our hands are tied

4
Our Hands Are Tied: Legally Induced Moral Tensions in Health Care Delivery MARSHALL B. KAPP, JD, MPH LAWYERS and the legal system tend to get blamed for many of the vicissitudes of contemporary health care decision making. One frequently hears the lament that binding legal dictates (that is, the need for providers to avoid litigation and liability) often act in opposition to good clinical judgment, accepted principles of medical ethics, and cost-containment precepts--in other words, that the law frequently compels certain deci- sions and decision-making processes that are inconsist- ent with the preferences and best interests of patients and society. To take one frequently cited example, health care providers sometimes express reluctance to discontinue life-sustaining medical interventions for critically ill patients out of fear of possible criminal, civil, or regulatory sanctions, even where there is vir- tually universal agreement that continued treatment is nonbeneficial and that its limitation would be consist- ent with sound clinical judgment, cost-efficiency, and ethical precepts of autonomy, beneficence, and non- maleficence. Another illustration is the widespread use of physical restraints in long-term care facilities, where many staff refer to potential lawsuits connected with patient falls or wandering as the sole reason for contin- uing to tie people down routinely, despite mounting evidence of the clinical, economic, and ethical perver- sity of this practice in most cases. The aim of this article is a critical examination of the "our hands are tied" syndrome, not for the purpose of defending lawyers and the legal system, but rather to place in some realistic perspective the impact-- actual and ideal m of legal principles on modern medical de- cision making. To what extent is the law inconsistent with good clinical judgment, ethics, and economic considerations, and what can be done about real incon- sistencies? To what extent is it perception of the law that must be corrected? Before trying to chisel away at these questions directly, several caveats are in order. First, exactly what constitutes good clinical treat- ment, ethical conduct, or economically optimal prac- tice in any particular case often is far from clear, and we should not complacently assume that such clarity exists. In terms of availability and interpretation of rele- vant scientific data (e.g., about clinical prognosis or the effectiveness of particular treatments), as well as the application of ethical values (e.g., autonomy versus Receivedfrom the Department of CommunityHealth, P.O. Box 927, Wright State University School of Medicine, Dayton, Ohio 45401-0927. Sponsored in part by a grant from the Commonwealth Fund. Address correspondence and reprint requests to Mr. Kapp. beneficence for a patient making a "bad" decision), strong disagreements among participants often surface over the best course of action, totally apart from any legal consideration. In these situations, resort to real or perceived legal requirements may be brought in to help resolve, rather than exacerbate, those disagreements. Further, the impacts of factors such as defensive medicine and cost-containment strategies on the qual- ity and availability of health services are subject to wide, disparate interpretations. What passes for data in this area is more often than not a conglomeration of anecdotes. In a related vein, a comparative look at other devel- oped nations reveals that many of the difficult issues confronting the American health care system, such as decision making for mentally incapacitated patients, especially near the end of life, or the spectre of health care rationing, are also debated hotly and agonized over abroad. Concern with these dilemmas exists in many nations (e.g., England, France, Canada) where the lia- bility climate is quite different (i.e., reduced) from that in the United States and where fear of legal repercus- sions cannot reasonably be blamed for the perplexing nature of the issues. A comparative perspective rein- forces the notion that the kinds of questions increas- ingly beguiling health care providers, consumers, fami- lies, and society in the realm of health care choices are, at their hearts, difficult ethically and clinically regard- less of what the law may or may not have to contribute to their analysis. To the extent that medical treatment dilemmas are more charged in the United States than elsewhere, the fault may lie less in our legal system than in the propen- sity of different private advocacy groups to try to con- trol or determine medical choices to serve their own social visions. Groups as disparate as the Pro-Life lobby and the American Medical Association, while decrying alleged abuse of the legal system by others, have vigor- ously pursued legal remedies and fostered governmen- tal intrusion themselves to try to effectuate their own philosophies. Third, a certain degree of tension engendered by real or perceived inconsistencies between legal, ethi- cal, clinical, and economic considerations may be healthy. One party's problem (e.g., the economic pres- sure to discharge a patient from the hospital earlier than the physician would clinically prefer) may be another party's solution (e.g., the government's need to contain costs). Forcing health care providers to walk a tight- rope balancing a variety of competing concerns may 345

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Page 1: Our hands are tied

Our Hands Are Tied:

Legally Induced Moral Tensions in Health Care Delivery

MARSHALL B. KAPP, JD, MPH

LAWYERS and the legal system tend to get b lamed for many of the vicissitudes of contemporary health care decision making. One frequent ly hears the lament that binding legal dictates (that is, the need for providers to avoid litigation and liability) often act in opposi t ion to good clinical judgment, accepted principles of medical ethics, and cost-containment p r e c e p t s - - i n other words, that the law frequent ly compels certain deci- sions and decision-making processes that are inconsist- ent with the preferences and best interests of patients and society. To take one f requent ly ci ted example, health care providers sometimes express reluctance to discontinue life-sustaining medical interventions for critically ill patients out of fear of possible criminal, civil, or regulatory sanctions, even where there is vir- tually universal agreement that cont inued treatment is nonbeneficial and that its limitation would be consist- ent with sound clinical judgment, cost-efficiency, and ethical precepts of autonomy, beneficence, and non- maleficence. Another illustration is the widespread use of physical restraints in long-term care facilities, where many staff refer to potential lawsuits connec ted with patient falls or wandering as the sole reason for contin- uing to tie peop le down routinely, despite mount ing evidence of the clinical, economic, and ethical perver- sity of this pract ice in most cases.

The aim of this article is a critical examination of the " ou r hands are t ied" syndrome, not for the purpose of defending lawyers and the legal system, but rather to place in some realistic perspect ive the i m p a c t - - actual and ideal m of legal principles on modern medical de- cision making. To what extent is the law inconsistent with good clinical judgment, ethics, and economic considerations, and what can be done about real incon- sistencies? To what extent is it percept ion of the law that must be corrected? Before trying to chisel away at these questions directly, several caveats are in order.

First, exactly what constitutes good clinical treat- ment, ethical conduct , or economical ly optimal prac- t ice in any particular case often is far from clear, and we should not complacent ly assume that such clarity exists. In terms of availability and interpretat ion of rele- vant scientific data (e.g., about clinical prognosis or the effectiveness of particular treatments), as wel l as the applicat ion of ethical values (e.g., au tonomy versus

Received from the Department of Community Health, P.O. Box 927, Wright State University School of Medicine, Dayton, Ohio 45401-0927.

Sponsored in part by a grant from the Commonwealth Fund. Address correspondence and reprint requests to Mr. Kapp.

beneficence for a patient making a " b a d " decision), strong disagreements among participants often surface over the best course of action, totally apart from any legal consideration. In these situations, resort to real or perce ived legal requirements may be brought in to help resolve, rather than exacerbate, those disagreements.

Further, the impacts of factors such as defensive medicine and cost-containment strategies on the qual- ity and availability of health services are subject to wide, disparate interpretations. What passes for data in this area is more often than not a conglomerat ion of anecdotes.

In a related vein, a comparative look at o ther devel- oped nations reveals that many of the difficult issues confronting the American health care system, such as decision making for mental ly incapacitated patients, especially near the end of life, or the spectre of health care rationing, are also debated hotly and agonized over abroad. Concern with these dilemmas exists in many nations (e.g., England, France, Canada) where the lia- bility climate is qui te different (i.e., r educed) from that in the United States and where fear of legal repercus- sions cannot reasonably be blamed for the perp lex ing nature of the issues. A comparative perspect ive rein- forces the notion that the kinds of questions increas- ingly beguiling health care providers, consumers, fami- lies, and society in the realm of health care choices are, at their hearts, difficult ethically and clinically regard- less of what the law may or may not have to contr ibute to their analysis.

To the extent that medical t reatment dilemmas are more charged in the United States than elsewhere, the fault may lie less in our legal system than in the propen- sity of different private advocacy groups to try to con- trol or determine medical choices to serve their own social visions. Groups as disparate as the Pro-Life lobby and the American Medical Association, while decrying alleged abuse of the legal system by others, have vigor- ously pursued legal remedies and fostered governmen- tal intrusion themselves to try to effectuate their own philosophies.

