Patient death from flawed care brings support for high risk surgery into focus

Jul 25, 2017

An inquest into what the coroner has described as the ‘preventable’ death of a 75-year old patient from sepsis after high risk elective surgery; highlights a number of lessons for surgeons.

Handing down his findings into the death of a patient from sepsis after surgical resection of a duodenal ampullary adenoma, a coroner raised several issues with her care. ‘This is not a case of a single error or even a series of errors. The whole care and treatment of [the patient] appears flawed from the beginning and at each significant step thereafter,’ he said.

The coroner emphasised the importance of providing support for second opinions, multidisciplinary team review and performing high risk surgery in hospitals with adequate resources and systems to reduce those risks.

The case  

In February 2015, the patient presented to her GP complaining of abdominal pain, nausea and mild jaundice. On the basis of an abnormally dilated common bile duct, the GP referred her to a general surgeon for an endoscopic retrograde cholangio-pancreatography (ERCP) at a private hospital.

The surgeon found a tumour in the common bile duct. Biopsy results showed chronic inflammation, but no evidence of malignancy. The surgeon told the GP that he had booked the patient in for another ERCP.

In March, the GP saw her and recommended that she undergo any further surgery at a hepatobiliary unit interstate.

The surgeon performed a second ERCP in April. The biopsy report indicated a suspected ampullary adenoma with low grade dysplasia, but no malignancy.

In late April, the surgeon told the patient that she had a pre-malignant tumour and recommended resection. Based on the GP’s advice, her husband said they would like to obtain a second opinion. However, the husband’s evidence was that the surgeon dissuaded this and said words to the effect of, ‘Why do you need to drag your wife down south, when I can do the operation here.’ The surgeon gave evidence that he explained the risks of the procedure, but the family said this was not so.

The surgeon gave the patient a consent form which listed the risks of the procedure as ‘Bile/pancreas leak. Infection, DVT’. He told the GP that he had scheduled her for a laparotomy and transduodenal resection of ampullary adenoma on May 27 at the private hospital and ‘She is aware of the potential risks of bile or pancreas leak at surgery’.  

The coroner stated that the surgeon did not tell the patient that the surgery was high risk; the hospital was not properly resourced for such an operation; he did not have access to a multi-disciplinary team; and that she might die from the operation.

The patient underwent the surgery and after the surgery she complained of extreme abdominal pain and ‘burning inside’. She was transferred to the High Dependency Unit (HDU) which had three patient beds and was monitored by one nurse. Contrary to The College of Intensive Care Medicine of Australia and New Zealand Guidelines, none of the three nurses who staffed the HDU possessed a post registration qualification in intensive care.

By 4am the next morning, the patient’s respiration had risen to 27 breaths per minute. According to the observation chart this was in the ‘yellow zone’ and indicated the need for clinical review. There was no indication that any action was taken.    

The nurse who commenced her shift at 7am that morning, gave evidence that she would have called the surgeon to seek permission to change the drain as per protocol, however neither she nor the surgeon could specifically recall such a telephone call. The coroner stated the weight of the evidence was that the nurse did seek permission from the surgeon to change the drain.

Half an hour later, the patient went into septic shock and her blood pressure dropped to 72/38 which was deep into the red zone on the chart. In line with the hospital’s ‘rapid response policy’, the surgeon was called. Just before 8 am he reviewed the patient and noted that she was thirsty, in pain and had moderate naso-gastric bile output and a small volume of 70 ml bile stained fluid in the abdominal drain. Before leaving for the theatre, he directed fluids, chest physiotherapy and requested blood tests. The surgeon’s evidence was that he was unaware there had been 400 ml of bile in the drain overnight.

By 12pm the patient’s blood pressure and respiration rate was again in the red zone. The surgeon communicated through his anaesthetist in the operating theatre. No rapid response was called. At 12.30pm the surgeon reviewed the patient. He ordered more fluids and a chest X-ray, and indicated in his notes that her blood pressure (70/30) may need to be treated with inotropes. There was no mention of the fluid in the drain. 

Soon after, the patient’s respiration rate and oxygen saturation levels reached critical levels and she was transferred to the Intensive Care Unit (ICU) at a teaching hospital. She was commenced on a noradrenaline infusion, given antibiotics for sepsis, intubated and ventilated.   

That evening, the surgeon sent the patient for an urgent CT scan of her abdomen and pelvis. The CT scan results were ambiguous. At 8pm, after reviewing the patient again, he believed she was suffering pancreatitis and a bilateral chest infection. He sought a second opinion from another surgeon via telephone based on the facts as he saw them, including that there was no bile in the drain. The surgeon agreed there was no indication to reoperate.

The next morning, the patient deteriorated further and the surgeon reoperated. He repaired a three millimetre hole in the duodenum from which bile was leaking. Unfortunately, the patient died of multi-organ failure on 30 May.        

The coroner outlined a series of concerns in the patient’s treatment, which coupled with the hospital’s inadequate resources and systems, contributed to her death.

After excision of the tumour, it was found there was no dysplasia or invasive malignancy.

Failure to consult multidisciplinary team

The coroner was critical of the failure to involve a multidisciplinary team to assist in decision-making in such a high risk and complex case. An expert believed that if surgery had been required, a less invasive procedure such as an endoscopic resection would have been more appropriate.   

