To tell the truth: the ethical and legal implications of disclosure of medical error.

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To tell the truth: the ethical and legal implications of disclosure of medical error.

Introduction (1)

In early 2004, Carol Smith and David Jones (as we will call them) were seriously ill patients in Intensive Care Units at the Foothills Medical Centre in Calgary. (2) On March 4, 2004, Carol, who was 83, died suddenly and unexpectedly. (3) Just prior to her death, Carol was alert, oriented and did not seem to be in imminent danger. (4) In these circumstances, it might have been easy to dismiss Carol's death as a result of complications from her serious underlying condition. However, an astute ICU physician investigated further and ultimately it was discovered that her death was the result of receiving potassium chloride instead of sodium chloride in her dialysate solution. (5)

As a result of this adverse event, a broader investigation was commenced and the 30 bags of improperly mixed solution were immediately taken out of use. (6) This quick decisive action undoubtedly prevented the deaths of other patients. However, when patient care and pharmacy records were examined, it became clear that another patient had also died as a result of the improperly mixed solution. (7) David Jones had also been a patient in the ICU at Foothills Medical Centre and had died unexpectedly a week before Carol. (8) If Carol had not died and had her physician not been astute and diligent enough to investigate her death further, it is possible that David's death would never have been properly explained and his family would never have known what occurred.

Soon after discovering the tragic error, the health providers disclosed the error to the victims' families. In addition, after an internal investigation and consulting with the families of the victims, the Calgary Health Region (CHR) publicly disclosed the facts and accepted responsibility for the deaths. (9) This decision to publicly accept responsibility, although not unprecedented, is extremely rare. (10)

After its own internal critical incident review, the CHR instituted a number of changes aimed at avoiding similar errors in the future. (11) In addition, the CHR also launched an external independent review of the incident and its broader patient safety culture and initiatives. This review culminated in a detailed report that was released June 29, 2004. (12) The report, while generally applauding the patient safety efforts of the CHR, made 66 recommendations regarding the specific incident and the broader patient safety issues facing the CHR. (13)

There are a number of extraordinary aspects of this tragic incident. While there is no doubt that a tragic preventable error occurred and that the system failed the victims and their families, the subsequent actions of the CHR in dealing with the adverse event have been impressive. On the one hand, this incident is an example of how vulnerable our systems still are to human error and highlights the need to be ever vigilant in our patient safety efforts. On the other hand, this incident is also an example of an appropriate and proactive response to error through the prompt disclosure of the error to the victims' families and the public acceptance of responsibility. In its response, the CHR did not focus primarily on damage control, but instead focused on the victims' families and learning from the error. In addition, the decision to launch an external review and publicly share its findings is an important positive step. Moreover, the Health Quality Council of Alberta and the Canadian Patient Safety Institute have been involved in various aspects of the process and will assist with spreading the lessons learned from these tragic deaths across the province and the country.

Unfortunately, proactive responses like those taken by the CHR in this situation are still the exception rather than the rule when health providers respond to medical error. In addition, while the conduct of the CHR was laudable, it should be noted that it is much easier to proactively disclose error and accept responsibility in circumstances of clear medication errors, than when dealing with other forms of error. In many circumstances of suspected error, it would be inappropriate to take action too early, as it will often not be clear whether an error even occurred, let alone what the cause of the error was. However, at the very least, the above response by the CHR should serve as an example for how health providers should respond to adverse events that result from clear error.

While patient safety and medical error have long been a concern of the health professions, it was not until the 1999 release of the To Err is Human report of the U.S. Institute of Medicine (IOM) that the issue received widespread public and political attention. (14) Since the release of the IOM report, patient safety has been vaulted into the spotlight and is now central to reform efforts by members of the health professions, hospital administrators and governmental health agencies. All over North America, tremendous pressure is being brought to bear on all aspe...

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