Full Disclosure: How To Apologize For Medical Errors
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Full Disclosure: How To Apologize For Medical Errors Of all the bad news physicians give patients, “I’m sorry” seems the most dangerous. Here, we look at how to confront disclosure and why the gold standard treatment for a medical error should be an apology. Heidi Mandel PhD, DPM, Steven Mandel MD, and Zac Haughn I n the past two decades a patient safety movement they are injured by medical care with full and has emerged in the US, UK, and other nations, truthful disclosure appropriate in all cases. and there has been an amendment to the Code of What is an apology? It is a communication that Ethics by the AMA to address the physicians’ obli- expresses responsibility. It is a statement that can gation to disclose the truth in cases of error. US hospi- acknowledge that an error has occurred and, as a con- tal and health systems have adopted new regulatory sequence, expresses regret for having caused harm. It standards on patient safety that require medical can decrease feelings of blame and anger. It can providers to implement disclosure policies. This is a increase feelings of trust and improve relationships. consequence of the greater empowerment that An apology may also include a promise to refrain patients and their families feel in relation to medical from engaging in similar conduct in the future. It may care and treatment. Patients, as consumers of medical include an assurance that a full investigation will take care and services, routinely access the Internet for place and the possibility for compensation for any medical knowledge, to evaluate their physicians, or to harm that has been done. It may become a positive join patient advocacy groups, among other reasons. objective of expectations and intentions for future The Internet gives patients more control over their relationships between the parties. own medical decision-making. In addition, there is also more recognition of the How to Disclose quality of life in relation to chronic disease, for Guidelines on apology and disclosure after adverse example, lifestyle factors, such as nutrition, diet, events and errors have been in place in medical set- exercise, and non-pharmaceutical treatments. tings for over five years. The research shows that Ultimately, patient safety has broadened and has patients and their families seem to respond positive- become sensitive to medical errors, full disclosure, ly to apology and acceptance of responsibility as and apology. Consensus exists among hospital long as it is followed by a pledge from the physician health systems and physicians, as well as patients of his commitment to continued care and optimal and their families, that patients should be told if recovery. Although there are apology laws in many November/December 2011 | Practical Neurology | 25
Apologizing for Medical Errors Definitions: medical events, has a disclosure program predicated on a three-step disclosure process. Serious Event – not limited to an event that requires additional Initial Disclosure. This is about empathy and re- treatment or monitoring. These events are not due to error. establishing trust and communication with patients Error – the failure of a planned action to be completed as and families immediately after an adverse event. intended or the use of a wrong plan to achieve the aim Doctors can say "sorry" but no fault is admitted or Incident – an event that occurred or situation involving the assigned. Sorry Works recommends taking care of clinical care of a patient in a medical facility that could have the immediate needs of the patient/family like food, injured the patient but did not either cause an unanticipated lodging, counseling, etc., and promising a swift and injury or require delivery of additional services to the patient. thorough investigation. The goal is to make sure the Sorry – feelings of regret, penitence, sadness, sorrow sympa- patient/family never feels abandoned. thy. The sincerity of the remorse needs to be genuine to be Investigation. The investigation is to learn the believed. truth. Was the standard of care breached or not? Sorry Works recommends involving outside experts states that are designed to protect physicians in the and moving swiftly so the patient/family doesn't process of remediation of medical errors, these laws suspect a cover-up. Staying in close contact with the may not, in practice, minimize the litigation risk for patient/family throughout the process is important. physicians and the health care team. Resolution. This is about sharing the results of It is difficult to apologize when the proper disclo- the investigation with the patient/family and their sure system isn’t set up. A study of 260 practicing legal counsel. If there was a mistake, apologize, pathologists and 81 academic hospital laboratory admit fault, explain what happened and how it will medical directors found that while nearly all be prevented in the future, and discuss fair, upfront “expressed near unanimous belief that errors should compensation for the injury or death. If there was be disclosed to hospitals, colleagues, and no mistake, continue to empathize ("we are sorry patients…only about 48 percent thought that cur- this happened"), share the results of investigation rent error reporting systems were adequate.”1 (hand over charts and records to patient/family and Even when health care providers want to disclose their legal counsel), and prove your innocence. an error, determining how to properly do so can be a However, no settlement will be offered and any daunting task. Many doctors, understandably so, are lawsuit will be contested. afraid of exposing themselves, their colleagues, and Again, timing can make a difference. A study on their employers to unintended legal consequences by two case reports followed the successful remedia- incorrect disclosure. One recent study asked residents tion efforts that accompanied the disclosure of med- to describe their worst medical error in an anony- ical errors to a pair of patients. It found that mous survey.2 It found that 31 percent reported apolo- providers should pledge to injured patients and gizing for the situation associated with the error and their relatives that they will assist and accompany only 17 percent reported disclosing the error to them in their recovery as long as necessary and patients and/or family. The researchers also found then follow through on their pledge—as soon as pos- that more male residents disclosed the error than did sible after the event.3 female residents (p=0.04). Surgery residents, they The potential healing value of an apology can be noted, scored higher on the subscales of safety cul- great. It can bring a sense of relief and finality; not ture pertaining to the residency program (p=0.02) that this terrible event is marginalized or forgotten, and managerial commitment to safety (p=0.05). but it can become a sad chapter of the past rather To help physicians with revealing errors, Sorry than a living tragedy. After being misdiagnosed, Works, an advocacy organization for disclosure, patient Trisha Torrey recounted the apology she apology, and upfront compensation after adverse received:4 26 | Practical Neurology | November/December 2011
Apologizing for Medical Errors “Among the dozen doctors who erred during my one stands, taking into account the nature of the misdiagnosis odyssey, there was one, the director relationship between the parties involved at specific of the hematopathology lab that misdiagnosed times during the relationship. The action involved me, who was very forthcoming after my misdiag- in truth telling is in “speaking.” nosis was confirmed. He took time with me on Telling the truth when a medical error occurs the phone, exchanged e-mail with me—and in means the practice of full disclosure, i.e. giving the general, helped me understand how it could have patient and family a complete and truthful account of happened. It didn't make it better, but it certainly what happened, why it happened, who is responsible made it more understandable. to prevent this error in the future, what will be the […] Today, for the first time, I met that treatment, an expression of apology, and a discussion hematopathologist, the man who was partially of fair compensation. It is context- and time-specific. responsible, but was willing to explain. I attend- ed a program which included him as a panelist, Medical Culture and afterwards I introduced myself. There exists among the medical culture a resistance to We shook hands, we even hugged—and he pro- admit mistakes despite hospital policies and protocols ceeded to tell me about all the changes they have for disclosure and despite the “sorry laws” in many US made in his lab, based on the procedure holes states. uncovered during my diagnosis. I was floored. He This resistance is part of the “hidden curriculum” thanked me for my post-misdiagnosis follow up in the process and hierarchy of medical training, i.e. that exposed the problems. He invited me to visit learning by example. Senior physicians may model the lab. And then... He apologized. […] I wept, all behavior that conceals errors. Research shows that the way home.” the values of physicians include telling the truth to Sincerity matters. The University of Massachusetts patients about errors they may have made. But the Medical School crafted guidelines on apology and practice may lead them to take a “don’t ask, don’t disclosure after adverse events and errors, hopes tell” position and practice avoidance. high that their policy could produce the same Physicians are expected to honor the perspective patient satisfaction.5 Five years later, they examined of those who suffer. However, if the physicians the impact they had on 78 patients who felt there view themselves as the victims in the scenario, due was an error in their care. “Patients' valued apology to the impact of the error, disclosure, and apology and expressions of remorse, empathy and caring, on their self-esteem, self-image, career, income, and explanation, acknowledgement of responsibility, and reputation among their colleagues, then they are efforts to prevent recurrences, but these key ele- putting their suffering ahead of the patient’s and ments were often missing,” researchers wrote. will refuse to understand and embrace full disclo- “Clinicians preparing