Health Level Seven , International

Project Scope Statement

Project Scope Statement

2011 Version
Release 1
HL7 Project Management Office
Project Services Work Group
Point of Contact Name and Email:
David Hamill ([email protected])
Co-Chairs of Project Services Work Group:
http://www.hl7.org/Special/committees/projectServices/leadership.cfm

Publication Date: January, 2011

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.

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Project Scope Statement

Template Usage Information:

 Replace Highlighted Courier New text with appropriate content.
 To check a box, double click on the box then select the 'Checked' Radio Button under the 'Default Value' heading.
 For assistance in completing each section, refer to Appendix A.
 Information on the Project Approval Process is documented in Appendix B.
 For FAQs (Frequently Asked Questions), refer to Appendix C
 Submit template change requests to [email protected]

1. Project Name, ID and Products

An ID will be assigned
Click here to go to Appendix A for more information regarding this section. by Project Insight
Enter the name of the project here. Project ID:
Non Product Project- (Educ. Marketing, Elec. Services, etc.) V3 Documents - Knowledge
Arden Syntax V3 Foundation – RIM
Clinical Context Object Workgroup (CCOW) V3 Foundation – Vocab Domains & Value Sets
Domain Analysis Model (DAM) V3 Messages - Administrative
Electronic Health Record (EHR) V3 Messages - Clinical
V2 Messages – Administrative V3 Messages - Departmental
V2 Messages - Clinical V3 Messages - Infrastructure
V2 Messages - Departmental V3 Rules - GELLO
V2 Messages – Infrastructure V3 Services – Java Services (ITS Work Group)
V3 Documents – Administrative (e.g. SPL) V3 Services – Web Services
V3 Documents – Clinical (e.g. CDA) - New Product Definition -

2. Project Intent (check all that apply)

Click here to go to Appendix A for more information regarding this section.
Create new standard Supplement to a current standard
Revise current standard Implementation Guide (IG) will be created/modified
Reaffirmation of a standard Project is adopting/endorsing an externally developed IG
Withdraw current standard (specify external organization in Sec. 6 below)
N/A (Project not directly related to an HL7 Standard) Externally developed IG is to be Adopted
Externally developed IG is to be Endorsed

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

Com
ment
Only Normative
Informative Joint Ballot (with other SDOs or HL7 Work Groups)
DSTU N/A (project won’t go through ballot)
If necessary, add any additional ballot information here. If artifacts will be
jointly balloted with other HL7 Work Groups or other SDOs, list the other groups.

3. Sponsoring Group(s) / Project Team

Click here to go to Appendix A for more information regarding this section.
Primary Sponsor/Work Group (1 Mandatory) Enter primary Sponsor/Work Group here.
Co-sponsor Work Group(s)

Project Team:
Project facilitator and email (1 Mandatory) Enter Project Facilitator name/email here.
Other interested parties
Multi-disciplinary project team (recommended)
Modeling facilitator
Publishing facilitator
Vocabulary facilitator
Domain expert rep
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Project Scope Statement

Data Analyst facilitator
Business requirement analyst
Requirements process facilitator
Other facilitators (SOA, SAIF)

Implementers (2 Mandatory for DSTU projects):

1)
2)

4. Project Definition
4.a. Project Scope
Click here to go to Appendix A for more information regarding this section.
Describe the project; include what is expected to be accomplished/delivered along
with specified features and functions.

4.b.Project Need
This information is required by ANSI for all ballots. Briefly explain the reason
behind the need for this project. This may be related to legislative requirements,
industry need, or similar justifications.

4.c. Success Criteria

Indicate the success criteria for the project.

4.d.Project Objectives / Deliverables / Target Dates..

Within each row, enter the explicit work product(s) / objective(s). Indicate their target date at the right in Target Date (in WGM or
WGM/Ballot Cycle format. Include the project end date as the last objective (for standards projects, the ballot cycle format, e.g.
end date will be the projected ANSI approval date). ‘2010 Sept WGM’ or
Click here for further information and an EXAMPLE ‘2010 Jan Ballot’)
Enter objective/deliverable here. Enter Target Date

Project End Date (all objectives have been met) Enter Pjt End Date

4.e. Project Dependencies

Enter any dependencies or the name & Project Insight ID of project(s) that this
project is dependent upon to achieve its objectives. Projects and their Project
Insight IDs can be found via
http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common

4.f. Project Document Repository Location

Enter the SPECIFIC URL where supporting project documents, deliverables, ballot
reconciliation work and other project information will be kept.

