For clinical laboratories with any significant outreach business, 2008 looks likely to be the year that connectivity with physicians’ electronic medical record (EMR) systems ceases to be optional. Whether under pressure from pay-for-performance reimbursement systems or simply because EMR-based efficiency improves their ability to compete, physician practices have adopted the EMR in record (and climbing) numbers. The laboratory that wants outreach work from those offices, along with the improved revenues that can ease its own financial problems, is increasingly compelled to provide EMR connectivity.

This is an ideal time for middleware to come to the rescue of laboratories that need to provide their referring physicians with EMR-based ordering and results reporting—and that need to do so quickly, easily, and inexpensively. Middleware is already performing multiple functions in clinical laboratories, filling the gaps between the laboratory information system (LIS) and other information systems and instruments. How much of a laboratory’s information handling is entrusted to middleware depends largely upon what its existing LIS can (and cannot) do.

Because replacing the LIS is an expensive and sometimes trying undertaking, a laboratory may now be working with a system that is more than a decade old. Depending on the facility’s budget and the staff’s enthusiasm for change, that LIS may have been upgraded frequently, haphazardly, or not at all. As a result, it may lack functions that were not anticipated when it was installed but are sorely missed now.

If EMR connectivity is one of these missing pieces, middleware may be the solution that provides the most rapid return on investment with the least operational retooling. Of course, many LIS vendors can supply their customers with upgrades and modules that will handle EMR connectivity, and application service providers (ASPs) offer another choice that may suit some laboratories well. The choice among these alternatives should begin with an understanding of exactly what is missing in the laboratory’s information capabilities, both now and for the coming few years.

If the gaps are significant, middleware may be a wise choice in filling them because it can perform many functions, sometimes made available in customized sets that can be implemented for less than $10,000. Prices typically increase along with capabilities, of course, but the five options described here represent broad functionality that can be purchased along with EMR connectivity, at a cost that may be surprisingly low.

Chameleon Middleware System

Clinical Data Sales & Service Inc, Newton, Mass, is the exclusive source of this system, developed by Medicus Middleware, Nashville, Tenn. Released in November 2006, Chameleon is marketed primarily to small clinical laboratories and to laboratories in physicians’ offices. Medicus Middleware, known for serving laboratory administrators in a consulting capacity, developed Chameleon to provide seamless EMR connectivity in an easy-to-use, prepackaged format that also includes interfaces for six analyzers.

The company has been creating interface modules and data-management software for the original equipment manufacturers of laboratory analyzers since 1996, becoming prominent in that market. Within a decade, Medicus also reported an installed base of more than 700 systems in five countries and listed many large, well-known facilities among its clients. This experience was combined with the developers’ past work in laboratories to create middleware that focuses on making the technologist’s job easier.

The MidLynx middleware engine serves as the foundation for Chameleon, but the newer system has hematology and chemistry combined in one system, with the LIS–EMR interface and six analyzer interfaces (plus quality-control functions) accessed from one workstation that can handle up to half a million samples per day. Rule-based process automation and autovalidation are so easily managed that a new user can be thoroughly trained in system use within a single day, the company says. Testing by technologists, with extensive feedback, was used to ensure the system’s ease of use, as well as to make its capabilities reflect users’ day-to-day needs.

FFlexConnect

From Fletcher-Flora Health Care Systems Inc, Anaheim, Calif, comes this connectivity middleware, designed specifically to work with Fletcher-Flora’s LIS. This self-contained approach helps to ensure that there will be no surprises encountered in extending the functions of the LIS to include EMR-based ordering and results reporting. FFlexConnect was also created to integrate the company’s encaLaber LIS with a laboratory’s analyzers and systems at an unlimited number of remote/satellite locations.

Because Fletcher-Flora has been among the most prominent companies pursuing interoperability for the past 20 years, the company says, it has worked closely with many manufacturers of the third-party clinical systems and EMRs found in physicians’ offices. When the company introduced FFlexConnect in September 2006, it began including it as part of every encaLaber LIS installation, in addition to making it available separately to existing encaLaber users.

The middleware uses a secure Internet connection to make information available as needed from any location, worldwide. In addition to interfacing with third-party systems, FFlexConnect manages information flow to and from the encaLaber LIS and instruments, label writers, printers, and other devices. The company reports that it now has 1,400 information systems of various types in place in hospital laboratories, clinics, and physician practices.

