The Criminalization of Human Errors in Healthcare

Criminal Prosecution for Clinician Error

While the occurrence of a healthcare provider facing felony charges after a patient death is not frequent, the Tennessee case was not an isolated event in the United States.

In 1990, a nursing home physician in New York was charged with reckless endangerment in the second degree and willful patient neglect following a patient’s death from chemical peritonitis after he mistook the patient’s peritoneal dialysis catheter for a gastrointestinal feeding tube, ordered the administration of a feeding solution through the dialysis catheter, and later delayed her transfer to a hospital.

In the late 1990s, three nurses in Colorado were indicted for criminally negligent homicide for their role in the death of a newborn who was ordered to receive intramuscular penicillin G benzathine but was administered a 10-fold overdose intravenously.

In 2006, an obstetrical nurse in Wisconsin was charged with neglect of a pregnant teenage patient causing great bodily harm after unintentionally administering an epidural anesthetic intravenously instead of the intended penicillin, resulting in the death of the patient (the baby survived following an emergency cesarean section).

In the late 2000s, a pharmacist in Ohio was charged with reckless homicide and manslaughter after a toddler died while undergoing chemotherapy.  The pharmacist had checked and dispensed the chemotherapy solution, which had been prepared by a pharmacy technician using 23.4 percent sodium chloride instead of 0.9 percent sodium chloride.

Not only do such felony charges span healthcare professions and states across America, but they also span the world as well.  In England, an optometrist, two general practitioners, a colorectal surgeon, a locum consultant anesthetist, and a pediatric trainee doctor have been charged with gross negligence manslaughter in separate cases.  Similar charges have also been reported in New Zealand, Japan, China, and Canada.  The outcomes of these domestic and international felony charges varied and included jail time, probation, an overturned conviction, plea deals to lesser misdemeanor or felony charges, dropped charges, and not guilty verdicts. 

Relatively few fatal medical errors are criminally prosecuted, which illustrates the irregular, inconsistent, non-standardized application of criminal law to such errors.  Where is the line drawn, why, and who draws it?  Because the line is obscure, criminal charges are not deterring “criminal” behavior, because healthcare providers are left to speculate when their actions may cross the line.

Furthermore, these criminal cases focused on errors that resulted in death, but not all healthcare errors are fatal or even cause harm.  Thus, the severity or outcome bias inherent in criminalizing fatal errors is not protecting society against similar future errors.  It punishes the unlucky and rewards the lucky by magnifying the human errors when system workarounds lead to a fatality and ignoring the human and system errors when the same behaviors do not have fatal consequences.  For example, the Tennessee nurse’s workaround of overriding a medication dispensing cabinet received intense critique, but other nurses who cared for the same patient overrode almost 12 medications prior to the subject nurse’s fatal override.

What is consistent throughout these cases, though, is that the healthcare providers were fallible humans working in very complex systems carrying on the inherently risky business of patient care.

Patient Harm and Defective Healthcare Systems

According to the World Health Organization, the risk of being harmed during healthcare is 1 in 300, whereas the risk of being harmed during air travel is 1 in 1 million.  The 14^th leading cause of global morbidity and mortality is patient harm.  In high-income countries like the United States, 1 in 10 patients are harmed while receiving care in a hospital, and nearly 50 percent of the adverse events that cause this harm are preventable.  

Most medical errors are the result of faulty systems.  Overlooked system issues – such as technological, environmental, cultural, and workflow difficulties – force the humans operating within these flawed systems to compensate by creating workarounds/safety bypasses to complete their tasks.  These bypasses (such as overriding a medication dispensing cabinet) are a direct consequence of defective systems, not of willfully reckless clinicians.  Individual healthcare providers have negligible, if any, control over every aspect of the complex system in which they work, which is why holding a single person accountable for a primarily system-derived outcome is not an approach that will yield meaningful patient safety results.  Imprisoning a single clinician does not protect future patients from harm, because it does not correct the latent system failures that led to the harm. 

In a complex system such as healthcare, patient harm can occur when latent and active errors intersect.  Latent errors are the obscure system design or process failures that enable harm to reach a patient by creating conditions that allow a clinician to make an active error.  For example, the aforementioned Ohio pharmacist made an active error of dispensing an incorrectly compounded medication. Yet according to his description of the incident, the error was allowed by various latent system failures, including:

• Routine computer maintenance, which delayed the printing of medication labels and created a backlog of orders which caused staff to feel rushed,
• An interdepartmental miscommunication which amplified the time pressure on staff,
• Reduced staffing,
• No rest breaks, and
• A small, cluttered work area in which materials used to compound multiple medications for multiple patients were present, leading to an incorrect assumption about the materials used for the solution in question.