Third, a certain degree of tension engendered by real or perceived inconsistencies be tween legal, ethi- cal, clinical, and economic considerations may be healthy. One party's problem (e.g., the economic pres- sure to discharge a patient from the hospital earlier than the physician would clinically prefer) may be another party's solution (e.g., the government 's need to contain costs). Forcing health care providers to walk a tight- rope balancing a variety of compet ing concerns may

345

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346 Kapp, OUR HANDS ARE TIED

sharpen and invigorate analytical skills, compel bet ter communica t ion within the health care team and be- tween the team and patient, encourage fuller explora- t ion and deve lopment of alternatives, and otherwise dispel some of the intellectual sloppiness that might creep into the health care decision-making process in the absence of such tension.

Having laid the groundwork, I will now at tempt to shed light on the issues posed earlier by examining the interaction of law, ethics, clinical judgment, and fi- nances in a couple of specific contexts.

TREATMENT DECISIONS FOR THE CRITICALLY ILL

One area in which clinically and ethically con- traindicated behavior sometimes occurs is decision making regarding the initiation, continuation, with- holding, or withdrawal of life-sustaining medical inter- ventions for critically ill patients. Out of a magnified anxiety about liability, health professionals may engage in the cont inued provision of aggressive, expensive treatment for critically ill patients even in circum- stances where the patient (if mental ly and physically capable of expressing a preference) and /or familywish treatment to be l imited and where, in the physician's reasonable medical judgment, cont inued treatment is likely to be nonbeneficial medical ly for the patient. Institutional ethics committees and ethics consultants sometimes behave more like risk managers than facili- tators of a sound moral decision-making process. The r e s u l t - - a n unwanted, futile, wasteful expendi ture of health resources, at least until the patient or family goes through the time, expense, and turmoil of obtaining a court order authorizing the limitation of t reatment m violates the decisional autonomy of the patient and family, nei ther benefits the patient nor protects him or her against harm, and maldistributes scarce resources.

The recent Linares tragedy I in Chicago illustrates the point. In that case, the parents of a hopelessly dying newborn were denied their request to wi thdraw artifi- cial life-sustaining medical technology due to exces- sive aversion to potential legal risk on the part of the hospital, resulting in the patient 's father's removing the machinery himself while holding hospital staff at gun- point. There, provider behavior based mainly on imag- ined, hypothet ical legal demons rather than a realistic, pragmatic appraisal of actual legal exposure inspired the providers to behave in a manner that contradicted the ethical interests of the patient and family, the hospi- tal itself and its medical and nursing staffs, and society.2

Health professionals who deal first-hand with these difficult situations are ethically obligated to act not just in accordance wi th a proclivity to anticipate every hypothetical scenario that, in the wildest dreams of a plaintiff 's attorney, might provoke litigation, but also in consideration of the ethical and financial inter-

ests of all involved parties, including the health care providers themselves. In turn, this requires that a num- ber of pragmatic questions be asked.

What is the realistic l ikel ihood of criminal prose- cut ion if medical t reatment is wi thheld or withdrawn? 3 Similarly, what is the actual probabil i ty of civil liabil- ity, or even litigation, in such cases? Assuming agree- ment among participants on the preferences of the pa- t ient or, alternatively, on what consti tutes the best interests of the patient under the circumstances, from whom do health professionals fear legal reprisal in the absence of preempt ive resort to the courts? The patient? The family that has agreed, or even requested, that treatment be abated? What is the legally compensable damage or injury in such cases, and where is the persua- sive proof of proximate causation? 4

Provider behavior that confounds the patient 's and family's ethical interests in autonomy, beneficence, and nonmaleficence, as wel l as society's interests in a just distribution of resources, would be problem enough. To compound the error, hyperconservatism in this realm also often overlooks the increasingly sub- stantial legal and financial risks to the provider running in the other direction, that is, the legal and financial risks attaching to the violation of patient or family au- tonomy, beneficence, or nonmaleficence. In several recent cases, courts have authorized the awarding of monetary damages to families against health care pro- viders for the infliction of unwanted medical treat- ment.5, 6 The filing of more such claims in the future is likely. 7 In other cases, courts have begun to excuse families and patients (and their estates) from financial responsibili ty for medical t reatment to which they ob- jected. 8 We ought to impose an affirmative obligation on providers to demonstrate the existence of informed, voluntary, and competen t consent as a necessary pre- condit ion to payment for any medical service. 9

Although some would likely disagree and prefer to cling to their comfortable paranoia, 1° the bet ter argu- ment is that, even if minimization of legal and financial loss were the sole criterion, a more realistic and prag- matic assessment of relative risks should suggest greater deference to patient and family values regarding the aggressiveness of medical treatment near the end of life. Respect for the ethical pr inciples of autonomy, beneficence, nonmaleficence, and social justice are in accord. Conversely, provider behavior that contravenes these ethical principles ironically increases, rather than diminishes, the very risks sought to be control led.

