It goes without saying that the computer has revolutionized the clinical laboratory. Patient records that were once kept in triplicate on paper forms and confined to whatever folder they happened to reside in are now recorded electronically for easy access and sharing of information. Tests that once had to be conducted manually (and laboriously) can now be queued and managed by automated workstations. The reporting of results, once limited by the speed of the US Postal Service or the give-and-take of phone tag, can now be conducted instantly via email.

Still, while the clinical laboratory has been made more efficient in the digital age, the rapid pace of technological advancement has also made its management more challenging. Accordingly, several companies have developed clinical lab software solutions in the form of laboratory information systems (LIS) to simplify laboratory requisitions, test management, and the reporting of results. CLP recently asked several leading software manufacturers to give us their impressions of current products, market trends, challenges facing laboratorians, and the future of clinical laboratory software.

Perhaps the most prevalent trend in the current market is the ever-increasing emphasis on connectivity. As stated previously, companies are adopting electronic systems for enhancing laboratory communications and maintaining patient information. Also, laboratories are increasingly moving their results reporting to Web-based systems so that results are available on demand to anyone with Internet access. SCC Soft Computer (Palm Harbor, Fla) has programmed real-time results access into its SoftWeb Laboratory Outreach Suite, designed for clinics and physicians’ offices. According to Gilbert Hakim, CEO of SCC Soft Computer, “The incorporation of Web-native applications in our Outreach product, SoftWeb, allows remote, anytime, anywhere access to results, order entry, and more, all via the Internet.”

Similarly, Psyche System’s (Milford, Mass) LabWeb™ LIS and Impac Medical Systems’ (Mountain View, Calif) IntelliLab® LIS offer Web-based result reporting. Additionally, Psyche Systems’ eXerva™ hosting services offer network-based utilization of the company’s LabWeb system in addition to its WindoPath™ anatomic pathology information system, Systematic Blood Bank (SBB) transfusion service software, and the e.lixa LIS add-on suite. According to Erika Schonberg, marketing director for Psyche Systems, this hosted system “offers laboratories flexible, Web-deployable laboratory systems that feature a modular design to adapt to specialized testing needs.”

Other outreach systems include Orchard Software’s (Carmel, Ind) Harvest Webstation module and eTeleNext Inc’s (Mission Viejo, Calif) physician office lab-link software packages. Mike Pauper, user interface manager for eTeleNext Inc, says that the company’s outreach package reflects its support for a Virtual LIS that “allows labs to select modular components to extend the life of their legacy systems or replace their system entirely with the eTeleNext Web-based LIS.”

The customizable rules-based systems offered by several manufacturers provide an extension of the flexibility offered by Web-based reporting. Rules-based systems allow the user to specify fixed responses from the software system in response to a wide range of results. As Gilbert reports, SCC Soft Computer’s rules-based framework ensures that “critical lab results do not have to wait for human intervention to push it to the next level. The system automatically recognizes it as needing immediate and further testing and/or analysis.”

Similarly, Kurt Johnson, vice president of sales and marketing for Orchard Software, reports that the rules-based design of the Orchard Harvest LIS “reduces errors and aids in decision-making for order routing, auto-approval of patient results, reflexing additional testing, automatic comments, and clinical follow-up recommendations.” Schonberg adds that Psyche System’s LabWeb LIS and WindoPath anatomic pathology information system can “interface to other information systems, instruments, and devices to help the laboratory fully automate testing from order and specimen procurement to results, report completion, and distribution.”

Impac Medical Systems’ Intellilab LIS offers Web-based result reporting.

Indeed, many software companies are extending automation beyond results reporting to areas such as billing, insurance claims, and interlab communication. One example of this is Antek HealthWare’s (Reisertown, Md) LabDAQ LIS and DAQbilling practice-management system; the programs are interfaceable to allow automated handling of most laboratory and financial concerns.

