Clinical Quality Workgroup Health IT Standards Committee February 21, 2014

Call To Order Call To Order/Roll Call Update on Workplan Michelle Consolazio, Office of the National Coordinator Meeting Objective: Provide information and updates to the Workgroup on HeD standards, the Technical Authority for the Unified Clinical Quality Improvement Framework (Tacoma) project, and the Quality Kaizen event held in DC last week.

Agenda 9:00 a.m. Call to Order/Roll Call 9:05 a.m. Review of Agenda Michelle Consolazio, Office of the National Coordinator 9:05 a.m. Review of Agenda Marjorie Rallins, co-chair Danny Rosenthal, co-chair 9:10 a.m. Presentation and Discussion with Workgroup on Health eDecision (HeD): Standards Update and Future Directions Ken Kawamoto, MD, PhD, Initiative Coordinator, Health eDecisions, Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center Aziz Boxwala, MD, PhD, President, Meliorix, Inc. Bryn Rhode, Veracity Solutions 9:35 a.m. Presentation and Discussion with Workgroup on Technical Authority for the Unified Clinical Quality Improvement Framework (Tacoma) project and standards harmonization activities Marc Hadley, MITRE, Software Systems Architect 10:00 a.m. Kaizen Overview and Report Out Floyd Eisenberg, member 10:25 a.m. Public Comment 10:30 a.m. Adjourn

Health eDecisions: Standards Update and Future Directions Kensaku Kawamoto, MD, PhD Initiative Coordinator, Health eDecisions Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center Aziz Boxwala, MD, PhD President, Meliorix, Inc. Bryn Rhodes Veracity Solutions

HeD Scope Use Case 1: standard format for sharing CDS knowledge artifacts Rules, order sets and documentation templates Goal: CDS knowledge authored in standard format can be imported and used in any EHR system Use Case 2: standard interface for accessing CDS Web services Goal: CDS capability encapsulated using standard interface can be integrated with any EHR system SCT 14May

Prior Work Analyzed Standard, universal format for CDS knowledge HL7 Arden Syntax, HL7 GELLO, HL7 Order Sets, ASTM GEM, GLIF3, CDS Consortium L3 model, SAGE, Asbru, PROforma, PRODIGY, AHRQ eRecommendations, etc. Standard interface for submitting patient data and obtaining patient-specific care guidance HL7 Decision Support Service, IHE Request for Clinical Guidance, OpenCDS, CDS Consortium ECRS, SEBASTIAN, etc. Standard information models HL7 Virtual Medical Record, C-CDA, QRDA, various HL7 V3 models, FHIM, FHIR, etc. All of these options but still not a universal adoption Ref. Kawamoto K et al. Open Medical Informatics Journal. 2010, 4:235-44. SCT 14May

Standards Overview Specification Description Status Knowledge Artifact IG R1 (use case 1) CDS artifact schema (rules, order sets, documentation templates) DSTU Published Decision Support Service IG R1 (use case 2) IG for CDS Web services for US Realm VMR Logical Model R2 UML data model for CDS Informative Published DSTU Pending VMR Templates R1 Terminology bindings and other constraints VMR XML Specification R1 XML schema for CDS input and output Decision Support Service R2 CDS Web service framework SCT 14May

vMR Logical Model

Example vMR Template and XML Format <clinicalStatement xsi:type="vmr:Problem"> <templateId root="2.16.840.1.113883.3.1829.11.7.2.5“ identifierName=“ActiveProblemListEntryCodeOnly”/> <problemCode codeSystem="2.16.840.1.113883.6.96" code="195967001"><displayName value="Asthma"/></problemCode> </clinicalStatement> SCT 14May

Use Case 1 Overview

Knowledge Artifact Schema Schemas defined by composition of components Currently supported CDS interventions Event-condition-action rules Order sets Structured documentation templates In future, can be expanded E.g., Plans of care, infobutton rules/knowledge, relevant data display

External Data Example Addressing the curly braces issue using HeD expression language and the VMR <def name="PertussisProblems"> <expression xsi:type="ClinicalRequest" dataType="vmr:Problem" cardinality="Multiple“ isInitial="true" useValueSets="true" dateProperty="diagnosticEventTime.begin" codeProperty="problemCode" triggerType="DataElementAdded"> <description>Pertussis problem</description> <codes xsi:type="ValueSet" id="2.16.840.1.114222.4.11.7005" version="1"/> </expression> </def>

Conditions Example <condition> <logic xsi:type="And"> <description>(Patient lives in SD or Care encounter was in SD) and (Diagnosed with Pertussis or Cause of Death was Pertussis or culture results positive for pertussis)</description> <operand xsi:type="Or"> <operand xsi:type="ExpressionRef" name="PatientLivesInSDCounty"/> <operand xsi:type="ExpressionRef" name="EncounterWasInSDCounty"/> </operand> <!-- Necessary clinical conditions --> <operand xsi:type="ExpressionRef" name="HasActivePertussisProblems"/> <operand xsi:type="ExpressionRef" name="DeathWasCausedByPertussis"/> <operand xsi:type="ExpressionRef" name="HasPositivePertussisCulture"/> </logic> <conditionRole value="ApplicableScenario"/> </condition>

