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Project Scope Statement

2018.1 Version

Release 1

Original Approval Date: 2007

Last Reviewed Date: Q1, 2018

Review Cycle: Annual

HL7 Project Management Office

Project Services Work Group

 

Point of Contact Name and Email: 

David Hamill ( pmo@hl7.org )

Co-Chairs of Project Services Work Group: http://www.hl7.org/Special/committees/projectServices/leadership.cfm

 

Publication Date: April, 2018

 

 

URL to download document:

  http://www.hl7.org/permalink/?ProjectScopeStatement

 

For prior versions of this document refer to:

 

http://www.hl7.org/Special/committees/projectServices/docs.cfm

 

 

The objective of this document is to communicate the type of activities a group is undertaking to achieve specific objectives or to produce specific work products.  It’s intended for projects to produce standards or Implementation Guides as well as infrastructure projects.


  1. Project Name and ID

 

Click here to go to Appendix A for more info regarding this section including guidance on naming conventions .

An ID will be assigned by Project Insight

CDISC Lab Semantics in FHIR

Project ID: 1425

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

Not applicable.

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

Click here to go to Appendix A for more information regarding this section.

2.a. Primary Sponsor/Work Group

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

Biomedical Research and Regulation (BR&R)

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

Co-sponsor Work Group(s)

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

 

OO (Orders and Observations - resource owner)

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

X

Request formal content review prior to ballot

 

Request periodic project updates. Specify period: 

 

 

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 )

Julie Evans/Hugh Glover

Other interested parties and their roles

CQI (Clinical Quality Information)

CBCP (Community-Based Care and Privacy)

Multi-disciplinary project team (recommended)

 

Modeling facilitator

Julie Evans

Publishing facilitator

Myron Finseth

Vocabulary facilitator

Julie James

Domain expert rep

Christi Denning, 2 other people from Lilly

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)  Transcelerate Biopharma

2)  Lilly

  1. Project Definition

3.a. Project Scope

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Biomedical Research and Regulation (BR&R) and Transcelerate Biopharma (TCB)are assessing the use of FHIR resources to exchange clinical trial lab data. The Clinical Data Interchange Standards Consortium (CDISC) Lab Model and LB domain standards currently contain the semantics that are used in Lab data exchange. These standards will be mapped to FHIR, and gaps will be identified. This project is expected to deliver a mapping spreadsheet, Clinical Research Lab Profile with needed extensions, and an Implementation Guide. These deliverables will be universal.

 

3.b. Project Need

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Clinical trials routinely exchange lab data between labs, contract research organizations, and trial sponsor companies. The project will provide another implementation option of the CDISC standards.

3.c. Security Risks

Click here to go to Appendix A for more information regarding this section.

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

 

 

No

 

X

Unknown

 

 

3.d. External Drivers

Click here to go to Appendix A for more information regarding this section.

The TCB team would like to test the deliverables at the September 2018 Connectathon.

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).

Click here for further information, FHIR project instructions, and an EXAMPLE

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

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

 

 

Mapping Spreadsheet Complete, candidate extensions identified

31 May 2018

Test at Connectathon

September 2018

Extensions and profiles created

May 2019

Implementation Guide Draft Published

September 2019

 

 

 

 

 

 

 

 

 

 

Project End Date (all objectives have been met)

October 2019

3.f.    Common Names / Keywords / Aliases

Click here to go to Appendix A for more information regarding this section.

CDISC Lab Model Project 

3.g. Lineage

Click here to go to Appendix A for more information regarding this section.

N/A

3.h. Project Dependencies

Click here to go to Appendix A for more information regarding this section.

None

3.i.    HL7-Managed Project Document Repository Location

Click here to go to Appendix A for more information regarding this section.

http://confluence.hl7.org/display/BRR/CDISC+Lab+Semantics+-+FHIR+Investigation+and+Implementation+Guide

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?

 

X

Yes

 

 

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies:

This is more of a probably than an absolute Yes.  The exact vocabularies are not known at this point.

  1. Products (check all that apply)

Click here to go to Appendix A for more information regarding this section

 

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)

X

FHIR Extensions

 

 

V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)

 

 

V3 Documents – Clinical (e.g. CDA)

X

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)

 

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

FHIR R4

  1. Project Intent (check all that apply)

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

 

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)

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

 

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

Click here to go to Appendix A for more information regarding this section

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

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Transcelerate Biopharma

For projects that have some of their content already developed:

How much content for this project is already developed?

80%

Was the content externally developed (Y/N)? 

Transcelerate Biopharma designees

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

 

 

 

 

 

 

 

 

Yes

 

X

No

6.b. Realm

Click here to go to Appendix A for guidelines regarding choosing Universal or Realm Specific.

X

Universal     - OR -

 

 

Realm Specific

 

 

 

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

 

 

6.c. Stakeholders / Vendors / Providers

Click here to go to Appendix A for more information regarding this section

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

 

Immunization Registries

 

EHR, PHR

 

Emergency Services

 

Quality Reporting Agencies

 

Equipment

 

Local and State Departments of Health

X

Regulatory Agency

 

Health Care IT

 

Medical Imaging Service

 

Standards Development Organizations (SDOs)

 

Clinical Decision Support Systems

 

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:  none

6.d. Project Approval Dates

Click here to go to Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

2018-05-17

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

2019-01-31
 

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

2019-02-06

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:

2018-08-03

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)

N/A – discussed by ARB 2019-01-29

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 CCYY-MM-DD