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Integrating Web-based Regulatory and Compliance Management Systems with LIMS at Florida Department of Agriculture to Unify Disparate Laboratory Systems
by James Maggio and Mike Lehtola, PerkinElmer Corporation, Weldon Collier, Florida Dept of Agriculture and Consumer Services

Every laboratory develops a unique approach to their work processes over time that periodically needs to be examined and streamlined in order to be as efficient as possible. The challenges inherent in updating a legacy system to an integrated enterprise solution are compounded when more than one lab is involved.

The Florida Department of Agriculture Consumer Services (FDACS) has statutory authority to license and regulate distributors of agricultural products within the state of Florida. Currently FDACS are transitioning from existing systems that perform these activities by manual processes with the use of an MS Access application and database and an Oracle Forms application and database. The Florida staff manually transmits registration forms to new registrants, and to current licensees at renewal.

Originally presented at the Pittsburgh Conference in Chicago, IL on June 10, 2009, this case study addresses the development and implementation of a modern web-based compliance application that will integrate with the FDACS Laboratory Information Management System (LIMS), provide secure access for Manufacturers and Distributors to monitor their compliance, and reduce -- and in some cases eliminate -- the need for redundant data entry and paper based communication. Significant economies of scale and cost reductions are expected once the new system is in place.

FDACS Business Overview

FDACS is tasked with monitoring and tracking pesticide, fertilizer, feed and seed producers and distributors of agriculture products within the state of Florida, and has separate laboratories designated to manage each specific area.

As part of this task, licensees within FDACS have monthly and quarterly reporting requirements that include verifying and maintaining the quality and reporting accuracy of the products being sold within the State of Florida. In addition, the different laboratories have implemented different systems, such as a self-reporting Fertilizer process that is configured to collect fertilizer tonnage data on a monthly basis. This is currently a paper form-based process requiring outside contracting to process the submitted forms. The Feed process is also self-reporting and is configured to collect Feed tonnage data on a quarterly basis. This paper form-based process is managed by Florida Feed staff and – while still not ideal – is the only self-reporting system that reduces the data management burden for staff.

Each Licensee is required to submit samples to FDACS laboratories or certified contract laboratories for analysis. The sample analyses are used to verify that the Licensee’s products are in compliance with Florida Pesticide, Feed, Fertilizer and Seed Regulations.

Simply managing the paperwork is a monumental task in today’s information-intensive regulatory environment. Verifying that the products are in compliance adds another layer of complexity. FDACS recognized that a move toward electronic self-reporting that could be automatically verified was the logical evolution. They selected PerkinElmer’s LABWORKS LIMS as the means to integrate the disparate systems and to handle the regulatory reports receipt and licensee information.

System Overview

The LIMS’ Oracle database was placed at the center of the laboratory systems that would need integration and was expected to do more than a typical LIMS. Connecting to it would be a variety of external users, such as Licensees, and internal staff who would manage regulatory compliance processes as well as laboratory processes. In addition, the LIMS database would connect to the state-wide reporting accounting and revenue databases. Thus, not only would laboratory data need to be supplied, but the accounting associated with the producers also needed to be confirmed and electronically tied to the materials (Figure 1). This system architecture would streamline the reporting process, make it easier to staff to manage workflows, and expedite verification. It would consolidate the existing disparate systems into an integrated enterprise solution.


Figure 1.

The trick, however, would be integrating the four very different laboratory systems with fragmented legacy processes while at the same time moving the system onto the Web for easy user access that would also dramatically reduce paperwork.

Legacy Processes

The four different labs utilize similar but different processes for virtually the same tasks. For instance, only the Pesticide lab was using PE LABWORKS LIMS. Both the Fertilizer and Seed labs were using different in-house LIMS solutions, while the Feed lab did not have a LIMS but used contract labs to manage and provide sample analysis data. Even with these systems, the labs processes often required duplicate data entry.