Communication Action <simpleAction xsi:type="CreateAction"> <actionSentence xsi:type="ObjectExpression" objectType="vmr:CommunicationProposal"> <property name="message"> <value xsi:type="ComplexLiteral"> <value xsi:type="dt:ED" value="This patient has or is suspected of having pertussis. Patients diagnosed with or suspected of having pertussis must be reported to County of San Diego Health and Human Services Agency within one working day of identification or suspicion"/> </value> </property> </actionSentence> </simpleAction>

CDS Guidance Requestor Use Case 2 Overview CDS Guidance Requestor CDS Guidance (care guidance) CDS Guidance Supplier CDS Request (patient data)

Sample CDS Guidance Services Evaluation Input Evaluation Output Patient age, gender, past health maintenance procedures List of health maintenance procedures due or almost due Medication identifier, age, gender, weight, serum creatinine level Recommended maximum and minimum doses for medication given patient's estimated renal function Insurance provider, data relevant to prescription Prior authorization to prescribe medication Patient summary Wide range of care recommendations SCT 14May

Pilots – HeD Use Case 1 EHR Pilot Content Supplier Design Clinicals Order Set – Heart Failure Zynx Health Allscripts Rule – NQF 068 (Million Hearts) newMentor Rule – San Diego Pertussis CDC VA Documentation Template – UTI Wolters Kluwer Health

Current CDS Web Service Implementers OpenCDS (www.opencds.org) Multi-institutional open-source effort led by Univ. of Utah Implements HL7 DSS and vMR; will support HeD UC 2 200+ members from 150+ organizations Example implementation: Immunization Calculation Engine (ICE), led by HLN Consulting, & used by New York City, Alabama, eClinicalWorks Enterprise Clinical Rules Service Part of CDS Consortium effort Epic EHR Will support CDS Guidance Services in 2014 release

Other Projects Representation of measures using HeD Development of eMeasures and CDS artifacts Immunization guidelines (CDSi) HIV, HCV, and Million Hearts measures and related CDS Highlights the need for harmonization Measure Rationale CMS117v2: Childhood Immunization Status Verify that the logic for selecting an arbitrary number of immunization events that each occurred on different days could be expressed. CMS179v2: Warfarin Time in Therapeutic Range Verify that the logic for calculating Medication Duration and Time in Therapeutic Range could be expressed. CMS32v3: Median Time from ED Arrival to ED Departure for Discharged ED Patients Verify that a continuous variable measure, and one based on encounters, could be expressed. CMS64v3: Fasting Low Density Lipoprotein (LDL-C) Test Performed The measure contains multiple variations of the numerator and denominator, as well as multiple stratifying criteria.

Harmonization of CDS and Measures Lessons learned from these activities and specifications are informing the harmonization Harmonization Projects Metadata harmonization Data models harmonization QIDAM = vMR + QDM (+CCDA, HQMF, QRDA) Expression logic harmonization HQMF, HeD, QDM HQMF modularization HeD Knowledge Artifact IG modularization

Backup Slide: Order Set Exchange Pilot

Backup Slide: WKH Doc. Template in VA CPRS © 2013, Kensaku Kawamoto

Thank You! Questions/Discussion amongst workgroup Kensaku Kawamoto, MD, PhD kensaku.kawamoto@utah.edu Aziz Boxwala, MD, PhD aziz.boxwala@meliorix.com Bryn Rhodes bryn@veracitysolutions.com

Technical Authority for the Unified Clinical Quality Improvement Framework (Tacoma) Overview Marc Hadley, MITRE

Tacoma Focus Areas QDM Transition and Evolution eCQM Testing Tools Assume stewardship of the QDM eCQM Testing Tools Bonnie tool for eCQM test driven development CDS/eCQM Standards Harmonization Unify clinical decision support (CDS) and electronic clinical quality measure (eCQM) standards for use with Electronic Health Record (EHR) systems eCQM Consultation and Review Support and QA for measure developers eCQM Governance and Communication Create and support a governance and communication framework for quality measurement and improvement

2014 2015* 2017* Timeline of Key Events April: EH Clinical Quality Measure annual update June: EP Clinical Quality Measure annual update Fall CMS NPRM for Stage 3 ONC NPRM for the 2017 Edition of the ONC Standards and Certification Criteria Draft MU Stage 3 eCQMs 2015* First half: Final Rule for Stage 3 2017* Begin Stage 3 for providers who have completed at least two years in Stage 2 * Source: http://www.cms.gov/eHealth/ListServ_Stage3Implementation.html

1. QDM Transition and Evolution Assume stewardship of the Quality Data Model Objective Improve the quality and reduce the cost and time to develop eCQMs Assumed responsibility of QDM in January 2014 Near-term Enhancing QDM for Meaningful Use 3 Long-term Replace QDM with unified standards QDM periodic assessment and continuous improvement through user feedback, metrics and performance indicators

