LRI+-+Overview+and+Scope

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2.0 Overview and Scope
The Laboratory Results Interface Initiative focuses on identifying the requirements, specifications and standards, and on providing the implementation guidance for electronic reporting of ambulatory care laboratory test results in the US Realm. The scope of this Use Case includes requirements to enable the incorporation of clinical laboratory test results into an EHR as standardized structured data using the defined inter-organizational laboratory transaction. The Use Case requirements are directed at lab test results reporting between a laboratory information system and an ambulatory EHR system in different organizational entities, e.g., different corporate structure, ownership or governance. However, the resulting implementation guide may also be useful within organizations and in non-ambulatory care settings.

There are at least two standard implementation guides for ambulatory laboratory test reporting, neither of which are adopted universally across the industry. The lack of a single, comprehensive implementation guide for the result reporting interfaces drives the cost and time to implement such interfaces up and consequently hampers broad adoption of such interfaces. Furthermore, the field by field details of HL7 v2 implementation guides used by clinical labs and EHRs vary; creating a need for mapping or configuration per interface, and the prevalence of core subsets of LOINC codes, where in use for common tests and analytes also varies, causing downstream issues in decision support and quality reporting.

Successful outcomes for this Initiative include:
 * 1) Number of Providers using Lab Results Interface Initiative Outputs
 * 2) Number of Labs using Lab Results Interface Initiative Outputs
 * 3) Number of Lab Results Reporting transactions using Lab Results Interface Initiative Outputs
 * 4) Number of vendors (EHRs, PHRs, LIS Vendors, HIEs) using Lab Results Interface Initiative Outputs
 * 5) Time Reduction to Create a New Laboratory Interface for the laboratory/EHR system
 * 6) Cost Reduction to Create a New Laboratory Interface for the laboratory/EHR system
 * 7) Meaningful Use Alignment

The Use Case scenario that is outlined in the subsequent sections focuses on the sending of clinical laboratory results to a certified EHR system. The scope has been limited to the core set of test results typically utilized for primary care functions provided by Internal Medicine, Family Practice and Pediatrics, but may also be leveraged by other providers and settings.

2.1 In Scope

 * Defining the core data elements required for ambulatory care core clinical laboratory test results
 * Reporting of ambulatory care clinical laboratory test results in the US Realm
 * Sending and Receiving of ambulatory care core clinical laboratory test results
 * Sending clinical laboratory test results as standardized structured data so they can be incorporated that way into certified EHR
 * Support certification criteria and MU requirements, the Use Case will develop requirements for an interface that enables the incorporation of clinical laboratory test results into certified EHR as standardized structured data
 * The reported test is a result of an order placed manually or electronically
 * To the extent an order has been placed the minimally required set of information related to that order will be returned through that transaction.
 * This Use Case covers all CLIA reporting requirements, including but not limited to: result reports statuses; preliminary, final, appended, corrected and/or amended

2.2 Out of Scope

 * Specifications and implementation guidance on laboratory ordering transactions. However, the establishment of requirements in the lab result message that will allow the matching of the reported result to an existing order initiated from the ordering clinician’s EHR is within the scope of this effort.
 * Querying for laboratory results
 * Querying for historical laboratory results
 * Receiving historical laboratory results
 * Secondary use of laboratory data (i.e., public health or bio surveillance uses of the reported lab results)
 * Specialty laboratory orders
 * Receiving specialty laboratory results
 * Hospital ordering and reporting of laboratory results
 * Advanced error messages related to application transport

2.3 Background
The Laboratory Results Interface Initiative and the subsequent Laboratory Results Reporting to Primary Care Providers (in an Ambulatory Setting) Use Case has been selected because of its alignment with Meaningful Use Stage 1 and foreseen Stage 2 indications as well as addressing various Prioritization Criteria as described below.

The Laboratory Results Interface Initiative holds importance and relevance because it enables stage 1 and potential stage 2 Meaningful Use criteria:


 * Stage 1: Incorporation of laboratory results as structured data
 * Stage 2: Incorporation of laboratory results through well defined interfaces as standardized structured data

The terms structured data and standardized structured data represent current Stage 1 certification criteria and possible extensions for Stage 2.

(please reference background section & Final Rule). || Established standards facilitate the exchange of the information across providers by ensuring data is structured in the same way. || We said that when the information was available in a structured format we expected that it be transferred in a structured format. However, if it was unavailable in a structured format, that the transmission of unstructured data was permissible." Final Rule || Standardized structured data is a related set of data encoded within an agreed-upon **syntactic and semantic** structure, using coding systems and metadata to formalize the meaning of each individual datum (which cannot be decomposed further) in the set where appropriate. Standardized structured data is driven by the goal of improving the **interoperability** of data between disparate systems, and simplifying the process of harmonizing data from disparate sources. ||
 * Definitions of Structured Data Applicable to Lab Results Reporting**
 * || Structured Data || Standardized Structured Data ||
 * Definition || "Structured data is not fully dependent on an established standard. Established standards facilitate the exchange of the information across providers by ensuring data is structured in the same way. However, structured data within certified EHR technology merely requires the system to be able to identify the data as providing specific information. This is commonly accomplished by creating fixed fields within a record or file, but not solely accomplished in this manner"
 * Source || 45 CFR Part 170 §170.302(h) 42 CFR Part 495 || Extension of definitions in cited final rules by Structured Data Sub-Workgroup ||
 * Applicability || Current requirement for EHR technology certification (testing) and demonstration of Meaningful Use for Stage 1 || Potential future requirement for EHR technology certification (testing) and demonstration of Meaningful Use for Stage 2/3 ||
 * Context || Receive, display (in human readable format) and incorporate structured (lab) data || (Proposed) Receive, display and incorporate __standardized__ structured (lab) data ||
 * Description || "Structured data is commonly accomplished by creating fixed fields within a record or file, but not solely accomplished in this manner. For example, in this case for it to be structured, if the patient is on aspirin, then that information should be in the system so that it can be automatically identified as a medication and not as an order, note, or anything else. An example of unstructured data would be the word aspirin, but no ability of the system to identify it as a medication...

