Ethics, Law, and Aging Review : Vol. 7: Liability Issues and Risk Management in Caring for Older Persons. 9780826114570, 0826114571

Citation preview

Ethics, Law, and

Aging Review Volume 7

Marshall B. Kapp, JD, MPH, FCLM, was educated at Johns Hopkins University (B.A.), George Washington University (J.D. With Honors), and Harvard University (M.P.H.). Since August 1980, he has been a faculty member in the School of Medicine at Wright State University, Dayton, Ohio, where he is the Frederick A. White Distinguished Service Professor in the Departments of Community Health and Psychiatry and Director of the WSU Office of Geriatric Medicine and Gerontology. He holds an adjunct faculty appointment at the University of Dayton School of Law. In addition to being admitted to practice law in a number of state and federal courts, he is also licensed as a Nursing Home Administrator in the District of Columbia. He is the author of a substantial number of published books, articles, and reviews.

Ethics, Law, and Aging Review Volume 7

Liability Issues and Risk Management in Caring for Older Persons

Marshall B. Kapp, JD, MPH, Editor

Springer Publishing Company

Volume 1-5 of Ethics, Law, and Aging Review, appeared as a biannual journal entitled the Journal of Ethics, Law, and Aging. These publications are available from the publisher.

Order ETHICS, LAW, AND AGING REVIEW, Volume 8, 2002, prior to publication and receive a 10% discount. An order coupon can be found in the back of this volume. Copyright ©2001 by Springer Publishing Company, Inc. All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Springer Publishing Company, Inc. Springer Publishing Company, Inc. 536 Broadway New York, NY 10012-3955 ISBN-0-8261-1457-1 ISSN-1076-1616 ETHICS, LAW, AND AGING REVIEW, is indexed/abstracted in Ageline, Cumulative Index to Nursing & Allied Health Literature, New Literature in Bioethics, Mental Health Abstracts, PsychlNFO & PsychSCAN, Social Planning/Policy & Development Abstracts, Social Work Abstracts, Sociological Abstracts. Printed in the United States of America by Sheridan Books.

Contents Contributors

vii

Acknowledgments

ix

Introduction

xi

Chapter 1.

Chapter 2.

Malpractice Liability Issues Associated With Caring for Older Persons Ronald W. Scott Risk Management, Health Care, and the Geriatric Patient Population Michael J. Bass

Chapter 3.

Medico-Legal Aspects of Hospital Siderail Use Elizabeth A. Capezuti and Julie A. Braun

Chapter 4.

Negotiated Risk Agreements: Opportunity or Exploitation? Keren Brown Wilson, Kenneth L. Burgess, and Mauro Hernandez

Chapter 5.

Chapter 6.

Chapter 7.

A Perfect Storm of Unlimited Risks for Florida Nursing Home Providers LuMarie Polivka-West, Howard Tuch, and Karen Goldsmith

1

11

25

59

81

Risk Management and Quality-of-Care Concerns in Long-Term Care Andrew Weinberg

101

Nursing Home Litigation: "The Good, the Bad and the Ugly" Lawrence A. Frolik

117

v

vi

Chapter 8.

Contents

Quality of Care and Quality of Life in Nursing Facilities: What's Regulation Got to Do With It? Marshall B. Kapp

133

Book Reviews

161

Bibliography: Medical Errors

165

Books Received

168

Index

171

Contributors

MichaelJ. Bass is an MD-JD candidate at Southern Illinois University. He received his BS from the University of Kentucky. During the summer of 2000, he was an intern at BJC Health System's risk management department in St. Louis, MO. He would like to recognize Drs. Susan and Alberto Vidal for their undying love and support. Julie A. Braun, JD, LLM, is the editor of the Elder Law Portfolio Series (Aspen Law & Business), co-editor of a nursing home litigation manual (Aspen), editorin-chief of the monthly Pharmaceutical and Medical Device Law Bulletin, co-chair of the American Bar Association Medicine and Law Committee, and former ViceChair of the ABA Seniors' Law Committee. She and co-author Elizabeth Capezuti are members of the Food and Drug Administration's hospital-bed work safety group and are co-investigators in a study exploring the medical and legal liability issues surrounding hospital-bed siderail use. Kenneth L. Burgess, JD, specializes in health care law as a member of the Hooper, Lundy & Bookman law firm in San Francisco. He serves as Legal Counsel to the Assisted Living Federation of America. Elizabeth A. Capezuti, RN, PhD, CS, FAAN, is Associate Professor and Independence Foundation/Wesley Woods Chair in Gerontological Nursing Scholarship at the Nell Hodgson School of Nursing, Emory University. She is also Associate Director for Nursing Science at the Emory Center for Health and Aging. Lawrence A. Frolik, JD, is Professor at the University of Pittsburgh School of Law. He has written, lectured, and consulted nationally and internationally regarding various aspects of elder law. Karen Goldsmith, JD, is a shareholder in the law firm of Goldsmith & Grout, P.A., Winter Park, FL. She received her law degree cum laude from the University of Florida in 1978, where she was designated Order of the Coif. She has practiced vii

viii

Liability Issues and Risk Management

primarily in the areas of health care, small business, and administrative law, and provides legal counsel to the Florida Health Care Association. Ms. Goldsmith serves as Chair of the American Health Care Association's Legal Subcommittee. Mauro Hernandez, BS, is a doctoral student at the University of California, San Francisco. He formerly served as Director of Public Policy for Assisted Living Concepts, Portland, Oregon. LuMarie Polivka-West, MSP (Urban & Regional Planning), is Director of Policy & Quality Assurance with the Florida Health Care Association and an adjunct faculty member in Urban & Regional Planning at Florida State University. She is the former Director of Licensure and Certification in Florida and former Medicaid Program Director in that state. Ronald W. Scott, JD, MSBA, MSPT, PT, OCS, is Director of the Department of Physical Therapy at Lebanon Valley College. He has extensive military and civilian experience in advising and representing health care providers, and has written and taught extensively about a variety of risk management topics. Howard Tuch, MD, is Director of Pain Management and Palliative Care Services for Genesis ElderCare. He is board certified in internal medicine and completed a fellowship in geriatric medicine at Johns Hopkins University School of Medicine. Dr. Tuch serves as a clinical consultant to the Florida Health Care Association and has reviewed numerous nursing home malpractice cases in Florida. Andrew Weinberg, MD, FACP, is Associate Professor of Medicine and Medical Director for Long-Term Care at the Wesley Woods Center, Emory University. He has written, lectured, and consulted extensively in the area of nursing home litigation and risk management. Keren Brown Wilson, PhD, is president of the Jessie F. Richardson Foundation, a non-profit organization in Portland, Oregon dedicated to research, education, and training in housing and long-term care. She is the founder and former Chief Executive Officer of Assisted Living Concepts in Portland, as well as Chair of the Assisted Living Federation of America.

Acknowledgments

Marshall B. Kapp, Quality of Care and Quality of Life in Nursing Facilities: What's Regulation Got to Do With It? originally appeared in 31 McGeorge Law Review 801 (2000) and is reprinted with permission of the McGeorge Law Review. All rights reserved.

ix

This page intentionally left blank

Introduction

mong health care and human service professionals, anxiety about potential adverse legal repercussions for actions taken or not taken in the course .of caring for patients/clients is real, strong, and powerful. Whether exaggerated or based on a realistic appraisal of the legal risks, the fears of liability that infect contemporary service providers in the United States often exert a powerful influence—sometimes salutary and sometimes deleterious—on the kinds and quality of care available to current and potential consumers. The legal anxiety factor applies with full force in the context of geriatric services, where concern about the filing of civil malpractice actions seeking substantial monetary damages for intentional or negligent wrongdoing is exacerbated by worries about other forms of legal penalties: possible criminal prosecutions, especially today brought under state resident abuse and neglect laws or federal antifraud and abuse statutes; regulatory sanctions, inflicting severe financial hardship, emanating from surveys for Medicare or Medicaid certification or facility/agency licensure; and the pressures of voluntary but economically essential accreditation programs that are continually becoming more demanding and punitive. Legal anxieties among those who care for older persons are fueled by a complex array of sources, including increasingly regular and politicized popular media portrayals of geriatric providers as, at best, mediocre and uncaring and, at worst, dangerously incompetent and malicious. The severe shortage of even minimally qualified individuals willing to work—let along stay in the same job for any appreciable length of time—as direct care staff in nursing facilities or home care agencies, along with tightening payment systems and a vigorously competitive provider marketplace, contribute to an uneasy professional climate in which liability concerns are one significant trouble spot. In this volume of the Ethics, Law, And Aging Review, a professionally distin-

A

xi

xii

Introduction

guished and diverse group of contributors aims to discuss, from their interesting respective vantage points, both the real and perceived legal liability context within which health and human service delivery to older persons presently takes place. The practical impact—benefits and costs—of litigious, legislative, and regulatory interventions on the quality of care and quality of life for recipients of geriatric services is evaluated. Perhaps most important, ideas about effectively reducing or managing legal risks and anxieties in a fashion that improves rather than detracts from patient care are set forth for geriatric professionals and their advisers and advocates. We commence with a primer by attorney/physical therapist Ronald Scott on malpractice, professional ethics, quality assurance, and risk management for clinical caregivers. Next are the reflections of MD-JD student Michael Bass, drawing significantly on his observations as a summer intern in the risk management department of a large academic medical center. This is followed by an in-depth medicolegal analysis by geriatric nurse Elizabeth Capezuti and attorney Julie Braun of one important aspect of clinical care that disproportionately affects older patients, namely, the use and abuse of hospital siderails. Assisted Living pioneer Keren Brown Wilson and colleagues Kenneth Burgess and Mauro Hernandez write perceptively about negotiated risk agreements as a strategy with liability and risk management implications in a rapidly emerging long-term care context that is still in the process of inventing and characterizing itself. LuMarie Polivka-West, Howard Tuch, and Karen Goldsmith use their extensive experience in educating and advocating for long-term care providers to dissect the turmoil that currently engulfs the nursing home industry in Florida, stemming mainly from a liability insurance crisis occasioned by a torrent of personal injury litigation brought in that state. These authors speculate about what the rest of the country should learn (and fear) from the present Florida situation. Moving from policy to practice, geriatrician Andrew Weinberg addresses liability and risk management concerns from his perspective as a seasoned nursing home Medical Director and attending physician. Law professor Lawrence Frolik next writes about the advantages and shortcomings of litigation as a strategy for achieving quality assurance in the long-term care arena. This analysis provides a logical segue into the final chapter, in which I award regulation a mixed grade as an effective strategy for promoting the quality of nursing home care and the meaningful exercise of older persons' rights as nursing home residents. This volume concludes with two short reviews of, respectively, a new book and a recent journal issue that relate to the volume's themes, as well as a bibliography encompassing recent literature on medical errors and a compilation of books received. Liability issues and risk management in caring for older persons is not an overexposed subject in the legal, ethical, medical, or gerontological literature. While anxieties run rampant among professionals and profoundly influence the shape and operation of the multifaceted system/marketplace that is supposed to provide health

Introduction

xiii

and human services to older patients/clients, careful and accurate analysis of the issues is rarely translated into practically useful advice for those who make that system/marketplace work and transmitted effectively to that audience. This volume hopes to make a meaningful stab at beginning to fill that void. Marshall B. Kapp Editor

This page intentionally left blank

Ethics, Law, and Aging Review, Vol. 7, 2001 © 2001 Springer Publishing Company

Chapter 1

Malpractice Liability Issues Associated With Caring for Older Persons Ronald W. Scott

eemingly, the United States is in a litigation crisis, characterized by a strong propensity on the part of its citizens to resort to litigation to resolve most everyday disputes. In fact, there are nearly 20 million new civil (private) lawsuits filed annually, adding to an already clogged litigation pipeline of tens of millions of existing civil and criminal lawsuits within the system. Added to the civil and criminal litigation caseload are millions of federal, state, and local regulatory agency administrative legal actions involving government, businesses, and individuals (Scott, 1997). Is there, however, a health care malpractice litigation crisis? While the effects of being a party to a health care malpractice lawsuit are potentially devastating in terms of time, monetary costs, and associated stress, the numbers of cases lodged by patients and clients against health care providers and organizations are relatively small—only about 30,000 to 50,000 per year. Health care providers and organizations prevail in a majority of those cases. Why is the United States so litigious? A widely variegated range of rationales have been proffered to explain this phenomenon. The United States is home base

s

1

2

Liability Issues and Risk Management

to seventy-five percent of the world's attorneys, and while ethical offenses such as barratry (solicitation) and champerty (fomenting litigation) are serious ethical offenses dealt with harshly by the legal system, even permissible attorney advertising and the strong zeal of attorneys for their clients' positions may inadvertently promote unnecessary litigation. Other rationales for the litigation crisis include: a strong national sense of consumerism; the contingent attorney-client fee system under which legal clients may have little or no monetary risk in pursuing their own lawsuits; and outright greed. Systematic measures, such as tort reform and sanctioning of attorneys and clients for pursuing frivolous lawsuits, may dampen the propensity to sue in the United States. Similarly, increasing resort by parties to disputes (including health care disputes) to alternative dispute resolution options employing facilitatory neutral third parties—mediation (conciliation) and (binding) arbitration—is also redirecting potential litigants away from the overburdened legal system for redress of perceived wrongs.

HEALTH CARE MALPRACTICE The traditional term for patient-health care provider care-related legal disputes was medical malpractice, which applied exclusively to malpractice lawsuits brought by patients against their physicians and surgeons. Today, however, a wider group of health care providers may be claimed against or sued in their own right by patients. Hence, the more expansive term "health care malpractice" (Scott, 2000a). These additional potential health care malpractice defendants include, among others, chiropractors, dentists, nurse practitioners, and physical and occupational therapists. Other primary care surrogates, especially including physician assistants, are legally agents or alter egos of the physicians whom they serve, and therefore are not normally claimed against or sued directly for their alleged health care malpractice. Mere patient/client injury or dissatisfaction with health care services does not give rise to legally actionable claims against health care providers and organizations. Patient injury can occur despite stellar care delivery, in the case of an expected and disclosed complication, or as a result of a non-actionable error in judgment, that is, a reasonable mistake. Instead, the law requires that, in addition to patient/client injury (psychological and/or physical), there also exist a legally recognized basis for liability imposition. Legally recognized bases for health care malpractice liability include: Professional negligence Intentional misconduct Breach of a therapeutic promise

Malpractice Liability Issues

3

Injury from abnormally dangerous clinical activities, and Injury from dangerously defective care-related commercial products. Each of these bases are discussed in turn below. Professional negligence is the most common alleged basis for health care malpractice liability. Professional negligence involves health care delivery that is objectively substandard. It is, in essence, legally actionable carelessness. Professional negligence entails care-related conduct (either an action or omission) that does not comport with minimally acceptable standards of practice for the defendant's health care discipline. The operant question in professional negligence health care malpractice cases is, Did the defendant's conduct comply with, or fall below, minimally acceptable practice standards? The question is always assessed retrospectively, that is, after patient injury and a claim or lawsuit have occurred. Since professional negligence is measured by the legal standard of care, evidence of the care standard for a given defendant's discipline is required for a decision. How is the standard of care established? In court, the legal standard of (health) care is normally established through the testimony of expert witnesses who opine on whether a defendant-health care provider's care of a plaintiff-patient met or fell below minimally acceptable practice standards. An expert witness is usually from the same discipline as a defendant, that is, physicians testify for and against physicians, physical therapists for and against physical therapists, and so on. In any case, all experts must be formally "qualified" through an open review of their credentials, to ensure that they have sufficient knowledge and experience to comment on the general standard of care for the treatment in issue. In many or even most cases, there is competing expert testimony in favor of both a patient-plaintiff and defendant-health care professional, so that a jury or judge, acting as fact finder, must reach an ultimate decision on culpability. Other sources for the legal standard of care include: respected peer-reviewed scientific journals, reference texts, and clinical practice guidelines and protocols. Health care professionals are urged not to refer to reference texts and journals as "authorities" in depositions or at trial, since this often triggers a legal maneuver carried out by trial attorneys to impeach (challenge the credibility of) expert witnesses who have unknowingly adopted the reference source as true in its entirety. A patient-plaintiff must prove professional negligence of a defendant-health care professional by a preponderance, or greater weight, of evidence in order to prevail at trial. Any trial decision may be subject to at least one level of appeal, and, depending on additional legal issues, to further state or federal court appellate procedures. The four requisite elements of proof for professional negligence include: duty, breach of duty, causation, and damages. A health care professional owes a special legal duty of care when he or she voluntarily agrees to care for, or undertakes the

4

Liability Issues and Risk Management

care of, a patient. A health care provider may refuse to accept a patient for care for any valid reason, including, for example, the geriatrician whose limited-scope practice disallows him or her from caring for pediatric patients. The four elements of patient-plaintiff proof for professional negligence are: 1. That the defendant health care provider owed a special legal duty of care toward the patient; 2. That the defendant-provider breached the duty owed by carrying out care in an objectively substandard manner; 3. That the breach of duty caused patient injury; and 4. That the patient is entitled to the award of money damages in order to be made as whole again as possible. In at least two circumstances, normal legal rules for when the special legal duty of care owed by providers to patients commences are modified. In cases involving patients presenting with life-threatening emergencies to a provider or facility, there exists since 1986 a legal duty, irrespective of a patient's ability to pay for services, to stabilize such patients before transferring them to follow-on facilities. It is because of the Emergency Medical Treatment and Active Labor Act (EMTALA, 1986), also called the federal "anti-patient-dumping" law, that emergency rooms in the United States are so crowded with what should be primary care patients. These patients cannot legally be turned away before being triaged. In spite of EMTALA's seemingly straightforward statutory requirements and social importance, case law on inappropriateness of indigent patient transfers by institutions persists. The second modification to the commencement of the health care professional's special legal duty owed to patients is a technical one. It holds that, in carrying out a patient screening examination to determine diagnosis and appropriateness of care by a given provider, the provider has a limited duty to obtain examinationbased informed consent and to carry out the patient examination and evaluation competently. When is it appropriate to terminate the health professional-patient relationship? Certainly a patient may unilaterally sever this relationship without legal sanction. However, if a health care professional unilaterally severs the professional-patient relationship inappropriately, this constitutes patient abandonment, which is generally considered a form of professional negligence. It is appropriate to discharge a patient, among other possible reasons: after resolution of a medical condition; upon achievement of the zenith of the patient's rehabilitative potential; for noncompliance with clear directives; and in the face of ineffective interpersonal relations between provider and patient. As risk management measures, clear documentation of the rationale for patient release or transfer, written notice to the patient, and a reasonable time delay, if appropriate, before discharge for the patient to seek follow-on care, are crucial to minimize the initiation of an abandonment lawsuit (Scott, 2000b).

