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3/26/2015
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Engaging Staff in EHR Implementation and Reducing Risk: Making Your
Laboratory Data SAFER
Megan E. Sawchuk, MT(ASCP)
Health Scientist
CLMA KnowledgeLab 2015 Orlando, FL
March 31, 2015
Center for Surveillance, Epidemiology, and Laboratory Services
Division of Laboratory Programs, Standards and Services
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Clinical Laboratory Improvement Advisory Committee (CLIAC)
Sent letter to HHS Secretary recognizing serious patient safety risks can arise from errors in the order entry, transmission, display and interpretation of laboratory data in electronic health records • 2012 Letter from CLIAC to HHS Secretary regarding Electronic Health
Records
• 2013 Letter from ONC to CLIAC regarding the Committee’s health IT recommendations
Included 4 part recommendation • Include laboratory experts on ONC advisory committees
• Support work on provider usability
• Establish national system for reporting EHR patient safety events
• Create a catalogue of solutions and consider human factors engineering
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LabHIT Team
Vision • Effective communication of laboratory information contributes to
optimized healthcare decision making.
Mission • Advance federal policy, standards development, and certification
of EHRs to ensure the safe and effective use of clinical laboratory information for the benefit of individuals, healthcare providers, researchers, and public health.
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LabHIT Team Left to right: Anne Pollock, MariBeth Gagnon, Megan Sawchuk, Nancy Cornish, Ira Lubin
Right inset: Alexis Carter
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The health system uses EHR data to inform decision making for
individuals, healthcare providers, researchers & public health
Learning Health System
Clinical Decision Support (CDS)
Tools
Health & Health IT Research
CDC Data Capture & World-Class Surveillance Capability
Public Health Interoperability
Clinical Setting Interoperability
Clinical Data Capture
Stage 1 Infrastructure
Stage 2 Information
Exchange
Stage 3 Advanced
Use of Data
Me
anin
gfu
l U
se
Sta
keh
old
ers
Individuals
Public Health
Healthcare Providers
Researchers
EHR LabHIT’s Primary
Focus
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LabHIT Team & Communication in Informatics Vision:
Engagement Forum to Engage and Coordinate
Laboratory Efforts
Laboratorians Participate Early In EHR/HealthIT
Planning
Regulations and Guidelines
Incorporate Lab Input
Interoperability
Support Harmonization (SNOMED® &
LOINC®)
Harmonized Interfaces
Meaningful Comparisons of Lab Information
Usability
Explore Innovative Information
Display
Results Interpreted Correctly
Adverse outcomes reduced
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Laboratory information contributes to optimized healthcare
decision making.
Logic Model
Engagement
Established the LabHIT Team from CDC staff with diverse clinical laboratory expertise
Convened Communication in Informatics Workgroup
• Clinical laboratory science and health IT experts to provide input on the challenges and opportunities associated with the ordering and interpretation of laboratory information in EHR systems
Implemented communication and distribution plans to inform laboratory professionals about relevant health IT and regulatory information
Sign-up for email alerts at http://www.cdc.gov/labhit/index.html
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Engagement
Published paper to illustrate the patient safety concerns related to interoperability issues and display discrepancies in EHR systems, and propose focus areas for action by clinical laboratory professionals and organizations
• http://www.cdc.gov/labhit/labhit_paper.html
Engaged pathologist informaticists on the ONC’s Laboratory Tiger Team which guides direction of health IT policy, standards and certification
Facilitated participation of companies producing EHR, LIS and middleware systems
Provide comments on proposed regulations, guidelines, and requests for information
Support use of the SAFER Guides and Patient Safety Event Reporting http://www.healthit.gov/safer/
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LabHIT Report: Ensuring the Safety and Effectiveness of Laboratory Data in EHRs
Includes
• 3 patient stories describing issues and opportunities with EHRs
• 3 Focus Areas for Action
• Informed by Communication in Informatics Workgroup, recommended by Clinical Laboratory Improvement Advisory Committee (CLIAC)
Announcement in
• May 16, 2014
Download from http://www.cdc.gov/labhit
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LabHIT Report: Ensuring the Safety and Effectiveness of Laboratory Data in EHRs
Engagement: Laboratory professionals can provide laboratory expertise for health IT decision-making in the design, development, and implementation of EHR systems at both national and local levels;
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Data Integrity and Usability: Laboratory professionals can guide and maintain data integrity and usability to ensure that laboratory data are accurately presented in the EHR and available at the point of care; and
Innovation: Laboratory professionals can partner with stakeholders to stimulate innovation in EHR technology and usability to reduce laboratory data-related errors attributed to the use of EHR systems.
