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Signed Consent: Does it Prevent Litigation?

Many healthcare professionals believe that a signed document equals informed consent, and that no further documentation is necessary. While that theory is basically true, there is definitely a difference between theory and practice. The obligation (in both the ethical and legal sense) to fully inform patients of the risks, benefits, and alternatives to treatment falls to the treating provider. Informed consent is best described as a process, not a single document. Patients must demonstrate their understanding of the treatment being pursued, as well as an explanation of both the provider’s and the patient’s roles in the treatment, as well as the risk of addiction to the medications prescribed.

Consider our recent case study(1) involving a patient who allegedly died of a prescription overdose because the plaintiff contends that the multiple providers he sought treatment from were negligent in monitoring his conditions and medications. Reading through the documentation, it seems that no single provider was aware of the patient’s entire medical history, nor his current medication intake. And while the patient provided informed consent about the possibility of drug interactions to multiple providers, the seriousness of the situation did not appear evident to all involved parties, including the providers and the patient.

CARE Professional Liability Association and OmniSure Consulting Group(2) suggest the following steps to reduce your professional risk(3):

  • Customize consent forms to be as procedure-specific as possible; generic forms are too generalized to communicate proper information
  • Document the entire consent process in the patient’s medical record, including the conversation with the patient and specific questions they asked and how they were answered
  • Create policies and procedures outlining who specifically can obtain informed consent
  • Audit medical records periodically to validate that documentation and informed consent processes are being followed correctly

Patients might be too embarrassed to ask questions about the procedure, or might not even know what to ask if they don’t understand the consent form. Or they might feel rushed, or simply downplay the consent form’s importance. It’s our job as healthcare providers to make sure patients are comfortable enough to ask pertinent questions so that their consent is not simply a signature, but a complete understanding of the treatment they receive.

Contact us today. We can help you develop an informed consent documentation plan that works for both you and your patients.

Footnotes

  • https://care-ins.com/case-studies/
  • https://www.omnisure.com/
  • https://www.riskfitness.com/informed-consent-recommendations