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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

 

HL7 Implementation Guide for CDA® Release 2: Personal Advance Care Plan Document, Release 1

Project ID: 8614

TSC Notification Informative/DSTU to Normative           Date :  6/6/2019

 

Check this box when the project proceeds from Informative to Normative or DSTU to Normative status.  Forward to the TSC for notification, as this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.  

Investigative Project                                                        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, 2, 3a, 3b, 3g [limited, 6b [if known], and 6c [applicable] are required).

Investigative Project specific instructions are yellow highlighted.

An investigative project must advance in two WGM cycles, requiring a full scope statement.  Otherwise the project will be closed.

 

The intention is to work toward Normative, but this first ballot will be a DSTU.

  1. Sponsoring Group(s) / Project Team

Primary Sponsor/Work Group ( 1 Mandatory )

Structured Documents (8/20/2015)

Co-sponsor Work Group(s)

Patient Care

Co-Sponsor Group Approval Date

8/26/2015

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: 

Monthly at PC WG call and as needed in the Care Plan group meeting.

Other Involvement. Specify details here: 

 

 

 

Project Team:

 

Project facilitator ( 1 Mandatory )

Lisa Nelson  (LisaRNelson@Cox.net)

Other interested parties and their roles

 

Multi-disciplinary project team (recommended)

Leslie Kelley Hall (PGD, Policy)

Brian Scheller (PGDH, Technical)

John Derr (LTPAC/SNF, JD&Associates,Inc.,HIT FACA)

Terry O’Malley (S&I eLTSS, Care Plan Clinical)

Paul Coyne – Diridium Technologies (Technical)

M’Lynda Owens Cognosante (consultant)

Joe Schneider

Ferdinando Mirarchi

Mike Wasserman

Dan Morhaim

Remington Johnson

Tony Chou

David Tao

Dan Hanfling

Russ Leftwich (Intersystems)

     Modeling facilitator

Lisa Nelson

     Publishing facilitator

TBD

     Vocabulary facilitator

Rob Hausam

     Domain expert rep

Scott Brown (ADVault) (Legal)

Terry O’Malley  (Clinical)

 

     Business requirement analyst

Lisa Nelson

Jeff Zucker (ADVault) (Business)

     Conformance facilitator (for IG projects)

 

     Other facilitators (SOA, SAIF)

 

 

 

Implementers (2 Mandatory for DSTU 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)  ADVault (Content Creator)

2)  Allscripts (Content Consumer)

  1. Project Definition

3.a. Project Scope

The scope of this project is to produce an HL7 Implementation Guide which specifies a CDA document template for a type of Patient Generated Document.

 

The document will reuse or reference (further constrain) templates defined in C-CDA R2.1 where appropriate. It also may create new section and entry templates where necessary.

 

The purpose of the document is to facilitate the exchange of a patient’s medical treatment goals, preferences, and priorities to be used in care planning. This document will enable an individual to share his or her directives with members of the care team for consideration when developing or updating the person’s care plan. The document will define a standard exchange format to support interoperability of this information. 

 

The project will identify source documents for establishing information exchange requirements. The scope is limited to the document content and does not address transport requirements. Input will be gathered from participants in: the HL7 SDWG, the HL7 PC WG, and a team of interested parties from within the Healthcare Industry. The implementation guide will clarify how the information generated by the individual relates to the clinician’s information in the EMR. Input on the creation of the implementation guide and the associated CDA templates will be gathered from participants in a team with technical CDA expertise.

 

Example Use Cases include: a person who cannot communicate for themselves, a person with a terminal illness, etc. or someone at the end of their life.

 

The US Realm will be addressed in the first phase, a longer-range goal may be to develop versions for other realms through the HL7 Affiliates.

 

Out of scope:

  • Does not replace the Care Plan document created by clinicians/service providers, but would augment the Care Plan by adding information created by the individual about his or her care goals, preferences, and priorities. 
  • Will not be a Physician Order for Life Sustaining Treatment (POLST) or Medical Order for Life Sustaining Treatment (MOLST), but would be used to inform the creation of a POLST or MOLST.
  • Does not address the issue of how consent to share the document is handled.
  • Does not address potential reimbursement practices.
  • Does not address legalities that may exist regarding the use of Advance Directives.