PHYSICAL RESTRAINTS IN NURSING HOMES

In long-term care facilities, the commonplace use of physical restraint devices represents another exam- ple of inappropriately defensive conduct , based on a highly questionable interpretat ion of legal dangers. Again, overblown apprehension of litigation and liabil-

Page 3: Our hands are tied

JOURNAL OF GENERAL INTERNAL MEDICINE, Volume 6 (July/August), 1991 347

ity possibil i t ies encourages clinical prac t ice that vio- lates important ethical pr inciples while, paradoxically, ordinari ly increasing rather than diminishing the pro- viders ' actual legal exposure. 11

In the United States, physical restraints are used (and have been used for centuries) on nursing home residents at m u c h higher rates than occur in o ther na- tions, despi te substantial evidence of their dele ter ious effects on the residents ' physical and mental well- being. 12 Overuse of restraints, that is, their invocat ion in c i rcumstances where less restrictive alternatives are reasonably available to accompl i sh the legit imate goal of resident safety, violates the resident 's interests in autonomy, beneficence, and nonmalef icence.

However , many long-term care administrators and their medical and nursing staffs overr ide resident and family objections, or else accede automat ical ly to unin- formed family requests for the use of restraints wi thou t explor ing less intrusive alternatives. This represents, at least in part, a provider response to anxiety about liabil- ity exposure connec ted to resident injuries associated with falls or wandering. Provider pract ice that encom- passes routine, indiscriminate util ization of physical restraints, wi thout meaningful explora t ion of less re- strictive alternatives, at best misperceives the realistic relative legal risks involved. This mispercep t ion and related pract ice unfor tunately are often the result of hysterical, unreflective risk management advice prof- fered to the long-term care industry. 13"17

Research, as opposed to the mythology and gossip that somet imes infiltrate the health care del ivery envi- ronment , reveals that far more lawsuits are filed based on injuries occasioned by the inappropr ia te applica- t ion of restraints than based on failure to app ly re- s t ra ints) 8"2° (The numbers of cases are very small in both categories. 21 ) Even i fa lawsuit based on failure to restrain were filed, available defenses wou ld include compl iance with standards of care based on evidence rather than cus tom 22 and the resident 's or family 's in- formed assumpt ion of risk. Government regulations, par t icular ly new federal standards p romulga ted to im- p l emen t the Omnibus Budget Reconcil iat ion Act of 1987, also contain a p re sumpt ion against the use of restraints, wi th the burden on the institution to demon- strate the appropr ia teness of restraints in terms of needed (i.e., no reasonable alternative) pro tec t ion (i.e., benef icence and nonmalef icence) for the particu- lar resident during a specific t ime period. 23, 24

Thus, here, as in the preceding discussion, a realis- tic perspect ive on relative risks should favor a pre- sumpt ion against the rout ine use of restraints. The ethi- cal pr inciples of resident au tonomy and benef icence point in the same direction.

Furthermore, economic considerat ions are in agreement wi th this approach. Although many long- term care facilities hypothesize that reduced rel iance on the use of restraints wou ld necessari ly increase staff-

ing requi rements and hence inflate the cost of care, the exper i ence of facilities that have moved toward re- straint-free or restraint-reduced envi ronments has been overwhelming ly the opposi te . These providers have found that fewer restraints lead to a less agitated resi- dent popula t ion that can be managed successful ly wi th fewer, not more, staff; moreover , the t ime that staff would otherwise spend on the imposit ion, monitor ing, and correct ion of restraints is el iminated.

Current pract ice regarding the overuse of re- straints offends ethical sensibilities most of all w h e n it is fueled not by a sincere but misguided concern about risk management , but by the citation (consciously or subconsciously) of a legally defensive rat ionale as only a pre tex t for furthering the interests of under lying pro- fessional bias and administrat ive convenience . Espe- cially where the au tonomy and wel l -being of pat ients and families are at stake, heal th professionals have an ethical responsibi l i ty to guard against a t tempts to jus- tify (i.e., " o u r hands are t ied" ) conduc t that in fact is driven by unexamined professional prejudices about pat ient care or expl ici t or implici t administrat ive poli- cies grounded on management rather than resident in- terests. The ethical integrity of health care providers demands that their ul t imate p roduc t be good decisions and actions, not excuses.

