The CSP supported 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.
The CSP participated in multiple meetings with the author and other lab organizations. Though AB 1774 passed the Assembly Business and Professions Committee on a unanimous vote of 18-0 it was held in the Assembly Appropriations Committee based upon the impact on state revenues and not a vote on the merits. Some lab organizations and the unions that represent lab personnel continued to question the wisdom of removing state licensing even though LFS could continue to inspect or investigate any clinical laboratory based upon a complaint.
What has happened in the last month is that LFS has finally approved or given deemed status to two important accrediting organizations, both the CAP and JCAHO. Both have waited years for approval and now join COLA as approved accrediting organizations. A lab can now indicate accreditation by any of these entities on their license renewals and not be subject to routine inspections by LFS. LFS can still inspect upon complaint or do validation surveys. Here is a link to the all laboratories letter from LFS that provides all the details.
There are also likely more changes to be made by LFS as they attempt to address the recommendations for change made by the State Auditor. Some of those include an evaluation of current state license fees with hopeful reductions to be forthcoming. The Auditor found that LFS overcharged labs by $1M in 2014. LFS has also tried to ramp up their regulatory overhaul on lab personnel standards which again have been languishing for many years. We will continue to engage in the reform process.