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https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/NHQAPI

https://asq.org/quality-resources

https://guidehouse.com/capabilities/industries/healthcare/solutions/health-systems/sectors/performance-improvement

4 Strategies to Unlock Healthcare Performance
Management Constraints

hfma.org/Content.aspx

Hospitals and health systems are confronted with unprecedented challenges in
managing performance in the current business environment, yet all too many
organizations have limited understanding of how best to meet these
challenges.

When asked about their organizations’ readiness to manage performance in today’s
environment, a majority of respondents to a recent survey said, “Not so much.” Based on
responses from more than 350 senior finance executives of U.S. hospitals and health systems,
the January 2018 survey report identified three realities that are cause for concern:

Only 25 percent of the respondents are “very confident” in their team’s ability to quickly
and easily adjust strategies and plans.
Only 15 percent say their organization is “very prepared” to manage evolving payment
and delivery models with current financial planning processes and tools.
A slim 8 percent are “very satisfied” with the performance management reporting at their
organization, yet 73 percent think that performance management “plays a critical role in
the finance team’s partnership with the broader organization to meet strategic goals.”

An organization’s readiness and ability to manage performance affect its operating risks, and
by extension, overall enterprise risk. Finance leaders have a pivotal role to play in reducing
such risks, and that role centers on building organizational agility, defined as the ability to
nimbly operate in the current business while preparing for changing/new conditions.

Agility is enhanced through high-quality enterprise performance management processes and
tools that enable finance professionals to develop scenarios, set targets, track and
communicate progress toward goals, and respond to problems in a timely fashion. In the
current healthcare environment, with dual challenges related to changing payment and
delivery models, robust performance management is essential to the required organizational
transformation.

Additional 2018 survey findings suggest the following four performance management
strategies that can boost agility and transformation readiness.

Increase Use of Data and Analytics to Improve Strategic
Decision Making

a

b

1/7

Constant changes in the healthcare industry have placed an increased emphasis on improving
performance across the clinical, financial, and operational performance management areas
shown in the exhibit below. According to 2018 survey findings, 90 percent of the CFOs and
other senior finance executives think their organization should be doing more to leverage data
to inform strategic decisions. When trustworthy data are lacking, however, which 56 percent of
CFOs cite as the reality, improved analytics and reporting for strategic decision making are
effectively out of reach.

Key Data and Analytics for Enterprise Performance Management in Health Care

Benchmark-rich databases and analytic tools are now critical elements in the successful
operation of a healthcare business. Using such tools, hospital and health system executives
and clinicians can assess strategic performance that will drive the required transformation of
care quality, costs, and patient experience. Because 94 percent of survey respondents use
spreadsheets to supplement their core systems, recommended software tools should provide
finance teams with an interface that supports spreadsheet-like analytics. But access to an
extensible, robust data model for sophisticated modeling and analysis also is strongly
recommended. Healthcare organizations with comprehensive data sets that are consistently
analyzed and used to monitor outcomes, improve performance, and leverage a broad array of
planning processes are in the best position to successfully establish and execute strategic
plans.

Improve Cost Measurement and Related Tools
Senior finance executives regard identifying and managing cost-reduction initiatives as
themost important performance management activity. This priority is consistent with
September 2017 survey results focused on gauging industry efforts to reduce total cost of
care, in which 96 percent of senior finance executives said that cost transformation is a
“significant” or “very significant” need for their organizations today.

Although finance executives recognize the specific urgency of cost improvements, it is evident
from both surveys that executives are struggling with data, processes, and tools that lack
structure, transparency, accuracy, and hence, credibility. Indeed, leveraging data and analytics
to know where to focus cost efforts was the most commonly cited impediment to achieving
cost-reduction goals in the 2017 survey findings.

Further, 70 percent of respondents to that survey said their cost measurement tools are too
simplistic or provide inaccurate data that cannot be trusted; or worse yet, they have no tools in
place at all. Only 25 percent expressed confidence in the accuracy of results provided by their

c

2/7

existing cost accounting systems. Developing a plan to improve the validity and reliability of
cost information is a must, as is executing the plan on a timely basis.

Cost benchmarking is particularly important, given industry pressures for dramatic
improvement. Although about half of CFOs say their organizations benchmark costs to external
peer groups, 18 percent do not perform any cost benchmarking. Nonethelesss, all
organizations should be benchmarking quality and cost performance to understand their
competitive position. Historical trend analytics allow a hospital’s or health system’s leadership
team to assess the performance of the organization using its own data in multiple ways—e.g.,
by hospital, service line, department, physician, treatment type, patient diagnosis, or other
relevant consideration. Data from public and commercial sources enable risk-adjusted
comparisons of the organization’s performance with that of an appropriate peer group, defined
as of similar type with like functions, services, operating revenue, or other factors.

Using benchmark-based reports and scorecards, hospital executives and managers can
observe patterns of performance that impact utilization, cost, quality, outcomes, and patient
experience based on factors such as diagnosis, comorbidities, treatment type, department,
and physician. Areas of undesirable variation can be explored and targeted for improvement;
development of best practices can be considered for areas of outstanding performance.

Two caveats of benchmarking warrant mention.

First, organizations that are in the top quartile of national or regional benchmarks cannot afford
to be complacent. Being at the highest level of efficiency in an industry that has an
overwhelming need for dramatic cost improvement, for example, means only that the
organization has less far to travel than its peers. It does not mean that the organization has
completed its journey.

Second, leaders should keep in mind that substantial reporting lags may occur with published
benchmarks. Older numbers for the external comparative group may have shifted materially in
the organization’s current comparative period, so directional as well as specific benchmark
movement should be considered.

Redesign Financial Planning Processes for Enhanced
Integration
The 2018 survey findings point to considerable room for improvement in the integration of
plans and budgets. More than one-fourth of represented organizations do not include the
financial impact of large strategic and capital initiatives in their long-range plans. Organizations
cannot ensure these initiatives will be affordable or fully understand their financial impact if the
initiatives are not covered within long-term financial planning forecasts.

An additional concern is that, among survey respondents, 37 percent are attempting to
manage performance in organizations that do not integrate long-range and capital planning;
and 31 percent are doing so in organizations that lack integration of operational budgeting and

3/7

capital planning. The first year of a long-range plan should directly establish the performance
targets for the current year’s operational budget. Rolling forecasting can bridge gaps between
the long-range plan and operational budget through quarterly forecasts extending out one to
two years.

Survey responses related to long-range planning are both encouraging and discouraging.
Seventy-five percent of respondents have a two- to five-year long-range plan; 17 percent have
a six- to 10-year plan; 6 percent do not develop a long-range plan. The fact that three-quarters
of CFOs say their organizations have two- to five-year plans is a positive finding, but the good
news in that finding is limited to organizations whose plans cover the long end of that time
range. A two-or even three-year plan is insufficient to meet organizational planning needs in
the current business environment, and a minimum of a five-year plan with regular updates is
recommended as best practice. Even better is a six- to 10-year planning horizon, which is
common today in large health systems.

The 6 percent of organizations without any long-range plan must be “driving” with only an
annual budget. Given the almost impossible challenge of ensuring that an annual budget
accounts for the organization’s long-term strategic financial interests, piloting without a long-
range plan is a dangerous practice. It offers limited visibility for what is ahead. Seeing the
horizon and navigating a changing environment clearly require longer-term forecasts well
beyond an annual budget.

Many hospitals and health systems could strongly benefit from redesigning their financial
planning processes for better integration of data sources and analytics across their
organizations. They should do so with the firm and well-documented belief that a continuous
and integrated strategic, financial, and capital planning process is essential to thrive in a
dynamic environment. Through this process, hospital and health system leadership teams
can identify the strategies that will best advance their organizations’ missions and objectives,
ensure the viability of such strategies through scenario analyses and other analytics, and then
support the selected strategies with needed capital. This process gives leaders the ability to
balance what they wantto spend for strategic needs, and what they actually can spend.
Continuous measurement of performance ensures that the strategies meet expectations.

A Recommended Integrated Planning Process

An integrated planning model, such as that depicted in the exhibit above allows leadership
teams to quantify the financial impact of business strategies and tie those strategies to specific
capital plans and operating budgets. The process begins in the top middle box, with
identifying, through solid financial testing and planning, the strategies best able to achieve the
organization’s purposes. Through comparative review of consistently prepared capital requests

d

4/7

for these strategies, spending decisions are prioritized by a structured capital allocation
process. Coordinated annual operating and capital budgets, which reflect the strategic-
financial-capital plan, are reviewed by the leadership team and board, and if approved, are
implemented. Outcomes measurement of implemented initiatives includes clinical, financial,
and other performance management data and analytics as identified in the earlier exhibit
above. Feedback and control mechanisms exist to ensure proper integration of all planning
stages.

Increase Enterprise Performance Management Resources
Today is not a time for “business as usual” in health care, where incremental change suffices.
For most hospitals and health systems, a transformational shift involving capital-intensive IT,
delivery system redesign, and human resources is required to meet community needs under
health care’s new imperatives. Capital requests have increased not only for traditional items
such as clinical and management technologies, but also for nontraditional items such as
partnerships related to managed care, networks, and post-acute care services. These
expenditures introduce higher financial risk because the ROI often is not quantifiable or is
difficult to determine.

New needs notwithstanding, two-thirds of surveyed CFOs whose responses were included in
the 2018 report say their organization is experiencing resource constraints, up from 55 percent
reported in the 2017 survey results. About half (49 percent) of CFOs indicate that their
organization has outdated processes and insufficient tools for effective financial planning and
analysis.

To succeed in today’s environment, organizations must pivot from a siloed, micro-view of
disconnected financial management processes and tools to a macro-view. The macro-view
integrates information and analytics to inform (versus simply document) the development of
strategies across healthcare systems and continuum-of-care partners.

In addition, significant new talent is needed with expertise in such areas as:
Value-based care delivery and payment models and associated risks
Clinical, business, and consumer intelligence
Innovation
Performance optimization
Advanced data analytics and supporting technology to transform organizational costs

In particular, cost accounting teams with the time and expertise to accurately and efficiently
identify sources of disproportionate costs, and the right systems and tools to do so, are no
longer optional. Leadership must ensure that the data, analytics, and software platform is in
place to develop, execute, and achieve the organization’s strategic and financial goals. Depth
of expertise is needed to understand and reshape underperforming management processes
and systems.

e

f

5/7

At a minimum, leaders should consider a “reimplementation” of a current underperforming
system. The right processes and the right team may be able to offset system shortcomings.
Leaders should not allow complex and capital-intensive processes, systems, and tools to
become unwieldy or underfunded, which can slow progress, but new technology might not be
required in every situation. An organization may be able to reimplement the current systems
and adopt more effective and efficient processes to capture their value. The most important of
all are the people using the systems and how leadership leverages the information.

The Central Role for Finance
To effectively manage organizational risk, hospitals and health systems should establish high-
level teams, with financial leaders playing a key oversight role as performance improvement
executives. The improvement efforts of these teams might include activities such as:

Developing and implementing credit and interest rate risk-mitigation plans to improve the
probability of meeting or exceeding bond covenants
Enhancing the management of quality performance indicators to reduce care variation,
thereby lowering costs and improving patient outcomes
Performing detailed, data-rich analyses to support well-informed decisions for capital
investments and partnerships that will improve market share or minimize the risk of
market-�share disruption

Some hospitals and health systems are in a position today where they are not achieving strong
enough financial performance to warrant the level of risk they are incurring. These
organizations can better manage performance while mitigating operational risk by applying the
four survey findings-based approaches described here. By helping to remove common
performance management constraints, these approaches constitute an important step on an
organization’s path toward effectively addressing risk within the changing healthcare
landscape. Better processes and integrated systems yield better financial planning, analysis,
and reporting, all of which lower organizational risk.

By assuming a leadership role on a team armed with skills and tools across the components of
enterprise performance management, finance leaders can ensure that their organizations’
response to the question of whether they are manage performance will be “yes.”

Daniel Seargeant, DrPH, �is vice president and product manager of decision support
solutions, Software Division, Kaufman, Hall & Associates, LLC, Skokie, Ill., and a member of
HFMA’s First Illinois Chapter.

Jay Spence is vice president of healthcare solutions, Kaufman, Hall & Associates, LLC,
Skokie, Ill.

Footnotes

6/7

a. Kaufman, Hall & Associates, LLC, 2018 CFO Outlook: Performance Management Trends
and Priorities in Healthcare, January 2018.

b. Krakovsky, M., “Charles O’Reilly: Why Some Companies Seem to Last Forever,” Stanford
Business Magazine, May 31, 2013.

c. Kaufman, Hall & Associates, LLC, 2017 State of Cost Transformation in U.S. Hospitals: An
Urgent Call to Accelerate Action, September 2017.

e. Arlotto, P., “Technology for Population Health Management,” California Hospital Association
and Kaufman, Hall & Associates, LLC, 2015.

f. Seargeant, D., Savage, C., “Cost Accounting Talent and Resources: The Missing Link to
Support Cost Transformation,” Healthcare Cost Containment, December 2017.

Publication Date: Sunday, April 01, 2018

7/7

Copyright of hfm (Healthcare Financial Management) is the property of Healthcare Financial
Management Association and its content may not be copied or emailed to multiple sites or
posted to a listserv without the copyright holder’s express written permission. However, users
may print, download, or email articles for individual use.

31Journal of Health Care Compliance — March–April 2016 31

SURVEYS
JILLIAN BOWER

How Surveys Can Guide Your
Health Care Compliance Program

The Use of Surveys Can Be Your Answer
to Questions from the Board of Directors

H
ealth care compliance surveys provide revealing
data on how well an organization’s compliance
program is functioning. A professional analysis

of the result data may reveal gaps and weaknesses in
the compliance program, as well as areas of risk that
warrant attention. On the other hand, the data can evi-
dence strengths and positive aspects of the compliance
program. Now, more than ever, boards of directors are
looking to their compliance offi cers to provide evidence
and insight on the effectiveness of the operation of com-
pliance programs. In April 2015, the Offi ce of Inspector
General (OIG) issued practical guidance to health care
governing boards. The OIG states in the guidance that
“[b]oards are expected to put forth a meaningful effort
to review the adequacy of existing compliance systems
and functions.”1 The use of surveys can be your answer
to the board’s questions.

The OIG from its earliest compliance guidance docu-
ments has recommended the use of “[q]uestionnaires
developed to solicit impressions of a broad cross sec-
tion” of the workforce.2 Evaluating effectiveness through
the use of questionnaires or surveys can measure the
compliance culture and/or knowledge of the organiza-
tion. The right instrument will evidence the necessary
metrics to determine strengths, weaknesses, and over-
all effectiveness of the compliance program and can be
used to guide your compliance program.

Compliance culture surveys measure the perceptions
and attitudes of organizations’ employees on a number
of issues as they relate to them personally, their imme-
diate work group, their supervisor, and the management
of the organization. The purpose of culture surveys is
to specifi cally assess the compliance culture and work
environment of an organization and assist in the design
of or improvements of compliance programs. The results
provide important insights as to organization’s strengths

Jillian Bower, MPA, is the vice presi-
dent at Compliance Resource Center,
LLC, a company that provides com-
pliance management solutions. She

works directly with clients delivering
employee survey services and analy-
sis of results. For more information,

she can be reached at [email protected]
complianceresource.com or

at 703/683/9600.

Journal of Health Care Compliance — March–April 2016

Surveys

32

care compliance strategies. Other organiza-
tions utilize products already on the mar-
ket that offer an off-the-shelf solution. The
results of the survey will guide the organi-
zation on whether to engage a health care
compliance specialist, utilize a solution, or
use a combination of both approaches.

When using this approach to evaluate
the advancement of a compliance pro-
gram, it is important that any survey has
been developed properly to ensure consis-
tency and accuracy of the results. Just sit-
ting down and drafting questions does not
do much. In fact, there are many things
to consider if we want to use a survey to
provide objective and credible information
regarding the compliance program. These
include data collection method, respon-
dent effort requested, question wording,
order, format, structure, factors to be mea-
sured, and accuracy of the elicited informa-
tion, among others.

Although all these issues are important,
at the end of the day, what we want is to
create surveys that yield results that are
valid and reliable. In the case of validity,
the concern is the accuracy of the survey
method in framing the questions to mea-
sure the right things and to ensure the
questions adequately cover the subject and
the degree in which the results can be gen-
eralized to the entire work force. On the
other hand, reliability relates to the degree
to which the questions used elicit the same
type of information each time they are used
under the same conditions — and also the
consistency by which different questions
measure the same characteristic.3

The manner by which the survey is
administered is also very important.
Employees must know and believe their
input is confi dential and cannot be made
known to management. Otherwise, the
honesty of the answers will be question-
able. For results of surveys to be viewed as
convincing and credible evidence of how
the compliance program is progressing, it is

on which to advance the compliance cul-
ture and areas warranting special attention.
The compliance culture survey questions
should address these specifi c areas:
1. Personal job satisfaction
2. Compliance with laws and regulations
3. Quality of care/service
4. Employee communication
5. Management practices

Compliance knowledge surveys are
designed to assess the employees’ level of
awareness and understanding of the orga-
nization’s compliance program. Organi-
zations gain feedback from employees by
querying them on their knowledge of the
compliance program elements drawn from
their general observations and personal
experiences. The survey results evidenc-
ing employees’ knowledge, awareness, and
understanding of the compliance program
are used to identify positives and weak-
nesses of the compliance program. This
kind of survey should specifi cally focus on
the OIG’s seven elements of an effective
compliance program.

Both survey types provide great insight
into the compliance program’s effective-
ness. When deciding to conduct an annual
survey it is advisable to alternate the sur-
vey types each year. Use of the same survey
has an advantage to benchmark or measure
survey results from the current year against
past years. Survey data can also be bench-
marked against peer organizations that
utilized the same survey. Benchmarking
against peers is an invaluable measure-
ment that can be gained when working
with a fi rm. The OIG in its Compliance
Program Guidance for Hospitals states that
“[t]he existence of benchmarks that demon-
strate implementation and achievements
are essential to any effective compliance
program.”

Through an analysis of the result data
you may fi nd that health care compliance
solutions are needed to close gaps or reme-
diate risks. Many organizations engage with
health care compliance specialists who can
provide customized and tailored health CONTINUED ON PAGE 52

Journal of Health Care Compliance — March–April 201652

SURVEYS
CONTINUED FROM 32

is done professionally and independent of
outside infl uences.

Among the areas that survey data fre-
quently identifi es that need improvement is
written compliance guidance in the form of
policies and procedures and code of conduct.
They are foundation stones for any effective
program, and surprisingly, they are often
not properly laid out. For remedial action,
there are two common approaches: engage
a compliance specialist or purchase policy
and procedure templates from a health care
compliance specialist or fi rm. Engage with a
health care compliance specialist with expe-
rience and expertise to update and revise pol-
icies and procedures. The advantage is that
specialists are knowledgeable on health care
laws, regulations, and program rules with
which the organization must comply and
they know how to interpret those laws, regu-
lations, and rules into understandable poli-
cies and procedures for the covered parties.

An alternative approach is to purchase
compliance policy and document tem-
plates from a health care compliance spe-
cialist or fi rm. On the market today are
companies that specialize in health care
compliance, offering suites of compliance
policies and document templates. If this is
the approach chosen, then it is critical to
fi nd a company that has the expertise in
health care; maintains templates that are
current with laws, regulations, and rules;
and uses a template that requires minimal
changes and edits by you. The purpose of
using a document template is to save you
time, but it must be refl ective of the orga-
nization and health care sector in which
they operate. Any template should be easy
to use, easily adaptable to the organization,
and require minor reworking on your part.

Another area frequently identifi ed in sur-
vey results relates to adequacy of compliance
training. When a survey indicates defi cien-
cies in this area, the compliance training
program will need to be carefully reviewed
in content, delivery, and frequency. The
survey results should provide direction as to
what is needed to be addressed. There are

very important to have the survey adminis-
tered by an outside party that can ensure it

Question: What is the most important skill
of a compliance offi cer?

Answer: Interpersonal skills are the most
important. You have to ask yourself why
our profession was created. It was created
because business failed to prevent, fi nd, and
fi x ethical and regulatory problems. All the
elements of a compliance program — audit,
risk, education, investigations, et cetera —
have been around for years, so doing more
of all that is not going to change anything.

We do not have problems fi nding problems
in business; we have a problem fi xing prob-
lems in business. Enron, WorldCom, Tyco,
Penn State University, VW, and many other
major failures were discovered years before
they were discovered and corrected by the
enforcement community. At some point there
was at least one meeting of leadership to dis-
cuss the problem and determine what to do.
In all those meetings everyone in the room
decided to do nothing. I assume there were
people in the room who wanted to fi x the prob-
lem; however, they clearly lacked the ability
to infl uence leadership to fi x the problem.

More legal analysis would not have helped;
a 5th grader could tell you that some of the
problems they discovered and discussed
were real. A risk assessment could not have
helped Penn State University; they chose to
look the other way because there was no one
in the room that had the authority and abil-
ity to convince leadership to fi x the problem.

To answer the question regarding the
most important skill set of a compliance
offi cer you have to ask yourself: what was
missing from the equation before our pro-
fession was created? What was missing
when leadership got together to discuss a
problem? What was missing was the skill
set required to help the others in the room
make the right decision.

Journal of Health Care Compliance — March–April 2016 53

REFERRAL COMPENSATION
CONTINUED FROM 48

nor any other restrictions on how payment
may be structured, is mentioned in the
bona fi de employee safe harbor. Further,
the safe harbor itself begins with the phrase
“any amount paid by an employer …” These
observations tend to support the notion
that the bona fi de employee safe harbor
should protect the per-patient referral fees
at issue in Crinel and Starks.

WHAT DOES THIS MEAN FOR PROVIDERS?
Per-patient referral fee arrangements
are not per se illegal, but neither are they
entirely risk-free. First, Crinel is a district
court opinion. While the court’s opinion

many health care compliance solutions for
training. In today’s tech-savvy work envi-
ronment, delivering training online is the
most logical and cost-effective solution. The
training must be customized to your unique
organization and must refl ect relevant com-
pliance concerns.

Compliance surveys are invaluable
tools to guide your compliance program.
The use of surveys and implementation
of compliance solutions identifi ed through
the survey results can enhance an existing
compliance program.

Endnotes:
1. Offi ce of Inspector General, U.S. Department of

Health and Human Services. Practical Guidance
for Health Care Governing Boards on Compliance
Oversight. 20 Apr. 2015. oig.hhs.gov/compliance/
compliance-guidance/docs/Practical-Guidance-for-
Health-Care-Boards-on-Compliance-Oversight.pdf.

2. Offi ce of Inspector General, U.S. Department of
Health and Human Services. Publication of the OIG
Compliance Program Guidance for Hospitals. 63
Fed. Reg. 35, 8987, 8997 (Feb. 23, 1998).

3. Public Opinion Quarterly, Vol. 68 No. 1 Pp. 109–
130, American Association for Public Opinion
Research 2004; Methods for Testing and Evaluating
Survey Questions. isites.harvard.edu/fs/docs/
icb.topic1352376.fi les/Presser%20et%20al%20
Cognitive%20Testing.pdf.

was well-reasoned, district court opinions
are treated by other courts as persuasive, not
binding, authority. And even where the hold-
ing in Crinel may apply, a person still has the
burden to prove, not only that the payment
was made to a bona fi de employee but that
the referred item or service was medically
necessary under the relevant federal health
care program’s regulations and policies. The
latter is no easy burden, particularly for post-
acute providers who are frequently at odds
with Medicare’s administrative contractors
over medical necessity issues.

In any event, without any OIG guid-
ance, or further decisions by other federal
courts, we suggest that, when structuring
compensation arrangements for market-
ing employees, providers focus particular
attention on mitigating the risks of fraud
and abuse. As an initial matter, providers
should consider compensating marketing
employees based on a salary or an hourly
wage, rather than a per-patient referral fee.
Salaries and hourly wages may provide
indicia of a bona fi de employment relation-
ship and, unlike per-patient referral fees,
may reduce the incentive for referrals to be
made without regard to medical necessity.

Similarly, in determining the market-
ing employee’s specifi c compensation,
including bonuses, we suggest that provid-
ers evaluate a variety of factors, includ-
ing employee compliance with internal
fraud and abuse policies (which every pro-
vider, large or small, should maintain and
enforce), feedback from referring health
care professionals who interact with the
marketing employee, and other qualita-
tive performance measures. These are just
a few examples of useful metrics. Indeed,
providers should seek further guidance —
based on their specifi c operations — to
ensure protection under the exception and
safe harbor, while also maintaining effec-
tive marketing efforts.

Endnotes:
* The views and opinions expressed in this article are

solely those of the authors and do not represent the

Copyright of Journal of Health Care Compliance is the property of Aspen Publishers Inc. and
its content may not be copied or emailed to multiple sites or posted to a listserv without the
copyright holder’s express written permission. However, users may print, download, or email
articles for individual use.

performance improvement

A New Framework for Healthcare
Performance Improvement
Building a new, patient-centric continuum of care requires a
fundamental restructuring of the healthcare system.

By Gary Auton

The move to value-based payment is alter-
ing the structure and focus of healthcare
organizations. Every sea change demands
strong leadership and a winning game plan
to achieve enduring success. That game
plan is performance improvement.