Malpractice Liability Issues

5

The remedy of money damages is the standard resolution for health care malpractice lawsuits, in the event that a patient-plaintiff prevails. Damages may be compensatory, designed to attempt to make the aggrieved patient whole, and/or punitive, designed to sanction a defendant-health care provider who may have acted maliciously toward the patient. Punitive damages may not be subject to indemnification (i.e., payment) by a defendant-provider's professional liability insurance carrier, depending on applicable state insurance law. While every person is personally legally responsible for his or her conduct, certain entities, such as employing health care organizations, bear indirect or vicarious liability for the official conduct of their employees. Vicarious liability does not imply culpability on the part of the responsible employer, but rather reflects social policy that, as a commercial entity, the employer is better able to prevent and insure against health care malpractice than an innocent injured patient, and therefore should bear the cost of indemnifying against it. Employers are not normally vicariously liable for the operational conduct of contract professionals, unless their identity as contractors is in question, in which case, business entities (e.g., hospitals and health care delivery systems) may face vicarious liability for their conduct under apparent or ostensible agency theories (Pozgar, 1993). Health care organizations face corporate liability for their own health-related misfeasance. Corporate liability, in effect in a majority of states, may be based on negligent hiring, monitoring, or retention of health professionals and failure to sufficiently maximize safety of patients and others within the organization's facilities, among other non-delegable duties. A recent United States Supreme Court case, Pegram v. Here/rich (2000), rejected managed care organization liability based on the theory of a breach of fiduciary duty for the payment to physicians of monetary incentives to limit health care delivered to patients. Whether other bases for corporate liability of managed care entities survive Herdrich remains to be seen. The other bases for health care malpractice—breach of contract and strict liability—are less often invoked by patients, and less often successful when invoked, against health care professionals and organizations. This is so, in part, because courts traditionally view the health professional-patient relationship as a special status fiduciary relationship, like attorney-client and minister-parishioner, rather than as an ordinary arms-length commercial business relationship. For that reason, state court legal systems may require special proof of an express contractual therapeutic promise (i.e., a clear written contract so stating) in order for a patient's specific expectation to be enforceable. Similarly, it is normally medical product manufacturers, and not health care providers and organizations, that bear strict liability (without regard to fault) for patient injuries from dangerously defectively designed or manufactured care products. Normally, only when health care providers and organizations regularly engage in the commercial sale of health products to clients (e.g., as orthotists, prosthetists and optometrists do) do they face exposure to potential strict product liability.

6

Liability Issues and Risk Management

Strict or absolute liability for abnormally dangerous clinical activities similarly is rarely applied to health care (Furrow, 2000). One possible basis for such liability might be high velocity thrust spinal manipulation procedures. When monetary settlements or judgments are paid by parties other than the individual health care malpractice defendants themselves, a report of such payment must be made to the National Practitioner Data Bank (HCQIA, 1986), which tracks adverse licensure, privileging, and malpractice settlements and adjudications involving licensed health care professionals. Hospitals are required to, and state licensure boards may, query the Bank on the status of medical staff members every two years.

INFORMED CONSENT Informed consent is both a legal and professional ethical prerequisite to patient examination and intervention. Legally, informed consent is required by state and federal statutes, professional licensure rules and regulations for direct care providers, and case law. From a professional ethical standpoint, making relevant disclosure of important care-related information and formalizing patient assent to care evidence respect for patient autonomy over health care decision making. Autonomy has in recent decades supplanted beneficence and paternalism as preeminent guiding health-related ethical principles (Scott, 1998). Although specific provider-informed consent disclosure elements vary from state to state (as well as in their application to specific practice settings, for example, surgery, anesthesia, and other invasive procedures), common information disclosure includes: Patient diagnosis(es) Information about the proposed intervention(s) Expected benefits of the proposed intervention(s) Material (decisional) risks of harm or complication associated with the proposed intervention(s), and Reasonable alternatives to the proposed interventions, and its/their relative benefits and risks (Swisher, 1998). After making this disclosure, providers are required to solicit and satisfactorily answer patient, or in the case of patients lacking adequate mental capacity, surrogate decision maker questions. Nuances of informed consent law and ethics include issues of patients objectively lacking capacity to understand and consent but who have not formally been adjudicated as lacking capacity, and patients who do not comprehend English or complex medical jargon (Lo, 1995). Exceptions to informed consent requirements include the emergency doctrine and therapeutic privilege. The emergency doctrine relieves health care professionals

Malpractice Liability Issues

1

of the legal duty to make disclosure and obtain patient-informed consent when a patient presents with a life-threatening emergency and cannot give consent, as in when a patient arrives at an emergency room comatose. The rationale for this exception is that it is commonly presumed that a normal person would wish that his or her life be saved. Exceptions to the exception include valid advance directives and do-not-resuscitate orders. Therapeutic privilege involves the exercise of physician discretion in imposing a gag order on professional colleagues who are members of a given patient's health care team, disallowing then from discussing that patient's diagnosis or prognosis with the patient. The rationale for this exception is the subjective physician belief that the patient cannot psychologically accept and/or process such information. This exception is rarely invoked, and even more rarely allowed by courts, because it so clearly derogates respect for patient autonomy. Non-physician provider-team members may challenge the physician's judgment in such cases through team processes or invocation of the advice of the institutional ethics committee.

RISK MANAGEMENT Risk management is normally considered to be an integral component of quality management, along with measurement and evaluation of patient care activities, competency assessment, and utilization management. In fact, however, risk management philosophy is the antithesis of quality management philosophy. Quality management (a.k.a., quality assurance or quality improvement) focuses on optimizing the quality of patient care delivery through systematic and ad hoc monitoring of patient care outcomes and modification of patient care procedures. Quality management processes are focused exclusively on patient welfare. Risk management, on the other hand, focuses on the legal standard of care, that is, what is minimally acceptable practice. Its processes are designed exclusively for selfprotection of the organization and its employees from liability exposure. In fact, risk management processes do serve indirectly to improve quality of patient care. From safety and security to calibration of equipment, to incident report evaluation and remediation of deficiencies, risk management activities contribute to the enhancement of quality patient care. The difference in goal between quality and risk management is borne out by focusing on the qualified privilege generally afforded to health care facility incident reports. In most states, these reports, generated in response to patient injury (or injury to any other person), among other reasons, enjoy qualified immunity from release to third parties in litigation so long as they are either: (1) part of a systematic quality management/improvement program, or (2) a risk management document, generated at the direction of the facility attorney, in anticipation of possible resultant litigation.

Liability Issues and Risk Management

8

INTEGRATIVE CASE STUDY Consider the following hypothetical case and its attendant legal issues: A is a 71-year old African American male, in good general health, who presents at 1:00 am, December 26, to the emergency room of ABC Medical Center, Anytown, northeastern USA. A is confused, displays slurred speech, and has no identification or insurance documentation. He has numerous abrasions, contusions, and superficial lacerations on his arms and legs; is dressed in dirty short pants and a sleeveless tee-shirt; and is clutching his right forearm. A is accompanied by his nephew, B, who reports that A just fell down a 3-step flight of stairs at home. B does all of the talking for A during physician C's history taking. Without further discussion, C orders x-rays of A's right arm, which show a Colles (distal radial) fracture. A's surface arm wounds are cleansed by D, an emergency room nurse. C applies a short-arm cast to A's right antebrachium, and discharges him home with B. What legal and ethical issues are presented in this scenario?

Issues presented in this case example include at least the following: Emergency medical care pursuant to EMTALA Patient autonomy (privacy and confidentiality of medical information in the history taking, during which B was present) Informed consent to examination/intervention Professional negligence (failure to report suspected elder abuse through social services to the appropriate Adult Protective Services state agency; patient abandonment)

CONCLUSION Health care malpractice is a serious concern for patients, health care providers and organizations, governmental policy makers, judges, attorneys, and society at large. While the raw numbers of health care malpractice legal cases are relatively small compared to general litigation cases, the devastating effects of alleged and actual health care malpractice on patients and providers make its minimization critically important. Health care malpractice may be grounded in professional negligence (substandard care), intentional misconduct, breach of contract, or strict (absolute) liability. In no case, however, does patient injury alone give rise to health care malpractice liability. Quality and risk management measures are designed to achieve very different goals. While quality management purports to optimize the quality of patient care delivery and is patient-focused, risk management measures focus on self-protection of health care organizations and providers from liability exposure incident to patient care activities. Both management systems, however, serve ultimately to

Malpractice Liability Issues

9

improve quality patient care through systematic and ad hoc vigilance of patient care activities.

REFERENCES American Physical Therapy Association. (1996). Risk management. Author: Alexandria, VA. Emergency Medical Treatment and Active Labor Act (EMTALA) of 1986, 42 U.S.C. 1395dd. Furrow, B. R., Greaney, T. L., Johnson, S. H., lost, T. S., Schwartz, R. L. (2000). Health Law, 2nd ed. St. Paul, MN: West Group, Inc. Health Care Quality Improvement Act (HCQIA) of 1986, 42 U.S.C. 11101 et seq. Lo, B. (1995). Resolving ethical dilemmas: A guide for clinicians. Baltimore, MD: Williams & Wilkins, Inc. Pegram v. Herdrich, 120 S.Ct. 2143 (June 12, 2000). Pozgar, G. D. (1993). Legal aspects of health care administration, 5th ed. Gaithersburg, MD: Aspen Publishers, Inc. Scott, R. W. (1997). Promoting legal awareness in physical and occupational therapy. St. Louis, MO: Mosby, Inc. Scott, R. W. (1998). Professional ethics: A guide for rehabilitation professionals. St. Louis, MO: Mosby, Inc. Scott, R. W. (200()a). Health care malpractice: A primer on legal issues, 2nd ed. New York: McGraw-Hill, Inc. Scott, R. W. (2()0()b). Legal aspects of documenting patient care, 2nd ed. Gaithersburg, MD: Aspen Publishers, Inc. Swisher, L. L, Krueger-Brophy, C. (1998). Legal and ethical issues in physical therapy. Boston, MA: Butterworth-Heinemann, Inc.

This page intentionally left blank

Ethics, Law, and Aging Review, Vol. 7, 2001 © 2001 Springer Publishing Company

Chapter 2

Risk Management, Health Care, and the Geriatric Patient Population Michael J. Bass

f anything, health care delivery takes place in a complex and often amorphous environment. The human condition lends itself to continual change, which must be adapted to a particular health care institution. Risk managers must, among other tasks, assess their institutions' strengths and weaknesses, modify and train their staffs, purchase and replace equipment, purchase and build new facilities, and contract with suppliers. The freedom to choose what to do in response to new regulations or budget surpluses is constrained by the cost of those adventures, both monetarily and in terms of legal liability exposure. Some institutions address the legal complexity of health care delivery by assigning specific tasks to particular persons. Such an environment divides labor among risk managers to specific areas of the corporation's legal work: litigation, contracts, employee issues, and compliance with federal and state regulations. This method is applied in many risk management departments of large corporations. Because many risk managers are attorneys, they are capable of shifting from their particular niche—such as contractual work—and dealing with more pertinent issues as they arise—such as surprise inspections. Thus, risk managers have flexibility and

I

11

12

Liability Issues and Risk Management

can morph their structures to accommodate the issues dujour—an important feature in the dynamic health care environment. This article discusses risk management in terms of its most fundamental definition. Several contemporary issues in health care are evaluated as they pertain to managing risk, minimizing liability, and preventing patient injury. Medical error, the Emergency Medical Treatment and Active Labor Act (EMTALA), and temporary housing of patients are examined. Each of these issues is discussed in relation to its impact on the elderly population. Each of these issues involves risk management and clinicians with respect to caring for the elderly.

Defining Risk Management Risk management can best be defined by its two fundamental concepts: risk and management. Risk is the exposure to harm, danger, peril, or even death. The harm associated with risk includes the obvious physical element of health, as well as the often neglected mental element. Every life activity contains some inherent level of risk. We can divide and classify life activities according to how much any given activity may cause harm to our bodies and/or minds. People may choose to participate in activities based on the level of harm they are willing to sustain should the worst possible scenario occur. A good example is driving. Though 41,345 Americans lost their lives in motor vehicle accidents during 1999, most adults climb behind the wheel of a car on a daily basis (Get the Facts, 2000). Thus, risk is a subjective gauge by which different people choose to do certain things. Management is the act of control by direction or persuasion. As people make life choices, they participate in various activities. Most of these personal decisions are made with regard to oneself. Thus, the effect of any such choices—positive or negative—mostly has an inward reflection. Most of us would consider sleep habits, food choices, and dental hygiene to fall under the category of personal management. Some managerial tasks affect others, such as parental control of a child. Other regulatory forces affect an entire society, such as speed limit laws discouraging driving at an excessive velocity. Thus, management can be viewed as the body of choices imposed on oneself or others. Combining the two concepts—risk and management—we can create a fundamental understanding of risk management: the choosing of exposure to specific harms in our daily lives and the lives of others. Risk management is an activity inherent in all persons' everyday lives, as exemplified by the risk-averse nature of humans. We work in factories operating dangerous machines, eat food prepared by other persons, and send our children to day care with other, frequently infectious, kids. All these activities expose us to diseases, infirmity, and potential death. Yet, these activities are considered commonplace; risk is just part of daily life. There seems to be some inherent acceptance of the risks associated with these somewhat vital functions for survival in our contemporary culture. Thus, there is

Risk Management and the Geriatric Patient Population

13

a purpose of survival and accomplishment implicit in the choice to take on personal exposure to risk, The health care environment creates new dimensions in risk management. The sick patient who enters a physician's office or hospital grounds is no longer fully autonomous. Health care professionals—physicians, nurses, technicians, and others—participate in the patient's decision making with respect to diagnostic and therapeutic procedures. This influence creates a relationship with—and fiduciary duty to—the patient. Health care professionals are not alone in their responsibility to patients. Health care facilities must conform to federal regulations (e.g., those implementing Medicare/Medicaid and EMTALA), state tort law doctrine (e.g., vicarious liability, corporate negligence), and private accreditation requirements (e.g., JCAHO), all of which govern various aspects of medical care. Further, corporate staff can be held personally liable in certain instances (e.g., fraud and abuse). Both health care professionals and facilities must coordinate self-protective activities that prevent or minimize extraneous financial costs—through fines and civil liability damage awards—and that maximize profits or excess revenues for the corporate entity (Kraman & Hamm, 1999).

Duties of the Risk Manager Private health care organizations have their operations coordinated by executive officers, financial advisers, boards of directors or trustees, and other corporate officials particular to each institution. Statutory law and regulatory agencies place constraints and guidance on corporate health care, as described above. Interpretation of, and reaction to, the myriad legal risks associated with health care delivery are the risk manager's responsibility. There are always lawsuits, depositions, court appearances, and hearings that need attention. There is always accreditation compliance or state inspection of facilities to address. Incident reports are always being generated in response to accidents, equipment failures, and other potential sources of litigation. The role of the risk manager to meet federal, state, and common law requirements is complicated by national health policy concerns, and rightly so. The majority of health care takes place in hospitals, and nosocomial infections have risen by 36% over the past 20 years (Weinstein, 1998). Medical error—studied vaguely in the past three decades—has recently received executive and legislative attention on the federal level. A patients' bill of rights regarding managed care was almost pushed through the last Congress (S. 1256, 1999). In the health care arena, concern about exposure to harm (i.e., risk management) has become more a function of regulatory compliance than institutional choice. As a result, these complex issues make it the responsibility of the risk manager to make changes within the health care institution. This challenge includes adjusting

14

Liability Issues and Risk Management

institutional policy to prevent situations exposing the institution to liability as well as dealing with current litigation. There are various other reasons for performing risk management aside from statutory and regulatory compliance and avoidance of lawsuits. Money can easily be lost through the poor use of staff, equipment failures and nonuse, and negative publicity (O'Rourke, 2000). The risk manager must recognize all sources of inefficient expenditure and work with the financial officer to minimize or eliminate it. The Typical Risk Manager The highly legal environment of risk management almost requires that risk managers be attorneys. The self-fulfilling prophecy of complex liability issues and regulatory guidelines requires an interpretive viewpoint. Law students—attorneys-intraining—are taught how to evaluate cases, statutes, and regulations. This training is enhanced by experience in dealing with particular issues repeatedly. This is especially important with regard to health care, where interpretive guidelines from the Health Care Finance Administration (HCFA) are continually updated. In this context, the application of numerous general and specific rules often presents numerous "holes" when applied to particular factual scenarios. One must be adept at determining the meaning and intent of relevant laws as applied to one's own particular health care institution. Failure to do so may result in financial loss from regulatory sanctions for noncompliance or losses due to lawsuits. Risk managers are not exclusively attorneys. Nurses, physicians, and even surgical technicians can work in several aspects of risk management. Experience and knowledge of common themes—such as Occupational Safety and Health Administration (OSHA) regulatory compliance for nursing homes—can be highly valuable. Experienced medical professionals can effectively work to minimize liability through staff education about proper chart documentation, filling out and filing of incident reports, and how the risk management department serves the facility staff. Regarding the delegation of duties, experience in the medical field can be valuable in assessing risks, potential sources of error, and institutional liability exposure. Medical professionals are the first line of defense against costly liability claims. Even beyond legal responsibility, nothing can replace safe medical practices by highly skilled physicians and nurses. Clinicians that know when and where errors occur in a given procedure may prevent injury to patients. Those medical facilities that recognize the value of trained clinicians may lower their liability risks and financial losses.

THE IMPORTANCE OF HEALTH CARE Illness is a failure of bodily resilience toward disease. Becoming infirm is synonymous with life. We enhance our statistical odds of avoiding illness through

Risk Management and the Geriatric Patient Population

15

behavioral modifications and adaptions: use of closed sewer systems, water purification, vaccinations, and regulation of our dietary intake. Also, the use of vitamins, herbal supplements, and other forms of complementary alternative therapy are gaining enormous popularity in America. Without question, the concept of preventative medicine has value, especially for those individuals in good health. Unfortunately, our attempts to cheat disease and death are doomed to eventual failure. The common cold is an annual ritual for most. Also, physically active persons are prone to injuries of various types: sprains, bruising, and the occasional broken bone(s). These injuries are very temporary, often lasting only a couple of months or less. A greater concern lies with complex and life-threatening illnesses such as cancer and myocardial infarctions. The human body becomes less capable of fighting the plagues of life as we age. Body weight, dietary habits, and environmental factors directly influence the ability of elder Americans to prevent or react to disease.

