Is it ever possible to obtain the consent of a patient who has received preoperative medication, and what are the possible repercussions? Fay A. Rozovsky, president of The Rozovsky Group examines the questions.
A hypothetical case illustrates what can happen when the effects of preoperative medication blur the ability to make a treatment decision.
The orthopedic surgeon entered the preoperative holding area and said to the patient: “I wanted to tell you that I am going to change the planned procedure, just a little.”
She continued: “Instead of entering the hip through the front, I am going to use the more traditional approach with you. The outcome should be the same. You might experience a little more discomfort, but having discussed your case with my colleagues, I think this is the best approach for you.
“I see the nurses have you all set, so I will see you in the operating room. Someone will come by to get your signature on the revised consent form.”
The patient nodded his head and the surgeon left the holding area for the surgical suite. What the surgeon did not know was that 20 minutes prior to this “conversation” the patient had received preoperative medication. He was quite mellow and relaxed. Most importantly, the patient was not in any condition to participate in a consent communication process.
A nurse came into the holding area and roused the patient. “I need you to sign this form. I know you do not have your eyeglasses, but I will tell you that by signing it you consent to the surgeon changing the technique for your hip replacement. Just sign here,” she said.
The nurse pointed to the signature line and the patient signed the document. “Is that your regular signature? It does not look like the signature on the form you signed previously. Oh well, it will have to do,” she said.
The patient had an eventful postoperative period. He was in much more pain than he had anticipated and the ability to get up and walk with assistance was very trying for him. The patient developed a postoperative wound infection that required prompt attention and it delayed his recovery.
“I am sending you to a fine rehabilitation center to get you back on track,” said the surgeon. She continued: “I regret that you developed a postoperative infection, but this happens sometimes.”
The patient responded. “Just a second, doctor. I did not agree to this stuff. When we discussed the procedure in your office you told me I would have a minimally invasive procedure and that there would not be any need to cut through the muscles and tendons.
“You said the recovery is faster too than the old way of doing the operation. I never agreed to you doing it the old way. What gives? I am really angry,” said the patient.
“I guess you do not remember the conversation we had in the pre-op area the day of the operation,” said the surgeon.
“What conversation? I never had a conversation with you the day of the operation,” replied the patient.
“Oh we did. In fact you signed a revised surgical permit for the procedure,” responded the surgeon.
“Look doctor, I am telling you I never agreed to a different operation. I am really very, very angry. Just leave me … please,” said the patient.
The aftermath
After the patient was discharged from the rehabilitation center and he returned home, he contacted his attorney.
“I am not crazy. I know that I never agreed to this stuff. Now I have a bill for a procedure that was done without prior authorization from my insurer, too. I want you to help me get this resolved. And I am not paying for something that I did not agree to in the first place,” said the patient.
"An individualized assessment is in order to establish that notwithstanding the medication administered, the patient was able to exercise his or her thought processes to make a treatment decision."
The attorney guided the patient through the formal grievance process under the Conditions of Participation for Hospitals under Medicare and Medicaid. Working with the assistance of his attorney, a formal complaint was registered with the accrediting body for the healthcare facility.
The patient requested a copy of his medical records from the hospital. A legal nurse consultant reviewed the record and pointed out the glaring disparity in the patient’s signatures on the two forms. She also noted the time that the patient received his preop medication and the time when the second form was signed.
“I think your client was right. He had received powerful, preoperative medication some time prior to the alleged ‘conversation’ claimed by the surgeon. It is well-known that the medication can impair a person’s ability to understand and appreciate information, let alone sign a legal document,” said the legal nurse consultant.
At the request of the patient, a lawsuit was filed against the surgeon for lack of informed consent. A separate action was brought against the hospital on the theory that its employee, the nurse, failed to meet the standard of care of a surgical nurse since she knew or ought to have known that the patient was unable to understand and appreciate the nature and consequences of the revised consent document.