However, health systems have perfor-
mance improvement strategies that often
are not in sync with emerging marketplace
requirements. Performance improvement
plans are frequently based on slow, incre-
mental improvement centered on labor
productivity, supply, and other non-labor
costs. These traditional approaches, while
useful, cannot alone offset payment and
volume declines for most organizations.

Building a new, patient-centric con-
tinuum of care requires a restructuring of
the healthcare system and a new taxonomy
of performance improvement interven-
tions that are faster, broader, and more
strategic than those adopted in the past.
Improvement initiatives must increasingly
focus on long-term, high-impact areas that
re-engineer clinical care, sharpen service
portfolios, and exploit scale of operations.

Levels of Performance Improvement
Performance improvement opportunities
accrue at different points and with varying
scope in a health system. Specifically, per-
formance improvement takes place at three
levels: the department or program (pro-
cess) level, the cross-functional or cross-
site (structural) level, and the cross-market
or cross-population (portfolio) level.

Process Level
Process changes represent the routine
operational modifications leaders make
daily in their areas of responsibili-
ties. Process initiatives include routine

department-level changes in work sched-
ules, role design, and workflow improve-
ments that improve staff utilization and
service to patients. Specifically, program
level changes include:

Process improvement. Strengthens the
services and value provided to patients,
families, physicians, and other stakehold-
er groups. Department-level initiatives
usually focus on reducing waste, improving
cycle time, and building reliability into key
work processes.

Facilities optimization. Modifies the layout
and workspace of a department to improve
patient flow and facilitate the effective use
of resources.

Demand smoothing. Improves patient and
work activity scheduling to balance work-
load across days and weeks.

Role and team design. Creates jobs and as-
signs responsibilities to improve flexibility
and workload balance across work teams.

Dynamic staffing. Improves staff scheduling
and deployment to meet variable workload
demand.

The organizational impact resulting from
process-level changes depends on depart-
ment size and complexity. Organizations in
the early stages of performance improve-
ment should first focus on building depart-
ment-level processes and systems.

Structural Level
At some point, health system leaders find
that further improvement only can occur
by addressing processes and systems that

2 Fall 2018 Strategic Financial Planning

ISSN: 1934-7103

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cross over into other areas of organizations.
These improvement opportunities occur at
the second, or structural, level. Structural
improvements represent operational inter-
ventions that are executed among functions
both in single facilities and across multiple
facilities in health systems. These inter-
ventions often challenge and alter the foun-
dational assumptions of hospital and health
system processes and organizations.

Structural improvement levers include:

Structural process improvement. Improves
key business processes across functions
and system entities to enhance service
continuity.

Management restructuring. Redesigns lead-
ership roles to better leverage management
resources across departments, programs,
and sites.

System rationalization. Leverages the advan-
tages of system scale to rationalize staffing
and resources across multiple entities.

Service redeployment. Relocates resources
and services to different areas to improve
service and lower operating costs.

Non-labor optimization. Builds processes
and systems to manage enterprisewide
supplies and other non-labor expenses.

Demand regrouping. Reaggregates work to
achieve better resource alignment, build
proficiencies, and improve workload bal-
ancing across time and functions.

Utilization improvement. Lowers case cost
and contribution margins by reducing un-
necessary utilization of clinical services.

Off-quality improvement. Improves clinical
quality outcomes and minimizes the costs
of unfavorable quality events.

Structural improvement projects are of-
ten complex, requiring a great deal of time
and effort and the involvement of large, di-
verse groups of leaders and staff. When ex-
ecuted effectively, structural improvement

initiatives can yield substantial gains in
organizational performance.

Portfolio Level
Beyond process and structural changes,
further performance improvement is
achieved through alterations in health sys-
tems’ portfolio of services and programs.
Portfolio-level changes occur when health
systems reconfigure and redesign programs
and services to respond to changes in

market demand. The aim of portfolio man-
agement is to maintain a service offering
that meets market demand and maximizes
revenues and margins. For health systems,
portfolio improvement includes:

Service divestment. Identifies services to
eliminate or markets to exit.

Service outsourcing. Determines which
care continuum components should be

Performance Improvement Levels in Health Systems

Performance improvement takes place at the department or program (process) level,
the cross-functional or cross-site (structural) level, and the cross-market or cross-population
(portfolio) level.

Pro
ces

s

Str
uct

ure

Por
tfol

io

Department/
Program-Level Improvement

Cross-Functional,
Cross-Site Improvement

Cross-Market, Cross-
Population Improvement

Source: Galloway Consulting, an ADAMS company. Used with permission.

5 Keys to Successful Performance Improvement

Think big. Leaders need to break with traditional, incremental improvement approaches and
pursue broader, bolder interventions that have the promise of long-term strategic and opera-
tional payoff.

Leaders don’t have to start from scratch. Most health system improvement opportunities can be
anticipated. The key is to apply the appropriate “levers” to the most important areas and issues.

Don’t wait too late. This work should begin while health systems are prosperous and are still
evolving as integrated systems. It is difficult to make long-term changes when an organization is
struggling with immediate margin challenges.

Engage key constituents. Leaders must align and motivate physicians, employees, and other
stakeholders throughout the process or face a lack of support and opposition.

It’s mostly about leadership. Large-scale performance improvement requires strong, visionary
leadership from assessment through implementation. Organizational change and renewal is not
possible without effective executives leading the way.

hfma.org/sfp Fall 2018 3

Example of a System-Level Gap Closure Plan

A hospital executive team developed a multiyear gap closure strategy featuring the deployment of 11 expansive performance improvement initiatives,
including three initiatives focused exclusively on the physician practices division. The plan enabled the organization to achieve a positive operating
margin by the second year.

Performance
Improvement Initative Improvement Levers

Economic Improvement Targets

Year 1 Year 2 Year 3 Year 4

H
os

p
it

al

an
d

S
ys

te
m

-L
ed

In
it

ia
ti

ve
s

Labor productivity* #1-Process improvement, #2-Structural process
improvement, #3-Facilities optimization,
#4-Demand smoothing, #5-Demand grouping,
#6-Role and team redesign, #7-Dynamic staffing,
#10-Service redeployment

$10,450,000 $11,495,000 $12,644,500 $13,908,000

Leadership restruc-
turing and functional
consolidation†

#8-Management restructuring, #9-System
rationalization, #10-Service redeployment

$2,000,000 $5,340,000 $9,450,000 $10,395,000

Supplies and
purchased services‡

#11 Non-labor optimization $3,500,000 $4,025,000 $4,628,500 $5,323,000

Portfolio review§ #16-Service outsourcing, #17-Service divest-
ment, #18-Continuum realignment

$500,000 $1,000,000 $3,200,000 $4,000,000

Clinical utilization|| #12-Utilization improvement $2,500,000 $3,250,000 $4,387,500 $6,142,000

Quality improvement# #13-Off-quality improvement $0 $1,950,000 $2,340,000 $2,808,000

Revenue cycle** #15-Revenue optimization $5,800,000 $5,280,000 $5,280,000 $5,280,000

Growth†† #14-Demand growth $2,580,000 $2,760,600 $2,953,842 $3,614,000

P
hy

si
ci

an
E

nt
er

p
ri

se

In
it

ia
ti

ve
s

Labor productivity‡‡ #1-Process improvement, #2-Structural process
improvement, #3-Facilities optimization,
#4-Demand smoothing, #5-Demand group-
ing, #6-Role and team redesign, #7-Dynamic
staffing, #10-Service redeployment, #17-Service
divestment

$1,580,000 $1,896,000 $2,370,000 $2,844,000

Revenue cycle§§ #2-Structural process improvement, #15-Reve-
nue optimization

$1,500,000 $3,000,000 $3,000,000 $3,000,000

Growth## #14-Demand growth $4,950,000 $5,692,500 $6,546,500 $7,528,000

Forecasted gap $36,500,000 $45,000,000 $51,000,000 $60,000,000

Gap closure total $35,360,000 $45,689,000 $56,800,000 $64,842,000

Remaining gap $1,140,000 -$689,000 -$5,800,000 -$4,842,000

Source: Galloway Consulting, an ADAMS company. Used with permission.

* Target 35th percentile benchmark staffing in all departments
† Start initially with regional management restructuring
‡ Physician preference, commodity, pharmaceuticals, and purchased services
§ Will take longer to implement
|| Focus on length of stay for Medicare patients and cost per case on cardiac, neurology, and orthopedic patients
# Focus on reducing readmission, deep vein thrombosis, and ventilator-associated pneumonia
** Improve charge capture and coding; reduce denials
†† Reduce leakage; build service line referrals
‡‡ Improve staffing to 65th percentile Medical Group Management Association Benchmarks, divest low-performing practices, and consolidate support and administrative

services
§§ Improve clinical documentation and coding
## Open new practices and improve access to existing practices

4 Fall 2018 Strategic Financial Planning

produced internally versus by partnering
entities.

Demand growth. Identifies strategic mar-
keting opportunities and tactical growth
initiatives to build top-line revenues.

Revenue optimization. Improves net reve-
nues and margins through enhancements
to organizations’ revenue cycles.

Continuum realignment. Realigns programs,
resources, and investments to build a
stronger service continuum.

Portfolio improvement is a growing area
of focus for large healthcare systems. As
accountable care and population health
initiatives transform healthcare delivery,
health systems must institute changes to
their service portfolio by reducing invest-
ments in existing programs and building
new programs and capabilities. Similarly,
growth and revenue cycle improvements
are necessary for building and sustaining
operating margins.

System-Level Gap Closure Plan
Performance improvement strategies must
address an increasingly broad range of
operational issues and extend for multiple
years. For example, in a four-year financial
gap closure strategy for a regional health-
care system, a hospital CFO prepared a
forecast of the organization’s expected de-
cline in operating margins under a scenario
that net revenues per inpatient case for all
payers would approach prevailing Medicare
rates. Based on this scenario, the organi-
zation’s operating margins would drop by
$36 million in the first year and grow to
$60 million by the fourth year.

The executive team then developed a
multiyear gap closure strategy featuring the
deployment of 11 performance improve-
ment initiatives, including three focused
exclusively on the physician practices
division (see exhibit on page 4). The plan
enabled the organization to achieve a posi-
tive operating margin by the second year.

Of note is that the strategy was built on
assumptions of when benefits were expect-
ed to be achieved and that these savings

would be sustained over time. For example,
the labor productivity team forecasted a
savings of 175 FTE staff in the first year. The
$10.4 million savings would be sustained
and accrue over subsequent years.

This example illustrates several dynamics
of multiyear performance improvement:

> Financial gap closure requires a
multiyear portfolio of short-term and
longer-term initiatives.
> Short-term improvements are found
primarily through a focus on labor pro-
ductivity and non-labor expenses.
> Revenue cycle improvements may
generate substantial revenue gains in
the short term as well, depending on
organizations’ current performance.
> These short-term initiatives are nec-
essary but insufficient for closing large
financial gaps over extended periods.
> Savings resulting from clinical utiliza-
tion, quality, and portfolio improve-
ments can be substantial, but they take
longer to implement than other cost and
revenue improvements, with benefits
from the long-term initiatives generally
accruing two to three years after launch.
> Revenue growth normally includes
short-term tactical improvement and
long-term strategic opportunities.

The work required to transform health-
care systems can be daunting. Large-scale
performance improvement challenges
leaders at all levels of the organization and
usually surfaces unaddressed operational,
strategic, and cultural gaps. Paradoxically,
leaders who are tasked with driving per-
formance improvement are often those
individuals most threatened by the change.
It is not surprising that many transforma-
tion initiatives fall short of expectations.
However, by demonstrating organizational
value and the impact on future viability,
performance improvement champions can
bring others on board.

Gary Auton
is senior director, Galloway Consulting, an ADAMS
Company ([email protected]).

data analysis

Hospitals Are Using
Cost Reduction
To Reduce Patient
Charges
By Jamie Cleverley

Within a decade, average
charge inflation for U.S.
acute-care hospitals fell
from 6-8 percent.

I was talking with a group of hospital ad-
ministrators recently, and we were discuss-
ing levels of price and cost inflation in the
industry. I remarked that when I started in
the industry more than 15 years ago, it was
common to see price inflation exceeding
10 percent per year. It’s almost difficult to
imagine or remember those times now with
significantly lower rates of gross charge
inflation.

That discussion prompted a question
from the group about how cost changes
have influenced or aided the reduction in
gross price inflation. The thought was that
perhaps a portion of the lower gross charge
inflation rates in the industry today could
be attributed to the efforts hospitals have
made at containing cost growth. As a result
of lower utilization of services per patient
encounter, overall charge growth could
be reduced. This speculation should be
explored further.

A Construct to Measure Inflation
Although there are multiple ways to eval-
uate cost and charge inflation, we decided
to consider the average cost and charge for
the “products” that acute-care hospitals
provide: patient encounters. To measure,
we used Medicare claims data and reviewed
average claim charges in 2005-06, as well
as, 2015-16. Costs were estimated by using
department-specific ratios of cost-to-
charge (RCC) found on filed Medicare
Cost Reports applied to corresponding

hfma.org/sfp Fall 2018 5

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posted to a listserv without the copyright holder’s express written permission. However, users
may print, download, or email articles for individual use.

EVIDENCE-
BASED CARE
SHEET

Authors
Jennifer Kornusky, RN, MS

Cinahl Information Systems, Glendale, CA

Debra Balderrama, RN, MSCIS
Clinical Informatics Services, Tujunga, CA

Reviewers
Darlene Strayer, RN, MBA

Cinahl Information Systems, Glendale, CA

Sara Richards, MSN, RN
Cinahl Information Systems, Glendale, CA

Nursing Executive Practice Council
Glendale Adventist Medical Center,

Glendale, CA

Editor
Diane Pravikoff, RN, PhD, FAAN

Cinahl Information Systems, Glendale, CA

September 7, 2018

Published by Cinahl Information Systems, a division of EBSCO Information Services. Copyright©2018, Cinahl Information Systems. All rights
reserved. No part of this may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by
any information storage and retrieval system, without permission in writing from the publisher. Cinahl Information Systems accepts no liability for advice
or information given herein or errors/omissions in the text. It is merely intended as a general informational overview of the subject for the healthcare
professional. Cinahl Information Systems, 1509 Wilson Terrace, Glendale, CA 91206

Adverse Healthcare Events: Prevention – Failure Modes
and Effects Analysis (FMEA)

What We Know
› According to The Joint Commission (TJC), the likelihood of adverse events occurring can

be reduced by participating in a proactive risk assessment process(6)

• Risk assessments should focus on processes that have the greatest risk for impacting
patient safety

• TJC standards address the need for hospitals to regularly evaluate safety. These
standards include having a process that focuses on and addresses safety, using data
when making decisions regarding processes and their impact on performance, and
implementing process changes as needed to promote improved performance(8)

• The World Health Organization (WHO) defines adverse healthcare events as
“undesirable incidents” that result from the care provided by healthcare services that
may or may not hurt the patient but extend the length of stay (LOS) in the hospital
because of the adverse event that was not related to the patient’s initial admission
diagnosis(9)

› Failure Modes and Effects Analysis (FMEA) is a team-based systematic and proactive
approach for identifying the ways that a process or system can fail, why it might fail, the
effects of failure, and how the process can be made safer(1,4,5,6)

• FMEA is also known as Failure Modes Effect and Criticality Analysis (FMECA) and
Potential or Process Failure Modes and Effects Analysis (PFMEA)(10)

› FMEA is a widely used technique in health care for the proactive identification of
possible failures in high-risk clinical processes and systems(2,4,6)

• High-risk clinical processes are those that involve multiple steps and for which process
failure is likely to cause severe harm to patients(4,5,6)

– Examples of high-risk clinical processes in health care are medication use, operative
procedures, blood transfusions, and emergency care/resuscitation(5)

– Failure in such processes can result in a sentinel event (i.e., severe temporary or
permanent patient injury or death)(5,6,7)

› Definitions of key terms used in FMEA(1,6,10)

• Failure means any malfunction, error, or defect that results in a process not being
performing as intended

• Failure mode means anything that could go wrong during the completion of a step in the
process

• Effects analysis means studying the effects, results, or consequences of the failure mode
› FMEA is used prospectively to identify potential failures in high-riskclinical systems and

to fix the potential failure before an adverse event can actually occur(1,4,5,6)

• The goal of using FMEA is to prevent patient harm(1,4,5,6)

• FMEA is performed before an adverse event occurs. It is preventive and poses the
question, “What could go wrong?”(5)

• FMEA is not performed as a retrospective analysis after an adverse event occurs and
does not pose the question, “What went wrong?”(5)

• FMEA does not focus on a specific event, but rather on a specific process
› The FMEA technique was not initially developed for use in health care(4)

• FMEA was first used in the 1940s by the United States military(2)

• FMEA began to be used in the aerospace industry in the 1960s and its use expanded to other fields in the 1970s and 1980s,
including nuclear power, aviation, chemical, and electronics fields(5,10)

• FMEA was introduced in health care in 2002 when TJC initiated the requirement that hospitals perform a proactive risk
assessment on all high-risk processes at least once each year(1,2,5)

› There are several specialized types of FMEA that are specific to the purpose for performing the FMEA
• In 2001, the US Department of Veterans Affairs (VA) National Center for Patient Safety developed a specialized tool for

health care called the Health Care-FMEA (HFMEA)(1,3)

– Although the first 3 steps in FMEA and HFMEA are the same, HFMEA includes additional steps that are not part of
FMEA

– HFMEA includes a Hazard Scoring Matrix, which simplifies the scoring system
– With the exception of the use of HFMEA in the VA, FMEA is more commonly taught and utilized in health care(4,6)

› A series of sequential steps are required to conduct an FMEA(1,3,4,5,6,10)

• Step 1: Select a high-risk clinical process to analyze with FMEA
– For example, to identify where and how medication errors occur, the system for medication use and administration would

be analyzed
• Step 2: Identify a multidisciplinary team of healthcare clinicians

– It is essential that all members of the team know and understand the process being analyzed. Clinicians who use the
system are knowledgeable regarding its vulnerabilities and the points at which failure could occur(1,4,5,10)

– To review medication use, nurses, pharmacists, and physicians would be assigned to the team
• Step 3: The team should identify and document all steps that are performed in the process of medication use and

administration
– The first step would be the physician who is ordering/prescribing a medication

• Step 4: For each step, the team should list all potential failure modes
– In the first step of the system for medication use, a potential failure mode would be that the physician writes an

incomplete order
• Step 5: For each failure mode the team should identify possible causes

– Identified causes are the reasons why certain steps in the process could fail. The team should list all possible causes for
failure(1,4,5)

– For example, possible causes for a physician to write an incomplete order are that the physician
– is distracted
– hand-writes the order and his/her writing is not legible
– does not follow the facility’s established protocol for writing orders

• Step 6: For each failure mode that is identified, the team should identify the potential effects of failure
– Potential effects of an incomplete order are that the patient could receive the

– wrong dosage of the medication
– medication by the wrong route

• Step 7: For each failure mode that is identified, the team should assign a numeric value of 1–10 to represent the likelihood
of occurrence, likelihood of detection, and severity of the failure (i.e., the severity of the effect on the patient if failure
occurs)(1,4,5)

– The team determines the likelihood of occurrence and assigns a score of 1–10, with 1 meaning it is very unlikely to occur
and 10 meaning it is very likely to occur

– The team determines the likelihood of detection before the failure occurs and assigns a score of 1–10, with 1 meaning it is
very likely to be detected and 10 meaning it is very unlikely to be detected

– The team determines the severity of the failure and assigns a score of 1–10, with 1 meaning it is very unlikely that harm
to the patient will occur and 10 meaning it is very likely that severe harm will occur
– Assigning a severity score of 10 indicates that it is very likely the patient would die as a result of the failure

• Step 8: The team should calculate the risk priority number (RPN) for each failure mode(1,4,5)

– An RPN is calculated for each identified failure mode by multiplying the 3 scores for likelihood of occurrence, likelihood
of detection, and severity assigned to each failure mode

– For example, if a failure mode was scored 3 for likelihood of occurrence, 5 for likelihood of detection, and 5 for severity,
the failure mode would receive an overall RPN of 75 based on the calculation 3 x 5 x 5

• Step 9: The team should redesign the process or system to prevent, avoid, or mitigate the identified failure modes
– Process/system redesign strategies focus on decreasing the frequency of occurrence, increasing detectability, and/or

reducing the severity of a failure mode(1,4,5)

– Strategies for decreasing the frequency of occurrence of a failure mode include implementing checklists, performing
double-checks, establishing procedural redundancy, and eliminating causes

– Strategies for increasing the detectability of a failure mode include implementing automated warning systems,
technologic alerts, and/or devices with alarms

– Strategies for reducing the severity of the effects of a failure mode include implementing methods that facilitate early
identification of an adverse event such as increased monitoring of vital signs and developing rapid response teams

– Failure modes with a high RPN, especially those with high severity scores, should be prioritized(1,4,5)

• Step 10: The redesigned process/system should be implemented, tested, and serially evaluated(1,4,5,6)

What We Can Do
› Learn about FMEA and participate in the multidisciplinary team performing FMEA in your facility so you can prevent

adverse healthcare events in your patient population
› Collaborate with your colleagues to identify a high-risk clinical process and perform FMEA to reduce the incidence of

adverse events. Apply FMEA methodology to list the steps in the process/system; identify failure modes, causes, and effects;
assign values for likelihood of occurrence and detection and for severity; and calculate RPN. Use the following template, as
appropriate:(4)

.

Steps in
Process

Failure
Mode

Failure
Causes

Failure
Effects

Occurrence
(1–10)

Detection
(1–10)

Severity
(1-10)

RPN

Actions
Taken to
Redesign
Process

1
2

.
› Consider performing FMEA on the use of restraints, chemotherapy administration, parenteral electrolyte use, admission/

discharge/transfer processes, and/or the patient identification process
› After performing FMEA, redesign the analyzed process/system, implement the new process, test the new process, and

serially monitor and evaluate changes in the process

Coding Matrix
References are rated using the following codes, listed in order of strength:

M Published meta-analysis

SR Published systematic or integrative literature review

RCT Published research (randomized controlled trial)

R Published research (not randomized controlled trial)

C Case histories, case studies

G Published guidelines

RV Published review of the literature

RU Published research utilization report

QI Published quality improvement report

L Legislation

PGR Published government report

PFR Published funded report

PP Policies, procedures, protocols

X Practice exemplars, stories, opinions

GI General or background information/texts/reports

U Unpublished research, reviews, poster presentations or
other such materials

CP Conference proceedings, abstracts, presentation

References
1. Brook, O. R., Mendiratta-Lala, M., & Hallett, D. T. (2011). Application of Failure Mode and Effect Analysis in a radiology department. RadioGraphics, 31, 281-293. doi:10.1148/

rg.311105018 (QI)

2. California Hospital Patient Safety Organization (CHPSO). (2011). FMEA: Not just for compliance anymore. Patient Safety News. Retrieved August 23, 2018, from
http://www.chpso.org/sites/main/files/file-attachments/201104_0.pdf (QI)

3. DeRosier, J., Stalhandske, E., Bagian, J. P., & Nudell, T. (2002). Using health care failure mode and effect analysis: The VA national center for patient safety’s prospective risk
analysis system. The Joint Commission Journal on Quality Improvement, 28(5), 248-267. (PGR)

4. Institute for Healthcare Improvement. (n.d.). Failure modes and effects analysis (FMEA). Retrieved August 23, 2018, from http://www.ihi.org/resources/pages/tools/
failuremodesandeffectsanalysistool.aspx (G)

5. Institute for Safe Medication Practices Canada. (n.d.). Failure modes and effects analysis workshop. Retrieved August 23, 2018, from
https://www.ismp-canada.org/download/ISMP_Canada_FMEA_presentation.pdf (CP)

6. The Joint Commission. (2016). 2016 Comprehensive accreditation manual for hospitals: The Patient Safety Systems Chapter. Retrieved August 23, 2018, from https://
www.jointcommission.org/assets/1/18/PSC_for_Web.pdf (G)

7. The Joint Commission. (2016, January 1). Sentinel events (SE). In Comprehensive accreditation manual for hospitals (CAMH) (pp. 1-19). Oakbrook, IL: Joint Commission
Resources, Inc. (G)

8. The Joint Commission. (2018). 2018 Comprehensive accreditation manual for hospitals. Oakbrook Terrace, IL: Joint Commission Resources. (G)

9. Serafim, C. T. R., Dell’Acqua, M. C. Q., Castro, M. C. N. E., Spiri, W. C., & Nunes, H. R. C. (2017). Severity and workload related to adverse events in the ICU. Revista
Brasileira de Enfermagem, 70(5), 942-948. doi:10.1590/0034-7167-2016-0427 (R)

10. Tague, N. R. (2005). In Failure Mode Effects Analysis (FMEA). The Quality Toolbox <http://asq.org/quality-press/display-item/index.html?item=H1224> (2nd ed., pp. 236-240). :
American Society of Quality, Quality Press, Milwaukee. (QI)

Quality/patient safety

20 years after To Err Is Human
A look back on the landmark study on human error and broken systems

by Brian Ward

On November 29, 1999, the landmark study To Err Is
Human: Building a Safer Health System was released. In it, the
authors claimed that to prevent countless instances of medical
errors and harm, providers needed to stop placing blame on
individuals and start looking at the systems those individuals
worked in instead. This was completely at odds with the
prevailing culture in healthcare, and its release kicked off the
patient safety movement as we know it.

