How Risk Managers Should Conduct an Adverse Event Investigation

When the phone rings and you learn that a patient has died from a medication error, are you prepared to implement your investigation protocol immediately? Or are you caught unprepared and wondering what to do first?

Having an action plan for that moment will greatly improve an adverse event investigation, says Edwin G. Foulke Jr., JD, partner with the law firm of Fisher Phillips in Atlanta. Foulke was the head of the Occupational Safety and Health Administration from 2006 to 2008 and directed more than 300 workplace fatality investigations. Exactly how you carry out the investigation can determine how and what crucial information is obtained and, potentially, the course of future litigation.

“You cannot do this on the fly. You have to have an accident investigation process in place before anything happens,” Foulke says. “When you have situations in which someone has died and there may be governmental inquiries, you need to be able to act quickly to gather information before it disappears or becomes spoiled. There can be evidence that you need to isolate and protect, and you may need to get to witnesses before they are influenced by others or forget key details.”

An investigation’s primary focus should be preventing a recurrence of the adverse event, but the potential legal liability cannot be set aside, Foulke says. That potential liability means that one of the first steps should be notifying legal counsel of the event and noting that the investigation is being conducted in anticipation of litigation. That step will provide a basis for asserting an attorney work product privilege to the investigation, Foulke says.

It may be necessary to have counsel direct the investigation in order to provide the most protection to the resulting documents, witness statements, and reports, Foulke says. (See the story in this issue for more on the role of privilege in an adverse event investigation.) Issuing a document hold also is an immediate concern, including the preservation of electronic documentation such as emails.

Expertise Needed?

Determining the right people to involve in the investigation will depend on the particular situation, particularly with clinical matters. If the adverse event involved an area of medicine or type of procedure that is beyond the understanding of counsel and, perhaps, even a risk manager with a nursing background, it will be necessary to draw in a staff member who is knowledgeable, but not involved, to guide the investigation.

Securing the scene is another immediate concern. After an injury or death, there often is an urge among those involved and their managers to clean up the area right away, almost as a subconscious desire to make the bad situation go away, Foulke says. Valuable evidence can be lost. Plaintiffs’ attorneys will argue adverse inferences and say you must have destroyed the evidence because it was detrimental to your case.

“Sometimes people are more interested in interviewing witnesses right away and, before they realize it, housekeeping has gone in and cleaned up the area, tossed evidence in the garbage, and you can never get that evidence back or rely on its validity,” Foulke says. “That room should be locked down, [with] no one allowed to enter or do anything to it until you’ve investigated and documented the scene.”

Don’t Let Witnesses Talk

Identifying and interviewing witnesses comes next. Risk managers should consider the nature of the incident and the role of privilege when determining who should conduct witness interviews, notes Amy Hampton, JD, partner with the law firm of Bradley Arant Boult Cummings in Nashville, TN.

For example, the interview of a witness who is potentially subject to employment action as a result of the incident should be managed with human resources or counsel.

Risk managers should avoid concurrent or group interviews in favor of individual interviews, Hampton suggests, and they should caution witnesses to avoid the natural tendency to discuss the event or the investigation among peers. Explain the reasons for this warning, she advises. First, it insulates the witness’ memory of the event, and it avoids influence of another witness over the witness’ memory. It also helps avoid a claim that witnesses collaborated on a story to cover up misconduct. Talking among witnesses and with uninvolved people also opens up the possibility of criminal conspiracy charges, Foulke notes.

“If you have a doctor and nurses standing around talking about what happened, the doctor might say, ‘Well, remember I did this and then I did that,’” Foulke says. “The nurses don’t want to contradict the doctor, and so that becomes part of the nurse’s story when she’s interviewed. She doesn’t really remember him doing that, but he said he did, so she passes it on as part of her memory.”

In addition, keeping witnesses quiet helps avoid drawing in individuals who did not observe the incident and who would not otherwise be involved in the investigation.

“When a witness is questioned or deposed regarding an incident, the examiner inevitably will inquire with whom the witness has spoken about the event,” Hampton explains. “The otherwise uninvolved individual now becomes a potential witness because of the shared information.”

From his experience in hundreds of accident investigations, Foulke learned how easy it is for people to jump to conclusions and find fault. He warns risk managers to avoid that tendency and keep the investigation focused on “why” for as long as possible. Conduct a thorough root cause analysis even when the answer seems obvious, he says.

“We saw it all the time where people would think right away that they knew what went wrong and who did it, then the investigation would come to a halt,” he says. “They stopped asking the ‘why’ questions that could eventually lead them to the real explanation.”

The Oregon Patient Safety Commission also offers advice on how to best gather information from adverse event witnesses, and the Agency for Healthcare Research and Quality has debriefing tips and a new toolkit for responding to adverse events. (See the stories in this issue for more on those resources. Foulke’s advice for some of the hard questions to ask witnesses also is included in this issue.)

Some sensitivity is required when interviewing witnesses, especially those who are emotionally upset by the event, Foulke notes. Having one person to conduct the interview and a second taking detailed notes is good, but avoid having several investigators interview the witness at once, which can be overwhelming and intimidating. The investigator should explain the purpose of the investigation and emphasize that it is not to place blame on individuals, he says.

Urge the witness to speak up if a question is not clear or to ask what the investigator is seeking, and offer to take breaks or go as slowly as the witness wants. The goal is to put the witness at ease so that you can obtain as much information as possible, rather than the witness feeling on guard and careful about every word, Foulke says.

It will be necessary to ask some specific questions, including difficult ones, but start with letting the witness tell the story from beginning to end, Foulke advises.

“Ask the person to recount what happened, from the earliest point in the day all the way through what happened and the aftermath. Encourage even the smallest details that seem unimportant, and then just let them talk,” Foulke says. “The hardest thing for interviewers is to just let people talk uninterrupted. Let them pause and think, gather their thoughts, and continue. That’s how you get the whole story.”

SOURCES

• Edwin G. Foulke Jr., JD, Partner, Fisher Phillips, Atlanta. Telephone: (404) 240-4273. Email: [email protected].
• Amy Hampton, JD, Partner, Bradley Arant Boult Cummings, Nashville, TN. Email: [email protected].