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SAFER System Configuration General Instructions Safety Assurance Factors (Office of the National Coordinator)

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SAFER
Safety Assurance Factors
for EHR Resilience
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Self-Assessment
System Configuration
General Instructions
for the SAFER Self-Assessment Guides
The SAFER Guides are designed to help
healthcare organizations conduct self-assessments
to optimize the safety and safe use of electronic
health records (EHRs) in the following areas.
Each of the nine SAFER Guides begins with a Checklist
of “recommended practices.” The downloadable SAFER
Guides provide fillable circles that can be used to indicate the
extent to which each recommended practice has been
implemented. Following the Checklist, a Practice Worksheet
gives a rationale for and examples of how to implement each
recommended practice, as well as likely sources of input into
assessment of each practice, and fillable fields to record team
members and follow-up action. In addition to the
downloadable version, the content of each SAFER Guide, with
interactive references and supporting materials, can also be
viewed on ONC’s website at www.healthit.gov/SAFERGuide.
The SAFER Guides are based on the best evidence available
at this time (2016), including a literature review, expert
opinion, and field testing at a wide range of healthcare
organizations, from small ambulatory practices to large health
systems.
The recommended practices in the SAFER Guides are
intended to be useful for all EHR users. However, every
organization faces unique circumstances and will implement
a particular practice differently. As a result, some of the
specific examples in the SAFER Guides for recommended
practices may not be applicable to every organization.
The SAFER Guides are designed in part to help deal with
safety concerns created by the continuously changing
landscape that healthcare organizations face. Therefore,
changes in technology, practice standards, regulations and
policy should be taken into account when using the SAFER
Guides. Periodic self-assessments using the SAFER Guides
may also help organizations identify areas in which it is
particularly important to address the implications of change
for the safety and safe use of EHRs. Ultimately, the goal is to
improve the overall safety of our health care system.
The SAFER Guides are not intended to be used for legal
compliance purposes, and implementation of a recommended
practice does not guarantee compliance with HIPAA, the
HIPAA Security Rule, Medicare or Medicaid Conditions of
Participation, or any other laws or regulations. The SAFER
Guides are for informational purposes only and are not
intended to be an exhaustive or definitive source. They do not
constitute legal advice. Users of the SAFER Guides are
encouraged to consult with their own legal counsel regarding
compliance with Medicare or Medicaid program requirements,
HIPAA, and any other laws.
For additional, general information on Medicare and Medicaid
program requirements, please visit the Centers for Medicare
& Medicaid Services website at www.cms.gov. For more
information on HIPAA, please visit the HHS Office for Civil
Rights website at www.hhs.gov/ocr.
▪ High Priority Practices
▪ Organizational Responsibilities
▪ Contingency Planning
▪ System Configuration
▪ System Interfaces
▪ Patient Identification
▪ Computerized Provider Order Entry
with Decision Support
▪ Test Results Reporting and Follow-up
▪ Clinician Communication
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SAFER
Safety Assurance Factors
for EHR Resilience
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Self-Assessment
System Configuration
Introduction
The System Configuration SAFER Guide identifies
recommended safety practices associated with the way EHR
hardware and software are set up (i.e., “configured”). EHR
configuration includes the creation and maintenance of the
physical environment in which the system will operate, as
well as the implementation of the required hardware and
software infrastructure. Working through this guide with a
multi-disciplinary team will focus the team’s attention on
configuration-related recommended practices to optimize the
safety and safe use of the EHR.
Configuration of an EHR’s hardware and software
components within a particular environment is complex and
vulnerable to errors. EHRs are profoundly influenced by their
configuration, and numerous decisions must be made by the
multi-disciplinary configuration team. Generally, this team
should include practicing clinicians to ensure that technical
components align with and support the clinical processes and
workflows impacted by their decisions.
In addition to the substantial initial configuration effort, a
continuous, reliable configuration review and maintenance
process must be developed and followed. For example,
periodic system review and improvements are necessary to
maximize the potential benefits of the EHR, and these
changes are often less disruptive to business operations and
more likely to be successful if implemented through
coordinated change management processes. EHR safety and
effectiveness can be improved by establishing proper
configuration procedures, policies, and practices.
