Circular No. 26/2013/TT-BYT guiding blood transfusion activities

CIRCULAR

Guidelines for Blood Transfusion Activities

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Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medical Examination and Treatment and the Head of the Legal Department;

The Minister of Health issues this Circular guiding blood transfusion activities.

Chapter I GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular guides professional and technical blood transfusion activities, including: selection of blood donors, blood collection, testing, processing, storage, transportation, management, and use of blood and blood products in treatment; risk monitoring in blood transfusion; Blood Transfusion Councils at medical examination and treatment facilities; record keeping and reporting procedures.

2. This Circular does not regulate promotional and mobilization activities for blood donation; products derived from plasma, monoclonal antibodies, recombinant proteins; tissue, organ transplantation, and stem cell transplantation.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. A blood donor is a person who meets the blood donation conditions set forth in this Circular and voluntarily donates whole blood or certain blood components.

2. Blood component refers to one or more types of blood cells and/or plasma obtained directly from a blood donor through apheresis and anticoagulated.

3. Whole blood is blood collected from a vein of a blood donor containing various types of blood cells, plasma, and anticoagulated.

4. Apheresis of blood components is a technique for collecting one or more blood components directly from a blood donor.

5. Blood product is a product prepared at a blood bank, consisting of one or more types of blood cells, plasma originating from whole blood or blood components.

6. Blood bag (blood unit) is a volume of blood or blood product packaged in a separate bag.

7. Testing protocol is the sequence of performing tests with a specific combination of reagents chosen for each testing purpose.

8. Closed system processing is the use of techniques to produce blood products where the blood unit is contained within a set of interconnected bags without cutting or connecting, or cutting and connecting the bags using an automatic sterile device.

9. Pooling is the mixing of blood products of the same type from multiple blood units to prepare test samples or ensure sufficient dosage for treatment.

Article 3. Principles for Implementing Blood Transfusion Activities

1. For humanitarian purposes, not for profit.

2. Ensuring voluntariness for blood donors; not forcing others to donate blood or blood components.

3. Using blood and blood products only for medical treatment, training, and scientific research.

4. Keeping confidential information related to blood donors, recipients, and blood products.

5. Ensuring safety for blood donors, patients receiving blood transfusions or blood products, and relevant healthcare personnel.

6. Conducting reasonable blood transfusions for patients.

Chapter II SELECTION OF BLOOD DONORS AND BLOOD COLLECTION

Section 1 BLOOD DONATION CONDITIONS

Article 4. Blood Donor Standards

A blood donor is a person meeting the age, health, and other conditions as follows:

1. Age: from 18 years old to 60 years old.

2. Health:

a) A woman weighing at least 42 kg and a man weighing at least 45 kg may donate whole blood; a person weighing between 42 kg and under 45 kg may donate up to 250 ml of whole blood per session; a person weighing 45 kg or more may donate whole blood not exceeding 9 ml/kg body weight and not more than 500 ml per session.

b) A person weighing at least 50 kg may donate blood components through apheresis; a blood donor may donate one or more blood components in each apheresis session, but the total volume of donated blood components shall not exceed 500 ml; a person weighing at least 60 kg may donate a total volume of blood components not exceeding 650 ml per session.

c) Not suffering from chronic or acute diseases affecting the nervous system, mental health, respiratory system, circulatory system, urinary system, digestive system, liver and bile ducts, endocrine system, blood and hematopoietic tissue, systemic diseases, autoimmune diseases, severe allergies; not pregnant at the time of registering to donate blood (for women); no history of organ donation or transplantation; not addicted to drugs or alcohol; not having severe or extremely severe disabilities as defined in the Law on Persons with Disabilities; not using certain medications listed in Appendix 1 attached to this Circular; not suffering from blood-borne infectious diseases or sexually transmitted diseases at the time of registering to donate blood.

d) Clinically: - Alert, good interaction; - Systolic blood pressure between 100 mmHg and below 160 mmHg, diastolic blood pressure between 60 mmHg and below 100 mmHg; - Regular heart rate, frequency between 60 to 90 beats per minute; - Free from any of the following symptoms: emaciation, rapid weight loss (more than 10% of body weight in six months); pale skin, mucous membranes; dizziness, vertigo; night sweats; enlarged lymph nodes appearing in multiple locations; fever; edema; cough, shortness of breath; diarrhea; various types of bleeding; abnormal skin lesions or signs.

đ) Testing: - For whole blood donors and those donating blood components through apheresis: hemoglobin concentration must be at least 120 g/l; if donating more than 350 ml of whole blood, it must be at least 125 g/l. - For plasma donors through apheresis: total serum protein concentration must be at least 60 g/l and tested within one month; - For platelet, granulocyte, and stem cell donors through apheresis: platelet count must be greater than or equal to 150 x 10^9/l.

