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Record of quality management standard of blood station
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1 1.2 The recording system must be complete, including the whole process from blood donor screening and registration to blood collection, testing, preparation, storage, distribution and transportation, so as to ensure its traceability.

1 1.3 The preservation period of records and files shall comply with the relevant provisions of the state, and the original records of blood donation, testing and blood supply shall be kept for at least ten years. Records should be kept safely to prevent tampering, loss, aging, damage, unauthorized contact and illegal copying. Records should be classified and managed, and a retrieval system should be established.

1 1.4 Implement relevant national laws and regulations, establish and implement management procedures for electronic signatures and data messages, and ensure the reliability, integrity, effectiveness and confidentiality of data messages and electronic signatures in the process of generation, maintenance, preservation, transmission and use. This procedure should include:

1 1.4. 1 Education and training should be given to personnel involved in the generation or use of data messages and electronic signatures.

1 1.4.2 The data message should be able to effectively express the content and be available for retrieval at any time. It can reliably ensure that the contents of data messages remain intact and unchanged from the time they are finally formed.

1 1.4.3 has the ability to correctly and completely back up data messages;

1 1.4.4 Call the reference at any time within the data message storage period;

1 1.4.5 shall clearly specify the scope and form of electronic signature, as well as the methods for generating, receiving and identifying the production data of electronic signature, so as to ensure the reliability of electronic signature. Strictly control the changes of data information after publication.

1 1.5 A confidentiality system shall be established and implemented to keep the personal data, blood donation information, blood test results and corresponding blood use information of blood donors confidential to prevent unauthorized contact and external disclosure.