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NRSE_4510_M5_IM_How_to_Identify_and_Address_Unsafe_Conditions_Associated_with_Health_IT.pdf
Anticipating Unintended Consequences
of Health Information Technology
and Health Information Exchange How to Identify and Address
Unsafe Conditions Associated
with Health IT
November 15, 2013 Authors Prepared for ECRI Institute:
Cynthia Wallace, CPHRM The Office of the National Coordinator
for Health Information Technology Karen P. Zimmer, MD, MPH, FAAP Washington, DC Lorraine Possanza, DPM, JD, MBE
Robert Giannini, NHA, CHTS–IM/CP
Ronni Solomon, JD Prepared by Westat
1600 Research Boulevard
Rockville, MD 20850-3129
(301) 251-1500 Contract No: HHSP23320095655WC
Task Order: HHSP23337003T Table of Contents
Chapter Page Introduction .............................................................................................................................. 1 Health IT Overview ................................................................................................................. 3 Socio-Technical Model ...................................................................................... 5 Common Health IT-Related Problems ................................................................................. 6 Computer-Related Issues...................................................................................
Human-Computer Issues .................................................................................. 9
10 Identifying Health IT’s Unintended Consequences ............................................................ 11 High-Reliability Organizations’ Commitment to Health IT Safety .............
Event Reporting within a Safety Culture ........................................................ 12
13 How to Collect Health IT Event Data.................................................................................. 14 Educating Staff About Health IT Event Reporting ......................................
What to Include in a Health IT-Related Event Report.................................
AHRQ Common Formats for Health IT Event Data ..................................
Beyond the Common Formats: Hazard Manager..........................................
Health IT Event and Hazard Analysis ............................................................ 14
14
15
16
17 Staff Feedback and Monitoring .............................................................................................. 20 Other Sources of Information for Health IT-Related Issues....................... 20 Reporting Health IT Events to PSOs ...................................................................................
EHR Developers’ Role in Assuring Patient Safety.............................................................. 20
22 Teaming Up With PSOs .................................................................................... 24 Conclusion ............................................................................................................................... 25 Resources ............................................................................................................................... 26 References ............................................................................................................................... 27 How to Identify and Address Unsafe
Conditions Associated with Health IT ii Table of Contents (continued)
Tables Page 1 What is Health IT? ............................................................................................. 4 2 Examples of Health IT-Related Incidents ...................................................... 7 1 Health IT Safety: A Shared Responsibility...................................................... 2 2 Socio-Technical Model for Health IT ............................................................. 5 3 ECRI Institute PSO Deep Dive Identifies Top Five Safety Issues
from Health IT Events ...................................................................................... 8 4 Continuous Feedback Approach to Health IT System Safety ..................... 12 5 Sample Screenshot from AHRQ’s Hazard Manager ..................................... 17 6 Case Study of a Laboratory Event Involving Health IT ............................... 19 7 Intended Flow of Patient Safety Event Data and Feedback ........................ 23 Figures How to Identify and Address Unsafe
Conditions Associated with Health IT iii Introduction
Health information technology (IT) can provide multiple benefits to enhance patient care if the
technology is optimally designed by the system developer, thoughtfully implemented by the
healthcare organization, and appropriately used by the organization’s staff.
Health IT’s potential can also be undermined by the hazards created when a health IT system
operates in unintended and unanticipated ways.
For example, studies have found that the same health IT systems can have varied results when
implemented in different facilities. In its 2011 report Health IT and Patient Safety: Building Safer Systems
for Better Care, the Institute of Medicine (IOM) cites three studies conducted at different children’s
hospitals that adopted the same computerized provider order entry (CPOE) system. In one hospital,
the mortality rate did not change (Del Beccaro, Jeffries, Eisenberg, &amp; Harry, 2006); however, in the
other hospital, CPOE implementation led to a significant increase in mortality (Han et al., 2008).
And when that same system was used in several other hospitals, mortality rates either did not change
or dropped (Longhurst et al., 2010). According to IOM’s report (IOM, 2011), “The differing impact
on mortality rates may be due to the hospitals’ differences in the implementation and use of the
CPOE system.”
“Designed and applied inappropriately, health IT can add an additional layer of complexity to the
already complex delivery of health care, which can lead to unintended adverse consequences,” says
IOM.
Adding to the complexity is the challenge of recognizing the technology’s involvement in patient
safety incidents and near misses—i.e., patient safety issues that are caught before they reach the
patient. An electronic health record (EHR) system developer recently notified its customers that a
software glitch in its emergency department module prevented emergency physicians’ notes about
medications from transferring to the patients’ charts (U.S. Food and Drug Administration [FDA],
2013). Healthcare organizations may have viewed any incidents that occurred as a result of the bug
as a medication omission, unaware that a software defect in the health IT system was at fault.
