IHE-SNI Lab Harmonization

Proposed Work Item: Comparison of IHE Profiles to US-Realm specific Lab related IGs (IHE-S&I-Lab Harmonization)

Proposal Editor: Riki Merrick, Vernetzt, LLC
Work Item Editor: Riki Merrick
Date: 08/12/2014, last updated 09/16/2016
Version: 1.0 (draft)
Domain: Clinical Laboratory
Status: Work in progress Fall 2016.

Summary

Create comparison documents of IHE profiles to US realm Lab related Implementation Guides expected to be included in Standards Advisory and other US regulations in the future in order to identify gaps and differences, with the goal of harmonizing approaches to common laboratory use cases.

The Problem

The following US realm S&I lab related Implementation guides: HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm - being balloted Sep2014 at HL7 - SUPERSEDED BY Release 1 DSTUR2 September 2015 HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Orders from EHR, Release 1 - US Realm - being balloted Sep2014 at HL7 - SUPERSEDED BY Release 1 DSTUR2 November 2015 HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2 DSTU Release R1.1 - US Realm Mach 2014 - SUPERSEDED BY Release 2 DSTUR2 September 2015

the predecessor to the Release 1 DSTU1 = HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm has been named in MU 2014 Certification (stage 2).

This means that vendors with a customer base in the US will have to support these IGs. It would be beneficial, if the IHE-Lab-Technical Framework and its profiles were congruent with requirements prescribed in these guides.

Vendor participation in IHE is key to determining the most acceptable denominator. Vendors implementing in the US realm will have to adhere to US regulations – those may not be needed to be ported all the way into the IHE profiles, but the IHE profile and the IG should not require opposite solutions to the same use case. GOAL: 1. Create a gap analysis between the IHE proifles and the US realm Lab IGs Assess potential to harmonize existing profiles with US realm profiles and then republish, where changes were needed. Get Clarifications on different interpretations of the base standard between the US realm IGs and IHE profiles through work at HL7 Orders and Observations WG.

Use Cases

LIS and EHR-S Vendors operate in an international arena – reducing customization as much as possible will reduce system development resource costs for these workflows:

Receive results, update results

Exchange of the test compendium between the laboratory and the provider: eDOS (Electronic Directory of Service) guide to IHE LCSD (Laboratory Code Sets Distribution) profile

1. Link to eDOS eDOS
2. Link to LCSD profile LCSD
3. Link to the gap anlysis document against older version of eDOS: media:EDOS_to_IHEprofile_Delta.xlsx - AGAINST NEW EDOS version - this is the one to use: media:EDOSR2D2_to_IHEprofile_Delta.xlsx
4. Comments/Discussion ADD your comments to the comparison document here!.
5. Resulting CPs Add CPs here as sub-bullets, or link to CP table Change Proposals on Main IHE Technincal Committee page?

Place a laboratory order, update a laboratory order: LOI (Laboratory Order Interface) guide to IHE LTW (Laboratory Testing Workflow) profile and possibly the upcoming LCC (Laboratory Clinical Communications) profile

1. Link to LOI LOI
2. Link to LTW profile LTW

Specific references in LTW: Placer Order Management (LAB-1) and possibly Filler Order Management (LAB-2)

1. Link to LCC profile LCC Long Proposal - wiki
   

Specific references in LCC:
Order replacement (LAB-6):
HL7 v. 2.5.1, Ch. 4 Order Entry
HL7 v. 2.7.1, Ch. 4 Order Entry
HL7 v. 2.7.1, Ch. 2C, Code Tables (Tables 38 and 119)

1. Link to the comparison document against older version of LOI: media:LOI_to_IHEprofile_Delta.xlsx - AGAINST NEW LOI version - this is the one to use: media:LOI_R1D2_to_IHEprofile_Delta.xlsx
2. Comments/Discussion ADD your comments to the comparison document here!.
3. Resulting CPs Add CPs here as sub-bullets, or link to CP table Change Proposals on Main IHE Technincal Committee page?

Report test results between the laboratory and the provider: LRI (Laboratory Result Interface) guide including the ELR (Lab results to Public Health profile) to IHE LTW (Laboratory Testing Workflow) profile

1. Link to LRI LRI - to be updated when COMPLETED< current version uses the older LRI and IHE documentation
2. Link to ELR ELR R2 - ELR R2 has NOT yet been updated to follow the NEW LRI R1D2 document - is part of planned Jan 2017 ballot
3. Link to LTW profile LTW

Specific references in LTW: Order Results Management (LAB-3)

1. Link to the comparison document against older version of LRI: media:ELR_R2_to_IHEprofile_Delta.xlsx - AGAINST NEW LRI version - this is the one to use: To be updated when COMPLETED!
2. Comments/Discussion ADD your comments to the comparison document here!.
3. Resulting CPs Add CPs here as sub-bullets, or link to CP table Change Proposals on Main IHE Technincal Committee page?

Breakdown of tasks 2014-2017

eDOS to LCSD Comparison

1. Completion of gap analysis [Sep 2016]:
2. Create list of proposed CPs for IHE profile [Nov 2016]
3. Create list of proposed STU comments for eDOS document [Nov 2016]
4. IHE balloting [Spring 2017]
5. HL7 balloting [TBD if these will be included in Jan 2017 ballot]

LOI to LTW (LAB-) Comparison

1. Completion of gap analysis [Sep 2016]:
2. Create list of proposed CPs for IHE profile [Nov 2016]
3. Create list of proposed STU comments for LOI document [Nov 2016]
4. IHE balloting [Spring 2017]
5. HL7 balloting [TBD if these will be included in Jan 2017 ballot]]

LRI to LTW (LAB-) Comparison

1. Completion of gap analysis [Sep 2016]:
2. Create list of proposed CPs for IHE profile [Nov 2016]
3. Create list of proposed STU comments for LRI document [Nov 2016]
4. IHE balloting [Spring 2017]
5. IHE balloting [Spring 2017]
6. HL7 balloting [TBD if these will be included in Jan 2017 ballot]]

Change Proposals

LCSD

1. TBD

LTW

1. TBD