4.g.Backwards Compatibility
Are the items being produced by this project backward compatible?
Yes No Don’t N/A
Know
If desired, enter any additional information regarding Backwards Compatibility.

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5. Project Approval Dates

Click here to go to Appendix A for more information regarding this section.
Sponsoring Group Approval Date Work Group Approval Date
Steering Division Approval Date SD Approval Date
Technical Steering Committee Approval Date TSC Approval Date

6. External Project Collaboration

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

6.a. 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
Quality Reporting Agencies Equipment Local and State Departments of Health
Regulatory Agency Health Care IT Medical Imaging Service
Standards Development Organizations Clinical Decision Support Healthcare Institutions (hospitals, long term
(SDOs) Systems 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.b.Synchronization With Other SDOs / Profilers

Click here to go to Appendix A for more information regarding this section
Check all SDO / Profilers which your project deliverable(s) are associated with.
DICOM IHE ISO
Other (specify below) N/A
For standards and implementation guides (IG) being developed by this project,
please indicate:
- Similarities to standards or IGs from the checked SDO/Profilers
- How they will be different
- How overlaps will be coordinated with the checked SDO/Profilers
- Why coordination is not needed with other SDOs/Profilers

7. Realm
Click here to go to Appendix A for guidelines regarding choosing Universal or Realm Specific.
Universal Realm Specific (Enter “U.S.” or name of HL7 affiliate here)

8. Strategic Initiative Reference

Click here to go to Appendix A for more information regarding this section
Check which Strategic Initiative best relates to your project.
A. Lead the development of global technical and functional health informatics standards.
B. Streamline the HL7 standards development process.
C. Facilitate HL7 standards adoption and implementation.
D. Define an overarching and internally consistent interoperability framework.
E. Ensure broad and encompassing stakeholder engagement in the standards development process.
F. Align HL7's business and revenue models to be responsive to national bodies while supporting global standards development.
G. None of the above apply to this project.

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Project Scope Statement

Appendix A - Instructions (Delete prior to submitting the completed scope statement)

Click here to return to this section in the template above.

Project Scope Statement Purpose:

This Project Scope Statements is intended for products used outside HL7, such as projects to produce standards or Implementation Guides.
Infrastructure projects (the RIM, HL7 maintained vocabulary, wrappers, and methodology) should also use this scope statement but are
not required to complete all sections as noted in the instructions.

The objective of this template is to communicate the type of activities a group is undertaking to achieve specific objectives or to produce
specific work products. Project Scopes should provide sufficient information to allow inexperienced individuals to anticipate what a group is
working on and decide if they wish to become involved. Project Scope statements should also assist committee chairs to manage the
workload of the committee and help to set priorities and recognise inter-dependencies with the work of other committees.

The Steering Divisions, TSC, and other appropriate approval bodies, as defined by the HL7 organization and Project Approval and Initiation
Process, review and approve the project request. This includes analysis to avoid project overlaps or dependency gaps. A project not aligned
with HL7 strategies established by the HL7 Board, or requiring extensive resources may not be approved. A “hosted” project (funded by an
external source) may be approved as long as the sponsors provide adequate resources and the project is not detrimental to HL7 strategy;
funding may be in the form of resources or financial support, grants, etc.

Required Information:

The HL7 Project Management Office (PMO) will review project statements to ensure the names and descriptions are clear and unambiguous
across all projects and that required information is provided so as to obtain project approval.

Project Insight Note:

The following instructions indicate how the information in this form is mapped to certain fields in Project Insight’s project description form. The
fields are mapped to specific fields in the project description form available in Project Insight:
http://healthlevelseven.projectinsight.net/Login.aspx?ReturnUrl=%2fdefault.aspx
If you need system login setup for Project Insight, contact the HL7 Director of the Project Management Office at [email protected]

Recommendation for Non-infrastructure Projects:

The HL7 Product Lifecycle recommends ballots proceed through Informative  DSTU  Normative phases, however, HL7 policy allows
projects to proceed to normative ballot without an Informative or Draft Standard for Trial Use (DSTU) in special circumstances, such as such
the need to respond to government mandate or resolve a critical issue raised by a stakeholder or noted in an existing American National
Standard. Bypassing the Informative and/or DSTU ballot must be approved by the TSC. Refer to the HL7 Governance and Operations
Manual Section 13 – Review Ballot and Section 14 – Normative Ballot for additional information.

