Undisclosed Medical Errors and the Affordable Care Act

Written by: Dr. Kathy Gennuso

Transparency is a vital element of efforts to enhance patient safety and satisfaction. One aspect of transparency that has received particular attention is the disclosure of medical errors.  The ethical opinion of the American Medical Association is “it is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients.”

The Joint Commission added “requirement to disclose unanticipated outcomes to accreditation standards” in 2001. Although disclosure of harmful errors to patients is widely recommended, current practice falls far short of this goal. The Affordability Care Act is requiring all medical errors be documented; failure to do so results in a penalty.  Disclosure of Undocumented Medical Error (UME) is an increasingly important topic within medical education and practice, especially when these questions are considered:

• Are physicians doing disclosure appropriately?
• Are there standards or policies regarding disclosure for physicians to follow and are they effective?
• Does full disclosure have an impact on litigation outcome or incidence?
• What are physicians’ attitudes regarding disclosure of medical errors and UME?

When physicians were asked about factors that might have prevented proper UME disclosure documentation, the most common issues identified by physicians were

• Time constraints,
• Being unsure about what needs to be disclosed, and
• Fear of being sued.

At many hospitals physicians are not the only institutional participants in disclosure conversations. For non-physicians, the top three hindering factors were

• Being unsure of whose responsibility it is to document,
• Being unsure of what to document, and
• Lack of training in document disclosure.

One recent study found that only 10% of UME disclosures had any level of documentation internal to the facility.

Good human resources practice will also be more important as ACA now allows whistleblowers to use public information as evidentiary support for an allegation of Medicare fraud and abuse. The human resources policies must provide a safe place to report any compliance concerns as well as a clear and objective process that addresses the concern. Whistleblowers have a legal right to bring these compliance concerns to their employer without fear of losing their jobs.

Patients want disclosure of all harmful medical care errors. They want to know what happened, know what has been done to fix it, and receive an apology. One study evaluated patient views regarding medical error disclosure by way of a hypothetical scenario with a survey.  They found that full UME disclosure increased the reported likelihood of patient satisfaction and trust with physicians. Not only do patients and the public support UME disclosure, so do physicians in general. Responsibilities to patients, to the profession of medicine, to self, and to the medical community are factors that have been identified that compel physicians to give adequate disclosure of medical errors.

A recent study shows that UME disclosures, showing the cost of litigation may be reduced by more than 60% when timely disclosure is an integral part of a claims resolution process. The same study found full disclosure increased the reported likelihood of patient satisfaction and trust with the physician. If these findings were more widely understood, fear of litigation might become a motivator rather than an impediment to proper disclosure.

Based upon UME, disclosure may occur with implementation of policies regarding process and content while addressing fears of litigation and locus of responsibility.  Even after implementation of policies, this may not be of significant impact unless there is a process of education and monitoring for sustained improvement. The lack of awareness points out the need to look at the effectiveness of existing methods of communication to professional staff and how best to address the implementation of a new policy of disclosure.

Because organizations and professionals vary widely in how they disclose errors to patients, and because of the lack of effective documentation, disclosure standards and training are necessary to meet public expectations, to promote professional responsibility, and most important, to support patient safety and quality improvement following unintended outcome errors. This will require education of healthcare providers regarding disclosure, documentation, and follow-up after unintended medical outcomes.