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SAFER Test Results Reporting and Follow-Up (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
Test Results Reporting
and Follow-Up
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.
▪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
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.
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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
Test Results Reporting
and Follow-Up
Introduction
The Test Results Reporting and Follow-Up SAFER Guide
identifies recommended safety practices intended
to optimize the safety and safe use of processes and
EHR technology for the electronic communication
and management of diagnostic test results. Processes
relating to test results are fragile, requiring careful
planning, implementation, and maintenance to
deliver correct information promptly to the intended
recipients.
1
In the EHR-enabled healthcare environment,
providers rely on technology to support and manage the
reporting and follow-up of test results. This guide offers
recommended practices related to the content and
communication of test results to the clinician, as well as
recommended practices related to the documentation
and follow-up of test results.
2, 3
If implemented and used correctly, EHRs have the
potential to improve diagnostic test result reporting and
follow-up. Initial evaluation of the impact of health IT for
test results reporting and follow-up has produced mixed
results.
4, 5, 6, 7
Furthermore, laboratory and radiology/
imaging results reporting in EHRs remains vulnerable to
safety events.
8
Failure to follow-up appropriately on
diagnostic test results can lead to misdiagnosis, patient
harm, and liability.
The Test Results Reporting and Follow-Up SAFER Guide
recommends practices that optimize the safety and safe
use of the EHR with respect to diagnostic test reporting.
It will enable assessment of whether those aspects of the
EHR associated with communication of diagnostic test
results and related processes work as they should, are
used correctly, and are designed and implemented to
minimize the potential for errors.
5, 6, 9, 10, 11, 12
Completing the self-assessment requires the
engagement of people both within and outside the
organization (eg., EHR technology developers,
diagnostic services providers). Clinician leadership in the
organization should be engaged in assessing 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
status in terms of test results reporting-related safety. In
addition, it 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 test
results-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
Test Results Reporting
and Follow-Up
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.
Table of Contents
General Instructions
1
Introduction
2
About the Checklist
4
Checklist
5
Team Worksheet
8
About the Recommended Practice Worksheets
9
Recommended Practice Worksheets
10
References
33
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
About the Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Self Assessment
SAFER
5 of 17
Contingency Planning
SAFER Self Assessment | Contingency Planning
December xx, 2013
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 level
of implementation
achieved by your
organization for
each
Recommended
Practice.
Your Implementation
Status
will be
reflected on the
Recommended
Practice Worksheet
in this PDF
.
T
o 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
Test Results Reporting and Follow-Up
Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
Recommended Practices for Domain 1 — Safe Health IT
1.1
Test names, values, and interpretations (i.e., outside
of normal reference ranges) for laboratory results are
stored in the EHR as structured data using
standardized nomenclature.
Worksheet 1.1
reset
1.2
Predominantly test-based test reports (e.g.
radiology or pathology reports) have a coded (e.g.
abnormal/normal at a minimum) interpretation
associated with them.
Worksheet 1.2
reset
1.3
Functionality for ordering tests and reporting
results is tested pre- and post-go-live.
Worksheet 1.3
reset
1.4
After system changes in components or applications
related to CPOE and diagnostic services, the data and
data presentation are reviewed to ensure accuracy and
completeness.
Worksheet 1.4
reset
Recommended Practices for Domain 2 — Using Health IT Safely
2.1
Orders for diagnostic tests are placed using
CPOE and electronically transmitted to the
diagnostic service provider (e.g., laboratory,
radiology).
Worksheet 2.1
reset
2.2
The EHR is able to track the status of all orders and
related procedures (e.g., specimen received and
collected; test completed, reported, and
acknowledged).
Worksheet 2.2
reset
2.3
The ordering clinician is identifiable on all ordered
tests and test reports, and, if another clinician is
responsible for follow-up, that clinician is also
identified in the EHR.
Worksheet 2.3
reset
2.4
When test results are amended, the change is clearly
visible in the EHR and printed reports.
Worksheet 2.4
reset
2.5
When test results are changed or amended, the
ordering clinician and other clinicians responsible for
follow-up are notified electronically. For clinically
significant changes, the clinicians are also contacted
directly.
Worksheet 2.5
reset
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
Recommended Practices for Domain 2 — Using Health IT Safely
2.6
"Send-out" (or reference lab) tests are electronically
traced, and their results are incorporated into the EHR,
with a coded test name, result value, and interpretation.