1. Project Name, ID and Products Click here to return to this section in the template above.
The name should be concise, based on the objective and unique among all other projects the group Project ID: A project ID will be
takes on. Project Insight: Enter into “Name”. assigned by Project Insight
Product(s): Indicate the associated Product line(s); check all that apply. Refer to the “Products” tab of the worksheet at the following URL
for the definition of the products: http://www.hl7.org/documentcenter/public/wg/sips/Products&ServicesRevenueMatrix.xls . Additional
information regarding HL7 Products is available at http://wiki.hl7.org/index.php?title=Product_List_FAQ.
Project Insight: Enter into “Product Type”.

2. Project Intent Click here to return to this section in the template above.
Indicate if/how this project affects a standard.
If a project is adopting/endorsing an externally developed Implementation Guide, additional information can be found in the GOM Section 18
(available at: http://www.hl7.org/documentcenter/public/membership/HL7_Governance_and_Operations_Manual.pdf).
Project Insight: Enter into “Project Intent”.

2.a. Ballot Type

If applicable, indicate the type of balloting the deliverables will go through
Project Insight: Select a value from the “Type” dropdown.

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Project Scope Statement

3. Sponsoring Group(s) / Project Team Click here to return to this section in the template above.
Primary Sponsor/Work Group (1 Mandatory): Some projects are jointly sponsored and the name of all sponsoring Work Groups should be
noted. Every project must have at least one project sponsor and a project facilitator; a multi-disciplinary project team is recommended, e.g.
domain expert, UML modeling facilitator, HL7 modeling facilitator, requirements process facilitator, data analyst facilitator, business
requirement analyst. Sponsorship may be in the form of resources or funding. Project Insight: Enter into “Sponsor(s)”.

Project Facilitator (1 Mandatory): This is mandatory for all projects and should be the contact person if there are questions about the Project
Scope Statement. The Project Facilitator serves as the Project Lead; the 'go to' person for the project who can answer questions regarding
status, scope, objectives, issues, risks, etc. regarding the project. Project Insight: Enter into “Project Facilitator”.

Other Interested Parties: This section should also describe other ‘interested parties’, e.g. anticipated interactions with other committees or
other projects.

Facilitators: Modeling, Publishing, and Vocabulary facilitators are formal roles recognized by HL7, and highly recommended as project
participants. If your project has not filled this role, please indicate a contact person for the role, for example, your project may not have a
formal vocabulary facilitator but a committee participate has volunteered to serve as liaison with the Vocabulary Committee.

Infrastructure projects, for example, the RIM, HL7 maintained vocabulary, wrappers, and methodology are required to name only the Primary
Sponsor and Project Facilitator.

Implementers (2 Mandatory): If this project will produce a standard, identify at least two implementers who agree to implement a DSTU prior
to normative ballot (this is a non-binding agreement). Contact information is mandatory. The intended implementers must be identified at
project initiation; however, it is a non-binding agreement. Refer to explanation of Candidate Standard validation below for additional
information. Project Insight: Enter into “Project Implementers”.

Candidate Standard validation

Candidate Standard Executing the Candidate Standard validation approach. HL7 will have a modified open approach to candidate
validation standard validation. All those participants that made a non-binding commitment when the project was initiated will be
included if they choose to honor the commitment. Others may be added to achieve a balance or for other necessities
for validation. The previous notwithstanding, HL7 will limit the number of participants to ensure a manageable
process and reasonable time frame.

Candidate Standard A project step that ensures that the Candidate Standard is validated by external industry resources before it is
validation approach finalized as a normative standard. Where the standard is for interoperability, it is expected that the validation will
include at least two independent entities (vendors, user organizations, etc.) building trial implementations and testing
them together. Where the standard serves another purpose the validation approach will involve a trial effort to use
the draft standard in the manner for which it was created.

At the planning stage the entities willing to test must make a non-binding declaration of their intent to participate in
validation. Without such a declaration the project should not be initiated.

