KHIE+LRI+Pilot+Brief

include component="page" wikiName="siframework" page="LRI Header" PROJECT BRIEF: KHIE Harmonization Services, Proof of Concept

**Sponsor(s)/Contact(s): Organization Name and Contact Name**
Polly Mullins-Bently, Acting Director of the Governor's Office of Health Information Exchange Randy McCleese, CIO at St. Claire Regional Medical Center

**Objectives**

 * 1) Conduct a gap analysis of the LIMS vendor interface against the minimum required fields of an LRI compliant test message.
 * 2) Establish a secure connection between the data provider and the KHIE.
 * 3) Consume HL7 messages associated with LRI in-scope microbiology tests.
 * 4) Validate message cardinality and harmonize key terminology ( i.e. LOINC, SNOMED-CT, UCUM)
 * 5) Incorporate validated LRI messages in to an open-source EMR.
 * 6) Demonstrate CLIA compliance.

**Pilot Term**
Defined by ONC.

Team Composition

 * **Laboratory** || **LIMS Vendor** || **System Integrator** || **EHR Vendor** || **Ambulatory Provider(s)** ||
 * St. Claire Regional Medical Center || Meditech || KHIE/Mirth || FreeMED ||  ||

Description
>>> Administrative sex, Event type, Race, Specimen action code, Message type, Observation interpretation, Observation result status, Processing ID, Version ID, Order control, Value type, Application ACK condition, Address type, Name type, Identifier type, Universal ID type, Message structure, Coding system and Specimen type. The transformation workflow will incorporate JavaScript developed for harmonization of ELR against ELINCS v1.1 and made available under the GNU General Public License by Spencer Smith.
 * 1) **General description of the pilot**. The KHIE will transform electronic laboratory results from Saint Claire Regional Medical Center (SCRMS) in to LRI complaint messages, via a Mirth interface engine, for subsequent consumption and display by FreeMED, a free, open-source EMR.
 * 2) **Describe how you will demonstrate all of the In Scope items of the S&I Framework Use Case.** Post-transformation messages should suffice to demonstrate that test results can be presented to our chosen EMR as structured data. Screenshots will show that order specific data can be used to correlate the results back to the originating order in the receiving EMR. Similarly, screenshots will be used to demonstrate that CLIA reporting requirements are met.
 * 3) **List which S&I Framework in scope tests you will include.** KHIE will include the microbiology tests in the in-scope test list, however, specific tests cannot be identified until we receive the Meditech microbiology test dictionary from SCRMC.
 * 4) **List which Implementation Guide Profiles you will include.** Profile: 2.16.840.1.113883.9.19
 * 5) **What will be your source of test data?** Test data will be defined by the KHIE and consist of patient data supplied by the S&I vocabulary work group [LRI-Data-20111212A.xls] combined with in-scope tests. The test data will remain fixed with the exception of laboratory test and results codes.
 * 6) **Summarize the contribution of each team member**
 * 7) Laboratory
 * 8) **Contribution** The laboratory will be responsible for manually entering paper laboratory orders created by FreeMED.
 * 9) **Briefly described your approach to covering all CLIA reporting requirements, including but not limited to: result reports statuses; preliminary, final, appended, corrected and/or amended.** All result statuses for in-scope microbiology tests will be tested.
 * 10) **If there is no laboratory on your team, address which team member will be responsible for the laboratory items # ??? to ??? and describe your approach to addressing the items.**
 * 11) LIMS Vendor
 * 12) **Contribution** SCRMS will supply their Meditech interface documentation and laboratory dictionaries as well as help determine if a gap exists between the data elements collected by the LIMS and the minimum data elements of an LRI compliant test result. In addition, SCRMS will work with the KHIE to establish an MLLP connection between their Cloverleaf engine and the KHIE Mirth engine running the LRI transformation workflow.
 * 13) **To which Guide or Standard will the output test result comply?**
 * HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, Release 1 [DRAFT]
 * LOINC
 * SNOMED-CT
 * UCUM
 * 1) **Describe how will you capture the LIMS output message for compliance verification?** LIMS output will be captured as HL7 messages.
 * 2) **Describe how you will be returning the minimally required set of information related to an order through a transaction.** This pilot assumes the LRI IG defines the minimally required set of order information to return to the ordering provider, hence adherence to the IG meets this requirement.
 * 3) System Integrator
 * 4) **Contribution** As system integrator, KHIE will be responsible for the transformation and validation of result messages received from SCRMS related to organism cultures and antibiotic susceptibilities. In addition, KHIE will also assume the responsibility for incorporating validated messages in to FreeMED.
 * 5) **Describe any transformations that you will be doing between the LIMS output and EHR input. These should include structure and data transforms.** KHIE will validate that the required segments and fields are present, per the LRI implementation guide, for culture and susceptibility results. In addition, KHIE will harmonize local values associated with controlled terminology from HL7 value sets:
 * 1) **Describe your transport system that is being used in Production environments. Include**
 * 2) **Established network and policy infrastructure to enable consistent, appropriate, and accurate information exchange across provider systems, data repositories and locator services. This includes, but is not limited to:**
 * 3) **Methods to identify and authenticate users;** Access to all software component used in this proof of concept will be controlled by user credentials.
 * 4) **Methods to identify and determine Providers of care;** Providers will be identified by name and NPI.
 * 5) **Methods to enforce data access authorization policies;** Access to the LIMS is controlled by the paricipating laboratory, presumably using standard authentication practices. (i.e. user credentials and roles) The same is true of technologies owned and operated by the KHIE.
 * 6) **Methods to ensure the veracity of data;** Post-transformation content will be verified against the pilot test data set and with the assistance of the laboratory.
 * 7) **How the transport mechanism will provide guaranteed delivery and error handling.** <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">MLLP is a reliable message transport protocol that guarantees “in order” and “at least once” delivery of HL7 messages.
 * 8) **Describe your approach to how detailed audit trails are kept as necessary by all participating systems.** <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The Mirth interface engine supplies components for transaction and error logging.
 * EHR Vendor
 * 1) **Contribution** <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">FreeMED, a free and open-source EMR will be used by the KHIE to emulate the receiving system.
 * 2) **Describe how will you capture the EHR input message for compliance verification?** <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">After the inbound message has been processed by the LRI transformer, the message will be passed to a JavaScript parser for insertion in to the FreeMED database. The FreeMED insertion routine will incorporate JavaScript developed for the insertion of laboratory results in to FreeMED made available by FreeMED.
 * 3) **Describe how you will obtain evidence that the EHR can incorporate test data from the laboratory message as standardized structured data.** Natively, FreeMED<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;"> does not have the capability to incorporate structured data, however, in conjunction with a Mirth interface engine, structured data can be consumed. The programming code, as well as screenshots, can be provided as evidence that the structured messages were incorporated in to the EMR.
 * Ambulatory Provider(s)
 * 1) Contribution
 * 2) If there are no providers on your team, address which team member will be responsible for the provider functions and describe your approach to addressing the provider functions.

