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Unnecessary mastectomy following biopsy swap (12HDC00690)
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(12HDC00690, 3 December
Pathology laboratory ~ Biopsy ~ Biopsy swap ~
Multidisciplinary meeting ~ Breast cancer ~ Incorrect treatment ~
A woman was diagnosed with, and successfully treated for cancer
in her right breast. From that time onwards the woman underwent
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.