Report 2015-507 Recommendation 3 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 #3 To: Public Health, Department of

To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should develop and implement proficiency testing policy and procedures for ensuring that it can promptly identify out-of-state labs that fail proficiency testing.

1-Year Agency Response

Laboratory Field Services (LFS) revised its proficiency testing policies and procedures to ensure that out-of-state laboratories (OOS) proficiency testing results are reviewed twice a year to ensure that laboratories are enrolled in appropriate proficiency testing. The monitoring begins when OOS laboratories submit their annual license renewal, and a follow up review is conducted six months later. In addition, OOS laboratory proficiency testing is reviewed during on-site visits by both LFS and accrediting organizations.

LFS staff was trained on these new proficiency policy and procedures on August 18, 2016.

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

Laboratory Services developed proficiency testing policies for out-of-state labs, which helps ensure it reviews those labs' test results as required. In addition, Laboratory Services has trained its staff on the updated policies.

6-Month Agency Response

The Laboratory Field Services Branch continues to convene work groups to analyze business processes, policies, and procedures to determine efficiencies and reduce redundancies related to out-of-state applications and proficiency testing. This continues to result in changing recommendations that are vetted internally and implemented when appropriate, and will be used to update the policies and procedures as necessary by April 30, 2016 as indicated in the Corrective Action Plan. One of the changes evaluated is how to implement proficiency testing reviews more than one time per year. A Staff Services Analyst (SSA) was hired. The SSA assists the examiners in analyzing the proficiency testing data and make recommendations to the examiner for action, and tracks follow up responses.

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

60-Day Agency Response

LFS work groups continue to review and revise its business processes related to out-of-state proficiency testing (PT). This includes re-assigning clerical support for this activity, and recruiting for a dedicated analyst position to provide analytical support. By assigning administrative tasks to non-Examiners, Examiners will be utilized more efficiently and be able to focus on technical (pass/fail) aspects of PT performance. The analyst will complete statistical reports that will enable LFS to identify labs with unsatisfactory and unsuccessful PT performance for the Examiner's follow-up on laboratory corrective action.

LFS is developing a protocol to select and review out-of-state PT events more frequently than at the annual renewal.

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

The California Department of Public Health has convened work groups to focus on Laboratory Field Services and states it is developing a protocol to review the results from proficiency testing for out-of-state labs.

All Recommendations in 2015-507

Agency responses received are posted verbatim.