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Terminating medical treatment: What risk managers need to know The following article was written by Colleen H. Petrello, R.N., I.D., staff attorney, St. Luke’s Hospital, Cleueland.

One can hardly pick up a publication without reading about termination of life support. Now that the U.S. Supreme Court has decided the Cruzan case, many articles are analyzing the deci- sion in terms of its impact on similarly situated patients. However, most articles in medical/legal and ethics journals appear to be opinion-oriented.

Although health care risk managers must be cognizant of current trends and opinions, it is more important that they know the applicable federal, statutory, and case law particular to the state in which their hospital is located. This knowledge is critical to formulating policies and procedures that are medically, ethically, and legally sound and can protect a hospital, its patients, and its health care practitioners.

of the questions left unanswered in court decisions such as the Cruzan case, the role of health care risk managers in developing their hospitals’ termination-of-treatment policies is gaining in importance. It proposes that federal, statutory, and case law provide a resource for risk managers to consult in developing those poli- cies, and makes recommendations for formulating such policies.

This article proposes that as a result

The Cruzan case

The much-publicized case of Crumn u. Director, Missouri Department of Health involved a young woman, Nancy Cruzan, who was left in a persistent vegetative state as a result of a car accident. She had been sus- tained for several years by feeding tube.

After the health care facility refused to disconnect her feeding tube with- out a court order, her parents attempted to seek such an order from Missouri’s trial court. The order was obtained; however, the state and Ms. Cruzan’s court-appointed guardian appealed the decision to Missouri’s Supreme Court, which held that there must be clear and convincing evidence that

the incapacitated person would have wanted treatment terminated. Because the court determined that the evidence did not reach a “clear and convincing” standard, it reversed the trial court’s ruling.

The Cruzans then took their case to the U.S. Supreme Court with support from such groups as the American Medical Association and the American Hospital Association. On June 25,1990, the U.S. Supreme Court, in a 5-4 decision, held that Missouri could require that a “clear and convincing” standard of evidence be met before treatment is withdrawn on an incompetent individual and that this procedural safeguard, given the consequences, was not unconsti- tutional (ref. 1).

What health care risk managers need to understand is that the actual holding in Cruzan-that it was not unconstitutional for Missouri to have a “clear and convincing” evidentiary procedural safeguard in place - applies only to Missouri.

Unfortunately, the Crtlzan decision did not address every issue regarding termination of treatment. The opinion raised as many questions as it answered. For example, how can a “clear and convincing” standard ever be met if the individual has never been competent or is a minor? What if no surrogate decision maker exists and the individual’s desires are unknown? To help address some of those issues, health care risk managers can look to state as well as federal legislation.

State law

Prior to Cruzan, many states had already addressed termination-of- treatment issues through some type of legislation, whether in the form of a living will, termination of treatment acts, or a durable power of attorney for health care. Since Crtlzan, other states are formulating, revising, or supplementing their legislation. Thus most states now have legislation addressing some aspect of this issue (ref. 2), or have bills pending before their legislatures (ref. 3 ) .

It is important for risk managers to be aware of activity in their own juris- diction, whether legislation actually exists or is proposed. To generate and review policies regarding withholding or withdrawing medical treatment, health care risk managers must know what their state statute permits and what it limits.

In states without an applicable statute (living will [ref. 41, durable power of attorney for health care), risk managers should contact their state’s hospital association to deter- mine whether such legislation has been drafted and is pending before the state legislature. The hospital association can provide useful infor- mation regarding the direction in which the legislation is going, as well as key points attempting to be passed. Risk managers can thus gain a head start in familiarizing themselves with new legislation for their state, which they can discuss with the hospital staff in preparation for eventual drafting and/or revising of existing policies.

Case law

In addition, risk managers should consult their state’s applicable case law, as well as trends in the case law of other jurisdictions, to gain perspec- tive as to how their state visualizes this issue. Following are some questions that may help in analyzing case law:

rn Has case law created an evidentiary standard in the state? (For example, Missouri has articulated a “clear and convincing” standard.) rn Has any of the state’s case law addressed a competent patient’s right to refuse treatment? Also, has there been any case law involving incom- petent patients? rn Have the courts articulated any tests (such as substituted judgment or best interest) that would be applied when the patient is incompetent? rn Is the state’s case law applicable to the risk manager’s particular county or city?

