Women recalled to hospitals after mistakes in breast cancer tests: Regulator launches 'urgent inspection' into patient care at Sherwood Forest hospitals NHS foundation trust
Seventy-nine women are being recalled to hospitals in Nottinghamshire after the discovery that mistakes were made in the testing of breast cancer tissue samples which could have led to some being given inappropriate treatment.
News of the recall came as the Care Quality Commission (CQC), which monitors standards in hospitals, announced that its investigators had gone in to Sherwood Forest hospitals NHS foundation trust for an "urgent inspection", to ensure there were no other issues affecting patient care in the trust's four hospitals.
The trust is already in trouble with Monitor, the regulator of the foundation trusts, over its finances. It is struggling to meet its payments on a private finance initiative (PFI) loan of £320m, which was taken out more than six years ago to expand King's Mill hospital, and could run out of money by January.
The trust has invited 79 women who were treated for breast cancer between 2004 and 2010 to come back to hospital for an apology and a review of their treatment. All of them had samples of their tumour removed after diagnosis to determine what sort of drug treatment would work best. The test is to find out the oestrogen receptor status of the tumour, which tells doctors whether hormone therapy will be effective or not.
In a statement, the trust said that there had been concerns about inconsistencies on the results of these tests, carried out in the trusts' pathology labs. An audit by the East Midlands screening programme found that Sherwood Forest had fewer oestrogen receptor positive breast cancers than other hospitals in the six years between 2004 and 2010.
All the samples were reviewed by experts who found that the tumours of 120 women had been wrongly classified. About half of them may not have had the best treatment as a result. The trust says the mistakes may have led to 5% more deaths than there should have been over 10 years. The records of women who died are being reviewed and their relatives will be contacted.
"Caring for patients is our absolute priority and so we are extremely sorry that some women's tests had been under reported. We very much regret that some women received wrong advice," said Dr Nabeel Ali, the executive medical director.
"I should make it absolutely clear that there are no problems with the diagnosis of breast cancer itself, only with a test that helps to decide on the most appropriate prevention therapy following treatment for breast cancer."
From February last year, when the problems were first suspected, the tests were all outsourced, said Ali, who wanted to reassure women about the current service.
The CQC said its inspectors had been sent in for an urgent look at what had happened in the breast screening programme, the pathology labs and in clinical governance. It also wants to ensure that the hospital, which has had four chief executives in the past three years, two of whom were interim appointments, is being effectively run and no other patient services were compromised.
"This urgent inspection will allow us to take an in-depth look at the quality and safety of the trust's services that relate to breast cancer screening," said the CQC chief executive, David Behan. "The action we are taking, alongside Monitor's intervention, will ensure that both regulators have a good picture of the quality and safety of the trust's services and the robustness of its governance."
Monitor has instructed the trust to embark on a series of reviews into its performance, including a look at its long-term financial viability.
Monitor's chief operating officer, Stephen Hay, said: "We are using our formal regulatory powers of intervention because we are concerned the trust has failed to get to grips with the scale of the problems it faces.
"In addition to the trust's financial difficulties our concern about its leadership has been heightened by the disclosure that some breast cancer patients are to receive an apology from the trust and an urgent review of their treatment after an investigation into faulty pathology test results.
"The reviews we have commissioned will assess whether or not this issue was identified and dealt with sufficiently promptly. If either the CQC's inspection, or the trust's own external expert review, reveals any other matters of concern we will not hesitate to intervene again." The Guardian
Seventy-nine women are being recalled to hospitals in Nottinghamshire after the discovery that mistakes were made in the testing of breast cancer tissue samples which could have led to some being given inappropriate treatment.
News of the recall came as the Care Quality Commission (CQC), which monitors standards in hospitals, announced that its investigators had gone in to Sherwood Forest hospitals NHS foundation trust for an "urgent inspection", to ensure there were no other issues affecting patient care in the trust's four hospitals.
The trust is already in trouble with Monitor, the regulator of the foundation trusts, over its finances. It is struggling to meet its payments on a private finance initiative (PFI) loan of £320m, which was taken out more than six years ago to expand King's Mill hospital, and could run out of money by January.
The trust has invited 79 women who were treated for breast cancer between 2004 and 2010 to come back to hospital for an apology and a review of their treatment. All of them had samples of their tumour removed after diagnosis to determine what sort of drug treatment would work best. The test is to find out the oestrogen receptor status of the tumour, which tells doctors whether hormone therapy will be effective or not.
In a statement, the trust said that there had been concerns about inconsistencies on the results of these tests, carried out in the trusts' pathology labs. An audit by the East Midlands screening programme found that Sherwood Forest had fewer oestrogen receptor positive breast cancers than other hospitals in the six years between 2004 and 2010.
All the samples were reviewed by experts who found that the tumours of 120 women had been wrongly classified. About half of them may not have had the best treatment as a result. The trust says the mistakes may have led to 5% more deaths than there should have been over 10 years. The records of women who died are being reviewed and their relatives will be contacted.
"Caring for patients is our absolute priority and so we are extremely sorry that some women's tests had been under reported. We very much regret that some women received wrong advice," said Dr Nabeel Ali, the executive medical director.
"I should make it absolutely clear that there are no problems with the diagnosis of breast cancer itself, only with a test that helps to decide on the most appropriate prevention therapy following treatment for breast cancer."
From February last year, when the problems were first suspected, the tests were all outsourced, said Ali, who wanted to reassure women about the current service.
The CQC said its inspectors had been sent in for an urgent look at what had happened in the breast screening programme, the pathology labs and in clinical governance. It also wants to ensure that the hospital, which has had four chief executives in the past three years, two of whom were interim appointments, is being effectively run and no other patient services were compromised.
"This urgent inspection will allow us to take an in-depth look at the quality and safety of the trust's services that relate to breast cancer screening," said the CQC chief executive, David Behan. "The action we are taking, alongside Monitor's intervention, will ensure that both regulators have a good picture of the quality and safety of the trust's services and the robustness of its governance."
Monitor has instructed the trust to embark on a series of reviews into its performance, including a look at its long-term financial viability.
Monitor's chief operating officer, Stephen Hay, said: "We are using our formal regulatory powers of intervention because we are concerned the trust has failed to get to grips with the scale of the problems it faces.
"In addition to the trust's financial difficulties our concern about its leadership has been heightened by the disclosure that some breast cancer patients are to receive an apology from the trust and an urgent review of their treatment after an investigation into faulty pathology test results.
"The reviews we have commissioned will assess whether or not this issue was identified and dealt with sufficiently promptly. If either the CQC's inspection, or the trust's own external expert review, reveals any other matters of concern we will not hesitate to intervene again." The Guardian
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