As experience with exchange of clinical data between providers and laboratories expands, policy makers and cross‐sector stakeholders will have a greater opportunity to address key structural and process barriers that impede lab exchange. Challenges currently identified range from relatively limited adoption of health IT by ambulatory care providers in general (current estimates indicate that fewer than one in four ambulatory care practices use EHRs) to the cost of developing, validating, and maintaining interfaces. The lack of incentive for providers to invest in electronic capture of patient‐specific laboratory data in the absence of an imperative to report on or track clinical outcomes or participate in quality improvement initiatives also presents a significant challenge. A series of more specific barriers are described below.
Limited use of standards. We found limited evidence that clinical laboratories or EHR vendors have moved towards greater use of standards recommended by HITSP or used as criteria by CCHIT. While we found that clinical laboratories and EHR vendors are “gearing up” and in some cases “ramping up” for use of these standards including LOINC, most are still relying primarily on proprietary data formats and definitions that must be reconciled through one‐off interfaces between the particular implementation of the LIS and a particular implementation of an EHR.
While the ability for lab and clinical software to support some HITSP recommended standards such as LOINC is expanding, we found that laboratories, EHR vendors, HIE organizations and others that have worked to map specific tests to LOINC codes have found this to be a time‐consuming process. There is no empirical evidence regarding the consistency of LOINC code mappings across various laboratories. Also, we found some resistance to the notion that there is a viable business case for labs and EHR vendors to pursue other standards such as UCUM and OIDs. Our study participants also indicate that another key barrier to standards adoption is the lack of easily understood and sufficiently concise implementation guides relating to each of the HITSP recommended standards. There is a strong case for the development of implementation guides that will promote broader use of standards, and to which health centers could refer their laboratory and EHR vendor business partners.
For now, there are some important challenges associated with the use of very basic standards including provider identification. Where EHR and practice management systems have moved to a National Provider Identifier (NPI) based on CMS requirements, many major clinical laboratories use Unique Provider Number (UPN) codes to identify individual providers. In addition, most results and order records within LIS make use of proprietary coding systems that are application specific. When interfaces fail due to changes in results or order codes within an LIS, interfaces to EHR systems need to be updated. One EHR vendor stated that their clients are provided with user‐friendly software in the engine which allows the clinics to enter new codes into their system when a laboratory informs the providers of the new tests. The same EHR vendor is trying to develop a HL7‐ based specification, but has not taken this initiative to HL7 because the application and approval process with the Standards Development Organization (SDO) is a long tedious process.
Limited understanding of best practices in interface development. Because of the various business interests involved in lab exchange and the relative inexperience of most providers with EHR systems, we found little evidence that the health care sector has developed clearly defined best practices around interface development. Each lab respondent described a similar approach to interface development, but it was clear that the process remains relatively loose, with large variations in the time required to set up an interface (between six weeks and six months), the level of effort required, and the exact steps that need to be employed. Such variations may be due to: an inherent variation in the different EHR and LIS systems on the market; the manner in which any given software product is implemented in a clinic or laboratory; differing levels of experience or skills to support interfaces at the provider level; and other inherent variation in inputs. Variations could also be in part a result of the lack of a strong incentive on the part of providers, EHR vendors, labs and LIS vendors to work together to define best practices.
Relationship between use of standards and regulatory compliance. Key regulatory issues relevant to lab exchange include the need for laboratories to verify the screenshot or view of laboratory results under CLIA as well as the privacy and security regulations specific to CLIA, HIPAA and individual State medical information privacy statutes. In general, labs that provide interfaces are familiar with their regulatory responsibilities and have worked out processes to comply with these requirements routinely as part of the interface development process. However, there is limited understanding of how the use of HITSP proposed standards would affect these certification processes. For example, some discussants noted that use of standards such as UCUM may impede regulatory compliance because the UCUM conventions for units of measures for any given lab test are not consistent with what clinicians are used to seeing for the purposes of clinical evaluations. To address clinician needs regarding the representation of results, EHRs may need to maintain a mapping between UCUM and human readable codes. These maps will need to be updated and validated periodically.
Cost considerations. While discussants would not (or in some cases could not) provide specific details regarding the cost and price of developing interfaces, it was clear from our discussions that the costs of establishing lab interfaces are substantial and cover a range of elements, including: the additions to the LIS and EHR software itself; the time required to monitor and maintain the interface, and to identify and resolve problems; and the cost of procuring legal counsel to assure compliance with state and federal laws. Discussants noted that it is challenging to calculate interface costs because there are a number of highly variable factors that contribute to the total. Additionally, messaging standards will influence this expense. The major drivers of the costs of establishing the interface, and those associated with validation and ongoing maintenance, are not entirely clear.
