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Informed Consent; *Patients Rights. ABSTRACT. This paper examines the variety of legal rules and processes which have been established to assess and ensure ...
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MiteOfEdit:ShensiResearchandImprovement1.11L-DEPARTMENTOFEDUCATION EDUCATIONALRESOURCES-INFORMATION CENTER(ERIC) 0Thai_document-has_beanreproduced-asreceivedfromthepersonororganization asginatingrt.nor-changeshavebeenmadetoimprove urst ualArion Phintargviewofofsnionsstatedinthisdocu- matdo_notneCeNsinlyrepresentofficial OERIpoalt,onorpolicy.
MATERIALHASBEEN-GRANTEDBY^ PERMISSIONTO-REPFMDUCETHIS
, TOTHEEDUCATIONALRESOURCESINFORMATIONCENTER(ERIC)."
Marshall B. 'Capp, .7.D., M.P.H. Associate Professor Department of Medicine in Society
School of Medicine Box 927 Dayton, Ohio 45401
BESTCOPYAVAILABLE
for treatment by students and postgraduate trainees, the need for an Institutional ReView Board if either the nursing home or the affiliated educational institution conducts human subject research sponsored in any part by federal money, maintaining acceptable standards of care by all participants and consequent shared liability for substandard tare, and confidentiality. Because the "teaching nursing home" phenomenon has developed in earnest only recently, little specific substantive law has been forged yet in this area. (^) Nonetheless, certain precautionary legal measures are advisable, and recommendations in this regard have been laid out elseWhere (Kapp 1984).
is followed by specific attention first to the matter of residents' rights and then to the question of decisionmaking for nursing home residents. Finally, some modest speculation about the future of nursing home law is offered. OVERVIEW OF NURSING HOME LAW Sources-of-Nursinx-Home Law Legal regulation of nursing homes derives from a variety of sources (Grimaldi, 1984). (^) We utilize for this purpose state licensure statutes and reimbursement (primarily Medicare and Medicaid) certification requirements and surveys of both state and federal government (20 Code of Federal Regulations Part 405). Facilitie0 Seek Veldittary forms Of accreditation from private agencies such as the Joint Commission on Accreditation of Hospitals (Joint Commission of Accreditation of Hotpitals, 1986), whose guidelines are frequently relied on by courts as legally enforceable industry standards. (^) Internal and external utilization and quality assurance
Mechanisms bave proliferated. (^) Several crislinal prosecutions against nursing tones and their staffs bave emerged in the last few years (Menne, 1984). Finally, end of growing importance in the long term care setting (Tapp, 1986; Tapp, 1987), there is tbe professional liability or malpractice claim. This is the individual civil lawsuit brought by or ior an individual nursing home resident against one or a combination of institutionalor individual providers. Theories of Liability The overWheiming majority of eases alleging nursing home wrongdoing fall on the civil (as opposed to criminal) side of the law. There are three primary areas of potential civil liability for nursing home nalpractice (Douglas, Feinberg, Jacobson, et al., 1985): (1) Failure to obtain effective consent before intervening in the life of a resident; (2) breach or violation a a contract or promise; and (3) the rendering of substandard, poor quality resident care. Although tbese three legal theories are analytizally distinct (that is, any one by itself may support a successful malpractice claim if properly substantiated), in actual practice, allegations regarding two or more of these grounds are frequently cited in combination by the plaintiff in the complaint against the ecregiver. The let=i implications of informed consent are mentioned later in this zhapter. We focus in this section, therefore, on the iegal principles surrounding nalpractice lawsuits tbat are grounded on a claim of substandard care (nbich is tbe basis for most resident claims) or breach of premise. A civil lawsuit predicated on the violation of some duty arising from a source other than a promise is called a tort. (^) A tort may be either an intentionally committed or an unintentional, accidental wrong. (^) The nost common sorts of intentional torts in the nursing tome environment are fraud
writing. (^) Lawsuits baeed on these types of promise 'have been rare in the nursing hose context. However, the variety of provider promises commonly found in the written Admission Agreements that are prevalent in nuraing hoses (Brown, 1985; Harris, 1986; Leonard, 1982), as well as in advertisements and distributed informational and promotional materials, provide the aggrieved resident with a fertile source of potential breach of contract claims. number of implied promises may be teased out of any health cart provider/patient relationship. (^) Host important, and always present, is the provider's implied promise or warranty to use due or reasonable care under the circumstances in rendering services to the patient (Brown, 1975; Regan, 1979). A. malpractice lawsuit, thus, may be brought on an intentional or unintentional (negligent) tort basis, a contractual basis, or both bases simultaneously. In^ other^ words,^ a^ plaintiff^ may^ plead^ (make^ formal accust,tions of) malpractice ex delicto (based on the wrong) or ex contractu (based on the promise), or both.
