Pharmacy
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Warning:

Do not launch ANY of the links while your are in create or edit mode. There is a good chance all of your work will be gone.


Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Standardized Medication Profile

Project ID: 1529

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:  Submission date

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

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 : 2019-Feb-13

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. 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 for Investigative Project. 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.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Pharmacy

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

Co-sponsor Work Group(s):

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

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 (1Mandatory)

Jean Duteau (HL7), Margaret Welker (NCPDP)

Other interested parties and their roles

Clinical Decision Support - an update prior to ballot.

Clinical Interoperability Council - an update prior to ballot.

Clinical Quality Information - an update prior to ballot.

Multi-disciplinary project team (recommended)


     Modeling facilitator


     Publishing facilitator

Jean Duteau

     Vocabulary facilitator

Enter a name here (or ask Vocab for a name):

     Domain expert rep

     Business requirement analyst


     Conformance facilitator (for IG projects)


     Other facilitators (SOA, etc)

Margaret Weiker, NCPDP Liaison



Implementers (2Mandatory 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) 

3. Project Definition

3.a. Project Scope

Create a white paper that will identify and define the components of an interoperable medication profile. Harmonizing NCPDP and HL7 standards and projects related to the medication related information pertinent to Post-Acute Care settings.

3.b. Project Need

IMPACT Act requires an interoperable medication profile to address

“(E) Accurately communicating the existence of and providing for the transfer of health information and care preferences of an individual to the individual, family caregiver of the individual, and providers of services furnishing items and services to the individual, when the individual transitions— ‘‘(i) from a hospital or critical access hospital to another applicable setting, including a PAC provider or the home of the individual; or ‘‘(ii) from a PAC provider to another applicable setting, including a different PAC provider, a hospital, a critical access hospital, or the home of the individual.”

Per the Draft Specifications for the Medication Profile Transferred Measures for Skilled Nursing Facilities, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, and Home Health Agencies document from CMS:

“…a Medication Profile is seen as a comprehensive summary of information for the current prescribed and over the counter (OTC) medications, nutritional supplements, vitamins, and homeopathic and herbal products administered by any route to the patient/resident. Medications also include total parenteral nutrition (TPN) and oxygen. A medication profile also includes information about the patient/resident that is relevant to the medications.”

Since NCPDP and HL7 are both Standards Development Organizations that focus on pharmacy information, this project will evaluate commonalities and identify gaps between the NCPDP SCRIPT Standard, the HL7 FHIR Pharmacy Resources, and the HL7 Pharmacy CDA Template where it concerns conveying a Medication Profile.

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

None

3.e. Project Objectives / Deliverables / Target Dates

Medication Profile White Paper Ballot

2020 January Ballot

Medication Profile White Paper Reconciliation

2020 January WGM

Medication Profile Published

2020 February

Project End Date

2020 March

3.f.   Common Names / Keywords / Aliases

Medication Profile White Paper, Medication List, MAR

3.g. Lineage

N/A

3.h. Project Dependencies

N/A

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).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept. 
https://confluence.hl7.org/display/PHAR/Documents


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

No

X

Unknown

N/A

If Yes, please enter the vocabularies:


4. 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)


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

X

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)

If you checked New Product Definition or New Product Family, please define below:


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



5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

Revise current standard (see text box below)


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


X

Balloted Informative OR

Non-balloted WG White Paper


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











If revising a current standard, indicate the following:


-    Name of the standard being revised:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)


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


Comment (aka Comment-Only)


Joint Ballot (with other SDOs)

X

Informative


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

STU to Normative     - OR -

Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



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?


X

Yes

No

We believe that the joint copyright is covered by the Statement of Understanding between NCPDP and HL7.   PMO confirmed that this is correct.

6. Project Logistics

6.a. External Project Collaboration


NCPDP

For projects that have some of their content already developed:

How much content for this project is already developed?

0%

Was the content externally developed ? :

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

Enter “U.S.” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here. 

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project. Note: This status is subject to change during the investigative process.



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

 X
 

Pharmaceutical

  

Clinical and Public Health Laboratories

  

Immunization Registries

X
  

EHR, PHR

  

Emergency Services

  

Quality Reporting Agencies

  

Equipment

  

Local and State Departments of Health

  

Regulatory Agency

  

Health Care IT

  

Medical Imaging Service

X
  

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

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

WG Approval Date

2019-04-08

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


List each Co-Sponsor and their Approval Date

N/A

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

N/A

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

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

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 CCYY-MM-DD

2019-04-22

Last PBS Metrics Score:

 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)

ARB Approval Date

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

2019-04-29