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


Support for Automated Dispensing Cabinet Updates to HIS floor stock table

Enter the name of the project here: Project name

Project ID: An ID will be assigned by Project Insight

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)       

 02/28/2019

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

 

N/A

 

U.S.

Metric

 

Both

 

Investigative Project (aka PSS-Lite)

Date : 

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)

Copy this table as needed for each co-sponsor

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 periodMonthly, at WGM's, Etc.
?  Other Involvement. Specify details here: Enter other involvement here

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Dennis Tribble

Other interested parties and their roles


Multi-disciplinary project team (recommended)


     Modeling facilitator

Enter a name here (or ask MnM for a Name)

     Publishing facilitator

With the exception of FHIR projects, mandatory if balloting in the same cycle as project submission

     Vocabulary facilitator

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

     Domain expert rep

Enter a name here:

     Business requirement analyst


     Conformance facilitator (for IG projects)


     Other facilitators (SOA, etc)




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


Definition of triggers and content in support of interaction between healthcare information systems (HIS) and automated dispensing cabinet systems (ADC).

Specifically, the HIS maintains a "floor stock" table that permits it to know whether or not a pharmacy dispense will be required for a new or changed medication order. This table maintains a list of the medications that are "floor stock" (that is, stored in an automated dispensing cabinet) on a particular nursing unit, and a list of the patient rooms on that unit. Using this table, the HIS can determine whether the pharmacy needs to dispense medication in response to a new or changed order based on whether or not that medication is already available in one or more automated dispensing cabinets that service that unit.

The list of medications stored is incremented based on a "load" event (placement of a new medication into the cabinet) or an "unload" event (removal of a medication supply from the cabinet). As a result of such events, the ADC system must notify the HIS that its floor stock table must be updated.

Typically, these interactions also provide information on the current inventory of the medication in the cabinet(s) serving a particular nursing unit, and the location(s) within the cabinet(s) where those medications may be loaded. This information permits electronic Medication Administration Records (eMAR) published by the HIS to inform the nurse where medications are located. Messages from the ADC to the HIS may therefore be generated any time the inventory within a cabinet is incremented (refilled, or loaded) or decremented (dispence from cabinet, unload from cabinet).

These activities are distinct from traditional "dispense" activities in that they are not patient-specific (that is, they represent the intent to store medication in cabinets on patient care areas that will be "dispensed" to individual patients from the cabinets as is needed).


3.b. Project Need


Current HL7 transactional systems do not support this interaction use case. The result is that these interactions are maintained in version 2.x HL7 messages using non-standard segments (Z-segments). The result of this implementation is that health systems that either change out HIS products (host conversions) or ADC systems are required to purchase and implement new interfaces at significant costs in both money and time. Standardizing these interactions would remove some, but not all, of the effort associated with such changes.


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


Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project..


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). 

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

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

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

Example: Submit for STU Ballot(First Ballot Cycle)

2018 Jan Ballot

Example: Complete STU Reconciliation

2018 May WGM

Example: Submit for 2nd STU Ballot

2018 May Ballot

Example: Request STU Publication

2018 Sep WGM

Example: STU Period – 12 months

2019 Jan - 2015 Jan

Example: Submit for Normative Ballot

2019 May Ballot

Example: Complete Normative Reconciliation

2019 Sep WGM

Example: Submit Publication Request

2019 Oct

Example: Receive ANSI Approval

2020 Nov

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


3.f.   Common Names / Keywords / Aliases


What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced?  Some examples: C-CDA, LRI, eDOS.  


3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release:

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).

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
HTTP://


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)

X

Yes

?

No

?

Unknown

?

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


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


?

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:Name of the standard
-    Date it was published (or request for publication, or ANSI designation date)Date published ( or request for publication, or ANSI designation date)
-    Rationale for revisionRationale 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.)Relationship between the new standard and the current standard.


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


?

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)












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?


?

Yes

?

No


6. Project Logistics

6.a. External Project Collaboration


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.

For projects that have some of their content already developed:

How much content for this project is already developed?

Indicate % here

Was the content externally developed ? :

Y/N

If Y, list Developers

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

?

Yes

?

No


6.b. Realm


?

Universal 

- OR -

 ?

Realm Specific



?  

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

"U.S" or HL7 Affiliates

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

X  

Health Care IT

 ?  

Medical Imaging Service

?   

Standards Development Organizations (SDOs)

 ?  

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)

X
 
 

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

CCYY-MM-DD

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)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

CCYY-MM-DD or indicate N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

CCYY-MM-DD or indicate N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

CCYY-MM-DD or indicate N/A

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

CCYY-MM-DD or indicate N/A

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

USRSC Approval Date

CCYY-MM-DD or indicate 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 CCYY-MM-DD

CCYY-MM-DD or indicate N/A


Last PBS Metrics Score:

X

 Green

X

 Yellow

X

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

X

 Yes

X

 No


ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

CCYY-MM-DD or indicate N/A

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