 

3.b. Project Need

Systems used to created patient-centered care plans through a patient mediated process need a way for individuals to share information about their care goals, preferences, and priorities.

 

Individuals need a way to generate information about their care goals, preferences and priorities so that their wishes will be considered when providers create and update their care plan.

 

Enabling interoperable exchange of this information makes it more possible for a person’s care plan to be centered on the person’s goals, preferences and priorities.

3.c. Success Criteria

Successful balloting of DSTU Release in the January ballot and publishing before May 2016 and adoption.

 

3.d. Project Risks

Risk Description:

Content “requirement flux” driven by emerging or changing requirements as this new type of Patient Generated Document is specified formally.

Challenges associated with acceptance or lack of acceptance of “patient generated documents”.

Working across multiple HL7 Work Groups may slow progress.

Impact:

Critical

Serious

Significant

Low

Likelihood:

High

Med

Low

Risk Type:

Requirements

Resources

Social-Political

Technology

Risk To HL7:

Internal to HL7

 

External to HL7

 

Mitigation Plan:

Rigorous documentation of requirements will be maintained on an HL7 SDWG project wiki and diligent project management practices will be used to contain scope creep.

Leverage acceptance of PHMR standard if possible.

Primary Governance for the project will go through Structured Documents changes will be proposed through PC WG then ratified in SDWG.

Will use a rigorous process for documenting decisions made and proposals that have been made and need to considered and ratified. Process will be to work with individual stakeholders then take material to Patient Care for gathering input, then governance will be managed through SDWG.  Process will be documented and tracked on the project wiki area (under SDWG wiki).

3.e.   Security Risks

Will this project produce executable(s), for example, schemas, transforms, stylesheets, executable program, etc.  If so the project must review and document security risks.

Providing schematron? Yes.

Yes

No

Unknown

3.f.    External Drivers

Interest for use in upcoming eLTSS Pilot project (2016).

Overlaps with CBCC work on Patient-friendly Consent Language and Privacy Consent Directives (DAM and IG).

Overlaps with PC work on Care Plans (DAM).

 

3.g. Project Objectives / Deliverables / Target Dates

Target Date

DSTU-1 ballot

Jan 2016 ballot

DSTU-1 published

May 2016 WGM

Normative Release 1 ballot

September 2019

Normative Release 1 published

TBD

3.h. Common Names / Keywords / Aliases

Universal Advance Digital Directive; uADD; Advance Directives; Personal Care Plan; Emergency, Critical, and Advance Care Plan; ECA Care Plan; ECACP; Advance Care Plan; ACP; Patient Generated Advance Care Plan, Patient Generated Advance Care Planning Document.

Lineage

Informed by the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA R2.1

Informed by the Document template for the Continuity of Care Document and other clinical summaries that include Advance Directives sections and entries.

3.i.    Project Requirements

Requirements for this project are driven by national initiatives to shift toward patient-centered care, and the creation and maintenance of Care Plan documents that include and are consistent with the individual’s goals, preferences, and priorities. The specific content to include in a Personal Advance Care Plan document has been developed as a result of years of research surveying the content requirements of advance directive documents throughout the US.

3.j.    Project Dependencies

The Document Template will use templates defined in C-CDA R2.1

3.k. Project Document Repository Location

http://wiki.hl7.org/index.php?title=Advance_Care_Plan_Document

3.l.    Backwards Compatibility

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

Are the items being produced by this project backward compatible?

Yes

No

Unknown

N/A

 

For V3, are you using the current data types? 

Yes

No

 

 

If you check 'No' please explain the reason: CDA R2 is based on data types R1.

3.m.                      External Vocabularies

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

Will this project include/reference external vocabularies?

Yes

No

Unknown

N/A

If yes, please list the vocabularies: SNOMED CT, LOINC and value sets maintained in the VSAC. As the project progresses to other realms, additional code systems and value sets may be utilized.

 

  1. Products

Non Product Project- (Educ. Marketing, Elec. Services, etc.)

