S.I. No. 552/2006 - European Communities (Quality System for Blood Establishments) Regulations 2006

1. Self-inspection or audit systems shall be in place for all parts of the operations to verify compliance with the standards set out in this Schedule. They shall be carried out regularly by trained and competent persons in an independent way according to approved procedures.

2. All results shall be documented and appropriate corrective and preventive actions shall be taken in a timely and effective manner.

1

OJ L 183, 29.6.1989, p.1.

2

OJ L262, 17.10.2000, p.21.

1

OJ L 169, 12.7.1993, p.1 Directive as last amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p.1).

2

OJ L 331, 7.12.1998, p.1 Directive as amended by Regulations (EC) No.1882/2003.

1

OJ L262, 14.10.2003, p.22.

3. All errors and accidents shall be documented and investigated in order to identify system problems for correction.

4. Appropriate records of inventory and distribution shall be kept.

5. Packaging shall maintain the integrity and storage temperature of blood or blood components during distribution and transportation.

6. Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all quality requirements and procedures laid down by the blood establishment to ensure blood component integrity are fulfilled.

7. STORAGE AND DISTRIBUTION

8. CONTRACT MANAGEMENT

Tasks that are performed externally shall be defined in a specific written contract.

9. NON-CONFORMANCE

9.1.

Deviations

Blood components deviating from required standards set out in Regulation 9 (3) (c of

SI No 360 of 2005

shall be released for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and the blood establishment physician.

9.2.

Complaints

All complaints and other information, including serious adverse reactions and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent recurrence. Procedures shall be in place to ensure that the Irish Medicines Board is notified as appropriate of serious adverse reactions or serious adverse events in accordance with regulatory requirements.

9.3.

Recall

10. SELF-INSPECTION, AUDITS AND IMPROVEMENTS

European Communities (Quality System for Blood Establishments) Regulations 2006

S.I. No. 552 of 2006

.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by

section 3

of the

European Communities Act 1972

(No.27 of 1972) and for the purpose of giving effect to Directive 2005/62/EC of the European Commission implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments, hereby make the following Regulations