11.4.5 shall clearly specify the scope of use of electronic signatures, forms, and electronic signatures to produce data generation method, receiving and recognizing the way to ensure the reliability of electronic signatures. Strictly control the changes to the data message after issuance.
11.5 A confidentiality system shall be established and implemented, and the confidentiality of the blood donor's personal data, blood donation information, blood test results, and the corresponding information on the use of blood shall be maintained to prevent unauthorized access and external leakage.
12. Monitoring and Continuous Improvement
12.1 The monitoring and continuous improvement procedures of the quality system shall be established and implemented to ensure the effective operation and continuous improvement of the quality system.
12.2 Establish and implement procedures to control the blood collection and supply process and blood quality to ensure that the blood collection and supply and related service process and blood quality meet the expected requirements.
12.3 Establish and implement a validation program to systematically review new or changed processes, procedures, equipment, software, reagents, or other critical materials to ensure that they meet the requirements for intended use prior to official use. Validation shall be conducted on a predetermined schedule. Confirmation report should be formed after the completion of the confirmation. Confirmation report should include confirmation of the plan, confirmation of the data and confirmation of the conclusions.
12.4 The establishment and implementation of nonconforming product control procedures to ensure the timely detection, identification, isolation, evaluation and disposal of non-compliant blood and materials, etc., to prevent the unintended use of nonconforming products.
12.5 Establish and implement procedures for identification, reporting, investigation and disposal of nonconformities to ensure timely detection and identification of nonconformities, analyze the causes of deviations, take measures to eliminate the causes of nonconformities, and prevent recurrence of similar nonconformities.
12.6 Establish and implement internal quality audit program. Internal quality audit should cover all processes and departments of blood collection and related services. Internal quality audits should be planned in advance, specifying the guidelines, scope, frequency and method of audit. Internal quality audit includes the audit of the quality system and the audit of the implementation of the quality system.
12.7 The internal quality auditor shall be trained and have the corresponding qualification and auditing ability of the internal auditor, and have no direct responsibility relationship with the audited party. The internal quality auditor shall be appointed by the legal representative.
12.8 The internal quality audit should be completed to form an audit report, including audit and evaluation, non-conformity and its corrective and preventive measures.
12.9 The implementation of corrective and preventive measures and their effects should be tracked, verified and recorded.
12.10 After the completion of the internal audit of the quality system, the organization of management review to ensure that the quality management system continues to run the suitability, effectiveness and adequacy. The results of the management review and its corresponding measures must be recorded, the legal representative of the content involved in the summary, to explore opportunities for continuous improvement, the direction of the future quality work and improvement goals. The person responsible for quality prepares a management review report, which is approved by the legal representative and distributed to the relevant departments to ensure that the measures are implemented within the specified timeframe. Management review at least once a year, according to the actual need to increase the number of management review arrangements.
13. Blood Donation Services
13.1 To establish, implement, monitor and improve the quality system of blood donation services, to ensure the provision of safe and high quality blood donation services to donors, to collect blood from low-risk groups and to ensure the quality of blood.
13.2 Establish and implement management procedures for blood donation sites to ensure the safety of blood donation and the quality of blood. Blood donation sites should have adequate facilities with reasonable layout to meet the health and safety requirements of blood donation work and blood donors as well as employees. The privacy and relevant information of blood donors should be kept confidential in the pre-donation counseling and physical examination. There should be facilities and medicines to deal with adverse reactions to blood donation. Each blood collection station should have separate facilities and meticulous procedures for blood collection, sampling, recording, labeling, and eliminating potential factors that could lead to errors in donor recording or labeling.
13.3 Establishment and implementation of blood donor recruitment guidelines, with voluntary unpaid low-risk groups as the recruitment target, to ensure the effectiveness of donor education, mobilization and recruitment, and to encourage voluntary regular unpaid blood donation.
13.4 Health counseling and assessment of blood donors are conducted by trained healthcare personnel in accordance with the Requirements for Health Screening of Blood Donors to ensure that the health of the donors and the safety and efficacy of blood are not compromised. The donor and the examiner*** shall sign together after the completion of the health counseling and health examination. The examiner shall make a judgment as to whether the donor is able to donate blood.
13.5 Establish and implement procedures for the acceptance and confidential abandonment of blood donors after donation. To establish and implement procedures for reporting the donation of blood by donors with risky behaviors that are susceptible to blood-borne diseases, as well as a system for shielding and eliminating blood donations.
13.6 Establish and implement blood collection management procedures to ensure donor safety and blood quality.
13.7 Blood donor information should be verified before blood collection to ensure that blood is collected from donors who comply with the Requirements for Health Examination of Blood Donors.
