Complaints as Safety Surveillance
Approach to Improving Safety
Setting of Care
A 42-year-old woman presented to the emergency department with abdominal pain. She said the pain came on suddenly that morning after binge-drinking vodka. The pain was in the epigastrium, radiated around to her back, and was accompanied by nausea and vomiting. Her laboratory studies showed elevated amylase and lipase, and a CT scan confirmed the diagnosis of acute pancreatitis. She was admitted to the hospital and given intravenous fluids and intravenous hydromorphone (Dilaudid) for pain control.
The next morning, the patient was still experiencing moderately severe abdominal pain. She requested "more of the medicine that starts with a 'D.'" The hospitalist—not being entirely familiar with the pain medication she was on—said that he would increase it. He decided to increase her 1 mg dose of Dilaudid to 4 mg and asked the nurse to administer another dose immediately. The nurse thought it unusual to increase the pain medication so much, but she remembered that this hospitalist had a reputation for being brusque and defensive when his orders were questioned. She administered the medication without challenging the order.
About 10 minutes later, the nurse returned to check on the patient and found her to be unresponsive and apneic. She immediately called the hospital's rapid response team, who administered naloxone (a medication that reverses the effects of opioid medications). Despite this treatment, the patient remained unresponsive and had to be transferred to the intensive care unit. She was intubated for airway protection and treated with a naloxone infusion overnight until her mental status and respiratory status improved. She was successfully extubated the next day. Her hydromorphone was discontinued and the patient was treated with oral pain medications for the remainder of her hospital stay. Following improvement in her pancreatitis, she was discharged home in stable condition.
Due to the severity of the event, the hospital's patient safety committee investigated the incident with a formal root cause analysis. The hospitalist was interviewed and admitted that he was unfamiliar with prescribing hydromorphone. He had assumed it was similar in potency to morphine, but in fact, 1 mg of intravenous hydromorphone is equivalent to 4 mg of morphine. The hospital's patient relations committee reviewed its records and found that in the past 2 years, 3 other patients had filed complaints about the care provided by the hospitalist. None of those patients had clearly experienced an adverse event, but the hospital faced a decision about how best to address the concerns about the quality of the physician's care.
by Jennifer Morris and Marie Bismark, MD
This case involves a doctor who was the subject of multiple patient complaints in the years preceding a significant adverse event. Most doctors will receive at least one patient complaint over the course of their career. However, complaints are not spread evenly or randomly across the profession. Rather, certain doctors attract a disproportionate share of complaints.
An Australian study found that 3% of doctors accounted for 49% of formal complaints to complaints-handling bodies.(1) A similar study in the United States, published in the New England Journal of Medicine, found that 1% of physicians account for 32% of paid medical negligence claims.(2) Both studies showed that as doctors accumulate more complaints or paid claims, the likelihood of another similar event increases sharply. Past behavior really is the best predictor of future behavior.
Complaints matter, both as a sign of patient dissatisfaction and as a risk factor for potentially preventable adverse events.(3-5) Patients and their families often pick up clinical errors and preventable adverse events that are not identified by more formal detection systems such as incident reporting (5), and the likelihood of a complaint increases with the severity of harm.
However, few patients who experience harm from preventable adverse events actually lodge complaints, with patients who are older or poor facing particular barriers in having their voices heard.(3) This reporting gap makes it especially important that complaints processes are safe and accessible for all. In the case above, the three previous complaints were quite likely the tip of the iceberg, with dozens of instances of unsatisfactory care below the surface.
A Different Kind of System Problem
In our experience, most hospital-based practitioners admit that they are aware of "problem" colleagues who attract multiple complaints, underperform, behave poorly, or have health issues that impair their ability to practice safely. And yet, individuals and institutions within health care have a poor record of addressing these issues in a timely, effective, and ethical way.(6) Problematic practitioners are often "moved on" to another institution, or their performance issues simply go unaddressed or even unacknowledged.(6)
As part of the patient safety movement, there has been a shift from individual blame toward a systems approach. While unsafe systems are undoubtedly at the root of many errors, we also know that—when choosing care for a family member—there are some doctors who we would trust over others. In seeking to reconcile this tension between systems and individuals, Lucian Leape helpfully suggests that we think of problem doctors as another form of systems problem.(6) That is, some doctors will perform poorly, but it is the responsibility of the health care system to support them back into safe practice and it is a system failure when it does not.