THE OVER-65 POPULATION IN AMERICAN HEALTH CARE The demographics of health care are changing. The baby boomers are growing older. Americans are living longer. The life expectancy for both sexes increased by nearly 30 years in the last century, from 47.3 years in 1900 to 76.5 years in 1997 ("Estimated life expectancy," 1999). In fact, there are currently 7.5 million Americans over the age of 80 (Patterson et al, 1998). Longer life expectancy, combined with increased numbers of persons at the extremity of the normal human life span, poses unique problems for health care providers. In 1997, the leading causes of death among Americans 65 years of age and older were heart disease, malignant neoplasms (i.e., cancer), cerebrovascular diseases, chronic obstructive pulmonary disease (COPD), pneumonia and influenza, diabetes mellitus, unintentional injuries, Alzheimer's disease, nephritic diseases, and septicemia (U.S. Department of Health and Human Services, 1999, p. 156). These ailments resulted in the death of 1,728,872 persons age 65 and older (U.S. Department of Health and Human Services, 1999, p. 156). Compare this with 584,472 deaths for all other age categories for the year 1997 (U.S. Department of Health and Human Services, 1999, p. 155-156). Part of the explanation of this phenomenon is the effective care and management of more traditional ailments today. Thus, there is a shift from single, localized health problems to more complex disease processes in persons with weaker immune systems. Whether health care has the purpose of always prolonging life in finite humans brings up ethical questions as much as questions of medical feasibility. There seems to be a paradoxical desire in American culture that is preventing appropriate care for the elderly. We desire perfect health—however this may be

16

Liability Issues and Risk Management

defined—for the duration of our lives. Simultaneously, we desire the longest life possible. Whether perfect health with very long duration of life is achievable for all seems to depend on the approach taken by health care practitioners. Further, each individual has unique life-long influences that current medical professionals may not be able to contemplate in caring for patients. Some steps can be taken to treat the diseases most prevalent in the 65-years-ofage and older Americans. Medical efforts can focus clinical research on the management of chronic ailments. Certainly, physicians must consider the patient's wishes and desires in treating elder patients. Modern health care can become more adept at treating the human condition, with the perspective that life is at least an eight-decade process. With no signs of slowing down, the "baby boomers" of yesteryear are quickly becoming the complex geriatric patients of today.

MEDICAL ERROR AND MEDICAL NEGLIGENCE Society relies on health care practitioners and institutions to heal our wounds, whatever the source of our pain and suffering. As part of our desire for optimum health, we permit health care practitioners to poke and prod our bodies with needles and complex gadgets. The often uncomfortable and embarrassing experiences we endure in seeking relief—such as a colonoscopy or mammography—are part of our frivolous pursuit of eternal life. While the great majority of medical procedures result in a positive outcome, the delivery of health care services has certain flaws. There is an inherent risk in any medical procedure that the treatment will not alleviate the patient's illness. Further, the patient may be injured by the course of therapy. For example, reaction to the anesthesia, infection of a surgical wound, and the severance of nerves are unlikely, but potential, outcomes associated with any surgical procedure. These are unavoidable risks, inherent in any procedure, given the current level of medical knowledge. Medical errors can be defined as those events that lead to patient injury, as well as those mishaps or deviations from proper practice that do not result in substantial harm to patients (Leape, 1994). Thus, error is a function of the medical delivery system's failure to help patients, as well as its failure to prevent patient harm (Liang, 2000). However, a greater concern lies with harming a patient than with a neutral outcome. Current medical malpractice litigation distinguishes medical error from negligence. The law defines a physician's duty to his patient as how a physician in the same or similar circumstance would act. Similarly situated surgeons, for example, face the same perils for any given procedure. In this context, avoidance of medical risks is not considered part of a physician's duty to the patient, so long as the patient is forewarned, understands, and accepts the risks a priori. Perfection in any procedure—surgical or otherwise—unfortunately does not exist in a realm of com-

Risk Management and the Geriatric Patient Population

17

plex biology and behavioral matters. Further, physicians are trained at numerous medical institutions and, hence, differ somewhat in their clinical training. For this reason, the practice of medicine is as much an art as a science.

Concern Over Medical Error There is a growing concern with respect to the quality and safety of medical services. Not much is known about where and under what circumstances medical errors occur in the practice of health care. There are only a handful of studies performed in ambitious attempts to analyze patient injury due to medical error in the health care setting, despite the seriousness of such potential injury. The Harvard Medical Practice Study (HMPS)—by far the most famous study on medical error—attempted to quantify the frequency and types of medical error. Patient charts were examined for "adverse events"—injury caused by medical management (rather than the underlying disease) that prolonged hospitalization, produced a disability or both. (Brennan et al., 1991). This limited study examined 30,121 patient medical records from 51 area hospitals from the year 1984 to determine the frequency of adverse events in the delivery of health care (Brennan, 1991). Identified adverse events were judged by at least two physicians as to whether the injury was attributable to negligence. In addition to reviewing the patient medical charts, the project conducted (1) 739 interviews with doctors to learn their experiences with and perceptions of medical malpractice and litigation, and (2) 3,341 interviews with patients who were victims of malpractice as determined by their charts. The HMPS concluded that 3.7% of all hospitalized patients suffer an adverse event, compared to 1.0% for adverse events due to negligence. When these percentages are extrapolated to the 2,671,863 patients discharged from acute care hospitals in New York in 1984, one would estimate that 98,609 adverse events took place, 27,179 of which were due to negligence. Of the patients deemed to be victims of adverse events due to negligence, mathematical projections are that 13,451 (13.6%) led to death in the state of New York. If the HMPS's New York findings were extended to the entire nation, the incidence of injury for hospitalized patients would become staggering. The U.S. would, for the year 1984, have experienced 150,000 iatrogenic fatalities, with over one-half due to negligence (Saks, 1994). This numerical extrapolation—the only estimate available—has prompted several reform proposals for minimizing medical error, including suggestions by the Institute of Medicine (Kohn, Corrigan, & Donaldson, 1999). The findings of the Harvard Medical Practice Study are fascinating, and its data—while biased as outcome research and collection in hindsight—paint a telling picture of the medical malpractice system. The use of patient charts as a source of uncovering medical error poses two filters on the information: the chart writer and the chart reader. The health care practitioner recording the information in the patient's chart must have done so without regard to potential liability. Also, the

18

Liability Issues and Risk Management

HMPS investigator had to be able to discover medical error knowing only what is written in the patient's chart. The HMPS exemplifies the importance of proper charting. Risk managers need to train medical staff on the legal importance of recording a patient's information in the chart. Proper charting creates an historical document that gives clinicians a better understanding of the patient's medical care. Yet, the medical record is more than a document between the patient and the physician. It is a legal document whose value substantially increases when the health care provider is faced with legal threat. Charting must be done in a timely, accurate, and systematic fashion. If information is not recorded in the patient's chart, then it does not exist for legal purposes.

Medical Error and the Elderly The causes of many bodily failures are not well understood. The ability of the human body to withstand six and a half decades of utilization and more is an amazing feat in itself. At some point, injury and disease cannot be avoided, and death is an inevitable fate to our lives. There is a great variance among diet, environmental influences, and socioeconomic forces that are virtually impossible to classify for each individual. In addition, cosmic irradiation bombards us from the heavens, damaging our cellular DNA which codes for necessary components of life. Further, some disease states manifest in middle age (e.g., adult onset diabetes), while others are more characteristic of the elderly (e.g., Alzheimer's disease). The HMPS has provided the medical and legal profession with an outdated, but initial, understanding of how medical errors affect senior citizens. The HMPS found that patients 65 years of age and older accounted for 27 percent of the hospitalized population, but 43 percent of all adverse events (Leape et al., 1991). Further, the elderly experienced double or higher rates of adverse events due to non-technical operative complications, non-operative therapeutic mishaps, falls, and fractures when compared to all age categories (Leape et al., 1991). Explaining why the elderly are susceptible to certain types of medical errors is not an easy task. Older patients with weakened immune systems and damaged organ systems may not tolerate medical care as well as younger patients. The inability of the medical profession to adequately manage multiple health problems may be a contributing factor. The complexity of pharmaceutical therapy, multiple drug interactions, and the individual patient's ability to tolerate the effects of medical intervention may also play a role in explaining the impact of medical errors on older patients.

Risk Management and Medical Errors Affecting the Elderly The risk manager has the goal of minimizing the health care organization's financial losses due to accidents or legal liability. Failure to comply with statutes and regulations (e.g., EMTALA) can result in significant fines. To prevent liability

Risk Management and the Geriatric Patient Population

19

under state tort law, elimination of patient injury due to medical error and medical negligence is necessary. Greater use of health care increases the possibility of being exposed to a medical error. This risk factor is particularly significant with respect to the consumption of health care by Americans age 65 and older. From 1994 to 1996, Americans in this age category had a mean of 11.4 ambulatory physician contacts (U.S. Department of Health and Human Services, 1999, pp. 3-14). Risk of medical error can be minimized through the actions of clinicians, including the collection of data on past medical errors. Clinicians as Risk Managers. The first step in eliminating medical mistakes, and ultimately legal liability, is to reach clinicians. Simply put, as Oscar London's self-explanatory book title says, "Kill as Few Patients as Possible" (London, 1987). Otherwise, the first step in avoiding patient injury and occasional death is to develop a strong, positive relationship between nurses, doctors, and other medical personnel and the patients under their care. Part of good medical practice encompasses patient understanding and acceptance of medical care. Accomplishing this goal requires good communication skills, a particularly important factor when treating patients with complex medical issues. The Risk Management Foundation of the Harvard Medical Institutions (RMF) makes several suggestions to enhance a clinician's professional relationship with patients (Risk Management Foundation, 2000). Most of the suggestions are common-sensical: use compassion and sensitivity, keep eye contact (i.e., do not continually look at the clock or check your watch), and use formal names when addressing patients. These suggestions are too easily overlooked. Given the almost insane schedules of some clinicians, formality is quickly ignored. Other suggestions are less obvious. Clinicians should use layman terminology when explaining a patient's condition and proposed therapy, provide for follow-up phone calls or letters to maintain rapport with patients after a visit or procedure, and maintain close contact with a patient after an adverse event. The RMF suggestions go beyond being a good clinician. The best medical care is meaningless if the physician cannot effectively relay the relevant information. This skill is particularly important in caring for patients with complex care issues. Hence, there are two functions. One is to accurately relay information to the patient to assure optimal post-clinic care. If patients do not understand the importance of finishing their antibiotics even though they feel better after a couple of days, those patients are not cured and multidrug-resistant bacteria may result. The other function of good communication skills is to decrease a patient's desire to seek legal redress via a medical malpractice claim. The public image of physicians is somewhat that of rich aristocrats, despite the enormous debt incurred by many and the years of dedication invested by them in their medical education. Physicians must be cognizant of the public attitude toward them, and must actively work to improve physician-patient relations one patient at a time. Many patients are educating themselves to take more control of their own medical care (McCall,

20

Liability Issues and Risk Management

1996). Further, older patients are often accompanied by family members. Thus, the physician must communicate with both patient and family in an effective and comprehensive manner. Patients have a hard time bringing a malpractice lawsuit, justified or not, against a physician whom they respect and who they believe has their best interest at heart. Conversely, angry family members may motivate a patient to seek the advice of an attorney and file suit. Collecting Data. Equally important in the process of eliminating medical error, medical negligence, and associated financial loss is identifying the root causes of medical error. In any large health care organization, thousands of procedures and patient encounters take place every day. Mistakes are inevitable, albeit the great majority of them have little or no consequence. For example, giving a post-surgical patient lactate ringers instead of saline intravenous solution probably will have no negative consequences. However, making the same mistake on a patient with a metabolic electrolyte disorder could be disastrous. Risk managers study these types of medical mistakes via two methods: sentinel event meetings and incident reports. Sentinel events are defined as: . . . any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injuries specifically include a loss of limb or function. The phrase 'or the risk thereof includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. (Joint Commission on Accreditation of Healthcare Organizations [JCAHO], 2000).

Health care organizations must perform a root cause analysis for each sentinel event under the accreditation requirements of JCAHO. This applies to the majority of hospitals, since 80% of them participate in the JCAHO accreditation program rather than undergo state inspection as part of their compliance strategy to receive Medicaid funds. The study of sentinel events from root cause analysis documents is a costly and time-consuming process. Also, these documents may be subject to discovery in a medical malpractice action. The likelihood of a defense attorney's ability to persuade a jury that the hospital is not responsible for a sentinel event is abysmal. Risk managers need some assurance of privacy and protection from pretrial discovery before creating documents that are tantamount to an admission of guilt. Risk managers rely on incident reports generated by clinical staff to study medical mistakes. Risk managers compile incident reports and keep statistical records. Generally, these internal documents are not subject to pretrial discovery, depending on state law. This encourages hospital staff to create these documents and make improvements for avoiding repeat occurrences without the threat of litigation. Incident reports serve as a heads-up notice of equipment failures, staffing problems, and anything else that may endanger patients. Further, risk managers can train clinical staff to watch out for common mistakes. Eliminating sources of error correlates to less litigation and losses of revenue. Thus, incident reports provide an ideal source for discovering and eliminating medical mistakes.

Risk Management and the Geriatric Patient Population

21

Incident reports do have their problems, though. Primarily, if a medical mistake occurs but no one reports it, then it does not exist for the risk manager unless the patient sues. Analogously, a tree does not fall unless someone hears it fall, sees it fall, or sees the tree on the ground and realizes that it fell. Risk managers can only work to fix problems about which they are informed. Physicians avoid incident reports because they do not want to risk their staff privileges if they continually admit to making mistakes. Other clinicians may not realize that a mistake has occurred. The only incentive for creating incident reports is protection from discovery, and this only has real meaning for defense attorneys. However the risk manager discovers medical mistakes—sentinel events, incident reports, word of mouth, or other methods—litigation is avoidable. The risk manager must decide whether to fight a lawsuit, usually by hiring outside counsel, or to settle the case. Lawsuits must be evaluated for evidence of negligence, a process that often involves the use of staff and outside physicians as consultants. Physicians should be encouraged to perform this function as honestly as possible. Documents created by consulting experts are generally not subject to discovery unless the consultant becomes an expert witness at trial.

ACCESS TO MEDICAL CARE Currently, there is no recognized constitutional right to health care in the U.S. Even if health care became each American's right, the human body prevents an enforceable right to good health (Churchill, 1989). Our bodies are quite resilient to foreign pathogens, physical injury, and stress. However, the physical bodies in which we are imprisoned occasionally cannot maintain homeostasis and become infirm. Many Americans prepare for devastating illness by purchasing insurance to cover the expense associated with the receipt of modern medicine. Access to health care services has traditionally been linked to the patient's ability to pay medical providers for services (Barrett, 1996). However, during the year 1998, an estimated 42.6 million Americans were without health insurance (Mills, 2000). Consequently, these people generally do not actively seek out health care at the earliest signs of disease or infirmity. Noninsured individuals either rely on preventative care, good fortune in avoiding disease or both as health care "insurance." Some may have access to free clinics or the county health department. Others show up in the emergency department in a critical condition. The noninsured or underinsured elderly may have some difficulty accessing necessary health care services. Physiological weakness and susceptibility to pathogens increase the likelihood and frequency of illness. Further, seeking care from a clinic may not be physically possible for various reasons: lack of transportation, too ill to move, or use of certain medications. For these people, the ambulance service and the emergency department serve as their access to health care. Compounding the issue of impaired access to health care is the Emergency

22

Liability Issues and Risk Management

Medical Treatment and Active Labor Act (EMTALA). EMTALA is a nonfunded federal law designed to prevent private Medicare-participating hospital emergency departments from rejecting—or "dumping"—uninsured patients onto public hospitals that may be miles away. No longer can an emergency department assess a patient's ability to pay for services as a criterion for deciding whether to stabilize that patient. Thus, EMTALA requires hospitals with emergency departments to provide stabilizing treatment to whoever requests it, regardless of ability to pay. The Department of Health and Human Services (DHHS) has interpreted EMTALA to require emergency departments to "screen and stabilize" all patients. Hence, the emergency department must first screen patients to assess the status of their medical condition. The emergency department must render necessary care to stabilize the patient. Those patients with unstable health conditions—myocardial infarction, shock, and severe blood loss, for example—must receive medical care so as to stabilize their condition. EMTALA does not require a hospital to admit the patient and, in fact, the hospital can transfer the patient to another hospital (e.g., from a private institution to a public one) under certain conditions of patient stability. The statute serves to protect patients from a total denial of care. Each emergency department across the country is different with respect to staffing, support services, medical equipment, location, and the number of patients at any given time. Not all patients can be stabilized in the emergency department. In one scenario, certain emergency medical conditions may have progressed beyond a particular facility's capabilities. For these patients, transfer to an appropriate facility is not objectionable. A second scenario is an emergency department capable of caring for a patient's medical condition but which denies care based on inability to pay. This is the blatant economic discrimination that was the basis for EMTALA's passage. Risk to a patient's life is objectionable when medical reasons do not support the denial of care (Kilner, 1990). A third scenario is the patient with a medical condition that is untreatable by any emergency department. No statute can protect against this scenario; medical knowledge is the limiting factor. Risk managers must be especially alert to on-call physicians who refuse to come in and see a patient or who order the patient transferred without coming in to stabilize the patient. This is mostly an issue at rural hospitals. There is no feasible solution to this situation other than requiring on-call physicians to actually stay at the emergency department or on hospital grounds. This option may be impractical for small hospitals with tight budgets. Failure to comply with EMTALA may result in fines to the hospital, fines to the physician, and civil liability. One must be wary of how the emergency department discharges patients. Federal law does not govern this area. There is more or less an assumption that patients want to leave the emergency department as quickly as possible; when the emergency ceases to exist, one should want to go home. However, risk managers need to train clinicians to watch for patients that fake illness or refuse to leave the premises at the end of their medically and legally appropriate care.