A variety of parties form a variety of relationships with nursing home residents, and consequently owe certain responsibilities to those residents for Which the parties may be held legally liable. These parties may include: (^) (1) employees or volunteers of the nursing home, (2) governing board Members (Bird, 1983), (3) physicians and other independent health professionals (e.g., podiatrists and dentists) with admitting and/or treatment privileges in the facility, (4) laboratories, pharmacies, and other independent corporations with which the nursing hone contracts for
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goods and services, (5) students Who are placed within the nursing home for learning experiences, and (6) tile nuvaing home itself. In a malpractice lawsuit initiated by or on behalf of a resident, it is conceivable that any or all of these parties might end up being named as defendants (either by the plaintiff in the original complaint or by the original defendants in a cross-complaint). (^) /n this context, a party way be exposed to potential liability, depending on the facts, either (I) personally, (2) vicariously, or (3) corporately. Personal liability is the doctrine that holds an individual responsible for What he or she personally does or does not do. (^) Each of us may be held accountable for our own acts or omissions. (^) For example, a physician who prescribes the wrong drug or dosage for a resident may be found personally lieble for that wrongful act (assuming that it directly resulted in injury). In addition to (not in place of) claims that may arise from an individual's personal conduct, that individual's supervisors and the nursing home itself may also face vicarious liability for the individual's misconduct. Under the principles of "agency," Which is the part of contract law that embodies the concept of "master" (employer, supervisor, principal) and "agent" (employee, supervise; agent); a "master" is civilly liable for injuries to the person or property of third persons occasioned by the tortious.negligenze of a "servant" that occurred within the scope of that "servant's" employment or responsibilities. (^) This doctrine is referred to as "respondeat superior." The vicarious liability doctrine applies with full force in the healtn care context generally (Ring, 1986; Richards arid Rathbun, 1983); and regarding nursing homes particularly (Goldberg; 1983); (^) Hence, if an agent
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nursing home's own direct liability to an injured resident rests on the theory of corporate or institutional litdsility (Frantz, 1978; Davidson, 1971). The corporate or institutional liability theory imposes on a nursing home a variety of specific duties. The basic categories into Which these duties fall include (Peters and Peraino 1984; Southwick, 1978):
privileges; and (c) the duty to conduct ongoing assessments of their Physicians' competence and performance (Goldberg, 1984). RZSIORRTS RIGHTS As explained earlier, legal liability may occur When a nursing home violates a responsibility that it awes to a resident. Every nursing tome bas a responsibility to respect and protect the rights of all of its residents, and to develop and implement policies and procedures that ensure the protection of those rights, consistent with the protection of the rights of others and the operation of a safe and caring health care facility (Harris, 1985). Sources-of-Itiehts Resident rights, and accompanying nursing home obligations, derive from several legal. sources. Among the most important of these sources is the
case decisions, based on our society's history, culture, and values. (^) Common law principles have evolved in the United States to protect and promote respect for the autonomy, integrity, self-determination, and dignity of all individuals, including (perhaps especially) vulnerable nursing home residents, and imposing a responsibility on those in a fiduciary relationship to fulfill those rights. Another major source of nursing home resident rights is specific statutes (laws promulgated by administrative or executive agencies, sueh as health department). (^) Applicable statutes and regulations are in force on both the federal and state levels. On the federal level, regulations called the Conditions of Participation set minimum requirements for all Skilled Nursing Facilities that receive financial reimbursement from the Hmdicare (Title 18 of the
