American College of Physicians: Internal Medicine — Doctors for Adults ®


To err is human … to not plan for it is trouble

Hospitals should plan in advance for serious medical mistakes

From the December ACP Hospitalist, copyright © 2008 by the American College of Physicians

By Kathleen Louden

Hospitals should always work to prevent serious or fatal medical errors, but they also need to have a plan in place for what to do if an error occurs. Chances are, it will happen eventually. Medical errors kill 44,000 to 98,000 people a year in U.S. hospitals, according to a 1999 Institute of Medicine (IOM) report.

“Even if a hospital has great preventive policies and teamwork, a fatal medical error can still occur,” said patient safety expert Robert Wachter, FACP, chief of the hospital medicine division at the University of California San Francisco (UCSF) Medical Center. Hospitals are under more pressure than ever to have a plan for responding to these errors, Dr. Wachter said. Since October 2007, the District of Columbia and 25 states mandate reporting of serious medical errors, and as of Oct. 1, 2008, Medicare no longer pays for the extra costs of care stemming from certain preventable medical errors. The Joint Commission also requires that patients be informed of unanticipated outcomes.

To err is human … to not plan for it is trouble“A hospital that doesn’t have a plan will be in serious trouble,” Dr. Wachter said. “In states with reporting requirements, there is a risk of the hospital being closed or losing Medicare payments. The hospital may lose its accreditation. More importantly, patients will die.”

Elements of the plan

Because most serious errors are not fatal and because it’s not always clear that an error was the cause of an event, hospitals should develop a plan that guides what they do after any unexpected adverse outcome, experts said.

Harvard-affiliated hospitals, for example, use an adverse events plan that includes guidelines for securing the drugs and equipment that may have contributed to the error or events; disclosing what happened to the patient or family promptly and documenting these conversations; delaying billing until an investigation can be done; investigating and identifying the cause; and offering compensation to the patient or family if appropriate.

The most important part of this process is learning from the error, and making sure it doesn’t happen again, Dr. Wachter said. That means performing a “root cause analysis”—a structured retrospective method to analyze serious adverse events and near-misses, experts said. The analysis should focus mostly on systems and processes, not on individual performance, The Joint Commission says in its guidelines for responding to adverse or “sentinel” events.

A planning team for responding to adverse events also involves staff from multiple disciplines, and may include hospitalists. Most often the team leader is a member of the hospital leadership, such as the chief executive officer and the chief medical officer. The team also should include the quality/safety officer, regulatory officer and the senior representatives from nursing, pharmacy, risk management/legal, and information technology, Dr. Wachter said.

Disclosure as a process

Informing the patient and/or patient’s family about what happened is one of the most important parts of the response plan. Indeed, there is a trend toward full disclosure of a medical error and an apology to the patient’s family, Dr. Wachter said. As of 2007, 35 states have passed “I’m sorry” laws granting limited legal immunity to health care providers who apologize after adverse events, according to the Sorry Works! Program, which advocates for disclosure and apology after such events.

As such, a response plan should state which hospital professional will have the initial conversation to disclose what happened, and who will be the continuing main contact person. Talking to the patient and/or family about the medical error is one of the most important parts of the response plan.

Talking to the patient and/or family about the medical error is one of the most important parts of the response plan.

Talking to the patient and/or family about the medical error is one of the most important parts of the response plan.

If an error caused the incident, hospital personnel need to identify the factors that led to the error and eliminate them, experts said. To ensure objectivity, it is often the hospital’s risk manager or another senior staff member not involved in the event who leads the root cause analysis. This person will conduct confidential interviews with all providers and with the patient and/or family.

Unlike a traditional morbidity and mortality conference, a root cause analysis is multidisciplinary, said Timothy McDonald, MD, JD, chief safety and risk officer for health affairs, University of Illinois at Chicago (UIC) Medical Center. It includes involved caregivers, departmental managers, hospital leaders, and risk management and safety officers, who collectively provide a variety of perspectives and ensure that corrective actions are taken.

