A well-chosen middleware application can bridge the technology gap and keep the laboratory humming.

The definition of “middleware” varies depending on who you ask. Call it a virtual bridge between software and hardware, or perhaps a necessary layer on top of already complex systems. Regardless of the definition, the middleware phenomenon is an undeniably common element in today’s clinical laboratory.

With automation and computerization continuing to revolutionize the lab, legacy systems can become “old” in a scant 2 to 3 years. When new instruments must communicate with relatively time-worn software, nimble middleware providers can provide the crucial plumbing, allowing for the seamless transfer of data.

For most clinical labs, middleware sits between the primary software—the laboratory information system (LIS)—and the laboratory equipment. “There is a natural ‘tug of war’ between middleware and LIS, because middleware is moving into a space the LIS has traditionally controlled,” says Deborah Hewett-Smith, director of marketing for middleware, Sysmex America Inc, Mundelein, Ill. “In our hematology market, for example, technology advances give our customers an increasing array of choices in instrument and automation configurations. Often middleware can better adapt to the change, giving the laboratory greater operational efficiency and tighter integration.”

As for customers who believe that middleware companies will lack the ability to maintain a functional HL7 interface over time, Pat Heniff, vice president of Lattice Inc, Wheaton, Ill, thinks their fears are unfounded. “People tend to think that when the legacy vendor introduces new upgrades, the middleware (HL7) interface won’t keep up,” Heniff says. “The last misconception is believing that their legacy software vendor will introduce future software products to fill application holes in a timely manner, and that they will be as feature-rich. Legacy vendors have a knack at inferring that certain features are just around the corner, when the reality is that they won’t be available for a couple of years.”

Middleware companies tend to be more focused on specific applications, so Heniff reasons that they are likely to bring new feature-rich products to market more quickly. “Lab managers are often at the mercy of their more powerful IT department,” Heniff laments. “IT people tend to favor an integrated solution from a single legacy vendor, even though the legacy software is application poor and will cost the lab plenty in terms of productivity.”

The opposite of the “integrated solution” is the so-called “best in breed” approach, where lab directors may seek the best LIS from one company and a different middleware or EMR from yet another company. Experts concede advantages to both approaches, but Hewett-Smith says it ultimately comes down to a company’s individual goals and objectives.

Jim O’Neill, vice president of sales and marketing, Computer Service & Support Inc, Linwood, NJ, contends that most lab directors mistakenly believe that middleware applications only have the ability to take existing analyzers and connect them to a LIS or HIS system. “What middleware provides is not only the ability to connect instrumentation,” O’Neill says, “but also the ability to bridge the gaps for EMR and facilitate remote Web-based reporting, in addition to outreach order-processing systems.”

From dispatching specimens to verifying and reporting results, Leslie Dakarian, MT (ASCP), believes middleware has now grown into a valuable product offering, able to optimize the technical aspects specific to laboratory workflow. “Middleware installation is usually easier to accomplish compared to that of an LIS upgrade, and can also be utilized to supplement instrumentation features that would have required hardware changes in the past,” says Dakarian, senior manager, Global Informatics Marketing, at Siemens Healthcare Diagnostics, Deerfield, Ill. “With middleware, labs benefit from the increased functionality without the expense of acquiring new hardware/equipment. The LIS still provides the laboratory critical functions—in most cases, middleware does not handle laboratory billing—which is an important role for the LIS.”

Middleware with Care

Anne Tate, MT (ASCP) SC, MBA, cautions that trusting any system without proper preparation will only turn the “garbage in garbage out” cliche into reality. Tate, who serves as senior product manager at Sysmex, is quick to sing the praises of middleware, but she points out that realizing the technology’s full potential takes time and dedication. “The biggest misconception is that all you have to do is plug it in and it works,” Tate says. “If you’re going to make a big change in your laboratory, you have to put in the time and effort. Some customers may think it is just a simple software, but it has a lot of logic in it that many people do not consider. In the end, customers want it, but middleware is powerful, and it should be treated as such.”

According to Dakarian, surveys indicate that up to 75% of laboratories believe their best middleware option is to connect instruments to the LIS—which she believes is not always ideal. The practice, she says, often leads to middleware not reaching its full potential. “There is a great opportunity for laboratories to improve the workflow and efficiency of their operations by fully leveraging the features of their middleware systems,” Dakarian says, drawing from a 2009 study by Information Dynamics Middleware Market Monitor. “The limiting factor in optimization of middleware use in the laboratory is time. Lab managers do not have time to dedicate to learning about the capabilities and functions of their middleware without focused and comprehensive training from the vendor. Full utilization requires a partnership and commitment between the customer and the vendor.”

Talking with peers at local and national trade shows is one way to find out if middleware companies really support their customers and truly care about that partnership. Heniff recommends lab directors schedule on-site visits to labs that are using the middleware to see if the software works as efficiently as the middleware company says it does.