Worksheet 2.6
reset
2.7
Written policies specify unambiguous responsibility for
test result follow-up with a shared understanding of
that responsibility among all involved in providing
follow-up care.
Worksheet 2.7
reset
2.8
Workflows that are particularly vulnerable to
mishandling of test results, especially critical ones, are
identified, and back-up procedures ensure test results
are received by someone responsible for the affected
patient's care.
Worksheet 2.8
reset
2.9
Results outside normal reference ranges, or
otherwise determined to be abnormal, are flagged
(e.g., presented in a visually distinct way).
Worksheet 2.9
reset
2.10
Display of results (e.g., numeric, text, graphical,
image) should be easily accessible, clearly
visible, not easily overlooked, and
understandable.
Worksheet 2.10
reset
2.11
Automated non-interruptived results notifications
(also called "in-basket alerts" or flags) are limited
to those that are clinically relevant to minimize
"alert fatigue."
Worksheet 2.11
reset
2.
12
Results notifications remain in clinician inboxes
until a clinician action occurs to address them.
Worksheet 2.12
reset
2.13
There is an EHR-based process for clinicians to either
assign surrogates for reviewing notifications or enable
surrogates to access the principle clinicians' inboxes.
Worksheet 2.13
reset
2.14
There are mechanisms to forward results and results
notifications from one clinician to another.
Worksheet 2.14
reset
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Checklist
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
Implementation Status
Fully
in all areas
Partially
in some areas
Not
implemented
Recommended Practices for Domain 2 — Using Health IT Safely
2.15
Summarization tools to trend and graph laboratory
data are available in the EHR.
Worksheet 2.15
reset
2.16
Test results can be sorted in the clinician's EHR
inbox according to clinically relevant criteria (e.g.,
date/time, severity, read/unread, hospital
location, patient).
Worksheet 2.16
2.17
The EHR has the capability for clinicians to set
reminders for themselves and other responsible
clinical staff for future tasks to facilitate test result
follow-up.
Worksheet 2.17
Recommended Practices for Domain 3 — Monitoring Safety
3.1
As part of quality assurance activities, organizations
monitor selected practices related to test result
reporting and follow-up. Monitored practices include
clinician use of the EHR for test results review and
clinician follow-up on abnormal test results.
Worksheet 3.1
reset
3.2
As part of quality assurance, the organization monitors
and addresses test results sent to the wrong clinician
or never transmitted to any clinician (e.g., due to an
interface problem or patient/provider misidentification).
Worksheet 3.2
reset
reset
reset
reset
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reset
3.
3
Worksheet 3.3
Organizational policies and procedures ensure timely
patient notification of both normal and abnormal test
results and the timeliness of notification is monitored.
SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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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Self-Assessment
Test Results Reporting and Follow-Up
About the Recommended
Practice Worksheets
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Self Assessment
Contingency Planning
SAFER
Recommended Practice 4
Worksheet
Phase 1 —
Safe Health IT
>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 level of
implementation.
The Examples
section lists
potentially useful
practices or
scenarios to inform
your assessment and
implementation of the
specific
Recommended
Practice.
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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
Implementation Status
1.1
Test names, values, and interpretations (i.e., outside of normal
reference ranges) for laboratory results are stored in the EHR as
structured data using standardized nomenclature.
6, 12, 13, 14, 15, 16, 17
Checklist
Rationale for Practice or Risk Assessment
Structured laboratory results facilitate EHR-based result
reporting and tracking functions.
4
Structured data enable
use of clinical decision support (CDS) that can avoid
errors and optimize patient safety.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Test result names (e.g., sodium, potassium) that are sent
along with LOINC codes are stored as coded data.
18
▪ Abnormal test result values and interpretations are defined
and stored in a standardized, coded format (e.g., high/low
sodium, critical potassium, positive/negative fecal occult
blood test).
10, 19
▪ There is a process to handle paper-based test results that
includes, at a minimum, the entry of coded values into the
EHR to indicate Test Result Name, Test Result Value,
Units, Normal Range, Abnormal Flag, and Date/Time, along
with a scanned copy of the report in the EHR.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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Off
SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
1.2 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
1.2
Predominantly text-based test reports (e.g., radiology or
pathology reports) have a coded (e.g., abnormal/normal at
a minimum) interpretation associated with them.
Checklist
Rationale for Practice or Risk Assessment
Coded results in structured fields facilitate EHR-based result
reporting and tracking functions.