3. In addition to the criteria specified in Clause 1 and Clause 2 of this Article, eligibility for blood donation is determined by the physician responsible for selecting blood donors.

Article 5. Postponement of Blood Donation

1. Persons who must postpone blood donation for twelve months from the date:

a) Full recovery following surgical interventions;

b) Recovery from one of the following diseases: malaria, syphilis, tuberculosis, tetanus, encephalitis, meningitis;

c) Completion of a series of rabies vaccine injections after being bitten by an animal, or receiving blood transfusions, blood products, and biologics derived from blood;

d) Giving birth or terminating pregnancy.

2. Persons who must postpone blood donation for six months from the date:

a) Tattooing on the skin;

b) Piercing ears, nose, navel, or other body parts;

c) Exposure to blood and bodily fluids from individuals at risk or infected with blood-borne infectious diseases;

d) Recovery from one of the following diseases: typhoid fever, sepsis, snake bite, arterial thrombosis, venous thrombosis, spinal cord inflammation, pancreatitis.

3. Persons who must postpone blood donation for four weeks from the date:

a) Recovery from one of the following diseases: gastroenteritis, urinary tract infection, infected skin, bronchitis, pneumonia, measles, whooping cough, mumps, dengue fever, dysentery, rubella, cholera, mumps;

b) Completion of a series of vaccinations against rubella, measles, typhoid fever, cholera, mumps, chickenpox, BCG.

4. Persons who must postpone blood donation for seven days from the date:

a) Recovery from one of the following diseases: influenza, common cold, allergic rhinitis, pharyngitis, migraine headache;

b) Receiving vaccinations, except those specified in Point c Clause 1 and Point b Clause 3 of this Article.

5. Certain provisions related to occupations and special activities of blood donors: persons engaged in certain jobs and special activities listed below may donate blood only on their day off or may resume these jobs and activities at least twelve hours after donating blood:

a) Working at heights or underwater: pilots, crane operators, high-rise workers, climbers, miners, sailors, divers;

b) Operating public transportation vehicles: bus drivers, train drivers, ship captains;

c) Other cases: professional athletes, people engaging in heavy physical labor, intense training.

6. For cases not covered by Clauses 1, 2, 3, 4, and 5 of this Article, the postponement of blood donation shall be considered and decided by the physician screening the blood donor.

Article 6. Minimum Interval Between Blood Donations and Blood Components

1. The minimum interval between two consecutive whole blood donations or red cell apheresis donations is twelve weeks.

2. The minimum interval between two consecutive plasma or platelet apheresis donations is two weeks.

3. Neutrophil granulocyte donation or peripheral blood stem cell donation by apheresis should not exceed three times within seven days.

4. In cases where whole blood donation alternates with different blood component donations from the same donor, the minimum interval between donations is determined based on the type of blood component donated in the most recent donation.

Section 2 SCREENING AND SELECTION OF BLOOD DONORS AND BLOOD COLLECTION

Article 7. Registration and Management of Blood Donation Information and Blood Components

1. Blood donors and blood components must present one of the following identification documents: national identity card, passport, military service card, police service card, driver's license, work permit, student card, blood donation card, or personal identification certificate issued by government agencies, organizations, social groups, or local authorities.

2. Individuals registering to donate blood or blood components must complete the health status questionnaire for blood donors as prescribed in Appendix 2 attached to this Circular.

3. Blood collection facilities must organize the management of donor information according to the record-keeping model prescribed in Appendix 3 attached to this Circular. Personal information about blood donors must be kept confidential and used solely for ensuring the health of the donor and preventing disease transmission to recipients.

Article 8. Content of the blood donor selection examination

1. Conducting medical history inquiries, health examinations, and performing tests as prescribed in Article 4 of this Circular.

2. Performing rapid HBsAg testing before blood donation for first-time blood donors.

3. Not mandating rapid HBsAg testing during the selection process for repeat blood donors who have had a non-reactive screening test result for HBsAg in their most recent blood donation unit or a negative HBsAg test result in their most recent health check-up within twelve months prior to the date of registration for blood donation.

4. In cases where individuals with a suspected positive HBsAg history wish to donate blood, they must have two consecutive negative HBsAg test results using ELISA or chemiluminescence techniques, six months apart, and simultaneously perform testing using molecular biology techniques.

Article 9. Whole Blood and Component Collection

1. Before collecting blood or components, the type, expiration date, integrity, and anticoagulant composition of the blood collection bag (blood container) must be checked and verified.

