661 patients have cancer files reviewed

Hundreds of patients whose test results indicated they may have prostate cancer are having their files reviewed.

The 661 patients were identified out of a review of 15,000 tests carried out on 11,000 patients attending Mayo General Hospital between July 2012 and June 2013. The reviews are due to be completed tomorrow.

The HSE was compelled to order the review after it emerged that the test kit used was giving false positives, as revealed in the Irish Examiner.

Analysis of the data following the review has confirmed that 661 patients were “above the upper reference limits” — in other words, their test results were outside safe limits within which case patients can be sent for further investigation, including biopsy. A prostate biopsy carries risks ranging from mild to fatal.

MGH has been in contact with referring doctors since the Irish Examiner broke the news of the faulty kit last month, notifying each doctor of the specific patients who require following up. According to the HSE, the hospital is working with the doctors “to ensure that each patient’s case is examined in detail” and will only contact patients “if that becomes necessary”.

The HSE expects this process to be completed by tomorrow and any patients about whom there are concerns will be contacted by Oct 11.

A review at Connolly Hospital in Blanchardstown of 2,186 patients tested between February and June this year using the same faulty Siemens Immulite test kit revealed 145 patients received a result “which may have indicated a need for further investigation”, the HSE said.

Of these 145 patients, five had gone on to have biopsies and three were found to have prostate cancer.

Connolly is also reviewing the results of each of the 145 patients and is making follow-up contact with GPs to track patient outcomes.

The test kit has been recalled globally by Siemens, which has not funded the cost of the Irish review. When asked if it was playing any role in funding the reviews, Siemens said it would provide replacement tests if the doctors involved considered that retesting was necessary.

The recall notice issued by Siemens states that the kits in question were reading 20% to 23% higher than other similar tests and relative to the World Health Organisation standard.

The test measures the blood level of PSA, a protein produced by the prostate gland. A high PSA level can be an indicator of cancer.

Beaumont has taken over the running of PSA testing from Connolly on all samples arriving since June 29.