Risk Management

Tip

Obtaining informed consent for a treatment or procedure is a two-step process based upon a conversation between the treating physician and the patient. In addition to fulfilling the legal requirement that informed consent be obtained, the process serves as an effective risk management technique. It provides an opportunity to establish a patient-physician relationship based upon open, honest communication. Such a relationship is critical, especially in the event of an unexpected outcome.

The first step in the informed consent process is a discussion wherein the physician explains the recommended procedure, alternatives to the procedure and material risks of the procedure. The physician should also discuss risks associated with not undergoing the procedure. Once this conversation has taken place, the physician should encourage questions and answer them to the patient's satisfaction. It is at this point that the patient has (or has not) given "informed consent" for the recommended procedure.

The second step of the informed consent process is documentation of the informed consent. Although these are separate steps in the process, both the discussion and documentation of the discussion must take place. The documentation may be done in two ways:

1. the patient can sign a consent form outlining the conversation, and

2. the physician can document the conversation in the medical record.

This process helps to establish a relationship based upon mutual understanding and trust. It encourages the patient to be a partner in their care rather than the physician dictating what the patient should and should not do. If an unexpected event occurs, the patient will be less likely to blame the physician if this format for informed consent has taken place.

Remember: The informed consent process is an opportunity to clearly and thoroughly communicate with your patients. Documentation of informed consent is necessary, however, it cannot replace the dialogue that must occur between physician and patient.

UPDATE - YEAR 2000

For those of you that are interested in a Y2K update, the following is a website that identifies Y2K compliance status for most physician office equipment: http://www.fda.gov/cdrh/yr2000/y2kprblm.html

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