Risk Management and the Geriatric Patient Population

23

An important issue for emergency departments is discharge planning. For most patients, the options are simple: admission to the hospital or being sent home. As previously discussed, some patients may require transfer to more appropriate facilities for financial or medical reasons. Occasionally, there is a problem regarding patients without a home to which to be discharged. Post-care housing is mainly a social worker's concern, but special problems may arise with comatose or handicapped patients.

SUMMARY Risk management is a job shared by health care practitioners and legal staff. Often, these groups work separately, although they share the same goal: to avoid legal liability and financial loss. There is a risk of harming patients in every medical procedure, an outcome which may lead to fines and civil liability. Since health care institutions provide facilities for medical procedures, this risk is inherent in the business. A greater focus must be placed upon older Americans and their susceptibility to medical error and the use of emergency facilities. The numerous and complex medical problems of the elderly make them ripe for suffering patient injury and pursuing legal liability. Further, long-term care must be considered for those patients with extended needs for assistance. The health care industry must work to create an environment where clinicians and risk managers work together to eliminate patient harm. A decrease in financial losses will correspondingly follow.

REFERENCES Barrett, C. L. (1996). Elder law issues. American Law Institute—American Bar Association Continuing Legal Education, SA84ALI-ABA, 1073. Brennan, T. A., Leape, L. L., Laird, N. M, Hebert, L., Localio, A. R., Lawthers, A. G., Newhouse, J. P., Weiler, P. C., & Hiatt, H. H. (1991). Incidence of adverse events and negligence in hospitalized patients. New England Journal of Medicine, 324, 370-376. Churchill, L. R. (1989). Rationing health care in America: Perceptions and principles of justice. Notre Dame, IN: University of Notre Dame Press. Emergency Medical Treatment and Active Labor Act, 42 U.S.C.A. § 1395dd (1986). Estimated life expectancy at birth in years, by race and sex: Death registration states. National Vital Statistics Report [On-line] 47(28). Available at http://www.cdc.gov/ nchs/fastats/pdf/, visited Nov. 3, 2000. Get the Facts: Car-accidents.com [On line]. Available: http://www.car-accidents, com/pages/stats.html, visited Nov. 4, 2000. Joint Commission on the Accreditation of Healthcare Organizations. (2000). Facts about the sentinel events policy [On-line]. Acailable:http://www.jcaho.org/searchfrm.html visited Nov. 6, 2000.

24

Liability Issues and Risk Management

Kohn, L. T., Corrigan, J. M., &Donaldson, M. S. (Eds.) (1999). To err is human: Building a safer health system. Washington, DC: National Academy Press. Kilner, J. F. (1990). Who lives? Who dies? Ethical criteria in patient selection. New Haven & London: Yale University Press. Kraman, S. S., & Hamm, G., (1999, December 21). Risk management: Extreme honesty may be the best policy. Annals of Internal Medicine, 131, 963. Leape, L. L. (1994). Error in medicine. Journal of the American Medical Association , 272, 1851-1852. Leape, L. L., Brennan, T. A., Laird, N., Lawthers, A. G., Localio, A. R., Barnes, B. A., Hebert, L., Newhouse, J. P., Weiler, P. C., & Hiatt, H. (1991). The nature of adverse events in hospitalized patients: Results of the Harvard medical practice study II. New England Journal of Medicine, 324 (6), 378-379. Liang, B. A. (2000). Promoting patient safety through reducing medical error: A paradigm of cooperation between patient, physician, and attorney. Southern Illinois University Law Journal, 24, 541, 542. London, O. (1987). Kill as few patients as possible: And fifty-six other essays on how to be the world's best doctor. Berkeley, CA: Ten Speed Press. McCall, T. B. (1996). Examining your doctor: A patient's guide to avoiding harmful medical care. Secaucas, NJ: Carol Publishing Group. Mills, R. (2000). Chances of having health insurance increase, reversing 12-year trend, Census Bureau says. U.S. Census Bureau [On-line]. Available at http://www.census.gov/ Press-Releaselwwwl2000lcbOO-160.html, visited Nov. 6, 2000. O'Rourke, A. (2000). Clinical risk management. Wisdom Centre, Institute of General Practice & Primary Care, Sheffield University [On-line]. Available at www.shef.ac.ukl unilprojectslwrplcgcrm.htm, visited Nov. 6, 2000. Patterson, J. A., Bierman, A. S., Splaine, M., Goodlin, S. J., Schreiber, R. J., & Wasson, J. H. (1998). The population of people age 80 and older: A sentinel group for understanding the future of health care in the U.S. Journal of Ambulatory Care Management, 27(3), 10-16. Risk Management Foundation of the Harvard Medical Institutions. (2000). Available at http:llrmf.harvard.edu, visited Nov. 3, 2000. Saks, M. J. (1994). Medical malpractice: Facing real problems and finding real solutions. William and Mary Law Review, 35, 693-726. Senate Bill 1256, 106lh Cong., 2nd Sess. (1999). U. S. Department of Health and Human Services. (1999). Health, United States, 1999: With Health and Aging Chartbook. Washington, DC. Weinstein, R. A. (1998, July - September). Nosocomial infection update. Emerging Infectious Diseases [On-line serial], 4(3). Available at http://www.medscape.com/ govmtlCDCIElDH998lv04.n03le0403.15.weinle0403.15.wein-01.html.

Ethics, Law, and Aging Review, Vol. 7, 2001 © 2001 Springer Publishing Company

Photograph courtesy of Jeffrey M. Levine, MD

Chapter 3

Medico-Legal Aspects of

Hospital Siderail Use Elizabeth A. Capezuti and Julie A. Braun

25

26

Liability Issues and Risk Management

iderails traditionally have been viewed as a risk management tool to prevent or reduce falls and, consequently, the possibility of litigation. This perspective changed in 1995, when the Food and Drug Administration (FDA) released a safety alert addressing potential entrapment issues associated with siderail use. Canada (Roy, 1990) and Great Britain (Medical Devices Agency, 1997) recognized the same safety issues and published similar alerts. Hospital patients most at risk for entrapment are frail, elderly, or confused. In July 1999, the Health Care Financing Administration (HCFA) issued an interim final rule announcing new hospital Conditions of Participation (CoP) for patients' rights. All hospitals, including short-term, psychiatric, rehabilitation, long-term, children's, and alcohol-drug, must satisfy these CoP to be approved for, or to continue participation in the Medicare and Medicaid programs. This new rule addresses, among other items, restraint use in the provision of acute medical and surgical care. HCFA stresses that an object is a restraint by functional definition. Thus, siderails that inhibit a patient's ability to voluntarily get out of bed constitute a restraint. This chapter explores the medico-legal aspects of hospital siderail use within the context of current industry practice and new patients' rights standards.

s

WHAT ARE SIDERAILS? Siderails are adjustable metal or rigid plastic bars that attach to the bed and come in an assortment of sizes (full-length rail, three-quarter-length rail, half-length rail, quarter-length rail, split rail configuration, and alternate split rail configuration) and shapes (Capezuti & Lawson, 1999) as illustrated in Figure 3.1. Commonly used synonymous terms include bed side rails, bed rails, cotsides, guardrails, safety rails, and sideboards. "Restrictive" siderail use references rails that function as restraints to prevent a patient's voluntary movement (Capezuti, 2000). Most hospitals rely on four "half or "split" siderails attached to the bed, allowing diverse combinations of rails from one upper (or head) rail to both upper and lower (foot) rails (Levine et al., 2000). An upper or head rail typically features controls that adjust the bed position as well as an over-the-bed light and television (Letizia, 1999a). In addition, the upper rail is the favored location for call bell placement (Letizia, 1999a). Lastly, the rail serves as a holder offering the patient easy access to personal care items such as urinals (Letizia, 1999a).

ARE SIDERAILS PHYSICAL RESTRAINTS? The functional definition of physical restraint that applies to hospitals, specifically for acute medical and post-surgical care, appears at 42 C.F.R. § 482.13(e) and reads:

Medico-Legal Aspects of Si derail Use

27

Full-Length Rail: a onepiece rail that extends along the side of the bed from the head to the foot section. %-Length Rail: A onepiece rail that extends along the side of the bed three quarters of the way down from the head of the bed. Half-Length Rail: A onepiece rail that extends along the side of the bed one-half the length of the bed from the head of the bed. Quarter-Length Rail: A one-piece rail that extends along the side of the bed approximately !4 the length of the bed from the head of the bed. Split Rails: A pair of half rails. One set extends along the side of the bed from the head of the bed to the midsection of the bed. The other set extends from the midsection of the bed to the foot of the bed. Generally, there is a space between the two sets of rails.

Figure 3.1 Types of Siderails.

28

Liability Issues and Risk Management [a] physical restraint is any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body.

This broad functional definition does not name each device or identify every situation that may inhibit an individual's movement. Instead it promotes a case-bycase examination. Thus, an object, such as a siderail, may be considered a restraint by functional definition. Whether a siderail is a restraint depends on its effect on the particular patient for whom it is being used, not on size, shape, or number of rails used. When siderails impede the patient's desired movement or activity (such as getting out of bed), they meet the definition of a restraint according to HCFA Interpretive Guidelines. If a patient chooses to use siderails for enhancing mobility in and out of bed, then the rails are not restraints. Siderails must be evaluated as a restraint when they serve multiple purposes, such as facilitating in-bed mobility and keeping the patient from getting out of bed, when the patient wants to get out of bed under HCFA Interpretive Guidelines.

PREVALENCE OF SIDERAIL USE IN HOSPITALS Siderail Use in American Hospitals Rarely were siderails available on adult hospital beds before the 1930s (Brush & Capezuti, in press), when the primary intervention for agitated, confused or other adults at risk of bed-related falls was the "careful and continuous watchfulness" of a nurse (Merck Manual, 1934). Siderail usage became commonplace in the 1950s, when rails became permanently affixed to hospital beds. Raising bed rails was directly linked to concerns over institutional legal liability. The mistaken notion that rails were benign safety devices, accompanied by the standardization of their use through hospital-wide policies in the 1950s, deterred health care professionals from questioning their efficacy in fall prevention and discovering alternatives to their use. Furthermore, the escalating nurse shortage of the 1960s and 1970s, coupled with changes in hospital architecture from multi-patient wards to semiand private- patient rooms, encouraged the substitution of siderail and physical restraint use in place of direct observation by nurses (Lynaugh & Brush, 1996). Simultaneously, falls, especially from bed, were identified as a major liability issue (Rubenstein et al., 1983). A 1980 National Association of Insurance Commissioners report relates that falls represented 10 percent of paid claims between 1975 and 1978, identifying the absence of siderails as a principal justification for claim payment. As a result, "routine use of bedrails" became "the standard of good nursing practice" (Rubenstein et al., 1983). This phenomenon is representative of defensive medicine, a pattern of practice based on consensus rather than scientific evidence (Rubenstein et al., 1983; Staudenmaier, 1996). In other words, nurses, as

Medico-Legal Aspects ofSiderail Use

29

hospital employees, raised siderails to substitute for themselves and to protect their hospitals' legal interests (Braun & Capezuti, 2000; Brush & Capezuti, in press). The authors are aware of no national figures or large multi-site studies that quantify current siderail usage in American hospitals. A 1997 study conducted in a hospital setting reports a prevalence rate of 30 percent of restrictive (all four rails raised) nighttime siderail use among hospitalized adults in medical surgical units and 58 percent in critical care units (Capezuti, 2000). The same research discloses that more than three-quarters of the hospitalized nursing home residents studied experienced restrictive siderail use during most of their stay (Capezuti, 2000). Restraint standards developed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO, 1996) have led to reductions in overall physical restraint use as well as changes in restraint use patterns (Capezuti et al., 2000; Minnick, Mion, Leipzig, Lamb & Palmer, 1998; Sullivan-Marx & Strumpf, 1996). Mion and colleagues assert that current restraint usage is more often to prevent treatment disruption than to avert falls and related injuries (Frengley & Mion, 1998; Minnick et al., 1998, Mion, 1996; Mion et al., 1996). As with other hospital restraint studies (Bryant & Fernald, 1997), their research did not include siderails within the definition of restraint. Recent changes in hospital physical restraint usage follow more dramatic reductions observed in long-term care secondary to federal regulations and companion interpretive guidance restricting restraint use (Omnibus Budget Reconciliation Act of 1987, with the Nursing Home Reform Act codified at 42 U.S.C. §§1395r-i (a)-(h) and 1396r (a)-(h); Castle & Mor, 1998). Interestingly, evidence suggests that physical restraint reduction in nursing homes triggers increased siderail use (Capezuti, Strumpf, Evans, & Maislin, 1998). A study conducted on the medical-surgical units of one large urban medical center likewise found a significant decrease in restraint use associated with an increase in restrictive (all four rails raised) siderail use (Capezuti et al., 2000). If most restraint reduction in hospitals occurred in response to fall risk, arguably siderail use would increase in response to less physical restraint. The new hospital Conditions of Participation for patients' rights (effective August 2, 1999), coupled with expected changes in JCAHO restraint standards, may counteract this effect and decrease restrictive siderail use.

Hospital Siderail Use in Other Countries Siderails are not widely accepted in other countries and rail removal from hospital beds is encouraged (Ball, Hanger, & Thwaites, 1997; O'Keefe, 1996). The prevalence of siderail use in British hospitals is low, with one recent study reporting only 8.4 percent of hospitalized adults with raised rails (O'Keefe, 1996). A British medical journal editorial describes the "absurd" and "distasteful" use of siderails in the United States (Editorial, 1984). This aversion toward siderails is traced to a 1975 policy established by the Joint Working Party of the British Geriatrics Society and the Royal College of Nursing which clearly discourages routine

30

Liability Issues and Risk Management

siderail use (Everitt & Bridel-Nixon, 1997). In 1999, the Royal College of Nursing issued guidelines seeking to further restraint reduction, listing bedrails as the most likely form of restraint. A 1989 study in a Scottish hospital found a decrease in bed-related falls following a dramatic reduction in siderail use (Jehan, 1999, quoting Watson & Brunton, 1990). Similarly, a prospective study conducted in a New Zealand hospital linked a decrease in bed-related fall injuries to hospital policy emphasizing reduced siderail use. An editorial written by an American geriatrician questioning the utility of siderails accompanied the report of research results (Frengley, 1999).

WHY USE SIDERAILS? Siderails serve a wide range of purposes, especially in the acute care setting. Raised rails, for example, are used on stretchers or beds while transporting patients following surgery or when relocating a patient to a new room or unit. In Parker v. Dade County Public Health Trust (1987), a man sustained a head injury resulting in severe brain damage after climbing over a transport stretcher's raised siderails and striking his head on the hospital's emergency room floor. The hospital unsuccessfully argued that the patient was negligent in disobeying instructions to remain on the stretcher. The New Jersey Supreme Court in Tobia v. Cooper Hospital University Medical Center (1994) likewise rejected instructing the jury on a patient's contributory negligence for injuries received when she fell from an emergency room stretcher with lowered rails. In Parker v. Centenary Heritage Manor Nursing Home (1996), a negligence action brought against a hospital following an unrestrained 80-year-old, one-armed male patient's fall from an emergency room stretcher with lowered rails, the Supreme Court of Louisiana noted the presentation of conflicting evidence as to whether the bed rails were raised and refused to disrupt a lower court's ruling favoring the defendant hospital. A rail also may enable the patient to reposition within the bed or facilitate independent transfer in or out of the bed. Some patients and family members believe that raised siderails impart a feeling of comfort and security (Neufeld & Dunbar, 1999). In addition, rails could function as a physical barrier that reminds the patient of the bed perimeter during episodes of acute illness, for instance, when bed boundaries require definition. The rail may prompt a patient to ask for nursing assistance before attempting movement in or out of bed. As illustrated in Norris v. Rowan Memorial Hospital (1974), "[t]he presence of the rails in the raised position would have also served to arouse a patient. . . made drowsy by a sedative, and alert her that she should ring for assistance if she needed to go to the bathroom." Finally, in some circumstances, raised rails restrict a patient's voluntary movement (Braun & Capezuti, 2000; Capezuti et al., 1999). The latter purpose ignites concern, given that such use has been re-conceptualized as a physical restraint in both the clinical and legal sense.

Medico-Legal Aspects of Siderail Use

31

Although health care providers employ siderails for varied reasons (Matthieson, Lamb, McCann, Hollinger-Smith, & Walton, 1996), their primary reason is the prevention of bed-related falls and injuries (Capezuti et al., 1999). Fall-related injuries are the leading cause of mortality due to unintentional injuries among older Americans in the United States (National Safety Council, 1992; Studenski & Wolter, 1998). Almost one-third of all fall-related injuries occur among persons 85 years of age or older (Baker et al., 1992). Approximately three to ten percent of falls happening in hospitals (Mahoney, 1998) result in either serious (i.e., fractures, dislocated joints, subdural hematoma, lacerations requiring sutures, and soft tissue injuries requiring medical treatment) or minor (i.e., lacerations without sutures, bruises, abrasions, and certain sprains) injuries. Hip fractures, occurring in about one to four percent of hospital falls (Mahoney, 1998), are particularly significant because older adults are more likely to suffer from a substantial decline in physical functioning (in their ability to dress, transfer from bed to chair, walk, or climb stairs, for instance) and often require longer periods of active rehabilitation services as compared to younger persons (Magaziner et al., 2000; Mahoney, 1998; Sartoretti et al., 1997). A majority of hospital incident or occurrence reports describe patient falls, making falls a major risk management issue. Roughly two to five percent of older adults fall during hospitalization (Bakarish et al., 1997; Mahoney, 1998). The number of falls per 1,000 patient days is highest in hospital units admitting mostly older adults, such as geropsychiatry (13.3 to 25), rehabilitation (7.6 to 12.6), and geriatric medicine (5.5 to 7.8) (Mahoney, 1998; Wexler et al., 2000). Among hospitalized older adults, falls from bed account for approximately one-third of all falls (Gaebler, 1993), making prevention of bed-related falls a priority among hospital staff and risk managers.

