Electronic Exchange of Clinical Laboratory Information: Issues and Opportunities. IMPORTANCE AND RELEVANCE OF THE PAPER


Based on 2007 data from the Centers for Medicare and Medicaid (CMS) Online Survey, Certification, and Reporting (OSCAR) database, the Centers for Disease Control and Prevention (CDC) estimates that approximately 6.8 billion laboratory tests are performed annually in the U.S.2 These lab tests are a critical element in patient care, affecting around 70 percent of clinical decisions.3 However, in an ambulatory setting lab results are not always readily accessible which makes following up on abnormal test results in a timely manner challenging. When test results are not followed by an appropriate response, the quality of care delivered and patients’ safety and satisfaction are compromised.4 Also, there is a general agreement among most experts that there are numerous inefficiencies due to same tests being ordered by different ambulatory providers in different locations, lost records and laboratory tests sometimes being over utilized resulting in unnecessary costs of repeat testing.56 While most laboratories process test orders and perform lab tests in a timely and efficient manner to ensure good turnaround times, there are various issues with the communication of test orders and results between provider offices and clinical laboratories. Many of these issues are largely outside the range of direct control of the clinical laboratories. For these reasons, electronic exchange of lab information in an ambulatory setting can play an integral role in facilitating clinical decisions and avoiding unnecessary or repeated testing by allowing clinicians timely access to patients’ lab information within an EHR.

It is believed that bi‐directional interoperability, or the ability to support seamless exchange of information (not just data) between laboratory information systems and EHRs (primarily lab test results) and EHRs and labs (primarily lab orders) can “reduce medical errors, increase appropriate testing and reduce unnecessary testing, and improve quality and efficiency of health care.” 7 Most also agree that assiduous reporting and monitoring of lab results represent key components of quality improvement for the treatment of chronic illnesses such as diabetes, hypercholesterolemia and heart disease. Most recently, the importance of lab test results to health has been demonstrated by dramatic improvements in risk adjustment models following inclusion of patient‐level laboratory results.8 Electronic access to lab information through an EHR may offer many features, including real time access to lab results, patient and clinic‐level views of historical lab data, automated alerts in case of abnormal reports, and an integrated, comprehensive view of clinical information and lab reports.9 These features can result in a higher quality of care, attributable to a more efficient and comprehensive system of storing and sharing patient information.

Today, electronic exchange of lab test results is increasingly, albeit slowly, being adopted as part of a comprehensive, coordinated patient care system. Even providers that do not use EHRs with built‐in lab exchange interfaces are able to communicate electronically with labs via online portals set up by many of the major clinical laboratories. While electronic exchange with laboratories in this manner represents a form of electronic exchange, leaders in both the laboratory and health care quality sectors note that the ideal form of lab exchange, and the one we focus on in this paper, involves seamless, bi‐directional (e.g. including orders to the laboratory and test results returned to the provider) electronic exchange between a clinical health IT application used by the provider (e.g. an EHR or CPOE system) and the laboratory information system (LIS) directly. We describe this model in greater detail in the next section of the paper.

In his January 2004 State of the Union Address, President Bush emphasized the importance of information technology in health care, noting that “by computerizing health records, we can avoid dangerous medical mistakes, reduce costs and improve care.” With an increasing push towards EHRs encompassing lab data, clinical laboratories are becoming a new and integral addition to networks of providers and other organizations that exchange clinical data electronically. These organizations typically include hospitals, health plans, academic medical centers, integrated delivery networks (IDNs), other providers, and health information exchange organizations (HIEs that also include Regional Health Information Organizations).10 Exchange of clinical data between provider information systems and laboratory information systems seeks to minimize errors, decrease unnecessary redundancy and help clinicians provide coordinated, timely and improved care.

Conventionally, information transactions between clinicians and laboratories (both test ordering and test results retrieval) occur via fax¸ mail, and dedicated phone lines and printers set up in physician offices. In some cases, patients may even act as carriers of information. There are a number of inconveniences associated with these mechanisms. First, these methods involve lag time in the transfer of test results and do not always allow clinicians to access and review results in a timely fashion. Second, results become available at differing times which makes aggregating incoming lab paper reports in an organized manner an administrative burden. Third, paper results cannot be easily integrated into a computerized provider record and so this mode often requires manual entry of data which is subject to human error.

Another challenge with paper‐based test results is the complexity and lag time associated with obtaining lab test results.11 It is believed that an EHR system’s value increases dramatically with electronic lab results because it makes test results, an important piece in clinical decision‐making, easily available along with other clinical data. Further, these results can be trended over time or integrated with clinical decision support logic. While existing research suggests that electronic lab exchange can improve patient safety and quality of care,12 it is clear that these benefits can only be achieved if there is tight integration between lab test result data and other clinical data in a computerized patient record.13 Overall, evidence from existing research demonstrates that the electronic exchange of information in clinical laboratories should continue to represent a priority for achieving quality and efficiency improvements in health care delivery.

In addition to issues facing all providers seeking to develop electronic connectivity to lab results, safety net providers face a special set of issues and opportunities. On the one hand, because safety net providers treat a large number of the nation’s underserved and chronically ill residents, their efforts may stand to benefit disproportionately from establishment of electronic lab exchange as a means to increase the efficiency and quality of care. On the other hand, safety net providers,14 including federally funded community health centers, are less likely to use EHRs than other providers. They are also less likely to have the resources to work with clinical laboratories and contribute the resources (human, technical and financial) necessary to achieve robust exchange with their partners. As we shall explore in greater depth, health centers that have access to IT applications and services may be better positioned to realize electronic exchange with clinical labs and reap the benefits, but also face significant technical challenges.

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