Comment: This is expected to be a significant hurdle for new project initiation. At the same time it helps to assure
that HL7 member resources will be concentrated on efforts that have a greater likelihood at industry adoption.

4. Project Definition Click here to return to this section in the template above.

4.a. Project Scope

The detail should be sufficient that an individual with no previous exposure to the group (or even HL7) could understand the expected
activities and results. The scope description should also include high level expectations for the project and indicate alignment with market
demands or other drivers for the project, such as government mandates, requirements from industry interoperability connectathon, etc.

Typically projects to produce standards are routinely supported by the volunteer resources committing to complete the project, and HL7 in
the form of meeting rooms, conference call facilities, etc. If additional funding is required, you must provide a budget for the project. A
proposed budget is required for any project that will be contracted, for example, website redesign or tooling development.
Project Insight: Enter into “Description”.

4.b. Project Need

Explain the reason behind the need for this project. This may be related to legislative requirements, industry needs or similar justifications.
This section must be completed for projects containing items that are expected to be ANSI approved, as it is an ANSI requirement for all
ballots. The information will be used in the NIB form.
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Project Insight: Enter into “Project Need”

4.c. Success Criteria

Indicate the success criteria for the project.
Project Insight: Enter into “Succss Criteria”

4.d. Project Objectives / Deliverables / Target Dates

Click here to return to this section in the template above.
Enter a list of objectives the project is trying to meet. If the project is to develop one or more work Target Dates
products, the work products’ descriptions should be clear, concise and unambiguous. Work Exact dates are not needed.
products intended to produce a standard should be in terms of the deliverables: Enter in WGM or ballot cycle format,
 new elements methodology (e.g. a new way of deriving message specification from a in e.g. : ‘2010 Sept WGM’ or
information model) ‘2010 Jan Ballot’.
 new interface specification for services or application roles
 new functional models Target dates in Project Insight are
 new message specification (e.g. a new message structure that refers a the state only provided in the above format.
transitions of a new type of clinical act)
 new standard profiles (e.g. CDA implementation guide) Target dates can be updated.
 new terminology subsets or mapping
 new tools intended to improve productivity and support the methodology

In those cases where the objectives are not work products, they should be described so that an
outside observer can answer “yes” or “no” to the question “has this objective been met?”
As the project progresses, objectives and work products can be refined.
Projects that have more than one work product to deliver should list each work product’s expected
delivery date, taking into consideration expected dependencies among work products.
Project Insight: Enter into “Pjt Objectives and Deliverables ”.

Example of Objectives / Deliverables / Target Dates:

Click here to return to this section in the template above.

The following attempts to convey how to identify various objectives /deliverables and their
target dates.
Objective / Deliverable Target Date
Complete analysis, design, draft specification work on Standard XYZ 2009 Sept WGM
Submit for Comment Only Ballot 2010 Jan Ballot
Consider Comments from the Comment Only Ballot 2010 Jan WGM
Submit for DSTU Ballot 2010 May Ballot
Consider Comments from the DSTU Ballot 2010 May WGM
Submit to TSC for DSTU approval 2010 Sept WGM
DSTU Period – 2 years Jan, 2011 – June, 2012
Submit Implementation Guide for Informative Ballot 2011 Jan Ballot
Submit Standard XYZ for Normative Ballot 2012 Sept Ballot
Reconcile from Normative Ballot 2012 Sept WGM
Submit for Normative Ballot v2 2013 Jan Ballot
ANSI Approves Standard XYZ 2013 May WGM
Close Project (project end date) 2013 May WGM

4.e. Project Dependencies

This section is not required for Infrastructure Projects.
The dependency may be the work of another project undertaken by this group or by another group. Anticipating dependencies can allow
groups to coordinate their effort to ensure the overall objectives of HL7 can be met. An example of a dependency is: The CDA ballot needed
the Data Types produced by Infrastructure and Management Project to be through ballot before the CDA ballot could be finalised.
Project Insight: Enter into “Pjt Dependencies”.

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4.f. Project Document Repository Location.

Indicate where can one go to find deliverables/documents created by the project team by entering the EXACT URL(s) where one can go to
find deliverables, documents, artefacts created by the project team for this project. The URL could point to the HL7 Wiki, TSC Wiki, GForge,
Project Insight, etc.
Project Insight: Enter into “Project Document Repository”.

