Transcript Health IT Safety Webinar Series

RTI International
Health IT Safety Webinar Series
The Role for the EHR in Patient Safety
- What does the Evidence Tell Us?
December 18, 2014
1:00-2:30pm EST
RTI International is a trade name of Research Triangle Institute.
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www.rti.org
RTI International
Housekeeping

For any technical questions, please type your question
into the Questions or Chat panels at lower right.
 All telephone lines are muted. Due to the number of
attendees, please use the Questions panel to ask any
questions during the webinar.
 Q&A will take place at the end of each presentation.
Slides and a copy of the recording of this session will be
posted in early January at: www.healthitsafety.org
 For general questions about the webinar series, please
contact [email protected]
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RTI International
Health IT Safety Webinar Series
This series of 10 webinars focused on health IT and patient
safety issues will occur monthly through September 2015.
These webinars are funded by the Office of the National
Coordinator for Health Information Technology (ONC) and
are being conducted by RTI International, a non-profit
research organization, as part of a year-long project to
develop a Road map for a Health IT Safety Center for the
ONC (contract HHSP23320095651WC).
Additional information is available at:
www.healthitsafety.org
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RTI International
Ways We Learn About HIT Safety
Safety reports to PSOs
Analyzing adverse event data
Directly observing
Studying patient
users
outcomes
Industry analyses
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Stress tests
RTI International
Today’s Presentations
Health IT’s Effects on Patient Safety
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Bill Marella, MBA
Program Director, Pennsylvania Patient Safety
Authority
Mr. Marella is Director, Patient Safety Reporting Programs for ECRI Institute and serves as the Program
Director for the Pennsylvania Patient Safety Reporting System (PA-PSRS), a statewide adverse event
and near miss reporting system, under contract to the Patient Safety Authority. He oversees the
program’s operations and its’ principal output, the Pennsylvania Patient Safety Advisory. His articles have
appeared in the Advisory, as well as the Journal of Patient Safety, the Joint Commission Journal of
Quality and Patient Safety, Medicare Patient Management, Patient Safety and Healthcare Quality, and
others.
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Health IT’s Effects on Patient
Safety
William M. Marella, MBA
Program Director, Patient Safety Authority
Muhammad Zia Hydari, Ph.D.
Carnegie Mellon University
Rahul Telang, Ph.D.
Carnegie Mellon University
7/18/2015
© 2014 Pennsylvania Patient Safety Authority
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About PSA
• State agency created in 2002
• Mission: Reduce medical errors by identifying
problems and implementing solutions that
promote patient safety
• Non-regulatory agency governed by
independent board
• Mandatory statewide surveillance system for
patient safety (2.25 million reports)
• Methods: Educate, Analyze, Collaborate
7/18/2015
© 2014 Pennsylvania Patient Safety Authority
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What kinds of HIT-related events
are reported?
• Lab results not transmitted to EHR
• Drug order entered into wrong patient’s chart
• Progress note copied & pasted into another
patient’s chart with incorrect data
• EHR system failure/unavailability
• Wrong drug selected from pick list in CPOE
• Duplicate patient records
Sparnon E, Marella WM. The Role of the Electronic Health Record in Patient Safety Events. PA Patient Saf Avis 2012 Dec;9(4):113-21.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9(4)/Pages/113.aspx
7/18/2015
© 2014 Pennsylvania Patient Safety Authority
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Early findings
• At least as many problems at the humancomputer interface or on the human side of the
equation as are attributable to hardware or
software
• Persistence of problems from paper
• Importance of user-centered design & robust
clinical decision support
• Health IT as a double-edged sword: challenges and
solutions
Default values
0.25 mg/mL
0.5 mg/mL
0.75 mg/mL
1.0 mg/mL
1.25 mg/mL
1.5 mg/mL
1.75 mg/mL
Saving Patient Ryan
• Research question: What is the net effect
of advanced EMRs on patient safety?