Beyond Web-based interfaces and customizable rules-based systems, there are numerous other unique features in the clinical laboratory software market. For blood donation and transfusion management, Wyndgate Technologies® Inc (El Dorado Hills, Calif) offers, respectively, its Safe Trace and Safe Trace Tx systems. The former is used to manage donor infectious disease testing as well as inventory, distribution, and billing, while the latter, widely used in centralized transfusion services, manages patient history, pretransfusion orders, and test results. Combined, these systems provide complete Vein-to-Vein® tracking, according to Wyndgate’s Noah Bentley, senior director of marketing.

Schuyler House’s (Valencia, Calif) SchuyLab LIS is designed to provide data efficiency and quick response times. As Jan Chennault, vice president of Schuyler House, explains, the SchuyLab database is compactly designed to require less hard-drive space. “This enables data to be available rapidly, even when the database has grown large,” Chennault says. The SchuyLab system also takes advantage of the operating efficiencies of using standard off-the-shelf hardware and the Windows® operating system, a philosophy they sum up as, “Bill Gates works for us.”

Looking to extend electronic communication, eTeleNext Inc features an AP Anywhere reporting tool, which, Pauper states, is “A customizable Web-based software package that enables online collaboration; electronic data collection from a wide variety of laboratory devices such as flow cytometers; case tracking; and electronic report distribution via several methods, including auto-faxing and the Web.” The AP Anywhere systems also promise easy incorporation of images and graphs into reports, in addition to facilitating remote report viewing and download capabilities.

Finally, SCC Soft Computer has incorporated PUSH technology into its laboratory software products. PUSH technology’s name comes from its design; it is formulated so that relevant information for specific tasks is “pushed” to users by the program without them having to request it. This interactive feature helps automate LIS function and ensures that the user does not overlook important information.

Concomitant Complications
While the development of a more advanced LIS is helping to make the laboratorian’s job more efficient, a common sentiment is that the advancement of testing and software technology also is making the job more complicated. As more tests and programs become expected components of the laboratorian’s knowledge base, more pressure is placed on lab workers to master these new tools. As Pauper from eTeleNext Inc explains, “Wholly changing systems, new system implementations, massive data-migration projects, and user training are often cost-prohibitive or just too overwhelming for management teams to consider.” Psyche Systems’ Schonberg adds that, “Emerging testing areas like genetic testing and the availability of new, more complex instrumentation poses a challenge to already overstretched lab techs who must learn the proper use of such equipment.”

Many in the industry share Schonberg’s view on overstretched lab professionals. The learning demands of these new technologies are in many ways working against the changing dynamics of the laboratory workforce. As Paul Taylor, director of sales and marketing for Antek HealthWare, says, “There are fewer trained medical technologists available, so more work is performed by staff with less education.” Interestingly, though, several companies viewed this as a problem that advancements in clinical laboratory software could help to alleviate. Johnson of Orchard Software predicts that increased LIS adoption will help to “improve efficiency and production with fewer staff.” Taylor predicts that lab workforce demographics will influence software designers to produce systems that are “easy to use, easy to troubleshoot, and require minimal training time.” Finally, Chennault from Schuyler House adds that as testing options expand, the pressure on the laboratorian will expand as well, when they move from running a test to determining whether the result is good.

This last point is especially relevant, as testing options are certainly expanding. Anatomic pathology suites, microbiology suites, blood-bank software, toxicology suites, hematology software, diagnostic genetics systems, and radiology modules all are specialized software options offered by the companies contacted for this article. Antek HealthWare’s LabDAQ features LabDAQ LiTe (for low-volume laboratories) and LabDAQ Toxicology modules, while Orchard’s Harvest LIS features anatomic pathology and microbiology modules. eTeleNext Inc features pathologist, logistics, and management modules, and Psyche Systems offers the WindoPath anatomic pathology information system and Systematic Blood Bank (SBB) transfusion service software previously mentioned. Finally, SCC Soft Computer has designed a range of specialized data-management systems to complement its central SoftLab LIS, including SoftMic® (microbiology), SoftPath® (pathology), SoftBank II® (blood transfusion), SoftDonor® (blood donation), and SoftGene® (genetics).