4.g. Backward Compatibility.

Indicate the backward compatibility of the expected project artefacts/deliverables, if known.
Project Insight: Enter into “Backward Compatibility”; enter additional information into ‘Misc. Notes’..

5. Project Approval Dates Click here to return to this section in the template above
Note that the SD and TSC Approval dates don’t need to be captured in this template; this section simply reminds project facilitators about the
need to gather SD and TSC approval. SD/TSC approval dates will be entered into Project Insight as they occur.
Work Group Approval Date: The date the sponsor’s Work Group approved the project. Project Insight: Enter into “Start Date”.
SD Approval Date: The date the sponsor’s Steering Division approved the project. Project Insight: Enter into “SD Approval Date”.
TSC Approval Date: The date the Technical Steering Committee approved the project. Project Insight: Enter into “TSC Approval Date”.

6. External Project Collaboration Click here to return to this section in the template above.
Include SDOs or other external entities you are collaborating with, including government agencies. Indicate the nature and status of the
Memorandum of Understanding (MOU) if applicable.

Agreement Status: Memorandum of Understanding (MOU) or Associate Charter Status types are: Negotiating or signed (please indicate the
date signed.) Leave blank if there is no agreement in place. Refer to http://www.hl7.org/about/agreements.cfm for a current listing of HL7’s
MOU agreements.

Project Insight: Enter into “Collaboration Efforts”.

6.a. Stakeholders / Customers / Providers

This section must be completed for projects containing items that are expected to be ANSI approved, as it is an ANSI requirement for all
ballots. The information will be used in the NIB form.

Indicate the associated stakeholders, customers and providers for which this project is intended. Check all that apply.
Project Insight: Enter into “Stakeholders / Customers / Providers”; enter additional information into ‘Misc. Notes’.

6.b. Synchronization With Other SDOs / Profilers Click here to return to this section in the template above.
Indicate the existence, or absence, of related implementation guides or standards with the appropriate SDO/Profiler.

The main goal of this section is to get to get clarity on potential conflicts with other SDO/Profiler deliverables that we can address at the time of
project definition. Also, we want to avoid confusion for stakeholders that have to deal not only with HL7 but also other SDO/Profiler
deliverables. An example of this is the development of implementation guides where we want to make sure that it is done jointly with, say,
IHE, or that it is clearly stated in this section why the proposed IG is different from similar IGs.
Project Insight: Enter into “Synchronization With Other SDOs / Profilers”; enter additional information into ‘Misc. Notes’.

7. Realm Click here to return to this section in the template above.

Indicate whether the project is applicable globally (universal), or intended for a specific country or region (realm). Note that Non-US realm
project scope statements should be directed to the appropriate HL7 Affiliate.
Projects meeting one or more of the following guidelines are candidates for being universal realm projects.
 Stakeholders representing 2 Realms at a minimum, where stakeholder should be interpreted as a specific group or organization
listed in the External Project Collaboration section or the Stakeholders / Vendors / Providers section of the project scope statement
 Requirements coming from a minimum of 2 Realms
 Project will be implemented in a minimum of 2 Realms
 Minimum of 2 Realms represented on project team

Also note that if the Realm changes from ‘Realm Specfic’ to ‘Universal’ additional project resources may be necessary to support that change.
This is considered a ‘significant’ or ‘major’ change and should go through the project approval process as a Universal Realm project.

Project Insight: Enter into “Realm” and “HL7 Affiliate” (if applicable).

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8. Strategic Initiative Reference Click here to return to this section in the template above.
For more detail regarding the HL7 Strategic Initiatives, go to: http://www.hl7.org/documentcomments/index.cfm
Project Insight: Enter into “Strategic Initiatives Reference”

Appendix B - Project Approval

Click here to return to this section in the template above.
Every project scope statement must follow the appropriate review/approval process based on its project sponsor:
 Work Group
 TSC
 Marketing or Board Committee
 Board of Directors or a Contract project
 International Council
 HL7 Affiliate

Documentation detailing these processes is located at:

www.HL7.org > Participate > Templates > Project Scope Statement and Project Approval Process or directly at the permalink
http://www.hl7.org/participate/templates.cfm?ref=nav .

