Chapter One
The Legal Context for Disclosing Bad News
The health care industry is like a ship being tossed by high waves in the middle of a severe storm. It is being buffeted by angry and often distrusting patients, regulators, and legislators calling for rigorous scrutiny and payers demanding evidence-based quality care. At the same time, litigation-minded lawyers have fomented a wave of malpractice. The result has been a contracting of insurance carriers willing to write health professional liability insurance coverage. Those who are left in the field are demanding very expensive premiums for less coverage than was available only a few years ago. In the malpractice cases that go to trial, juries are sending a signal that the health care industry must transform itself into a quality-driven, accountable endeavor or be prepared to take the consequences in large damage awards.
To understand why there is so much emphasis on patient communication in the health care field, it is important to reflect on the drivers of this change: the change agents found in the government, accreditation, consumer, and payer sectors. Although many may not welcome this pressure for change, the result may be a health care system better prepared to partner with patients in the delivery of quality treatment and services.
THE FEDERAL PERSPECTIVE
In 1999, the Institute of Medicine (IOM) issued a landmark report that seemed to capture these shifting winds of dissatisfaction and distrust. In To Err Is Human: Building a Safer Health System, the IOM noted that the American health care industry kills an estimated forty-four thousand to ninety-eight thousand patients every year through medical error-related events. The report pointed out that many of these deaths were preventable. Subsequently, a number of federal entities known as the Quality Interagency Coordination (QuIC) Task Force made their own recommendations in response to the IOM report. This QuIC report, Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, delineated one hundred action items for the federal government to take to rectify the situation. In part, the government strategy focused on institutional accountability, leadership, and communication.
After the QuIC report, the Agency for Health Care Research and Quality (AHRQ; formerly known as the Agency for Health Care Policy and Research) took on a leadership role among federal authorities committed to patient safety. AHRQ has funded a variety of studies and research. One particular report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices, reflects AHRQ's research commitment. Prepared by the University of California at San Francisco (UCSF)-Standard Evidence-Based Practice Center (EPC), it focuses on evidence-based patient safety practices.
Working with the National Forum for Quality Measurement and Report, better known as the National Quality Forum (NQF), a partnership of private and public sector entities, the EPC developed a definition for a patient safety practice: "a type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures." This definition encompasses communication skills and consent to treatment. Indeed, the report contained a discussion about informed consent and the need for research on the topic in conjunction with patient safety practices.
The Food and Drug Administration, the Conditions of Participation for Hospitals in Medicare and Medicaid Patients Rights Standards, and federally sponsored reports addressing the issue of patients rights all point to the need for strong communication processes. Involving the patient in the decision-making process is viewed as a key ingredient to successful medical treatment.
THE STATE GOVERNMENT PERSPECTIVE
At the state level, the move toward patient safety has been demonstrated by legislative initiatives geared toward reporting serious adverse events or patient deaths to databases in the belief that collecting such information will be useful in holding health care entities accountable for their performance. As distinguished from voluntary reporting methodologies, the mandatory reporting procedures found in some states are at times linked to fines and penalties, and the format is tied to public disclosure.
Some innovations have also occurred at the state level to facilitate reporting of adverse events without fear of disclosure of this information in medical malpractice litigation. The idea is to create an atmosphere conducive to the examination of adverse event information with a view to process improvement in patient safety. Examples of this approach include evidentiary use laws in Oklahoma, Minnesota, and Louisiana. However, these laws are more the exception than the rule.
In addition, at the urging of the IOM in To Err Is Human: Building a Safer Health System, consideration is being given to a rethinking of health professional licensure at the state level. The intent is to consider a variety of methodologies, including periodic relicensure.
The IOM report also emphasized the need for institutional accountability on the part of health care facilities. Indeed, To Err Is Human: Building a Safer Health System explored the idea of enterprise liability, that is, holding health care entities legally responsible for the errors and omissions of nonemployee health professionals who had been accorded staff privileges. According to this concept, the health care entity could not avoid liability even when it contracted out delivery of health care services to physician groups for such departments as radiology or emergency medicine. Following the logic of this enterprise accountability theory, the hospital could be held negligent for a substandard consent to treatment on the part of a staff physician.