2. The blood collection bag must be labeled with a number as prescribed in Clause 3, Article 21 of this Circular.

3. Blood collection must ensure sterility and safety for the blood donor.

4. The volume of blood collected must comply with the provisions of Point a and Point b, Clause 2, Article 4 of this Circular and must be consistent with the available anticoagulant volume in the blood collection bag.

5. Ensuring traceability of information related to blood units and components: code number, actual blood volume, time point, duration, name of the blood collector, component type.

6. In cases where the collected blood volume is less than or more than 10% of the specified volume for each type of blood collection bag or if there are other abnormalities during the blood collection process, the blood collector must record a warning on the blood bag with permanent ink or attach a special label for separate review and handling.

Article 10. Requirements for Blood Sample Collection for Testing

1. Blood samples for testing must be taken from the blood donor at the same time as blood or component collection or directly from the blood bag or component bag.

2. Blood samples must be labeled with a corresponding number to the blood bag or component bag as prescribed in Clause 2, Article 9 of this Circular.

Article 11. Immediate Handling of Blood Units and Components After Collection

Blood units and components must be packaged and transported under appropriate temperature conditions suitable for intended use as prescribed in Article 20 of this Circular.

Section 3 ENSURING THE RIGHTS AND INTERESTS OF BLOOD DONORS

Article 12. Rights and Interests of Blood Donors

1. Providing information about signs and symptoms of diseases caused by hepatitis viruses, HIV, and other blood-borne infections.

2. Explaining the blood collection procedure, potential adverse events that may occur, and pre- and post-donation tests.

3. Ensuring confidentiality regarding clinical examination results and test results; providing counseling on health irregularities discovered during health checks and blood donations; guiding on health care; providing counseling on abnormal test results according to Clause 4, Article 17 of this Circular.

4. Receiving care and treatment when adverse events occur during and after blood donation as prescribed in Appendix 4 attached to this Circular. Receiving support for care and treatment costs when adverse events occur during and after blood donation. Funding for supporting care and treatment of blood donors according to this provision shall be implemented in accordance with the law.

5. Being considered and decided by competent authorities to honor, reward, and ensure other spiritual and material benefits for blood donors as prescribed by law.

Chapter III TESTING OF WHOLE BLOOD AND BLOOD COMPONENTS

Article 13. Principles of Testing

1. Blood units and blood components must undergo screening tests. The results of previous tests or from prior donations cannot be referenced for new blood units or components, except as provided in Clause 3, Article 15 of this Circular.

2. Select and use reagents, biological products, equipment, and testing devices that ensure the quality of blood unit screening tests in accordance with the law. Implement quality control of biological products and test quality checks.

3. Conduct testing procedures, methods, and analysis of results that are appropriate to existing biological products, equipment, and tools and have been approved by the leadership of the testing entity.

4. When conducting screening tests for infectious agents transmitted through blood for blood units and components, the following requirements must be met:

a) The blood sample for testing must be from the same source as the blood unit or component, as stipulated in Article 10 of this Circular;

b) It should be possible to trace the blood bag from the sample and vice versa;

c) Testing must be conducted using methods that ensure sensitivity, prevent false negative results, and have been approved by leadership;

d) The results of screening tests for infectious agents transmitted through blood for blood units and components can only be used to control safety for the blood units and components to prevent transmission of infectious agents and cannot be used to answer or advise donors.

5. When multiple blood draws are made from a donor, compare the test results with those of the most recent donation. If there are discrepancies or doubts about sample or record mix-ups, retest directly from the blood unit or component.

6. When conducting confirmatory tests on infectious agents transmitted through blood for donors, the following requirements must be met:

a) Accurately verify the identity of the person whose blood is being tested;

b) Conduct testing using methods that ensure specificity, prevent false positive results, and have been approved by the competent authority;

c) Confirmatory test results can only be used to provide answers and health advice to donors and cannot be used to control safety for blood units and components.

Article 14. Types of Blood Unit Screening Tests

1. Compulsory tests that must be performed on all whole blood and blood components include:

a) Serological blood group testing: determine ABO red cell groups, Rh(D), screen for abnormal antibodies;

b) Testing for certain disease-causing agents: screen for HIV, hepatitis B virus, hepatitis C virus, and syphilis.

2. In addition to the tests specified in Clause 1 of this Article, additional tests must be performed in the following cases:

a) Determine Rh(C, c, E, e) or other systems such as MNSs, Kidd, Duffy, P, Lewis blood groups when a physician prescribes compatible antigen selection for blood transfusion;

b) Screen for malaria in whole blood and blood components from donors living or working in areas with malaria transmission according to the Ministry of Health's announcement or those returning from malaria-endemic areas within six months or those with a history of malaria within twelve months since recovery;

c) Screen for CMV (Cytomegalovirus) in blood products for patients undergoing tissue or stem cell transplantation or for fetal blood transfusions or other special cases as required by the treating physician.

