Documentation is key to case alleging experiment
The bread and butter of risk management is documentation, but it becomes even more important when you are accused of performing experimental therapy without the proper consent. If you can’t prove that you thoroughly explained the situation to the patient and obtained the proper consent, you’re dead in the water.
Risk managers should strongly encourage surgeons and other physicians to err on the side of caution when explaining aggressive treatment to patients and their families, says Steve Johnson, director of risk management for Wellstar Health System in Marietta, GA. "If there is even a hint that what they’re doing could be considered by their peers to be outside the norm, then the patient should be fully informed of that fact," he says. "It could only help you. Go into as much detail as you want to explain the benefits and why you’ve decided to do this, but be very thorough in explaining that this is an unusual procedure."
The risk increases when the procedure is highly complex and confusing, as with neurosurgery. It is imperative that the surgeon explain the situation as clearly as possible, avoiding medical terminology that will be meaningless to the patient, Johnson says. If the surgeon doubts that the patient fully comprehends the risks, and especially if death is a possibility, the surgeon should bring in a family member or friend to help the patient understand, if the patient agrees. Document that person’s involvement.
"I would tell surgeons that you have to document, document, document in these gray areas," he says. "When you’re in cutting-edge medicine, the more you can do to show that you’ve discussed this with the patient and they wanted to proceed, the better you are. You don’t want to be left with just the doctor’s word that he did everything he could to inform the patient."
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