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Dáil Éireann debate -
Wednesday, 5 Apr 2000

Vol. 517 No. 4

Written Answers. - Blood Donations.

Alan Shatter

Question:

205 Mr. Shatter asked the Minister for Health and Children the circumstances which resulted in the Blood Transfusion Service Board taking and using blood from donors whose blood should not have been so utilised and which was not detected due to a failure in its computer system; the number of batches of blood involved; the number of persons involved; the reason for excluding them as donors; the number of patients to whom it was administered; the follow up action taken to ensure no patient to whom this blood was administered is at risk; and the proposed action, if any, he will take to ensure no repetition of any such incident in the future. [10199/00]

The incident referred to by the Deputy was caused by a problem which arose in December 1999 when work was being completed on the Blood Transfusion Service Board's computer system to make it year 2000 compliant. As a result, the computer check which identified any donations received from donors who were temporarily deferred did not function properly. The board's own staff identified the malfunction which was rectified as soon as it was discovered.

When the computer problem was rectified, reports for December were re-run and two donations were identified which had been taken from donors who were temporarily deferred due to recent nose piercing in one case, and recent acupuncture from a non-medically registered practitioner in the other. On investigation, the BTSB found that both of the deferred donors attended at a clinic which was different to one previously attended, completed the medical questionnaire and omitted to give the information which had previously led to their deferrals. The vital security check when processing blood is the sensitive laboratory testing which is carried out on all donations. Both donations had been subjected to rigorous laboratory checks and were found to be safe. Nevertheless, the recall procedure was initiated immediately and resulted in one donation being recalled and discarded before use. Red cells and plasma from the second donation were also recalled and discarded, however platelets had been infused into one patient. The donor whose platelets had been infused was traced in early January and agreed to undergo further tests. Blood samples were obtained and tested negative for all viral markers.

Any potential breach of security is recorded by the BTSB and in turn is inspected by the Irish Medicines Board, which is the regulatory authority. In this instance, the BTSB notified the IMB on 4 January of the problem with the deferred donors and the IMB requested a report on the incident and on corrective actions. The IMB notified my Department on 7 January and the Department also requested the BTSB to provide a report on the incident as soon as possible. On 11 January the medical director of the BTSB made his report to the IMB and supplied a copy to my Department. As soon as final testing was completed on the donor whose blood had been infused, the BTSB gave the Department details of the tests which had been completed and the results which, as I have already stated, were all negative.
My Department has made available approximately £4 million to replace the existing computer system which was the original cause of the problem. The new system – Progesa – is in use in many other transfusion centres internationally. Implementation of the new software is under way and a period of parallel running will take place before the system goes live during the summer.
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