violations of ;one's constitutional rights Where the violations occur "under color of state law" (Regan, 1977). An increasing number of lawsuits by or for residents may be based on this ground. Resident rights may also emanate from obligations that the nursing home voluntarily agrees to undertake as conditions of the admission agreement made between the nursing home and the resident. This is a contractual source of resident rights. Standards of the Joint Commission on Accreditation of Hospitals may also serve as the source of resident rights. As a requirement for JCAH accreditation (Which is voluntary), compliance with the resident rights section of the JCAH Accreditation Manual for Long Term Care Facilities is mandatory. In^ a^ lawsuit^ brought^ against^ a^ JCAH-accredited^ nursing^ home,^ a resident may introduce at trial as evidence of the applicable legal standard of care a copy of the JCAH provisions that the nursing home voluntarily agreed to obey. Finally, voluntarily-adopted, written internal institutional policies and procedures regarding resident rights and grievance/complaint resolution (American Health Care Association, 1981; Phillips, 1980; Wilson, 1978) may be used as evidence to help prove the professional standard of care to Which the nursing home and its staff should be held answerable. (^) Once a nursing home has agreed to live by certain rules--even if those rules are internally
to expect that the rules will be followed and the opportunity to seek redress When they are not. Substantive-Provisions Specific resident rights protections may vary from jurisdiction to jurisdiction and facility to facility, depending on the particular
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applicability of the sources of rights that are discussed above; One must become thoroughly familiar with the specific provisions in force in any nursing tome with Which that person is affiliated. Despite some variability, the fundameeal types of resident rights that any nursing home in the United States today must honor may be roughly catalogued into these basic categories (Buford, 1964): --The right to be treated fairly, witaout discrimination --The right to voice concerns awl to have complaints resolved ==The right to be informed of costs and charges (Caldwell and Kapp,
--The right to be informed about, and to participate in, decisions about care and treatment to choose the source of services and supplies to manage personal financial affairs not to be unfairly transferred or dischaiged to be free from unreasonable restraint to privacy, including privacy with a spouse or other sexual (Seyle, 1985) not to be required to perform services to communicate and associate with others to use personal clothing and keep personal possessions
--The right -7-=The right --The right --The right --The right partner --The right --The right --The right (Timmreck, 1983) --The right to participate in a Resident Council .--The right to be treated Nith respect and dignity =-The tight not to have confidential informatiOn revealed
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residents (Goldberg, 1983). Requirements concerning informed consent for nursing home residents stem not only from common law court decisions, but alas) from federal and state statutes and regulations and various voluntary guidelines. The first requirement for a valid legal consent is that the resident's participation in the decisionmaking process and ultimate decision must be voluntary. The usual definition of voluntariness in th c. context of consent is that the person giving or withholding consent must be "so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion" (Turnbull, 1977). It means simply that the person must be free to reject participation in tte proposed intervention. The nursing home must do all that it can to minimize any coercion inherent in the facility/resident relationship, and to make sure that advice and recommendations are transmitted to the resident in as nonpressured and empathetic a manner as possible. Such a practice best respects the dignity of the resident as a human being, promotes the therapeutic value of the alternative selected, and protects the legal flanks of the nursing home and its professional staff. The second essential requirement for valid consent is that the resident's agreement be informed. The legal doctrine of informed consent requires that the service provider, before undertaking an intervention, disclose certain information to the individual wbo is the subject of the proposed intervention. The disclosure standard currently enforced in the majority of American jurisdictions is referred to as the "professional," "reasonable physician" (Rosoff, 1981; Rozovsky, 1984), or community" (Christoffel, 1962)
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amount and type of information that a reasonable, prudent health care professional would hive disclosed under siMilar circumstances. A growing, although slowing (LeDlang, 1983), minority of jurisdictions have accepted a more expansive standard of information disclosure: (^) the "reasonable patient" or "aaterial risk" standard (Hiller, 1980; Rosoff, 1981; Rozovsky, 1984). This standard dictates that the health care professional communicate the information that a "reasonable patient" in the same situation would need to make a voluntary and intelligent decision.
