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Version

1

Modifier

Lindsey Hoggle

Modify Date

Oct 14, 2019 17:42

1a. Project Name

VANGUARD PSS

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Clinical Quality Information

2b. Co-Sponsor WG

Clinical Information Modeling Initiative

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Stan Huff

2e. Other Interested Parties (and roles)

Nursing Knowledge Big Data Science Initiative

2f. Modeling Facilitator

Richard Esmond

2g. Publishing Facilitator

Richard Esmond

2h. Vocabulary Facilitator

Susan Matney

2i. Domain Expert Representative

Kevin Baskin, James Morrison, Julia Skapik

2j. Business Requirements Analyst

Kevin Baskin

2k. Conformance Facilitator

Richard Esmond

2m. Implementers

PenRad, Cognitive Medical Systems

3a. Project Scope

Work with stakeholders across the spectrum to collaboratively define logical clinical models related to central venous access and relevant to longitudinal patient management. Scope begins at the identification of need for access through venous pathway evaluation, device selection and insertion, use, device and venous pathway salvage with applications for monitoring, safety, and clinical effectiveness. This includes continuing care across device, disease and patient life cycles, device safety and effectiveness evaluation, cost and quality analysis, decision support, and development and communication of relevant standards and guidelines.

Stakeholders will include patients, families and support groups, multidisciplinary clinical experts (clinical providers and researchers), healthcare institutions, industry representatives (catheter manufacturing and health IT), payers, other interested private agencies and government agencies (including FDA, AHRQ, NLM, ONC, CMSS, CDC, NIH, DOD, and VA).

Detailed Clinical Models will be compatible with emerging HL7 interoperability standards. CIMI/CIMPL, FHIR and CQL compatibility are to be the initial priority for implementation. FHIR Profiles, FHIR Extensions and Implementation Guides will be the final deliverable work-products.

The work will be project managed by the VANGUARD registry leads with technical support and direction from a group of highly experienced modeling SMEs (Huff, Esmond, McDonald) who will provide quality assurance, validation and problem solving for content. The primary modeling team will be comprised of clinical domain SMEs who will be trained by a modeling expert on the method of creating models and will use a modeling IG (optimally one reviewed by or generated from HSPC). This team will be comprised of US clinicians from VANGUARD and Australian members from AVATAR (https://www.avatargroup.org.au/).

3b. Project Need

Detailed clinical models and FHIR Profiles are required to support reliable and consistent capture and exchange of interoperable medical records. This content, if coded, could be entered into the US Core Dataset for Interoperability (USCDI) under the 21st Century Cures Act. The use case costs billions of dollars a year in procedures and complications, with central line associated bloodstream infections having a mortality rate of 12-25%. Better tracking and monitoring of these devices could allow prevention and mitigation of risks and costs. Clinical Decision Support, Clinical Quality Metrics, Evidence-based and Precision Medicine all require a standardized specification for computable data-elements (aka Clinical Models). This project will define, review and ballot those required specifications and publish them in all appropriate formats.

3c. Security Risk

No

3d. External Drivers

Submission for review by US Regulatory groups by end of 2020

3e. Objectives/Deliverables and Target Dates

Informative: Jan 2020
STU: May 2020
Normative: Jan 2021

3f. Common Names / Keywords / Aliases:

Central Line Care; Central Venous Access; Vascular Access

3h. Project Dependencies

Clinical Information Modeling Initiative (CIMI), FHIR STU4, Clinical Quality Language (CQL)

3i. HL7-Managed Project Document Repository URL:

VANGUARD

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, NCI

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

v4

5a. Project Intent

Create new standard

5b. Project Ballot Type

Comment (aka Comment-Only)

5d. Joint Copyright

No

6a. External Project Collaboration

Part of public-private partnership Medical Device Epidemiology Network (MDEpiNet)

6b. Content Already Developed

20%

6c. Content externally developed?

