California Bill Revamps Regulation of Clinical Laboratories

A bill is pending in the California Legislature that would take the licensing and inspection of clinical laboratories away from state regulators if signed into law.

Authored by Assemblywoman Susan Bonilla, a Democrat from the Northern California city of Concord, the bill would strip laboratory licensing from the California Department of Public Health (CDPH), the primary regulator in the state for both hospitals and laboratories. Licensure is required from that agency if a lab is performing tests that are considered moderate or high complexity. The CDPH also collects fees for various inspections, which range from $25 for a clinical laboratory scientist’s license renewal to $5,260 to relicense a lab that is performing more than one million tests annually. Bonilla’s office was not immediately available for comment on the bill.If the bill becomes law, the duties for inspection and enforcement would likely be transferred to the Centers for Medicare & Medicaid Services (CMS), which was given the authority under the Clinical Laboratory Improvement Amendments (CLIA) passed in the 1980s.

The CDPH has come under scrutiny in recent years for personnel shortages, particularly in its hospital division. Fines and administrative penalties against acute care facilities have dropped in recent years, although the agency has recently made new hires of dozens of inspectors in Los Angeles County, the state’s most populous county by a wide margin, CDPH officials said. CDPH also recently approved the use of private non-profit organizations to approve a lab’s ongoing deemed status after their initial licensure. The state’s primary lobbying group for laboratories has yet to take a position on the bill, which was introduced last month. Michael Arnold, executive director of the California Clinical Laboratory Association, said it is currently in a “watch position” on the measure, and that its position would evolve after an initial public hearing.

“We are working with the author. There are amendments being discussed,” Arnold said. He added that “there is considerable opposition (to the bill) from employee organizations representing clinical lab scientists and others.” The bill’s first committee hearing is scheduled for April 19.

Takeaway: California could take actions to delegate laboratory licensure and inspections back to the federal government.


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