Difference between revisions of "IHE-SNI Lab Harmonization"

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Proposal Editor: [mailto:rikimerrick@gmail.com Riki Merrick], Vernetzt, LLC<br />
 
Proposal Editor: [mailto:rikimerrick@gmail.com Riki Merrick], Vernetzt, LLC<br />
 
Work Item Editor: Riki Merrick<br />
 
Work Item Editor: Riki Merrick<br />
Date: 08/12/2014, last updated 08/12/2014<br />
+
Date: 08/12/2014, last updated 09/16/2016<br />
 
Version: 1.0 (draft)<br />
 
Version: 1.0 (draft)<br />
 
Domain: Clinical Laboratory<br />
 
Domain: Clinical Laboratory<br />
Status: Work in progress Fall 2014.
+
Status: Work in progress Fall 2016.
  
 
== Summary ==
 
== Summary ==
  
Create comparison documents of IHE profiles to US realm Lab related Implementaion Guides cited in Meaningful Use (MU) regulation in order to identify gaps and  
+
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.
 
differences, with the goal of harmonizing approaches to common laboratory use cases.
  
 
== The Problem ==
 
== The Problem ==
 
The following US realm S&I lab related Implementation guides:
 
The following US realm S&I lab related Implementation guides:
HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 2 - US Realm - being balloted Sep2014 at HL7
+
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2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm - being balloted Sep2014 at HL7 - SUPERSEDED BY Release 1 DSTUR2 September 2015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 2 - US Realm - being balloted Sep2014 at HL7
+
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Implementation Guide: S&I Framework Laboratory Orders from EHR, Release 1 - US Realm - being balloted Sep2014 at HL7 - SUPERSEDED BY Release 1 DSTUR2 November 2015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
+
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Guide: S&I Framework Laboratory Test Compendium Framework, Release 2 DSTU Release R1.1 - US Realm Mach 2014 - SUPERSEDED BY Release 2 DSTUR2 September 2015
are expected to be included in Meaningful Use regulation (MU) in the US for MU 2017 certificaiton (stage 3), involving product certification testing in order for
 
 
 
providers to be eligible for MU payment incentives.
 
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
+
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).
  
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.
+
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.
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.
+
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 ==
 
== 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  
+
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:
 
 
workflows:
 
 
   
 
   
 
Receive results, update results
 
Receive results, update results
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# '''Link to eDOS''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151 eDOS]''
 
# '''Link to eDOS''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151 eDOS]''
 
# '''Link to LCSD profile'''  [http://wiki.ihe.net/index.php?title=Laboratory_Code_Sets_Distribution LCSD]''
 
# '''Link to LCSD profile'''  [http://wiki.ihe.net/index.php?title=Laboratory_Code_Sets_Distribution LCSD]''
# '''Link to the comparison document''' [[media:EDOS_to_IHEprofile_Delta.xlsx]]''
+
# '''Link to the gap anlysis document''' [[media:EDOS_to_IHEprofile_Delta.xlsx]]'' - to be updated when COMPLETED< current vesion sues the older eDOS and IHE documentation
# '''Comments/Discussion''' ADD your comments to the comparison doument here!.''
+
# '''Comments/Discussion''' ADD your comments to the comparison document here!.''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | Change Proposals]] on Main IHE Technincal Committee page?''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | Change Proposals]] on Main IHE Technincal Committee page?''
  
Line 63: Line 54:
 
HL7 v. 2.7.1, Ch. 4 Order Entry<br>
 
HL7 v. 2.7.1, Ch. 4 Order Entry<br>
 
HL7 v. 2.7.1, Ch. 2C, Code Tables (Tables 38 and 119)<br>''
 
HL7 v. 2.7.1, Ch. 2C, Code Tables (Tables 38 and 119)<br>''
# '''Link to the comparison document''' [[media:LOI_to_IHEprofile_Delta.xlsx]]''
+
# '''Link to the comparison document''' [[media:LOI_to_IHEprofile_Delta.xlsx]]'' - to be updated when COMPLETED< current version uses the older LOI and IHE documentation
# '''Comments/Discussion''' ADD your comments to the comparison doument here!.''
+
# '''Comments/Discussion''' ADD your comments to the comparison document here!.''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | Change Proposals]] on Main IHE Technincal Committee page?''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | 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 ====
 
==== 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 ====
  
# '''Link to LRI''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279 LRI]''
+
# '''Link to LRI''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279 LRI]'' - to be updated when COMPLETED< current version uses the older LRI and IHE documentation
# '''Link to ELR''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=329 ELR R2]''
+
# '''Link to ELR''' [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=329 ELR R2]'' - ELR R2 has NOT yet been updated to follow the NEW LRI R1D2 document - is part of planned Jan 2017 ballot
 
