13.2 establish and implement management procedures for blood donation sites to ensure blood donation safety and blood quality. Blood donation sites should have adequate facilities and reasonable layout, which can meet the requirements of blood donation and the health and safety of blood donors and employees. Consultation and physical examination before blood donation should keep the privacy and relevant information of blood donors confidential. There should be facilities and drugs to deal with the adverse reactions of blood donation. Each blood collection and supply station should have independent operating facilities and detailed procedures for blood collection, sample retention, recording and marking, so as to eliminate potential factors leading to mistakes in recording or marking blood donors.
13.3 establish and implement the criteria for recruiting blood donors, target low-risk people who are willing to donate blood for free, ensure the effectiveness of education, mobilization and recruitment of blood donors, and encourage voluntary and regular blood donation.
13.4 trained medical personnel should consult and evaluate the health status of blood donors according to the requirements of blood donors' health examination to ensure that the health of blood donors and the safety and effectiveness of blood are not affected. After the health consultation and health examination are completed, the blood donors and examiners should jointly sign. Inspectors should judge whether blood donors can donate blood.
13.5 establish and implement procedures for reporting and accepting blood after blood donation and giving up blood in confidence. Establish and implement the reporting procedures, blood donation screening and elimination system for blood donors susceptible to blood-borne diseases.
13.6 establish and implement blood collection management procedures to ensure the safety of blood donors and blood quality.
13.7 check the information of blood donors before blood collection to ensure that the collected blood comes from blood donors who meet the requirements of blood donors' health examination.
13.8 check the appearance of blood bag and blood preservation solution before blood collection to ensure that the blood bag is free from damage and mildew, and it is within the validity period; The appearance of blood preservation solution meets the requirements.
13.9 unique bar codes should be used to identify blood donation records, blood bags (including original bags and transfer bags) and specimen tubes. The identification process should be strictly controlled to ensure that the blood bags, specimen tubes and blood donation records of the same donor correspond to each other one by one, and the identification is correct.
13. 10 to formulate the workflow of venous puncture blood collection. Strictly adopt aseptic technique for venipuncture. In the process of blood collection, blood and anticoagulant must be fully and evenly mixed. The amount of blood collected should be controlled by weighing method, which should conform to the scope specified in Quality Requirements for Whole Blood and Blood Components.
13. 1 1 At the end of blood collection, check the identity, blood bags, blood samples and related records of the blood donors again to ensure accuracy.
13. 12 Establish and implement blood sample collection procedures to ensure that samples should come from corresponding blood.
13. 13 establish and implement the service standard for blood donors, formulate the procedures for receiving and nursing blood donors, fulfill the obligation of informing before blood donation, and follow the principle of informed consent for blood donation. Give full care and emotional communication to blood donors before, during and after blood donation.
13. 14 should establish and implement the procedures for the prevention and treatment of adverse blood donation reactions, including the prevention, observation, treatment, recording, reporting, evaluation and follow-up, so as to correctly handle and reduce the adverse blood donation reactions.
13. 15 establish and constantly improve the follow-up and return visit service system for blood donors, implement procedures such as blood donor satisfaction survey, blood donor complaints and feedback processing, and ensure the continuous improvement of blood donation service.
13. 16 blood donation records shall at least include personal data of blood donors, health consultation results and signatures of blood donors and consultants, health examination results and inspectors' signatures, blood donation date, blood donation amount, blood donation response and treatment, and employee's signatures.
13. 17 blood components blood donors should meet the requirements of blood donors' health examination and related specific requirements.
13. 18 blood component sampling must be carried out by trained medical professionals and monitored by trained medical personnel. Blood cell separators should be maintained and monitored to ensure safety and effectiveness. Disposable blood component separation pipelines approved and registered by the US Food and Drug Administration must be used. All used disposable component separation pipelines should be safely discarded and destroyed according to procedures, and illegal reuse should be put an end to.
13. 19 should record the health examination results of blood component donors and the key indicators in the process of blood component collection, including collection time, variety, extracorporeal circulation blood volume, anticoagulant dosage, exchange fluid dosage, blood component quality, donor status, etc.