EHR System Function and Information Model (EHR-S FIM) Release 2 EHR System Function and Information Model (EHR-S FIM) Release 2.1 HL7 Project ID# 688 Executive Summary for EHR-S FIM Prototype on Results Management Stephen.Hufnagel.ctr@tma.osd.mil , EHR WG Modeling Facilitator Nancy.Orvis@tma.osd.mil , DoD-MHS Proponent May 29, 2012 – Original Working-Draft Jul 5, 2012 – Most Recent Working-Draft Work in Progress Call for Participation This work is being done by the HL7 EHR Interoperability Work-group, meeting every Tuesday at 2 PM ET, dial-in: 1-770-657-9270, Passcode: 510269#  The most current artifacts are at: http://wiki.hl7.org/index.php?title=EHR_Interoperability_WG 11/16/2018

RED: Recommended deletion, Blue: Recommended Insertion CP.5 Manage Results Statement: Manage Present, annotate, and route current and historical test results to appropriate providers for review. Provide the ability to filter and compare results. Description: Results of tests are presented in an easily accessible manner to the appropriate providers. For example, flow sheets, graphs, or other tools allow care providers to view or uncover trends in test data over time. In addition to making results viewable, it is often necessary to send results to appropriate providers using electronic messaging systems, pagers, or other mechanisms. In addition, the system may have the ability to redirect or copy specific test results to a specified individual, according to scope of practice, organizational policy and/or jurisdictional law. Documentation of notification is accommodated. Results may also be routed to patients electronically or by letter. Note: “Results” are understood as applying to any type of test, whether biological or psychological. Manage results may enable the provider to communicate with the patient (see function DC.3.2.3 (Provider-Patient Communication)). There may also be a need to notify public health agencies based on the result. See function DC.2.6.1 (Support for Epidemiological Investigations of Clinical Health Within a Population). Example: (notional scenario based on conformance criteria) Current test results are linked to the original order (if one exists), may be grouped with historical test results and are routed to the requesting provider for review; and, the provider may contact the patient. Patient test results may reported-to or coordinated- with appropriate sources, appropriate clinicians and organizations (e.g., PHRs, schools, registries, public health). 11/16/2018 RED: Recommended deletion, Blue: Recommended Insertion

CP.5.1 Manage Results of Diagnostic Tests Statement: Enable the receipt and display of results for diagnostics tests. Description: Diagnostic test results are received and should be stored and displayed while linked to the original order in the system. Example: (notional scenario based on conformance criteria) Current test results are linked to the original order (if one exists), may be grouped with historical test results and are routed to the requesting provider for review; and, the provider may contact the patient. Patient test results may reported-to or coordinated- with appropriate sources, appropriate clinicians and organizations (e.g., PHRs, schools, registries, public health). RECOMMENDATION: Merge Manage Results and Manage Results of Diagnostic Tests or make Manage Results types correspond with Manage Orders types. 11/16/2018 RED: Recommended deletion, Blue: Recommended Insertion

CP.5 Manage Results EHR-S Components Dependent-on Clinician-Activities NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! ISSUE: Things that happen between order and results generally involve clinical documentation, follow-on orders, … Recommendation: Merge results and Results of Diagnostic Tests 11/16/2018 RED: Recommend deletion, Blue: Recommended Insertion

CP.4 Manage Results Conceptual Information Model (CIM) ISSUE: data associated with Clinical Decision Support (CDS) 11/16/2018 DRAFT WORKING DOCUMENT

CP.5. Manage Results Conformance Criteria (CC) Applicable to this CDM SHALL CCs have bolded borders. RECOMMENDATION: Delete “Results of Diagnostic Test” class 11/16/2018 DRAFT WORKING DOCUMENT

