By: Carl L. Ricciardi
Note: The following article was published at: Becker's Hospital Review.
Hospital administrators are not immune from civil and criminal prosecution for serious injury and death resulting from hospital acquired infections (HAIs). Neither the criminal code nor tort law provides a grant of immunity for hospital personnel for decisions they make or fail to make that results in injury or death to others. Such decisions would include, but are not limited to:
1. Failure to take reasonable steps to eliminate pathogens from the environment,
2. Failure to provide sufficient staffing to carry out a defined program to eliminate bio-burden,
3. Failure to provide sufficient funds to purchase equipment and the staff to operate it,
4. Failure to inform patients of the risk posed by "superbugs",
5. The purchase of technology that does not have a "reasonable probability" of eliminating Superbugs (
( RSA, VRE,C. difficile, etc.) from the environment. UV light products can, at best, can only achieve
a two to three log reduction of bio- burden.
6. Failure to adopt a standard of cleanliness that will ensure a reasonably safe environment for patients
THERE IS A LONG HISTORY OF HOLDING CORPORATE EXECUTIVES CRIMINALLY LIABLE FOR DEATHS AND SERIOUS INJURY RESULTING FROM THEIR DECISIONS
Both the criminal code and the common law have demonstrated a long history of holding corporate executives responsible for their conduct that results in harm or death to others. Healthcare administrators are no different than executives in pharmaceutical and manufacturing companies; both have faced civil suits and jail time.
In an early departure from imposing civil penalties on a corporate executive for the deaths of others, the Unites States Supreme Court in 1943, upheld criminal sanctions against the president of Buffalo Pharmacal Company, Inc. for the violation of a federal statute. The court, in this case, established the "responsible corporate officer doctrine" holding a corporate officer criminally responsible for the actions of his company. In its explanation, the court stated, "the purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection." United States v. Dotterweich, 320 U.S. 277, 284 (1943).
The Supreme Court reaffirmed this position in United States v. Park, 421 U.S. 658 (1975) under circumstances similar to those in Dotterweich. Park was the president of a large national food chain; he and the company Acme were charged with violating the Federal, Food, Drug and Cosmetic Act because certain of Acme's food warehouses were contaminated by rodents and the conditions had not been remedied after warning. Park was aware of the incident and had been informed that one of the corporate vice presidents was investigating and correcting the problem. Park contended that he had no reason to distrust the vice president's ability to remedy the problem, but he did concede that as chief executive officer he had ultimate responsibility for sanitation in the warehouses. Similarly, hospital executives have the same duty to ensue that the premises are as safe as reasonable possible.
Since 1975 the "responsible corporate office doctrine", or Park Doctrine, as it is often referred to, has been used often to enforce environmental laws, as well as cases falling under the Federal Food, Drug and Cosmetic Act. On February 22, 2013 executives of the Peanut Corporation of America were indicted by the Federal Government regarding a deadly our break of salmonella from a tainted product it had placed into the stream of commerce. It was their failure to take remedial action in light of knowledge of the condition that led to their indictment.
Interestingly, history repeated itself in September of 2015 when an owner of a peanut butter manufacturing facility in Georgia was sentenced by a Federal Judge to twenty-eight (28) years in prison for the Salmonella related deaths of nine individuals. In a September, 2015 the Wall Street Journal further reported that this was the toughest sentence since April, 2015 when a Federal Judge in Iowa sentenced the owner and his son to three months in prison for their involvement in a Salmonella outbreak that sickened thousands. In each case the defendants had knowledge of the danger and risk but proceeded forward. Acting Associate Attorney General Stuart Delery was quoted as saying, " Monday's sentence is an example of the Justice Department's "forceful actions" against any individual or company who "compromises the safety of America's food supply for financial gain".
Accepting a continuation of this line of cases, it is only a matter of time before criminal action is commenced against a hospital executive for allowing serious injury or death to occur in his/her facility when the application of known technology would eliminate the risk. In an article published in September of 2015, Dr. Stephen B. Calderwood, President, Infectious Disease Society of America; Professor of Medicine, Harvard School of Medicine; Chief, Division of Infectious Diseases Massachusetts General Hospital that each year at east 2 million people are sickened by antibiotic-resistant infections or superbugs. There is a unanimity of expert opinion,that HAIs from contaminated surfaces can be greatly reduced or eliminated. With all the information that has been published in recognized medical journals and provided at seminars, it will be impossible for health care executives to assert a defense of lack of knowledge of the cause of the problem and the escalating number of deaths and injuries from hospital contamination.
CRIMINAL CONDUCT DEFINED:
Whether the entity is the Federal or a state government, criminal liability arises by the violation of a statute. For example, in the State of Wisconsin one's conduct may be determined to be criminal if:
Sec. 939.25 Wis. Stats. Criminal negligence:
(1) In this section, "criminal negligence" means ordinary negligence to a high degree, consisting of conduct that the actor should realize creates a substantial and unreasonable risk of death or great bodily harm to another, except that for purposes of ss. 940.08 (2), 940.10 (2) and 940.24 (2), "criminal negligence" means ordinary negligence to a high degree, consisting of conduct that the actor should realize creates a substantial and unreasonable risk of death or great bodily harm to an unborn child, to the woman who is pregnant with that unborn child or to another.