Completing the self-assessment in the System Configuration
SAFER Guide requires the engagement of people both within
and outside the organization (e.g., EHR technology
developers). Because this guide is designed to help
organizations prioritize EHR-related safety concerns,
clinician leadership in the organization should be engaged to
assess whether and how any particular recommended
practice affects the organization’s ability to deliver safe, high
quality care. Collaboration between clinicians and staff
members while completing the self-assessment in this guide
will enable an accurate snapshot of the organization’s EHR
configuration status (in terms of safety), and even more
importantly, should lead to a consensus about the
organization’s future path to optimize EHR-related safety and
quality: setting priorities among the recommended practices
not yet addressed, ensuring a plan is in place to maintain
recommended practices already in place, dedicating the
required resources to make necessary improvements, and
working together to mitigate the highest priority configuration-
related safety risks introduced by the EHR.
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SAFER
Safety Assurance Factors
for EHR Resilience
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Self-Assessment
System Configuration
Table of Contents
General Instructions
1
Introduction
2
About the Checklist
4
Checklist
5
Team Worksheet
7
About the Recommended Practice Worksheets
8
Worksheets
9
References
22
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The SAFER Self-Assessment Guides were developed by health IT safety researchers and informatics experts:
Joan Ash, PhD, MLS, MS, MBA, Professor and Vice Chair, Department of Medical Informatics and Clinical Epidemiology, School of Medicine, Oregon
Health & Science University;
Hardeep Singh, MD, MPH, Associate Professor of Medicine at the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of
Medicine and Chief of the Health Policy, Quality and Informatics Program at the Houston VA HSR&D Center of Excellence, and Director of the Houston
VA Patient Safety Center of Inquiry; and
Dean Sittig, PhD, University of Texas School of Biomedical Informatics at Houston, UT–Memorial Hermann Center for Healthcare Quality & Safety.
This guide was developed under the contract Unintended Consequences of Health IT and Health Information Exchange, Task Order HHSP23337003T/HHSP23320095655WC.
The ONC composite mark is a mark of the U.S. Department of Health and Human Services. The contents of the publication or project are solely the responsibility of the authors and do not necessarily represent the
official views of the U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology.
SAFER
Self-Assessment
System Configuration
About the Checklist
> Table of Contents
>About the Checklist
> Team Worksheet
>About the Practice Worksheets
> Practice Worksheets
The Checklist is structured as a quick way to enter and print your self-assessment.
Your selections on the checklist will automatically update the related section
of the corresponding Recommended Practice Worksheet.
The Domain associated with the Recommended Practice(s) appears
at the top of the column.
The Recommended
Practice(s) for the
topic appear below
the associated
Domain.
Select the status
of implementation
achieved by your
organization for each
Recommended
Practice.
Your Implementation
Status will be
reflected on the
Recommended
Practice Worksheet
in this PDF.
To the right of each Recommended Practice is a link
to the Recommended Practice Worksheet in this PDF.
The Worksheet provides guidance on implementing
the Practice.
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SAFER
Self-Assessment
System Conguration
Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practices for Domain 1 — Safe Health IT
1.1
There are an adequate number of EHR
access points in all clinical areas.
Worksheet 1.1
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
reset
1.2
The EHR is hosted safely in a physically
and electronically secure manner.
Worksheet 1.2
1.3
The organization’s information assets are
protected using strong authentication mechanisms.
Worksheet 1.3
1.4
System hardware and software required to run the
EHR (e.g., operating system) and their modifications
are tested individually and as-installed before go-
live and are closely monitored after go-live.
Worksheet 1.4
1.5
Clinical applications and system interfaces are
tested individually and as-installed before go-live
and are closely monitored after go-live.
Worksheet 1.5
1.6
Computers and displays in publicly accessible areas
are configured to ensure that patient identifiable
data are physically and electronically protected.
Worksheet 1.6
1.7
There are processes in place to ensure data
integrity during and after major system changes,
such as upgrades to hardware, operating
systems, or browsers.
Worksheet 1.7
Recommended Practices for Domain 2 — Using Health IT Safely
2.1
Clinical content used, for example, to create
order sets and clinical charting templates, and to
generate reminders within the EHR, is up-to-date,
complete, available, and tested.
Worksheet 2.1
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
reset
reset
reset
reset
reset
reset
2.2
There is a role-based access system in place to
ensure that all applications, features, functions, and
patient data are accessible only to users with the
appropriate level of authorization.