13.8 Check the appearance of blood bag and blood preservation solution before blood collection to ensure that the blood bag is not damaged, moldy and within the validity period; the appearance of blood preservation solution meets the requirements.
13.9 A unique bar code should be used to label blood donation records, blood bags (including original and transfer bags), and specimen tubes. The labeling 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 and are labeled without error.
13.10 Develop procedures for venipuncture and blood collection. Strictly adopt aseptic operation techniques for venipuncture. Blood and anticoagulant must be mixed well during blood collection. The volume of blood collected should be controlled by weighing methods and should be in accordance with the prescribed range of "Quality Requirements for Whole Blood and Component Blood".
13.11 At the end of blood collection, re-verify the identity of the donor, blood bag, blood specimen and relevant records to ensure accuracy.
13.12 Establish and implement blood specimen retention procedures to ensure that the specimens should be derived from the corresponding blood.
13.13 Establish and implement blood donor service norms, formulate procedures for the reception and care of blood donors, fulfill the obligation of notification before blood donation, and follow the principle of informed consent for blood donation. Provide full nursing care and emotional communication to blood donors before, during and after blood donation.
13.14 Procedures for the prevention and treatment of adverse reactions to blood donation should be established and implemented, including prevention, observation, treatment, recording, reporting, evaluation and follow-up of adverse reactions to blood donation, so as to correctly handle and minimize adverse reactions to blood donation.
13.15 To establish and continuously improve the tracking and return visit service system for blood donors, and to implement the procedures of blood donor satisfaction survey, blood donor complaint and feedback handling procedures to ensure the continuous improvement of blood donation services.
13.16 Records of blood donation should at least include the personal data of blood donors, results of health enquiries and signatures of donors and enquirers, results of health checkups and signatures of examiners, date of blood donation, amount of blood donated, reaction to blood donation and its handling and signatures of employees.
13.17 Blood component donors shall fulfill the Requirements for Health Screening of Blood Donors and the specific requirements thereof.
13.18 Blood component mono-collection must be performed by trained medical professionals and technicians, and should be supervised by trained healthcare professionals. Blood cell separators should be maintained and monitored to ensure safety and effectiveness. Disposable blood component separation tubing that meets the State Food and Drug Administration's approval for registration must be used. Procedures should be followed to safely dispose of and destroy all used disposable tubing to prevent illegal reuse.
13.19 The results of the health examination of blood component donors and the key indicators of the process of blood component mono-collection should be recorded, including the time of collection, the species, the volume of blood in extracorporeal circulation, the amount of anticoagulant used, the amount of exchange solution, the quality of the blood components, as well as the state of the donor, etc. The blood component mono-collection process should be performed in a timely manner.
14. Blood Testing
14.1 For blood stations conducting blood testing business, the blood testing laboratory must obtain a certificate of compliance with the audit of the "Code of Practice for the Quality Management of Laboratories in Blood Stations".
14.2 Blood stations that do not carry out blood testing business, should establish and implement blood specimen collection, transportation and handover procedures to ensure that the blood specimens are correctly collected, transported and handed over, and save the blood specimens transported throughout the temperature monitoring and handover records; should be established and implemented to receive and utilize the test report procedures, to ensure that the correct receipt and utilization of test reports.
14.3 The blood station quality control laboratory should comply with the relevant requirements of the "Blood Station Laboratory Quality Management Code".
15. Blood Preparation
15.1 Establish and implement the quality system of blood preparation to ensure that blood is safe and effective.
15.2 Blood preparation must comply with the Quality Requirements for Whole Blood and Component Blood.
15.3 Procedures for blood preparation, labeling, packaging, and warehousing should be established and implemented.
15.4 The environment of blood preparation should be neat and hygienic, regularly and effectively disinfected, and environmental temperature control should be carried out to ensure the safety and effectiveness of blood.
15.5 Blood preparation should be carried out in closed system as far as possible. If preparation can only be done in an open system, it should be strictly controlled to avoid microbial contamination.
15.6 Critical equipment for blood preparation should be maintained and calibrated as required to ensure reliable and stable operation.
15.7 Procedures and methods of blood preparation must be audited and confirmed.
15.8 The quality of disposable plastic blood bags used in the process of blood preparation and the qualification of their manufacturers should be in line with the requirements of the relevant regulations; the disposable plastic blood bags shall be put into use only after the quality control department confirms the qualification.
15.9 Throughout the preparation process, all blood and its packaging should be properly labeled. When using coupled bags, the consistency of the blood donation barcode on each bag should be checked before separating the original bag from the transfer bag. When operations such as filtering, pooling, dispensing or freezing of blood require the use of non-integral blood bags, it must be ensured that the correct donor bar code is affixed to each bag. When labeling eligible blood, the information in the label should be double-checked.
