The contemporaneous documentation of the informed consent process serves as the foundation for the defense of any subsequent claim by a patient for lack of informed consent. The signature of the patient on a consent form alone is not legally determinative evidence that the patient has given informed consent. Poor or absent documentation will force a physician to testify from recollection about an event which occurred several years previously, which will undermine his or her credibility. In addition, poor or absent documentation may be a significant factor in a patient's attorney's decision to institute a legal action.
To reiterate, the physician who had the discussion with the patient must document the details of the discussion in the patient's medical record. The entry in the medical record regarding the informed consent process should describe the information disclosed to the patient. Avoid the use of summary statements such as "The patient was advised of the potential risks/complications of the operation and alternatives" and instead, note at least some of the actual risks, complications and alternatives discussed with the patient. For example, the entry could state that "information regarding the risks, complications and alternatives were discussed with the patient and/or family, including but not limited to ...", followed by the specific information discussed. Note whether the patient was given any booklets or written material regarding the procedure or treatment. It is also important to document any questions asked by the patient and the answers given.
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