• Population: 163 acute care hospitals in
Pennsylvania
• Study period: 2005-12
• Advanced EMR: CPOE and/or physician
documentation
Hydari Z, Telang R, Marella WM. Saving Patient Ryan: Can Hospital IT Make Patient Care Safer? Evidence from
Pennsylvania Hospitals. 30 Sep 2014. Available on SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2503702
Data
Source
Description
Patient Safety Events
PSA
All patient safety events for 2005-2012 in
Pennsylvania Hospitals
EMR Adoption
HIMSS
Adoption of Basic EMR (CDR, CDSS) and Advanced
EMR (CPOE, Physician Documentation) and nonClinical IT for 2005-2012
Hospital Controls
PHC4,
AHA,
CMS
In-patient days, teaching status, residency program
status, JCAHO, medical school affiliation, transferadjusted case mix index
County Controls
AHRF
Population; percent white; percent over 65;
unemployment, household income
Methods
• Econometrics, difference-in-differences approach
•
•
Analyzes within-hospital variation in EMR adoption and safety
event reports
Fixed effects model controls for hospital reporting culture
• Unit of analysis: hospital-year
• Time-varying controls
•
Inpatient days, case mix index
• Time-invariant controls
•
•
County: population, household income, pop aged >65
Hospital: teaching, residency status, medical school affiliation, Joint
Commission accreditation
Difference in Differences Explained
E2
Treatment effect
Outcome
Expected difference
E1
C2
Observed difference
C1
T0
T1
Time
EMR Adoption in PA Hospitals
Advanced EMR
• CPOE and/or
• Physician
Documentation
(Dranove 2012)
Dranove, David, Christopher Forman, Avi Goldfarb, and Shane Greenstein. 2012. “The Trillion Dollar Conundrum: Complementarities and Health Information Technology.” Unpublished manuscript, last
modified February 20, 2013. http://www.nber.org/papers/w18281.
Safety Event Reports in PA Hospitals
240
1050
1000
Events per Hospital
220
200
950
900
180
850
Year
Events (across all hospitals in thousands)
Events per Hospital
2012
2010
2008
2006
800
2004
160
1.1
1
1.05
.95
Average [all] Event Measure
27% decline in all
(aggregated) events
• 30% decline in
medication errors
• 25% decline in
complications
•
.9
• Advanced EMR
leads to:
1.15
Results
-4
-3
-2
-1
0
1
Time To Adoption
2
3
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Robustness Checks
• Falsification test: Can non-clinical IT adoption
explain the change in safety reports?
• Reverse causality: Can lagged safety reports
predict AEMR adoption?
• Spurious correlation: AEMR adoption’s effect on
skin integrity reports
• Additional controls: transfer-adjusted case mix
index, electronic interface to PA-PSRS
Limitations
•
•
•
•
PSA reports not equal to safety events
HIMSS database incomplete (about 50% coverage)
All EHRs are not the same (“treatment” non-equivalence)
Even the “same” EHRs are not the same (differences in
implementation, adoption, intensity of use)
• Couldn’t identify adequate instrumental variable to reduce
risk of selection bias
• Data are observational, retrospective (best available
evidence mindset)
Implications
• These data suggest Advanced EHRs are a net safety
benefit
• These results are in the aggregate (YMMV)
• Unexpected problems are occurring and should be
identified and addressed
• Clinicians’ concerns about usability are genuine
and valid
• Implementation is never over
• Next phase: optimization
Resources
•
•
•
•
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Hydari Z, Telang R, Marella WM. Saving Patient Ryan: Can Hospital IT Make Patient Care Safer?
Evidence from Pennsylvania Hospitals. 30 Sep 2014. Available on SSRN:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2503702
Ash J, Singh H, Sittig DF. SAFER Guides. Jan 2014. http://www.healthit.gov/safer/
Sparnon E, Marella WM. The Role of the Electronic Health Record in Patient Safety Events. PA
Patient Saf Avis 2012 Dec;9(4):113-21.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9(4)/Pages/113.
aspx
Sparnon E. Spotlight on Electronic Health Record Errors: Paper or Electronic Hybrid Workflows.
PA Patient Saf Avis 2013 Jun;10(2):55-8.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2013/Jun;10(2)/Pages/55.a
spx
ECRI Institute. Risk Managers’ 10 Strategies for IT Success. 2013.
https://www.ecri.org/EmailResources/PSRQ/RMRep0613-HIT.pdf
ECRI Institute. Electronic Health Records. Healthcare Risk Control. 2011.
https://www.ecri.org/Products/patientsafety_quality_risk/Documents/MedRec1_1.pdf
AHLA. Minimizing EHR-related Serious Safety Events. 2012.
http://www.healthlawyers.org/hlresources/PI/InfoSeries/Pages/MinimizingEHRSSE.aspx
National Institute of Standards and Technology (NIST). Technical Evaluation, Testing and
Validation of the Usability of Electronic Health Records. 2012. http://www.nist.gov/manuscriptpublication-search.cfm?pub_id=909701
S.S. Jones, R. Koppel, M.S. Ridgely, T.E. Palen, S. Wu, and M.I. Harrison. Guide to Reducing
Unintended Consequences of Electronic Health Records Prepared by RAND Corporation under
Contract No. HHSA290200600017I, Task Order #5. AHRQ. 2011.
http://www.healthit.gov/unintended-consequences/
Questions?