This is not to say that clinicians have no accountability or responsibility – they absolutely do – but singling out and criminally charging the clinician who happened to be closest to the patient harm, who made the final and obvious error in a series of preceding latent system and active errors, will not prevent the same active error from happening again.  In fact, the Institute for Safe Medication Practices (ISMP) reported “errors that were eerily similar to the event [in the aforementioned Tennessee case] were reported to ISMP before (and since) the event, including incorrectly retrieving vecuronium from an [automated dispensing cabinet] after searching for Versed by entering just the first two letters, VE.”  Focusing on the low-hanging fruit and isolating an individual healthcare provider’s actions from the context of the complex, dynamic system in which those actions occurred does not address the larger system issues that continue to put patients at risk.  For example, in the Colorado case noted above, the ISMP “identified over 50 different failures in the system that allowed this error to occur, go undetected, and, ultimately, reach a healthy newborn child, causing his death. Had even just one of these failures not occurred, either the accident would not have happened, or the error would have been detected and corrected before reaching the infant.”  Criminally prosecuting the healthcare provider nearest to the patient harm is an inadequate solution given the complexity of the healthcare system and the number of departments and clinicians interacting to provide care to a single patient; it is not protecting society as a whole, as criminal law is intended to do.

Preventing Patient Harm through System Improvement

To protect patients, all workarounds, all errors, all questionable and risky behavior and decisions – regardless of the outcome – must be identified and critically analyzed to find opportunities to improve the system and reduce, if not eliminate, the need for workarounds.  Improving these system flaws by building redundancies into the system (multiple layers of safety barriers) and people-proofing the processes will help prevent inevitable human errors from reaching and harming patients.

For a healthcare organization to shift from being reactive (responding after patient harm occurs) to proactive (identifying and addressing system issues/workarounds after a near miss occurs), frontline clinicians (those who provide direct patient care and thus are directly interacting with the system day in, day out) must be comfortable reporting near misses/close calls, errors, adverse events, and concerns to the organization (e.g., the quality management department, leadership) and then freely and honestly discussing the incidents.  Such reporting is typically highly encouraged by organizational leadership and quality management staff but does not always occur due to fear (including fear of self-incrimination, punitive repercussions by leadership, etc.), a culture of blame and shame, lack of trust, time constraints, and busyness/workload.  Within the healthcare system, such honest, open, and frequent reporting requires a culture of psychological safety; a just, non-punitive culture; and trust that the institution will act upon the information provided.  Outside of the healthcare system, it requires an absence of fear of criminal repercussions.  According to numerous healthcare organizations, entities, and professionals, the long-term consequences of criminally prosecuting healthcare professionals (HCPs) lead to more, not fewer, errors and patient harm (Figure 1).  Criminal prosecution of healthcare providers creates fear in other clinicians - fear of criminal and civil legal action and that the information shared in event reporting and resultant quality improvement activities could be discoverable in legal proceedings and thus be used against them to apportion blame and find fault.  That fear inhibits incident reporting, without which system issues cannot be identified and corrected – leading to more patient harm. 

Criminal prosecution of clinicians also causes current and prospective healthcare providers to fear losing their livelihood, so they exit their profession (or take non-clinical positions) and choose another career path, respectively.  The resultant shortage of bedside clinicians creates unsafe conditions and decreased access to healthcare – leading to more patient harm.  Criminal prosecution of healthcare providers also sends the message that perfection in healthcare is an achievable goal (which it is not).  Due to this expectation of perfection, clinicians feel shame when errors occur, so they hide the errors (i.e., they do not report incidents).  The suppressed error reporting prevents organizations from being transparent to patients/families and disclosing adverse events, which reduces trust and results in more civil litigation.  Increased civil litigation also results from the message of attainable perfection in the provision of healthcare.  More civil litigation promotes defensive medicine, i.e., ordering additional/unnecessary testing – which may lead to more patient harm.

