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The reading level of your consent forms is important, but it is not the only reason you might want to review and improve the documents, says Sandra K.C. Johnson, RN, ARM, FASHRM, regional risk manager at Imperial Point Medical Center in Fort Lauderdale, FL.
Johnson and her colleagues recently revised their consent forms, partly to consolidate myriad documents in use at the time and partly to take a new, more streamlined approach to obtaining consent. Her system’s four hospitals and 38 ambulatory centers were using a wide variety of consent forms, but Johnson wanted to consolidate them about a year ago. Previously, the various centers required consent for actions that didn’t need consent, and there was no uniformity.
Readability is a good reason to review consent forms, Johnson says, and she made sure the revised consent forms were written at a much lower reading level than the previous ones. But she also suggests risk managers check other potential problems and improvements at the same time.
Johnson and her colleagues decided to make the consent forms simpler than anything they used before. For invasive medical and surgical procedures, the document affirms the patient has received informed consent from the surgeon and has no more questions. That approach stems from case law indicating the informed consent for procedures is the responsibility of the physician, not the hospital.
"The physician can use whatever consent process and document he or she wants, but we don’t want to hold ourselves to a higher standard than we should by suggesting that we are responsible for the informed consent process," she explains. "We even took a hard-line position and said we would not have the physician sign our informed consent document because we don’t want to put ourselves between that physician-patient relationship."
The invasive procedure consent also explains a few other things, such as the possibility that blood or general anesthesia may be necessary after the procedure starts, the possible use of any tissue removed from the patient, and the option to prohibit any nonclinical visitors in the operating room.
For all other consent in the hospital system, Johnson developed a general consent for treatment. The old one was two lines that stated "you could do anything to the patient, including surgery and giving blood," she says. The newer version is less inclusive, amounting to permission to examine the patient and explaining billing procedures.