LRI+-+Issues+and+Obstacles

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12.0 Issues and Obstacles
There is a lack of harmonization among data interoperability standards including vocabulary, laboratory and other messaging standards.

The Information Exchange workgroup identified many systematic issues related to standardization of electronic laboratory transactions. These issues were presented at the December 19, 2009 Health Information Technology Policy Committee meeting. They include:

//Weak market incentives prevent rapid growth in standards-based laboratory interfacing; interfaces still not replicable and are thus time-consuming and costly.//
 * CLIA recognizes over 200K labsto include the order compendium issue. Furthermore, the majority of these 'labs' only have certificates of waiver or provider-performed microscopy procedures, and therefore, would not be the type of lab to engage in the data exchange discussed within this Use Case.
 * Over 75% of laboratory tests conducted by hospitals and local labs
 * Most laboratory results delivered through paper-based means (letter, fax) or non-structured electronic means.
 * Laboratory interfaces cost $5-$25K each
 * Labs typically pay EHR vendors for lab interfaces
 * Users typically do not pay for laboratory interface or delivery as long as they are high enough volume users
 * Interface approval process can take months, which lengthens interface time and cost

//High degree of allowable variation in current messaging and vocabulary standards makes interfacing time-consuming and costly.//
 * Messaging and vocabulary standards exist but are not monitored or enforced
 * HL7 2.5.1 released in 2007 but still not widely used
 * Allowable variations in HL7 standards keeps costs high; high number of optional fields
 * Hospital labs usually use local legacy codes; national labs closer to conforming with LOINC, but still have internal legacy-based variations
 * LOINC and SNOMED still too complex for routine ambulatory implementation – not “clinically relevant”
 * There are different expectations that need to be resolved in order not to pose a barrier to the interoperability of laboratory results from ambulatory care environments.
 * Conversion to HL7 2.5.1 and LOINC would require investment by most hospitals for interface development and upgrading of systems
 * No standard automated way to update compendiums; usually happens manually after fax notification
 * Lack of process/workflow/technology that allows echoing of the original requisition (order) identifier and/or patient identifier back to placer makes implementation of results reporting lengthy, costly, and suboptimal.

//Interpretation of legal requirements across states and laboratory sources varies widely; no requirements exist for messaging or vocabulary standards, and no ability to monitor/enforce standards.//
 * CLIA regulation that holds laboratory responsible for how results appear in the EHR is being interpreted differently by various laboratory companies, hospitals, LIS vendors and EHR vendors.
 * CLIA Requirement 42 CFR 493.1291: “The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry to final report destination”
 * No regulatory requirements or market imperatives currently exist for messaging or vocabulary standards either on the receiving or on the transmitting ends

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