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

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 Nebraska Medicine (pilot) 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). The expected scope of the profiles to gather the data for ADE reports which may include: 1) ADE population summary questionnaire 2) ADE population summary response 3) ADE single person report questionnaire and 4) ADE single person report response. These protocols are subject to change based on analysis. “This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile we will request approval from US Realm SC, and provide the US Realm approved rationale for deviation in the implementation guide where applicable.” 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: https://github.com/HL7/nhsn-adverse-ig and PHER’s GForge trunck: https://gforge.hl7.org/gf/project/pher/scmsvn/?action=browse&path=%2Ftrunk%2FADE-hypoglycemia%2F 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 CDC and clinical (including endocrinology, hospital medicine, pharmancy), clinical laboratory/point-of-care, quality measurement, patient safety, and HIT SMEs 6b. Content Already Developed 10% 6c. Content externally developed? No 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), Other 6h. Other Providers Nutritionists/nutrition services 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Nov 03, 2020 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 Dec 10, 2020 7j. TSC Approval Date