CAP+Pilot+Brief


 * PROJECT BRIEF: CAP/North Shore - Long Island Jewish Health Systems Laboratories LRI Pilot **

College of American Pathologists: Mary Kennedy (mkenned@cap.org) North Shore - Long Island Jewish Health Systems Laboratories: Robert Guerra (Rguerra@NSHS.edu)
 * Sponsor(s)/Contact(s): Organization Name and Contact Name: **

-To demonstrate the feasibility of LIS/Lab-EHR/practice connectivity utilizing the proposed LRI IG standard -Report implementation findings back to ONC -Demonstrate the value of LOINC and UCUM codes in lab results reporting -Demonstrate the use and value of OIDS -Demonstrate the use of SNOMED CT, if possible (dependent on LIS/amubulatory provider capabilities) Health Systems Laboratories (NSLIJ HS) || Cerner || Halfpenny Technologies || MD-Report || Palmadessa & Brodsky MDS || ** Description ** 1. General description of the pilot The NSLIJ pilot will utilize a “Black box” concept and a system integrator (Halfpenny Technologies, Inc.) to formulate a compatible LRI IG HL7 and securely transmit that format to the participating EHR on the practice side (TBD). The practice EHR will accept the LRI IG content and will correctly integrate the discrete results within its system and display the results accordingly within the practice EHR lab results displays. The system integrator will be responsible for certifying the interface, including confirmation of receipt and the correct display of the results.
 * Objectives: **
 * Team Composition **
 * ** Laboratory ** || ** LIMS Vendor ** || ** System Integrator ** || ** EHR Vendor ** || ** Ambulatory Provider(s) ** ||
 * North Shore - Long Island Jewish
 * 2. Describe how you will demonstrate all of the In Scope items of the S&I Framework Use Case. **
 * Appropriate test results will be selected
 * Compliant LRI IG HL7 will be generated
 * Transmitted test results will be LOINC encoded
 * LRI IG HL7 is planned to include the use of: UCUM and OIDs as possible. The use of SNOMED codes for microbiology results – TBD.
 * Compliant content will we transmitted by the lab
 * Content authentication, receipt confirmation will be conducted
 * Integration and display of discrete lab results within the practice EHR will be verified, including CLIA certification

The system will include all transmitted lab results to the participating practice, including but not limited to the in scope lab results set considered for the LRI pilots. Microbiology tests will be delivered utilizing the LRI IG format but may not be discrete.
 * 3. List which S&I Framework in scope tests you will include **

GU, RN, including the LRI Common Profile Component.
 * 4. List which Implementation Guide Profiles you will include **

All actual lab tests transmitted from the NSLIJ lab to the participating practice EHR. All tests will have LOINC codes.
 * 5. What will be your source of test data? **

1. Laboratory a. Contribute test results, sponsor practice <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">b. Collaborate with the system integrator on pilot project management and leadership <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">c. All CLIA reporting requirements, including but not limited to: results reports statuses; preliminary, final, appended, corrected and/or amended will be handled by the system integrator, Halfpenny Technologies, Inc. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">2. LIMS Vendor N/A
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">6. Summarize the contribution of each team member **

3. System Integrator a. Contribution <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">i. Collaboration on pilot leadership and project management with the NSLIJ team <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">ii. Provide the middleware, i.e. ITF including NSLIJ-ITF interface and ITF-EHR inter face <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">iii. LOINC mapping of NSLIJ test compendium <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">iv. Creation of the LRI IG compliant content <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">v. Certification and validation of all interfaces and communications: lab-ITF-EHR-ITF-lab <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">b. Describe any transformations that you will be doing between the LIMS output and the EHR input. <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">These should include structure and data transforms.

