Fig. 38.1
Opportunities for patient and family engagement after a harmful event
Patients and families can be interviewed informally, be sent a written survey about the events they experienced, be included in the formal root cause analysis, be invited to discuss their experiences during patient safety training programs, or be asked to join a patient and family advisory council on quality improvement. Institutions with strong patient and family engagement programs may make several of these options available and have patients and family members choose among them.
An interview is preferable to a written survey because it allows an exchange of information and ideas. In developing a set of structured questions for patients and families, institutions should choose a format that allows them to tell their stories, identify specific causative factors they observed that might be prevented, and share recommendations they may have for improving health care in the institution. Beginning with open-ended questions gives patients permission to share the things most impactful to them. Following up with more focused questions helps patients remember other issues they may have identified, such as staff attitudes or handwashing practices.
The best person to carry out the interview depends on the situation. An objective facilitator who is trusted by the patient and family is often advisable. If the harm was serious, such as a patient’s death, this role may be best filled by a mental health professional trained in critical incident management or in the support of persons experiencing such events. Interviewers should be aware that patients and families may not be ready to tell their full story during a first interview, may need to stop or take a break, and may need to have someone with them for emotional support.
The Long Shadow of Medical Malpractice Liability
CRPs represent a significant advance over current practice with respect to medical injury, which is seldom timely, compassionate, transparent, or preventative. The United States expends over $3 trillion annually on health care, far more per capita than any other nation, and the high status and economic prosperity of American physicians reflect their careful selection, intense training, and ethical commitment. Why this massive investment has yielded so few dividends in terms of effectively responding to avoidable injury is an important question, which could also be asked about the safety, quality, and value of US health care more generally. If the goals are self-evident, and the methods for reaching them relatively clear, why have we not already achieved greater success?
Surprisingly often, the answer to such apparent paradoxes is that a century-long accumulation of legal and regulatory constraints that originally were intended to reinforce physician professionalism has ended up frustrating sound policy design as health care became more technically sophisticated and necessarily more industrialized and costly [24]. The legal domain principally responsible for erecting barriers to effectively communicating and resolving medical errors is medical malpractice law, which continues to influence physician perception and behavior to a far greater extent than an unbiased observer would predict given its actual frequency, outcomes, or expense [25].
An overtly adversarial system that targets individual physicians and thrives on secrecy, expense, and delay, medical malpractice litigation does none of the things that CRPs seek to accomplish [26]. Civil liability for medical negligence has always represented an imperfect solution to the problem described years ago by Gold of “holding experts accountable to non-experts” [27]. In an unmeasured world of professional judgment and discretion, contextual decisions by local judges and juries based on a “standard of care” that was determined by professional custom and introduced into evidence by the testimony of other physicians seemed reasonable. Almost from the outset, however, this approach evoked visceral opposition from the medical profession because the setting and language suggested a criminal proceeding, monetary damages with a hefty cut paid to plaintiffs’ lawyers smacked of blackmail, both patients and their testifying experts seemed to be engaged in acts of betrayal, and final decisions on clinical matters rendered by laypeople lacked legitimacy in physicians’ eyes.
As medicine grew in sophistication and expense, malpractice lawsuits became a greater threat to physicians and a more formidable obstacle to honesty about error [28, 29]. Fragmentation of care delivery among professional and institutional providers led plaintiffs’ lawyers in search of defendants with deep pockets, to which potential defendants responded with concealment or finger-pointing. As “captains of the ship,” physicians were forced to bear considerably greater financial responsibility for health system failings than their earnings could reasonably support. The solution, third-party liability insurance, in many ways compounded the failings of the malpractice system by regarding patients as both strangers and adversaries, as well as by creating a new political interest group to question the veracity of malpractice plaintiffs and lobby for legislative restrictions (“tort reform”) whenever insurance premiums rose.
