In the laboratory industry, the term “middleware” means different things to different people. For the purpose of this article, middleware describes a data conduit designed to transmit lab results from CLIA-waived devices to Electronic Health Record (EHR) systems in the physician office.
Most EHR vendors do not currently offer direct connectivity to lab instruments. To take full advantage of an EHR, CLIA-waived devices should be connected to the system using middleware. Middleware eliminates the need for manual data entry of results into the EHR, which also minimizes transcription errors that go along with data entry.
Since by definition CLIA-waived tests are viewed as “simple” tests, additional review may not be necessary, and results may be entered directly into the patient’s record. EHR connectivity via middleware allows for results to be distributed to the entire medical staff as soon as the test is run. There is no wait for the results to be manually entered.
In physician offices performing high volumes of waived testing—for example, urology practices—the staff often will not have time to place an order in a computer prior to running the test. In these instances, a practice may prefer to have a middleware solution which can accept an unsolicited result. This allows results to be matched to patient records without first placing an order.
Middleware is likely to play a significant role in whether physicians will receive financial incentives to adopt an EHR. These requirements are referred to as “Meaningful Use.” The HITECH act of the economic stimulus package passed by Congress and signed into law by President Obama in 2009 outlines criteria for “Meaningful Use” of an EHR. If the criteria are met, each qualifying physician will receive up to $44,000 in Medicare and Medicaid incentive payments.
Currently there are 15 core objectives which a physician must meet for Stage 1 of Meaningful Use. Physicians also must meet an additional five objectives from a list of 10 menu items, which include reporting lab results as “structured” data. Structured data allow health outcomes to be measured, aiding in the development of treatment protocols.
Today many physician offices scan laboratory results into patient records. As Stage 2 of Meaningful Use is implemented, reporting of laboratory results as structured data is likely to become a requirement, and use of middleware will grow in importance.
Scott Lavine is Director of Sales & Marketing, LIS, for New Jersey-based producer of instruments and products for clinical laboratories Alfa Wassermann.