Because there are approximately only 75 to 100 reported opinions in

28 Perspectives in Healthcare Risk Management Fall 1991

termination-of-medical-treatment cases, many states have not had an opportunity to hear such cases. There- fore, risk managers need to be aware of current trends in case law from other states and jurisdictions. Although a state’s case law has no binding or legal effect outside that state, such cases can certainly be used to support a position taken when aparticular state cannot draw upon its own case law.

One source of such cases is a publi- cation by the Society for the Right to Die, entitled Right-to-De Court Deci- sions (volumes 1 and 2). Beginning with Quinlun, the first landmark case to address termination of medical treatment, that publication traces all termination-of-treatment cases.

Risk managers also should consult with attorneys knowledgeable in health care law. Different interpretations may be drawn from the language of judicial opinions, and it is essential that risk managers be aware of the various interpretations - especially the majority and minority opinions drawn from those interpretations - when formulating policies for their own facilities.

Federal law: The Patient Self- Determination Act

After extensive debate in the House and Senate, coupled with pressure from various interest groups, including the American Hospital Association and American Medical Association, the Patient Self-Determination Act (PSDA) was passed. It is actually a section of the Omnibus Budget Reconciliation Act of 1990, and is entitled “Medicare Provider Agreement Assuring the Implementation of a Patient’s Right to Participate in and Direct Health Care Decisions Affecting the Patient” (ref. 5 ) . As of this writing, the effective date of that section is December 1,1991.

The PSDArequires hospitals, nursing homes, home health agencies, and hospice programs to provide, at the time of admission, information to each adult patient regarding the patient’s right under state law (whether statutory or case law) to make deci- sions regarding medical care, including

the right to accept or refuse medical or surgical treatment and the right to formulate advance directives. The act defines advance directives as “a written instruction, such as a living will or durable power of attorney for health care, recognized under state law (whether statutory or as nxognized by the courts of the state) and relating to the provisions of such care when the individual is incapacitated” (ref. 6 ) . The law mandates that the health care provider’s written policies regarding the implementation of such rights be provided to each patient.

Further, the PSDA requires that the medical facility document in the patient’s medical record whether or not the individual has executed an advance directive. It prohibits the health care facility from conditioning the provision of care, or otherwise discriminating against an individual, based on whether or not the individual has executed an advance directive.

Finally, the act requires the medical facility to educate not only its staff but also the community regarding advance directives.

The Medicaid portion of the bill contains a section entitled “Require- ments for Advance Directives under State Plans for Medical Assistance” (ref. 7). Under that section, each state must develop a written description of its statutory and case law concerning advance directives for distribution by health care providers.

law (therefore, binding on all states) that specifically addresses the issues of advance directives and the patient’s decision-making capacity to terminate medical treatment. It affords pro- tection to individuals making such decisions as well as to those health care providers acting on the decisions made by individuals.

Recommendations for formulating policy

To date, the PSDA is the only federal

Once the risk manager becomes knowledgeable about provisions and limitations in state codes and case law regarding withdrawing medical treatment, he or she should address

the following issues (keeping in mind that by December 1, 1992, under federal law, health care providers must have policies in place):

Ascertain whether the hospital has a policy regarding withdrawal of medical treatment. If so, determine if it is consistent with the PSDA, appli- cable state and/or case law, and the state’s position on the issue.

In terms of systems, analyze what hospital departments need to be directly involved in ensuring compli- ance with the PSDA. (For example, who should initially ask patients whether they have an advance directive? Should that question be part of the nursing admission assessment, or should it be the admitting department’s task?)

Because federal law mandates that each state formulate a position on termination of treatment, determine whether the state’s hospital association has given any guidance on that position. Who should be contacted to obtain such information?

Ascertain whether the hospital has an ethics committee to review with- drawing treatment decisions. If so, is it aware of the current laws? Will the committee need to draft or update a terminal care policy?

Education is an integral element of the PSDA; the act specifies not only the audience, but also the breadth of the education to be provided. Risk managers must know what those pro- visions are and must see that education programs are implemented accordingly.

Conclusion

Risk managers must work with their institutions in formulating or updating termination-o f-medical-treatment policies to be in compliance with the new federal law by the end of the year. To do that, they must be aware of not only the specifics of the PSDA but also of their state law and applic- able case law. They must consult health care attorneys knowledgeable in statutory and case law for advice on interpretations and limitations. Well-drafted and carefully implemented

29 Perspectiws in Healrhcare Risk Managemenr Fall 1991

policies regardlng termination of treat- ment should decrease the frequency of situations and conflicts like the Cruzan case.