Twenty years later, providers are still trying to achieve
zero harm. While no one would say that we’re close to that
goal, a lot of progress has been made—progress that’s saved
many lives.

When it came out

Klaus Nether is the executive director of high reliability
product delivery at The Joint Commission Center for Trans-
forming Healthcare. He was working in laboratory manage-
ment when he first read the report.

“Many times, especially with liability issues, it becomes
very difficult to be open and honest and transparent about
errors that occur in healthcare,” he says. “When To Err Is
Human came out, it was groundbreaking because it brought all
that to light.”

Nether says everyone he has met in healthcare wants to do
the best job they can. But even at the best facilities, there are
processes and systems that don’t work as expected—some-
times resulting in harm or death. Learning to prioritize
patients and fix errors rather than laying blame has been a step
forward, in his opinion.

“For me personally, from a laboratory standpoint, I think it
changed my way of thinking,” he added. “Because it was
always about ‘How good were we?’ and we were always 95%
good or 97%, 99% good. But we never thought of the flip side
of it—1%, 3%, 5% errors and what that actually meant and the
magnitude of it.”

Anne Marie Benedicto, MPP, MPH, vice president of The
Joint Commission Center for Transforming Healthcare,
remembers when To Err came out.

January 2020 | Volume 21, Issue No. 1

In this Issue

Patient Safety Monitor Journal

Training for excellent care

“When a positive and open culture is created,
great things happen and everyone benefits,
especially patients.”

PSMJ decade review, part two

Looking ahead to 2020 and beyond.

Waters of life

Care capability can be degraded by 99% within two
hours when a hospital has a water system disruption

Drug diversion in the opioid crisis

A return to TJC’s Quick Safety 48 alert, and how to
keep medicines in the correct hands.

Five strategies for treating opioid addiction

System-level strategies for hospitals to improve
prevention, identification, and treatment of opioid
use disorder.

P4

Credit: Evgeny555. Image Source: www.gettyimages.com

P5

P6

P8

P11

HCPro.com

2 | Patient Safety Monitor Journal January 2020

© 2020 HCPro, a Simplify Compliance brand.

“I was fairly young in healthcare,” she says. “I
thought that this whole idea that you can’t prevent people
from making mistakes because it’s part of the human
condition—to fail, to make mistakes, to not always be
100% vigilant because we’re not robots—I thought that
wasn’t a big deal. Coming in as a fairly new person in
healthcare, I made mistakes several times a day.”

After spending more time in healthcare, Benedicto
realized why the report was such a big leap. There’s a
huge pressure to be perfect, she says, because mistakes
can result in harm to the patient and staff.

“Instead of expecting people to be doing
120% every day and every time, it might
be easier to address the systems and

structures that support them so it’s easi-
er for them to not make mistakes.”

Anne Marie Benedicto, MPP, MPH

“We put such a high bar on perfection in how we
perform, without really understanding that it’s not
about making people perfect,” she says—adding that
other industries do understand this. “It’s making
systems as good and strong as they can be so you’re
supporting the humans in them and creating an envi-
ronment where they can do their best work.”

It’s hazardous when healthcare systems require
providers to be super vigilant to avoid patient harm, she
says. It’s detrimental to have a culture that punishes
people for making mistakes, even when those mistakes
are based on flawed systems. And it’s an issue when
there’s no infrastructure to learn from mistakes and use
those lessons to make your system stronger.

“What we have in healthcare is really good, smart,
talented people working in flawed systems,” she adds.
“And we expect heroic behavior every day when some-
times instead of expecting people to be doing 120%
every day and every time, it might be easier to address
the systems and structures that support them so it’s
easier for them to not make mistakes. And if they do
make mistakes, there are enough protections within
your system that mistakes don’t always result in harm.
[So] people can just be human and make errors.”

What’s changed?

When To Err Is Human came out and healthcare
organizations digested what it meant, a lot of attention
and resources were directed at healthcare improvement.
How can we strengthen our practice? How can we make
things better? How can we incorporate improvement
methodology into healthcare?

There was a recognition that this was necessary,
Benedicto says, and much has been done. There’s been
progress on things like healthcare-acquired infections,
with rates continuing to decline. Nether points to
decreases in central line–associated bloodstream
infections, falls, and falls with injuries.

“However,” Benedicto says, “if we got healthcare
leaders together and asked them, ‘Are you happy with
the state of improvement? Have we achieved zero
harm? Are healthcare organizations as safe as they
could be?’ I think generally we will hear people say,
‘No, we are not where we need to be.’ ”

“There’s still a lot of work to do,” Nether adds. “I
think one of the things healthcare organizations strug-
gle a lot with is sustaining the improvements they make.
There’s so many different variables that get introduced
into an organization. One of the things that I see is that
people leave one organization or come in from another,
bringing a variation to the process that sometimes
results in bad outcomes.”

“It was always about ‘How good were
we?’ and we were always 95% good

or 97%, 99% good. But we never
thought of the flip side of it—1%, 3%,

5% errors and what that actually
meant and the magnitude of it.”

Klaus Nether

Aviation and nuclear power

You might have heard the airline industry or
nuclear power industries cited as examples of high
reliability organizations. True, there have been some
famous and catastrophic disasters in both those fields.
But since then, they’ve built off of past mistakes to
become some of the safest industries around.

“If you compare their rates of harm to healthcare,
we pale in comparison; we have much more harm than
commercial airlines or nuclear power,” Benedicto says.

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Patient Safety Monitor Journal | 3January 2020

© 2020 HCPro, a Simplify Compliance brand. .

“And that’s because the mindset, culture, and practices
that support that outcome of nearly zero harm in airline
and nuclear power is very different from healthcare.”

The commercial airlines have such low rates of
harm that they’ve learned to become even safer by
investigating events and variations in their process that
have not resulted in harm. While healthcare organiza-
tions have more than enough harmful errors, Benedicto
says there’s been a growing awareness of the need to
study close calls—events or mistakes that happened but
didn’t harm the patient.

“Those are free lessons—you didn’t harm anyone,
but you can see the flaws in your system,” she says.

While the safety of the healthcare industry is often
compared to that of commercial aviation and nuclear
power, some argue that healthcare is too different for
the comparison to be fair. And Benedicto says there’s
truth to that.

“Even a small hospital is a very complex organiza-
tion,” she says. “I think the level of complexity in
healthcare organizations is bigger than even a nuclear
power plant, which is amazing if you think about it.
And if you start looking at healthcare organizations
now, the gigantic systems that are being created and
formed, you can see the level of complexity is increas-
ing. It’s not quite apples to apples [with nuclear power].”

Another barrier is that healthcare organizations
have not built the infrastructure they need to make
improvements common practice. Dawn Allbee works at
The Joint Commission Center for Transforming
Healthcare as the executive director of customer
engagement. Part of the Center’s work is helping
healthcare organizations strengthen their robust pro-
cess improvement programs.

“The key thing is having the tools to do [improve-
ment],” Allbee says. “Currently, healthcare organiza-
tions are looking for the best practice to fix hand
hygiene, the best practice to eliminate wrong-site
surgery. Best practices work when the causes are few
and variation is little.”

With persistent healthcare problems, she says, you
need a strong set of tools to identify where the root
causes are. That’s not something healthcare organiza-
tions necessarily have, she says, but it’s something they
need.

“Everything we’ve been doing to this point [to solve
problems] has been working to a modest level,” she

says. “But you really need to dig in deep to understand
what those root causes are to come up with that tar-
geted solution to solve that problem vs. ‘We think this
might work, let’s try this—oh, it didn’t work; let’s try
something else.’ ”

People working in healthcare are there for the
patients, she says, and need to be caring directly for
those patients. That can limit their time for improve-
ment training.

“However, it’s very important to give them the
toolset so they can go ahead and work on these im-
provements in their daily work,” she says.

What’s next?

“This is a very exciting time to be in healthcare,”
Benedicto says. “A lot of the things we’ve taken for
granted—hierarchies in healthcare, the way organiza-
tions engage their employees, what kind of investments
they make—all those ideas are being challenged, and
we are starting to see very exciting results in organiza-
tions who have made a commitment to zero harm.”

“You really need to dig in deep to under-
stand what those root causes are to

come up with that targeted solution to
solve that problem vs. ‘We think this
might work, let’s try this—oh, it didn’t

work; let’s try something else.’”
Dawn Allbee

As a next step, she says, leaders need to recognize
that zero harm is achievable. It’s their job—they set the
vision for their organization, allocate resources, and
ultimately are the ones who make zero harm possible.
However, in a recent Center study on zero harm and
care excellence, 77% of respondents identified leader-
ship as a barrier to excellence.

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“That’s not my experience talking to a lot of health-
care leaders across the country; they’re very committed
to excellence,” says Benedicto. “But there appears to be
a disconnection between that commitment and what
their team sees and experiences.”

Leaders need to visibly and vocally set the goal of
zero harm, she says, and “connect the dots so that
people see that ‘This is our goal, this is how we’re going
to get there, and this is what I expect from you.’ ”

Those types of communications and the actions
that follow them show providers that their leaders value
the pursuit of excellence just as much as they do. What
strikes Benedicto about the goal of zero harm—as put
forth in To Err Is Human—is that even within very
complex organizations, safety comes down to the
people and leaders within them.

“When staff starts getting engaged in zero harm
and see their role in keeping patients safe and doing the
best work they can, you can really see an organization
change,” she says. “That transformation to high reliabil-
ity, you need to have near-perfect systems, you need to
become a strong organization to produce zero harm. It’s
probably the biggest transformational journey any of us
will see right now in healthcare, and it’s a long-term
journey, but it is an exciting one.”

“It’ll probably be a 10-year journey, but if you
commit you’ll see change in six months, three months,”
she adds. “And that kind of change accrues to become
transformation.”

Patient safety

Providing excellent
care through training
and culture
by Thom Wellington

The most successful hospitals not only focus on
patient safety and positive outcomes, they also create a
collective winning mindset within the organization.
When a positive and open culture is created, great
things happen and everyone benefits, especially pa-
tients. Two leaders—one in the Navy and one at a
top-five hospital system—had simple but effective ways
to create a culture that drove success. They understood
they could not change the individuals or the physical

environment, so they focused on what they could
change: culture and attitudes.

Captain D. Michael Abrashoff’s book, It’s Your
Ship, is a surprisingly apt read for hospital administra-
tors that want to improve outcomes. When Captain
Abrashoff took the helm of the USS Benfold, it was the
worst-performing ship in the Navy. Though it was
loaded with the most advanced technology, the crew did
not fully understand their mission. But instead of
scrutinizing his team, Abrashoff took a different
approach. While analyzing each process on the ship, he
asked, “Is there a better way to do what you do?”

“When a positive and open culture is cre-
ated, great things happen and everyone

benefits, especially patients.”
Thom Wellington

The approach paid off as he started making small
changes to practices based upon this feedback. Soon,
more suggestions came in, and new approaches and
protocols were established. The crew felt like they were
part of the management process and were eager to
learn more skills. In response, Abrashoff started
duplicate training to ensure at least two people always
knew each job task and received continual training.
Part of being a team is filling in for other members
when needed with no loss of skill set.

When a leader demonstrates that employee input is
important and incorporates suggestions, attitudes
change. According to Abrashoff, “Some leaders feel
that by keeping people in the dark, they maintain a
measure of control. But that is a leader’s folly and an
organization’s failure. Secrecy spawns isolation, not
success.” Aboard a ship are sailors from every type of
background and education—and a hospital’s staff is
similarly diverse. Making sure everyone feels they are
part of the team and have a voice is the key to pushing
success to excellence.

The Cleveland Clinic, like other prominent healthcare
systems, embraces change to optimize patient outcomes.
Former CEO Toby Cosgrove, MD, understood leading
was not about him, but about empowering the entire team
to achieve superior results. Like Abrashoff, Cosgrove
created a culture that allowed everyone to be set up for
success—with the patient as the focus.

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be copied or emailed to multiple sites or posted to a listserv without the copyright holder’s
express written permission. However, users may print, download, or email articles for
individual use.

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H o w To | P r o d u c t i v i t y a n d P r o c e s s I m p r o v e m e n t

A New Framework for Healthcare

Performance Improvement
Aug 14, 2018

By Gary Auton

Building a new, patient-centric continuum of care requires a

fundamental restructuring of the healthcare system.

The move to value-based payment is altering the structure and focus of

healthcare organizations. Every sea change demands strong leadership

and a winning game plan to achieve enduring success. That game plan is

performance improvement.

However, health systems have performance improvement strategies that

often are not in sync with emerging marketplace requirements.

Performance improvement plans are frequently based on slow,

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incremental improvement centered on labor productivity, supply, and

other non-labor costs. These traditional approaches, while useful, cannot

alone offset payment and volume declines for most organizations.

Building a new, patient-centric continuum of care requires a

restructuring of the healthcare system and a new taxonomy of

performance improvement interventions that are faster, broader, and

more strategic than those adopted in the past. Improvement initiatives

must increasingly focus on long-term, high-impact areas that re-engineer

clinical care, sharpen service portfolios, and exploit scale of operations.

Levels of Performance Improvement

Performance improvement opportunities accrue at different points and

with varying scope in a health system. Specifically, performance

improvement takes place at three levels: the department or program

(process) level, the cross-functional or cross-site (structural) level, and

the cross-market or cross-population (portfolio) level.

Performance Improvement Levels in Health Systems

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Process Level

Process changes represent the routine operational modifications leaders

make daily in their areas of responsibilities. Process initiatives include

routine department-level changes in work schedules, role design, and

workflow improvements that improve staff utilization and service to

patients. Specifically, program level changes include:

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Performance improvement takes place at three levels: process. Structure, and

portfolio.

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Process improvement. Strengthens the services and value provided to

patients, families, physicians, and other stakeholder groups. Department-

level initiatives usually focus on reducing waste, improving cycle time,

and building reliability into key work processes.

Facilities optimization. Modifies the layout and workspace of a

department to improve patient flow and facilitate the effective use of

resources.

Demand smoothing. Improves patient and work activity scheduling to

balance workload across days and weeks.

Role and team design. Creates jobs and assigns responsibilities to

improve flexibility and workload balance across work teams.

Dynamic staffing. Improves staff scheduling and deployment to meet

variable workload demand.

The organizational impact resulting from process-level changes depends

on department size and complexity. Organizations in the early stages of

performance improvement should first focus on building department-

level processes and systems.

Structural Level

At some point, health system leaders find that further improvement only

can occur by addressing processes and systems that cross over into other

areas of organizations. These improvement opportunities occur at the

second, or structural, level. Structural improvements represent

operational interventions that are executed among functions both in

single facilities and across multiple facilities in health systems. These

interventions often challenge and alter the foundational assumptions of

hospital and health system processes and organizations.

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Structural improvement levers include:

Structural process improvement. Improves key business processes

across functions and system entities to enhance service continuity.

Management restructuring. Redesigns leadership roles to better

leverage management resources across departments, programs, and

sites.

System rationalization. Leverages the advantages of system scale to

rationalize staffing and resources across multiple entities.

Service redeployment. Relocates resources and services to different

areas to improve service and lower operating costs.

Non-labor optimization. Builds processes and systems to manage

enterprisewide supplies and other non-labor expenses.

Demand regrouping. Reaggregates work to achieve better resource

alignment, build proficiencies, and improve workload balancing across

time and functions.

Utilization improvement. Lowers case cost and contribution margins by

reducing unnecessary utilization of clinical services.

Off-quality improvement. Improves clinical quality outcomes and

minimizes the costs of unfavorable quality events.

Structural improvement projects are often complex, requiring a great

deal of time and effort and the involvement of large, diverse groups of

leaders and staff. When executed effectively, structural improvement

initiatives can yield substantial gains in organizational performance.

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Portfolio Level

Beyond process and structural changes, further performance

improvement is achieved through alterations in health systems’ portfolio

of services and programs. Portfolio-level changes occur when health

systems reconfigure and redesign programs and services to respond to

changes in market demand. The aim of portfolio management is to

maintain a service offering that meets market demand and maximizes

revenues and margins. For health systems, portfolio improvement

includes:

Service divestment. Identifies services to eliminate or markets to exit.

Service outsourcing. Determines which care continuum components

should be produced internally versus by partnering entities.

Demand growth. Identifies strategic marketing opportunities and

tactical growth initiatives to build top-line revenues.

Revenue optimization. Improves net revenues and margins through

enhancements to organizations’ revenue cycles.

Continuum realignment. Realigns programs, resources, and investments

to build a stronger service continuum.

Portfolio improvement is a growing area of focus for large healthcare

systems. As accountable care and population health initiatives transform

healthcare delivery, health systems must institute changes to their

service portfolio by reducing investments in existing programs and

building new programs and capabilities. Similarly, growth and revenue

cycle improvements are necessary for building and sustaining operating

margins.

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System-Level Gap Closure Plan

Performance improvement strategies must address an increasingly broad

range of operational issues and extend for multiple years. For example, in

a four-year financial gap closure strategy for a regional healthcare

system, a hospital CFO prepared a forecast of the organization’s

expected decline in operating margins under a scenario that net revenues

per inpatient case for all payers would approach prevailing Medicare

rates. Based on this scenario, the organization’s operating margins would

drop by $36 million in the first year and grow to $60 million by the fourth

year.

The executive team then developed a multiyear gap closure strategy

featuring the deployment of 11 performance improvement initiatives,

including three focused exclusively on the physician practices division

(see exhibit on page 4). The plan enabled the organization to achieve a

positive operating margin by the second year.

Of note is that the strategy was built on assumptions of when benefits

were expected to be achieved and that these savings would be sustained

over time. For example, the labor productivity team forecasted a savings

of 175 FTE staff in the first year. The $10.4 million savings would be

sustained and accrue over subsequent years.

See related sidebar: 5 Keys to Successful Performance Improvement

(/bin/hfma/legacy.61627.html)

Example of a System-Level Gap Closure Plan

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A hospital executive team developed a multiyear gap closure strategy featuring

the deployment of 11 expansive performance improvement initiatives.

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This example illustrates several dynamics of multiyear performance

improvement:

Financial gap closure requires a multiyear portfolio of short-term

and longer-term initiatives.

Short-term improvements are found primarily through a focus on

labor productivity and non-labor expenses.

Revenue cycle improvements may generate substantial revenue

gains in the short term as well, depending on organizations’ current

performance.

These short-term initiatives are necessary but insufficient for

closing large financial gaps over extended periods.

Savings resulting from clinical utilization, quality, and portfolio

improvements can be substantial, but they take longer to

implement than other cost and revenue improvements, with

benefits from the long-term initiatives generally accruing two to

three years after launch.

Revenue growth normally includes short-term tactical

improvement and long-term strategic opportunities.

The work required to transform healthcare systems can be daunting.

Large-scale performance improvement challenges leaders at all levels of

the organization and usually surfaces unaddressed operational, strategic,

and cultural gaps. Paradoxically, leaders who are tasked with driving

performance improvement are often those individuals most threatened

by the change. It is not surprising that many transformation initiatives fall

short of expectations. However, by demonstrating organizational value

and the impact on future viability, performance improvement champions

can bring others on board.

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Gary Auton

Gary Auton (mailto:[email protected]) is senior director,

Galloway Consulting, an ADAMS Company.

About the Author

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c a r e /p h y s i c i a n – p a y m e n t – a n d – r e i m b u r s m e n t

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System (MIPS) program needs to be simplified to allow all providers

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cultural transformation was an accompanying focus on business and

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clin.html)
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11/19/2020 A New Framework for Healthcare Performance Improvement

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11/19/2020 A New Framework for Healthcare Performance Improvement

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While each market is unique in the volume to value paradigm, healthcare providers face a

consistently similar challenge – the need to eliminate excess costs, increase revenue and properly

maximize the existing resources in place to work at …

Root cause analysis: An effective Ql tool

K aren Z u lk o w s k i

DNS, RN
Email [email protected]

ABSTRACT

The purpose o f a root cause analysis (RCA) is to clarify exactly
which adverse event has happened, determine why it happened and
help prevent it occurring again. It is not punitive to any individual;
rather the goal o f an RC A is to prevent fu tu re harm by eliminating
A LL errors or issues that underlie adverse events. It could also be
used to determine ivhy something worked well. A n R C A looks at all
the reasons something happened that are not immediately obvious,
rather than focusing on a single cause.

A n RC A helps identify these underlying problems using a systems
approach to identify active errors (errors occurring at the point of
contact between humans and a complex health care system) and
latent errors (hidden problems w ith in health care system s that
contribute to adverse events). It looks at the “big” picture1. The
problems that are uncovered may result in changes in reporting,
record keeping or process. It is im portant to keep in m ind that
m u ltip le errors and system fla w s m u st intersect fo r a critical
incident to reach the patient. Labelling one or even several o f these
fa cto rs as the cause, w ith o u t consideration o f all factors, may
obscure the true picture o f patient care.

USING ROOT CAUSE ANALYSIS FOR ADVERSE EVENTS

U nfortunately, adverse events h ap p en d u rin g m edical care.
Som e m ay be life-th reaten in g , m ajor erro rs, w h ile o th ers
m ay be problematic b u t not life-threatening2. U nderstanding
w h y p ro b le m s o ccu rred can h e lp c h an g e care p ro cesses
an d im prove p atien t outcom es. Root cause analysis (RCA)
can be especially h elp fu l w h en ex am in in g w h y a p a tie n t
developed a pressure injury. Often both patients and families
attribute the developm ent of pressure injuries to an event that
should never occur. However, patient factors such as medical
conditions, m edications, as well as facility issues are often the
actual “cause”.

The aim of an RCA is to clarify w h ich ad v erse ev en t has
occurred, determ ine the causes and help prevent it happening
again3. It is n ot in ten d ed to be p u n itiv e to any individual;
ra th e r th e goal of an RCA is to p re v e n t fu tu re h a rm by
elim inating any errors or issues th at m ay u n d erlie adverse

events. It co u ld also be used to assess a process th a t has
w orked well. It looks at all the causes rather than focusing on
a single cause.

A n RCA uses a system s approach to identify active errors
(errors occurring at the point of contact betw een hum ans and
a complex system) and latent errors (hidden problem s w ithin
health care systems that contribute to adverse events). It looks
at the “big” picture. The problem s th at are uncovered m ay
require a change in reporting, record keeping or process. It
is im p o rta n t to rem em ber th a t m u ltip le errors an d system
flaws m ust intersect for a critical incident to reach the patient.
Labelling one or even several of these factors as the cause,
w ith o u t co n sideration of all factors, m ay obscure the true
picture of caring for a p atient’s w o u n d 4.

P erform ing an RCA m u st be an in terd iscip lin ary process.
It n e e d s to in v o lv e th o s e p e r s o n s m o s t fa m ilia r w ith
w h a t h a p p e n e d , b u t also th e p e o p le fam ilia r w ith o th e r
d e p a r t m e n t s th a t in f lu e n c e d o r c o n t r i b u t e d to w h a t
h a p p e n e d . C o n d u c tin g an RCA m ean s g o in g d e e p e r by
asking the question w hy at each level of cause an d effect.
The goal is to identify changes for the system and, as such,
it should be conducted in a m an n er th at is as im partial as
possible.

To be thorough, an RCA m ust include: exam ination of hum an
an d system factors; analy sis of the u n d e rly in g cause and
effect through a series of “w hy” questions; identification of
risks th a t occu rred an d th eir p o te n tia l co n trib u tio n s; and
d e te rm in a tio n of w hich im p ro v e m e n ts cou ld be m a d e to
the processes w ith in the system to p re v e n t this o ccurring
again. To be cred ib le, an RCA m ust: in v ite p a rtic ip a tio n
by o rganisational lead ersh ip as w ell as those m ost closely
in v o lv e d in th e p ro c e s s e s a n d s y ste m s; be in te r n a lly
consistent; include consideration of relev an t literatu re and
examine the basis for best practice4.

The process also in v olves rep eated ly asking the q u estio n
why, sometimes called the rule of five whys. The event that
happened is the outcome. For example, a patient developed

w w w . w c e t n . o r g

a pressure injury, which is an adverse outcome. Why did it
develop? The five whys were:

1. He was immobile.

2. He refused to move because of pain.

3. He was not offered pain medication before an attempt to
turn him.

4. The certified nursing assistant (CNA) did not know to
ask the nurse.

5. Lack of education, and so on.

In this example, the direct cause is lack of movement, but the
indirect causes are the most significant and require changes in
the system.

THE “HOW” OF RCA:

1. An RCA begins with data collection and reconstruction
of the event in question through record review and
participant interviews. It is im portant to stress to
staff that this process is not designed to blame any
individual(s).

2. The interdisciplinary RCA team analyses the sequence
of events leading to the event or error, with the goal
of identifying how the event occurred (through
identification of active errors) and why the event
occurred (through system atic identification and
analysis of latent errors). It looks at all departments and
processes within the facility. This is the five whys stage.

