LabLynx+Pilot+Brief

**Sponsor(s)/Contact(s): Organization Name and Contact Name**
Mike Long (LabLynx) - mlong@lablynx.com Steve Roll (LabLynx) - sroll@lablynx.com Sheree Crowe (mdDigest) - sheree.crowe@mddigest.com Paul Blanchard (mdDigest) - paul.blanchard@mddigest.com

**Objectives**

 * Demonstrate the feasibility of providing results from tests to an EHR directly via the new HL7 message format
 * The provider request can be either manual or electronic, not important to objective
 * Use of LOINC, SNOMED and UCUM as applicable in the information being sent back
 * Demonstrate use of the validation suite on the message file by the EHR vendor before results are imported.

LRI Use Case that will be demonstrated:
 * NHIN Direct: Laboratory sends lab results to ordering provider

LRI Service that will be demonstrated:
 * EMR will be able to display the results provided by the LIMS in a format suitable for the provider.

In summary, we would like to demonstrate that if a single format is agreed upon for sending test requests and test results, that the labs can provide to the provider results directly through whatever EHR they are using.

**Pilot Term**
ONC envisions Pilot activity through completion of Pilot

Team Composition

 * **Laboratory** || **LIMS Vendor** || **System Integrator** || **EHR Vendor** || **Ambulatory Provider(s)** ||
 * Genoa Health Care || LabLynx, Inc || N/A || mdDigest || Suzanne Ferree MD ||

Description

 * 1) Pilot Description
 * [|LABLynx home page] LabLynx Inc is a supplier of browser-based LIMS (LIS) applications. One of the possible outputs, ie getting results to providers, is via EDDs. The LRI Pilot project will provide the opportunity to demonstrate that a standard format, much like the standard format for instruments interfaces used in the clinical labs, can allow for interaction directly to and from the clinical lab from providers where such is desired.
 * LabLynx will provide our Elab LIMS on a hosted basis which will work with the EHR provided by mdDigest.
 * The use of an actual clinical laboratory and provider will further demonstrate the Pilot success or help identify issues.
 * Genoa Health Care, St. Paul, MN will provide tesing orders, samples, and test data that can be used for the pilot scripts.
 * The testing requests, sample tracking, and results reporting will be handled by the LabLynx ELab clinical LIMS.
 * LabLynx will provide an output file configured according to the document: //HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, release 1//.
 * Order of items:
 * Determine what fields are needed in output file and hence need to be captured during the process the samples are undergoing evaluation in the LIMS.
 * Create output message file template conforming to //HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, release 1// using fields in LIMS.
 * Receive orders from mdDigest (manual or electronic).
 * Enter samples and relevant information.
 * This will be handled via secure ftp at the moment or could easily be handled via HL7 router in the actual implementation if available.
 * mdDigest runs Validation Suite to verify the message file.
 * mdDigest uses copy of report to verify results in message are same (Pilot only).
 * If message file passes validation, mdDigest imports results into the EHR.
 * Benefits:
 * This Pilot project will prove very beneficial for clinical laboratories in that they can easily receive test requests and send results.
 * Provider can order tests via EHR and view results in EHR.
 * Results are available electronically using devices that interface to the EHR.
 * Can easily see status/results of tests without actually having to use a separate program.
 * 1) Describe how you will demonstrate all of the In Scope items of the S&I Framework Use Case:
 * 2) Looking at data in LIMS
 * 3) Looking at Results Report and compare with information in LIMS
 * 4) Ensure that it is CLIA compliant
 * 5) List which S&I Framework in scope tests you will include:
 * 6) CBC W Auto Differential panel in Blood
 * 7) Lipid
 * 8) CMP
 * 9) List which Implementation Guide Profiles you will include:
 * 10) NG
 * 11) RN
 * 12) What will be your source of test data?
 * 13) The Laboratory: Genoa Health Care (GHC) located in St Paul, MN
 * 14) Summarize the contribution of each team member
 * 15) Laboratory
 * 16) Contribution
 * 17) Provide access to LIMS Data that includes providers, patients, samples, tests and results.
 * 18) 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.
 * 19) Results of tests not available for reporting until test has status of complete.
 * 20) LIMS Vendor
 * 21) Contribution
 * 22) LabLynx will develop the interface between the LIMS and EHR.
 * 23) LabLynx will use their ELab Clinical LIMS (LIS) as configured for GHC.
 * 24) LabLynx will provide an output file configured according to the //HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, release 1//.
 * 25) Will set up a secure FTP site for message transfer to the EHR. HL7 message files will be uploaded to the FTP site by the LIMS automatically upon completion of each test in an order.
 * 26) We believe that down the road the files can be transferred via HL7 router or something like Microsoft Health Vault.
 * 27) To which Guide or Standard will the output test result comply?
 * 28) LOINC
 * 29) HL7 v2.5
 * 30) UCUM
 * 31) Describe how will you capture the LIMS output message for compliance verification?
 * 32) Electronic Data Deliverable (EDD)
 * 33) Describe how you will be returning the minimally required set of information related to an order through a transaction.
 * 34) The LIMS will run a configured proc that will create the message file for each record that is to be returned. The information will be parsed into a delimited text file using the HL7 Ver 2.5.1 protocol and naming conventions.
 * 35) LabLynx will confirm with mdDigest the protocol format.
 * 36) EHR Vendor
 * 37) Contribution
 * 38) Provide EHR and use the Electronic Data Deliverable
 * 39) Accept HL7 lab results
 * 40) Parse and store in SQL db
 * 41) Provide results list view for unsolicited results
 * 42) Associate results with patients, manually from list or automatically when in response to a order
 * 43) Describe how will you capture the EHR input message for compliance verification?
 * 44) Initial transfer mechanism is SFTP and therefore the file being transferred is the input message. A copy will be logged for future access.
 * 45) If a different transport is introduced the interface engine will log the message to a file.
 * 46) Describe how you will obtain evidence that the EHR can incorporate test data from the laboratory message as standardized structured data.
 * 47) View Database storage directly
 * 48) Display in EHR U/I as individual fields
 * 49) Allow query over the structured data
 * 50) Ambulatory Provider
 * 51) Contribution
 * 52) Place order for labs through the EHR.
 * 53) Verify lab results in the EHR.

