CHILD HEALTH

Alert over blood test mix-up

Source: IrishHealth.com

August 14, 2013

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  • The HSE has moved to try to reassure anxious parents after it emerged that a number of mothers and babies have been told by hospitals that there may be a small chance the baby has been given the wrong blood group at birth.

    There is a chance too that some of the mothers and babies may have been given treatments they did not need or else did not receive treatments they needed as a result of the mislabelling.

    The HSE, however has stressed that there are no immediate safety concerns and that the chances of babies being assigned a wrong blood group are extremely low.

    The errors were due to a mislabelling of around 540 blood testing kits.

    RTE News reported that the five maternity hospitals affected are the Rotunda Hospital in Dublin, Cavan General, Sligo General, Limerick Regional  and University Hospital Galway, with the majority of cases at the Rotunda.

    The hospitals began contacting affected mothers on Monday and GPs are also being notified about the 540  mislabelled kits.

    It is undersood that the risk of a wrong blood group being assigned arises from a defect in the labelling of the kits which could cause a hospital staff member to tick the wrong box on the label.

    The HSE says there are four groups of patients potentially affected:

    - Mothers who may have required an anti-D injection but did not get it  - 30 cases.

    - Mothers who may have received anti-D when they did not need it - 220 cases.

    - Babies who received a red blood cell transfusion when they may not have needed it -12 cases.

    - Babies whose blood group result may have been reported incorrectly - 278 cases.

    The test kit involved is the ORTHO BioVue System Cassette.

    As part of routine hospital procedures, a baby’s blood group is checked at the time of delivery. One of the blood group test kits used for this was the Ortho BioVue System Cassette (manufactured by Ortho Clinical Diagnostics, a Johnson and Johnson company).
     
    The HSE, in a statement, said it was was recently notified by the Irish Medicines Board that a safety notice had been issued as a small number of the testing kits supplied worldwide had been incorrectly labelled.

    "This means that there is a small chance that the results of some blood group tests may have been incorrectly reported in some cases. The manufacturer has estimated that the potential risk of a kit being labelled incorrectly is less than 1 in 11 million," the HSE said.

    The health executive said as part of the response to this, every hospital that used these type of kits had completed an inspection of the remaining kits in stock and has removed any potentially affected batches. Each hospital had also conducted a review of the results of the testing done using these kits in each hospital.

    The HSE stressed that all patients, including babies, will always have a repeat blood group test when being admitted to any hospital or in pregnancy.

    It said there were no immediate safety concerns; however anyone affected can discuss the implications for them directly with their hospital.

    Each hospital has set up a dedicated phoneline for those affected - contact details have been provided in the letters sent to those affected or are available from the HSE Information line -1850 24 1850.

     

    © Medmedia Publications/IrishHealth.com 2013