A recent analysis of health IT-related events submitted by healthcare organizations to a federally
certified patient safety organization (PSO) identified many of the common problems that can arise
with health IT systems. The challenge for healthcare organizations is to detect the problems before
the system is fully implemented. If a particular defect escapes detection, the organization must also
have processes in place to identify those problems as soon as possible after the system is brought
online.
In short, healthcare organizations must operate as high-reliability organizations to ensure the safety
of their health IT systems. Their safety culture should foster a willingness to learn about unsafe
conditions with their health IT systems that can lead to patient harm and to make improvements to
the systems before accidents do occur.
To achieve their goals as high-reliability organizations in an increasingly wired healthcare
environment, organizations must sharpen their internal processes to identify health IT flaws and How to Identify and Address Unsafe
Conditions Associated with Health IT 1 make improvements. These processes must be ongoing because new safety risks can arise as
software is upgraded and new interfaces are built.
Organizations must also be able to call upon their EHR developers for assistance in addressing
unanticipated system faults. As their customers expose the systems to the busy, complex healthcare
environment, developers may find that their systems function within that environment in
unexpected ways. They must be prepared to work with their customers to correct those bugs.
But organizations should also be prepared to turn to other outside experts as the healthcare sector,
collectively, gains experience with health IT and learns about the issues that can arise with the
technology, as well as ways to ensure that health IT fulfills its promise of improved patient care.
Within the protected and confidential framework offered by PSOs, healthcare organizations can also
share with others their experiences with health IT systems to better understand problems that can
occur with health IT systems and identify solutions.
Additional guidance on health IT safety is available from federal and state healthcare safety oversight
authorities, including various agencies of the U.S. Department of Health and Human Services—the
Office of the National Coordinator for Health Information Technology (ONC), the Centers for
Medicare and Medicaid Services, the Office for Civil Rights, and the FDA—and state licensing
authorities.
Ultimately, a healthcare organization’s approach to health IT safety relies on the collective guidance
provided by internal and external experts ( see Figure 1). Working together, healthcare
organizations, PSOs, EHR developers, and policymakers can learn how to achieve the full potential
of health IT.
Figure 1. Health IT Safety: A Shared Responsibility Healthcare Organizations Patient Safety Organizations Internal reporting of incidents, near misses,
unsafe conditions Analysis of aggregated data, feedback,
education Health IT Safety
EHR Developers
Safety alerts, software updates How to Identify and Address Unsafe
Conditions Associated with Health IT Federal and State Authorities
Guidance from agencies of the Department
of Health and Human Services, as well as
state licensing authorities 2 This White Paper is intended to help healthcare organizations lay the foundation for a process to
identify health IT hazards, using both internal and external resources. It covers the following:
1. Describes health IT systems and addresses their operation within a complex healthcare
environment. 2. Identifies five common health IT problems that can occur within the context of this
complex environment and contribute to the unsafe use of health IT systems, leading to
potential and actual patient harm. 3. Examines the role of organization’s internal reporting systems to identify and address
unsafe scenarios for health IT systems and to continually monitor health IT systems’
safety and make improvements. 4. Discusses the role of external reporting programs, such as PSOs, in helping to identify
areas for health IT system improvements. 5. Reviews the role of EHR developers in working with healthcare providers and external
reporting programs to identify and manage health IT system improvements. Health IT Overview
Broadly defined, health IT systems comprise the hardware and software that are used to
electronically create, maintain, analyze, store, or receive information to help in the diagnosis, cure,
mitigation, treatment, or prevention of disease (AHRQ, 2013a). For many healthcare organizations,
health IT is synonymous with EHR, but it also includes various other components as depicted in
Table 1.
Numerous studies support health IT’s important role in patient safety. For example, CPOE systems
can improve patient safety by eliminating transcription errors for illegible handwriting, providing
clinical decision support, and alerting clinicians to potentially dangerous orders, such as a patient
allergy to a selected medication (Kaushal, Shojania, &amp; Bates, 2003).
But studies also point to the so-called “unintended consequences” of health IT (Ash, Berg, &amp;
Coiera, 2004). Continuing with the CPOE example, studies have documented that, among several
possible hazards with the systems, clinicians can mistakenly select the wrong patient file when
placing an order in a CPOE system if the computer display is confusing, resulting in a medication
order for the wrong patient. How to Identify and Address Unsafe
Conditions Associated with Health IT 3 Table 1. What is Health IT? Health IT involves the exchange of health information in an electronic environment as in the following
examples.
