James Reilly (Dublin North, Fine Gael)
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Question 256: To ask the Minister for Health and Children the blood banks here which have not met the ISO standards which the Irish Medicines Board has set as a requirement to operate in the future; the blood banks which have met the ISO standards; the implications if the blood banks do not meet the standards set by the Irish Medicines Board by 8 November 2008; and if she will make a statement on the matter. [31900/08]

Mary Harney (Dublin Mid West, Progressive Democrats)
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Under the European Communities (Quality and Safety of Blood and Blood Components) Regulations, 2005 (S.I. No. 360 of 2005) hospital blood banks are required to comply with certain good practice requirements and to obtain accreditation to ISO 15189 by the 8th November 2008. The Irish Medicines Board (IMB) is responsible for monitoring compliance with the legislation. The Irish Medicines Board has informed me that all hospital blood banks have engaged in the ISO 15189 accreditation process. At this time a number of blood banks have been accredited or have successfully completed the evaluation process. For others, the accreditation process is ongoing. Obtaining accreditation to the ISO 15189 standard is one aspect of the requirements for compliance with the Regulations.

In parallel with the accreditation process, the IMB monitors blood bank activities on a regular basis. Based on a review of annual reports received from all hospital blood banks for 2006 and 2007, the IMB has carried out inspections at a number of blood banks during 2007 and 2008 and, where necessary, has sought the implementation of corrective actions. The IMB has confirmed that considerable progress towards full compliance has been observed during the majority of inspections that have been carried out in 2008 and it continues to follow up closely with those that have outstanding issues. The IMB has informed me that compliance of all blood banks with the Regulations is being kept under regular review and, if necessary appropriate action will be taken.