Engaging Staff in EHR Implementation and Reducing Risk: Making Your Laboratory Data SAFER

Transcription

1 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 2 1

2 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 3 Vision LabHIT Team 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. 4 2

3 Meaningful Use Stakeholders 3/26/2015 LabHIT Team Left to right: Anne Pollock, MariBeth Gagnon, Megan Sawchuk, Nancy Cornish, Ira Lubin Right inset: Alexis Carter 5 The health system uses EHR data to inform decision making for individuals, healthcare providers, researchers & public health Stage 3 Advanced Use of Data Learning Health System Clinical Decision Support (CDS) Tools Individuals Healthcare Providers Stage 2 Information Exchange Health & Health IT Research CDC Data Capture & World-Class Surveillance Capability Researchers Public Health Stage 1 Infrastructure Public Health Interoperability Clinical Setting Interoperability Clinical Data Capture EHR LabHIT s Primary Focus 6 3

4 LabHIT Team & Communication in Informatics Vision: Laboratory information contributes to optimized healthcare decision making. Logic Model 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 7 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 alerts at 8 4

5 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 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 9 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

6 LabHIT Report: Ensuring the Safety and Effectiveness of Laboratory Data in EHRs 3 Focus Areas for Action 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; 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. 11 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. -Quotes from SAFER Guide Test Results Reporting and Follow-Up 12 6

7 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 Frequency of serious safety events in the last 5 years 53% admitted to at least one EHRrelated 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 (in press) 14 7

8 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 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) 16 8

9 Safety Assurance Factors for EHR Resilience (SAFER) Guides The Office of the National 9 SAFER Guides with 158 Coordinator (ONC) for Health recommended practice elements Information Technology released a for assessment. 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 ITrelated patient safety risks dimensional Socio-Technical Model of Safe & Effective EHR Use (Sittig & Singh. Qual Saf Health Care Oct;19 Suppl 3:i68-74.) 18 9

10 SAFER: Safety Assurance Factors for EHR Resilience 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 19 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 Apr 12;13:

11 Safety Assurance Factors for EHR Resilience (SAFER) Guides 21 How to get started 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

12 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) 23 Options for Resolving Identified Issues Organizational IT Staff Health IT Technology Developer Health IT Certification Body Patient Safety Organization FDA Proposed Health IT Patient Safety Center See:

13 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. 25 Health Health Information Information Exchange Exchange in in the the Healthcare Healthcare System System 26 13

14 Achieving National Laboratory Data Interoperability The foundation to building local, regional and national surveillance capability TEST SYSTEMS Commercial Instruments CLINICAL SETTINGS EHR & LIS Systems PUBLIC HEALTH Local & State LIMS Systems CDC Various Health Surveillance Program IT Systems VOCABULARY SETS IDENTIFIED FOR EACH TEST SYSTEM Partnerships with standards development organizations, government agencies, and manufacturers VOCABULARY STANDARDS DEVELOPMENT LOINC, SNOMED, UCUM MESSAGE FORMAT STANDARDS DEVELOPMENT HL7 v2.5.1 and HL7 v3 (aka CDA) 27 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) 28 14

15 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 29 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 30 15

16 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 Innovation Potential exists in the future for laboratory professionals to provide input into the graphical display of laboratory information and innovative technology 31 Thank you! For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Mailstop F-11, Atlanta, GA CLIA Information Line: TTY: msawchuk@cdc.gov Web: 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 16