Biopsies viewed by Awanui Labs showed cancer cells twice, but it was not picked up. Photo / Supplied
A retired nurse with persistent gastrointestinal bleeding died from stomach cancer after pathologists failed to detect the disease in two different biopsies.
It wasn’t until her fourth and final gastroscopy on Christmas Eve 2021 that the Invercargill woman’s stomach cancer was found.
A “hindsight review” undertaken of the original three biopsies revealed gastric adenocarcinoma had been present in two previous biopsies and missed by Awanui Labs pathologists.
Now, Deputy Health and Disability Commissioner (HDC) Vanessa Caldwell has found a lead GI pathologist and Awanui Labs breached the code after the woman’s family laid a complaint about the care provided by Southland Hospital, which resulted in a “significantly delayed diagnosis”.
“I acknowledge that [her] misdiagnosis and subsequent delayed treatment would have had a profound impact on her extended family, and I commend their reasons for wishing to continue with an investigation to ensure that this does not happen to anyone else.”
During 2021, the woman was referred to Southland Hospital by her local GP, who reported that the woman had black tarry stools because of recurrent gastrointestinal (GI) bleeding.
She was referred to a consultant general surgeon at Southland Hospital, Invercargill, and she had an appointment that day.
The first gastroscopy was undertaken by the consultant general surgeon on April 30, 2021.
The surgeon’s clinical notes include “anaemia and his finding of two gastric ulcers and two large ulcers associated with surrounding inflammation”. The doctor noted it was “[s]uspicious for malignancy” and there were “oozing gastric ulcers”.
However, the referral they sent to Southern Community Laboratories Limited, now Awanui Labs, listed only anaemia in the clinical details.
The biopsy results were carried out by a consultant pathologist who said on May 5, 2021, that there was no evidence of “metaplasia, dysplasia, or malignancy”.
Because of this, no second opinion was sought.
Days later, the woman had a follow-up CT scan of the chest, abdomen, and pelvis. The results indicated no cancer at that time but noted what was thought to be a left atrial appendage thrombus.
The woman had a second follow-up gastroscopy in June, which was done by the consultant general surgeon again.
The referral form sent to Awanui Labs listed the clinical details as a gastric ulcer.
The same pathologist reported on the biopsy and again found no evidence of metaplasia, dysplasia or malignancy. Again, no second opinion was sought.
In October, the woman was seen by a new doctor, this time a consultant general and renal physician, when she was admitted to Southland Hospital’s Day Surgery Unit with “symptomatic iron deficiency anaemia, without overt GI bleeding symptoms, while on rivaroxaban”.
She then had another gastroscopy performed by the original surgeon, where he found “localised severe inflammation” and ulcerations in the gastric body and stomach.
The referral form sent to Awanui Labs by the doctor stated “upper GI bleeding”.
The biopsy result reported by an anatomical pathologist and reviewed by a consultant pathologist again noted that there was no evidence of metaplasia, dysplasia, or malignancy.
In late December, the woman was still having concerning symptoms and was sent for another gastroscopy on Christmas Eve.
A doctor who hadn’t treated the woman before undertook the procedure and found a “30mm nodular area of markedly inflamed mucosa around a partially healed ulcer scar”.
The biopsy reported on by the original pathologist confirmed that gastric adenocarcinoma had been found.
As a result of the December biopsy finding, and in line with Awanui Labs’ routine quality assurance, the pathologist undertook a “hindsight review” of the original three biopsies and found that gastric adenocarcinoma had been present in both the April and October biopsies.
In January 2022, the woman was referred for prioritised treatment but, despite this, she died on May 17, 2022.
HDC was provided with expert advice, which was based on a blind review of the stained biopsy slides from April, June, and October by a panel of five histopathologists.
It found the changes present in the April 2021 biopsy were “extremely subtle” and that, only with appreciation of the changes in the later biopsies, with hindsight it becomes “possible to pick out the very rare lesional cells in the inflammatory background”.
One pathologist told the HDC in relation to the October 2021 biopsy slides, he found that there was a failure to recognise the serious changes in the biopsies, which were highly suspicious for malignancy.
