Report 2007-040 Recommendation 4 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 #4 To: Public Health, Department of

Laboratory Services should continue its efforts to license California laboratories that require licensure. Further, it should take steps to license out-of-state laboratories that perform testing on specimens originating in California but are not licensed, as the law requires.

Annual Follow-Up Agency Response From October 2016

Laboratory Field Services (LFS) continues to annually license California and out-of-state (OOS) laboratories. LFS implemented an interagency agreement with the Department of Health Care Services (DHCS). When laboratories bill DHCS for Medi-Cal reimbursement for lab services, DHCS checks with LFS for license verification. In the process of verifying licensure, LFS identifies unlicensed labs, which must be licensed by LFS pursuant to Welfare and Institutions Code section 14043.27. As of June 2016, LFS licensed 446 OOS laboratories and as of September 2016, LFS registered 15,405 and licensed 2,403 in state laboratories that perform tests on specimen from California patients.

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

Laboratory Services is taking steps to license both in-state and out-of-state laboratories that perform tests on specimens from California patients.

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 November 2013

As of September 30, 2013, Laboratory Field Services (LFS) licensed 13,025 of the 14,724 waived laboratories. LFS has also licensed 249 out-of-state laboratories performing testing on California patients. LFS has 50 pending applications for initial or renewal out-of-state licensing.

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 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 for the Examiner series. We anticipate completion of this change by June 30, 2015

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

Annual Follow-Up Agency Response From October 2012

LFS continues its efforts to license California laboratories and those outside California performing testing on California patients. As of September 14, 2012, LFS has registered 11,734 of the estimated 12,266 laboratories required to be registered. LFS has also licensed 398 out-of-state laboratories performing testing on California patients. LFS has 50 pending applications for either initial out-of-state licensing or renewal.

In 2009, SB 744 (Strickland, Chapter 201, Statutes of 2009), authorized a sliding fee schedule for laboratory license fees based on the volume of testing performed by a laboratory and increased the registration fee for registered laboratories. SB 744 increased funding and improved LFS efficiency to allow better enforcement of clinical laboratory standards. LFS expected to use the additional $3.5 million generated by SB 744 to fund additional staff positions needed to identify and license laboratories within and outside of California. 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 in 2014.

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.