The legal complaint alleged that the hospital was vicariously liable for the negligence of the nurse who knew or ought to have known that the duty of care expected in such a situation was not met.
Outcomes
The hospital was compelled to respond on several levels, including a response requested by the state agency on behalf of Centers for Medicare & Medicaid Services (CMS), an unanticipated site visit by the accrediting body, and the patient’s formal grievance. With the addition of the lawsuit, formal notice was given to the facility’s captive insurer and excess insurance liability carrier.
Once an internal investigation had been completed under the direction of panel counsel, leadership realized what had transpired in the situation. The patient was offered an apology and an early resolution was reached with him.
The hospital had to address a number of standards issues identified by the accrediting body and concerns raised by the state agency, too. Following the medical staff bylaws, the surgeon was the subject of a focused professional practice evaluation (FPPE) and a formal peer review process.
The nurse was the subject of a review completed through human resources. She was counseled to never request a patient sign a form when she knew or ought to know by reviewing the patient’s record that the patient had received preoperative medication precluding such action. Finally, a mandatory in-service was required of all preoperative, anesthesia and surgical personnel to reinforce required practices involving surgical consents practices.
Could it happen today?
This situation was a hypothetical event. In reality, it could take place in healthcare facilities in which consent is viewed more as a form and less as a communication process. No doubt the revised consent form could have been used in the surgical “time-out” with no-one realizing that there was a serious flaw in the underlying consent communication.
The situation illustrated what can happen when a care provider decides to alter a care plan without first completing a cogent consent communication with the patient at a time when he or she can make a treatment choice. Here the patient had received powerful medication that impeded his ability to understand and appreciate the nature and consequence of a treatment decision. The result was a flawed consent process and a signed form that lacked credibility.
A waterfall of legal and regulatory consequences was unleashed, all of them avoidable if the surgeon and the nurse had abided by accepted practices when completing a consent communication process.
Is a valid consent ever possible in such circumstances?
That the patient has received a strong, preoperative medication does not automatically lead to the conclusion that the patient lacks the ability to make a treatment choice. Instead, an individualized assessment is in order to establish that notwithstanding the medication administered, the patient was able to exercise his or her thought processes to make a treatment decision. The responsibility is placed on a qualified healthcare provider to make that determination and to document it accordingly.
The facts presented in the hypothetical case suggest that the patient lacked that decision-making ability. Moreover, the consent communication process was incomplete. The surgeon never explained the indications for the revised surgical plan, the probable benefits and risks, the alternatives and related probable benefits and risks and the consequences of declining the revised plan of care.
At no time was the patient encouraged to ask questions or to discuss the modified approach. Coupled with the unusual signature on the form the “consent” interaction between the surgeon and the patient was incomplete and unacceptable.
The situation triggered ethical issues. It also implicated billing and payment. In the end, the case demonstrates a number of enterprise risk exposures that may emerge from an incomplete and unacceptable consent process.
Lessons learned
Several lessons can be learned from this case illustration. These lessons include the following points:
Establish organizational policy, procedure and protocols for managing consent communications with patients who have received preoperative medication.
Reinforce on a regular basis with surgeons and other surgical personnel the requirements for a valid consent communication and documentation process.
Monitor data for outlier practices with a view to working one-on-one with care providers whose consent communication practices jeopardize patient safety and regulatory compliance.
Observe communications with patients in the preoperative area with a view to stopping unacceptable consent practices.
Encourage nursing personnel to “speak up” and, when necessary, to utilize chain-of-command protocols to address aberrant consent communication practices involving surgical patients who have received preoperative medications and who appear unable to make treatment decisions.
Fay A. Rozovsky is president of The Rozovsky Group, a firm specializing in healthcare enterprise risk management and patient safety. She is the author of Consent to Treatment: A Practical Guide, 5th Edition (2015) published by Wolters Kluwer Law and Business. Further information of the subject matter of this article can be found in the book. She can be contacted at: fay@therozovskygroup.com
Fay A Rozovsky, The Rozovsky Group, US
