Our current approach to root causeanalysis is it contributi.docx

Our current approach to root cause
analysis: is it contributing to our
failure to improve patient safety?
Kathryn M Kellogg,1 Zach Hettinger,1 Manish Shah,2 Robert L
Wears,3
Craig R Sellers,4 Melissa Squires,5 Rollin J Fairbanks1
ABSTRACT
Background Despite over a decade of efforts to
reduce the adverse event rate in healthcare, the
rate has remained relatively unchanged. Root
cause analysis (RCA) is a process used by
hospitals in an attempt to reduce adverse event
rates; however, the outputs of this process have
not been well studied in healthcare. This study
aimed to examine the types of solutions
proposed in RCAs over an 8-year period at a
major academic medical institution.
Methods All state-reportable adverse events
were gathered, and those for which an RCA was
performed were analysed. A consensus rating
process was used to determine a severity rating
for each case. A qualitative approach was used
to categorise the types of solutions proposed by
the RCA team in each case and descriptive
statistics were calculated.
Results 302 RCAs were reviewed. The most
common event types involved a procedure
complication, followed by cardiopulmonary
arrest, neurological deficit and retained foreign

body. In 106 RCAs, solutions were proposed.
A large proportion (38.7%) of RCAs with
solutions proposed involved a patient death. Of
the 731 proposed solutions, the most common
solution types were training (20%), process
change (19.6%) and policy reinforcement
(15.2%). We found that multiple event types
were repeated in the study period, despite
repeated RCAs.
Conclusions This study found that the most
commonly proposed solutions were weaker
actions, which were less likely to decrease event
recurrence. These findings support recent
attempts to improve the RCA process and to
develop guidance for the creation of effective
and sustainable solutions to be used by RCA
teams.
INTRODUCTION
The problem of morbidity and mortality
from adverse events in healthcare has
undergone over 15 years of intense scru-
tiny, funding, regulation and research
worldwide. Despite dramatically intensi-
fied efforts to increase the safety of the
healthcare system, reports have suggested
that safety has not improved. The adverse
event rate has remained essentially the
same, suggesting that our current solu-
tions to the problem are not working.1–10
This lack of progress persists despite the
devotion of a tremendous amount of
financial and human resources at the
local, state and national levels in an effort

to reduce errors and patient harm.11
One common, resource-intensive, prac-
tice is the root cause analysis (RCA)
process, which is used by most hospitals
in the USA.12–15 The RCA process has
been mandated in response to sentinel
events by the Joint Commission since
1997.16 Although the RCA process has
been presumed to induce change, its
effectiveness has been questioned and
there is not robust literature to support
its efficacy.17 18 In healthcare, there are
reports of difficulty in both determining
the causes (more accurately termed the
contributing factors) of events and devel-
oping and implementing the appropriate
corrective actions.13 19 The goal of the
RCA is twofold. First, the process aims to
determine the contributing factors, with
a focus on the latent hazards in the
system, which contributed to the occur-
rence of the event. The second is to
develop the solutions or proposed
changes that, once implemented, will
eliminate or reduce the hazard and there-
fore reduce the chance that a similar
event could occur in the future. Previous
publications on RCAs have largely
involved case reports or editorials, and
there have been small studies characteris-
ing RCA solutions within a single
Original research
► Additional material is

published online only. To view
please visit the journal online
(http:// dx. doi. org/ 10. 1136/
bmjqs- 2016- 005991).
For numbered affiliations see
end of article.
Correspondence to
Dr Kathryn M Kellogg, MedStar
Health, MedStar Institute for
Innovation, Washington, DC
20008, USA; kate. [email protected]
medicalhfe. org
Received 10 August 2016
Revised 29 September 2016
Accepted 21 October 2016
Published Online First
2 February 2017
To cite: Kellogg KM,
Hettinger Z, Shah M,
et al. BMJ Qual Saf
2017;26:381–387.
► http:// dx. doi. org/ 10. 1136/
bmjqs- 2016- 005511
► http:// dx. doi. org/ 10. 1136/
bmjqs- 2016- 006229
381Kellogg KM, et al. BMJ Qual Saf 2017;26:381–387.
doi:10.1136/bmjqs-2016-005991
group.bmj.com on January 3, 2018 - Published by

http://qualitysafety.bmj.com/Downloaded from
http://www.health.org.uk/
http://qualitysafety.bmj.com/
http://crossmark.crossref.org/dialog/?doi=10.1136/bmjqs-2016-
005991&domain=pdf&date_stamp=2017-03-21
http://group.bmj.com
department.20 However, few analyses of the process
itself are available in the literature, and those that
have been done have looked at the types of cases for
which RCAs have been performed or the root causes
identified by the teams.13 21 22 Our team has previ-
ously examined solution types in a small sample of
RCAs, and this study will further contribute by exam-
ining event types and solution types in a larger data
set.23
Although RCAs have been proposed as a mechanism
for change, safety scientists believe that the lack of
improvement of adverse event rates in healthcare is
largely because our methods of approaching change
are ineffective.24 25 RCAs attempt to offer solutions
to effect change, yet few studies have attempted to
categorise or evaluate the recommendations that result
from the process.25 One study showed that fewer than
half of RCAs reviewed included recommendations
directed at robust system-level improvements.21 Many
authors have asserted that recommended actions that
involve education or policy change are inherently
weaker than those that involve redesign of a product
or process, as the former are less likely to introduce
effective and sustained change into the system.17 26–28

Despite the intent to use RCAs to evaluate system-
level problems, studies have shown that RCAs in
healthcare often focus on attempts to fix individuals
rather than on system improvements, while safety
engineering fields show us that system-level interven-
tions are more effective.27–29
Most states, including New York, require RCAs to
be completed after a sentinel event.30 Despite the
large prevalence of the RCA process in adverse event
review and work to identify improved RCA techni-
ques, a systems-based approach to RCAs, and in how
to properly respond to the identified causes in a way
that will increase system safety in a sustained manner,
is not widespread. As a step towards this goal, this
study aims to build on prior work by examining the
types of solutions proposed in response to RCAs con-
ducted at a large, tertiary care academic medical
centre over an 8-year period.
METHODS
This is a qualitative and quantitative analysis of the
content of RCAs performed at one large academic
medical centre over an 8-year period. The goal of the
study was to determine a taxonomy of solution types
proposed by the RCA teams and to determine the
number of solution types for all RCAs reviewed.
Hospital leadership consented to data review and IRB
approval was obtained prior to initiation of data
collection.
Setting
The study was conducted at a 750-bed tertiary care
academic medical centre which, at the time of data
collection, employed 597 graduate medical trainees

across 67 training programmes, and treated 38 000
inpatients, 950 000 outpatients, 98 000 emergency
patients and performed 35 000 surgeries annually.
Mandatory reporting was delivered to a central
agency (New York Patient Occurrence Reporting and
Tracking System, or NYPORTS) for any occurrence,
defined as ‘an unintended adverse and undesirable
development in an individual patient’s condition
occurring in a hospital’.30
Protocol
Occurrences were coded by type prior to submission,
according to NYPORTS standards, and any occurrence
coded as a serious reportable event’ required an RCA
be conducted.31 RCAs were done within 30–60 days
following the occurrence. At the study facility, the RCA
was led by a member of the quality team from within
the office of Quality and Safety. The typical RCA team
was six to eight individuals and included one quality
officer and at least one member of physician and
nursing leadership from each involved or affected dis-
cipline. One to two face-to-face meetings were con-
ducted in which involved parties were typically
interviewed, with follow-up emails and phone calls
used to reach consensus on the final report document.
The report was then shared with the hospital’s Safety
and Risk Management Committee, and the Board of
Directors’ Quality and Patient Safety Committee and
uploaded to NYPORTS, which allows analysis of
multi-institutional data.22 The RCA team gave a final
designation to each case, chosen from one of the fol-
lowing: ‘standard of care met, no action needed’,
‘standard of care met with room for improvement’,
‘standard of care not met, attributable to systems’ or
‘standard of care not met, attributable to individual
practitioner’.

