AB 2107: Clinical laboratory technology: remote review.

Existing law requires the State Department of Public Health to license, inspect, and regulate clinical laboratories and specified clinical laboratory personnel. Existing law requires a clinical laboratory, as defined, performing clinical laboratory tests or examinations classified as of moderate or of high complexity under the federal Clinical Laboratory Improvement Amendments (CLIA) to obtain a clinical laboratory license, as specified. Existing law requires a separate license or registration to be obtained for each laboratory location, except for, among other things, laboratories that are not at a fixed location, as specified.

This bill would authorize, upon determination by the department that the authorization conforms to federal law, practice by a pathologist who is performing pathology services at a primary laboratory site licensed by the state to review digital materials, as defined, at a remote location under a primary sites CLIA certificate. The bill would require the department, on or before June 30, 2025, to consult with the federal Centers for Medicare and Medicaid Services and would require the department to make a determination on or before January 1, 2026, for those purposes. This bill would require the department, if it determines that the authorization conforms to federal law, to communicate its determination to the Legislature and the Legislative Counsel Bureau. The bill would classify a location where digital materials are accessed by pathologists through virtual private networks, or other secure method, to be an extension of a primary sites CLIA certificate and would prohibit that remote location from requiring a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, as specified.