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J Patient Saf. Author manuscript; available in PMC 2022 December 01.
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Published in final edited form as:

J Patient Saf. 2021 December 01; 17(8): e959–e963. doi:10.1097/PTS.0000000000000621.

Evidence That Nurses Need to Participate in Diagnosis: Lessons

From Malpractice Claims
Kelly Therese Gleason, RN, PhD*, Rebecca Jones, MBA, BSN, RN, CPHRM, CPPS†,
Christopher Rhodes, MSN*, Penny Greenberg, MS, RN, CPPS‡, Gene Harkless, DNSc,
APRN, FNP-BC, CNL, FAANP§, Chris Goeschel, ScD, MPA, MPS, RN, FAANǁ, Maureen
Cahill, MSN, RN, APN-CNS¶, Mark Graber, MD, FACP**
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*Johns Hopkins University, Baltimore, Maryland

†Pennsylvania Patient Safety Authority, Harrisburg, Pennsylvania
‡CRICO Strategies, Boston, Massachusetts
§University of New Hampshire, Durham, New Hampshire
ǁMedStar Health, Baltimore, Maryland
¶National Council of State Boards of Nursing, Chicago, Illinois
**Society to Improve Diagnosis in Medicine, Chicago, IL.

Abstract
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Objectives: There is a pressing need for nurses to contribute as equals to the diagnostic process.
The purpose of this article is twofold: (a) to describe the contributing factors in diagnosis-related
and failure-to-monitor malpractice claims in which nurses are named the primary responsible party
and (b) to describe actions healthcare leaders can take to enhance the role of nurses in diagnosis.

Methods: We conducted a review of the Controlled Risk Insurance Company Strategies'

repository of malpractice claims, which contain approximately 30% of United States claims.
We analyzed the malpractice claims related to diagnosis (n = 139) and physiologic monitoring
(n = 647) naming nurses as the primary responsible party from 2007 to 2016. We used logistic
regression to determine the association of contributing factors to likelihood of death, indemnity,
and expenses incurred.

Results: Diagnosis-related cases listing communication among providers as a contributing factor

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were associated with a significantly higher likelihood of death (odds ratio [OR] = 3.01, 95%
confidence interval [CI] = 1.50–6.03). Physiologic monitoring cases listing communication among
providers as a contributing factor were associated with significantly higher likelihood of death
(OR = 2.21, 95% CI = 1.49–3.27), higher indemnity incurred (U.S. $86,781, 95% CI = $18,058–
$175,505), and higher expenses incurred (U.S. $20,575, 95% CI = $3685–$37,465).

Conclusions: Nurses are held legally accountable for their role in diagnosis. Raising system­
wide awareness of the critical role and responsibility of nurses in the diagnostic process and

Correspondence: Kelly Gleason, RN, PhD, Johns Hopkins University School of Nursing, Rm 457, 525 N Wolfe St, Baltimore, MD
21225 ([email protected]).
 Gleason et al. Page 2

enhancing nurses' knowledge and skill to fulfill those responsibilities are essential to improving
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diagnosis.

Keywords
diagnostic error; nursing; malpractice claims

Nurses have always been essential members of the diagnostic team. The medical-surgical
nurse who calls a rapid response based on concern,1,2 the emergency department nurse who
triages a patient based on perceived urgency,3,4 and the home care nurse who advises when
further care is necessary are all examples of nurses across settings significantly contributing
to diagnosis. However, there remains a pervasive view that medical diagnosis is considered
solely a physician responsibility.5 The physician-centric perspective is often reinforced in
nursing education with an emphasis that nurses make “nursing diagnoses” but not “medical
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diagnoses.”6 This distinction between nursing and medical diagnoses further drives the
impression that the medical diagnostic process is outside the scope of nursing practice.

The need for nurses to contribute to their full potential in the diagnostic process is
particularly important in consideration of how complex arriving at the correct diagnosis
is.5 Diagnostic errors affect an estimated 12 million people each year in the United States
and approximately one third of cases result in harm or death.7,8 The National Academy
of Medicine (NAM)'s report, Improving Diagnosis Healthcare, highlighted the prevalence
and catastrophic impact of diagnostic errors.5 The report's foremost recommendation to
improve diagnosis is to “Facilitate more effective teamwork in the diagnostic process among
health care professionals, patients, and their families.”5 The report specifically recommends
increasing nursing engagement in the diagnostic process.5 The devastating consequences of
diagnostic error and the potential for nurses to be a part of the solution underscore the need
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to understand the responsibility of nurses in the diagnostic process.

