The meaningful use requirement under the federal ARRA/HITECH Act provides financial incentives to physicians for the adoption and use of electronic medical records. And that use is growing. A report published last year by IDC Digital Marketplace entitled “IDC Marketscape: U.S. Ambulatory EMR/EHR for Midsize and Large Practices 2011 Vendor Assessment” predicts that ambulatory EMR use will grow from less than 25% adoption in 2009 to more than 80% by 2016.
Because an EMR is supposed to be a complete digital patient record that includes patient history, physician notes, radiology images, vital signs, and all lab test results, it needs to be connected to other hospital systems that can collect, manage, and transfer data. And that includes the laboratory information system (LIS).
Developed in the 1980s by analyzer manufacturers, the LIS was first used to gather and organize test results coming directly from analyzers in the lab. With the growing use of point-of-care tests, test results are now coming from the bedside or physician’s office as well. These results need to be sent to the LIS and then to the EMR where the patient’s physician can view them.
But connecting an LIS to an EMR or to a hospital information system (HIS) can be difficult, especially if these systems are from different vendors. It also can be expensive. An average interface engine provided by an interface vendor can cost as much as $200,000 and may require the expertise of a qualified and certified IT staff to operate and maintain it.
Still, there are a number of interface options available from integration specialists to meet the specific needs and budgets of a lab.
One of the earliest interfaces was the ASTM (American Society for Testing and Materials) interface, which is a bidirectional protocol that has been largely used to connect clinical devices. It also is simple enough to be launched by the IT staff of most hospitals and larger labs. However, some analyzers are still not compatible with the ASTM interface.
A more recently-developed interface—and the one that has become the industry standard—is Health Level 7 (HL7), which defines the format of data that can be shared between systems. Either uni- or bidirectional, the HL7 interface was developed by a group of manufacturers and information system vendors primarily to connect an LIS and other clinical systems to an HIS.
Because there are requirements as to how data needs to be structured when transmitted to an EMR, some healthcare facilities are adopting Continuity of Care Documents (CCD) and Continuity of Care Records (CCR) as a way to retain the format of reports and other information.
The development of CCD was a joint effort between ASTM and Health Level Seven, Inc., to facilitate the interoperability of clinical data so that one physician, for example, can send electronic medical data to another physician without the loss of meaning. CCD links ASTM’s CCR with HL7’s clinical documentation architecture.
Which brings us to the rise of middleware. Middleware is a suite of applications that resides between devices and systems or systems and systems and serves as an interface between them. It is a next generation approach from ASTM and HL7 that adds more intelligence and user control to the process. Because it uses a rules engine, middleware can be configured to set rules that facilitate such processes as autoverification, error discovery, or review by exception. It also can add to the LIS scheduling, sample management, or test order entry functions.
In many ways, middleware fills the gap between the LIS and the lab’s need for data management. It also can fill functionality gaps in an older LIS, allowing it to accept newer upgrades from a vendor. And because of middleware’s rules-based decision-making quality, it allows a lab to write physician-specific or practice-specific rules that interact in real time with the lab’s instrumentation, thereby increasing autoverification. In this case it acts as a real-time conduit of data between the instruments and the LIS.
There is, however, a call from some industry experts and vendors to make middleware solutions more customizable since no one software solution can fit the various ways in which individual labs manage everything from the transport and storage of samples to reagent qualification.
Still, installing middleware can be the first step in establishing a web-based interface that uses a secure virtual private network (VPN) which can support all the standards like ASTM, HL7, and DICOM for image transfer and management. Such an interface can route lab test orders directly from the physician’s EMR to the LIS. Test results are then transmitted through the interface engine from the LIS back to the EMR. And because this type of interface is web-based, the physician can view all lab test results and reports from his office, home, or any location where he or she has Internet access.