Thus far, only two states have clearly adopted the legal theory of enterprise liability. In neither instance was consent the issue. Rather, it was the matter of substandard delivery of emergency treatment. However, at least one court has examined the idea of enterprise liability for negligent consent. The point is that consent and the communication process underlying it may well be the basis for holding a hospital responsible for the negligence of a staff doctor. This type of liability exposure gives impetus to those who are trying to improve provider-patient communications and discussion of negative treatment outcomes.
THE ACCREDITATION PERSPECTIVE
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is the accrediting body for hospitals in the United States. In addition, it accredits nursing homes, integrated delivery systems, managed care organizations, and other health care organizations. The accreditation process is about quality of care, safe environments of care, and patient safety. It requires health care organizations to demonstrate compliance with standards developed for guiding health care services. Surveys are done to compare performance with the standards, and depending on the outcome, a health care entity may or may not receive a grade that is comparable to similarly situated facilities. Facilities that are in noncompliance will receive what are known as Type I or Type II findings, which require work to align the organization with the standards. In serious standards noncompliance situations, JCAHO may revoke or deny accreditation status.
Accreditation is a voluntary process. However, by becoming accredited, a hospital can host approved medical residency programs. Moreover, an accredited health care organization is automatically qualified to participate in Medicare and Medicaid. It need not seek separate approval from either the Centers for Medicare and Medicaid Services (CMS) or a state agency. Moreover, many health plans require JCAHO accreditation to be a participating provider for members, and many professional liability carriers look to JCAHO accreditation as a key indicator in deciding whether to offer insurance coverage.
At its best, the accreditation survey process is but a snapshot in time. In the interval between the previous survey and the subsequent evaluation, many things can happen that can result in a poor level of care or diminished patient safety. This fact was recognized in reports issued by the Government Accounting Office (GAO) and the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services.
Calling into question the value of the costly accreditation process, both the GAO and the OIG made several criticisms that went to the core of the JCAHO process. JCAHO responded by revamping many aspects of the accreditation model. The reformation is ongoing to make the accreditation process more efficient, practical, and directed to delivery of high-quality, patient-safe care.
As a result of publication of To Err Is Human, JCAHO ramped up its efforts in patient safety. Indeed, it is noteworthy that prior to publication of this IOM report, JCAHO had embarked on a course of reducing risk-prone processes through the use of root cause analysis for what it termed reviewable sentinel events. Borrowing a page from industry, JCAHO set out to have accredited facilities drill down into the systems failures that gave rise to patient injury or death. The vehicle for this effort was root cause analysis, which would pinpoint the common, latent, and special causes of iatrogenic illness or death.
After the IOM report, JCAHO stepped up its activity, introducing a set of so-called patient safety standards designed to address a variety of systemic concerns that contribute to patient injury. Among the many patient safety standards is one that mandates a discussion of the outcomes of care with patients. JCAHO requires that patients, and when appropriate their families, receive information about the outcomes of care. Outcomes here refers to both anticipated and unanticipated results, whether good or bad. However, JCAHO placed emphasis on the unanticipated outcomes of care, believing that doctors and other caregivers are reticent to share bad news with patients.
Many in the health care community interpreted the JCAHO requirement as compelling doctors and other health care professionals to make an admission of liability, although JCAHO adamantly denied this was the case. Others questioned how one could share bad outcome information with patients and their loved ones without leaving the implication of medical malpractice liability. The American Society for Healthcare Risk Management (ASHRM) issued a white paper on the subject that provided some perspectives on delivering such information without making an admission of culpability. It has proved to be a good starting point for managing disclosure of unanticipated outcomes of care. The ASHRM white paper emphasizes the need for frank and candid discussion of risks and benefits with patients prior to embarking on treatment. It views consent as laying the foundation for solid communications with patients and family members so that should unanticipated events occur, there is a preexisting relationship and framework for subsequent discussions.
