Quality system standards and specifications
1. INTRODUCTION AND GENERAL PRINCIPLES
1. Personnel in blood establishments shall be available in sufficient numbers...
2. All personnel in blood establishments shall have up to date...
3. All personnel in blood establishments shall receive initial and continued...
4. The contents of training programmes shall be periodically assessed and...
5. There shall be written safety and hygiene instructions in place...
1. All equipment shall be validated, calibrated and maintained to suit...
2. Equipment shall be selected to minimise any hazard to donors,...
3. Only reagents and materials from approved suppliers that meet the...
4. Inventory records shall be retained for a period acceptable to...
5. When computerised systems are used, software, hardware and back-up procedures...
6. BLOOD COLLECTION, TESTING AND PROCESSING
6.2. Collection of blood and blood components
1. The blood collection procedure shall be designed to ensure that...
2. The sterile blood bag systems used for the collection of...
3. Blood collection procedures shall minimise the risk of microbial contamination....
4. Laboratory samples shall be taken at the time of donation...
5. The procedure used for the labelling of records, blood bags...
6. After blood collection, the blood bags shall be handled in...
1. All laboratory testing procedures shall be validated before use.
2. Each donation shall be tested in conformity with the requirements...
3. There shall be clearly defined procedures to resolve discrepant results...
4. There shall be data confirming the suitability of any laboratory...
5. The quality of the laboratory testing shall be regularly assessed...
6. Blood group serology testing shall include procedures for testing specific...
1. The quality system of the blood establishment shall ensure that,...
2. Procedures for storage and distribution shall be validated to ensure...
3. Autologous blood and blood components as well as blood components...
4. Appropriate records of inventory and distribution shall be kept.
5. Packaging shall maintain the integrity and storage temperature of blood...
6. Return of blood and blood components into inventory for subsequent...