Worksheet 2.2
reset
reset
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SAFER
Self-Assessment
System Conguration
Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practices for Domain 2 — Using Health IT Safely
2.3
The EHR is configured to ensure EHR users work in
the “live” production version, and do not confuse it
with training, test, and read-only backup versions.
Worksheet 2.3
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
reset
2.4
System configuration settings that limit clinicians in
their practice are minimized, carefully implemented
following clinician acceptance, and closely monitored.
Worksheet 2.4
reset
2.5
The human-computer interface is configured for
optimal usability for different users and clinical
contexts.
Worksheet 2.5
reset
Recommended Practices for Domain 3 — Monitoring Safety
3.1
The organization has processes and methods in
place to monitor the effects of key configuration
settings to ensure they are working as intended.
Worksheet 3.1
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
reset
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SAFER
Self-Assessment
System Conguration
Team Worksheet
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
reset page
A multi-disciplinary team should complete this self-assessment and evaluate potential health IT-related patient safety risks addressed
by this specific SAFER Guide within the context of your particular healthcare organization.
This Team Worksheet is intended to help organizations document
the names and roles of the self-assessment team, as well as
individual team members’ activities. Typically team members will
be drawn from a number of different areas within your
organization, and in some instances, from external sources. The
suggested Sources of Input section in each Recommended
Practice Worksheet identifies the types of expertise or services to
consider engaging. It may be particularly useful to engage specific
clinician and other leaders with accountability for safety practices
identified in this guide.
The Worksheet includes fillable boxes that allow you to document
relevant information. The Assessment Team Leader box allows
documentation of the person or persons responsible for ensuring
that the self-assessment is completed. The section labeled
Assessment Team Members enables you to record the names of
individuals, departments, or other organizations that contributed to
the self-assessment. The date that the self-assessment is
completed can be recorded in the Assessment Completion Date
section and can also serve as a reminder for periodic
reassessments. The section labeled Assessment Team Notes is
intended to be used, as needed, to record important
considerations or conclusions arrived at through the assessment
process. This section can also be used to track important factors
such as pending software updates, vacant key leadership
positions, resource needs, and challenges and barriers to
completing the self-assessment or implementing the
Recommended Practices in this SAFER Guide.
Assessment Team Leader
Assessment Completion Date
Assessment Team Members
Assessment Team Notes
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SAFER
Self-Assessment
System Conguration
About the Recommended
Practice Worksheets
> Table of Contents
>About the Checklist
> Team Worksheet
>About the Practice Worksheets
> Practice Worksheets
Each Recommended Practice Worksheet provides guidance on implementing a
specific Recommended Practice, and allows you to enter and print information about
your self-assessment.
The Rationale section
provides guidance
about “why” the
safety activities
are needed.
Enter any notes
about your self-
assessment.
Enter any follow-up
activities required.
Enter the name
of the person
responsible for the
follow-up activities.
The Suggested
Sources of Input
section indicates
categories of personnel
who can provide
information to help
evaluate your status of
implementation.
The Examples section
lists potentially useful
practices of scenarios
to inform your
assessment and
implementation of the
specific
Recommended
Practice.
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SAFER
Self-Assessment
System Conguration
Recommended Practice
1.1 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.1
There are an adequate number of EHR access points in all
clinical areas.
1
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Rapid, reliable access to the patient’s computer-based
record is essential for safe and effective care. Such access
depends critically on configuring the EHR in clinical care
areas such that a computer is always conveniently available.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Organizational policy sets minimum standards for EHR
access by clinicians (e.g., clinicians walk no more than 50
feet to access an EHR; if there are waiting lines for access,
they are minimal and ensure that urgent clinical needs can
be addressed).
▪ Resources are dedicated to acquiring sufficient computer
hardware to ensure appropriate access, in accordance with
policy.
▪ Workflows (i.e., both physical and logical) have been
mapped to ensure ready and timely access devices and
needed EHR functionality in clinical areas.
▪ There is at least one EHR access point for every clinician
and administrative staff member in an outpatient clinic.
2
▪ Computer terminals used to access the EHR are mapped to
the appropriate (e.g., a nearby) printer. There is at least one
printer available for use on all acute care nursing units or
within easy reach of each outpatient exam room (e.g., less
than 25 feet).
