Electronic Exchange of Clinical Laboratory Information: Issues and Opportunities. CONCLUSIONS


EHR adoption and lab exchange go hand in hand for Quality Improvement (QI) in ambulatory care. Given that safety net providers and health centers, in particular, serve a disproportionate share of chronically ill individuals, QI in health centers depends significantly on close tracking of laboratory results, such as HbA1c and LDL. Health centers typically engage in disease management programs that rely on EHRs and disease registries to track lab‐based indicators among specific populations. As such, having an automated, seamless electronic link between provider systems and laboratory results reporting can serve as an important component of QI.

More needs to be learned about costs, and how to make sure those who benefit pay. While we were able to secure conversations with clinical laboratories and vendors, they were not forthcoming regarding the true cost or prices associated with development of interfaces. Health centers and health center network discussants indicated that while there are some up front costs associated with purchasing interface functionality from vendors and third party interface providers, there are also significant ongoing costs associated with monitoring and maintaining each interface. The latter costs are largely borne by providers and their networks. Because pricing for lab interfaces is often packaged with a broader set of services, additional research is needed to understand the true costs of developing interfaces and how these costs are different if exchange is achieved in the context of a laboratory portal, health information exchange or RHIO.

Little is known about the cost and complexity associated with life cycle cost adoption, validation and maintenance (including managing upgrades) of these standards. Part of the difficulty with estimating costs of establishing and using lab interfaces relates to the complexity of implementation. Our discussions demonstrated that even once an interface is in place and operating for a time, constant monitoring is required to assure that orders and results are validated and adjudicated appropriately as laboratory results codes change or new tests create new interface requirements. The burden of validation on a single provider is multiplied by the number of labs they work with (which is usually dictated by payers). For standards that are currently in use, there exist gaps and limitations that will need to be addressed. While much work has been done with respect to delivery of lab results, new work is underway to outline the standards and specifications to support the ordering of labs. In addition to the technical aspects of standards adoption, completing a more systematic review of costs associated with adopting standards and how the benefits accrue to various participants will help make the business case for standards adoption. The experiences of stakeholders serving as discussants for this paper demonstrate that there is a risk if standards are recommended absent practical assessment of the willingness and ability of stakeholders to implement them. Finally, health center networks that work with multiple providers, sites, and their associated clinical labs may bear a particularly high cost associated with process validations and other maintenance activities.

Widespread adoption of clinical standards takes time. It is important to note that the typical trajectory for adoption of clinical standards in health care may be slower than administrative transactions in health care and other industries. The experience with the slow adoption of SNOMED may be illustrative of the natural trajectory of standards adoption. In the absence of an immediate imperative in the form of a regulatory or business requirement to use standard‐based interoperable HIE, those stakeholders and vendors involved in HIE may not converge on standards for several years. Even with efforts underway to encourage consensus and generate recommendations, the lack of clear incentives to converge on a single set of standards and confusion regarding regulatory requirements may extend this trajectory even further.

It is important to combine standards recommendations with specific implementation approaches and realistic best practices. The efforts of federal agencies, the AHIC, HITSP and various standards development organizations have created momentum for identifying standards for adoption as well as highlighting current gaps that will need to be addressed. To promote information exchange between hospitals, health centers and labs, standards need to be implemented in a consistent and replicable way. By developing detailed and concise guides that outline optimum approaches to implementation, organizations will be able to establish electronic connectivity within a shorter time frame, at a significantly reduced cost and with a limited need for interface expertise. For health centers and networks, which are often resource constrained, this is particularly important. Focused efforts to develop implementation guides for safety net clinics and health centers and their business partners are likely to accelerate standards‐based exchange.

Current standards apply to a limited set of laboratory functions and results. While there are major standards identified that support the exchange of lab information – notably HL7, LOINC, SNOMED, UCUM and OID – there appears to be limited adoption of the standards by laboratories and vendors. Further, standards that apply to anatomical pathology, genetic testing, and other fields have not yet been fully developed. Although the adoption of HL7 V2.x is fairly broad, the variability in its implementation continues to pose challenges. While HL7 V3 can be implemented in a more standard way, experience with V3 is very limited both in the United States and internationally. Today, there are no large scale implementations of V3, and the migration path from V2 to V3 is costly due to the lack of backward compatibility between versions. 45

Regulatory Compliance and Certification. Currently, significant regulatory impediments prevent effective laboratory information exchange. In a networked environment, CLIA regulations will need to be re‐examined with respect to who should be held accountable for correct display of lab results to the authorized provider, transmission of data consistent with CLIA requirements, and timeliness of results delivery. While CLIA has many applications, it is important to note that there are many exceptions to CLIA regulations. Most notably, CLIA applies to physician office labs, with modification for waived testing as noted above.46 A review of the consistent interpretation of CLIA at a state level is essential. Similarly, State laws and regulations with respect to privacy, data use limitations and confidentiality remain significant barriers and will need to be reviewed from the context of laboratory information exchange. Finally, under CLIA, labs are required to test and verify the integrity of every lab interface they establish with provider offices and health centers.

Additionally, through CMS has approved accrediting organizations like CAP, labs may be periodically required to verify all interfaces with provider offices or health centers. This requirement is considerably different from CCHIT certification where particular versions of a product are certified rather than every implementation of the lab interface.

CCHIT certification currently applies to EHR vendors and looks to both HITSP and the industry on understanding market readiness for the adoption of functions and standards. Assessing the feasibility of similar certification for hospital systems and lab systems may need to be explored. Although, as noted above, such a certification system does not necessarily assure that each interface in the installed base is functioning correctly. For broad scale standards adoption, all of the participants in the chain of information exchange will need to play a role in either sending or receiving data in a consistent way.

Finally, health centers and other safety net providers will continue to face additional barriers to achieving lab exchange. A number of health centers have been able to establish networks to adopt health IT. Health centers, by virtue of their mission and the populations they serve, may also benefit more than other providers from health IT adoption. Yet, the complexity involved in lab exchange and the burdens associated with establishing and maintaining interfaces underscore the particularly difficult path facing safety net providers.


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