Contributing to the lack of clarity related to the nurse's role in diagnosis is the variability
and ambiguity in scope of practice laws. Each state has its own unique set of nurse practice
regulations, and in many cases, it is unclear what actions nurses can or cannot undertake
relating to diagnosis. Although a handful of states strictly prohibit nurses from medical
diagnosis, the nursing practice act language in most other states is either vague on this
topic or sanctions nursing participation in diagnosis to varying degrees. Thus, there is
understandable confusion about the role and legal obligation of the nurse in diagnosis.
Analyses of malpractice cases have been used to gain a better understanding of diagnostic
error9,10; however, no analyses to date have examined cases where nurses were named as the
primary responsible service.
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We sought to determine the following: (a) what are the contributing factors when nurses are
named as the primary responsible service in cases related to diagnostic error or failure to
monitor? (b) what is the level of patient harm associated with these cases? and (c) what is
the financial burden of these malpractice cases? Based on the answers to the questions, we
suggest actions for healthcare leaders in healthcare administration and education to take to
appropriately prepare nurses to engage in diagnosis.

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METHODS
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We conducted an analysis of the Controlled Risk Insurance Company (CRICO) Strategies'

repository of malpractice claims, which contains approximately 30% of U.S. claims. This
review, which included closed claims made between 2007 and 2016, determined that nursing
was named as the primary responsible service in 139 diagnosis-related cases. We also
reviewed a subset of failure-to-monitor claims categorized as “failure to monitor physiologic
status,” as monitoring is an essential component of the diagnostic process. The review
determined that in 647 closed failures to monitor physiologic status cases, nursing was
identified as the primary responsible service.

The cases in the CRICO repository of malpractice claims are coded by a team of registered
nurses trained as taxonomy specialists. The coding process includes assigning contributing
factors to the cases. A governance committee consisting of physicians, attorneys, and other
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risk management specialists oversee the coding process, which includes systematic auditing.
Level of severity was rated according to the 0-to-9 National Association of Insurance
Commissioners Severity Scale (Table A1, http://links.lww.com/JPS/A236): 0–2 = low, 3–5
medium (3 = temporary minor harm; 4 = temporary major harm; 5 = permanent minor
harm), 6–9 high (6, 7, 8 = permanent significant, major, or grave harm; 9 = death).

We conducted separate analyses using the data set of diagnosis-related malpractice cases
naming nurses as the primary responsible service and the data set of failure-to-monitor
physiologic status malpractice cases naming nurses as the primary responsible service.
We determined summary statistics for the contributing factors of each case type, the level
of patient harm, and the financial burden. We then conducted ordinal logistic regression
using the level of patient harm as the dependent variable and contributing factors as the
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independent variables. We additionally conducted linear regression using indemnity incurred

and expenses incurred as the dependent variables and contributing factors as the independent
variables.

RESULTS
This review determined that in 139 diagnosis-related malpractice claim cases from 2007
to 2016, nursing was identified as the primary responsible service. The characteristics of
the diagnosis-related and failure to monitor malpractice claim cases naming nursing are
described in Table 1. The harm was “high severity” in 102 cases, including 70 deaths. Most
cases (n = 103) occurred in an inpatient setting, 14 occurred in the emergency department,
and 22 occurred in an ambulatory setting. Expenses incurred ranged from $0 to $537,066.
Indemnity incurred ranged from $0 to $3,800,000. One tenth of the cases (n = 15) incurred
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no expense or indemnity.

Failure to monitor a patient's physiologic status accounted for 647 malpractice cases naming
nursing as the primary responsible service. Most cases (n = 616) occurred in an inpatient
setting. The remaining occurred in an outpatient setting or the emergency department. Death
was the ultimate outcome of 40%(n = 263) of the cases. Temporary major harm (n = 178)

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and a significant level of permanent harm (n = 99) accounted for 43% of the cases. Expenses
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incurred ranged from $0 to $1,418,882. Indemnity incurred ranged from $0 to $5,950,000.

