Report 2015-507 Recommendation 9 Responses

Report 2015-507: Follow-Up—California Department of Public Health: Laboratory Field Services Is Unable to Oversee Clinical Laboratories Effectively, but a Feasible Alternative Exists (Release Date: September 2015)

Recommendation #9 To: Public Health, Department of

To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should ensure that its information technology data systems have necessary safeguards, contain accurate and complete data, and support its program needs.

Annual Follow-Up Agency Response From September 2021

As of January 25, 2021, LFS has successfully launched ELLFS to all clients. Staff are currently using the program, which has facilitated processing of approximately 2,200 applications (initial, renewal, and business changes) being submitted to ELLFS on a monthly basis. LFS is now working on improving functionality of ELLFS with the CDPH Information Technology Services Division (ITSD) as well as pushing general maintenance and operations updates. Laboratory Field Services is monitoring end user adoption of ELLFS and using feedback from internal and external stakeholders as needed. Go-Live Documents are attached in a zip file for auditors' review.

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

Annual Follow-Up Agency Response From October 2020

Our previous response submitted on 9/2/20 is still current.

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

Annual Follow-Up Agency Response From September 2020

The external launch of ELLFS was tentatively scheduled for Spring 2020 but was delayed as CDPH prioritized IT resources on COVID-19 related activities. However, ELLFS continues to be used internally and some development work has continued. Specifically, LFS conducted User Acceptance Testing on July 21-22, 2020, then conducted informal follow-up testing from July 28 - August 4, 2020. LFS is now working with ITSD to target the external launch of ELLFS during the second week of November 2020.

In addition, a Data Unit was formed that would bring staff working on ELLFS and PERL together to assist with troubleshooting and put LFS in a stronger position to withstand any turnover.

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

Annual Follow-Up Agency Response From September 2019

PERL (Personnel Licensing), the licensing system for applicants, was fully online as of November 2017. In 2018, Public Health addressed clean up issues to improve the system and make it more functional for clients. As of June 18, 2019, the PERL system has a new feature that will enable all registrants who complete the online application to print their certificate in real time.

Regarding ELLFS (Electronic Laboratory Licensing and Registration for Facilities System), in December 2018, program issues were identified by ITSD. Data in the legacy system required corrections so that data could be accurately migrated into ELLFS fields. Therefore, Public Health pushed back the implementation date to address those issues. Some of the data migration issues were: missing/incorrect CLIA ID numbers, missing issuance/ expiration dates of licenses, missing tax ID, missing laboratory director or owner names. LFS has corrected the critical data issues. Also during December 2018, Public Health held a Beta Testing session with several external users such as Kaiser, Dignity Health, and representatives from public health labs. The users identified improvements to make ELLFS more user-friendly and effective. We anticipate the application will go online in September 2019. This will automate the processes, but we will still accept paper applications for several months until we release the online application to all users in early 2020.

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

Annual Follow-Up Agency Response From October 2018

CDPH submitted its last annual follow-up in September 2018. No further changes have been made since the last response. However, CDPH anticipates to fully implement CSA's recommendations by December 2018 as stated in the last response.

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

Annual Follow-Up Agency Response From September 2018

Laboratory Field Services has invested considerable resources in updating its information technology to meet the needs of its stakeholders. In November 2017, it updated PERL from being an internal offline tracking system to an online system where lab personnel can submit applications and renew licenses without submitting physical paperwork. Instead of waiting for mailed documents to be processed, or incurring the risk of having lost checks, applicants and licensees can go online to upload documents, pay their fees, and modify their account information in real time. In addition to simplifying processes for the customers, it also allows program staff to process applications more quickly. In Fall 2018, LFS is scheduled to launch its Electronic Laboratories Licensing for Facilities System (ELLFS) program, which will take the laboratory registration application and renewal process online. Moving both processes from being paper-based to electronic will allow LFS to increase processing time, reduce backlogs, and more easily and accurately track payment. Additionally, the program now has functionality to track numerous customer service metrics including emails/voicemails sent through two systems (MOSS and Cherwell), controlled correspondence, and complaints. These systems both have electronic safeguards to protect customer information, and in the process of migrating information to these new systems, databases were reviewed for accuracy. Additionally, data verification steps have been added to lessen the likelihood of data entry errors. During the past year, LFS has begun the process of generating weekly data reports that help the program to measure performance and identify opportunities for enhancement. The program has also initiated organizational changes to measure response times and evaluate the quality of responses to customer service inquiries.