Withdrawal of medical treatment is a medical, legal, and moral issue, and will probably remain controversial for many years. Although there are still many unanswered questions, federal and state laws are providing direction. Termination-of-care policies need to be drafted and/or reviewed. The medical and nursing staff, as well as hospital administrators, must be edu- cated and updated on the continually changing trends regarding these very complex issues. Health care risk managers play a very significant role in these processes.

References

1. Cruzan v. Director, Missouri Department of Health, 310 S.Ct. 2841 (1990). 2. See Alabama Natural Death Act, Ala. Code $9 22-8A-1 to 22-8A-10; Alaska Rights of the Terminally I11 Act, Alaska Stat. $9 18.12.010 to 18.12.100; Alaska Statutory Form Power of Attorney Act, Alaska Stat. $5 13.26.332 to 13.26.353; Arizona Medical Treatment Decisions Act, Ariz. Rev. Stat. Ann. $8 36-3201 to 36-3210; Arizona Powers of Attorney Act, Ariz. Rev. Stat. Ann. 90 14-5501-59-5502; Arkansas Rights of the Terminally I11 or Permanently Unconscious Act, Ark. Stat. Ann. $0 82-3801 to 82-3804; Arkansas Rights of the Terminally I11 or Permanently Unconscious Act, 20-17-214; Cali- fornia Natural Death Act, Cal. Health & Safety Code $0 7185-7195; Cali- fornia Statutory Form Durable Power of Attorney for Health Care Act, Cal. Civil Code $9 2430 to 2444; Colorado Medical Treatment Decision Act, Colo. Rev. Stat. 0 15-18-101 to 15-18-113; Colorado Powers of Attorney Act, Colo. Rev. Stat. $ 3 15-14-501 to 502; Connecticut Removal of Life Support Systems Act, Conn. Gen. Stat. Ann. $8 19a-570 to 19a-575; Connecticut Removal of Life Support Systems Act, Connecticut General Stat. Q 19a-571; Delaware Death with Dignity Act, Del. Code Ann. tit. 16. $9 2501-2509;

District of Columbia Health Care Decisions Act, D.C. Code Ann. $0 6-2421 to 2430; Distria of Columbia Health Care Decisions Act, D.C. Code Ann. $0 21.2201 to 2213; District of Columbia Health Care Decisions Act of 1988, 11; Florida Life Prolonging Procedure Act, Fla. Stat. Ann. §§ 765.01 to 765.15; Florida Life Pro- longing Procedure Act, Fla. Stat. Ann. 0 765.07; Georgia Living Wills Act, Ga. Code Ann. $0 31-32-1 to 31-32-12; Georgia Durable Power of Attorney for Health Care Act, Ga. Code §§ 31-36-1 to 31-36-36; Hawaii Medical Treatment Decisions Aa, Haw. Rev. Stat. $5 327D-1 to 327D-27; Idaho Natural Death Act, Idaho Code 09 39-4501 to 39-4509; Illinois Living Will Act, 111. Ann. Stat. ch. l10.5, Q Q 701-710; Illinois Power of Attorney for Health Care Act, 111. Ann. Stat.

Indiana Living Wills & Life Prolonging Procedures Act, Ind. Code Ann. $0 16-8-11-1 to 16-8-11-22; Iowa Life- Sustaining Procedures Act, Iowa Code Ann. $0 144A.1 to 144A.31; Iowa Life Sustaining Procedures Act, Iowa Code Ann. 0 144A.7; Kansas Natural Death Act, Kansas Stat. Ann. $0 65-28, 101-128; Kentucky Living Will Act, Ky. Acts ch. 122; Kentucky Health Care Surrogate Act, ch. 123; Louisiana Life-Sustaining Procedures Act, La. Rev. Stat. Ann. $0 40:1299.58.1 to 40:1299.58.10; Louisiana Declarations Concerning Life-Sustaining Procedures Act, La. Rev. Stat. Ann. Q 40:1299.58.5; Maine Uniform Rights of the Termi- nally I11 Act, Me. Rev. Stat. Ann. tit. 18-A, $0 5-701 to 5-714; Maine Powers of Attorney Act, Me. Rev. Stat. Ann. tit. 18-A, Q 5-501; Maine Uniform Rights of the Terminally I11 Act, Me. Rev. Stat. Ann. tit. 18-A, Q 5-707; Maryland Life-Sustaining Procedures Act, Md. Health-Gen. Code Ann. $5-601-614; Maryland Durable Power of Attorney Act, Md. Est & Trusts Code Ann. $0 13.601 to 603; Minnesota Adult Health Care Decisions Act, Minn. Stat. $0 145B.01 to 345B.17; Mississippi Withdrawal of Life-Saving Mechanisms Act, Miss. Code Ann. $9 41-41-101 to 41-41-121; Mississippi Durable Power of Attorney for Health Care Act, Miss.