The Importance of Standardization
Additionally, many LIS have subsystems designed to complement specific lab hardware. This raises a further point. With the greater emphasis on connectivity and electronic records previously discussed, an associated challenge is ensuring that systems are compatible. As Johnson from Orchard Software reports, “The biggest challenge the laboratory faces is integration and the successful communication of orders and results.” One response to the need for standardized communication is the development of the Health Level 7 (HL7) Standards Development Organization. According to the organization, HL7 represents “an international community of health care subject matter experts and information scientists collaborating to create standards for the exchange, management, and integration of electronic health care information.”

All of the companies interviewed by CLP support HL7 standardization and are working to make their systems compatible with a range of laboratory hardware, electronic medical records (EMR), and practice-management systems. Schonberg reports that “Psyche Systems is working with clients to address the challenge of more easily sharing data between the lab system and various physician/practice EMR systems without traditional interfaces,” while Antek Healthware’s Taylor says that the upcoming version of LabDAQ will have “true bidirectional interfaces with regional and national reference laboratories, as well as HL7 interfaces to a host of EMRs and practice-management systems.” Finally, Johnson of Orchard Software notes that, “Orchard specializes in seamless integration, which makes host system, EMR, billing, and reference lab interfaces routine.”

Several companies raised a related point about the necessity for increased standardization with regard to specimen management. Noah Bentley from Wyndgate Technologies® Inc identified the potential of bar-code systems to track samples from collection through testing, while Psyche Systems’ Schonberg discussed the similar potential of radio frequency identification (RFID).

The Future
Moving from today’s challenges to the future of the clinical software industry, many companies stress that connectivity, Web-based communication, standardization, and automation will continue to be key topics over the next 5 years. However, there is considerable diversity in other key issues raised. Orchard Software’s Johnson suggests that, “The needs of the health care industry are so broad and expansive that it is too much for any one integrated vendor to handle. Best-of-breed systems and middleware will continue to exist and thrive to fill the gaps left by legacy systems.”

SCC Soft Computer’s Hakim says that, “Hospital laboratories are moving into the commercial lab market and changing the structure of their finances from a cost center to a profit center. They are acting as commercial labs, soliciting business from physicians and doctors’ offices as well as clinics.” At the same time, Schuyler House’s Chennault feels that continuing advancements in computer hardware will be utilized by next-generation clinical laboratory software systems. She predicts a move toward “enhanced graphics, interactive screens, multi-thread programming, and ubiquitous information,” adding that these systems will utilize interactive icons and drag-and-drop functionality to simplify software management.

Taylor of Antek Healthware foresees acceleration in the trend toward “systems that can perform testing more quickly, using less sample, less reagent, and less technologist time.” In a related point, Schonberg expresses hope that companies will see “advancements and new practical applications in the area of point-of-care testing—possibly arising from the Gates Foundation grants to develop a lab-in-a-box for testing in developing nations.” And on the common theme of connectivity, Schonberg says that she expects to see “more connectivity within the laboratory to new types of instruments and devices, beyond its walls to EMR systems and regional health-information networks, and more broadly to tumor registries and organizations monitoring infectious diseases.”

Ultimately, while developments in clinical laboratory software provide challenges for laboratorians, they carry the promise of benefits as well. Increased management-system compatibility and enhanced Web-based results reporting and outreach systems should streamline testing and communication. At the same time, increasingly specialized and customizable software packages will ensure that every lab can find a LIS to meet its needs. In the end, the continuing development of clinical laboratory software should enable computers to handle a greater share of the most routine work, allowing laboratory professionals to apply their skills to the areas where they are most needed.

James Seidler is a contributing writer for Clinical Lab Products.