4A-2015 April CLMA LabHIT SAFER PPT

3/26/2015

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

3/26/2015

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

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.

4

3/26/2015

3

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

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

6

3/26/2015

4

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

7

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

8

3/26/2015

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

• 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/

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 http://www.cdc.gov/labhit

10

3/26/2015

6

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;

11

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.”

12

-Quotes from SAFER Guide Test Results Reporting and Follow-Up

3/26/2015

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. 2014

13

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)

14

3/26/2015

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. 2014

15

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

3/26/2015

9

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.

17

8-dimensional Socio-Technical Model of Safe & Effective EHR Use

(Sittig & Singh. Qual Saf Health Care. 2010 Oct;19 Suppl 3:i68-74.)

18

3/26/2015

10

• 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

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. 2013 Apr 12;13:46.

20

3/26/2015

11

21

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

22

3/26/2015

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

See: http://www.cdc.gov/labhit/ehr_patient_safety_event_reporting.html

24

Proposed Health IT Patient Safety Center

FDA

Patient Safety Organization

Health IT Certification Body

Health IT Technology Developer

Organizational IT Staff

3/26/2015

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 Information Exchange in the Healthcare System

Health Information Exchange in the Healthcare System

26

3/26/2015

14

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

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

3/26/2015

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

3/26/2015

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

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

31

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!