4
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Imaging results are coded by the interpreting radiologist
as abnormal by using a structured code if there is a new
or unexpected abnormality that requires follow-up.
20, 21, 22
▪ Mammography results are stored according to
BI-RADS
®
®
criteria.
23, 24
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
1.3 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
1.3
Functionality for ordering and reporting results is tested pre-
and post-go-live.
Checklist
Rationale for Practice or Risk Assessment
Problems related to system configuration errors leading to
results routing logic errors are inevitable. With testing, many
such unforeseen problems can be identified and addressed
before they result in patient harm. Errors related to closed loop
test order entry and results delivery are difficult to detect and
can lead to delays in care.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Efforts are made to proactively identify failure points related
to EHR-enabled test results delivery.
▪ Specifically designed testing scripts are used to identify
remediable points of vulnerability
25
to build systems that are
more fault-tolerant.
▪ Specific testing of routing logic, provider recipients,
and configuration is performed to ensure accurate
results delivery.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
1.4 Worksheet
Domain 1 —
Safe Health IT
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
1.4
After system changes in components or applications related to
CPOE and diagnostic services, the data and data presentation
are reviewed to ensure accuracy and completeness.
Checklist
Rationale for Practice or Risk Assessment
System changes can unexpectedly affect the integrity of
the data as it moves through organizations in ways that
may not be recognized without proactive review.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The organization identifies specific types of EHR system
changes that impact CPOE and diagnostic services (e.g.,
application upgrades, changes to interfaces) and carefully
reviews data integrity at all points where data are used.
▪ Whenever code sets or configuration table data are
changed, all downstream logic and systems relying on
these code sets should be thoroughly tested.
▪ Error queues are used to monitor for proper system
performance; results that cannot be automatically delivered
are manually delivered.
▪ Order entry and result reporting interfaces are tested after
every change to the laboratory or diagnostic imaging
ordering catalog.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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
Implementation Status
Recommended Practice
2.1
Orders for diagnostic tests are placed using CPOE and
electronically transmitted to the diagnostic service provider
(e.g., laboratory, radiology).
6, 26, 27, 28
Checklist
Rationale for Practice or Risk Assessment
A hybrid paper and electronic environment for test ordering is
hazardous. CPOE can facilitate closed loop communication
and results accessibility via the EHR, but only if the results
are available in the system. Test results can be lost or missed
if on paper, when clinicians have come to rely on the EHR.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ For common tests, there is a two-way system-to-system
interface (i.e., for ordering, resulting, acknowledging, and
canceling orders) between the clinical staff, ordering
staff, and organization and the testing facility.
29
▪ Diagnostic tests that are not orderable through CPOE for
any reason are promptly added to the system (Note: The
healthcare organization or the EHR developer should be
careful to map the new orderable test to the appropriate
LOINC code).
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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
Implementation Status
Recommended Practice
2.2
The EHR is able to track the status of all orders and
related procedures (e.g., specimen received and
collected; test completed, reported, and acknowledged).
4
Checklist
Rationale for Practice or Risk Assessment
Tracking orders facilitates closed loop communication.
This enables detection of problems regarding order
processing and delivery of test results.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The EHR can record, display, and report whether orders
were received, specimens collected, tests completed,
results reported, and results acknowledged.
30, 31, 32, 33, 34,
35, 36, 37
▪ Clinical practices where test result information is not fully
integrated into the EHR use additional tracking strategies
to enable follow-up.
38
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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
Implementation Status
Recommended Practice
2.3
The ordering clinician is identifiable on all ordered tests and
test reports, and, if another clinician is responsible for
follow-up, that clinician is also identified in the EHR.
9
Checklist
Rationale for Practice or Risk Assessment
Clear identification of the ordering clinician facilitates closed
loop communication. Ambiguous responsibility increases
the risk of follow-up failure.
4
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Result routing systems support delivery of results to the
ordering provider.
5, 10, 12, 36
▪ The EHR supports assignment or transfer of responsibility
for test order follow-up.
36
▪ Policies and procedures address situations vulnerable to
follow-up failures, including shift hand-offs and when
providers are out of the office or have departed the
organization.
▪ There are escalation processes for high priority or urgent
test results that are not responded to by providers within a
pre-specified time period, including an alternate
communication method.
▪ When another user other than the ordering clinician enters
an order under the clinician's name (e.g., per protocol
ordering) the entering user's name is visible on the order
information.