<span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">i. Data is expected from existing LIS (Cerner) in HL7 2.3.1 format <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">ii. System integrator will convert HL7 2.3.1 to LRI IG HL7 2.5.1 including the application of LOINC <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">codes, UCUM (and potentially SNOMED) where applicable. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">c. Describe your transport system that is being used in Production environments. <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">i. Established network and policy infrastructure to enable consistent, appropriate, and accurate <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">information exchange across provider systems, data repositories and locator services. This <span style="color: black; font-family: 'arial','sans-serif'; font-size: 15px;">includes, but is not limited to: <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">1. Methods to identify and authenticate users: This is a system-to-system proposal. End-to-end <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">communication will be handled by Halfpenny’s ITF-SecureConnect secure connectivity layer <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">that offers VPM/VPN-like secure connectivity and is fully HIPAA compliant. Human access to <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">interfaces is limited via web-based secure portal with appropriate user authentication and <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">logging. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">2. Methods to identify and determine Providers of care: As provided by the existing LIS system <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">utilizing standard use of NPI and other relevant information. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">3. Methods to enforce data access authorization policies: See above. Role-based access is <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">applied and logged where relevant. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">4. Methods to ensure the veracity of data: See above

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">ii. Describe your approach to how detailed audit trails are kept as necessary by all participating <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">systems. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">1. The system integrator, Halfpenny Technologies, Inc. via its ITF-Hub middleware will provide <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 15px;">comprehensive logging for aspects of data transformation, access, and other transactions. 4. EHR Vendor (TBD) a. Contribution i. Provide LRI-compatible version of its product that can be used by the participating practice. ii. If web-based, support appropriate data pipe between the lab and the hostsed system. b. Describe how you will capture the EHR input message for compliance verification? i. As part of the EHR-middleware interface and as provided by the EHR vendor. c. Describe how you will obtain evidence that the EHR can incorporate test data from the laboratory message as standardized structured data. i. To be handled by the system integrator as part of the certification process utilizing screenshots and other appropriate means. 5. Ambulatory Provider(s) (TBD) a. Contribution i. Practice EHR and support for the implmentation process.



** 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
 * The system integrator will LOINC-map the participating lab test compendium at the onset of the project. If the LIS is unable to hold LOINC codes, LOINC mapping will be completed on-the-fly by the middleware.
 * SNOMED
 * TBD
 * OIDS
 * Planned based on the selected profiles
 * UCUM
 * Planned
 * Participants/Stakeholders **

North Shore - Long Island Jewish: Robert Guerra (Rguerra@NSHS.edu) College of American Pathologists: Mary Kennedy (mkenned@cap.org) Halfpenny Technologies, Inc.: Gai Elhan (drgai@halfpenny.com) Charles Halfpenny (chalfpenny@halfpenny.com)

Include at least the following Milestones:
 * LRI Pilot Project Time Line **

** Validation Suite ** 1. Identify if you intend to use the validation suite: ** Success Metrics ** Since this proposal intends to use the "BlackBox" concept with Halfpenny Techonologies, Inc. as the system integrator, it will utilizie the same success metrics. Success will be determined by: ** Required Artifacts and/or Support ** Describe any artifacts and support that you need from the LRI Pilots Workgroup, workgroup support staff or ONC.
 * ** Milestone ** ||  ** Target Date **  ||
 * LIMS generates the first in scope test result || + 45d ||
 * Transport system available and tested || + 75d ||
 * Transformations available and tested || + 90d ||
 * EHR receives and incorporates first test result || +120d ||
 * LIMS can generate all in scope test results || + 120d ||
 * EHR can receive and incorporate all in scope test results || + 120d ||
 * Planned
 * Demonstrating successful integration into EMR solution:
 * % of selected pilot tests successfully introduced and discrettly displayed in a provider's EHR
 * % of non-pilot selected tests successfully integrated and discreetly displayed in a provider's EHR
 * Provide metrics, as available, regarding implmentation steps provided by the project management team (time and effort)
 * Provide feedback regarding the LRI IG implmentation as compared to currenly used internal and external HL7 formats
 * Demonstrating the ability to repeat additional integration projects more quickly and with less work
 * Halfpenny addresses any new project as a "reusable connector" and will provide feedback as to the effectiveness of the LRI IG towards resuability compared with its experience with existing connectors.
 * 1)  Describe the artifacts and verifications that will be used to confirm pilot success.
 * 2)  Describe how you will collect data for input to the LRI Success Metrics
 * Provide support in interpretation of IG and validation suite