Innovative Approach Promises Integration of Clinical Lab Data

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CEO SUMMARY: Any laboratory executive with several years in the business has confronted the limitations of laboratory information system (LIS) software. For a variety of reasons, LIS software seldom delivers the full range of benefits and cost-effectiveness sought by laboratories. But in the fee-for-service world of the past, such limitations were tolerated by the healthcare system. That is changing with managed care. As integration of clinical services evolves, it will be mandatory that both hospital laboratories and commercial laboratories become leaders in making clinical integration a reality. THE DARK REPORT predicts that any laboratory first to the marketplace with effective integrated LIS capability will achieve a dominant market position. Industry vendors with innovative integration solutions are now beginning to bring their products into the marketplace.

NO SINGLE TYPE of healthcare provider has a greater need to integrate clinical data than laboratories. In fact, the ability of a single laboratory to pass laboratory information through a variety of information systems will prove to be a significant success factor in the immediate future.

Industry vendors and laboratory executives alike consider information systems to be one of the most difficult areas to manage within the clinical laboratory.

Information systems create four problems for a typical laboratory. First, any time a laboratory wants to upgrade or change laboratory information system (LIS) software, the process is expensive, time consuming and disruptive to laboratory clients.

Second, taking orders from physician clients and reporting laboratory test results represents a major source of laboratory errors, customer satisfaction issues, compliance problems and billing/reimbursement failures. This is true whether the laboratory is hospital-based or an independent commercial laboratory.

Third, hospital laboratories want CPU-to-CPU links with their reference laboratories. When their two computers talk directly to each other, the benefits in productivity, accuracy and speed are remarkable. However, both reference laboratories and their clients find the process of creating a CPU-to-CPU link to be expensive, time consuming and difficult.

Fourth, the emergence of integrated delivery systems which seek to clinically integrate various aspects of healthcare creates a new challenge for both hospital laboratories and commercial laboratories. If laboratories cannot pass laboratory test data to all providers within the system, the laboratory becomes an impediment to clinical integration. Because more than 60% of a patient’s medical record typically consists of laboratory data, it is imperative that laboratory test data flow uniformly throughout the integrated healthcare system.

Any laboratory that develops an effective solution to one of these challenges will find itself with a competitive advantage in its marketplace. A survey of existing technology and available products reveals, however, that the LIS industry has yet to develop practical, low-cost options. The next generation of LIS still must demonstrate effectiveness in actual use.

In fact, most healthcare information system vendors are racing each other to incorporate the latest computer hardware and software technology into a product which makes integration of clinical data feasible in a wide variety of organizational models.

In King of Prussia, Pennsylvania, a company called Healthworks Alliance, Inc. is striving to create practical software bridges between existing clinical information systems. Performance of their earliest IS networks involving hospital systems and clinical laboratories provides evidence that a cost-effective way to link clinical laboratories with other providers in an integrated healthcare system may be just around the corner.

Because clinical integration of laboratory test data is a critical success factor for laboratories, Healthworks Alliance’s pioneering efforts provide evidence of the difficulties in achieving clinical integration within an integrated delivery system.

“We originally started as part of Advacare,” stated David Tribbett, Executive Vice President of Healthworks Alliance. “This was a company which primarily offered billing and collection services to hospital-based physicians. Advacare wanted to expand that business by offering billing to physicians who were ambulatory-based as well.

“Our original business goal was to permit the hospital to leverage excess capacity through our software, the hospital could encourage physicians to use laboratory, radiology, cardiology and other services. We would then go to the physicians and offer to do their billing as well.

“We’ve been developing software to integrate clinical services since the mid-1980s,” explained Tribbett. “As managed care began growing, we realized that products we developed as a way to sell billing services to physicians had greater value to hospitals and ancillary service providers in expediting clinical integration.”

Separate Company

In 1992, Advacare went public. As part of that transaction, Healthworks Alliance was spun off as a separate company. “This is when our emphasis on laboratory services began,” stated Tribbett. “Until then, our product was positioned as a way for the hospital to compete against commercial laboratories.

