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

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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

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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

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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.

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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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