Labs in the Information Age

LIS and LIMS are contributing value for a growing number of clinical lab operations

By Elaine Sanchez Wilson, MPP

When it comes to adopting any form of information technology (IT), the healthcare sector has a well-earned reputation for being careful, conservative, and glacially slow. Even with significant carrot-and-stick incentives from both government and private payors, IT-based systems have been slow to penetrate many healthcare settings.

But over the past decade, as an increasing number and variety of IT systems have demonstrated their value to payors, providers, and patients alike, the barriers to IT adoption have gradually begun to fall. Today, with initiatives and opportunities ranging from electronic health records (EHRs) to big data analytics, IT systems are reshaping the healthcare landscape.

For clinical laboratories, adoption of IT systems can mean a lot of different things, starting with the selection of IT-enabled analyzers and point-of-care systems, and progressing all the way to the delivery of test results and billing statements. Along the way, labs can select from a number of systems that are designed essentially to record, store, and analyze patient test results, but often feature many other capabilities. While such options are plentiful, lab personnel face a host of challenges along the path to their digital future. Key issues include data integrity, usability, and compliance with regulations and voluntary standards, as well as the need to achieve system interoperability among the growing number of collaborators in today’s healthcare delivery systems.^{1, 2}

For laboratory directors, selecting a laboratory information system (LIS) to perform such tasks is an onerous but important duty. An LIS represents a significant commitment of resources—including both time and money—for converting paper records to electronic formats, synchronizing paper and electronic records, optimizing workflow, and training staff. And even the most tech-savvy of laboratorians can find it challenging to navigate a marketplace that includes both LIS and laboratory information management systems (LIMS)—traditionally distinct systems whose functionalities and feature sets are increasingly converging.³

INDIRECT GUIDANCE

An added layer of complexity results from the large number of government agencies and other organizations whose regulations and standards can decisively influence the ways that laboratories manage the data under their control. “An LIS or LIMS may be indirectly guided by regulations or standards meant for other systems that interface with the laboratory, such as the certification requirements of the Office of the National Coordinator for Health Information Technology (ONC),” say MariBeth Gagnon, MS, CT(ASCP)HTL, and Megan E. Sawchuk, MT(ASCP), members of the LabHIT team at the Centers for Disease Control and Prevention (CDC). ONC certification requirements specify that health IT systems must use the Health Level 7 (HL7) format for communications, and must adopt the logical observation identifiers names and codes (LOINC), systematized nomenclature of medicine (SNOMED), and unified code for units of measure (UCUM) systems for vocabularies. “If a lab’s LIS or LIMS does not have the capability to transmit electronic messages using a standard specified by an interfaced health IT system, the lab will incur additional costs for middleware to make communications possible.”

In the absence of a single, centralized agency with authority to oversee performance standards for LIS and LIMS, clinical laboratories can find themselves in doubt about what standards should apply to such systems. Because LIS and LIMS operate alongside EHRs that have benefited from unprecedented federal incentives to stimulate widespread adoption, for instance, laboratory professionals must keep abreast of guidance regarding health data exchange from both ONC and the Centers for Medicare and Medicaid Services (CMS).⁴ Other standards that labs may need to keep up with include FDA’s current good manufacturing practices, good clinical practices, and application integration policies.⁵

Labs must also comply with pertinent regulations established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which delineate the required elements for reporting test results. “There are eight or 10 required elements that determine the validity of test results, including patient identification, reference ranges, and units of measure,” says J. Mark Tuthill, MD, head of the pathology informatics?division at Henry Ford Health System, and a member of the informatics council of the American Society for Clinical Pathology (ASCP). “Following current CLIA requirements ensures quality lab reporting. But satisfying the requirements means that labs have to pay special attention to results validation.”

There is a small upside to the absence of specific requirements for LIS and LIMS used in clinical laboratories. According to Gagnon and Sawchuk, the lack of specific performance standards “allows laboratories the latitude they need to address their own LIS and LIMS needs, while also accommodating the paper-based systems that continue to exist in small healthcare settings, such as physician offices and clinics.”

But such flexibility may be short-lived. Although no current regulations apply directly to LIS and LIMS used in clinical laboratories, a number of standards-writing organizations are working separately to compile consensus-based guidance documents. “We believe there is an opportunity for further coordination of the efforts by such stakeholders, which include standards-setting bodies, laboratory accrediting organizations, industry stakeholders, and federal partners,” say Gagnon and Sawchuk.

