Tim Bone

Navigating the muddy waters of “informed consent”

JACKSONVILLE— In most instances, before treatment may be provided to a patient, consent must be obtained. If this step is omitted and medical care is then provided, the doctor may be liable for battery. And even in those instances when consent is obtained, liability may still be imposed if the consent was not informed.

Therefore, a methodology should be provided to document the fact that informed consent was actually obtained, and suggestions on how best to assure that consent is informed consent should be offered, says Timothy R. Bone, president of Jacksonville-based MedMal Direct Insurance.

By limiting the situation to consent for surgical procedures at a surgical clinic or hospital, the issue focuses on failure to document an informed consent. The solution: 100 percent of all charts of patients who undergo surgical procedures should include an informed consent document.

“The review procedure involves obtaining a sample of 50 charts of patients who recently underwent surgical procedures at your surgical clinic or hospital,” said Bone. “Review each chart for the presence or absence of documented informed consent. If all is in order, notify the Medical Executive Committee. If problems exist, devise a solution, implement it, re-audit the issue within a given time frame and continue to report to the Medical Executive Committee.” 

In many surgical clinics and hospitals, the operating room supervisor or the anesthesiologist enforces the requirement of documenting informed consent. “Therefore,” noted Bone, “no documentation equals no anesthesia!”

All personnel responsible for obtaining informed consent should be provided with a 3-by-5 card with the following information “to impart to the patient or his representative,” and carry this card while on duty, said Bone.

• Nature of illness
• Recommended course of therapy
• Substantial risks of recommended therapy
• Reasonable alternative courses of therapy
• Substantial risks of alternative courses of therapy
• Risks of no therapy

“There’s no one ‘best’ way in which to obtain informed consent, as long as the above basic points are discussed with the patient, and documented in the chart,” said Bone. “For example, one of the most effective informed consents I’ve ever seen was done by an orthopedic surgeon, who actually drew the operation on a piece of paper, listed the top three complications, noted the risk of no therapy, and then had the patient sign the document. Great! This clearly documents that informed consent was obtained from the patient.”

Even though the process of obtaining informed consent takes some effort, it’s shown over time to achieve the stated goal: mitigation of the risk that leads to medical malpractice lawsuits, said Bone. 

Editor’s Note: This article marks the fifth in a risk management series with Timothy R. Bone, president of Jacksonville-based MedMal Direct Insurance. Florida Medical News addresses some of the most common non-clinical problems by objectively approaching each issue and its resolution via the scientific method. This process includes providing an “outcome goal” or objective, and then offering a relatively simple approach to data-gathering via chart review, observations, or simple surveys.

The series flows from the following known fact: as much as 80 percent of all medical malpractice lawsuits are generated from non-clinical issues in the practice of medicine.

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