Full records of all state-reported incidents at the
study institution between 2001 and 2008 were
obtained from the NYPORTS database in the form of
a Microsoft Access database file (Redmond,
Washington, USA). Data were deidentified, and a
check for duplicates was performed. This database
included all information reported by the hospital to
the reporting agency during the study period. Data
included patient demographic information, a descrip-
tion of the event and the proposed solutions. Only
unique reports that reviewed reportable incidents for
which an RCA was required were included. Cases
designated as ‘standard of care met, no action
needed’, for which no solutions were proposed, were
reviewed in the initial analysis for case type but were
excluded from the analysis of solution types, and no
further analysis of these cases was conducted.
Data analysis
Once the RCA data were compiled, a severity rating
process was performed. In this step, two physicians
with safety experience (RJF and MNS) independently
Original research
382 Kellogg KM, et al. BMJ Qual Saf 2017;26:381–387.
doi:10.1136/bmjqs-2016-005991
arvinth
Sticky Note
None set by arvinth

arvinth
Sticky Note
MigrationNone set by arvinth
arvinth
Sticky Note
Unmarked set by arvinth
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
reviewed details from each case including the study ID
number, patient age and gender and the event
summary. Each reviewer assigned a severity category
to the case outcome, using the previously reported
National Coordinating Council for Medication Error
Reporting and Prevention error taxonomy (see online
supplementary appendix 1), in which errors are rated
from A (circumstances or events that have the capacity
to become a hazard) to I (patient death).32
Raters did not attempt to determine causation but
rated the severity of case outcomes based on the infor-

mation available in the RCA. For cases where ratings
were inconsistent by more than two categories, con-
sensus was reached by discussion during a second
meeting. If case ratings were off by only one category,
the more severe outcome was selected. Subsequently,
the data were analysed using Stata (Stata 1C 11,
College Station Texas, USA).
Next, a qualitative analysis was performed on the
RCA documents. Qualitative research is the optimal
method to develop an understanding of an otherwise
relatively unknown topic and to capture elements that
might be missed in a standardised quantitative
approach with previously determined categories.33
The complete text from each RCA was imported into
Atlas.ti (Berlin, Germany) and reviewed by the quali-
tative analysis team. All three members of the team
(KK, MS, RJF) performed the review for the first 50
cases to generate consistent understandings of the
coding definitions. Two members (KK and MS) inde-
pendently reviewed subsequent cases, and inconsistent
results were reviewed by the third member (RJF).
Thematic analysis was performed using well-
established qualitative research methods.34 Categories
were created and expanded to iteratively develop a
codebook. Through this standard process, each event
summary was assigned a category. A similar process
was undertaken with each RCA solution until each
was assigned a solution type.34 As part of the same
project, but subsequent to this analysis, solution-type
category definitions for this study have been previ-
ously reported by our team.23
RESULTS

Three hundred and two RCA cases were conducted
during the 8-year study period. Duplicate records
were excluded. All RCAs were included in the initial
analysis; subsequently, those cases proposed solutions
were included in the solutions analysis (figure 1).
Table 1 shows descriptive information for all 302
cases, as well as severity outcome categories for RCAs
in which solutions were proposed (n=106). A large
proportion (38.7%) of RCAs with solutions proposed
involved a patient death. Adverse events resulting in
RCAs occurred throughout the hospital, most fre-
quently in surgical departments (52.6%), with depart-
ments such as psychiatry and neurology submitting
cases with the lowest frequency (2% and 1.3%,
respectively).
The most common event types were procedure
complication, cardiopulmonary arrest, neurological
deficit and retained foreign body (table 2). The least
frequent cases involved electrolyte imbalances, equip-
ment failures or conducting the incorrect study for a
patient. During the study period, several event types
Figure 1 Determination of root cause analyses included in the
study sample.
Table 1 Characteristics of RCAs performed between 2001 and
2008 (n=302)
Patient age (mean, SD) 54 (32–66)
Male (%) 49.3
Hospital departments involved (%)
Surgery/surgical subspecialties 52.6

Medicine/medical subspecialties 13.9
OB/GYN 7.6
Radiology 6.3
Paediatrics 4.3
Anaesthesia 4.3
Emergency medicine 4.0
Psychiatry 2.0
Other 1.7
Neurology 1.3
Dentistry 1.0
Outcome severity (n, %)*
A 0
B 0
C 8 (7.5)
D 17 (16.0)
E 15 (14.2)
F 6 (5.7)
G 13 (12.3)

H 6 (5.7)
I 41 (38.7)
*Outcome severity was only rated for RCAs in which solutions
were
proposed (n=106).
OB/GYN, obstetrics/gynaecology; RCA, root cause analysis.
Original research
doi:10.1136/bmjqs-2016-005991
http://dx.doi.org/10.1136/bmjqs-2016-005991
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
arvinth
Sticky Note
None set by arvinth

arvinth
Sticky Note
arvinth
Sticky Note
were repeated multiple times, including retained
foreign body, medication administration error and
wrong-site surgery. Figure 2 shows the recurrence of
retained foreign body events during the study period,
despite RCAs being performed for each of these
events.
The average number of solutions proposed per RCA
was 4.7, with 499 total solutions identified in the ana-
lysis (table 3).
The most common category of solutions was train-
ing, most often proposed as didactic teaching,
discussions at faculty/staff meetings or via in-service
training. For example, in a case where a patient suf-
fered neurological complications from an air embol-
ism that occurred during an interventional radiology
procedure, the RCA team stated that, ‘The treatment
of air embolism should be reviewed annually for the
staff in the angio[graphy laboratory] and interven-
tional radiology departments and included as part of
the formal teaching of Interventional Radiology resi-
dents’. Following a case of intraoperative nerve com-
pression resulting in peroneal nerve injury, one of the

proposed solutions was, ‘For educative purposes and
to heighten awareness of the possibility this could
occur due to positioning, this case will be reviewed at
Anesthesia’s…QI [Quality Improvement] Grand
Rounds, and at Orthopedics’ QA [Quality Assurance]
meeting’.
The second most common solution type proposed
was a process change, which could involve a change
in workflow, a clinical protocol or procedures around
communication. These solutions could involve train-
ing staff in the new process. For example, following a
case where a patient had a respiratory arrest upon
transport to MRI from the Surgical Intensive Care
Unit (SICU), a clinical protocol in the form of a
written algorithm was developed to determine the sta-
bility of SICU patients for transfer for non-urgent
diagnostic testing. In another case, an incorrect surgi-
cal count prompted the performance of an abdominal
X-ray; however, the entire abdomen was not imaged,
and thus, a sponge was not identified at the time the
X-ray was read. The proposed process change to
facilitate communication was, ‘The surgeon and the
radiologist should collaborate with regard to the plan
for imaging the area under review’.
The third most commonly proposed solution was
policy reinforcement. In this category, the RCA team
Table 2 Event types for RCAs reviewed between 2001 and
2008
Type Frequency Per cent
Procedure complication 63 20.7

Cardiopulmonary arrest 41 13.5
Neurological deficit 35 11.5
Retained foreign body 25 8.2
Pulmonary/arterial embolus 21 6.9
Birth complication 15 4.9
Medication administration error 13 4.3
Incorrect procedure/study 12 3.9
Sepsis 11 3.6
Wrong-site surgery/procedure 9 3.0
Devastating illness 9 3.0
Myocardial infarction 8 2.6
Haemorrhage/haematoma 7 2.3
Arrhythmia 6 2.0
Unknown cause of death 6 2.0
Adverse medication event 4 1.3
Compartment syndrome 3 1.0
Fall, inpatient 3 1.0
Event proximate to discharge 2 0.7

Self-harm 2 0.7
Electrolyte disturbance 2 0.7
Assault, inpatient 1 0.3
Bowel perforation 1 0.3
Equipment failure 1 0.3
Sleep apnoea 1 0.3
Ventilator complication 1 0.3
Total 302
RCA, root cause analysis.
Table 3 Types of solutions proposed in RCAs between 2001
and 2008
Solution
type Frequency (n=499) Per cent
Training 100 20.0
Process change 98 19.6

Policy reinforcement 76 15.2
Policy change 44 8.8
Counselling 34 6.8
Forms and paperwork change 28 5.6
Physical environment change 24 4.8
IT structure change 23 4.6
Review 23 4.6
Vague 17 3.4
Compliance check/chart review 13 2.6
Institutional change 9 1.8
Contact third party 5 1.0
Risk management 5 1.0
RCA, root cause analysis; IT, information technology.