Assessment Notes
Follow-up Actions
Person Responsible for Follow-up Action
reset page
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
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
Implementation Status
Recommended Practice
2.4
When test results are amended, the change is clearly visible
in the EHR and printed reports.
10
Checklist
Rationale for Practice or Risk Assessment
Results that are subsequently changed carry a significant
potential for delayed or wrong treatment based on outdated,
incorrect results.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Changed results are clearly flagged as such in the EHR
(e.g., marked as “amended”).
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2.5 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.5
When test results are changed or amended, the ordering clinician and
other clinicians responsible for follow-up are notified electronically. For
clinically significant changes, the clinicians are also contacted directly.
39
Checklist
Rationale for Practice or Risk Assessment
Results that are subsequently changed carry a significant
potential for delayed or wrong treatment based on
outdated, incorrect results.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The individual changing the results is responsible for
notifying appropriate clinicians of those changes. Electronic
systems may not always ensure that a critical
communication was received and reviewed promptly, and
thus for clinically important changes to results, appropriate
clinicians should be contacted directly.
10
▪ Policies and procedures ensure that changes in test results
and accompanying documentation are effectively
communicated to the appropriate clinicians responsible for
patient care, including after the patient has transitioned to
another setting of care.
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2.6 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.6
"Send-out" (or reference lab) tests are electronically tracked,
and their results are incorporated into the EHR, with a coded
test name, result value, and interpretation.
Checklist
Rationale for Practice or Risk Assessment
“Send-out” tests are vulnerable to loss to follow-up.
40
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The EHR facilitates the tracking of “send-out” tests at the
point of ordering and provides a mechanism to allow
clinicians or organizations to incorporate these results into
the EHR and assign them to the correct patient.
▪ Procedures exist to ensure that all test results, including
those received from outside the organization through fax
or mail, are properly incorporated into the EHR.
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2.7 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.7
Written policies specify unambiguous responsibility for test result
follow-up with a shared understanding of that responsibility among
all involved in providing follow-up care.
4, 6, 10, 13, 14, 33, 36, 41, 42, 43
Checklist
Rationale for Practice or Risk Assessment
New workflows resulting from the introduction of EHRs can
introduce new hazards related to miscommunication of
responsibility for follow-up. Ambiguous responsibility
increases the risk of follow-up failure.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
Examples of Potentially Useful Practices/Scenarios
▪ In the outpatient setting, the ordering provider is
responsible for follow-up unless he or she delegates this
responsibility (e.g., to a covering provider). Delegation
should be documented in the EHR and accepted by the
delegate.
44
▪ Ordering clinicians in any setting assume responsibility for
follow-up care, unless that responsibility is unambiguously
transferred to another clinician who accepts
responsibility.
36
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Recommended Practice
2.8 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.8
Workflows that are particularly vulnerable to mishandling of test
results, especially critical ones,
32
are identified,
45
and back-up
procedures ensure test results are received by someone
responsible for the affected patient's care.
6, 39
Checklist
Rationale for Practice or Risk Assessment
Lost or mishandled test results, especially critical ones,
are a significant risk to patients, especially in situations
where workflows are particularly vulnerable to such
failures (e.g., shift changes, transitions of care).
46
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Situations that are vulnerable to test results follow-up failures
are identified.
47, 48, 49
These include handoffs between
clinicians (e.g., between residents, part-time physicians, ER
physicians, and hospitalists),
46
and care transitions
15, 50, 51
between clinical settings (e.g., between different units of a
hospital; between the hospital and home or a post-acute
facility). In these situations, processes should be in place to
ensure that test results are communicated to a clinician
responsible for follow-up care.
44
▪ Life threatening results are notified through verbal means to
ensure positive confirmation of receipt.
10
▪ Notifications of abnormal test results that remain
unacknowledged after a pre-specified time period are
forwarded (or escalated) to an alternate responsible
provider.
36, 52
▪ Diagnostic services should ensure that test results are
communicated to a back-up provider in a timely fashion in
the event that the ordering provider is not available. The
necessary timeliness is dependent on the significance of
the test result.
53
▪ The organization maintains an updated contact list of all
practicing providers, and this list includes their coverage
schedules.
9, 36
▪ The organization maintains a patient-provider link (e.g.,
patient's PCP is identified) in the EHR as a back-up. In the
event that the ordering provider does not acknowledge the
result, a responsible clinician in the ordering practice must
be notified.