Protecting and managing personal information has always been a central aspect of preserving reputation [30]. Because allegations of medical malpractice were so entwined with physicians’ professional and personal reputations, publicity about possible errors (which often took the form of malicious gossip rather than objective proof) was fraught with peril. Silence when error was unsuspected by patients, and quiet settlement when error was self-evident, therefore became the modus operandi of many malpractice defendants. This resistance to sharing information about medical errors has carried over to the modern era of clinical practice in several ways, each of which CRPs must confront and overcome if they are to succeed.
First is the increased diversity of parties in whose good graces physicians must remain, which used to be limited to colleagues who referred them patients, malpractice insurers, and state licensing boards. Relevant constituencies now include hospitals, health insurance networks, and various other contracting partners, as well as Internet-based rating systems which patients and competitors can manipulate instantly and costlessly to harm physicians’ reputations. Second is the paradoxical way in which some physician groups and malpractice insurers have responded to new knowledge about the frequency of medical errors. After decades hearing such groups assert that lawsuits should be curtailed because few physicians committed errors, one might have expected revelations that errors are in fact common to cause some backpedaling. To the contrary, many of these stakeholders redoubled their efforts to secure tort reform, arguing that only if physicians are protected from litigation and its associated publicity will they report problems internally and work collectively to improve patient safety. When Pennsylvania in 2003 became the first state to mandate disclosure of serious adverse events, for example, many health-care providers and malpractice insurers dismissed it as a trick of the trial lawyers designed to gin up additional business.
Third is informed consent, which is well accepted by recent generations of physicians as an ethical and legal obligation in advance of surgery or other procedures. If physicians are obligated to tell patients about bad things that might happen, how can physicians conceal information about bad things that did happen? Yet informed consent is not generally understood to encompass error disclosure. Even worse, some physicians incorrectly believe that informing a patient about a potential complication absolves them from fault if that complication occurs, regardless of whether the particular occurrence was preventable. Fourth is confidentiality in the settlement of malpractice lawsuits. Settlement was only in physicians’ reputational interest if it was done quietly (something that the National Practitioner Data Bank and mandatory reporting to state licensing boards has made more difficult). As a result, settlement agreements typically prohibit claimants and their lawyers not only from publicizing the amounts received or disparaging the physicians involved but also from discussing the circumstances of the care received—a bitter pill for patients and family members seeking validation of their experiences and protection for future patients [31].
On the other hand, the dark cloud that hangs over effective communication and resolution of errors because of medical malpractice contains a few silver linings for CRPs. Physicians fear malpractice suits in part because they feel unable to control them; tort reform, for example, requires sustained political engagement and costly campaign contributions and can be undone by state constitutional courts even if legislatures and governors remain sympathetic. By contrast, the decision to be honest with a patient, and quite possibly to defuse a potential lawsuit, is fully within each physician’s individual control. Transparency coupled with early resolution has even greater advantages relative to conventional litigation: less anxiety and hostility, less time away from one’s medical practice, quicker analysis with greater opportunity to implement safety improvements, and perhaps the chance to avoid mandatory reporting of a settlement to a licensing board or the national data bank, with its associated blemish on one’s professional reputation.
From Error Disclosure to CRPs
The move toward CRPs began voluntarily in a few institutions as early as the 1980s, expanded and acquired support from professional associations and regulatory bodies in the early 2000s, and became more systematic following the enactment of the ACA in 2010. Leaders in early settlement models include the Veterans Health System, several self-insured academic institutions (Michigan, Illinois, Harvard, Stanford), and some nonprofit hospital groups (Catholic Healthcare West, Ascension Health), while non-captive liability insurers (COPIC, Coverys, West Virginia Mutual) have pioneered limited compensation models not requiring release of legal claims or reporting to the National Practitioner Data Bank [32–34]. Patient advocacy groups also embraced transparency following error, notably the SorryWorks! Coalition, which urged hospitals to be honest with patients as a compassionate obligation and a sound customer relations strategy more than for litigation risk management or patient safety. With leadership from the federal Agency for Healthcare Research and Quality (AHRQ), which began funding demonstration projects and developing consensus standards in 2010, the focus shifted from simple disclosure of error, often with apology, to a structured process of patient engagement, compensation, and safety improvement.