SEARCH CRITERIA

As they finalize their choice of system, clinical laboratories review a number of factors. According to several LIS and LIMS vendors, there is one checkbox in particular that users seek to mark off.

“Integration, integration, integration,” says Nancy Stoker, director of product management at Orchard Software, Carmel, Ind. “Tight integration with many different types of systems, and less reliance on middleware to accomplish such connections, are key features for today’s laboratories. Clinical laboratories are seeking greater connectivity, and fewer systems that require support. From point-of-care devices to outreach, from core laboratory to molecular workflow management, greater connectivity and ease of support is necessary.”

Adam Hasler, head of design at Ovation, Cambridge, Mass, says his company completed extensive interviews with a wide range of clinical lab team members in an effort to understand customer demand. “The results surprised us,” he says. “Rather than emphasizing sophisticated scientific processes or activities, most folks in the lab want more visibility and analytics for information currently locked in their LIMS, and better communication among their many disparate systems.”

“We spoke with many labs that are forced to purchase and integrate multiple systems to complete their analytics and business capabilities,” Hasler continues. “Bringing these capabilities into the LIMS is a goal for many users.”

“Today, clinical labs are generating more and more data. But storing, analyzing, and interpreting such large amounts of data makes the adoption of modern informatics technologies essential,” says Jacqueline Barberena, director of global marketing and communications for informatics at Abbott Laboratories, Abbott Park, Ill. “Labs are also facing pressure to deliver results faster, which necessitates integrated systems that achieve seamless management of data and analytics. To ensure the lab’s success, clinical laboratorians are looking for a LIMS to help increase efficiency, eliminate the use of paper, increase user flexibility, and provide a capacity for growth.”

Clinical labs are also looking for systems that can be specifically tailored to their individual operational needs. “Every lab has unique requirements when it comes to workflow,” says Joseph Nollar, associate vice president of product development at Xifin Inc, San Diego. “Labs are demanding that the LIS provide capabilities to create a unique workflow that reflects the lab’s actual processes for each testing modality. System requirements include data integration capabilities at each workflow step to facilitate communications with electronic medical records, device-native or interface middleware, and analytics via Web application programing interface (API) services. Labs require workflow solutions that facilitate new revenue-generating opportunities, such as offering technical component and professional component (TCPC) consultation and collaboration. Further, labs want control via an API to be able to write their own interfaces and extract data from the LIS for management reporting and analysis.”

When moving to adopt a LIS or LIMS, it is important for labs to fully dissect their specific operational processes, and to exercise due diligence in modeling their workflow and understanding their overall user activities. “Making sure that there are standard procedures and standard operating functions and activities is critical,” says Tuthill. “Once a lab understands its workflow and how it will use the application, it will find that the application is not a perfect match. Workflow will need to be redesigned to leverage the application. Labs also have to make sure that staff are executing procedures in a consistent fashion, so that they aren’t coming up with creative ad hoc solutions.”

According to Richard Callahan, vice president of sales and marketing at NovoPath, Princeton, NJ, a laboratory’s LIS and LIMS needs are largely a function of its size. “Clinical laboratories’ needs vary in accord with the client base they support, the number of specimens they process, their financial outlook, and a plethora of other secondary factors,” he says. “In general, small, start-up, and specialty labs are looking for basic system functionality that provides the ability to add functionality as the lab grows, ‘plug-and-play’ software and hardware, and reasonable pricing.

“Medium-sized laboratories are looking for an easy-to-use system with functionality that is tailored to their clients’ needs; the ability to retrieve and analyze data; interoperability among laboratory instruments and other software used in the lab, hospital, or clients’ facilities; and value pricing.

“Large labs have needs that are similar to those of medium-sized labs, but with the additional capabilities of tracking a specimen throughout the entire testing process, and streamlined management using real-time data to inform the lab’s Lean Six Sigma process.”

LIS and LIMS customers are also paying close attention to the systems’ capabilities for customized reporting of test results. “Labs want to be able to create unique and aesthetically pleasing reports that reflect their test results in the best way possible,” says Nollar. “Desirable features include a robust process for creating report templates, support for clients who want to manage the components of custom templates, client-specific templates, case summary reporting across lab departments, and templates for technical and professional reports. Labs also demand that reports are extensible in a variety of formats, including PDF, XML, and HL7.”

“Also in demand are decision-support rules for managing test orders, particularly as labs move from a fee-for-service environment to the new regime of outcomes- and results-based medicine,” says Stoker. “LIS and LIMS need to incorporate algorithms that enable labs to receive orders correctly and in a timely manner. It’s imperative that the systems have decision-support rules for evaluating test results and for triggering proper billing.”