An oncologist provided the HDC with an opinion on the progression of the woman’s gastric cancer in a two-month period.
He concluded that it was reasonable to contend “that a two-month delay in diagnosis caused clinically meaningful cancer growth in [the woman’s] specific situation and had a negative impact on her outcome. This would likely not be the case in a typical case but is influenced by the aggressive nature of her cancer.”
All the doctors and pathologists involved in the case provided an apology to the woman’s family.
In a response to HDC, Awanui Labs acknowledged that there were errors in diagnosis of the biopsies from May and October 2021.
“[The] May diagnosis missed a subtle area of cancer. The diagnosis of limited (small) amounts of poorly differentiated gastric adenocarcinoma is difficult.”
In relation to the October incorrect diagnosis, it said there was no indication of high suspicion for cancer at the time in the clinical information provided, and the diagnosis was influenced by this information and the previous two negative biopsies.
Deputy Commissioner Vanessa Caldwell found both Awanui Labs and the lead GI pathologist breached the Code of Health and Disability Services Consumers’ Rights.
“Awanui Labs had a duty to ensure that services were provided to [the woman] with reasonable care and skill. In this regard, Awanui Labs failed [her] on two occasions in April 2021 and October 2021.
“I consider that, ultimately, Awanui Labs was responsible for ensuring that its pathologists reported on the biopsy specimens appropriately. Given the number of gastroscopies requested during April to December 2021, in my view this should have also raised suspicion for those carrying out the biopsies”.
However, she said from the blind review carried out by the six pathologists involved that, for the April 2021 biopsy review, only three of the six pathologists would have found the gastric adenocarcinoma.
“I also note that the contributing factor to the missed diagnosis appears to be the lack of clinical information provided on the histology request by [the first doctor].
“However, all pathologists have acknowledged that they missed the gastric adenocarcinoma in their reporting of the April and October 2021 biopsies. These were missed opportunities for [the woman] to have commenced chemotherapy at an earlier stage.”
In her recommendations, she said Awanui Labs was to develop education/training on the importance of ensuring that appropriate, detailed, and relevant clinical information, including the endoscopy report, is provided with the biopsy specimen and histology request forms sent to the pathology laboratories.
It was also to implement a policy, protocol or procedure for pathologists to follow when reviewing and reporting histology cases to ensure that the options available for consideration are clear.
She said the original surgeon had changed his practice, now providing the gastroscopy reports with the histology requests but suggested he reflect on how he can make improvements in the provision of pertinent clinical information on pathology request forms when submitting the specimen for analysis.
She also recommended Health NZ Southern change its process for all gastrointestinal histology requests to include a copy of the endoscopy report to provide pathologists with a more rounded view of the clinical diagnosis.
“I express my sympathy and heartfelt condolences to the late [woman’s] family for their loss.
“I note from the clinical records that prior to her diagnosis, [the woman] was described as in ‘excellent health of body and mind’ and was a retired nurse and caregiver for her husband.”
Awanui Labs chief medical officer, Dr Richard Steele, said Awanui Labs accepted the commissioner’s recommendations and had taken steps to strengthen its systems and processes.
This included requiring pathologists to review available endoscopy information alongside biopsy samples, reinforcing the importance of complete clinical information, and giving additional training to teams.
“We are committed to learning from this case and continuing to improve the safety and quality of our services so that patients and their families can have confidence in the care we provide.”
Health NZ Te Waipounamu chief medical officer Dr David Gow said in a statement it accepts the findings and recommendations.
“Our aim is always to provide excellent healthcare, and we deeply regret that in this case we did not meet those high standards.
“The report identified multiple factors across a number of organisations that contributed to this tragic outcome.”
Gow said it had taken “significant steps” to implement the commissioner’s recommendations and will continue to work closely with Awanui Labs and its clinicians to help prevent incidents occurring in the future.
Brianna McIlraith is a Queenstown-based reporter for Open Justice covering courts in the lower South Island. She has been a journalist since 2018 and has had a strong interest in business and financial journalism.