Report 2007-040 Recommendation 1 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 #1 To: Public Health, Department of

This recommendation has been superseded by a recommendation from a subsequent report. See 2015-507 #2.

Laboratory Services should perform all its mandated oversight responsibilities for laboratories subject to its jurisdiction operating within and outside California, including, but not limited to the following:
• Inspecting licensed laboratories every two years.
• Sanctioning laboratories as appropriate.
• Reviewing and investigating complaints and ensuring necessary resolution.

Annual Follow-Up Agency Response From September 2016

Laboratory Field Services (LFS) approved two additional Accreditation Organizations (AO) applications during SFY 2015/2016. As of September 2016, of the 2,688 licensed facilities that require biennial inspections, 1,234 are AO certified, reducing the number of inspections LFS will be required to perform in SFY 2016/2017. LFS continues to work to fill vacant positions.

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 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.

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.

LFS revised its complaint policies and procedures; increased staffing dedicated to focusing on complaints by three, and enhanced its complaint database. Changes made to the complaint database include documenting the rationale for not investigating a complaint, and when to perform follow-up investigations to verify corrective action has been completed. In addition, the database now has a reporting function that provides "due dates" of complaint investigations, which staff review to ensure that the appropriate timeframes are being met. LFS staff was trained on the sanction and complaint policies and procedures on August 18, 2016.

California State Auditor's Assessment of Annual Follow-Up Status: See 2015-507 #2 for the most current assessment

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) leveraged existing staff 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 to review state issues when we biennially inspect unaccredited laboratories. This minimal review consists of a checklist with ten elements specific to state requirements. Deficiencies identified are referred as a complaint for state follow up. Between October 2012 and September 2013, LFS performed biennial inspections of 700 or 95% of the 1476 non-accredited laboratories. Between September 2012 and July 2013, state surveyors conducted 133 initial licensure surveys and 44 validation inspections of accredited laboratories.

LFS 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.

LFS continues to identify Examiner candidates and recruit to fill 11 vacant Examiner positions. Because Examiner salaries are 30-50 percent lower than comparable positions in the private sector, LFS continues to work with CDPH Human Resources Branch to implement a recruitment and retention bonus by fall 2014. LFS is also working with CalHR to remove the requirement for supervisory experience for entry level Examiners to allow more scientists to qualify. We anticipate completion of this change by June 30, 2015.

From October 2012 through September 2013, LFS received 147 complaints, investigated and closed 138, referred 18 to the responsible board or program, and performed 6 onsite inspections.

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

Annual Follow-Up Agency Response From October 2012

Laboratory Field Services (LFS) continues its efforts to inspect licensed laboratories every two years, sanction laboratories as appropriate, review and investigate complaints, and ensure necessary resolution.

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. Between September 2010 and September 2012, LFS performed biennial inspections of 1361 or 92% of the 1,476 non-accredited laboratories. Between September 2011 and September 2012, state surveyors also conducted 239 initial surveys of laboratories applying for licensure and approximately 27 validation inspections of accredited laboratories in California.

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 be able to 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 of 2013 and will continue to review new applications as we receive them.

In 2010, LFS received approval to add 35.5 additional Examiner and program support staff. However, budget cuts in 2012 resulted in the loss of 17 vacant Examiner positions and 5 vacant support staff positions. In addition, LFS lost 17 retired annuitant support staff pursuant to the mandate to eliminate such staff. LFS will need to re-establish and fill these positions to conduct all mandated activities.

LFS continues to identify new Examiner candidates and recruit to fill the remaining 11 vacant Examiner positions. Because Examiner salaries are 30-50 percent lower than those for comparable positions in the private sector, LFS continues to work with CDPH Human Resources Branch to implement a recruitment and retention bonus. When the bonus is in place (anticipated in 2014), LFS anticipates improved ability to fill vacant positions. LFS is also working with CalHR to remove the requirement for supervisory experience for entry level Examiners to allow more scientists to qualify for the Examiner series. We anticipate completion of this change by 2014.

LFS redirected staff to review and investigate complaints and ensure resolution. From October 2011 to September 2012, LFS received 122 complaints, investigated and closed 72, referred 20 to the responsible board or program, and performed 6 onsite inspections.

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.