NHSN Inpatient COVID-19 Medication Administration Reports (NHSN-COVID-19-Medication-Administration-FHIR) (HL7 Implementation Guide for FHIR® Release 4)

1a. Project Name NHSN Inpatient Medication COVID-19 Administration Reports (NHSN-COVID-19- Medication-Administration-FHIR) (HL7 Implementation Guide for FHIR® Release 4) 1b. Project ID 1654 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 Pharmacy 2b. Co-Sponsor WG Public Health 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballotRequest periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2c. Co-Sponsor Update Periods Update at each major milestone (e.g. NIB, prior to Connectathon, etc.) 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) 2j. Business Requirements Analyst 2k. Conformance Facilitator Zabrina Gonzaga (zabrina.gonzaga@lantanagroup.com) Sarah Gaunt (sarah.gaunt@lantanagroup.com) 2l. Other Facilitators 2m. Implementers Emory University Hospital 3a. Project Scope This IG will support electronic submission of line-level medication administration 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 that can be used to describe medications administered (name, formulation, route, dose, duration) to hospitalized patients (inpatients) diagnosed with COVID-19 as part of NHSN COVID-19 reporting pathways. Medication administration events would be reported irrespective of whether or not medication administration was linked to an adverse event, refer to clinician-administered events (e.g., nurse giving a patient their medication dose), and only those occurring in inpatient settings; this excludes: emergency department, observation/short stay, inpatient rehabilitation, outpatient surgical centers, and other outpatient (including physician office) settings. With feedback from CDC and pharmacy informatics SMEs, this project will develop the following IG: • HL7 Implementation Guide for FHIR® Release: NHSN Inpatient Medication Administration Reports “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 Medication data are integral to informing the quality, safety, and costs of U.S. healthcare, supporting federal, state, and local public health, and guiding clinical decision-making in patient care. In inpatient workflows, medication administration—as captured by electronic medication administration (eMAR) records—is considered the gold standard for accurately measuring in-hospital medication exposure, including identifying the exact medications patients have received, in what formulations, doses, and for what duration of time. Published data indicate that alternate data sources for medication exposure, such as pharmacy “order” (or billing) data and medication “lists” are inaccurate representations of in-hospital medication exposure. Pharmacy order/billing data are discordant with medication administration data due to variability in when billing events occur relative to actual medication administration (1,2). For example, order/billing can occur upon order entry or upon dispensing, neither of which reflects actual medication administration to the patient. Despite an order/billing event, actual administration to the patient can be held, missed, or discontinued (prior to a discontinuation order reaching the pharmacy). Medication “lists”, such as those generated during medication reconciliation are based on processes that are highly variable across U.S hospitals with regard to their accuracy and comprehensiveness (3). Medication lists can also have a high level of discordance with actual administration of medications (4,5). The need for medication administration information has never been clearer as during the COVID-19 pandemic, where identification of the medications that acutely ill hospitalized patients with COVID-19 had received was integral to understanding clinical management of this new public health threat and directing public health resources, including scarce medications. The continued reliance on the “medication list” resource instead of the “medication administration" resource is a severe limitation in achieving accurate representation of medication exposure in U.S. healthcare data through FHIR resources.     1. Courter JD, Parker SK, Thurm C, Kronman MP, Weissman SJ, Shah SS, Hersh AL, Brogan TV, Patel SJ, Smith MJ, Lee BR, Newland JG, Gerber JS. Accuracy of administrative data for antimicrobial administration in hospitalized children. J Pediatric Infect Dis Soc 2018;7(3):261-63.   2. Schwartz DN, Evans RS, Camins BC, Khan YN, Lloyd JF, Shehab N, Stevenson K. Deriving measures of intensive care unit antimicrobial use from computerized pharmacy data: methods, validation, and overcoming barriers. Infect Control Hosp Epidemiol 2011;32(5):472-80.    3. Pevnick JM, Shane R, Schnipper JL. The problem with medication reconciliation. BMJ Qual Saf 2016; 25(9):726-30. 4. Rose AJ, Fisher SH, Passche-Orlow MK. Beyond medication reconciliation. The correct medication list. JAMA 2017;317(20):2057-8.  5. Gupta A, Yek C, Hendler RS. Phenytoin toxicity. JAMA 2017;317(23):2445-6.  3c. Security Risk No 3d. External Drivers CDC/NHSN Application Release cycles 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: 3g. Lineage n/a 3h. Project Dependencies None 3i. HL7-Managed Project Document Repository URL: Will add pages under on the Pharmacy WG Projects; https://github.com/HL7/nhsn-inpatient-ig 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, LOINC, RxNorm 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products FHIR Implementation Guide 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 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 Pharmacy 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, Payors 6f. Other Stakeholders 6g. Vendors Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems 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 19, 2020 7c. Co-Sponsor Approval Date Oct 22, 2020 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