CASE STUDY: Failure to Follow Protocols, Poor Documentation, and Inadequate Postmortem Investigation Worsens Liability
Theodore Passineau, JD, HRM, RPLU, CPHRM, FASHRM
This case study discusses how multiple missteps can play a role in an adverse outcome and increase the risk of liability. As such, the case study focuses on a healthcare providers' involvement with a patient from a two-phase perspective: clinical care provided to the patient during the patient's hospitalization and compliance with hospital protocols prior to and following the patient's death.
Case Details
The patient was a 49-year-old female who had a history of high blood pressure and high cholesterol. Although the patient smoked and had a family history of heart disease, she had no history of heart or lung disease.
The patient experienced a sudden onset of a lump-type sensation in her throat, which quickly progressed to overwhelming chest pain radiating through to her back. She said it felt as though her chest was being "ripped open." She became weak, diaphoretic, and developed noticeable weakness in her left arm. An ambulance transported the patient to a local emergency department (ED), where she arrived at 12:48 p.m.
ECGs showed some changes, although not consistently, and the ED physician interpreted a portable chest X-ray as showing some widening of the mediastinum. The patient's cardiac enzymes were normal. Cardiology was called, and the patient was examined by a physician assistant (PA) from the cardiology practice.
The PA noted that the patient was "sore all over" and drowsy, but arousable. Her blood pressure initially was 127/79 mmHg; it then rose to 160/80 mmHg and finally returned to 130/80 mmHg. The patient's heart rate and rhythm were regular, without murmur. Her abdomen had some tenderness, and she had a weaker hand grip on the left than the right. Subsequent ECGs showed some flattening of the T wave, and CPK and troponin tests were unremarkable.
The PA ordered a nitroglycerine drip, enoxaparin, beta-blockers and aspirin, and an echocardiogram. The plan was to admit the patient and perform a cardiac catheterization the following morning.
The cardiologist interpreted the echocardiogram as showing left ventricular hypertrophy, but with normal systolic function and a normal aorta. The patient had an estimated ejection fraction of 70 percent. The nitroglycerine did not relieve the patient's pain, but it was abated by morphine. The working diagnosis at that time was unstable angina. Because no coronary care unit (CCU) beds were available, the patient was kept in the ED.
The patient's vital signs were not taken every 10 minutes (as specified by hospital protocol for patients on nitroglycerine drips). The serial documentation by the nurse attending the patient in the ED was not consistent and included a gap in documentation of vital signs from 4:36–5:05 p.m.; further, nothing was documented from 6:50–7:49 p.m. At 7:50 p.m., the patient's blood pressure was 68/56 mmHg, and her heart rate was 133 bpm.
While the patient continued to wait in the ED for a CCU bed, she developed nausea and vomiting and had a seizure. Following that, she quickly progressed into respiratory arrest. She was promptly intubated and stabilized. However, she soon developed profound bradycardia followed by cardiac arrest. CPR was initiated without success, and the patient was pronounced dead at 8:20 p.m.
The patient's husband was approached with a request for organ donation, for which he gave consent. During the organ retrieval procedure, the technician (not a physician) noted that the patient's aorta was dissected, and that the pulmonary artery was lacerated, although the chest cavity was not noted to be full of blood.
An autopsy had not been ordered at the time of death; however, according to hospital policy related to unanticipated death, it should have been. An autopsy was performed 1 week later; however, documentation indicated that the heart had not been properly preserved, and the sternum and a portion of the aorta were missing entirely. Given the condition of the body, the pathologist could not establish a definitive cause of death.
A malpractice suit was brought against the cardiologist and the PA (both MedPro insureds), as well as the hospital. A settlement in the mid-range was made on behalf of both the cardiologist and the PA, and defense costs also were in the mid-range. A settlement also was made on behalf of the hospital, but that amount is not known.
Discussion
This case is somewhat difficult to analyze and discuss because so many facts are not known with certainty. Nevertheless, when examining this case, three general areas of risk become apparent: (1) inattention to a critically ill patient, (2) failure to follow established protocols, and (3) inadequate documentation.
The first issue, inattention to the critically ill patient, is suggested by the long time gaps in the documentation of approximately 30–60 minutes. Further, the patient was in the ED for 2 hours before she received any analgesia, other than what she had received in the ambulance. However, information is not available as to how many other patients the ED nurse was attending during this time.
In regard to the second risk issue, at least two hospital protocols were violated. First, the hospital had a protocol that required staff to check vital signs of patients on nitroglycerine drips every 10 minutes; this protocol was not followed in this particular case.
Additionally, the hospital had a policy stating that autopsies should be performed in cases of unanticipated death. Despite this policy, the cardiologist did not order an autopsy. Instead, the cardiologist indicated that she would sign the death certificate, which normally removes the case from the attention of the medical examiner. Although the medical examiner ultimately took authority over this case and performed an autopsy the following week, critical evidence had been lost by that point.
The cardiologist may not have been aware of the hospital's autopsy protocol, but hospital personnel should have been. If a timely autopsy had been performed, it is likely that an accurate cause of death could have been established.
The third risk issue in this case was inadequate documentation, which created questions about whether the patient had other signs or symptoms that were not identified. What is known is that the patient was kept in the ED for more than 7 hours because no CCU beds were available. Whether this was avoidable — and whether a transfer to the CCU would have made any difference — is not known.
The defense experts who reviewed this case were mixed in their opinions regarding the care rendered by the cardiologist following the echocardiogram. Some felt the case was handled correctly in all respects, while others felt the cardiologist did not pay sufficient attention to the symptoms of aortic dissection (i.e., the slightly widened mediastinum, the back pain, and the "ripping" sensation). All agreed that the cardiologist treated the patient appropriately for unstable angina — if, in fact, that was the correct diagnosis.
This case poses two dilemmas — one clinical and one legal — that may complicate the management of similar medical malpractice cases. The clinical challenge occurs when a patient presents with symptoms that could be consistent with more than one serious condition for which radically different treatments are indicated. At some point, the physician must diagnose and then treat the patient's condition. If the diagnosis is correct, all is well; if not, the patient may suffer.
The second dilemma concerns the design of a defense strategy for this type of case. Because of the many deficiencies in the hospital care, the hospital administration was agreeable to settling the case. That left the cardiologist and the PA, members of the same medical group, with the decision of whether to go to trial or to settle as well.
When the defense experts have varying opinions as to whether the doctor handled the case correctly, it is very difficult to predict how a jury will react. Further, given the patient's relative youth and the fact that she had young children, it is possible that a jury might award a large financial payment on her behalf due to the sympathetic nature of the case.
Although any award would be offset by the hospital settlement, the remainder could be substantial, possibly exceeding the doctor's and/or the PA's insurance policy limits. As an additional consideration, any payment made on behalf of the doctor or the PA becomes part of his/her claims history and must be reported to the National Practitioner Data Bank and possibly the state board of medicine.
Together, these issues complicate the defense of the case, and the imprecise knowledge about the patient's cause of death further challenges the defense strategy.
Conclusion
The practice of medicine never has been, and never will be, a completely straightforward activity. Physicians must rely on their clinical judgment and decision-making skills to diagnose and treat patients. Although adhering to established protocols can greatly enhance the likelihood of favorable patient outcomes and provide support for providers' decisions and actions, incorrect or delayed diagnoses can occur.
Careful documentation of each patient's condition and the factors that went into determining the diagnosis, combined with thorough post-treatment investigation of unanticipated outcomes, may help support the defense of a potential malpractice claim.