CONSEQUENCES OF SIDERAIL USE Bed-Related Falls No clinical evidence supports restrictive siderail use as an appropriate intervention to prevent bed-related falls (Braun & Capezuti, 2000; Mahoney, 1998). Several studies conducted over the last 20 years report that between 37 to 90 percent of bed-related falls happen with raised siderails (Barbieri, 1983; Bates et al., 1995; Catchen, 1983; Mahoney, 1998; Walshe & Rosen, 1979). One study relates that the vast majority of bed-related falls involved confused older adults in beds with raised rails (Bates et al., 1995). Experts encourage eliminating or minimizing siderail use to the upper rails in the acute care setting (Bradway, Hernly, & NICHE faculty, 1998; Driscoll, 1999; Fletcher, 1996; Jensen et al., 1998; Quinn, 1996; Mahoney, 1998; Wexler et al., 2000). Siderail use is expected to decrease in response to regulations restricting their use and evidence that restraint reduction does not significantly increase falls and

32

Liability Issues and Risk Management

related injuries. In the last decade, several empirically based studies conducted in nursing homes demonstrated that restraints could be removed without adverse consequences (Cali & Kiel, 1995; Capezuti & Talerico, 1999; Capezuti et al., 1999; Capezuti et al., 1998; Castle & Mor, 1998; Ejaz, Jones, & Rose, 1994; Evans et al., 1997; Neufeld et al., 1999; Werner, Cohen-Mansfield, Koroknay, & Braun, 1994). Similarly, a few studies examining reduction of siderail use in nursing homes (Feinsod et al., 1997; Capezuti et al., 1999) and on a short-term rehabilitation unit within a nursing home (Si et al., 1999) demonstrated no significant increases in bed-related falls or injuries.

A Dangerous Combination: Siderails and Restraints In the last decade, there have been numerous accounts of siderail and restraint/ siderail-related injuries and deaths in the print and electronic media, professional literature, sentinel event reporting to JCAHO (Sentinel Event Alert, 1998), and in reports to the FDA (FDA, 1995; Todd et al., 1997). Many injuries result from attempts to remove restraints or to transfer out of bed while restrained. The most common mechanism of restraint-related death is by asphyxiation; the person is fully or partially suspended by a restraint from a bed or chair and the ability to inhale is inhibited by gravitational chest compression (Miles, 1996; Miles & Irvine, 1992). A study of 122 such cases found that 58 percent of such deaths occurred from bed; most victims were suspended over the top of raised rails, in the slot between the upper and lower rails or between the inner bars of the rails (Miles & Irvine, 1992). In Estate of Minnie Viola Wilson v. HealthSouth Corporation d/blal HealthSouth Rehabilitation Hospital (1996), a Texas jury awarded the family over five million dollars, following the death of a 66-year-old woman found hanging from her hospital bed with a vest restraint wrapped around her neck. A reportable sentinel event is one that results in an unanticipated death or major permanent loss of function, not related to the natural course of the patient's illness or underlying condition (Cartwright & Kole, 2000). JCAHO, the oldest private accreditation organization, launched its sentinel events policy in 1996. A November 18, 1998, Sentinel Event Alert, entitled Preventing Restraint Deaths, details 20 instances of restraint death (Sentinel Event Alert, 1998). Notably, all strangulation deaths (suspended by vest restraint) occurred among older patients and, in half the cases, "the patient died when they slipped between unprotected split side rails." A nationally recognized expert, Dr. Steven Miles of the University of Minnesota Medical School, described the "recognized interaction between split bed rails and restraint asphyxiation" and unequivocally stated that "there is no therapeutic advantage to employing split rails for persons who are restrained" (Miles, 1996). Use of either vest or belt restraints with only the upper rails raised also has resulted in asphyxial deaths (Miles & Irvine, 1992). Restraint manufacturers now are marketing devices specific for bed use, such

Medico-Legal Aspects of Siderail Use

33

as "roll belts" and "roll jackets," as being "least restrictive" because the patient can sit up or partially turn from side to side (Capezuti et al., 1999). Patients suffering from dementia probably will perceive these devices the same way they view other restraints, as "annoyances" to be removed (Capezuti & Talerico, 1999). Unfortunately, patients will continue their attempts to exit the bed environment even with these newer devices and thus continue to place themselves at risk for injury and/or death (Capezuti et al., 1999) and the hospital at risk of liability.

Siderail Entrapment Problems In addition to descriptions of injuries secondary to the use of physical restraints with raised siderails, there is a growing literature describing siderail-related injury and death. The FDA received 371 incident reports involving patients caught, trapped, entangled, or strangled in beds with rails between 1985 and 1999 (FDA, 1995; FDA Taskforce Brochure, 2000; Todd et al., 1997), representing 228 deaths, 87 persons with nonfatal injury, and 56 persons who avoided injury because staff intervened (FDA, 1995; Todd et al., 1997; FDA Taskforce Brochure, 2000). These incidents occurred in hospitals, long-term care facilities, and private homes (FDA 1995; Todd et al., 1997). As suggested by the examples in Figure 3.2, the entrapments occurred: through the siderail bars; through the space between split siderails; between the siderail and mattress; or between the head or footboard, siderail, and mattress (FDA, 1995). All deaths involved entrapment of the head, neck, or thorax, while most injuries included fractures, cuts, and abrasions of the extremities (FDA, 1995). The majority of the deaths and injuries involved older adults, especially those with pre-existing conditions such as altered mental status (organic or medication related), restlessness, lack of muscle control or a combination of these factors (FDA, 1995). Parker and Miles categorized 74 siderail-related deaths and injuries taken from the U.S. Consumer Product Commission files into three types: asphyxiation; rail and in-bed entrapment; and rail and off-bed entrapment (Parker & Miles, 1997). Seventy percent of the victims were asphyxiated between the siderail and the side of the mattress or the head/foot board (Parker & Miles, 1997). This problem occurs when the mattress does not fit flush against the siderail (Parker & Miles, 1997). Hospital beds can remain in use for five to ten years, while the mattress may only last one to five years. Although the original bed mattress may fit correctly, the replacement mattress may be too narrow or short for the bed frame. Further, many siderails have wide gaps within the rails that can lead to entrapment of the head or limbs. Also struggling to escape can trigger rail latch failure collapsing the widely spaced vertical bars on the resident's neck (Parker & Miles, 1997). In a few cases, those who climbed over the rail slipped and their heads and necks landed on the rail; asphyxiation followed unless patients had the strength to raise

34

Liability Issues and Risk Management

Figure 3.2 Examples of siderail entrapment. Note: From "Siderail Use and Legal Liability in Illinois Nursing Homes," by Julie A. Braun and Elizabeth A. Capezuti, 2000, Illinois Bar Journal, 88, p. 329. Reprinted by permission.

their heads from the rail (Parker & Miles, 1997). One study conducted in a New Zealand rehabilitation hospital found that rails even in the down position can be an obstacle for some older patients attempting to egress from bed (Ball, Hanger & Thwaites, 1997). HCFA Interpretive Guidelines to the hospital Conditions of Participation for patients' rights mention that siderails present an inherent safety risk, particularly when the patient is elderly or disoriented. The Guidelines acknowledge that, even when a siderail is not intentionally used as a restraint, patients may become trapped between the mattress or bed frame and the rail.

Medico-Legal Aspects of Siderail Use

35

Other Potential Consequences of Restrictive Rail Use It is well documented that functional decline or deconditioning occurs in one-third to one-half of older hospitalized patients (Creditor, 1993; Fortinsky et al., 1999; Hirsch, Sommers, Olsen, Mullen & Winegrad, 1990; Hoenig & Rubenstein, 1991; Mahoney, 1998; Mahoney et al., 1998; Warshaw et al., 1982) and is correlated with higher mortality rates, longer lengths of hospital stay, higher costs, and increased rate of nursing home placement (Inouye et al., 1993; Janelli, 1995; Robbins et al., 1987). Functional decline often results from immobilization linked to "forced" bedrest, immobilizing devices (such as catheters), physical restraint use (a vest restraint, for example) and lack of encouragement of independence in self-care (Inouye et al., 1993). Restrictive siderail use, similar to physical restraint, is associated with immobility (Capezuti, 2000). Specifically, immobility has been correlated with muscle atrophy, loss of muscle strength and endurance, bone loss, joint contractures, and problems with balance and coordination (Clark et al., 1990; Greenleaf et al., 1983; Hoenig & Rubenstein, 1991; Mahoney, 1998; Mobily & Kelley, 1991). As these impairments lead to increased incidence of falls, immobility is viewed as a contributor to fall risk (Creditor, 1993; Harper & Lyles, 1988; Mobily & Kelley, 1991, Mahoney, 1998; Tinetti et al., 1992). Moreover, reduced bone mass, which is a consequence of decreased weight-bearing and physical activity, can contribute to the increased likelihood that falls will result in serious injury (Grisso et al., 1991). Further, immobilization also strongly correlates with development and worsening of pressure ulcers, contractures, and decline in appetite (Braun & Capezuti, 2000; Creditor, 1993; Inouye & Charpentier, 1996; Lofgren et al., 1989). Prolonged immobilization also has behavioral effects, including increasing delirium, depression, agitation, combativeness, and paranoia (Inouye & Charpentier, 1996; Mahoney, 1998; Murray et al., 1993). Fortunately, several clinical trials testing the effects of clinical intervention models (Inouye et al., 1993) that emphasize mobility demonstrate positive outcomes of reduced incidence of delirium, functional decline, and pressure ulcers (Hamilton & Lyon, 1995; Inouye et al., 1993; McVey et al., 1989). Reducing routine and prolonged siderail use is consistent with a "mobility-enhancing" or a "functional recovery" approach to care (Hamilton & Lyon, 1995). These clinical practices are supported by federal regulations.

FEDERAL RESPONSE TO ROUTINE RESTRICTIVE SIDERAIL USE Patients' Rights Conditions of Participation: An Overview On December 19, 1997, the Health Care Financing Administration published a Notice of Proposed Rulemaking, 62 Fed. Reg. 66,726, entitled Medicare and Medic aid Programs: Hospital Conditions of Participation; Provider Agreements and

36

Liability Issues and Risk Management

Supplier Approval, seeking to revise the entire set of the Conditions of Participation (CoP) for hospitals that appear at 42 Code of Federal Regulations Part 482. All hospitals, including short-term, psychiatric, rehabilitation, long-term, children's, and alcohol-drug, must satisfy the CoPs to be approved for, or to continue participation in, the Medicare and Medicaid programs. In response to increasing concerns about the need to ensure basic protections for patient health and safety in hospitals, most particularly the right to freedom from restraints and seclusion, the patients' rights CoP was carved out from the larger package of hospital CoPs and published separately in the Federal Register as an interim final rule, effective August 2, 1999 (64 Fed. Reg. 36,069 (July 2, 1999)). The lion's share of the patients' rights CoP, as well as the majority of comments received by HCFA, concerned the two standards on restraints and seclusion. HCFA attempted to distinguish between situations where restraints are used to provide acute-level medical and surgical care (42 C.F.R. § 482.13(e)) and those where restraint or seclusion is used to manage patient behavior (42 C.F.R. § 482.13(f)). The preamble to the rule stresses that the standards for restraint use are not specific to the treatment setting, and instead pertain to the situation the restraint is being used to address. Consequently, an issue that may arise under the new patients' rights CoP is how hospitals characterize a particular restraint application—employing siderails for medical and surgical care versus behavior management (Annas, 1999; Kahn-Kothmann, 1999). Patient Right to Freedom From Restraint. According to federal regulation, "[t]he patient has the right to be free from restraints of any form that are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by the staff' (42 C.F.R. § 482.13(e)(l)). Arguably, the phrase "restraint of any form" includes siderails when their use functions as a restraint for a particular patient. Attempting Less Restrictive Interventions. Restraints can be used only if needed to improve the patient's well-being and less restrictive interventions have been determined ineffective (42 C.F.R. § 482.13(e)(2); HCFA Interpretive Guidelines). HCFA expects patient medical records to contain information on less restrictive measures considered before ordering restraints (HCFA Interpretive Guidelines). Alternative measures do not always need to be tried, but should be considered prior to restrictive siderail use (HCFA Interpretive Guidelines). Documentation is critical to successful risk management. It should reflect interventions attempted but not successful, those in use, and a systematic evaluation of other interventions considered and the reasons for their rejection. Rail Orders Written by Physician or Licensed Independent Practitioner. A physician or other licensed independent practitioner (LIP) permitted by both state law and hospital policy to have the independent authority to order restraints must order the raised siderail if it functions as a restraint for a particular patient (42 C.F.R. § 482.13(e)(3)(ii); HCFA Interpretive Guidelines). The hospital should have

Medico-Legal Aspects of Siderail Use

37

a written policy, conforming to state law, indicating which practitioners may order restraints in that facility (HCFA Interpretive Guidelines). The hospital must learn whom state law or the state's regulatory mechanism recognize as an LIP or as having the right to order restraint. For example, if a physician's assistant is licensed by the state to order restraint, and the order does not have to be countersigned by a physician to make it legal pursuant to state law, then that individual is an LIP who may carry out the functions listed in the CoP (CoP Questions and Answers, 2000). In Georgetti v. United Hospital Medical Center (1994), the complaint alleged a failure to maintain siderails in an upright position (Kohlman, 1999). "The plaintiff [unsuccessfully] contended that had this precautionary measure been taken, he would not have been able to get out of his bed, and, thus, he would not have fallen as he was exiting his hospital room." The court found no departure from the accepted standard of practice, reasoning that raising the siderails would have interfered with the permissive physical activity order given by the patient's attending physician. Prohibiting Standing or PRN Orders for Raised Rails. Automatic or routine use of hospital bed siderails poses unwarranted hazards to patient safety and exposes the institution to liability. Federal regulation prohibits the use of standing or "as needed" (that is, PRN) orders for restraint (42 C.F.R. § 482.13(e)(3)(ii)(A); HCFA Interpretive Guidelines). A review of the patient's medical record and/or physician's written or verbal (telephonic) order should verify that restrictive siderail use was ordered for a particular reason and a specified time period (HCFA Interpretive Guidelines). Consulting With Treating Physician Required. If the patient's treating physician did not order restrictive siderail use, federal regulations demand that the treating physician be consulted "as soon as possible" about the prescribed intervention (42 C.F.R. § 482.13(e)(3)(ii)(B); HCFA Interpretive Guidelines). The treating physician is the physician responsible for the management and care of the patient (that is, the patient's attending physician, primary care physician, psychiatrist, or other specialist). The patient's medical record must document contact with the treating physician if he or she did not order the restrictive rail use (HCFA Interpretive Guidelines). Assessing Patient Need for Siderails. The condition of a restrained patient must be continually assessed, monitored, and reevaluated (42 C.F.R. § 482.13(e)(4)). Individualized patient assessment should guide decisions to use or to discontinue siderails. In Garabedian v. William Beaumont Hospital (1996), the Michigan Supreme Court struggled with the role such an assessment might have played in preventing the fall of an 87-year-old woman from a hospital bed with lowered rails before denying leave to appeal a directed verdict for the defendant hospital. Correspondingly, the Georgia Court of Appeals in Smith v. North Fulton Medical Center (1991) focused on evidence that a hospital patient's nursing assessment sheet recommended restrictive rail use and the patient's fall from bed occurred with the siderail in the down position at a time when the patient was heavily sedated.

38

Liability Issues and Risk Management

Rail use must be predicated on a thorough assessment that examines the patient's medical symptoms and builds or modifies a care or treatment plan to meet patient needs (42 C.F.R. § 482.13(e)(3)(iii); HCFA Interpretive Guidelines). Regulatory reference to a "modified" plan of care reinforces the expectation that restrictive siderail use should not be a standard response to a particular behavior or situation (Kahn-Kothmann, 1999). Siderails present an inherent safety risk even when assessment indicates the presence of a medical symptom that may warrant restrictive rail use (HCFA Interpretive Guidelines). Hence, a risk-benefit analysis should be undertaken before raising the rails. A review of progress notes, flow charts, and nursing notes, among other records, may indicate that siderail use is not based on patient need, but on issues such as inadequate staffing or lack of training (HCFA Interpretive Guidelines). For example, does the number of patients with raised rails increase on weekends, on holidays, at night, on certain shifts, where contract nurses are used, or in one unit more than other units? Interpretive Guidelines for Patients' Rights Conditions of Participation On May 19, 2000, HCFA amended the State Operations Manual (SOM) to include interpretive guidelines on hospital Conditions of Participation for patients' rights, effective June 18, 2000 (SOM, 2000). Hospital surveyors rely on these guidelines when enforcing the new requirements. EVOLVING STANDARD OF CARE Satisfying Accreditation Standards Accreditation is a process used by an independent review organization to assess a health care organization's internal system from a qualitative perspective, using standards developed by the organization itself (Hospital Law Manual, 2000). Hospital accreditation standards developed by voluntary organizations may prove helpful in establishing the requisite legal standard of care. The circumstances allowing such accreditation standards to be admitted into evidence vary among jurisdictions (Kapp, 1992). Compliance with accreditation standards, however, will not insulate a hospital from liability if a court concludes that the standards themselves are not adequate. Since the 1950s, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been the predominant private accrediting body for hospitals (Kinney, 1994). "Courts may be persuaded to admit JCAHO standards as probative, albeit not conclusive, evidence in actions" brought against hospitals (Kapp, 1991). JCAHO's accreditation requirements must, at a minimum, meet applicable federal law and regulation. Certainly, the hospital Conditions of Par-

Medico-Legal Aspects ofSiderail Use

39

ticipation concerning patients' rights fall under the "applicable law and regulation" requirement JCAHO must satisfy. A few requirements in the new patients' rights CoP appear more stringent than JCAHO's accreditation standards; therefore, even though hospitals typically are deemed to meet CoP requirements as long as they maintain accreditation, hospitals should take whatever measures are necessary to satisfy those CoP requirements which are more demanding than accreditation requirements. Changing Customary Practice The legal standard of care in professional liability cases is determined, in part, by customary industry practice at the time of the alleged negligence. The permissible contexts for siderail usage are narrowing in response to clinical research and governmental regulations, making it difficult to argue in court that their routine use constitutes accepted good practice in the hospital setting. Despite the trend away from routine rail use, many physicians, nurses and administrators remain hesitant to alter their practice of restrictive siderail use. Changing medical practices is a complex dynamic, especially where habits and beliefs are longstanding (Kapp, 1999; Lown, 1996). Clinical Practice Guidelines To determine whether a health care provider complied with the standard of care in a particular case, the court may consider (or instruct the jury to consider) a variety of evidence, including clinical practice guidelines or protocols (Hospital Law Manual, 2000). The opinion in Robinson v. Medical Center of Central Georgia (1995), for example, references the affidavit of a senior registered nurse and employee describing a hospital's fall risk protocol concerning siderail usage. The impact of clinical practice guidelines on patient care liability has not been fully determined yet (Hospital Law Manual, 2000). However, because clinical practice guidelines as well as other methods of standardizing care (such as protocols) are prevalent in the hospital setting, it is important for health care providers and administrators to understand the potential implications (Hospital Law Manual, 2000). Providers acting in accordance with an accepted clinical practice guideline should cite compliance as evidence of satisfying the requisite standard of care (Hospital Law Manual, 2000). In contrast, plaintiff's counsel should underscore the provider's deviation from the guideline as evidence of negligence (Hospital Law Manual, 2000). Adhering to Hospital Policy and Procedure Policies and procedures to protect hospital patients are an important component of state licensure, JCAHO accreditation, and customary good practice. They are

40

Liability Issues and Risk Management

critical to an effective risk management strategy. Risk management involves, among other actions, a continuing review and revision of policy and procedure to reflect an acceptable quality of care. Institutional policy and procedure may persuade jurors that the hospital failed to provide the patient with the care that the hospital thought necessary and proper (Kohlman, 1999). In Thorson v. Rosewood General Hospital (1980), for instance, the hospital's bed rail policy, which was introduced into evidence, provided the standard of care in the case. In Polonsky v. Union Hospital (1981), the court considered hospital policy "in a sense, an expert opinion concerning the necessity for raising bed rails in the circumstances[.] . . . It was evidence of what the hospital had determined to be necessary and proper to insure the safety of its patients." In Burks v. Christ Hospital (1969), a hospital administrator testified that a "Nurses' Procedures Manual" prescribed a standard of care which nurses are required to follow with regard to siderail use. In Haber v. Cross County Hospital (1975), the hospital's failure to abide by its own rule respecting siderail use was considered as "some evidence of negligence."

