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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

 

 

CIMI Analysis Normal Form (ANF) Project

Project ID:

 

 

TSC Notification:  Informative/STU to Normative 

Date:  4/15/2018

 

 

- or -                     Direct to Normative (no STU)       

 

 

 

 

Investigative Project

Date :  4/15/2018

Seeking to prepare a “ballot for comment” on the proposed ANF model and framework

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

CIMI Working Group

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

Co-sponsor Work Group(s)

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates [PK1] [JC2] )

 

 

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

 

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 )

Keith Campbell

Other interested parties and their roles

US Department of Veterans Administration (VHA)

Multi-disciplinary project team (recommended)

 

Modeling facilitator

 

Publishing facilitator

 

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 project will produce an iso-semantic supplement to the current CIMI Reference model and Detailed Clinical Models. It will be designed specifically to support data analysis, rather than data entry, and will be called Analysis Normal Form (ANF). 

 

 

3.b. Project Need

  Clinicians typically enter clinical information via a manner that we call here the

‘clinical input form’ (CIF).  However, the CIF is not a literal form that clinicians select and enter data in.  Rather, it refers to the manner in which information is presented to the clinicians and how they enter the data, such as by constraining the information to allow only certain values to be entered, such as through a drop-down list or radio button, or breaking up large chunks of related information into smaller parts.

 

Ideally, the way the information is presented to clinicians is in a manner that is most familiar and efficient for the clinicians to use.  However, what is an efficient way for clinicians to select and enter data may not be the most efficient or reliable way for data analysts to use when they are querying data once it has been normalized and stored in a database, such as for CDS rules or the computation of prevalence statistics.  For these purposes, the data is normalized using the analysis normal form (ANF) and stored in a database.  Again, the ANF is not necessarily a physical structure, but is how a data analyst might see the data when they are looking at it in a database, and not as clinicians would see it in the user interface (i.e., CIF).

 

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 .

 

x

Yes

 

 

No

 

 

Unknown

 

3.d. External Drivers

VHA use of Knowledge Artifacts (KNARTs)

3.e. Project Objectives / Deliverables / Target Dates

 

Target Date

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

For Comment

2019 May

STU (Proposed)

2019 September

 

 

 

 

 

 

 

 

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.

Enter Project End Date   No End Date

3.f.    Common Names / Keywords / Aliases

CIMI Analysis Normal Form / ANF

3.g. Lineage

 

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.  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 ).

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept. A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Clinical_Information_Modeling_Initiative_Work_Group .

3.j.    Backwards Compatibility

Are the items being produced by this project backward compatible?

 

 

Yes

 

 

No

 

x

Unknown

 

 

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

 

x

Unknown

 

 

N/A

 

We will support V3 Datatypes

 

 

 

 

 

 

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?

 

x

Yes

 

 

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies:

SoLoR, SNOMED-CT, RXNORM, LOINC, VSAC

  1. Products (check all that apply)

 

Arden Syntax

 

 

V2 Messages – Administrative

x

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

x

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

 

 

V3 Foundation – Vocab Domains & Value Sets

x

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?

  1. Project Intent (check all that apply)

 

Create new standard

 

x

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)

This project will supplement the existing CIMI reference model and detailed clinical models with an Analysis Normal Form (ANF) representation.

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)

 

 

 

 

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

 

 

No

 

 

  1. Project Logistics

6.a. External Project Collaboration

  ???

For projects that have some of their content already developed:

How much content for this project is already developed?

5%

Was the content externally developed (Y/N)? 

VA KNART Project (Y)

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

 

 

 

 

 

 

 

X

Yes

 

 

No

6.b. Realm

[PK3] [JC4] [PK5]

Universal     - OR -

 

X

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

 

 

 

 

6.d. Project Approval Dates

Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date: [DKH6] [JC7]

2018-05-24

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

List each Co-Sponsor and their Approval Date CCYY-MM-DD
or indicate “N/A”
 

Family Management Group Approval Date(s)

 

 

CDA Projects: CDA Management Group

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

FHIR Projects: FHIR Management Group

FMG Approval Date CCYY-MM-DD
or “N/A”

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date CCYY-MM-DD
or “N/A”

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

USRSC Approval Date “N/A”

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date CCYY-MM-DD or indicate “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 2018-08-20

Last PBS Metrics Score :

X

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)

ARB Approval Date CCYY-MM-DD
or “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

 


[PK1] There are no co-sponsors – wouldn’t there be a clinical group who would use the output of this project, perhaps CDS?

[JC2] There are no co-sponsors at this point.

[PK3] Are there non-US participants?

[JC4] Not at this point

[PK5] Then this should be US Realm given there is no participation to justify Universal.

[DKH6] What date did the CIMI Work Group approve the PSS?

[JC7] Done