3. Supplementary tests: in some cases to ensure patient safety, blood transfusion facilities with adequate technical conditions may perform supplementary tests as directed by the treating physician.

4. Technical requirements for compulsory tests:

a) ABO blood grouping: must be performed using two serological tube and red cell tube techniques with a minimum technique equivalent to or higher than tube testing. Blood type can only be concluded when the results of both methods match or confirmed by additional tests;

b) Rh(D) blood grouping: must be performed using serological tube technique with a minimum technique equivalent to tube testing. Only conclude that the blood unit has Rh(D) negative after confirming with a test equivalent to or higher than indirect antiglobulin test;

c) Abnormal antibody screening must be performed using a technique capable of detecting abnormal antibodies, at least in Rh, MNSs, Kell, Kidd, Duffy, Lutheran systems according to the schedule set out in Article 70 of this Circular;

d) HIV screening: must be performed using a technique with sensitivity and specificity equivalent to or higher than ELISA or chemiluminescence with reagents capable of simultaneously detecting HIV-1 and HIV-2 antigens and antibodies;

đ) Hepatitis B virus screening: must be performed using a technique with sensitivity and specificity equivalent to or higher than ELISA or chemiluminescence to detect HBsAg;

e) Hepatitis C virus screening: must be performed using a technique with sensitivity and specificity equivalent to or higher than ELISA or chemiluminescence with reagents capable of detecting hepatitis C antibodies;

g) HIV-1 and HIV-2, hepatitis B virus, hepatitis C virus screening using NAT technology is applied to all blood units and components according to the schedule set out in Article 70 of this Circular;

h) Syphilis screening: must be performed using a technique with sensitivity and specificity equivalent to or higher than RPR;

i) Malaria screening: must be performed using a technique with sensitivity equivalent to or higher than thick smear, thin smear microscopy reading with optical microscope.

k) CMV testing: must conduct IgM antibody detection and CMV antibody testing using techniques with sensitivity equivalent to or higher than ELISA or chemiluminescence techniques.

5. The order of performing HIV screening tests, hepatitis B virus, hepatitis C virus, and syphilis tests shall be approved by the unit's leadership. The conclusion that blood units and blood components are safe from these agents must be based on test results conducted using ELISA and NAT techniques or chemiluminescence and NAT techniques.

6. Quality assurance measures for blood unit and blood component testing must be applied according to the provisions set out in Appendix 5 and Appendix 6 issued together with this Circular.

Article 15. Screening Tests for Bloodborne Pathogens in Special Cases

1. HIV-1 and HIV-2, hepatitis B virus, and hepatitis C virus screening tests for blood units before transfusion using rapid testing methods may only be performed when the following conditions are met:

a) Only applicable to healthcare facilities in mountainous areas, remote regions, border areas, and islands;

b) Only applicable to whole blood units; not applicable to blood component units;

c) The treating physician orders the blood transfusion and records it in the patient’s medical file;

d) Contact has been made with the nearest blood bank but there is no compatible blood unit available or the time required to obtain blood from the nearest blood bank does not meet emergency requirements;

đ) The patient or their legally authorized representative signs the medical record confirming their agreement to receive a blood unit screened only by rapid testing method after being informed by healthcare staff about the possible risk of infection;

e) Confirmation by the head of the department, outpatient clinic, or person authorized regarding the lack of suitable stored blood units at the healthcare facility or insufficient supply relative to treatment needs, and recording in the medical file the permission to perform rapid testing at the time of emergency blood transfusion.

2. In cases where the provisions of Clause 1 of this Article concerning rapid testing of blood units are applied, healthcare facilities must act as follows:

a) Within 24 hours from the time of performing the rapid screening blood transfusion, the healthcare facility must continue to fully implement all tests prescribed in Article 14 of this Circular and retain samples according to the provisions of Article 16 of this Circular;

b) If it is not possible to perform the tests as prescribed in Article 14 and Point a of Clause 2 of this Article, the healthcare facility must send serum or plasma samples of the transfused blood unit to another facility capable of conducting the tests as prescribed in Article 14 of this Circular within the latest period of 07 days from the time of performing the rapid screening blood transfusion; must retain serum samples of the transfused blood unit at the facility conducting the screening tests according to the provisions of Article 16 of this Circular.