(2) If criminal negligence is an element of a crime in chs. 939 to 951 or s. 346.62, the negligence is indicated by the term "negligent" or "negligently". With some variation, this definition would be consistent across the country.
Under Federal Law, liability arises by violation of a Federal Statute such as the FDA, USDA, EPA or others. Interestingly, the manufactures of pharmaceuticals or food products are held to strict compliance with numerous safety standards. At the state, county and city level, manufacturers and sellers of food products are held to strict standards of cleanliness.
COMMON LAW NEGLIGENCE DEFINED:
Black's Law Dictionary, revised forth edition, defines negligence as "the failure to exercise ordinary care, the omissions to do something which a reasonable man, guided by those ordinary considerations which ordinarily regulate human affairs would do, or doing some thing that a reasonable and prudent man would not do, or the failure to exercise due care".
Clearly, the failure of hospital administrators to take reasonable effective steps to eliminate the risk of nosocomial infections would constitute negligence. The key is, effective steps that have a reasonable probability of eliminating the risk of serious injury or death, There are a limited number of drugs that might work and there are no news drugs in the pipe line to reduce the seriousness of the problem. To knowingly accept the status quo as a "reasonable consequence of medical treatment" in a hospital setting without implementing a "no touch" technology (NTT) that has the highest probability of ensuring a sterile environment......constitutes negligence. A facility that is partially cleaned is like a fire that is partially extinguished.
THE GENESIS OF THE CURRENT SITUATION:
The genesis of the current HAIs problem parallels the discover, broad use and decline of the number of antibiotics available for the treatment of infections. Prior to the discovery of Penicillin, around 1937, the treatment of infections was at best a hope and a prayer. With Penicillin, and the drugs that quickly followed, most infections acquired in a hospital setting were not seen as threating because, in the main, they could be successfully treated. Over time, the bugs mutated and became resistant to drugs that normally would work. In the last ten to fifteen years the types of bugs that have become resistant has accelerated while the number of drugs to treat the has declined, this coupled with a lack of interest of pharmaceutical companies to invest in research for new drugs, has created the perfect storm. This situation has been intensified by the recent ability of pathogens to swap genetic material. The creation of these superbugs, with their ability to produce toxins 20 to 30 times more powerful than non-superbugs has dramatically increased the risk of serious injury or death.
In years past, hospital administrators assumed that they had no direct liability for HAIs because it was a problem to which there was no solution. Furthermore, all patients were required to sign a waiver acknowledging that he/she may acquire an infection while an inpatient and that this occurrence was a natural and accepted consequence of being in a hospital. Acquiring an "infection" is one thing, but acquiring an infection that may result in serious injury or death is another. Most patients do not understand the consequences of signing such a waiver, and certainly one that is silent as to the seriousness or probability of death if a hospital infection is acquired. The failure to provide an informed consent in light of the published studies and serious consequences, constitutes negligence. The plethora of published and highly disseminated articles in the last few years has created a new standard of cleanliness, one that cannot be ignored.
For example, Dr. Magen Shaughnessy published a paper in the peer reviewed journal Infection Control and Hospital Epidemiology, March 2011, Vol. 32, No. 3, stating that a patient placed in a patient room where the prior patient had an infectious disease such as MRSA or C. difficile would expose the new patient to a statically significant risk of contracting the same infection. She further opined that the sharing of a bathroom, specially in the case of C. difficile, would expose the unaffected patient to the disease organism and should be avoided.
In the last year there have been numerous instances where national TV stations, printed media and talk show hosts have discussed the hospital acquired infection issue. The problem remains unabated despite emphasis on hand washing, use of alcohol gels and general hygiene. The main reason for the lack of progress is not that technology is not available that will eliminate the risk or that the problem has not been throughly studied, it is the seemly lack of concern at both the individual hospital C-suite level and the failure of governmental authorities to prosecute criminal sanctions.
One might wonder why there has not been a tidal wave of patients demanding a safer hospital environment. Until lately, the magnitude of the injury and death have been obfuscated by the self reporting system followed by discretion in stating the " cause" of the injury or death. It is not uncommon for an individual who presents at a hospital with pneumonia and who later dies as the result of an HIA to have the cause of death shown as "complications" of pneumonia and not from an HAI. This practice of not reporting or under reporting cases of serious injuries or death from an HAI has contributed to the continuation of an unacceptable situation.
Each year more people die from hospital acquired infections than die from auto accidents, breast and prostate cancer, or war. This number is more than the total number of fans that fill the University of Michigan's football stadium on a fall afternoon . By doing nothing, selecting inferior technology, or failing to put the full weight and economic power of the C-suite to bare on the resolution of the HAIs problem, in light of the serious risk of injury or death, constitutes criminal negligence as defined above. Not only has the inaction of the hospital community created a "substantial and unreasonable risk to another" but individuals in large numbers have in fact been injured or killed.