Figure 2 Occurrence of retained foreign body events, as
extracted from root cause analyses performed between 2001
and 2008.
Original research
doi:10.1136/bmjqs-2016-005991
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note

arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
stated that a policy already in place would be empha-
sised to staff. For example, in another surgical case of
a retained sponge, the RCA team stated, ‘Analysis con-
firmed that our counting policy is effective as written
despite this occurrence. However, sponge was
retained. Human error determined to be a factor’,
and thus proposed the following solution:
‘Re-emphasise policy and procedures at OR staff
meeting and at the next Perioperative Service Chiefs

meeting’. In a case where two patients on a unit had
the same last name and the wrong patient received a
ventilation/perfusion scan, the RCA team proposed
the following solution: ‘Staff were reminded of the
correct procedure for identifying patients’.
DISCUSSION
This study examined RCAs performed at a major US
academic medical centre over an 8-year period. We
determined the categories of cases being reviewed by
the RCA team, as well as the types of solutions pro-
posed to reduce similar future occurrences. Analyses
such as this provide a crucial step to understanding
the RCA process and to provide a framework to facili-
tate future studies that examine the utility of the
process. The safety industry recognises that a hier-
archy of safety interventions exists, the power of
which can lead to greater or lesser improvements in
safety. In its most general form, the hierarchy is as
follows (from most effective to least); (1) Design
changes to remove the hazard, (2) Guard (physically)
against the hazard, (3) Warn the personnel about the
hazard.35 Relatively few of the solutions offered by
the RCA teams included design of changes to remove
hazards, and we believe that this is representative of

RCAs as performed throughout the USA.
We found that in this time period, RCAs were per-
formed for cases from most services in the hospital
with the most common being surgical cases. This
coincided with the fact that the greatest proportion of
cases was related to a procedure complication, the risk
for which is higher during surgery than in other hos-
pital settings, as a higher frequency of procedures are
performed there. The frequency of different types of
cases may also be related to the types of events that
are required to be reported in New York. Our data
showed a high (38.7%) rate of patient death related to
the adverse event; however, there is likely under
reporting of patients who are less severely injured,
making this likely to be an over-representation of
overall severity.36 In figure 2, we show that, despite
repeated RCA team examination of retained foreign
body events, occurrences of that same event continued
throughout the study period. While recognising that
some types of events are impossible to eliminate com-
pletely, we propose that repeat events occur despite
repeat RCAs because of the quality and types of solu-
tions that are proposed by RCA teams.

The effectiveness of the RCA process has been ques-
tioned in the literature previously, but few studies
have critically examined the process as it is used in
healthcare to review sentinel events.14 Many times,
the RCA does not identify meaningful aspects of the
event but simply observes that humans are imperfect.
For example, failures involving people forgetting
something previously known or taught to them simply
observes that human memory is imperfect. This
finding is trivial and will not contribute to sustainable
change without some kind of change in the work
setting to support the cognitive work of the healthcare
worker or reduce the burden of having to remember
critical pieces of information. Additionally, in health-
care, many errors are ‘slips’ or ‘lapses’ that occur
when the practitioner is in automaticity mode and is
not consciously thinking about his or her actions. To
begin to address errors due to ‘slips’ and ‘lapses’, the
conditions under which these errors occur must be
identified.37 38 Systems-based changes have been
found to be most effective in mitigating safety in
other industries; however, this has not yet become a
standard of practice in patient safety in healthcare.
Our data around policy reinforcement highlights

one of the most compelling demonstrations of the
ineffectiveness of RCAs, as they have historically been
performed in the USA. In what resilience engineers
would refer to as the ‘work as imagined’ space, we see
solutions such as reminding staff of the correct pro-
cedure, and human error was determined to be a
factor. This violates the basic premise of safety engin-
eering involving sociotechnical systems, which recog-
nises that human errors will always be repeated. Just
as our parents taught us when we were toddlers,
human error is inevitable, thereby proposing a solu-
tion for safety mitigation that focuses on reminding
people not to make mistakes is an indictment of our
approach to safety.
Work done by our team examined the same categories
of RCA solutions discussed here and, through front-line
personnel and discussions with safety science experts,
developed a model of sustainability and effectiveness for
solutions.23 In that study, the categories developed in
this project were used to determine the effectiveness
and sustainability of different solutions proposed by
RCA teams. This work showed that solutions, such as
technology changes and institutional-level changes,
were most effective and sustainable, and solutions, such

as counselling and disciplinary changes, were the least
effective and sustainable. This study can serve as a basis
for future analyses of the effectiveness of the RCA
process for preventing similar future occurrences.
It is clear that RCA teams need validated tools to
use when proposing solutions in order to meet the
goal of reducing future similar outcomes. However,
no trials have examined the effectiveness of the
process or its proposed solutions.10 Therefore, more
work needs to be done to specifically review
Original research
doi:10.1136/bmjqs-2016-005991
arvinth
Sticky Note
None set by arvinth

arvinth
Sticky Note
arvinth
Sticky Note
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
interventions and evaluate their quality. RCA teams
need guidance on solution types and the timing of

their implication, and this needs to be validated in
order to propose the most effective solutions for
change. Work needs to be done to determine how to
study near misses and hazards to include information
from these events in proposed solutions, as these
events are often incredibly informative and predictive
of future events but are often not evaluated.
There are limitations of this study, which should be
considered when interpreting our results. This study
was performed at a single institution. However, this
institution performs RCAs in a manner similar to
other major medical centres across the country and is
in accordance with Joint Commission recommenda-
tions.39 A multicentre study of RCAs is needed in the
future, as studies of the RCA process are scarce.
While an 8-year period is likely representative of the
types of RCAs and the solutions proposed, examining
a greater length of time might also reveal more about
the process. We were unable to review each case in
detail and each solution in context, as this information
was not submitted to NYPORTS, which may have
yielded more information about the derivation of the
different solutions.

CONCLUSION
Our study evaluates the RCA process as performed at
a major medical centre, building on prior work to
classify and understand the recommendations being
made by RCA teams. Our results show that certain
event types are seen repeatedly, even following recom-
mendations from RCA teams. Our qualitative analysis
reveals that solution types most commonly proposed
are not usually the types shown to be more effective
and sustainable in other industries. Our study high-
lights the need for further critical evaluation of the
RCA process in healthcare in order to understand if
and how the process can be improved to meet the
goal of reducing error and increasing patient safety.
Author affiliations
1MedStar Health, MedStar Institute for Innovation, Washington
District of Columbia, USA
2BerbeeWalsh Department of Emergency Medicine, University
of Wisconsin School of Medicine & Public Health, Madison,
Wisconsin, USA
3Department of Emergency Medicine/CSRU, University of
Florida/Imperial College London, Jacksonville, Florida, USA
4University of Rochester School of Nursing, Rochester,
New York, USA

5Nationwide Children’s Hospital, Columbus, Ohio, USA
Correction notice This article has been corrected since it first
published Online First. The abstract has been restructured to
include a conclusions section.
Acknowledgements Joseph Duckett, Diane Cockrell, Robert
Panzer, MD.
Funding This study was funded by the ‘Year-Out Research
Fellowship’ grant from the University of Rochester School of
Medicine and Dentistry and by the Emergency Medicine Patient
Safety Foundation. At the time of this study, RF was supported
by a Career Development Award from the NIBIB,
K08EB009090.
Competing interests None declared.
Ethics approval University of Rochester School of Medicine and
Dentistry.
Provenance and peer review Not commissioned; externally
peer reviewed.

