LRI+-+Dataset+Considerations

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

**13.1 Message Content Requirements** The following table lists the expected content of a lab test result as defined by this Use Case. Order control should be fixed to RE. ||
 * **Section Description** || **Data Elements (Required if available and applicable to support use case but not inclusive of any underlying standards)** || **Additional Notes** ||
 * Patient Identification Segment (Required) || PID, Patient Identifier List, Patient Name, Patient Mother’s Maiden Name, Patient Date/Time of Birth, Patient Address, Patient Administrative Sex, Patient Race, Patient Ethnic Group, Patient Telecommunication /Patient Contact Information, Patient Identity Unknown Indicator || Sufficient to identify patient in the EHR system as required by 42 CFR 493.1291(c)(1) at a minimum and to enable lab to apply correct reference ranges, abnormal flags and calculations. ||
 * Patient Visit Information (Optional) || If needed. || As applicable in some circumstance to ambulatory setting for primary care (Give consideration to inpatient test being reported to PCP). The current Use Case doesn't require this information but it should be left as optional. ||
 * Patient Visit Additional Segment (Optional) || If needed. || As applicable in some circumstance to ambulatory setting for primary care (Give consideration to inpatient test being reported to PCP). The current Use Case doesn't require this information but it should be left as optional. ||
 * Common Order Segment (Required if Available) || Placer Group Order Number, Order Control, Placer Order Number (Same as OBR), Filler Order Number (same as OBR), Ordering Provider (Same as OBR), Ordering Location and Ordering Facility || May be "virtual" order and sufficient to match test result with order if available in the EHR system.
 * Observation Request Segment (Required) || Placer Order Number (same as ORC), Ordering Provider (same as ORC), Filler Order Number (same as ORC), Universal Service Identifier, Results Report Time, Results Report Status, Copy to Providers, Linking Parent Child via Orders and Linking Parent Child via Results || Includes results report status (final, preliminary, corrected, amended and appended).

This is where parent and child are linked, e.g., reflex test result is linked backed to original result. Another example is an microbiology culture that identifies two organisms and susceptibility panels are linked to the culture but they also need to be linked to the individual organisms that were identified in the culture.

Universal service identifier is bound in this Use Case to the list of In Scope Tests.

The test report date is required by 42 CFR 493.1291(c)(3). || The observation ID is bound to In Scope test lists for this Use Case.\* The test performed and test results and, if applicable, units of measurement or interpretation or both are required by 42 CFR 493.1291(c)(4) and (6). The name and address of the laboratory where test was performed is required by 42 CFR 493.1291(c)(2). || Specimen source is required by 42 CFR 493.1291(c)(5). Other information regarding condition and disposition of the specimen that did not meet laboratory’s criteria for acceptability is required by 42 CFR 493.1291(c)(7). ||
 * Notes and Comments Segment (Required if Available) || Comment/Note and Type Comment/Notes || May be associated with either observation request or observation result. ||
 * Timing/Quantity Segment (Optional) || Order Start and end date/time, Order Priority (of test performance) ||
 * Observation/Result Segment (Required) || Sequencing of result in relation to order, Value Type, Observation ID, Observation Value, Units, Reference Range, Abnormal Flags, Result Status Date/Time of Observation and of Analysis, Responsible Observer, Performing Organization, Address and Medical Director || Includes result status as defined in Pre-conditions.
 * Specimen (Required) || Specimen Type, Specimen Source Site, Specimen Accession Number and Date Time of Specimen Collection, Specimen Reject Reason and Specimen Condition || Specimen collection process was out of scope -- however necessary specimen data are to be entered into lab system and included with the result.
 * In scope test results are of four standard reporting formats as discussed next in Table 9 and the list of expected lab test results necessary to support the ambulatory care setting are in Appendix xx **// (this will be updated once the appendices are finalized) .//**

13.2 Standard Reporting Format Requirements
To avoid multiple interfaces at both the laboratory and ambulatory EHR systems, the interface must accommodate all test results that will be transmitted electronically. The failure to achieve the above goals will have a significant negative impact on the electronic communications of laboratory results, harmonization of laboratory data, and the ability of physicians to meet the goals of meaningful use in all phases.

Therefore, the S&I framework for laboratory test interfaces should accommodate all laboratory results. To avoid a situation where complex data requirements of certain results (e.g. specific anatomic pathology, cytology, genetics tests) would cause exclusion, the scope will support these tests without current constraint on format or clinical terminology (e.g. as PDFs, narrative text or data blobs). The balance of the laboratory tests that have standard reporting formats as defined below will be broken into two categories: A) Those with simple data types (positive/negative, numeric values and units of measure) or use standard terminology (e.g. LOINC and SNOMED CT where available or appropriate). B) Those that may have laboratory specific local terminology used in the electronic reporting of the results

The standard reporting formats are included in the following table: Example 2: cytology / Anatomic Pathology Example 3: mutation type and location Example 4: organism name ||
 * **#** || **Reporting Format Requirement** || **Example** ||
 * 1 || Tests and/or components with numeric results, units, and normal ranges ||  ||
 * 2 || Tests and/or components with a limited set of textual results with or without normal ranges || Example 1: positive/negative/indeterminate, resistant/intermediate/susceptibility
 * 3 || Tests with defined structure in OBX-3 thru OBX-8 for the reporting of Culture Results and Antimicrobial Sensitivities ||  ||
 * 4 || Semi Structured or Unstructured || Tests and/or components reported in a PDF or data blob ||

If the targeted format cannot be met, then it is acceptable to use an alternate reporting format that conveys the result information and contains as much of the discreet meaning of the result as possible.

To meet these goals, the initial deployment for the resulting LRI S&I Framework should accommodate the full range of laboratory tests as described above utilizing an existing standard constrained with an existing implementation guide. The initial set of tests that should be addressed for harmonization and to determine success metrics should encompass or be selected from the list of LOINC coded tests in **Appendix XX** **//(this will be updated once the appendices are finalized).//**

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