3. The RCA process then identifies where changes/
improvements should be made.

4. The changes are trialled or pilot-tested.

5. Outcomes are tracked and examined.

6. The process to be changed is refined.

7. The change is made facility-wide.

8. Re-evaluation is ongoing.

In other words, exactly what happened, why did it happen
and where did it happen? Problems are identified in:

1. Policy/procedures.

2. Safeguards (barriers and controls).

3. Environment.

4. Equipment.

5. Information technology.

6. Fatigue in scheduling.

7. Training.

8. Communication.

9. Other issues.

Once the issues have been identified then required changes
need to be planned and im plem ented. This includes
addressing how this problem can be corrected so it does
not reoccur. Other considerations include deciding which
changes will be implemented and who is responsible for the
implementation. The process must be tested and evaluated,
then redesigned or modified, as required. This process is
often represented as a fishbone diagram (see Figure 1). It
considers: equipment/supply factors; environmental factors
(location, physical layout, and safety); policy/procedures/
rules factors (standards or compliance with standards,
and documentation); and people/staff factors (ability/
supervision/staffing, lack of knowledge or information,
scheduling, and communication). One of the best ways to
learn how to follow this process is with an example. The
results are often conceptualised in a fishbone or Ishikawa
diagram to help see the bigger picture5-6. However, this is just
a guide to the question how and is often rather intimidating
to people using it for the first time. The important point
is to remember this is just a tool to help look at quality
improvement in a bigger picture7. An RCA is effective when
looking at the big picture with pressure injury8-10.

CASE STUDY: AMANDA’S STORY — HOW DID THIS
WOUND HAPPEN?

Day 1: Amanda is brought to the emergency room (ER) via
ambulance and on a backboard at 1930 on Saturday. Her
daughter arrives shortly thereafter. Amanda is a 78-year-
old widow, with a history of arteriosclerotic heart disease
(ASHD), diabetes mellitus (DM) and hypertension. She had a
coronary artery bypass graft (CABG) six years ago. Currently,
she is complaining of nausea, blurred vision and pain in her
left hip. The ride in the ambulance was 45 minutes. When
Amanda arrives, the ER is very busy, with patients from
a traffic accident. She is put in a trauma bay and her vital
signs are taken right away. The ER is short-staffed by two
registered nurses (RNs) due to a local flu outbreak. Therefore,
her history isn’t taken for another 30 minutes (2000) and the
physician arrives at 2015.

Amanda appears to be alert and oriented to time and place
but is a poor historian. However, her daughter Ginger tells
you her mother has had periods of confusion over the past
several days and fell at home yesterday and again today,
although she is sure her mother was “only on the floor for
15 minutes before we found her”. She goes on to say that
she recently moved her mother into her home from out of
town, because she wasn’t looking after herself or taking her
medications. In the last six months, she has lost 30 lb. As a
result of the long-distance move, no previous medical records
are immediately available.

Ginger tells you that her mother had been receiving medical
care for episodes of atrial fibrillation and flutter prior to the
move. Currently she is on 0.125 mg of digoxin daily, and
quinidine sulphate and Catapres, but she can’t remember the

WCET Journal Volume 38 Number 1 – Januaty/March 2018

E q u ip m e n t/S u p p ly
Factors

Lack o f proper

E n v iro n m e n ta l Factors
t | R o o t C a u s e A n a l y s i s | , J g | §

L a y o u t

equipment V is ib ility
Lack of oversight of
equipm ent Space

1C Cl 1C
■ I w O l I C

D o c u m e n ta tio n /
/

S t a f f i n g / back o f k n o w le d g e o r
issues / / tra in in g/ Su pervisio n / C o m m u n ic a tio n issues

/ O u td a te d

/ p o lic ie s /p ro c e d u re s / S ch edu lin g

P o lic y /p ro c e d u re s
/r u le s

/
P e o p le /s ta ff

dose or times for these. Amanda has rales in her lung sounds
and 3+ pitting oedema in her lower extremities. She is started
on 4 L of oxygen ( 0 2) via nasal cannula and intravenous
(IV) Lactated Ringers at 100 m l/hr. She is transferred to the
cardiac intensive care unit (ICU) at 0145. The time on the
backboard is 90 minutes. Her stay in ER is 4.5 hours, where a
hip and chest X-ray are taken. The chest X-ray showed fluid
and presence of pneumonia in both lower lobes of her lungs,
but the hip results were not received until after her transfer to
the ICU.

Day 2 in the ICU: the cardiac monitor shows atrial fibrillation
with a ventricular rate of 189 beats per minute (BPM). Her
blood pressure (BP) is 120/82. She has pulse oximetry (pulse
ox), and a 12-lead electrocardiogram (ECG), portable chest
and hip X-ray and serum digoxin level are ordered. Pulse
ox is 80% and Oz is increased to 6 L. She is started on Lasix.
The hip X-ray shows a left hip fracture (Fx). The orthopaedic
department is consulted, but surgery is deemed not possible
until she is medically stable; they order a morphine pump to
control the pain, and no turning to her left side.

After being in ICU for four hours, Amanda is more confused
b u t her 0 2 statistics are now 90% (0545). She becomes
incontinent of urine and tries to climb out of bed several
tim es, pulling off her 0 2 and p u llin g out her IV. She is
restrained for the next eight hours, but documentation shows
she was turned only once (1345). Unfortunately, when she
was placed on her right side her 0 2 statistics dropped and she

has to be maintained on her back with the head of her bed
elevated. An adult diaper is used to manage the incontinence
when excessive due to the Lasix given. Her Braden scale score
was 14 on day 2 at 1130.

A fter another eight h ours (2145) h er m edical condition
stabilises enough that the restraints can be removed. She
is bathed and at this time a stage III pressure injury and a
friction injury are noted on her coccyx.

Think about Amanda to answer these questions but imagine
if this case happened in your hospital. The idea is to look at
the big picture. No one departm ent or person is to blame.
Rather there were multiple failures, both in the care provided
and the system. The goal is to improve care by addressing the
large issues.

So, who is at fault? The answer is no one. Go through the case
step by step. Root cause does not blame — it improves and is
a positive.

So, the problems are multifactorial:

1. Equipment: H ad not been evaluated for condition,
so pressure redistribution was not being adequately
provided.

2. Rules/policy/procedure: Training was not adequate
for w o u n d p re v e n tio n . There w as no p o licy on
communication between departm ents or oversight of
cumulative time spent on hard surfaces. There was poor

___________________________________________________________________________w w w . w c e t n . o r g

Look at the p atien t and the event

A m anda’s prim ary diagnosis (Dx) and secondary Dx ASHD, DM and hypertension, confusion, decreased O,,
w eight loss

W hich of these increased pressure injury risk?

W hich increased m oisture dam age risk?

Decreased micro and macro vascularisation, potential
decreased nutrition, decreased oxygenation

Incontinence, climbing o ut of bed increased friction

W hen and w here w ere the w o unds first noted? In ICU 2145

W hen w as the medical provider notified? N ot docum ented

Was family notified of the w o u n d /w h e n ? N ot docum ented

Was skin team consulted? Y /N N ot docum ented

Was a dietary consultation ordered? N ot docum ented

1. Was a skin assessm ent docum ented and where?

Am bulance No

ER No

ICU N ot until w ound w as noted

2. Was a pressure injury risk assessm ent scale completed
on ICU admission?

Day 2 at 1130

3. W hat pressure injury and w o u n d risk factors were
problem atic and should have been addressed in the
care plan?

Immobility-related pain and hip Fx and restraints

Decreased turning sites available

Incontinence / m oisture

N utrition

Decreased tissue perfusion

4. W hat medical conditions and changes in condition
increased A m anda’s pressure injury risk in the ICU?

H ip Fx

Decreased oxygenation

Incontinence

5. Was skin reassessed and docum ented every 4 or 8
hours in ICU?

No

6. Was m oisture adequately addressed? No and it resulted in m oisture-associated skin dam age

Think about w h at else could have been c au sin g /
contributing to increased confusion and incontinence.
Were appropriate tests conducted?

C ontributing factor: Lasix for oedem a increased urine o u tp u t
w ith no toileting plan

Possible urinary tract infection (UTI)

7. W hen did staff last have training on pressure ulcer
prevention?

One year ago, at skills day

U nknow n for staff hired to ICU in past year

W hat d e p a rtm en ts/p eo p le w ere connected to the event?
Think broadly (and not just the obvious ones)

Family
Am bulance
ER
ICU
X-ray
Education
N ursing
Medicine

WCET Journal Volum e 38 N um b er 1 – janu ary/M arch 20 18

►► Continued.

Staffing ER was inadequately staffed as 2 RNs were ill and not
replaced

Surface/transportation factors Time spent
– on backboard
– in ER
– in restraints

Surface evaluation for each department was not done for the
past 3-4 years

Intra- and interdepartmental communication Time spent in ambulance, on backboard, and in X-ray was
not communicated between departments

documentation of risk and skin condition. The required
consultations were not carried out. Care planning was
not adequate for risk. Wound policy and procedures
had not been updated for four years and were no longer
based on current evidence.

3. People: The ER was short-staffed, which impacted time
to treatment and skin examination. The patient was a
poor historian.

4. Environment: Facility building was not at fault.

You need to decide: Could this pressure injury have been
prevented? What should this facility do next?

CONCLUSION

Multiple issues cause adverse events. A pressure injury is
not the fault of one person; rather it can be caused by a
series of failures that occur. Yet nurses often feel that an RCA
will blame them for the pressure injury and they will be
penalised. The purpose of an RCA is to improve patient care
by examining and correcting all the contributing factors. This
is part of an ongoing quality improvement process.

In the above example, m ultiple failures occurred from
before admission, to unit and system issues. Unfortunately,
the patient is the one that suffered the consequences and
developed a pressure injury. If everything was done correctly
and an RCA found no errors, the pressure injury would be
unavoidable. Everything was done that could be done. An
RCA can highlight good care as well as any deficiencies.

REFERENCES
1. Black NH & Vernetti B. Root-cause analysis. Prof Saf 2015; 60-62.
2. Makary MA & Daniel M. Medical error — the third leading cause

of death in the US. BM] [Online] 2016; 353.
3. Uberoi R el al. Root cause analysis in healthcare. Apollo Medicine

2007; 4(l):72-75.

4. AHRQ. Root cause analysis. 2017 [cited 2017 November 20].
Available from: h ttp s ://p s n e t.a h rq .g o v /p rim e rs /p rim e r/1 0 /
root-cause-analysis.

5. AHRQ. How to use the fishbone design, [cited N ovem ber
20, 2017], Available from: h ttp s ://w w w .c m s.g o v /m e d ic a re /
p r o v id e r – e n r o llm e n t- a n d – c e r tif ic a tio n /q a p i/d o w n lo a d s /
fishbonerevised.pdf.

6. ASQ. Fishbone (Ishikaw a) d iagram . N ovem ber 20, 2017];
Available from: h ttp ://a s q .o r g /le a r n -a b o u t- q u a lity /c a u s e –
analysis-tools/overview/fishbone.html.

7. Kader Ali NN, Wilson P & Mohammad 1Y. Symptoms Versus
Problems Framework (SVP): an innovative root cause analysis
tool. International Journal of Organizational Innovation 2014; 7.

8. Dolansky MA et al. N ursing student medication errors: a case
study using root cause analysis. J Prof Nurs 2013; 29(2):102-108.

9. Nixon J et al. Severe pressure ulcer study. 2015.
10. Samuriwo R. Pressure ulcer-related harm: beyond root cause

analysis. J Wound Care 2015; 24(8):331—331.

www.wcetn.org

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Page 1 of 18

FRAMEWORK FOR ROOT CAUSE ANALYSIS AND CORRECTIVE ACTIONS*

The Joint Commission’s Framework for Root Cause Analysis and Action Plan provides an example of a comprehensive systematic
analysis. The framework and its 24 analysis questions are intended to provide a template for analyzing an event and an aid in organizing
the steps and information in a root cause analysis.

An organization can use this template to conduct a root cause analysis or even as a worksheet in preparation of submitting an analysis
through the online form on its Joint Commission Connect™ extranet site. Fully consider all possibilities and questions in seeking “root
cause(s)” and opportunities for corrective actions. Be sure to enter a response in the “Analysis Findings” column for each item.
Unexpected findings may emerge during the course of the analysis, or there may be some questions that do not apply in every situation.
For each finding continue to ask “Why?” and drill down further to uncover why parts of the process occurred or didn’t occur when
they should have. Significant findings that are not identified as root causes themselves have “roots.” “Corrective Actions” should be
developed for every identified root cause.

While the online form provides drop-down menus for many of the form’s cells, the options for these columns are provided here in the
following tables:

The following are in the Root Cause Analysis section:
Root Cause Types: Table A-1 (column 1)
Causal Factors/Root Cause Details: Table A-1 (column 2)

In the Corrective Actions section, the following are added:
Action Strength: Table A-2
Measure of Success: Table A-3
Sample Size: Table A-4

*Disclaimer: The framework found on Joint Commission Connect™ will show the most current iteration of this form.

Page 2 of 18

EVENT DESCRIPTION

When did the event occur?

Date: Day of the week: Time:

Detailed Event Description Including Timeline:

Diagnosis:

Medications:

Autopsy Results:

Past Medical/Psychiatric History:

Page 3 of 18

ROOT CAUSE ANALYSIS – QUESTIONS

# Analysis

Questions
Prompts Analysis

Findings
Root Cause Types

(Table A-1)
Causal

Factors/Root
Cause Details

(Table A-1)
1 What was the

intended process
flow?

List the relevant process steps as defined
by the policy, procedure, protocol, or
guidelines in effect at the time of the
event. You may need to include multiple
processes.
Examples of defined process steps may
include, but are not limited to:
• Site verification protocol
• Instrument, sponge, sharps count

procedures
• Patient identification protocol
• Assessment (pain, suicide risk,

physical, and psychological)
procedures

• Fall risk/fall prevention guidelines
Note: The process steps as they occurred in
the event will be entered in the next
question.

2 Were there any
steps in the
process that did
not occur as
intended?

Explain in detail any deviation from the
intended processes listed in Analysis
Question #1 above.

3 What human
factors were
relevant to the
outcome?

Discuss staff-related human performance
factors that contributed to the event.
Examples may include, but are not limited
to:
• Boredom
• Failure to follow established

policies/procedures

Page 4 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
• Fatigue
• Inability to focus on task
• Inattentional blindness/confirmation

bias
• Personal problems
• Lack of complex critical thinking skills
• Rushing to complete task
• Substance abuse
• Trust

4 How did the
equipment
performance
affect the
outcome?

Consider all medical equipment and
devices used in the course of patient care,
including automated external defibrillator
(AED) devices, crash carts, suction,
oxygen, instruments, monitors, infusion
equipment, etc. In your discussion,
provide information on the following, as
applicable:
• Descriptions of biomedical checks
• Availability and condition of

equipment
• Descriptions of equipment with

multiple or removable pieces
• Location of equipment and its

accessibility to staff and patients
• Staff knowledge of or education on

equipment, including applicable
competencies

• Correct calibration, setting, operation
of alarms, displays, and controls

5 What controllable
environmental

What environmental factors within the
organization’s control affected the

Page 5 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
factors affected
the outcome?

outcome? Examples may include, but are
not limited to:
• Overhead paging that cannot be

heard in physician offices
• Safety or security risks
• Risks involving activities of visitors
• Lighting or space issues
The response to this question may be
addressed more globally in Question #17.
This response should be specific to this
event.

6 What
uncontrollable
external factors
influenced the
outcome?

Identify any factors the health care
organization cannot change that
contributed to a breakdown in the
internal process, for example natural
disasters.

7 Were there any
other factors that
directly influenced
this outcome?

List any other factors not yet discussed.

8 What are the
other areas in the
health care
organization
where this could
happen?

List all other areas in which the potential
exists for similar circumstances. For
example:
• Inpatient surgery/outpatient surgery
• Inpatient psychiatric care/outpatient

psychiatric care
• Identification of other areas within

the organization that have the
potential to impact patient safety in a
similar manner. This information will
help drive the scope of your action

Page 6 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
plan.

9 Was staff properly
qualified and
currently
competent for
their
responsibilities?

Include information on the following for
all staff and providers involved in the
event. Comment on the processes in
place to ensure staff is competent and
qualified. Examples may include but are
not limited to:
• Orientation/training
• Competency assessment (What

competencies do the staff have and
how do you evaluate them?)

• Provider and/or staff scope of
practice concerns

• Whether the provider was
credentialed and privileged for the
care and services he or she rendered

• The credentialing and privileging
policy and procedures

• Provider and/or staff performance
issues

10 How did actual
staffing compare
with ideal level?

Include ideal staffing ratios and actual
staffing ratios along with unit census at
the time of the event. Note any unusual
circumstance that occurred at this time.
What process is used to determine the
care area’s staffing ratio, experience level,
and skill mix?

11 What is the plan
for dealing with
staffing
contingencies?

Include information on what the health
care organization does during a staffing
crisis, such as call-ins, bad weather, or
increased patient acuity. Describe the

Page 7 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
health care organization’s use of
alternative staffing. Examples may
include, but are not limited to:
• Agency nurses
• Cross training
• Float pool
• Mandatory overtime
• PRN pool

12 Were such
contingencies a
factor in this
event?

If alternative staff were used, describe
their orientation to the area, verification
of competency, and environmental
familiarity.

13 Did staff
performance
during the event
meet
expectations?

Describe whether staff performed as
expected within or outside of the
processes. To what extent was leadership
aware of any performance deviations at
the time? What proactive surveillance
processes are in place for leadership to
identify deviations from expected
processes? Include omissions in critical
thinking and/or performance variance(s)
from defined policy, procedure, protocol,
and guidelines in effect at the time.

14 To what degree
was all the
necessary
information
available when
needed?
Accurate?
Complete?

Discuss whether patient assessments were
completed, shared, and accessed by
members of the treatment team, to
include providers, according to the
organizational processes. Identify the
information systems used during patient
care. Discuss to what extent the available
patient information (e.g., radiology

Page 8 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
Unambiguous? studies, lab results, or medical record) was

clear and sufficient to provide an
adequate summary of the patient’s
condition, treatment, and response to
treatment. Describe staff utilization and
adequacy of policy, procedure, protocol,
and guidelines specific to the patient care
provided.

15 To what degree is
communication
among
participants
adequate?

Analysis of factors related to
communication should include evaluation
of verbal, written, electronic
communication or the lack thereof.
Consider the following in your response,
as appropriate:
• The timing of communication of key

information
• Misunderstandings related to

language/cultural barriers,
abbreviations, terminology, etc.

• Proper completion of internal and
external hand-off communication

• Involvement of patient, family, and/or
significant other

16 Was this the
appropriate
physical
environment for
the processes
being carried out?

Consider processes that proactively
manage the patient care environment.
This response may correlate to the
response in Question #6 on a more
global scale. What evaluation tool or
method is in place to evaluate process
needs and mitigate physical and patient
care environmental risks? How are these
process needs addressed
organizationwide? Examples may include,

Page 9 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
but are not limited to:
• Alarm audibility testing
• Evaluation of egress points
• Patient acuity level and setting of

care managed across the continuum
• Preparation of medication outside of

pharmacy
17 What systems are

in place to identify
environmental
risks?

Identify environmental risk assessments.
Does the current environment meet
codes, specifications, regulations? Does
staff know how to report environmental
risks? Was there an environmental risk
involved in the event that was not
previously identified?

18 What emergency
and failure-mode
responses have
been planned and
tested?

Describe variances in expected process
due to an actual emergency or failure
mode response in connection to the
event. Related to this event, what safety
evaluations and drills have been
conducted and at what frequency (e.g.
mock code blue, rapid response,
behavioral emergencies, patient abduction
or patient elopement)? Emergency
responses may include, but are not limited
to:
• Fire
• External disaster
• Mass casualty
• Medical emergency
Failure mode responses may include, but
are not limited to:
• Computer down time
• Diversion planning

Page 10 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
• Facility construction
• Power loss
• Utility issues

19 How does the
organization’s
culture support
risk reduction?

How does the overall culture encourage
change, suggestions, and warnings from
staff regarding risky situations or
problematic areas?
• How does leadership demonstrate

the organization’s culture and safety
values?

• How does the organization measure
culture and safety?

• How does leadership address
disruptive behavior?

• How does leadership establish
methods to identify areas of risk or
access employee suggestions for
change?

• How are changes implemented?

20 What are the
barriers to
communication of
potential risk
factors?

Describe specific barriers to effective
communication among caregivers that
have been identified by the organization.
For example, residual intimidation or
reluctance to report co-worker activity.
Identify the measures being taken to
break down barriers (e.g. use of SBAR). If
there are no barriers to communication
discuss how this is known.

21 How does
leadership address
the continuum of
patient safety
events, including

Does leadership demonstrate
accountability for implementing measures
to reduce risk for patient harm? Has
leadership provided for required
resources or training? Does leadership

Page 11 of 18

# Analysis
Questions

Prompts Analysis
Findings

Root Cause Types
(Table A-1)

Causal
Factors/Root
Cause Details

(Table A-1)
close calls,
adverse events,
and unsafe,
hazardous
conditions?

communicate corrective actions stemming
from any analysis following reported
risks?

22 How can
orientation and
in-service training
be improved?

Describe how orientation and ongoing
education needs of the staff are evaluated
and discuss its relevance to event. (e.g.,
competencies, critical thinking skills, use
of simulation labs, evidence based
practice, etc.)

23 Was available
technology used
as intended?

Describe variances in the expected
process due to education, training,
competency, impact of human
factors, functionality of equipment,
and so on:
• Was the technology designed to

minimize use errors or easy-to-catch
mistakes?

• Did the technology work well with
the workflow and environment?

• Was the technology used outside of
its specifications?

24 How might
technology be
introduced or
redesigned to
reduce risks in the
future?

Describe any future plans for
implementation or redesign. Describe the
ideal technology system that can help
mitigate potential adverse events in the
future.

Page 12 of 18

CORRECTIVE ACTIONS

Root Cause
Types

(Table A-1)

Causal
Factors/Roo

t Cause
Details

(Table A-1)

Corrective Actions Action
Strength

(Table A-2)

Measure of Success
(Numerator /

Denominator) (Table A-
3)

Sample
Size

(Table A-4)

Action Item #1:

Action Item #2:

Action Item #3:

Action Item #4:

Action Item #5:

Action Item #6:

Action Item #7:

Action Item #8:

Page 13 of 18

BIBLIOGRAPHY

Cite all books and journal articles that were considered in developing this root cause analysis and action plan.

Page 14 of 18

TABLE A-1. ROOT CAUSES

Root Cause Types Causal Factors / Root Cause Details
Communication
factors

• Communication breakdowns between and among teams, staff, and providers
• Communication during handoff, transition of care
• Language or literacy
• Availability of information
• Misinterpretation of information
• Presentation of information

Environmental
factors

• Noise, lighting, flooring condition, etc.
• Space availability, design, locations, storage
• Maintenance, housekeeping

Equipment/device/
supply/
healthcare IT factors

• Equipment, device, or product supplies problems or availability
• Health information technology issues such as display/interface issues (including display of information),

system interoperability
• Availability of information
• Malfunction, incorrect selection, misconnection
• Labeling instructions, missing
• Alarms silenced, disabled, overridden

Task/process
factors

• Lack of process redundancies, interruptions, or lack of decision support
• Lack of error recovery
• Workflow inefficient or complex

Staff performance
factors

• Fatigue, inattention, distraction or workload
• Staff knowledge deficit or competency
• Criminal or intentionally unsafe act

Team factors • Speaking up, disruptive behavior, lack of shared mental model
• Lack of empowerment
• Failure to engage patient

Page 15 of 18

Management/
supervisory/
workforce factors

• Disruptive or intimidating behaviors
• Staff training
• Appropriate rules/policies/procedure or lack thereof
• Failure to provide appropriate staffing or correct a known problem
• Failure to provide necessary information

Organizational
culture/leadership

• Organizational-level failure to correct a known problem and/or provide resource support including
staffing

• Workplace climate/institutional culture
• Leadership commitment to patient safety

Adapted from: Department of Defense, Patient Safety Program. PSR Contributing Factors List – Cognitive Aid, Version 2.0. May
2013.

Page 16 of 18

TABLE A-2. ACTION STRENGTH

Action Strength Action Category Example
Stronger
Actions

(These tasks
require less
reliance
on humans
to remember to
perform the task
correctly)

Architectural/physical plant
changes

Replace revolving doors at the main patient entrance into the building with powered
sliding or swinging doors to reduce patient falls.

New devices with usability
testing

Perform heuristic tests of outpatient blood glucose meters and test strips and select
the most appropriate for the patient population being served.

Engineering control (forcing
function)

Eliminate the use of universal adaptors and peripheral devices for medical
equipment and use tubing/fittings that can only be connected the correct way (e.g.,
IV tubing and connectors that cannot physically be connected to sequential
compression devices [SCDs]).

Simplify process Remove unnecessary steps in a process.
Standardize on equipment
or process

Standardize the make and model of medication pumps used throughout the
institution. Use bar coding for medication administration.

Tangible involvement by
leadership

Participate in unit patient safety evaluations and interact with staff; support the
RCA2 process (root cause analysis and action); purchase needed equipment; ensure
staffing and workload are balanced.

Intermediate
Actions

Redundancy Use two registered nurses to independently calculate high-risk medication dosages.
Increase in staffing/decrease
in workload

Make float staff available to assist when workloads peak during the day.