15.10 Establish and implement procedures for routine blood sampling, and conduct statistical analysis and investigation of deviations in sampling results, and take corrective and preventive action.
15.11 Each bag of blood should be subjected to strict visual inspection at every stage of its preparation. Labeling, isolation, and further processing must be implemented for blood bags with signs of leakage, damage, and defects, suspected bacterial contamination, or other abnormalities.
15.12 Blood preparation records should ensure the traceability of information related to personnel, equipment, blood sources and raw materials, methodological steps, environmental conditions and other relevant information of the blood preparation process, including at least: the handover of blood, the process of component preparation, the routine sampling of components and the analysis of quality results, the use of instrumentation, maintenance and calibration, the environmental control of component preparation, and the disposal of medical waste. The record should be signed by the operator.
16. Blood segregation and release
16.1 Establish and implement blood segregation procedures, physical segregation and management of blood to be tested (including possible quality problems but not yet finalized) and unqualified blood, to prevent misdistribution of unqualified blood.
16.2 Establish and implement procedures for the release of qualified blood and comply with the following principles:
16.2.1 Clearly define the responsibilities for the release of blood, and the releasing personnel should be trained and qualified in the examination and authorized to undertake the release, and the quality management personnel should monitor the release of blood.
16.2.2 Inventory of all unqualified blood in each batch of blood, accurate and safe transfer and disposal before the release of qualified blood.
16.2.3 Identify all prepared Qualified Blood in each batch, label it as Qualified Blood, and approve its release before it is transferred from the Isolation Bank to the Qualified Blood Repository for clinical distribution.
16.2.4 Document the release of each lot of blood. Ensure that all blood components are identified and inventoried for verification; all unqualified blood is inventoried and verified and has been safely transferred and disposed of. All qualified blood meets national standards. The person releasing the blood should sign the name, date and time of release.
17. Blood Preservation, Release and Transportation
17.1 Establish and implement the management procedures for blood preservation and meet the following requirements:
17.1.1 The place where blood is preserved shall be with measures of fire prevention, anti-theft and rodent prevention, and shall not be accessed by unauthorized personnel.
17.1.2 The equipment for preserving blood shall operate reliably, have balanced temperature, and have temperature recording device and alarm device.
17.1.3 The preservation status shall be monitored, including continuous monitoring and recording of temperature and other preservation conditions, to ensure that blood is always preserved in the correct conditions.
17.1.4 Blood of different varieties and blood types are kept separate and clearly labeled according to storage requirements.
17.2 Establish and implement procedures for blood distribution. The principle of first-in-first-out should be followed. The appearance of blood should be checked before issuance, and blood with abnormal appearance shall not be issued. Records of blood distribution should be established and maintained.
17.3 Establish and implement procedures for the management of blood transportation to ensure that blood is transported in a complete cold chain, so that the blood remains within the required temperature range throughout the process from collection to distribution to the hospital. The storage temperature of blood throughout transportation should be monitored. Records of blood transportation should be established and maintained.
17.4 Blood with different storage conditions and destinations should be packed in separate boxes with packing lists. The blood transportation box should be labeled with the type of blood and the destination of transportation.
18. Blood Inventory Management
18.1 Establish and implement blood inventory management procedures to ensure adequate blood supply and maximize control of blood expiration and obsolescence. Minimum stock levels of different types of blood should be determined according to clinical needs, and blood in the process of preparation should be included in inventory management. Blood inventory should be regularly inventoried.
18.2 Practical blood emergency plan should be formulated to ensure the blood supply for emergencies.
19. Blood retrieval
19.1 Blood retrieval procedures should be established and implemented to determine the blood to be retrieved, the person responsible for retrieval and his/her duties, and to ensure that there is a dedicated person to receive and deal with the complaints about the quality of blood and the discovery of deficiencies at any time, and to be able to quickly retrieve the issued blood or trace the destination of the blood, and to notify the relevant units to take appropriate measures in a timely manner. The unit to take appropriate measures in a timely manner.
19.2 When blood with serious quality defects is withdrawn, a full investigation should be conducted. Records of blood retrieval should include the retrieval, tracking, analysis, evaluation and disposition of the defective blood, as well as the corrective and preventive actions taken.
20. Complaints and Adverse Transfusion Reaction Reporting
20.1 Procedures for handling blood quality complaints should be established and implemented, with personnel from the QC Laboratory and the QA Department designated as responsible. Complaints about blood quality and reports of adverse reactions to blood transfusion related to the blood station shall be investigated and handled and recorded in detail. When receiving complaints of major problems in blood quality, report them to the local health administration in a timely manner.