“We quickly saw the need was widespread to integrate laboratory data between the hospital and the reference laboratory. We also saw how commercial laboratories were placing computers into physician offices to create test requisitions and report results.

“We recognized that the marketplace was already linking physician to laboratory by computer,” noted Tribbett. “With our experience at integrating laboratory, cardiology, radiology and other ancillary services, we believed we had an established capability to build data integration bridges between all providers in an integrated system.”

Marketplace Dynamics

“We could see that marketplace dynamics would force clinical integration between two categories of providers: laboratory with its physician office client and reference laboratory with its hospital laboratory client.

For Healthworks Alliance, the first opportunity to develop workable solutions came several years ago with a contract involving The Malden Hospital in Boston, Massachusetts. “Malden saw its laboratory outreach business going to commercial laboratories because of managed care contracts. Our information system network has linked their ancillary services to physician offices since early 1994. Malden decided to protect their laboratory outreach business by partnering with SmithKline Beecham Clinical Laboratories. Both companies were to share in testing and split revenues from the contracts.”

It was Healthworks Alliance’s job to create an integrated data bridge between Malden and SmithKline. The goal was for physicians to order laboratory tests using one system. Specimens and data would flow to the Malden and SmithKline laboratories from that single order system. Results from both laboratories would go back to the physician through the same system.”

Partnership Dissolves

“After one year of this arrangement, for various reasons Malden and SmithKline parted ways,” continued Tribbett. “But Malden still wanted to pursue outreach testing with a commercial laboratory partner.

“Malden looked at Laboratory Corporation of America as a potential partner. LabCorp agreed. But the challenge for Malden was how to plug LabCorp into the existing relationship with Malden’s clients and not disrupt those physicians’ offices.

“It was easy for us to accomplish this because our product is designed to make test directory changes invisible to the end user,” noted Tribbett. “We had previously mapped Malden’s test directory to SmithKline’s catalog. This produced a consolidated ordering menu and a consolidated test report to the physician and ambulatory environment.

“When LabCorp joined Malden, we took LabCorp’s test catalog and mapped it on top of existing data fields,” he continued. “Physicians continued to order tests by the same name and received test results in the same format. Equally important, Malden and LabCorp received specimens and reported results using their existing systems without change or alteration.

“We solved another problem,” added Tribbett, “which involved billing. Our software collects all the information necessary to prepare a consolidated bill. This information is forwarded to a third party billing service. We utilize a common patient identifier and pass along patient demographic data accompanied by CPT codes as provided by the ordering physician.

“The third party billing service is called Coastway Corp. and is part of The Malden Hospital organization,” explained Tribbett. “It is an arrangement that Malden and LabCorp cleared in advance with HCFA, so it meets regulatory requirements governing billing and reimbursement practices.”

Why LIS Is Difficult To Link With Different Info Systems

CONSIDER THE SUPPOSEDLY SIMPLE project to connect a hospital LIS with a reference laboratory LIS. Both parties eagerly want a single entry arrangement which can pass information back and forth. Yet commonly such an interface is too expensive and too time consuming to accomplish.

After all, if the reference laboratory uses Antrim, for example, and the hospital laboratory is on Cerner, SMS, or one of the other major systems, wouldn’t pre-written interfaces already exist between these software products?

“Unfortunately, the answer is generally no,” responded David Tribbett, Executive Vice President at Healthworks Alliance. “The reason is simple. Take HL-7, for example. HL-7 was designed to be a common standard for healthcare software. It is actually a well-designed code structure for laboratory data.

“But many programmers, when adapting the hospital’s new information system to meet their custom needs, find it easier to write in-house interfaces using ‘z segments’ instead of HL-7’s existing format. These are user-defined segments with user-defined fields within the segments.

“Because the hospital ends up with customized ‘z segments’ buried in the HL-7 code, each time an interface is needed between the reference laboratory’s LIS, like Antrim, and the hospital’s LIS, like Sunquest, the interface code literally has to be created line by line to accommodate the individualized ‘z segments’ found in the hospital’s LIS.”