# '''Link to LTW profile'''  [http://wiki.ihe.net/index.php?title=Laboratory_Testing_Workflow LTW]
 
# '''Link to LTW profile'''  [http://wiki.ihe.net/index.php?title=Laboratory_Testing_Workflow LTW]
 
Specific references in LTW:''
 
Specific references in LTW:''
 
Order Results Management (LAB-3)''
 
Order Results Management (LAB-3)''
# '''Link to the comparison document''' [[media:ELR_R2_to_IHEprofile_Delta.xlsx]]''
+
# '''Link to the comparison document''' [[media:ELR_R2_to_IHEprofile_Delta.xlsx]]'' - to be updated when COMPLETED< current version uses the older LRI and IHE documentation
 
# '''Comments/Discussion''' ADD your comments to the comparison doument here!.''
 
# '''Comments/Discussion''' ADD your comments to the comparison doument here!.''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | Change Proposals]] on Main IHE Technincal Committee page?''
 
# '''Resulting CPs''' Add CPs here as sub-bullets, or link to CP table [[#Change_Proposals | Change Proposals]] on Main IHE Technincal Committee page?''
Line 82: Line 73:
 
==== Introduction ====
 
==== Introduction ====
  
== Breakdown of tasks 2014-2015 ==
+
== Breakdown of tasks 2014-2017 ==
  
 
=====eDOS to LCSD Comparison=====
 
=====eDOS to LCSD Comparison=====
  
# Completion of gap analysis [Nov 2014]:  
+
# Completion of gap analysis [Sep 2016]:  
# Create list of proposed CPs for IHE profile [Jan 2015]  
+
# Create list of proposed CPs for IHE profile [Nov 2016]  
# Create list of proposed CPs for eDOS document [Jan 2015]
+
# Create list of proposed STU comments for eDOS document [Nov 2016]
# IHE balloting [Fall 2015]
+
# IHE balloting [Spring 2017]
# HL7 balloting [Fall 2015]  
+
# HL7 balloting [TBD if these will be included in Jan 2017 ballot]  
  
 
=====LOI to LTW (LAB-) Comparison=====
 
=====LOI to LTW (LAB-) Comparison=====
# Completion of gap analysis [Nov 2014]:  
+
# Completion of gap analysis [Sep 2016]:  
# Create list of proposed CPs for IHE profile [Jan 2015]  
+
# Create list of proposed CPs for IHE profile [Nov 2016]  
# Create list of proposed CPs for eDOS document [Jan 2015]  
+
# Create list of proposed STU comments for LOI document [Nov 2016]  
# IHE balloting [Fall 2015]
+
# IHE balloting [Spring 2017]
# HL7 balloting [Fall 2015]  
+
# HL7 balloting [TBD if these will be included in Jan 2017 ballot]]  
  
=====LOI to LTW (LAB-) Comparison=====
+
=====LRI to LTW (LAB-) Comparison=====
# Completion of gap analysis [Nov 2014]:  
+
# Completion of gap analysis [Sep 2016]:  
# Create list of proposed CPs for IHE profile [Jan 2015]  
+
# Create list of proposed CPs for IHE profile [Nov 2016]  
# Create list of proposed CPs for eDOS document [Jan 2015]
+
# Create list of proposed STU comments for LRI document [Nov 2016]
# IHE balloting [Fall 2015]
+
# IHE balloting [Spring 2017]
# Initial Connectathon implementation [N.A. Connectathon, Winter 2016]
+
# IHE balloting [Spring 2017]
# IHE balloting [Fall 2015]
+
# HL7 balloting [TBD if these will be included in Jan 2017 ballot]]  
# HL7 balloting [Fall 2015]  
 
  
 
== Change Proposals ==
 
== Change Proposals ==

Revision as of 15:49, 16 September 2016

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 media:EDOS_to_IHEprofile_Delta.xlsx - to be updated when COMPLETED< current vesion sues the older eDOS and IHE documentation
  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 media:LOI_to_IHEprofile_Delta.xlsx - to be updated when COMPLETED< current version uses the older LOI and IHE documentation
  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 media:ELR_R2_to_IHEprofile_Delta.xlsx - to be updated when COMPLETED< current version uses the older LRI and IHE documentation
  2. Comments/Discussion ADD your comments to the comparison doument here!.
  3. Resulting CPs Add CPs here as sub-bullets, or link to CP table Change Proposals on Main IHE Technincal Committee page?

Technical Approach Overview

Introduction

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