REFERENCES
1 Wachter RM. Patient safety at ten: unmistakable progress,
troubling gaps. Health Aff 2010;29:165–73.
2 Shekelle PG, Pronovost PJ, Wachter RM, et al. Advancing the
science of patient safety. Ann Intern Med 2011;154:693–6.
3 Landrigan CP, Parry GJ, Bones CB, et al. Temporal trends in
rates of patient harm resulting from medical care. N Engl J Med
2010;363:2124–34.
4 Leape LL, Berwick DM. Five years after To Err Is Human:
what
have we learned? JAMA 2005;293:2384–90. http://www.ncbi.
nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&
dopt=Citation&list_uids=15900009.
5 Wachter RM. The end of the beginning: patient safety five
years after “To Err Is Human”. Health Aff 2004;Suppl Web
Exclusives:W4–534–545.
6 Brennan TA, Gawande A, Thomas E, et al. Accidental deaths,
saved lives, and improved quality. N Engl J Med
2005;353:1405–9.

7 Longo DR, Hewett JE, Ge B, et al. The long road to patient
safety: a status report on patient safety systems. JAMA
2005;294:2858–65.
8 Shojania KG, Thomas EJ. Trends in adverse events over time:
why are we not improving? BMJ Qual Saf 2013;22:273–7.
9 Baines R, Langelaan M, de Bruijne M, et al. How effective are
patient safety initiatives? A retrospective patient record review
study of changes to patient safety over time. BMJ Qual Saf
2015;24:561–71.
10 Austin JM, Andrea GD, Birkmeyer JD, et al. Safety in
numbers: the development of leapfrog ‘ s composite patient
safety score for U. S. Hospitals. J Patient Saf 2013;9:1–9.
11 Provonost P, Ravitz A, Stoll R, et al. Transforming Patient
Safety: A Sector-Wide Systems Approach. Report of the WISH
Patient Safety Forum 2015. 2015. http://cdn.wish.org.qa/app/
media/1430
12 Williams PM. Techniques for root cause analysis. Proc (Bayl
Univ Med Cent) 2001;14:154–7. http://www.ncbi.nlm.nih.gov/
pubmed/16369607.

13 Percarpio KB, Watts BV, Weeks WB. The effectiveness of
root
cause analysis: what does the literature tell us? Jt Comm J Qual
Patient Saf 2008;34:391–8. http://www.ncbi.nlm.nih.gov/
entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=18677870
14 Commission TJ. Sentinel Event Policy and Procedures.
http://
www.jointcommission.org/Sentinel_Event_Policy_and_
Procedures/
15 Flink E, Chevalier CL, Ruperto A, et al. Lessons learned
from
the evolution of mandatory adverse event reporting systems.
Adv Patient Saf From Res to Implement 2005;3:135–52. http://
www.ncbi.nlm.nih.gov/books/NBK20547/
16 AHRQ. Root Cause Analysis. Patient Safety Primer. 2014.
https://psnet.ahrq.gov/primers/primer/10/root-cause-analysis
17 Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and
efficiency of root cause analysis in medicine. JAMA
2008;299:685–7.

Original research
doi:10.1136/bmjqs-2016-005991
http://dx.doi.org/10.1377/hlthaff.2009.0785
http://dx.doi.org/10.7326/0003-4819-154-10-201105170-00011
http://dx.doi.org/10.1056/NEJMsa1004404
http://dx.doi.org/10.1001/jama.293.19.2384
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d
b=PubMed&dopt=Citation&list_uids=15900009
http://dx.doi.org/10.1056/NEJMsb051157

http://cdn.wish.org.qa/app/media/1430
http://www.ncbi.nlm.nih.gov/pubmed/16369607
http://www.jointcommission.org/Sentinel_Event_Policy_and_Pr
ocedures/
ocedures/
ocedures/
ocedures/
http://www.ncbi.nlm.nih.gov/books/NBK20547/

arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note

arvinth
Sticky Note
18 Polancich S, Roussel L, Patrician P. Best practices for
conducting an RCA: are there any? Patient Saf Qual Healthcare
2014. http://psqh.com/september-october-2014/best-practices-
for-conducting-an-rca
19 Peerally MF, Carr S, Waring J, et al. The problem with root
cause
analysis. BMJ Qual Saf 2016;doi:10.1136/bmjqs-2016-005511.
20 Perotti V, Sheridan MM. Root cause analysis of critical
events
in neurosurgery, New South Wales. ANZ J Surg
2015;85:626–30.
21 Mills PD, Neily J, Luan D, et al. Actions and implementation
strategies to reduce suicidal events in the Veterans Health
Administration. Jt Comm J Qual Patient Saf 2006;32:130–41.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve
&db=PubMed&dopt=Citation&list_uids=16617944
22 Faltz LL, Morley JN, Flink E, The New York model: root
cause
analysis driving patient safety initiative to ensure correct
surgical and invasive procedures. In: Henriksen K, Keyes MA,
Grady ML, et al, eds. Advances in patient safety: new
directions and alternative approaches. Rockville, MD: Agency
for Healthcare Research and Quality, 2008.
23 Hettinger AZ, Fairbanks RJ, Hegde S, et al. An evidence-
based
toolkit for the development of effective and sustainable root
cause analysis system safety solutions. J Healthc Risk Manag
2013;33:11–20.
24 Nemeth Cook RC. Reliability versus resilience: what does
healthcare need? Hum Factors Ergon Soc Annu Meet Proc
2007;51:621–5. http://www.ingentaconnect.com/content/hfes/
hfproc/2007/00000051/00000011/art00004
25 Choksi VR, Marn C, Piotrowski MM, et al. Illustrating the
root-cause-analysis process: creation of a safety net with a
semiautomated process for the notification of critical findings

in diagnostic imaging.[see comment]. J Am Coll Radiol
2005;2:768–76.
26 Wears RL, Fairbanks RJ. Design trumps training. Ann Emerg
Med 2016;67:316–17.
27 Gosbee J, Anderson T. Human factors engineering design
demonstrations can enlighten your RCA team. Qual Saf Health
Care 2003;12:119–21.
28 Varkey P, Karlapudi SP, Bennet KE. Teaching quality
improvement: a collaboration project between medicine and
engineering. Am J Med Qual 2008;23:296–301.
29 Xiao Y, Fairbanks RJ. Speaking systems engineering:
bilingualism in health care delivery organizations. Mayo Clin
Proc 2011;86:719–20.
30 NYPORTS—The New York Patient Occurrence and Tracking
System—Annual Report 1999. https://www.health.ny.gov/press/
releases/2001/nyports/nyports.htm. 2001 (accessed 8 Sep 2015).
31 NYPORTS—SECTION 2: CLINICAL DEFINITIONS
MANUAL. http://www.nashp.org/sites/default/files/NY_
PORTS_Clinical_Definitions.pdf. Published 2005 (accessed 8

Sep 2015).
32 NCC MERP Taxonomy of Medication Errors. Rockville, MD,
2007. https://www.nccmerp.org/sites/default/files/
taxonomy2001-07-31.pdf
33 Greenhalgh T, Taylor R. Papers that go beyond numbers
(qualitative research). Br Med J 1997;315:740–3.
34 Pope C, Ziebland S, Mays N. Qualitative research in health
care. Analysing qualitative data. Br Med J 2000;320:114–16.
35 Green M. Safety Hierarchy: Design Vs. Warnings.
http://www.
visualexpert.com/Resources/safetyhierarchy.html (accessed 8
Sep 2015).
36 Noble DJ, Pronovost PJ. Underreporting of patient safety
incidents reduces health care’s ability to quantify and
accurately
measure harm reduction. J Patient Saf 2010;6:247–50.
37 Rothschild JM, Landrigan CP, Cronin JW, et al. The Critical
Care Safety Study: the incidence and nature of adverse events
and serious medical errors in intensive care. Crit Care Med