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Person Responsible for Follow-up Action
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2.9 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.9
Results outside normal reference ranges, or otherwise
determined to be abnormal, are flagged (i.e.,
presented in a visually distinct way).
6, 10
Checklist
Rationale for Practice or Risk Assessment
Although absence of flags does not necessarily mean
that the result is normal, flagging can reduce the
likelihood of missing abnormal or critical results.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Abnormal results are flagged (e.g., bolded font, asterisk
beside values, use of “H” or “L,” different colors) or
marked for better visualization in the EHR.
▪ Color is not used as the only visual indicator of clinical
significance.
▪ Critical values are flagged in a distinct way from simply
abnormal values.
Assessment Notes
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Recommended Practice
2.10 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.10
Display of results (e.g., numeric, text, graphical, image)
should be easily accessible, clearly visible, not easily
overlooked, and understandable.
Checklist
Rationale for Practice or Risk Assessment
Missed or misunderstood test results as the consequence
of a poorly designed human-computer interface are as
dangerous to patients as lost or wrong results. Results
visualization and display should maximize safety to
ensure critical information is not missed.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Displays of test results undergo usability testing for the
intended clinical users.
▪ Information is displayed in columns that are sufficiently wide
to allow review of all pertinent information (i.e., providers do
not need to drag columns on the user interface to detect
abnormalities).
12
▪ Multicomponent results are reported together (e.g.,
lupus anticoagulant has 2-3 subcomponents that may be
individually positive or negative but should be reported
together).
▪
▪
Result details are reported on one screen, eliminating the
need for horizontal scrolling. For example, providers should
not have to use additional scrolling (e.g., on the “next
page”) to access critical information.
6, 12
Most recent test results should by default be displayed first
(e.g., either at the top of a row-based display or at the left
side on a columnar display) to ensure that clinicians are
always aware of current data.
54
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23 of 36
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Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
2.11 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.11
Automated non-interruptive results notifications (also called
"in-basket alerts" or flags) are limited to those that are clinically
relevant to minimize "alert fatigue."
4, 12, 14, 32, 41, 42, 55, 56
Checklist
Rationale for Practice or Risk Assessment
Information overload from too many alerts is associated
with more missed test results.
57
Results that are poorly
displayed increase risk of misinterpretation or being
overlooked completely.
Suggested Sources of Input
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ A multi-disciplinary committee that includes frontline
clinicians decides which abnormal test results should be
sent as high priority alerts.
▪ In integrated healthcare delivery networks that have a
combined in-patient and ambulatory EHR, ambulatory
clinicians have the option to turn off inbox result
notifications for their patients while they are admitted in the
inpatient environment.
▪ Notifications of a patient's results are batched (aggregated)
by type and/or date to minimize the number of notifications
and the cognitive load of notification processing.
▪ The organization monitors providers’ inboxes (i.e., the total
number of alert notifications sent to providers).
▪ The organization provides workflow support to help a
provider when the number of unread notifications in his or
her inbox grows large.
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2.12 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.12
Results notifications remain in clinician inboxes until a
clinician action occurs to address them.
4, 12, 58
Checklist
Rationale for Practice or Risk Assessment
If notifications drop off, clinicians can miss results.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Notifications remain in the inbox until acted on (e.g.,
when a clinician signs or actively removes them).
Assessment Notes
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SAFER
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Recommended Practice
2.13 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.13
There is an EHR-based process for clinicians to either assign
6, 9, 48, 59
surrogates for reviewing notifications or enable surrogates
to access the principal clinicians' inboxes.
Checklist
Rationale for Practice or Risk Assessment
Not using surrogate features and functions appropriately
increases risk of loss of test result follow-up.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ If clinicians plan to be away, they assign a covering
clinician to whom the system can automatically forward
test results or alert clinicians sending messages that they
are unavailable and another provider is covering.
▪ The organization has policies and procedures that
establish expectations for timely review of test results and
specifically address planned and unplanned absences.
Assessment Notes
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Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
2.14 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.14
There are mechanisms to forward results and results notifications
from one clinician to another.
12, 41
Checklist
Rationale for Practice or Risk Assessment
Notifications sometimes are sent to incorrect clinicians,
and this functionality allows clinicians to forward them to
the correct person.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ In addition to automatic forwarding, such as when a
clinician is on vacation, forwarding can be manually
performed by a clinician for a specific notification (e.g.,
when the notification is transmitted to the incorrect
clinician).
