Special Focus: Risk & Research

Successful risk assessment may not

always lead to successful risk control: A
systematic literature review of risk control
after root cause analysis
By Alan J. Card, MPH,
CPH, CPHQ, James
Ward, BEng, CEng,
PhD, MIET, and P. John
Clarkson, PhD, BA(Eng)

An abstract based on this

research was presented at
the 2011 International
Conference on Healthcare
Systems Ergonomics and
Patient Safety (HEPS);
Oviedo, Spain.

Root cause analysis is perhaps the most widely used tool in healthcare risk management, but does it actually lead to successful risk
control? Are there categories of risk control that are more likely to
be effective? And do healthcare risk managers have the tools they
need to support the risk control process? This systematic review
examines how the healthcare sector translates risk analysis to risk
control action plans and examines how to do better. It suggests that
the hierarchy of risk controls should inform risk control action planning and that new tools should be developed to improve the risk
control process.
I N TR O D U C TI O N
Root cause analysis (RCA) is a widely used approach to learning from patient
safety incidents and near misses. In the United States, its use is required by the
Joint Commission and the Veterans Health Administration (VHA), and internationally it is mandated by governments as diverse as the United Kingdom,
Denmark, and two states in Australia.(14)
Although the term is familiar to healthcare risk managers across a variety of settings, the way RCA is implemented may vary considerably between and within
organizations based on differing regulatory regimes, organizational cultures, or
internal procedures. It is not a single, well-defined technique, but rather a general approach to uncovering the systems-level causes and contributing factors
behind an incident or near-miss.
As a risk analysis approach, its purpose is to inform risk evaluation (determining
risk acceptability) and risk treatment (risk reduction).(5) As implemented in the
VHA, RCA has proven successful in its risk analysis goals, increasing the number
and quality of root causes identified.(6) But there is limited evidence to indicate
that this improved risk analysis leads to patient safety improvement.(7, 8)

2012 American Society for Healthcare Risk Management of the American Hospital Association
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/jhrm.20090
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While risk matrices are commonly packaged with RCA to

support risk evaluation, it is less clear how the RCA process supports decisions about risk treatment (also known
as risk control).(9, 10)
We conducted a systematic literature review to determine
what tools, if any, are being used to generate risk controls
after an RCA has been completed in the healthcare sector and whether certain categories of risk control (those
higher up the hierarchy of risk controls) were associated
with more successful outcomes.

Methods
Using the search terms root cause analysis or root-cause
analysis, or root cause AND RCA, we searched PubMed
and EMBASE as of April 25, 2010. Our exclusion criteria were these: published before 2000, no application of
RCA, not in healthcare, not in English, and not original
(i.e., repeated findings from another included article).
Our primary outcome measures were the use of a systematic method for generating control recommendations,
the types of risk controls recommended or implemented,
and whether the controls proved successful. Our secondary outcome measures were to study demographics (e.g.,
country of origin), the time and monetary costs associated
with the RCA process, and how success was measured.
Risk controls were categorized using a modified version of
the National Institute for Occupational Safety and Health
(NIOSH) hierarchy of risk controls(11):
Elimination: Stop using the hazardous process or materials.

protective equipment was rolled into the administrative

controls category, because the use of PPE is dependent
on people taking the correct action. The term engineering
control was changed to design control in order to make it
less likely to inspire images of strictly mechanical control
measures when used by healthcare workers.

Results
Study Demographics
Our search returned 231 unique articles, 60 of which met
the inclusion criteria. Eighteen were excluded because
they were published before 2000, 14 because they did not
pertain to healthcare, 127 because they did not describe
an application of RCA, 11 because they were not written in English, and 1 because it repeated the findings of
another included study.
The studies were overwhelmingly American and hospital
based: Not counting one study that took place in both
countries; the United States accounted for 41 of the studies, the United Kingdom for 6, and a joint U.S. and U.K.
study 1. No other country accounted for more than three.
Nearly 80% (n = 47) of the studies were from hospitals or
hospital systems, not counting 5 nationwide studies from
the VHA.