Still, the requirement for interoperability stands as the primary concern of LIS and LIMS customers. “The top issues continue to be the ease of connecting various EHR interfaces to a LIS or LIMS, and mapping LOINC and SNOMED coding for use by each test system,” say Gagnon and Sawchuk. “With more than 250,000 clinical laboratories or testing sites in the United States, the number of potential interfaces among LIS and LIMS is enormous. The path toward standardization of such interfaces has been challenging because of clinical laboratories’ longstanding desire to customize their services. Nevertheless, standardized interfaces and structured data collection are imperative for advancing patient health at all levels.”

In a bid to make codes publicly available in a format that is easily accessible for use by any healthcare system, CDC has partnered with FDA, the National Library of Medicine, and the Regenstrief Institute to promote code selection by in vitro diagnostic device manufacturers. “Once the codes are standardized and incorporated into a structured data format, it will be easier to use laboratory test result data to conduct surveillance at the local, regional, and national level, as well as provide greater insight into diagnostic decision making,” say Gagnon and Sawchuk.

MEETING MARKET DEMAND

“Clinical labs seek flexibility in processing orders and results, the ability to deploy affordable electronic interfaces among their clients, and the ability to easily configure LIS workflow to match changing lab operations,” says Oscar Ray Rodriguez, CEO of Apex Healthware, Springfield, Mass. Responding to such requirements, Apex has built a “rules-based” application that permits features and operations to be configured from within the database. “Deployment is configured to meet the needs the client has expressed,” says Rodriguez. “The inevitable changes are easily handled, simply by adjusting the applicable rule.”

Agreeing that ease of integration is a key market demand, Lisa-Jean Clifford, CEO of Psyche Systems Corp, Milford, Mass, says her company’s offerings, including Psyche NucleoLIS, are built to deliver. “Integration is an area we have down pat,” Clifford says. “We have always excelled at being able to integrate with everything from instruments to other applications. Our software solutions are all built on a very open architecture, and we have built a middleware communication and data-sharing platform that allows for fast, inexpensive, and accurate integrations.”

Susan Eben, MT(ASCP), BSc, product manager at McKesson Lab Solutions, Alpharetta, Ga, says customers of the McKesson Lab are privy to “experienced and knowledgeable service and support personnel” who keep current with changes in the healthcare market, such as technology advances, regulatory changes, and requirements imposed by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The LIS also offers intuitive workflows and “robust and feature-rich functionality that allows complete automation from the order being placed to the delivery of results,” she says.

StarLIMS, the LIMS technology of Abbott Laboratories, Abbott Park, Ill, is a similarly feature-laden system that provides labs with the cumulative analytics and data management tools that are needed for multidisciplinary healthcare environments. A Web-based system that uses a single, centralized data storage site, StarLIMS is fully scalable from single-site to multisite installations for all locations and lab disciplines. This allows for simpler and less costly validation for multisite rollouts.

“StarLIMS software provides advanced analytics that enable lab clinicians to analyze their stored data and gain a real understanding of how the lab is running, allowing them to make better, more-informed decisions,” says Barberena. “Analyzing data and looking at trends and patterns over weeks, months, and years, can provide valuable insights into the operations of a lab. It can help to answer questions for root cause analysis, to spot bottlenecks that are causing performance issues, and to identify opportunities for improvement.”

Callahan says that NovoPath’s modular approach permits labs “to grow at their own pace, from core functionality to functionalities that support cytogenetics, flow cytometry, fluorescence in situ hybridization, molecular, and other specialty tests.” He also notes that the company’s platform was designed with affordability in mind, addressing the constraints of budget-strapped customers.

“NovoPath provides labs with the ability to track a specimen from accessioning to archiving,” he says. “In addition, with NovoPath’s Lean process management and specimen tracking module, laboratories have the capability to manage by Lean principals using ‘real-time, in-the-moment’ data. With NovoPath, pricing is not based on volume, but on needed functionality, so that labs purchase only the functionalities that provide them the greatest returns for safety and efficiency.”

At Orchard, the company aims not only to serve but also to learn from customers of its Harvest LIS, which provides advanced decision-support to enable autovalidation, decision trees, and algorithms for reflex testing, routing of results, charge capture, and test interpretation. “Our customers are our greatest resource,” says Stoker, adding that the company’s products provide data mining and reporting capabilities and are configurable and flexible enough to manage workflow in patient-centric or batch-centric models. “We have an easy-to-use method to submit requests for software modification, including a forward-facing tracking system to assist our customers in following the development process. Our company places great value on our customer’s contributions, and continually seeks out and responds to their input.”