Software enhancements,
modifications

Use computer alerts for drug–drug interactions.

Eliminate/reduce
distractions

Provide quiet rooms for programming patient-controlled analgesia (PCA) pumps;
remove distractions for nurses when programming medication pumps.

Education using simulation-
based training, with periodic
refresher sessions and
observations

Conduct patient handoffs in a simulation lab/environment, with after-action
critiques and debriefing.

Checklist/cognitive aids Use pre-induction and pre-incision checklists in operating rooms. Use a checklist
when reprocessing flexible fiber optic endoscopes.

Eliminate look- and sound-
alikes

Do not store look-alikes next to one another in the unit medication room.

Standardized communication Use read-back for all critical lab values. Use read-back or repeat-back for all verbal

Page 17 of 18

tools medication orders. Use a standardized patient handoff format.
Enhanced documentation,
communication

Highlight medication name and dose on IV bags.

Weaker Actions

(These tasks rely
more on
humans to
remember
to perform the
task correctly)

Double checks One person calculates dosage, another person reviews their calculation.
Warnings Add audible alarms or caution labels.
New procedure/
memorandum/policy

Remember to check IV sites every 2 hours.

Training Demonstrate correct usage of hard-to-use medical equipment.

Reference: Action Hierarchy levels and categories are based on Root Cause Analysis Tools, VA National Center for Patient Safety,
http://www.patientsafety.va.gov/docs/joe/rca_tools_2_15.pdf. Examples are provided here.

Source: National Patient Safety Foundation. RCA2 Improving Root Cause Analyses and Actions to Prevent Harm. Boston, MA: National Patient
Safety Foundation; 2015. Reproduced with permission.

Page 18 of 18

TABLE A-3. MEASURE OF SUCCESS

Fraction Part Defined Identified Example
Numerator The number of

events being
measured

Ask a specific
question—what are
you measuring?

Falls that resulted in hip fractures
in diabetic patients over 70 years of
age

Denominator All the opportunities
in which the event
could have occurred

Identify the patient
population from
which to collect the
information.

The number of diabetic patients on
a unit who are older than 70 years
of age

TABLE A-4. SAMPLE SIZE*

*The sampling methodology was determined using quality assurance sampling methods which determines the sample size needed to be able
to say from a sample of cases that the “defect” rate is less than a specified amount (here we used 10%) with 95% confidence if no
“defects” are found in the sample.

Population Size Sample

Fewer than 30 cases 100% of cases

30 to 100 cases 30 cases

101 to 500 cases 50 cases

Greater than 500 cases 70 cases

  • Table A-1. Root Causes
  • Adapted from: Department of Defense, Patient Safety Program. PSR Contributing Factors List – Cognitive Aid, Version 2.0. May 2013.
  • Table A-2. Action Strength
  • Table A-3. Measure of Success

RCA2
Improving Root Cause
Analyses and Actions

to Prevent Harm

National Patient Safety Foundation
268 Summer Street | Boston, MA 02210 | 617.391.9900 | www.npsf.org

Version 2. January 2016

© Copyright 2015 by the National Patient Safety Foundation.
All rights reserved.
Second online publication, Version 2, January 2016.
First online publication June 2015.

This report is available for downloading on the Foundation’s website, www.npsf.org.

This report or parts of it may be printed for individual use or distributed for training
purposes within your organization.

No one may alter the content in any way, or use the report in any commercial context,
without written permission from the publisher:

National Patient Safety Foundation
Attention: Director, Information Resources
280 Summer Street, Ninth Floor [updated August 1, 2016]
Boston, MA 02210
[email protected]

About the National Patient Safety Foundation®

The National Patient Safety Foundation’s vision is to create a world where patients and
those who care for them are free from harm. A central voice for patient safety since
1997, NPSF partners with patients and families, the health care community, and key
stakeholders to advance patient safety and health care workforce safety and dissemi-
nate strategies to prevent harm.

NPSF is an independent, not-for-profit 501(c)(3) organization. Information about the
work of the National Patient Safety Foundation may be found at www.npsf.org.

®

CONTENTS

Acknowledgments iv

Endorsements vi

Executive Summary vii

Introduction 1
Objective
Definitions

I. Identifying and Classifying Events 5
Events Appropriate for RCA2 Review versus Blameworthy Events
Risk-Based Prioritization of Events, Hazards, and System Vulnerabilities
Close Calls

II. RCA2 Timing and Team Membership 9
Timing
Team Size
Team Membership
Interviewing

III. The RCA2 Event Review Process 14
Analysis Steps and Tools
Actions
Measuring Action Implementation and Effectiveness
Feedback
Leadership and Board Support
Measuring the Effectiveness and Sustainability of the RCA2 Process

IV. Conclusion and Recommendations 21

Appendix 1. The Safety Assessment Code (SAC) Matrix 23

Appendix 2. Triggering Questions for Root Cause Analysis 31

Appendix 3. Interviewing Tips for RCA2 Reviews 35

Appendix 4. Final Flow Diagram Example 37

Appendix 5. Cause and Effect Diagram Example 38

Appendix 6. The Five Rules of Causation 39

Appendix 7. Cause, Action, Process/Outcome Measure Table 40

References 41

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

ACKNOWLEDGMENTS • iv

Core Working Group
James P. Bagian, MD, PE
Project Co-Chair
Director, Center for Health Engineering and
Patient Safety, University of Michigan

Doug Bonacum, CSP, CPPS
Project Co-Chair
Vice President, Quality, Safety, and Resource
Management, Kaiser Permanente

Joseph DeRosier, PE, CSP
Program Manager, Center for Health Engineering
and Patient Safety, University of Michigan

John Frost
President, Safety Engineering Services Inc.
Member, Aerospace Safety Advisory Panel (ASAP)
National Aeronautics and Space Administration
(NASA)
Member, Board of Directors, APT Inc.

Rollin J. “Terry” Fairbanks MD, MS, FACEP, CPPS
Director, National Center for Human Factors in
Healthcare and Simulation Training & Education
Lab, MedStar Institute for Innovation, MedStar
Health
Associate Professor of Emergency Medicine,
Georgetown University

Tejal Gandhi, MD, MPH, CPPS
President and Chief Executive Officer,
National Patient Safety Foundation

Helen Haskell, MA
Founder, Mothers Against Medical Error
President, Consumers Advancing Patient Safety

Patricia McGaffigan, RN, MS
Chief Operating Officer and Senior Vice President,
Program Strategy, National Patient Safety
Foundation

Faye Sheppard RN, MSN, JD, CPPS
Principal, Patient Safety Resources

Expert Advisory Group
John S. Carroll
Professor of Organization Studies and
Engineering Systems, Massachusetts Institute of
Technology
Co-Director, Lean Advancement Initiative at MIT

Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon)
President, Institute for Safe Medication Practices

Thomas W. Diller, MD, MMM
Vice President and System Chief Medical Officer,
CHRISTUS Health

Noel Eldridge, MS
Senior Advisor, Public Health Specialist, Center for
Quality Improvement and Patient Safety, Agency
for Healthcare Research and Quality

Andrew R. Hallahan, MD
Medical Lead, Patient Safety, Children’s Health
Queensland Hospital and Health Service

Robin Hemphill, MD, MPH
Director, National Center for Patient Safety,
US Department of Veterans Affairs

James P. Keller, Jr., MS
Vice President, Health Technology Evaluation and
Safety, ECRI Institute

Carol Keohane, MS, RN
Assistant Vice President, Academic Medical
Center’s Patient Safety Organization, CRICO

Maria Lombardi, RN, MSN, CCRN
Clinical Nursing Director, Tufts Medical Center

Robert Schreiber, MD
Medical Director of Evidence-Based Programs,
Hebrew Senior Life Department of Medicine
Medical Director, Healthy Living Center for
Excellence
Clinical Instructor of Medicine, Harvard Medical
School

Julie Spencer, RN, CPHRM
System Director of Risk Management, BSWH Risk
Management

Mary J. Tharayil, MD, MPH
Staff Physician
Brigham and Women’s Hospital

Ailish Wilkie, MS, CPHQ, CPHRM
Patient Safety and Risk Management
Atrius Health

Ronald M. Wyatt, MD, MHA, DMS (hon.)
Medical Director, Healthcare Improvement, Office
of the Chief Medical Officer, The Joint Commission

ACKNOWLEDGMENTS

PANEL PARTICIPANTS

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

ACKNOWLEDGMENTS • v

NPSF STAFF

Tejal K. Gandhi, MD, MPH, CPPS
President and Chief Executive Officer

Patricia McGaffigan, RN, MS
Chief Operating Officer and
Senior Vice President, Program Strategy

Joellen Huebner
Program Coordinator, Special Projects

Patricia McTiernan, MS
Assistant Vice President, Communications

Elma Sanders, PhD
Communications Manager

The National Patient Safety Foundation gratefully acknowledges James Bagian, MD, PE, and
Doug Bonacum, CSP, CPPS, for their work as co-chairs of this project.

Special thanks are due to Joseph DeRosier, PE, CSP, for lead authorship of this report,
and to Mary Tharayil, MD, MPH, for preparatory research.

The National Patient Safety Foundation gratefully acknowledges
The Doctors Company Foundation for its critical and generous support of this project.

ACKNOWLEDGMENTS (cont)

u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

ENDORSEMENTS • vi

AAMI

AAMI Foundation

Alliance for Quality Improvement and Patient Safety (AQIPS)

American Society of Health-System Pharmacists (ASHP)

Association of Occupational Health Professionals in Healthcare (AOHP)

Atrius Health

Aurora Health Care

Canadian Patient Safety Institute

Children’s Health Queensland Hospital and Health Service

CHRISTUS Health

Citizens for Patient Safety

CRICO | Risk Management Foundation of the Harvard Medical Institutions

The Doctors Company

ECRI Institute

HCA Patient Safety Organization, LLC

Institute for Healthcare Improvement

Institute for Safe Medication Practices

The Joint Commission

Kaiser Permanente

MHA Keystone Center

National Association for Healthcare Quality (NAHQ)

National Council of State Boards of Nursing (NCSBN®)

Tufts Medical Center and Floating Hospital for Children

u

ENDORSEMENTS

The following organizations have endorsed the use of this document as a valuable
resource in efforts to create a more effective event analysis and improvement system:

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

EXECUTIVE SUMMARY • vii

EXECUTIVE SUMMARY

Millions of patients in the United States are harmed every year as a result of the health
care they receive.(1) The National Patient Safety Foundation (NPSF), with support from The
Doctors Company Foundation, convened a panel of subject matter experts and stakehold-
ers to produce recommended practices to improve the manner in which we can learn from
adverse events and unsafe conditions and take action to prevent their occurrence in the
future. Traditionally, the process employed to accomplish this learning has been called root
cause analysis (RCA), but it has had inconsistent success. To improve the effectiveness and
utility of these efforts, we have concentrated on the ultimate objective: preventing future
harm. Prevention requires actions to be taken, and so we have renamed the process Root
Cause Analysis and Action, RCA2 (RCA “squared”) to emphasize this point. This document
describes methodologies and techniques that an organization or individuals involved in
performing an RCA2 can credibly and effectively use to prioritize the events, hazards, and
vulnerabilities in their systems of care to accomplish the real objective, which is to under-
stand what happened, why it happened, and then take positive action to prevent it from
happening again. It cannot be over-emphasized that if actions resulting from an RCA2 are
not implemented and measured to demonstrate their success in preventing or reducing
the risk of patient harm in an effective and sustainable way, then the entire RCA2 activity
will have been a waste of time and resources.

The purpose of this document is to ensure that efforts undertaken in performing RCA2 will
result in the identification and implementation of sustainable systems-based improve-
ments that make patient care safer in settings across the continuum of care. The approach
is two-pronged. The first goal is to identify methodologies and techniques that will lead
to more effective and efficient RCA2. The second is to provide tools to evaluate individual
RCA2 reviews so that significant flaws can be identified and remediated to achieve the
ultimate objective of improving patient safety. The purpose of an RCA2 review is to iden-
tify system vulnerabilities so that they can be eliminated or mitigated; the review is not
to be used to focus on or address individual performance, since individual performance
is a symptom of larger systems-based issues. Root cause analysis and action team find-
ings must not be used to discipline or punish staff, so that the trust in the system is not
undermined. The maximum benefit for the safety of the patient population occurs when
system-based vulnerabilities are addressed, and this can be compromised if the root cause

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

EXECUTIVE SUMMARY • viii

analysis and action process is viewed as a witch hunt. It is critical that each organization
define blameworthy events and actions that fall outside the purview of the safety system
and define how and under what circumstances they will be handled or dealt with using
administrative or human resource systems.

Just as a well-performed and well-executed RCA2 must take a systems-based approach, the
same approach is important in formulating a methodology that will achieve these desired
objectives. Since unlimited resources are not available to identify, analyze, and remediate
hazards, it is essential that an explicit risk-based prioritization system be utilized to credibly
and efficiently determine what hazards should be addressed first. A risk-based approach
that considers both the potential harm and the probability of it impacting a patient—as
opposed to a solely harm-based approach—allows efforts to be focused in a manner that
achieves the greatest benefit possible for the patient population as a whole and allows
learning and preventive action to be taken without having to experience patient harm
before addressing a problem. This prioritization system must be a transparent, formal, and
explicit one that is communicated with both internal and external stakeholders.

The most important step in the RCA2 process is the identification of actions to eliminate or
control system hazards or vulnerabilities identified in the causal statements. Teams should
strive to identify stronger actions that prevent the event from recurring and, if that is not
possible, reduce the likelihood that it will occur or that the severity or consequences are
reduced if it should recur. Using a tool such as the Action Hierarchy will assist teams in
identifying stronger actions that provide effective and sustained system improvement.

The success of any patient safety effort lies in its integration into the fabric of the orga-
nization at all levels. This cannot happen without the active participation of leaders and
managers at all levels. For example, strength of actions should be actively reviewed by
leadership to ensure that teams are identifying strong actions that provide effective and
sustained system improvement. Their participation demonstrates the importance of activi-
ties related to patient safety not just by words but by tangible actions and involvement.

This document answers questions integral to patient safety and the root cause analysis
process including how to:

• Triage adverse events and close calls/near misses

• Identify the appropriate RCA2 team size and membership

• Establish RCA2 schedules for execution

• Use tools provided here to facilitate the RCA2 analysis

• Identify effective actions to control or eliminate system vulnerabilities

• Develop Process/Outcome Measures to verify that actions worked as planned

• Use tools provided here for leadership to assess the quality of the RCA2 process

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

EXECUTIVE SUMMARY • ix

Recommendations

1. Leadership (e.g., CEO, board of directors) should be actively involved in the root
cause analysis and action (RCA2) process. This should be accomplished by support-
ing the process, approving and periodically reviewing the status of actions, under-
standing what a thorough RCA2 report should include, and acting when reviews do
not meet minimum requirements.

2. Leadership should review the RCA2 process at least annually for effectiveness.

3. Blameworthy events that are not appropriate for RCA2 review should be defined.

4. Facilities should use a transparent, formal, and explicit risk-based prioritization sys-
tem to identify adverse events, close calls, and system vulnerabilities requiring RCA2
review.

5. An RCA2 review should be started within 72 hours of recognizing that a review is
needed.

6. RCA2 teams should be composed of 4 to 6 people. The team should include pro-
cess experts as well as other individuals drawn from all levels of the organization,
and inclusion of a patient representative unrelated to the event should be consid-
ered. Team membership should not include individuals who were involved in the
event or close call being reviewed, but those individuals should be interviewed for
information.

7. Time should be provided during the normal work shift for staff to serve on an RCA2
team, including attending meetings, researching, and conducting interviews.

8. RCA2 tools (e.g., interviewing techniques, Flow Diagramming, Cause and Effect Dia-
gramming, Five Rules of Causation, Action Hierarchy, Process/Outcome Measures)
should be used by teams to assist in the investigation process and the identification
of strong and intermediate strength corrective actions.

9. Feedback should be provided to staff involved in the event as well as to patients
and/or their family members regarding the findings of the RCA2 process.

The National Patient Safety Foundation strongly recommends that organizations across
the continuum of care adopt the recommendations of this report in order to improve their
root cause analyses and bring them to the next level, that of root cause analysis and action,
RCA2, to ensure the most effective prevention of future harm.

u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

INTRODUCTION • 1

INTRODUCTION

Millions of patients are harmed in the United States every year as a result of the health care
they receive.(1) Virtually all health care providers and organizations respond to some events
where patient harm has occurred by investigating the event in question with the intent of
eliminating the possibility or reducing the likelihood of a future similar event. This activity
is commonly referred to as root cause analysis (RCA), although other terms are sometimes
used to describe this process, such as focused review, incident review, and comprehen-
sive system analysis. Some health care organizations have robust RCA processes and have
made huge strides toward improving patient safety, including sharing lessons widely, both
internally and externally, so others can learn from their experience. This is, however, more
the exception than the rule.(2) Currently the activities that constitute an RCA in health care
are not standardized or well defined, which can result in the identification of corrective
actions that are not effective—as demonstrated by the documented recurrence of the
same or similar events in the same facility/organization after completion of an RCA. Some
of the underlying reasons for lack of effectiveness of RCAs in improving patient safety
include the lack of standardized and explicit processes and techniques to:

• Identify hazards and vulnerabilities that impact patient safety and then prioritize
them to determine if action is required

• Identify systems-based corrective actions

• Ensure the timely execution of an RCA and formulation of effective sustainable
improvements and corrective actions

• Ensure follow-through to implement recommendations

• Measure whether corrective actions were successful

• Ensure that leadership at all levels of the organization participate in making certain
that RCAs are performed when appropriate, in a timely manner, and that corrective
actions are implemented to improve patient safety

The National Patient Safety Foundation (NPSF), with support from The Doctors Company
Foundation, convened a panel of subject matter experts and stakeholders to recommend
practices to improve the RCA process in settings across the continuum of care. The term

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

INTRODUCTION • 2

RCA itself is problematic and does not describe the activity’s intended purpose. First, the
term implies that there is one root cause, which is counter to the fact that health care is
complex and that there are generally many contributing factors that must be considered
in understanding why an event occurred. In light of this complexity, there is seldom one
magic bullet that will address the various hazards and systems vulnerabilities, which means
that there generally needs to be more than one corrective action. Second, the term RCA
only identifies its purpose as analysis, which is clearly not its only or principal objective,
as evidenced by existing regulatory requirements for what an RCA is to accomplish. The
ultimate purpose of an RCA is to identify hazards and systems vulnerabilities so that actions
can be taken that improve patient safety by preventing future harm. The term RCA also
seems to violate the Chinese proverb “The beginning of wisdom is to call things by their
right names,” and this may itself be part of the underlying reason why the effectiveness of
RCAs is so variable. While it might be better not to use the term RCA, it is so imbedded in
the patient safety culture that completely renaming the process could cause confusion.

We introduce a more accurate term to describe what is really intended by performing an
RCA, and that is Root Cause Analysis and Action, RCA2 (RCA “squared”), which is the term
used throughout this document. Our discussion describes methodologies and techniques
that an organization or individuals can credibly and effectively use to prioritize the events,
hazards, and vulnerabilities in their systems of care that should receive an RCA2, and then
accomplish the real objective, which is to understand what happened, why it happened,
and what needs to be done(3) to correct the problem, and then to take positive action to
prevent it from happening again.

The actions of an RCA2 must concentrate on systems-level type causations and contrib-
uting factors. If the greatest benefit to patients is to be realized, the resulting corrective
actions that address these systems-level issues must not result in individual blaming or
punitive actions. The determination of individual culpability is not the function of a patient
safety system and lies elsewhere in an organization. “Preventing errors means designing
the health care system at all levels to make it safer. Building safety into processes of care is
a much more effective way to reduce errors than blaming individuals.”(4)

If actions resulting from an RCA2 review are not implemented, or are not measured to
determine their effectiveness in preventing harm, then the entire RCA2 activity may be
pointless.

Many organizations do not provide timely feedback to the parties who brought an issue
to the attention of the patient safety organization or those who were personally impacted
by a particular event. When this feedback loop is broken, the staff and patients involved
can easily come to the conclusion that the event either was ignored or that no meaningful
action was taken. In other words, the report of the event, hazard, or vulnerability fell into a
“black hole.” The lack of feedback can have a negative impact on the future involvement of
staff and patients, who may become cynical and distrustful in the belief that their efforts
or experience will not be used to effect change. To reap the greatest benefit for patients
everywhere, the lessons learned from RCA2—including contributing factors and hazards
that were identified, as well as the corrective actions—should be shared as openly as pos-
sible, both within and outside the organization.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

INTRODUCTION • 3

Finally, an RCA2 process cannot be successful and have lasting positive effect without
active and tangible leadership support with involvement at all levels, including board
involvement. Leadership demonstrates the real importance that they attach to patient
safety by their level of personal involvement and support.

Objective

The purpose of this document is to provide guidance for performing RCA2 reviews that will
result in the identification and implementation of sustainable and effective systems-based
improvements to make health care safer. The RCA2 approach described in this document
was developed for hospitals, but it is applicable to settings that range from nursing homes
to acute care, doctors’ offices to care units, and from single health care organizations to
large health care systems and patient safety organizations (PSOs).(5) While root cause analy-
sis has typically been used at the hospital level, RCA2 is also applicable at the unit level and
as part of comprehensive unit-based safety programs (CUSP).(6)

The approach presented is two-pronged. The first goal is to identify methodologies and
techniques that will lead to more effective and efficient use of RCA2. The second goal is to
provide tools to health care leaders to evaluate RCA2 reviews so that significant flaws in
individual RCA2 reports can be identified and remediated to achieve the ultimate objec-
tive of improving patient safety. Just as a well-performed, well-executed RCA2 must take a
systems-based approach, the same approach is important in formulating a methodology
that will achieve these desired objectives.

There are many other activities that may need to take place at the same time as RCA2. One
of these is disclosure to the patient or family that an adverse event has occurred. Although
the disclosure may be for the same adverse event for which an RCA2 is being undertaken,
these two processes are independent activities. The disclosure activities should in no way
interfere with the initiation or performance of the RCA2 and, accordingly, further discus-
sion of disclosure is not addressed in this document since it is outside the scope of RCA
improvement.

Definitions

The following definitions were adopted for the discussions and recommendations pre-
sented in this paper:

• Hazard: Potential for harm;(7) a condition precursor to a mishap (adverse event).

• Safety: Freedom from those conditions that can cause death, injury, illness, damage
to or loss of equipment or property, or damage to the environment. (7)

• Quality: The degree to which a set of inherent characteristics fulfills a set of require-
ments.(8)

• Risk: A measure of the expected loss from a given hazard or group of hazards. Risk is a
combined expression of loss severity and probability (or likelihood).(7)

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

INTRODUCTION • 4

• System: A set of interrelated or interacting elements(8) any one of which, if changed,
can impact overall outcome. Some examples of system elements are organizational
culture, technical and equipment related factors, physical environment, organiza-
tional goals and incentives, and professional performance and standards.

• Close Call/Near Miss: A close call is an event or situation that could have resulted in an
adverse event but did not, either by chance or through timely intervention. Some-
times referred to as near miss incidents.(9)

• Adverse Event: Untoward incident, therapeutic misadventure, iatrogenic injury, or
other occurrence of harm or potential harm directly associated with care or services
provided.(7)

u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

I. IDENTIFYING AND CLASSIFYING EVENTS • 5

I. IDENTIFYING AND CLASSIFYING EVENTS

Events Appropriate for RCA2 Review versus Blameworthy Events

The purpose of an RCA2 review is to identify system vulnerabilities so that they can be
eliminated or mitigated. RCA2 processes are not to be used to focus on or address individ-
ual health care worker performance as the primary cause of an adverse event, but instead
to look for the underlying systems-level causations that were manifest in personnel-related
performance issues. Findings from an RCA2 must not be used to discipline, shame, or pun-
ish staff.

