Thursday, July 10, 2008

Criminalizing Medical Errors

Criminalizing Medical Errors
By Mike McEvoy

Example scenario: While treating a 31-year-old heart failure patient, a paramedic mistakenly pushes 4 milligrams of intravenous norepinephrine instead of the intended lookalike vial of 1 milligram of bumetanide (Bumex®). The patient immediately develops a supraventricular tachycardia, becomes hypertensive, and deteriorates into ventricular fibrillation. Resuscitative efforts are unsuccessful; the patient is pronounced dead on arrival at the ED. After learning of the error from local media accounts, the district attorney launches a criminal investigation. A grand jury returns a felony indictment against the paramedic involved in the error.

Every medical provider fears making an error that harms a patient. The possibility of criminal prosecution adds to those fears — loss of personal freedom, property, certification or licensure, and potential loss of livelihood. Today, with increasing frequency, human errors in health care are being criminalized. The results may have far reaching consequences on the practice of medicine, nursing and EMS.

While the public and our legal system seek to blame and punish people who make fatal mistakes, health care experts and advocates believe that criminal prosecution of medical providers ultimately does far more harm than good. Such actions, they argue, will ultimately drive practitioners to stop reporting errors, and discourage recruitment and retention of a profession already in short supply.

The fact of the matter is that a fatal medication or procedural error could happen to any nurse, paramedic, EMT or physician. How then, should these tragic circumstances be dealt with? What leads society to criminalize medical mistakes? What role can you and I play in affecting how medical errors are managed?

Medicine is not the only profession susceptible to criminal indictments for mistakes. In September 2006, two U.S. pilots flying an executive jet clipped the wings of a commercial airplane over Brazil. The resulting crash was the worst aviation accident in the history of Brazil and killed all 154 people aboard the 737 airliner.
Criminal charges were later filed against the U.S. pilots involved(1). Like health care authorities, aviation safety experts commented that the charges would have a "chilling effect … on getting people to come forward and admit mistakes. We need to focus not on putting people behind bars, but rather on finding out what went wrong and why, and then to prevent its reoccurrence." (Kenneth Quinn, Flight Safety Foundation).

'Criminal human error'
History illuminates when and how safety experts and the criminal justice system arrived at their present day impasse. Attorney David Marx, writing in The Just Culture Community News and Views newsletter(2), calls this juncture the "birth of criminal human error." Marx traces the birth in the U.S. to a 1952 Supreme Court decision in the case of Morissette v. United States, 342 U.S. 246.

In December 1948, while deer hunting on an abandoned air force bombing range, Morissette salvaged 3 tons of abandoned bomb scrap metal. He did this in full view during broad daylight believing it was abandoned, and did not think he was stealing.

When the government charged him with theft, his attorneys argued for dismissal on the grounds that there was no evil or criminal intent, which they believed the law required(3). Justice Jackson, writing for the court, described a paradigm shift in defining the word "criminal," which until that time typically conjured up images of evil intent or intent to cause harm.
Jackson described how the industrial revolution had introduced powerful, complex machines with potential to cause significant harm not previously possible except by the hands of man or animal. He pointed out that automobiles became an instrument by which human behavior could inflict major damage. With the industrial revolution, vast harm became able to be caused from great distances. In response, legislatures started criminalizing acts where "evil intent" was no longer a necessary element. Criminal negligence was born.

Since the industrial revolution, many types of human error have been criminalized, especially where public health or welfare is at stake. Marx points out that today's convicted criminals are not all folks with "evil intent," but include those who breach a duty to others that our government labels "criminal." The Clean Water Act makes polluting waterways criminal. People who leave a child or pet in an unattended vehicle during hot summer months are likely to face criminal charges.

Unavoidable events
Considering the potential scope of actions that could expose any one of us to prosecution, statistics demonstrate a predictable randomness that would pronounce such events unavoidable. The only question is which one of us it will happen to next. And when egregious harm befalls an innocent victim, human nature is to react to the seriousness of the outcome. What firefighter is not happy to see criminal charges brought against an arsonist? What medic is not pleased to see a drunk driver marched off to jail?

Yet to effectively deal with errors, particularly medical errors, we need to suppress our natural reactions and try to ignore outcomes during the time it takes to analyze the circumstances that led to the error.

The greater question, as it pertains to medical providers, is why human error has become not only a violation of rules and regulations, but a criminal act when it threatens the safety of citizens. Are prosecutors becoming overzealous? Are lawyers running out of control? Are our elected officials so frustrated that they’ve turned to criminal law to protect society? Or is it perhaps the systems we designed and manage that are heading us in this direction? Probably no single one of these explanations accounts entirely for where we are today, but several will determine where we go in the future.

No one of us is perfect. As human beings, we are destined to make mistakes. The Just Culture Organization, working to improve patient safety, believes that medical systems often fail to recognize human beings have not one, but two "intentions" related to anything we do. But while we acknowledge human intention toward the outcome, we frequently overlook human intention toward the action or behavior that leads to the outcome.

