Report 2015-507 Recommendation 10 Responses

Report 2015-507: Follow-Up—California Department of Public Health: Laboratory Field Services Is Unable to Oversee Clinical Laboratories Effectively, but a Feasible Alternative Exists (Release Date: September 2015)

Recommendation #10 To: Public Health, Department of

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.

Annual Follow-Up Agency Response From September 2021

Public Health has completed its work on CLIA Crosswalk Part 2 (DPH-16-002), which retains six sections in California law that are more stringent than CLIA 2003 regulations. The package was approved by the Office of Administrative Law (OAL) on June 11, 2020, and became operative on October 1, 2020, as section 1053 of Title 17 of the California Code of Regulations. This rulemaking action completed the adoption of federal CLIA 2003 regulations into California law.

The large personnel standards package has been broken into eight parts to expedite review. Public Health completed work on the first package for personnel standards and submitted the package to OAL. It was approved on November 12, 2020, and became operative on January 1, 2021, as Article 1 and Article 5.3 of Title 17 of the California Code of Regulations. A second and third package are underway. Public Health planned to submit these packages to OAL by the end of the year, but work on regulations has been interrupted by the redirection of the regulations writing team to full time work on the LFS response to the COVID-19 emergency. Depending on the development of that response, LFS anticipates resuming work on this package as soon as possible.

In addition, LFS is now working on three additional regulation packages for tissue and blood banking, public health laboratories and laboratory personnel, and blood donation centers. All these regulation packages will require the assistance of a health economist to complete the complex fiscal and economic support documents.

California State Auditor's Assessment of Annual Follow-Up Status: Partially Implemented

Annual Follow-Up Agency Response From October 2020

Our previous response submitted on 9/2/20 is still current.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From September 2020

Public Health has completed its work on CLIA Crosswalk Part 2 (DPH-16-002), which retains six sections in California law that are more stringent than CLIA 2003 regulations and has submitted the package to the Office of Administrative Law, where it is under review. If promulgated, this rulemaking action will complete the adoption of federal CLIA 2003 regulations into California law.

The large personnel standards package has been broken into six parts to expedite review. Public Health has completed work on the first package for personnel standards and has submitted the package to the Office of Administrative Law, where it is under review. A second package is underway. Public Health anticipated submitting it to OAL by the end of the year, but work has been interrupted by the redirection of the regulations writing team to work on the LFS response to the COVID-19 emergency. Depending on the development of that response, LFS anticipates resuming work on this package as soon as possible.

In addition, LFS is working on two regulation packages for tissue and blood banking, and public health laboratories and laboratory personnel. The final package relates to blood donation centers. All these regulation packages will require the assistance of a health economist to complete the complex fiscal and economic support documents.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From September 2019

Public Health continues to work on CLIA Crosswalk Part 2 (DPH-16-002), which retains six sections in California law that are more stringent than CLIA 2003 regulations. If promulgated, this rulemaking action will complete the adoption of federal CLIA 2003 regulations into California law.

The large personnel standards package has been broken into six parts to expedite review. In addition, LFS is working on two large and complex packages for tissue and blood banking, and public health laboratories and laboratory personnel. The final package is a small one for blood donation centers. All these regulation packages will require the assistance of a health economist to complete the complex fiscal and economic support documents. LFS is working to contract with an economist to complete these documents, as LFS staff does not have the required economic expertise.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From October 2018

CDPH submitted its last annual follow-up in September 2018. No further changes have been made since the last response. However, CDPH anticipates to fully implement CSA's recommendations by June 2020 as stated in the last response.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From September 2018

Of the seven regulation packages that Laboratory Field Services (LFS) is working on, one (tissue bank - sperm washing) has been completed and went into effect on September 2017. Two are currently under review. One (personnel licensing standards - definitions) has been completed and approved by the Office of the State Public Health Lab Director and the Office of Regulations and was sent to agency on May 25, 2018. The text and ISOR of another package (personnel licensing standards - certified phlebotomists) have been completed and reviewed by center management; when the fiscal documents have been completed the package will be submitted to the Office of Regulations for review in December 2018. Two other packages (personnel licensing standards - licensed personnel and personnel licensing standards - applications and unlicensed personnel) are currently in the process of being drafted. The former package is 60% complete and LFS is in the process of enlisting a consultant to draft fiscal documents. The latter is 20% complete; work has been delayed while the program gathers information about how to integrate the two online licensing systems into draft regulations. Of the two remaining packages: for laboratory licensing - CLIA crosswalk, the Office of Regulations has assigned an attorney and analyst to help LFS draft the text and ISOR. For the tissue bank standards, the LFS regulations team has requested Office of Regulations to assign a regulations attorney and LFS will begin posting for an analyst to help with drafting. One issue that affects all proposed regulation packages is finding someone to conduct the fiscal and economic analysis. The program has contacted someone from UC Davis who has expressed interest in the project and has identified personnel who have a background in both public health and economics. A contract with them should be established this fall.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From September 2017

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.

California State Auditor's Assessment of Annual Follow-Up Status: Partially Implemented

1-Year Agency Response

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.

California State Auditor's Assessment of 1-Year Status: Pending

6-Month Agency Response

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.

California State Auditor's Assessment of 6-Month Status: Pending

60-Day Agency Response

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.

California State Auditor's Assessment of 60-Day Status: Pending

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.

All Recommendations in 2015-507

Agency responses received are posted verbatim.