Initiatives of Potential Interest to the Public Health Tiger Team

July 15, 2014

Robert Dieterle

S&I Initiative Portfolio Snapshot:

In production

* Community led initiatives leverage the S&I framework platform with minimal or no ONC funded contractor support.

Pre-Discovery Use Case Harmonization RI, Test & Pilot Evaluation

Active Initiatives

Structured Data Capture

Blue Button Plus

Data Provenance

EU/US eHealth Cooperation

2

Data Access Framework

Clinical Quality Framework

Community-Led* or Other Agency-Led

Inactive or Closed Initiatives

Laboratory Orders Interface

Longitudinal Coordination of Care

Lab Results Interface

Public Health

esMD

Transitions of Care

Direct Project (S&I Archetype)

Health eDecisions

Query Health

Data Segmentation for Privacy

PDMP & HIT Integration

3

S&I Laboratory Initiatives

• Laboratory Reporting Interface (LRI)– Results Reporting

• Laboratory Orders Interface (LOI)– Laboratory Orders

• Laboratory electronic Directory of Services (eDOS)– Electronic Test Compendium

• Laboratory Vocabulary Standards– LOINC Results– LOINC Orders– LOINC lab compendium

• EHR Functional Requirements– Laboratory EHR Functional Model Profile– Laboratory Results Functional Requirements– Laboratory Orders Functional Requirements

• LIS Functional Requirements– LIS Functional Model– Laboratory Orders Functional Requirements– Laboratory Results Functional Requirements

4

Laboratory Workgroup

Laboratory Reporting Tiger Team

Clinical Laboratories

HIT Suppliers

Regulatory and Accreditation Organizations

ProfessionalSocieties

• CLIAC and its member’s professional organizations are represented multiple times (CLIA CDC CAP API)

• At least 6 Pathologists are in regular attendance

Centers for Disease Control and Prevention (CDC) Laboratory Practice Standards Branch

Centers for Medicare and Medicaid Services (CMS) Division of Laboratory Services

College of American Pathologists (CAP)

Office of the National Coordinator (ONC)

Association of Pathology Informatics (API)

College of American Pathologists (CAP)

Cleveland ClinicDuke MedicineEmory University School of MedicineHenry Ford Health SystemLabCorpMassachusetts General HospitalNebraska Methodist HospitalQuest DiagnosticsWeill Cornell Medical College / New York Presbyterian Hospital

Cerner Corporation

Epic

Meditech

Sunquest

5

Participants ONC

– Robert Dieterle (Lead)– John Feikema

API – Dr. Alexis Carter

Emory University– Dr. J. Mark Tuthill

Henry Ford Health System

LabCorp– David Burgess– Don Chase– Cindy Johns

Nebraska Methodist Hospital– Dr. Thomas Williams

Quest Diagnostics– Gregory Lovell– Ken McCaslin– Virginia Sturmfels

Cerner Corporation– Dorthi Blair– Gaby Jewell– Dr. John David Nolen

Epic– Craig Newman

Meditech– Ellen Hawrylciw– Joe Wall

Sunquest Information Systems– Laurecia Dailey-Evans– Megan Schmidt

COLA– Dr. John Daly

CAP– Dr. Victor Brodsky

Weill Cornell Medical College / New York Presbyterian Hospital

– Julie Cantor-Weinberg– Dr. Raj C Dash

Duke Medicine

– Dr. Walter HenricksCleveland Clinic

– Mary Kennedy– Carolyn Knapik

CDC/LPSB– Dr. Nancy Cornish– Dr. Anand Dighe

Massachusetts General Hospital

– MariBeth Gagnon– Anne Pollock– Megan Sawchuk

CMS/DLS– Daniel Cajigas– Karen Dyer

6

Workgroup Goals

InitialReduce the time and cost to implement and verify (e.g. visual verification) laboratory result reporting interfaces, in the ambulatory environment, while maintaining the accuracy, completeness and usability of laboratory test result information viewed by the authorized person for safe and effective interpretation.

Execution PhaseProvide recommendations regarding the following subject areas to achieve the overall goal– Standards

• Use of and changes to Implementation Guides for Laboratory Reporting Interface (LRI), Laboratory Orders Interface (LOI) and electronic Directory of Services (eDOS)

• EHR Functional Requirements• Use of standard clinical vocabulary for laboratory testing

– Testing and Certification• NIST validation suite use cases and data sets• NIST usability framework • EHR certification requirements

– Policy• Guidance from CMS regarding CLIA• FDA guidance regarding laboratory testing and transfusion software• Accreditation Agencies’ relevant policies• CMS’s Conditions of Participation in regard to authentication of interpretive reports• ONC requirements for EHR certification and CMS requirements for meaningful use

