The Legal Risks of Paper Informed Consents – Surgeons and Hospitals in the Firing Line

     

Part 5 of Access’s Improving the Economy of Surgical Services series

In this week’s article on the Economy of Surgical Services, we turn our attention to the legal ramifications of obtaining informed consents with paper forms, and how this can adversely impact surgeons, hospitals, and patients.

The authors of a JAMA Surgery study entitled Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims found that of the 233 malpractice claims they evaluated related to spinal surgery malpractice, 153 lacked informed consent. That’s a whopping 66 percent! Before we dive deeper into why this lack of consent occurs, let’s define informed consent, and how this theoretical definition often differs from real-world practice.

Defining “Informed Consent”

An informed consent is not just another patient form, it carries with it patient expectations of being properly educated and assured of their impending procedure’s benefits and risks, as well as the legal statutes that protect them. Ideally, an informed consent would not just contain the standard legalese on the form itself, but also include a clear explanation of the procedure and the potentially positive and negative outcomes. An informed consent allows providers to then capture the patient’s signature in order to validate the interaction.

As K H Satyanarayana Rao writes in a Journal of Cutaneous and Aesthetic Surgery paper titled Informed Consent: An Ethical Obligation or Legal Compulsion?: “Mutual trust forms the foundation for [a] good relationship between doctor and patient.” For this trust to be maintained through the pre-surgery process, the author asserts that, “Informed consent must be preceded by disclosure of sufficient information. Consent can be challenged on the grounds that adequate information has not been revealed to enable the patient to make a proper and knowledgeable decision.”

Let’s imagine I am an orthopedic surgeon and you come to me with a hurt right shoulder. After asking you a few questions and reviewing your medical history, I send you for an MRI. The results show a partially torn rotator cuff. I explain to you that there are several treatment options, one of which is a surgical procedure. I explain in detail the potential benefits and pitfalls of such a course of action, and the long road to recovery that inevitably accompanies rotator cuff repair. You tell me you understand the risks involved and would like to schedule the surgery.

Next, I would need to complete an “Informed Consent” form for your procedure. Consent verbiage should be worded so you can understand it and enter into a contract or mutual covenant with your surgeon with full confidence. This is demonstrated by the fact that both parties must sign the document.

What I as your surgeon tell you about your upcoming rotator cuff surgery should be congruent with the detailed description and risks that I present to you on the Informed Consent. Otherwise there’s a disparity that can open up legal and compliance risks to me and the hospital, if you, the patient, later claim you didn’t receive a consistent and thorough verbal and written explanation.

When informed consents fall short, risk opens up

At Access, we’ve seen how thousands of hospitals manage Informed Consents, and we can definitively tell you that there is no universal method. However, there are three common approaches, and the primary variance between these three is how procedure-relevant content (name of procedure, description of procedure, risks of procedure) is populated on the form. These approaches are:

  1. Handwritten information on the procedural consent
  2. Retrieve a pre-printed form for each procedure that includes specific procedural content 
  3. Complete a generic informed consent

In a recent Access webinar with more 450 hospitals in attendance, we polled the audience about which of these three methods they used to place procedural content onto the Informed Consent. Here are the results of that poll:

The fact is all of these methods have potential pitfalls. Handwriting information can create inconsistency in how procedures and their accompanying risks are described from doctor to doctor, or even from case to case by the same physician. Such variability creates compliance issues.

Managing and maintaining pre-printed forms is a logistical nightmare with hundreds or even thousands of individual forms in a massive, often difficult to search library of procedure-specific forms.

But it’s the generic consent that might incur the biggest risks from a legal perspective. Without specific language for the individual procedure, it’s difficult for a hospital or surgeon to claim that the patient was accurately “informed” by the content on the form itself. No matter how thorough they might assert their verbal explanation of the surgery and its accompanying risks may have been.

Identifying and mitigating legal risks

Version control impacts each of these informed consent methods. Policies, regulations, provider information and other form data changes and require updates over time. We hear time and again about numerous versions of Informed Consents accumulating in hospitals over years of changing surgical staff. This requires a heavy-lifting consolidation effort if the facility is to avoid numerous compliance issues and possible legal exposure.

There’s also the constant risk of surgeons seeing an informed consent as largely a “checkbox.” As Daniel Hall, Allan V. Prochazka, and Aaron Fink write in their CMAJ article Informed Consent for Clinical Treatment, “Unfortunately, pressures for efficient workflow may shift the focus of the informed consent process from robust conversation to the mere requirement of getting a signature.”

Recently, one surgeon who practices at a hospital that uses a generic Informed Consent told me she’s terrified of a patient taking legal action because the form is not robust enough in describing the particulars (especially the risks) of the procedure. She knows if such a malpractice suit was brought to court, it would take years off her life, impact her financially, and put a serious mark against her professionally—not to mention her own self-perception of her competence as a surgeon.  

eForms offer protections for patient and provider

Fortunately, there is a way to avoid many of the manual, paper-based factors that can lead to negative consequences during the consent process. Replacing hard copies and print-on-demand consents with eForms eliminates or at very least minimizes legal risks by ensuring that every form is signed by both the clinician and patient, and date/time stamped.

Electronic consents also allow the hospital to easily replace the inherently risky generic consent with one that properly details specific procedural content. Then these forms can be easily tracked throughout their lifecycle and never lost or misplaced.

Once eForm consents are signed, they are made instantly available to authorized users in surgical services, HIM/medical records, and other areas across the hospital, helping avoid last-minute “day of surgery” delays and the need for patients to re-consent. This in turn eliminates the hefty costs associated with such operative case delays and cancellations, which we discussed in our previous post in this series.

eForms and electronic signatures for Informed Consents also reduce further stress on the patient. Imagine arriving at the hospital on the day of your surgery only to find your procedure has been delayed—as it is for 14% of all operative cases. Already in an anxious state of mind, you’re approached by a resident physician you’ve never met telling you that your Informed Consent is missing, and you have to sign and date a new one.

The JAMA study mentioned earlier confirms that 66% of patients are uncomfortable with a resident vs. their surgeon capturing their Informed Consent. Last-minute re-consenting is extremely risky for a hospital and its physicians given the patient’s current emotional mindset and perceived process breakdowns.

The great news is, it doesn’t have to be this way. An electronic and automated consent process is a targeted solution that can greatly reduce a hospital’s or surgeon’s exposure to a common source of legal risk and give patients the peace of mind they deserve.

Check back for article six in our Improving the Economy of Surgical Services series, which will bring the spotlight back to enhancing the patient experience.

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Resources:

Grauberger, Jennifer, Panagiotis Kerezoudis, Asad J. Choudhry, Mohammed Ali Alvi, Ahmad Nassr, Bradford Currier, and Mohamad Bydon. 2017. “Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.” JAMA Surgery 152 (6): e170544.

Rao, K H Satyanarayana. “Informed Consent: An Ethical Obligation or Legal Compulsion?” Journal of Cutaneous and Aesthetic Surgery (2008).

Hall, Daniel E, Prochazka, Allan V, Fink, Aaron S, “Informed Consent for Clinical Treatment,” CMAJ (March 2012).

 

About The Author - Cody Strate

For more than 10 years, Cody has helped healthcare organizations worldwide eliminate the costs and risks of paper through e-forms and e-signature solutions. In addition to helping others achieve their paperless goals, Cody finds time to put his biochemistry degree to work in the kitchen testing out new recipes on his unsuspecting family.

Feel free to email me here.