High Priority Focus Items
Describe your approach to addressing the following High Priority Focus items. The approach should include short term (3months) and long term(9 months)
 * LOINC - Tests will be LOINC encoded by the sending system. The KHIE will only validate the test codes against a lookup table of LOINC codes.
 * SNOMED - Non-standard result value "Not isolated" used in combination with organism specific LOINC tests will be replaced with SNOMED-CT value "absent". In test scenerios where a generic culture test is received a mapping table will be used to implement SNOMED-CT organism identifiers in OBX 5.
 * OIDS - OID use will be limited to message sender and receiver.
 * UCUM - A mapping table will be used to implement the UCUM standard in OBX 5 fields encoded as structured numeric.

LRI Pilot Project Time Line
Include at least the following Milestones
 * **Milestone** || **Target Date** ||
 * LIMS generates the first in scope test result || Start + 1.5 mo. ||
 * Transport system available and tested || Start + 2 mo. ||
 * Transformations available and tested || Start + 3 mo. ||
 * EHR receives and incorporates first test result || Start +3.5 mo. ||
 * LIMS can generate all in scope test results || Start + 4 mo. ||
 * EHR can receive and incorporate all in scope test results || Start + 4 mo. ||

Validation Suite
Will the pilot use the LRI validaiton suite? Yes

Success Metrics

 * Production of syntactically valid LRI-IG ELR:
 * Percentage of the KHIE pilot tests [in-scope microbiology cultures and sensitivities] that pass context free validation using the LRI validation suite.
 * Production of semantically valid LRI-IG ELR:
 * Percentage of the KHIE pilot tests [in-scope microbiology cultures and sensitivities] that pass contextual validation using the LRI validation suite.
 * Demonstration of successful integration of valid LRI-IG ELR in to pilot EHR:
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Percentage of pilot tests successfully integrated in to pilot EHR and displayed according to CLIA requirements.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Documentation of the pilot implementation process and tools, to be used for Meaningful Use modular certification of the KHIE.

Required Artifacts and/or Support
Describe any artifacts and support that you need from the LRI Pilots Workgroup, workgroup support staff or ONC.

Assistance with constructing in-scope test data set. Guidance on:
 * resolving potential inconsistency in the draft LRI IG.
 * special processing requirements for ELR given report status.
 * EMR workflow requirements to meet CLIA display requirements.

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