Figure 1

Figure 1 is a partial organization chart, current as of February 2015, which describes the functions three of Laboratory Services’ sections perform. It shows that the Office of the State Public Health Laboratory Director oversees the Chief of Laboratory Services who is in charge of two facility-licensing sections. The first facility licensing section is located in Richmond. It licenses, registers, and inspects labs; monitors labs’ proficiency testing results; receives and investigates complaints against labs; and sanctions labs. The second facility licensing section is located in Los Angeles. It inspects labs and investigates complaints against labs. Last, the CLIA Section, CLIA stands for Clinical Laboratory Improvement Amendments of 1988, is located in the Los Angeles office. The CLIA Section acts as an agent of the federal Centers for Medicare and Medicaid Services by enforcing CLIA which is federal clinical laboratory law. The CLIA Section’s responsibilities include certifying and inspecting labs; monitoring labs’ proficiency testing results; and investigating complaints against labs.

Figure 2

Figure 2 is a venn diagram that shows federal oversight over labs performing simple and complex tests. The requirements both types of labs are subject to are biennially renewing their certificates and paying a fee, complaints investigations, and sanctions. Labs performing complex tests are also subject to biennial inspections and proficiency testing. The Centers for Medicare and Medicaid Services, CMS for short, through its state agents, oversees both types of labs. Labs performing complex tests may choose to be overseen by CMS or a private, non-profit accreditation organization.

Figure 3

Figure 3, a flowchart showing federal and state oversight of nonaccredited and accredited labs in California that perform complex tests. One side of the flowchart shows Federal oversight consisting of the Centers for Medicare and Medicaid Services, CMS for short, overseeing the implementation of the Clinical Laboratory Improvement Amendments of 1988, also known as CLIA. To do this, CMS contracts with and monitors the California Department of Public Health’s Laboratory Services which oversees nonaccredited labs. Within Laboratory Services, the CLIA Section is responsible for ensuring that nonaccredited labs in California comply with CLIA requirements. CMS also approves and reauthorizes private, non-profit accreditation organizations which oversee accredited laboratories. Laboratory Services’ CLIA Section performs an additional function for CMS by monitoring the private, non-profit organizations’ implementation of CLIA. The other side of the flowchart shows state oversight consisting of Laboratory Services implementing state oversight requirements on nonaccredited and accredited labs.

Figure 4

Figure 4, is a bar chart showing the estimated percentages of lab inspections that Laboratory Services achieved for calendar years 2013 and 2014. For calendar year 2013, only 55 percent of labs requiring a biennial inspection received that inspection. 2013 is broken into three bars, one bar each for out-of-state labs, in-state accredited labs, and in-state nonaccredited labs. For 2013 zero out-of-state labs received a biennial inspection, and 90 in-state accredited labs received an inspection or approximately 13 percent of in-state accredited labs requiring an inspection. The third bar shows in-state nonacrredited lab inspections; the CLIA Section generally performs these inspections. However, Laboratory Services counts these inspections because it has the CLIA Section include some state criteria in the inspection to satisfy state requirements. The bar shows that 694 in-state nonaccredited labs received an inspection or roughly 99 percent of in-state nonaccredited labs requiring a biennial inspection.

For calendar year 2014, only 48 percent of labs requiring a biennial inspection received that inspection; down from 55 percent for 2013. The 2014 inspection data is also broken into three bars. Five out-of-state labs received a biennial inspection or approximately 7 percent of all out-of-state labs requiring an inspection. 113 or roughly 17 percent of the in-state accredited labs requiring an inspection received one. By counting inspections of in-state nonaccredited labs the CLIA Section performs, 577 in-state nonaccredited labs or about 83 percent of these labs requiting an inspection received one.

Figure 5

Figure 5 is a line graph that shows Laboratory Field Services’ facilities revenues, facilities expenditures, and ending fund balances for fiscal years 2008-09 through 2013-14. It shows that revenues exceeded expenditures for each of these fiscal years. For fiscal year 2013-14, facilities revenue is roughly $6.0 million and expenditures are roughly $3 million. The third line shows fund balance on a steep incline increasing by $12.5 million between fiscal year 2008-09 and 2013-14.

Figure 6

Figure 6, shows that state and federal oversight requirements for in-state lab and out-of-state labs are redundant. State and federal oversight requirements include inspecting labs biennially, monitoring proficiency testing results, investigating complaints and issuing sanctions.