to talk with patients after an sure and apology as an ethical norm. adverse event or medical error should be aware that One obstacle might be that physicians are patients expect their actions to be congruent with unaware of the exact protections they are afforded. their words of apology and caring.” The Patient Safety and Quality Improvement Act Truth telling is a practice that exists within (PSQIA) of 2005, inspired by the Institute of human relationships, in a social context, usually Medicine's (IOM) 1999 report “To Err Is Human,” involving a dynamic of tension between an individ- gives federal protections in exchange for error dis- ual or group and an authority. There can be various closures. Tasked with assessing the quantity of perspectives from both sides of the equation with publications regarding this protection within the regard to what is ethical, expedient, reasonable, and medical literature, one study found few published responsible. Telling the truth means something dif- studies in clinical journals describing the PSQIA.6 ferent according to the particular context in which Evaluating 2,060 safety-related articles through a November/December 2011 | Practical Neurology | 27
Apologizing for Medical Errors States with Apology Laws PubMed search, researchers separated articles into According to Sorry Works (sorryworks.net), 35 states have passed pre-IOM report (1990-1999) and post-IOM report laws allowing immunity when apologizing without their words being (2000-2008) literature. They found no articles to be used against them in court. Many of the laws share similar lan- "on topic" in the pre-IOM period (n=624), while “27 guage, including Ohio and Colorado, which used near identical bills, articles were considered ‘on topic’ in the post-IOM as shown below. period (n=1436), constituting 1.8 percent of the peri- Colorado Revised Statute 13-25-135 (2003) od total (95% confidence interval, 1.2%-2.6%).” Of the Oregon Rev. Stat. 677.082 (2003) 27 articles, seven appeared in practice-related jour- Massachusetts ALM GL ch.233, 23D (1986) nals, while the remaining 20 were in journals with a Texas Civil Prac and Rem Code 18.061(1999) health policy or health care administration focus. California Evidence Code 1160 (2000) Florida Stat 90.4026 (2001) Another study found 31 percent of US physicians are Washington Rev Code Wash 5.66.010 (2002) reluctant to report colleagues, while 12 percent fear Tennessee Evid Rule 409.1(2003) retribution from their colleagues for doing this.7 Ohio ORC Ann 2317.43 (2004) Georgia Title 24 Code GA Annotated 24-3-37.1 (2005) Wyoming Wyo. Stat. Ann. 1-1-130 Health Systems Oklahoma 63 OKL. St. 1-1708.1H (2004) The larger picture of how health systems respond to Maryland MD Court & Judicial Proceedings Code Ann. 10-920 (2004) errors and what kind of environment they foster is North Carolina General Stat. 8C-1, Rule 413 immensely important, since they have the power to Hawaii HRS Sec.626-1 (2006) set a high example of what it expects from its staff. Maine MRSA tit. 2908 (2005) A 2008 study documenting hospital adverse-event- South Dakota Codified Laws 19-12-14 (2005) West Virginia 55-7-11a (2005) reporting systems pointed to needed improvements Illinois Public Act 094-0677 Sec. 8-1901, 735 ILL. Comp. Stat. 5/8-1901 (2005) in reporting processes.8 Surveying 1,652 non-federal Arizona A.R.S. 12-2605 (2005) hospital risk managers using a mixed-mode Louisiana R.S. 13:3715.5 (2005) (mail/telephone) questionnaire, the authors found Missouri Mo. Ann. Stat. 538.229 (2005) that virtually all hospitals reported they have cen- New Hampshire RSA 507-E:4 (2005) Connecticut Public Act No. 05-275 Sec. 9 (2005) amended (2006) Conn. tralized adverse-event-reporting systems, although Gen. Stat. Ann. 52-184d characteristics varied. Scores on four performance Virginia Code of Virginia 8.01-52.1 (2005) indices suggested that only 32 percent of hospitals Vermont S 198 Sec. 1. 12 V.S.A. 1912 (2006) had established environments that support report- Montana Code Ann.26-1-814 (Mont. 2005) South Carolina Ch.1, Title19 Code of Laws 1976, 19-1-190 (2006) ing, only 13 percent had broad staff involvement in Delaware Del. Code Ann. Tit. 10, 4318 (2006) reporting adverse events, and 20-21 percent fully Indiana Ind. Code Ann. 34-43.5-1-1 to 34-43.5-1-5 distribute and consider summary reports on identi- Idaho Title 9 Evidence Code Chapter 2 .9-207 fied events. Interestingly, the authors guessed that Iowa HF 2716 (2006) because survey responses were self-reported by risk Nebraska Neb. Laws L.B. 373 (2007) Utah Code Ann. 78-14-18 (2006) managers, these may have been optimistic assess- North Dakota ND H.B. 1333 (2007) ments of hospital performance. OH, CO laws: In any civil action...any and all statements, affirma- In part to monitor errors and attitudes of health tions, gestures, or conduct expressing apology, sympathy, com- systems, the “Hospital Survey on Patient Safety miseration, condolence, compassion, or a general sense of benev- Culture 2010 User Comparative Database Report” is olence that are made by a health care provider or an employee of filed yearly by the federal Agency for Healthcare a health care provider to the alleged victim, a relative of the Research and Quality (AHRQ). It details results of 885 alleged victim, or a representative of the alleged victim, and that hospitals and 338,607 hospital staff respondents. It relate to the discomfort, pain, suffering, injury, or death of the alleged victim as the result of the unanticipated outcome of med- found three areas for systemic improvement.9 ical care are inadmissible as evidence of an admission of liability Nonpunitive Response to Error. This is an area or as evidence of an admission against interest. with potential for improvement for most hospitals. 28 | Practical Neurology | November/December 2011