Risk Control Generation

None of the studies reported the use of a systematic
method for generating risk control recommendations.
One, however, did report the use of force-field analysis
for prioritizing potential risk controls after they had been
generated.(13)

Substitution: Substitute a less hazardous process or material.

Engineering controls: With a focus on physical barriers,
isolation, forcing functions, human factors, and fail-safe
design, engineering controls improve safety independent
of worker interactions.(12)
Administrative controls: Policies, procedures, training,
and other controls that depend on people taking the
correct actions.
Personal protective equipment (PPE) such as respirators
or eye protection.
For the purpose of this analysis, we have reduced this to
three tiers:
Elimination: Same as above, but includes substitution as
a mechanism for eliminating a hazard.
Design controls: Equivalent to engineering controls in
the NIOSH hierarchy.
Administrative controls: Same as above, but includes the
use of PPE.
Wholesale substitution was subsumed by elimination, as it
is simply a mechanism for achieving elimination. Personal

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JHRM20090.indd Sec1:7

Risk Controls Recommended and Implemented

Twenty-eight studies reported a total of 196 risk controls recommended. Twenty-eight studies (only 12 of
which overlap with the first group) also reported 123 risk
controls implemented. Over 80% of risk control recommendations and 78% of implemented risk controls were
administrative controls. Most of the remainder were
design controls. Table 1 reports the mean and median
number of each category of risk control per study and
the percentage of the risk controls represented by each
category.
Implementation Rates
Implementation rates, among the 12 studies that reported
on both recommendations and implementation, were
elimination, 50%; design controls, 65%; and administrative controls, 78%.
Success of Risk Controls
Among the 28 studies that reported which risk controls
had been implemented, half reported the use of administrative controls only. Those that described the use of elimination or design controls were 1.6 times more likely to
have explicitly reported success than those that described

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Table 1: Risk Controls Recommended or Implemented by Category

Elimination
Design controls
Administrative controls

Risk Controls Recommended

Mediana
Percentb
Meana
0.21
0.0
1.5
1.29
1.0
18.4
5.61
3.0
80.1

Risk Controls Implemented

Meana
Mediana
Percentb
0.14
0.0
3.25
0.82
0.0
18.7
3.43
3.0
78.0

Mean or median number per study.

Percentage of pooled total from all studies (n = 28).

the use of administrative controls alone. None of the studies reported that the risk controls had proven ineffective.

Measures of Success
Of the 14 studies that explicitly stated that the risk controls had been successful, only two used any form of
control to demonstrate that the apparent improvement
was the result of the risk controls. Most described success
in the form of reduced (or no additional) incidents of the
type described, but typically it was not clear how this was
measured. The use of audits or other active surveillance
techniques was seldom noted.
Time and Monetary Investment
None of the studies reported the amount of money spent
in relation to an RCA, and few reported the time investment. One reported 66 person-hours spent on an RCA
related to a series of dispensing errors in community pharmacies.(14) Another required 640 person-hours from the
core team alone, even though the data needed for root
cause analysis were collected before the first team meeting.(15) One suggested that improvement teams should
commit to a schedule of 90-minute weekly meetings for 7
weeks, but it was not clear whether the authors followed
this advice themselves or how many team members were
involved.(16)
Mills et al. of the VHA reported that 143 single-incident
RCAs related to adverse drug events (ADE) took a median
of 35 person-hours (with a range of 6 to 1,590 hours).(17)
Mills et al. also reported that the 176 aggregate RCAs
examined in their paper on patient falls took 47.80 personhours on average (SD = 32.40 hours)(18) and that 94
aggregate RCAs on suicide or suicidal behavior took 33.5
hours on average (SD = 25.8 hours).(19) Aggregate RCA is
a process through which a series of already completed RCAs
on the same topic is assessed to identify trends and systems
issues across groupings of similar events.(20)

