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Unnecessary mastectomy following biopsy swap (12HDC00690)

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(12HDC00690, 3 December 2014)

Pathology laboratory ~ Biopsy ~ Biopsy swap ~ Multidisciplinary meeting ~ Breast cancer ~ Incorrect treatment ~ Right 4(1)

A woman was diagnosed with, and successfully treated for cancer in her right breast. From that time onwards the woman underwent annual mammograms.

Several years later, the results from an annual mammogram detected an area of indeterminate calcification in the woman's left breast. Vacuum-assisted core biopsies were taken and sent to a pathology laboratory for testing. The woman's biopsy results were reported as positive for pleomorphic invasive lobular cancer and the woman underwent a full mastectomy of her left breast. Throughout this period the woman's case was reviewed a number of times at multidisciplinary meetings (MDMs).

The post-surgical biopsy did not show any evidence of cancer. Investigations undertaken by the providers involved concluded that the woman's initial biopsy sample, and that of another patient, had been swapped inadvertently at the pathology laboratory. This resulted in the woman receiving positive biopsy results which did not belong to her, leading to unnecessary surgery.

It was held that, although it appears that human error led to the woman's tissue sample being swapped with a sample from another consumer, the pathology laboratory's processes for handling breast biopsies such as this woman's included unsafe practices. Those practices directly contributed to the woman receiving biopsy results that did not belong to her. By failing to ensure that its processes were sufficiently robust, the pathology laboratory failed to provide services with reasonable care and skill and, therefore, breached Right 4(1).

The actions of the clinicians present at the MDMs involved in the woman's care were not found to be in breach of the Code, however, lessons could still be learnt from the case. In particular, the Commissioner said that the district health board should encourage clinicians working in this area to consider critically the possibility of a "false positive", be mindful of the possibility that a specimen handling error may have occurred and, if appropriate, undertake additional tests.


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