BTSB accepts criticisms in report to Minister are valid

Strong criticisms of the Blood Transfusion Service Board's operating standards are contained in a report presented to the Minister…

Strong criticisms of the Blood Transfusion Service Board's operating standards are contained in a report presented to the Minister for Health, Mr Cowen. The continuing lapses relate to computer systems, deficiencies in training of personnel, and the delay in the transfer to new headquarters.

The Irish Medicines Board (IMB) had said that the operating standard in terms of computing, buildings and training of personnel was "not to standard for a fully accredited pharmaceutical operation," as it should be under EU standards, he said.

Inspectors from the IMB, in the 1998 annual report on the BTSB, were "very concerned" that there had been no significant change in some key areas since the previous year's report. These included concerns about quality assurance.

The report was recently sent by the Department of Health to the BTSB to give the board an opportunity to respond to the criticisms.

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The BTSB's medical director, Dr Willy Murphy, admitted yesterday that the criticisms were valid. However, he said that a number of them had already been addressed since the inspections were carried out last year, and work continued on others.

"All I can say is that these things do take time, there are a finite number of people to deal with them. Our emphasis has been to ensure that every unit of blood that goes out the door has been fully tested and we can stand over that.

"Once we get these things in place, including the move to the new headquarters, we will actually be above the standard of any blood transfusion service. We will get there but we are coming from an unfavourable position, probably more unfavourable than any other blood transfusion service setting out to achieve these standards."

The report also expressed concern about validation of the board's computer system, and that it was not yet Y2K-compliant. There were also concerns about the installation of the new system.

Dr Murphy said that since the inspection considerable work had been done, "but we cannot move any quicker. We are under tremendous pressure."

Criticism at the delay in training for good manufacturing practice, said Dr Murphy, was valid and had been raised on a number of occasions previously. "I think it is fair to say that there have been huge stresses and demands placed on BTSB staff. We have lost a number of senior people, three national donor service managers, two IT managers.

"The CEO, Mr Liam Dunbar, retired due to ill health, then we had no CEO for a few months and then one for six months. That made it difficult to maintain the head of steam required. However, since Martin Hynes was appointed as CEO things have started to progress."

The delay in moving to the new site at St James's Hospital in Dublin was also highlighted. According to Dr Murphy, the move would take place by the end of October.