I thank the Deputy for raising the issue. The incident referred to by Deputy Allen was caused by a problem which arose in December 1999 when work was being finalised 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 problem concerned two donors who had been deferred due to recent nose piercing in one case, and recent acupuncture from a non-medically registered practitioner in the other. The board's own staff identified the malfunction which was rectified as soon as it was discovered. The BTSB also reported the incident to the Irish Medicines Board, which is the appropriate regulatory authority.
Around 175,000 attendances to donate blood are recorded annually, either at fixed locations such as Pelican House in Dublin and St. Finbarr's Hospital in Cork, or at one of almost 300 mobile clinics throughout the country. People who attend these clinics are sometimes temporarily deferred from giving blood for a number of reasons. Before any blood is taken, the donors are required to answer a very detailed questionnaire regarding their health. As a result, some will be advised that their blood cannot be accepted, usually because their haemoglobin levels may be low or they may be suffering from a cold or flu. People who have undergone procedures such as acupuncture – except when given by a registered medical practitioner – tattoos or body piercing are also deferred for a time because of a very small risk that hepatitis may be transmitted in this way. The deferral period may be up to a year depending on the reasons for deferral. In 1998, 13.21% of those who attended the BTSB's clinics were deferred, which is one of the highest rates of deferrals anywhere in the world and is indicative of the BTSB's stringent policies on vetting potential donors. When a person's donation is temporarily refused, he or she is informed, and the deferral is noted on the donor's computer record. If this person volunteers again during the deferral period, and gives the same information which led to the original deferral, then he or she will again be advised that their blood cannot be accepted until the deferral period has expired.
If, for whatever reason, the individual forgets to mention relevant information on a subsequent visit, then the immediate identification of this fact will depend on whether the clinic attended is the same as the one previously visited. If the clinic is the same, then the computer system in the clinic will highlight immediately the fact that the donor is deferred and the donation will not be accepted. If the donor attends another of the almost 300 clinics nationwide, his or her existing computer records will not be immediately available and the donation will be accepted. In this instance, the computer records are downloaded into the main BTSB computer system at the end of the clinic session, and a computer generated report is run to identifiy any donors whose blood may have been taken during the deferral period. This "deferred donor" report is one of a number of reports reviewed by the board's medical staff prior to the release of a batch of donations.
On 29 December 1999 it was observed that the suite of donor reports did not contain a report on donations made during the active deferral period, and further investigation showed that the problem was traced to work on the computer system to make it year 2000 compliant. The problem was rectified at once.
Reports for December were then rerun and two donations were identified which had been taken from donors who were temporarily deferred. On investigation, the BTSB found that both of the deferred donors attended in December 1999 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. 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 by the BTSB, which were organised through her own general practitioner. Blood samples were obtained on 14 February and tested negative for all viral markers. The virus reference laboratory confirmed on 29 February that the sample tested negative for HIV 1 and 2, HIV antigen and HTLV 1 and 2. On 1 March 2000 confirmation was received from St. James's Hospital that the sample also tested negative for syphilis. On 3 March the virus reference laboratory indicated that the sample was also negative for hepatitis B and C.
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 Irish Medicines Board 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 Irish Medicines Board 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 were all negative.
The vital security check when processing blood is the sensitive laboratory testing which is carried out on all donations. This includes testing for HIV, hepatitis B and C, syphilis and other viruses. A new processing step, leucodepletion, has also been introduced to remove over 99.5% of white cells from each donation, and Ireland has been in the forefront of countries which have introduced this procedure. In addition, a particularly sensitive test known as polymerese chain reaction, PCR, has been introduced to all donations. This test, which increases the ability to detect very low levels of hepatitis C in blood donations, is currently being undertaken for the BTSB by the Scottish National Blood Transfusion Service.
Both donations were subject to standard virology testing by the BTSB and passed. Recall of these donations was a standard procedure for any security breach, no matter how minor. The BTSB has assured my Department that both donations were safe to use. If the position had been otherwise the various testing procedures would have identified the problem and the blood would not have been released.
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. Testing of the new software is currently under way, and implementation is scheduled to start in March and April, with a period of parallel running before the system goes live during the summer.
