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Healthcare Integration Won’t Be Solved, Unless We Know What Needs Fixing

Does More Data Hold the Key

Does More Data Hold the Key?

A recent report issued by the CDC in May of 2014, dealt with Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record (EHR) systems. The report’s goal was to take a close look at the severity of laboratory data-related interoperability issues in general and display discrepancies more specifically. The purpose of the report was also to propose an action plan for laboratory professionals to follow to help resolve the stated issues.

Lack of Central Reporting?

The report goes on to raise concerns about the rise in patient safety “events” with the increase in EHR use, but admits there is little hard evidence to determine, with any certainty, the actual numbers. So, here is the first flaw in the design of the Meaningful Use program, the lack of a central reporting agency to monitor these so-called “adverse events”.

The several examples of EHR usability issues and the life-threatening damage to patients highlighted in the report illustrate vividly what “adverse” means in laboratory reporting.

Meaningful Use Ground Rules and Delays

The ONC and CMS had laid some ground rules by issuing two sets of regulations, the ONC’s EHR Standards and Certification Criteria and the Medicare and Medicaid EHR Incentive Program. The rules were well intentioned and at first glance followed pretty logical steps. Meaningful Use attestation included standards and certification requirements plus, sequentially, clinical quality measures that had to be met. These clinical quality measures increased with each stage of implementation. As we all know by now, the dates for implementation of the three stages have changed, with various lobbies putting forth their recommendations for delay due to hardship, cost etc. The dates no doubt will continue to be extended for the near future.

FDA and Voluntary Adverse Events Reporting

The FDA meanwhile does have a mandatory reporting requirement for death or serious injury. These events get entered into the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. This database also includes voluntary adverse event reports that involve medical devices and events associated with EHR systems. While it is doubtful that it represents a totally accurate record of all events, the reporting does provide some insight into the problems that are occurring.

The FDA deserves credit for requiring at a minimum that all death or serious injury related events be reported. However, in the case of voluntary reporting, given the litigious nature of our society and the adverse press of documenting adverse events, it’s easy to see why manufacturers and vendors would choose not to report all events. That’s exactly why to get a true picture of the severity of the problem with EHR systems reporting of ALL adverse events needs to be mandated.

Standards and the Proliferation of EHR Systems

The report goes on to point out a disconnect between healthcare IT and those developing healthcare standards and institutional IT policies and underscores the need for collaboration. While I don’t argue the point, time does not stand still and more variables are at play now. There are over 450 EHR systems! Stronger standards should have been put in place with mandated interoperability requirements in the first place.

What do we do now?

A first step in ensuring patient safety is mandating reporting of all adverse effects to a central database. Once which EHR systems have the most adverse events can be tracked, root causes can be identified and solutions investigated and instituted. Those EHR systems with fewer adverse events and identified as more “interoperable” may hold the key on how to do healthcare integration right.

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Monika Vainius

Written by: Monika Vainius

Executive Vice President of Applied PilotFish Healthcare Integration. Monika has extensive experience with systems interoperability. She combines this experience with her professional passion for healthcare and healthcare technology to comment on current healthcare and IT news. Website

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