No

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems

6h. Providers

Clinical and Public Health Laboratories, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Jun 27, 2019

7c. Co-Sponsor Approval Date

May 23, 2019


1a. Project Name

VANGUARD PSS

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Clinical Interoperability Council

2b. Co-Sponsor WG

Clinical Genomics

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Stan Huff

2e. Other Interested Parties (and roles)

Nursing Knowledge Big Data Science Initiative

2f. Modeling Facilitator

Richard Esmond

2g. Publishing Facilitator

Richard Esmond

2h. Vocabulary Facilitator

Susan Matney

2i. Domain Expert Representative

Kevin Baskin, James Morrison, Julia Skapik

2j. Business Requirements Analyst

Kevin Baskin

2k. Conformance Facilitator

Richard Esmond

2m. Implementers

PenRad, Cognitive Medical Systems

3a. Project Scope

Work with stakeholders across the spectrum to collaboratively define logical clinical models related to central venous access and relevant to longitudinal patient management. Scope begins at the identification of need for access through venous pathway evaluation, device selection and insertion, use, device and venous pathway salvage with applications for monitoring, safety, and clinical effectiveness. This includes continuing care across device, disease and patient life cycles, device safety and effectiveness evaluation, cost and quality analysis, decision support, and development and communication of relevant standards and guidelines.

Stakeholders will include patients, families and support groups, multidisciplinary clinical experts (clinical providers and researchers), healthcare institutions, industry representatives (catheter manufacturing and health IT), payers, other interested private agencies and government agencies (including FDA, AHRQ, NLM, ONC, CMSS, CDC, NIH, DOD, and VA).

Detailed Clinical Models will be compatible with emerging HL7 interoperability standards. CIMI/CIMPL, FHIR and CQL compatibility are to be the initial priority for implementation. FHIR Profiles, FHIR Extensions and Implementation Guides will be the final deliverable work-products.

The work will be project managed by the VANGUARD registry leads with technical support and direction from a group of highly experienced modeling SMEs (Huff, Esmond, McDonald) who will provide quality assurance, validation and problem solving for content. The primary modeling team will be comprised of clinical domain SMEs who will be trained by a modeling expert on the method of creating models and will use a modeling IG (optimally one reviewed by or generated from HSPC). This team will be comprised of US clinicians from VANGUARD and Australian members from AVATAR (https://www.avatargroup.org.au/).

3b. Project Need

Detailed clinical models and FHIR Profiles are required to support reliable and consistent capture and exchange of interoperable medical records. This content, if coded, could be entered into the US Core Dataset for Interoperability (USCDI) under the 21st Century Cures Act. The use case costs billions of dollars a year in procedures and complications, with central line associated bloodstream infections having a mortality rate of 12-25%. Better tracking and monitoring of these devices could allow prevention and mitigation of risks and costs. Clinical Decision Support, Clinical Quality Metrics, Evidence-based and Precision Medicine all require a standardized specification for computable data-elements (aka Clinical Models). This project will define, review and ballot those required specifications and publish them in all appropriate formats.

3c. Security Risk

No

3d. External Drivers

Submission for review by US Regulatory groups by end of 2020

3e. Objectives/Deliverables and Target Dates

Informative: Jan 2020
STU: May 2020
Normative: Jan 2021

3f. Common Names / Keywords / Aliases:

Central Line Care; Central Venous Access; Vascular Access

3h. Project Dependencies

Clinical Information Modeling Initiative (CIMI), FHIR STU4, Clinical Quality Language (CQL)

3i. HL7-Managed Project Document Repository URL:

VANGUARD

3j. Backwards Compatibility

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, NCI

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

v4

5a. Project Intent

Create new standard

5b. Project Ballot Type

Comment (aka Comment-Only)

5d. Joint Copyright

No

6a. External Project Collaboration

Part of public-private partnership Medical Device Epidemiology Network (MDEpiNet)

6b. Content Already Developed

20%

6c. Content externally developed?

No

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems

6h. Providers

Clinical and Public Health Laboratories, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Jun 27, 2019

7c. Co-Sponsor Approval Date

May 23, 2019