Tuesday, 3 February 2004
Irish Blood Transfusion Service.
I thank the Chair for giving me an opportunity to raise this issue tonight. The Irish Medicines Board has warned that the blood screening irradiator which helps to prevent serious complications, or even death, at the Irish Blood Transfusion Service unit in Cork is faulty. The machine, which prevents a rare but sometimes fatal reaction in some patients who receive blood is in such poor condition that the service has been forced to suspend some of its activities at its Cork facility. Blood not used in one hospital is recalled and sent to another. An inspection carried out by the IMB was critical of policy control at the Cork unit. The minutes of the IMB's December board meeting stated that "quality assurance is not sufficiently aware of the urgency and extent of product recall". The December minutes also noted that the board has "major concern regarding the potential for inadvertent reissuing of recalled product". A spokesperson said that the programme would be suspended until there is greater clarity in "recall procedure". This includes determining if blood has been stored at the correct temperature and handled properly in the hospital from which it came.
An article in The Examiner today quoted the Irish Medicines Board as saying that the risk assessment analysis of the irradiator will be completed shortly. The article by Catherine Shanahan mentioned that the board's inspection also found problems with the premises and equipment in Cork. It was reported that the post of senior technical officer has been vacant since August 2002 and the post of quality officer has been vacant since April 2003. Yesterday's IBTS statement said that the difficulty in filling positions was due to "uncertainty regarding the development of the facility".
The Government promised a major new unit in Cork in the course of a by-election in Cork in the late 1990s. Very little has happened since then, despite the fact that the Irish Medicines Board has said the building is unsuitable for long-term use and is not compliant with good manufacturing practice. Although the Southern Health Board has offered a site for a new building, the Government has delayed the project regardless of its many promises. I call on the Minister to ensure that his Department will include this project in the 2004 capital programme. In a vital area such as blood quality, the Minister should have learnt that no stone can be left unturned to ensure the highest possible standards in the most modern of buildings. The people of Cork and Munster expect no further delays on this vital project.
The Irish Blood Transfusion Service is inspected twice yearly by the Irish Medicines Board, which is the regulatory authority for the service. The Irish Medicines Board identified a number of deficiencies following an inspection of the service's Cork centre between 3 and 5 December 2003. A presentation on the board's findings was made by the IMB's acting chief executive officer at the IBTS board meeting of 10 December 2003. The presentation was viewed with the utmost seriousness by the board. The matters raised by the IMB were addressed and appropriate action initiated. The position in this regard is being monitored closely by the board.
As the Deputy said, one of the deficiencies highlighted by the IMB related to the operation of the irradiator at the Cork centre. An irradiator is a machine which exposes blood products to a source of ionising radiation as a safeguard against possible post-transfusion problems. During inspection, it was noted that the irradiator required recalibration. This process has been completed and a risk assessment report on the irradiator machine in the Cork centre is due to be finalised shortly. Another deficiency identified by the IMB related to the pressure on existing quality assurance resources at the centre. The centre has vacancies for a senior technical officer and a quality assurance officer, but it has experienced difficulties in attracting applicants of a suitable calibre for senior posts. The technical post is being filled on an acting basis while the quality assurance post has been vacant for a number of months. Further efforts are being made to fill the posts in question, including the use of a recruitment agency and the extension of the advertising campaign to include the UK.
As the Deputy noted, the IMB expressed concern about the potential for inadvertent reissuing of recalled product. The IMB inspectors noted that problems might arise between the procedures for blood returned for re-routing between hospitals and procedures for dealing with blood returned for other reasons. They sought greater clarity with regard to the different procedures.
The re-routing programme allowed for the transfer of unused units of blood from one hospital to another, to make the best use of resources. Re-routing occurred if units of blood were issued for a specific patient to a specific hospital, but not used for that patient and were not immediately required by that hospital for another patient. The units were returned by the hospital to the Cork centre in such cases. The centre verified that the units had been suitably stored while they were in the hospital. When this verification had taken place, the units of blood were re-routed to Cork University Hospital, which has a higher usage of blood than other hospitals in the city. The re-routing programme has been discontinued pending a full review, as a response to the concerns expressed by the IMB. The standard operating procedures governing the re-routing programme and the product recall system are being reviewed with the assistance of external good manufacturing practice consultants.
Another deficiency highlighted by the IMB inspectors, as the Deputy has correctly identified, related to the building at St. Finbarr's Hospital which is used by the Cork centre. The inspectors indicated that the building was unsuitable for long-term use and was not compliant with good manufacturing practice standards. The IBTS and the Department are aware of the difficulties with the building and are working together to develop a suitable alternative. The development brief for the new Cork centre project was submitted to the Department by the Irish Blood Transfusion Service in March 2003. The capital cost of the project, inclusive of special testing facilities, is estimated at €28 million. Departmental officials are in discussions with the Department of Finance to agree a capital programme for 2004 and subsequent years. The Cork centre is one of my major priorities for approval as part of this programme. The issue of identifying a proper site delayed matters for some time.
While planning for the new centre is in progress, the board of the IBTS approved an interim development for the Cork centre in November 2003 to comply with IMB quality assurance standard recommendations. This interim solution for the ongoing delivery of services will be required for the next three to five years. The development, on the St. Finbarr's Hospital site, will cost an estimated €2 million, to be met from the IBTS's resources. The Southern Health Board has given its approval for the development of the interim facilities on the St. Finbarr's Hospital campus. The IBTS hopes to be in a position to apply for planning permission in the next few weeks.
Interviews for the position of architect to head up the design team for the interim refurbishment of the Cork centre have just been concluded. Shortlisting for the remainder of the design team is complete and interviews are being arranged. It is intended that the design of the facility, the seeking of planning permission and the procurement of interim construction works will be fast-tracked to ensure the earliest possible completion date. I am being kept fully briefed about the development of the Cork centre. I discussed capital facilities at the Cork centre with the chair of the board and the acting chief executive officer at a meeting on 10 November last. At this meeting, I confirmed my commitment to the provision of a new centre in Cork at the earliest possible date. I am committed to ensuring that the IBTS continues to have enough resources to maintain the highest possible standards in blood transfusion practice at all locations throughout the service.