3. Healthcare facilities in mountainous areas, remote regions, border areas, and islands that cannot perform tests as prescribed in Article 14 of this Circular and also cannot send samples to other facilities for testing as prescribed in Clause 2 of this Article may use blood units screened by rapid testing methods when the following conditions are met:

a) The blood donor has undergone screening tests according to the provisions of Article 14 of this Circular within a period not exceeding 12 months from the date of donation, with negative test result reports stored at the blood collection facility;

b) The donated blood unit must undergo rapid screening tests for HIV, hepatitis B virus, and hepatitis C virus, with all test results being negative.

Article 16. Retention of Test Samples

1. Blood serum or plasma samples used for screening tests on all whole blood units and blood components must be retained. The blood bag segment shall be retained in accordance with Appendix 6 of this Circular.

2. Test samples must be stored at a temperature of minus 18°C (-18°C) or lower, coded, and documented.

3. Test samples must be retained at the testing facility for a minimum of two years from the date of blood collection. For blood units and blood products with a usage period exceeding two years from the date of collection, the retention period of test samples must be extended by at least one year from the expiration date of those blood units and products. The department (team, group, division, room) responsible for retaining serum and plasma samples must be independent from the testing department.

Article 17. Management of Test Results

1. After obtaining test results, the testing department must notify the results in writing or electronically via a method approved by the unit's leadership to relevant departments.

2. If screening tests on blood units for blood-borne pathogens yield abnormal results, they must be handled according to the provisions set out in Appendix 6 of this Circular.

3. In cases where blood units or blood components collected from repeat donors show abnormal results for blood-borne pathogens, the blood unit screening testing department must retest blood samples from the same donor's previous donation; if the retest of the previous donation shows abnormalities, further retesting of the immediately preceding donation sample must be conducted simultaneously, while the testing department has the responsibility to inform related departments and units to follow the provisions set out in Appendix 7 of this Circular. Testing of previous donation blood samples must use techniques and reagents with sensitivity at least equal to or equivalent to those used previously.

4. Abnormal results may only be reported to the donor after confirmatory testing as stipulated in Appendix 6 of this Circular. In the case of HIV confirmatory testing, it must comply with current Ministry of Health regulations regarding the reporting of positive HIV test results.

Chapter IV REGULATION, STORAGE, AND TRANSPORTATION OF BLOOD AND BLOOD PRODUCTS

Section 1 GENERAL REQUIREMENTS

Article 18. General Principles

1. Only blood bags and blood component separation bags (blood packaging) that ensure quality and have clear origins may be used.

2. Blood component separation must be performed in a closed system, or in an open system, sterile procedures must be strictly followed.

3. Freezing and thawing of plasma and cryoprecipitate products

a) Plasma units must be frozen within a maximum of eight hours from the start of freezing at a temperature of minus 25°C (-25°C) or lower;

b) Frozen storage: must be maintained at a temperature of minus 18°C (-18°C) or lower;

c) Thawing and warming of blood bags and products must meet the following conditions: - Do not allow direct contact between the surface of the blood bag and the thawing solution; - Thawing must occur at a temperature between 30°C and 37°C, not exceeding 15 minutes for cryoprecipitate products and 45 minutes for frozen plasma; - Once thawed, blood units and products cannot be refrozen.

4. Gamma irradiation of blood bags and products

a) Blood bags and products must undergo gamma irradiation to inactivate lymphocytes to prevent graft-versus-host disease before transfusion to immunocompromised patients, with each irradiation dose reaching at least 25 Gy (2,500 cGy);

b) The shelf life of irradiated red blood cell units is 28 days and must comply with the shelf life of non-irradiated red blood cell units of the same type and time. The shelf life of irradiated platelet units does not change;

c) Labels distinguishing irradiated blood bags from non-irradiated ones must be affixed.

5. Isolation and destruction of blood units

a) Blood units, components, and all blood product units that have not been tested in accordance with Articles 14 and 15 of this Circular must be isolated and separately stored until they meet the required conditions. Handling methods for blood units and components with abnormal test results must comply with the provisions set out in Appendix 6 of this Circular.

b) All unsafe or expired blood units and products must be isolated, separately managed, and destroyed in accordance with current medical waste management regulations.

Article 19. Refrigeration equipment for storing blood units and blood products

1. General requirements for refrigeration equipment for storing blood units and blood products

a) The room where refrigeration equipment for storing blood is placed must be ensured to have stable voltage and good ventilation;

b) Refrigeration equipment must have sufficient space within the storage compartment to ensure air circulation, easy inspection, and observation;

c) Temperature must be uniform at all positions inside the storage compartment;

d) Refrigeration equipment must have a temperature monitoring system that meets the following requirements: - Capable of simultaneously monitoring temperature by two independent methods, continuously, and recording real-time parameters using an automatic temperature logging system or manual logging at least once every four hours; - The temperature monitoring system of the refrigeration equipment must operate in case of power failure; - Must have a system to alert abnormal temperatures with sound and light signals.

