Presentation
On June 9, a 60-year-old woman came to her primary care physician’s office with reports of abdominal pain and fullness, diarrhea, nausea, and vomiting for 10 days. She also reported watery and bloody stool.
The patient’s medical history included coronary artery disease, dyslipidemia, hypertension, pre-diabetes, obstructive sleep apnea, attention deficit disorder, and postoperative right leg deep vein thrombosis. The patient’s medications were atorvastatin, venlafaxine, losartan, mirtazapine, lisdexamfetamine, and aspirin.
Physician action
A physician assistant (PA) saw the patient and documented that she had normal conjunctivae and white sclerae, a non-tender abdomen with normal tone and no masses present, no hepatomegaly, and a non-tender spleen or liver.
The patient’s lab work showed abnormal liver test results: total bilirubin 12.9 (normal < 1.2); alkaline phosphatase 191 (normal 46-118); ALT 1779 (normal 5-50); and AST 1476 (normal 9-50). The patient’s creatinine was normal at 0.98.
After discussing options, the primary care physician and PA decided to obtain a viral hepatitis panel and CT scan of the patient’s abdomen without contrast. However, the CT scan was performed with contrast and revealed a “mildly distended gallbladder wall, no acute process, malignancy, obstruction noted.” The hepatitis panel was negative for acute hepatitis A and B. The patient was diagnosed with gastroenteritis and prescribed ciprofloxacin for 10 days.
On June 16, the patient returned with worsening symptoms. She was seen again by the PA, who noted the patient said she felt like her body was “shutting down” and was in “obvious distress.” The patient’s conjunctivae were yellowish, her sclerae was white, and the PA noted jaundice and abdominal tenderness and protuberance. After noting elevated liver enzymes and biliary obstruction, the patient was referred to a local emergency department (ED) with a triage report to the on-call ED physician.
The ED physician examined the patient and noted icteric sclerae and right upper quadrant abdominal tenderness. Additional lab work showed worsening liver test results; the test showed 1.5 creatinine (normal 0.6-1.3) and hyponatremia with a serum sodium of 129 (normal 136-145).
An abdominal ultrasound showed heterogenous liver parenchyma and non-specific gallbladder wall thickening. The primary impression was acute new onset biliary obstruction. The ED physician requested a gastroenterology consult.
An intake hospitalist noted the possibility of non-viral hepatitis and ordered a work up for autoimmune hepatitis; acute hepatitis B and hepatitis C; and acetaminophen/alcohol levels, after consulting with a gastroenterologist. Once the reports were returned, the hospitalist documented the absence of acetaminophen use, and her recommendation that if the patient’s liver function worsened, a liver transplant center should be contacted.
On June 17, the patient had worsening coagulopathy, increased creatinine at 3.88, and encephalopathy. The gastroenterologist contacted a liver transplant center. While awaiting transfer, a work up was done including magnetic resonance cholangiopancreatography, hepatitis B and C PCR, and acetaminophen levels. Anti-nuclear and anti-mitochondrial antibodies returned negative.
On June 18 at 2:30 p.m., the patient was transferred to receive a liver transplant. The delay was due to bed availability issues. After she was admitted, the plan was to consult the liver transplant center and continue supportive care, but no documentation of the consultation could be found.
On June 19, the patient died from cardiac arrest. According to the pathology report, the cause of death was sub-massive hepatic necrosis resulting in clinical hepatic failure.
Allegations
A lawsuit was filed against the primary care physician and physician assistant. Allegations included failure to quickly respond to abnormal lab values and failure to refer the patient to a liver specialist.
Legal implications
Consultants who reviewed this case stated that when the patient first came to the physician on June 9, the patient’s high bilirubin values would have caused her to look jaundiced. After the abnormal lab results came in, the patient should have immediately been referred to an acute care hospital. Instead, an evaluation was conducted with a viral serology and CT scan, and the patient was sent home.
However, these consultants believed that even if the patient had been admitted to an acute care hospital on June 9, there was no guarantee that a liver transplant could have occurred quickly enough to save the patient. The treating gastroenterologist at the transplant center said the patient was very ill when she arrived; there were 13,000 people on the transplant list; and no way to quickly determine when the patient could be prioritized for surgery.
The gastroenterologist thought the week the patient spent at home eliminated the patient’s chance of survival and agreed that the patient would have benefitted from being admitted on June 9 to an acute care hospital for specialist care.
Consultants for the plaintiff addressed the possibility of drug toxicity. One consultant believed that discontinuing the patient’s meds would have saved the patient, but another consultant stated the autopsy report did not provide the cause of liver failure, so drug toxicity could not be determined. This consultant believed a liver transplant was required due to the patient’s advanced liver failure.
A gastroenterologist reviewing the case for the plaintiff felt the primary care physician and the PA did not comprehend the serious nature of the patient’s illness, and the lab results clearly indicated one of the following: autoimmune hepatitis, ischemic hepatitis, or acute or reactivation viral hepatitis.
Disposition
The lawsuit was settled on behalf of the primary care physician and physician assistant.
Risk management considerations
In this case, the primary care physician and the PA did not read or note the patient’s abnormal test results on June 9. The reasoning behind the diagnosis of gastroenteritis was not documented in the patient record.
Poor documentation was a factor in this case. Keeping accurate, contemporaneous, complete, and legible patient records can be a physician’s best defense in defending a claim. Had the physician or PA documented the reasoning for the diagnosis, their actions may have been easier to defend.
Also, when employing an advanced practice provider, it is important to have written protocols regarding responsibilities, scope of practice, and standing delegation orders. The patient’s record did not reflect that the physician ever saw or evaluated the patient himself during these appointments. According to the documentation, the patient only saw the PA during her appointments on June 9 and June 16. Due to the patient’s condition, abnormal test results, and long history of medical issues, it would have been prudent for the physician to examine the patient.
Physicians who delegate duties are vicariously liable for the activities performed by advanced practice providers or staff members. To reduce the risk of errors, explicitly state in your practice’s policies and procedures when the physician needs to be contacted, such as when receiving abnormal test results.
In addition, protocols for handling test results should also be clearly stated in the policies and procedures. It is important that staff members have a clear understanding and knowledge of lab report standards and what constitutes an abnormal result. If the staff member does not understand a lab report or recognize a test value, he or she should be instructed in the policies and procedures to request clarification from the physician, lab, or hospital. Staff members should be required to regularly review the policies and procedures and acknowledge their understanding of the materials in writing.
There was also concern about the delays experienced by the patient after admission to the hospital. Physicians ordering diagnostic testing or treatments in a hospital are responsible for following up on the test results. The physician should provide clear orders about urgency (routine, stat, etc.) to ensure lab or test results are received and reviewed in a timely manner.
