CSP Supported Bill to Eliminate State Lab Licensing Moves Forward
The CSP is supporting AB 1774 (Bonilla) that would implement the recommendation of the State Auditor's review of Laboratory Field Services (LFS) performance in the licensing, inspection and regulation of clinical laboratories. Their recommendation was to eliminate separate state licensure of labs and rely on federal CLIA certification. The State Audit, which is a follow-up to a previous audit in 2008, found many areas of failure, poor performance and little improvement. Among its findings;
- LFS is still not performing required oversight activities of clinical labs and its management of its responsibilities is inadequate. It inspects only 50% of the labs that it is required to inspect on a biannual basis and has no system for notification of when a licensed out of state lab fails its required Proficiency Testing.
- It does not investigate complaints against labs and has issued a small number of sanctions in the last 7 years despite overseeing over 22,000 labs, approximately 19,000 are only registered while the rest are licensed.
- It made an unauthorized increase of $1 million in lab fees in 2014 while sitting on a surplus of over $12 million.
- LFS has missed significant opportunities to partner with non-profit accrediting organizations to conduct oversight, perform inspections and monitor proficiency testing. We are aware that two of the accrediting bodies, already recognized for years by CMS for Medicare, one being CAP with an application pending for 4 years and JCAHO for two years. The law passed in 2009 that raised lab licensing fees also required LFS to review and resolve applications by accrediting organizations within six months of application.
AB 1744 does not disrupt current unique California personnel standards or the enforcement of those standards. The specifics of the reform can be debated but it is clear that reform of the current LFS licensing authority is long overdue. AB 1774 passed the Assembly Business and Professions earlier this month on a bipartisan unanimous vote and awaits hearing in the Assembly Appropriations Committee in May. It is too soon to determine if the bill will make it through the process and obviously the Governor and Administration have final say should it reach the Governor's desk. There is clearly an opportunity to improve the regulatory function of LFS and have labs receive value for their fees.
Bill to Expand Direct Access to Lab Services Pulled From Hearing
SB 1418 (Lara) was amended in March to expand the current California law that allows consumers/patients direct access to a limited number of lab tests without the lab requiring physician or other provider referral and order. Current law limits direct access to those tests that are approved by the FDA for over the counter test kits and included pregnancy, glucose level, and occult blood.
SB 1418 would have expanded the ability to any lab test that a lab offers to the general public, require the report of the results go to the person that ordered the test, and include a notice in bold type that it is the responsibility of the patient to arrange with their health care provider for consultation and interpretation of the test results. It would have also exempted the patient's provider for any liability or sanction for failure to review a test that they did not order.
The CSP did not oppose the bill but suggested that the author consider the breath of the tests that could be ordered and the need for more consumer awareness of the types of tests and importance of certain results. We also suggested that any lab offering direct access should be required to enroll in a PT program for any test where a PT program was available. The bill was permissive so any lab was free to offer or not offer tests as they saw fit.
SB 1418 was sponsored by the author but we were aware that Theranos had indicated a desire to amend current law as was done in Arizona last year. SB 1418 was likely to have been amended at its hearing before the Senate Business and Professions Committee based upon recommendations form the Committee consultant. Ultimate the bill was pulled from the hearing and has missed the legislative deadline to move this year. SB 1418 is therefore dead for the year.
AB 2325 to Require Pathologist Reporting to
Ca. Cancer Registry
The CSP is supporting AB 2325 (Bonilla) that would require pathologists to report any cancer diagnosis to the Ca. Cancer Registry (CCR) using an electronic reporting process approved by CCR. The requirement would be triggered on 1/1/19.
The CSP has been actively engaged with the CCR and other stakeholders in the Cancer Data Modernization Consortium that will help develop the use of a standardized synoptic reporting process for use with the CCR. We are focused on the CAP electronic cancer checklist (eCC). The current CCR process has resulted in long delays in the entry of cancer diagnosis and we feel that shifting to the (eCC) process will greatly improve real time reporting and the ability to use that data by treating physicians and researchers. The (eCC) has been piloted in several hospital health systems in California and that experience is being explored by the Consortium.
AB 2325 has passed both the Assembly Health and Appropriations Committee and will be heard on the Assembly Floor in the coming weeks.
|California Society of Pathologists
One Capitol Mall Suite 800
Sacramento, CA 95814
Tel : 916-446-6001
Fax : 916-444-7462