By David Meyers, MD, FACEP

Sinai Hospital, Baltimore

Dr. Meyers reports no financial relationships relevant to this field of study.

“Medicine is inherently dangerous; the dangers cannot be fully controlled, and healthcare is not likely to be completely safe anytime soon.”1 Richard Boothman, JD, Chief Risk Officer, University of Michigan Health System

In 1999, the publication of To Err Is Human: Building a Safer Health System2 by the Committee on Quality in Health Care of the Institute of Medicine (IOM, now the National Academy of Medicine - NAM) brought the country’s attention to the magnitude of harm from medical errors, with estimates of up to 98,000 deaths and $50 billion in costs for adverse events each year. Nearly half these harmful events were deemed potentially preventable. Also alarming was the declaration that the disclosure of errors was discouraged by our professional liability system and threat of malpractice, which would mean “most errors and safety issues go undetected and unreported.”2

Two years later, in the follow-up IOM report, Crossing the Quality Chasm: A New Health System for the 21st Century,3 the argument was made that “the pursuit of confidentiality is not a reason for hiding the system’s performance from those who depend on the system for care,” and a challenge for the future was announced: “Have no secrets. Make all information flow freely so that anyone involved in the system, including patients and families, can make the most informed choices and know at any time whatever facts may be relevant to a patient’s decision-making.”3 In support of recommendations under Rule 7 of the report, reference was made to published studies that suggested the costs of malpractice might be reduced by disclosure of errors.

It is well known that patients harmed during their care often are subjected to strategies commonly known as “deny and defend,” “wall of silence,” “circling the wagons,” and other such terms reflecting resistance to disclosure of errors and immediate institution of efforts to defend against a possible professional liability action. Injured patients and/or their families are potential adversaries in actions that could affect the physicians’ well-being, finances, and future practice.

Patients, on the other hand, have seen the lack of communication as tacit acknowledgement that the clinician is trying to hide something he or she did wrong, that the clinicians don’t care or respect the patients and don’t want to take responsibility for their actions. The resultant anger leads to the kinds of lawyer commercials seen on television and a desire, not merely for compensation, but for punishment of the “perpetrators.”

Studies have shown that what patients really want in these situations is to know the truth about the event and occurrence, to know it promptly after its occurrence, for clinicians and healthcare organizations to accept responsibility, an apology in recognizing patient harm, an apology from the healthcare practitioner, and an assurance that other patients will not have similar experiences, i.e., corrective actions will take place. Although monetary reimbursement was not one of the top desires, compensation for injuries and future care needs often came up.4

Starting in the late 1980s, healthcare institutions in the United States and Canada undertook efforts to look at alternatives to lawsuits and courts for dealing with harms to patients incurred in the process of providing care. The Veterans Administration Hospital in Lexington, KY, was an early pioneer of a model that contained three elements: disclosing the facts surrounding the incident or injury, apologizing and accepting full responsibility, and offering compensation for the harm. Analysis of causes with an intent to address deficiencies also was an important aspect of the program. A similar effort was initiated at the Royal Victoria Hospital in Montreal, Quebec, around the same time.

A widely emulated program based on these ideas was developed and put in place in 2001 at the University of Michigan health system, and the ideas embodied in that program gained traction, inspiring others. The Seven Pillars5 approach developed at the University of Illinois and Sorry Works6 were established soon thereafter; in addition, many healthcare institutions and even some states have created their own models around these principles.

Since then, such “disclosure, apology, and offer” programs have evolved and become more widely disseminated, especially after The Joint Commission mandated in its accreditation standards for hospitals in 2002 that Sentinel Events and other unanticipated outcomes of care be disclosed to patients and family members, if appropriate.

In addition, the Charter on Physician Professionalism,7 published in 2002 with international support, states that physicians have a “commitment to honesty with patients … Physicians should also acknowledge that in healthcare, medical errors that injure patients do sometimes occur. Whenever patients are injured because of medical care, patients should be informed promptly because failure to do so seriously compromises patient and societal trust.” The American College of Emergency Physicians (ACEP) created a policy on disclosure of errors in 2003,8 and the topic has been addressed in other ACEP publications.9,10

In 2012, the Agency for Healthcare Research and Quality (AHRQ) initiated the Communication and Optimal Resolution (CANDOR)11 program, based on some of these earlier models and ideas. Initially aimed at hospitals and health systems, CANDOR has gained interest from physicians and their insurers, including The Doctors Company,12 Medical Protective,13 and others, as well as reinsurers.