CP.5 Manage Results Conformance Criteria CP.5#01 The system SHALL provide the ability to manage test results in according to scope of practice, organizational policy and/or jurisdictional law. CP.5#02 The system SHALL provide the ability to render numerical and non-numerical current and historical test results. CP.5#03 The system SHALL provide the ability to render results for an identified patient or group of patients. CP.5#04 The system SHALL provide the ability to render results by factors that supports results management including type of test, critical indicator and abnormal indicator. CP.5#05 The system SHALL provide the ability to tag and render normal and abnormal indictors for results based on data provided from the original data source. CP.5#06 The system SHOULD provide the ability to render numerical results in flow sheets, graphical form or other views that allow comparison of results, and display values graphed over time. CP.5#07 The system SHALL provide the ability to render results by date/time range including ordered date/time, specimen collection date/time and results received date/time. CP.5#08 The system SHOULD provide the ability to tag new results received and render to the relevant providers (ordering, copy to) that new results have been received but not reviewed. CP.5#09 The system SHOULD provide the ability to capture an indicator that a result has been rendered and acknowledged by a user. CP.5#10 The system SHOULD provide the ability to transmit results to other care providers. 11/16/2018 DRAFT WORKING DOCUMENT

CP.5 Manage Results Conformance Criteria CP.5#11 The system MAY provide the ability to transmit results to patients by methods such as phone, fax, electronically or letter. CP.5#12 The system MAY provide the ability to transmit results to an automated callback system. CP.5#13 The system MAY provide the ability to capture and transmit a request for action to another provider(s). CP.5#14 The system MAY provide the ability to receive a request for action regarding a result from another provider and capture an acknowledgement of receipt. CP.5#15 The system MAY provide the ability to render results in clinically logical sections (e.g., Pathology, Chemistry). CP.5#16 The system SHALL link results to the electronic order if the system contains the electronic order. CP.5#17 The system SHOULD provide the ability to annotate a result. CP.5#18 The system SHOULD provide the ability to link and render the results report to other data (e.g., images) with which it is associated. CP.5#19 The system SHALL provide the ability to import and receive preliminary and final result reports from ancillary systems according to scope of practice, organizational policy and/or jurisdictional law. CP.5#20 The system SHALL provide the ability to import or receive preliminary and final results as discrete data from ancillary systems according to scope of practice, organizational policy and/or jurisdictional law. 11/16/2018 DRAFT WORKING DOCUMENT

CP.5 Manage Results Conformance Criteria CP.5#21 The system SHALL provide the ability to capture, maintain and render preliminary (e.g., "wet read") and final result reports according to scope of practice, organizational policy and/or jurisdictional law. CP.5#22 The system SHALL provide the ability to tag and render a notification to the appropriate health care team member(s) (using role-based alerts) of clinically-significant results or result changes. CP.5#23 The system SHOULD provide the ability to link results to a specific medical condition, medication or therapeutic class of medication. CP.5#24 The system MAY provide the ability to link with Radiology Information Systems (RIS) or Picture Archiving & Communication Systems (PACS) to enable the presentation of images. CP.5#25 The system SHALL provide the ability to link one or more images to a result report. CP.5#26 IF the system provides the ability to annotate a result, THEN the system SHALL render the annotation with subsequent views of that result. CP.5#27 The system SHOULD provide the ability to capture an annotation from the patient on a result and render the annotation with subsequent views of that result. CP.5#28 The system SHALL provide the ability to tag and render a notification that results are received for a patient no longer actively at the facility. CP.5#29 The system MAY provide the ability to manage results of specific genetic tests, genetic markers, or findings according to scope of practice, organizational policy and/or jurisdictional law and subject to patient's preferences and consent. 11/16/2018 DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT CP.5.1 Manage Results of Diagnostic Tests Conformance Criteria (CC) Applicable to this CDM CP.5.1#01 The system SHOULD provide the ability to capture, maintain and render diagnostic results, including preliminary as well as final results. CP.5.1#02 The system SHOULD provide the ability to capture, maintain and render microorganism information/descriptions from laboratory results as free-text. CP.5.1#03 The system SHOULD provide the ability to capture, maintain and render microbiology laboratory results (with sensitivity testing) using standard coding methodology according to scope of practice, organizational policy and/or jurisdictional law. CP.5.1#04 The system SHOULD provide the ability to capture, maintain and render laboratory results that identify new and emerging laboratory procedures (e.g., processes that examine emerging organisms, new processes that examine existing organisms). CP.5.1#05 The system SHALL provide the ability to capture, maintain and render discrete diagnostic results received through an electronic interface. CP.5.1#06 The system SHALL provide the ability to render indicators of normal and abnormal diagnostic results based on information provided from the original source (e.g., from a laboratory or radiology department). NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! 11/16/2018 DRAFT WORKING DOCUMENT