Health IT System
Administrative (e.g., medical billing and scheduling,
practice management system) •

• Example
Coding/billing system
Master patient index
Registration/appointment scheduling system Automated dispensing system • Medication dispensing cabinet Computerized medical devices • Infusion pumps with dose-error-reduction
capability (i.e., “smart” pumps)
Patient monitoring systems (e.g., cardiac,
respiratory, fetal) •


• Electronic health record (EHR) or EHR component •

• Bar-coded medication administration
Clinical decision support system
Clinical documentation system (e.g., progress
notes)
Computerized provider order entry
Electronic medication administration record
Pharmacy system Human interface device •




• Keyboard
Monitor/display
Mouse
Printer
Speech recognition system
Touchscreen Laboratory information system (including microbiology
and pathology systems) •

• Microbiology system
Pathology system
Test results reporting Radiology/diagnostic imaging system • Picture archiving and communication system Adapted from “Device or Medical/Surgical Supply, Including Health Information Technology (HIT).” In Hospital
Common Formats—Version 1.2: Event Descriptions, Sample Reports, and Forms, April 24, 2013. Rockville,
MD: Agency for Healthcare Research and Quality. Retrieved August 20, 2013 from
https://www.psoppc.org/web/patientsafety/version-1.2_documents. Indeed, health IT-related incidents can occur under any of the following circumstances (Sittig &amp;
Singh, 2011): The system is unavailable for use. The system malfunctions during its use. The system is used incorrectly. The system interacts incorrectly with another and causes the loss of data or data being
incorrectly entered, displayed, or transmitted. How to Identify and Address Unsafe
Conditions Associated with Health IT 4 Socio-Technical Model
As with many events involving medical technology, health IT-related incidents, such as those
described above, do not occur in isolation. The technology operates within a complex environment,
and health IT must be considered in the context of that environment. In trying to understand why
an event occurs, researchers have developed a socio-technical model for evaluating health IT within
the context of eight dimensions (Sittig &amp; Singh, 2010), as illustrated in Figure 2.
Figure 2. Socio-Technical Model for Health IT Adapted by permission from BMJ Publishing Group Limited. Sitting 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 The eight dimensions of a socio-technical model for evaluating health IT are as follows:
1. Hardware and software (e.g., computers, keyboards, data storage, software to run health
IT applications); 2. Clinical content (data, information, and knowledge stored in the system); How to Identify and Address Unsafe
Conditions Associated with Health IT 5 3. Human-computer interface (hardware and software interfaces that allow users to
interact with the system); 4. People (software developers, IT department personnel, clinicians, healthcare staff,
patients, and others involved in health IT development, implementation, and use); 5. Workflow and communication (steps followed to ensure patients receive the care they
need at the time they need it); 6. Internal organizational policies, procedures, environment, and culture (internal
organizational factors, such as capital budgets, IT policies, and event reporting systems,
which affect all aspects of health IT development, implementation, use, and
monitoring); 7. External rules, regulations, and pressures (external forces, such as federal and state rules
to ensure privacy and security protections and federal payment incentives to spur health
IT adoption); and 8. System measurement and monitoring (processes to measure and monitor health IT
features and functions). In short, examining health IT incidents within the context of the socio-technical model enables
organizations to look beyond the incident to understand it in the context of the people who use the
system and the other technologies and processes affected by health IT. Understanding these
interactions enables high-reliability organizations to make improvements to their health IT systems
when flaws in the systems are identified that can lead to patient harm. Common Health IT-Related Problems
What are the most common problems that can occur with health IT systems? At the most basic
level, there are two general areas. First, problems can occur at the interface between a computer user
and the health IT system, causing a person to use the system incorrectly. Second, glitches can occur
in how the equipment and software functions; for example, if software designed to connect one
system to another has faulty coding, it could cause unexpected gaps in the transmitted data. Sample
scenarios from each of these two categories, human-computer interface and computer-specific, are
listed in Table 2.
As organizations try to understand why a particular problem arose with their health IT systems, they
can dissect these two general categories in greater detail. Did a problem at the human-computer
interface occur when data was entered into the health IT system or when it was retrieved? Did the
problem arise because the computer user was interrupted or distracted from a task? For computerspecific issues, the organization can explore an array of questions that could have caused the
incident. Was there a power interruption to the healthcare facility’s computer network? Did
information fail to display on the computer monitor? Was there a problem with the particular
system’s software, hardware, or both? How to Identify and Address Unsafe
Conditions Associated with Health IT 6 Table 2. Examples of Health IT-Related Incidents Human-Computer Related
A patient was not identified properly, and all
clinical information was entered into the wrong
record.
