HEALTH trust bosses have revealed that around 60 women were not given the best breast cancer treatment available because of a faulty tissue test carried out at King’s Mill Hospital.
Errors were made in oestrogen receptor tests carried out at Sherwood Forest Hospitals NHS Foundation Trust between 2004 and 2010 on women already diagnosed with breast cancer.
The tests of 120 women came back negative when they were actually positive and, as a result, around half of these may not have been given the most appropriate course of treatment.
Seventy-nine women are set to receive an apology and will have their breast cancer treatment reviewed now that the mistake has come to light.
Healthcare watchdog, the Care Quality Commission (CQC), is also carrying out an ‘urgent inspection’ of breast cancer screening, pathology and clinical governance at the trust.
Bosses at King’s Mill Hospital are keen to stress that the mistakes made had nothing to do with the diagnosis of breast cancer.
Dr Nabeel Ali, executive medical director, said that they ‘very much regret’ that some women received the wrong advice.
“When we found out about this we decided to investigate it thoroughly and to be completely open about what we found; above all to make sure that we put our patients first,” he said.
“We have contacted all the women affected by these pathology errors to apologise unreservedly for the error which has occurred and we will be in touch with the next of kin of any who have since died.
“The affected patients have been offered an urgent outpatient clinic appointment with their breast specialist to discuss whether any changes are needed to their treatment. If they have not been contacted, they do not need to be concerned in this matter.”
Oestrogen receptor status tests help doctors decide if hormone therapy will be an effective treatment for a certain type of breast cancer.
The mistakes centre on the preparation of slides created for biopsy analysis in the laboratory at King’s Mill, and not the interpretation of the slides by the pathologist.
Doctors raised concerns about inconsistent results in February 2011 and a decision was made to outsource the test to Nottingham’s Queen’s Medical Centre. In June 2011, an audit by the East Midlands Breast Screening Programme showed that between 2004 and 2010, the trust found fewer positive oestrogen receptor breast cancers than other hospitals in the area.
All 273 tests carried out during this time were then sent for re-testing at an external laboratory and an Expert Advisory Group was set up to review the results.
The review team looked at 120 women whose tests had come back negative when they were in fact positive.
The experts estimated that around half of these may have received less effective treatment because of the incorrect result.
The impact of this has been estimated as increasing the mortality rate among these women by around five per cent over 10 years - meaning around three people could have died because they received the wrong treatment.
Some of the 120 affected women have since died and an investigation into whether any of their deaths could have been caused by the mistake is now being carried out.
Dr Ali said it is ‘very, very difficult’ to know if anyone has died as a result of the faulty test, but the trust will make contact with the next of kin of those whose treatment was disadvantaged by the result of the test. It intends to commission a second external report into the technical aspects of laboratory procedures and if it is discovered that human error led to the mistakes, it will take disciplinary action against the individuals concerned.
Interim chief executive Dr Mark Goldman said people can be ‘very confident’ in pathology tests carried out at King’s Mill, with no other areas causing concern.
“We really are extremely sorry that this has happened. We would like to apologise to all the patients and their families,” he said.
In light of the findings, the CQC will also be carrying out a ‘deep dive’ review to reassure Monitor that it has no concerns about standards of patient care elsewehere at the trust. A helpline has been set up for anyone with any worries - Mansfield 672371.