3 Focus Areas for Action
“If implemented and used correctly, EHRs have the potential to improve diagnostic test result reporting and follow-up. Initial evaluation of the impact of health IT for test results reporting and follow-up has produced mixed results.”
“Furthermore, initial research finds that laboratory and radiology/imaging systems are frequently associated with EHR-related adverse events. Failure to follow-up appropriately on diagnostic test results can lead to misdiagnosis, patient harm, and liability.”
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-Quotes from SAFER Guide Test Results Reporting and Follow-Up
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Electronic health record–related safety concerns: A cross-sectional survey.
Menon, S., Singh, H., Meyer, A. N. D., Belmont, E. and Sittig, D. F. (2014)
• August - September 2012; 369 respondents
• Survey topic areas included:
– Frequency of EHR-related serious safety events
– Factors affecting EHR-related serious safety events
– Best practices to avoid EHR-related serious safety events
– Tracking of EHR-related safety measurements
EHR-Related Safety Concerns: A Cross-Sectional Survey. J Healthc Risk Manag. 2014
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Frequency of serious safety events in the last 5 years
• 53% admitted to at least one EHR- related serious safety event in the previous five years;
– 10% experienced more than 20 events
EHR-Related Safety Concerns: A Cross-Sectional Survey. J Healthc Risk Manag. 2014 (in press)
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Type and frequency of health IT-related safety events in the past 5 years
Type of safety event Frequently +
Occasionally - %
Data is incomplete, missing or misleading 52
Open or incomplete patient orders 51
Procedures and policies are ineffective 46
Failure to follow up abnormal test results 44
Confusing one patient with another 43
Reliance upon inaccurate or incomplete patient data 39
Intentionally or accidently subverting CDS 34
Automatic discontinuation of a prescription 29
Data aggregation leading to erroneous data reporting 27
Prolonged EHR downtime 20
Errors resulting from implementing legal mandates 17
EHR-Related Safety Concerns: A Cross-Sectional Survey. J Healthc Risk Manag. 2014
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Results of the ECRI Deep Dive ECRI formerly the “Emergency Care Research Institute”
ECRI Institute PSO Deep Dive: Health Information Technology. Plymouth Meeting, PA (2012)
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Safety Assurance Factors for EHR Resilience (SAFER) Guides
The Office of the National Coordinator (ONC) for Health Information Technology released a set of checklists and recommended practices for assessing the safe use of electronic health record (EHR) systems
The SAFER Guides encourage healthcare organizations to assemble multidisciplinary teams to complete the assessments and evaluate potential health IT-related patient safety risks.
9 SAFER Guides with 158 recommended practice elements for assessment.
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8-dimensional Socio-Technical Model of Safe & Effective EHR Use
(Sittig & Singh. Qual Saf Health Care. 2010 Oct;19 Suppl 3:i68-74.)
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• Foundational Guides – High Priority Practices
– Organizational Responsibilities
• Infrastructure Guides – System Configuration
– System Interfaces
– Contingency Planning
• Clinical Process Guides – Patient Identification
– Computerized Provider Order Entry with CDS
– Test Results Reporting and Follow-up
– Clinician Communication
SAFER: Safety Assurance Factors for EHR Resilience
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Methods used to develop guides
• Literature review to identify best practices
• Expert panel meetings
• Stakeholder engagement
• Fieldwork at purposively selected sites
• Cognitive interviews reviewing the guides
• Pilot testing the guides
Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study
protocol. BMC Med Inform Decis Mak. 2013 Apr 12;13:46.
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Safety Assurance Factors for EHR Resilience (SAFER) Guides
Laboratory leaders, LIS experts and other laboratory professionals can proactively engage with organizational leaders and health IT staff to assemble EHR assessment teams by doing the following:
• Watch the 6 minute video, “How to Use the SAFER Guides”.
• Download and review the SAFER Guides.
• Identify the checklist items and useful examples on the worksheets related to laboratory orders, results, and blood product administration.
• Work with your organization’s leadership and health IT staff to assemble an EHR assessment team.
• Perform the assessment.
• Work with EHR vendors to address the identified patient safety risks.