Battle of the Experts Expert testimony is usually useful and sometimes critical in establishing the reasonable standard of care for the hospital (Theuman, 2000; Weaver & Smith, 1996). A finding of negligent use or non-use of siderails usually turns on expert testimony about whether rails prevent injuries and whether the staff failed to supervise the patient (Parker & Miles, 1997). There is authority in some jurisdictions for the proposition that a decision on whether to raise rails involves the expert judgment of a physician and is, therefore, beyond the jury's common knowledge (Carrigan v. Sacred Heart Hospital, 1962; Douglass v. St. Joseph Hospital, 1998; Kolanowski v. Illinois Valley Community Hospital, 1989; Mossman v. Albany Medical Center, 1970; Taylor v. City of Beardstown, 1986; Wagner v. Fairview Gen I Hosp., 1988). Other jurisdictions take the opposite view, namely, that questions as to the necessity of siderails are within the common knowledge and experiences of lay jurors (Burks v. Christ Hospital, 1969; Cramer v. Theda Clark Memorial Hospital, 1969; Jones v. Hawkes Hospital ofMt. Carmel, 1964; Kadyszewski v. Ellis Hospital Association, 1993; Louis v. Chinese Hospital Association, 1967; McGravc v. St. Joseph's Hospital, 1997; Norris v. Rowan Memorial Hospital, 1974; Robbins v. Jewish Hosp. of St. Louis, 1983; Walker v. Southeast Alabama Medical Center, 1989).

RISK MANAGEMENT STRATEGIES Risk management presupposes that certain actions may prevent the occurrence of incidents involving siderails and/or minimize hospital liability associated with railrelated incidents that do occur (Hospital Law Manual, 2000). An objective of risk

Medico-Legal Aspects of Si derail Use

41

management is evaluating the risk of liability and taking steps to reduce that risk (by implementing new policies and procedures, for instance).

An Illustration: Hospital Siderail Use at Mount Sinai Medical Center Acute Care for the Elderly (ACE) units evolved in the 1990s as a systematic approach toward prevention of iatrogenic complications among hospitalized older adults (Covinsky et al., 1998; Landefeld et al., 1995). The ACE Unit at the Mount Sinai Medical Center in New York City created an innovative program to prevent falls and injuries while reducing restrictive siderail use (Wexler et al., 2000) in response to facility-specific data indicating that all bed-related fall injuries occurred when four half rails were raised (Wexler et al., 2000). Prior to reducing restrictive siderail use, they initiated several fall prevention policies: identification of patients at high fall risk with neon pink bracelets and signage outside of patient rooms, nonskid slipper socks, special attention to toileting rounds, and sharing fall data among all staff. This program reduced fall-related injury rates among hospitalized older adults on the ACE Unit (Wexler, 2000). A crucial component of the program was the involvement of all levels and types of staff (nurses aides, licensed nurses, and rehabilitation therapists, for example) through group educational sessions, unitbased fall analysis, and individual case consultation.

Staff Education and Performance Review Ongoing staff education must emphasize the risks associated with routine restrictive siderail use, safety evaluation of bed systems, assessment of bed-related fall risk, and interventions to reduce bedside fall incidence (Jensen et al, 1998; Quinn, 1996). Using siderail alternatives is directly related to administrative support for staff (Dunbar et al., 1997; Jensen et al., 1998). This includes consistent messages to staff regarding the legal liability implications of reduced siderail use (Frengley & Mion, 1998; Quinn, 1996). In one hospital, a decision tree facilitates minimal use of restrictive siderails (Jensen et al., 1998). In addition to the strategies employed by the Mount Sinai ACE Unit (Wexler et al., 2000), hospitals are adapting alternatives employed in nursing homes for use in the acute care setting. Good risk management also includes a continuing review of the performance of all persons providing care to patients within the hospital, including physicians and nurses, with the objective of discovering and correcting siderail use practices that may present unacceptable risks to patients.

Incident Reports Incident or occurrence reports are an essential part of good risk and claims management, and may be a fertile source of information for parties in litigation involving hospitals (Hospital Law Manual, 2000). An incident report typically

42

Liability Issues and Risk Management . .. includes spaces for the date and time of the incident; the date of the report; the patient's status and gender; the hospital unit involved; a description of the incident and the medical equipment involved; a notation as to whether a physician was called as a result of the incident; the patient's medical condition before and after the incident; whether the incident involved a fall, medication, or blood[.] . . . The incident report form has signature lines for the person providing the information on the form, the manager, the director, the person contacted, and a vice president, when applicablef.] . .. There is a [space for a] checkmark opposite an entry entitled Standard of Care Met. The last page of the form is captioned To Be Completed by Review Committee. The last page has boxes to be checked for an Analysis of Variances, as well as an evaluation of responsibility. The last page also has several lines which can be completed regarding recommendations and actions, along with boxes to be marked for follow-up. (State of Nebraska v. Buckley, 2000)

In some states, incident reports are sheltered from discovery (Hospital Law Manual, 2000). The scope of this protection is highly dependent on state law, allegations contained in the lawsuit, job duties of the individuals developing and reviewing the incident reports, and surrounding circumstances (Hospital Law Manual, 2000). The variability of court decisions on this matter highlights the importance of establishing specific, strictly implemented reporting procedures for all incidents involving siderails. The Nebraska Supreme Court in State of Nebraska ex ret. AM/SUB, Inc. (Saint Joseph Hospital) v. Buckley (2000), for example, rejected arguments that a hospital's incident report describing a patient's injuries sustained in a fall after climbing out of bed with four raised siderails was protected from discovery by state statute. In Brookwood Medical Center v. Lindstrom (2000), the Alabama Supreme Court listened to testimony about a quality-assurance incident report prepared by the charge nurse at the time of the patient's bedside fall and ultimately concluded that the hospital did not breach the appropriate standard of care in restraining the patient.

Educate Patients and Families About Siderail Alternatives Prior hospital experiences encouraging restrictive siderail use may confuse patients and their families when hospital staff lowers rails (Burger, 1998). Thus, patient and family education is necessary to ensure "buy-in" and to promote patient motivation to remain mobile, if physically possible, throughout hospitalization (Jensen et al., 1998; Kanski et al., 1996; Mahoney, 1998). It is important to include patients and families in the decision-making process. See Figure 3.3 for a sample educational brochure discussing bed safety in hospitals, among other settings (Bed Safety Brochure, Oct. 2000). In addition, consent forms outlining the risks and benefits may reduce potential liability concerns (Quinn, 1996).

Direct Observation of Patients Routine siderail use should not replace adequate observation of patients (Mahoney, 1998). Although alarms, video-monitoring, and "sitters" (that is, paid or volunteer

Bed Rail Entrapment Statistics Today there are about 2.5 million hospital and nursing home beds in use in the United States. Between 1985 and 1999. 371 incidents of patients* caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. food and Drug Administration. Of these reports, 228 people died, 87 had a nonfatal injury, and 56 were not injured because staff intervened. Most patients were frail, elderly or confused.

homes and home care providers to assess patients' needs and to provide safe care without restraints.

The Benefits and Risks of Bed Rails Potential benefits of bed rails include:

Patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm, such as falling. Assessment by the patient's health care team will help to determine how best to keep the patient safe. Historically, physical restraints (such as vests, ankle or wrist restraints) were used to try to keep patients safe in health care facilities. In recent years, the health care community has recognized that physically restraining patients can be dangerous. Although not indicated for this use, bed rails are sometimes used as restraints. Regulatory agaicies, health care organizations, product manufacturers and advocacy groups encourage hospitals, nursing * In llii'i brochure, the term paiienr refer* to a resident of a nursing home, any individual receiving services in a home care setting, nr patients in hospitals.

Figure 3.3 A guide to bed safety.

Most patients can be in bed safely without bed rails. Consider the following: Use beds that can be raised and lowered close to the floor to accommodate both patient and health care worker needs.

Aiding in turning and repositioning within the bed.

Keep the bed in the lowest position with wheels locked.

Providing a hand-hold for getting into or out of bed.

When the patient is at risk of falling out of bed, place mats next to the bed, as long as this does not create a greater risk of accident.

Providing a feelingof comfort and security.

Patient Safety

Meeting Patients' Meeds for Safety

Reducing the risk of patients falling out of bed when being transported. Providing easy access to bed controls and personal care items. Potential risks of bed rails may include: Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint.

Use transfer or mobility aids. Monitor patients frequently. Anticipate the reasons patients get out of bed such as hunger, thirst, going to the bathroom, restlessness and pain; meet these needs by offering food and fluids, scheduling ample toileting, and providing calming interventions and pain relief. When bed rails are used, perform an on-going assessment of the patient's physical and mental status; closely monitor high-risk patients. Consider the following: Lower one or more sections of the bed rail, such as the foot rail.

Feeling isolated or unnecessarily restricted.

Use a proper size mattress or mattress with raised foam edges to prevent patients from being trapped between the mattress and rail.

Preventing patients, who are able to get out of bed, from performing routine activities such as going to the bathroom or retrieving something from a closet.

Reduce the gaps between the mattress and side rails.

Which Ways of Reducing Risks are Best? A process that requires ongoing patient evaluation and monitoring will result in optimizing bed safety. Many patients go through a period of adjustment to become comfortable with new options. Patients and their families should talk to their health care planning team to find out which options are best for them.

jp^ Developed by the Hospital %T Bed Safety Workgroup Participating Organizations: AARP ABA Tort and Insurance PracticeSection American Association of Homes and Services for the Aging

A Guide to Bed Safety

American Health Care Association American Medical Directors Association American Nurses Association

Patient or Family Concerns About Bed Rail Use If patients or family ask about using bed rails, health care providers should: Encourage patients or family to talk to their health care planning team to determine whether or not bed rails are indicated. Reassure patients and their families that in many cases the patient can sleep safely without bed rails. Reassess the need for using bed rails on a frequent, regular basis.

American Society for Healthcare Engineering of the American Hospital Association American Society for Healthcare Risk Management Basic American Metal Products Beverly Enterprises. Inc. Care Providers of Minnesota Carroll Healthcare DePaul College of Law ECRI Evangelical Lutheran Good Samaritan Society Hill-Rom Co., Inc. Joint Commission on Accreditation of Healthcare Organizations Medical Devices Bureau. Health Canada

To report an adverse event or medical device problem, please call PDA's MedWatcb Reporting Program at 1-800-FDA-1088. For additional copies of this brochure, see th« FDA's website at http://www.fda.gw/cdrh/beds/ For more information about this brochure, conact Beryl Goldman at 610-388-5580 or by e-mail at [email protected]. She has volunteered to answer questions. For information regarding a specific hospital bed, contact the bed manufacturer directly.

National Association for Home Care National Citizens' Coalition for Nursing Home Reform National Patient Safety Foundation RN+ Systems Stryker Medical Sunrise Medical. Inc. The Jewish Home and Hospital Untie the Elderly. The Kendal Corporation U.S. Food and Drug Administration Dctoher 200fl

Figure 3.3 Continued.

Bed Rails In Hospitals, Nursing Homes and Home Health Care: The Facts

Medico-Legal Aspects ofSiderail Use

45

one-on-one observers) (Jensen et al., 1998; Mahoney, 1998) aid the nursing staff in supervising patient activities, each patient's fall and/or rail entrapment risk must be assessed on an individualized, case-by-case basis (Capezuti et al., 1998 & 1999; Mahoney, 1998). This evaluation guides the clinician in selecting patient-specific interventions (Capezuti et al., 1998). For example, siderails may be used to prompt a patient to call for assistance before attempting transfer out of bed; however, most patients for whom siderails are used lack the cognitive ability to correctly interpret their intended use (Capezuti & Talerico, 1999). Instead, the patient with memory loss may perceive the siderails as a barrier to go over, around, or through. Since the rails may add up to two feet to potential fall height, the likelihood of patient injury increases (O'Keefe, 1996). Alternatives that remind the patient of the bed's boundaries without adding height to the fall include concave mattresses, bed bumpers on mattress edges, full body pillows, pillows, or rolled blankets under the mattress edge (Capezuti et al., 1998; 1999).

Use Low Height Beds "Some patients fall while getting out of high hospital beds, sometimes while climbing over the bed rails. High beds are for the staff's convenience, not the patient's" (Beers & Berkow, 2000, p. 102). Some hospital beds simply are too high for some patients, even with bed placement in its lowest position, usually 21 inches from the floor (Mahoney, 1998). Several bed manufacturers have responded by producing hydraulically or electrically adjustable beds that promote safe transfer for certain patients who are 12 to 20 inches from the floor (Braun & Capezuti, 2000; Capezuti et al., 1998; 1999). "When risk of falling is thought to be significant, beds should be kept low to the ground unless elevation is needed temporarily for examination or procedures" (Beers & Berkow, 2000, p. 100). For patients unable to stand safely and who may accidentally roll out of or attempt an unsafe exit from bed, a very low bed height (6 to 13 inches from the floor) is recommended. Although most low bed height models are directed toward the nursing home setting, it is expected that manufacturers will produce similar beds for the acute care setting.

Lessen Impact on Hard Surfaces Falling onto hard surfaces increases the likelihood of serious injury such as fractures (Nevitt & Cummings, 1993). A bedside cushion, such as an exercise mat or an egg crate foam mattress, reduces impact (Capezuti et al., 1999; Letizia, 1999b). Hip pad protectors also reduce the risk of hip fracture among fallers (Kannus et al., 2000; Lauritzen et. al., 1993; Robinovitch et al., 1995; Studenski & Wolter, 1998).

Improve Bed Frame, Rail, and Mattress Design No universal standards exist for hospital bed siderail design. Researchers (and the chapter's authors) advocate a unified re-design of the relationship between rails,

46

Liability Issues and Risk Management

mattresses, and beds that are often assembled and used as separate products (Miles & Parker, 1998; Parker & Miles, 1997). In April 1999, February and October 2000 and March 2001, the chapter's authors joined representatives from government agencies, hospitals, resident and patient advocacy organizations, bed manufacturers, research institutions, and health care provider organizations convened by the FDA to consider, among other items, evidence-based hospital bed design guidance. In Trew v. Smith and Davis Manufacturing Company (1996), a case involving a nursing home resident's death following rail and in-bed entrapment, the plaintiff successfully argued that the hospital bed siderail was negligently designed to allow a person's head to fit between the bars. Discovery revealed that the manufacturer sold 300,000 units of the siderail model at issue in the litigation despite reports of entrapment involving the product, sometimes resulting in death. A $70,000 settlement offer extended by the manufacturer was rejected. A New Mexico jury returned a $4.5 million dollar wrongful death award. Risk Management Practice Tips If it is determined that rails are required and that other environmental or treatment considerations are inappropriate or have been tried unsuccessfully, then close attention must be given to the bed frame, mattress, and the rails themselves. An effective risk management strategy to prevent patient death and injury involves: Inspecting all bed frames, siderails, and mattresses during a regular maintenance program to identify possible entrapment areas (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). For example, widely spaced vertical bars within the rails allow a patient's head, neck, or body to pass through the opening and become entrapped. A dimensional cone-shaped device, depicted in Figure 3.4, may aid in identifying entrapment zones. Assessing the relationship between bed frame, rails, and mattress (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). The mattress-siderail interface, for instance, should be tight to prevent the patient from falling between the mattress and siderails. A tightly fitting mattress or an added inlay should fill the triangular space between the rails, headboard, and mattress. Evaluating patient size and/or weight. Increased risk occurs where patient size and/or weight are inappropriate for bed frame, mattress, and rail dimension (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). Replacing legacy equipment that may pose an injury or entrapment hazard. Checking for compression of the mattress at the perimeter. Easily compressed perimeters may increase the gap between the mattress and the rail. In addition, a patient's weight, movement, or bed position may compress the mattress and cause gaps (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). Conducting a random check to ascertain siderail latch strength and durability. Latch failure may collapse the widely spaced vertical bars on the resident's

Medico-Legal Aspects of Side rail Use

47

Figure 3.4 Proposed Assessment Tool by the Hospital Bed Safety Workgroup. The assessment process and the tool's dimensions are currently undergoing pilot testing at several clinical sites. neck. A check also ensures that the rails themselves are securely fastened. In Gerry v. The King David Convalescent Home (Settlement in Suit Against Nursing Home, 1998), a $125,000 settlement was reached in a case involving a 97-year-old nursing home resident who sustained multiple contusions and lacerations after falling from a hospital bed being wheeled down the hall when the siderail broke. A subsequent random check of approximately 25 rails was conducted and all were found securely fastened and, consequently, the facility was not cited for any deficiencies due to the incident (Settlement in Suit Against Nursing Home, July 1998). Confirming that the mattress matches and fits relative to rail width and height. Not all siderails, mattresses, and bed frames are interchangeable. In general, mattresses and bed frames should not be mixed, because mattresses are designed for particular bed frame sizes. Mixing increases the risk for enlarging the space between the rails and the mattress. Dimensions of replacement mattresses and siderails also may differ from the original equipment supplied or specified by the bed frame manufacturer. Hospitals should check with the manufacturer(s) to ensure compatibility if rails and mattresses are purchased separately (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). In addition, care

48

Liability Issues and Risk Management

should be taken that the mattress does not shrink over time or after cleaning. Such shrinkage may increase the space between the rails and the mattress. Installing siderails pursuant to manufacturer instruction should yield a proper fit and avoid bowing, among other possible problems, by assuring the appropriate distance from the head and footboard (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). Using protective barriers to close off open spaces where a patient might become entrapped. Hospital procedures and/or the manufacturer's recommendations should be followed for installing and maintaining protective barriers for a particular bed frame and siderail (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). Following hospital policy and procedure concerning siderail use. Prohibiting substitution of siderails for other restraints, such as a vest or wrist/leg device (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000). Identifying alternative interventions to replace siderail use for patients at highrisk of entrapment. The impact of the chosen intervention on the patient's safety and well-being should be assessed (Braun & Capezuti, 2000; FDA Entrapment Alert, 2000).

