Dáil Éireann debate -
Thursday, 20 Apr 2000

Vol. 518 No. 5

Written Answers. - Irish Blood Transfusion Service.

Bernard Allen

Question:

142 Mr. Allen asked the Minister for Health and Children if his attention has been drawn to the fact that the Irish Medicines Board has identified seven major deficiencies in good medical practice at the Blood Transfusion Service Board; if he will carry out an investigation into a report that the medical officer, who reviewed deferred donors between 6 and 28 December 1999, may not have been trained to the relevant standard particularly in view of the fact that it was during this period that two deferred donors managed to give blood, one unit of which was later transfused to a patient. [12304/00]

Minister for Health and Children (Mr. Martin)

The Irish Medicines Board reports on an annual basis in respect of its inspections of the Irish Blood Transfusion Service, formerly the Blood Transfusion Service Board. Two annual reports have been presented to date and I expect to receive shortly a third report in respect of the year ended December 1999. In its inspections, the IMB follows the requirements of good manufacturing practice, GMP and I presume it is this, rather than good medical practice, to which the Deputy is referring. GMP encompasses such items as quality management, personnel, premises and equipment, documentation, production and quality control. My Department has been advised that deficiencies in GMP identified by the IMB have been or are being rectified by the IBTS. My Department has and will continue to ensure that adequate resources are available for this purpose.

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

When the computer problem was rectified, donation reports for December were rerun 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 the one previously attended, and that both completed medical questionnaires and omitted to mention 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 standard recall procedure was initiated as soon as the problem was identified, which 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 examined by the IMB as 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 my Department also requested the BTSB to provide a report on the incident as soon as possible. On 11 January the national 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. In relation to staff training, the medical registrar who had temporarily replaced the medical officer normally assigned to this area had not been fully trained in all aspects of the procedure and the relevant training documentation was incomplete. I understand that this matter has now been addressed and that the training documentation is now in place.

My Department has made available approximately £4 million to replace the existing computer system. 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.