T. H. Gallagher & A. Kachalia
The New England Journal of Medicine
January 13, 2024
DOI: 10.1056/NEJMp2309554
Here are some excerpts:
Traditionally, recommendations regarding responding to medical errors focused mostly on whether to disclose mistakes to patients. Over time, empirical research, ethical analyses, and stakeholder engagement began to inform expectations - which are now embodied in communication and resolution programs (CRPS) — for how health care professionals and organizations should respond not just to errors but any time patients have been harmed by medical care (adverse events). CRPs require several steps: quickly detecting adverse events, communicating openly and empathetically with patients and families about the event, apologizing and taking responsibility for errors, analyzing events and redesigning processes to prevent recurrences, supporting patients and clinicians, and proactively working with patients toward reconciliation. In this modern ethical paradigm, any time harm occurs, clinicians and health care organizations are accountable for minimizing suffering and promoting learning. However, implementing this ethical paradigm is challenging, especially when the harm was due to an error.
Historically, the individual physician was deemed the "captain of the ship," solely accountable for patient outcomes. Bioethical analyses emphasized the fiduciary nature of the doctor-patient relationship (i.e., doctors are in a position of greater knowledge and power) and noted that telling patients...about harmful errors supported patient autonomy and facilitated informed consent for future decisions. However, under U.S. tort law, physicians and organizations can be held accountable and financially liable for damages when they make negligent errors. As a result, ethical recommendations for openness were drowned out by fears of lawsuits and payouts, leading to a "deny and defend" response. Several factors initiated a paradigm shift. In the early 2000s, reports from the Institute of Medicine transformed the way the health care profession conceptualized patient safety.1 The imperative became creating cultures of safety that encouraged everyone to report errors to enable learning and foster more reliable systems. Transparency assumed greater importance, since you cannot fix problems you don't know about. The ethical imperative for openness was further supported when rising consumerism made it clear that patients expected responses to harm to include disclosure of what happened, an apology, reconciliation, and organizational learning.
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CRP Model for Responding to Harmful Medical Errors
Research has been critical to CRP expansion. Several studies have demonstrated that CRPs can enjoy physician support and operate without increasing liability risk. Nonetheless, research also shows that physicians remain concerned about their ability to communicate with patients and families after a harmful error and worry about liability risks including being sued, having their malpractice premiums raised, and having the event reported to the National Practitioner Data Bank (NPDB).5 Successful CRPS typically deploy a formal team, prioritize clinician and leadership buy-in, and engage liability insurers in their efforts. The table details the steps associated with the CRP model, the ethical rationale for each step, barriers to implementation, and strategies for overcoming them.
The growth of CRPs also reflects collaboration among diverse stakeholder groups, including patient advocates, health care organizations, plaintiff and defense attorneys, liability insurers, state medical associations, and legislators. Sustained stakeholder engagement that respects the diverse perspectives of each group has been vital, given the often opposing views these groups have espoused.
As CRPS proliferate, it will be important to address a few key challenges and open questions in implementing this ethical paradigm.
The article provides a number of recommendations for how healthcare providers can implement these principles. These include:
- Developing open and honest communication with patients.
- Providing timely and accurate information about the error.
- Offering apologies and expressing empathy for the harm that has been caused.
- Working with patients to develop a plan to address the consequences of the error.
- Conducting a thorough investigation of the error to identify the root causes and prevent future errors.
- Sharing the results of the investigation with patients and the public.
