Initiatives of Potential Interest to
the Public Health Tiger Team
July 15, 2014
Robert Dieterle
S&I Initiative Portfolio Snapshot:
Pre-Discovery
Use Case
Harmonization
Structured Data Capture
Data Access Framework
Active Initiatives
RI, Test & Pilot
Evaluation
In
production
EU/US eHealth Cooperation
Blue Button Plus
PDMP & HIT Integration
Clinical Quality Framework
Data Provenance
Public Health
Community-Led*
or Other AgencyLed
Lab Results Interface
Laboratory Orders Interface
esMD
Longitudinal Coordination of Care
Direct Project (S&I Archetype)
Data Segmentation for Privacy
Inactive or Closed
Initiatives
Transitions of Care
Query Health
Health eDecisions
* Community led initiatives leverage the S&I framework platform with minimal or no ONC funded contractor support.
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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
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Laboratory Workgroup
Regulatory and
Accreditation
Organizations
Professional
Societies
Centers for Disease Control and Prevention
(CDC) Laboratory Practice Standards Branch
Association of Pathology Informatics (API)
Laboratory Reporting
Tiger Team
Centers for Medicare and Medicaid Services
(CMS) Division of Laboratory Services
College of American Pathologists (CAP)
College of American Pathologists (CAP)
Office of the National Coordinator (ONC)
Clinical
Laboratories
•
Cleveland Clinic
Duke Medicine
Emory University School of Medicine
•
HIT Suppliers
CLIAC and its member’s professional
organizations are represented
multiple times (CLIA CDC CAP API)
At least 6 Pathologists are in regular
attendance
Cerner Corporation
Epic
Henry Ford Health System
Meditech
LabCorp
Sunquest
Massachusetts General Hospital
Nebraska Methodist Hospital
Quest Diagnostics
Weill Cornell Medical College / New York Presbyterian Hospital
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Participants
ONC
CMS/DLS
–
–
CAP
–
Dr. Victor Brodsky
Julie Cantor-Weinberg
Dr. Raj C Dash
Duke Medicine
–
Dr. Walter Henricks
Cleveland Clinic
–
–
Mary Kennedy
Carolyn Knapik
Cerner Corporation
–
CDC/LPSB
–
Dr. J. Mark Tuthill
Henry Ford Health System
LabCorp
–
–
–
David Burgess
Don Chase
Cindy Johns
Nebraska Methodist Hospital
Dr. Thomas Williams
Quest Diagnostics
Dr. Nancy Cornish
Dr. Anand Dighe
Massachusetts General Hospital
–
–
–
Dr. Alexis Carter
Emory University
–
–
–
Daniel Cajigas
Karen Dyer
API
Weill Cornell Medical College /
New York Presbyterian Hospital
–
–
–
–
Robert Dieterle (Lead)
John Feikema
MariBeth Gagnon
Anne Pollock
Megan Sawchuk
–
–
–
Gregory Lovell
Ken McCaslin
Virginia Sturmfels
–
–
–
Dorthi Blair
Gaby Jewell
Dr. John David Nolen
–
Craig Newman
Epic
Meditech
–
–
Ellen Hawrylciw
Joe Wall
Sunquest Information Systems
–
–
Laurecia Dailey-Evans
Megan Schmidt
COLA
–
Dr. John Daly
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Workgroup Goals
Initial
Reduce 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 Phase
Provide recommendations regarding the following subject areas to achieve the overall goal
–
Standards
•
•
•
–
Testing and Certification
•
•
•
–
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
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
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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
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Examples
CLIA 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
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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
Policy
EHR Certification and Testing
• CLIA guidance to ensure that laboratories that adhere to
the recommendations and use the new procedures satisfy
CLIA EHR interface validation requirements
• Use cases and test data to validate support
for all common data types, limits and
common usability problems
• Focus on the “Test Report”
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LOINC Orders Effort
Goal:
To create a
standard
LOINC
definition for
90 % (by
volume)
of ambulatory
test orders
Participants
ONC
CDC
NLM
•S&I Workgroup
•Open to all
stakeholders
•Input to LOI /
eDoS Initiative
•Provides
workgroup
leadership
•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
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LOINC Reporting Name Effort
Goal:
To create a
standard
LOINC names
for ordering
and reporting
(long and
short name)
Participants
ONC
CDC
NLM
Regenstrief Institute
•Leadership
•Work with policy issues
•EHR Certification
•Provides expertise to
consolidate industry
examples and support
overall effort
•Provides clinical and
standards leadership
•Provides analytical
support
•Supports LOINC
•Provides expertise in
establishing new LOINC
name
LOINC_NUM COMPONENT
SHORTNAME
LONG_COMMON_NAME
7655-4
Ambrosia bidentata Ab.IgE
Southern Ragweed IgE Qn
Southern Ragweed IgE Ab [Units/volume] in Serum
15980-6
Ambrosia bidentata Ab.IgE.RAST class Southern Ragweed IgE RAST Ql Southern Ragweed IgE Ab RAST class in Serum
32731-2
32735-3
32739-5
54354-6
55915-3
Beta 2 globulin
Beta 2 globulin
Beta 2 globulin
Beta 2 globulin
Beta 2 globulin
Beta2 Glob SerPl Elph-mCnc
Beta2 Glob 24h Ur Elph-mRate
Beta2 Glob Fld Elph-mCnc
Beta2 Glob Ur Elph-mCnc
Beta2 Glob CSF Elph-mCnc
Beta 2 globulin [Mass/volume] in Serum or Plasma by Electrophoresis
Beta 2 globulin [Mass/time] in 24 hour Urine by Electrophoresis
Beta 2 globulin [Mass/volume] in Body fluid by Electrophoresis
Beta 2 globulin [Mass/volume] in Urine by Electrophoresis
Beta 2 globulin [Mass/volume] in Cerebral spinal fluid by Electrophoresis
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EHR Functional Requirements
o Create a LAB functional and behavioral requirements
Implementation guide for EHR technology
o Initial focus is “Incorporate” Lab Results
o Compatible with the HL7 Laboratory Result Interface (LRI)
implementation guide
o Bridge/Harmonize with HL7 EHR Functional Model
o Develop a generic conformance framework for specifying
“incorporate” requirements
o 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
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
Conformance
Framework
(Applicable to other domains)
Lab Results Interface
(LRI) IG
Community SMEs
Requirements
High-Level
EHR Functional
Model
Lab Profile
Functional and
Behavioral
Requirements
Very Specific
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
1
A
Store
Lab Results
Order
2
B
Associate
Use
Patient
Record
Incorporate
Link/combine specific data
elements received in LRI
message
Lab
Results
Associate
Provider
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
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Structured Data Capture
Charter/Scope Summary
Identify 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)
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Data Provenance
Charter/Scope Summary
The 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 Team
Notice 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
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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
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