Appendix C – Frequently Asked Questions

Click here to return to this section in the template above.

Q: What is the definition of a project?

Answer:
From the HL7 Development Framework, Section 2.2.1, HL7 Work Effort:
An HL7 work effort represents an activity being undertaken by an existing Work Group or Board appointed committee to achieve specific
objectives or to produce specific work products.

A Work Group shall consider a work effort to be a project if one or more of the following is true of that work effort:

• involves a group outside of HL7 (may require Board approval)

• requires external funding (may require Board approval)
• is going to be balloted
• requires cross-committee participation
• is determined to be a project by the committee

An HL7 project:

• has an objective (statement of what is going to be produced),

• will have a finite existence (the end date to be determined by the resources available and the start date), and
• if additional funding is required, it will have a budget (including resources and funding sources)
• will have at least one participant available to contribute and must have a project leader, if only an interim to get the project started
• will have at least two implementers (unless the project is intended to support the HL7 infrastructure)
• will have an estimated schedule

Project Management Institute’s PMBOK Guide and the publication “The Fast Forward MBA in Project Management” indicate the following:

Typically, a project is a temporary endeavor undertaken to create a unique product or service.  All projects have two essential characteristics.
(1) Every project has a beginning and an end. (2) Every project produces a unique product. HL7 also recognizes ‘Maintenance’ projects which
usually repeat on an annual basis; these maintenance projects do not need to be re-submitted or have a definite end date.

Temporary means that every project has a definite beginning and a definite end.  Temporary does not necessarily mean short in duration, it
just means that projects are not ongoing efforts.  Furthermore, projects involve something that has not been done before and which is,
therefore, unique.

Projects shouldn’t be confused with ongoing operations.  Ongoing operations have the opposite characteristics of projects in that they have no
defined end and they produce similar, often identical, products.  Examples of ongoing operations are (a) an insurance company processes
thousands of claims every day; (b) a bank teller serves over 100 customers daily, providing a few dozen specific services.

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Project Scope Statement

The objective of a project is to attain the objective and close the project.  The objective of an ongoing operation is typically to sustain the
business.

Q: Do I need to create a Project Scope Statement if my project isn’t going through the ballot process?

A: Yes, all projects need to have a Project Scope Statement completed and submitted to the HL7 PMO. A lot of work done by Education,
Marketing, Electronic Services, ArB, PIC, etc. does not need to go through the ballot process, however, visibility of that work is necessary.
Project Scope Statements are the foundation for communicating project information. They also serve as a tool for Project Facilitators to gather
the right information to begin a project as well as track the project’s progress.

Q: Do I need to create separate Project Scope Statements for each Implementation Guide or other support documents?

A: A single PSS can indicate multiple deliverables for the standard being addressed, so, no, a separate PSS does not need to be created for
each Implementation Guide or support document for that standard. Simply identify all of the Implementation Guides and documents in the
Project Objectives and Deliverables section that are to be produced for the project.

Q: The scope or objective of my project changed. Do I need to create a new PSS?

A: You may or may not have to as it depends on the change. Oftentimes, the scope or objectives of a project may change during its lifecycle,
perhaps due to regulatory changes or tying back to a different standard.

If the change in scope or objectives is minor, simply update the existing project scope statement, and within Project Insight, indicate the
modifications in the appropriate fields. You can also use the ‘Misc. Notes’ text box for documentation.

If the change in scope or objectives is major, the Project Facilitator should submit a new Project Scope Statement, as many of the original
information won’t accurately reflect what is being done anymore.

Q: What defines a ‘major’ or ‘significant’ change in scope?

A: Since ‘major’ and ‘significant’ are subjective terms, examples may provide better comprehension of a “major” or “significant” change to a
project scope statement.

A “major” or “significant change” in project scope is when the impact is that:

 The Project End date extends by 6+ months
 Additional HL7 funds are required
 The Project Intent changes (i.e. the project changes from “Revising a Standard” to “Creating a Standard”)
 The change in scope will result in an item that qualifies as ‘substantive change’ as defined in GOM Section 14.08.04.
 The Ballot Type changes to a Normative (i.e. the project changes from planning for an Informative ballot to a Normative ballot)
 The Realm changes from ‘Realm Specfic’ to ‘Universal’ (since additional project resources may be necessary to support that change)
 The deliverable’s backwards compatibility changes from ‘Yes’ to ‘No’

Q: Do I need to include budget figures in my scope?