▪ There is a mapping table that shows the physical location of
all hard-wired, network-attached devices (e.g., end-user
workstations, printers).
▪ Critical hardware is connected to a regularly tested
uninterruptible power supply (UPS).
3
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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SAFER
Self-Assessment
System Conguration
Recommended Practice
1.2 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
Implementation Status
1.2
The EHR is hosted safely in a physically and electronically
secure manner.
4
Checklist
Rationale for Practice or Risk Assessment
Whether the EHR is hosted locally or remotely, it can
only provide reliable support for safe, effective care if
it is available and secure.
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Key data required to take care of patients and run the
organization are available 24 hours per day and 7 days per
week, are not altered inadvertently or maliciously, and are
kept confidential.
▪ If the organization requires 24 hour per day, 7 day per week,
365 day per year access to their data, data and operational
systems are maintained on at least two geographically distinct
hosting sites that are mirrored in real-time (i.e., “hot” or
“warm” sites).
5
This redundancy reduces the risk of a single
natural or man-made disaster to disable operating capacity.
▪ There are at least two physically distinct network connections
between the hosting sites.
▪ Within a data center (i.e., hosting center), all servers are
mirrored on physically separate servers.
▪ The healthcare organization has a contract in place that
describes in detail how they will get functional access to their
data in the event that either the EHR system developer or the
remote hosting site goes out of business (e.g., EHR and
database management software has been placed in escrow,
current data backups are independently accessible).
6
▪ When multiple EHRs are being hosted on a remote hosting
facility, the data from different healthcare organizations are
maintained within separate virtual machine (VM)
environments or on separate physical servers.
7
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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SAFER
Self-Assessment
System Conguration
Recommended Practice
1.3 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.3
The organization’s information assets are protected using
strong authentication mechanisms.
8
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Failure to implement and manage secure processes to
authenticate access to any system or data (e.g., strong
passwords, fingerprints, role-based access) is an
avoidable source of erroneous data that can lead to patient
harm.
Suggested Sources of Input
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The organization has policies and procedures and conducts
regular risk assessments to define, implement, and monitor
authentication.
▪ Access to the organization’s “backbone network” via wireless
devices is password protected.
▪ Two-factor authentication is required for remote access to the
servers’ “administrative” accounts (e.g., root privileges on
Unix) and clinicians’ remote access to patient data. There are
three types of authentication, often described as something
you know, something you have, or something you are. Two-
factor authentication involves using at least two means of
identification, information one knows (i.e., password),
information one has (i.e., electronic ID card or random
number token), or information unique to a person (e.g.,
biometric such as iris or fingerprint scan).
9
▪ All users have a unique username and “strong” password
(e.g., contains letters, numbers, special characters). Periodic
changes to passwords are required.
10
▪ Employee login credentials are revoked as soon as their
employment ends.
▪ To the extent possible, the organization has implemented a
“single sign-on” solution that allows authorized clinicians to
rapidly move between disparate clinical applications without
requiring additional login information.
11, 12
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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Self-Assessment
System Conguration
Recommended Practice
1.4 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.4
System hardware and software required to run the EHR (e.g.,
operating system) and their modifications are tested individually
and as-installed before go-live and are closely monitored after
go-live.
13
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Failure to adequately test system hardware and
software can lead to suboptimal performance as
measured by response time, reliability, and error-free
operation.
Suggested Sources of Input
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Critical system infrastructure components, such as database
servers, network routers, and end-user terminals are
regularly load tested.
▪ All system software updates are installed and tested in the
“test” environment before they are moved into the production
or “live” environment and re-tested.
14
▪ The organization monitors system downtime and response
time.
2
▪ Organizational policies and/or procedures address post-
installation potential safety hazards (e.g., 24 hour per day
and 7 day per week support, help desk availability,
leadership walk-arounds).
15
▪ Organizational policies and/or procedures define criteria for
testing (e.g., testing in a simulated environment, day of week
testing, minimum number of test cases, types of user roles
associated with test cases, facility defined versus developer
defined test cases).
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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SAFER
Self-Assessment
System Conguration
Recommended Practice
1.5 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.5
Clinical applications and system interfaces are tested
individually and as-installed before go-live and are closely
monitored after go-live.