Apologizing for Medical Errors Nonpunitive response to error was defined as the Changes in Organizational Culture. Changes in extent to which staff feel that their mistakes and organizational culture, particularly creating a positive event reports are not held against them and that safety culture, are an essential element can improve mistakes are not kept in their personnel file. This patient safety. These changes primarily focus on area was one of the two patient safety culture com- human resources management procedures and prac- posites with the lowest average percent positive tices relative to the supervision and discipline of indi- response (44 percent). The survey item with the viduals reporting events to institutions and leadership. lowest average percent positive response was: “Staff Organizations found that to encourage reporting of worry that mistakes they make are kept in their per- medical errors, it was important to adopt a culture sonnel file” (an average of only 35 percent). that eliminated the blame and shame associated with Handoffs and Transitions. The extent to which medical errors. When these changes were made and important patient care information is transferred employees felt safe to report medical errors, harm, no across hospital units and during shift changes was harm, or near miss events, the organizations often the other patient safety culture composite with the found that their reporting rates increased—in some lowest average percent positive response (44 per- instances to incredible levels. cent). The survey item with the lowest average per- Involvement of Key Leaders. When organizational cent positive response was: “Things ‘fall between leadership, both administrative and clinical, actively the cracks’ when transferring patients from one engages in patient safety improvement, it can have an unit to another” (an average of only 41 percent). exceptionally beneficial impact on all employees and Number of Events Reported. On average, most staff of the organization. An example of this involve- respondents within hospitals (53 percent) reported ment is an “Executive Safety Round.” While it’s no events in their hospital over the past 12 months. important this not stray into a lecture session, it can It is likely events were underreported. Event report- be a routine visit to clinical units by an organization's ing was identified as an area for improvement for senior leaders to discuss patient safety issues. This most hospitals because underreporting of events technique is increasingly used to involve senior lead- means potential patient safety problems may not be ership in actively promoting safety and discovering recognized or identified and therefore may not be the risks and hazards to patients. addressed. However, responses varied widely, rang- Education of Providers. Provider education is ing from one hospital where 82 percent of respon- used nationwide to orient professionals about vari- dents had not reported a single event over the past ous aspects of patient safety and how errors are 12 months to a hospital where only 14 percent had identified. Education is also often used to introduce not reported an event. or reinforce safe practices that are proven to elimi- One outcome of underreporting is that it “creates nate or minimize harm to patients. Some AHRQ- a reservoir of information that is plagued with epi- supported researchers note that the process of col- demiological bias. This leads to inaccurate rates of lecting and analyzing medical error information also errors and an inability to generalize results to whole results in increased patient safety. patient populations. It leaves reporting incidents, in When key personnel are trained in and under- epidemiological terms, comparable to nonrandom stand the use of root cause analysis, the quality of samples from an unknown universe of events.”10 information obtained from the medical error report- ing systems is enhanced. Root cause analysis (RCA) Systemic Changes is an error analysis technique for determining the To address the larger picture of how health systems contributing causes of adverse events that have respond to medical errors, the AHRQ released already happened. It takes into account the severity guidelines of the efforts hospitals can make to and likelihood of occurrence of the adverse event to reduce them.11 ensure that significant problems are addressed and November/December 2011 | Practical Neurology | 29