GUIDELINES

These examples at least begin to scratch the sur- face in illustrating the m o d e m interact ion of legal, eth- ical, clinical, and economic considerat ions in heal th care. They have purpose ly been chosen to emphas ize that, in many situations, an accurate, realistic appraisal of legal risks points to the law's compat ib i l i ty wi th good clinical judgment , ethical principles, and desir- able economic incentive, and that the hands of the pro- vider and pat ient are not unduly " t i ed . " 25

Admittedly, this is not always the case. Indeed, there are cases where legal apprehens ion is justified and unreconc i led tensions exist and threaten to skew medical decision making to the pat ient ' s or society 's detr iment . A few guidelines may assist in such situations.

First, where unreasonable economic considera- tions stand in the way of sound legal, ethical, and clini- cal pat ient care, health professionals must learn to skillfully emp loy legal fears as a beneficial scapegoat to compe l administrators, trustees, and other private and publ ic pol icymakers to allocate resources appropr i - ately, even if involuntarily. Put differently, b lame fi- nancial needs on the lawyers, where such a c la im is true. The law should be p roud to serve this command- and-control role to ensure the vital e lements of quali ty and access in pat ient care.

Second, where the law is incompat ib le wi th ethi- cal, clinical, and economic considerations, its require-

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348 Kapp, OUR HANDS ARE TIED

ment s are sub jec t to change . The po l i t i ca l process is

capab le of r e s p o n d i n g to suff icient pressure , e spec ia l ly

w h e r e p r ed i ca t ed o n re l i ab le data and persuas ive argu- m e n t a t i o n . Hea l th profess ionals mus t be act ive in in- fo rming and i n f l u e n c i n g the p u b l i c and pr iva te deci- s ion -mak ing process to assure that laws are c l in ica l ly , e conomica l ly , and e th ica l ly sens ib le . It is impor t an t , t hough , that the po l i cy pos i t ions advoca ted by hea l th profess ionals be f ramed c lear ly in te rms of the e th ica l , med ica l , and e c o n o m i c in teres ts of i n d i v i d u a l pa t i en t s

and the genera l pub l i c , ra ther than (as has too of ten h a p p e n e d in the past) the f inancia l or admin i s t ra t ive in teres ts of hea l th care providers .

F ina l ly ( a l t hough this l i s t ing is ce r t a in ly no t ex-

haus t ive) , in f o rmu la t i ng dec i s ions bo th for i n d i v i d u a l pa t ien ts and in te rms of b roade r in s t i t u t iona l po l ic ies and p rocedures , legal cons ide ra t ions mus t be kep t in pe r spec t ive as o n l y one par t of a cons t e l l a t i on of factors to be taken in to accoun t , and they n e e d no t always

t r u m p all o the r factors. Certa inly, u n a m b i g u o u s legal dic ta tes (e.g., manda to ry r e p o r t i n g r e q u i r e m e n t s for specif ied med ica l c o n d i t i o n s ) may be v io la ted o n l y at

subs tan t ia l po ten t i a l p rov ide r per i l . However , r isk m a n a g e m e n t strategies for mos t s i tua t ions ar is ing at the e m e r g i n g in t e r sec t ion of l aw and m e d i c i n e gene ra l l y

o c c u p y s ignif icant gray zones of u n c e r t a i n t y and flexi- b i l i t y today, a l l owing for subs tan t ia l d i sc re t ion a nd m a n e u v e r a b i l i t y in risk m a n a g e m e n t strategies. These grey zones s h o u l d be i n t e r p r e t e d and m a n i p u l a t e d in a way that, w h e r e poss ib le and necessary, pe rmi t s ethi- cal, c l in ica l , and e c o n o m i c cons ide ra t ions to assume

p r i m a c y in the dec i s ion -mak ing process. The law, as the c u r r e n t exp res s ion of soc ie ty ' s

va lues and au thor i ty regard ing the t r e a tmen t of a spe- cific issue, may no t be ignored , b u t n e i t h e r s h o u l d it

au toma t i ca l l y dicta te disregard of o the r i m p o r t a n t sources of ou r values. It is the cons t e l l a t i on of va lues

f rom a b road range of perspect ives , l aw i n c l u d e d b u t no t a lone , that ough t to gu ide those w h o have unde r - t aken the awesome c l in ica l and e th ica l ob l iga t ions of

pa t i en t we l l -be ing .