Contact Info:
William M. Marella, MBA
Program Director, Patient Safety Authority
Tel 610-825-6000 x5173
Fax 610-567-1114
Email [email protected]
7/18/2015
© 2013 Pennsylvania Patient Safety Authority
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RTI International
Today’s Presentation
Investigations of Health IT-related Deaths, Serious
Injuries, or Unsafe Conditions
– Gerry Castro PhD, MPH
– Project Director, Patient Safety Initiatives, The
Joint Commission
Gerard M. Castro, PhD, MPH is the Project Director for Patient Safety Initiatives in the Office of
Patient Safety at The Joint Commission. In this role, he has primary responsibility for the Joint
Commission sentinel event database, and manages the coordination, reporting and tracking of
sentinel events, complaints, and other patient-safety initiatives in the Division of Healthcare
Improvement. Dr. Castro is the Principal Investigator for the Office of the National Coordinator for
Health IT project “Investigations of Health IT-related Deaths, Serious Injuries or Unsafe Conditions.”
He administers the Patient Safety Advisory Group (PSAG) which advises The Joint Commission on
high priority and emerging patient safety issues. He is also a member of the NQF Common Formats
and HIT Patient Safety and Expert Panels as well as the HTSI Coalition of Organizations for Reporting
Adverse Events (CORE) Committee.
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“Investigations of Health IT-related
Deaths, Serious Injuries, or Unsafe
Conditions”
Gerry Castro, PhD, MPH
Project Director, Patient Safety Initiatives
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© Copyright, The Joint Commission
ONC HIT Safety Webinar Series
December 18, 2014
Acknowledgement
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© Copyright, The Joint Commission
Office of the National Coordinator for
Health Information Technology,
Contract No: HHSP233201300019C
Provide an overview of the sentinel
event reporting process and data
limitations
Describe the analysis process
Share the analysis results
Describe the themes from learning
visits
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© Copyright, The Joint Commission
Objectives
Reviewable Sentinel Event – Definition
OR
Source: The Joint Commission. Sentinel event policy and procedures.
http://www.jointcommission.org/Sentinel_Event_Policy_and_Procedures/. Updated 2014.
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A reviewable sentinel event is defined
as an event that has resulted in an
unanticipated death or major
permanent loss of function, not related
to the natural course of the patient’s
illness or underlying condition.
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 Suicide of any patient receiving care, treatment and services in a staffed
around-the-clock care setting or within 72 hours of discharge;
 Unanticipated death of a full-term infant;
 Abduction of any patient receiving care, treatment, and services;
 Discharge of an infant to the wrong family;
 Rape, assault (leading to death or permanent loss of function), or
homicide of any patient receiving care, treatment, and services
 Rape, assault (leading to death or permanent loss of function), or
homicide of a staff member, licensed independent practitioner, visitor, or
vendor while on site at the health care organization
 Hemolytic transfusion reaction involving administration of blood or blood
products having major blood group incompatibilities;
 Invasive procedure, including surgery, on the wrong patient, wrong site,
or wrong procedure;
 Unintended retention of a foreign object in a patient after surgery or
other invasive procedures;
 Severe neonatal hyperbilirubinemia (bilirubin > 30 milligrams/deciliter);
 Prolonged fluoroscopy with cumulative dose >1,500 rads to a single
field or any delivery of radiotherapy to the wrong body region or >25%
above the planned radiotherapy dose.
Reviewable
Sentinel Events
Adverse events
No harm
incidents
Hazards and
risks
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Near misses
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Sentinel Event Reporting Process
De-identified Incident Report Data
Narrative
Incident summary
Patient safety
specialist synopsis
Organization
responses to RCA
Framework questions
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Categorical
Patient age range and
gender
Outcome
Setting and service
Event type
Root causes
1. What was the intended process flow?
2. Were there any steps in the process that did not occur as
intended?
