Skip to end of metadata
Go to start of metadata




1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

No

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

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Structured Documents

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

CDC/NHSN
Epic

3a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 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 4 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 4 is the inclusion of a new HAI CDA report
• Inclusion of COVID-19 data

Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. 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.

Attachments

3b. 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.

3c. Security Risk

Yes

3d. External Drivers

CDC/NHSN Application Release cycles

3e. Objectives/Deliverables and Target Dates

Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements)

Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements)

TBD: Additional HAI CDA IG STU Releases

TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels)

Sept 2022: CDA R4 Normative Release IG ballot

Dec 2022: Project End Date

3f. Common Names / Keywords / Aliases:

HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG

3g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm

3h. Project Dependencies

HAI CDA IG Release 3 passing Normative ballot and subsequent publication

3i. HL7-Managed Project Document Repository URL:

FHIR: https://github.com/HL7/HAI

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

CDA R2 (and FHIR)

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA)

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

R4

4c. FHIR Profiles Version

R4

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Revise current standard

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

- HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm
- Published: 2020
- Additional (new) reports are being added to the IG
- The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers.

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

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

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency

6f. Other Stakeholders

6g. Vendors

Health Care IT

6g. Other Vendors

6h. Providers

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

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Jun 09, 2020

7a. Management Group(s) to Review PSS

CDA, FHIR

7b. Sponsoring WG Approval Date

Jun 04, 2020

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

Jun 17, 2020

7f. FMG Approval Date

Jun 10, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Jun 23, 2020

7j. TSC Approval Date



 Show Changes

Version

5

Modifier

Austin Kreisler

Modify Date

Jun 23, 2020 17:30

1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

Technical Steering Committee

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

2m. Implementers

CDC/NHSN
Epic

3a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 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 4 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 4 is the inclusion of a new HAI CDA report
• Inclusion of COVID-19 data

Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. 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.

3b. 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.

3c. Security Risk

Yes

3d. External Drivers

CDC/NHSN Application Release cycles

3e. Objectives/Deliverables and Target Dates

Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements)

Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements)

TBD: Additional HAI CDA IG STU Releases

TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels)

Sept 2022: CDA R4 Normative Release IG ballot

Dec 2022: Project End Date

3f. Common Names / Keywords / Aliases:

HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG

3g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm

3h. Project Dependencies

HAI CDA IG Release 3 passing Normative ballot and subsequent publication

3i. HL7-Managed Project Document Repository URL:

FHIR: https://github.com/HL7/HAI

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

CDA R2 (and FHIR)

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA)

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

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

- HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm
- Published: 2020
- Additional (new) reports are being added to the IG
- The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers.

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency

6g. Vendors

Health Care IT

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

CDA, FHIR

7b. Sponsoring WG Approval Date

Jun 04, 2020

7d. US Realm Approval Date

Jun 09, 2020

7e. CDA MG Approval Date

Jun 17, 2020

7f. FMG Approval Date

Jun 10, 2020

7i. Steering Division Approval Date

Jun 23, 2020

Version

4

Modifier

Austin Kreisler

Modify Date

Jun 10, 2020 20:22

1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

Technical Steering Committee

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

2m. Implementers

CDC/NHSN
Epic

3a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 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 4 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 4 is the inclusion of a new HAI CDA report
• Inclusion of COVID-19 data

Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. 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.

3b. 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.

3c. Security Risk

Yes

3d. External Drivers

CDC/NHSN Application Release cycles

3e. Objectives/Deliverables and Target Dates

Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements)

Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements)

TBD: Additional HAI CDA IG STU Releases

TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels)

Sept 2022: CDA R4 Normative Release IG ballot

Dec 2022: Project End Date

3f. Common Names / Keywords / Aliases:

HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG

3g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm

3h. Project Dependencies

HAI CDA IG Release 3 passing Normative ballot and subsequent publication

3i. HL7-Managed Project Document Repository URL:

FHIR: https://github.com/HL7/HAI

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

CDA R2 (and FHIR)

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA)

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

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

- HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm
- Published: 2020
- Additional (new) reports are being added to the IG
- The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers.

