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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC article annex_I CELEX: 02002L0098-20090807 INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)
Part A: General information:
— identification of the blood establishment
— name, qualification and contact details of responsible persons
— a list of hospital blood banks which it supplies.
Part B: A description of the quality system, to include:
— documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships
— documentation such as site master file or quality manual describing the quality system in accordance with Article 11(1)
— number and qualifications of personnel
— hygiene provisions
— premises and equipment
— list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood and blood components and for the reporting and recording of serious adverse reactions and events. |