The Mills et al. Studies

Although not included in the analysis of risk controls
above (because the RCAs could not be tied to specific
incidents, controls, or outcomes), three aggregate RCA
studies by Peter D. Mills and others from the VHA were
8

highly relevant to our examination of risk controls. In

total, these covered 16,496 specific incidents: 65% related
to patient falls,(21) 30% on ADE,(22) and the remaining 5% related to suicides.(23) A pooled total of 1,982
risk controls was slated for implementation as a response,
69.4% of which were fully implemented. The controls
were categorized as focusing on education and training
(26.9%), policies and procedures (34.4%), and specific
clinical changes to patient care (19.7%). The remaining
controls (about 8% of the total) were characterized as
other. The first two categories fall under the heading of
administrative controls and amount to 61.3% of the total.
The actual number is somewhat higher; however, many
of the interventions categorized as clinical changes also
meet the definition of administrative controls. The papers
on falls(24) and suicides(25) subcategorized the clinical
change interventions, and on the basis of those subcategories, at least another 4.1% of the total would qualify
as administrative controls. Thus, no less than 65.4% of
all the risk controls reported in these studies fall into this
lowest rung of the risk control hierarchy.
Based on the 1,738 risk controls generated in the two
largest studies, the authors found that risk controls based
on training and education were negatively correlated with
reports of improved outcomes,(26, 27) that is, they made
things worse. Actions focused on clinical changes and
equipment/computers were found to be the most effective.(28, 29)

Discussion
After conducting an RCA, healthcare workers are left to
their own devices in generating risk control plans. Implicit
in this state of affairs is the notion that a good understanding of the risks will necessarily lead to good risk control. This may be a reasonable assumption in the industrial
settings where RCA originated (where its use is often led
by safety and reliability engineers), but healthcare workers
are generally not trained in the principles of safety engineering.(30, 31) They experience significant difficulty in
generating and implementing risk treatment recommendations, and those they produce are often not

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consistent with best practice.(3236) Indeed, some of

the most popular risk control strategies in healthcare
(training and education) may do more harm than good.
(37, 38) Perhaps as a result, there is limited evidence
that RCA actually leads to patient safety improvement.
(39, 40)
In the United States, RCA has been shown to increase
the number(41,42) and quality(43) of root causes and
contributing factors identified. Introducing an analogous
method to assist with the generation and assessment of
robust risk controls might prove similarly successful, thus
ensuring that this improved risk analysis does not go to
waste. Pham et al. have described an approach to selecting and implementing risk controls after they have been
generated,(44) and one of the studies included in this
review described the use of force-field analysis to prioritize
potential risk controls.(45) But it does not appear that
any widely used methods exist for generating high-quality
risk control options.
Time and money invested and patient safety outcomes
tend to be poorly reported, if at all, and strong publication bias is probably also at work,(46) making it
impossible to draw any firm conclusions about the costeffectiveness of current practice in RCA. However, the
results of this study suggest that there may be scope for
improvement through the implementation of more robust
risk controls. By increasing the proportion of non-admin-

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JHRM20090.indd Sec1:9

istrative controls that result from RCA, it may be possible

to significantly increase the techniques effectiveness.

C O N C LU S I O N
Very little research has touched on risk control methods in
healthcare.(47) This work provides evidence about the quality of risk control action planning after an RCA. It demonstrates that high-quality risk control plans do not reliably
result from current practice, even among published RCAs,
which are presumably of higher quality than run-of-the-mill
RCAs. Best practices have not been established for recommendations for action, follow-up, and analyzing results
after an RCA,(48), but administrative controls are widely
accepted to be the weakest form of risk control.(4956)
James Bagian, one of the pioneers of healthcare RCA,
has conducted an analysis of historical data from Joint
Commission surveys that lends further support to this
risk control hierarchy. He demonstrated that in scheduled
surveys, there was relatively little difference in compliance rates between standards classified as administrative
controls and those classified as engineering controls. But
in unannounced surveys, hospitals were far less likely to be
found in compliance with administrative controls versus
engineering controls.(57) The apparent implication is that
engineering controls (i.e., design controls) work even when
no one is watching; administrative controls often do not.