2005;33:1694–700. http://www.ncbi.nlm.nih.gov/entrez/query.
fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_
uids=16096443
38 Rasmussen J. The role of error in organizing behavior.
Ergonomics 1990;33:1185–99.
39 Joint Comission. Framework for Conducting a Root Cause
Analysis and Action Plan. https://www.jointcommission.org/
framework_for_conducting_a_root_cause_analysis_and_action_
plan/. Published 2013 (accessed 8 Aug 2016).
Original research
doi:10.1136/bmjqs-2016-005991
http://psqh.com/september-october-2014/best-practices-for-
conducting-an-rca
conducting-an-rca

conducting-an-rca
conducting-an-rca
conducting-an-rca
conducting-an-rca
conducting-an-rca
conducting-an-rca
conducting-an-rca
conducting-an-rca
http://dx.doi.org/10.1111/ans.12934
http://dx.doi.org/10.1002/jhrm.21122
http://www.ingentaconnect.com/content/hfes/hfproc/2007/00000

051/00000011/art00004
051/00000011/art00004
051/00000011/art00004
http://dx.doi.org/10.1016/j.jacr.2005.01.013
http://dx.doi.org/10.1016/j.annemergmed.2015.10.014
http://dx.doi.org/10.1016/j.annemergmed.2015.10.014
http://dx.doi.org/10.1177/1062860608317764
http://dx.doi.org/10.4065/mcp.2011.0400
http://dx.doi.org/10.4065/mcp.2011.0400
https://www.health.ny.gov/press/releases/2001/nyports/nyports.
htm
htm
htm
http://www.nashp.org/sites/default/files/NY_PORTS_Clinical_D
efinitions.pdf
efinitions.pdf
efinitions.pdf
https://www.nccmerp.org/sites/default/files/taxonomy2001-07-
31.pdf

31.pdf
31.pdf
31.pdf
31.pdf
http://www.visualexpert.com/Resources/safetyhierarchy.html
http://dx.doi.org/10.1097/PTS.0b013e3181fd1697
https://www.jointcommission.org/framework_for_conducting_a
_root_cause_analysis_and_action_plan/

arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth
Sticky Note
arvinth
Sticky Note
None set by arvinth
arvinth
Sticky Note
arvinth

Sticky Note
patient safety?
is it contributing to our failure to improve
Our current approach to root cause analysis:
R Sellers, Melissa Squires and Rollin J Fairbanks
Kathryn M Kellogg, Zach Hettinger, Manish Shah, Robert L
Wears, Craig
doi: 10.1136/bmjqs-2016-005991
2016
2017 26: 381-387 originally published online December 9,BMJ
Qual Saf
http://qualitysafety.bmj.com/content/26/5/381
Updated information and services can be found at:
These include:

References
#BIBLhttp://qualitysafety.bmj.com/content/26/5/381
This article cites 27 articles, 6 of which you can access for free
at:
service
Email alerting
box at the top right corner of the online article.
Receive free email alerts when new articles cite this article.
Sign up in the
Collections
Topic Articles on similar topics can be found in the following
collections
(119)Editor's choice
Notes
http://group.bmj.com/group/rights-licensing/permissions
To request permissions go to:
http://journals.bmj.com/cgi/reprintform

To order reprints go to:
http://group.bmj.com/subscribe/
To subscribe to BMJ go to:
http://qualitysafety.bmj.com/content/26/5/381
http://qualitysafety.bmj.com/content/26/5/381#BIBL
http://qualitysafety.bmj.com//cgi/collection/editors_choice
http://group.bmj.com/group/rights-licensing/permissions
http://journals.bmj.com/cgi/reprintform
http://group.bmj.com/subscribe/
http://group.bmj.comOur current approach to root cause
analysis: is it contributing to our failure to improve patient
safety?AbstractIntroductionMethodsSettingProtocolData
analysisResultsDiscussionConclusionReferences
S A F E T Y
Creating a System of Consistent Safety

in the Froedtert & Medical College
of Wisconsin Health Network
Catherine A. Jacobson, president and CEO, Froedtert Health,
Milwaukee, Wisconsin;
Susan Huerta, PhD, RN, enterprise vice president, quality and
patient safety, Froedtert Health;
and Jonathon Truwit, MD, enterprise chief medical officer and
senior administrative dean,
Froedtert Health and the Medical College of Wisconsin,
Milwaukee
In June 2013, Froedtert Health and the Medical College of
Wisconsin (MCW), operatingas the Froedtert & MCW health
network, developed a joint vision and supporting stra-
tegic plan for their combined clinical enterprise and set a goal
to achieve top-decile per-
formance in demonstrated quality metrics by 2020. Leaders
recognized that achieving this
goal would involve creating a system of safety across a 550-bed
urban academic medical
center (AMC), two community hospitals, and two physician
practices—one academic
and one community based—to ensure the same level of care for
patients regardless of
their location in the system.

Since that time, we have been on a journey to develop a culture
and practice of safety
across our clinical enterprise. Our goals are to continually
improve in quality and safety
and to implement systems and communications that are reliable
(through built-in re-
dundancies), repeatable, and sustainable.
Clearly, measuring outcomes to demonstrate our performance is
important. How-
ever, we know that patient safety metrics emphasize the
prevention of known or pre-
ventable complications and do not consider the nuances of care
and services provided
every day (Frankel, Federico, & Lenoci-Edwards, 2017; Winters
et al., 2016). Reliable
clinical and support systems that incorporate safety nets can
steer providers to the wise
choice and intervene when wise choices are not made. These
safety nets can be human;
nested in the electronic health record (EHR), such as clinical
pathways; or conveyed
through devices or cognitive computing. Strong systems have
redundancies because fail-

ures can occur at any point in a process, particularly failures
that involve human decisions
or require human response (Joint Commission, 2017).
For more information about the concepts in this column, contact
Dr. Huerta at
[email protected]
The authors declare no conflicts of interest.
© 2017 Foundation of the American College of Healthcare
Executives
DOI: 10.1097/JHM-D-17-00158
366
Executives
mailto:[email protected]
SAFETY
STRUCTURE
At the Froedtert & MCW health network, our efforts toward
patient-centered care, clinical
effectiveness, and population health are structured under the
systemwide Healthcare

Value Council. Clinical effectiveness, as measured by quality
and patient safety metrics, is
integrated through the health system’s Quality Collaborative.
The Quality Collaborative
unites the quality programs of the three hospitals and two
practice groups and achieves
its goals through five committees: inpatient, ambulatory,
epidemiology, pharmacy, and
therapeutics. Committee members represent all entities of the
health network. This design
enables us to implement common quality and safety programs
and practices across the
enterprise, hold each other accountable, and identify best
practices. Each year, the com-
mittees recommend areas for improvement or sustained
performance, accompanied by
fiscal year targets for furthering our goal to achieve top-decile
performance on existing
quality and safety measures. All goals set for the entities
throughout the health network
cascade from our enterprise goals. Our providers, leaders, and
staff are rewarded, finan-
cially and through recognition, by means of an aligned incentive
system when perfor-
mance goals are achieved or exceeded at the end of the fiscal

year. Data by entity and
subcomponent are transparently available to all committee
members, physicians, leaders,
and staff, and dissemination of these data fosters our
accountability for performance.
CULTURE AND COMMUNICATION
We began transforming the culture across the Froedtert & MCW
health network by en-
couraging all staff to speak up when they believe a patient’s
safety is at risk. In addition,
we have instituted the Good Catch Award, which rewards the
identification of sys-
temic problems that could harm patients and that require a
process change or rapid fix
(Frankel et al., 2017). Good Catch Award winners are featured
in quarterly announce-
ments on our intranet to highlight the individuals and the
program.
Miscommunication and failure to clearly escalate concerns are
top reasons adverse
events and near misses occur. We have trained staff to speak up
using the SBAR (situation,
background, assessment, and recommendation) format. We have

also instituted an event
assessment guide supporting a nonpunitive practice that seeks
system solutions for ad-
verse events and near misses (Harrison et al., 2015; Joint
Commission, 2017). The event
assessment guide avoids using the term “investigation.” Instead,
it prompts the user to ask
questions in a consistent order and make conclusions once the
questions have been an-
swered. Errors are attributed to the appropriate cause, system or
otherwise, and are asso-
ciated with interventions to avoid repeating the event. The event
assessment guide is
available to all staff on the intranet.
Our patient safety emphasis is on preventable events, patient
safety indicators, and
hospital-acquired infections. On the journey to zero patient
harm, we unexpectedly
found a culture of “opting out” of components in established
care bundles. Both physi-
cians and nurses participated in this behavior, despite their
agreement to adhere to
evidence-based care. To address this issue, we created colorful
placards that highlight

bundle components, engaged our electronic intensive care unit
to observe central line
insertions and speak up when breaks in sterility are seen, and
provided leaders with
pictures of poorly managed central line dressings and
ineffective room cleaning. We
367
Executives
JOURNAL OF HEALTHCARE MANAGEMENT 62:6
NOVEMBER/DECEMBER 2017
deployed our antibiotic stewardship committee across the health
network to reduce un-
necessary antibiotic use. Our patient safety and quality officers
examined existing indi-
cators and metrics and found opportunities to reset our
processes, leveraging the EHR to
advise and direct human behavior. We also empowered
providers and staff, through lo-
cally based inpatient and ambulatory teams, to focus on
preventable events and take
immediate and sustainable action (American College of