REFERENCES 1. Miles SH. Taking hostages: the Linares case. Hastings Cent Rep.

Jul/Aug 1989; 19:4.

2. Nelson LJ, Cranford RE. Legal advice, moral paralysis and the death of Samuel Linares. Law Med Health Care. Winter 1989; 17:316-24.

3. Glantz LH. Withholding and withdrawing treatment: the role of the criminal law. Law Med Health Care. Winter 1987/88; 15:231-41.

4. Kapp MB, Lo B. Legal perceptions and medical decision making. Milbank, Q. 1986;64(suppl 2):163-202.

5. Estate of Leach v. Shapiro, 13 Ohio App.3d 393, 469 N.E.2d 1047 (1984).

6. Strachan v. John F. Kennedy Memorial Hospital, 109 N.J. 523, 538 A.2d 346 (1988).

7. Margolick D. Patient's lawsuit says saving life ruined it. New York Times. 1990 Mar 18:1.

8. Grace Plaza of Great Neck v. Elbaum, Index No. 19068/88, Supreme Court of Nassau County, New York, Memorandum Opinion IAS Part 20, January 9, 1990 (J. McCabe) (appeal pending).

9. Kapp MB. Enforcing patient preferences: linking payment for medical care to informed consent. JAMA. 1989;261:1935-8.

10. Could an ethics committee have prevented the Linares tragedy? Med Ethics Advisor. 1989 Jun 19:69-70.

11. Kapp MB. Statement (pp 28-32); and Prepared testimony (pp 203-10). In: Untie the elderly: quality care without restraints. Washington, DC: Symposium before the Special Committee on Aging, United States Senate, lOlst Congress, 1st Session. S. Prt. 101-90, Serial No. IO1-H. 1989 Dec 4.

12. Evans LK, Strumpf NE. Tying down the elderly: a review of the literature on physical restraint. J Am Geriatr Soc. 1989; 37:65-74.

13. Mettler D. Statement. In: Untie the elderly: quality care without restraints. Washington, DC: Symposium before the Special Com- mittee on Aging, United States Senate, lOlst Congress, 1st Ses- sion. S. Prt. 101-90, Serial No. 101-H. 1989 Dec 4:22-4.

14. Yob M. Use of restraints: too much or not enough? Focus on Crit Care. 1988;15:32-3.

15. Creighton H. Are siderails necessary? Nurs Management. 1982;13:45-8.

16. Regan W. Restrain as needed: nursing judgment required. Regan Rep on Nuts Law. 1982;23(3):4.

17. ReganW. Restraints and bedfalls: most frequent accidents. Regan Rep on Nurs Law. 1983;23(10):4.

18. Mion LC, FrengleyJD, Jakovcic CA, Marino JA. A further explora- tion of the use of physical restraints in hospitalized patients.JAm Geriatr Soc. 1989;37:949-56.

19. Lofgren RC, MacPherson DS, Granieri R, Myllenbeck S, Spratka JM. Mechanical restraints on the medical wards: are protective devices safe? AmJ Public Health. 1989;79:735-8.

20. Robbins LJ, Boyko E, Lane J, Cooper B, Jahnigen DW. Binding the elderly: a prospective study of the use of mechanical restraints in an acute care hospital. J Am Geriatr Soc. 1987;35:290-6.

21. Johnson SH. The fear of liability and the use of restraints in nursing homes. Law Med Health Care. Fall 1990;18:263-73.

22. Rubenstein HS, Miller FH, Postel S, Evans HB. Standards of medi- cal care based on consensus rather than evidence: the case of routine bedrail use for the elderly. Law Med Health Care 1983;11:271-6.

23. Federal Register. 1989 Feb 2;54(21):5363. 24. Code of Federal Regulations. Sec. 483.13. 25. Hudson T. Risk managers still building professionalism. Hospi-

tals. 1990;64:46.