16
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Safety events can result from poor configuration between
critical applications, such as between CPOE and pharmacy.
Failure to adequately test applications and their interfaces
can lead to data integrity issues as well as impede
response time, availability, and error-free operation.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ New application software and updates (both major upgrades
and small “patches”) are installed and tested in the “test”
environment before they are moved into the production or
“live” environment, then re-tested and closely monitored in
the “live” environment for several days.
14
▪ System-system interfaces between key clinical applications
(e.g., CPOE and pharmacy, laboratory and EHR) are tested
and continuously monitored to detect new errors.
▪ Simulations are conducted for clinical processes such as
order entry, pharmacy review, nurse notification, medication
fill, medication administration, and nursing documentation to
ensure that the application addresses the organization’s
needs.
17
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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Self-Assessment
System Conguration
Recommended Practice
1.6 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.6
Computers and displays in publicly accessible areas are
configured to ensure that patient identifiable data are physically
and electronically protected.
18
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Failure to physically protect patient identifiable data to
ensure that it is not inadvertently or maliciously viewed,
changed, or deleted is vital to ensuring safe and
effective use of clinical applications.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Terminals used to access patient data in publicly accessible
locations have an automatic screen locking feature set,
appropriate to the clinical setting (e.g., lock after idle for three
minutes).
▪ Devices used to access patient data have their screens
facing away from publicly accessible locations and/or have
“privacy filters” (i.e., filters that restrict screen viewing at
angles).
▪ Public displays of patient names on EHRs are masked (i.e.,
only a portion of the patient’s name is visible in public areas,
e.g., ED, waiting rooms).
▪ The server room has physical security controls in place (e.g.,
room is locked, there is non-water-based fire suppression,
room is above ground to prevent flooding, backups are kept
in a different location).
▪ All portable computing devices used to access EHR data
have encrypted hard drives.
19
▪ Backups containing patient-identifiable data are encrypted.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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System Conguration
Recommended Practice
1.7 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
1.7
There are processes in place to ensure data integrity during and
after major system changes, such as upgrades to hardware,
operating systems, or browsers.
20
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Major system changes create the risk of loss or corruption
of patient data. Data persistence must be ensured
independent of hardware and software changes to maintain
continuity of care. Losing data due to “improvements” in the
underlying systems is not acceptable.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The organization has change management and internal
control policies and procedures to ensure data integrity, and
these apply to all major system changes. Major system
changes include, at a minimum, operating system or browser
version upgrades, or adding new system software (e.g., virus
protection upgrades).
▪ There are processes in place to migrate existing data to the
new system while ensuring it remains accurate, valid, and
accessible after changes to the:
21
Application (e.g., from one EHR system to another)
Format (e.g., from free text to structured data)
Coding system (e.g., from ICD-9 to ICD-10)
Storage mechanism (e.g., from magnetic tapes to solid state
hard drives)
▪ Standard, regularly used clinical and administrative reports
(e.g., length of stay, readmission rates, alert override rates)
are generated and reviewed periodically to ensure that the
data on which they are based has not changed in a way that
renders the report meaningless. When changes in underlying
data have the potential to lead to faulty conclusions, users are
notified as soon as possible, and repairs are implemented in a
timely manner.
▪ If data becomes corrupted, the organization has policies and
processes for reverting to a backup version of the data that
precedes the corruption. In addition, there are policies and
processes for:
Integrity checks to ensure a successful recovery after reverting
to the backup
Downtime processes to ensure access to critical data while the
system is brought back to an uncorrupted state
Methods for re-entry of data generated (e.g., orders, notes)
during the period of system corruption and subsequent
downtime
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
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SAFER
Self-Assessment
System Conguration
Recommended Practice
2.1 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
2.1
Clinical content used, for example, to create order sets and
clinical charting templates, and to generate reminders within
the EHR, is up-to-date, complete, available, and tested.
22
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Clinical content drives significant parts of the user
experience. Failure to update, test, and maintain this
content can result in significant degradations in the
accuracy and timeliness of information display and entry.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ There are no “broken links” to internet-based clinical
information resources.
▪ The organization has a naming convention and unambiguous
synonyms for common orders, results, procedures, order
sets, charting templates, and macros (e.g., dot phrases,
“canned text”).
23
▪ Default values are available for common orders (e.g.,
medication order sentences, routine laboratory draw times).