7

Successes

Meaningful Use Stage 2 EHR certification• Test Report definition• CLIA required elements and best practice elements• EHR behaviors for certification

Cancel test behaviors

Reflex and add-on testing definitions and behaviors

Results status and succession

Anatomic Pathology Reporting

Cardinality and Error Handling

8

ExamplesCLIA required elements and best practice elements

• Required 42 CFR 493.1291(c)(1-7)• Best practice additions from CLIA regulations and laboratory best practice

EHR behaviors for certification• Matching to patient /order• Store and/or display required and best practice information, for example:• Patient name• Patient identifiers• Gender / Age• Specimen information

Cancel test behaviors• Provider cancel including lab status indicators• Lab cancel• Appropriate cancel transactions and notifications

Reflex and add-on testing definitions and behaviors• Provider add-on• Reflex testing as defined by agreement between lab and provider• Includes Microbiology use case

9

Preliminary Recommendations

Standards• Reliable delivery of test results (Delivery Notification)• Support PDFs for complex reports• Support for Laboratory Validation Transactions (TBD)• Recommendations regarding Test Report display usability• Recommendation regarding the use of clinical

vocabularies such as LOINC, SNOMED and UCUM

Testable Behaviors (Required and Best Practice)• Consuming reported data• Displaying information in the Test Report• Saving information required for validation

of EHR behaviors

EHR Certification and Testing• Use cases and test data to validate support

for all common data types, limits and common usability problems

• Focus on the “Test Report”

Policy• CLIA guidance to ensure that laboratories that adhere to

the recommendations and use the new procedures satisfy CLIA EHR interface validation requirements

10

LOINC Orders Effort

Goal:

To create a standard LOINC definition for 90 % (by volume)of ambulatory test orders

Participants ONC•S&I Workgroup•Open to all stakeholders

• Input to LOI / eDoS Initiative

CDC•Provides workgroup leadership

NLM•Provides clinical and standards leadership

•Provides analytical support

Regenstrief Institute•Supports LOINC•Provides expertise in establishing new LOINC codes

CHCF•Provides funding for data collection

•Part of ongoing support of laboratory standardization initiatives

11

LOINC Reporting Name Effort

Goal:

To create a standard LOINC names for ordering and reporting (long and short name)

Participants ONC• Leadership•Work with policy issues•EHR Certification

CDC•Provides expertise to

consolidate industry examples and support overall effort

NLM•Provides clinical and

standards leadership•Provides analytical

support

Regenstrief Institute• Supports LOINC•Provides expertise in

establishing new LOINC name

LOINC_NUM COMPONENT SHORTNAME LONG_COMMON_NAME7655-4 Ambrosia bidentata Ab.IgE Southern Ragweed IgE Qn Southern Ragweed IgE Ab [Units/volume] in Serum15980-6 Ambrosia bidentata Ab.IgE.RAST class Southern Ragweed IgE RAST Ql Southern Ragweed IgE Ab RAST class in Serum

32731-2 Beta 2 globulin Beta2 Glob SerPl Elph-mCnc Beta 2 globulin [Mass/volume] in Serum or Plasma by Electrophoresis32735-3 Beta 2 globulin Beta2 Glob 24h Ur Elph-mRate Beta 2 globulin [Mass/time] in 24 hour Urine by Electrophoresis32739-5 Beta 2 globulin Beta2 Glob Fld Elph-mCnc Beta 2 globulin [Mass/volume] in Body fluid by Electrophoresis54354-6 Beta 2 globulin Beta2 Glob Ur Elph-mCnc Beta 2 globulin [Mass/volume] in Urine by Electrophoresis55915-3 Beta 2 globulin Beta2 Glob CSF Elph-mCnc Beta 2 globulin [Mass/volume] in Cerebral spinal fluid by Electrophoresis

o Create a LAB functional and behavioral requirements Implementation guide for EHR technology

o Initial focus is “Incorporate” Lab Resultso Compatible with the HL7 Laboratory Result Interface

(LRI) implementation guideo Bridge/Harmonize with HL7 EHR Functional Modelo Develop a generic conformance framework for

specifying “incorporate” requirementso In the end – 3 Documents

EHR Functional Model Lab Results Incorporate Profile Lab Results Incorporate Functional and Behavioral

Requirements IG• Specific the LRI messaging requirements

Conformance framework for Incorporate

EHR Functional Requirements

Problem Statement: MU-2 Criterion

• Patient Safety• Common expectations for handling Lab Results• Consistent implementations for handling Lab Results

• Regulatory Requirements• CLIA – general requirements (need more specificity)

• Lack of Specificity of MU Requirements• Transmit Laboratory Results OK

• LRI IG provides detailed requirements• Used by LIS (and EHRs with LIS module) for sending lab result messages to ambulatory EHR

technology• Receive Laboratory Results OK

• LRI IG provides detailed requirements• Used by ambulatory EHR technology for receiving lab result messages from LIS (or EHRs with LIS

module)• Incorporate Laboratory Results NOT OK

• LRI IG provides no guidance (not that it should, it is an interface specification)• MU-2 Criterion: “Incorporate Lab Results” – What does that mean?• Needed by ambulatory EHR technology for determining what to do with the data elements in the

lab result messages received from LIS (or EHRs with LIS module)

Incorporate Lab Results – What does it mean?