đ) Refrigeration equipment for storing blood units and blood products shall not be used to store test reagents, laboratory specimens, or food;

e) There must be separate storage spaces with labels distinguishing each type of blood and blood product, as follows: - Blood and blood products that have been tested safely and are ready for distribution; - Blood and blood products that have not yet been tested; - Blood and blood products that have been tested and have abnormal results.

2. Requirements for refrigerators storing blood units and blood products

a) The internal temperature of the storage compartment must always be between 2°C and 6°C;

b) Ensure uniform temperature within the storage compartment through forced ventilation with fans;

c) Allow observation of stored blood bags inside the storage compartment without opening the door.

3. Requirements for freezing racks storing blood units and blood products

a) The internal temperature of the storage compartment must always be at or below -18°C depending on the preservation requirements of the blood product and approved procedures;

b) Must be capable of periodically defrosting the cooling coil automatically or require periodic manual defrosting of ice buildup on the cooling coil.

4. Requirements for agitators and platelet storage refrigerators

a) The internal temperature of the storage compartment must always be between 20°C and 24°C;

b) Ensure uniform temperature within the refrigerator through forced ventilation with fans;

c) Allow observation of stored platelet bags inside the storage compartment without opening the door;

d) Agitator must oscillate horizontally;

đ) Must have a system to alarm when the agitator stops operating or experiences abnormalities.

Article 20. Transporting blood and blood products

1. Transport equipment must maintain appropriate temperatures suitable for the preservation requirements of each type of blood and blood product;

2. Transportation of blood units must ensure safety, temperature control, and monitoring during transport according to the following requirements:

a) For whole blood and packed red cells: ensure maintenance of temperature within the transport compartment between 1°C and 10°C throughout the entire transportation process; whole blood used for preparing platelets must be stored and transported in accordance with Point b Clause 2 Article 22 of this Circular;

b) For platelet concentrates and granulocyte concentrates: ensure maintenance of temperature within the transport compartment between 20°C and 24°C;

c) For plasma and frozen blood products: ensure maintenance of temperature within the transport compartment at or below -18°C;

d) Cold packs used for preservation must not come into direct contact with blood bags.

Article 21. Labeling of Blood Units and Blood Products

In addition to complying with current regulations on product labeling, the label of blood units and blood products must include the following information:

1. Name and address of the blood preparation and product manufacturing facility.

2. Type name of blood product.

3. Blood unit and blood product code: a unique code that allows tracing all information about the blood donor, blood collection process, screening, preparation, storage, transportation, distribution, and use of the blood unit and blood product.

4. ABO blood group and Rh(D) system; information on other blood groups (if applicable).

5. Date, month, year of blood collection.

6. Name of anticoagulant solution or preservation solution (for whole blood or packed red cells).

7. Expiration date.

8. Volume or weight of the blood product unit.

9. Storage temperature.

10. Note on all labels of blood bags and blood products: "Must be transfused through a filter set; shall not be transfused if there is evidence of hemolysis or abnormal color." For irradiated blood and blood products, it must also state: "Irradiated."

Section 2 STANDARDS FOR SOME BLOOD PRODUCTS

Article 22. Whole Blood

1. Standards: collected from donors selected according to the provisions of Article 4 of this Circular and who do not fall under the cases requiring deferral of donation as stipulated in Article 5 of this Circular. These whole blood units must have results safe for the tests prescribed in Articles 14 and 15 of this Circular.

2. Storage conditions and shelf life:

a) When stored at temperatures between 2°C and 6°C, the shelf life of whole blood does not exceed 21 days with Citrate-Phosphate-Dextrose anticoagulant solution and does not exceed 35 days with Citrate-Phosphate-Dextrose-Adenine solution;

b) When stored at temperatures between 20°C and 24°C, the shelf life of whole blood does not exceed 24 hours.

3. Quality control (to be conducted with random samples taken at a ratio of 0.1% to 1% of the total number of whole blood units and not less than five units each month) for the following standards:

a) Volume difference not exceeding 10% of the volume indicated on the label (excluding the volume of anticoagulant solution);

b) Checking the implementation of the tests prescribed in Articles 14 and 15 of this Circular;

c) Minimum hemoglobin concentration of 10g per 100ml of whole blood.

Article 23. Packed Red Cells

1. Packed red cells (red cell concentrate) is the remaining portion of whole blood after plasma separation by centrifugation or sedimentation without further processing.