A: Typically projects to produce standards are routinely supported by the volunteer resources committing to complete the project, and HL7 in
the form of meeting rooms, conference call facilities, etc. If additional funding is required from HL7, you must provide a budget for the project.
A proposed budget is required for any project that will be contracted, for example, website redesign.

Q: I’ve submitted my PSS to my Steering Division for approval but haven’t heard anything from them. What should I do?

A: First, check the Steering Division’s meeting minutes. Look to see if your project was on one of their agendas, and if so, if it was approved
or the SD had further questions. Your first point of contact with the SD should be their Project Facilitator. If you can’t contact them, contact
the Steering Division Representative and Alternate.

If the SD has approved your project, they will submit it to the TSC for approval via GForge’s tracker system. To view which approvals your
project has gathered, find your project by using the Searchable Project Database
(http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm), located on the www.HL7.org Homepage).

Q: Do I need to update the PSS if I discover after it’s approved that I need to coordinate ballots with other HL7 Work Groups?

A: Yes, we recommend updating the Ballot Strategy section of the Project Scope Statement as well as Project Insight. Include the ballot name
and release/version your project is coordinating with.

Q: When withdrawing or reaffirming a standard, does a PSS need to be created and go through the review/approval process?

A: Yes, for both cases.

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In this case ‘withdrawing a standard’ refers to many things, such as choosing not to extend a standard that has reached its 5 year end-of-life or
identifying the need to sunset a standard. By creating a PSS and following the approval process, you give the opportunity to communicate the
withdrawal to the HL7 membership and allow them to weigh in on any potential work needed to successfully withdraw the standard.
GOM Section 14.13 has more information on withdrawing a standard.

Reaffirmation of a standard requires a normative ballot.

Q: How do I know the approval status of my project?

A: Look up your project using the Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm),

located on the www.HL7.org Homepage). The search results will reflect SD and TSC approval statuses either by reflecting the date the group
approved the project or indicated ‘Awaiting Approval’ if the group has not approved the project.

Q: What approvals are needed if I revise my existing PSS, say the project’s scope changes?

A: The same approval process should be followed whether it’s a new project or a scope change to an existing project.
When the scope is changed in a project, an adjusted or new Project Scope Statement will be approved by the primary WG and the SD,
providing the TSC using the same time line and deadlines as submissions for new projects.
Best practice: Use Microsoft Word’s ‘Track Changes’ tool to highlight the changes being made to the Project Scope Statement.

Q: What ballot types are required to go through the project approval process?

A: All ballot types (Comment Only, Informative, Normative, DSTU) need to go through the project approval process, however, as identified in
the Project Scope Statement, a single project can define ballot plans for multiple types of ballots for the project, for example, Comment Only
>DSTU > Normative or Informative > Normative.

Q: Do I need to go through the project approval process if a standard has expired and will not be reaffirmed?

A: When a work group has balloted a standard at DSTU, informative, or normative ballot, and decides the standard will be withdrawn, the
withdrawal form at http://www.hl7.org/documentcenter/public/membership/ANSI_proposal_withdrawal.doc is needed for ANSI notification and
must be approved by the Work Group and the TSC.

Q: What is the approval process for HL7 projects that collaborate with ISO or the JIC?

A: Follow the process documented on via www.HL7.org > Participate > Balloting > HL7's Collaboration with ISO and JIC
(http://www.hl7.org/participate/isojic.cfm).

Q: How should a Work Group document the voting results after seeking approval for the PSS?

A: The ideal way is to post it in meeting minutes, so that they are documented and easily referenced. If that’s not possible, an email to the
Listserv will suffice.

Q: Define ‘task’ and ‘activity’ as related to project management.

A: Theoretically, ‘activity’ is the action verb within a ‘task’. However, for HL7 projects, ‘task’ and ‘activity’ can be considered synonymous
terms.

Task/activities should be:

 Specific - a single, well defined, discrete activity. The 8/80 is a good guideline -- no task should be smaller than 8 hours or larger than 80
hours.
 Achievable - it should be something that can be done as a single deliverable and can be defined as being completed or done such as a
document being produced.
 Measurable - it should be an activity that can be measured such as a deliverable produced, an elapsed period of time or number of
iterations

Q: How should a Work Group document annual work/maintenance within Project Insight?