CONCLUSION There has been growing recognition over the last decade that siderail use that restricts or deters movement out of bed is contrary to a rehabilitative or restorative approach to care. Increasing reports of siderail entrapment injuries and deaths, coupled with a lack of evidence supporting their use in fall prevention, have prompted experts to question their clinical utility (Frengley, 1999). Appropriately, this has led to the redesign of hospital bed systems and the development of interventions seeking to prevent bed-related falls. These initiatives, coupled with federal regulations supporting clinical judgment based on individualized fall assessment, likely will lead to reductions in restrictive siderail use in the acute care setting. A hospital's multiple interests in regulatory compliance, maintenance of voluntary accreditation, and the limitation of tort liability exposure will all be well served by reducing or eliminating restrictive siderail use (Kapp, 1999).

REFERENCES ACS Position Statement: Guidelines for Restraint Use (1991), available at http:// www.americangeriatrics.org/products/positionpapers/restrain.shtml Annas, G. J. (1999). The last resort—The use of physical restraints in medical emergencies. New England Journal of Medicine, 341, 1408-1412. Anwar, H. R., & Weinstein, K. R. (May, 1998). Proposed Medicare hospital conditions of participation: How will they affect you and your clients? Health Lawyer, JO (5), 1-7.

Medico-Legal Aspects of Siderail Use

49

Bakarich, A., McMillan, V., & Prosser, R. (1997). The effect of a nursing intervention on the incidence of older patient falls. Australian Journal of Advanced Nursing, 15, 26-31. Baker, S. P., O'Neill, B., Ginsburg, M. J., & Li, G. (1992). The injury fact book. New York: Oxford University Press. Ball, M. C., Hanger, H. C., & Thwaites, J. H. (1997). Bed rails: A barrier to independence? Clinical Rehabilitation 11, 347^9. Barbieri, E. B. (1983). Patient falls are not patient accidents. Journal of Gerontological Nursing, 9, 165-172. Barry, P. P. (1986). latrogenic disorders in the elderly: Preventive techniques. Geriatrics, 41,42-41. Bates, D. W., Pruess, K., Souney, P., & Platt R. (1995). Serious falls in hospitalized patients: Correlates and resource utilization. American Journal of Medicine, 99 (2), 137-143. Beers, M. H., & Berkow, R. (Eds.). (2000). Merck Manual of Geriatrics. (3rd ed.). Whitehouse Station, NJ: Merck & Co., Inc. Bradway, C. W., Hernly, S., & NICHE Faculty. (1998). Urinary incontinence in older adults admitted to acute care. Geriatric Nursing, 19, 98-102. Braun, J. A. & Capezuti, E. (2000a). Siderail use and legal liability issues in nursing homes. Illinois Bar Journal, 88. 324-326, 328-329, 332, 334. Braun, J. A., & Capezuti, E. (2000b). The legal and medical aspects of physical restraints and bed siderails and their relationship to falls and fall-related injuries in nursing homes. De Paul Journal of Healthcare Law, 3(1) 1-72. Braun, J. A., & Capezuti, E. (2000c). Legal implications of hospital siderail use [Abstract]. Gerontologist, 40 (Special Issue I), 117. BrookwoodMed. Ctr. v. Lindstrom, No. 1980526, 2000 WL 146816 (Ala. Feb. 11, 2000). Brush, B. L., & Capezuti, E. (in press). A historical analysis of siderail use in American hospitals. Journal of Nursing Scholarship. Bryant, H., & Fernald, L. (1997). Nursing knowledge and use of restraint alternatives: Acute and chronic care. Geriatric Nursing, 18, 57-60. Burger, S. G. (1998). Working with families and residents. [Abstract]. Gerontologist, 38 (Special Issue I), 22.7. Burks v. Christ Hosp., 249 N.E.2d 829 (Ohio 1969). Clorinda M., Cali, C. M., & Douglas P. Kiel, D. P (1995). An epidemiologic study of fallrelated fractures among institutionalized older people. Journal of the American Geriatrics Society, 43, 1336-40. Capezuti, E. (2000a). Preventing falls and injuries while reducing siderail use. Annals of Long-Term Care, 8 (6), 57-63. Capezuti, E. (2000b). Analysis of advanced practice nurse recommendations to reduce siderail use [Abstract]. Gerontologist, 40 (Special Issue I), 146. Capezuti, E., Bourbonniere, M., Strumpf, N., & Maislin, G. (2000). Siderail use in a large urban medical center [Abstract]. Gerontologist, 40 (Special Issue I), 117. Capezuti, E., Evans, L., Strumpf, N., & Maislin, G. (1996). Physical restraint use and falls in nursing home residents. Journal of the American Geriatrics Society, 44, 627-633. Capezuti, E. & Lawson, W. T. Ill (1999). Falls and restraint liability issues. In P. Iyer (Ed.), Nursing Home Litigation: Investigation and Case Preparation. Tucson, AZ: Lawyers and Judges Publishing Company.

50

Liability Issues and Risk Management

Capezuti, E., Strumpf, N., Evans, L, Grisso, J. A., & Maislin, G. (1998). The relationship between physical restraint removal and falls and injuries among nursing home residents. Journal of Gerontology: Medical Sciences, 53A, M47-M53. Capezuti, E., Strumpf, N., Evans, L., & Maislin, G. (1998). Siderail use and nighttime falls among nursing home residents [Abstract]. Gerontologist, 38 (Special Issue I), 226. Capezuti, E., Strumpf, N., Evans, L., & Maislin, G. (1999). Outcomes of nighttime physical restraint removal for severely impaired nursing home residents. American Journal of Alzheimer's Disease, 14, 157-164. Capezuti, E., & Talerico, K. A. (1999). Review article: Physical restraint removal, falls and injuries. Research and Practice in Alzheimer's Disease, 2, 338-355. Capezuti, E., Talerico, K. A., Strumpf, N., & Evans, L. (1998). Individualized assessment and intervention in bilateral siderail use. Geriatric Nursing, 19 (6), 322-330. Capezuti, E., Talerico, K., Wagner, L., Strumpf, N., Becker, H., & Maislin, G. (1999). The effect of a low-height bed intervention on nightfalls among frail nursing home residents [Abstract]. Gerontologist, 39 (Special Issue I), 196. Capezuti, E., Talerico, K. A., Cochran, L, Becker, H., Strumpf, N., & Evans, L. (1999). Individualized interventions to prevent bed-related falls and reduce siderail use. Journal of Gerontological Nursing, 25, 26-34. Carrigan v. Roman Catholic Bishop, 178 A.2d 502 (N.H. 1962). Castle, N. G., & Vincent Mor, V. (1998). Physical restraints in nursing homes: A review of the literature since the nursing home reform act of 1987. Medical Care Research & Review, 55, 139-70. Catchen, H. (1983). Repeaters: Inpatient accidents among the hospitalized elderly. Gerontologist, 23, 273-76. Clark, L. P., Dion, D. M., & Barker, W. H. (1990). Taking to bed: Rapid functional decline in an independently mobile older population living in an intermediate-care facility. Journal of the American Geriatrics Society, 38, 967-972. Code of Federal Regulations, Vol. 42, § 482.13 Conditions of Participation: Patients' Rights (as of Oct. 1, 1999). Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register. Section 482.13 begins on pages 354 through 356. Covinsky, K. E., Palmer, R. M., Kresevic, D. M., Kahana, E., Counsell, S. R., Fortinsky, R. H., & Landefeld, C. S. (1998). Improving functional outcomes in older patients: lessons from an acute care for elders unit. Joint Commission Journal on Quality Improvement, 24, 63-76. Cramer v. Theda Clark Memorial Hosp., 172 N.W.2d 427 (Wis.1969). Creditor, M. C. (1993). Hazards of hospitalization of the elderly. Annals of Internal Medicine, 118 (3), 219-223. Department of Health & Human Services, Food & Drug Administration, FDA Safety Alert: Entrapment Hazards with Hospital Bed Siderails (Aug. 23, 1995). Donius, M., & Rader, J. (1994). Use of siderails: rethinking a standard practice. Journal of Gerontological Nursing, 20 (11), 23-27. Donius, M., & Rader, J. (1996). Siderails: Rethinking a standard practice. In V. Burggraf & R. Barry (Eds.), Gerontological Nursing: Current Practice and Research (pp. 225-232). Thorofare, NJ: SLACK Incorporated. Douglas v. St. Joseph Hosp., 667 N.Y.S.2d 477 (N.Y. App. Div. 1998).

Medico-Legal Aspects of Siderail Use

51

Dunbar, J. M., Neufeld, R. R., Libow, L. S., Cohen, C. E., & Foley, W. J. (1997). Taking charge: The role of nursing administrators in removing restraints. Journal of Nursing Administration, 27, 42-48. Editorial. (1984). Cotsides - Protecting whom against what? Lancet, 35, 383-384. Ejaz, F. K., Jones, J. A., & Rose, M. S. (1994). Falls among nursing home residents: An examination of incident reports before and after restraint reduction programs. Journal of the American Geriatrics Society, 42 (9), 960-964. Estate of Minnie Viola Wilson v. Wilson v. HealthSouth Corp. dlblal HealthSouth Rehabilitation Hasp., No. 096-160043-95 (Dist. Ct. 96th Jud. Dist. Tarrant Cty. Tex., Aug. 5,1996). Evans, L. K., & Strumpf, N. E. (1989). Tying down the elderly: A review of the literature on physical restraints. Journal of the American Geriatrics Society, 36 (1), 65-74. Evans, L. K., Strumpf, N. E., Allen-Taylor, S. L., Capezuti, E., Maislin, G., & Jacobsen, B. (1997). A clinical trial to reduce restraints in nursing homes. Journal of the American Geriatrics Society, 45, 675-681. Everitt, V., & Bridel-Nixon, J. (1997). The use of bed rails: Principles of patient assessment. Nursing Standard, 12 (6), 44-47. Feinsod, F. M., Moore, M., & Levenson, S. A. (1997). Eliminating full-length bed side rails from long-term care facilities. Nursing Home Medicine, 5, 257-263. FDA Safety Alert: Potential hazards with restraint devices. U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD, July 15, 1992. FDA Safety Alert: Entrapment Hazards with Hospital Bed Siderails. U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD, August 23, 1995. Fletcher, K. (1996). Use of restraints in the elderly. AACN Clinical Issues, 7, 611-635. Food and Drug Administration, Hospital Bed Safety Workgroup. (2000). A Guide to Bed Safety. [Brochure]. Washington, DC: FDA. Fortinsky, R. H., Covinsky, K. E., Palmer, R. M., & Landefeld, C. S. (1999). Effects of functional status changes before and during hospitalization on nursing home admission of older adults. Journals of Gerontology: Medical Sciences, 54, M521-M526 (1999). Frengley, J. D. (1999). Bedrails: Do they have a benefit? Journal of the American Geriatrics Society, 47, 621-62%. Gaebler, S. (1983). Predicting which patient will fall again . . . and again. Journal of Advanced Nursing, 18, 1895-1902. Garabedian v. William Beaumont Hosp., 547 N.W.2d 654 (Mich. 1996), reconsideration denied, 546 N.W.2d 255 (Mich. 1996). Georgetti v. United Hosp. Med. Ctr., 204 A.D.2d 271 (N.Y. App. Div. 1994). Greenleaf, J. E., Van Beaumont, W. Convertine, V. A., & Starr, J. C. (1983). Handgrip and general muscular strength and endurance during prolonged bedrest with isometric and isotonic leg exercise training. Aviation Space Environmental Medicine, 54, 696-700. Grisso, J. A., Chiu, G. Y., Maislin, G., Steinmann, W. C., & Portale, J. (1991). Risk factors for hip fractures in men: A preliminary study. Journal of Bone & Mineral Research, 6 (8), 865-868. Haber v. Cross County Hosp., 340 N.E.2d 734 (N.Y. 1975). Hanger, H. C., Ball, M. C., & Wood, L. A. (1999). An analysis of falls in the hospital: Can We Do Without Bedrails? Journal of the American Geriatrics Society, 47, 529-531.

52

Liability Issues and Risk Management

Hamilton, L., & Lyon, P. S. (1995). A nursing-driven program to preserve and restore functional ability in hospitalized elderly patients. Journal of Nursing Administration, 25 (4), 30-37(1995). Hammond, M., & Levine, J. M. (1999). Bedrails: Choosing the best alternative. Geriatric Nursing 20, 297-300. Hendrich, A. L. (1988). An effective unit-based fall prevention plan. Journal of Nursing Quality Assurance, 3 (28), 28-36. Hendrich, A. L. (1988). Unit-based fall prevention. Journal of Nursing Quality Assurance 10(15), 15-17. Hirsch, C. H., Sommers, L., Olsen, A., Mullen, L., & Winegrad, C. H. (1990). The natural history of functional morbidity in hospitalized older patients. Journal of the American Geriatrics Society, 38, 1296-1303. Hoenig, H. M., & Rubenstein, L. Z. (1991). Hospital-associated deconditioning and dysfunction. Journal of the American Geriatrics Society, 39, 220-2. Hospital Law Manual (Kara Kinney Cartwright & Susan M. Kole eds., 1998 & Supp. Sept. 2000). Innes, E. M., & Turman, W. G. (1983). Risk management: Evaluation of patient falls. Quality Review Bulletin, 9, 30-35. Inouye, S. K., Wagner, D. R., Acampora, D., Horwitz, R. I., Cooney, L. M., Hurst, L. D., & Tinetti, M. E. (1993). A predictive index for functional decline in hospitalized elderly medical patients. Journal of General Internal Medicine, 8 (12), 645-52. Inouye, S. K., & Charpentier, P. A. (1996). Precipitating factors for delirium in hospitalized elderly patients. Journal of the American Medical Association, 275, 852-857. Janelli, L. M. (year). Physical restraint use in acute care settings. Journal of Nursing Care Quality, 9, 86-92. Jarvinen, K., & Jarvinen, P. (1968). Falling from bed as a complication of hospital treatment. Journal of Chronic Disease, 21, 375-378. Jehan, W. (1999). Restraint or protection? The use of bedside rails. Nursing Management, 6 (2), 9-13. Jensen, B., Hess-Zak, A., Johnston, S. K., Otto, D. C., Tebbe, L., Russell, C. L., & Waller, A. S. (1998). Restraint reduction a new philosophy for a new millennium. Journal of Nursing Administration, 28 (7/8), 32-38. Joint Commission on accreditation of Healthcare Organizations (1996). Comprehensive Accreditation Manual for Hospitals (Restraint and Seclusion standards plus scoring: Standards TX7.1-TX7.1.3.3, 191-193J). Oakbrook: Terrace, II: Joint Commission on accreditation of Healthcare Organizations. Joint Commission on Accreditation of Healthcare Organizations, Issue 8 Sentinel Event Alert: Preventing Restraint Deaths (Nov. 18, 1998). Available: (visited July 10, 2000). Jones v. Hawkes Hasp. ofMt. Carmel, 196 N.E.2d 592 (Ohio 1964), opinion modified by, Wagner v. Fairview Gen'lHosp., No. 54168, 1988 WL 87528 (Ohio Ct. App. Aug. 4, 1988). Kadyszewski v. Ellis Hosp. Ass'n, 192 A.D.2d 765 (N.Y. App. Div. 1993). Kahn-Kothmann, A. M. (August, 1999). HCFA interim final rules on patients' rights under Medicare hospital conditions of participation. Health Lawyer, 11 (6), 18-22. Kannus, P., Parkkari, J., Niemi, S., Pasanen, M., Palvenen, M., Jarvinen, M., & Vuori, I. (2000). Prevention of hip fracture in elderly people with use of a hip protector. New England Journal of Medicine, 343, 1506-1513.