The cloud-based architecture of Xifin’s LIS Anywhere platform was developed as “a flexible and adaptable product that allows customers to create tailored workflows, custom patient reports, and robust management reports,” says Nollar. “LIS Anywhere is designed to help labs create new revenue streams by facilitating TCPC consultation and collaboration workflows with client-specific report templates. The system has a robust Web-service API that allows the lab to integrate devices, electronic medical records, and software and analytics solutions. Xifin’s LIS Anywhere is one component of an integrated platform of solutions that include billing, business intelligence analytics, clinical data management, and consultation and collaboration tools.”

Aspiring to “break the mold of what a LIMS does,” Ovation responds to its customers’ desire for information, says Hasler. “When it comes to information, labs are looking for details surrounding turnaround time, accurate sample logs, and easily accessible reports,” he says. “With existing LIMS, this information is trapped inside the computer, and the lab technician has to become an expert in writing SQL statements just to get information from work that’s already been done. We hope to make that information a lot easier to access, not just for the sake of audits, but for the sake of the lab’s business.”

Hasler says that Ovation has combined LIMS with “the essential elements of document management and training management, to create a seamless experience that unites all three.”

“While viewing an activity in a lab, a user can quickly and easily see who’s received the training required to perform that activity, and the SOP related to it,” he explains. “Similarly, the system can easily control access to activities based on a user’s training status and lab policy. At the end of sample analysis, data are stored automatically and, if the client needs it, sent electronically to an external reporting agency. Then, that report is delivered back into the system, and the appropriate people are notified to review or approve, all within the same system. We were called crazy for blending these capabilities together, but it has enhanced the LIMS, and dramatically improved lab operations.”

“The cloud-based, HIPAA-compliant infrastructure of the Ovation system not only provides significant flexibility to customers, it paves the way for moving a lab to operate entirely on tablets,” Hasler says.

WHAT’S AHEAD

According to CDC, LIS and LIMS vendors have an opportunity to demonstrate the value of their products. “We see an emerging opportunity for industry reports and LIS and LIMS vendor performance reports, both of which will help hospital administrators make informed buying decisions,” say Gagnon and Sawchuk. They add that the National Institute of Standards and Technology is in the process of updating its lab validation suite to incorporate all CLIA- and accreditor-required test report elements for a variety of common laboratory challenges.

“Also, ONC publishes a series of nine safety assurance factors for EHR resilience (SAFER) guides for assessing the safety and usability of EHR design features, such as evaluating how critical results are communicated. It would be highly useful for hospital administrators to have a report that provides insight into how well an EHR performs for their staff in terms of safety and usability for laboratory data.”

As LIS and LIMS operators handle an increasing amount of data, patient safety will be an area they need to address, says Callahan. “Administratively, laboratories will need to continue reducing the probability of lab errors, increasing efficiency, and reducing costs,” he says. “These goals can be accomplished by using ‘live,’ easily accessible data to guide Lean processes.”

Ensuring data integrity through rigorous patient sample identification, tracking, and management is another opportunity to be addressed by the next generation of LIS and LIMS. “If a lab doesn’t have integrity of patient identity, all other downstream processes are a waste of time, resulting in tremendous rework, callbacks, wasted money, and a direct impact on patients who may have to come in and give another sample,” Tuthill cautions.

Other major areas of anticipated growth include expanded molecular workflow functionality, support for personalized medicine, oversight of point-of-care testing, and integration with business solutions. And in an era of value-based care, LIS and LIMS stand to boost the role of the clinical laboratorian.

“Clinical labs are looking for a comprehensive laboratory solution that includes integrated LIS, billing software, and business intelligence tools to address the requirements of the emerging value-based marketplace,” says Nollar. “Achieving this objective will assist in keeping diagnostic service providers relevant as part of a collaborative patient care team. Lab systems need to be able to manage and share clinical data with external systems of all types in order to facilitate collaboration. An LIS must be able to integrate increasingly complex data sets such as those generated by next-generation diagnostics. The LIS of the future needs to be able to manage these complex data sets in order facilitate secondary consultations and multidisciplinary team review to assist in patient treatment planning and long-term care.”

“In the next 5 years, an LIS or LIMS will not only ensure that a lab’s patient data are collected and stored,” says Hasler, “but will also become the number-one tool for growing the lab’s business.”

Elaine Sanchez Wilson, MPP, is associate editor of CLP. She can be reached via [email protected].

REFERENCES

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