3. What human factors were relevant to the outcome?
4. How did the equipment performance affect the outcome?
5. What controllable environmental factors directly affected
this outcome?
6. What uncontrollable external factors influenced this
outcome?
7. Were there any other factors that directly influenced this
outcome?
8. What are the other areas in the organization where this
could happen?
Source: The Joint Commission. Framework for conducting a root cause analysis and action plan.
http://www.jointcommission.org/assets/1/6/RCA_Questions_Framework.docx. Updated 2013.
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RCA Framework
9. Was the staff properly qualified and currently competent for
their responsibilities at the time of the event?
10. How did actual staffing compare with ideal levels?
11. What is the plan for dealing with staffing contingencies?
12. Were such contingencies a factor in this event?
13. Did staff performance during the event meet expectations?
14. To what degree was all the necessary information available
when needed? Accurate? Complete? Unambiguous?
15. To what degree was the communication among
participants adequate for this situation?
16. Was this the appropriate physical environment for the
processes being carried out for this situation?
Source: The Joint Commission. Framework for conducting a root cause analysis and action plan.
http://www.jointcommission.org/assets/1/6/RCA_Questions_Framework.docx. Updated 2013.
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RCA Framework (cont.)
17. What systems are in place to identify environmental risks?
18. What emergency and failure- mode responses have been
planned and tested?
19. How does the organization’s culture support risk reduction?
20. What are the barriers to communication of potential risk
factors?
21. How is the prevention of adverse outcomes communicated
as a high priority?
22. How can orientation and in-service training be revised to
reduce the risk of such events in the future?
23. Was available technology used as intended?
24. How might technology be introduced or redesigned to
reduce risk in the future?
Source: The Joint Commission. Framework for conducting a root cause analysis and action plan.
http://www.jointcommission.org/assets/1/6/RCA_Questions_Framework.docx. Updated 2013.
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© Copyright, The Joint Commission
RCA Framework (cont.)
De-identified data from sentinel events
(SEs) reported to The Joint
Commission from January 1, 2010 to
June 30, 2013 (n = 3,375)
Two-step process: (1) database
queries, and (2) content analysis of the
full sentinel event incident reports
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Sample and Process for Analysis
Process for Analysis
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Potentially
Health ITrelated SEs
120 Health ITrelated SEs
• Query relevant “sentinel event type” and “root cause”
categories
• Keyword queries
• Content analysis of full SE incident reports to
determine how health IT contributed or caused the
event
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© Copyright, The Joint Commission
3,375 SEs
• SEs reported to The Joint Commission from January 1,
2010 to June 30, 2013
Health IT-related Sentinel Event Types
29%
19%
12%
8%
6%
6%
4%
4%
3%
3%
2%
2%
1%
1%
1%
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© Copyright, The Joint Commission
30%
25%
20%
15%
10%
5%
0%
Hardware and software
Clinical content
Human-computer interface
People
Workflow and communication
Internal organizational policies,
procedures, environment, and culture
External rules, regulations,
and pressures
System measurement and monitoring
Adapted by permission from BMJ Publishing Group Limited. Sittig DF and Singh H. A new socio-technical model for
studying health information technology in complex adaptive healthcare systems. Quality and Safety in Health Care.
19(Supplement 3): i68-74, October 2010; doi: 10.1136/qshc.2010.042085
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The Eight Dimensions of the SocioTechnical Model
Classification of Contributing
Factors
24%
Content
23%
33%
Hardware &
Software 6%
1%
Personnel
6%
Measurement
& Monitoring 1%
Note: Multiple contributing and causal factors (n = 305) are identified for each sentinel event.
Image source: Dean Sittig, PhD
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7%
Workflow & Communication
External Rules & Regulations
Organizational Policies,
Procedures, & Culture
Health IT-related Contributing Factors – Top 10
Contributing factors (n = 305)
Human
computer
interface
Communication - Among team members
Data entry or selection (e.g., entry or selection of
wrong patient, wrong provider, wrong drug, wrong
dose)
Workflow and
communication
Clinical content
37
37
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Clinical content - Unexpected software design issue
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Sub-optimal support of teamwork (situation
awareness)
Totals
22
Decision support – Missing recommendation or
safeguard
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22
20
20
Information hard to find
14
14
Information display or interpretation (e.g., font size,
color of font, location of information in display
screen)
13
13
Mismatch between user mental models/expectations
and HIT
12
12
Human computer interface - Unexpected software
design issue
11
11
Hardware location (e.g., awkward placement for use)
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© Copyright, The Joint Commission
Sociotechnical Dimensions
Human-Computer Interface
Contributing Factors
% (n=101)
32% (32)
14% (14)
13% (13)
11% (11)
10% (10)
6% (6)
4% (4)
4% (4)
3% (3)
2% (2)
1% (1)
1% (1)
Note: The percentages listed are a proportion of the total human-computer interface contributing factors.