▪ Items necessary to provide clinical care are available as
orderable items within the CPOE system.
▪ Clinical content is tested to ensure that items entered in one
system are accurately transmitted through the system-to-
system interface and received by the remote system
unchanged.
▪ Clinical content is reviewed by the organization at least
annually.
▪ The organization has a clinical informatics committee to
review content.
24
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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Self-Assessment
System Conguration
Recommended Practice
2.2 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
2.2
There is a role-based access system in place to ensure that all
applications, features, functions, and patient data are accessible
only to users with the appropriate level of authorization.
4
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Role-based access helps ensure that users can only see,
enter, or modify data when necessary to perform their
jobs. Organizations are expected to configure and
maintain the correct associations between the roles and
the functions of the EHR and maintain correct assignments
of user roles.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ User roles with different data input and review capabilities
are defined for both clinical and non-clinical users. Within
each of these groups, subcategories of users are defined
with very specific capabilities (e.g., only credentialed MDs,
DOs, or NPs can order Schedule 2 medications without a
co-signature).
▪ There is a multi-disciplinary committee responsible for
creating new roles and determining that the appropriate
features and functions are assigned to each role.
▪ Employees who change jobs are reassigned to the
appropriate roles promptly.
▪ Periodically (e.g., yearly), supervisors are prompted to
review and re-authorize (or revoke) their clinical and
administrative staff members’ roles and specific
authorizations to access various clinical systems and
functions.
4
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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Self-Assessment
System Conguration
Recommended Practice
2.3 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
2.3
The EHR is configured to ensure EHR users work in the “live”
production version, and do not confuse it with training, test,
and read-only backup versions.
25
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Failure to clearly differentiate training, testing, and
live EHR environments can lead to data review and
entry errors.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ There is a dedicated “training” environment for the EHR that
includes de-identified patient data to allow high-fidelity
testing and training with real-world data.
▪ Both the training and test environments are as complete as
possible (e.g., within the training and test environments
users can enter and sign orders that will display for another
user, review laboratory data, and see alerts firing
appropriately).
▪ There is a dedicated “test” environment for the EHR that
facilitates the configuration and testing of all new software
and hardware updates.
▪ The read-only backup system is password protected and
clearly identifiable as read-only.
26
▪ The EHR is configured to make it difficult to confuse the live
version of the EHR with other versions (e.g., the screen
background color or the color of the patient headers could
be different).
▪ The organization has a policy and process for creating and
naming test patients. Avoid “cute” names like Dr. Spock, and
instead use unmistakable test names like “ZZZ” as a prefix
for the name and include numbers in the name.
14
▪ Use of generic accounts in the production environment
(e.g., "MD-Test" used by HIT support staff and others for
role-based testing) are tightly controlled (e.g., with regular
password changes, restricted admin-level rights, regular
review of real patient data that were accessed).
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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Self-Assessment
System Conguration
Recommended Practice
2.4 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
Implementation Status
2.4
System configuration settings that limit clinicians in their
practice are minimized, carefully implemented following
clinician acceptance, and closely monitored.
27
Checklist
Rationale for Practice or Risk Assessment
Configuration decisions that result in mismatches between
institutional policies, routine practices, and EHR settings
often result in “work-arounds” by clinicians, which
increase patient safety risks and lead to suboptimal use of
EHRs.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ EHR change/configuration management related
organizational policies and procedures that address
decisions to limit clinicians in their practice (e.g.,
mandatory clinical alert settings, hard stops that cannot be
overridden by clinicians, alerts that cannot be turned off by
clinicians) are developed with clinician input, judiciously
implemented, and carefully monitored.
28
▪ Organizational policy and procedures minimize
configurations that limit clinicians’ ability to continue
practicing (e.g., enter new orders) due to incomplete work
(e.g., overdue co-signatures, incomplete discharge
summaries).
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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Self-Assessment
System Conguration
Recommended Practice
2.5 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
2.5
The human-computer interface is configured for optimal
usability for different users and clinical contexts.
29
Checklist
Implementation Status
Rationale for Practice or Risk Assessment
Failure to support differences in user interface
requirements for different locations, specialties, and
users can lead to suboptimal system safety and
effectiveness.
