Late last year the California State Auditor released a report on the performance of CDPH and Laboratory Field Service in licensing and regulating clinical labs and clinical lab personnel. This was a second audit after a previous review 5 years ago that concluded that there were many problems in the performance of LFS. This second audit suggested serious problems in their licensing and inspection responsibilities including the following;
- LFS has inspected only 50% of the labs on a biannual basis that they are required to inspect
- LFS has no process in place to be aware of out of state labs that fail PT evaluations
- Though state law adopted in 2009 requires LFS to review and provide deemed status to laboratory accrediting bodies they have failed to complete those evaluations. The CAP request for deemed status has been pending since 2011.
- Auditor concluded that LFS has collected more than $12M in lab licensing fees that it has not spent and has overcharged labs by more than $1M.
The Auditor's recommendation was to eliminate separate state licensing and inspection of clinical labs and to rely on the federal requirement for CLIA certification. In reaction to that report Assemblywoman Bonilla ( D-Concord), Chair of the Assembly Business and Professions Committee , has introduced AB 1774 that would eliminate state licensure and fees. Though the Auditor also suggested that clinical lab personnel licensure may be better handled by transferring that function to the Department of Consumer Affairs, AB 1744 would not change current personnel licensing requirements for LFS.
The CSP supports AB 1774 because it would eliminate unnecessary fees for labs and would require that LFS rely on the inspection and accreditation programs utilized by many clinical labs as required under current law. It is incomprehensible that the applications for recognition by both CAP and JCAHO have been pending for years while they have been recognized by CMS and others for many years.
