13,000 prostate cancer tests face review

Close to 13,000 prostate cancer tests carried out on patients who attended Mayo General Hospital have to be reviewed after it emerged the test kits were faulty.

The admission by the HSE that MGH is the second hospital to withdraw the faulty kit follows an Irish Examiner report yesterday that Connolly Hospital in Blanchardstown ceased using the defective kits in June after being notified by the manufacturers, Siemens, that it was giving false positive readings, averaging 20%-23% too high.

The latest revelation comes ahead of the meeting today of the harmonisation board of the National Cancer Control Programme which is looking at how to standardise PSA (prostate specific antigen) testing across Irish hospitals. The need for standardisation was highlighted earlier in a research paper showing how six different test methods in use across nine hospitals produced significant variability in test results using the same patient samples.

An NCCP spokesperson said a survey of PSA testing in nine hospitals was conducted and the results should inform how standardised testing can be introduced.

The HSE has confirmed that MGH will review all the 12,866 tests carried out at the hospital from Jul 6, 2012, to Jun 25, 2013, to establish how many had an elevated reading and if further action is necessary.

In relation to Connolly Hospital, the HSE said 2,186 patients were tested between February and June this year using the faulty Siemens Immulite test kit. Of these patients, 145 received a result “which may have indicated a need for further investigation”, the HSE said.

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

The HSE said yesterday that Connolly is “also reviewing the results of each of the 145 patients, as a precautionary step... and is making follow-up contact with GPs to track patient outcomes”.

According to the HSE, Connolly Hospital wrote to all GPs and urologists informing them of the Siemens recall in a letter that included each GP’s individual patients’ results and advising that re-testing was available if required.

MGH said that since June 26, it had attached a comment to all new PSA results alerting doctors to the positive bias in the previous tests. The hospital is also “in the process of contacting all doctors who requested this test” over the relevant 12- month period, offering to re-test any affected patients.

The HSE said when it became aware of the recall, an incident management team was set up. It said the recall is “considered to be of low clinical risk in relation to long-term negative outcome for patients”.

However, the risk to patients sent forward for biopsy range from mild to fatal. Consultant urologist Peter Ryan, of the Bon Secours Hospital in Cork told the Irish Examiner that mild complications included urinary tract infection and mild prostatitis (inflammation of the prostate) but major complications included septicaemia and even death.

The PSA is a blood test which may be raised in patients with prostate cancer.

However, it can also be raised in certain benign prostate conditions.