Report 2007-040 Recommendation 9 Responses

Report 2007-040: Department of Public Health: Laboratory Field Services' Lack of Clinical Laboratory Oversight Places the Public at Risk (Release Date: September 2008)

Recommendation #9 To: Public Health, Department of

To demonstrate that it has used existing resources strategically and has maximized their utility to the extent possible, Laboratory Services should identify and explore opportunities to leverage existing processes and procedures. These opportunities should include, but not be limited to, exercising clinical laboratory oversight when it renews licenses and registrations, developing a process to share state concerns identified during federal inspections, and using accreditation organizations and contracts to divide its responsibilities for inspections every two years.

Annual Follow-Up Agency Response From September 2016

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.

LFS reviewed and approved two additional Accreditation Organizations (AO) applications during SFY 2015/2016. Laboratory Services 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.

-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

The required routine clinical laboratory facility inspections will be performed by AOs or in coordination with Laboratory Services federal Clinical Laboratory Improvement Amendments surveys. Laboratory Field Services staff was trained on the ACLL letters on August 18, 2016. COLA, a Public Health approved Accrediting Organization (AO) for clinical laboratories, completed 187 inspections.

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

As a result of a follow-up audit of Laboratory Field Services that the State Auditor issued in August 2015 (report 2015-507), Public Health has partnered with several accreditation organizations to perform inspections and investigate complaints. The department addressed the remainder of this recommendation in 2012.

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

Laboratory field Series (LFS) has leveraged existing staff by using the state portion of federal Clinical Laboratory Improvement Amendments (CLIA) surveys to biennially inspect licensed laboratories. LFS uses the 20 percent state portion of CLIA surveys for review of state issues when we perform biennial inspections of unaccredited laboratories. This entails a minimal review consisting of a checklist with ten elements specific to state licensing requirements. Any deficiencies identified are referred as a complaint for state follow up.

LFS also initiated validation surveys of accredited laboratories by state surveyors. Since September 2008, LFS staff inspected 4500 laboratories. This includes all initial biennial and validation inspections. LFS implemented ongoing reviews of facility license renewal applications to verify ownership and qualifications of the director and ten percent of testing personnel.

LFS has received four applications from accrediting organizations to conduct state surveys. In September 2013, LFS approved COLA's application. COLA currently accredits approximately 450 or 35% of the total 1,281 accredited laboratories. Their inspections will increase the number of licensed laboratories that are inspected every two years. LFS anticipates approving the remaining three applications from accrediting organizations by spring 2014 and will review new applications as we receive them.

LFS meets quarterly with the Centers for Medicare and Medicaid Services to share state concerns identified during federal and state inspections and to provide an update on LFS programs.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2012

LFS implemented several mechanisms to leverage existing processes and procedures.

LFS has leveraged existing staff by using the state portion of federal Clinical Laboratory Improvement Amendments (CLIA) surveys to biennially inspect licensed laboratories. LFS uses the 20 percent state portion of CLIA surveys for review of state issues when we perform biennial inspections of unaccredited laboratories. This entails a minimal review consisting of a checklist with ten elements specific to state licensing requirements. Any deficiencies identified are referred as a complaint for state follow up.

LFS also initiated validation surveys of accredited laboratories by state surveyors. Since September 2008, LFS staff inspected 3607 laboratories. This includes all initial biennial and validation inspections. LFS implemented ongoing reviews of facility license renewal applications to verify ownership and qualifications of the director and ten percent of testing personnel.

Senate Bill (SB) 744 (Strickland, Chapter 201, Statutes of 2009) allows laboratories accredited by a private, nonprofit organization to be deemed by the Department to meet state licensure or registration requirements. Once the accrediting organizations are approved, the state will leverage its ability to perform biennial inspections of accredited laboratories by using the accrediting organizations. This will increase the number of licensed laboratories that are inspected every two years. Beginning January 2011, the Department has accepted accrediting organization applications to conduct state surveys. The Department has received four applications and is reviewing those applications. We anticipate approving these applications by spring 2013 and will continue to review new applications as we receive them.

LFS meets quarterly with the Centers for Medicare and Medicaid Services to share state concerns identified during federal and state inspections and to provide an update on LFS programs.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

All Recommendations in 2007-040

Agency responses received after June 2013 are posted verbatim.