a registered clinical laboratory to perform these tests if the test is subject to a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 and the laboratory has registered with the State Department of Public Health. SB 1418 would have repealed those provisions and allowed a person to request, and a licensed clinical laboratory or public health laboratory to perform, any laboratory test that the laboratory offers to the public on a direct access basis without a health care provider’s request. SB 1418 was sponsored by Theranos. SB 1418 was set to be heard in the Senate Business and Professions committee on 4/18/16, but after the urging from CAMLT, was pulled at the request of the author..
Have You Met with Your Legislators? If Not, Why Not?
For the last fifty years, CAMLT has continued to successfully weather advertent or inadvertent legislative assaults on clinical laboratory testing that would jeopardize patient safety, but these assaults continue. It is critical that CAMLT build its membership and engage with and educate California's elected officials. Legislators are eligible to serve up to 12 years under our new term limit law. It is imperative to build "legislative champions" for clinical laboratory science and the patients who rely on educated, qualified laboratory personnel for accurate and reliable testing results.
Have you met with your legislators? They are at home in their districts until January. Make sure to educate your elected officials about clinical laboratory issues! Meet with your legislators in your district, send letters explaining CAMLT's philosophy, invite legislators and their staff to tour your laboratories, and introduce yourself as a constituent. The sponsors of legislation, such as optometrists and chiropractors, to expand their scope of practice into areas of clinical laboratory testing are well heeled and well organized. It is imperative that CAMLT members engage in the process that affects the laboratory profession.
- Which Legislator represents your home or laboratory? Visit the current roster below of Legislators and the cities they represent.
- Visit their offices. Make an appointment with your Legislators’ District offices.
- EDUCATE! Explain to Legislators and their consultants what it takes to be a CLS, MLT or CPT; what you do; why it is important to maintain the integrity of the Laboratory Director when other personnel are doing laboratory tests, even if they are waived; why other allied health providers shouldn't be Laboratory Directors; the laboratory personnel shortage and what it takes to eliminate it.
Make it a priority to meet with your Legislators. Remember, these interactions are integral components of your grassroots program. For tips, please refer to the CAMLT Grassroots Guide on this website.
Laboratory Brochure for Legislators Now Available
CAMLT has developed an attractive tri-fold brochure which is now available to members and others for use in explaining the Laboratory profession to Legislators. This brochure is appropriate to use to describe the role of the clinical laboratory in the delivery of quality of healthcare. This brochure can be downloaded and printed by you or ordered directly from CAMLT (email: email@example.com) to hand out to legislators or their staff when you meet with them.
Please note that it is particularly crucial to meet with Legislators who participate on the Assembly and Senate committees through which CAMLT bills most frequently pass so they are better prepared to tackle complex laboratory issues that arise in committee.
Assembly Business, Professions and Consumer Protection Committee: Susan Bonilla (D-Chair), Brian Jones (R-Vice Chair), Catharine Baker (R),Richard Bloom (D), Nora Campos (D), Ling Ling Chang (R), Bill Dodd (D), Susan Talamantes Eggman (D), Mike Gatto (D), Chris Holden (D), Kevin Mullin (D), Phillip Ting (D), Scott Wilk (R), Jim Wood (D)
Assembly Health Committee: Bob Bonta (D-Chair), Brian Maienschein (R-Vice Chair), Susan Bonilla (D), Autumn Burke (D), Rocky Chavez (R), David Chiu (D), Jimmy Gomez (D), Lorena Gonzalez D), Roger Hernandez (D), Tom Lackey (R), Adrin Nazarian (D), Jim Patterson (R), Sebastian Ridley-Thomas (D), Freddie Rodriguez (D), Miguel Santiago (D), Marc Steinorth (R), Tony Thurmond (D), Marie Waldron (R), Jim Wood (D)
Senate Business, Professions and Economic Development Committee: Jerry Hill (D-Chair), Pat Bates (R-Vice Chair), Tom Berryhill (R), Marty Block (D), Cathleen Galgiani (D), Ed Hernandez (D), Hannah-Beth Jackson (D), Tony Mendoza (D) Bob Wieckowski (D)
Senate Health Committee: Ed Hernandez (D-Chair), Janet Nguyen (R-Vice Chair), Isadore Hall (D), Holly Mitchell (D), Bill Monning (D), Jim Nielsen (R), Richard Pan (D), Richard Roth (D), Lois Wolk (D)
Below are the Legislators for the 2015-2016 Legislative Session:
Senator and Cities Represented by District:
Assembly Member and Cities Represented by District
Strengthen Your Voice: Contribute Today!
Please donate to the CAMLT Lab-PAC fund. Lab-PAC is a critical means of supporting and electing Legislators to the California Legislature who share a like-minded philosophy with CAMLT and who are open-minded to learning the issues and challenges facing your profession. Encourage the colleagues you work with. Get your chapters and chapter members to contribute. Talk to your vendors. Get involved! Your voice in the political process is much louder as CAMLT than as an individual. Contribute to the collective resources of CAMLT to grow your political clout. Visit the Lab-PAC page to donate online or for a donation form. Your gift in any amount will help your profession. Contribute now!
Please mail donations made payable to:
39656 Mission Blvd., Fremont, CA 94539-1766
Please write a check to LAB-PAC or donate online now!
Recruit New CAMLT Members!
This has been a very rigorous and active legislative session in terms of bills legislating a frontal attack on the laboratory profession. Only you can ensure the growth and vibrancy or a strong, well organized CAMLT. Rise to the challenge. Recruit members to your professional organization - CAMLT. Contribute to your Lab-PAC. Meet with your legislators.
Ensure the best possible patient safety in laboratory testing, and preserve your important profession.