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Contributing factors
Ergonomics—Data entry or selection (e.g., entry or selection of wrong
patient, wrong provider, wrong drug, wrong dose)
Ergonomics—Information hard to find
Ergonomics—Information display or interpretation (e.g., font size, color of
font, location of information in display screen)
Unexpected software design issue (i.e., event in which the safety issue is
caused by an unforeseen or unexpected aspect of the software design)
related to the human-computer interface
Ergonomics—Hardware location (e.g., awkward placement for use)
Ergonomics—Alert fatigue/alarm fatigue
Ergonomics—Inadequate feedback to the user
Ergonomics—Data retrieval error—(human) missing data (i.e., did not look at
complete record)
Ergonomics—Difficult data entry
Equipment/device function—Image orientation incorrect
Equipment/device function—Image measurement/corruption
Ergonomics—Excessive demands on human memory
Workflow and Communication
Contributing Factors
Contributing factors
Communication—Among team members
Suboptimal support of teamwork (situation awareness)
Mismatch between user mental models/expectations and health IT
Communication—Staff to patient or family
% (n=72)
51% (37)
31% (22)
17% (12)
1% (1)
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Note: The percentages listed are a proportion of the total workflow and communication contributing factors.
Clinical Content Contributing Factors
% (n=70)
39% (27)
29% (20)
13% (9)
9% (6)
4% (3)
3% (2)
1% (1)
1% (1)
1% (1)
Note: The percentages listed are a proportion of the total clinical content contributing factors.
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Contributing factors
Unexpected software design issue (i.e., event in
which the safety issue is caused by an unforeseen or
unexpected aspect of the software design) related to
clinical content
Decision support—Missing recommendation or
safeguard
Loss or delay of data—availability
Loss or delay of data—missing
Incorrect software programming calculation
Unpredictable elements of the patient’s record
available only on paper/scanned documents
Incorrect or inappropriate alert
Loss or delay of data—accuracy
Decision support—Inadequate clinical content
Health IT Device Involved
% (n=147)
66% (97)
22% (32)
20% (29)
9% (13)
7% (10)
6% (9)
3% (4)
14% (20)
7% (10)
6% (9)
5% (7)
3% (4)
Note: Multiple devices can be involved in a sentinel event.
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© Copyright, The Joint Commission
Health IT categories
EHR or component of EHR
EHR
CPOE system
e-MAR
Clinical documentation system (e.g., progress notes)
Pharmacy system
CDS system
Radiology/diagnostic imaging system, including PACS
Human interface device (e.g., keyboard, mouse, touchscreen,
speech recognition system, monitor/display, printer)
Administrative/billing or practice management system—
Registration/appointment scheduling system
Automated dispensing system
LIS, including microbiology, and pathology systems
Source: Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237): 768-70.
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Reason’s Swiss Cheese Model
IT integration with biomedical
engineering and patient safety
“Loss of clinical context”
“Documentation is not communication”
Health IT changing workflow
Relevant clinical information is
sometimes difficult to find
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Learning Visit – Themes
Findings from the sentinel event
analysis and learning visits suggest that
optimizing the human-computer
interface and workflow are necessary
for safe health IT
– Develop an e-learning module
– Publish paper in peer review literature
– Consider as topic for Sentinel Event
Alert
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Conclusion
RTI International
Questions and Wrap Up
Speaker Contact Information
William M. Marella, MBA
Program Director, Patient Safety
Authority
Tel: 610-825-6000 x5173
Fax: 610-567-1114
Email: [email protected]
Gerry Castro, PhD, MPH
Project Director, Patient Safety
Initiatives
Phone: 630-792-5972
Email: [email protected]
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Upcoming Webinar
Tentatively scheduled for
– Thursday, January 22,
2015
– Topic: E-prescribing

Please visit
www.healthitsafety.org for
more information