The Initiative requires and supports information interchange. Messaging and vocabulary standards exist but due to the high degree of allowable variation implementation of laboratory interfaces is time consuming and costly. This Initiative will leverage existing interoperability standards and specifications when defining the Use Case and functional requirements.

There are at least two implementation guides and specifications for laboratory results.


 * The HITSP/IS01 specification, or more properly the Implementation Guide: Order and Observations; Interoperable Laboratory Results Reporting to Electronic Health Record (EHR), Release 1 (Lab to EHR guide), that HITSP points to, and HITSP/C36 Laboratory Message Component in combination define and constrain the use of the HL7 Version 2.5.1.
 * EHR-Laboratory Interoperability and Connectivity Specification (ELINCS) also constrained the HL7 Version 2.5.1 Implementation Guide which resulted in the HL7 2.5.1 Implementation Guide: Orders and Observations; Ambulatory Laboratory Results (ELINCS), Release 1.

2.4 Policy Issues
The Use Cases strive to address relevant and timely policy issues that will have downstream effects on the US healthcare reform agenda; specifically relevant to healthcare information technology. Without a widely accepted standard for laboratory results exchange several issues will arise in relation to clinical decision support and quality reporting.


 * Certification Criteria: Receive results in structured format and display in human readable format. However the certification criteria for Stage 1 do not specify that the structured lab results that are received be in a standard format or use code set standards in meeting the measure for this objective. However, the Office of the National Coordinator for Health Information Technology (ONC) has adopted Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, when such codes were received within an electronic transaction from a laboratory, for the entry of structured data for this measure and made this a requirement for EHR technology to be certified.
 * Meaningful Use Requirement for Stage 1: Incorporate Laboratory results as structured data into Electronic Health Record.

The requirements of this Use Case when fulfilled by the Standards and Interoperability Framework should provide policy makers to have a viable implementation guide for sending lab results as standardized structure data to EHR systems within the ambulatory care setting. This would enable policy makers to require such exchanges if they so decided in Stage 2 and/or Stage 3.

2.5 Regulatory Issues
This Use Case acknowledges the variations in requirements for reporting across local, state, tribal, and territorial boundaries as well as voluntary versus mandatory requirements.

In the Final Rule 42 ONC required that EHR systems receive and incorporate lab results as structured data. CFR 493.1291(c) requires that the test report must indicate the following:

(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (2) The name and address of the laboratory location where the test was performed. (3) The test report date. (4) The test performed. (5) Specimen source, when appropriate. (6) The test result and, if applicable, the units of measurement or interpretation, or both. (7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. Interpretations of legal requirements across the states and laboratory sources vary widely and there is currently no ability to monitor/enforce standards.

2.6 Communities of Interest
Communities of Interest are public and private stakeholders that are directly involved in the business process or are involved in the development and use of interoperable implementation guides and implementation of the Solution. Some members are business actors. Communities of Interest may directly participate in the exchange, that is they are actors, or indirectly through the results of the improved business process.

The following list of Communities of Interest and their definitions are for discussion purposes for clinical information exchange:
 * **Members of Communities of Interest** || **Working Definition** ||
 * Patient || Members of the public who require healthcare services from ambulatory, emergency department, physician’s office, and/or the public health agency/department. ||
 * Consumers || Members of the public that include patients as well as caregivers, patient advocates, surrogates, family members, and other parties who may be acting for, or in support of, a patient receiving or potentially receiving healthcare services. ||
 * Care Coordinators || Individuals who support clinicians in the management of health and disease conditions. These can include case managers and others. ||
 * Clinicians || Healthcare providers with patient care responsibilities, including physicians, clinical laboratory personnel, advanced practice nurses, physician assistants, nurses, psychologists, pharmacists, and other licensed and credentialed personnel involved in treating patients. ||
 * Provider || An individual clinician or care delivery setting delivers care to the patient and in that role accepts laboratory test results in this Use Case. ||
 * Laboratories || A laboratory (often abbreviated lab) is a setting where specimens are sent for testing and analysis, after which results are communicated back to the requestor. The types of laboratories may include clinical/medical and may be both private and/or public ||
 * Provider Organizations || Organizations that are engaged in or support the delivery of healthcare to include Hospital Ambulatory Centers and Provider Practices. ||
 * Standards Organizations || Organizations whose purpose is to define, harmonize and integrate standards that will meet clinical and business needs for sharing information among organizations and systems. ||
 * Electronic Health Record/Personal Health Record Vendors || Vendors which provide specific EHR/PHR solutions to clinicians such as software applications and software services. These suppliers may include developers, providers, resellers, operators, and others who may provide these or similar capabilities. ||
 * Federal Agencies || Organizations within the federal government that deliver, regulate or provide funding for health and health care. ||
 * Health Information Exchange (HIE) || HIE is defined as the mobilization of healthcare information electronically across organizations within a region, community or hospital system. ||

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