Pioneers and Early Adopters
Disclosure and Apology: Veterans Health System
In 1987, the Veterans Affairs Medical Center in Lexington, Kentucky, in response to losing two malpractice judgments totaling more than $1.5 million, instituted a radical policy of apologizing to patients as soon as possible after the occurrence of a medical error, giving a full explanation of the cause and the steps taken to prevent future harm and, when appropriate, offering a fair settlement. Between 1990 and 1996, 88 malpractice suits were filed of which only one proceeded to trial (and was won by the government). A total of $1,330,790 was paid out over the 7-year period (averaging $190,113 per year), and the average payment per claim was $15,622. Compared to 35 similar VA hospitals, disclosure and apology suggested a financial advantage for full disclosure [35]. A follow-on study with 12 years of data showed an average of 14 settlements per year totaling $215,000 – averaging roughly $15,000 per settlement, compared to the mean VA system settlement in 2000 of $98,000 [36].
Based largely on the Lexington VA experience, the Department of Veterans Affairs adopted in 1995 a policy requiring all its medical centers to inform patients or their families when medical errors result in injury, to offer appropriate medical treatment, and to advise them of their right to file a claim. In 2005, the Veterans Health System issued a national directive titled “Disclosure of Adverse Events to Patients.” This policy has been renewed and improved several times [12, 37]. The Veterans Health System has important advantages in its CRP operations, including employed physicians, “enterprise liability” for malpractice defined and limited by federal statute, exemption from many state laws, and the ability to enter into memoranda of understanding with other federal agencies and to define its own legal standards for evaluating the cause of patient injuries and reporting individual but not system-based settlements to the National Practitioner Data Bank [37].
Early Resolution: University of Michigan and University of Illinois – Chicago
In 2002, the University of Michigan Health System (UMHS) launched a comprehensive claims management model with disclosure as its centerpiece. Its core principles, articulated by system counsel Richard Boothman, were as follows: “We will provide effective and honest communication to patients and families following adverse patient events; we will apologize and compensate quickly and fairly when inappropriate medical care causes injury; we will defend medically appropriate care vigorously; and we will reduce patient injuries and claims by learning from the past.” The model, which applies an expert construct of “reasonable” care rather than a legal standard of negligence, was associated with a sharp decline in the number of new claims against UMHS from 121 in 2001 to 61 in 2006 [38, 39]. The model also reduced the average claim processing time from 20.3 months to roughly 8 months. This had the effect of decreasing the number of open claims from 262 in 2001 to 83 in 2007, dropping required insurance reserves by two thirds and more than halving litigation expenses.
Drawing on the Michigan approach, the University of Illinois Medical Center at Chicago (UIMCC) in 2004 began to implement a comprehensive process for responding to patient safety incidents with “seven pillars”:
Report incidents that could harm patients; investigate those cases and fix problems before an error happens; communicate when an error occurs, even if no harm was done; apologize and ‘make it right’ by waiving hospital and doctors’ fees; fix gaps in the system that can cause things to go wrong; track data from patient safety reports and see if changes make things safer; and educate and train staff how to make care safer. [40]
UIMCC emphasized teaching young physicians to report and analyze unsafe conditions and providing “care for the caregiver” when injuries occur. In the first 2 years, the process doubled the number of safety incidents reported, prompted more than 100 investigations with root cause analysis, generated nearly 200 system improvements, and served as the foundation of 106 disclosure conversations and 20 full disclosures of inappropriate or unreasonable care causing harm to patients. A 2012 UIMCC communication to AHRQ updating the program’s results showed a continued increase in patient safety reporting to 7500 incidents per year, with a 50 % decrease in new claims filed by patients and a reduction in median resolution time from 55 months prior to program implementation to 12 months afterwards [32]. A later article noted that the initiative seemed to have significantly slowed the practice of defensive medicine, reducing the rate of growth in clinical lab orders by 24 % and radiology orders by 18 % [41].