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Our comparison of studies that reported the exclusive use

of administrative controls versus those that also employed
elimination or design controls must be viewed as far from
definitive, given the obvious publication bias among
qualifying studies (i.e., none reported that the risk controls they had implemented proved unsuccessful), but our
findings are consistent with the notion that administrative
controls are generally less effective.

10. Veterans Health Administration. VHA National

Patient Safety Improvement Handbook. Washington,
DC: Veterans Health Administration;2008:22.
11. CDC NIOSH. NIOSH Topic: Engineering Controls.
2010. Available at: http://www.cdc.gov/niosh/topics/
engcontrols. Accessed December 6, 2011.
12. Ibid.

The fact that we also demonstrated the healthcare industrys overwhelming reliance on administrative controls is
quite troubling. In view of this, the use of formal methods
to improve the quality of the risk treatment process may
be warranted.

13. Burroughs TE, Cira JC, Chartock P, Davies AR,

Dunagan WC. Using root cause analysis to address
patient satisfaction and other improvement opportunities. Jt Comm J Qual Improv. 2000;26(8):439449.

RE FE REN C ES

14. Knudsen P, Herborg H, Mortensen AR, Knudsen M,

Hellebek A. Preventing medication errors in community pharmacy: Root-cause analysis of transcription
errors. Qual Saf Health Care. 2007;16(4):285290.

1. Joint Commission. I. Sentinel Events II. Goals of the

Sentinel Event Policy III. Standards Relating to Sentinel
Events Standards Organization-Specific Definition
of Sentinel Event Expectations Under the Standards
for an Organizations Response to a Sentinel Event.
Washington, DC: Joint Commission. 2007;13.
2. Bagian JP, Lee C, Gosbee J, et al. Developing
and deploying a patient safety program in a large
health care delivery system: You cant fix what
you dont know about. Jt Comm J Qual Improv.
2001;27(10):522532.
3. NPSA. Root Cause Analysis (RCA) Toolkit. 2004.
Available at: http://www.msnpsa.nhs.uk/rcatoolkit/
ourse/iindex.htm. Accessed December 6, 2011.
4. Taitz J, Genn K, Brooks V, et al. System-wide learning from root cause analysis: A report from the New
South Wales Root Cause Analysis Review Committee.
Qual Saf Health Care 2010;19(6):e63.
5. ISO. ISO/FDIS 31000: Risk managementPrinciples
and guidelines on implementation. 2008; ISO, Geneva.
6. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight
SD, Mannos DM. The Veterans Affairs root cause
analysis system in action. Jt Comm J Qual Improv.
2002;28(10):531545.
7. Percarpio KB, Watts BV, Weeks WB. The effectiveness
of root cause analysis: What does the literature tell us?
Jt Comm J Qual Saf. 2008;34(7):391398.

15. Hellwig SD, Piper L, Naylor E. Forty hours under

pressure: A rapid-response improvement team achieves
synergy. J Healthc Qual. 2002;24(3):2123,35.
16. Burroughs TE, Cira JC, Chartock P, Davies
AR, Dunagan WC. Using root cause analysis to
address patient satisfaction and other improvement opportunities. Jt Comm J Qual Improv.
2000;26(8):439449.
17. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.
Effective interventions and implementation strategies
to reduce adverse drug events in the Veterans Affairs
(VA) system. Qual Saf Health Care. 2008;17(1):37
46.
18. Mills PD, Neily J, Luan D, Stalhandske E, Weeks
W. Using aggregate root cause analysis to reduce falls
and related injuries. Jt Comm J Qual Patient Safety.
2005;31(1):2131.
19. Mills PD, Neily J, Luan D, Osborne A, Howard K.
Actions and implementation strategies to reduce suicidal events in the Veterans Health Administration. Jt
Comm J Qual Patient Saf. 2006;32(3):130141.
20. Neily J, Ogrinc G, Mills P, Williams R, Stalhandske
E, Bagian J, et al. Using aggregate root cause analysis to improve patient safety. Jt Comm J Qual Saf.
2003;29(8):381,434439.