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

Annual Follow-Up Agency Response From September 2017

LFS, in partnership with ITSD, began formal development of an electronic licensing system in June, 2017, and continues development using an agile project management model. Agile project management is an iterative approach to planning and guiding project processes. CDPH is utilizing the Department's existing licensing platform, Pega system, to build this application.

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

1-Year Agency Response

Laboratory Field Services (LFS) is working with the Information Technology Services Division (ITSD) to develop an electronic licensing system for clinical laboratory facilities that would provide better record keeping and tracking of facility licensure, registration, ownership, complaint tracking, enforcement tracking and management reports; accelerate the applications processing time, which will help ensure that all labs testing California specimens are inspected in a timely manner and are in compliance with federal and state laws; centralize the application process for both new and renewal license and registration applications; streamline workload for LFS staff; and establish better accountability for management within Public Health.

The application will be developed on the department's existing PEGA System. The PEGA System licensing platform will replace the existing legacy mainframe and will be a foundation on which all new and existing licensing applications are built. The new online personnel licensing application (PERL) was built on the PEGA platform, and it is anticipated that LFS will be able to leverage lessons learned from that application build for the facilities licensing application design.

The department is developing a scope of work to bring a contractor on-board to begin configuring the licensing system for LFS. The LFS electronic licensing system now has an approved Stage 1 Business Analysis (S1BA). Department of Technology, Technology Letter 16-08, as of September 12, 2016 delegated approval of S1BA documents to Agency Chief Information Officers (ACIO). As of July 8, 2016 the S1BA was approved by the California Health and Human Services' ACIO. LFS continues to work with the Department's ITSD on the Stage 2 Alternative Analysis (S2AA), which is estimated to be completed by December 31, 2016.

California State Auditor's Assessment of 1-Year Status: Pending

6-Month Agency Response

In September 2015, CDPH launched the Laboratory Field Services Branch (LFS)' new online personnel licensing system (PERL). This is the baseline system that in subsequent phases will be expanded to include complaints tracking, and moving facilities licensing online. LFS continues to work with the Department's Information Technology Systems Division on the Stage One Business Analysis (S1BA), which will be completed by March, 2016.

This initiative will support the restructure of LFS by replacing the substantially paper-based processes with information technology solutions that will enable online applications, and allow recording and tracking of facility licensure, registration, ownership, complaint tracking, enforcement tracking, required inspection scheduling, proficiency testing tracking, and management reports. This redesign will enable LFS to be compliant with state law, as well as comply with the CSA recommendations, while also improving the quality and timeliness of services provided to facilities. Once complete, the redesign will enable LFS to provide more accurate and timely information about clinical and public health laboratory performance. This information will assist health care consumers and provide transparency and accountability of licensed and registered facilities. Further, the redesign will enable LFS to achieve greater staff efficiencies by eliminating a substantively paper-based, and time-consuming, tracking activities that currently take place.

California State Auditor's Assessment of 6-Month Status: Pending

60-Day Agency Response

In September 2015, CDPH launched LFS' new online personnel licensing system (PERL). This is the baseline system that in subsequent phases will be expanded to include or tracking complaints, and moving facilities licensing online. CDPH continues to actively recruit state staff to support the current and future PEGA Enterprise applications for development, maintenance and operations. In the short term ITSD has engaged the services of a contractor to provide support for the PEGA Enterprise platform and maintenance and operations of the existing applications. ITSD plans to hire a contractor to assist in the development of the requirements and functional design required to develop the facilities licensing and complaint phase.

California State Auditor's Assessment of 60-Day Status: Pending

The California Department of Public Health (Public Health)'s response discusses various plans for taking corrective action. We will re-evaluate the status of this recommendation once Public Health substantiates the steps it has actually taken.

All Recommendations in 2015-507

Agency responses received are posted verbatim.