It is certainly tempting to write an April Fools’ blog post today – like Big Ben going digital, for example (you hadn’t heard about that?). But there are actually an abundance of active, germane topics in health IT which deserve a closer look.
As we mentioned previously, one of the big challenges in developing a national healthcare infrastructure – part of the vision put forward by Obama, and part of the charge laid before the Office of the National Coordinator (ONC) for Health IT – has been coordinating local and state regulations and standards into a unified structure on a national level. Each state has local laws and regulations that govern consent, and the ability to exchange personal health information. And these rules vary, quite literally, all over the map.
One of the key pieces of clinical data that is routinely transmitted electronically is laboratory test results. On March 1, the Centers for Medicare and Medicaid Services (CMS) together with the ONC released new guidance, clarifying that the Clinical Laboratory Improvement Amendments (CLIA) – federal law that regulates standards and quality assurance of all clinical laboratories, whether commercial labs, hospital labs, or doctors’ in-house labs – permits the electronic exchange of lab data. This kind of guidance (at the federal level) is a very helpful step in trying to move forward.
One of the items in the ONC guidance is the encouragement of labs to use a particular standard method and vocabulary when exchanging lab data (HL7 2.5.1 as the transport standard, with LOINC as the test-identification vocabulary). As we had previously commented, a surprising number of laboratories – local hospital labs, as well as some regions of large commercial labs (specifically Quest) – do not currently conform to these standards. Encouragement from the ONC for everyone to “speak the same language” is good news – we can build a robust Electronic Health Record (EHR) for physicians to use, but the reporting outside enterprises (laboratories) need to be able to use the same vocabulary in order for us to interpret their data.
Another item in the ONC guidance is that some local state laws prohibit the release of release of lab test reports directly to patients, and even to other providers treating the patient. The ONC is working with states to address their concerns, and clear the way for secure exchange of such data, including the uploading to such data to Health Information Exchanges (HIEs).
The direct release of lab data to patients is a multi-faceted issue. Advocates in the e-patient movement have rightly claimed that the patient is who ultimately manages her/his medical data, and access to lab reports should be directly accessible. As a clinician, my own experience is that, while patients want copies of their lab data, the most important thing being asked is interpretation – what do these results mean? Therefore, forwarding copies of the lab reports (electronically or by printout) really should be accompanies by a clinical interpretation (“your results are all at target” or “your cholesterol is a bit high still, so increase the dose of your medication,” etc.).
There is also the issue of “alert fatigue” and the phenomenon that lab results can “sit in someone’s bin for later review,” or a warning about an important time-critical result can get overlooked. This is largely a function of EHR design, but has been reported in the literature. This kind of concern is what has given those who desire direct result reporting to patients, without having to sit in a clinician’s In Box for some uncertain period of time, a very reasonable argument.
Regardless of how such reporting is managed by an EHR system – and its ability to report information directly to patients, either by secure email or by a Personal Health Record (PHR) interface – the CLIA rules, and the guidance from the ONC, help clear the path for such reporting. Places where local, state regulations stand in the way are being identified and addressed. The goal of widespread, yet secure, availability of accurate and meaningful health information for patients, clinicians and public health interests is still a ways off, “but we can see it from here.”
Robert Rowley, MD
Chief Medical Officer, Practice Fusion, Inc.