Sample collection processes differed. Licensing processes differed. Management of compliance and penalty information differed from lab to lab and typically required staff to enter both license and analytical data from other systems manually into their in-house solutions. Sometimes the tonnage reporting process was self-reporting, but in most cases it was not, and was a paper-based process that staff manually re-input into the appropriate database. In all cases, the financial data was not integrated with any of the systems. These legacy solutions had grown more complex over time as well as more laborious and error-prone.

While reviewing the legacy business processes, many parallel processes where identified and mapped. Processes that were similar between labs could be accommodated by lab-specific fields configured in the LIMS. For instance, it was found that the Fertilizer, Feed and Seed programs all utilize similar paper-based processes to manage the required Licensing information – a relatively easy task to integrate across the labs. In addition, the Fertilizer, Seed and Pesticide programs all utilize the same field inspector staff who collect most of the regulatory samples submitted for analysis. Having one sample collection and login process would be a great advantage with any new system. Finally, the Fertilizer, Feed and Seed programs all utilize the same revenue processing procedures and revenue processing staff. Thus, the similarities between processes made an excellent starting point for mapping the integration.

During the review meetings with Florida staff, a master database design was developed that addressed the four labs and three program area requirements. A blueprint was created to expand the LABWORKS LIMS application from the Pesticide laboratory implementation to support all the LIMS, Licensing and Compliance programs within FDACS.

This blueprint examined the legacy processes for each laboratory from sample login to reporting, inspecting each step in the lab’s processes.

Legacy Compliance Systems

Next, a review of the legacy compliance systems was conducted that examined the compliance processes for each lab from the forms used for tonnage reporting, to compliance sample labeling and analysis, to the lab’s probationary, penalty and administrative fine assessment processes. Each compliance system proved quite different.

For instance, the Feed Registration and Compliance Monitoring application was an Access-based solution that required not only manual staff data entry and maintenance, but also creating all Access-based reports and forms. The result: Licensee and lab data is duplicated across multiple databases and systems.

The Fertilizer compliance and enforcement system, on the other hand, while built in Oracle Forms, used separate databases that were no longer supportable due to staff and platform issues.

Therefore, whether sophisticated or not, the various laboratory solutions were greatly inhibiting staff’s ability to operate effectively, making an integrated enterprise solution imperative.

New Integrated Enterprise System

With process and systems mapping complete, the development of an integrated system could be envisioned. First, a common vocabulary was provided between programs that enabled PerkinElmer and FDACS staff to establish a core LIMS and Licensing database structure design that, in turn, enables all four laboratories to share one enterprise LIMS running on one Oracle database.

The first design goal was to build the Feed, Seed, and Fertilizer New Applicant Web-based processes. This allows the application to be initiated and completed through Web pages that communicate with the Oracle database and eliminate the former paper-based application forms. Best of all, the registration Web pages accommodated the needs of the Seed, Feed, and Fertilizer programs, and started with the same password-protected login that would automatically direct the user to the correct area within the system (Figure 2).

Figure 2.

For instance, each licensing program area provides a similar web page for new applicants to become licensed for the specific program within the state of Florida. The application process utilizes multiple frames similar for collecting all application required data (Figure 3).


Figure 3.

The registration Web pages were just the start. New sample login, result entry, sample validation and final reporting processes were created for better data management and access. New Windows-based sample login, result entry, sample validation and final reporting processes were also placed on the Web for end-to-end Web data management and access. Additional pages for sample receiving were added for the labs that needed those processes. The result streamlined all processes, made all sample validation conform to a standard LIMS validation process, and automatically compile reports for emailing to Licensees or hard copy printing. In the case of the self-reporting processes used by the Feed laboratory, Licensees could access reports from the Web site after samples were validated by the LIMS.

In all cases, once samples were input, automatic calculations performed by the LIMS would automatically flag results that were out of specification. Once results are accurate, automated reports that combine lab data, accounting and compliance data were delivered via a consistent web-user interface.

New Streamlined Processes

New LIMS sample login and receiving processes were also implemented. The Field Inspectors will start the login process by entering demographic information about the sample collected. No analyses are assigned until the sample is received by the laboratory for analysis. Once the sample is received, the sample custodian locates the pre-logged sample information by barcode scan and completes the login process by assigning analysis codes and entering the sample guarantees from the sample label used to calculate the specifications required by that sample and the selected analyses.