While there are strategies to minimize costs such as using the availability of a lab module as a criterion for EHR selection, there are inevitably costs associated with customization of those pre‐set modules. For example, costs will depend on the way in which the EHR is used in a particular setting and the features of the LIS systems used by the clinical labs to which interfaces are being built. Some larger labs offer free interfacing as a market differentiator. Fees for labs that do charge tend to be nominal. However, EHR vendor costs to clinicians associated with developing a custom interface may be substantial and are not well understood. For large EHR vendors, the direct costs of CCHIT certification are nominal and are part of company strategy to gain market share. Consequently, the costs for certification incurred by these large vendors are not transferred to providers that purchase CCHIT certified systems. The same situation may not hold true for smaller EHR vendors. Both large and small vendors are likely to encounter additional development costs to include functionalities required for CCHIT certification and these costs may impact the price of the EHR.
Discussants stated that there can be significant soft costs associated with the interface implementation. One larger health center network indicated that it has one staff person spending around 20 hours per week on monitoring lab feeds for about 45 interfaces for member health centers. They estimated that two to four hours of the 20 are spent cleaning errors in the system. Another health center network reported having to pay $35,000 up front to the EHR vendor to set up the lab interface specification to support its providers.
Variation and fragmentation among laboratory information systems. We found that there is considerable existing fragmentation in laboratory information systems even within the same larger clinical laboratory corporation. As the large laboratories expand by acquiring regional laboratories, they do not automatically and immediately convert each facility to a single corporate LIS. As a result, lab interfaces must be customized for different LIS systems. In addition, given the complexity and continuous innovation in laboratory sciences, we found that labs are often forced to update results codes for the same test based on differences in methods or instrumentation used in the testing that affect reference ranges. While the relevance of the testing methods varies depending on the clinical context, the testing methods do not always materially impact the interpretation of the results by the provider.
Experience from the regional health information exchange organizations (HIEs) shows that no two laboratories use the same local codes and laboratories change codes frequently as new testing procedures are introduced.42 To address this issue HIEs are moving toward LOINC mapping. In most cases, the approach has been incremental whereby the most common lab tests are mapped to LOINC codes.
Limited EHR adoption and availability to HIE systems. Interoperability between provider systems and laboratory systems implies the existence of computerized clinical information systems at provider offices. The most recent research indicates that fewer than one in four physician offices are using EHRs. Another opportunity for interoperable lab exchange could be supported by HIE‐based platforms. However, most ambulatory care providers do not have access to information or data applications supported by HIEs.
Opportunities for standards adoption and identification of best practices. While there are significant barriers to achieving widespread lab exchange, there are also some important opportunities originating from industry, the federal government, and charitable foundations. First, while our respondents indicated that some of the standards being recommended by HITSP are too difficult to implement at this time, most indicated that HITSP and specifically CCHIT play an important role in helping the technology industry move towards adoption of a consistent set of standards to support the lab exchange use cases most important for quality improvement. In particular, it may be useful to explore alignment of certification programs that relate to non‐EHR systems, including those used in hospitals and labs with CCHIT. Given the large investments that labs have made in their existing laboratory information systems they are more likely to upgrade rather than purchase a new system. The return on investment will need to be demonstrated before the laboratory industry will replace existing systems.
In addition, a recent effort sponsored by the California HealthCare Foundation (CHCF) called the EHR‐Lab Interoperability and Connectivity Specification (ELINCS) project has worked to take a step beyond identification of a standard and has mapped out an implementation guide. The guide not only focuses on mapping specific standards to lab results, but also discussed the whole process of using lab exchange to deliver real‐time laboratory results from a lab's information system to an EHR.
As part of ELINCS, CHCF worked to standardize the formatting and coding of electronic messages exchanged between clinical laboratories and EHR systems. The project used LOINC as a tag for each common test, and then refined the process for exchange through a series of pilot studies involving providers, clinical laboratories and integrated delivery systems in the state of California. ELINCS has worked closely with other national and international efforts to develop their specifications and implementation approach. ELINCs has been tested with: a number of the major ambulatory EHR vendors including AllScripts, NextGen, Emdeon and e‐MD; major reference labs such as Quest, LabCorp, and Spectrum; and hospital laboratory information systems including Misys, McKesson and Antek.43 The California HealthCare Foundation has also granted approximately $720,000 to support various ELINCs pilot projects.44