To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should update and develop its regulations as necessary to ensure consistency with existing state law.
LFS continues to meet regularly with the Clinical Laboratory Technical Advisory Committee (CLTAC) regulations sub-committee to review regulation packages to provide feedback to LFS. The sub-committee met 16 times in State Fiscal Year (SFY) 2016/17.
During SFY 16/17, in partnership with the Office of Legal Service and the Office of Regulations, LFS has completed an additional two regulation packages: "1050 Repeal Part 1", and one related to establishing a, "CLIA Crosswalk, Part 1". In July, 2017, "1050 Repeal Part 2" was completed. In addition, the Tissue Bank "Sperm Washing" package is in the public comment period, which ends on September 5, 2017.
To date, LFS has one facilities-related regulation package remaining to be completed, one tissue bank-related regulations package, and the four personnel licensing regulations packages.
To ensure that Laboratory Field Services (LFS) develops regulations as necessary, the department dedicated staff in LFS and the department's Office of Legal Services to coordinate and work on regulatory needs for LFS. To ensure local stakeholder feedback is received and considered on regulation needs and changes, the Clinical Laboratory Technical Advisory Committee (CLTAC) organized a separate subcommittee to review regulation packages and provide feedback to LFS. The subcommittee met over 12 times in State Fiscal Year 2015/2016 and has provided comments and suggestions to proposed regulations to CLTAC and LFS.
The department continues to make progress on addressing regulation packages noted in the audit report and has completed actions to repeal outdated state regulations, and developed internal controls to improve and maintain its tracking and monitoring of LFS regulatory needs. In addition, the department has split the Clinical Laboratory Personnel Standards regulation package into four separate packages in order to minimize the complexity of the package to ensure better stakeholder engagement and to ensure that forward momentum on completing the packages can continue.
LFS and legal staff have formalized an interactive process to identify regulation needs by organizing a separate CLTAC subcommittee representative of stakeholders specific to LFS regulations to provide feedback to LFS during the regulations process. The regulations process team consisting of staff from CDPH Budget, OLS, and LFS met February 3, 2015 to discuss tissue bank regulations.
Laboratory Field Services (LFS) is working with Department's Office of Legal Services (OLS) to provide staff for all outstanding regulation needs. In June 2015, one attorney was hired to specifically work on regulation packages for LFS, and one additional attorney serves as LFS in house counsel who is also working on regulation packages as of August 2015.
Working internally, with staff in LFS, legal staff and staff dedicated to regulations, CDPH has continued its collaborative efforts to develop, monitor and promulgate LFS's regulation packages through the rulemaking process. Two CDPH attorneys, in coordination with LFS, are dedicated to LFS to draft the regulation documents. LFS and legal staff are researching methods to formalize an interactive process to identify regulation needs. Ongoing completion of numerous regulations packages will be completed over the next few years. CDPH expects the final filing for the last scheduled regulations package to be complete by January 1, 2019.
The California Department of Public Health (Public Health)'s response discusses various plans for taking corrective action. We will re-evaluate the status of this recommendation once Public Health substantiates the steps it has actually taken.
Agency responses received are posted verbatim.