JCAHO also has embarked on a new strategy to involve patients in their own care better. Termed "Speak Up: Help Prevent Errors in Your Care," this public relations strategy was designed to motivate patients to become more involved and informed participants as members of the health care team. According to JCAHO, the new concept is based on research demonstrating "that patients who take part in decisions about their health care are more likely to have better outcomes." At the core of the initiative is the enhancement of professional-patient communications.
There is little doubt that the JCAHO's patients' safety standards are a key driver of change shaping the delivery of safe care to patients.
PRESIDENT'S ADVISORY COMMISSION ON CONSUMER PROTECTION AND QUALITY IN THE HEALTHCARE COMMUNITY
In 1999, a report was published on the findings and recommendations of the President's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry. Not only did it address accessibility and affordability of health care services, it stressed the needs to involve patients better in designing treatment plans and for patients to have sufficient communication with health care providers. Tying information to the quality of health care, the report reinforced the idea of a patient's right to information. As such, it became an important driver in the push for patient safety.
THE PAYER PERSPECTIVE
Payers have many interests in promoting quality-based health care. With so many employers paying ever-increasing premiums for health care coverage, there is an expectation that the money should be spent wisely in promoting wellness and curing illness. When employees complain that care is inadequate or shoddy or that they come away from a health care encounter injured, employers have reason to be concerned. Not only does this suggest that health care premiums are not being spent wisely, but employers may not be meeting their obligations under federally qualified health care plans. At the same time, employers worry about worker productivity if health care does more harm than good.
In January 2000, a group of the Fortune 500 from the Business Roundtable formed a coalition called "The Leapfrog Group" to respond to the situation. With a mandate to alter the situation in terms of patient safety, Leapfrog has positioned itself to jump over government regulatory inroads and accreditation standards to effect change. In 2001, it published three standards for hospitals to meet: referrals to facilities that have a high volume of procedures, computerized order entry, and use of intensivists in intensive care units. The idea was that these three steps would start the health care industry down the road to effective change. In 2002, it completed a survey of hospital compliance with the standards. More standards are expected in future.
The payer is not going to remain silent. Increased health care costs, employee dissatisfaction, and perceived quality-of-care issues are driving the formation of so-called baby Leapfrogs, or state-based initiatives to compel change. Greater participation of employees in treatment planning is seen as a key point, especially with the results of benchmark studies designed to inform consumers about how well hospitals compare with one another in the delivery of care based on the Leapfrog standards.
THE CONSUMER PERSPECTIVE
The President's Advisory Commission Report is a reflection of the concerns articulated by consumers. Many are afraid to seek health care. They fear becoming another medical error statistic. They want more information, not less, about their health care. Many want to know about the treatment or outcome results of a surgeon who proposes to perform a surgical procedure. Others want information about hospital performance, medication error rates, and infection control statistics before seeking treatment at an acute care facility. Web site-based information is becoming available on disciplinary activity surrounding physicians, data made available through the auspices of some state boards of medicine. JCAHO publishes "Quality Check" data on hospital performance, information that is easily accessible over the Internet.
The point is that consumers want to make informed choices about their health care. Knowing the "batting average" of a doctor or a hospital is important to consumers in deciding from whom to seek health care services. To consumer groups, making this information available to the public helps drive competition for the delivery of quality, patient-safe health care services.
THE INSURANCE INDUSTRY PERSPECTIVE
Beyond legislative, regulatory, accreditation, payer, and consumer-driven demands for greater disclosure of information, there are other key groups to consider. One group in particular is the medical malpractice or professional health care liability insurance carriers.
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Excerpted from What Do I Say?by James R. Woods Jr. Fay A. Rozovsky Copyright © 2003 by James R. Woods Jr.. Excerpted by permission.
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