A 57-year-old male patient presented to Dr. S, an otolaryngologist, complaining of throat pain. Physical examination revealed swollen, reddening, nontender tonsils. Dr. S performed a nasopharyngolaryngoscopy to further examine the area. Inspection of the nasopharnyx revealed no discrete lesions with asymmetric enlargement of the right tonsil. Examination of the hypopharnyx also revealed no discrete lesions. The larynx inspection revealed bilaterally symmetric true vocal fold motion with no discrete lesions and good glottis closure.
A computed tomography (CT) scan was ordered and showed concern for bilateral cervical lymphadenopathy, larger on the right side than the left. Fine needle aspirates were taken from the right cervical lymph node. Pathological findings were negative for both epithelial and granulomatous cells. The pathologist reported that cytologic features indicated that low-grade lymphoid neoplasm could not be excluded if the adenopathy was not significantly resolved within one month. It was recommended the patient have an excision biopsy with submission of fresh tissue for flow cytometry.
One month later the patient returned to Dr. S to discuss and schedule the biopsy and tonsil removal. The patient underwent the procedure without complications and was discharged home the same day with a scheduled one-month follow-up visit with Dr. S.
The next day, Dr. S called the patient. Since the patient was not able to speak on the phone, Dr. S asked the patient’s wife to contact the office about her husband’s status. The wife reported that her husband was experiencing significant pain. Dr. S recommended the patient take ibuprofen.
A couple of weeks after the surgery the patient resumed normal work duties. After two days back at work, the patient came home and told his wife he was tired, not feeling well, and experiencing a choking sensation. Several days later the patient woke up at 4:30 a.m. and told his wife he was coughing up blood. The patient and his wife remembered that the surgery center informed them that if the amount of blood did not exceed one tablespoon, they did not have anything to be concerned about. Later that morning the patient woke up again telling his wife he was coughing up blood in excess of one tablespoon.
The patient’s wife took her husband to the emergency department at their local hospital. On arrival, the patient was choking, gagging, unable to speak, and coughing up excessive blood.
Soon thereafter, the patient went into cardiac arrest. It was difficult to intubate the patient due to a large blood clot. At one point, the staff initiated CPR and established an airway. After he stabilized, the patient was taken to surgery to address an atrial bleed from the central left tonsillar fossa, the same area where Dr. S removed the left tonsil.
The patient remained in a coma for several weeks and was eventually discharged to a skilled nursing facility.
The patient was ventilator dependent and suffering from anoxic encephalopathy due to the cardiac arrest and delayed intubation depriving him of oxygen for an extended period of time.
The patient sued Dr. S, alleging negligence and failure to provide medical care within the standard of care for physicians practicing in the field of Otolaryngology. In particular, the plaintiff's attorney focused on two areas: 1) lack of an adequate informed consent and 2) failure of Dr. S to respond appropriately to several calls to his office reporting that the patient was experiencing bleeding post operatively. As part of the complaint, the patient’s wife alleged that she called Dr. S’s office several times, reporting that the patient was coughing up blood, felt like he was choking, and was unable to swallow food or liquids. The wife claimed the office staff told her that it was all right if the patient did not eat or drink temporarily. This instruction concerned the wife because the patient had a blood pressure condition which would cause him to pass out from standing up if he did not eat.
During discovery, defense experts reviewed the medical records and concluded the overall care the patient received was appropriate, of good quality, and within the standard of care. However, plaintiff experts opined the informed consent was insufficient and the care was negligent, specifically with respect to the plaintiff’s claims that the patient’s wife called the office several times about the patient bleeding prior to presenting to the emergency department, where he experienced cardiac arrest.
The defense medical experts confirmed that the patient was informed of various outcomes after the surgery, including the possibility of minor bleeding, which can occur and is a known risk of the procedure. The defense expert concluded, “There does not seem to be anything different that could have been done for this patient, any sooner. Nor does there appear to have been any sort of surgical error, because if there had been a problem it would have occurred sooner. The tonsillar fossa is very vascular and, if dehydration is present, can easily commence bleeding, especially if the patient is coughing. It appears that what happened to the patient was a known risk of the tonsillectomy and that it was not caused by any negligence on the part of the doctor.” Plaintiff experts faulted the informed consent for underestimating the percentage of possibility of post- operative bleeding. In any event, the patient was told that if bleeding were to exceed one tablespoon of blood, then the doctor’s office was to be called or the patient should report to the hospital emergency room, which they eventually did.