EHR-S FIM Action Verb Hierarches Manage (Data) Capture Maintain Render Exchange Determine Manage- Data- Visibility Auto-Populate Enter Import Receive Store Update Remove Extract Present Transmit Export Analyze Decide De-Identify Hide Mask Re-Identify Unhide Unmask Archive Backup Decrypt Encrypt Recover Restore Save Annotate Attest Edit Harmonize Integrate Link Tag Delete Purge 11/16/2018 NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! DRAFT WORKING DOCUMENT

Event Conformance Criteria (CC) Applicable to this CDM 11/16/2018 RED: Recommended deletion, Blue: Recommended Insertion

DRAFT WORKING DOCUMENT Dependencies R1.1 / R2.0 DC.2.4.3 / CPS.5 - Support for Result Interpretation S.2.2.1 / CPS.9.3 - Health Record Output S.3.7.1 / CPS.3.9 - Clinical Decision Support System Guidelines Updates IN.1.6 / TI.1.6 - Secure Data Exchange IN.1.7 / TI.1.7 - Secure Data Routing IN.2.4 / RI.1.1.13 - Extraction of Health Record Information IN.2.5.1 / ??? - Manage Unstructured Health Record Information IN.2.5.2 / ??? - Manage Structured Health Record Information IN.6 / TI.6 - Business Rules Management 11/16/2018 DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT Dependencies 11/16/2018 DRAFT WORKING DOCUMENT

BACKUP Project Overview Slides 11/16/2018 DRAFT WORKING DOCUMENT

EHR System Function and Information Model EHR-S FIM Vision The EHR-S FIM vision is that analysts, engineers or testers can efficiently compose and refine the architecture-and-workflow agnostic EHR-S FIM into interoperability-specifications, which meet their system acquisition, implementation or test needs. NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! 11/16/2018 DRAFT WORKING DOCUMENT

EHR-S FM Release 2.0 Contents Overarching (O) – 2 major subsections Care Provision (CP) - 9 major subsections Care Provision Support (CPS) – 9 major subsections Population Health Support (POP) – 10 major subsections Administrative Support (AS) – 9 major subsections Record Infrastructure (RI) – 3 major subsections Trust Infrastructure (TI) – 9 major subsections EHR-S FM R2 ballot package can be downloaded at: http://wiki.hl7.org/index.php?title=December_2011_Ballot_Package NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! 11/16/2018 DRAFT WORKING DOCUMENT

PART 1: Executive Summary For EHR-S FIM Release 2.1, this prototype has the purpose to Add conceptual information and data models for each EHR-S function make the EHR-S FM easier to use for analysts and engineers verify and validate EHR-S FM Release 2.0 Demonstrate Service Aware Interoperability Framework (SAIF) use Support specific profiles (e.g., DAMs, DIMs, DCMs). The DoD-VA Joint Immunization Capability (JIC), Pharm-Lab-Rad, and than ISO 13940 Continuity-of-Care System-of Concepts-and-Glossary harmonization are proposed as a set of demonstration prototypes of increasing complexity. 11/16/2018 NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! DRAFT WORKING DOCUMENT

DRAFT WORKING DOCUMENT EHR-FIM Model Legend NOTE: EHR-S FIM is NOT intended to imply a specific architecture or workflow! 11/16/2018 DRAFT WORKING DOCUMENT