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency

6g. Vendors

Health Care IT

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

CDA, FHIR

7b. Sponsoring WG Approval Date

Jun 04, 2020

7d. US Realm Approval Date

Jun 09, 2020

7f. FMG Approval Date

Jun 10, 2020

Version

3

Modifier

Austin Kreisler

Modify Date

Jun 09, 2020 17:24

1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

Technical Steering Committee

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

2m. Implementers

CDC/NHSN
Epic

3a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 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 4 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 4 is the inclusion of a new HAI CDA report
• Inclusion of COVID-19 data

Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. 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.

3b. 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.

3c. Security Risk

Yes

3d. External Drivers

CDC/NHSN Application Release cycles

3e. Objectives/Deliverables and Target Dates

Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements)

Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements)

TBD: Additional HAI CDA IG STU Releases

TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels)

Sept 2022: CDA R4 Normative Release IG ballot

Dec 2022: Project End Date

3f. Common Names / Keywords / Aliases:

HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG

3g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm

3h. Project Dependencies

HAI CDA IG Release 3 passing Normative ballot and subsequent publication

3i. HL7-Managed Project Document Repository URL:

FHIR: https://github.com/HL7/HAI

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

CDA R2 (and FHIR)

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA)

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

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

- HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm
- Published: 2020
- Additional (new) reports are being added to the IG
- The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers.

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency

6g. Vendors

Health Care IT

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

CDA, FHIR

7b. Sponsoring WG Approval Date

Jun 04, 2020

7d. US Realm Approval Date

Jun 09, 2020

Version

2

Modifier

Sarah Gaunt

Modify Date

Jun 08, 2020 07:15

1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

Technical Steering Committee

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

2m. Implementers

CDC/NHSN
Epic

3a. Project Scope

With cooperation from CDC and Healthcare Associated Infections (HAI) software vendors, this project will develop Normative Release 4 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 4 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 4 is the inclusion of a new HAI CDA report
• Inclusion of COVID-19 data

Continue to develop a FHIR Implementation Guide in parallel with the CDA Implementation Guide. 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.

3b. 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.

3c. Security Risk

Yes

3d. External Drivers

CDC/NHSN Application Release cycles

3e. Objectives/Deliverables and Target Dates

Aug 2020: CDA R2 Normative Release 3 IG Publication (publication date depends on COVID-19 requirements)

Sept 2020: CDA R2 Normative Release 4, STU Release 1 IG Ballot (includes COVID-19 requirements)

TBD: Additional HAI CDA IG STU Releases

TBD: Additional FHIR IG Releases (release type depends on used FHIR resource maturity levels)

Sept 2022: CDA R4 Normative Release IG ballot

Dec 2022: Project End Date

3f. Common Names / Keywords / Aliases:

HAI CDA IG, NHSN CDA IG, HAI, HAI FHIR IG

3g. Lineage

HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm

3h. Project Dependencies

HAI CDA IG Release 3 passing Normative ballot and subsequent publication

3i. HL7-Managed Project Document Repository URL:

FHIR: https://github.com/HL7/HAI

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

CDA R2 (and FHIR)

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CD, LOINC, cdcNHSN, RxNorm, Standard Occupational Classification, NUCCProviderCodes, UMLS, CVS, ABC Codabar, ISBT-128, CPT-4

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, V3 Documents – Clinical (e.g. CDA)

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

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

- HL7 Implementation Guide for CDA® Release 2: Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm
- Published: 2020
- Additional (new) reports are being added to the IG
- The new standard would normally be considered a replacement, but Release 3 of the IG is being included in US Federal Regulation and needs to remain available for implementers.

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency

6g. Vendors

Health Care IT

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

CDA, FHIR

7b. Sponsoring WG Approval Date

Jun 04, 2020

Version

1

Modifier

Sarah Gaunt

Modify Date

Jun 08, 2020 07:07

1a. Project Name

HL7 Implementation Guide(s) for CDA® Release 2 & FHIR® Release 4: Healthcare Associated Infection Reports

1b. Project ID

1192

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

Technical Steering Committee

2d. Project Facilitator

Andrea Benin (aqb4@cdc.gov)

2f. Modeling Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com), Austin Kreisler (AUSTIN.J.KREISLER@leidos.com)

2g. Publishing Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2j. Business Requirements Analyst

Ahmed Tahir (tahira@leidos.com)

3j. Backwards Compatibility

No