The major elements of the CANDOR process are:

  1. Promptly communicate with the patient and/or family about the known facts of the adverse event and what might not yet be known with expression of regret/apology.
  2. Initiate very early contact after the event with the clinicians involved for fact-finding as well as support in dealing with their feelings related to the event.
  3. Stop all billing processes pending investigation and decision-making about how to proceed, including possible offers of compensation.
  4. Investigate the factors contributing to the event for purposes of preventing future episodes.

In May 2016, AHRQ published its comprehensive CANDOR Toolkit to assist healthcare institutions and clinicians with implementation. The toolkit consists of slide sets, lecture materials, and videos in modules to facilitate establishing such a program.

Two elements are critical to the success of this effort. One is the full support and active commitment of hospital C-suite leaders, not just administrators — CEO, COO, senior legal counsel, and risk managers, but also clinical leaders, including the chief nursing officer and chief medical officer. Their involvement can be demonstrated by:

  • aligning CANDOR processes with the organization’s other strategic priorities;
  • helping develop a shared vision among all the players;
  • helping the team set goals;
  • facilitating progress toward goals;
  • removing identified barriers to progress;
  • helping define and promote shared accountability for the work of implementing the CANDOR process.

The other element is an organizational culture predicated on principles recognizing that errors will occur, most often not due to negligence or intention, but rather due to human factors such as knowledge deficits, distractions, biases, performance under stress, and so-called system factors such as the work environment, production and time pressures, sudden unexpected occurrences requiring rapid responses, and others.

This “Just Culture”14 recognizes three types of behavior related to error. Simple human error is an inadvertent mistake, a slip, or lapse — accidentally doing something other than the correct thing. At-risk behaviors are actions that unknowingly increase risk of an adverse event or error, even though they may be possibly justified by circumstances. Reckless behaviors are chosen with knowing disregard for significant and/or unjustifiable risk. A Just Culture avoids “blame, name, shame, and train” approaches to all errors, supports and consoles the clinician who inadvertently errs, and identifies and corrects factors contributing to the error. Those with at-risk behaviors are coached to recognize the potential dangers of these behaviors. Incentives for appropriate behaviors are put in place. There is no tolerance for those who behave recklessly, and remediation and discipline are pursued aggressively with close observation and termination if not improved.

Another important consideration is recognition of and attention to the ongoing needs — financial and emotional — of the victims of harm and their families. The days, weeks, months, and years following the event are difficult for injured patients and families in many ways, as attested to by the countless comments one sees and hears on the CANDOR videos, on websites, and at meetings of patients and advocacy groups for victims of medical harm. It is essential that patients’ interests have primacy, including the offer of legal assistance to help patients in having their interests best served in the disclosure, apology, and offer process.

Where Are We Now?

It is notable that successful disclosure and apology programs have so far been concentrated among hospitals and healthcare systems that employ many of the physicians on their medical staffs and have a greater ability to influence how physicians practice. These physicians often are insured through corporate entities, allowing for coordination of approaches among the parties and the availability of greater resources devoted to resolving these cases.

Adoption among individual and group physician practices has been growing under the influence of insurers promoting their use and providing training for clinicians, but significant concerns remain, impeding widespread acceptance.

Notwithstanding the interest, there is ongoing debate over the actual effects of these programs. Although several studies have been published demonstrating greater transparency, significantly fewer malpractice claims, and lower related costs,15 a recent Vanderbilt study16 disputed this result. The reasons are not clear, and the study itself has been criticized for its assumptions and conclusions. Other studies are in progress.

The skills used in disclosure and apology are not natural to many; therefore, training is required so that the situation is not made worse. Furthermore, nothing in the disclosure and apology programs prevents patients who have been injured from filing claims in the legal system, and, although the trend is away from this, the disclosures and apology themselves still may be used as evidence against the physician in some states.