Undoubtedly, few medical providers intend to hurt their patients — the outcomes. But what about their intentions toward their actions? Did the paramedic in our opening scenario consciously disregard what he knew to be a significant and unjustifiable risk to his patient? If he did, the Just Culture model would call that behavior "reckless" and that is precisely the question they believe should be applied when considering criminal charges in medical errors.

The belief that punishment or criminal charges are unjustified merely because a health care provider did not intend to cause harm flies in the face of accountability, our legal system and good patient safety.

Provider's intentions
When investigating medical errors, our systems must carefully weigh the provider's intentions toward their behavior for recklessness. Regularly, we need to look for risky behavior and coach providers to straighten up and fly right.

Reckless behavior, on the other hand, should be punished. Yes, you read that correctly: some behaviors need to be punished. Perhaps our failure to consistently address reckless practices has prompted attorneys, prosecutors and legislators to take up our slack themselves.

A highly intoxicated partygoer who chooses to drive themselves home does not intend to strike and kill a pedestrian. But when such an incident happens, the courts will likely find the behavior — driving drunk — was intended, and consciously disregarded a significant risk to others.
Recklessness that harms others is criminal, and society sends the guilty to jail. Health care providers should not enjoy special exemption from the rules that govern the rest of society.
Our regulatory systems need to do a better job of dealing with providers who aren't living up to professional standards. Using the criminal justice system to accomplish this should rarely be necessary.

Speaking at the Society of Critical Care Medicine's 2007 Congress in Orlando, Lucian Leape, a Harvard physician and founder of the National Patient Safety Foundation, told the audience that problem health care providers are not bad people but, "our friends and colleagues whose performance poses a potential threat to patient safety.

Our failure to insure that all of our colleagues are competent and safe is ethically indefensible, and we have to do something about it." Dr. Leape continued, "We are the only ones capable of judging and taking action with our peers. We have to take the responsibility."

Equally important are our safety systems. Many error investigation models, the Just Cause model included, see two inputs for every adverse outcome: the system we design around the provider and the behavioral choices they make within that system.

Some systems facilitate risky behaviors; others fail to implement safeguards to reduce risks. In 1998, a Denver nurse was indicted for criminally negligent homicide in the death of a newborn from a dose of penicillin. The Institute for Safe Medication Practices (ISMP) investigating the case found more than 50 deficiencies in the hospital medication-use system contributed to the error(4). Had any one of them been corrected, the error would not have reached the infant.

Protecting patients, providers
Safety systems are critical to protect patients and providers. Too often, safety nets are lacking or non-existent. Human beings will continue to make mistakes. System operators, administrators, manufacturers and regulators own responsibility for the environment of care.

When two drugs are packaged in lookalike vials, the department has an obligation to prevent potential errors. While we often focus on individuals involved in errors, the fire service and EMS community collectively are responsible to gather and analyze near miss reports and feedback from the streets to improve patient safety. Without strides in meeting that obligation, future criminal focus may well take aim at chiefs, administrators, medical directors and system operators.

The increasing trend toward criminalizing medical errors is very likely to discourage health care providers from reporting errors, hurt recruitment and retention, and bring important patient safety initiatives to a screeching halt. EMS providers, like our physician and nursing colleagues, need to step forward and take a more proactive role in how medical errors are managed.
We need to look for risky behavior before they result in errors, and consider whether recklessness contributed to errors that do occur. We must begin to hold our systems accountable for their contributions to errors in the environment of care.

Until we manage to convince the public, our legal system and legislators that we take mistakes seriously, they will continue attempts to fix our problems themselves with legislation, regulations and criminal charges.

Far better outcomes could be had if we, the people who know health care, lead change from within. It's time to begin — we owe it to our patients and each other.

References:
1. ISMP Medication Safety Alert! Criminal prosecution of human error will likely have dangerous long-term consequences. 2007; 12(5):1-2.
2. The Just Culture Community News and Views. The Criminal Edition. Marx, D, Cassidy, KM. Eds. January/February 2007.
3. Morissette v United States, 342 U.S. 246 (1952)
4. ISMP Medication Safety Alert! Since when is it a crime to be human? 2006; 11(23):2.
________________________________________
Mike McEvoy is the EMS Coordinator for Saratoga County and the EMS Director on the Board of the New York State Association of Fire Chiefs. Formerly a forensic psychologist, he is a clinical specialist in Cardiac Surgery and teaches Critical Care Medicine at Albany Medical College. Mike is a paramedic for Clifton Park-Halfmoon Ambulance, chief medical officer for West Crescent Fire Department, past chair and current member of the New York State EMS Council. He is the fireEMS editor for Fire Engineering magazine and recently published a book titled "Straight Talk About Stress for Emergency Responders." Mike is a popular speaker at fire, EMS, and medical conferences and in his free time, is an avid hiker and winter mountain climber

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