8. Pham JC, Kim GR, Natterman JP, et al. ReCASTing

the RCA: An improved model for performing root
cause analyses. Am J Med Qual. 2010;25(3):186191.

21. Mills PD, Neily J, Luan D, Stalhandske E,

WeeksWB. Using aggregate root cause analysis to reduce falls. Jt Comm J Qual Patient Saf.
2005;31(1):2131.

9. NPSA. A risk matrix for risk managers. 2008. Available

at: http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=60149&type=full&
servicetype=Attachment.

22. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.

Effective interventions and implementation strategies to
reduce adverse drug events in the Veterans Affairs (VA)
system. Qual Saf Health Care. 2008;17(1):3746.

10

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23. Mills PD, Neily J, Luan D, Osborne A, Howard K.

Actions and implementation strategies to reduce suicidal events in the Veterans Health Administration. Jt
Comm J Qual Patient Saf. 2006;32(3):130141.
24. Mills PD, Neily J, Luan D, Stalhandske E, Weeks
WB. Using aggregate root cause analysis to reduce
falls. Jt Comm J Qual Patient Saf. 2005;31(1):2131.
25. Mills PD, Neily J, Luan D, Osborne A, Howard
K. Actions and implementation strategies to
reduce suicidal events in the Veterans Health
Administration. Jt Comm J Qual Patient Saf.
2006;32(3):130141.26.
26. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.
Effective interventions and implementation strategies
to reduce adverse drug events in the Veterans Affairs
(VA) system. Qual Saf Health Care. 2008;17(1):37
46.

Final Report (Rev.). 2006. Department of Health,

London.
37. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.
Effective interventions and implementation strategies
to reduce adverse drug events in the Veterans Affairs
(VA) system. Qual Saf Health Care. 2008;17(1):3746.
38. Mills PD, Neily J, Luan D, Stalhandske E, Weeks
W. Using aggregate root cause analysis to reduce falls
and related injuries. Jt Comm J Qual Patient Safety.
2005;31(1):2131.
39. Percarpio KB, Watts BV, Weeks WB. The effectiveness
of root cause analysis: What does the literature tell us?
Jt Comm J Qual Saf. 2008;34(7):391398.
40. Wu AW, Lipshutz AKM, Pronovost PJ. Effectiveness
and efficiency of root cause analysis in medicine.
JAMA. 2008;299(6):685687.

27. Mills PD, Neily J, Luan D, Stalhandske E, Weeks

WB. Using aggregate root cause analysis to reduce
falls. Jt Comm J Qual Patient Saf. 2005;31(1):2131.

41. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight

SD, Mannos DM. The Veterans Affairs root cause
analysis system in action. Jt Comm J Qual Improv.
2002;28(10):531545.

28. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.

Effective interventions and implementation strategies
to reduce adverse drug events in the Veterans Affairs
(VA) system. Qual Saf Health Care. 2008;17(1):37
46.

42. Pham JC, Kim GR, Natterman JP, et al. ReCASTing

the RCA: An improved model for performing root
cause analyses. Am J Med Qual. 2010;25(3):186191.

29. Mills PD, Neily J, Luan D, Stalhandske E, Weeks

WB. Using aggregate root cause analysis to reduce
falls. Jt Comm J Qual Patient Saf. 2005;31(1):2131.

43. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight

SD, Mannos DM. The Veterans Affairs root cause
analysis system in action. Jt Comm J Qual Improv.
2002;28(10):531545.

30. Pham JC, Kim GR, Natterman JP, et al. ReCASTing

the RCA: An improved model for performing root
cause analyses. Am J Med Qual. 2010;25(3):186191.

44. Pham JC, Kim GR, Natterman JP, et al. ReCASTing

the RCA: An improved model for performing root
cause analyses. Am J Med Qual. 2010;25(3):186191.