How to get started
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Priority SAFER Guides for Laboratory Data
The following four SAFER Guides are specifically noted for review by the LabHIT Team, however elements in all of the SAFER Guides may have relevance to laboratory testing:
1. Patient Identification (relates to blood product administration, laboratory test ordering, and laboratory results retrieval and display) (14 Recommended Practices)
2. Computerized Provider Order Entry with Clinical Decision Support (29 Recommended Practices)
3. Test Results Reporting and Follow-up (23 Recommended Practices)
4. High Priority Practices (relates to order sets, order status, use of SNOMED and LOINC, interface testing, and decision support recommending or relying on laboratory tests) (18 Priority Practices)
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Options for Resolving Identified Issues
See: http://www.cdc.gov/labhit/ehr_patient_safety_event_reporting.html
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Proposed Health IT Patient Safety Center
FDA
Patient Safety Organization
Health IT Certification Body
Health IT Technology Developer
Organizational IT Staff
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Interoperability LabHIT’s Vision & Goals
Vision • Full-scale EHR interoperability for laboratory data supported by a
set of recommended vocabulary sets with mapping of test systems to code systems.
Goals • Laboratories: Reduce initial and ongoing nomenclature coding
burden.
• Clinicians: Enable meaningful comparisons of data over time for clinical decision support and advanced patient analytics.
• Populations: Enable local, regional and national surveillance and quality monitoring.
• Patients: Enable meaningful comparisons of data over time.
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Health Information Exchange in the Healthcare System
Health Information Exchange in the Healthcare System
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Achieving National Laboratory Data Interoperability
The foundation to building local, regional and national surveillance capability
MESSAGE FORMAT STANDARDS DEVELOPMENT HL7 v2.5.1 and HL7 v3 (aka CDA)
VOCABULARY STANDARDS DEVELOPMENT
LOINC®, SNOMED®, UCUM®
VOCABULARY SETS IDENTIFIED FOR EACH TEST SYSTEM
Partnerships with standards development organizations, government agencies, and manufacturers
TEST SYSTEMS
Commercial Instruments
CLINICAL SETTINGS
EHR & LIS Systems
PUBLIC HEALTH
Local & State LIMS Systems
CDC
Various Health Surveillance Program
IT Systems
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Interoperability
Nomenclature Standards
• LOINC – Test and Analyte Names, e.g. Potassium
oaLOINC Common Laboratory Test Order Codes Initiative Internal CDC LOINC Coordination
• SNOMED – Result codes, e.g. name of microorganisms
oDeveloping specimen coding for laboratory test orders with the APHL/CDC Laboratory Community of Practice (CoP)
• UCUM – Unified Code for Units of Measure (Projects TBD)
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Interoperability
Message Format Standards – HL7
• Ensure CLIA requirements and accrediting organizations’ standards are met
• ONC Laboratory Tiger Team – Provides overarching guidance for other laboratory related S&I Framework activities
• ONC Standards & Interoperability Framework Initiatives to impact policy, standards and certification. Includes workgroups and subworkgroups for:
oLaboratory Order Interface (LOI)
oLaboratory Results Interface (LRI)
oElectronic Directory of Service (eDOS)
oElectronic Laboratory Reporting (ELR) – adhoc to ensure LOI/LRI support ELR
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Interoperability
HL7 Standards
• NIST EHR Certification Tool – Submitted “CLIA Profile” with targeted “round trip” use cases for the EHR certification tool
o“Round trip” use cases for S&I simplification and harmonization
• Genomics standards development
oClinical Grade Variant File Working Group
Laboratory Information Exchange Survey
• Provide guidance to ONC
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Usability
S&I Laboratory Functional Requirements Guide Workgroup
Display - Ex. Is it clear that the report continues on another screen?
Translation - Is the translation accurate and traceable to the source of truth?
Persistence - Is the data correct over time in the record?
Health IT Implementation, Usability and Safety Workgroup Reports to ONC Health IT Policy Committee
http://www.healthit.gov/facas/health-it-policy-committee/hitpc-workgroups/health-it-implementation-usability-and-safety-workgroup
Innovation
Potential exists in the future for laboratory professionals to provide input into the graphical display of laboratory information and innovative technology
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For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop F-11, Atlanta, GA 30333
CLIA Information Line: 1-404-498-2290 TTY: 1-888-232-6348
E-mail: [email protected] Web: http://www.cdc.gov/labhit
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Center for Surveillance, Epidemiology, and Laboratory Services
Division of Laboratory Programs, Standards and Services
Thank you!