Report 2007-040 Recommendations and Responses in 2013-041

Report 2007-040: Department of Public Health: Laboratory Field Services' Lack of Clinical Laboratory Oversight Places the Public at Risk

Department Number of Years Reported As Not Fully Implemented Total Recommendations to Department Not Implemented After One Year Not Implemented as of 2012-041 Response Not Implemented as of Most Recent Response
Department of Public Health 5 11 9 9 9

Recommendation 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.

Response

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

Recommendation To: Public Health, Department of

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.

Response

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.

Recommendation 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.

Response

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.

Recommendation To: Public Health, Department of

To update its regulations, Laboratory Services should review its clinical laboratory regulations and repeal or revise them as necessary. As part of its efforts to revise regulations, Laboratory Services should ensure that the regulations include requirements such as time frames it wants to impose on the laboratory community.

Response

Laboratory Field Services (LFS) continues to review its clinical laboratory regulations and repeal or revise them as necessary. In September 2010, LFS issued draft personnel certification regulations and is revising the draft based on the 15,000 public comments we received. LFS expects to reissue the revised regulations in spring 2014. LFS has also drafted regulations for sperm washing. LFS will draft an additional regulation package for new license categories for clinical biochemists and endocrinologists when the current personnel certification regulation package has been adopted in 2014.

Recommendation To: Public Health, Department of

To strengthen its complaints process, Laboratory Services should identify necessary controls and incorporate them into its complaints policies. The necessary controls include, but are not limited to, receiving, logging, tracking, and prioritizing complaints, as well as ensuring that substantiated allegations are corrected. In addition, Laboratory Services should develop and implement corresponding procedures for each control. Further, Laboratory Services should establish procedures to ensure that it promptly forwards complaints for which it lacks jurisdiction to the entity having jurisdiction.

Response

In March 2009, Laboratory Field Services (LFS) developed a master complaint register that tracks the following for each complaint: the facility or professional identified by the complaint, the sequential case number, date opened, date closed, acuity/priority, acknowledgement of receipt, disposition (letter to facility/professional, referral to outside agency or internal section). LFS uses the complaint register to track complaint investigation or referral to the appropriate agency.

LFS has developed policies and procedures for receiving, processing, and following up on complaints.

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

Recommendation To: Public Health, Department of

To strengthen its sanctioning efforts, Laboratory Services should do the following:
• Maximize its opportunities to impose sanctions.
• Appropriately justify and document the amounts of the civil money penalties it imposes.
• Ensure that it always collects the penalties it imposes.
• Follow up to ensure that laboratories take corrective action.
• Ensure that when it sanctions a laboratory it notifies other appropriate agencies as necessary.

Response

Laboratory Field Services (LFS) has developed written procedures to maximize its opportunities to impose sanctions, appropriately justify and document the amounts of the civil money penalties it imposes, ensure penalties imposed are always collected, to ensure laboratories take corrective action, and notify other appropriate agencies when we sanction laboratories. Investigations of complaints have identified issues that could result in civil money penalties.

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

Recommendation To: Public Health, Department of

Public Health, in conjunction with Laboratory Services, should ensure that Laboratory Services has sufficient resources to meet all its oversight responsibilities.

Response

In 2009, SB 744 (Strickland, Chapter 201, Statutes of 2009), authorized a sliding fee schedule for laboratory license fees and increased phlebotomy certification fees. Laboratory Field Services (LFS) expected to use the additional $3.5 million dollars generated by SB 744 to provide the resources necessary to meet LFS oversight responsibilities.

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.

Recommendation To: Public Health, Department of

Laboratory Services should work with its Information Technology Services Division and other appropriate parties to ensure that its data systems support its needs. If Laboratory Services continues to use its internally developed databases, it should ensure that it develops and implements appropriate system controls.

Response

The Information Technology Services Division (ITSD) continues to provide database support to LFS. LFS staff continues to identify and correct data inaccuracies within the existing databases and develop and implement appropriate system controls. LFS and ITSD identified a strategy for replacing the Health Application Licensing (HAL) system and it is incorporated in the CDPH IT Capital Plan.

Recommendation 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.

Response

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.

Current Status of Recommendations

All Recommendations in 2013-041