In an exam of the contributing factors for diagnosis-related claims (Table 2), issues involving
communication among providers were identified in 55%(n = 77) of the cases. Failure to
communicate with patients was present in 16% (n = 22) of the cases. Inadequate assessments
contributed to 19% (n = 27) of the cases. Documentation failures were present in 28% of
the cases (n = 39); this included the following: inaccurate documents (n = 5), inconsistent
documentation (n = 6), and insufficient documentation (n = 32). Failure to respond was
present in 41% of the cases (n = 43). Staff training and education were identified as a
contributing factor in 15% (n = 18) of cases. Failure to establish a differential diagnosis was
listed in 13% (n = 18) of the cases. In 8% of the cases (n = 11), failure to respond to a
patient's concern, in specific, was listed as a contributing factor.
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As a contributing factor, communication among providers was linked to a significantly

higher likelihood of death among diagnosis-related claims (odds ratio [OR] = 3.01,
95% confidence interval [CI] = 1.50–6.03). A deidentified example of a case involving
communication among providers is described in the vignette (sidebar 1). None of the other
contributing factors were significantly associated with a higher likelihood of death.

In an exam of the contributing factors of failure to monitor cases (Table 3),

documentation failures were highly prevalent. Issues with documentation included
insufficient documentation (n = 276), inaccurate documentation (n = 18), and inconsistent
documentation (n = 136). Communication was a contributing factor in 29% of cases:
communication among providers (n = 128) and communication (n = 41) and education
to patients (n = 17). A failure to follow policy was noted in 28%(n = 183) of the cases.
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Communication among providers (OR = 2.21, 95% CI = 1.49–3.27) and weekend, night
shift, and holiday shifts (OR = 3.65, 95% CI = 1.98–6.72) were associated with a
significantly higher likelihood of death in failure-to-monitor physiologic status claims. None
of the other contributing factors were significantly associated with a higher likelihood of
death. Communication among providers was associated with significantly higher indemnity
incurred (U.S. $86,781, 95% CI = $18,058–$175,505) and higher expenses incurred (U.S.
$20,575, 95% CI = $3685–$37,465). Weekend, night, and holiday shifts were significantly
associated with higher expenses incurred (U.S. $50,902, 95% CI = $26,358–$75,448) but
not higher indemnity incurred. No other contributing factors were significantly associated
with higher indemnity or expenses incurred.

DISCUSSION
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Although the expectation that nurses exercise independent judgment and effective
communication has been in place for more than 50 years,11 findings of this study that nurses
were the primary party responsible for hundreds of malpractice claims related to diagnosis
and physiologic monitoring points to opportunities for improvement in nursing education.
The NAM report concludes that all health professionals should work to improve diagnostic
safety by improving diagnostic reasoning education and develop strong interprofessional

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curricula that emphasizes shared accountability and promotes a common, understandable

language for professional communication.5 Furthermore, all barriers, including outdated
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regulations in nursing statutes and old beliefs regarding the responsibility of diagnosis, must
be addressed to empower nurses to be full members of the diagnostic team.

The dual responsibilities of professional nursing to monitor physiologic status and

communicate effectively to assure safe, competent care are the foundation of professional
nursing practice. The findings of this study, identifying catastrophic lapses in these
important, highly intertwined responsibilities, echo one of the most important legal cases
in nursing, that of Darling v. Charleston Community Hospital (1965).12 This and other
cases that defined nursing's responsibility for professional judgment and accountability have
formed the backbone of professional nursing education for nearly six decades. In Darling, a
young man fractured his lower leg and required a cast. For nearly 2 weeks, nurses observed
and documented deterioration of the lower leg (severe pain, foot blisters, edematous,
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cyanotic, and foul odor) but believed their responsibility for care stopped at this–simply
document, report, and continue to follow medical orders.13 A hospital transfer ensued, an
amputation followed, and a lawsuit was filed. In this case, the Illinois Court in 1965 held
that the nurses were expected to be skilled and responsible to promptly recognize that there
was a critical physiologic impairment and had a duty to exercise independent judgment
and report substandard medical treatment to higher medical and administrative authority.
Furthermore, other court cases from more than 50 years ago found nurses negligent if
physician orders are followed because of faulty judgment, if physician orders are followed
when the nurse should have made an independent judgment not to, and when the nurse fails
to intervene when an order is wrong.11 The legal mandate is clear that nurses must exercise
independent judgment and communicate effectively to ensure safe, competent medical care.
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Only a minority of states (n = 12) have language indicating that there is a medical diagnostic
process that restricts participation by nurses. Most states (n = 38) use diagnostic-inclusive
language, nursing diagnostic language, or do not refer to it at all. Nursing diagnostic
language indicates application of the nurse's judgment to the assessment, reporting, and
intervening of actual or potential health problems for their patients. The language of
nursing diagnosis is often problem oriented and vague, whereas those states without such
restrictions may indicate that the registered nurse is accountable for determining actual or
potential diagnoses. The statutory language regarding registered nurses' scope of practice,
specific to diagnosis, is influenced by professional boards and organizations, and interested
stakeholders. Statutory language is often a reflection of thinking at a specific point in time.
Anyone can introduce new language and make a case for change, when new insights are
learned and new information is known. We must evolve from “nursing diagnosis” language
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for nurses to be fully recognized as the essential diagnostic team members they always have
been. Many states have legislation sunset and sunrise statutes so that an act does not remain
in force indefinitely, creating the opportunity to influence changes to the recognition of
registered nurses in contributing to and making a patient diagnosis.

