Report 2015-507 Recommendation 5 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 #5 To: Public Health, Department of

To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should dedicate multiple staff to sanctioning efforts and update its sanctioning policy and procedures, including identifying steps to ensure that labs adhere to sanctions and that it collect civil money penalties. In addition, it should develop a single sanctions tracking system that multiple managers can monitor and that will allow it to periodically reconcile the monetary penalties it receives with Public Health's accounting records.

1-Year Agency Response

Laboratory Field Services (LFS) revised its sanctioning and enforcement policies and procedures and developed a database system to track sanctions. These efforts will help LFS track deficiencies and identify opportunities to impose sanctions, document sanctions imposed and civil money penalty amounts, and document our penalty collection procedure and follow-up policy.

The new tracking system is available and accessible by authorized LFS managers to monitor and track sanctions in process. The On-Site Licensing Section Chief responsible for sanctioning efforts was hired in December 2015.

LFS staff was trained on these revised sanctioning and enforcement policy and procedures on August 18, 2016.

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

Laboratory Services has developed policies to better define its sanctioning and enforcement practices. In addition, it has designated multiple staff roles in these processes and trained the staff to perform these roles.

6-Month Agency Response

The Laboratory Field Services Branch (LFS) continues to convene work groups to analyze business processes, policies and procedures related to the enforcement and civil money penalties policies, including identifying steps to ensure that labs adhere to sanctions and that LFS collects civil money penalties. This continues to result in change recommendations that are vetted internally and implemented when appropriate. LFS will update the policies and procedures as necessary by April 30, 2016 as indicated in the Corrective Action Plan. In addition to the Examiner III, Section Chief hired in December 2015 to coordinate sanctioning efforts and develop the accrediting organization program LFS has met to discuss a systematic, team approach to enforcement, sanctions, and civil money penalties. Draft policies and procedures are being developed. A Staff Services Analyst (SSA) was hired. This SSA provides administrative and analytical support to the examiners, allowing them more time to focus on the technical aspects of laboratory enforcement and sanctioning efforts.

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

60-Day Agency Response

LFS is hiring an Examiner III, who will act as a designated lead for enforcement/civil money penalties and sanctions process. The lead is responsible for coordinating with staff to ensure compliance with sanction efforts, collection of monetary penalties and developing a centralized tracking system to monitor sanctions. In addition, the lead will implement improvements recommended by the LFS consultant who is assigned to research the department's accounting process. LFS work groups continue to review its policies and business processes; and a tracking function will be integrated in the new information systems database for facility and personnel licenses which will assist with crosschecking sanctions and complaints.

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.