Proponents of criminally charging healthcare providers for fatal errors have equated it to charging drivers distracted by their cell phones who kill someone with their vehicle.  While there may be some superficial parallels to draw, the driving analogy fails to account for the lack of willful recklessness, the context (system) in which healthcare providers work, and the effect on society’s safety.  Those distracted drivers make a conscious choice to engage in reckless, unsafe, and illegal behavior and to disregard its known risk.  They are acting independently (not within the constraints of a complex system), and thus criminal sanctions will deter this reckless behavior and protect society by removing unsafe drivers from the streets.  Conversely, the clinicians in these cases were not making conscious decisions to be reckless, to ignore substantial and unjustifiable risks.  While they knowingly engaged in workarounds that were normalized, engrained in the organization’s system and processes, and thus were routinely used by numerous clinicians, they either failed to see the potential risk of performing the workaround (because it regularly occurred without error) or they underappreciated it and perceived it to be a justifiable means to the end of providing patient care in a timely manner.  These workarounds (drifting into “at-risk” behavioral choices, as it is termed in the just culture world) are the result of complex, substandard systems.  Automatically removing an individual clinician who made an inadvertent mistake from the healthcare setting does not change the faulty system that necessitated the workaround; the defective system persists, which continues to endanger patients by allowing other clinicians to engage in the same workarounds.  Thus, the focus and the path to patient safety must be proactively improving system design, thereby reducing the need for such workarounds.

Clinician and Organization Accountability

The blame-free culture within a healthcare system that creates psychological safety for incident reporting does not negate clinicians’ and organizations’ accountability for their contributions to errors.  There must be shared accountability between the healthcare provider(s) and the organization. 

On the individual clinician level, accountability and responsibility include being mindful, consciously present, and focused on the task at hand.  They involve minimizing or eliminating distractions as needed and when performing higher-risk work.  They also include minimizing workarounds/safety bypasses, avoiding assumptions, and seeking clarification/confirmation instead.  Proactively, healthcare providers have a responsibility to maintain vigilance against complacency and drifting into at-risk behaviors and correcting themselves and others when such behaviors are observed; to advocate to leadership about systems issues, processes, or conditions that require improvement; and to consistently report errors and near misses.  After an incident occurs, accountability and responsibility include reporting the incident; actively participating in the incident investigation and analysis; actively participating in making the necessary system changes; acknowledging one’s mistake(s) and the resultant harm; engaging in education, coaching, retraining, and remediation; and talking with others about the incident and mistake so the lessons can be more broadly applied. 

Institutions, in turn, have a responsibility to prioritize patient safety and create the blame-free environment that allows clinicians to report near misses and patient safety events.  They must be willing to listen and learn when clinicians share their concerns and report incidents.  Organizations must invest time and resources in investigating the events and in making the identified improvements that will positively affect patient safety.  They must also proactively and continuously review alerts, bulletins, warnings, and other information put forth by national patient safety organizations, analyze this information relative to their organization’s processes and systems, and devote the necessary resources to reconcile any discrepancies and implement recommendations and best practices.

Alternative Solutions to Criminal Prosecution of Clinicians

Given the system issues that are pervasive in cases involving fatal medical errors, some have advocated for corporate manslaughter charges against healthcare institutions and their leadership (decision-makers) for their role in leading and in allocating resources in such a way that patients could be harmed.  Others have advocated for a no-fault system like that in New Zealand, which implemented it upon finding that “criminal law was poorly designed to deal with the complex mix of error, violation, and system failure that typically characterise the deaths that lead to [prosecutions of health professionals for gross negligence manslaughter].”

Additionally, given the complexities and nuances of both the provision of care and the healthcare system, a state’s professional licensing board (comprised of peers to the subject clinician) is a more suitable and reliable avenue for evaluating care rendered, examining allegations of harm, upholding professional standards of practice, and determining appropriate sanctions (including restricting or revoking a license).  This administrative route still protects the public but more appropriately “reflects failures in clinical practice rather than any suggestion of criminality.”

Conclusion

There will always be errors when humans are involved.  Thus faulty healthcare systems and latent failures that allow those predictable human errors to reach patients are the actual causes of harm.  Because criminalizing human errors in healthcare does not correct or prevent these causes, it does not protect society and the patients who entrust their care to healthcare systems.  In fact, it has the opposite long-term effect.  Understanding that imperfect humans are practicing the imperfect art of medicine in an imperfect system allows the focus to be on the most reliable way to prevent patient harm: continually refining and improving the dynamic system.