As most hospital laboratory administrators know, creating such CPU-CPU interfaces with the reference laboratory often takes up to one year and $50,000. This is the key reason why relatively few CPU-CPU interfaces exist between hospital and reference laboratories today despite the important benefits that both laboratories would realize from such interfaces.

“The other basic source of LIS incompatibility derives from the fact that the three national laboratories still operate on an ASTM standard instead of HL-7,” observed Tribbett. “This need for clinical integration is what spurs efforts to move toward common standards like HL-7 and LOINC (laboratory ordering information numeric code).”

Among the three blood brothers, Quest Diagnostics Incorporated is in the transition from ASTM version 94 to HL-7. SmithKline Beecham Clinical Laboratories is in the transition from ASTM version 88 to HL-7. At Laboratory Corporation of America, the transition must convert from ASTM version 92 to HL-7.

“This illustrates the wide variation in the basic structure of LIS software used even by the national laboratories,” stated Tribbett. “Until most healthcare providers move to a soft- ware system based on a common HL-7 platform, one of the trickiest decisions facing laboratory administrators is how to upgrade their existing LIS and still be compatible with future changes and developments to software systems.”

Capabilities Illustrated

“The Malden Hospital project illustrates what capabilities our systems can deliver,” observed Tribbett. “We can move data to outpatient/outreach order entry stations for five ancillary services: laboratory, radiology, cardiology, physical therapy and occupational therapy. We are able to capture ‘medical records,’ such as discharge summaries, operative reports, inpatient laboratory reports, inpatient radiology reports and move them to any appropriate physician or nursing home desktop computers.”

Building from the first generation product used to initially link clinical services within The Malden Hospital system, Healthworks Alliance developed a “clearinghouse” concept with their technology. “The concept of the ‘clearing- house’ is the easiest way to understand how we make it easy for users of our system to pass data,” said Tribbett. “We create a master linking dictionary of laboratory tests. Applets (application software modules) create a registration screen which permits the physician’s office to pull patient data from its office data base, incorporate it in the registration form and order services for that patient.

“This registration, or patient requisition, goes into the clearinghouse. There it is matched against the appropriate procedures which are in our master directory. The procedure is ordered and results are sent back to the physician.”

What makes the clearinghouse unique is a distinctive feature: Healthworks Alliance can permit each user to continue to work from an established test catalog or requisition procedure. This eliminates the disruption to clients which is caused when the laboratory upgrades LIS software or makes major revisions to its test catalog.

“Probably the best way to describe the benefit of our clearinghouse function is this,” elaborated Tribbett. “We can create an interface for the end user which never changes, regardless of how the laboratory changes test codes, switches reference ranges or alters the way testing is performed.”

Discusses LOINC’s Potential

Our system is already compliant with LOINC,” said David Tribbett, Executive Vice President of Healthworks Alliance, Inc. “LOINC, which stands for ‘laboratory information ordering numeric code,’ promises to simplify how laboratory data is transmitted around the world by becoming the single standard.

“Unfortunately, few laboratory information systems are compliant,” he continued. “It is something that the three national laboratories are diligently working towards. I believe that we are three to five years away from seeing LOINC become widespread.

“The challenge with making LOINC an effective tool is that it must eventually incorporate the business ordering rules affecting laboratory testing. By this I mean, what happens when a CBC is ordered? Although it is the same CBC, it is treated differently if it is ordered within the hospital, is an outreach test with private pay or is done for a Medicare patient. Right now the LOINC development teams are still working upwards from the simplest level of laboratory testing and have yet to tackle these more complicated issues.”

Clients Saw No Changes

“Let me give you an example. When Malden Hospital’s laboratory switched from partnering with SmithKline to LabCorp, Malden’s outreach clients saw no changes to ordering procedures, test catalogs or normal ranges. Our clearing-house matched existing order procedures with the appropriate tests from either Malden or LabCorp.

“An even more extreme example is Nazareth Hospital, which has used our network system linking ancillary services with outpatient providers for seven years. A while back they were purchased by Franciscan Health. Franciscan used a different HIS and LIS than Nazareth and converted Nazareth to their IS platform. Then, two years ago, Franciscan Health was purchased by the Catholic Health Initiative. They had a different HIS and LIS than Franciscan. Again, Nazareth Hospital switched platforms.

