Informed Consent: A Checklist for PatientsA number of errors have recently come to light in the investigation of the tragic death of Joan Rivers. The endoscopy clinic that treated the 81-year old comedian was cited by the New York State Department of Health for numerous deficiencies including, failing to obtain informed consent for each procedure performed. It is clear that Ms. Rivers agreed to something when she presented at Yorkville Endoscopy on August 28. What is also clear is that the documentation of that consent was woefully inadequate.

As consumers we risk complacency about providing our consent as we click through countless agreements to update operating systems or engage in on-line transactions. In healthcare it is absolutely essential that we be engaged participants in any treatments or procedures that we undergo. The following is a checklist of key elements to discuss and document as part of the informed consent process for any procedure. Many of these elements have received some level of scrutiny in the Joan Rivers’ case, and had they been acted upon, held the potential to alter the events that may have contributed to her death.

• Ensure that the informed consent document states the exact procedure or treatment to be performed. If multiple procedures are contemplated, including possible procedures, they should all be listed.

• The best consent forms will also list the location of the procedure, if applicable. Safety conscious providers will review your written consent as part of a pre-procedure verification process or an operative “time out” or to confirm that their understanding of the surgical site matches yours.

• Review the consent closely for language that gives providers the leeway to perform other procedures if they deem necessary. Discuss with your physician what an intraoperative change in direction might entail and limit that discretion, and/or require the participation of your medical representative, if appropriate.

• The consent form should spell out exactly which providers will perform which aspects of a procedure – this is important information to understand if surgeons are assisted by medical residents or technicians. You should be comfortable with the supervision provided if several practitioners will be involved in your treatment.

• Look for language on the consent documentation that may allow for observers or photography. This may be important for medical training in some instances; however, it is your right to withhold consent, if appropriate.

• Ensure that your informed consent documentation lists the risks, potential complications and alternative procedures for the contemplated operation. Physicians, appropriately, tend to be optimistic and may emphasize the benefits with less time spent discussing potential negative outcomes.

• If consent for anesthesia is not clearly spelled out in the surgical consent form, including the type of anesthesia to be employed and who will administer the anesthesia, request a separate written anesthesia consent that documents those items. Often patients have several choices for anesthesia for a given treatment or procedure – ensure that you have the opportunity to thoughtfully weigh the risks and benefits of your anesthesia options.

• Ask your physician for the opportunity to review the informed consent documents well in advance of the planned procedure – signing a consent form at the registration desk or in the pre-operative holding area is not true informed consent.

• Bring a family member to assist you during the informed consent process. As patients, we are often preoccupied with our condition, the prospect of surgery and the impact that our treatment may have on other aspects of our lives. Having a less-distracted advocate present to help us ask the appropriate questions and document providers’ answers is essential to fully informed consent.

• Obtain copies of all consent forms that you sign.

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Timothy Kelly, MS, MBA , serves on the National Quality Forum and as Marketing Director for Standard Register Healthcare, he is responsible for the SMARTworks® iMedConsent™ Solution and other patient engagement solutions. Tim presented on a variety of informed consent topics at the ACRP, AHIMA and ASHRM conferences in 2014.