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IHI Issues Guidelines for Managing Clinical Adverse Events

 |  By cclark@healthleadersmedia.com  
   October 04, 2010

The call wakes the hospital CEO at 3:00 AMA patient has died because of a terrible medical error," he is told. "The family is upset and talking with a reporter. The nurses and doctors are pointing fingers. This looks very bad for us. What should we do?"

 

Versions of this chaotic scenario happen with increasing frequency in many healthcare facilities nationally. But "many organizations do not have a plan for when a serious clinical adverse event occurs," says Jim Conway, senior fellow with the Institute for Healthcare Improvement.

In a white paper "Respectful Management of Serious Clinical Adverse Events"  released Friday, Conway and colleagues with IHI and the Harvard School of Public Health offer a way for providers to prepare.

Conway has firsthand experience with the dos and don'ts of crisis management. He was chief operating officer at Dana Farber Cancer Institute in Boston in 1994 when 39-year-old Boston Globe health reporter Betsy Lehman died of complications from a chemotherapy overdose she received while undergoing breast cancer treatment there.

Conway, who learned many lessons during and after that event, has devoted the rest of his career to improving organizational safety and transparency.

"The risks of not responding to these adverse events in a timely and effective manner are significant," he and his colleagues wrote. The ramifications include:

  •  Loss of trust
  •  Absence of healing
  •  No learning and improvement
  •  The sending of mixed messages about what is really important to the organization.
  •  Increased likelihood for regulatory action or lawsuits
  •  Increased likelihood of challenges by the media.


"For any organization, the fact that these events occur doesn't differentiate tem," the authors wrote in the introduction.

"In the crisis that often emerges, what differentiates organizations, positively or negatively, is their culture of safety, the role of the board of trustees and executive leadership, advanced planning for such an event, the balanced prioritization of the needs of the patient and family, staff and organization, and how actions immediately and over time bring empathy, support, resolution, learning and improvement."

The paper is divided into sections offering sample plans, questions to ask about preparedness, and checklists. For example:
Priority 1: The Patient and Family

  • "Has there been appropriate communication and disclosure to the patient and family, most often by a team of two staff persons (or in some cases more), including a clinician who has a pre-established relationship with them?"
  • "Has the organization made a statement of empathy and issued an apology in cases where there is fault?"

Priority 2: The Front-line Staff

  • "Are there people and resources available to coach the staff involved as they prepare for disclosure of the event, and to support them through the process?"
  • "Is there ongoing support to the clinicians and team at the front line of the harm? Are they at risk of personal harm? When are they safely able to return to providing care? Would it be helpful for the CEO to meet with the front-line staff?"
  • "Do not jump to conclusions: Ask 'What happened?' and not 'Who did it?' "

The IHI team acknowledges that fighting off shame and blame is a huge challenge after serious events.
Priority 3: The Organization

  • "There is a visible CEO ('I care,' 'I'm accountable')."
  • "The organization has issued a call to action grounded in values, integrity and doing the right thing."
  • "The board of trustees is notified, as are relevant regulatory agencies" and "a root cause analysis of the event has been activated immediately."

The 36-page paper includes a list of important words hospital officials should use to assure the public and staff understand that the hospital take responsibility and has absorbed the severity of the incident.  It suggests CEOs use words or phrases of compassion, concern, empathy, and remorse, such as "alarmed, appalled, ashamed, and disappointed."

It also includes a list of 14 hospital CEOs willing to talk about tragic events at their institutions, including  Rady Children's Hospital in San Diego, which grappled with incidents involving sexual abuse of children by employees.

Other parts of the paper deal with how to engage with the media.

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