Report 2007-040 Recommendation 2 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 #2 To: Public Health, Department of

Laboratory Services should adopt and implement proficiency-testing policies and procedures for staff to do the following:
• Promptly review laboratories' proficiency-testing results and notify laboratories that fail.
• Follow specified timelines for responding to laboratories' attempts to correct proficiency-testing failures and for sanctioning laboratories that do not comply.
• Monitor the proficiency-testing results of out-of-state laboratories.
• Verify laboratories' enrollment in proficiency testing, and ensure that Laboratory Services receives proficiency-testing scores from all enrolled laboratories.

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.

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 2016 [report 2015-507], Public Health has taken steps to address weaknesses in its proficiency testing practices including ensuring it reviews the results of proficiency testing for out-of-state labs it has licensed.

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 Services (LFS) promptly notifies laboratories of proficiency test results and follows specified timelines for responding to proficiency testing failures. LFS reviews proficiency testing results every 30 days for two of three failed proficiency tests. LFS mails the laboratory a warning letter within 10 days after review and the laboratory must respond within 10 days of receipt of the letter. If LFS does not receive a response, we send a second letter 10 to 15 days after the first letter. If the laboratory does not respond to the second letter, LFS initiate sanctions. LFS monitors out-of-state laboratory proficiency test results once a year during the annual license renewal. LFS continues to verify laboratory enrollment in appropriate proficiency testing when we conduct biennial inspections.

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 ensure that the laboratories they accredit are surveyed according to state standards. LFS anticipates approving the remaining three applications by spring 2014 and will review new applications as we receive them. Once approved, the accrediting organizations will review proficiency test results for their accredited laboratories and refer to LFS laboratories that fail proficiency testing.

LFS monitors proficiency testing results of out-of state laboratories to ensure that the laboratories are enrolled in appropriate proficiency testing. LFS does this when the out-of state laboratories submit their annual license renewal and compare that with the testing menu that is submitted.

Full implementation of these policies and procedures is pending sufficient staffing.

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

Annual Follow-Up Agency Response From October 2012

LFS continues to promptly review and notify laboratories of proficiency test results and to follow specified timelines for responding to proficiency testing failures. LFS reviews proficiency testing results every 30 days for two out of three failed proficiency test events. LFS mails the laboratory a warning letter within 10 days after review and the laboratory must respond within 10 days of receipt of the letter. If LFS does not receive a response, we send a second letter 10 to 15 days after the first letter. If the laboratory does not respond to the second letter, LFS initiate sanctions. LFS monitors out-of-state laboratory proficiency test results once a year during the annual license renewal. LFS continues to verify laboratory enrollment in proficiency testing appropriate to the testing performed when we conduct biennial inspections. Since September 1, 2008, LFS has conducted 3018 biennial inspections, using the state portion of the federal CLIA surveys to inspect licensed laboratories and perform validation inspections of accredited laboratories.

LFS has applications to conduct state surveys from four accrediting organizations and we are reviewing those submissions with a crosswalk of state and federal clinical laboratory law. Once approved (anticipated spring 2013), the accrediting organizations will be able to conduct biennial inspections on behalf of LFS and we will issue those laboratories a certificate of deemed status. The accrediting organizations will review proficiency test results for their accredited laboratories, monitor proficiency test results, and refer to LFS laboratories that fail proficiency testing.

LFS continues to monitor the proficiency testing results of out-of state laboratories to ensure that the laboratories are enrolled in appropriate proficiency testing. LFS reviews proficiency test results when the out-of state laboratories submit their annual license renewal and compare that with the testing menu that is submitted.

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.