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1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

1b. Project ID

1655

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

Public Health

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2j. Business Requirements Analyst

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2l. Other Facilitators

2m. Implementers

UC Davis Health

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

Attachments

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

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?

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, RxNorm

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

n/a

4a. Products

FHIR Implementation Guide

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

FHIR R4

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new 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

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?

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6f. Other Stakeholders

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6g. Other Vendors

6h. Providers

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

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Oct 08, 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

7f. FMG Approval Date

Oct 14, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



 Show Changes

Version

6

Modifier

Dave Hamill

Modify Date

Oct 16, 2020 18:45

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

1b. Project ID

1655

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2m. Implementers

UC Davis Health

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, RxNorm

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

n/a

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Oct 08, 2020

7f. FMG Approval Date

Oct 14, 2020

Version

5

Modifier

Sarah Gaunt

Modify Date

Oct 14, 2020 21:17

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2m. Implementers

UC Davis Health

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, RxNorm

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

n/a

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Oct 08, 2020

7f. FMG Approval Date

Oct 14, 2020

Version

4

Modifier

Sarah Gaunt

Modify Date

Oct 08, 2020 20:48

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2m. Implementers

UC Davis Health

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, RxNorm

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

n/a

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

3

Modifier

Sarah Gaunt

Modify Date

Oct 08, 2020 17:36

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2m. Implementers

UC Davis Health

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC RxNorm

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

Yes

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

2

Modifier

Sarah Gaunt

Modify Date

Oct 08, 2020 04:11

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2i. Domain Expert Representative

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com) Andrea Benin (aqb4@cdc.gov)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of adverse drug events (ADEs) occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.


3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC RxNorm

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

Yes

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

1

Modifier

Sarah Gaunt

Modify Date

Oct 08, 2020 04:07

1a. Project Name

NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR) (HL7 Implementation Guide for FHIR®R4)

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

Publishing

2d. Project Facilitator

Nadine Shehab (ftn0@cdc.gov, nadine.shehab@lantanagroup.com)

2f. Modeling Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2g. Publishing Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2h. Vocabulary Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

2k. Conformance Facilitator

Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com)

3a. Project Scope

This IG will support electronic submission of adverse drug event (ADE) 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 existing workflows and eliminates duplicate documentation. This project will work with EHR vendors to identify data elements for use in the NHSN ADE surveillance definition.

With feedback from CDC and clinical (including endocrinology and hospital medicine), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs, this project will develop the following IG: HL7 Implementation Guide for FHIR® Release 1: NHSN Adverse Drug Event-Hypoglycemia Report (NHSN-ADE-Hypoglycemia-FHIR)

3b. Project Need

Adverse drug events (ADEs) are among the most common causes of iatrogenic harm in U.S. hospitals. An effort to establish an EHR- and vendor-neutral standard for submitting ADE data to NHSN is being sought to improve patient safety and facilitate quality improvement effort. This promising initiative seeks to enable EHRs of acute care facilities to serve as source systems for reporting ADE data to the National Healthcare Safety Network (NHSN) via industry electronic messages. This initiative leverages NHSN’s longstanding experience working closely with the Health Level Seven (HL7) standards development organization and HL7 consultants in developing and maintaining electronic healthcare-associated and antibiotic use and resistance 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 EHR vendors join forces to advance the field of electronic ADE reporting.

This first module, Hypoglycemia, planned for the NHSN Medication Safety Component, would enable hospitals to track and benchmark inpatient medication-related hypoglycemia (low blood sugar). Inpatient hypoglycemia can be severe and life-threatening and is associated with longer hospital stays and increased medical costs. Severe hypoglycemia (<40 mg/dL) occurs in 2%-5% of hospitalized patients with diabetes mellitus (DM). Medication-related hypoglycemic events are common causes of ADEs occurring in inpatient settings, with rates of severe hypoglycemia varying across hospitals, suggesting opportunities for improvement in the quality of care. Measurement of medication-related hypoglycemia in a meaningful and standardized way may improve glycemic management. The NHSN ADE – Hypoglycemia Module provides a mechanism for facilities to report and analyze medication-related hypoglycemia as part of patient safety and glycemic management quality improvement efforts.

The measures planned for used in this module are based on quality reporting metrics previously- or currently-endorsed by the National Quality Forum (NQF): NQF #2363 Glycemic Control - Hypoglycemia and NQF #3503 Hospital Harm – Severe Hypoglycemia. The metrics reported in this module would be primarily based on linked eMAR (antidiabetic medication administration) and laboratory (blood glucose) data. These long-standing linkages 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.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot (First Ballot Cycle): 2021 May Ballot
Complete STU Reconciliation: 2021 Sept WGM
Project End Date (all objectives have been met): 2024 May WGM

3f. Common Names / Keywords / Aliases:

ADE, NHSN ADE, FHIR ADE, FHIR NHSN ADE

3g. Lineage

n/a

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

Will add page under the Public Health Project Roadmap menu item

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

FHIR

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC RxNorm

4a. Products

FHIR Implementation Guide

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

FHIR R4

5a. Project Intent

Create new standard

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

Yes

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

Yes

6f. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab

6h. Providers

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

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR