These are the risks that, while not completely preventable, can be greatly reduced in frequency or severity. These include such risks as a patient falling out of bed, a wound becoming infected, and other risks that are not necessarily the result of negligence. The legal liability for these risks flows from the extent to which reasonable precautions were taken to prevent or mitigate them. The mishandling of normally prevented risks forms the basis of most medical malpractice litigation. This is because the occurrence of any normally prevented risk could have been the result of negligence and thus must be investigated to determine any possible liability exposure. The legal liability for these risks and the quality control techniques involved in preventing them are inextricably linked. Sterile techniques, sponge counts, proper diagnostic tests--all the precautions that form the "standard of care" in medical practice--are part of the quality control strategy. Although these precautions are usually thought of in the negative sense (as actions whose absence is the concern of the quality control manager), the explicit description and documentation of the precautions taken can prevent many malpractice suits from being filed. This is because a poor record forces the attorney to rely on court ordered discovery to find out what really happened.
The normally prevented risk class includes the risks that are usually discussed as medical complications. When a patient suffers a complication of medical treatment, that complication may be an expected sequela of the treatment, a "bad result," or the result of negligence. While any of these complications could form the basis of a lawsuit (depending on the informed consent issue), it is useful to differentiate among them.
An expected sequela is an adverse outcome that usually accompanies the treatment, even when the treatment is properly performed. (This would be an unpreventable risk in our classification system.) For example, if several vertebrae of the back are fused together to treat a degenerative bone disease, the patient will have a stiff back and consequent loss of mobility. In most cases, this disability will be offset by an overall gain in quality of life. Even if the gain in quality of life does not offset the induced disability, there would be no basis for a lawsuit if the operation was properly performed and proper consent was obtained. Malpractice suits must be based on negligence, either in technique or in communication. In the case of expected sequelae, most lawsuits are based on negligent management of the complication rather than on informed consent.
A "bad result" is a complication that occurs unpredictably in some cases, irrespective of negligence. Bad results may be nonpreventable, normally not prevented, or managed risks. Negligent treatment will increase the probability of a normally randomly distributed bad result occurring in a specific case. An unusually high incidence of bad results should prompt an investigation of the efficacy of the quality control program. For example, a wound infection will occur in a certain percentage of operations without any negligence on the part of the provider. However, if a wound infection occurs and it is found that the surgical instruments were improperly sterilized, there would be a negligent action to support a lawsuit. If many wound infections occur, it may be gross negligence not to investigate the underlying cause of the infections.
Negligent complications belong in the class of prevented risks. A simple negligent complication, such as leaving a sponge in the patient, should alert the quality control manager to the possibility of a lawsuit. When the negligence is clear, the only issue is mitigation of damages. Prompt recognition of the mistake and honest treatment of the patient will often prevent the filing of a lawsuit. Less obvious negligence invites a cover-up. Aside from the ethical issues, cover-ups must be avoided, because a cover-up that causes needed treatment to be delayed will have devastating legal consequences. The quality control program must explicitly deal with the issue of covering up negligent acts. A clear statement of position is the best approach, with particular efforts devoted to reducing the pressure that many hospital employees feel to "go along" with efforts to hide incidents.
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