In hindsight, the surgeon conceded that the elective surgery was not necessary.

Dissuading the patient from seeking a second opinion  

The coroner also highlighted that the surgeon had dissuaded the patient from seeking a second opinion, contrary to The Medical Board’s: Good medical practice: A Code of Conduct for doctors in Australia, which states that good medical practice involves: ‘Supporting the patient’s right to seek a second opinion. ’

Failure to inform patient of risks  

The coroner was critical of the surgeon for failing to inform the patient of the options available for diagnosis, the high risk nature of the surgery and other options available to her to mitigate those risks.

Undertaking high risk surgery in a hospital without adequate resources and systems

The high risk surgery was undertaken in a hospital without the resources and systems to mitigate the risks. The risks were heightened because the hospital did not possess a multi-disciplinary team, an ICU, gastroenterology support or an adequate HDU.

The coroner also emphasised the hospital’s inadequate escalation policy for deteriorating patients, highlighting a failure to call the ‘Rapid Response Team’ when the patient’s blood pressure, respirations and oxygen saturations fell into the red zone. While the surgeon was called, a Code Blue was not called. In comparison, a Code Blue would have been called in the teaching hospital for the second time.

Communication failure between doctors and nurses  

Attention was also drawn to the lack of communication between the surgeon, anaesthetist and nurse who comprised the ‘Rapid Response Team,’ about the patient’s deterioration.

Poor medical note keeping  

A significant issue in this case included the poor medical notes by both doctors and nurses, particularly accurately writing up the Fluid Balance Sheet.

‘Various entries were clearly in the wrong columns and on two occasions figures were written and crossed out, but no further entries made,’ the coroner said. On May 28 he noted that there were no outputs recorded for the drain except for an entry at 7am which stated ‘400 – change drain’.

The lack of robust notes had a significant effect on the patient’s management as the surgeon’s failure to recognise that the drain had been changed was crucial.

Surgeon’s care under scrutiny
Failure to identify bile in abdomen drain

The coroner raised several issues about the surgeon’s care. These included failing to properly investigate the patient’s drop in blood pressure to critical levels on the morning of May 28 and his failure to recognise the significant amount of bile drained from her abdomen.

The surgeon said he did not see the 400 ml on the Fluid Balance Sheet on the morning in question and that he was not aware until months later that the drain had been changed overnight and the amount was 400 ml. Had he known this fact, he would have reoperated immediately, meaning that the patient would have been reoperated on 18 hours earlier.

Based on evidence from the nurse that the 400 ml would have been written along with the other observations on that morning at 8 am, the coroner believed it was possible the notation was written after the surgeon had left for theatre. However, he noted that on the Fluid Balance Sheet was 280 ml in the ‘drain’ column made up of a number of entries recorded prior to midnight on May 27. ‘One might think a doctor looking at the sheet and seeing no notations for the last 8 hours might look over the page, the more so given the rapid deterioration of [the patient],’ the coroner said.

Contrary to the surgeon’s belief, the coroner also concluded that the patient’s file from the private hospital was available to him in ICU.

‘The seeming failure to look at the Fluid Balance Sheet or talk to the nurse about the fluid balance remains perplexing,’ the coroner said.

Failure to take patient back to operating theatre until too late

Irrespective of the failure to recognise the fluid drained, the coroner found there were significant signs that the patient should have been taken back to theatre earlier. Expert evidence indicated that if bile is leaking from an anastomosis and the patient is developing a first systemic inflammatory response syndrome, followed by multi-organ dysfunction syndrome, early intervention is required. The expert said the patient should have been returned to theatre after transfer to the ICU.

As a result, the surgeon made a series of improvements to his practice including enhancing collaboration with local and interstate colleagues, sharing rooms with a new heptobillary surgeon and upskilling in endoscopic ultrasound, and access to a complex case committee.

Coroner’s recommendations

The coroner referred the findings to the Medical Board of Australia and recommended that the private hospital:

  • Not permit high risk surgery to be undertaken where it does not have the resources to mitigate those risks.
  • Implement an escalation system to provide a proper rapid team response when the rapid response criteria are met.
  • Should it continue to operate a HDU, it be properly and appropriately resourced, and conform with the National Standards on Safety and Quality in Health Care and College of Intensive Care Medicine of Australia and New Zealand Guidelines.

Key lessons

Doctors who treat patients in small private hospitals should be aware of the limitations of the resources. These should be discussed with patients and other doctors in the treating team and documented in the medical records. Download our factsheet, Medical records – the essentials.

When admitting patients to small private hospitals, doctors should:

1. Consider whether the surgery is high risk.
2. Involve a multidisciplinary team to assist in decision-making in high risk and complex cases.
3. Support the patient’s right to seek a second opinion.
4. Inform patients of the options available for diagnosis, the high risk nature of any surgery and any other options available which can reduce those risks.
5. Consider whether the hospital has adequate resources and systems in place to support high risk surgery, particularly adequate ICU and HDU facilities, and escalation policies.
6. Recognise the importance of communication between all treating doctors and nurses involved. View our webinar More than words: communication and clinical handover and earn CPD points.
7. Recognise the importance of accurate and timely medical notes.

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