Yes, the cardiologist says that he cleared the patient for surgery, but he claimed it was for local anesthesia only. The surgeon and anesthesiologist say they heard otherwise, thinking that the cardiologist had cleared the 54-year-old man for local and general anesthesia. As this fatal case illustrates, your anesthesia provider should clarify any ambiguity concerning the surgical clearance and the choice of anesthesia.
You Make the Call
Right shoulder closed manipulation
The patient had pain and limited motion of his right shoulder. An orthopedic surgeon diagnosed right shoulder adhesive capsulitis and treated the man with three separate subacromial cortisone injections, a conservative treatment from which the patient didn't benefit.
The surgeon recommended a right shoulder closed manipulation, a 30-second procedure that can be done with local or general anesthesia. The surgeon preferred local anesthesia since it would facilitate therapy afterwards. What's more, the patient had a history of chronic obstructive pulmonary disease, coronary artery disease, ischemic cardiomyopathy, class IV congestive heart failure and diabetes. He was a longtime pack-a-day smoker and in the preceding months he'd been putting on weight uncontrollably.
When seeking medical clearance from the patient's cardiologist, the surgeon said the procedure would be done under local anesthetic. The cardiologist cleared the patient for the contemplated procedure.
???No general anesthesia'
On the day of surgery, in the holding area, the patient told the anesthesiologist that his cardiologist had told him "no general anesthesia." This wasn't contained in the patient's documentation from the cardiologist. The surgeon and the anesthesiologist later testified that they discussed this contraindication before the procedure and that they agreed that it didn't make medical sense. Neither the surgeon nor the anesthesiologist sought clarification from the cardiologist. The surgical consent form specified the use of an interscalene block and the anesthesiologist proceeded accordingly.
Shortly after the administration of the block, the patient became restless and short of breath. The anesthesiologist elevated the patient's head, but the patient became even more anxious and short of breath. The anesthesiologist then sedated and intubated the patient. The patient soon stabilized and, after lengthy discussion, the physicians agreed to proceed with the surgery with a very small dose of general anesthetic. The procedure was completed in less than 30 seconds. However, upon the patient's transfer to the PACU, he went into cardiac arrest. CPR was administered, but the patient didn't recover. No autopsy was done. The patient's estate sued the surgeon, the cardiologist, the anesthesiologist and the hospital.
Who's at fault?
During the trial, which ended in January 2006, the surgeon testified that when the cardiologist cleared the patient for the contemplated procedure, he understood that the cardiologist had cleared the patient for both local and general anesthesia. He testified that this was standard practice. The surgeon admitted that during discussions he advised the cardiologist that he preferred a local anesthetic and that he couldn't recall specifically discussing the use of a general anesthetic. Further shielding himself from liability, the surgeon testified that while he preferred local anesthesia, the choice of anesthesia fell squarely upon the anesthesiologist's shoulders.
The cardiologist testified that when he spoke with the surgeon and cleared the patient for the procedure, he believed that the procedure would involve only local anesthetic. He claimed that he never envisioned a scenario in which the block would fail and the surgeon would move forward with the use of general anesthesia. Based on this evidence, the plaintiff dropped the surgeon and the cardiologist from the suit and proceeded solely against the anesthesiologist and the hospital.
The anesthesiologist testified that when he learned that the patient was cleared for the procedure, based upon standard practice, he understood that this clearance encompassed the use of general anesthesia. He testified that it was common knowledge that when a patient was cleared for a procedure, the clearance would encompass all methods of anesthesia. He argued this was true since it is well known that the block could fail and that general anesthesia would be necessary to complete the procedure. He believed that both local and general anesthesia were safe for the patient and, therefore, that both were indicated. The anesthesiologist said that general anesthesia was actually the safer of the two alternatives, but because the surgeon preferred local anesthesia, he accommodated the surgeon's preference at the start of the case.
The parties introduced expert testimony in support of their respective positions. In the end, the verdict favored the anesthesiologist, even though he failed to seek clarification concerning the clearance for the procedure.
It could very easily have gone the other way. Lesson learned: It's important for the anesthesiologist to be privy to the conversations involving the surgeon and the clearing physician. If there is any ambiguity concerning the surgical clearance and the choice of anesthesia, the anesthesiologist should make an effort to clarify it in the medical chart.
Tighter surgical informed consent
The hospital was also sued in this case, but because of Pennsylvania law, the hospital couldn't be held responsible for inadequate informed consent. The hospital was only exposed to damages under the theory of vicarious liability, otherwise known as respondeat superior. Recently however, CMS mandated that hospitals develop and implement systems to ensure proper informed consent, especially when dealing with medical records and surgical services. CMS expects each hospital to have in place a well-designed informed consent process which includes a description of the procedure, the patient's diagnosis, the procedure's risk, the potential benefits, treatment alternatives, the patient's prognosis if he declines treatment, whether other practitioners will be involved and a discussion of the role of residents, if they'll be present. The more detailed the policy, the less guesswork and risk involved.
The new interpretive guidelines apply only to hospitals. Conditions of participation for ambulatory surgery centers have no specific guidance regarding informed consent and only require that the record contain informed consent. To ensure compliance with the most recent interpretation on the issue and to provide consistency for patients, many recommend that ASCs follow suit with hospitals regarding the content of their informed consent policies, procedures and forms.
On the Web
To see a full copy of the new CMS guidelines for informed consent, go to www.cms.hhs.gov/ SurveyCertificationGenInfo/ downloads/ SCLetter07-17.pdf.