Multiple conversations with the family are needed in the first 24 hours and subsequent weeks, Dr. McDonald said.

“Disclosure is a process, not an event,” he said. “The family wants to know you’re not going to abandon them.”

Often in these cases, it is the attending physician who is primarily responsible for communicating with the family. If a hospitalist is the first responder, Dr. McDonald said, he encourages the hospitalist to be involved in subsequent family communications.

Many physicians do not know the best way to communicate a hospital accident to a patient’s loved ones, since serious medical errors are infrequent in an individual physician’s career and medical schools are just beginning to teach students how to have this difficult conversation, Dr. Wachter said.

Having a disclosure conversation without preparation could lead to saying something you will regret or being unable to answer a question, said Thomas Gallagher, FACP, member of the ACP Ethics, Professionalism and Human Rights Committee.

“Hospitalists should practice these communication skills and know what resources the hospital offers in this situation,” said Dr. Gallagher, associate professor of medicine at the University of Washington. “Be prepared to get help.”

Some medical centers with disclosure programs provide physicians with “just-in-time training” in the form of on-call experts or staff members who are trained in disclosure skills. UIC, for example, trains doctors and nurses in disclosure and mobilizes them within one hour of an adverse event to walk through what to say and how to say it.

Increasingly, health care systems offer training courses to their care providers on how to inform a patient and family about adverse events, Dr. Gallagher said. One of those is Kaiser Permanente, which has trained more than 8,000 of its 14,000 physicians in communicating unanticipated adverse outcomes, said Annie Herlik, RN, director of national risk management.

“[A serious medical error] is an incredibly emotional and difficult time for everyone,” Herlik said. “It’s too hard a time to get into learning.”

Kathleen Louden is a freelance health writer in Gurnee, Ill.



A quick primer on a difficult conversation

When initially disclosing a medical error to a patient or family, a hospitalist should state what happened in factual terms. “Say what you know [is true],” said Lachlan Forrow, FACP, director of the ethics service at Beth Israel Deaconess Medical Center in Boston.

“Be very careful about calling something an error,” he advised about the early disclosure process. “Don’t be premature about assigning fault.”

For instance, if a patient received an overdose of a medication, don’t say, “The nurse gave you the wrong dose of the medication.” A root cause analysis may find that the fault lay elsewhere. A better statement would be, “You received the wrong dose of medication. We are working to find out how that could have happened. We will let you know as soon as we know.”

Family members want an apology if an error occurred. However, Dr. Forrow said, “Initially, ‘I’m sorry’ is ‘I’m sorry this happened.’”



Elements of an adverse-events response plan

  • Inform staff of the hospital’s commitment to open and honest communication of adverse events.
  • Train physicians and other care providers in how to immediately respond to a medical error that causes harm or death, including how to disclose an adverse event to the patient and/or family, and how to conduct a root cause analysis.
  • Immediately after a serious error, the involved care provider or a designated rapid response team should:
  • sequester implicated equipment, drugs and records;
  • debrief all members of the care team;
  • decide who will tell the patient/family (usually the attending physician or other trusted caregiver); and
  • ensure that person gets just-in-time guidance from trained staff members (sometimes called disclosure coaches) about communicating with the patient and family.
  • Disclose a serious adverse event to the patient/family in private by:
    • providing facts about what happened (not how or why);
    • expressing regret for the outcome or, if an error was the cause, apologizing; and
    • taking responsibility: be the primary contact person, let them know more information as soon as you know it and, after the investigation, tell them what changes the hospital will make to prevent future incidents.
  • Investigate quickly while memories are fresh (root cause analysis).
  • Offer emotional support to patients, family members and health care providers.
  • Document and report the incident to the proper hospital officer and to external regulatory agencies.
  • Hold off billing pending investigation.
  • Decide whether to offer a settlement.

Sources: When Things Go Wrong: Responding to Adverse Events. A Consensus Statement of the Harvard Hospitals, March 2006; National Quality Forum.


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