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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: FHIR Quality Measure Implementation Guide

Project ID: 1499

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 

TSC Notification:  Informative/STU to Normative 

Date:  Submission date

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.

Yes

 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 

N/A

 

U.S.

Metric

 

Both

 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Clinical Quality Information

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Clinical Decision Support

Indicate the level of involvement that the co-sponsor will have for this project:
 Request formal content review prior to ballot
x Request periodic project updates. Specify periodWGMs
 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Bryn Rhodes, Rob Samples

Other interested parties and their roles

Paul Denning (MITRE)

Multi-disciplinary project team (recommended)


     Modeling facilitator

Bryn Rhodes

     Publishing facilitator

Bryn Rhodes

     Vocabulary facilitator

Rob McClure

     Domain expert rep

Floyd Eisenberg, Lisa Anderson, Claudia Hall, Patty Craig, Anne Smith

     Business requirement analyst

Floyd Eisenberg, Lisa Anderson, Claudia Hall, Patty Craig, Anne Smith

     Conformance facilitator (for IG projects)

Bryn Rhodes

     Other facilitators (SOA, etc)




Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) National Committee for Quality Assurance, 2) Medisolv, 3) MITRE


3. Project Definition

3.a. Project Scope


The Institute of Medicine (IOM) defines quality as: “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” [1] For care quality to be evaluated, it must be standardized and communicated to the appropriate organizations. To that end, this Implementation Guide will be written to provide guidance for authoring electronic Clinical Quality Measures (eCQMs) utilizing the following standards: 

  • Fast Health Interoperability Resources (FHIR) R4 Clinical Reasoning Module (with reference to FHIR R3 Clinical Reasoning to support existing implementations
  • Clinical Quality Language (CQL)
  • FHIRs QICore Implementation Guide STU 3.2 (based on FHIR 3.0 and US Core 3.0) - provided as examples without restricting the FHIR Quality Measure IG to any data model or any specific realm.

The requirements were established by experience and implementations of eCQMs using existing HL7 V3 standards:

  • Health Quality Measure Format (HQMF) R1 Normative
  • CQL-based HQMF STU 3
  • Quality Data Model (QDM)-based HQMF DSTU 1.4


3.b. Project Need

FHIR Clinical Reasoning provides infrastructure requirements for representing a health quality measure as an electronic format. A quality measure is a quantitative tool to assess the performance of an individual or organization’s performance in relation to a specified process or outcome via the measurement of an action, process, or outcome of clinical care. Quality measures are often derived from clinical guidelines and are designed to determine whether the appropriate care has been provided given a set of clinical criteria and an evidence base. 

FHIR Clinical Reasoning defines the components for classification and management of the quality measure as well as important metadata and sections that also define the specific elements that carry the content of the quality measure. 

Through standardization of a measure’s structure, metadata, definitions, and logic, FHIR Clinical Reasoning ensures measure consistency and unambiguous interpretation. A health quality measure encoded in this format is referred to as an electronic clinical quality measure (eCQM). Standardization of document structure (e.g., sections), metadata (e.g., author, verifier), and definitions (e.g., numerator, initial population) enable a wide range of measures currently existing in a variety of formats to achieve consistency. This formal representation of the clinical, financial, and administrative concepts and logic within an eCQM produce unambiguous interpretation and consistent reporting. 

This implementation guide (IG) provides specific guidance to eCQM developers and implementers to assure consistency for applying CQL expressions using any data model, enhancing ability to share eCQM artifacts for direct implementation and calculation. The IG will provide examples using the US Realm FHIR QICore data model but it will not restrict usage of any data model and, therefore, it is relevant for Universal Realm.


3.c. Security Risks


Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 

Yes

X

No

Unknown


3.d. External Drivers


The project will support existing efforts by health plans, eCQM developers and EHR implementers to express and process eCQMs using FHIR to measure clinical performance. National Committee for Quality Assurance (NCQA) has prototyped Healthcare Effectiveness Data and Information Set (HEDIS) measures as eCQMs using FHIR starting in 2018 and this IG will support standardization. US governmental agencies (e.g., Centers for Medicare and Medicaid Services (CMS)) are considering transitioning eCQMs from existing HQMF and CQL-based HQMF standards to FHIR. While CMS has not made a decision to move the process to FHIR and there is no established date for such a transition, the FHIR-based eCQM IG will support necessary testing to provide sufficient evidence to support any such future decisions.


3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Enter objective/deliverable here.