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
 * Short-term - We are going to add a field into the LIMS where one of the associated LOINC codes can be entered at the time of test setup.
 * Long-term - None
 * SNOMED
 * Short-term - Will do 4 parameters/tests to demonstrate use of SNOMED
 * Long-term - None
 * UCUM
 * Short-term - Implement UCUM as standard units in ELab LIMS (LIS)
 * Long-term - None

Participants/Stakeholders

 * Personnel - Mike Long, John Jones, Bob Walters, Paul Blanchard
 * Infrastructure - LIMS software, LIMS/EHR Interface
 * S&I Contractor technical assistance/support -
 * Other

LRI Pilot Project Time Line
Include at least the following Milestones
 * **Milestone** || **Target Date** ||
 * LIMS generates the first in scope test result || 2/3/2012 ||
 * Transport system available and tested || 2/10/2012 ||
 * Transformations available and tested || N/A ||
 * EHR receives and incorporates first test result || 2/15/2012 ||
 * LIMS can generate all in scope test results || 2/17/2012 ||
 * EHR can receive and incorporate all in scope test results || 2/20/2012 ||

Validation Suite
We intend to use the Validation Suite.

Success Metrics

 * 1) Describe the artifacts and verifications that will be used to confirm pilot success.
 * 2) Success will be determined through a combination of testing validation, as well as ONC feedback on ease of use and value to the Laboratory and Ambulatory Provider
 * 3) Describe how you will collect data for input to the LRI Success Metrics
 * 4) Via written comments and examples of what worked and what did not.

Required Artifacts and/or Support
Describe any artifacts and support that you need from the LRI Pilots Workgroup, workgroup support staff or ONC.
 * 1) Feedback on the HL7 file construction / photograph with format