Limited Compensation: COPIC
In 2000, the physician-owned medical professional liability insurer in Colorado, COPIC Insurance Company, launched a post-incident risk management program called the 3Rs Program (“Recognize, Respond, Resolve”) [42]. Within 72 h of a complication or injury to a patient, the 3Rs Program enables the physician and patient to engage in open, honest, empathic conversation. In cases in which no lawyer is involved and which are unlikely to incur large damages, COPIC offers patients immediate, unconditional compensation for out-of-pocket losses, which are capped at $50,000. Within 5 years, 65 % of COPIC-insured physicians in procedurally based specialties and 28 % of other physicians were enrolled in the program. As of October 2006, 2853 Colorado physicians had enrolled, and the program had handled 3200 events involving disclosure of medical errors. Of these events, 25 % of patients received payments at an average of $5400 per case. Of the cases in which compensation was paid (roughly 800 cases), seven cases proceeded to litigation with two resulting in tort compensation. Of the cases without compensation paid (roughly 2400 cases), 16 proceeded to litigation with six resulting in tort compensation.
Broadening Consensus
Self-Regulatory and Professional Bodies
Organizations directly concerned with the quality of medical care became supportive of error communication early in the 2000s. In 2001, The Joint Commission adopted a standard requiring a limited form of error disclosure, involving “unanticipated outcomes of care,” as a condition of facility accreditation. The Institute of Medicine offered liability reform based on CRP principles as a “Rapid Advance” recommendation to the Department of Health and Human Services in 2002 [43]. The Joint Commission’s Tort Resolution and Injury Prevention Roundtable issued a white paper endorsing transparency in conjunction with a CRP-type approach to compensation and safety improvement [44]. In 2006, the National Quality Forum included full disclosure of “serious unanticipated outcomes” among its 30 “safe practices” for health care and promulgated disclosure standards as guidance for physicians and hospitals [45].
Medical professional associations were somewhat slower to follow because of the difficulty disentangling commitments to honesty and improvement from concerns over malpractice liability, particularly during the liability insurance crisis of that time. In 2003, the AMA’s Council on Ethical and Judicial Affairs issued a report explaining physicians’ ethical obligations to study and prevent error and harm [46]. Opinion 8.21 of the AMA’s Code of Medical Ethics reads:
Physicians must offer professional and compassionate concern toward patients who have been harmed, regardless of whether the harm was caused by a health care error. An expression of concern need not be an admission of responsibility. When patient harm has been caused by an error, physicians should offer a general explanation regarding the nature of the error and the measures being taken to prevent similar occurrences in the future. Such communication is fundamental to the trust that underlies the patient-physician relationship, and may help reduce the risk of liability.
The American College of Surgeons has not included error disclosure in its code of ethics but stated in a recent report on medical liability reform and safety improvement that “Adverse events should be approached with open communication and recognition that an unfortunate outcome is not synonymous with negligence. Compensation for injured patients, monetary or otherwise, should be fair and timely without the unnecessary delay commonly associated with the current tort process” [9]. Similarly, the Institute of Medicine has renewed its endorsement of error disclosure and specifically recommends that states encourage the development of CRPs [47].
State Laws
State laws requiring disclosure to patients of medical errors were a novel and important part of the legislative response to surging malpractice insurance premiums nationally in the early 2000s, not long after the IOM reports thrust patient safety onto the national health policy agenda. In 2002, Pennsylvania enacted a heavily negotiated set of malpractice reforms, including the first state law duty on hospitals to notify the patient or patient’s family in writing within 7 days of a “serious event,” which the statute defines as “(a)n event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient” (Pennsylvania MCARE Act, 2002 40 P.S. § 1303).