Application for Blood Establishment Authorisation
Blood Establishments must apply to the HPRA for a Blood Establishment Authorisation.
In doing so, the applicant is required to complete the Application for a Blood Establishment Authorisation, and submit to the HPRA for approval. The process of approval of a Blood Establishment Authorisation involves the review of supporting documentation and inspections.
Variation to Blood Establishment Authorisation
Regulation 6 (9) of S.I. 360 of 2005 states that “A blood establishment shall not make any substantial change in the prescribed activities which it undertakes without the prior written approval of the HPRA.”
Should a blood establishment authorisation holder need to change any detail contained in their authorisation, they must submit an application to the HPRA to vary the authorisation.
All applications must be submitted prior to the change being implemented by the authorisation holder.
Variations to the blood establishment authorisation can be classified as administrative – requiring a limited amount of assessment by an inspector or technical – requiring significant assessment by an inspector with possible scheduling of a site inspection.
Hospital Blood Banks and ISO 15189 Accreditation
A Steering Committee was established to assist the Department of Health and Children (DoH&C) to implement Directive 2002/98/EC. The Steering Committee agreed that ISO 15189 would be the Quality System required for hospital blood banks and this was specified in S.I. No. 360 of 2005. The Irish National Accreditation Board (INAB) is responsible for accrediting medical testing laboratories to the international standard IOS 15189.
For further information and for application details please go to the Irish National Accreditation Body website (INAB).
As ISO 15189 does not fully meet the requirements of the Blood Directives in the areas of Traceability and Haemovigilance, an Expert Group on Blood and Blood Components was established. The aim of this group was to specify the minimum requirements that need to be in place to ensure that hospital blood banks comply with the requirements of Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events).
The ‘Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC’ – AML-BB was compiled by this Group. This document is intended to assist INAB Assessors during the assessment of hospital blood banks to ISO 15189 Accreditation. It may also be used by HPRA inspectors during the inspections of hospital blood banks in the circumstances described in Regulation 16 of S.I. No. 360 of 2005. It is also hoped that these standards will provide guidance to all personnel, involved in relevant activities, in ensuring that the necessary requirements are in place.
Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC’ AML-BB: Issue 2
The guide to fees and application form can be found at the following links:
Guide to Fees for Human Products
Fee Application Form Human Products
The appropriate codes are 310, 311, 312, 313, 314, 315, 316, 371 & 372.