Middleware Must Contribute More Than Connectivity

Countless physician offices have welcomed point-of-care (POC) devices and EHRs into their labs in a bid to improve efficiency and patient care. The only problem is, these measures alone are only part of the puzzle when it comes to optimizing workflows and remaining compliant with CLIA regulation. The final piece — middleware.

Running POC testing without middleware in place to link devices to the EHR, and automate the transmission of test results, leaves a heavy administrative burden on staff and can lead to a number of problems with regulators. Both can have a serious impact on revenues and reputation, which ought to be avoided at all costs.

Where middleware is needed

Reporting test results alone is not enough — there are a multitude of ways in which a lack of middleware can hinder the compliance of a physician’s office lab (POL). For example, if tests require demographic reference ranges — those that vary by age and gender — to determine abnormalities, then these values must be detailed in test reports. Without this information, CLIA accreditation organizations, such as the Commission on Office Laboratory Accreditation (COLA), will list the report as deficient. This can lead to the requirement for costly and time-consuming remediation plans or, at worse, a POL being prohibited from conducting testing on-site.

Unfortunately, POC devices don’t have the functionality to set demographic reference ranges, they only provide the value of the analytes tested. EHRs do allow demographic reference ranges to be entered with each individual result but this presents a repeated task that will quickly become time-consuming. EHRs can’t manage these ranges, so you can’t set them and save them. This means that ranges are not automatically applied so the user needs to manually calculate and mark if a result is abnormal.

Many POLs turn to a laboratory information system (LIS) to fix these problems, as there was no other solution available. However, this solution is prohibitively expensive and far too complex for use in this setting. It’s overkill for the task at hand.

More than just connectivity

So where does this leave POLs? How do they ensure CLIA compliance if traditional middleware/POC connectivity solutions only transmit the test result to the EHR and an LIS is unsuitable?

We also work closely with EHR manufacturers — such as Allscripts and athenahealth — and have gained a comprehensive understanding of their functionality. That’s why demographic reference ranges were added to our solution — because they are necessary to remain CLIA compliant and provide a true LIS alternative.

Relaymed was designed to provide the full connectivity and management solution. Not only is the transmission of test result data to the EHR completely automated but users have complete control of their data, making demographic reference ranges are simple to implement.

Middleware needs to do more to meet the needs of primary care. It needs to be more than just middleware.

Relaymed clients can now use the myRelaymed portal to set different demographic reference ranges. Then, when a test result is sent to the EHR by Relaymed, not only is the correct range sent, it is also identified as abnormal in correspondence with the demographic of the patient. This is made possible as Relaymed receives the patient demographics from the EHR as our interface is bidirectional. All of this occurs automatically and instantly, meaning that any worries regarding CLIA compliance can be forgotten — you’re covered!

Of course, there’s a lot more to CLIA compliance than correctly handling and reporting demographic reference ranges. But these are often overlooked. For instance, ensuring the correct address, date, and time are on the result is vital. Logging quality controls (QCs) is also a must for POC data management (as we’ve written about before). Luckily, these are all taken care of by Relaymed, meaning more time for your patients.

Start today

See for yourself the numerous ways in which middleware from Relaymed can help keep your lab CLIA compliant and save you time through automation. Discover Relaymed today.