is, those factors that might make a difference to a reasonable, average resident under similar circumstances. The age of a resident may be relevant in affecting what information is material to that resident's decisionmaking (Schwartz, Nathanson, Hardwick, et al., 1984). For instance, a likely side effect that will not manifest itself for another twenty years probably will not be very important to an older person. However, the probability that a particular intervention will be accompanied by a great amount of physical pain or discomfort may make quite a difference to an old, frail nursing home resident. (^) Physicians and other health care professionals should always consider the physical and mental effects of aging, among numerous other factors, When deciding whether information regarding an intervention might be material to the specific individual. Within these standards of disclosure, the specific informational items have usually been enumerated as follows (Gregory, 1981): (^) (1) Diagnosis; (2) Nature and purpose of the proposed intervention; (3) Risks, consequences, or
Where resident rights are assiduously respected, may--simply by virtue of being a total institution--exert a debilitating influence on the resident's sense of control (White and Janson, 1985). The combination of illness and institutionalization may substantially impair the ability to make and cowmunicate autonomous choices on important matters. Legal competency refers to a relative, rather than an absolute, degree of ability scale (Tepper and Elwork, 1984). To say that a person is legally incompetent implies that the individual is below some minimum level of capacity and rage of opportunity, and not simply that the person has less capacity and opportunity than certain other people (Miller, 1982). While courts generally (in the minds of critics of the guardianship system too routinely) grant petitions for appointment of substitute decisionmakers for elderly nursing home residents (as well as older community-dwellers), in seriously contested cases there is a strong judicial preference for and deference toward letting older persons make and live (or die) With their own decisions (Douglas. Feinbert, Jacobson , et al., 1985). However, the great majority of situations Where the decisionmaking capacity of a resident is called into question is handled on a de facto rather than de jure basis. That is, aost such cases are quite properly--and without adverse legal consequences--managed by the nursing home, usually in conjunction with'the family, without formal court involvement in deciding and acting upon the resident's decisionmiking impairment. In most circumstances, competency should be addressed as an ethical matter by those Wu, are closest to the resident, and resort to the courts is neither necessary nor desirable, since it is expensive, time-consuming, and emotionally draining. Initiation^ of^ judicial^ involvement^ in^ competency determinations should be the exception instead of the rule. It will depend
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on a variety of factors in any case, but elements that might point toward the adVitibility of advante formal legal clarification include (4n6rican Hospital Association, 1985): (1)^ the^ incapacity^ is^ great^ and^ likely^ to^ be prolonged, and there is no obvious surrogate; (2) the capacity of the resident is questionable, and the decision to be made is significant; (3) the views of the surrogate are strongly at variance with medical judgment or the resident's known views; or (4) the choice of the individual to serve as surrogate is controversial and all efforts to resolve the matter at the nursing home level have failed; and (5) family panthers radically disagree about the course of action for a resident Who lacks adequate decisionmaking capacity. In some situations, such as the resident in a 1Ing-term coma or a persistent vegetative state (PVS), the determination of incompetence is fairly straightforward. In most circumstances, though, clinical presentations of potential incompetence are more cloudy: transient incapacity, due to acute illness or medication side-effects; nental retardation; mental illness or emotional preblems; or physical handicap (Hunetz, Lidz, and Meisel, 1985). Ruch more is entailed in determining legal status than simple diagnostic labelling of a clinical condition. There exists no single, uniform standard of competence. (^) Instead, competence to engage in decisionmaking has been only rarely and vaguely defined in statutes and court decisions. In daily practice, it I. frequently the attending physician acting alone, in his or her sole discretion, Who decides When a person is not capable of making decisions and a substitute should be involved, without any explicit standards for that determination being employed;