In a 2015 report, the NASA Aerospace Safety Advisory Panel cautions about the inadvisabil-
ity of focusing on individuals and assigning blame:

The releasable nature of NASA mishap reports also creates a vulnerability to focusing
on blame. Generally speaking, all organizations in public view are subject to pres-
sures of answering for errors. These pressures can lead to a focus on fault and assign-
ing blame in a mishap investigation that will inherently inhibit the robustness of an
investigation. Such investigations have two shortcomings: (1) filtered or less-than-
transparent reporting of information, and (2) the inability to discover the true root and
contributing causes. The first can affect the culture of mishap investigation, because
the desire to protect an individual, program, or organization in the short term hinders
risk reduction in the long term. In the second case, disciplinary action associated with
the resultant blame gives a false sense of confidence where it rids the organization of
the problem; however, the root cause likely remains, and latent risk waits patiently for
the next opportunity to strike. . . . In addition, when blame is the focus of the investiga-
tion, the true cause of a mishap can be missed or hidden, thus increasing the risk of
repeating the mishap. This danger is introduced when releasable information is “spun”
to appease short-term public interest. It can contribute to second and third order
negative cultural effects in other areas such as misinterpreting risk and subsequent
incorrect resolution.(10)

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

I. IDENTIFYING AND CLASSIFYING EVENTS • 6

It is critical that each organization define blameworthy events and actions that will
be handled or dealt with using administrative or human resource systems. A common
definition of blameworthy events includes events that are the result of criminal acts,
patient abuse, alcohol or substance abuse on the part of the provider, or acts defined by
the organization as being intentionally or deliberately unsafe.(9,11,12) In the unlikely event
that during a review an RCA2 team discovers that the event is or may be blameworthy, the
team should notify the convening authority and refer the event to the convening author-
ity to be handled as dictated by the local policy. Referral of an event to the convening
authority does not mean that the opportunity to learn from it has been lost or that no
action will ultimately be taken. Referral just means that the primary responsibility to fully
look into the event and formulate and implement corrective actions is assumed by a dif-
ferent organizational entity that will not only look for systems-based solutions, as should
be the case with any safety investigation, but may also take actions that are directed at a
specific individual. Doing so preserves the integrity of a safety system that has committed
to using safety activities for system improvement, not for individual punitive action. This
is important because even the perception that an RCA2 review has led to punitive actions
can permanently and negatively impact the effectiveness of future reviews, as has been
demonstrated in other industries.(13)

To be effective, a risk-based prioritization system must receive reports of adverse events,
close calls, hazards, or system vulnerabilities from staff. Not receiving reports can nega-
tively impact the ability to estimate the probability that an event or hazard may occur.
Solutions to this include educating staff about reporting, making it easy for staff to report,
taking visible action as a result of reports, and providing feedback to reporters when

Developing Trust within the Organization and in the Community

Reports of hazards, vulnerabilities, and adverse events are the fuel for the safety improve-
ment engine. An organization is made up of people, and if the people in an organization aren’t
motivated to report, then the organization is at a definite disadvantage. An organization cannot
fix a problem if they don’t know that it exists.

One of the barriers or disincentives to people reporting is fear of negative results for them-
selves or their colleagues and organization. Adoption of a clear and transparent organizational
policy and absolute adherence by the organization to faithfully following it provides staff clarity
as to how reports that they make will be used and the ramifications for them personally. It is
critical to gain the trust of the members of the organization. Implementing such policies where
employees perceive that they are being treated in a fair and consistent manner is an essential
part of developing that trust. Policies that achieve these goals often include discussions of what
activities are viewed as at risk or blameworthy and often are characterized as promoting a just
culture.

Clear policies and the rationale behind them that are openly communicated to the commu-
nity also are essential to gain the trust and support of the community at large, which includes
patients. When an organization publicly and concretely states what it will do to promote patient
safety, it makes itself accountable to the community it serves. u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

I. IDENTIFYING AND CLASSIFYING EVENTS • 7

they submit reports. When staff members realize that their input makes a difference, they
are more likely to report to improve safety. Reports that do not end up being reviewed
through the RCA2 process still have significant value in improving patient safety.

Risk-Based Prioritization of Events, Hazards, and
System Vulnerabilities

As resources necessary to identify, analyze, and remediate hazards are not unlimited, it
is essential that an explicit, risk-based prioritization system be utilized so that an orga-
nization can credibly and efficiently determine what hazards should be addressed first.
An explicit, risk-based RCA2 prioritization system is superior to one based solely on the
harm or injury that a patient experienced. In a harm-based approach, currently the most
commonly used, an event must cause harm to a patient to warrant an RCA. A risk-based
system prioritizes hazards and vulnerabilities that may not yet have caused harm so that
these hazards and vulnerabilities can then be mitigated or eliminated before harm occurs.
This thinking is consistent with successful practices in many high-reliability industries, such
as aviation, as well as the recommended approaches of various health care accreditation
organizations.(14,15) (Methodology and examples of risk-based prioritization systems are
shown in Appendix 1.)

Establishing a risk-based prioritization system—and making it transparent to all stakehold-
ers—allows an organization to concentrate on eliminating or mitigating hazards rather
than being distracted by having to explain why they will or will not conduct an RCA. Use
of an explicit, risk-based prioritization methodology lends credibility and objectivity to the
process and reduces the chance of misperception by both internal and external stakehold-
ers that decisions to conduct an RCA are inappropriately influenced by political pressure or
other factors to cover up problems rather than discover what is in the best interests of the
patient.

Risk-based selection criteria should incorporate both the outcome severity or consequence
and its probability of occurrence.(16) An efficient way of doing this is to develop a risk matrix
(see Appendix 1) that has predefined and agreed-upon definitions for the levels of severity
or consequence as well as the probability of occurrence, along with predefined steps that
will be taken when matrix thresholds established by the organization are reached.* When
the definitions for severity or consequence also incorporate events or outcomes that man-
date root cause analysis by accrediting organizations, use of the matrix will ensure compli-
ance with their standards and make the process easier to communicate and operationalize.
The source (e.g., safety reports) of the information related to events, hazards, or vulnerabili-
ties is not important as long as enough information is received to allow prioritization using
an explicit risk-based prioritization tool.

The actual implementation of the prioritization system should be performed by an individ-
ual and not a committee; an explicit, well-devised prioritization system should not require
group deliberation. Also, the efficiency of the process is enhanced and needless inertia is

* Risk-based selection criteria must meet the requirements of applicable accrediting and regulatory
organizations.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

I. IDENTIFYING AND CLASSIFYING EVENTS • 8

eliminated when prioritization for hazards does not have to wait for a group to be con-
vened and to deliberate. Periodically (e.g., quarterly, semiannually) reviewing a summary of
the recently scored/prioritized events as part of the facility’s quality assurance program will
ensure that scoring does not deviate from the approved prioritization system.

Finally, the prevention of harm is the goal of these efforts. The organization should not be
distracted from taking immediate actions to minimize risk of harm while it is engaged in
the more formal RCA2 process.

Close Calls

Close calls (also called near misses or good catches) should also be prioritized using the
risk matrix by asking what is a plausible severity or consequence for the event, hazard, or
vulnerability, coupled with the likelihood or probability of the event/hazard scenario occur-
ring. This plausible outcome is then used as the severity or consequence when applying
the risk matrix to determine the appropriate response (RCA2 or other actions). Some may
believe that since there was no patient injury, close calls do not need to be reported or
investigated. However, close calls occur 10 to 300 times(17) more frequently than the actual
harm events they are the precursors of and provide an organization the opportunity to
identify and correct system vulnerabilities before injury or death occurs. A concern some-
times expressed is that reviewing close calls will increase the workload to an unmanage-
able level. This concern is unwarranted since the organization can construct a risk matrix
(such as the one provided in Appendix 1) to prioritize all events, hazards, and system
vulnerabilities that also accounts for the level of resources required for RCA2 reviews.(11,18,19)
Additionally, performance of an aggregated review of predefined and pre-selected catego-
ries of events that have the potential for a severe outcome can also ensure that the work-
load is kept to an acceptable level to provide value.

u

Aggregated Review

Aggregated review is a process of analyzing similar events to look for common causes. For
example, close call events in high frequency event categories that would typically require root
cause analysis (e.g., falls, medication adverse events) are collected and reviewed as a group on
a quarterly or semi-annual basis. Data and information on each event is collected as it occurs
by front line staff who complete forms developed for this purpose. The review team looks for
trends or recurring issues in the data or information associated with the events to identify sys-
tem issues needing correction. u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

II. RCA2 TIMING AND TEAM MEMBERSHIP • 9

II. RCA2 TIMING AND TEAM MEMBERSHIP

Timing

When a hazard is first identified there needs to be a mechanism in place that promptly
assesses if actions are required to mitigate the risk to the patient even before the formal
RCA2 process is under way. Immediate actions may include taking care of the patient,
disclosure, making the situation safe, notifying police or security if appropriate, preserv-
ing evidence, and gathering relevant information to fully understand the situation. Also
included may be tasks such as sequestering equipment, securing the scene as needed,
and conducting fact finding. These immediate actions may be performed in parallel to the
initiation of the RCA2 process.

Immediate actions following the event include taking care of the patient, making the situ-
ation safe for others, and sequestering equipment, products, or devices that were involved.
Within 72 hours of the event’s occurrence, it should be scored using the facility’s approved
risk-based prioritization system. If an RCA2 is required, the review needs to be initiated as
soon as possible following the event in order to capture details while they are still fresh in
the minds of those involved. Starting the event review promptly can be achieved if steps
have been taken ahead of time to ensure staff and resources will be available. Tech-
niques such as scheduling standing RCA2 team meetings each week, which may be can-
celled if not needed, establishes a placeholder and permits meeting space to be reserved.
Requesting that each department or service identify at least one or two staff to be on call
each week to serve on a review team will facilitate timeliness by allowing for the quick
convening of a team if one is needed.

The more rapidly well-thought-out actions are implemented, the less exposure there is for
additional patient injury to occur from the same type of event, hazard, or system vulner-
ability. A number of organizations have recommended that RCA2 type activities be com-
pleted in no longer than 30–45 days.(9,14,20)

Several meetings will be required to complete the RCA2 process. Meetings are typically
1.5 to 2 hours in length, with work required by individual members prior to and between
meetings to complete interviews or locate and review publications and documents. It is
critical that the organization provide adequate resources for the RCA2 process.

2

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II. RCA2 TIMING AND TEAM MEMBERSHIP • 10

Team Size

For the purposes of this document the team is defined as those individuals who see the
RCA2 process through from beginning to end. The work of the team is certainly augmented
and assisted through involvement with a myriad of other individuals (e.g., staff, patients,
and subject matter experts) but the involvement of those individuals may not encompass
all activities in which the team must engage. It is suggested that an RCA2 review team be
limited in size to 4 to 6 members. Rationales for doing so include the likelihood that larger
review teams will use more person-hours to complete the review, increase the difficulty
of scheduling team meetings, and add inertia that reduces the nimbleness of the RCA2
process.

Team Membership

For the purposes of this document, “team members” are those who are assigned by the
organization’s leadership to officially serve on the team, participate in the process by
attending meetings, conduct research and interviews, and identify root cause contributing
factors. These team members also are the individuals who make the determination as to
the final contents, findings, and recommendations of the RCA2 report.

Team membership (see Figure 1) should include a subject matter expert and someone who
is familiar with the RCA2 process but is not familiar with (i.e., is naïve to) the event process
being reviewed. Ideally a single team member will meet more than one team experi-
ence requirement; for example, the subject matter expert may be front line staff member
who is also capable of serving as the team leader. This may require bringing in experts
from the outside, provided confidentiality protection is not compromised. Managers and
supervisors may serve as team members provided the event did not occur in their area of
responsibility and their subordinates are not team members. This avoids the possibility of
subordinates censoring themselves if their supervisor or manager is present, thus inhibit-
ing free and open communication.

Team members should have a basic understanding of human factors to provide insight
into how people can be set up to fail by improperly designed systems, equipment, devices,
products, and processes. A patient representative, unrelated to any patient or family mem-
ber of a patient who might be involved in the event undergoing analysis, should be con-
sidered to serve on each RCA2 review team to represent the patient perspective and voice.
Some organizations have experimented with including the patient involved in the adverse
event or their family members on RCA teams, but data supporting this as an effective
method are currently lacking. There are many organizations outside of and within health
care that have prohibited the patient or family members being on RCA teams because of
concern that it inhibits free and open communication.

One team member should be appointed as the team leader and charged with ensuring the
team follows the RCA2 process and completes the work on schedule. The leader needs to
be skilled in the RCA2 process and problem solving in general, and be an effective commu-
nicator. Another team member should be assigned to serve as the recorder. The recorder’s
responsibilities include documenting team findings during the meetings. Less rework will

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

II. RCA2 TIMING AND TEAM MEMBERSHIP • 11

be required if the recorder uses an LCD projector or similar method to project the team’s
work during the meeting so all team members can review and comment on what is being
generated.

Individuals who were involved in the event should not be on the team because they may
feel guilty and insist on corrective measures that are above and beyond what is prudent, or
they may steer the team away from their role in the event and activities that contributed
to the event. It may also be hard for other team members to ask difficult questions and
have frank discussions with these individuals present in the room. These same reasons
apply to having patients or family members who were involved in the event serve on RCA2
teams. However, it is certainly appropriate and usually vital that involved individuals (staff,
patients, family members) should be interviewed by the team, in order to understand
what happened and to solicit feedback on potential corrective actions. Outside individual
and patient involvement with RCA2 reviews should be considered with respect to “federal
statutes, state statutes and case law as well as the readiness and availability of the patient/
family member to participate in a productive manner with the shared goal of significantly
reducing the risk of recurrence of the event and making the system safer.” (21)

It is important to remember that the team is convened to discover what happened, why it
happened, and what can be done to prevent it from happening again. Staff may be drawn
from across the organization and not just from the departments or services intimately
involved with the close call or adverse event being reviewed. Having those intimately
involved in the event on the review team creates a real or perceived conflict of interest
that can negatively impact the success of the RCA2 and must be avoided. It is important
to remember that, in teaching institutions, trainees (e.g., nursing students and resident
physicians) deliver a substantial portion of patient care, and their incorporation in the

Figure 1. RCA2 Team Membership* and Involvement

NOTE: An individual may serve in multiple capacities Team Member? Interview?

Subject matter expert(s) on the event or close call process
being evaluated

Yes
Yes, if not

on the team

Individual(s) not familiar with (naïve to) the event or close
call process

Yes No

Leader who is well versed in the RCA2 process Yes No

Staff directly involved in the event No Yes

Front line staff working in the area/process Yes Yes

Patient involved in the event No Yes**

Family of patient involved in the event No Yes**

Patient representative Yes Yes

* Strongly consider including facility engineering, biomedical engineering, information technology,
or pharmacy staff on an RCA2 team, as individuals in these disciplines tend to think in terms of
systems and often have system-based mindsets. Including medical residents on a team when they
are available is also suggested.

** This might not be needed for some close calls or events that are far removed from the bedside
(e.g., an incorrect reagent that is used in the lab).

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RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

II. RCA2 TIMING AND TEAM MEMBERSHIP • 12

RCA2 process both as team members or as sources for information can be invaluable to
understanding what happened. They may also contribute effectively to the formulation
of effective and sustainable corrective actions. Their inclusion may provide a fresh look at
existing systems and a deeper understanding for those involved with how the organization
operates, and that can have future benefits.

Serving on a review team should not be “additional work as assigned.” Serving on an
RCA2 review team is “real work” and it should be prioritized, acknowledged, and treated
as such. Time within the normal work schedule needs to be provided for staff to participate
in the review to send a clear message that management values and supports the activity
to improve patient safety. Facilities may want to consider rotating RCA2 team membership
to include staff in all services/departments throughout the facility, including those working
afternoons, nights, and weekends. Permitting all staff to have the opportunity to partici-
pate in the process exposes them to how and why adverse events occur and may bring
about new understanding. In particular, staff may better understand the way that systems
influence how they complete their daily tasks as well as gain a better understanding of the
value of the RCA2 process.

Patient and Family Involvement

The National Patient Safety Foundation’s report Safety Is Personal: Partnering with Patients and
Families for the Safest Care (2014) challenges leaders of health care systems to “involve patients
and families as equal partners in the design and improvement of care across the organization
and/or practice,” and health care clinicians and staff to not only “provide clear information, apol-
ogies, and support to patients and families when things go wrong” but also “engage patients as
equal partners in safety improvement and care design activities.”

What might this level of involvement and engagement look like with respect to root cause
analysis and action reviews? While there is little industry experience regarding the involve-
ment of patients/families in the process of root cause analysis, an article by Zimmerman and
Amori asserts that, when properly handled, involving patients in post-event analysis allows risk
management professionals to further improve their organization’s systems analysis process,
while empowering patients to be part of the solution.21 The article also acknowledges there are
a number of legal and psychological issues to be considered.

Patients and families are among the most important witnesses for many adverse events,
and organizations are encouraged to interview them if the patient and/or family are able and
willing. This will enable the RCA2 team to gain a more complete understanding of the circum-
stances surrounding the event under consideration and may offer additional perspectives on
how to reduce the risk of recurrence. Consideration should be made to include an uninvolved
patient representative as a member of the RCA2 team. This will help protect the confidentiality
of the process while broadening the perspective on how to further improve organizational per-
formance. This representative may be a member of the organization’s patient and family advi-
sory council (or equivalent) or simply a patient representative selected for this specific RCA2. In
either case, the representative should be unrelated to any patient or family member of a patient
who is involved in the event, should have received education regarding quality and peer review
protections, and should have a signed confidentiality form on file. This can help mitigate the
legal and psychological barriers to direct patient/family involvement in the RCA2 process, while
obtaining the benefit that patient representatives can bring to improvement efforts. u

2

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II. RCA2 TIMING AND TEAM MEMBERSHIP • 13

Interviewing

Expertise required for the review that is not already represented or possessed by those on
the team may be obtained through the interview process (tips for conducting these inter-
views are presented in Appendix 3). Individuals who were involved in the event should be
interviewed by the team. Patients and/or the patient’s family, as appropriate, should be
among those interviewed unless they decline. Requesting information from the patient
and family will enable the team to gain a more complete understanding of the circum-
stances surrounding the event under consideration. Patients and/or their family members
provide a unique perspective that would otherwise be unavailable.

u

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 14

III. THE RCA2 EVENT REVIEW PROCESS

Analysis Steps and Tools

Figure 2 graphically describes the RCA2 process from the occurrence of the event through
fact finding, corrective action effectiveness measurement, and feedback to the patient
and/or family, staff in the organization, and externally to the patient safety organization.
The initial fact finding is used to discover what happened and why it happened. The review
process should include the following actions:

• Graphically describe the event using a chronological Flow Diagram or timeline;
identify gaps in knowledge about the event.

• Visit the location of the event to obtain firsthand knowledge about the workspace
and environment.

• Evaluate equipment or products that were involved.

• Identify team-generated questions that need to be answered.

• Use Triggering Questions (see Appendix 2) and team-generated open-ended ques-
tions that can broaden the scope of the review by adding additional areas of inquiry.

• Identify staff who may have answers to the questions and conduct interviews (see
the Interviewing Tips in Appendix 3) of involved parties including staff and affected
patients.

• Include patients, family, or a patient representative as appropriate to ensure a thor-
ough understanding of the facts.

• Identify internal documents to review (e.g., policies, procedures, medical records,
maintenance records).

• Identify pertinent external documents or recommended practices to review (e.g.,
peer reviewed publications, manufacturers’ literature, equipment manuals, profes-
sional organization guidance and publications).

• Identify and acquire appropriate expertise to understand the event under review. This
may require interactions with internal and external sources of expertise (e.g., manu-
facturers, vendors, professional organizations, regulatory organizations).

• Enhance the Flow Diagram (see the sample in Appendix 4) or timeline to reflect the
final understanding of events and where hazards or system vulnerabilities are located.

• Use the flow diagram to compare what happened with what should have happened
and investigate why all deviations occurred.

• Provide feedback to the involved staff and patients, as well as feedback to the organi-
zation as a whole.

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RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 15

72 hours72 hours

30–45 days 30–45 days

Event, hazard,
system vulnerability

Risk-based
prioritization

What happened?
Fact finding and flow

diagramming

Development of
causal statements

Identification of solutions
and corrective actions

Implementation

Measurement

Feedback

Immediate actions are taken to care for the
patient, make the situation safe for others, and
sequester equipment, products, or materials.

Patient safety, risk or quality management is
typically responsible for the prioritization; for con-
sistency one person is assigned responsibility for
applying the risk matrix. See Appendix 1.

Multiple meetings of 1.5 to 2 hours may be
required to: prepare and conduct interviews (see
Appendix 3); visit the site; review equipment or
devices; and prepare the report.
Managers/supervisors responsible for the
processes or areas should be invited to provide
feedback for the team’s consideration.

See Appendix 2 for suggested Triggering
Questions.

See Appendix 6 for the Five Rules of Causation.

Patients/families and managers/supervisors
responsible for the process or area should be
provided feedback and consulted for additional
ideas; however they should not have final deci-
sion authority over the team’s work. See Figure 3
for the Action Hierarchy.

A responsible individual with the authority to act,
not a team or committee, should be responsible
for ensuring action implementation.

Each action should have a process or outcome
measure identifying what will be measured, the
expected compliance level, and the date it will be
measured. An individual should be identified who
will be responsible for measuring and reporting
on action effectiveness.

Feedback should be provided to the CEO/board,
service/department, staff involved, patient and/or
patient’s family, the organization, and the patient
safety organization (if relevant).

Typically a single RCA2 team is
responsible for the entire review
process, however, if different staff
is used for these RCA2 review
phases it is recommended that a
core group of staff from the RCA2
team participate on all phases for
consistency and continuity.

The RCA2 team is not usually
responsible for these activities.

Figure 2. Individual RCA2 Process

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 16

With the new information acquired through the review process, teams are in a position to
identify contributing factors. Tools such as Cause and Effect Diagramming (a sample is pre-
sented in Appendix 5) and the “Five Whys,” best known as the Five Rules of Causation (see
Appendix 6), may also be used to identify and document contributing factors, but their use
is not mandatory. The Cause and Effect Diagram is an investigative tool as well as a means
to improve communication to stakeholders. Health care processes are complex, and there
are many contributing factors to adverse events or near misses that when identified and
addressed will improve patient safety. Review teams should strive to identify the multiple
contributing factors and not stop the analysis when only a single contributing factor is
found. Once identified, contributing factors should be identified in a manner that focuses
on system issues and does not assign blame to one or more individuals. Applying the Five
Rules of Causation to each contributing factor statement will help ensure that this goal is
met. It is important that supporting evidence or rationale be provided in the report to cor-
roborate or substantiate why a contributing factor was selected.

Actions

The most important step in the RCA2 process is the identification and implementation
of actions to eliminate or control system hazards or vulnerabilities that have been
identified in the contributing factor statements. Therefore, review teams should strive
to identify actions that prevent the event from recurring or, if that is not possible, reduce
the severity or consequences if it should recur. Using a tool such as the Action Hierarchy
(see Figure 3) will assist teams in identifying stronger actions that provide effective and
sustained system improvement.(22) The Action Hierarchy developed by the US Department
of Veterans Affairs National Center for Patient Safety in 2001 was modeled on the National
Institute for Occupational Safety and Health Administration’s Hierarchy of Controls,(23)
which has been used for decades in many other industries to improve worker safety.

Teams should identify at least one stronger or intermediate strength action for each
RCA2 review. In some cases it may be necessary to recommend actions classified as weaker
actions in the Action Hierarchy as temporary measures until stronger actions can be imple-
mented. It should be understood that “weaker” actions such as training and policy changes
are often necessary to establish proficiency and expectations, but when used alone are
unlikely to be sufficient to provide sustained patient safety improvements.(24,25)

Keeping Team Members Engaged and Involved

Projecting the RCA2 team’s work using an LCD projector or displaying it on a large flat screen
monitor during meetings is an effective way of keeping team members engaged. Also, using
self-stick notes to construct Flow Diagrams and Cause and Effect Diagrams during meetings
helps ensure everyone has the same level of knowledge about the event and allows efficient
adjustment of diagrams as the understanding of facts changes with addition of new informa-
tion. Both techniques reduce the need for rework after the meeting, thus saving everyone
time. u

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RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 17

Figure 3. Action Hierarchy

Action Category Example

Stronger
Actions

(these tasks
require less reli-
ance on humans
to remember to
perform the task
correctly)

Architectural/physical plant
changes

Replace revolving doors at the main patient entrance into the building with
powered sliding or swinging doors to reduce patient falls.

New devices with usability
testing

Perform heuristic tests of outpatient blood glucose meters and test strips and
select the most appropriate for the patient population being served.

Engineering control (forcing
function)

Eliminate the use of universal adaptors and peripheral devices for medical equip-
ment and use tubing/fittings that can only be connected the correct way (e.g.,
IV tubing and connectors that cannot physically be connected to sequential
compression devices or SCDs).

Simplify process Remove unnecessary steps in a process.

Standardize on equipment
or process

Standardize on the make and model of medication pumps used throughout the
institution. Use bar coding for medication administration.

Tangible involvement by
leadership

Participate in unit patient safety evaluations and interact with staff; support the
RCA2 process; purchase needed equipment; ensure staffing and workload are
balanced.

Intermediate
Actions

Redundancy Use two RNs to independently calculate high-risk medication dosages.

Increase in staffing/decrease
in workload

Make float staff available to assist when workloads peak during the day.

Software enhancements,
modifications

Use computer alerts for drug-drug interactions.

Eliminate/reduce
distractions

Provide quiet rooms for programming PCA pumps; remove distractions for
nurses when programming medication pumps.

Education using simulation-
based training, with periodic
refresher sessions and
observations

Conduct patient handoffs in a simulation lab/environment, with after action
critiques and debriefing.

Checklist/cognitive aids Use pre-induction and pre-incision checklists in operating rooms. Use a checklist
when reprocessing flexible fiber optic endoscopes.

Eliminate look- and
sound-alikes

Do not store look-alikes next to one another in the unit medication room.

Standardized communica-
tion tools

Use read-back for all critical lab values. Use read-back or repeat-back for all ver-
bal medication orders. Use a standardized patient handoff format.

Enhanced documentation,
communication

Highlight medication name and dose on IV bags.

Weaker
Actions
(these tasks require
more reliance on
humans to remem-
ber to perform the
task correctly)

Double checks One person calculates dosage, another person reviews their calculation.

Warnings Add audible alarms or caution labels.

New procedure/
memorandum/policy

Remember to check IV sites every 2 hours.

Training Demonstrate correct usage of hard-to-use medical equipment.

