Written Answers. - Blood Transfusion Service.
Róisín Shortall
Question:
67
Ms Shortall
asked the
Minister for Health and Children
his views on whether a new centre is required to be provided by the end of 1999 for the Cork Blood Transfusion Service Board for the Irish Medicines Board to renew its licence; if he will give a commitment to provide the necessary funding to enable the Cork Blood Transfusion Service Board to meet this deadline; and if he will make a statement on the matter.
[24302/98]
I have approved a multi-million pound investment programme to support the re-organisation and re-development of the BTSB nationally. The primary objective is to ensure that the BTSB is resourced to provide a transfusion service in line with best international standards. I am making significant additional resources available to the BTSB to support the following programmes: a new national headquarters at a cost of approximately £25 million; the introduction of new technologies to improve the safety of the blood supply, at a total annual cost of £4.7 million; additional staff appointments.
Additional medical consultants will be recruited including consultant support to be located at the Cork centre. My Department has also approved the recruitment of four additional quality assurance staff, two of whom will be at the Cork centre.
The total additional costs of the development programme, excluding the capital funding, will be approximately £6.5 million 1999.
I am also providing a total of approximately £4 million to replace the existing IT system to ensure Year 2000 compliance. These resources will ensure the accelerated implementation of the new IT system which involves the Cork centre in particular. Five technical staff at the centre have been released on a full time basis on this project. Resources have been made available to backfill these five posts, one person has been released full time on the IT project at the Dublin centre and that position has also been backfilled.
The Blood Transfusion Service Board is licensed by the Irish Medicines Board to collect and process whole blood and human plasma for the use in the manufacture of medicinal products. The BTSB is not a manufacturer of blood products. It collects plasma for fractionation abroad, which is used for the production of blood products such as albumin and plasma-derived factor IX which are used in Irish hospitals. The Irish Medicines board is a statutory independent body and is the regulatory authority for the BTSB. Accordingly, the regulatory requirements specified by the IMB must be met by the BTSB in order to retain their licence. The manner in which these requirements are met is a matter for the BTSB, provided it meets with the approval of the IMB. For my part, I will ensure that the BTSB is sufficiently resourced to ensure regulatory compliance.
The BTSB's current manufacturing licence covers the period 1 August 1998 to 31 October 1999. There are four conditions attached to the licence as follows: validation of the existing computer system for control of donations and components at the Dublin and Cork centres; the new computer system to be installed in both centres is to be fully validated; a construction and validation timetable is to be provided in relation to the new national headquarters; replacement of the area for the processing of donations at the Cork centre.
Considerable work has been completed to date on the validation of the existing system, and additional work is on-going. The IMB's validation requirements for the new system (which is currently being installed and will be operational before the end of next year) will also be met. The new system is one which is in use in a number of European and American blood centres.
As regards the requirement for capital investment in the Cork centre to meet regulatory requirements, a number of options have been considered by the BTSB. The options include the upgrade of existing buildings and/or replacement of existing buildings on site, or a move to a new site and the construction of a new centre. In November 1997, the BTSB commenced evaluation of these options, including evaluation work on a new centre. The BTSB also undertook a substantial capital investment programme at the Cork centre which involved the provision of: a new components processing laboratory; a new compatibility testing laboratory; a new product storage area; an upgrade of the donor clinic; and new office accommodation.
The resources to complete this programme were made available by my Department at a total cost of £464,000, with an additional £60,000 for equipment. The BTSB has advised my Department that the new components processing laboratory which is referred to in its licence is now among the best of its kind in Europe, and that, at a recent inspection by the IMB, the level of compliance was considered acceptable and in accordance with the EC Guide to Good Manufacturing Practice. My Department has been given to understand that at a meeting on 3 November 1998 between the BTSB and the IMB, it was agreed that a review of the proposals involving the Cork facility would take place after the current inspections have been completed on 27 November. The BTSB has also advised my Department that it has identified a number of areas at the centre which require improvement or replacement, including storage and accommodation for equipment validation. The BTSB will discuss these matters and the implementation of any recommendations of the IMB arising from its inspections at both centres.
The BTSB is fully committed to ensuring that the Cork centre continues to meet the requirements of the IMB. For my part, further capital investment in the centre will be dictated by the requirements of the IMB and any additional resources necessary for this purpose will be made available. Furthermore, proposals submitted by the board of the BTSB for capital investment which are over and above those necessary to ensure regulatory compliance will also be considered by my Department.