Healthcare Executives & National
Patient Safety Foundation, 2017; Frankel et al., 2017).
EXTENDING BEYOND THE HOSPITAL
Improving performance on hospital patient safety metrics
toward preventing harm is a
start, but we continue to ask whether patients are safe in each of
our health network set-
tings. Our approach to providing the same standard of care
throughout the network uses
metrics from both the Centers for Medicare & Medicaid
Services (CMS) and the Health-
care Effectiveness Data and Information Set and focuses on
areas where we recognize
opportunity to improve reliability, even those not rewarded by
CMS or insurance contracts.
Engaging clinical informatics has accelerated our quality and
patient safety programs
by enabling us to design care pathways from the perspectives of
both the patient and the
end user to improve adoption of the EHR’s clinical decision
support (CDS) capabilities
(Frankel et al., 2017). For instance, our respiratory risk
assessment is applied to inpatient

and ambulatory surgery patients (Chung et al., 2012), whereby
those patients at moder-
ate or severe risk trigger suggestions from the EHR for
respiratory care consultation and
augmented monitoring, such as cardiac telemetry, pulse
oximetry, and end-tidal CO2.
Alerts also pop up when sedatives or narcotics are ordered,
highlighting a risk for sleep
apnea and the need to consider correct drugs and dosages for the
patient. For ambulatory
surgery, we combine the patient’s risk for sleep apnea with a
procedural factor score to
determine whether outpatient surgery is appropriate and to
guide postoperative recovery
time. This program has dramatically reduced postoperative
events and rapid response
team calls related to sedation. A recent review of 300 patients
undergoing outpatient
surgery found that only one patient required a rapid response
team intervention and one
patient was admitted from the emergency department within 48
hours of the procedure.
Another CDS tool helps us identify potential hazards for
patients. In one case, mag-

netic resonance imaging was ordered for a patient who had
metal implants, a fact that was
unknown to the ordering provider and bedside nurse. The CDS
tool, which recognizes
risk factors for magnetic resonance imaging, found an earlier
note highlighting the im-
plant, and the order was stopped.
Our use of technology is not limited to the EHR or electronic
intensive care unit. We
have implemented teleobservation for patients identified at high
risk for falls, which has
decreased the need for 1:1 observation by a staff member and
improved staffing con-
straints. Fall rates did not increase during this transition.
Augmenting our proactive approach to reducing preventable
events, readmissions,
and mortality using technology and data, we rely on information
derived from postevent
huddles and reviews. Candid discussions of what did or did not
go well guide future
improvements, particularly systemwide opportunities involving
multiple disciplines in
the care team.

368
Executives
SAFETY
CONCLUSION
This column describes just a few of our quality and patient
safety initiatives, but they are
representative of our overall efforts in system design, change
management, analysis, and
review and our ability to leverage human and digital capital
together. These techniques
and methods extend beyond the hospital setting and deliver
results across our health
network. Our attention to both quality outcomes and prevention
of harm has helped our
AMC rank in the top five for the past three years among
participating AMCs in the Vizient
annual quality and accountability study. In addition, our two
community hospitals
achieved top-decile performance in 2017.
Outside the inpatient setting, our ambulatory quality metrics

have moved perfor-
mance from the bottom quartile to the top quartile in the
Wisconsin Collaborative for
Healthcare Quality and the Merit-Based Incentive Payment
System databases. In 2016, we
were one of five organizations nationally recognized by Vizient
for excellence in effi-
ciently delivering high-quality outpatient care. Now we intend
to drive the incidence of
preventable harm in our care environments to zero.
Sustaining a culture in which patient safety underpins quality
outcomes demands
teamwork and reliable, predictable care and service across the
health network. We are
committed to delivering the right care in the right setting, where
every patient, every time,
is assured of excellent and safe care.
REFERENCES
American College of Healthcare Executives & National Patient
Safety Foundation. (2017). Leading a
culture of safety: A blueprint for success. Retrieved from
www.npsf.org/cultureofsafety

Chung, F., Subramanyam, R., Liao, P., Sasaki, E., Shapiro, C.,
& Sun, Y. (2012). High STOP-Bang score
indicates a high probability of obstructive sleep apnoea. British
Journal of Anaesthesia, 108(5),
768–775. doi:10.1093/bja/aes022
Frankel, A. H. C., Federico, F., & Lenoci-Edwards, J. (2017). A
framework for safe, reliable, and effective care.
Cambridge, MA: Institute for Healthcare Improvement and Safe
& Reliable Healthcare.
Harrison, R., Walton, M., Manias, E., Smith-Merry, J., Kelly,
P., Iedema, R., & Robinson, L. (2015). The
missing evidence: A systematic review of patients' experiences
of adverse events in health care.
International Journal of Quality in Health Care, 27(6), 424–442.
doi:10.1093/intqhc/mzv075
Joint Commission. (2017). Sentinel event alert 57: The essential
role of leadership in developing a safety
culture. Retrieved from
https://www.jointcommission.org/sea_issue_57/
Winters, B., Bharmal, A., Wilson, R., Zhang, A., Engineer, L.,

Defoe, D., Bass, E., Dy, S., & Pronovost, P.
(2016). Validity of the Agency for Health Care Research and
Quality patient safety indicators
and the Centers for Medicare & Medicaid hospital-acquired
conditions: A systematic review and
meta-analysis. Medical Care, 54(12), 1105–1111.
369
Executives
http://www.npsf.org/cultureofsafety
https://www.jointcommission.org/sea_issue_57/
Safety Resource Provides Helpful Blueprint for Healthcare
Leaders
Leading a Culture of Safety: A Blueprint for Success provides
practical and tactical
tools for creating a culture that puts safety at its core. The free
guide is a
collaborative project of the American College of Healthcare
Executives and the
Institute for Healthcare Improvement/National Patient Safety
Foundation

Lucian Leape Institute. Download it at
www.npsf.org/cultureofsafety.
JOURNAL OF HEALTHCARE MANAGEMENT 62:6
NOVEMBER/DECEMBER 2017
370
Executives
http://
November 1999
I N S T I T U T E O F M E D I C I N E
Shaping the Future for Health
TO ERR IS HUMAN:
BUILDING A SAFER HEALTH SYSTEM
Health care in the United States is not as safe as it should be--
and can be. At least 44,000 people, and perhaps as many as

98,000 people, die in hospitals each year as a result of medical
errors that could have
been prevented, according to estimates from two major studies.
Even using
the lower estimate, preventable medical errors in hospitals
exceed attributable
deaths to such feared threats as motor-vehicle wrecks, breast
cancer, and
AIDS.
Medical errors can be defined as the failure of a planned action
to be
completed as intended or the use of a wrong plan to achieve an
aim. Among
the problems that commonly occur during the course of
providing health care
are adverse drug events and improper transfusions, surgical
injuries and
wrong-site surgery, suicides, restraint-related injuries or death,
falls, burns,
pressure ulcers, and mistaken patient identities. High error rates
with serious
consequences are most likely to occur in intensive care units,
operating rooms,
and emergency departments.