Action Hierarchy levels and categories are based on Root Cause Analysis Tools, VA National Center for Patient Safety,
http://www.patientsafety.va.gov/docs/joe/rca_tools_2_15.pdf. Examples are provided here.

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III. THE RCA2 EVENT REVIEW PROCESS • 18

Measuring Action Implementation and Effectiveness

In order to improve patient safety, corrective actions must be implemented and their
effectiveness measured. To ensure that actions are implemented, assign an individual,
not a committee, the responsibility for each action, and set a date by which the action
must be completed. This individual must have the authority to effect change and the
resources or access to resources to implement the action. Multiple individuals or a commit-
tee should not be assigned this responsibility because to do so dilutes accountability and
undermines the probability of successful implementation.

Each action identified by the review team requires at least one measure, which may
be either a process measure or an outcome measure. A process measure may be some-
thing as simple as documenting that the action was implemented. For the overall RCA2
process, it is wise to have a combination of both process and outcome measures. Process
measures confirm the action has been implemented, while outcome measures determine
if the action was effective. The length of time required to implement the measure should
also be considered. For example, if an action required beta testing of new technology to
improve staff use of alcohol-based hand gel before and after each patient encounter, a
potential process measure might be to observe 100 staff-patient encounters over a 7-day
period with an expected compliance rate of 95%. A potential outcome measure for this
same action might be a 20% reduction in hospital-acquired infections (HAI) transmitted
by staff-patient contact. The data for the process measure may be collected more quickly

Why Is “Human Error” Not an Acceptable Root Cause?

While it may be true that a human error was involved in an adverse event, the very occur-
rence of a human error implies that it can happen again. Human error is inevitable. If one well-
intentioned, well-trained provider working in his or her typical environment makes an error,
there are system factors that facilitated the error. It is critical that we gain an understanding of
those system factors so that we can find ways to remove them or mitigate their effects.

Our goal is to increase safety in the long term and not allow a similar event to occur. When
the involved provider is disciplined, counseled, or re-trained, we may reduce the likelihood that
the event will recur with that provider, but we don’t address the probability that the event will
occur with other providers in similar circumstances. Wider training is also not an effective solu-
tion; there is always turnover, and a high-profile event today may be forgotten in the future. This
is reflected in Figure 3, the Action Hierarchy, which is based upon safety engineering principles
used for over 50 years in safety-critical industries. Solutions that address human error directly
(such as remediation, training, and implementation of policies) are all weaker solutions. Solu-
tions that address the system (such as physical plant or device changes and process changes)
are much stronger. This is why it’s so important to understand the system factors facilitating
human error and to develop system solutions.

Review teams should not censor themselves when it comes to identifying corrective actions.
This is important because the team’s job is to identify and recommend the most effective
actions they can think of, and it is leadership’s responsibility to decide if the benefit likely to be
realized is worth the investment, in light of the opportunity cost and its impact on the system in
general. Only the top leadership of an organization can accept risk for the organization, and this
is a responsibility that should not be delegated to others. u

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 19

than the HAI data, and therefore the technology (if effective) may be implemented sooner
to reduce future potential patient harm. Deciding what type of measures to employ is a
risk-based decision. A balance must be struck between the precision and accuracy of mea-
surement required and what conclusions it will permit as opposed to the downside if the
effectiveness is inaccurately determined. Measures should identify what is being measured,
by whom, what compliance level is expected, and a specific date that the measure will be
assessed. An individual, not a committee or group, should be made responsible for ensur-
ing the action effectiveness is reviewed. (Appendix 7 provides the Cause, Action, Process/
Outcome Measure Table structure, plus a sample causal statement.) When actions have
been measured, the CEO, review team, patient, and/or patient’s family should be provided
with feedback on its effectiveness.

Feedback

It is essential that involved staff as well as involved patients/families be provided
feedback of the findings of the RCA2 process, and be given the opportunity to comment
on whether the proposed actions make sense to them. Feedback to the organization as a
whole is also essential in order to create a culture of safety and reporting, permitting staff
to see the improvements that result from these reports.

Leadership and Board Support

For the RCA2 process to be successful it is critical that it be supported by all levels of the
organization including the chief executive officer and the board of directors, as dem-
onstrated by an appropriate investment of resources. Each action recommended by a
review team should be approved or disapproved, preferably by the CEO or alternatively
by another appropriate member of top management. If an action is disapproved, the rea-
son for its disapproval should be documented and shared with the RCA2 team so that the
constraint preventing implementation can be understood and another action developed
by the team to replace it, unless it is otherwise effectively addressed in the action plan.

RCA2 results on significant events as defined by the organization—including the hazards
identified, their causes, and corresponding corrective actions—should be presented
to the board of directors for their review and comment. Figures 3 and 4 present cogni-
tive aids that may be used by CEOs and board members when reviewing RCA2 reports.
These tools will aid the CEO and board in making a qualitative assessment to determine
whether a thorough RCA2 review has been completed. Leaders then need to determine
the applicability of the findings on a broader scale across their organization or beyond and
take further action as appropriate if required. It is recommended that the review of RCA2
reports be added to the board of directors meeting agenda as a recurring topic as part of
efforts to address enterprise risk management. The visible and tangible involvement of
leadership and the board demonstrates that the process of root cause analysis and action
is important.

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

III. THE RCA2 EVENT REVIEW PROCESS • 20

Measuring the Effectiveness and Sustainability of the RCA2 Process

It is recommended that the RCA2 program be reviewed annually by senior leadership
and the board for effectiveness and continued improvement. The following are examples
of measures that may be useful:

• Percent of contributing factors written to meet the Five Rules of Causation

• Percent of RCA2 reviews with at least one stronger or intermediate strength action

• Percent of actions that are classified as stronger or intermediate strength

• Percent of actions that are implemented on time

• Percent of actions completed

• Audits or other checks that independently verify that hazard mitigation has been
sustained over time

• Staff and patient satisfaction with the RCA2 review process (survey)

• Response to AHRQ survey questions pertinent to the RCA2 review process

• Percent of RCA2 results presented to the board

u

Figure 4. Warning Signs of Ineffective RCA2

If any one or more of the following factors are true, then your specific RCA2 review
or your RCA2 process in general needs to be re-examined and revised because it is
failing:

• There are no contributing factors identified, or the contributing factors lack
supporting data or information.

• One or more individuals are identified as causing the event; causal factors point to
human error or blame.

• No stronger or intermediate strength actions are identified.

• Causal statements do not comply with the Five Rules of Causation (see Appendix 6).

• No corrective actions are identified, or the corrective actions do not appear to
address the system vulnerabilities identified by the contributing factors.

• Action follow-up is assigned to a group or committee and not to an individual.

• Actions do not have completion dates or meaningful process and outcome
measures.

• The event review took longer than 45 days to complete.

• There is little confidence that implementing and sustaining corrective action will
significantly reduce the risk of future occurrences of similar events.

2

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

IV. CONCLUSION AND RECOMMENDATIONS • 21

IV. CONCLUSION AND RECOMMENDATIONS

Conclusion

The key to establishing a successful root cause analysis and action process lies in leader-
ship support. The components of a successful program include establishing a transparent
risk-based methodology for triaging events, selecting the correct personnel to serve on the
team, providing the team with the resources and time to complete the review, identifying
at least one stronger or intermediate strength action in each review, and measuring the
actions to assess if they were effective in mitigating the risk. Using tools such as risk-based
prioritization matrices, Triggering Questions, the Five Rules of Causation, and the Action
Hierarchy will aid the team in identifying and communicating causal factors and taking
actions that will improve patient care and safety.

Recommendations

1. Leadership (e.g., CEO, board of directors) should be actively involved in the root
cause analysis and action (RCA2) process. This should be accomplished by support-
ing the process, approving and periodically reviewing the status of actions, under-
standing what a thorough RCA2 report should include, and acting when reviews do
not meet minimum requirements.

2. Leadership should review the RCA2 process at least annually for effectiveness.

3. Blameworthy events that are not appropriate for RCA2 review should be defined.

4. Facilities should use a transparent, formal, and explicit risk-based prioritization sys-
tem to identify adverse events, close calls, and system vulnerabilities requiring RCA2
review.

5. An RCA2 review should be started within 72 hours of recognizing that a review is
needed.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

IV. CONCLUSION AND RECOMMENDATIONS • 22

6. RCA2 teams should be composed of 4 to 6 people. The team should include pro-
cess experts as well as other individuals drawn from all levels of the organization,
and inclusion of a patient representative unrelated to the event should be consid-
ered. Team membership should not include individuals who were involved in the
event or close call being reviewed, but those individuals should be interviewed for
information.

7. Time should be provided during the normal work shift for staff to serve on an RCA2
team, including attending meetings, researching, and conducting interviews.

8. RCA2 tools (e.g., interviewing techniques, Flow Diagramming, Cause and Effect Dia-
gramming, Five Rules of Causation, Action Hierarchy, Process/Outcome Measures)
should be used by teams to assist in the investigation process and the identification
of strong and intermediate strength corrective actions.

9. Feedback should be provided to staff involved in the event as well as to patients
and/or their family members regarding the findings of the RCA2 process.

u

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 23

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX
This appendix reproduces a modified version of the VA National Center for Patient Safety’s Safety Assessment Code Matrix
as an example of a risk-based prioritization methodology for ranking hazards, vulnerabilities, and events so that an orga-
nization can consistently and transparently decide how to utilize its available resources to determine which risks to study
and mitigate first. Five sample scenarios and their assessments are provided on pages 25–30.

Any event prioritization tool such as the SAC Matrix presented in this appendix should meet local organizational regulatory
requirements and standards as well as those of applicable accrediting and regulatory organizations. For a prioritization
tool’s use to be successful, a system should be instituted to ensure that the tool is updated periodically to reflect changes
in applicable requirements, regulations, and standards.May 23, 2008 VHA HANDBOOK 1050.01

APPENDIX B

B-1

THE SAFETY ASSESSMENT CODE (SAC) MATRIX

The Severity Categories and the Probability Categories that are used to develop the Safety Assessment Codes
(SACs) for adverse events and close calls are presented in the following, and are followed by information on the
SAC Matrix.

1. SEVERITY CATEGORIES

a. Key factors for the severity categories are extent of injury, length of stay, level of care required for remedy, an d
actual or estimated physical plant costs. These four categories apply to actual adverse events and potential events (close
calls). For actual adverse events, assign severity based on the patient’s actual condition.

b. If the event is a close call, assign severity based on a reasonable “worst case” systems level scenario. NOTE: For
example, if you entered a patient’s room before they were able to complete a lethal suicide attempt, the event is
catastrophic, because the reasonable “worst case” is suicide.

Catastrophic Major
Patients with Actual or Potential: Patients with Actual or Potential:
Death or major permanent loss of function (sensory, motor,
physiologic, or intellectual) not related to the natural course of
the patient’s illness or underlying condition (i.e., acts of
commission or omission). This includes outcomes that are a
direct result of injuries sustained in a fall; or associated with an
unauthorized departure from an around-the-clock treatment
setting; or the result of an assault or other crime. Any of the
adverse events defined by the Joint Commission as reviewable
“Sentinel Events” should also be considered in this category.

Visitors: A death; or hospitalization of three or more visitors
Staff: A death or hospitalization of three or more staff*

Permanent lessening of bodily functioning (sensory, motor,
physiologic, or intellectual) not related to the natural
course of the patient’s illness or underlying conditions
(i.e., acts of commission or omission) or any of the following:

a. Disfigurement
b. Surgical intervention required
c. Increased length of stay for three or more patients
d. Increased level of care for three or more patients

Visitors: Hospitalization of one or two visitors

Staff: Hospitalization of one or two staff or three or more
staff experiencing lost time or restricted duty injuries or
illnesses

Equipment or facility: Damage equal to or more than
$100,000**, ♦

Moderate Minor
Patients with Actual or Potential: Increased length of stay or
increased level of care for one or two patients
Visitors: Evaluation and treatment for one or two visitors (less
than hospitalization)
Staff: Medical expenses, lost time or restricted duty injuries or
illness for one or two staff
Equipment or facility: Damage more than $10,000, but less than
$100,000**, ♦

Patients with Actual or Potential: No injury, nor increased
length of stay nor increased level of care
Visitors: Evaluated and no treatment required or refused
treatment
Staff: First aid treatment only with no lost time, nor
restricted duty injuries nor illnesses
Equipment or facility: Damage less than $10,000 or loss of
any utility without adverse patient outcome (e.g., power,
natural gas, electricity, water, communications, transport, heat
and/or air conditioning)**, ♦

*Title 29 Code of Federal Regulations (CFR) 1960.70 and 1904.8 requires each Federal agency to notify the Occupational Safety and
Health Administration (OSHA) within 8 hours of a work-related incident that results in the death of an employee or the in-patient
hospitalization of three or more employees. Volunteers are considered to be non-compensated employees.

**The Safe Medical Devices Act of 1990 requires reporting of all incidents in which a medical device may have caused or contributed to
the death, serious injury, or serious illness of a patient or another individual.

♦The effectiveness of the facilities disaster plan must be critiqued following each implementation to meet The Joint Commission’s
Environment of Care Standards.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 24

Based on Department of Veterans Affairs, Veterans Health Administration, VHA Patient Safety Improvement Handbook
1050.01, May 23, 2008. Available at http://cheps.engin.umich.edu/wp-content/uploads/sites/118/2015/04/Triaging-
Adverse-Events-and-Close-Calls-SAC.pdf

VHA HANDBOOK 1050.01 May 23, 2008
APPENDIX B

B-2

2. PROBABILITY CATEGORIES

a. Like the severity categories, the probability categories apply to actual adverse events and close calls.

b. In order to assign a probability rating for an adverse event or close call, it is ideal to know how ofte n it occurs
at your facility. Sometimes the data will be easily available because they are routinely tracked (e.g., falls with
injury, Adverse Drug Events (ADEs), etc.). Sometimes, getting a feel for the probability of events that are not
routinely tracked will mean asking for a quick or informal opinion from staff most familiar with those events.
Sometimes it will have to be your best educated guess.

Like the severity categories, the probability categories apply to actual adverse events and close calls.

c. In order to assign a probability rating for an adverse event or close call, it is ideal to know how often it occurs
at your facility. Sometimes the data is easily available because the events are routinely tracked (e.g., falls with
injury, ADEs, etc.). Sometimes, getting a feel for the probability of events that are not routinely tracked will mean
asking for a quick or informal opinion from staff most familiar with those events. Sometimes it will have to be the
best educated guess.

(1) Frequent – Likely to occur immediately or within a short period (may happen several times in 1 year).

(2) Occasional – Probably will occur (may happen several times in 1 to 2 years).

(3) Uncommon – Possible to occur (may happen sometime in 2 to 5 years).

(4) Remote – Unlikely to occur (may happen sometime in 5 to 30 years).

3. How the Safety Assessment Codes (SAC) Matrix Looks

Probability

and
Severity

Catastrophic

Major

Moderate

Minor

Frequent

3

3

2

1

Occasional

3

2

1

1

Uncommon

3

2

1

1

Remote

3

2

1

1

4. How the SAC Matrix Works. When a severity category is paired with a probability category for either an
actual event or close call, a ranked matrix score (3 = highest risk, 2 = intermediate risk, 1 = lowest risk) resu lts.
These ranks, or SACs, can then be used for doing comparative analysis and for deciding who needs to be notified
about the event.

5. Reporting

a. All known reporters of events, regardless of SAC score (one, two, or three), must receive appropria te and
timely feedback.

b. The Patient Safety Manager, or designee, must refer adverse events or close calls related solely to staff,
visitors, or equipment and/or facility damage to relevant facility experts or services on a timely basis, for assessment
and resolution of those situations.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 25

Using the Safety Assessment Code Matrix: Five Examples
Excerpted and adapted from Bagian JP, Lee CZ, Cole JF, “A Method for Prioritizing Safety Related Actions,” in
Strategies for Leadership: a Toolkit for Improving Patient Safety, developed by the Department of Veterans Affairs
National Center for Patient Safety, sponsored by the American Hospital Association.

EXAMPLE 1
The nursing staff was providing the patient with routine a.m. care. This consisted of showering the
patient in the shower room on the ward. The patient was seated in a chair being washed when
he slid off the chair and hit his face, hip, and shoulder. The patient was examined by the doctor at
7:55 a.m. and transferred to the acute evaluation unit (AEU) for further evaluation. The AEU physi-
cian ordered x-rays. No fractures noted. The patient was returned to the ward where neuro checks
were initiated as per policy and reported as normal.

Severity Determination
The first step in assigning the SAC score is determining the severity of the event. We can see
from the report that no injury was reported after evaluation by x-ray and clinical evaluation on
the ward. Therefore, the actual severity would be rated as minor.

Actual Severity Score = MINOR

However, when one considers the potential for injury, the evaluator could reasonably assess it
as potentially catastrophic. This is true because their past experience with similar falls had dem-
onstrated that the most likely worst case scenario could have resulted in a lethal injury. Therefore,
while the actual severity would be rated as minor the potential severity would be considered to be
catastrophic.

In general, the severity score assigned should be whichever one is the most severe when com-
paring the actual versus the potential/risk thereof (close call) assessment. In this way, the most
conservative course will be selected, which will maximize the potential to prevent future events
of this nature.

Potential Severity Score = CATASTROPHIC

Probability Determination
The probability determination should be made based on the situation that results in the most
severe severity assessment. The evaluator should base the probability assessment on their
own experience at their facility and locally generated data. This, in most cases, will be the most
subjective portion of the SAC score determination. It should be noted that the SAC Matrix that
is used has been constructed in such a way that it minimizes the impact of this subjectivity.
The purpose of the SAC score process is to provide a framework to prioritize future actions. If
the facility feels that there are circumstances that warrant a more in-depth follow-up than that
which the SAC score indicates, they are free to pursue it.

Based on the experience of the evaluator, the probability of a catastrophic (using the SAC
definition) outcome for a patient of this type whose head struck a hard object as the result of a

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 26

fall would be occasional to uncommon. Wanting to be conservative, the occasional assessment
would be selected.

Probability Score = OCCASIONAL

Using the SAC matrix one need only locate the severity rating and then follow down the column
until reaching the row containing the probability score. In this case this would yield the SAC score of
“3.” Notice that even if the probability of the event had been rated as uncommon, the SAC score still
would have been determined to be a “3.”

SAC Score = 3, therefore an RCA2 review would be conducted.

All actual SAC 3 and potential SAC 3 events require that a root cause analysis and action review be
conducted.

EXAMPLE 2
YXZ monitor did not trigger an alarm in the Surgical ICU. The problem was observed by the nurses
while they cared for a DNR patient who developed cardiac arrhythmias, but the monitor failed to
trigger the alarm. Since the patient had a DNR order he was not resuscitated.

Severity Determination
The first step in assigning the SAC score is determining the actual severity score for the event.
We can see from the report that the actual outcome of this event was the death of the patient.
While this would definitely be thought of as a catastrophic event, there are other factors to be
considered.

Since the patient was classified as a DNR, and the nurses who were caring for the patient wit-
nessed the cardiac arrhythmias, the patient’s death was not the result of the failure of the alarm
to annunciate the cardiac abnormalities. Instead, there was an appropriate decision made not
to resuscitate based on the DNR order. This then would mean that the actual outcome would be
considered to be a result of the natural course of the patient’s disease. As such, the severity code
based on the actual outcome would be N/A (not applicable) and the case would not receive any
further consideration if scoring were to stop at the actual severity.

However, such an action does not take into account the potential/risk thereof (close call) assess-
ment and does not make common sense. It was purely serendipitous that the patient was a

Example 1 SAC Matrix
Severity and Probability Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 27

DNR. Had this not been the case, the death would not have been placed in the natural course
of the disease category. It was probably also serendipitous that the cardiac arrhythmias were
witnessed. This would mean that had this happened in a patient that was not in DNR status,
a catastrophic event may reasonably be construed to have occurred. For these reasons the
severity for this event would be determined to be catastrophic from a potential perspective.
Remember, the severity score assigned should be whichever one is the most severe when com-
paring the actual versus the potential/risk thereof (close call) assessment. In this way, the most
conservative course will be selected, which will maximize the potential to prevent future events
of this nature.

Severity Score = CATASTROPHIC

Probability Determination
The probability determination should be made based on the situation that results in the most
severe severity assessment. The evaluator should base the probability assessment on their own
experience at their facility. This, in most cases, will be the most subjective portion of the SAC
score determination. It should be noted that the SAC Matrix that is used has been constructed
in such a way that it minimizes the impact of this subjectivity. It must be remembered that the
entire purpose of the SAC score process is to provide a framework within which to prioritize
future actions and that a higher rating can be assigned if the facility feels that there are particu-
lar circumstances that warrant more in-depth follow-up.

The probability determination would rely on the experience of the evaluator. For the purposes
of this illustration we will assume that the probability is thought to be uncommon.

Probability Score = UNCOMMON

Using the SAC matrix one need only locate the severity rating and then follow down the column
until reaching the row containing the probability score. In this case this would yield a ‘”3.” Notice
that even if the probability of the event had been rated as remote, the SAC score still would have
been determined to be a “3.”

SAC Score = 3, therefore an RCA2 review would be conducted.

Example 2 SAC Matrix
Severity and Probability Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 28

EXAMPLE 3
An outpatient received an MRI scan and bought his oxygen cylinder into the magnet room, where
it was pulled into the bore of the magnet. The MR technician activated the emergency shutdown,
which turned off all electrical power to the magnet and expelled the liquid helium cooling the mag-
net to atmosphere outside of the building. Neither the patient nor the tech was injured. The magnet
sustained superficial damage but was out of service for 5 days until a contractor could be brought
in to replace the helium. (Appendix 4 provides the Final Flow Diagram for this event.)

Severity Determination
The first step in assigning the SAC score is determining the actual severity score for the event.
We can see from the report that the actual outcome of this event was no injury to either the
patient or staff, superficial damage to the MRI, and loss of business income generated by the
MRI for 5 days.

As such, the severity score based on the actual severity for the patient is minor, for the staff mem-
ber is minor, and for the equipment is moderate when lost income is factored in.

Actual Severity Score = MODERATE

However, such an action does not take into account the potential/risk thereof (close call) assess-
ment. It was by chance or luck that the patient or tech was not injured by the flying oxygen
cylinder as it was pulled into the bore of the magnet or that the MR magnet did not crack. The
most likely worst case scenario for this event is determined to be major to catastrophic. Had the
oxygen cylinder struck the tech or patient in the head it likely would have resulted in death or
permanent loss of function; a likely outcome for the magnet after quenching is cracking from
the thermal shock, and a replacement magnet costs in excess of $100,000. Based on the poten-
tial injury, a severity level of catastrophic was selected.

Potential Severity Score = CATASTROPHIC

Probability Determination
The probability determination should be based on the situation that results in the most severe sever-
ity assessment. In this case it is the probability of ferromagnetic objects being brought into the MRI
magnet room that could result in catastrophic severity. Based on past experience at the facility, this
was assessed to be uncommon (possible to occur, may happen sometime in 2 to 5 years).

Probability Score = UNCOMMON

Using the SAC matrix the score is a ‘”3” which would require that a root cause analysis and action
review be completed.

SAC Score = 3, therefore an RCA2 review would be conducted.

Refer to Appendix 4 for a sample Final Flow Diagram, and Appendix 5 for a Cause and Effect Dia-
gram, of this (fictitious) MRI close call event.

Example 3 SAC Matrix
Severity and Probability Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 29

EXAMPLE 4
An employee working in Food and Nutrition Service was loading large cans of vegetables into a
flow-through rack in the dry goods storage area. A can slipped and fell, hitting the employee on the
toe. The employee sustained broken bones and was on medical leave for 5 days before returning to
work in a light/limited duty position.

Severity Determination
The first step in assigning the SAC score is determining the actual severity score for the event.
We can see from the report that the actual outcome of this event was an injury that required
time away from work and a limited/light duty assignment when the employee returned to work.
The employee was not wearing safety shoes, which are required for employees performing this
task.

The severity score based on the actual severity for the employee is moderate.

Actual Severity Score = MODERATE

The severity score for most likely worst case scenario for this event is determined to be major
based on the possibility for permanent loss of function.

Potential Severity Score = MAJOR

Probability Determination
The probability determination should be based on the situation that results in the most severe
severity assessment. Based on past experience at the facility this was assessed to be occasional
(probably will occur, may happen several times in 1 to 2 years).

Probability Score = OCCASIONAL

SAC Score = 2, therefore an RCA2 review is not mandated.

Example 4 SAC Matrix
Severity and Probability Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 1. THE SAFETY ASSESSMENT CODE (SAC) MATRIX • 30

EXAMPLE 5
An Environmental Management staff member was cleaning a waiting room in the pediatrics hospi-
tal and noticed that there were new potted philodendron plants on the end tables by the couches.
Understanding that philodendrons can be poisonous if ingested, the staff member submitted a
patient safety report.

Severity Determination
The first step in assigning the SAC score is determining the actual severity score for the event.
We can see from the report that the actual outcome of this event was no injury to patients or
employees.

The severity score based on the actual severity for the employee or patient is minor.

