Report 2015-507 Recommendation 2 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 #2 To: Public Health, Department of

To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should inspect all in-state and out-of-state labs it has licensed every two years.

Annual Follow-Up Agency Response From September 2017

LFS has completed 100% of surveys for in-state clinical laboratories requiring routine, biennial surveys. As of June, 2017, 2,476 in-state clinical laboratories required routine, biennial surveys. Of this number, 1,120 were the responsibility of an Accrediting Organization (AO), 48 were the responsibility of LFS' On-site Licensing Section, and 1,308 were the responsibility of LFS' CLIA section. As of June, 2017, all required in-state clinical laboratory surveys have been completed.

LFS has completed 94% of surveys for United States (US)-based out-of-state clinical laboratories requiring routine, biennial surveys. As of August, 2017, 472 US-based out-of-state clinical laboratories required routine, biennial surveys. Of this number, 335 were the responsibility of an AO, and 137 were the responsibility of LFS' On-site Licensing Section. The AOs have completed their surveys. LFS has only 20 US-based out-of-state laboratories remaining to survey.

LFS has nine clinical laboratories located outside the US, termed "out-of-country labs". Of these nine, six are accredited. LFS has responsibility for the three facilities not accredited. None of these "out-of-country" laboratories have been surveyed to date.

Overall, through August, 2017, LFS has completed 99% of the required, biennial surveys.

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

LFS has demonstrated that it has implemented necessary processes, including a robust monitoring mechanism, to inspect all in-state and out-of-state labs as it is required.

1-Year Agency Response

To assist with performing inspections, Laboratory Field Services (LFS) approved two additional Accreditation Organizations (AO) applications during State Fiscal Year (SFY) 2015/2016. As of September 2016, of the 2,688 licensed facilities that require biennial inspections, 1,234 are now AO certified, reducing the number of in-state and out-of-state inspections LFS will be required to perform in SFY 2016/2017. LFS also continues to work closely with the Department's Human Resources Branch to fill vacant positions, including examiners.

In SFY 2015/2016, 1,274 of California clinical laboratories required routine in-state inspections; of these, 1, 020 (80%) were performed. COLA, a Public Health approved Accrediting Organization (AO) for clinical laboratories, completed 187 inspections. LFS Clinical Laboratory Improvement Amendments (CLIA) Section completed 652 surveys that were both state licensing and CLIA inspections. LFS On-Site Licensing Section performed 181 inspections. Additionally, 30 out-of-state labs were inspected, LFS inspected 26 and COLA inspected 4.

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

6-Month Agency Response

The Laboratory Field Services Branch (LFS) continues to analyze business processes, policies, and procedures to determine efficiencies and reduce redundancies. This continues to result in change recommendations that are vetted internally and implemented when appropriate. Some preliminary changes are revised licensing application forms, form availability on website, and FAQs for license applications. These changes helped to streamline processes and alleviate time spent on administrative tasks. As indicated in the Corrective Action Plan, a draft facility survey schedule was implemented for all licensed labs in and out of state. LFS held an in-service meeting in December 2015 to re-train staff on renewal/routine survey processes to improve LFS' efficiency, productivity, and provide consistent results. In January 2016, new criteria to perform new license application surveys were implemented. LFS established baseline performance metrics in January 2016. These metrics are used to help develop a dashboard that will support LFS in tracking and managing inspection workload. At the December 2015 CLTAC meeting, a charge was made to form subcommittees to assist the Department. These committees are meeting on the following subjects: CSA Audit, Regulations, and Recruitment and Retention. 1. CLTAC CSA Audit subcommittee: Meetings occurred on February 10, 2016 and February 25, 2016. The members discussed which recommendations they will focus on going forward. 2. CLTAC Regulations subcommittee: The Subcommittee Chair discussed the format for questions to be listed and brought before the subcommittee for recommendations. The initial issues have been prepared. An introductory meeting will be scheduled the members will decide on prioritization and how to bring additional issues to the Department's attention. CLTAC Recruitment and Retention subcommittee: The Chair and members will finalize the date of the initial meeting before the next CLTAC meeting set in March 2016.

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

60-Day Agency Response

In response to the audit, California Department of Public Health (CDPH) convened work groups to focus on Laboratory Field Services (LFS). These LFS work groups are comprised of LFS staff and managers with technical skills in various operational areas. These work groups continue to analyze its business processes, policies, and procedures to determine efficiencies and reduce redundancies. This has resulted in some change recommendations which are currently being vetted internally; in addition, other changes are discussed with LFS' Clinical Laboratory Technical Advisory Committee (CLTAC). CLTAC is a legislative mandated, multi-disciplinary advisory committee, with members of interest groups related to clinical laboratories. It is composed of 21 voting members and one non-voting member. Members come from a wide background including: blood centers, respiratory care, the California Association of Medical Laboratory Technology, the California Medical Association, Engineers & Scientists of California Local 20, the American Association for Clinical Chemistry, the California Association of Public Health Laboratory Directors, the California Clinical Laboratory Association, the Philippine Association of Medical Technologists, the California Association of Cytotechnologists, the California Association of Bio analysts, and others.

Accrediting Organizations (AO) will assist LFS with the laboratory inspection function and those efforts are described in Response #6.

Due to attrition and turnover, staffing resources have impacted the ability to conduct inspections. Activities related to recruitment and retention are discussed in #7.

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

The California Department of Public Health (Public Health) has convened work groups to focus on Laboratory Field Services; however, Public Health's response to this recommendation has yet to articulate any specific action steps that will be taken.

All Recommendations in 2015-507

Agency responses received are posted verbatim.