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EHR-S Func Reqs Doc for Laboratory Interoperability Transactions - EHR-S Func Reqs IG for LRI

Basics

EHR-S Func Reqs Doc for Laboratory Interoperability Transactions - EHR-S Func Reqs IG for LRI

1095
Ballot - STU to Normative



Create New Standard

Details

This is part of a larger current work project, whose goal it is to create a suite of functional requirements documents for EHR technology for laboratory orders and results with 4 deliverables (3 going to ballot). Deliverables for this project: (1) EHR-S Functional Requirements Implementation Guide for Lab Results Interface (LRI) for ballot (2) Laboratory Information System - Functional Profile (LIS-FP) issues list document for use in a follow up future project This particular project will focus on creating EHR-S Functional Requirements Implementation Guide for laboratory results compatible with the S&I Laboratory Results Interface (S&I LRI) guide. Additional regulatory requirements (CLIA) and clinical best practices beyond the LRI IG will be considered in the development of this project's artifact. This document is intended to bridge the gap and harmonize between the LRI and LOI IGs and the concurrently to be developed EHR-S Functional Profile for Laboratory. As part of this project we will need to clarify what level in the HL7 artifact hierarchy this document fits in - it is at the same detail level as an implementation guide, however, it does not constrain a currently existing standard (though we are developing it concurrently, hence we retained the name Implementation Guide). It has been likened to a Logical Specification from SAIF and is similar to an IHE's Integration Profile, where both communication and behavior are defined. It leverages and will inform the planned conformance framework specifications for Incorporate (a CGIT project). At this time there are existing functional models for the EHR-System side (receive results / send orders). These transactions have two actors however, and it is planned as a future project to develop the corresponding Laboratory Information System (LIS) Functional Model focused initially on receive orders and send results. Requirements on the LIS side should be taken into account in development of the EHR-S side artifacts that are the deliverables for this project, so a LIS-Functional Model issues list document will be developed to capture related requirements.


Several Meaningful Use (MU) certification requirements are broader than what is usually described in an interface based implementation guide like the S andI LRI guide cited in MU stage 2. For example the criterion of incorporate lab results. In order to test and certify products for this criterion the functional requirements on the EHR-system need to be defined.



Submit for DSTU Ballot - Target: 2014 Sep Ballot Complete DSTU Reconciliation - Target: 2015 Jan WGM Request DSTU Publication - Target: 2015 Feb WGM DSTU Period - 12 months - Target: 2015 Mar - 2016 Mar Submit for Normative Ballot - Target: 2016 May Ballot Complete Normative Reconciliation - Target: 2016 Sep WGM Submit Publication Request - Target: 2016 Oct Project End Date - Target: 2016 Nov UPDATE: Requesting an extension Sept 2019


http://wiki.siframework.org/LRI+EHR-S+Functional+Requirements+IG

ONC's S and I Framework Laboratory related Working Groups (LRI, LOI))

Laboratory Order Interface Implementation Guide (LOI IG) DSTU - 922 Ambulatory Laboratory Results Reporting IG for LRI, Release 1 - 792 Electronic Health Record-System (EHR-S)Functional Requirements Documentation for Laboratory Interoperability Transactions - EHR-S Functional Requirements Implementation Guide for Lab Orders Interface (LOI)-1096 Electronic Health Record-System (EHR-S)Functional Requirements Documentation for Laboratory Interoperability Transactions - EHR-S Functional Profile for Laboratory - 1097 Planned conformance framework specifications for Incorporate (a CGIT project) - ADD NUMBER once in Project insight

Clinical and Public Health Laboratories, Regulatory Agency,Clinical and Public Health Laboratories; Healthcare Institutions (hospitals, long term care, home care, mental health),EHR, PHR; Health Care IT; Lab

1) National Institute of Standards and Technology (NIST)(used to write the test cases for the Meaningful Use criteria) 2) ONC S and I Framework pilots





N/A


2026 March: TSC approved an STU Extension Request for HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface (LRI) Edition 5 – US Realm with 2024DEC Errata 2024 April: TSC approved STU Publication Request for HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface (LRI), Edition 1 STU Release 5 - US Realm for 2 years Sept 2022 TSC approved: STU Publication Request for HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 4 - US Realm for two years 09/2022 Update - extension request 2022 February: TSC approved STU Extension Request for HL7 EHR-S Functional Requirements: S&I Framework Laboratory Results Messages, Release 1 - US Realm May 2016: TSC approved DSTU Publication Request for HL7 EHR-S Functional Requirements: S and I Framework Laboratory Results Messages, Release 1, US Realm at TSC Tracker 9891 for 24 months. through May 25, 2018 Oct 2015: Finalizing ballot reconciliation with target to publish November 2015. May 2018: Next step will be to do an STU update (with focused review) to sync with LRI R3 having been published. May 2019 investigate whether we still want to do an STU update or drop to informative
Organization & Realm

Realm Specific - Enter "U.S." or name of HL7 Affiliate below

U.S.
People

Riki Merrick, Robert Dieterle



Orders and Observations Work Group

Conformance Work Group; Electronic Health Records Work Group

Status & Dates

Active

STU - Test Period/Accepting Comments

05/08/2014

05/01/2028

2028 May WGM/Ballot

05/15/2028

2028 May WGM/Ballot

2015 Jan Ballot Cycle Info: DSTU Ballot results: Met basic vote requirements. 33 Negatives to reconcile Document Name: HL7 EHR-S Implementation Guide: S and I Framework EHR-S Functional Requirements for Laboratory Results Interface (LRI), Release 1 - US Realm Suggest we ballot this as Informative in the May 2021 cycle
Approvals

06/09/2014








System Info






04/09/2026

Anne Wizauer