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December 10, 2014 Readers Write 4 Comments

Automate Your Informed Consent Process: Lessons Learned from the Joan Rivers Tragedy
By Tim Kelly


A 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. Organizations should review the following processes and ensure that they are in place to avoid deficiencies such as those cited at Yorkville Endoscopy.

  • Append the consent to the electronic medical record at the time it is executed. A recent study published in JAMA Surgery found that signed consents were missing for 66 percent of patients at the time of surgery, resulting in delays for 14 percent of the cases. It is clear that Ms. Rivers agreed to a specific treatment when she presented at Yorkville Endoscopy on August 28. It also appears that the documentation of that consent may not have been adequate to address all aspects of the procedures that were ultimately attempted.
  • Ensure that the informed consent document states the exact procedure(s) or treatment(s) to be performed. Many hospital consents are one-size-fits-all consents or fill-in-the-blank consents. The former are of little value in verifying the patient’s understanding of the planned procedure if the document is reviewed retrospectively. The latter are frequently flawed by illegible handwriting or abbreviations. An analysis of the Rivers case suggests that consent may have been obtained for an esophagogastroduodenoscopy (EGD) but not the two nasolaryngoscopy procedures that may have resulted in complications that in turn may have contributed to her death. Automated systems can force the clear delineation of planned procedures while also documenting possible treatments and interventions that may be pursued intraoperatively.
  • Identify and confirm the providers who will perform the treatment or procedure. Many organizations employ electronic credentialing systems to identify which providers have privileges to perform certain procedures. Yorkville Endoscopy was cited for allowing a physician who was not privileged at the facility to participate in the treatment of Ms. Rivers. Automating the consent process, and integrating that process with a credentialing system, ensures that only providers authorized to perform the contemplated procedures are documented on the consent form. This practice can mitigate the potential for deviations involving non-credentialed providers.
  • Obtain the patient’s permission for observers and photography. It is vital to teaching organizations to allow for the presence of observers and sometimes the recording of surgical procedures. It is also essential that the patient give his or her permission to the presence of observers and use of photography. It appears in the Rivers case that unauthorized observers were present and unauthorized photographs were taken during the procedure. Automating documentation of consent, including allowance for observers, authorization for photography, preferred disposition of tissue samples, and similar permissions, allows for those preferences to be communicated to other HIT systems. This practice can help ensure that patients’ wishes are followed.
  • Leverage the consent in the time out. Yorkville Endoscopy was cited for not following an acceptable time out procedure. Review of the consent form immediately prior to the start of a surgical procedure is a key component of the Joint Commission’s Universal Protocol. Significantly, verification of informed consent documentation – documentation that lists the procedures and well as the surgical site – has been found to be the most effective mechanism for avoiding wrong person / wrong procedure / wrong site surgery.

It should be noted that informed consent documentation alone cannot correct all of procedural deficiencies that were identified by the Department of Health in the Joan Rivers case. However, a well-prepared, procedure-specific consent can serve as both a contract and a roadmap for how a procedure or course of treatment should be performed. When the consent process is facilitated electronically and that process is integrated with other HIT systems, including the EHR, the risk of deviations or errors may be minimized.

Many of the findings in the New York State Department of Health report were not that policies were lacking; it was determined that established policies were not followed. Automation, by its nature, helps ensure compliance with an organization’s policies and procedures.

An excellence policy on automating the informed consent process has been developed by the Department of Veterans Affairs.

Tim Kelly is director of marketing of Standard Register Healthcare of Dayton, OH.

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Currently there are "4 comments" on this Article:

  1. Unfortunately even the best 3-part form would not have changed the outcome. Consent was not the probable cause of death.

  2. No the lack of a consent form was not the cause of death but if the spirit (substance) of INFORMED consent had been followed, Ms. Rivers may be alive today.

    She likely would have more carefully in considering the risks and repercussions of having the initial procedure done in a clinic and it’s possible she would not have given permission for the second one which they had no legal right to perform “on the fly” whether her own MD was standing there or not.

    Lack of “consent” in my mind was clearly a contributing factor in the tragic result.

  3. Part of the consent should also clearly state who will have access to your data and if your data is anonymized then used by in house researchers and/or sold to other researchers.

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