Report 2007-040 Recommendations

When an audit is completed and a report is issued, auditees must provide the State Auditor with information regarding their progress in implementing recommendations from our reports at three intervals from the release of the report: 60 days, six months, and one year. Additionally, Senate Bill 1452 (Chapter 452, Statutes of 2006), requires auditees who have not implemented recommendations after one year, to report to us and to the Legislature why they have not implemented them or to state when they intend to implement them. Below, is a listing of each recommendation the State Auditor made in the report referenced and a link to the most recent response from the auditee addressing their progress in implementing the recommendation and the State Auditor's assessment of auditee's response based on our review of the supporting documentation.

Recommendations in Report 2007-040: Department of Public Health: Laboratory Field Services' Lack of Clinical Laboratory Oversight Places the Public at Risk (Release Date: September 2008)

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Recommendations to Public Health, Department of
Number Recommendation Status
1

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.

Superseded By Subsequent Report
2

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.

Fully Implemented
3

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.

Superseded By Subsequent Report
4

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.

Fully Implemented
5

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.

Superseded By Subsequent Report
6

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.

Fully Implemented
7

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

Superseded By Subsequent Report
8

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.

Superseded By Subsequent Report
9

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.

Fully Implemented
10

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.

Fully Implemented
11

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

Fully Implemented


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