A report into how a woman with breast cancer was mistakenly given the all-clear has concluded that it was caused by human error. Fiona Gartlandreports.
The report, from Cork University Hospital, found that "internal and external reviews" into the case pointed to "the original test result being an interpretive error".
The report into the misdiagnosis was supplied to the O'Malley family last night.
Rebecca O'Malley (41), from Ballina, Co Tipperary, underwent a biopsy test for breast cancer in the Midwestern Regional Hospital, Limerick, in March 2005.
The test was sent to the pathology department at Cork University Hospital (CUH) for analysis and was returned with a negative result.
However, on the recommendation of her GP, Ms O'Malley took a repeat biopsy 14 months later and the results showed she had breast cancer.
The four-page report outlined how Ms O'Malley's sample was initially diagnosed as a fibroadenomia (benign tumour) in March 2005 by the reporting consultant pathologist at CUH.
In November 2006, after a request from Ms O'Malley's consultant surgeon at the Limerick hospital, the case was reviewed, "both internally at CUH and externally at the Mater hospital", the report said.
The results of the review were supplied to Limerick hospital at the end of January 2007 and it was found the sample contained cells deemed "highly suspicious for malignancy".
The report did not identify the pathologist who carried out the original diagnosis. But it recommended that the faculty of pathology conduct an external, blind test of his work.
It acknowledged that CUH did not respond in a timely manner to the complaint received in April 2007 and did not communicate with Ms O'Malley at the earliest opportunity.
It also said that in future, if any clinically significant errors are identified, an incident form should be completed and submitted to the risk management department for follow up.
The report was also forwarded to the Minister for Health, Mary Harney, who said she would make a decision on whether to seek an independent investigation once she had studied it.
Speaking last night, Ms O'Malley said the report did not explain how a conclusion of human error was reached and did not satisfy her request for an independent review.
"Behind every human error is a systems error and that has not been identified," she said. "There are clearly not the structures in place to catch errors. It only informs my view that there must be an external report."
She said that the decision of the Limerick hospital to review 300 cancer test cases, taking 28 of them a stage further as a precautionary measure, only skimmed the surface of the problem.
"I can't understand what the parameters for choosing the cases to be reviewed were," she said. "There were many more than 300 samples sent to that lab for analysis."
Meanwhile, Ms Harney has said women will be put at risk if new standards on the treatment of breast cancer are not adopted.
The Quality Assurance Standards for Symptomatic Breast Disease report, published yesterday, sets out the requirements for specialist breast care centres and defines how the quality of services provided there can be measured.
It calls for the establishment of a network of specialist breast centres, each caring for a minimum of 150 newly diagnosed patients with breast cancer each year, servicing a population of 300,000 to 350,000. This would reduce the number of centres treating breast cancer in the State from 32 to 12.