Healthcare leaders are faced with a persistent and dizzying array of pressures to improve
the cost, quality, and effectiveness of care, as well as the professional satisfaction and
health of the provider workforce.14,15 Successful organizations are often innovative in their

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efforts to establish delivery networks that maximize efficiency and effectiveness through
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patient-centered frameworks that emphasize the importance of collaborative practice, shared

decision-making, and interdisciplinary models of care.16,17 This evolution in thinking and
care delivery was heavily influenced by a growing body of evidence demonstrating both the
need and the efficacy of viewing healthcare delivery as a system.5

The role of professional nurses is increasingly recognized as critical to the quality- and
safety-related performance of high-performing hospitals, as well as to the health and well­
being of patients.18 This evolution has been heavily informed by research, regulatory,
programmatic, and policy pressures.18 For example, The American Nurses Credentialing
Center Magnet Recognition Program, established in 1990, was initially seen primarily as
a nurse recruitment tool because of its emphasis on nursing excellence.19 Now, however,
it is recognized more broadly by healthcare purchasers, financial regulators, and patients
as a reliable marker of high-quality healthcare.20 The 2010 NAM report on The Future
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of Nursing called for nurses to be full partners with physicians and other health care
professionals in redesigning healthcare in the United States.18 This recommendation is now
reality, with nurses participating actively in projects to re-engineer healthcare delivery in a
wide range of organizations and consulting groups internationally.20 The 2015 NAM report
on Improving Diagnosis in Healthcare provides the most recent and direct mandate for
nurses to participate as a co-equal in the diagnostic process.5 Recognizing that diagnosis is
a “dynamic team-based activity,” the NAM report calls upon organizations to ensure that
health care providers have the requisite knowledge, skills, resources, and support to carry out
the diagnostic process and to promote a team-based concept of diagnosis that includes both
the nurse and the patient.5

LIMITATIONS
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This study has several important limitations that must be taken into consideration when
interpreting findings. Malpractice claims databases are, most importantly, limited to cases
where a malpractice case was filed; thus, the cases examined are inherently biased.21
Malpractice claims are affected by the relationship of the patient and the provider, and
the local culture, which complicates applying these findings across settings.22 Although
CRICO has a stringent process for training the staff who determines the contributing
factors, the process is subject to human error. The CRICO database protects privacy by
withholding certain key information; for example, we do not know in which states these case
occurred; thus, we cannot examine malpractice cases against states' scope of practice laws.
However malpractice claims offer substantial insight into the causes of diagnostic errors,23
particularly because diagnostic errors are largely unmeasured by health care systems.5
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CONCLUSIONS
Informed by the NAM report,5 our study validates and helps clarify the legitimate role
of nurses in the diagnostic process. We anticipate that strategies and tactics successfully
used to diffuse findings and implement recommendations in earlier nursing reports and
programs will be equally successful in advancing recognition of nurses as key contributors
to the diagnostic process. These strategies and tactics include early engagement of senior

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leaders—they must understand the concepts related to diagnostic error, as well as its impact
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on costs, quality, and satisfaction. This awareness is often more palatable if combined
with methods for addressing the problem. Fortunately, the ability to “tackle” this new
lens on quality and safety can begin by integrating concepts and existing opportunities
and clarifying roles and responsibilities in established programs. Obvious places to start
include nursing-specific programs, such as new-employee orientation, competency training
and assessment, and career ladder opportunities. Healthcare organizations can also expand
existing system-wide programs to state explicitly the role and responsibility of nurses
in the diagnostic process and legitimacy as members of the diagnostic team. This work
can fit nicely within most high-reliability programs, dyad leadership programs, shared
decision-making programs, team training programs, and patient and family advisory council
programs. Understanding turns into action when nurses are included as key members of
diagnostic-related workgroups, diagnosis safety teams, and the like. The specifics of how to
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move forward are context sensitive, but in aggregate, organizational change is needed.

