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.
Monitoring and continuous improvement.
12. 1 Establish and implement the monitoring and continuous improvement procedures of the quality system to ensure the effective operation and continuous improvement of the quality system.
12.2 establish and implement blood collection and supply flow and blood quality control procedures to ensure that blood collection and supply and related service flow and blood quality meet the expected requirements.
12.3 Establish and implement verification procedures, and systematically inspect new or changed processes, procedures, equipment, software, reagents or other key materials before formal use to ensure that they meet the expected use requirements. Confirmation shall be carried out as scheduled. After confirmation, a confirmation report shall be formed. Confirmation report shall include confirmation plan, confirmation data and confirmation conclusion.
12.4 establish and implement nonconforming product control procedures to ensure that unqualified blood and materials can be found, identified, isolated, evaluated and disposed of in time, and prevent unintended use of nonconforming products.
12.5 establish and implement procedures for identifying, reporting, investigating and handling nonconformities, ensure that nonconformities can be found and identified in time, analyze the causes of deviations, and take measures to eliminate the causes of nonconformities to prevent similar nonconformities from happening again.
12.6 Establish and implement internal quality audit procedures. Internal quality audit should cover all processes and departments of blood collection and supply and related services. Internal quality audit should be planned in advance, and the audit criteria, scope, frequency and methods should be specified. Internal quality audit includes quality system audit and quality system implementation audit.
12.7 the internal quality auditor must be trained, have the corresponding qualifications and auditing ability of the internal auditor, and have no direct responsibility with the auditee. The internal quality auditor shall be appointed by the legal representative.
12.8 after the internal quality audit is completed, an audit report shall be formed, including the audit situation and evaluation, nonconformities and their corrective and preventive measures.
12.9 the implementation of corrective and preventive measures and their effects shall be tracked, verified and recorded.
12. 10 after the internal audit of the quality system is completed, organize management review to ensure the suitability, effectiveness and sufficiency of the continuous operation of the quality management system. The results of management review and corresponding measures should be recorded, and the legal representative should summarize the contents involved, discuss the opportunities for continuous improvement, and point out the direction and improvement objectives of quality work in the future. The person in charge of quality shall prepare the management review report, which shall be approved by the legal representative and distributed to relevant departments to ensure the implementation of relevant measures within the specified time limit. Management review shall be conducted at least once a year, and the number may be increased according to actual needs.
13. Blood donation service
13. 1 Establish, implement, monitor and improve the blood donation service quality system to ensure safe and high-quality blood donation services for blood donors, collect blood from low-risk groups and ensure blood quality.
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.
14. Blood test
14. 1 A blood testing laboratory of a blood station that conducts blood testing business must obtain the audit certificate of "Standards for Quality Management of Blood Station Laboratories".
14.2 blood stations that do not carry out blood testing business shall establish and implement procedures for blood sample collection, transportation and handover to ensure the correct collection, transportation and handover of blood samples, and keep records of temperature monitoring and handover during the whole process of blood sample transportation; Procedures for receiving and using inspection reports shall be established and implemented to ensure the correct receipt and use of inspection reports.
14.3 the blood station quality control laboratory shall comply with the relevant requirements of the quality management standard for blood station laboratories.
15. Blood samples
15. 1 Establish and implement the quality system of blood preparation to ensure the safety and effectiveness of blood.
The blood prepared by 15.2 must meet the quality requirements of whole blood and blood components.
15.3 procedures for blood preparation, labeling, packaging and storage shall be established and implemented.
15.4 the blood preparation environment should be clean and hygienic, disinfected regularly and effectively, and the ambient temperature should be controlled to ensure the safety and effectiveness of blood.
15.5 blood preparation should be carried out in a closed system as far as possible. If it can only be prepared in an open system, it should be strictly controlled to avoid microbial pollution.
15.6 key equipment for blood preparation shall be maintained and calibrated according to regulations to ensure reliable and stable operation.
15.7 The procedures and methods of blood preparation must be verified.
15.8 the quality of disposable plastic blood bags used for blood preparation and the qualification of their manufacturers shall meet the requirements of relevant laws and regulations; Disposable plastic blood bags can only be put into use after being confirmed by the quality control department.
15.9 During the whole preparation process, all blood and its packaging should be labeled correctly. When using the combined bag, before separating the original bag from the transfer bag, the consistency of the blood donation barcode on each blood bag should be checked. When it is necessary to use non-integrated blood bags for blood filtration, collection, sub-packaging or freezing, it is necessary to ensure that the correct blood donation barcode is affixed to each blood bag. When labeling qualified blood, check the information on the label again.