Beyond their cost in human lives, preventable medical errors
exact
other significant tolls. They have been estimated to result in
total costs (in-
cluding the expense of additional care necessitated by the
errors, lost income
and household productivity, and disability) of between $17
billion and $29
billion per year in hospitals nationwide. Errors also are costly
in terms of loss
of trust in the health care system by patients and diminished
satisfaction by
both patients and health professionals. Patients who experience
a long hospi-
tal stay or disability as a result of errors pay with physical and
psychological
discomfort. Health professionals pay with loss of morale and
frustration at
not being able to provide the best care possible. Society bears
the cost of er-
rors as well, in terms of lost worker productivity, reduced
school attendance
by children, and lower levels of population health status.

A variety of factors have contributed to the nation’s epidemic of
medi-
cal errors. One oft-cited problem arises from the decentralized
and frag-
mented nature of the health care delivery system--or
“nonsystem,” to some
observers. When patients see multiple providers in different
settings, none of
whom has access to complete information, it becomes easier for
things to go
Errors…are costly
in terms of loss of
trust in the health
care system by pa-
tients and dimin-
ished satisfaction
by both patients
and health profes-
sionals.
Types of Errors

Diagnostic
Error or delay in diagnosis
Failure to employ indicated tests
Use of outmoded tests or therapy
Failure to act on results of monitoring or testing
Treatment
Error in the performance of an operation, procedure, or test
Error in administering the treatment
Error in the dose or method of using a drug
Avoidable delay in treatment or in responding to an abnormal
test
Inappropriate (not indicated) care
Preventive
Failure to provide prophylactic treatment
Inadequate monitoring or follow-up of treatment
Other
Failure of communication
Equipment failure
Other system failure
SOURCE: Leape, Lucian; Lawthers, Ann G.; Brennan, Troyen
A., et al. Pr e-

venting Medical Injury. Qual Rev Bull. 19(5):144–149, 1993.
wrong. In addition, the processes by
which health professionals are licensed
and accredited have focused only limited
attention on the prevention of medical er-
rors, and even these minimal efforts have
confronted resistance from some health
care organizations and providers. Many
providers also perceive the medical liabil-
ity system as a serious impediment to sys-
tematic efforts to uncover and learn from
errors. Exacerbating these problems, most
third-party purchasers of health care pro-
vide little financial incentive for health
care organizations and providers to im-
prove safety and qua lity.
Health Care System at Odds with Itself
The Quality of Health Care in America
Committee of the Institute of Medicine
(IOM) concluded that it is not acceptable
for patients to be harmed by the health

More commonly,
errors are caused
by faulty systems,
processes, and
conditions that
lead people to
make mistakes or
fail to prevent
them.
care system that is supposed to offer healing and comfort--a
system that promises,
“First, do no harm.” Helping to remedy this problem is the goal
of To Err is Hu-
man: Building a Safer Health System, the IOM Committee’s
first report.
In this report, issued in November 1999, the committee lays out
a compre-
hensive strategy by which government, health care providers,
industry, and con-
sumers can reduce preventable medical errors. Concluding that
the know-how
already exists to prevent many of these mistakes, the report sets
as a minimum

goal a 50 percent reduction in errors over the next five years. In
its recommenda-
tions for reaching this goal, the committee strikes a balance
between regulatory
and market-based initiatives, and between the roles of
professionals and organi-
zations.
One of the report’s main conclusions is that the majority of
medical er-
rors do not result from individual recklessness or the actions of
a particular
group--this is not a “bad apple” problem. More commonly,
errors are caused by
faulty systems, processes, and conditions that lead people to
make mistakes or
fail to prevent them. For example, stocking patient-care units in
hospitals with
certain full-strength drugs, even though they are toxic unless
diluted, has re-
sulted in deadly mistakes.
Thus, mistakes can best be prevented by designing the health
system at all
levels to make it safer--to make it harder for people to do

something wrong and
easier for them to do it right. Of course, this does not mean that
individuals can
be careless. People still must be vigilant and held responsible
for their actions.
But when an error occurs, blaming an individual does little to
make the system
safer and prevent someone else from committing the same error.
2
Strategy for Improvement
To achieve a better safety record, the report recommends a four-
tiered approach:
• Establishing a national focus to create leadership, research,
tools,
and protocols to enhance the knowledge base about safety.
Health care is a decade or more behind many other high-risk
industries in

its attention to ensuring basic safety. This is due, in part, to the
lack of a single
designated government agency devoted to improving and
monitoring safety
throughout the health care delivery system. Therefore, Congress
should create a
Center for Patient Safety that would set national safety goals
and track progress in
meeting them; develop a research agenda; define prototype
safety systems; de-
velop, disseminate, and evaluate tools for identifying and
analyzing errors; de-
velop methods for educating consumers about patient safety;
and recommend ad-
ditional improvements as needed.
Funding for the center should be adequate and secure, starting
with $30
million to $35 million per year and growing over time to at least
$100 million an-
nually--modest investments relative to the consequences of
errors and to the re-
sources devoted to other public safety issues. The center should
be housed within
the Agency for Healthcare Research and Quality (AHRQ),

which already is in-
volved in a broad range of quality and safety issues, and has
established the infra-
structure and experience to fund research, education, and
coordinating activities.
• Identifying and learning from errors by developing a
nationwide
public mandatory reporting system and by encouraging health
care organi-
zations and practitioners to develop and participate in voluntary
reporting
systems.
Under the mandatory reporting system, state governments will
be required
to collect standardized information about adverse medical
events that result in
death and serious harm. Hospitals should be required to begin
reporting first, and
eventually reporting should be required by all health care
organizations. This
system will ensure a response to specific reports of serious
injury, hold health care
organizations and providers accountable for maintaining safety,

provide incen-
tives to organizations to implement internal safety systems that
reduce the likeli-
hood of errors occurring, and respond to the public’s right to
know about patient
safety. Currently, about a third of the states have mandatory
reporting require-
ments.
Voluntary reporting systems will provide an important
complement to the
mandatory system. Such systems can focus on a much broader
set of errors,
mainly those that do no or minimal harm, and help detect
system weaknesses that
can be fixed before the occurrence of serious harm, thereby
providing rich info r-
mation to health care organizations in support of their quality
improvement ef-
forts. To foster participation in voluntary systems, Congress
should enact laws to
protect the confidentiality of certain information collected.
Without such legisla-
tion, health care organizations and providers may be
discouraged from partic i-

pating in voluntary reporting systems out of worry that the
information they pro-
vide might ultimately be subpoenaed and used in lawsuits.
Health care is a
decade or more be-
hind many other
high-risk industries
in its attention to
ensuring basic
safety.
Voluntary reporting
systems will pro-
vide an important
complement to the
mandatory system.
3
The process of de-
veloping and

adopting standards
also helps to form
expectations for
safety among pro-
viders and con-
sumers.
Medication errors
now occur fre-
quently in hospi-
tals, yet many hos-
pitals are not mak-
ing use of known
systems for im-
proving safety…
• Raising performance standards and expectations for improve
ments in safety through the actions of oversight organizations,
professional
groups, and group purchasers of health care.
Setting and enforcing explicit performance standards for patient
safety
through regulatory and related mechanisms, such as licensing,
certification, and

accreditation, can define minimum performance levels for
health professionals,
the organizations in which they work, and the tools (drugs and
devices) they use
to care for patients. The process of developing and adopting
standards also helps
to form expectations for safety among providers and consumers.
Standards and expectations are not only set through regulations,
however.
The values and norms set by the health professions influence
the practice, train-
ing, and education for providers. Thus, professional societies
should become
leaders in encouraging and demanding improvements in patient
safety, by such
actions as setting their own performance standards, convening
and communicat-
ing with members about safety, incorporating attention to
patient safety in training
programs, and collaborating across disciplines.
The actions of large purchasers of health care and health care
insurance, as
well as actions by individual consumers, also can affect the