Apologizing for Medical Errors then identifies contributing factors and mitigating aspects of healing and positive rewards for all those actions. Failure modes and effects analysis (FMEA) involved in the medical error context. Doctors can is a proactive analysis technique for identifying learn from their mistakes through continued train- potential failure modes, determining their effect on ing and self-reflection. They have the opportunity to the product or service under examination, and iden- forgive themselves. Patients and families can forgive tifying actions to mitigate the failures. While RCAs them for their “human error.” focus on what went wrong, FMEAs focus on what Within western societies, the Judeo-Christian tradi- could go wrong. tions of confession, repentance, and forgiveness sur- When complete root cause analysis is performed, round the many social contexts of errors, including a more precise corrective action can be implement- medical errors. ed in that the types of changes that are initiated Patients and families expect this from their physi- move away from the usual employee counseling to cians. They feel it is the professional and ethical the modification of organizational processes and thing to do. Research suggests that medical educa- procedures. Being able to link corrective actions to tion should include teaching trainees how to disclose root causes is much more effective. errors, apologize to injured patients and families, Establishment of Patient Safety Committees. and reinforce the commitment to continued care and Many organizations participating in reporting systems, repair of trust. The education should also stress con- particularly in Georgia, describe establishing special fronting the emotional dimensions of the errors by patient safety committees made up of physicians, the physician trainees, with the full acceptance by nurses, pharmacists, and other health care providers the senior attending medical staff. ■ to examine medical error reports. The establishment The authors have no relevant disclosures. of these committees helps the organizations identify more effective corrective actions and to implement Heidi Mandel PhD, DPM is in private practice in New safe procedures that involve all stakeholders. York City in Hospice and Palliative Care. Development and Adoption of Safe Protocols Steven Mandel MD, is Professor of Neurology and and Procedures. Health care facilities and hospitals Anesthesiology at Jefferson Medical College. report that they have been able to develop and 1. Dintzis SM., et al. Communicating pathology and laboratory errors: anatomic pathologists' and adopt safe protocols and procedures to effectively laboratory medical directors' attitudes and experiences. Am J Clin Pathol. 2011 May;135(5):760- 5. reduce medical errors. These protocols and proce- 2. Kronman AC, Paasche-Orlow M, Orlander JD. Factors associated with disclosure of medical dures are often similar to those developed by the errors by housestaff. BMJ Qual Saf. 2011 Sep 22. Institute of Safe Medication Practices (ISMP). 3. Helmchen LA, Richards MR, McDonald TB. Successful remediation of patient safety incidents: a tale of two medication errors. Health Care Manage Rev. 2011 Apr-Jun;36(2):114-23. Examples include alerts for medications with a high 4. Torrey, T. A Doctor's Apology, An Intensely Moving Experience. About.com. potential for harm if not managed appropriately and http://patients.about.com/b/2008/02/11/a-doctors-apology-an-intensely-moving-experi- ence.htm. Accessed June 23, 2011. guidelines on the use of standard abbreviations. 5. Mazor KM, Greene SM, Roblin D, Lemay CA, Firneno CL, Calvi J, Prouty CD, Horner K, Gallagher TH. More than words: Patients' views on apology and disclosure when things go wrong in cancer Conclusion care. Patient Educ Couns. 2011 Aug 6. 6. Howard J., et al. New legal protections for reporting patient errors under the Patient Safety and Silence from the doctor provokes confrontation, feel- Quality Improvement Act: a review of the medical literature and analysis. J Patient Saf. 2010 ings of abandonment, cover-up, and lack of account- Sep;6(3):147-52. ability from patients and families. They believe that 7. Abbasi, K. A way forward for whistleblowing. J R Soc Med. 2011 July; 104(7): 275. 8. Farley DO, Haviland A, Champagne S, Jain AK, Battles JB, Munier WB, Loeb JM. Adverse-event- an apology is not necessarily an admission of guilt. reporting practices by US hospitals: results of a national survey. Qual Saf Health Care. 2008 States’ disclosure laws in general seek to protect the Dec;17(6):416-23. doctor by allowing him or her to express sympathy, 9. Sorra, J. et al. Hospital Survey on Patient Safety Culture: 2010 User Comparative Database Report. AHRQ Publication No. 10-0026. March 2010. regret and condolence without the liability of blame 10. Noble DJ, Pronovost PJ. Underreporting of patient safety incidents reduces health care's abili- in malpractice litigation. ty to quantify and accurately measure harm reduction. J Patient Saf. 2010 Dec;6(4):247-50. Disclosure and apology can have beneficial 11. AHRQ's Patient Safety Initiative. Chapter 2. Efforts to Reduce Medical Errors: AHRQ's Response to Senate Committee on Appropriations Questions. 30 | Practical Neurology | November/December 2011
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