Harmful Errors: How Will Your Facility Respond?

In our August 24, 2006 newsletter, we shared the tragic story of a 16-year-old woman who died during labor due to accidental IV administration of a bag of epidural analgesia instead of penicillin. According to news reports, the nurse who was caring for the patient no longer works at the hospital. The hospital would not comment whether this was a voluntary or forced termination, but many speculate the latter.

In our last newsletter (September 21, 2006), we reported another tragic event: the death of three premature infants from an overdose of heparin after the wrong strength was used to prepare flush solutions. In stark contrast, media reports noted that staff involved in this error were on leave, receiving supportive care until they felt ready to return to work. Furthermore, a letter of public support for the nurses and pharmacy technician involved in the error, along with collective resolve to do more to protect patients, appeared in an October 1, 2006, IndyStar news article. The letter was signed by chief nursing officers and nursing deans from more than 20 hospitals and universities around the Indianapolis area where the error occurred. The nursing leaders noted: “Anger and outrage over the deaths of these three children is understandable. But it’s important for all of us to understand that no amount of blaming or finger-pointing will undo the harm or fix the system weaknesses that allowed this medication error to occur in the first place… As we grieve, we must support all the families and friends rocked by this tragedy, including the clinicians and staff involved in the babies’ care. This was everyone’s worst nightmare.”

Why the glaring differences between the two organizations when responding to harmful errors? Certainly, human error—perhaps even at-risk behaviors or policy violations—occurred in both events. Nevertheless, the culture appears to be far more “just” in dealing with the staff involved in the most recent event (see our September 7 and September 21 articles for details about a Just Culture). Without minimizing the vast importance of a culture that treats the workforce fairly when an error occurs, there is another reason that organizations might respond differently in the wake of an error: the absence or presence of a thoughtful readiness plan to handle medical errors that harm patients before they occur.

Organizations should not underestimate the emotional toll that accompanies harmful medical errors. Often, hindsight bias (akin to Monday morning quarterbacking) and external pressure inevitably lead to finger pointing during the immediate analysis of the event. Sadly, this sometimes leads to ill-conceived employment terminations or other unwarranted disciplinary actions which are often later regretted by the organization. To help guide the most appropriate response to a harmful error, all practice sites should have a well-designed plan that is fully supported by the organization, including the board of trustees, executive leaders, professional staff, risk managers and attorneys, human resources, staff development, public relations staff, and middle managers. The plan should address the following:

Internal notification. Who needs to be notified about the event internally, such as the physician, manager, senior leaders, board of trustees, risk management, patient safety officer, director of pharmacy (if drug-related event), and professional staff? Who provides that notification? How should staff report a harmful event to risk management? What is the timeline for notification of the event? How will affected staff be notified about the event? How are staff and the board updated about the investigation and action plan? How will internal public relations activities be conducted so that appropriate staff know the story and how it is being addressed?

External notification. As required, who will notify external organizations (e.g., department of health, state reporting program) about the event? Who will the organization voluntarily notify (e.g., Joint Commission, USP-ISMP Medication Errors Reporting Program, product or device manufacturers) so others can take precautions to prevent like errors? How should information about the causes of the event be handled according to state peer review statutes? How will the organization accommodate visits from regulatory or investigative bodies?

Disclosure. What specifically should be disclosed to patients and families (e.g., circumstances of the event, consequences to the patient, treatment, plans for investigation, system-based causes, improvement efforts, other parties informed about the event, contact information for support and counseling from the organization and external sources)? Who should disclose the information? How should the disclosure happen? Who should be present during the disclosure? Who will be the contact person for follow-up or to answer questions from the patient or family? How is just compensation for injuries determined and offered to the patient or family? Who should inquire about the patient’s or family member’s desires regarding the level of disclosure to the public, and how will that information be communicated to all who need to know? 

Treatment of staff. How will staff involved in the event be evaluated and treated? How will system-wide accountability be assessed? What forms of support and psychological counseling will be offered to those involved in the event and those affected by the event?

Interaction with patients. How should staff, both those involved and not involved in the event, interact with patients and families who have been victims of a harmful error? How should staff interact with other patients who have heard about the event?

Media inquires. With inquiries from the news media, how can the organization provide useful and accurate information to the public without breaching patient confidentiality? Who will provide ongoing feedback to the community? How should staff respond to unsolicited media questions?  

Investigation. What procedures must be undertaken to safeguard documents and involved containers and equipment for further investigation? How should the immediate internal review and investigation of an event be carried out? How should a more detailed event analysis occur? What criteria will be used to determine whether an independent review of the event by outside experts should be carried out? How will the results of the investigation be communicated to the patient and/or family and to applicable staff and the board (and the public, if appropriate)?

Improvement. What process(es) will be used to ensure that appropriate immediate and long-term preventative actions are taken (e.g., ongoing evaluation of action plan implementation, policy development, measurement to determine positive or negative change)?

If you have implemented a plan to respond to harmful medical errors in your organization, please consider submitting it to ISMP ([email protected]) so we can post examples on our Web site to help others adopt similar strategies. While we are confident that all healthcare providers hope that such a plan will never be needed in their organization, the insight gleaned from developing the plan and communicating it to the workforce will set the stage for an appropriate response should such an event happen.