The care of 49 women facing a potential diagnosis of cancer was affected by mistakes, or discrepancies, in the analysis of their biopsies at University College Hospital Galway (UCHG), a report has found.
Today’s report by the Health Information and Quality Authority (HIQA) published the findings of an investigation into the provision of services to a woman referred to as "Ms A", who was misdiagnosed twice within 18 months as being clear of breast cancer.
The Tipperary woman was referred to the private Barrington’s Hospital in Limerick in September 2005. She had a mammogram and ulstrasound, which indicated she had cancer, but a biopsy analysed at UCHG was negative.
She subsequently referred herself for further tests and a second biopsy, carried out 18 months after the first, was also returned with a negative result.
The HIQA report focuses only on the UCHG tests, as it is only authorised to inquire into HSE-funded hospitals.
It found that two different pathologists at UCHG “misdiagnosed Ms A’s breast cancer – Dr B in September 2005 and Dr C, a locum pathologist, in March 2007.
“As a result of the misdiagnosis which occurred, Ms A’s treatment for breast cancer was delayed,” the report said.
It also found there was no arrangement in place for pathologists from UCHG to participate in multidisciplinary review of cases at Barrington’s Hospital and that, as a result, “an important opportunity to correct for these interpretative errors was lost”.
“Although UHG was paid for the service, the agreement between the two hospitals was based on an informal arrangement between clinicians, and no formal governance arrangements were in place to oversee the service.”
The investigation team reviewed the caseloads of the two pathologists, including 200 breast histology patient cases reported on by Dr B. It also examined 747 breast and non-breast cytology cases and 123 gynaecological cytology cases reported on by Dr C.
The review found that Dr B had made a “single interpretive error” in the misdiagnosis of Ms A and that there was “no cause for wider concern about their work”. However, the review of Dr C’s work identified 49 patients where the reviewers “differed from Dr C in their findings”, according to the HIQA report.
“The discrepancies found in these 49 patients had the potential to affect the clinical management and care for those patients and therefore all patients were followed up by UHG and, where necessary recalled for consultation, further investigation or treatment."
Of the 123 gynaecological cytology cases reviewed by the investigation team, 35 women whose specimens were reported on by Dr C were contacted for precautionary follow-up as a result of a difference of opinion between the review and Dr C’s reporting.”
The HIQA report said there were also “questions for UHG and the wider HSE” in relation to some aspects of Dr C’s appointment, although it was carried out in accordance with guidance in place at the time.
HIQA director of healthcare quality Jon Billings said the fact that Ms A experienced two interpretive errors, separated by 18 months, by two different consultant pathologists “serves to emphasise the importance of having fully functioning triple assessment and multidisciplinary team meetings (MDTs) in place, irrespective of where the patient is cared for”.
“Failure by the clinicians and institutions concerned to have such arrangements in place was a significant factor in her delayed diagnosis.”
Mr Billings said that overall the investigation team found that the symptomatic breast disease services at UHG were “well run”, but the report makes recommendations for improvements in the pathology department’s quality assurance systems.
“The hospital was responsive once the interpretive errors came to light. Lessons learned by UHG in responding to this incident should be examined by corporate HSE to inform the approach adopted nationally,” Mr Billings said.
He said Ms A had shown “great courage at a time of great personal difficulty” in sharing her experiences with the investigation team.
The report makes 12 recommendations which it believes must be implemented by the HSE in order to safeguard the delivery of a quality service to patients. It calls on the HSE to nominate a specific director accountable for ensuring the development of an implementation plan for these recommendations.
Ms A’s solicitor Cian O’Carroll said today that his client was very concerned that “standards are not being applied in private hospitals". He said that while Barrington’s did not conduct private cancer care anymore, the quality of regulation was not the same in a private hospital as in a public hospital.
He said that the HIQA was not allowed to examine private hospitals, but at the same time the Department of Health is encouraging co-location and the “explosion” of private health care.
Mr O’Carroll said Ms A was “adamant that these recommendations must be implemented” and that the serious harm caused to her and her family must not be repeated.
A separate investigation was conducted by the Department of Health and Children and Barrington’s Hospital into Ms A’s care in that hospital and this report was published in April.
Minister for Health Mary Harney welcomed what she said was a "clear and thorough" report today and she reiterated her apology to Ms A.
"This report again highlights the need for continued implementation of the National Quality Assurance Standards for symptomatic breast disease Services which I approved last year. It also reinforces the importance of providing symptomatic breast cancer services in eight designated centres, a policy which we are pressing ahead with under the National Cancer Control Programme."
Fine Gael health spokesman Dr James Reilly said previous warnings on the recruitment of locums had been “ignored” by the Government.
“If the technical ability and history of this locum had been fully assessed Ms A and the 12 other patients might never have been misdiagnosed,” he said.
He urged the Government to implement the the 2002 Lynott report to ensure that procedures around the recruitment of locums, including those from other countries, are tightened.
Dr Reilly also asked that a HSE director be made responsible for the implementation of the HIQA recommendations.
Labour Party health spokeswoman Jan O'Sullivan said the report "tells another sorry story of women badly let down by our health service with their health damaged and lives jeopardised by unreliable procedures and unacceptable mistakes".
She said new procedures governing the recruitment of locums and the verification of their qualifications and records were needed.
Ms O'Sullivan said the decision to proceed with privately funded co-located hospitals beside public hospitals must not be allowed to proceed until there are proper procedures in place for the regulation and monitoring of all private hospitals and clinics.