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The EHR user interface (i.e., those aspects of an EHR that
users see and use) is configured (and configurable) to
enable users with different capabilities and requirements to
use the system safely and effectively (e.g., fonts large
enough for all users to see, reduced screen brightness on
night shifts, variable color and contrast schemes to
accommodate color-blind users).
▪ The EHR user interface is monitored for safe use
(e.g., user-reported usability hazards) and user
satisfaction, and is improved over time.
▪ Default column widths, or display fields, are set wide
enough to see key data.
16
▪ The EHR user interface is configured to address clinical
specialty requirements. Clinical specialties have their
“favorites” or 20 most commonly ordered medications,
clinical laboratory, and imaging tests available on a single
screen.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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Self-Assessment
System Conguration
Recommended Practice
3.1 Worksheet
Domain 3 —
Monitoring Safety
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Recommended Practice
Implementation Status
3.1
The organization has processes and methods in place to
monitor the effects of key configuration settings to ensure they
are working as intended.
30
Checklist
Rationale for Practice or Risk Assessment
Failure to monitor configuration settings associated with
key clinical components (e.g., CPOE interface to
pharmacy) or processes (e.g., medication reconciliation)
can lead to serious safety events that are otherwise
difficult to identify.
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Key configuration settings include the number and size of
database servers dedicated to the EHR application,
password strength, system timeouts, and other similar
settings. The organization has policies and procedures that
identify the key configuration settings and the persons
responsible for monitoring them.
▪ The organization has a method of automatically monitoring
(e.g., by periodically checking) all internet-based links
presented within the EHR.
▪ System response time is measured and reported
regularly.
31
▪ The interface error log is regularly reviewed and all errors
are identified and fixed promptly.
▪ The alert override rate is monitored and regularly reviewed.
Alerts that are ignored 100 percent of the time (or nearly
so) are re-evaluated and fixed or disabled.
32
▪ Clinical decision support is monitored using statistical
processes (e.g., control charts) to identify malfunctions.
33
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
September 2016
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SAFER
Safety Assurance Factors
for EHR Resilience
References
1. Howard, J., Clark, E. C., Friedman, A., Crosson, J. C., Pellerano, M., Crabtree, B. F., ... & Cohen, D. J. (2013). Electronic health
record impact on work burden in small, unaffiliated, community-based primary care practices. Journal of General Internal
Medicine, 28(1), 107-113.
2. Sittig, D. F., Campbell, E. M., Guappone, K. P., Dykstra, R. H., & Ash, J. S. (2007). Recommendations for monitoring and evaluation
of in-patient computer-based provider order entry systems: results of a Delphi survey. American Medical Informatics Association Annual
Symposium Proceedings, 2007, 671–675.
3. Haskins, M. (2002). Legible charts! Experiences in converting to electronic medical records. Canadian Family Physician, 48, 768.
4. Fernández-Alemán, J. L., Señor, I. C., Lozoya, P. Á. O., & Toval, A. (2013). Security and privacy in electronic health records: a
systematic literature review. Journal of Biomedical Informatics, 46(3), 541-562.
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(pp. 311-334). Apress.
6. O'Connor, K. J. (2005). Everything you always wanted to know about software escrow agreements--and then some! Journal of
Healthcare Information Management, 19(1), 10.
7. Zissis, D., & Lekkas, D. (2012). Addressing cloud computing security issues. Future Generation Computer Systems, 28(3), 583-592.
8. Tipton, S. J., Forkey, S., & Choi, Y. B. (2016). Toward proper authentication methods in electronic medical record access compliant to
HIPAA and CIA triangle. Journal of Medical Systems, 40(4), 1-8.
9. Sasse, M. A. (2013, August). “Technology Should Be Smarter Than This!”: A Vision for Overcoming the Great Authentication Fatigue.
Workshop on Secure Data Management (pp. 33-36). Springer International Publishing.
10. Clayton, P. D., Boebert, W. E., Defriese, G. H., Dowell, S. P., Fennell, M. L., Frawley, K. A., ... & Rindfleisch, T. C. (1997). For the
record: protecting electronic health information. National Research Council. (Washington, DC: National Academy Press, 1997).
