Report 2007-040 Recommendations

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.

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.

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.

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.

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.

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.

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

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.

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.

Laboratory Services should work with Public Healths budget section and other appropriate parties to ensure that it adjusts fees in accordance with the budget act.

Laboratory Services should perform all its mandated oversight responsibilities for laboratories subject to its jurisdiction operating within and outside California, including monitoring proficiency-testing results