Minister for Health Mary Harney has issued a public apology to the woman whose diagnosis of breast cancer was delayed by 18 months due to pathology test errors. The woman was twice given the all-clear following tests for cancer, but both tests subsequently proved false.
Ms Harney has also ordered a "prompt investigation" which may extend beyond the laboratory at University College Hospital, Galway (UCHG) where the errors occurred on two separate dates over 18 months.
She has asked her officials to examine "the most appropriate and effective mechanism" for the investigation, including the option of a statutory inquiry which would require Government approval.
She says she intends the Medical Council to be fully briefed on the case and to request it to examine "relevant aspects" under its own statutory powers.
The Health Information and Quality Authority (HIQA) has already confirmed that it has been asked to undertake a review of pathology services at UCHG at the hospital's request.
This follows the discovery that two separate biopsy tests on the woman - living in the midwest and a patient at Barringtons Hospital, Limerick - were both erroneously confirmed as clear of cancer.
The tests were carried out at Barringtons Hospital and sent to the UCHG laboratory for analysis in September 2005 and March 2007. When the second test came back as negative, the Barringtons Hospital consultant sought another check through the Bon Secours Hospital, Cork, laboratory. It was confirmed as positive for cancer, and a recheck of the first slide was also identified as positive.
UCHG subsequently issued a full apology to the woman and initiated investigations. The woman, who is said to be severely traumatised, is undergoing intensive treatment.
HIQA told The Irish Times at the weekend that its review could not extend to the woman's hospital, as it was a private institution. However, the Minister has now said she has consulted HIQA on how a "prompt and wide-ranging review" of all aspects of the woman's care could be progressed, "including those components provided in the independent hospital sector".
Ms Harney said HIQA was taking part in the Commission on Patient Safety, established last January, which will be examining a statutory system of licensing all healthcare providers. She said the best advice made available to her was that a licensing system for independent providers should be in place so that HIQA could carry out investigations into non-publicly funded healthcare provision.
Referring to a new system of quality assurance standards for symptomatic breast disease services, Ms Harney called on hospitals in the independent sector to take "immediate steps" to ensure that such services provided in non-HSE funded institutions complied with the standards.
Organisations which fund and insure care in this sector must also ensure they are compliant, Ms Harney said.
The standards reduce the likelihood of clinical errors and improve a woman's chances of surviving her cancer and "maximising" her quality of life, she said.
The case is the second review which HIQA is conducting into a misdiagnosis of breast cancer. It is also investigating the care provided to Tipperary mother of three, Rebecca O'Malley, whose treatment for breast cancer was delayed by 14 months due to a misdiagnosis.
The telephone helpline at UCHG (1800-252016) operates 9am-5pm daily.