___________________________________________________________________________ Risk Management
Standard of Care and Medical Negligence In a medical malpractice case, the plaintiff has the burden of establishing the appropriate standard of care and demonstrating that the standard of care has been breached. The standard of care is primarily defined by other practitioners with similar qualifications, who provide expert testimony about how they would have managed an individual’s care under the same or similar circumstances [35]. In general, expert testimony is based on the physician expert’s knowledge, skill, experience, and training and may be supplemented by published literature, practice guidelines, and surveys of practitioners [35]. The focus is whether the physician’s actions met or breached the standard of care and, if the latter, whether the plaintiff was harmed as a result of the breach [35]. According to tort law, four elements must be established for a ruling of malpractice [34; 36]: • Duty: The physician owed a duty to meet a particular standard of care. • Breach of duty: The physician failed to perform the owed duty. • Causation: There is a causal connection between the physician’s failure and the patient’s injury. • Damages: An injury occurred for which monetary compensation is adequate relief. These elements must be shown by a “preponderance of the evidence,” defined as more than 50% probability, a lower standard than the “beyond a reasonable doubt” used in criminal law [35; 37]. Malpractice cases are decided on the basis of what a “jury is likely to think is fact” rather than actual fact [38; 39]. A duty is owed if there is an active patient-physician relationship at the time of alleged injury [34]. This relationship is defined as any service given by a provider to an individual, whether in the provider’s office, in an emergency department, or within a telephone discussion [34]. Breach of duty can be claimed if the healthcare provider does not meet a relevant standard of care or there is an obvious error (e.g., retained surgical instruments). Causation requires that the plaintiff establishes that the physician’s negligence led to the stated injury; an association can be interpreted as causation by a jury who may be sympathetic to the plaintiff [34]. Damages sustained by the patient are compensatory and/or punitive. Compensatory damages consist of compensation for directs costs, such as for lost earnings and medical expenses (current and future), as well as compensation for indirect costs, such as pain, emotional distress, and loss of consortium. Punitive damages are awarded to a plaintiff when the physician’s actions are found to be intentionally harmful or grossly negligent [34].
Informed Consent The informed consent law in medicine was originally developed from battery, an intentional tort [36]. The definition of battery as unwanted physical touching of the body by others was extended to include a treatment provided by a physician without a patient’s consent [36]. Battery was also applied to cases in which the procedure performed was substantially different from the one for which consent was given, in which the procedure exceeded the scope of the consent, or in which the procedure was performed by a physician other than the one to whom consent was given [36]. Cases of medical informed consent are now classified as negligence, carrying with it the burden to prove the four elements for liability [36; 40]. The primary goal of informed consent is to protect patients by requiring that physicians provide a balanced discussion of a proposed procedure/treatment as well as of the alternative options, so patients can make informed medical decisions [36]. Informed consent was once required only for invasive procedures but the scope of procedures has expanded to include complex treatments (e.g., radiation therapy, chemotherapy), and a separate written consent is required for the use of anesthesia (general, spinal/epidural, or regional) in some states [6; 40; 41]. The informed consent discussion should focus on the expected benefits, the risks involved with the procedure/treatment, and the feasible alternatives [6; 40]. The adequacy of the disclosure of risks is defined differently among states. In most states, a “professional standard” is applied, which means that adequate disclosure is defined as what a reasonable medical practitioner would disclose in a similar situation; in other states, a “lay standard” is applied, with adequate disclosure defined as what a reasonably prudent individual would want to know before consenting to the particular procedure/treatment [6]. In general, physicians must disclose all severe risks, such as death, paralysis, or loss of an extremity, regardless of the likelihood of the event. Less severe events should be disclosed if they are frequent, whereas nominal risks do not need to be disclosed if they are not frequent [36; 40]. The Centers for Medicare and Medicaid Services (CMS) mandates that all medical records (inpatient and outpatient) contain completed written informed consent forms for all procedures and treatments [41]. In 2007, CMS issued new interpretive guidelines for informed-consent documentation in patients’ medical records. According to these guidelines, informed consent is defined as, “the patient or patient representative is given (in a language or means of communication he/she understands) the information, explanations, consequences, and options needed in order to consent to a procedure or treatment” [41]. In 2024, the CMS issued an update to informed consent guidance for hospitals [42; 43].
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MDMI1826
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