Actual Severity Score = MINOR

The severity score for the most likely worst case scenario for this event is determined to be mod-
erate since the risk of fatal poisonings is extremely rare in pediatric patients; however, the plants
contain calcium oxalate, which if ingested could cause inflammation of the mucus membranes
in the mouth or throat.

Potential Severity Score = MODERATE

Probability Determination
The probability determination should be based on the situation that results the most severe
severity assessment. There has been no experience with pediatric patients eating plants in the
waiting rooms, but there have been reports of patients eating other objects. The best educated
guess is that the probability is remote to uncommon.

Probability Score = UNCOMMON

SAC Score = 1, therefore an RCA2 review is not mandated.

However, just because no RCA2 review was required, action to mitigate the risk was still thought to
be appropriate. The plants were removed from the hospital, and the contract with the vendor was
reviewed and modified to prevent a recurrence.

u

Example 5 SAC Matrix
Severity and Probability Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 2. TRIGGERING QUESTIONS FOR ROOT CAUSE ANALYSIS • 31

APPENDIX 2. TRIGGERING QUESTIONS FOR
ROOT CAUSE ANALYSIS

Developed by Department of Veterans Affairs National Center for Patient Safety. Available at http://cheps.
engin.umich.edu/wp-content/uploads/sites/118/2015/04/Triggering-Questions-for-Root-Cause-Analysis.pdf

Introduction

Triggering Questions are used by the RCA2 team to help them consider areas of inquiry that might
otherwise be missed. The questions are initially answered as “yes,” “no,” or “not applicable.” When
questions are answered “no,” it is incumbent upon the team to investigate further to understand
why and determine if corrective actions need to be identified and implemented.

Instructions

• After reviewing the initial Flow Diagram (which is based on what is known about the event
before the RCA2 team’s first meeting), identify and document all questions team members
have about the adverse event or close call. (These are referred to as the team questions.)

• Review the Triggering Questions as a team, with the goal of identifying those questions that
are applicable to the adverse event being investigated.

• Combine the applicable Triggering Questions with the team questions, and as a team identify
where the answers may be obtained. This may include: interviewing staff, reviewing docu-
mentation (e.g., policies, procedures, the medical record, equipment maintenance records),
regulatory requirements (e.g., The Joint Commission, CMS, other accreditation or regulatory
agencies) guidelines (e.g., AORN, ISMP, ECRI Institute), publications, and codes and standards.

• As the investigation progresses, the team may identify additional questions that will need to
be answered.

• By the end of the investigation, the RCA team should be able to identify which Triggering
Questions are not applicable and the answers to the remaining questions.

Triggering Questions

Communication

1. Was the patient correctly identified?

2. Was information from various patient assessments shared and used by members of the treat-
ment team on a timely basis?

3. Did existing documentation provide a clear picture of the work-up, the treatment plan, and the
patient’s response to treatment? (e.g., Assessments, consultations, orders, progress notes, medica-
tion administration record, x-ray, labs, etc.)

4. Was communication between management/supervisors and front line staff adequate? (i.e., Accu-
rate, complete, unambiguous, using standard vocabulary and no jargon)

5. Was communication between front line team members adequate?

6. Were policies and procedures communicated adequately?

7. Was the correct technical information adequately communicated 24 hours/day to the people
who needed it?

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 2. TRIGGERING QUESTIONS FOR ROOT CAUSE ANALYSIS • 32

8. Were there methods for monitoring the adequacy of staff communications? (e.g., Read back,
repeat back, confirmation messages, debriefs)

9. Was the communication of potential risk factors free from obstacles?

10. Was there a manufacturer’s recall/alert/bulletin issued on the medication, equipment, or prod-
uct involved with the event or close call? If yes, were relevant staff members made aware of this
recall/alert/bulletin, and were the specified corrective actions implemented?

11. Were the patient and their family/significant others actively included in the assessment and
treatment planning?

12. Did management establish adequate methods to provide information to employees who
needed it in a timely manner that was easy to access and use?

13. Did the overall culture of the department/work area encourage or welcome observations, sug-
gestions, or “early warnings” from staff about risky situations and risk reduction? (Also, if this has
happened before what was done to prevent it from happening again?)

14. Did adequate communication across organizational boundaries occur?

Training

15. Was there an assessment done to identify what staff training was actually needed?

16. Was training provided prior to the start of the work process?

17. Were the results of training monitored over time?

18. Was the training adequate? If not, consider the following factors: supervisory responsibility,
procedure omission, flawed training, and flawed rules/policy/procedure.

19. Were training programs for staff designed up-front with the intent of helping staff perform their
tasks without errors?

20. Were all staff trained in the use of relevant barriers and controls?

Fatigue/Scheduling

21. Were the levels of vibration, noise, or other environmental conditions appropriate?

22. Were environmental stressors properly anticipated?

23. Did personnel have adequate sleep?

24. Was fatigue properly anticipated?

25. Was the environment free of distractions?

26. Was there sufficient staff on-hand for the workload at the time? (i.e., Workload too high, too low,
or wrong mix of staff.)

27. Was the level of automation appropriate? (i.e., Neither too much nor not enough.)

Environment/Equipment

28. Was the work area/environment designed to support the function it was being used for?

29. Had there been an environmental risk assessment (i.e., safety audit) of the area?

30. Were the work environment stress levels (either physical or psychological) appropriate? (e.g.,
Temperature, space, noise, intra-facility transfers, construction projects)

31. Had appropriate safety evaluations and disaster drills been conducted?

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 2. TRIGGERING QUESTIONS FOR ROOT CAUSE ANALYSIS • 33

32. Did the work area/environment meet current codes, specifications, and regulations?

33. Was the equipment designed to properly accomplish its intended purpose?

34. Did the equipment work smoothly in the context of: staff needs and experience; existing proce-
dures, requirements, and workload; and physical space and location?

35. Did the equipment involved meet current codes, specifications, and regulations?

36. Was there a documented safety review performed on the equipment involved? (If relevant, were
recommendations for service/recall/maintenance, etc., completed in a timely manner?)

37. Was there a maintenance program in place to maintain the equipment involved?

38. If there was a maintenance program, did the most recent previous inspections indicate that the
equipment was working properly?

39. If previous inspections pointed to equipment problems, where corrective actions implemented
effective?

40. Had equipment and procedures been reviewed to ensure that there was a good match between
people and the equipment they used or people and the tasks they did?

41. Were adequate time and resources allowed for physical plant and equipment upgrades, if prob-
lems were identified?

42. Was there adequate equipment to perform the work processes?

43. Were emergency provisions and back-up systems available in case of equipment failure?

44. Had this type of equipment worked correctly and been used appropriately in the past?

45. Was the equipment designed such that usage mistakes would be unlikely to happen?

46. Was the design specification adhered to?

47. Was the equipment produced to specifications and operated in a manner that the design was
intended to satisfy?

48. Were personnel trained appropriately to operate the equipment involved in the adverse event/
close call?

49. Did the design of the equipment enable detection of problems and make them obvious to the
operator in a timely manner?

50. Was the equipment designed so that corrective actions could be accomplished in a manner that
minimized/eliminated any undesirable outcome?

51. Were equipment displays and controls working properly and interpreted correctly and were
equipment settings including alarms appropriate?

52. Was the medical equipment or device intended to be reused (i.e., not reuse of a single use
device)?

53. Was the medical equipment or device used in accordance with its design and manufacturer’s
instructions?

Rules/Policies/Procedures

54. Was there an overall management plan for addressing risk and assigning responsibility for risk?

55. Did management have an audit or quality control system to inform them how key processes
related to the adverse event were functioning?

56. Had a previous investigation been done for a similar event, were the causes identified, and were
effective interventions developed and implemented on a timely basis?

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 2. TRIGGERING QUESTIONS FOR ROOT CAUSE ANALYSIS • 34

57. Would this problem have gone unidentified or uncorrected after an audit or review of the work
process/equipment/area?

58. Was required care for the patient within the scope of the facility’s mission, staff expertise and
availability, technical and support service resources?

59. Was the staff involved in the adverse event or close call properly qualified and trained to per-
form their function/duties?

60. Did the equipment involved meet current codes, specifications, and regulations?

61. Were all staff involved oriented to the job, department, and facility policies regarding: safety,
security, hazardous material management, emergency preparedness, life safety management,
medical equipment and utilities management?

62. Were there written up-to-date policies and procedures that addressed the work processes
related to the adverse event or close call?

63. Were these policies/procedures consistent with relevant state and national guidance, regulatory
agency requirements, and/or recommendations from professional societies/organizations?

64. Were relevant policies/procedures clear, understandable, and readily available to all staff?

65. Were the relevant policies and procedures actually used on a day-to-day basis?

66. If the policies and procedures were not used, what got in the way of their usefulness to staff?

67. If policies and procedures were not used, what positive and negative incentives were absent?

Barriers

(Barriers protect people and property from adverse events and can be physical or procedural. Nega-
tive/positive pressure rooms are an example of a physical barrier that controls the spread of bacteria/
viruses. The pin indexing system used on medical gas cylinders is another example of a physical barrier
that prevents gas cylinders being misconnected. The “surgical time out” is an example of a procedural
barrier that protects patients from wrong site, wrong patient, wrong procedure surgeries.)

68. What barriers and controls were involved in this adverse event or close call?

69. Were these barriers designed to protect patients, staff, equipment, or the environment?

70. Was patient risk considered when designing these barriers and controls?

71. Were these barriers and controls in place before the adverse event or close call occurred?

72. Had these barriers and controls been evaluated for reliability?

73. Were there other barriers and controls for work processes?

74. Was the concept of “fault tolerance’”applied in the system design? (A fault tolerant system can
withstand the failure of one or more barriers without the patient being harmed.)

75. Were relevant barriers and controls maintained and checked on a routine basis by designated
staff?

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 3. INTERVIEWING TIPS FOR RCA2 REVIEWS • 35

APPENDIX 3. INTERVIEWING TIPS FOR RCA2 REVIEWS

The goal of the interview process is to discover information about what happened and why that
will lead to the identification of system issues and ultimately to effective and sustainable corrective
actions.

From the writings of Sidney Dekker, we find that a fundamental question of this process is not
“where did people go wrong?” but “why did their action make sense to them at the time?”(26) To
answer questions like these and to achieve the goal of the interview process requires effective inter-
viewing skills and close attention to the tips provided below.

• Interviews should be conducted by the RCA2 team immediately after they have identified
their interview questions. The preferred method is to conduct interviews in person. In some
cases it may be necessary to conduct an interview via telephone. This may be acceptable if the
individuals involved know and trust each other.

• After an adverse event, staff should be asked not to discuss the event among themselves, in
order to promote the integrity and objectivity of the review process.

• If needed, notify the staff member/employee’s immediate supervisor that the employee will
be needed for an interview so that coverage can be arranged. Supervisors should not be pres-
ent during the interview.

• Interview only one individual at a time, which will permit information to be compared and
weighed. Expect differences between descriptions given by different staff when they describe
what happened, and use additional information gathered by the team to support the final
conclusions.

• Have the team’s questions ready so that the required information may be obtained in one ses-
sion.

• Ask only one or two RCA2 team members to conduct the interview. Approaching the inter-
viewee with a large group may be intimidating and potentially add to the stress of recounting
the event.

• In some cases staff members/employees may wish to have a representative or attorney pres-
ent during the interview. The institution should set the ground rules for such participation.

• Patients may have family present during their interview.

• If the staff member/employee was involved in the adverse event, be sensitive to this. Let them
know that no one is judging them and that the interview is being conducted to identify and
implement systems-level sustainable corrective actions so a similar event does not happen
again.

• Express to the patient and/or any family present that you are sorry the event occurred. Explain
to them that the review is being conducted to identify system issues and implement sustain-
able and effective corrective actions, and that the team will not be assigning blame to anyone
involved in the event.

• Conduct the interview in the staff member’s/employee’s area or in an area that may help them
relax. Avoid the appearance of summoning them to a deposition or administrative review.

• For interviews of patients and/or family members conduct the interview at a location that is
acceptable to them.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 3. INTERVIEWING TIPS FOR RCA2 REVIEWS • 36

• If practical, match your attire to that of the interviewee, while maintaining a level of profes-
sionalism. The goal is to avoid having them feel intimidated.

• Request permission to take notes and explain what the notes will be used for.

• Explain the purpose of the interview. Stress that the RCA2 review team is seeking to identify
system issues and not to assign blame to any individuals.

• Effective interview skills help make fact finding easier and the staff involved more comfortable
with the process. Start with broad, open-ended questions and then narrow them down; move
from general interrogatories, to specific clarifying questions, and then where appropriate, to
closed questions to clarify your understanding of what has been shared. The process should
not feel like an inquisition, and it is essential that you make the interviewee feel as safe as pos-
sible.

• Use active listening and reflect what is being said. Build confidence by restating and summa-
rizing what you have heard. Keep an open body posture, good eye contact, and nod appro-
priately. Demonstrate empathy and be patient. Do not prejudge, lay blame, or interrupt. Tell
them that the information obtained during the RCA2 process is protected and confidential
and will not be shared outside of the process. Union representatives, if present, should be
informed that they are not permitted to talk about what was discussed with anyone other
than the employee and RCA2 team members.

• If the interviewee is having difficulty remembering the details surrounding the event, ask
them to describe what they normally do when completing the task/procedure that was
involved. Drawing a sketch of the process or work area may also trigger their memory.

• Thank the interviewee at the conclusion of the process, provide your contact information in
case they have additional information that they remember, and if you sense they need emo-
tional support, be aware of what resources are available to them.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 4. FINAL FLOW DIAGRAM EXAMPLE • 37

APPENDIX 4. FINAL FLOW DIAGRAM EXAMPLE
All events appearing in this diagram are fictitious. Any resemblance to real events is purely coincidental.

3. JP arrives at the MRI
suite with his oxygen
cylinder.

7. The MR tech is called
away in the middle of
questioning JP and
returns a few minutes
later to finish.

11. A vendor is contacted,
the MR unit helium
is recharged and the
cracked cowling is
replaced.

The oxygen cylinder that JP is using
looks identical to the MRI safe oxygen
cylinders used in the MRI suite. The
receptionist didn’t question the oxygen
cylinder as it wasn’t part of the job
but sometimes he did to help out; the
MRI tech thought that the cylinder had
already been switched to an MRI safe
cylinder.

The tech was called away to answer
a question from a physician; while
he was taking care of this the clerk
reminded him that they were 3
appointments behind and that maybe
they could get caught up over lunch.
The day before staff had been told that
their new quality measure was timeli-
ness and patient waiting times.
The MR unit was short staffed on this
day due to an illness.

4. JP checks in and is
asked to change out of
his street clothes and
put on scrubs. He was
also asked to remove
any chains, watches,
and jewelry.

8. The MR tech asks JP
to follow him into the
magnet room. JP does
so pulling the oxygen
cylinder behind him.

12. MRI service is resumed
approximately 5
days after the event
occurred.

It is the policy to change into scrubs.
A changing room is available along
with lockers for patient use.

A ferrous metal detector is not pro-
vided at the entrance into the magnet
room and hand held scanners are not
used. A sign on the door warns to
remove all metal before entering.
The magnet room does not have piped
in oxygen.

1. Patient (JP) has COPD
and is on oxygen
(2 lpm) and requires
knee surgery.

JP could have had his oxygen therapy
discontinued for the duration of
the MR scan without causing
complications.

5. The MR tech escorts
JP from the changing
room to just outside the
entrance of the magnet
room. JP still has his
oxygen cylinder with
him.

9. As JP approaches the
MR table the oxygen
cylinder is drawn into
the bore of the magnet
narrowly missing the
tech as it flies by him.

The MR suite is not designed in accor-
dance with the four zone, dirty (ferrous
metal) to clean (no ferrous metal)
concept advocated by the American
College of Radiology.

There are no visual clues or indicators
in the room to warn individuals about
the increasing magnetic field.

2. JP reports for a
previously scheduled
outpatient MRI.

6. The MR tech questions
JP about jewelry,
implants, patches, etc.

10. The tech activates
the emergency
MRI shutdown.
Engineering/Facilities
are called.

There were no notes in the EMR
about the patient being on oxygen or
whether it could be discontinued for
the duration of the scan.
JP was not given any informational
material about the scan.

A standardized form/checklist is used
to question all patients about metal
objects they may be carrying or have
implanted; oxygen cylinders are
supposed to be provided by the facility
and are not on the form.
The protocol is for objects such as
gurneys, wheelchairs, oxygen cylinders
to be switched out to MR safe or MR
conditional equipment before the MR
tech meets the patient.

The tech thought that the oxygen
cylinder could explode. He was not
aware of the possible safety conse-
quences or equipment damage when
the magnet is quenched by instituting
an emergency MRI shutdown.
The tech did not recall any training
being done on emergency shutdowns.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 5. CAUSE AND EFFECT DIAGRAM EXAMPLE • 38

APPENDIX 5. CAUSE AND EFFECT DIAGRAM EXAMPLE
Based on the Cause and Effect Diagramming Model
from Apollo Root Cause Analysis: A New Way of Thinking
by Dean L. Gano (Apollonian Publications, 1999.)

All events appearing in this diagram
are fictitious. Any resemblance to
real events is purely coincidental.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 6. THE FIVE RULES OF CAUSATION • 39

APPENDIX 6. THE FIVE RULES OF CAUSATION
The wording of the rules below is based on The Five Rules of Causation developed by the Department of
Veterans Affairs, Veterans Health Administration, and appearing in their NCPS Triage CardsTM for Root Cause
Analysis (version October 2001, see http://cheps.engin.umich.edu/wp-content/uploads/sites/118/2015/04/
Five-Rules-of-Causation.pdf ) and their document Root Cause Analysis (RCA), http://nj.gov/health/ps/
documents/va_triage_questions.pdf. The five rules were adapted from the Federal Aviation Administration
technical report “Maintenance Error Causation,” by David A. Marx, June 9, 1999.

After the RCA2 team has identified system vulnerabilities, these need to be documented and written up
to comply with the Five Rules of Causation. Applying the rules is not a grammar exercise. When the rules
are met, causal statements will be focused on correcting system issues. Causal statements also have to
“sell” why the corrective actions identified by the team are important. Using the format described in this
appendix will increase the likelihood that the corrective actions will be supported.

Causal statements are written to describe (1) Cause, (2) Effect, and (3) Event. Something (Cause) leads to
something (Effect) which increases the likelihood that the adverse Event will occur.
Example: A high volume of activity and noise in the emergency department led to (cause) the resident
being distracted when entering medication orders (effect) which increased the likelihood that the wrong
dose would be ordered (event).

Rule 1. Clearly show the “cause and effect” relationship.
INCORRECT: A resident was fatigued.
CORRECT: Residents are scheduled 80 hours per week, which led to increased levels of fatigue,
increasing the likelihood that dosing instructions would be misread.

Rule 2. Use specific and accurate descriptors for what occurred, rather than negative and vague
words. Avoid negative descriptors such as: Poor; Inadequate; Wrong; Bad; Failed; Careless.
INCORRECT: The manual is poorly written.
CORRECT: The pumps user manual had 8 point font and no illustrations; as a result nursing staff
rarely used it, increasing the likelihood that the pump would be programmed incorrectly.

Rule 3. Human errors must have a preceding cause.
INCORRECT: The resident selected the wrong dose, which led to the patient being overdosed.
CORRECT: Drugs in the Computerized Physician Order Entry (CPOE) system are presented to the
user without sufficient space between the different doses on the screen, increasing the likelihood
that the wrong dose could be selected, which led to the patient being overdosed.

Rule 4. Violations of procedure are not root causes, but must have a preceding cause.
INCORRECT: The techs did not follow the procedure for CT scans, which led to the patient receiv-
ing an air bolus from an empty syringe, resulting in a fatal air embolism.
CORRECT: Noise and confusion in the prep area, coupled with production pressures, increased
the likelihood that steps in the CT scan protocol would be missed, resulting in the injection of an
air embolism from using an empty syringe.

Rule 5. Failure to act is only causal when there is a pre-existing duty to act.
INCORRECT: The nurse did not check for STAT orders every half hour, which led to a delay in the
start of anticoagulation therapy, increasing the likelihood of a blood clot.
CORRECT: The absence of an assignment for designated RNs to check orders at specified times
increased the likelihood that STAT orders would be missed or delayed, which led to a delay in
therapy.

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

APPENDIX 7. CAUSE, ACTION, PROCESS/OUTCOME MEASURE TABLE • 40

APPENDIX 7. CAUSE, ACTION, PROCESS/OUTCOME MEASURE TABLE

Cause/Contributing
Factor (CCF) Statement #1:

Each RCA2 will most likely have multiple CCFs.

Action 1 Each CCF may have multiple Actions.
Action Due Date
Date Action Completed
Responsible Person:

Process/Outcome Measure 1 (Each
Process/Outcome Measure needs to include: what
will be measured; how long it will be measured; and
the expected level of compliance.)

Each Action may have multiple
Process/Outcome Measures.

Date Measured:
Responsible Person:
Was the Compliance Level Met? Y/N

Management concurs with this Action and
Process/Outcome Measure

Y/N

If No, why not? (Answered by Management)
Is the identification of another action required? Y/N

Causal statement example based on the MRI close call scenario in Appendices 1, 4, and 5:

Cause/Contributing
Factor (CCF) Statement #1:

The lack of a ferromagnetic detection system at the entrance into
the MR magnet room increased the likelihood that the patient’s
oxygen cylinder would be permitted in the room resulting in the
cylinder being drawn into the bore of the magnet, the magnet being
quenched, and the MR room being out of service for 5 days.

Action 1 Install a ferromagnetic detection system at the entrance to all four

MRI magnet rooms.
Action Due Date April 30, 2015
Date Action Completed Pending
Responsible Person: Ms. B, Facility Engineer

Process/Outcome Measure 1 (Each
Process/Outcome Measure needs to
include: what will be measured; how
long it will be measured; and the
expected level of compliance.)

Five ferrous objects including an oxygen
cylinder will be passed by the ferromagnetic
sensors of each detector and 100% will result
in alarms sounding in the adjacent MR
Control Room.

Date To Be Measured: May 10, 2015
Responsible Person: Dr. A, MRI Safety Officer

Was the Compliance Level
Met?

To be determined

Management concurs with this Action and
Process/Outcome Measure

Yes

If No, why not? (Answered by Management)
Is the identification of another action
required?

To be determined

RCA2 Improving Root Cause Analyses and Actions to Prevent Harm

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  • Acknowledgments
  • Endorsements
  • Executive Summary
  • Introduction
    • Objective
    • Definitions
  • I. Identifying and Classifying Events
    • Events Appropriate for RCA2 Review versus Blameworthy Events
    • Risk-Based Prioritization of Events, Hazards, and
      System Vulnerabilities
    • Close Calls
  • II. RCA2 Timing and Team Membership
    • Timing
    • Team Size
    • Team Membership
    • Interviewing
  • III. The RCA2 Event Review Process
    • Analysis Steps and Tools
    • Actions
    • Measuring Action Implementation and Effectiveness
    • Feedback
    • Leadership and Board Support
    • Measuring the Effectiveness and Sustainability of the RCA2 Process
  • IV. Conclusion and Recommendations
  • Appendix 1. The Safety Assessment Code (SAC) Matrix
  • Appendix 2. Triggering Questions for
    Root Cause Analysis
  • Appendix 3. Interviewing Tips for RCA2 Reviews
  • Appendix 4. Final Flow Diagram Example
  • Appendix 5. Cause and Effect Diagram Example
  • Appendix 6. The Five Rules of Causation
  • Appendix 7. Cause, Action, Process/Outcome Measure Table
  • References

Pick a topic from the list and discuss it in terms of the concept and application. Support your statements with credible evidence and offer an example.

·
Measures and Metrics 
– Select one or more options from this category: KPIs, Process Measures, Outcome Measures, Structure Measures, Value-Based Healthcare Metrics, Quality Control Measures, Efficiency Metrics, Patient-Centered Measures, Financial Metrics, or Operational Measures. (If selecting the topic of measures and metrics, then select one or more specific areas from this list to learn more about or discuss.) 

·
Quality Improvement (QI)Tools and Resources
 – Select one or more options from this category: RCA, Process Map, QAPI tools, Balanced Scorecard, Charts, PDSA, Lean tools, Six Sigma tools, DMAIC Cycle, DMADV, 5 Whys Approach, Cause and Effect Diagram, CMS Star Ratings, CMS Compare Sites, or any other quality improvement tool or resource that you would like to learn more about for this week’s discussion.  (If selecting the topic of QI Tools and Resources, then select one or more specific areas from this list to learn more about or discuss.) 

·
Quality Improvement (QI) Programs, Systems, and Methodologies – 
Select one or more options from this category: Six Sigma, Lean, QAPI, PDSA, CMS Reporting Programs, Medicare Value-Based Care Programs, CMS Quality Improvement Initiatives, Quality Assurance vs Quality Improvement, Deming’s 14 Points, Donabedian Model of Care, Medicaid Quality Improvement Initiatives, or any other quality improvement program, system, or method that you would like to learn more about for this week’s discussion.  (Note: Some of these methods and systems were reviewed in early weeks, if you are selecting this category, you must select a different topic than one that you previously discussion in prior weeks.) (If selecting the topic of QI  Programs, Systems, and Methodologies, then select one or more specific areas from this list to learn more about or discuss.) 

A minimum of two APA references with correlating in-text citation 

are required

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