• HL7, S&I Framework, and NIST collaborate to produce the conformance framework• Community subject matter experts determine the laboratory result-specific

requirements• The combination of the conformance framework and requirements = Functional

and Behavioral Requirements (defining capabilities, such as Incorporate Lab Results)

HL7 GCIT, EHR, & OO WG

NIST S&I Framework

Requirements

Community SMEs

Functional and Behavioral

Requirements

Conformance Framework

EHR FunctionalModel

Lab Profile

High-Level

Very Specific

(Applicable to other domains)

Lab Results Interface (LRI) IG

Incorporate Lab Results

• Incorporating lab results involves Storing data elements that were received in the LRI message (elements in scope)

• Stored data elements are associated (linked) with a patient record• Stored data elements may be combined (linked) together in the EHR system to provide

capabilities such as– Clinical Decision Support– A Public Health Report sent by an EHR system– A Laboratory Results Report display

Store Associate Use Patient Record

Lab Results

AssociateLink/combine specific data

elements received in LRI message

Incorporate

Lab Results

Order

Provider

A B 2

1

Test Framework – Incorporate Data

esMD

• Author of Record -- Digital Signatures for:– Transactions– Bundles of documents– HL7 CDA

• Electronic Determination of Coverage (eDoC)– Standards for communication of medical records for

• Prior-authorization• Pre-payment review• Post payment Audit

– Use of structured and coded elements for specific user stories• Power Mobility Devices• Lower Limb Prosthetics

17

18

Structured Data Capture

Charter/Scope SummaryIdentify the functional and technical specifications to enable an EHR system to retrieve, display, and fill a structured form or template, and store/submit the completed form to an external repository.

Technical Work Streams (focused on the four guidance areas: • Data Element Structure, Form/Template Structure• EHR-Interaction, and Auto-population of Forms)• SDC SOAP/SAML IG (complete – balloting)• SDC FHIR Profile IG (in progress)

Content Work Streams (to identify domain-specific data elements, form templates and pilots)• Patient Safety Event/Adverse Event (PSE/AE) • Patient-Centered Outcomes Research (PCOR)• Public Health Tiger Team (Led by CDC/ONC; across CQF, SDC and DAF Initiatives) 3 use cases identified

(cancer reporting, early detection and case reporting); • Prior-authorization / e-clinical templates (within the esMD pilots)

Two Implementation Guides • SDC SOAP/SAML IG (Complete - Balloting)

Consensus-approved SOAP/SAML IG published on 3/18/14• SDC FHIR Profile IG (Under Development)

Scope is to create implementation guidance on the use of FHIR Profile(s) for SDC on new Data Element and existing Questionnaire/Questionnaire Answers resources.

Will be balloted through HL7 as Comment-Only in Sep 2014; DSTU in Jan 2015 (aligned with HL7 FHIR Resources publication)

19

20

Data Provenance

Charter/Scope SummaryThe Data Provenance Initiative aims to establish a standardized way of capturing (including inbound, system generated, and outbound provenance), retaining, and exchanging the unaltered provenance of health information.

Goals :– Establish guidance for handling data provenance in the content standards including the level to

which provenance could be applied– Establish the minimum set of provenance data elements and vocabulary bindings– Standardize the provenance capabilities

Tiger TeamNotice for Intent to Ballot approved on 6/30/2014 (HL7) for ballot during the September 2014 HL7 Ballot Cycle– Community Based Collaborative Care (CBCC) WG approved on 4/29/2014- HL7 Co-Sponsor– Structured Docs (SDC) WG approved 06/19/2014 – HL7 Co-Sponsor– US Realm Task force approved 4/29/2014– Domain Experts Steering Division (DESD) approved 5/28/2014

21

Conclusion

• Multiple Initiatives of interest to the Public Health Tiger Team– The Laboratory Effort at ONC/S&I/HL7

• Orders, Results, Compendium• EHR Functional Requirements• LOINC results, orders, names

– Laboratory Workgroup• Provided guidance for MU2/3 EHR certification• Provided guidance for standards, certification and policy

– esMD• Digital Signatures• CDA templates

– SDC• Ability to gather information based on templates external to an EHR

– Data Provenance• Source and history of data