During the trial, emphasis shifted away from informed consent and the plaintiff’s attorney focused on the numerous times when the patient’s wife called the doctor claiming the patient was experiencing bleeding. However, all phone calls were well documented in the patient’s medical record. There was no report of the patient bleeding. The patient’s wife mentioned the patient’s discomfort and pain, which was not out of the ordinary. The patient was advised to take ibuprofen for pain and reminded to hydrate appropriately, which, it appears, he did not.
One defense expert opined, “Bleeding in the week or more after surgery is a known risk. The possibility of slow healing is increased by dehydration, which was likely in this patient.” The other phone calls documented in the record were reports from the patient’s wife that the patient was doing fine overall.
There is no denying that the outcome of the matter was tragic for the patient who is no longer able to work and requires lifelong daily care and assistance. Dr. S’s defense attorney was able to successfully defend his care due to the thorough informed consent discussion had with the patient. The diligent documentation of the informed consent discussion and the calls later made by his wife to the office thoroughly captured the patient’s condition and instructions for care based on the information provided.
To avoid the allegations that are associated with improper or incomplete informed consent, the Cooperative of American Physicians (CAP) recommends the following:1, 2
- Explanation of the nature and purpose of the proposed treatment, including:
- The risks, complications, and expected benefits of the recommended treatment, including the likelihood of success or failure.
- Any alternatives to the recommended treatment and their risks and benefits.
- The risks and benefits of declining the proposed treatment.
- For planned procedures, do not wait to obtain consent on the day of the procedure. The informed consent process should begin as early as two weeks prior to the planned procedure, preferably in the provider’s office setting. This allows enough time for the patient and physician to have a detailed discussion and to answer all the patient’s questions in a stress-free setting as opposed to a pre-operative holding area.
- Thoroughly document the informed consent discussion and be sure to include all the previously mentioned elements. Also be sure to include any pertinent questions that the patient had, and what answer was provided.
- Do not just rely on the language in a standardized or general consent form. Your documentation of the informed consent conversation and the potential risks should be specific to the procedure being performed.
- Ensure that the copy of the signed consent form is placed in the patient’s medical record and a copy is added to the hospital record as well, if the procedure takes place in a hospital setting.
- Stay within the scope of the procedure noted on the signed consent form. Outside of an emergent life-threatening occurrence that would require the physician to take immediate life-saving measures, do not be tempted to “fix other problems” you might encounter intraoperatively.
Documenting phone calls in a medical office practice is an essential part of ensuring accurate and thorough patient records. Here are some guidelines for documenting phone calls effectively:
- Date and Time: Start by noting the date and time of the phone call.
- Caller Information: Record the name, phone number, and any relevant patient information of the person calling.
- Reason for the Call: Document the purpose of the phone call, whether it is a general inquiry, appointment scheduling, medication refill request, test result inquiry, or any other reason.
- Conversation Summary: Summarize the key points of the conversation, including any symptoms or concerns mentioned by the caller, advice given, instructions provided, or referrals made.
- Actions Taken: Detail any actions taken as a result of the phone call, such as scheduling an appointment, forwarding a message to the healthcare provider, or arranging a prescription refill.
- Follow-Up: Note any follow-up actions required, such as calling the patient back with additional information or scheduling a callback from the healthcare provider.
- Signatures: If required, obtain the signature of the staff member who took the call and documented the information.
- Electronic Health Record (EHR): Ensure that the phone call is documented in the patient's electronic health record if your practice uses an EHR system.
Remember, patient confidentiality and privacy should always be maintained when documenting phone calls. Only record necessary information and ensure that it is stored securely according to HIPAA guidelines.
Bradford S. Dunkin, MHA, is CAP's Assistant Vice President, Risk Management and Patient Safety. Questions or comments related to this article should be directed to BDunkin@CAPphysicians.com.
References
¹Informed Consent Best Practices – How to Minimize Risk, Cynthia Mahan, Cooperative of American Physicians, CAPsules, August 25, 2021
²Avoiding Critical Flaws in the Consent Process, Cooperative of American Physicians Webinar, https://www.capphysicians.com/avoiding-critical-flaws-consent-process (accessed November 6, 2024)