Leaving the Paper Chase Behind

With the help of a new laboratory information management system, the Portland, Ore., Bureau of Water Works has managed to make its paper-based data system a thing of the past and streamline with throughput electronically

Implementation of a new Laboratory Information Management System (LIMS) has helped the Portland, Ore., Bureau of Water Works meet regulatory requirements while increasing laboratory throughput. Water quality laboratories across the country face the need to perform a higher volume of testing and improve data security in order to ensure the safety of the nation's water supply.

After determining that their previous paper-based system would be hard-pressed to meet upcoming regulations, the technical staff selected a LIMS that demonstrated the ability to adapt to their existing workflow, eliminating the need for disruptive and potentially expensive custom coding. "Implementation of the new LIMS has improved our control of data to the point that we can now easily determine exactly who entered or changed any piece of information and when and why it was done," said Alberta Seierstad, laboratory manager for the Portland Bureau of Water Works. "The new LIMS has also helped us increase throughput by automatically scheduling most samples and allowing field data to be collected on handheld computers and uploaded to the LIMS."

The Portland Bureau of Water Works operates the water supply system that delivers high-quality drinking water to more than 830,000 people who live in the Portland metropolitan area. The primary water source is the Bull Run Watershed, located 26 miles east of downtown Portland in the Mt. Hood National Forest. Portland also uses groundwater as a supplemental water supply. The city's water quality laboratory is staffed by seven people who perform a wide range of tests designed to ensure the quality of the city's water supply, including tests for bacteria, physicals, nutrients, organic compounds and biological parameters such as chlorophyll and algae. The lab operates six days a week and analyzes approximately 10,000 samples per year, performing about 100,000 analyses on those samples.

Water Labs Face Higher Demands
Seierstad said that the requirements faced by the lab have progressively increased over the past few years, particularly after the lab was required to obtain accreditation through the National Environmental Laboratory Accreditation Program (NELAP) program in the state of Oregon. Some of the requirements specify that laboratories must prevent changes to analysis data and enable the reproduction of original results by linking data and outcomes. Traceability must be guaranteed by a secure audit trail. Laboratories must be able to retrieve stored data for a specified number of years.

"The new regulations go considerably beyond what was required of us in the past," Seierstad said. "We could have potentially met them with our old paper-based system, but it would have been an enormous challenge to ensure against, for example, the possibility that someone could have simply thrown away a piece of paper and replaced it with a different one." Even prior to the new requirements, management had already made the decision to implement a LIMS. They reasoned that a LIMS inherently provides a far superior platform for meeting the new regulatory requirements. Leading edge LIMS automate the process of ensuring data integrity by limiting access to data to authorized users. The more advanced systems automatically generate an audit trial that makes it possible to trace the history of any particular piece of data.

LIMS Selection Process
The process of selecting a LIMS began by identifying key stakeholders in the decision, including all laboratory personnel, as well as key information technology staff members and a variety of water operations personnel. A core team of six to eight people, including key lab users, Information Technology (IT) staff, regulatory compliance reporting staff and an operations staff, handled the day-to-day decision making while a larger group was brought together when needed. The lab selected Black and Veatch as consultants to help conduct planning, needs assessment, workflow analysis and processing mapping, as well as surveying available LIMS products and developing a request for proposal (RFP). Seierstad and her staff visited several labs that were actively using the LIMS products under consideration.

Vendors demonstrated their products for the selection team and other interested persons. The vendors submitted written proposals and the selection team reviewed and scored the proposals and chose three finalists. Each of the three finalists presented a demonstration based on a script that was designed to highlight the ability of each system to address the lab's current workflow and NELAP requirements.

The decision was made to select LABWORKS LIMS from PerkinElmer. "We selected LABWORKS because it came the closest to being able to meet our requirements out of the box," Seierstadt said. "The PerkinElmer scripted demonstration showed LABWORKS performing a series of scenarios that mirrored our daily operating procedures. We were surprised that LABWORKS was able to handle our current workflow and meet many NELAP requirements without any customization. Their presentation demonstrated that the software was flexible enough to adapt to our needs so we could maintain our existing business processes with only minor modifications. It also eliminated the need for extensive customization that would have driven up the cost of the system, delayed implementation and raised the risks of running into problems down the line."

"At the beginning of the project, an IT person, Sisay Mengistu, was assigned to the laboratory work group to work full-time on this project," Seierstad said. "By working full-time on the project, Sisay was able to become very knowledgeable in the operations of our laboratory. He brought an IT perspective to the project that helped to avoid downstream problems. Mike Lehtola directed the implementation process from the vendor's side. We walked Mike through our workflow in detail, went over the regulatory requirements and also filled him in on some of the things we were planning, such as enabling our sample collectors and field engineers to enter data into handheld computers and synching them with the LIMS," Seierstad said.

LABWORKS modules track the sample through processing sample requests, sample collection, sample receipt, sample identification, sample tracking, sample analysis and chemical and equipment maintenance. This makes it possible to determine holding times for each test and the overall sample, report on its progress, monitor the time spent at each step and on each test, alert the user concerning samples that are nearing holding time limits, etc. In addition to "what has been done" and "what still needs to be completed," LABWORKS has an "internal" chain of custody feature, which "remembers" where the sample has been, who has handled it, when they had it, etc.

No Coding Required
LABWORKS' built-in tools to mold the software to their lab process and accreditation requirements without having to do any coding at all. "The base software already meets the regulatory requirements by providing features such as electronic signatures and traceability of data from time of entry through all succeeding business processes. The next version, which is due out shortly, will go considerably further by providing a single centralized point of authentication that controls access to all applications and data. The results entry portion of the program was configured to accept data from the handheld computers and also to accept input from four instruments providing pH, conductivity, turbidity and color measurements at a single workstation. Finally, 20 custom reports were designed to match and exceed the Portland Bureau of Water Works' existing reporting requirements. Besides installing and testing the software and training the users, that was about all that was needed to get them up and running.

LABWORKS provides complete quality assurance/quality control tracking and validation procedures. Analysts immediately receive visual feedback when a result is entered out of specification ranges, such as quality control limits for duplicate precision and spike recoveries or operational limits specific to the sampling point. A historical trend chart can be generated by the analyst with the click of a mouse, giving the analyst a wealth of information with which to make timely decisions. These features not only increase the quality of the data, but address quality and operational issues at the bench instead of becoming larger problems later in the sample lifecycle. The same set of tools is available to the Quality Control Officer and end-users of the laboratory data

Portable Data Entry
The Portable Data Entry Terminal (PDET) is a handheld, heavy-duty computer with barcode and Global Positioning System (GPS) capabilities that provides a portable remote sample collection and data recording terminal.

Seierstad said that the new LIMS has substantially improved laboratory operations. "We have automated a number of previous manual operations," she said. "For example, the majority of samples are now scheduled automatically by the LABWORKS Process Scheduler module. Most test results are electronically entered into the LIMS through direct interfaces. The entry of field data with handheld computers eliminates what used to be an additional data entry step. The new system also has automated many calculations that were performed by hand in the past, saving time and improving accuracy. In addition, we have a clear record of each sample and each result that was generated, including an audit trail and validation records. Mike and the rest of the PerkinElmer staff were very responsive to our needs throughout the process. All of the major project elements were completed on time and within budget. All in all, this was a successful project that met our objectives and will continue to pay dividends many years in the future."


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This article originally appeared in the 09/01/2003 issue of Environmental Protection.

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