Page tree

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

 

 

Representation of Clinical Practice Guideline Recommendations in FHIR

Project ID: 1505

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

 

X

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 in bold outline are mandatory for project approval of an investigative project; all other sections are optional. 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.

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.

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Clinical Decision Support

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 Quality Information

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 period: 

At Least WGMs.

 

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 )

Bryn Rhodes

Other interested parties and their roles

 

Multi-disciplinary project team (recommended)

 

Modeling facilitator

 

Publishing facilitator

Bryn Rhodes

Vocabulary facilitator

Rob McClure

Domain expert rep

Maria Michaels, Blackford Middleton, Matt Burton, Linn Brandt

Business requirement analyst

Julie Scherer

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)  Centers for Disease Control and Prevention

2)  Motive Medical

3)  Apervita

4)  Medisolv

5)  Allscripts

6)  MAGIC

  1. Project Definition

3.a. Project Scope

Over the past year, the U. S. Centers for Disease Control and Prevention (US CDC) has been conducting a multi-stakeholder initiative called “Adapting Clinical Guidelines for the Digital Age” with the goal of connecting research and evidence swiftly and accurately to those who need it most, including clinicians and patients.

 

This project will assemble the content developed by that initiative into a set of implementation guidance that can be used by clinical guideline developers and implementers to help facilitate the creation of consumable recommendations, with the goal of accelerating guideline adoption.

 

Specifically, the project will continue to refine profiles on Library, ActivityDefinition, PlanDefinition, ValueSet, and CodeSystem that have been developed as part of the Informatics stream within the US CDC Kaizen. These profiles provide guidance and constraints in support of consistent representation of decision support that is derived from and built as part of clinical guidelines.

3.b. Project Need

The US CDC’s Clinical Decision Support workgroup, initiated by the Office of Public Health Scientific Services (now under the Deputy Director for Public Health Science and Surveillance), with representation throughout the agency,   was started in 2016 to help standardize and improve our approach to clinical decision support. Feedback from stakeholders reveals that CDCs biggest value-add in the industry would be to help the guidelines more easily translate into digital products used in patient care settings. Based on these findings the workgroup is developing an agency-wide strategy to help get CDC’s evidence-based guidance quickly, accurately, and consistently into patient care. The intent is to support a multi-stakeholder project that results in not only CDC, but various stakeholders from across the industry participating in the development, implementation, and refinement of the implementation guide.

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

Submit for STU Ballot

2019 Sep Ballot

Complete STU Reconciliation

2019 Sep WGM

Request STU Publication

2019 Oct

STU Period – 12 months

2019 Jan – 2020 Jan

Submit for Normative Ballot

2020 May

Complete Normative Reconciliation

2020 May WGM

Submit Publication Request

2020 Jun

Receive ANSI Approval

2020 Nov

Example: Receive ANSI Approval

2020 Nov

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2020 Dec

3.f.    Common Names / Keywords / Aliases

Adapting Clinical Guidelines (ACG)

Clinical Practice Guidelines On FHIR (CPG-On-FHIR)

3.g. Lineage

N/A

3.h. Project Dependencies

N/A

3.i.    HL7-Managed Project Document Repository Location

http://github.com/cqframework/cdc-acg

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

 

X

No

 

 

Unknown

 

 

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)

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)

 

FHIR R5, potentially R4, and STU3

  1. 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)

 

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)

 

 

 

 

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

None

For projects that have some of their content already developed:

How much content for this project is already developed?

N/A

Was the content externally developed (Y/N)? 

N

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

 

 

 

 

 

 

 

 

Yes

 

X

No

6.b. Realm

X

Universal     - OR -

 

 

Realm Specific

 

 

 

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

 

This project will produce guidance and profiles that are not specific to the U.S. Realm, informed by participation from the MAGIC project, an international initiative focused on guideline development and implementation.

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

X

EHR, PHR

 

Emergency Services

 

Quality Reporting Agencies

 

Equipment

X

Local and State Departments of Health

 

Regulatory Agency

 

Health Care IT

 

Medical Imaging Service

 

Standards Development Organizations (SDOs)

X

Clinical Decision Support Systems

X

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

 

Payors

 

Lab

 

Other (specify in text box below)

 

Other (specify in text box below)

 

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:

WG Approval Date 2019-01-15

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

Clinical Quality Information 2019-01-16

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

N/A

CDA Projects: CDA Management Group

N/A

FHIR Projects: FHIR Management Group

2019-01-23

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:

2019-02-18

Last PBS Metrics Score :

 

Green

x

Yellow

 

Red

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

x

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 Steering Division approved PSS to: tscpm@HL7.org )

TSC Approval Date CCYY-MM-DD