11. Cresswell, K. M., Mozaffar, H., Lee, L., Williams, R., & Sheikh, A. (2016). Safety risks associated with the lack of integration and
interfacing of hospital health information technologies: a qualitative study of hospital electronic prescribing systems in England. BMJ
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12. Berger, R. G., & Baba, J. (2009). The realities of implementation of Clinical Context Object Workgroup (CCOW) standards for
integration of vendor disparate clinical software in a large medical center. International Journal of Medical Informatics, 78(6), 386-390.
13. Ancker, J. S., Singh, M. P., Thomas, R., Edwards, A., Snyder, A., Kashyap, A., & Kaushal, R. (2013). Predictors of success for
electronic health record implementation in small physician practices. Applied Clinical Informatics,4(1), 12-24.
14. Wright, A., Aaron, S., & Sittig, D. F. (2016). Testing electronic health records in the “production” environment: an essential step in the
journey to a safe and effective health care system. Journal of the American Medical Informatics Association.
15. Frankel, A., Grillo, S. P., Baker, E. G., Huber, C. N., Abookire, S., Grenham, M., ... & Gandhi, T. K. (2005). Patient safety leadership
WalkRounds™ at Partners HealthCare: learning from implementation. The Joint Commission Journal on Quality and Patient Safety,
31(8), 423-437.
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evaluation, testing, and validation of the usability of electronic health records. National Institute of Standards and Technology.
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and think-aloud protocol analysis with “near-live” clinical simulations in evaluating clinical decision support. International Journal of
Medical Informatics, 81(11), 761-772.
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269-282). ACM.
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validation when transitioning between electronic health record systems. Journal of the American Medical Informatics Association.
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SAFER
Safety Assurance Factors
for EHR Resilience
References
22. Ash, J. S., Sittig, D. F., Guappone, K. P., Dykstra, R. H., Richardson, J., Wright, A., ... & Middleton, B. (2012). Recommended practices
for computerized clinical decision support and knowledge management in community settings: a qualitative study. BMC Medical
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computerized provider order entry. Journal of the American Medical Informatics Association, 14(1), 41-47.
24. Wright, A., Ash, J. S., Erickson, J. L., Wasserman, J., Bunce, A., Stanescu, A., ... & Middleton, B. (2014). A qualitative study of the
activities performed by people involved in clinical decision support: recommended practices for success. Journal of the American Medical
Informatics Association, 21(3), 464-472.
25. Sittig, D. F., Gonzalez, D., & Singh, H. (2014). Contingency planning for electronic health record-based care continuity: a survey of
recommended practices. International Journal of Medical Informatics, 83(11), 797-804.
26. Lincke, S. (2015). Designing Information Security. In Security Planning (pp. 115-133). Springer International Publishing.
27. Eikey, E. V., Murphy, A. R., Reddy, M. C., & Xu, H. (2015). Designing for privacy management in hospitals: understanding the gap
between user activities and IT staff’s understandings. International Journal of Medical Informatics, 84(12), 1065-1075.
28. Strom, B. L., Schinnar, R., Aberra, F., Bilker, W., Hennessy, S., Leonard, C. E., & Pifer, E. (2010). Unintended effects of a
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Medicine, 170(17), 1578-1583.
29. Middleton, B., Bloomrosen, M., Dente, M. A., Hashmat, B., Koppel, R., Overhage, J. M., ... & Zhang, J. (2013). Enhancing patient
safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA. Journal of the
American Medical Informatics Association, 20(e1), e2-e8.
30. Meeks, D. W., Takian, A., Sittig, D. F., Singh, H., & Barber, N. (2014). Exploring the sociotechnical intersection of patient safety and
electronic health record implementation. Journal of the American Medical Informatics Association, 21(e1), e28-e34.
31. Smith, M. W., Ash, J. S., Sittig, D. F., & Singh, H. (2014). Resilient practices in maintaining safety of health information technologies.
Journal of Cognitive Engineering and Decision Making, 8(3), 265-282.
32. McCoy, A. B., Waitman, L. R., Lewis, J. B., Wright, J. A., Choma, D. P., Miller, R. A., & Peterson, J. F. (2012). A framework for
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33. Wright, A., Hickman, T. T. T., McEvoy, D., Aaron, S., Ai, A., Andersen, J. M., ... & Bates, D. W. (2016). Analysis of clinical decision
support system malfunctions: a case series and survey. Journal of the American Medical Informatics Association.
September 2016
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