Ask-At-Order Entry Guidance

1a. Project Name HL7 Cross Paradigm Specification Laboratory Ask at Order Entry (AOE), US Realm 1b. Project ID 1634 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 N/A 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 Orders & Observations 2d. Project Facilitator Freida Hall 2e. Other Interested Parties (and roles) 2f. Modeling Facilitator 2g. Publishing Facilitator Freida Hall 2h. Vocabulary Facilitator 2i. Domain Expert Representative 2j. Business Requirements Analyst 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers 3a. Project Scope This project is based on Appendix A of the ONC Standards & Interoperability (S&I) V2 Implementation Guide last published in 2018 as: HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework (eDOS) Release 2, STU Release 3 (US Realm) HL7 Standard for Trial Use June 2018, also referred to as eDOS (Electronic Directory Of Service). Since the laboratory Ask at Order Entry (AOE) questions are not standard specific, this project extracts Appendix A to produce a stand-alone guidance document for laboratories, EHRs, and Laboratory Information Systems (LIS) implementing laboratory test compendium information for ordering laboratory tests. While this is being initially developed for the US Realm, it could be expanded to the Universal Realm in the future. Attachments 3b. Project Need This specification provides guidance for industry to more effectively implement laboratory Ask at Order Entry questions so the laboratory test order can effectively provide necessary information for the laboratory to conduct the laboratory test and to report to state and federal agencies. Additionally, updates will be made to include AOEs specific to COVID-19 and expand V2 datatype recommendations to include FHIR (R4) datatype recommendations. 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates Initial Draft - January 2021 ballot but will request to reference in the associated September 2020 ballot of FHIR IG for Laboratory Test Catalog (project 1010): https://build.fhir.org/ig/HL7/fhir-order-catalog/index.html Re-ballot May 2021 (if substantive changes) or publish following ballot reconciliation 3f. Common Names / Keywords / Aliases: AOE 3g. Lineage Based on “Appendix A – Ask at Order Entry” last published in HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework (eDOS) Release 2, STU Release 3 (US Realm) HL7 Standard for Trial Use June 2018 Also referred to as eDOS (Electronic Directory Of Service) 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/pages/viewpage.action?pageId=76152954 3j. Backwards Compatibility N/A 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies LOINC, SNOMED CT 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products FHIR Implementation Guide, FHIR Profiles, Guidance (e.g. Companion Guide, Cookbook, etc), V2 Messages - Clinical 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 Supplement to a 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 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 Most of the content already developed in conjunction with V2 STU published in 2018, but this version will include new STU comments, COVID-19, and FHIR datatype information. 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders Clinical and Public Health Laboratories, Regulatory Agency, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors EHR, PHR, Health Care IT, Lab, HIS 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories, Local and State Departments of Health 6h. Other Providers 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Jun 23, 2020 7a. Management Group(s) to Review PSS FHIR, V2 7b. Sponsoring WG Approval Date May 07, 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 Jun 24, 2020 7g. V2 MG Approval Date Jun 26, 2020 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Jul 16, 2020 7j. TSC Approval Date Jul 27, 2020