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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

 

 

HL7 Implementation Guide for CDA® Release 2: National Healthcare Safety Network (NHSN) Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI-LTCF-CDA)

and

HL7 Implementation Guide for FHIR® Release 4: NHSN Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI-LTCF-FHIR)

Project ID:

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: 

 

 

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

 

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

NA

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

 

X

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 : 

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-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.

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.

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Public Health Work Group

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

Co-sponsor Work Group(s)

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

 

  Structured Documents Work Group none

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 WGMs, 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 ( 1 Mandatory )

Jeneita Bell (hqp8@cdc.gov);

Other interested parties and their roles

Clinical Quality Information WG

Multi-disciplinary project team (recommended)

 

Modeling facilitator

Zabrina Gonzaga ( zabrina.gonzaga@lantanagroup.com )

Sarah Gaunt (sarah.gaunt@lantanagroup.com)  

Publishing facilitator

Zabrina Gonzaga ( zabrina.gonzaga@lantanagroup.com )

Sarah Gaunt (sarah.gaunt@lantanagroup.com)  

Vocabulary facilitator

Zabrina Gonzaga ( zabrina.gonzaga@lantanagroup.com )

Sarah Gaunt (sarah.gaunt@lantanagroup.com)  

Domain expert rep

Jeneita Bell (hqp8@cdc.gov); Mindy Durrance ( mdq1@cdc.gov )

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)  MatrixCare

2)  PointClickCare

  1. Project Definition

3.a. Project Scope

With feedback from LTCF Vendors and CDC, this project will develop, in parallel, two setting specific implementation guides (IG):

  • HL7 Implementation Guide for CDA® Release 2: NHSN Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI -LTCF-CDA)
  • HL7 Implementation Guide for FHIR® Release 4: NHSN Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI -LTCF-FHIR)  

These IGs will support electronic submission of HAI data to the National Healthcare Safety Network (NHSN).  The intent of this project is to establish an electronic submission standard that is vendor-neutral that leverages LTCF existing workflows and eliminates duplicate documentation. This project will work with LTCF EHR vendors to identify data elements for use in the NHSN HAI surveillance definition.

3.b. Project Need

The current status of healthcare information technology in LTCFs is both a challenge and an opportunity.  While adoption of EHRs and other electronic systems lags behind the uptake in other settings, the possibilities for public health to partner with technology developers and implementers—and collaboratively influence the design and use of systems as they evolve in the LTCF arena—is in many ways greater than in the acute care sector.  Further, because several leading technology vendors in the LTCF market seek to provide analytics services as well as technology systems, links between public health and vendors can be leveraged in ways that yield benefits for surveillance and prevention that are tightly coupled to business models and growth.  

        Capitalizing on the promise of a public-private sector partnership calls for strategic vision and plans that are actualized by achieving near-term successes with specific projects and deliverables.  One promising initiative is joint development of plans and work products to enable LTCF EHRs to serve as source systems for reporting HAI data to NHSN via industry electronic messages.  NHSN, working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants, has developed and maintained electronic HAI reporting implementation guidance for EHRs and infection surveillance system vendors in the acute care arena. That experience, and the working relationships developed over a 10-year partnership, are an important foundation for a collaborative effort in which NHSN, HL7, HL7 consultants, and LTCFs EHRs vendors join forces to advance the field of electronic HAI reporting in the LTCF sector.

 

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

CDC/NHSN Application Release cycles

3.e. Project Objectives / Deliverables / Target Dates

 

Target Date

Project Scope Statement (PSS) 

2019 Jan

Draft Template Content

2019 February

Notice of Intent to Ballot (NIB)

2019 February

Pre-ballot Review and approval

2019 March

Final Ballot Content submitted for STU Ballot

 

2019 March

Start STU Reconciliation

2019 May WGM

Complete STU Reconciliation

2019 July

Request STU Publication

2019 August

Project End Date (all objectives have been met)

 

2019 September

3.f.    Common Names / Keywords / Aliases

Healthcare Associated Infection (HAI) Report for Long Term Care Facilities (LTCF), LTCF HAI Report, NHSN, laboratory identifiend (LabID) Event, Clostridium difficile infections ( CDI), Multidrug-Resistant Organism’ (MDRO) and Clostridiodes difficlie (C. diff)

3.g. Lineage

NA

3.h. Project Dependencies

None

3.i.    HL7-Managed Project Document Repository Location

 

https://confluence.hl7.org/pages/viewpage.action?pageId=39159811

 

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:

NA

3.k. External Vocabularies

Will this project include/reference external vocabularies?

 

x

Yes

 

 

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies:

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes

  1. 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)

X

FHIR Extensions

 

 

V3 Documents – Administrative (e.g. SPL)

x

FHIR Implementation Guide (enter FHIR product version below)

 

x

V3 Documents – Clinical (e.g. CDA)

X

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? FHIR Release 4

  1. Project Intent (check all that apply)

x

Create new standard

 

 

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)

NA

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)

x

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

 

x

No

 

 

  1. 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 Yes, list developers

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

 

 

 

 

 

 

 

 

Yes

 

 

No

6.b. Realm

 

Universal     - OR -

 

x

Realm Specific

 

 

 

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

 

US  

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

 

Pharmaceutical

 

Clinical and Public Health Laboratories

 

Immunization Registries

x

EHR, PHR

 

Emergency Services

x

Quality Reporting Agencies

 

Equipment

 

Local and State Departments of Health

x

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)

 

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

Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

January 3, 2019

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

January 14, 2019 N/A
 

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

“N/A”

CDA Projects: CDA Management Group

January 9, 2019

FHIR Projects: FHIR Management Group

FMG Approval Date CCYY-MM-DD
or “N/A”
Jan uary 9, 2019

V2/Publishing Projects: V2 Management Group

“N/A”

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

Jan 22, 2019

Affiliate Specific Projects: 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 2019-02-04

Last PBS Metrics Score :

 

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)

“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