“Through all these changes, the physicians, surgicenters and nursing homes were completely unaffected. They continued to register patients the same way, place orders the same way, and receive results the same way. There was no disruption or turmoil, even though the hospital changed HIS twice in a four-year period!”

These are impressive results for any information system vendor. Healthworks believes that it has refined this technology to the point where the company is ready to tackle the challenge of hospital-reference laboratory CPU-CPU links.

Healthworks Alliance is currently exploring how to develop a reference laboratory clearinghouse which would allow any reference laboratory to create a seamless data integration capability with their clients. Discussions are under way with the national laboratories and the leading reference laboratories.

“There are two major benefits that this reference laboratory clearinghouse offers both clients and reference laboratories,” noted Tribbett. “First, the client and reference laboratory can be linked quickly and economically. This eliminates the $10-$50,000 cost and six-month to one- year wait for a custom interface to be written, tested and implemented.

“They continued to register patients the same way, place orders the same way, and receive results the same way. There was no disruption or turmoil even though the hospital changed HIS twice in a four-year period!”

“Second, the clearinghouse maintains a testing dictionary which handles updates and changes to the test catalog, procedures and reference changes by the reference laboratory. These changes are unnoticed by the client because the registration/order module remains constant.

“Further, the clearinghouse also maintains a cumulative charting capability. Even as a laboratory changes tests or reference ranges, we can report the cumulative test history of that patient in a consistent format. We do this by reporting the individual tests accompanied by the normal ranges effective on the date the test was performed.

“Another feature of the clearinghouse is its capability to support accurate billing. For example, within an integrated delivery system, we maintain a unique patient registry. This permits the clearing- house to track all clinical procedures done on the same patient, then deliver that data with the appropriate information to the reimbursement department. It improves the accuracy of reimbursement claims.

As a corporate strategy, Healthworks Alliance has accurately recognized the need for a simpler solution to clinical integration among various healthcare providers. In many respects, the solution developed by Healthworks Alliance also seems user-friendly. This uncommon benefit distinguishes it from the complicated information systems dominating the marketplace today.

Four “Components” Support Integration

Currently we are implementing our third generation network product,” noted Geri Beyer, Director, Corporate Accounts at Healthworks Alliance. “There are four components which permit us to maintain a constant entry and reporting process, regardless of changes to test catalog and other elements.

“The first component, or module, is ‘Universal Order Entry.’ Orders can be placed by any healthcare enterprise,” she explained. “The second is ‘Universal Results Reporting.’ This obviously provides reports for all procedures which are performed.

“Module Three is ‘Universal Registration.’ This a unique part of our network system. It allows us to collect all the required financial and demographic information required to prepare an accurate and detailed bill.

“What is common to these three components is that the user sees and interacts with them,” stated David Tribbett, Executive Vice President. “The fourth component is the glue which binds these applications. We call it the object broker. It communicates between all the applications. It uses a universal communications protocol and a plain-vanilla HL-7 standard. There are no z segments to be found.

“This permits us to offer a turnkey solution which can be dropped into the desktop or network at a clinic. Now they can register the patient, place orders and receive results from any provider within the integrated delivery system.”

Link Ancillary Services

In developing a way to economically and easily link ancillary services at the hospital with physicians in the community, Healthworks Alliance further realized something that all laboratorians have understood from day one: it is clinical laboratory data which is used most frequently and which has cumulative value over time.

Healthworks further recognized that the marketplace was already moving to integrate laboratory data ahead of any other service. This process began in the early 1990s as commercial laboratories began placing PC-based requisition and reporting systems into physician offices and linked them with the laboratory using a dedicated telephone line.

Parallel Dynamic

The parallel dynamic was under way between reference laboratories and their hospital laboratory clients. Creating the CPU-CPU link between reference laboratory and client has become a major service requirement.

Healthworks Alliance should get recognition for bringing early solutions for clinical data integration to the marketplace. If they can get their reference laboratory clearinghouse into operation in the near future, they may become the leading vendor for integrating laboratory information systems with integrated healthcare delivery systems.

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