Report 2007-040 Recommendation 3 Responses

Report 2007-040: Department of Public Health: Laboratory Field Services' Lack of Clinical Laboratory Oversight Places the Public at Risk (Release Date: September 2008)

Recommendation #3 To: Public Health, Department of

This recommendation has been superseded by a recommendation from a subsequent report. See 2015-507 #10.

To update its regulations, Laboratory Services should review its clinical laboratory regulations and repeal or revise them as necessary. As part of its efforts to revise regulations, Laboratory Services should ensure that the regulations include requirements such as time frames it wants to impose on the laboratory community.

Annual Follow-Up Agency Response From September 2016

To ensure that Laboratory Field Services (LFS) develops regulations as necessary, Public Health dedicated staff in LFS and Public Health'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 suggestion to proposed regulations to CLTAC and LFS. Public Health 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to make progress on addressing regulation packages noted in the audit report and has completed actions to repeal outdated state regulations, and developed internal controls to improve and maintain its tracking and monitoring of LFS regulatory needs.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, Public Health 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.

California State Auditor's Assessment of Annual Follow-Up Status: See 2015-507 #10 for the most current assessment

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

Laboratory Field Services (LFS) continues to review its clinical laboratory regulations and repeal or revise them as necessary. In September 2010, LFS issued draft personnel certification regulations and is revising the draft based on the 15,000 public comments we received. LFS expects to reissue the revised regulations in spring 2014. LFS has also drafted regulations for sperm washing. LFS will draft an additional regulation package for new license categories for clinical biochemists and endocrinologists when the current personnel certification regulation package has been adopted in 2014.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2012

LFS continues to review its clinical laboratory regulations and repeal or revise them as necessary. In September 2010, LFS issued draft revised personnel certification regulations and is revising the draft based on the 15,000 public comments we received. LFS expects to reissue the revised regulations in spring 2013. We anticipate drafting additional regulation packages for new license categories such as Clinical Biochemist when the current personnel regulation package has been adopted.

In 2009, SB 744 (Strickland, Chapter 201, Statutes of 2009), authorized a sliding fee schedule for laboratory license fees based on the volume of testing performed by a laboratory and increased the registration fee for registered laboratories. SB 744 increased funding and improved LFS efficiency to allow better enforcement of clinical laboratory standards. LFS will continue to use a portion of the $3.5 million generated by SB 744 to fund additional legal staff to review regulations.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

All Recommendations in 2007-040

Agency responses received after June 2013 are posted verbatim.