behaviors of health
care organizations. Public and private purchasers, such as
businesses buying in-
surance for their employees, must make safety a prime concern
in their contract-
ing decisions. Doing so will create financial incentives for
health care organiza-
tions and providers to make needed changes to ensure patient
safety.
• Implementing safety systems in health care organizations to
en-
sure safe practices at the delivery level.
Health care organizations must develop a “culture of safety”
such that
their workforce and processes are focused on improving the
reliability and safety
of care for patients. Safety should be an explicit organizational
goal that is dem-
onstrated by strong leadership on the part of clinicians,
executives, and governing
bodies. This will mean incorporating a variety of well-
understood safety princ i-
ples, such as designing jobs and working conditions for safety;

standardizing and
simplifying equipment, supplies, and processes; and enabling
care providers to
avoid reliance on memory. Systems for continuously monitoring
patient safety
also must be created and adequately funded.
The medication process provides an example where
implementing better
systems will yield better human performance. Medication errors
now occur fre-
quently in hospitals, yet many hospitals are not making use of
known systems for
improving safety, such as automated medication order entry
systems, nor are they
actively exploring new safety systems. Patients themselves also
could provide a
major safety check in most hospitals, clinics, and practice. They
should know
which medications they are taking, their appearance, and their
side effects, and
they should notify their doctors of medication discrepancies and
the occurrence of
side effects.

4
Progress Under Way
The response to the IOM report was swift and positive, within
both government
and the private sector.
Almost immediately, the Clinton administration issued an
executive order
instructing government agencies that conduct or oversee health-
care programs to
implement proven techniques for reducing medical errors, and
creating a task
force to find new strategies for reducing errors. Congress soon
launched a series
of hearings on patient safety, and in December 2000 it
appropriated $50 million to
the Agency for Healthcare Research and Quality to support a
variety of efforts
targeted at reducing medical errors.

The AHRQ already has made major progress in developing and
imple-
menting an action plan. Efforts under way include:
• Developing and testing new technologies to reduce medical
errors.
• Conducting large-scale demonstration projects to test safety
interve n-
tions and error-reporting strategies.
• Supporting new and established multidisciplinary teams of
researchers
and health-care facilities and organizations, located in
geographically diverse lo-
cations, that will further determine the causes of medical errors
and develop new
knowledge that will aid the work of the demonstration projects.
• Supporting projects aimed at achieving a better understanding
of how
the environment in which care is provided affects the ability of
providers to im-
prove safety.

• Funding researchers and organizations to develop,
demonstrate, and
evaluate new approaches to improving provider education in
order to reduce er-
rors.
Casting its net even more broadly, the AHRQ has produced a
booklet of
practical tips on what individual consumers can do to improve
the quality of
health-care services they receive. The booklet focuses on key
choices that indi-
viduals and their families face, such as choosing doctors,
hospitals, and treat-
ments, and it stresses the importance of individuals taking an
active role in se-
lecting and evaluating their care. (The booklet is available on
the organization’s
Web site at www.ahrq.gov.)
In efforts focused at the state level, during the past year the
National
Academy for State Health Policy (NASHP) convened leaders
from both the ex-
ecutive and legislative branches of the states to discuss

approaches to improving
patient safety. The NASHP also helped lead an initiative to
better understand
how states with mandatory hospital error-reporting requirements
administer and
enforce their programs. (A report on this initiative is available
on the organiza-
tion’s Web site at www.nashp.org). In addition, the Agency for
Healthcare Re-
search and Quality has contracted with the National Quality
Forum to produce a
list of so-called “never events” that states might use as the basis
of a mandatory
reporting system.
Among activities in the private sector, the Leapfrog Group, an
association
of private and public sector group purchasers, unveiled a
market-based strategy to
improve safety and quality, including encouraging the use of
computerized phys i-
5

� � ��
With adequate
leadership, atten-
tion, and resources,
improvements can
be made.
cian-order entry, evidence-based hospital referrals, and the use
of ICUs staffed by
physicians credentialed in critical care medicine.
Professional groups within the health-care community also have
been ac-
tive. As but one example, the Council on Graduate Medical
Education (COGME)
and the National Advisory Council on Nurse Education and
Practice (NACNEP)
held a joint meeting on “Collaborative Education Models to
Ensure Patient
Safety.” Participants addressed such issues as the effect of the
relationships be-
tween physicians and nurses on patient safety, the impact of

physician-nurse col-
laboration on systems designed to protect patient safety, and
educational pro-
grams to ensure interdisciplinary collaboration to further patient
safety. (A report
on the meeting is available on the COGME’s Web site at
www.cogme.org.)
Pulling Together
Although no single activity can offer a total solution for dealing
with medical er-
rors, the combination of activities proposed in To Err is Human
offers a roadmap
toward a safer health system. With adequate leadership,
attention, and resources,
improvements can be made. It may be part of human nature to
err, but it is also
part of human nature to create solutions, find better
alternatives, and meet the
challenges ahead.
For More Information…
Copies of To Err is Human: Building a Safer Health System are

available for
sale from the National Academy Press; call (800) 624-6242 or
(202) 334-3313 (in
the Washington metropolitan area), or visit the NAP home page
at www.nap.edu.
The full text of this report is available at
http://www.nap.edu/books/0309068371/html/
Support for this project was provided by The National Research
Council and The
Commonwealth Fund. The views presented in this report are
those of the Institute
of Medicine Committee on the Quality of Health Care in
America and are not
necessarily those of the funding agencies.
The Institute of Medicine is a private, nonprofit organization
that provides health
policy advice under a congressional charter granted to the
National Academy of
Sciences. For more information about the Institute of Medicine,
visit the IOM
home page at www.iom.edu.
Copyright ©2000 by the National Academy of Sciences. All

rights reserved.
Permission is granted to reproduce this document in its entirety,
with no additions
or alterations
6
� � ��
COMMITTEE ON QUALITY OF HEALTH CARE IN
AMERICA
WILLIAM C. RICHARDSON (Chair), President and CEO, W.K.
Kellogg
Foundation, Battle Creek, MI
DONALD M. BERWICK, President and CEO, Institute for
Healthcare
Improvement, Boston
J. CRIS BISGARD, Director, Health Services, Delta Air Lines,

Inc., Atlanta
LONNIE R. BRISTOW, Past President, American Medical
Association, Walnut
Creek, CA
CHARLES R. BUCK, Program Leader, Health Care Quality and
Strategy
Initiatives, General Electric Company, Fairfield, CT
CHRISTINE K. CASSEL, Professor and Chairman, Department
of Geriatrics
and Adult Development, Mount Sinai Medical Center, New
York City
MARK R. CHASSIN, Professor and Chairman, Department of
Health Policy,
The Mount Sinai Medical Center, New York City
MOLLY JOEL COYE, Vice President and Director, West Coast
Office, The
Lewin Group, San Francisco
DON E. DETMER, Dennis Gillings Professor of Health
Management,

University of Cambridge, UK
JEROME H. GROSSMAN, Chairman and CEO, Lion Gate
Management, LLC,
Boston
BRENT JAMES, Executive Director, Intermountain Health
Care, Institute for
Health Care Delivery Research, Salt Lake City, UT
DAVID McK. LAWRENCE, Chairman and CEO, Kaiser
Foundation Health
Plan, Inc., Oakland, CA
LUCIAN LEAPE, Adjunct Professor, Harvard School of Public
Health
ARTHUR LEVIN, Director, Center for Medical Consumers,
New York City
RHONDA ROBINSON-BEALE, Executive Medical Director,
Managed Care
Management and Clinical Programs, Blue Cross Blue Shield of
Michigan,
Southfield
JOSEPH E. SCHERGER, Associate Dean for Clinical Affairs,

University of
California at Irvine College of Medicine
ARTHUR SOUTHAM, Partner, 2C

Our current approach to root causeanalysis is it contributi.docx

Recommended

Recommended

More Related Content

Similar to Our current approach to root causeanalysis is it contributi.docx

Similar to Our current approach to root causeanalysis is it contributi.docx (20)

More from gerardkortney

More from gerardkortney (20)

Recently uploaded

Recently uploaded (20)

Our current approach to root causeanalysis is it contributi.docx