Standards Harmonization Unify CQM and CDS stovepipes to produce a single integrated CQI data model and expression language eCQM and CDS standards alignment eClinical Quality Improvement (eCQI) expression language eCQI data model with mapping from QDM and vMR HQMF and HeD standards updates as required Common metadata standard

Status of Standards Work Clinical Quality Common Metadata Conceptual model in ballot reconciliation Clinical Quality Data Model Cross-walked Virtual Medical Record (vMR) and Quality Data Model (QDM) Domain Analysis Model in ballot reconciliation Investigating use of FHIR as basis for logical model, will ballot results in HL7 May ballot cycle (comment only) Clinical Quality Expression Language Functional requirements for unified CQI expression language in ballot reconciliation Investigating applicability of HeD expression language to eCQMs HQMF R2.1 Modularization Higher fidelity identification of episodes of care Composite measure metadata Updates complete, in WG review phase of DSTU update process HeD Knowledge Artifact R1.1

New Standards & Interoperability Initiative Clinical Quality Improvement (CQI) Follow-on to HeD and Query Health S&I initiatives Vision Work closely with HL7 standards work groups (similar model to HeD with joint meetings) Pilot standards with proof-of-concept implementations Provide implementation feedback during development Use for broad input on CQI-related topics Looking for volunteers and participants – stay tuned Coming Soon!

Resource Center Provide a centralized location for the QDM and other critical resources for eCQM and CDS development Definitive location for MU stage 2 and 3 eCQMs Unify the eCQI community and connect related activities Streamline the time and effort to find guidance and provide feedback Links to S&I Framework, JIRA and SITE

Standards Harmonization Timeline

Thank You! Questions/Discussion amongst workgroup

Kaizen Event Washington, February 10-14, 2014 Marjorie Rallins Danny Rosenthal Floyd Eisenberg

Kaizen: February 10-14, 2014 CMS/ONC: Hosts Attendees: contractors Series of 5 since January 2013 Lean – process management philosophy; eliminate waste, variation and duplication. Toyota Principles because of roots in the Toyota production system. Kaizen – event or activities that continually improve all functions, and involves all employees from the CEO to the front line workers.

Group 1: Measure Authoring Tool/Unit Testing Scope Start: Creating a Synthetic Test Record Scope End: Test Completed In Scope: All Types of Measures Out of Scope:

Group 2: VSAC Harmonization Scope Start: Need for a Value Set Scope End: Value Set Created and Harmonized In Scope: All Types of Measures Out of Scope:

Group 3: Measure Updates Scope Start: Need for a Change to a measure Scope End: Changes Implemented In Scope: All Types of Measures Annual Update Out of Scope:

Group 4: Logic Harmonization Scope Start: Need for logic harmonization Scope End: Logic harmonized In Scope: All Types of Measures Out of Scope:

Group 5: EHR Certification Scope Start: Change to certification requirement Scope End: Vendor is certified In Scope: Out of Scope:

Group 7: Data Processing/Re-Use 1 Scope Start: Submission Requirements Created Scope End: Data Processed at CMS In Scope: QRDA 1 & 3 Other Data Sources, Claims, Registries, etc. Feedback Loop Out of Scope:

Data Processing/Re-Use 2 Scope Start: Submission Requirements Created Scope End: Data Processed at CMS In Scope: QRDA 1 & 3 Other Data Sources, Claims, Registries, etc. Feedback Loop Out of Scope:

Group 8: eCQM/CDS Standards and Implementation Scope Start: Change to a Standard Scope End: Standard Implemented In Scope: Clinical Decision Support, Measure Development HQMF, QRDA Out of Scope:

ONC/CMS Measurement Kaizen Findings: Multiple Standards (HL7 Draft Standards for Trial Use – DSTU) Measures Health Quality Measure Format (HQMF) (R2) HQMF Quality Data Model (QDM) Implementation Guide Reporting Quality Report Document Architecture (QRDA) Category 1 (R2) Quality Report Document Architecture (QRDA) Category 3 (R1) Clinical Decision Support Virtual Medical Record for Clinical Decision Support (vMR-CDS), R1 CDS Knowledge Sharing Implementation Guide

ONC/CMS Measurement Kaizen Findings: HL7 and 2 CMS Versions of Implementation Guides: CMS Informative Document: Quality Report Document Architecture (Eligible Providers) http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/Guide_QRDA_2014eCQM.pdf Hospital Quality Reporting (HQR) Quality Reporting Document Architecture Category I Release 2 http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/QRDA_Guide2014_Hospital_CQM.pdf

ONC/CMS Measurement Kaizen Next Steps: Consolidate CMS QRDA implementation guides Provide consistency for standards implementation Coordinate more closely with HL7 standards activities Coordinate HHS-wide strategy for quality-related standards Quality Measurement Clinical Decision Support Identify and and provide one Internet site for all Meaningful Use Program quality artifacts (standards, measures, CDS artifacts)

Wrap-Up Final discussion/questions amongst workgroup Public Comment Adjourn