▪ Mechanisms are in place for tracking acknowledgment
and acceptance of forwarded notifications.
Assessment Notes
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2.15 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
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Implementation Status
Recommended Practice
2.15
Summarization tools to trend and graph laboratory data are
available in the EHR.
60
Checklist
Rationale for Practice or Risk Assessment
Displaying certain laboratory test results over time
helps identify clinically relevant anomalies or trends.
Summarization tools in the EHR improve visualization,
interpretation, and accessibility of results.
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The EHR incorporates tools and reports that enable
selected laboratory results to be graphed and
displayed to view trends over time. The associated
graphs follow standardized display criteria.
60
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Recommended Practice
2.16 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.16
Test results can be sorted in the clinician's EHR inbox
according to clinically relevant criteria (e.g. date/time,
severity, hospital location, patient).
6, 12, 39, 42
Checklist
Rationale for Practice or Risk Assessment
Clinicians need ways to prioritize results review so that
they can address the most pressing issues first and
cope with information overload.
61
Sorting also
improves visualization and accessibility of results.
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Results can be sorted according to important parameters
(e.g., date, type, read/unread, urgency, patient, location).
Assessment Notes
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SAFER
Self-Assessment
Test Results Reporting and Follow-Up
Recommended Practice
2.17 Worksheet
Domain 2 —
Using Health IT Safely
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
2.17
The EHR has the capability for clinicians to set reminders
for themselves and other responsible clinical staff for future
tasks to facilitate test result follow-up.
42, 62
Checklist
Rationale for Practice or Risk Assessment
The EHR can help clinicians follow-up with patients
regarding test results.
63
Unless they set reminders
for themselves, clinicians may forget about follow-
up tasks that they need to do.
64
Suggested Sources of Input
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The EHR has a function for setting a reminder for a
follow-up action due on a future date.
37
Assessment Notes
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Person Responsible for Follow-up Action
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Recommended Practice
3.1 Worksheet
Domain 3 —
Monitoring Safety
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
3.1
As part of quality assurance activities, organizations monitor selected
practices related to test result reporting and follow-up. Monitored
practices include clinician use of the EHR for the test results review and
clinician follow-up on abnormal test results.
4, 5, 6, 13, 36, 39, 48, 65, 66, 67, 68
Checklist
Rationale for Practice or Risk Assessment
Effective quality assurance patient safety programs
include monitoring of core clinical metrics.
69
Errors related
to missed or delayed follow-up of test results are a
significant cause of adverse events that harm patients.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ The organization has in place processes to monitor and
report alert responses (e.g., acknowledged or not,
34
time to
acknowledgment)
9
and test result follow-up with patients.
5
▪ Clinicians document communication of test results to
patients in the EHR.
70
▪ Organizational quality assurance activities select and
measure test results-related benchmarks for ongoing
monitoring, starting in areas of identified concern and high
risk.
47
For example, an organization could develop a
measurement system for test results reporting using
measures along the following lines:
▪ Percentage of all active clinicians who have reviewed at
least one laboratory test result in the EHR within the last
month. If the percentage is greater than 95 percent, this
measure could indicate if the EHR is perceived as the
“source of truth” for laboratory test results versus
dependence on paper-based communication.
▪ Test results with the lowest follow-up rate are investigated
to understand the root causes of the problem.
6, 67
▪ Percentage of all test results reviewed by the ordering
provider within four days, or sooner if results are
considered more urgent, should be greater than 90
percent.
▪ Results not reviewed for more than one week should be
minimal.
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SAFER
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Recommended Practice
3.2 Worksheet
Domain 3 —
Monitoring Safety
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
3.2
As part of quality assurance, the organization monitors and
addresses test results sent to the wrong clinician or never
transmitted to any clinician (e.g., due to an interface problem
or patient/provider misidentification).
25, 36
Checklist
Rationale for Practice or Risk Assessment
When test results are “lost in the system,” there is a
danger that there will be no follow-up, posing a significant
risk of patient harm.
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
EHR developer
Health IT support staff
Examples of Potentially Useful Practices/Scenarios
▪ Error logs are used to detect results such as those that
were never delivered, results without any ordering provider,
or results with unidentifiable providers.
▪ National Provider Identification (NPI) numbers are used for
provider attribution of orders.