ch. 110 1/2, $0 804-1 to 804-ll;

Code Ann. 41-41-15; Missouri Life Support Declarations Act, Mo. Rev. Stat. $8 459.010 to 459.055; Montana Living Will Act, Mont. Code Ann. QQ 50-9-101 to 50-9-104,50-9-iii, 50-9-201 to 50-9-206; Nevada Withholding and Withdrawal of Life-Sustaining Pro- cedures Act, Nev. Rev. Stat. §§ 449.540 to 449.690; Nevada Durable Power of Attorney for Health Care Act, Nev. Rev. Stat. Ann. $0 449.800 to 449.860; New HampshireLiving Wills Act, N.H. Rev. Stat. Ann. ch. 137 H; New Jersey Act, N.J. Stat. Ann. 0 46:28-8; New Mexico Right to Die Act, N.M. Stat. Ann. $0 24-7-1 to 24-7-ll; New Mexico Right to Die Act, N.M. Stat. Ann. $9 45-5-501 to 45-5-502; New Mexico Right to Die Act, N.M. Stat. Ann. 0 24-7-9.1; New York Pub. Health Law $§ 2980-2994; North Carolina Right to Natural Death Act, N.C. Gen. Stat. $9 90-320 to 90-322; North Carolina Power of Attorney Act, N.C. Gen. Stat. $ Q 32A-8 to 32A-14; North Carolina Right to Natural Death Act, N.C. Gen. Stat. 0 90-322; North Dakota Uniform Rights of the Terminally I11 Act, N.D. Cent. Code $5 23.06.4-01 to 23.06.4-14; Ohio Power of Attorney for Health Care Act, Ohio Rev. Code Ann. $5 1337.ll to 1337.17; Oklahoma Natural Death Act, Okla. Stat. tit. 63, $0 3101-3lll; Oregon Rights with Respect to Terminal Illness Act, Or. Rev. Stat. §§ 97.050 to 97.090; Oregon Durable Power of Attorney for Health Care Act, Or. Rev. Stat. $0 127.505to 127.585; Oregon Rights with Respect to Terminal Illness Act, Or. Rev. Stat. Q 97.083; knnsylvania Durable Powers of Attorney Act, Pa. Stat. Ann. tit. 20, $3 5604 to 5607; Rhode Island Health Care Power of Attorney Act, R.I. Gen. Laws $9 23-4.10.1-2; South Carolina Death with Dignity Act, S.C. Code Ann. $5 44-77-10 to 44-77-160; South Dakota Durable Powers of Attorney Act, S.D. Codified Laws Ann. $8 59-7-2.1 to 4; Tennessee Right to Natural Death Act, Tenn. Code Ann. $9 32-11-101 to 32-11-120; Tennessee Durable Power of Attorney for Health Care, Tenn. Code Ann. tit. 34, ch. 6; Texas Natural Death Act, Tex. Rev. Civ. Stat. Ann. art. 4590h; Texas Durable Power of

30 Perspectiws in Healthcare Risk Management Fall 1991

Legal and ethical issues

Attorney for Health Care Act, Tex. Rev. Civ. Stat. art. 4590h-1; Texas Natural Death Act, Tex. Rev. Div. Stat. Ann., art. 4590h-4(c); Utah Personal Choice and Living Will Act, Utah Code Ann. $5 75-2-1101 to 75-2-1118; Utah Personal Choice and Living Will Act, Utah Code Ann. Q 75-2-1102(2); Vermont Terminal Care Document Act, Vt. Stat. Ann. tit. 18, $0 5251-5262 and tit. 13, Q 1801; Vermont Durable Power of Attorney for Health Care Act, Vt. Stat. Ann. tit. 14, $ 3 3451 to 3467; Virginia Natural Death Act, Va. Code QQ 54.1-2981 to 54.1-2992; Virginia Durable Powers of Attorney for Health Care Act, Va. Code $9 ll-9.1 to 11-9.4; Virginia Natural Death Act, Va. Code Q 54.1-2986; Washington Natural Death Act, Wash. Rev. Code Ann. Q Q 70.122.010 to 70.122.905; Washington Durable Power of Attorney Health Care Decisions Act, Wash. Rev. Code Ann. 11.94.010; West Virginia Natural Death Act, W. Va. Code 00 16-30-1 to 16-30-10; West Virginia Medical Power of Attorney Act, W. Va. Code $5 16-3OA-1 to 16-30620; Wisconsin Natural Death Act, Wisc. Stat. Ann. $0 154.01 to 154.15; Wis- consin Power of Attorney for Health Care Act, 1989 Wisc. Act. 100; Wyoming Act, Wyo. Stat. Q Q 33-22-101