All planned ballots and their target dates should be included

The example below is a "STU to Normative" path

Enter Target Date

FHIR Connectathon Testing (initiated in several cycles starting with May 2016)

May 2016 FHIR Connectathon and every FHIR Connectathon since then

Digital Quality Summit 2017 and 2018

MiHIN Connectathon 2017

1st STU Ballot

2019 May Ballot

Complete 1st STU Ballot Reconciliation

2019 May WGM

Request 1st STU Publication

2019 Sep WGM

1st STU Period – 12 months

2019 Sep - 2020 Sep

2nd STU Ballot

2020 Sep Ballot

Complete 2nd STU Ballot Reconciliation

2020 Sep WGM

Request 2nd STU Publication

2021 Jan WGM

2nd STU Period - 12 months

2021 Jan - 2022 Jan

Additional STU cycles as needed

as needed

Normative Ballot2022 Jan Ballot
Complete Normative Ballot Reconciliation2022 May WGM
Submit Publication Request Normative Version2022 Sep WGM
Receive ANSI Approval2023 Jan WGM
Project End Date (All objectives have been met)2023 Jan WGM


3.f.   Common Names / Keywords / Aliases


What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced? 
FHIR Quality Measure IG


3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release:

No prior FHIR eCQM IG, however, the IG is based on experience gained from implementation of:

  • HL7 Version 3 Standard: Representation of the Health Quality Measures Format (eMeasure), Release 1 (PI ID: 508)
  • HL7 Version 3 Implementation Guide: Quality Data Model (QDM)-based Health Quality Measure Format (HQMF), Release 1 - US Realm (PI ID: 756)
  • HL7 Version 3 Implementation Guide: Clinical Quality Language (CQL)-based Health Quality Measure Format (HQMF), Release 1 - US Realm (PI ID: 1142)
  • HL7 FHIR® Implementation Guide: Clinical Quality Framework (CQF on FHIR), Release 1 (PI ID: 1234) (project generates FHIR Clinical Reasoning)

3.h. Project Dependencies


Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:

FHIR

CQL
 

Projects and their Project Insight IDs can be found via http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common


3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept
(To be determined)


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?

Yes

No

Unknown

X

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)

Yes

No

Unknown

X

N/A



If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

Yes

No

X

Unknown


N/A

If Yes, please enter the vocabularies:


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)


FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)


V3 Documents – Clinical (e.g. CDA)


FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge


FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO


White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4 and STU3 and R5


5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

Revise current standard (see text box below)


X

Implementation Guide (IG) will be created/modified

Reaffirmation of a standard


Project is adopting/endorsing an externally developed IG:

New/Modified HL7 Policy/Procedure/Process


Specify external organization in Sec. 6 below;





Externally developed IG is to be (select one):


White Paper (select one):


Adopted  - OR -

?

Endorsed


Balloted Informative OR

Non-balloted WG White Paper


N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:NA
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)


5.a. Ballot Type (check all that apply)


Comment (aka Comment-Only)


Joint Ballot (with other SDOs)

Informative


N/A  (project won’t go through ballot)

X

STU to Normative     - OR -

Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?


Yes

X

No


6. Project Logistics

6.a. External Project Collaboration


Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed: Not Applicable

How much content for this project is already developed?

Was the content externally developed ? :

Y/N

Is this a hosted (externally funded) project?  (not asking for amount just if funded)

Yes

No


6.b. Realm



Universal 

- OR -

Realm Specific - U.S. Note, the content will not restrict to USRealm but there are currently no international participants. Hence, the USRealm Steering Committee recommended USRealm until international participation is assured.



 

Check here if this standard balloted or was previously approved as realm specific standard

Enter “U.S.” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here. 

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project. Note: This status is subject to change during the investigative process.



6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers

 

Clinical and Public Health Laboratories

  

Pharmaceutical

  

Clinical and Public Health Laboratories

  

Immunization Registries

 

EHR, PHR

  

Emergency Services

X

Quality Reporting Agencies

  

Equipment

Local and State Departments of Health

X

Regulatory Agency

 X

Health Care IT

  

Medical Imaging Service

  

Standards Development Organizations (SDOs)

 

Clinical Decision Support Systems

X

Healthcare Institutions (hospitals, long term care, home care, mental health)

 

Payors

  

Lab

  

Other (specify in text box below)

 X 

Other (specify in text box below)

X

HIS

  

N/A

  

N/A

  

Other (specify below)


 

 


  

N/A

 

 


Other:  Indicate other stakeholders, vendors or providers not listed above.

Quality Measure Development Organizations, Clinical Professional Societies










6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

Clinical Quality Information

2019-01-14 Mon Q2 WGM Minutes

Administrative review – in parallel with Work Group Approva

Co-Sponsor Group Approval Date


Clinical Decision Support

2019-01-16 in joint meeting with CQI Wed Q2 WGM Minutes


Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

2019-01-23

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2019-01-25

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

N/A

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date

2019-02-04

Last PBS Metrics Score:

X

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

N/A

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date