When the sample custodian clicks the analysis lookup button, the analysis selection frame is displayed which provides a filtered list of analysis codes. The sample custodian adds all of the required tests and enters the Label Guarantee values for the analyses selected. The LIMS will automatically calculate all required specifications for the selected analysis added to the sample.

The LABWORKS LIMS Process Scheduler program tracks the sample status throughout its lifecycle. FDACS staff can now easily identify all samples requiring analysis and complete their analysis work on the requested analysis.

In addition to new sample login and receiving processes, new sample results entry processes were implemented. Whether the result(s) is manually entered, brought in from an instrument interface, or is loaded from a contract lab supplied data file, a results entry screen will provide significant figure formatting and compare the result with specifications. Visual color changes and popup notification as well as email notification of the violation are provided to appropriate staff (Figure 4).


Figure 4.

New Reporting and Compliance Processes

New reporting processes were also implemented for not only compliance reporting but also tonnage automation and the self-reporting system. For instance, the Fertilizer Monthly Tonnage Compliance self-reporting process now provides the registered Licensee with a web page that must be completed each month. If not completed on time, the report is considered late and late fees and interest changes are calculated on the inspection fee amount due to FDACS. All reported values are calculated into the invoice tables and payment coupon processes are provided to the Licensee to submit the required Inspection fee amount including any late fee and interest charges. Failure to follow the reporting procedures can result in the Licensee’s license being suspended and penalties or fines can be levied against the Licensee for non-compliance (Figure 5).

Figure 5.

Another critical compliance process within this project is the Feed Registrant submittal of required compliance samples. A web page is provided that identifies the required compliance samples calculated from the tonnage values submitted. These pages provides the Feed Registrant with the ability to login samples into the LIMS as well as download the file to be sent with the compliance samples to the Contract Lab for analysis. The Web login page provides the entries used by FDACS to capture the result data from the Contract Lab and provide compliance information to the Feed Registrant.

Such automated calculations, automated compliance, and automated tonnage and self-reporting have the potential to provide FDACS with significant cost-savings from reduced staff reporting management.
For instance, providing a Web page to enter or upload the Fertilizer data prevents transcription errors. The data is entered one time by the owner of the data and not reentered by FDACS staff.

In addition, the Web self-reporting process shifts the burden of tonnage reporting to the thousands of Licensees instead of the few FDACS staff who are already over burdened with the data entry of the tonnage forms into the Access and Oracle Forms systems.

Best of all, the new self-reporting system enforces a standard set of calculation and validation rules on the data being reported.

Finally, the data is 100 percent controlled by the FDACS staff, eliminating the need for an outsourced contract.

Technical Development Platform

The technologies employed to develop the system include the Microsoft .NET Framework and AJAX (Asynchronous JavaScript and XML). Programs written for the .NET Framework execute in a software environment that manages the program's runtime requirements. AJAX, on the other hand, is a group of interrelated web development techniques used for creating interactive web applications or rich Internet applications. With AJAX, web applications can retrieve data from the server asynchronously in the background without interfering with the display and behavior of the existing page.

The benefits of this approach include a solution that works on SQL Server or Oracle database platforms, delivering platform flexibility and not locking the laboratories into a single solution. This database independence makes migration to new hardware, operating systems, or database server releases easier. In addition, scalability is built into the Application delivery tools, which enables easier development at lower cost.

The result? A modern architecture that leverages scalability, security, supportability and shared data between the Web and Windows applications. The platform design enables custom applications to be developed on top of the standard services-based architecture as well as the ability to share the code library between all applications. And, future extensions of the LIMS platform to custom applications can be developed with leading-edge tools.

Summary

In summary, FDACS sought to pull their disparate, aging systems together into a single, integrated, web-based enterprise solution that would still accommodate the different laboratories’ requirements while upgrading the entire system to more flexible, state-of-the-art functionality. It is still a work in progress as they implement the upgrades by stages, but the end is in sight and success is visible on the near horizon.