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Instrument Manager

Data Innovations, South Burlington, Vt, is the source for this system. Data Innovations is the largest supplier of third-party middleware, according to the company, with more than 6,500 systems in 49 countries installed to date. Customized implementations are the company’s focus, so system acquisition begins with a review of the laboratory’s concerns, goals, and environment. Then, the necessary components are selected from a wide range of capabilities (and the more than 700 interfaces that the company has already programmed).

In addition to providing connectivity for laboratories with many workstations, multiple sites, and even more than one LIS, Data Innovations maintains business partnerships with the major manufacturers of in vitro diagnostics to ensure interoperability. Instrument Manager can handle information systems and instruments (including automated systems) at as many locations as necessary.

The system’s Notifier application can be set to send a message whenever a predefined event occurs, and to deliver that message to the correct recipient in the format that he or she prefers, including e-mail and text messaging. This degree of flexibility allows the system to adapt to a great range of circumstances with maximal efficiency. Alerts sent for connection errors, elevated test results, identification of specimens meeting study criteria, quality-control timing lapses, low reagent supplies, and inadequate hard-drive space are examples of Notifier messages that can get the attention of the right person in time to prevent problems.

Instrument Manager is accessed using the laboratory’s Windows-based computers, typically eliminating hardware costs for middleware implementation. Each system can manage 200 or more instruments; standardized, rules-based result autoverification is used to minimize turnaround times and make the best use of scarce technologist time (by letting staff focus on actual exceptions). Each facility uses the rules to create the system functions that it needs, allowing autoverification to be managed from one location, but to cover all locations (and all disciplines).

JResultNet

Made by Dawning Technologies, Fort Myers, Fla, this system can be customized in so many ways that a good fit with the laboratory’s needs and existing procedures is likely. This system offers a high level of flexibility at a cost that can be lower than other options because the purchaser pays only for the capabilities that the laboratory needs (or can afford) during the initial implementation; other functions can be added later, the company says.

JResultNet is an interface engine based on Java; it can stand alone (running on a networked desktop) or can be embedded within a larger JavaLin interface. It uses rules-based processing and autovalidation, and it simplifies user training by using the same user interface found in the company’s other products.

Of particular interest to laboratories that need EMR connectivity are the custom applications offered for JResultNet’s Access 2000 Database module. This uses a bidirectional framework that is set to upload test requests and to extract and import results; both activities are handled automatically, with no need for manual entry of any data.

JResultNet controls connections to instruments and information systems while reducing network traffic substantially, according to the company. The middleware can be accessed from remote locations using a Web browser or a local Java utility. The key to this system’s adaptability is its use of mapping tools described as both flexible and powerful. This lets incoming messages be separated into individual data fields and reconstituted automatically as desired. Because outgoing messages are built the same way, any format can be accommodated. Connectivity, therefore, is as seamless as possible.

SoftExpress

SCC Soft Computer, Clearwater, Fla, provides this system to laboratories for the management of their outreach programs. The company, which has been providing information systems for laboratory settings for nearly 30 years, begins the implementation process by applying its experience to an evaluation of the client’s current workflow. Process improvement and educational services are then provided to ensure successful middleware implementation, along with other services as required.

SoftExpress facilitates comprehensive outreach automation by including key capabilities such as incident management and case management; tracking is available by account, symptom, case, and cause. Service requests are logged, prioritized, and monitored, with escalations and notifications handled as needed.

According to the company, high levels of service to outreach customers are promoted through multiple management tools, including inventory management to ensure that materials are always on hand, as demand fluctuates, to meet the testing needs of referring physicians. A courier-tracking function manages test orders, customer inquiries, and specimen pickup/delivery services, so there are never any mysteries concerning the whereabouts of samples. In addition, the company says, specialized reports help users manage overall outreach activities and pinpoint new opportunities.

Beneficial Side Effects

While middleware, in its early days, was sometimes thought of as merely a patch for a hole that the latest LIS upgrade could not fill (or even as the nearly invisible eraser for the LIS buyer’s mistake), middleware has clearly grown into a wise acquisition in its own right. Even the owner of a state-of-the-art LIS may need the help of middleware to meet unforeseen needs. Laboratories in which the LIS incorporates fewer of the interfaces now needed between systems and instruments will need even more of middleware’s assistance.

If EMR connectivity is among the laboratory’s unmet needs, a judicious middleware purchase may have benefits that reach beyond the ability to compete for the business of physician practices. Because the capabilities of today’s middleware systems are so extensive, the laboratory may find that it has bought functions that it did not even realize that it needed, thereby improving efficiency, productivity, and staff satisfaction without even trying. In this way, the need to provide referring physicians with interoperable EMR-based ordering and results might start with a scramble, but end with a smile.

Kris Kyes is technical editor of CLP.