[Closed Claim Study] Retained foreign body and alteration of medical record
Presentation and physician action
On December 14, an otolaryngologist performed a revision endoscopic sinus surgery on a 50-year-old man. The patient had previously been diagnosed with pansinusitis with contents that indicated allergic fungal sinusitis.
The patient had a history of sinus surgeries for polyps and chronic sinusitis over the past four years. The patient’s history also included fibromyalgia, asthma, hypertension, hypothyroidism, and migraine headaches.
At the first postoperative visit on December 18, the otolaryngologist removed the patient’s nasal packing and purulent drainage was present. On December 22, the patient reported a worsening headache and additional nasal packing was removed from his left frontal duct. The dosage of the patient’s antibiotic prescription was increased.
The next day, the patient underwent a CT scan of the brain. The results showed pansinusitis with abscess within the inferior right frontal lobe. The scan also showed an enlarging right-sided subdural hematoma with a secondary mass effect with a 9 mm right to left midline shift.
A sinus CT scan showed a deficient right cribriform plate measuring 3.4 mm. The otolaryngologist concluded that this was the site of the intracranial extension of the sinus infection. The patient was diagnosed with an intracranial abscess.
On December 24, the patient was taken to surgery for a right-sided craniotomy to evacuate the subdural empyema with cranialization of the frontal sinus. During the procedure, a foreign object was removed from the patient’s left ethmoid sinus. Although initially thought to be cotton, a pathologic examination of the object revealed it to be Surgicel.
On December 28, the patient died from complications of septic thrombophlebitis infection, that resulted from the sinus surgery.
Three years later, the otolaryngologist added operation notes to the patient record upon receiving notice of the claim. She stated that she made amendments to the record to clarify what occurred during the December 14 surgery.
Allegations
A lawsuit was filed against the otolaryngologist. It was alleged that during the sinus surgery, the otolaryngologist created a defect in the right ethmoid sinus wall, which exposed the dura and created a pathway for infection. This led to brain infection and swelling, septic clotting, strokes, and death.
Legal Implications
The majority of TMLT consultants who reviewed the case were not supportive of the otolaryngologist’s actions. It was suggested that an image-guided operation system should have been used during the procedure because the patient’s previous surgeries may have caused anatomic changes, making the December 14 procedure difficult. Using such a system could have potentially prevented the cribriform plate and dura defects.
One consultant believed the intracranial infection occurred due to a defect in the cribriform plate, allowing the ethmoid sinus contents to spread to the intracranial area. Another consultant noted that the “veins in the middle third of the face and within the skull do not have valves, which cause the infection to ascend and disseminate causing septic thrombophlebitis, leading to arterial compromise and intracerebral bleeding.”
Another consultant noted the severity of the patient’s sinusitis and the extensive surgery. He believed the otolaryngologist should have been familiar with post-surgical anatomic landmarks of the patient, since she had operated on the patient two times before. Another consultant believed there was enough bleeding to justify using Surgicel on the operative site, and that this was a common risk for sinus surgery.
A treating neurosurgeon noted that the right medial wall of the maxillary sinus was absent when they performed emergency surgery on the patient; however, an expert for the plaintiff said this was not significant.
The plaintiff’s expert believed the otolaryngologist should have removed all remaining packing material when the purulent drainage was found. Failure to do this was a breach in the standard of care, and led to the intracranial abscess, stroke, and death.
The otolaryngologist explicitly mentioned that she does not perform CT scans on patients with postoperative complications. A defense consultant criticized this statement and maintained that if the patient had received a CT scan sooner, he may have had a greater chance of survival.
The defense of this case was also complicated because the otolaryngologist dictated changes to her operative notes in the patient’s record three years after the procedure.
Disposition
This case was settled on behalf of the otolaryngologist.
Risk management considerations
In this case, it was strongly advised that the physician use an image-guided system or computer-assisted navigation system due to the anatomic complexity and the high risk for error during endonasal surgery.1
The otolaryngologist was also criticized for updating the patient’s medical record three years after the surgery. For physicians in Texas, the Texas Administrative Code states that each licensed physician “shall maintain an adequate medical record for each patient that is complete, contemporaneous and legible.” When documentation is not completed contemporaneously, it can be difficult for physicians to recall detailed information from a patient encounter. 2
The Code continues that any late changes made to a medical record “shall be noted by indicating the time and date of the amendment, supplementation, change, or correction, and clearly indicating that there has been an amendment, supplementation, change, or correction.” Physicians practicing outside of Texas should refer to their own state regulations on medical records. 2
According to the American Academy of Professional Coders, documentation into the patient’s record should not occur more than 48 hours after last seeing the patient. Within that time frame, physicians can clarify, correct errors, or add additional information to the record.
Physicians should not alter or correct a medical record after being notified of a claim. Doing so can lead to accusations that the physician made mistakes and is trying to conceal them. This can make the claim more difficult to defend.
If there is no notice of a claim and an addendum must be added to the patient’s record, it is appropriate to amend a record but only if the physician clearly states the reasons for the amendment and signs the addendum. When making an addendum, the following information should be documented in the patient record: 3
the date the record is being amended;
details of the amended information including the reason for making the addendum;
clearly noting that the added information is an addendum; and
the signature of the physician.
Even when done in a timely manner, amending patient records should be avoided and not become a routine occurrence.
To protect the integrity of the medical record once you are notified of a claim, place your original medical records in a secure place for future reference. Do not make any additions, deletions, or any other type of alteration to the medical records. Secure any other pertinent information or items in your possession, such as billing records, x-rays, hospital charts, etc.
Sources
Pruliere-Escabasse V, Coste A. Image-guided sinus surgery. European Annals of Otorhinolaryngology, Head and Neck Diseases. Volume 127. Issue 1. March 2010. Science Direct. Available at https://www.sciencedirect.com/science/article/pii/S1879729610000104.
Accessed January 26, 2021.Texas Administrative Code. Title 22. Examining Board. Part 9. Texas Medical Board. Chapter 165. Medical Records. Section 165.1 (a). Available at https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=9&ch=165&rl=1.Accessed March 2, 2021.
Pelaia RA. Medical record entry timeliness: What is reasonable? September 1, 2007. Advancing the Business of Healthcare website. Available at https://www.aapc.com/blog/23844-medical-record-entry-timeliness-what-is-reasonable/#:~:text=Delayed%20entries%20within%20a%20reasonable,at%20the%20time%20of%20service.
Accessed January 26, 2021.
Gracie Awalt can be reached at gracie-awalt@tmlt.org