At least 39 states have enacted laws addressing alternative resolution, including one or more elements of disclosure and apology. A 2010 study17 reviewed the landscape of statutes across the country and found wide variation in definitions, protected and required actions, and how they should be carried out. The authors recommended some best practices they believed would make the statutes more effective and the programs more acceptable to physicians.

The unique character of emergency medicine presents numerous challenges to the implementation and effectiveness of disclosure and apology efforts. The unpredictable nature of the work environment; often high volumes and patient acuity; production pressures; episodic care with no long-term patient relationships; limited historical information about patients; frequent transitions of care between and among physicians, nurses, and others; lack of accurate contact information for patients; difficulty monitoring outcomes for patients who have left the ED either via discharge or admission to in-patient beds — all these factors can increase the risk of errors and reduce opportunities to recognize and disclose them at all, let alone in a timely way.18

Finally, CANDOR and similar approaches do not alleviate the concerns of physicians about reporting to state regulatory and licensing bodies nor the National Practitioner Data Bank (NPDB), since now there is no standard waiver from those reporting requirements.19 Reporting to the NPDB can be avoided by several means consistent with the law, but fear of reporting is still a strong incentive to avoid open communication, disclosure, and apology. Robert Blasio, CEO of Western Litigation, Inc., which handles hundreds of emergency medicine claims for many of the largest emergency medicine physician practice management companies as well as hospitals and healthcare institutions, has seen movement toward disclosure and apology, but so far, institutional use far outpaces its adoption in the physician sector, and that is likely to continue.

Although CANDOR and other programs of disclosure, apology, and offer provide some relief to the victims of healthcare-induced harm, and are gaining in acceptance, their actual effect on claims, costs, and satisfaction is yet to be fully determined.

While most agree transparency, forthrightness, and “doing the right thing” for patients and their families are ethical imperatives, practical concerns and lack of definitive data have yet to prove conclusively they will make a difference.

REFERENCES

  1. Boothman RC. CANDOR: The antidote to deny and defend? Health Serv Res 2016;51 Suppl 3:2487-2490.
  2. Institute of Medicine, Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. National Academies Press; 2000.
  3. Institute of Medicine, Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press; 2001.
  4. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994;343:1609-1613.
  5. McDonald TB, Helmchen LA, Smith KM, et al. Responding to patient safety incidents: The “seven pillars.” Qual Saf Health Care 2010;19:e11.
  6. Sorry Works! Available at: http://bit.ly/1WLJEqy. Accessed March 1, 2017.
  7. ABIM Foundation. Medical professionalism in the new millennium: A physician charter. Ann Intern Med 2002;136:243-246.
  8. American College of Emergency Physicians. Disclosure of medical errors. Available at: http://bit.ly/2meB9f7. Accessed March 1, 2017.
  9. Marco AC. How to handle a medical mistake. ACEP Now, April 13, 2016. Available at: http://bit.ly/2mLqq8n. Accessed March 1, 2017.
  10. Moskop J. Patients and medical errors — to tell the truth? ACEP News, August 2007. Available at: http://bit.ly/2mtYpX2. Accessed March 1, 2017.
  11. Agency for Healthcare Research and Quality. Communication and Optimal Resolution (CANDOR) Toolkit. Available at: http://bit.ly/2m9fch7. Accessed March 1, 2017.
  12. The Doctors Company. CANDOR Toolkit: Physicians now have the right tools to do the right thing after an adverse event. Available at: http://bit.ly/2lX88C7. Accessed March 1, 2017.
  13. MedPro Group. Disclosure: When an unanticipated event occurs. November 2012. Available at: http://bit.ly/2ld4OWo. Accessed March 1, 2017.
  14. Outcome Engenuity. What does our model of accountability look like? Available at: http://bit.ly/2mFJSV6. Accessed March 1, 2017.
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  16. McMichael BJ, Van Horn RL, Viscusi WK. Sorry is never enough: The effect of state apology laws on medical malpractice liability risk, Dec. 10, 2016. Available at: http://bit.ly/2lrSBbk. Accessed March 1, 2017.
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