Abstract
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 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 enhancing nurses' knowledge and skill to fulfill those responsibilities are essential to improving 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 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 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.
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.
METHODS
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 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 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 no expense or indemnity.
TABLE 1.
Characteristics of Failure to Monitor Physiologic Status and Diagnosis-Related Cases
| Diagnosis-Related | Failure to Monitor 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) |
| 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) |
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) and a significant level of permanent harm (n = 99) accounted for 43% of the cases. Expenses 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.
TABLE 2.
Impact of Contributing Factors on Likelihood of Death Among Diagnosis-Related Malpractice Cases
| No Fatal Injury |
Death |
||
|---|---|---|---|
| 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)
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.
TABLE 3.
Impact of Contributing Factors on Likelihood of Death Among Failure to Monitor Malpractice Cases
| No Fatal Injury |
Death |
||
|---|---|---|---|
| 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) |
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
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 curricula that emphasizes shared accountability and promotes a common, understandable language for professional communication.5 Furthermore, all barriers, including outdated 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, 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.
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 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 efforts to establish delivery networks that maximize efficiency and effectiveness through 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 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
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
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 leaders—they must understand the concepts related to diagnostic error, as well as its impact 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 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
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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