Clinical laboratories.

(1) Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health and makes a violation of those provisions a crime. Existing law requires the department to deem certain laboratories accredited by private, nonprofit organizations as meeting state licensure or registration requirements if certain conditions are met. Under existing law, the private, nonprofit organization must, among other things, be approved by the Health Care Financing Administration (HCFA) of the federal Department of Health and Human Services and must be approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure or registration. The laboratory must meet the accreditation standards of that organization and must agree to permit the organization to provide records or other information to the department. This bill would require the private, nonprofit organization to be approved by the federal Center for Medicare and Medicaid Services instead of HCFA, to conduct inspections of clinical laboratories in a manner that will determine compliance with existing law, as specified, and to provide the department with additional information including, among other things, a detailed description of the inspection process and a description of the process for monitoring proficiency testing performance. The bill would require the organization to be approved by the department as meeting these requirements and would require the department to begin accepting applications for approval by January 1, 2011. The bill would also require the laboratory to meet additional conditions, including authorizing the private, nonprofit organization to release specified proficiency testing results and notification of condition-level requirement violations or withdrawal of laboratory accreditation. The bill would prohibit the department from conducting routine inspections of laboratories receiving a certificate pursuant to these provisions. Existing law specifies various fees applicable to clinical laboratories and laboratory personnel and requires the deposit of those fees in the Clinical Laboratory Improvement Fund. Existing law requires that, upon appropriation, moneys deposited in that fund be expended by the department to administer these provisions. Existing law requires the issuance of a separate license for each laboratory location, except as specified. Among other entities, not-for-profit, or federal, state, or local government laboratories engaging in limited public health testing are authorized to apply for a single license or registration, as specified. This bill would impose a fee for approval of each of those laboratories and would increase certain other fees applicable to laboratories and laboratory personnel. The bill would prohibit the fees imposed from exceeding the costs incurred by the department in regulating clinical laboratories and their personnel. The bill would require all interest earned on moneys deposited in the Clinical Laboratory Improvement Fund to be maintained in the fund and would prohibit the redirection of moneys in the fund for any other purpose. The bill would require the department to report to the Legislature by July 1, 2013, on the extent to which the state clinical laboratory oversight program meets or exceeds federal standards, the extent to which the federal government is accepting exemption applications from states relative to federal CLIA oversight, and the potential cost to the state for an exemption. Existing law provides for the renewal of a clinical laboratory license or registration and requires that the renewal fee be paid during the 30-day period before the expiration of the license or registration. Existing law specifies that failure to pay the renewal fee results in forfeiture of the license or registration after a period of 60 days from the expiration date. This bill would require a licensee or registrant that fails to renew a license or registration before the expiration date to pay a specified delinquency fee for up to 60 days after the expiration date, in addition to the renewal fee. (2) This bill would declare that it is to take effect immediately as an urgency statute.