A: A project entry should be opened in Project Insight indicating the annual work and the respective years. This project should have a Project
Status of ‘3 Year Plan Item’; note that a Project Scope Statement isn’t needed for this entry because it’s a 3 Year Plan item and only high level
information is necessary. This project can then remain ‘as-is’, or modified so it indicates accurate future years.

When the Work Group actually begins the annual work, they should complete a PSS indicating the scope of work involved and gather the
necessary approvals for the PSS. A new project in Project Insight will be created (and will have a Project Status of ‘Active Project’). Once the
scope of work has been completed for this project, it will be closed/archived.

Hence, the 3-Year Plan project always remains open; the ‘Active Project’ PSS will be the project reflecting the specific annual maintenance
being done.
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An example of the above situation can be found for Project Service’s annual updates to the PSS Template. Project 531 is the 3YP entry
indicating the need for the work in 2010, 2011, 2012, 2013 and beyond. Project 581 was created to identify the specific work that would be
done for the 2010 updated template. In January, 2010, project 581 was closed because the new PSS template was released to membership,
however project 531 was modified to remove references to ‘2010’ and remains open to indicate the need for the work each year.

Q: Should a project remain open/active during it’s DSTU Test Period?

A: Yes, it should. This means that the project will continue to show up in the Searchable Project Database and on Project Insight reports.

Q: Why was I asked to Disable or Enable a macro when I opened this document?

A: This document contains a macro that, when run by the user, removes the green ‘help’ text within the template portion of this document and
provides a cleaner version of their project scope statement. To run the macro, select Tools > Macro > Macros… > Run.
Note that the macro will NOT remove the Appendices; the user must remove the Appendix verbiage on their own.

Q: How do I search/view HL7 Projects?

A: There are three ways to view HL7 projects, all located at www.HL7.org > Participate > Tools and Resources > Project Tracking Tools
(http://www.hl7.org/participate/toolsandresources.cfm):
1. The Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm, located on the
www.HL7.org Homepage and titled ‘Search current projects from Project Insight)
2. An Excel spreadsheet of all HL7 projects is available via GForge > TSC File tab (http://gforge.hl7.org/gf/).
3. Project Insight (a Project Insight User ID and Password is required – this differs from your HL7 User ID and Password). Contact the
HL7 PMO for more information ([email protected]). The URL is: http://healthlevelseven.projectinsight.net/l.aspx?ReturnUrl=%2fdefault.aspx.

Q: Where can I find the Project Scope Statement Template?

A: The most recent version of the Project Scope Statement Template (MS Word document) is located at www.HL7.org > Participate >
Templates (http://www.hl7.org/participate/templates.cfm).

Q: Where can I find the list of Steering Division Leaders or Steering Division Project Facilitators?
A: Current Steering Division leaders can be found via their Steering Division webpage at http://www.hl7.org/Special/committees/index.cfm.
Current Steering Division Project Facilitators can be found via a PDF file at www.HL7.org > About > People and Organizations > HL7
Facilitators (http://www.hl7.org/About/hl7facilitators.cfm).

Q: Do I need to specify a Reference Information Model (RIM) version in the V3 standard I am developing?

A: Unless specified, it is assumed that a project incorporates the current version of HL7 infrastructure (RIM, Datatypes and Vocabulary).

Project Services recommends that your Work Group’s modeling facilitator monitor proposed RIM changes that may impact the standards you
are developing for the duration of your project. The modeling facilitator can do this by subscribing to the [email protected] listerv.
For more information on RIM change proposals, contact the MnM Work Group.

Q: What do I need to do if I want a project document to be publically available outside of HL7?

A: It’s a rare instance that a project will create and distribute a public document in accordance to the GOM’s ruling.   In the instance that a
project deliverable does adhere to it, the project team will need to present a proposal to the Executive Committee to provide funding to create
and distribute a document publicly.  GOM Section 09.01(d) indicates that the Executive Committee determines what is publically available.
More information can be found at: http://www.hl7.org/documentcenter/public/membership/HL7_Governance_and_Operations_Manual.pdf .

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