For years you’ve been told that informed consent is a process, not just a piece of paper. That’s true, and now there’s increasing scrutiny of those forms by regulatory agencies. What we’ve found, as with many of the Centers for Medicare and Medicaid Services (CMS) regulations, is that enforcement by state Department of Health investigators and review by The Joint Commission surveyors has been somewhat inconsistent. Interpretation of the regulations largely depends on the investigator’s or surveyor’s background. New Conditions of Participation (CoP) from CMS went into effect in 2007, but several hospitals and physician practices aren’t aware of all the changes.
Years ago, consent forms only mentioned the risks, benefits and alternatives of the procedure. Every form often had the same risks for each intervention: bleeding, infection, and death. The 2007 changes make the consent more informative for the patient and his/her family and/or legal decision maker. The regulations defining a “properly executed informed consent form” for non-emergent cases can be found in the Surgical Services CoP at 42 CFR 482.51 (b)(2).
A well designed informed consent should include:
- A description of the proposed procedure, including site and laterality
- The indications for the proposed procedure
- Material risks/side effects and benefits for the patient related to the procedure, the likelihood of each based on the available clinical evidence, in the reasonable judgment of the practitioner
- Treatment alternatives, including not performing the procedure
- Who will conduct the procedure (exact names, not “associates”)
- Whether other practitioners, including but not limited to residents, will be performing important elements of the procedure, often defined as opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, implanting devices, and placing invasive lines
- Whether, as permitted by state law, qualified medical practitioners who are not physicians will perform important parts of the procedure, if so, the types of tasks that the practitioner will carry out, and that such practitioners will be performing tasks within their scope of practice.
The Medical Records CoP (42 CFR 482.24 (c) (2) (v)) also requires that the form contain the signature of the patient or their legal representative which should include the date and time of the signature as well as the signature of the practitioner who conducted the informed consent conversation, also with the date and time. There should also be witness signatures, with dates and times of the signatures.
We are now seeing many practitioners move toward procedure specific consent forms, so that the risks, benefits, alternatives, likelihood of success, and recuperation information can be pre-populated. Some practitioners like this option and use the procedure specific forms to guide their conversations with patients. Some of these forms may need to be tailored to address state specific laws or regulations, so please make sure that your forms comply with your state’s rules and regulations. Your MagMutual Risk Management and Patient Safety Consultant is available to assist you with developing a solution that works for you.
To find out more about informed consent in your state visit our Learning Center.