Response to the Audit
Response From the California Department of Public Health
August 24, 2015
Ms. Elaine M. Howle
621 Capitol Mail, Suite 1200
Sacramento, CA 95814
Dear Ms. Howle:
Enclosed is the California Department of Public Health's (CDPH) response to the California State Auditor draft report titled "Follow-up: California Department of Public Health: Laboratory Field Services Is Unable to Oversee Clinical Laboratories Effectively, but a Feasible Alternative Exists" Report 2015-507, September 2015. Thank you for the opportunity to respond. If you have questions please contact Monica Vazquez, Chief, Office of Compliance at (916) 440-7387.
(Original signed by Karen L. Smith)
Karen L. Smith, MD, MPH
Director & State Health Officer
California Department of Public Health Response to Draft Report: “Follow-up: California Department of Public Health: Laboratory Field Services Is Unable to Oversee Clinical Laboratories Effectively, but a Feasible Alternative Exists”
Report 2015-507 September 2015
Inspecting licensed labs within and outside of California that test samples that
originate within the state every two years.
The California Department of Public Health (CDPH) agrees with this recommendation and is in the process of implementing. While our compliance rate for reviewing in-state non-accredited laboratories has been high, Laboratory Field Services (LFS) acknowledges that our overall compliance rate must improve. To that end, LFS is analyzing its business processes, policies and procedures to ensure efficiencies and reduce redundancies. LFS will focus specific personnel on clear tasks and streamlined processes will increase the number of inspections performed. In addition to improving existing processes, LFS has approved one accrediting organization (AO) that can perform inspections on behalf of the State, and is currently reviewing two additional AO applications. Approval of AOs will significantly decrease onsite workload and will facilitate LFS meeting its mandated workload.
LFS, in partnership with CDPH’s Human Resources Branch (HRB), will increase its recruitment and retention efforts to hire and maintain staff who can assist with this effort.
LFS will have a corrective action plan developed by December 31, 2015 to address this recommendation.
Developing and implementing proficiency testing policy and procedures for
ensuring that it can promptly identify out-of-state laboratories that fail proficiency
CDPH agrees with this recommendation. As a result of the audit released in 2008, LFS updated its proficiency testing policies and procedures and implemented this revision in March 2015. As a result, in-state laboratory proficiency testing has improved. However, LFS will continue to update the out-of-state laboratory proficiency testing policies and procedures. These updates will address the California State Auditor’s (CSA) concerns and improve the rate at which LFS monitors and responds to proficiency testing results of out-of-state laboratories. A corrective action plan will be developed by December 31, 2015.
Improving its complaints policy and procedures to ensure that allegations are
either investigated promptly or that management’s rationale for not investigating
is clearly documented, and to establish clear expectations for when staff must
visit a laboratory to verify successful corrective action.
CDPH agrees with this recommendation. As a result of the audit released in 2008, LFS updated its complaints policies and procedures and implemented this revision in March 2015. Further, LFS established a complaints investigator position, and this person started employment in August 2015. LFS will improve its monitoring system to track complaints and perform audits to ensure complaints are timely completed and properly documented. When possible and applicable, LFS coordinates complaints with field surveys to efficiently utilize staff, and will enhance the complaint policies and procedures to address complaints for registered facilities. We are currently reviewing the complaints policies and procedures to address CSA’s concerns and will have a corrective action plan in place by December 31, 2015.
Dedicating multiple staff to sanctioning efforts and updating its sanctioning
policy and procedures, including steps to ensure that sanctions are adhered to
and civil money penalties are collected. In addition, it should develop a single
sanctions tracking system that multiple managers can monitor and with which
monetary penalties received can be periodically reconciled with Public Health’s
CDPH agrees with this recommendation and is in the process of implementing. As a result of the audit released in 2008. LFS is in the process of updating its enforcement and civil money penalties policies and procedures. The updates will allow us to determine the number of staff needed to oversee our sanctioning efforts and update the tracking system as required. LFS will establish a system to track sanctions, monitor issuance and collection of penalties, reconcile penalty payments with our accounting records, and allow staff to perform compliance audits necessary. LFS will have a corrective action plan in place by December 31, 2015 that will address all issues in this recommendation.
Working with Public Health’s budget section and other appropriate parties in
developing a process to assess the budget act annually and to adjust fees
accordingly, including management’s review and approval of fee adjustments
before those fees are posted publically.
CDPH agrees with this recommendation. LFS will work closely with our Budget Division to ensure annual fee adjustments are accurately calculated. In partnership with CDPH’s Administration Division and Office of Legal Services, LFS will also develop policies and procedures for calculating annual fees, including fee adjustments, and ensuring these fees are posted appropriately. These policies and procedures will help ensure consistent application of fee increases in the event of staff retirement or separation. A corrective action plan will be developed by December 31, 2015.
Maximizing the opportunity to partner with accreditation organizations by
developing an accreditation organization program and issuing an All Clinical
Laboratories Letter detailing the program’s components. In addition, consulting
with legal counsel and drafting an agreement outlining the role and the
responsibilities Laboratory Services and an accreditation organization will
Addressing staffing issues by preparing and resubmitting a recruitment and
retention proposal, developing a succession plan, and taking necessary steps to
implement its planned reorganization.
CDPH agrees with this recommendation and is in the process of implementing. LFS has partnered with CDPH’s Human Resources Branch (HRB) to address this recommendation. LFS has loaned two positions to HRB to assist LFS with its recruitment efforts. These positions will allow LFS to work closely with HRB and continue to improve its recruitment, advertising, hiring, and succession planning.
Ensuring that its information technology data systems have necessary
safeguards, contain accurate and complete data, and support its program needs.
CDPH agrees with this recommendation. CDPH’s Information Technology Services Division (ITSD) has already purchased and installed the PEGA Enterprise platform software and has expanded its capabilities to support the many licensing applications within the department. Some of these reusable enhancements that support rapid application development and lower costs include a specialized licensing framework, electronic pay, electronic signature, email communication, CDPH accounting interfaces, and legacy systems interfaces. CDPH has already developed an online personnel licensing system that will be in production by the end of September 2015 which will be the second production application hosted by the PEGA enterprise platform. Also, CDPH is initiating a follow-on project to develop the requirements and functionally required to develop the facilities licensing application on the PEGA Enterprise platform for LFS. In addition, CDPH is actively recruiting staff to support the current and future PEGA Enterprise platform applications.
Updating and developing its regulations as necessary to ensure consistency with
existing state law.
CDPH agrees with this recommendation and has already implemented a plan. As a result of the audit released in 2008, LFS has partnered with CDPH’s Office of Legal Services (OLS) and Office of Regulations to develop a strategy to complete regulations efficiently and timely. This joint effort utilizes a regulations tracking system to identify all of LFS’ regulation packages and to establish timelines for completion of each package. LFS’ packages will update the current regulations to ensure consistency with existing state law. In addition, LFS has committed resources to assist with its regulations efforts. LFS provided a position to OLS for full-time regulation writing attorney dedicated to LFS. This employee started work in August 2015. In addition, LFS has partnered with OLS to establish an Attorney III position to bolster LFS’ regulations efforts and assist with LFS’ complex needs