▪ Monitor provider master files (e.g., address book) to ensure
that they are synchronized to avoid scenarios in which the
ordering provider’s contact information is outdated or
unknown.
Assessment Notes
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Person Responsible for Follow-up Action
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November 2016
SAFER Self-Assessment | Test Results Reporting and Follow-Up
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SAFER
Self-Assessment
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Recommended Practice
3.2 Worksheet
Domain 3 —
Monitoring Safety
> Table of Contents > About the Checklist > Team Worksheet > About the Practice Worksheets
> Practice Worksheets
Implementation Status
Recommended Practice
3.3
2UJDQL]DWLRQDOSROLFLHVDQGSURFHGXUHVHQVXUHWLPHO\
SDWLHQWQRWLILFDWLRQRIERWKQRUPDODQGDEQRUPDOWHVWUHVXOWV
DQGWKHWLPHOLQHVVRIQRWLILFDWLRQLVPRQLWRUHG
1
Checklist
Rationale for Practice or Risk Assessment
)DLOXUHLQWLPHO\SDWLHQWQRWLILFDWLRQRIWHVWUHVXOWVLVD
PDMRUVRXUFHRIGLDJQRVWLFHUURUDQGOLDELOLW\
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QRWLILFDWLRQUHGXFHVWKHULVNRIORVVRIIROORZXS
Suggested Sources of Input
Clinicians, support staff, and/or
clinical administration
Diagnostic services
Examples of Potentially Useful Practices/Scenarios
▪
Organizations use patient portals to automatically release
test results to patients who have activated their accounts. A
link to lab test interpretations (such as http://
labtestsonline.org/ ) is provided to portal users to explain
their test results in more detail.
▪
▪
1DWLRQDO9$SROLF\³&RPPXQLFDWLQJ7HVW5HVXOWVWR
3URYLGHUVDQG3DWLHQWV´'LUHFWLYHVWDWHVWKDW
³,WLV9+$SROLF\WKDWDOOWHVWUHVXOWVPXVWEHFRPPXQLFDWHG
E\WKHGLDJQRVWLFSURYLGHUWRWKHRUGHULQJSURYLGHURU
GHVLJQHHZLWKLQDWLPHIUDPHWKDWDOORZVIRUSURPSW
DWWHQWLRQDQGDSSURSULDWHDFWLRQWREHWDNHQ$OOWHVWUHVXOWV
UHTXLULQJDFWLRQPXVWEHFRPPXQLFDWHGE\WKHRUGHULQJ
SURYLGHURUGHVLJQHHWRSDWLHQWVQRODWHUWKDQFDOHQGDU
GD\VIURPWKHGDWHRQZKLFKWKHUHVXOWVDUHDYDLODEOH)RU
WHVWUHVXOWVWKDWUHTXLUHQRDFWLRQUHVXOWVPXVWEH
FRPPXQLFDWHGE\WKHRUGHULQJSURYLGHURUGHVLJQHHWR
SDWLHQWVQRODWHUWKDQFDOHQGDUGD\VIURPWKHGDWHRQ
ZKLFKWKHUHVXOWVDUHDYDLODEOH'HSHQGLQJRQWKHFOLQLFDO
FRQWH[WFHUWDLQWHVWUHVXOWVPD\UHTXLUHUHYLHZDQG
FRPPXQLFDWLRQLQVKRUWHUWLPHIUDPHV´
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SAFER Self-Assessment | Test Results Reporting and Follow-Up
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▪
Notification of test results to patients is monitored for
timeliness (i.e. did the provider notify the patient within the
correct time frame).
Certain time sensitive test results, as well as results for
which clear, unambiguous communication is essential
(e.g., HIV status, cancer diagnosis), are discussed in-
person or via the telephone rather than using asynchronous
electronic means (e.g., secure messaging, voice-mail, or
patient portals).
If unable to confirm patient communication and
acknowledgment for abnormal results, alternative strategies
are used to ensure follow-up (e.g., if secure message is not
read, then telephone or send a letter).
▪
For patients who have not activated their on-line accounts,
traditional methods such as letter or phone calls are used to
inform patients of their results on a timely basis.
▪
Off
SAFER
f
Saf
or EHR R
ety Assur
esilience
ance Factors
References
1. Singh, H., Naik, A. D., Rao, R., & Petersen, L. A. (2008). Reducing diagnostic errors through effective communication: harnessing
the power of information technology. Journal of General Internal Medicine, 23(4), 489-494.
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