Clinical Quality Workgroup

Health IT Standards CommitteeFebruary 21, 2014

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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.

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Agenda

• 9:00 a.m. Call to Order/Roll Call– 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– Marjorie Rallins, co-chair– Floyd Eisenberg, member

• 10:25 a.m. Public Comment• 10:30 a.m. Adjourn

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Health eDecisions: Standards Update and Future Directions

Kensaku Kawamoto, MD, PhDInitiative Coordinator, Health eDecisions

Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center

Aziz Boxwala, MD, PhDPresident, Meliorix, Inc.

Bryn RhodesVeracity Solutions

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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

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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.

Ref. Kawamoto K et al. Open Medical Informatics Journal. 2010, 4:235-44. 6

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

DSTU Published

VMR Logical Model R2 UML data model for CDS Informative PublishedDSTU Pending

VMR Templates R1 Terminology bindings and other constraints

Informative PublishedDSTU Pending

VMR XML Specification R1 XML schema for CDS input and output

Informative PublishedDSTU Pending

Decision Support Service R2 CDS Web service framework

DSTU Published

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vMR Logical Modelclass encounter

EncounterEv ent

+ encounterEventTime :IVL_TS

ScheduledAppointment

+ appointmentTime :IVL_TS [0..1]

AppointmentRequest

+ frequency :Schedule [0..1]+ requestedAppointmentTime :IVL_TS [0..1]+ requestIssuanceTime :IVL_TS [0..1]+ urgency :CD [0..1]

AppointmentProposal

+ frequency :Schedule [0..1]+ proposedAppointmentTime :IVL_TS [0..1]+ urgency :CD [0..1]

EncounterBase

+ encounterType :CD [0..1]

ClinicalStatement

+ attribute :CodedNameValuePair [0..*]+ comment :Documentation [0..*]+ dataSourceType :CD [0..1]+ documentationTime :IVL_TS [0..1]+ evaluatedPersonId :II [0..1]+ id :II [0..1]+ templateId :CodedIdentifier [0..*]

MissedAppointment

+ appointmentTime :IVL_TS

Example vMR Template andXML Format

Example:<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>

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Use Case 1 Overview

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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

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External Data Example

<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>

Addressing the curly braces issue using HeD expression language and the VMR

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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> <operand xsi:type="Or"> <!-- Necessary clinical conditions --> <operand xsi:type="ExpressionRef" name="HasActivePertussisProblems"/> <operand xsi:type="ExpressionRef" name="DeathWasCausedByPertussis"/> <operand xsi:type="ExpressionRef" name="HasPositivePertussisCulture"/> </operand> </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>

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Use Case 2 Overview

CDS Guidance Requestor

CDS Guidance(care guidance)

CDS Guidance Supplier

CDS Request (patient data)

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Sample CDS Guidance Services

Evaluation Input Evaluation Output

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

Patient age, gender, past health maintenance procedures

List of health maintenance procedures due or almost due

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Pilots – HeD Use Case 1

EHR Pilot Content SupplierDesign Clinicals

Order Set – Heart Failure

Zynx Health

Allscripts Rule – NQF 068 (Million Hearts)

newMentor

Allscripts Rule – San Diego Pertussis

CDC

VA Documentation Template – UTI

Wolters Kluwer Health

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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

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• 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

Other Projects

Measure RationaleCMS117v2: 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.

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• 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

Harmonization of CDS and Measures

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Backup Slide:Order Set Exchange Pilot

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Backup Slide:WKH Doc. Template in VA CPRS

© 2013, Kensaku Kawamoto 22

Thank You!

Questions/Discussion amongst workgroup

Kensaku Kawamoto, MD, PhDkensaku.kawamoto@utah.edu

Aziz Boxwala, MD, PhDaziz.boxwala@meliorix.com

Bryn Rhodesbryn@veracitysolutions.com

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Technical Authority for the Unified Clinical Quality Improvement Framework (Tacoma)

OverviewMarc Hadley, MITRE

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Tacoma Focus Areas

1. QDM Transition and Evolution– Assume stewardship of the QDM

2. eCQM Testing Tools– Bonnie tool for eCQM test driven development

3. CDS/eCQM Standards Harmonization– Unify clinical decision support (CDS) and electronic clinical quality

measure (eCQM) standards for use with Electronic Health Record (EHR) systems

4. eCQM Consultation and Review– Support and QA for measure developers

5. eCQM Governance and Communication– Create and support a governance and communication framework for

quality measurement and improvement

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Timeline of Key Events

• 2014– 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.html26

1. QDM Transition and Evolution

• 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

Assume stewardship of the Quality Data Model

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Standards Harmonization

• 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

Unify CQM and CDS stovepipes to produce a single integrated

CQI data model and expression language

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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– Modularization

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• 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

New Standards & Interoperability Initiative

Coming

Soon!

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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

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Standards Harmonization Timeline

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Thank You!

• Questions/Discussion amongst workgroup

Kaizen EventWashington, February 10-14, 2014

Marjorie RallinsDanny RosenthalFloyd Eisenberg

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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.

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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:

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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:

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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:

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Group 4: Logic Harmonization

• Scope Start: Need for logic harmonization• Scope End: Logic harmonized• In Scope:

– All Types of Measures

• Out of Scope:

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Group 5: EHR Certification

• Scope Start: Change to certification requirement• Scope End: Vendor is certified• In Scope:• Out of Scope:

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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:

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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:

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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:

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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

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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

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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)

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Wrap-Up

• Final discussion/questions amongst workgroup• Public Comment• Adjourn

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