Traditionally, patient complaints have been resolved using a case-by-case approach with little attention paid to identifying broader patterns or assessing future risk of harm. Recent research suggests that routinely collected administrative data can be used to construct a Predicted Risk of New Event (PRONE) score for individual clinicians.(7) Like other clinical scoring systems, such as the Apgar score for newborns or cardiovascular risk calculators for adults, the PRONE score could one day help to inform individual clinicians about their future complaints risk and allow systems to improve their targeting of early intervention efforts.
In the meantime, educators, employers, boards, professional societies, and insurers should all be encouraged to "lift their gaze" from individual complaints to explore emerging patterns of concern. In this case, careful review of the three previous complaints along with the current event may reveal much more than did the root cause analysis of the single prescribing error on its own. Organizations like Vanderbilt University have demonstrated the benefits of systematically identifying and intervening with problem clinicians.
To maximize the patient safety benefits of complaints, individuals and institutions need to foster an environment and culture of respectful relationships and communication. It is well documented that both professionals (8) and patients (9) are less likely to raise concerns when they lack confidence those concerns will be acted on appropriately, feel disempowered, or fear reprisals. Patients and families have much to contribute, but, unless speaking up is encouraged, their voices often go unheard.
Early intervention for doctors who incur multiple complaints is essential to protect patients from harm, while also providing support for doctors to practice safely and preventing the need for late-stage punitive action by regulators or the courts. With this particular doctor, earlier intervention may have averted a potentially life-threatening opioid overdose.
Once a doctor is identified as being at risk (for example, because of multiple complaints), remediation options should be chosen based on the nature of the underlying problem. Issues contributing to complaints fall into three broad categories: conduct (personal behavior below expected standards), performance (clinical care or communication below expected standards), and health (illness or substance misuse impairing safe practice). More than one of these may be relevant to a single case. This case shows elements of conduct concerns ("being brusque and defensive when his orders were questioned") and performance ("unfamiliar with prescribing hydromorphone").
For health concerns, especially substance misuse, specialized doctors' health programs, such as the various Physician Health Programs offered in many US states, can be effective.(10) For performance concerns, assessment, followed by training, education, mentoring, or supervision may be useful. Assessment is especially important because evidence suggests that doctors with performance problems are especially poor at evaluating their own competence.(11)
For conduct concerns, specialized behavioral intervention programs, such as that linked to the Patient Advocacy Reporting System, may be helpful. This peer-review–based system detects doctors in difficulty. Well-trained peers then offer nonpunitive, nondirective, insight-promoting information to the doctor about their complaints records, and the impact of their behavior on other people, their medico-legal risk, and clinical safety. The program has shown significant success in reducing patient complaints against participants.(12)
For certain issues or individuals, involving authorities such as state medical boards may be appropriate or required by law. The duty to report varies by jurisdiction, but typically arises where the health, competence, or conduct of a physician poses a serious risk to patient safety.(13) Regardless of whether this is necessary, options for remediation should be considered. And in cases where recurrent complaints arise from an unsafe environment (inadequate supervision, excessive workloads, or flawed technology) those factors should be addressed as well. The aim should be a just culture where physicians are not punished for isolated lapses or systems failures, but face clear consequences if they repeatedly or willfully put patient safety at risk.(14)
In this case, the hospitalist appears to have deficiencies in both his clinical knowledge and communication. We suggest that a senior colleague should provide clear feedback to him on the hospital's concerns, seek to understand possible contributing factors, and agree on a program of remedial action. Depending on the nature of the three other complaints this may include, for example, a tailored program of educational activities coupled with closer oversight for a period of time. If the physician is unwilling or unable to engage in such an educative approach, and patients are at risk, stronger forms of accountability will be required.
- Patient complaints and paid malpractice claims are not evenly distributed across the medical profession: some doctors are at significantly higher risk than others.
- There is an association between patient complaints and quality of care. Patients and families will often identify patient safety risks that are not detected by other mechanisms.
- Past behavior is a strong predictor of future behavior. Effective resolution of complaints should therefore consider not just the needs of the current patient who has been harmed, but also the risk of harm to future patients.
- Patient complaints offer just one window on poor performance and should be considered in the context of information obtained from clinical audits, practice reviews, and recertification.
- Individuals and institutions must proactively support doctors with multiple complaints to learn from those complaints and provide them with the necessary help to return to safe practice.
- Remediation for high-risk doctors should be tailored to the underlying cause of concern and may include health programs, behavioral interventions, mentoring, or clinical education.
Melbourne School of Population and Global Health
The University of Melbourne
Marie Bismark, MD
Associate Professor of Law and Public Health
Melbourne School of Population and Global Health
The University of Melbourne
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