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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(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

Project ID: 1192

 

x

TSC Notification Informative/STU to Normative          

Date :  3-MAR-2020

Check this box when the project proceeds from Informative to Normative or STU 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-Project Name and Scope, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3g-Project Objective, 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)

Structured Documents

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

Co-sponsor Work Group(s)

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

 

n/a

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 )

Dan Pollock  (dap1@cdc.gov)

Other interested parties and their roles

 

Multi-disciplinary project team (recommended)

 

Modeling facilitator

Sarah Gaunt ( sarah.gaunt@lantanagroup.com )

Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

Publishing facilitator

Sarah Gaunt ( sarah.gaunt@lantanagroup.com )

Vocabulary facilitator

Sarah Gaunt ( sarah.gaunt@lantanagroup.com )

Domain expert rep

 

Business requirement analyst

Mindy Durrance (mdq1@cdc.gov )

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)  CDC/NHSN

2)  Epic

  1. Project Definition

3.a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 3 of the HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection Reports. The implementation guide will continue to support electronic submission of HAI data to the National Healthcare Safety Network.

 

It is the intent of this project to incrementally move to Release 3 of the IG via a series of new DSTU releases, each with incremental changes in scope over time as well as the planned introduction of at least one new HAI Report. Potential incremental changes include but are not limited to:

  • Addition or deletion of data elements for existing HAI reports
  • Further alignment of existing HAI IG templates with C-CDA templates

 

One likely major change for Normative Release 3 is the inclusion of a new HAI CDA report

  • Hemovigilance Denominator Report

 

Develop a FHIR Implementation Guide (a new standard) in parallel with the CDA Implementation Guide starting with the May 2018 Ballot Cycle. This new standard will include several STU releases on the path to a Normative Release 1 of the HL7 Implementation Guide for FHIR Release 4: Healthcare Associated Infection Reports. This PSS likely will not see a Normative release of the FHIR IG. The FHIR and CDA implementation guides will be aligned (i.e. if there is a change made in one product, that change will need to be made in the other product). The approach will primarily use the Questionnaire and QuestionnaireResponse resources (note: these resources will not go normative in FHIR R4), though other resources will be used as needed.

 

CDC is providing NHSN developers, vocabulary experts and CDA experts to support this project. SDWG will devote committee time to review the design and draft specification before ballot, as well as to support ballot reconciliation.

3.b. Project Need

The CDC’s National Healthcare Safety Network (NHSN) is being used by the Centers for Medicare and Medicaid Services and 30 states plus the District of Columbia as the technical infrastructure by which they obtain healthcare-associated infection and quality measure data. Currently, more than 12,000 facilities are reporting data into NHSN.   This project revises existing reports and adds new ones to collect data that are relevant to CDC’s surveillance plan.

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

CDA R3 DSTU-1 IG ballot (completed)

Sept 2015 ballot cycle (actual date)

CDA R3 DSTU-1 IG published (completed)

Feb 2016 (actual date)

CDA R3 STU-2 IG ballot (completed)

May 2017 ballot cycle (actual date)

CDA R3 STU-2 IG published (completed)

Sept 2017 (actual date)

CDA R3 STU-3 IG ballot (completed)

May 2018 ballot cycle

FHIR R1 STU-1 IG ballot (completed)

May 2018 ballot cycle

CDA R3 STU-3 IG published (completed)

October 2018

FHIR R1 STU-1 IG published (completed)

October 2018

CDA R3 STU-4 IG ballot (completed)

May 2019 ballot cycle

FHIR R1 STU-2 IG ballot (completed)

May 2019 ballot cycle

FHIR R1 STU-2 IG published (completed)

Sept 2019

FHIR R1 STU-2 IG published (completed)

~Sept 2019

CDA R3 Normative Release 3 IG ballot

May 2020 ballot cycle

CDA R3 Normative Release 3 IG published

Sept 2020

 

 

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.

2021 May WGM

3.f.    Common Names / Keywords / Aliases

HAI CDA IG, NHSN CDA IG  

3.g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 2 – US Realm

3.h. Project Dependencies

HAI CDA IG Release 2 passing Normative ballot and subsequent publication (this has already happened)

3.i.    Project Document Repository Location

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

3.j.    Backwards Compatibility

Are the items being produced by this project backward compatible?

 

 

Yes

 

x

No

 

 

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

 

x

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

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

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, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

  1. Products (check all that apply)

 

Arden Syntax

 

 

V2 Messages – Administrative

 

Clinical Context Object Workgroup (CCOW)

 

 

V2 Messages - Clinical

 

Domain Analysis Model (DAM)

 

 

V2 Messages - Departmental

 

Electronic Health Record (EHR) Functional Profile

 

 

V2 Messages – Infrastructure

x

FHIR Extensions

 

 

V3 Domain Information Model (DIM / DMIM)

x

FHIR Implementation Guide

 

 

V3 Documents – Administrative (e.g. SPL)

x

FHIR Profiles

 

x

V3 Documents – Clinical (e.g. CDA)

 

FHIR Resources

 

 

V3 Documents - Knowledge

 

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

 

 

V3 Foundation – RIM

 

Logical Model

 

 

V3 Foundation – Vocab Domains & Value Sets

 

New/Modified/HL7 Policy/Procedure/Process

 

 

V3 Messages - Administrative

 

New Product Definition (please define below)

 

 

V3 Messages - Clinical

 

New Product Family (please define below)

 

 

V3 Messages - Departmental

 

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

 

 

V3 Messages - Infrastructure

 

White Paper

 

 

V3 Rules - GELLO

 

 

 

 

V3 Services – Java Services (ITS Work Group)

 

Creating/Using a tool not listed in the HL7 Tool Inventory

 

 

V3 Services – Web Services (SOA)

 

  1. Project Intent (check all that apply)

 

Create new standard

 

 

Supplement to a current standard

x

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;

 

Withdraw an Informative Document

 

 

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)

-         HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 2 – US Realm

-         Published: 2015

-         Additional (new) reports are being added to the IG

-         The new standard would normally be considered a replacement, but Release 2 of the IG is being included in US Federal Regulation and needs to remain available for implementers .

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)

 

 

 

 

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

 

U.S.

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

 

EHR, PHR

 

Emergency Services

x

Quality Reporting Agencies

 

Equipment

x

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

 

 

 

6.d. Project Approval Dates

Affiliate Approval Date (for Affiliate Specific Projects):

n/a

US Realm Steering Committee Approval Date
(for US Realm Specific Projects):

PSS update approval date: 2018-02-13

Sponsoring Work Group Approval Date:

Original PSS approval date: 2015-07-19

PSS update approval date: 2018-02-08

Co-Sponsor Group Approval Date

(Copy this entire row for each co-sponsor; indicate the specific cosponsor that issued approval)

n/a

FHIR Project: FHIR Management Group Approval Date:

PSS update approval date: 2018-02-07

CDA Management Group Approval Date:

PSS update approval date: 2018-02-09

Architectural Review Board Approval Date:

(required for externally developed content)

n/a

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

Last PBS Metrics Score :

 

Green

 

Yellow

 

Red

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

 

Yes

 

No

Technical Steering Committee Approval Date:

2015-08-19

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

 

 

 

 

 

 

 

 

Yes

 

No

 

N/A