September 25, 2015
Area(s) of Interest: Licensing & Regulatory Issues
On September 10, the California Bureau of State Audits issued a report that said the California Department of Public Health's (CDPH) Laboratory Field Services should be eliminated because it duplicates a service provided by the Centers for Medicare and Medicaid Services (CMS).
CMS regulates all human laboratory testing in the U.S. through the Clinical Laboratory Improvement Amendments system. In California, labs must also be licensed through the state's Laboratory Field Services. This dual regulatory system is a huge burden on physician-operated labs in our state, and the California Medical Association has for many years advocated for the elimination of this unnecessary and duplicative licensing system.
In a letter to legislators and the governor, the auditors said the oversight provided by CDPH was “redundant and ineffective,” and that eliminating its laboratory oversight would save labs from unnecessary and duplicative fees and inspections.
The audit also found that not only is the state's laboratory oversight unnecessary and duplicative, but it is also ineffective—only performing half of the required biennial inspections in 2013 and 2014; failing to investigate laboratory-related complaints; and without a process to ensure that it is aware, in a timely manner, when out-of-state labs that are licensed in California fail required proficiency testing.
Read the Auditor’s report here.