31. Youngson GG, Flin R. Patient safety in surgery: Nontechnical aspects of safe surgical performance. Patient
Saf Surg. 2010;4(1):4.

45. Burroughs TE, Cira JC, Chartock P, Davies AR,

Dunagan WC. Using root cause analysis to address
patient satisfaction and other improvement opportunities. Jt Comm J Qual Improv. 2000;26(8):439449.

32. Percarpio KB, Watts BV, Weeks WB. The effectiveness

of root cause analysis: What does the literature tell us?
Jt Comm J Qual Saf. 2008;34(7):391398.
33. Pham JC, Kim GR, Natterman JP, et al. ReCASTing
the RCA: An improved model for performing root
cause analyses. Am J Med Qual. 2010;25(3):186191.
34. Youngson GG, Flin R. Patient safety in surgery: Nontechnical aspects of safe surgical performance. Patient
Saf Surg. 2010;4(1):4.
35. Lyons M, Woloshynowych M, Adams S, Vincent C.
Error reduction in medicine: Final report to the Nuffield
Trust. London: Nuffield Trust; 2005.
36. Wallace LM, Spurgeon P, Earll L. Evaluation of the
NPSA 3 Day Root Cause Analysis Training Programme:

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46. Percarpio KB, Watts BV, Weeks WB. The effectiveness

of root cause analysis: What does the literature tell us?
Jt Comm J Qual Saf. 2008;34(7):391398.
47. Dckers M, Faber M, Cruijsberg J, Grol R,
Schoonhoven L, Wensing M. Safety and risk management interventions in hospitals: A systematic review
of the literature. MCRR. 2009;66(6 suppl):90S
119S.
48. Wu AW, Lipshutz AKM, Pronovost PJ. Effectiveness
and efficiency of root cause analysis in medicine.
JAMA. 2008;299(6):685687.
49. CDC NIOSH. NIOSH Topic: Engineering Controls.
2010. Available at: http://www.cdc.gov/niosh/topics/
engcontrols/. Accessed December 6, 2011.

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50. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB.

Effective interventions and implementation strategies
to reduce adverse drug events in the Veterans Affairs
(VA) system. Qual Saf Health Care. 2008;17(1):3746.

55. Wu AW, Lipshutz AKM, Pronovost PJ. Effectiveness

and efficiency of root cause analysis in medicine.
JAMA. 2008;299:685687. Available at: http://www
.ncbi.nlm.nih.gov/pubmed/18270357.

51. Mills PD, Neily J, Luan D, Stalhandske E, Weeks

W. Using aggregate root cause analysis to reduce falls
and related injuries. Jt Comm J Qual Patient Safety.
2005;31(1):2131.

56. Manuele FA. Risk assessment and hierarchies of control. Prof Safe. 2005;50:3339.

52. Lyons M, Woloshynowych M, Adams S, Vincent

C. Error Reduction in Medicine: Final Report to the
Nuffield Trust. London: Nuffield Trust; 2005.
53. Wallace LM, Spurgeon P, Earll L. Evaluation of the NPSA
3 Day Root Cause Analysis Training Programme: Final
Report (Rev.). 2006. Department of Health, London.
54. Dckers M, Faber M, Cruijsberg J, Grol R,
Schoonhoven L, Wensing M. Safety and risk management interventions in hospitals: A systematic review
of the literature. MCRR. 2009;66(6 suppl):90S119S.

12

57. Bagian J. Personal communication to Alan Card.

September 26, 2011.

A BO U T TH E A U TH O R S
Alan J. Card, MPH, CPH, CPHQ, is a doctoral candidate at the University of Cambridge Engineering Design
Centre and President/CEO of Evidence-Based Health
Solutions, LLC. James Ward, BEng, CEng, PhD, MIET,
works for the University of Cambridge as a researcher in
patient safety, and for a number of hospitals in the local
region. P. John Clarkson, PhD, BA(Eng), is a professor at
the University of Cambridge and director of the Engineering
Design Centre.

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