2. Standards and quality control Conduct quality control (with random samples taken at a ratio of 0.1% to 1% of the total number of units prepared and not less than five units each month) for the following standards:

a) Unit volume of packed red cells equal to 60% ± 15% of the initial whole blood volume;

b) Minimum hemoglobin quantity of 10g from each 100ml of prepared whole blood;

c) Hematocrit from 0.65 to 0.75.

3. Storage conditions and shelf life: as specified in Point a Clause 2 Article 22 of this Circular for whole blood.

Article 24. Packed Red Cells with Preservation Solution

1. It is packed red cells with added red cell preservation solution to improve red cell quality.

2. Standards and quality control Conduct quality control (with random samples taken at a ratio of 0.1% to 1% of the total number of units prepared and not less than five units each month) for the following standards:

a) Must use a preservation solution containing Adenine;

b) Unit volume of the product equals 70% ± 15% of the initial whole blood unit volume;

c) Minimum hemoglobin quantity of 10g from each 100ml of prepared whole blood;

d) Hematocrit from 0.50 to 0.70;

3. Storage conditions and shelf life:

a) For packed red cells with preservation solution prepared in a closed system: the shelf life follows the manufacturer's recommendations for blood collection bags and blood preservation solutions, but does not exceed 42 days from the date of blood collection and storage at temperatures between 2°C and 6°C;

b) For packed red cells with preservation solution prepared in an open system: can only be used within a period not exceeding 24 hours if stored at temperatures between 2°C and 6°C and not more than 6 hours if stored at room temperature (between 18°C and 24°C) from the time of preparation in an open system.

Article 25. Leukoreduced Red Blood Cells

1. Leukoreduced red blood cells are red blood cells from which more than 70% of white blood cells have been removed from whole blood units using centrifugation methods.

2. Quality Standards and Testing Conduct quality testing (with random samples taken at a ratio of 0.1% to 1% of the total number of prepared units, but not less than five units each month) for the following standards:

a) The volume of each leukoreduced red blood cell unit is 70% ± 15% of the initial whole blood volume;

b) The minimum hemoglobin content is 9.5g per 100ml of initial whole blood;

c) The hematocrit level ranges from 0.50 to 0.70;

d) The remaining white blood cell count is less than 1.2×10^9 per leukoreduced red blood cell unit. At least 75% of the tested units must meet this standard;

3. Storage Conditions and Shelf Life: Leukoreduced red blood cells are stored according to Clause 3, Article 24 of this Circular.

4. Leukoreduced Red Blood Cells with Preservative Solution: According to Clause 2, Article 25 of this Circular and Article 24 of this Circular.

Article 26. Washed Red Blood Cells

1. Washed red blood cells are red blood cells from which plasma has been removed through multiple washes (at least three times) with isotonic saline solution and diluted in isotonic saline solution, preservative solution, or compatible plasma.

2. Quality Standards and Testing Conduct quality testing (with random samples taken at a ratio of 10% of the total number of prepared units) for the following standards:

a) The volume of each preparation unit is 65% ± 15% of the initial whole blood volume;

b) The final supernatant protein concentration is less than 0.5g per washed red blood cell unit;

c) The minimum hemoglobin content is 9.0g per 100ml of initial whole blood;

d) Hematocrit from 0.50 to 0.70;

3. Storage Conditions and Shelf Life: Washed red blood cells in an open system, when stored at temperatures between 2°C and 6°C, have a shelf life of 24 hours; when stored at temperatures between 20°C and 24°C, they have a shelf life of 6 hours from the end of preparation. Washed red blood cells in a closed system, supplemented with red blood cell preservative solution, stored at temperatures between 2°C and 6°C, have a shelf life of 14 days.

Article 27. Filtered Red Blood Cells

1. Filtered red blood cells are red blood cells from which white blood cells have been removed using a white blood cell filter. White blood cell filtration must be completed within 72 hours from the time of blood collection from the donor.

2. Quality Standards and Testing Conduct quality testing (with random samples taken at a ratio of 5% of the total number of prepared units) for the following standards:

a) The volume of each filtered red blood cell unit is 65% ± 15% of the initial whole blood volume;

b) The minimum hemoglobin content is 9.0g per 100ml of initial whole blood;

c) The hematocrit level ranges from 0.50 to 0.70;

d) The remaining white blood cell count is less than 1.0×10^6 per filtered red blood cell unit. At least 90% of the tested units must meet this standard;

3. Storage Conditions and Shelf Life: According to Clause 3, Article 24 of this Circular.

Article 28. Frozen Red Blood Cells

1. Frozen red blood cells are red blood cells preserved in a freezing solution containing glycerol and stored at temperatures of -60°C or lower. Before being transfused to patients, frozen red blood cells must be thawed, washed, and the glycerol removed, then diluted in isotonic saline solution or supplemented with a red blood cell preservative solution.