Medico-Legal Aspects of Si derail Use

53

Kanski, G. W., Janelli, L. ML, Jones, H. M., & Kennedy, M. C. (1996). Family reactions to restraints in an acute care setting. Journal of Gerontological Nursing, 22 (6) 17-22. Kapp, M. B. (1991). Malpractice liability in long-term care: A changing environment. Creighton Law Review, 24, 1235-1260. Kapp, M. B. (1992). Geriatrics and the law. Patient rights and professional responsibilities (2nd ed.). New York: Springer Publishing. Kapp, M. B. (1994). Physical restraints in hospitals: Risk management's reduction role. Journal of Healthcare Risk Management, 14 (1), 3-8. Kapp, M. B. (1996). Physical restraint use in critical care: Legal issues. AACN Clinical Issues, 7, 570-585. Kapp, M. B. (1999). Restraint reduction and legal risk management. Journal of the American Geriatrics Society, 47, 375. Kapp, M. B. (Summer, 1999). Physical restraint use in acute care hospitals: Legal liability issues. Elder's Advisor, 1, 1-10. Kapp, M. B. (1999). Geriatrics and the law: Understanding patient rights and professional responsibilities. (3rd ed.). New York: Springer Publishing. Kinney, , E. D. (1994). Private accreditation as a substitute for direct government regulation in public health insurance programs: When is it appropriate? Law & Contemporary Problems, 57, 47-80. Kobs, A. (1997). Questions and answers from the JCAHO: Patient restraints. Nursing Management, 2 See, e.g., JOEL F. HANDLER, DOWN FROM BUREAUCRACY: THE AMBIGUITY OF PRIVATIZATION AND EMPOWERMENT 51-53 (1996) (noting the costs entailed for nursing facilities to comply with regulatory requirements); Jeremy Sugarman et al., The Cost of Ethics Legislation: A Look at the Patient Self-Determination Act, 3 KENNEDY INST. ETHICS J. 387, 389-95 (1993) (estimating the financial costs to a hospital from complying with the federal Patient Self-Determination Act); John F. Schnelle & Cornelia Beck, Costs of Promoting Independence, 47 J. AM. GERIATRICS SOC'Y 1151 (1999) (arguing that costs must be analyzed for all areas subject to OBRA regulations). 66 59Fed. Reg. 3040(1994). 61 Id. at 3041. M See Troy J. Crotts & Daniel A. Martinez, The Nursing Home Residents' Rights Act—A Good Idea Gone Bad!, 26 STETSON L. REV. 599,612-13 (1996) (criticizing Florida's Residents' Rights Act for its potential adverse effects on both residents and the nursing facility industry). M See HANDLER, supra note 65, at 149-50 (illustrating how long term care consumers may have choices constrained because of the regulatory straight]acket into which providers

152

Liability Issues and Risk Management

are placed); Kapp, supra note 14, at 32-44 (illustrating how nursing facility residents may have their choices constrained because regulatory requirements prevent nursing facilities from honoring certain resident choices); see also infra notes 109-10 and accompanying text. 10 See generally Kane, supra note 7 (suggesting alternative means). 7 The Balanced Budget Act of 1997, Pub. L. 105-33, 111 Stat. 251 (1997), section 4432 required the implementation of a prospective payment system (PPS) for SNFs covering all costs (routine, ancillary and capital) related to covered services furnished to beneficiaries under Part A of the Medicare program. The PPS provides for per diem payment rates adjusted for case mix, or the resource intensity of each resident, and for geographic variation in wages. n See HCFA, supra note 7, at 5-16 (addressing the private accreditation alternatives in depth). "RAND E. ROSENBLATT ET AL., LAW OF THE AMERICAN HEALTH CARE SYSTEM 1212 (1997). 74 Winick, supra note 58, at 184; Christopher Slobogin, Therapeutic Jurisprudence: Five Dilemmas to Ponder, 1 PSYCHOL., PUB. POL'Y, & L. 193, 204-07 (1995). 7i See Catherine Hawes et al., The OBRA-87 Nursing Home Regulations and Implementation of the Resident Assessment Instrument: Effects on Process Quality, 45 J. AM. GERIATRICS SOC'Y 977, 983-84 (1997) (explaining that even the strongest supporters of federal regulation admit the difficulty of proving that positive change should be attributed to new regulation); supra note 48 and accompanying text. 16 See, e.g., GENERAL ACCOUNTING OFFICE, GAO/HEHS-99-46, NURSING HOMES: ADDITIONAL STEPS NEEDED TO STRENGTHEN ENFORCEMENT OF FEDERAL QUALITY STANDARDS (1999) (blaming weak enforcement efforts); GENERAL ACCOUNTING OFFICE, GAO/HEHS-98-202, CALIFORNIA NURSING HOMES: CARE PROBLEMS PERSIST DESPITE FEDERAL AND STATE OVERSIGHT (1998) (blaming weak enforcement for quality problems). Cf. GENERAL ACCOUNTING OFFICE, GAO/HEHS-99154R, NURSING HOME OVERSIGHT: INDUSTRY EXAMPLES Do NOT DEMONSTRATE THAT REGULATORY ACTIONS WERE UNREASONABLE (1999) (rejecting claims of the nursing home industry that state surveyors are overzealous in their enforcement of regulations). "COMMONWEALTH FUND, RECENT GRANTS AWARDED BY THE BOARD OF TRUSTEES 3 (1999). n See CATHERINE HAWES, THE COMMONWEALTH FUND, ASSURING NURSING HOME QUALITY: THE HISTORY AND IMPACT OF FEDERAL STANDARDS IN OBRA-1987 (1996) (reviewing some of the literature available at that time). ™See Bruce C. Vladeck, The Past, Present, and Future of Nursing Home Quality, 275 JAMA 425 (1996). But see Bruce C. Vladeck & Marvin Feuerberg, Unloving Care Revisited, GENERATIONS, Winter 1995-1996, at 9 (the same individual with a more limited endorsement of OBRA's positive impact). w See Nancy-Ann Min DeParle, Message from the Administrator, HCFA HEALTH WATCH , Aug. 1998, at 3; HCFA, supra note 7, at 19-21, 22-35. *]See Vladeck, supra note 79. *2See Karen Dorman Marek et al., OBRA '87: Has It Resulted in Better Quality of Care? 22 J. GERONTOLOGICAL NURSING 28 (1996). "See Elon & Pawlson, supra note 31; Jonathan M. Evans et al., Medical Care of Nursing Home Residents, 70 MAYO CLINIC PROCEEDINGS 694 (1995).

Quality of Care and Quality of Life in Nursing Facilities

153

"4See 42 U.S.C.A. § 483.20 (West Supp. 1999); 62 Fed. Reg. 67174 (1997). K See Marilyn J. Rantz et al., Minimum Data Set and Resident Assessment Instrument: Can Using Standardized Assessment Improve Clinical Practice and Outcomes of Care? 25 J. GERONTOLOGICAL NURSING 35 (1999); Hawes et al., supra note 75; Charles D. Phillips et al., Geriatric Assessment in Nursing Homes in the United States: Impact of a National Program, GENERATIONS, Winter 1997-1998, at 15. *''See Hawes et al., supra note 75, at 979, 981. "See id. at 981-82. m See id. at 982. m See id. ""See id. ^See id. "Brant E. Fries et al., Effect of the National Resident Assessment Instrument on Selected Health Conditions and Problems, 45 J. AM. GERIATRICS SOC'Y 994 (1997). '"David R. Zimmerman, The Power of Information: Using Resident Assessment Data to Assure and Improve the Quality of Nursing Home Care, GENERATIONS, Winter 1997-1998, at 52, 52. '"Joseph G. Ouslander, The Resident Assessment Instrument (RAI): Promise and Pitfalls, 45 J. AM. GERIATRICS SOC'Y 975, 975 (1997); see also Mark Snowden, et al., Validity and Responsiveness of the Minimum Data Set, 47 J. AM. GERIATRICS SOC'Y 1000 (1999) (finding that the MDS may be limited as an outcome assessment instrument); J. Johnson-Pawlson & Donna L. Infeld, Nurse Staffing and Quality of Care in Nursing Facilities, 22 J. GERONTOLOGICAL NURSING 36, 44 (1996) (providing that state survey data "is at best gross measures of how well nursing care is provided"). "''See Charles D. Phillips et al., Association of the Resident Assessment Instrument (RAI) with Changes in Function, Cognition, and Psychosocial Status, 45 J. AM. GERIATRICS SOC'Y 986 (1997). % Paul Y. Takahashi et al., The Physician's Response to Institutional Mistreatment, 6 ETHICS, L. & AGING REV. 191 (2000). vl See GENERAL ACCOUNTING OFFICE, GAO/HEHS-99-46, NURSING HOMES: ADDITIONAL STEPS NEEDED TO STRENGTHEN ENFORCEMENT OF FEDERAL QUALITY STANDARDS (1999) (blaming weak enforcement efforts); GENERAL ACCOUNTING OFFICE, GAO/HEHS-98-202, CALIFORNIA NURSING HOMES: CARE PROBLEMS PERSIST DESPITE FEDERAL AND STATE OVERSIGHT (1998) (blaming weak enforcement for quality problems). 98 U.S. DEP'T OF HEALTH AND HUMAN SERVICES, OFFICE OF INSPECTOR GENERAL, QUALITY OF CARE IN NURSING HOMES: AN OVERVIEW (1999); see also GENERAL ACCOUNTING OFFICE, GAO/HEHS-00-6, NURSING HOME CARE: ENHANCING HCFA OVERSIGHT OF STATE PROGRAMS WOULD BETTER ENSURE QUALITY (1999) (reporting significant failures in the monitoring of nursing home quality of care). w See Bragg, supra note 26, at 3-4; see also Harriet A. Fields, Closed for Good, WASH. POST, June 22, 1997, at Cl (describing horrible conditions for residents at D.C. Village, the now boarded up nursing home once operated by the District of Columbia). '""Vladeck & Feuerberg, supra note 79, at 9; see also Rebecca J. Coccia & Elizabeth A. Cameron, Caring for Elderly Individuals in Nursing Homes, 25 J. GERONTOLOGICAL NURSING 38, 40 (1999) (lamenting that substandard care continues to be provided in nursing homes more than a decade after the OBRA reforms were enacted).

154

Liability Issues and Risk Management

""Kane, supra note 1, at 233. W2 See supra notes 34-44 and accompanying text. m See, e.g., Bruce J. Winick, On Autonomy: Legal and Psychological Perspectives, 37 VILL. L. REV. 1705, 1755-68 (1992) (summarizing the literature on the psychology of choice); WINICK, THE RIGHT TO REFUSE, supra note 59, at 328-37 (discussing the psychological value of choice). l(M Marek et al., supra note 82, at 31. 105 REBECCA D. ELON, Medical Practice in Nursing Facilities: Assessing the Impact of OBRA, in QUALITY CARE IN GERIATRIC SETTINGS 18, 23 (Paul R. Katz et al. eds. 1995). m See Kapp, supra note 14, at 32-35. m See Jiska Cohen-Mansfield et al., Autonomy for Nursing Home Residents: The Role of Regulations, 13 BEHAV. Sci. & L. 415 (1995). m See generally MARSHALL B. KAPP, OUR HANDS ARE TIED: LEGAL TENSIONS AND MEDICAL ETHICS 99-100, 109-10 (1998) (discussing this source of legal anxiety for providers). m See A GOOD DEATH: SHAPING HEALTH CARE FOR THE LAST MONTHS OF LIFE (Joan K. Harrold & Joanne Lynn eds., 1998) (discussing relationship between feelings of control and quality of life during the dying process); ROGER C. BONE, REFLECTIONS: A GUIDE TO END OF LIFE ISSUES FOR You AND YOUR FAMILY (1997) (same); NORMAN L. CANTOR, ADVANCE DIRECTIVES AND THE PURSUIT OF DEATH AND DIGNITY (1993) (same). l[a See Dwight B. Brock & Daniel J. Foley, Demography and Epidemiology of Dying in the U.S. with Emphasis on Deaths of Older People, 13 HOSPICE J. 49 (1998). "'Pub. L. 101-508, 104 Stat. 1388 (1997). m ld. "'Nursing facilities as well as hospitals, home health agencies, health maintenance organizations, preferred provider organizations, and hospices are included. See generally PATIENT SELF-DETERMINATION IN LONG-TERM CARE: IMPLEMENTING THE PSDA IN MEDICAL DECISIONS (Marshall B. Kapp ed., 1994) (discussing application of the PSDA to nursing facilities and home health agencies). "4Cruzan v. Director, Missouri Dep't of Health, 497 U.S. 261 (1990); see Sandra H. Johnson, PSDA in the Nursing Home, HASTINGS CENT. REP, Sept.-Oct. 1991, at S3 (discussing implications of the PSDA in nursing facilities in the wake of the Cruzan decision). "The literature on advance medical directives is voluminous. See, e.g., Bretton J. Horttor, A Survey of Living Will and Advanced Health Care Directives, 74 N. DAKOTA L. REV. 233 (1998) (summarizing the law on advance directives); NANCY M.P. KING, MAKING SENSE OF ADVANCE DIRECTIVES (1996) (providing an excellent explanation of advance directives); CANTOR, supra note 109 (explaining advance directives). "657Fed. Reg. 8194(1992). '"Veronica F. Engle, Care of the Living, Care of the Dying: Re conceptualizing Nursing Home Care, 46 J. AM. GERIATRICS SOC'Y 1172, 1173 (1998). 118 Nicholas G. Castle & Vincent Mor, Advance Care Planning in Nursing Homes: Pre- and Post-Patient Self-Determination Act, HEALTH SERV. RES., Apr. 1998, at 101; see also Joan M. Teno et al., Changes in Advance Care Planning in Nursing Homes Before and After the Patient Self-Determination Act: Report of a 10-State Survey, 45 J. AM.

Quality of Care and Quality of Life in Nursing Facilities

155

GERIATRICS SOC'Y 939 (1997) (finding that implementation of the PSDA, as measured by execution of advance directives, varied widely by geographic location). But see Mathy Mezey et al, Implementation of the Patient Self-Determination Act (PSDA) in Nursing Homes in New York City, 45 J. AM. GERIATRICS SOC'Y 43 (1997) (finding that the number of advance directives per bed did not vary significantly by facility size, ownership, religious affiliation, or whether or not the nursing home had a formal ethics committee). '"See Elizabeth H. Bradley et al., The Patient Selj"-Determination Act and Advance Directive Completion in Nursing Homes, 1 ARCHIVES FAM. MED. 417 (1998); see also Elizabeth H. Bradley & John A. Rizzo, Public Information and Private Search: Evaluating the Patient Self-Determination Act, 24 J. HEALTH POL., POL'Y & L. 239 (1999) (finding that the effect of the law varies among identifiable subgroups). 12 "For a discussion of potential implementation barriers, see Kapp, supra note 14, at 35-43. i: 'Leslie Walker & Barbara Blechner, Continuing Implementation of the Patient Self-Determination Act in Nursing Homes: Challenges, Opportunities, and Expectations, GENERATIONS, Winter 1995-1996, at 73, 73. But see Connie Zuckerman, Looking Beyond the Law to Improve End-of-Life Care, GENERATIONS, Spring 1999, at 30, 33 ("Legal 'solutions,' then, may not actually solve many of the real clinical dilemmas inherent in end-of-life care."). t22 See Kayser-Jones & Kapp, supra note 12, at 362-74 (explaining a variety of advocacy possibilities). 121 42 U.S.C.A. § 3027(a)(l2)(A)(i) (West Supp. 1999). For a thorough overview of the theory, practice, and history of the long-term-care ombudsman program, see INSTITUTE OF MEDICINE, REAL PEOPLE, REAL PROBLEMS: AN EVALUATION OF THE LONGTERM CARE OMBUDSMAN PROGRAMS OF THE OLDER AMERICAN ACT 41-77 (1995) [hereinafter IOM REAL PROBLEMS]. I24 42 U.S.C.A. § 3027 (West Supp. 1999). I25 IOM REAL PROBLEMS, supra note 123. 126 Mat 161. I27 HANDLER, supra note 65, at 154. ™See, e.g., Mary E. Tinetti et al., Mechanical Restraint Use Among Residents of Skilled Nursing Facilities: Prevalence, Patterns, and Predictors, 265 JAMA 468 (1991) (regarding the earlier widespread prevalence of NF restraints); Lois K. Evans & Neville E. Strumpf, Tying Down the Elderly: A Review of the Literature on Physical Restraint, 37 J. AM. GERIATRICS SOC'Y 65 (1989) (providing an excellent historical account of physical restraint use). I2 M2 C.F.R. § 483.13(a)(2000); 42 U.S.C.A. § 1395i-3(c)(l)(A)(ii) (West Supp. 1999) (Medicare) and 1396r(c)(l)(A)(ii) (West Supp. 1999) (Medicaid). m ld. m See, e.g., Jerry Avorn et al., Use of Psychoactive Medications and Quality of Care in Rest Homes, 320 NEW ENG. J. MED. 227 (1989) (regarding the previous prevalence of chemical restraints in NFs); Wayne A. Ray, et al., A Study of Antipsychotic Drug Use in Nursing Homes: Epidemiologic Evidence Suggesting Misuse, 70 AM. J. PUB. HEALTH 485 (1980) (finding drugs often overused as chemical restraints). n2 See Marshall B. Kapp, Nursing Home Restraints and Legal Liability: Merging the Standard of Care and Industry Practice, 13 J. LEGAL MED. 1, 21-22 n.l 13 (1992) (citing state statutes presenting the permissible use of restraints in NFs).

156 m

Liability Issues and Risk Management

See, e.g., ELON, supra note 105, at 23-28 (concluding that OBRA has led to a reduction in the use of inappropriate restraints in nursing facilities); Robert L. Kane et al., Restraining Restraints: Changes in a Standard of Care, 14 ANNUAL REV. PUB. HEALTH 545 (1993) (reasoning that physical restraint use has fallen because of OBRA). But see Nicholas G. Castle & Vincent Mor, Physical Restraints in Nursing Homes: A Review of the Literature Since the Nursing Home Reform Act of 1987, 55 MED. CARE RES. & REV. 139, 140 (1998) (finding that: implementation of restraint reduction varies widely, and there still is some concern that physical restraints are overused in some facilities. There was significant resistance to reducing restraints, and the majority of facilities are not restraint free. Moreover, isolated examples of facilities abandoning restraint-free care and becoming significant users of physical restraints have been documented.). 134 Hawes et al., supra note 75, at 982; accord Farida K. Ejaz et al., Restraint Reduction: Can It Be Achieved? 34 GERONTOLOGIST 694 (1994). '"Joan M. Dunbar et al., Retrain, Don't Restrain: The Educational Intervention of the National Nursing Home Restraint Removal Project, 36 GERONTOLOGIST 539(1996); Perla Werner et al., Individualized Care Alternatives Used in the Process of Removing Physical Restraints in the Nursing Home, 42 J. AM. GERIATRICS SOC'Y 321 (1994). l36 Joan M. Dunbar et al., Taking Charge: The Role of Nursing Administrators in Removing Restraints, 27 JONA 42, 44 (1997). '"Mary E. Tinetti et al., Mechanical Restraint Use and Fall-related Injuries among Residents of Skilled Nursing Facilities, 116 ANNALS INTERN. MED. 369 (1992); see also Richard R. Neufeld et al., Restraint Reduces Serious Injuries Among Nursing Home Residents, 47 J. AM. GERIATRICS SOC'Y 1202 (1999). ""Charles D. Phillips et al., Reducing the Use of Physical Restraints in Nursing Homes: Will It Increase Costs? 83 AM. J. PUB. HEALTH 342 (1993). '39Marshall B. Kapp, Restraint Reduction and Legal Risk Management, 47 J. AM. GERIATRICS SOC'Y 375 (1999).