When you visit, vendor representatives should not be in attendance. Colleagues will likely speak more freely about benefits and flaws in the vendor’s absence. “Avoid replacing on-site visits with conference calls thinking that it is a more cost-effective way of doing your due diligence,” Heniff adds. “Prepare a detailed application checklist, and send that list in advance to the host location so they can prepare for the upcoming visit.”

Labor Saver

At one time, the application of middleware was limited to large institutions with huge budgets and full IT staffs, but Neal Flora, president and CEO of Fletcher Flora Health Care Systems Inc, Anaheim, Calif, says the advantages of today’s middleware products can be shared by even the smallest of labs. And increasingly labs both large and small are making do with fewer employees.

According to the Bureau of Labor Statistics the United States graduates fewer than half the personnel needed to staff the country’s clinical laboratories. “These statistics underscore the importance of middleware solutions,” Flora says. “With the push for total electronic health records adoption, which is intended to reduce labor, we have actually seen some labs experience an increase in their labor requirements because they didn’t successfully integrate the EHR with the devices and systems within their operation. … So while improved technology and innovation should have a drastic impact on future labor shortages in the lab, it is imperative that labs use and integrate technology, including middleware, to make a positive impact on their workflow.”

In addition to the Bureau of Labor Statistics information, Hunter Bagwell, marketing and consulting manager, Data Innovations Inc, says it is estimated that an average of 13% of the current laboratory staff is likely to retire within the next 5 years, further increasing the medical technologist shortage, which is currently at 10.4%—with some areas of the country experiencing levels as high as 13.1% (according to the 2008 American Society for Clinical Pathology Wage and Vacancy Report). “The impact is far greater than replacing a 25-year veteran with a recent graduate,” says Bagwell, from DI’s headquarters in South Burlington, Vt. “What is often overlooked in many of the statistics is the years of experience that is retiring or leaving the profession.”

Bagwell offers the example of auto verification as one way that technology and innovation can help the situation. “By automating the results-review process via middleware, 80% to 90% of the results that previously required manual review are automatically sent to the requesting physician, freeing scarce resources (such as the medical technologist) to handle the ‘true exceptions,’ ” Bagwell explains. “This provides fast turnaround times for results and consistency in quality. And what many are experiencing are decreased retirements and an increased satisfaction with their work environment.”

With the labor benefits come financial perks. For example, Bagwell says that automating the storage and retrieval of samples by only using middleware can save an average laboratory $40,000 to $60,000 per year and reduce retesting time significantly. “This does not require an instrument or an LIS to be connected,” Bagwell adds. “It is one of the most overlooked areas for improvement and an example of how middleware resides in the middle of your laboratory operations while increasing efficiencies in the laboratory.”

Heather Selmyer, marketing coordinator, Dawning Technologies Inc, Fort Myers, Fla, agrees that middleware has been an integral tool in providing increased efficiencies to make up for staff shortages. “The implementation of rules to laboratory data processing allows for less user intervention, where the majority of test results will pass through stringent rules filters and require no attention, and those few that fail will be flagged and held for release,” Selmyer says. “Middleware is a low-cost solution offering laboratories tight integration between systems.”

Unfortunately, the labor shortage is not new, and many experts agree that it will not change anytime soon—yet another reason to invest in labor-saving middleware technologies. Ravi Sharma, president and CEO of Culver City, Calif-based 4Medica, says lab managers can learn from other fields. “Industries have largely chosen two approaches—outsourcing and technology,” Sharma says. “There is some evidence that preliminary outsourcing is already under way in a small way. The large commercial labs have operations outside the US, and some of these initiatives may emerge from them. However, many successful industries in the US have competed effectively with automation that can lessen the menial tasks at labs and utilize the staff in more value-added services.”

Anne Tate agrees that labor is one of the main drivers of middleware, and she reminds us that one of the main purposes of middleware is auto validation. With auto validation, each technician need not look at each sample ID, but instead at only about 20%. The remaining 80% are auto validated to the LIS. “Middleware provides the decision logic so they only have to look at 20% of their work,” Tate says. “These are the types of tools that are going to make laboratories more efficient when it comes to the deficit in the labor pool. But it is also the right thing to do. It is the best thing to do to make laboratories more efficient and cost effective.”

If the large legacy software systems continue to lack the ability or desire to “offer a full suite of software products that fulfill a myriad of applications,” Heniff says the move toward greater middleware utilization will only quicken. “This trend will continue in the future as large software developers introduce products with application holes that middleware companies can fill,” Heniff adds.

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Rather than choosing between middleware and LIS, Dakarian predicts labs will gravitate toward simplifying laboratory management with one system and one integrated workflow. Meanwhile, IVD and LIS companies will continue to focus on software solutions that enhance data management and process management. “The next big breakthrough in information technology will come from integrating the workflow that spans laboratory information systems, middleware, and analytical instruments,” Dakarian says. “Diagnostics companies will need to have strength in information technology and systems design to lead in this area. Expect to see significant innovation in process-management technologies and continued rapid adoption of auto verification.”

Greg Thompson is a contributing writer for CLP.