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Open disclosure failure following biopsy swap (12HDC01574)
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(12HDC01574, 11 March
Pathology laboratory ~ District health board ~ Biopsy ~
Biopsy swap ~ Multidisciplinary meeting ~ Breast cancer ~ Incorrect
treatment ~ Open disclosure ~ Rights 4(1), 6(1)
A woman found a lump in her right breast. She underwent a number
of clinical examinations including biopsies of both breasts. The
biopsy result from her right breast revealed sclerotic
fibroadenoma, a benign lump. That result was considered to be
inconsistent with the woman's clinical presentation and, following
a multidisciplinary meeting, it was agreed that the woman should
undergo another biopsy. The woman underwent a further biopsy, which
revealed invasive lobular carcinoma (invasive breast cancer). The
woman subsequently elected to have a bilateral mastectomy.
A month later, concerns were raised that another patient,
Patient Y, had had unnecessary surgery due to a biopsy swap.
Internal investigations undertaken by the providers involved
concluded that the woman's first biopsy, and Patient Y's biopsy of
the same day, had been swapped inadvertently at the laboratory.
Both women therefore received results which did not belong to them.
While the district health board informed Patient Y of the biopsy
swap as soon as it came to light, the woman was not informed until
three months later.
Although it appears that human error led to the woman's tissue
sample being swapped with a sample from another consumer, the
laboratory's processes for handling late-delivery breast biopsies
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
laboratory failed to provide services with reasonable care and
skill and, therefore, breached Right 4(1).
Open disclosure should occur where a consumer has been exposed
to possible harm, irrespective of whether harm has occurred or is
immediately apparent. In this case, a biopsy swap occurred, and
both consumers involved should have been informed in a prompt and
transparent manner. However, the district health board did not
inform the woman of the error in a timely and appropriate manner.
As a result, the district health board failed to provide the woman
with information that a reasonable consumer in her position would
expect to receive, and breached Right 6(1).