V3 Domain Information Model (DIM / DMIM)

Arden Syntax

V3 Documents – Administrative (e.g. SPL)

Clinical Context Object Workgroup (CCOW)

V3 Documents – Clinical (e.g. CDA)

Domain Analysis Model (DAM)

V3 Documents - Knowledge

Electronic Health Record (EHR) Functional Profile

V3 Foundation – RIM

Logical Model

V3 Foundation – Vocab Domains & Value Sets

V2 Messages – Administrative

V3 Messages - Administrative

V2 Messages - Clinical

V3 Messages - Clinical

V2 Messages - Departmental

V3 Messages - Departmental

V2 Messages – Infrastructure

V3 Messages - Infrastructure

FHIR Resources

V3 Rules - GELLO

FHIR Profiles

V3 Services – Java Services (ITS Work Group)

New/Modified/HL7 Policy/Procedure/Process

V3 Services – Web Services (SOA)

New Product Definition

 

New Product Family

 

 

 

  1. Project Intent (check all that apply)

Create new standard

Revise current standard ( see text box below )

Reaffirmation of a standard

New/Modified HL7 Policy/Procedure/Process

Withdraw an Informative Document

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

Supplement to a current standard

Implementation Guide (IG) will be created/modified

 

Project is adopting/endorsing an externally developed IG: Specify external organization in Sec. 6 below;

Externally developed IG is to be (select one):

Adopted   - OR - Endorsed

 

Endorsed

-           

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

Comment Only

Informative

DSTU to Normative

Normative (no DSTU)

Joint Ballot (with other SDOs or HL7 Work Groups)

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

 

 

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

  1. Project Logistics

6.a. External Project Collaboration

Participating in the S&I Framework eLTSS initiative.  Content defined in this IG could be used in collaboration with that project.

For projects that have some of their content already developed:

How much content for this project is already developed?

>95%

Was the content externally developed (Y/N)? 

Yes

Date of external content review by the ARB?

Approval date CCYY-MM-DD

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

Yes

No

6.b. Realm

Universal

    Realm Specific

 

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

 

US

 

6.c. Project Approval Dates

Affiliate/US Realm Task Force Approval Date
(for US Realm Specific Projects)

USRTF Approval Date 2015-09-01

Sponsoring Work Group Approval Date

WG Approval Date 2015-08-20

Steering Division Approval Date 

SD Approval Date CCYY-MM-DD [LN1]

PBS Metrics and Work Group Health Reviewed ? (required for SD Approval)

Yes

No

FHIR Project: FHIR Management Group Approval Date

FMG Approval Date CCYY-MM-DD [LN2]

 

Technical Steering Committee Approval Date

TSC Approval Date CCYY-MM-DD [LN3]

TSC has received a Copyright/Distribution Agreement (which contains the verbiage outlined within the SOU), signed by both parties.

Yes

No

6.d. 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 (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

 

Individuals who want to share their care goals, preferences, and priorities for medical treatments with their Care Team so that their wishes can be considered in the development of their care plan, Care Team members, Skilled Nursing Facilities, Assisted Care Facilities, Care Plan developers in general.

6.e. Synchronization With Other SDOs / Profilers

Check all SDO / Profilers which your project deliverable(s) are associated with.

ASC X12

CHA

LOINC

AHIP

DICOM

NCPDP

ASTM

GS1

NAACCR

BioPharma Association (SAFE)

IEEE

Object Management Group (OMG)

CEN/TC 251

IHE

The Health Story Project

CHCF

IHTSDO

WEDI

CLSI

ISO

Other (specify below)

- Similarities to standards or IGs from the checked SDO/Profilers: Will be aligned with template designs specified in C-CDA R2.1; also aligned with LOINC document ontology and LOINC code system; aligned with mission statement of the Health Story Project.

- How they will be different: Author will be the person (recordTarget).

- How overlaps will be coordinated with the checked SDO/Profilers: will use the US Patient Generated Document Header; section template for Advance Directives; Section template for Goals and entry template for Goals. Further constraints may be applied to make the template designs more specific. 

 

 


[LN1] This was 9/28/2015

[LN2] This should be N/A

[LN3] This was 10/14/2015