Data were entered incorrectly into the
electronic record due to multiple records being
open. Computer Related
Data were not displaying properly in the
system. The network was down or slow. Interface issues with the laboratory system
caused delays in the ability to retrieve data. The software was not up to date. Software did not meet the needs of the
specialty provider. The system failed to alert the user of an
identified concern with a flag or pop up. The user ignored or overrode an alert. Data were not entered into the system. The software was not functioning properly. Data were incomplete and missing from the
entry. Data were lost. There was not enough equipment/devices for
providers, causing delay in data entry. Internet or server connectivity issues prevented
real-time data entry. Lab test results were not reviewed in a timely
manner. There was a breach in the security of the
system (e.g., virus or malware). An item from an outside source was scanned
into the wrong patient record. Unapproved data-entry devices were used. The hardware malfunctioned (e.g., mouse,
keyboard, monitor, or touchscreen). There was no evidence in the patient record of
a written order or the care provided. Data from the archived paper record were not
available at the time of the patient visit. Test results were sent to the wrong provider
causing a delay in action. There were gaps in training among staff
causing processes to be missed or done
incorrectly. Text entries were not shared due to poorly
designed interfaces between systems. Reasons for not using clinical decision support
were not documented. How to Identify and Address Unsafe
Conditions Associated with Health IT 7 Using a taxonomy designed for in-depth analysis of health IT-related incidents (Magrabi, Ong,
Runciman, &amp; Coiera, 2012), ECRI Institute PSO, one of the first PSOs to be federally certified,
conducted an evaluation of health IT-related events and unsafe conditions to advance the healthcare
sector’s understanding of the technology and its impact on healthcare delivery. *
In its report ECRI Institute PSO Deep Dive: Health Information Technology, the PSO shared information
learned from the events, as well as strategies to ensure health IT is appropriately implemented and
used to improve healthcare quality without jeopardizing patient safety (ECRI Institute PSO, 2012).
Figure 3 presents a summary of the five most frequently identified health IT-related problems found
by the analysis.
Figure 3. ECRI Institute PSO Deep Dive Identifies Top Five Safety Issues from Health IT Events The percentage identified with each event type represents the accumulative total of that event type and any
preceding event types as a portion of the 211 safety events. * ECRI Institute PSO’s Deep Dive analysis evaluated more than 170 health IT-related events reported by 36 healthcare organizations over a nine-week
period. The events ranged from data entries in the wrong patient records to gaps in reporting critical test results because the results could not be
relayed electronically from one system to another. Some events involved more than one safety issue; consequently, the analysis identified 211 patient
safety issues that were grouped into 22 event categories. How to Identify and Address Unsafe
Conditions Associated with Health IT 8 ECRI Institute PSO’s analysis reinforces findings in the clinical literature and reports from
policymakers, such as ONC and IOM, about the unintended consequences of the technology
(ONC, 2013; IOM, 2011). A statewide analysis of health IT events in Pennsylvania reported to the
state also reached similar conclusions about common health IT-related incidents (Sparnon &amp;
Marella, 2012). Computer-Related Issues
Three of the five categories—system interface, system/software configuration, and software
function—are considered computer-related events that occur, for example, as a result of design
issues (e.g., difficult-to-read screen displays) or software interfaces that jeopardize the exchange of
data between separate health IT systems. There can be numerous other reasons for these glitches.
Identifying these reasons starts with understanding the type of problem associated with the incident. System Interface
System interface problems were the most commonly identified health IT concern in ECRI Institute
PSO’s analysis. These problems arise if there are failures with the system interfaces, often resulting
in missed orders for medications and various other types of tests, as in the following example:
The physician ordered the patient’s anticoagulation medication be discontinued after
reviewing results for the patient’s prothrombin time. The order did not cross over to the
pharmacy system, and the patient received eight extra doses of the medication before it was
discontinued. System/Software Configuration
A large percentage of computer-related safety issues were also associated with the configuration of a
system’s hardware and software as in the following event:
Following the wound team consult, the nurse tried to enter instructions and comments in
the patient’s record, but the system prevented the nurse from typing more than five letters
in the comment field. How to Identify and Address Unsafe
Conditions Associated with Health IT 9 Software Function
Computer-related problems also occurred when a health IT system’s software failed to function as
intended. Examples of software problems affecting the system’s function include the following: Inability to order a particular item, such as a specific magnetic resonance imaging study. Failure to record the correct medication dose when the medication label is scanned into
the medication administration record. The system does not alert when a pregnancy test is ordered for a male patient. Human-Computer Issues
Two of the five common health IT problem categories—wrong data input and wrong record
retrieved—involved user interactions with the health IT system, or the so-called “human-computer
interface.” In these cases, a user’s mistake in entering data or retrieving a record may have been
prompted by the design features of the health IT system or the way in which the IT system was
implemented. For example, an organization may choose to display drug names in a drop-down list
by alphabetical order based on the premise that the drug names will be easier for users to find. But
once the system is put into operation, the organization finds that users make frequent errors in
selecting drugs with similar names. Wrong Data Input
The most common problem encountered with the human-computer interface in ECRI Institute
PSO’s analysis...
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