As with other sustainable efforts to improve patient safety, enhancing the role of nurses in
diagnosis will require a culture shift, along with strong support and visible commitment
from healthcare leaders. Change management approaches will likely be needed to overcome
outdated beliefs about the nurse's role in the diagnostic process and to set an expectation of
diagnostic teamwork in daily clinical operations. Updating state nursing practice regulations
should follow in parallel. It is imperative not only that physicians, patients, and healthcare
team members acknowledge nurses as key contributors to the diagnostic process, but that
nurses themselves recognize this as well.

Supplementary Material
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Refer to Web version on PubMed Central for supplementary material.

ACKNOWLEDGMENT
The authors thank CRICO/Risk Management Foundation of the Harvard Medical Institutions.

C.R. receives support from Predoctoral Fellowship in Interdisciplinary Training in Cardiovascular Health Research
(T32 NR012704).

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TABLE 1.

Characteristics of Failure to Monitor Physiologic Status and Diagnosis-Related Cases

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Failure to Monitor
Diagnosis-Related Physiologic Status

n = 139 n = 647

n (%) n (%)
Setting
Inpatient 103 (74) 616 (95)
Ambulatory 22 (16) 19 (3)
Emergency department 14 (10) 8 (1)
Injury severity level
High 102 (73) 348 (54)
Medium 34 (24) 284 (44)
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Low 3 (2) 15 (2)

Death
Yes 70 (50) 263 (41)
No 69 (50) 384 (59)
Indemnity incurred, $
Mean (SD) 117,523 (444,645) 126,897 (407,746)
Expense incurred, $
Mean (SD) 62,981 (101,563) 48,805 (87,473)
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TABLE 2.

Impact of Contributing Factors on Likelihood of Death Among Diagnosis-Related Malpractice Cases

No Fatal Injury Death

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n (%) n (%) OR, 95% CI

Communication among providers 29 (38) 48 (62) 3.01 (1.50–6.03)
Inadequate assessment (e.g., inadequate history and physical, premature discharge) 15 (59) 11 (41) 0.62 (0.26–1.45)
Failure to follow policy 13 (62) 8 (38) 0.56 (0.21–1.44)
Training/education 9 (50) 9 (20) 0.98 (0.36–2.65)
Failure to consult 11 (46) 13 (54) 1.20 (0.50–2.90)
Failure to respond 20 (47) 23 (53) 1.20 (0.58–2.46)
Weekend/night/holiday 10 (62) 6 (38) 0.55 (0.19–1.63)
Insufficient documentation 15 (47) 17 (53) 1.15 (0.52–2.55)
Altered or inconsistent documentation 5 (55) 4 (44) 1.25 (0.32–4.86)
Supervision 4 (57) 3 (43) 0.73 (0.16–3.38)

Bold data indicates finding was significant (P < 0.05)

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TABLE 3.

Impact of Contributing Factors on Likelihood of Death Among Failure to Monitor Malpractice Cases

No Fatal Injury Death

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n (%) n (%) OR, 95% CI

Training/education 28 (51.8) 26 (48.2) 1.39 (0.79–2.44)
Failure to follow policy 106 (57.9) 77 (42.1) 1.08 (0.77–1.54)
Insufficient documentation 174 (63.0) 102 (37.0) 0.76 (0.56–1.05)
Altered or inconsistent documentation 80 (58.8) 56 (41.2) 1.03 (0.70–1.51)
Inadequate assessment (e.g., inadequate history and physical, premature discharge) 57 (66.3) 29 (33.7) 0.71 (0.44–1.15)
Failure to rescue and respond 49 (53.8) 42 (46.2) 1.30 (0.83–2.02)
Self-management 40 (52.0) 37 (48.0) 1.41 (0.87–2.27)
Communication among providers 56 (43.7) 72 (56.3) 2.21 (1.49–3.27)
Failure to consult 61 (65.6) 32 (34.4) 0.73 (0.46–1.16)
Inadequate staffing 3 (33.3) 6 (66.7) 2.96 (0.73–11.96)
Weekend/night/holiday 16 (30.8) 36 (60.2) 3.65 (1.98–6.72)
Supervision 12 (44.4) 15 (56.6) 1.88 (0.86–4.07)

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