Electronic health records and the lab

Two opposing agendas confront clinical labs in terms of electronic health records (EHRs): privacy/security on the one side, and interoperability, on the other. The former involves an inward push for isolation, while the latter tends to pull technology in the other direction.
There also is a major financial challenge. While healthcare providers have been given a host of incentives to adopt EHRs (especially in the US), labs have been pretty much left out on their own.

EHRs and lab systems populate different worlds
Clearly, lab-compatible EHR systems which meet both (privacy and interoperability) criteria promise the quickest returns. EHR developers have however shown little enthusiasm, until recently, to incorporate clinical lab requirements as a sufficient driver, while laboratory system vendors have tended to ignore EHRs or postpone taking them into account until EHR development has matured sufficiently. 

US EHR adoption drives lab applications
In the US, this limbo is being shaken up by healthcare providers, who are compelling vendors to take account of their need for EHR-friendly clinical lab systems.
At end 2012, the US Centers for Disease Control and Prevention (CDC) released a survey which found 72 percent of office-based physicians using EHR systems, up from 48 percent in 2009 and 18 percent in 2001. 
The reason for the dramatic increase in EHR adoption lies in the Meaningful Use requirements of the 2009 Health Information Technology for Economic and Clinical Health Act, also known as the HITECH Act. The Act provides billions of dollars in incentive payments through the Medicare and Medicaid programmes to increase physician adoption of EHR systems.

Clinical labs are now being lifted by the rising tide of EHR adoption. According to the US Office of the National Coordinator for Health Information Technology (ONC), the “availability of structured lab results within the EHR contributes to office efficiencies while also assisting providers in the ability to make real time decisions about the patient’s care.”
The ONC explicitly specifies the threshold for EHR-friendly clinical lab practices in Stage 1 – of over 40 percent of all lab test results ordered by a provider and incorporated in certified EHR technology as structured data.
Stage 2 Meaningful Use requirements, finalised in August 2012, increase the clinical lab results threshold to 50 percent. The ONC has subsequently announced plans to assess health information exchange (HIE) in clinical laboratories.

Labs left to own resources
While healthcare providers have the financial incentives of the HITECH Act, clinical labs have been left to their own resources to set up interfaces from their laboratory information systems (LIS) to providers.
Compounding this has been inconsistencies in the way different EHR systems generate lab test orders.
However, the alternative has been stark – to be left out of referrals from tests.

EHR systems remain heterogeneous
The US EHR landscape is however hardly uniform. As of September 2013, there were 3,652 non-enterprise certified ambulatory EHR software systems, almost half of which were classified as “complete” to qualify for Meaningful Use Stage 1 or Stage 2.
In spite of efforts to set standards for semantic interoperability of healthcare data, standards so far are only syntactic (based on HL7 and XML). 
The alternative, to develop a common US-wide EHR system, has been accepted as being technically insurmountable – due to hurdles in specifying, developing, testing and deploying standardized tools, common architectures and vocabularies, within secure, real-time and scalable networks, and doing all this within the fast-changing world of information and communications technologies.
For proponents of a decentralized approach to EHR technology, in the US in particular, the sharp increase in offtake of EHR systems has shown that it has delivered – as far as healthcare IT objectives are concerned.

EHR faces teething problems
Still, teething troubles for EHRs also clearly remain.
In early September 2013, one of the leading EHR systems, from EPIC, crashed across seven major healthcare facilities of Sutter Health, a nearly 100 year-old healthcare provider in California. Some suspect the role of a routine upgrade a few days earlier in the EHR system, which was launched by Sutter at a cost of $1.2 billion in 2004, but has so far reached only a halfway mark.

EHR challenges for labs remain to be resolved
Such issues with the evolution of maturity of EHRs pose especially major problems for labs, who (as mentioned) have to develop and fund interfaces between their LISs and the EHRs of their client physicians but are also forced to cope with the lack of uniform EHR standards.

Some vendors have nevertheless sought to fill the gap.
A leading example is HDD Access, a joint initiative by the US Department of Defense, the Department of Veterans Affairs and 3M Health Information Systems to create a public use version of 3M’s Healthcare Data Dictionary (HDD). HDD Access consists of a relational database and Application Programming Interface (API) runtime services to which other applications can interface. The terminology is organized as a controlled medical vocabulary – a comprehensive set of clinical and other concepts used in healthcare.
HDD Access offers specific benefits for integrating LIS and EHR platforms. Independent of source system, it can track local fields and translate them into laboratory concepts. Nevertheless, HDD Access warns that it is “not a standard terminology and is not a replacement for standard terminologies.

In effect, in the US, clinical labs are likely to continue to face a host of technical challenges with respect to EHRs in the years to come.

EHR Big Bang fizzles in Europe
Unlike the US, Europe made a massive effort in 2004 to devise common semantic standards for EHR interoperability as part of its Single eHealth Area. The EU’s EHR objectives sought to integrate all patient information – from primary to tertiary settings, and include emergency and in-patient care. Also on the radar were ambitious plans to connect pharmacies as well as the web of disparate billing/reimbursement procedures, and do so across Europe.
In mid–2008, the EU Commission set 2015 as the target year for EHR interoperability, to ensure that key EHR datasets could cross European borders, and do so in conformity with medical rules and other relevant legal frameworks.

In January 2011, however, these ambitions were put on the backburner, after an official report criticized the effort as being both impractical and ‘grandiose’. The report found that a pan-EU EHR system would neither be technically feasible, cost-effective or even medically justified, and instead urged more emphasis on decentralized efforts – in other words, just like the US.
Technical challenges aside, massive differences in physician and medical cultures across Europe played a major role in derailing efforts toward a common EHR. Or, as EuroRec, an umbrella organization tasked with pan-EU EHR implementation, states: it was “widely recognized that social and organizational aspects are as likely to ruin an implementation process as technical factors are.”

European focus shifts to national efforts
The EHR focus in Europe has now totally shifted to national efforts. A new eHealth Governance Initiative (eHGI) encourages cooperation “between Member States” and “between national authorities and standardization bodies”, and seeks to “enable the recommendation of standards and (harmonized) profiles based on selected use cases.” On the technical side, compared to the Big Bang efforts of the Single eHealth Area, it also aims to “link and harmonize coding systems” and “facilitate access to existing standards and medical vocabularies.”
The second area for Europe’s EHR focus is a minimalistic intra-EU/regional approach embodied in a project called epSOS, which dates back to 2008, but was (temporarily) eclipsed by the ambitions of the Single eHealth Area. epSOS, which went live in April 2012, has the modest goal of connecting 20 EU nations (and 3 non-EU members) to a secure database, and sharing only Patient Summaries and ePrescription records via IHE X* profiles. Its target consists of Europeans holidaying overseas.

Today, EHR adoption varies considerably in Europe. The Nordic countries have been using the technology for over a decade and are fairly advanced as a result in EHR implementation.
However, adoption in France, Germany, Spain and the UK is ‘on course’ with the US.

Shift from Single eHealth Area encourages new EHR-directed lab applications
The shift away from forcing through a Single eHealth Area has also opened the way for innovative working approaches aimed at clinical labs. One good example of this is Valle de los Pedroches Hospital at Cordoba, Spain, which has  designed and implemented a unified lab test request module for the Andalusian regional EHR.
In spite of some outstanding issues (such as rigidity in error solving, and the need to adapt to a new nomenclature), implementation of the laboratory module in the EHR improved the analytical process, with better patient safety and less programming or container errors and shorter response times. Clinical professionals gave a rating of 7.8 out of 10, positively highlighting the speed at which results are delivered and their integration in the EHR.
Such efforts are likely to grow with time.