Report 2015-507 Recommendation 7 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 #7 To: Public Health, Department of

To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should maximize the opportunity to partner with accreditation organizations by developing an accreditation organization program and issuing an All Clinical Laboratories Letter detailing the program's components. In addition, it should consult with legal counsel and draft an agreement outlining the role and the responsibilities that Laboratory Services and the accreditation organizations will assume.

1-Year Agency Response

Laboratory Field Services (LFS) reviewed and approved two additional Accreditation Organizations (AO) applications during SFY 2015/2016. LFS now has three AOs working in partnership to perform inspections and investigate complaints. All Clinical Laboratory Letters (ACLL) have been developed in partnership with the Department's Office of Legal Services and issued detailing the program components. The required routine clinical laboratory facility inspections will be performed by AOs or in coordination with LFS federal Clinical Laboratory Improvement Amendments surveys.

-Initial Notice of Approval of LFS Accrediting Organizations: http://www.cdph.ca.gov/programs/lfs/Documents/Initial%20Notice%20-%20LFS%20Approval%20of%20Accrediting%20Organizations.pdf

-ACLL 16-01: http://www.cdph.ca.gov/programs/lfs/Documents/ACLL%2016-01%20Final%20Action.pdf

-ACLL 16-02: http://www.cdph.ca.gov/programs/lfs/Documents/AOs%20-%20ACLL%2016-02.pdf

LFS staff was trained on the ACLL letters on August 18, 2016.

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

Laboratory Services has expanded the number of accreditation organizations authorized to perform laboratory inspections and investigate complaints. In addition, through All Clinical Laboratory Letters posted on its website, Laboratory Services has outlined the role and responsibilities associated with that authorization.

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 Accrediting Organization (AO) program to ensure efficiency, productivity, and timeliness. LFS released the All Clinical Laboratories Letter (ACLL) introducing the program's components on February 24, 2016. The first notice introduces the AO program. However, upon legal review it was determined that since an ACLL has the force of regulation, and the initial introductory notice does not contain any new regulatory material, it was posted as an "important notice" on the LFS website.

An ACLL (16-01) notifying laboratories of the AO program details, has been posted on the LFS website.

An ACLL is forthcoming regarding oversight requirements for the AOs. It is anticipated that this ACLL will be completed and posted on the LFS website by March 2016 with an April 2016 effective date.

LFS currently has one AO approved to complete inspections, and is finalizing the approval for a second AO. LFS is still reviewing the application for the third AO.

As mentioned in response # 4, LFS hired an Examiner III, Section Chief who is responsible for developing and overseeing the LFS's AO program. A Staff Services Analyst (SSA) was hired. This SSA provides administrative and analytical support to the AO program.

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

60-Day Agency Response

LFS has met with OLS to discuss issues related to the Accrediting Organizations (AO). LFS is drafting oversight requirements, which will include inspections, for the AO, and LFS is also drafting an All Clinical Laboratory Letter detailing the program's components. LFS continues to review its business processes to make the necessary changes for inclusion of deemed facilities.

LFS had three AO applications, one has been approved and is performing inspections, one has completed the review and one is currently under review. The one that has completed review had four items identified as needing clarification from the AO. As a result, a response will be sent to the AO to clarify the four items. The one currently under review will be completed by the end of January 2016.

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.