As in Dotterweich above, patients that enter a hospital setting, are for the most part beyond "self help" in that they must trust that the hospital staff has taken all reasonable precautions not to expose them to unreasonable risks. The fact that not all hospital acquired infections (HAIs) can be easily cured renders the risk unreasonable in light of proven technology that can eliminate the risk. The literature is replete with peer reviewed papers showing that certain technologies can leave a patient room in an almost sterile condition. It is intuitively obvious that if other vectors of transmission are controlled the predictable risk of infection will decrease. Because so many human lives have been lost each year and millions more injured, it becomes unreasonable for administrators not to embrace advanced technology that can eliminate the risk, or knowingly select technology that can only reduce the risk.
THE C-SUITE, WHERE THE BUCK STOPS:
The ultimate decision to implement technology that offers the greatest probability of eliminating, not merely reducing, pathogens lies within the "C-suite"/ office of the president or CEO. When dealing with human life or serious injury, the decision whether to implement, or what to implement, should not reside in any department of the hospital other than the corporate suite (C-suite), having first obtained an informed opinion from the department of infectious disease. Whether to adopt technology to eliminate "nosocomial" infections is no longer an option. To continue to allow this situation to exist without taking aggressive affirmative action that provides the best means of eliminating the risk constitutes negligence.
Ultimately, it is the responsibility of the hospital management and its board of directors to establish the standard of cleanliness best positioned to eliminate, the possibility of a patient contracting a hospital acquired infection. To allow either the in house janitorial staff (EVS) or an outside provider to determine the standard of cleanliness, which will directly impact patient health, is not acceptable.
In the main,delegating that decision to the EVS (environmental services department) constitutes negligence for they have neither the training nor experience to make that type of a decision. The President, CEO, CFO, and the board of directors, would also be negligent for not allocating adequate funds to the EVS department to accommodate an increased demand on its resources.
The duty of hospital administrators in selecting a NTT is no different than a physician faced with selecting an antibiotic to treat a patient with a serious infection. The goal is the same... the total elimination of the pathogen causing the problem; accepting less is to leave the patient exposed to a reinfection and possible death. Such a choice is unacceptable. Neither the medical literature nor the standard of care supports merely "reducing" an infection by selecting a lesser or cheaper solution. Applying this principal to the hospital acquired infection (HAIs) issue, choosing a technology that only reduces the risk by a two to three log reduction is unacceptable when compared to technologies that can totally eliminate the risk in less time and at a comparable price. If a hospital administrator were to select a "reducing technology" such as UV light for example, then a duty is owed to the patient to provide sufficient information of the risk, so that he/she can make an informed decision when selecting a treatment facility.
For example, the selection of a UV light technology, knowing that it only has the capability to reduce, and not eliminate bacterial contamination is unacceptable when other technologies exist that can totally eliminate the risk. When human life is at stake, choosing an inferior technology is not an acceptable option. No published peer reviewed article has shown that UV light can eliminate pathogen contamination in an actual hospital setting. Actually, the published literature clearly shows that because of shadowing, at best, this technology can only reduce the contamination.
No paper has been published establishing that a residual level of contamination is safe or will offer a safe harbor for hospital administrators. Merely, reducing the risk of contracting an infection in a hospital setting will not eliminate the risk of both civil and criminal liability for the C-suite and board of directors.
WHAT HOSPITAL ADMINISTRATORS AND THE BOARD OF DIRECTORS MUST DO TO ELIMINATE THE RISK OF CRIMINAL OR CIVIL LIABILITY
1. Assume, at the C-suite level, the responsibility for eliminating HAIs in the hospital environment by formulating a comprehensive management plan that sets a high standard of cleanliness for patient safety. Adopt a Zero Tolerance cleanliness plan for pathogen contaminations.
2. Select a modality or a suite of products that have the highest combined probability of eliminating the risk of surface contamination. The EVS department, whether in house or contracted should have no responsibility in establishing the standard of cleanliness.
3. Provide adequate funding to the EVS department to implement the plan.
4. Appoint a trained individual to lead the infectious disease elimination plan with authority to impose the cleanliness standard on the EVS staff.
5. Ensure that the cause of death is accurately reported so that HAIs can be accurately tracked and the
root cause rectified.
6. Make sure that a room formerly occupied by a patient with an infectious disease is cleaned by a high level disinfection technology that will totally eliminate, not merely reduce, the risk of a patient contracting the same infection because the surfaces are not clean.
Carl L. Ricciardi has been board certified by the National Board of Trial Advocacy and has litigated cases for more than thirty-five years in both state and Federal Courts. He began his legal career as an Assistant Attorney General with the State of Wisconsin Department of Justice. In private practice he represented physicians and hospitals in matters concerning medical negligence and represented individuals injured by defective products and the negligent acts of others.
B.S University of Wisconsin-Madison
M.S University of Wisconsin-Madison,
JD Marquette Law School.
Copyright © 2016, Carl L. Ricciardi, All Rights Reserved.
© Copyright ASC Communications 2016.
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