NOTE : Please spell out all acronyms the first time the acronym occurs. 

For Reaffirmations, please refer to the FAQ within Appendix C of the PSS_with_instructions template for a list of which sections and fields should be completed.

PSS-Lite/Investigative Projects:  Sections surrounded by a BOLD OUTLINE must be completed for approval of "Investigative Projects" (a.k.a PSS-Lite).

  1. Project Name and ID

 

 

CDA Implementation Guide Quality Criteria Maintenance

Project ID: 1480

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: 

 

 

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

 

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

 

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 : 

 

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Structured Documents

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

Co-sponsor Work Group(s)

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

 

Vocabulary

Indicate the level of involvement that the co-sponsor will have for this project:

x

Request formal content review prior to ballot

x

Request periodic project updates. Specify period: 

Monthly updates and WGM

 

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 ( 1 Mandatory )

Austin Kreisler (austin.j.kreisler@leidos.com)

Other interested parties and their roles

Templates Work Group – Note that Templates was approach to be a co-sponsor but was unable to muster quorum to agree to be a co-sponsor.

Multi-disciplinary project team (recommended)

Andrew Statler

Gay Dolin

Sean P. McIlvenna

Calvin Beebe

Benjamin Flessner

Lisa Nelson

Brett Marquard

Emma Jones

Modeling facilitator

 

Publishing facilitator

Austin Kreisler (austin.j.kreisler@leidos.com)

Vocabulary facilitator

 

Domain expert rep

 

Business requirement analyst

 

Conformance facilitator (for IG projects)

 

Other facilitators (SOA, etc)

 

 

 

Implementers (2 Mandatory 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) 

2) 

  1. Project Definition

3.a. Project Scope

This projects intent to provide a framework within which the Structured Documents Work Group will develop and maintain a set of CDA Implementation Guide quality criteria. Sources for the criteria may include the following:

  • Existing CDA IG quality criteria developed by the Structured Documents Work Group
  • Standards Governance Board (SGB) precepts
  • Template quality criteria identified by the Templates work group

This project covers the development of the initial set of CDA IG quality criteria as well as the ongoing maintenance of those criteria.

 

The project will identify the process for updating/maintaining the criteria going forward as we find criteria lacking, ineffective, inherently subjective, inappropriate, or in some other way insufficient to serve as an objective quality criteria statement for this purpose. The project will address the following:

  • How can changes be submitted/recommended?
  • How will they be reviewed?
  • How will they be approved?
  • Will we use versioning to track the criteria release?

The project intends to use the Draft for Comment ballot approach to allow the CDA community to submit comments on the proposed quality criteria. The project envisions seeking such feedback every 1-2 years, or when substantive changes are made to the quality criteria. The project team will incorporate the feedback into the proposed quality criteria and seek Structured Documents approval of the quality criteria. Once approved by the work group the CDA IG quality criteria will be made available to CDA IG developers and the CDA Management Group (CDA-MG). The CDA-MG determines when and how to utilize the CDA-IG quality criteria.

3.b. Project Need

With the formation of the CDA Product Family and the CDA-MG, there is now a requirement for the Structured Document work group to formally maintain a set of quality criteria for CDA related products that can be used by the CDA-MG to assess the quality of CDA products.

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

N/A

3.e. Project Objectives / Deliverables / Target Dates

 

Target Date

Review existing CDA IG Quality Criteria and create draft version for formal review

2019 Jan WGM

Formal Review (Draft for Comment Ballot) of Draft CDA IG Quality Criteria

2019 May Ballot

Reconcile comments

2019 May WGM

Approve initial version of CDA IG Quality Criteria and make available to CDA IG developers and CDA Management Group

2019 Sept WGM

Repeat every 1-2 years as needed

TBD

 

 

 

 

 

 

 

 

 

 

Project End Date (all objectives have been met)

Ongoing maintenance project

3.f.    Common Names / Keywords / Aliases

N/A

3.g. Lineage

N/A

3.h. Project Dependencies

N/A

3.i.    HL7-Managed Project Document Repository Location

https://confluence.hl7.org/display/SD/CDA+IG+Quality+Criteria

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:

 

3.k. External Vocabularies

Will this project include/reference external vocabularies?

 

 

Yes

 

 

No

 

 

Unknown

 

x

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies:

 

  1. 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)

 

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

X

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)

 

 

  1. Project Intent (check all that apply)

 

Create new standard

 

 

Supplement to a current standard

 

Revise current standard (see text box below)

 

 

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

 

x

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

 

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

x

Comment (aka Comment-Only)

 

 

Joint Ballot (with other SDOs)

 

Informative

 

 

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

 

STU to Normative     - OR -

 

Normative (no STU)

 

 

 

The project plans to use Draft for Comment ballots to periodically gather feedback from the CDA community regarding the CDA IG quality criteria.

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

 

 

  1. Project Logistics

6.a. External Project Collaboration

N/A

For projects that have some of their content already developed:

How much content for this project is already developed?

Indicate % here

Was the content externally developed (Y/N)? 

If Yes, list developers

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

 

 

 

 

 

 

 

 

Yes

 

 

No

6.b. Realm

X

Universal     - OR -

 

 

Realm Specific

 

 

 

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

 

 

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

x

Clinical and Public Health Laboratories

x

Pharmaceutical

x

Clinical and Public Health Laboratories

x

Immunization Registries

x

EHR, PHR

x

Emergency Services

x

Quality Reporting Agencies

x

Equipment

x

Local and State Departments of Health

x

Regulatory Agency

x

Health Care IT

x

Medical Imaging Service

x

Standards Development Organizations (SDOs)

x

Clinical Decision Support Systems

x

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

x

Payors

x

Lab

 

Other (specify in text box below)

 

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.

 

6.d. Project Approval Dates

Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

2018-10-25

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

Vocabulary – 2018-10-25
 

Co-Sponsor Group Approval Date

 


 

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date CCYY-MM-DD
or “N/A”

FHIR Projects: FHIR Management Group

N/A

V2/Publishing Projects: V2 Management Group

N/A

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

N/A

Affiliate Specific Projects: 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 CCYY-MM-DD

Last PBS Metrics Score :

 

Green

 

Yellow

 

Red

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

 

Yes

 

No

ARB and SGB approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

N/A

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 CCYY-MM-DD