A report into the misdiagnosis of breast cancer patient Rebecca O'Malley has found it was due to a "once off interpretive error" at Cork University Hospital.
However, the report by the Health Information and Quality Authority (HIQA), was highly critical of the way Ms O'Malley's case was dealt with by the HSE and the two hospitals involved.
In a statement this afternoon, the HSE apologised to Ms O'Malley and her family "for the distress caused".
Ms O'Malley (42), a mother of three from Ballina, Co Tipperary, had her breast cancer diagnosis delayed for 14 months after a laboratory error was made at Cork University Hospital (CUH).
She had been attending the Mid-Western Regional Hospital (MWRH) in Limerick, which sent her samples to Cork for analysis.
Ms O’Malley had a breast removed in a London clinic in 2006, over a year after being told by CUH that biopsy lab tests were negative. In May last year a HSE report concluded the misdiagnosis was a result of an interpretative error.
HIQA's investigation team interviewed 35 people during the course of its investigation and carried out a detailed review of documents, policies and procedures at MWRH and CUH.
The HIQA report said a locum consultant pathologist in CUH had made a "once-off" error, leading to the delay in Ms O'Malley's diagnosis. It said the clinical systems in place within and between the two hospitals at the time did not detect theerror. As a result, it said, a further delay took place before she was diagnosed with cancer.
"The investigation found that this in itself might not have led to a delay in diagnosis for Rebecca O'Malley had a fully functioning multi-disciplinary review meeting about her case been held at the MWRH. This did not happen and an opportunity to correct the error was lost," the HIQA report said.
HIQA said its investigation also identified "serious issues" with the way the the Health Service Executive (HSE) and the two hospitals responded to Ms O'Malley's concerns. "Rebecca O’Malley’s concerns about the accuracy of her original diagnosis was hampered by there being no effective system wide approach initiated involving both clinical and managerial staff and no single nominated lead to manage the response," it said.
It also said there were problems with communications between the two hospitals and the HSE and that quality of the samples sent by the MWRH to CUH was routinely "poor".
The report made 15 recommendations that it says the HSE must implement to safeguard patients.
"Every effort must be made to ensure this cannot happen again and those involved in leading and developing the health service in Ireland must learn from her experience and recognise that they are in [Ms O'Malley's] debt for having the courage and resilience to bring her experience to their attention," the report concluded.
The report was initially due to be published last December but was deferred.
The HSE said today it accepts the report's recommendations. A number have already been implemented and others are in the process of being introduced, it said.
The executive said it acknowledges that the issues raised in the report may cause concern for current or former patients of the two hospitals and has set up helplines for anyone with questions.
Cancer charity Europa Donna Ireland and Labour Party health spokesman Jan O’Sullivan both called for he report’s recommendations to be implemented immediately.