You could not run a modern diagnostic lab without software. Paper records and manual sample handling and testing are part of a bygone era for labs because lab information systems (LIS)—basically, IT systems and information tracking—have not only replaced them, but have become vital to diagnostics. A LIS receives, processes, and stores information generated by medical laboratory tests, and its functions typically support such features as patient check-in, order entry, specimen processing, result(s) entry, reporting, and patient and physician demographics.

Other functions can include Web-based order entry and results inquiry, faxing and e-mailing of lab reports, custom report creation, HL7 interfaces with reference labs and EMRs, preliminary reporting, final reporting, med tech worksheets, workload balancing, Medicare medical-necessity checking, and billing. The LIS often interfaces with instruments and other information systems, such as hospital information systems. Physicians can view results anywhere they can get online.

In an inpatient setting, the LIS is used to order tests, provide specimen-processing assistance, receive results from analyzers, and deliver lab reports to the attending physician. Orders are usually placed in the system by a physician, physician’s assistant, nurse, office clerk, or laboratory technologist. A LIS can run, track, and report a wide variety of tests.

The Current State of the Art

But how well is a LIS meeting the needs of today’s labs and physicians? What’s the state of the technology, how are vendors responding to the need for improvements, and what are the priorities?

According to Curt Johnson, vice president of sales and marketing for Orchard Software, Carmel, Ind, “In today’s marketplace, state-of-the-art LIS means software that can integrate tightly with other software packages in an organization to benefit providers and patients. Systems also have a sophisticated physician-support element: rules-based technology that allows the software to look for ‘if/then’ statements to facilitate the next step in the process,” he says.

In oncology, so that decisions can be made regarding whether or not chemotherapy should be recommended, data is transferred to an electronic medical records (EMR) format, Johnson notes.

Two areas play into LIS and oncology, he says—clinical and anatomic pathology (AP)—and it’s desirable and necessary to integrate both of them into the EMR. “AP is more difficult because clinical testing deals in numeric data such as CBC and PSA testing. You get a quantifiable number as a result.

But pathology testing, which includes biopsies, presents a big block of data for interpretation by a physician, and therefore the data doesn’t fit into a nice slot like clinical testing does.”

A nice feature of newer pathology software is that it can take digital photos of slides and other material, which can normally be tough to interpret from an EMR.

“An ideal LIS can handle both clinical lab and AP information and seamlessly integrate it into EMR. This type of software is state-of-the-art,” Johnson says. Therefore, end users want more of such software because there aren’t many products on the market yet that can do this, he says. But the demand for such software will mean more such products will be on the market because for labs, they’re an absolute necessity, he reiterates.

“Digital pathology is here now; it’s not something of the future,” Johnson says. Offering digital photography of slides is a great leap forward, he says, because the photos can be put on the Web so pathologists and physicians in widely spread areas can look at the photos and discuss treatment based on them. “A specialist at the Mayo Clinic can discuss treatment in real time with a physician in Arkansas in real time while both are looking at digitally photographed slides. There’s no need to mail or ship the slides from one to the other. This is a great advantage,” Johnson says.

Molecular testing is another technology that’s continuing to evolve, he adds, and as it grows, more tests are being developed and ordered by oncologists.

For instance, two types of breast cancer tests—VRCA and HER2—are being done, which take into account individual patients’ genetics when recommending treatment.

Where is all this leading? “Software must have both clinical and AP modules because about half of testing is one and half is the other. It’s a hybrid, and it’s necessary for labs since they do both kinds of testing. Labs have to be able to provide interpretive results and have to have systems that integrate seamlessly into EMR, including digital capability, Johnson says.

“Some labs are already using these hybrid systems, although they haven’t made it into the mainstream yet. But these systems are not experimental; they’re being used. Cost is a factor, but their use will continue to grow,” Johnson says.

Advanced Materials Processing enhances patient safety by labeling and tracking case materials through the pathology workflow.

Capturing Critical Oncology Data

Scott Lavine, group marketing manager, Antek HealthWare LLC, Reiserstown, Md, says that the LIS plays an important role in capturing clinical data from the diagnostic analyzers that are responsible for measuring various laboratory tests specific to oncology practices. “The interface between the instrumentation and LIS is the first step. After the data is reviewed in the LIS by the clinical laboratory personnel, the LIS delivers the test results to the oncology practice software via an electronic interface to be reviewed by clinicians. The efficient and accurate dissemination of this data to the oncology software is crucial to an oncology practice due to the sensitive turnaround time needed for oncology treatments,” Lavine says.

“Data mining and access to that data are what we are hearing from oncology practices,” he says. The data-management system needs to have the ability to separate patient populations so statistical data analysis can be performed. Epidemiological study capabilities are important to oncology practices to better understand their patient populations that require the gathering of specific data. Accessing that data through queries and filtering tools are key elements that allow for the statistical analysis, Lavine says.

What’s coming next? “We see that patient access as well as clinician access to information is driving technology in health care,” Lavine says. In the future, Patient Web portals—where both oncology software and LIS software will export data so that patients can access it and better monitor their health care—will be prevalent.

Order Entry in IntelliLab offers keyword ordering to route specimens to the appropriate laboratory (in-house, reference lab) based upon patient insurance.

“We see mobile technologies allowing for doctors to receive text messaging on patient testing and treatment alerts to deliver more comprehensive care. The latest buzz with in vitro diagnostic vendors is delivering three-dimensional hematological histograms,” Lavine says.

The primary focus for IMPAC Medical Systems, Mountain View, Calif, is to provide software solutions for oncology treatment, according to Rob Macmillan, vice president of product management. He says that about 85% of IMPAC’s clinical laboratory system customers are oncology centers that test blood to determine a patient’s reaction to previous treatment and readiness for future treatment.

Erin Fast, product manager for clinical laboratory solutions at IMPAC, says that customers typically do basic tests such as CBCs and PSAs in-house and outsource the more sophisticated tests. Laboratory systems must be able to efficiently manage the differing workflow for each test performed.

Fast says that clinical laboratory system vendors in the United States offer most of the flexibility that laboratories need today. That includes flexible options for ordering tests, supporting laboratory automation, and tracking materials throughout the laboratory and the courier process. Newer demand to support molecular diagnostics is not so widely supported.

IMPAC also provides one of the leading anatomic pathology software solutions in the United States, and the connection to oncology is obvious, Macmillan says. AP has always given the ultimate determination of the type and extent of cancer present, he notes.

The AP laboratory workflow is being changed and improved dramatically with the advent of material tracking using bar codes on specimen containers, cassettes, and slides. Macmillan says that the IMPAC solution allows customers to optimize workflow and thereby improve turnaround time—which is essential in the oncology setting.

While anatomic pathology reports used to be quite different from clinical pathology results, this is changing rapidly. The almost completely textual nature of the report is being changed with more discrete data values being reported in addition to the pathologist’s microscopic description and diagnosis, Macmillan adds.

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In addition to determining diagnosis, anatomic pathology—and, in particular, molecular diagnostics—is starting to play an important role in guiding oncology treatment. “If you have a particular gene marker, certain treatments won’t be effective,” says Norris Abella, IMPAC product manager for anatomic pathology.

Personalized medicine will become critical as the effectiveness of treatment varies from patient to patient. “Costs of health care can be better contained if we can determine the most effective treatment for each patient in advance. IMPAC sees the future need and is building its software solutions for a close and ongoing dialogue between the oncologist and the pathologist in order to ensure optimal patient care,” Macmillan says.

Gary Tufel is a contributing writer for CLP.