3. For information regarding pending legislation involving advance directives, living wills, or health care power of attorney, contact your state hospital association. 4. It is important to realize that the absence of a living will statute does not necessarily invalidate such a document. A living will is a form of advance directive that embodies the person’s desires as to what medical care should or should not be under- taken. In such a situation, a living will provides at least some evidence of the patient’s desires, although that may not be enough to meet a “clear and convincing” standard. 5. 42 U.S.C. Q 1396. 6. 42 U.S.C. Q 1395(a)(3). 7. 42 U.S.C. 0 1395cc.

to 33-22-109.

in the practice The following article was written by Reinhard Priester, J.D., research associate, and Arthur L. Caplan, Ph.D., director, Center for Biomedical Ethics, University of Minnesota, Minneapolis.

Introduction

Historically, since the invention of the steam autoclave in 1880, hospitals themselves have processed and steril- ized for reuse nearly all medical and surgical equipment for in-house use, including glassware, surgical instru- ments, hypodermic needles, rubber gloves, and catheters. In-hospital sterilization became a cottage industry existing side-by-side with the sterile disposable industry. Except for con- sumables such as bandages and phar- maceuticals, “nearly everything else that could be sterilized in a steam autoclave was considered durable, to be processed and reprocessed in-house” (ref. 1).

With the plastics explosion in the 1950s, hospital supply companies switched from using glass, stainless steel, and other easily sterilized materials to plastics. The new products were abundant, reliable, and inexpensive - all prepackaged, pre- sterilized, and prelabeled “for single use only.”

Hospitals did not possess the tech- nology to resterilize those products and thus were forced to discard them after a single use. Moreover, the new disposables were less expensive than buying durable supplies and resteril- izing them for reuse (ref. 2). Manu- facturers and hospital suppliers also profited from the switch to dispos- ables-making and selling innumer- ably more devices.

tions thus combined to support the growth of disposable medical equip- ment. Soon, in addition to the common disposable items such as gloves, syringes, and surgical sponges, more sophisticated and more costly medical devices - including dialyzers, pace- makers, and orthopedic appliances - were manufactured for single use only.

However, by the late 1970s, hospitals

Economic and technical considera-

of reuse had obtained the technical capability to sterilize plastics. In light of this capability, as well as mountingenviron- mental and economic pressures, hos- pitals began exploring the cost- effectiveness - as well as the safety and reliability- of reusing and repro- cessing disposable medical equipment.

The Centers for Disease Control (CDC) distinguishes between critical devices (which enter the vascular sys- tem or any sterile area of the body), semicritical devices (which come into contact only with intact mucous mem- branes), and noncritical devices (which come into contact only with intact skin) (ref.3). The reuse of all types of disposable devices was explored, though the more critical the device, the greater the concern about the safety of reprocessing and reuse.

State-of-the-art of reuse

Reprocessing and reuse of disposables is common practice in both the United States and Canada, despite manu- facturers’ label instructions to the contrary. Most single-use products are made of the cheapest suitable materials, which are not tested for their ability to withstand reprocessing. An informal 1984 survey of health care professionals at a national con- ference disclosed that 79 percent reported the reuse of a wide variety of disposables (a total of 44 different medical devices) by the institutions with which they were affiliated (ref. 4). Hemodialyzers, catheters, and other critical devices were among the most commonly reused items. A 1986 survey of all Canadian hospitals found that 41 percent regularly reused a wide variety of disposable medical devices (ref. 5). In light of the widespread practice of reusing disposables, the distinctions among “durable,” “con- sumable,” and “single-use disposable” medical devices have become blurred (ref. 6).

Despite its apparent growing popu- larity, there are virtually no data on the safety and effectiveness of reusing disposables, except for hemodialyzers and supplies related to them (refs. 7, 8, 9), and, to a much lesser extent,

31 Perspectlvcs in Healthcare Ri9k Mmagernent FdI 1991