15. 10 Establish and implement routine blood sampling procedures, conduct statistical analysis and deviation investigation on sampling results, and take corrective and preventive measures.
15. 1 1 Every bag of blood must undergo strict visual inspection at every step of preparation. For blood bags with signs of leakage, breakage and defects, blood suspected of bacterial contamination or other abnormal conditions must be identified, isolated and further processed.
15. 12 blood preparation records shall ensure the traceability of relevant information such as personnel, equipment, blood sources and raw materials, methods and steps, and environmental conditions during blood preparation, including at least: blood handover, component preparation process, routine sampling inspection and quality result analysis of components, instrument use, maintenance and calibration, environmental control of component preparation, and treatment of medical wastes. Records shall be signed by the operator.
16. blood separation and release
16. 1 Establish and implement blood isolation procedures, physically isolate and manage blood to be tested (including blood with possible quality problems but not yet finalized) and unqualified blood to prevent unqualified blood from being wrongly distributed.
16.2 establish and implement qualified blood release procedures, following the following principles:
16.2. 1 clearly defines the responsibilities of blood release, and the release personnel should be trained, qualified and authorized to undertake the release work, and the quality management personnel should monitor the blood release.
16.2.2 check all unqualified blood in each batch of blood, and release qualified blood after accurate and safe transfer.
16.2.3 All prepared qualified blood in each batch of blood shall be identified and labeled with qualified blood. Only after the release is approved can it be transferred from the isolation warehouse to a qualified blood bank for clinical distribution.
16.2.4 Record the release of each batch of blood. Ensure that all blood components are identified and verified; All unqualified blood has been counted and verified, and it has been safely transferred for disposal. All qualified blood meets the national standards. The releaser shall sign the name, date and time of release.
17. blood preservation, distribution and transportation
17. 1 Establish and implement blood preservation management procedures and meet the following requirements:
17. 1. 1 Blood storage places should have fire prevention, anti-theft and rat prevention measures, and unauthorized personnel are not allowed to enter.
17.10.2 blood preservation equipment should be reliable, with temperature balance, temperature recording device and alarm device.
17.10.3 Monitor the preservation status, including continuous monitoring and recording the preservation conditions such as temperature, to ensure that the blood is always preserved under the correct conditions.
17.10.4 according to the storage requirements, blood of different varieties and blood types should be stored separately and clearly marked.
17.2 establish and implement blood distribution procedures. We should follow the principle of first in first out. The appearance should be checked before blood distribution, and blood with abnormal appearance should not be distributed. Blood distribution records should be established and kept.
17.3 establish and implement the management procedure of blood transportation to ensure that blood is transported in a complete cold chain, so that blood is always within the required temperature range from collection to distribution to hospital. The storage temperature of blood during the whole transportation process should be monitored. Blood transport records should be established and kept.
17.4 blood in different storage conditions and sent to different destinations should be packaged separately with packing list attached. Blood transport box should be marked, indicating blood type and transport destination.
18. Blood inventory management
18. 1 establish and implement blood inventory management procedures, which can not only ensure adequate blood supply, but also control expired and discarded blood to the maximum extent. The minimum inventory level of different kinds of blood should be determined according to clinical needs, and the blood in the preparation process should be included in inventory management. Blood stocks should be counted regularly.
18.2 a feasible blood emergency plan should be made to ensure the blood supply in an emergency.
19. Blood recovery
19. 1 We should establish and implement a blood recovery procedure, determine the blood to be recovered, the person in charge of recovery and their responsibilities, ensure that there is a special person to answer and deal with blood quality complaints and defects at any time, quickly recover the distributed blood or track the whereabouts of the blood, and promptly notify the relevant units to take corresponding measures.
19.2 when collecting blood with serious quality defects, a comprehensive investigation should be conducted. Blood recovery records should include the recovery, tracking, analysis, review and disposal of defective blood, as well as the corrective and preventive measures taken.
20. Complaints and reports of adverse reactions to blood transfusion
20. 1 A blood quality complaint handling procedure shall be established and implemented, and the personnel of quality control laboratory and quality control department shall be designated to be responsible. Investigate and deal with blood quality complaints and reports of adverse reactions of blood transfusion related to blood stations, and make detailed records. When receiving complaints about major blood quality problems, report to the local health administrative department in time.