2. Quality Standards and Testing Conduct quality testing (with random samples taken at a minimum of 10% of the total number of thawed and glycerol-removed frozen red blood cell units) for the following standards:

a) The volume of each filtered red blood cell unit is 65% ± 15% of the initial whole blood volume;

b) The minimum hemoglobin content is 8.0g per 100ml of initial whole blood;

c) The hematocrit level ranges from 0.50 to 0.75;

d) The maximum osmolality does not exceed 340 mOsm/L;

đ) Negative bacterial culture detection;

3. Storage conditions and shelf life:

a) The shelf life is 10 years when stored with a 40% glycerol solution at temperatures between -80°C and -60°C;

b) The shelf life is 10 years when stored with a 20% glycerol solution in liquid nitrogen at temperatures between -150°C and -120°C;

c) The shelf life is 14 days from the date of thawing, washing, and removing glycerol in a closed system with added red blood cell preservative solution;

d) The shelf life does not exceed 24 hours if stored at temperatures between 2°C and 6°C, and does not exceed 6 hours if stored at room temperature from the time of thawing and washing, and removing glycerol in an open system.

Article 29. Platelet Concentrates Prepared from Whole Blood Units

1. A platelet concentrate contains a large majority of platelets prepared from whole blood units stored at a temperature between 20°C to 24°C for up to 24 hours from the time of blood collection.

2. Quality standards and testing for platelet concentrates prepared from one whole blood unit. Quality testing shall be conducted (with random samples taken at a ratio of 1% to 5% of the total number of units prepared, and not less than 10 units each month) on the following standards:

a) Unit volume: the volume ranging from 40 ml to 60 ml prepared from each whole blood unit with a volume of 250 ml or more;

b) Platelet count: there must be a minimum of 13×10^9 platelets in each unit of platelet concentrate prepared from every 100 ml of whole blood. At least 75% of the units tested must meet this standard;

c) Leukocyte count in each unit of platelet concentrate: - Less than 0.05×10^9 leukocytes for platelet concentrates prepared using the leukocyte-platelet separation method. At least 75% of the units tested must meet this standard; - Less than 0.2×10^9 leukocytes for platelet concentrates prepared using the rich platelet plasma method. At least 75% of the units tested must meet this standard;

d) pH level must be between 6.4 and 7.4 when measured at 22°C at the end of storage period;

đ) Bacterial culture test must yield negative results.

3. Quality standards and testing for pooled platelet concentrates prepared from multiple whole blood units. Quality testing shall be conducted (with random samples taken at a ratio of 1% to 5% of the total number of units prepared, and not less than 10 units each month) on the following standards:

a) Unit volume: the volume ranging from 120 ml to 200 ml prepared from 1,000 ml of whole blood;

b) Platelet count: there must be a minimum of 140×10^9 platelets in a unit of platelet concentrate prepared from 1,000 ml of whole blood. At least 75% of the units tested must meet this standard;

c) Leukocyte count: less than 1.0×10^9 leukocytes in each unit of platelet concentrate;

d) pH level and bacterial culture test: in accordance with Clause 2, Points d and đ of this Article.

4. Storage conditions and expiration date

a) For platelet concentrates prepared from whole blood units in a closed system: the expiration date follows the manufacturer's recommendation for the blood collection bag, but not exceeding 05 days from the date of blood collection and storing platelets at a temperature between 20°C to 24°C with continuous agitation;

b) For platelet concentrates prepared from whole blood units in an open system: the expiration date does not exceed 06 hours from the end of preparation when stored at a temperature between 20°C to 24°C with continuous agitation.

Article 30. Platelet Concentrates Separated from Donors

1. Platelet concentrates separated directly from donors using automated cell separators.

2. Quality standards and testing Quality testing shall be conducted (with random samples taken at a ratio of 10% of the total number of units separated) on the following standards:

a) Each unit's volume must not deviate more than 15% from the volume indicated on the label;

b) Each unit of platelet concentrate (250 ml) must have a minimum of 300×10^9 platelets; in cases where the platelet concentrate has a volume of 120 ml to under 250 ml, it must have a minimum of 150×10^9 platelets;

c) The platelet concentration must be lower than 1.5×10^9/ml;

d) pH level must be between 6.4 and 7.4 and the bacterial culture test must be negative at the end of the storage period.

3. Storage conditions and expiration date: follow the manufacturer's recommendation for the platelet collection bag, but not exceeding 5 days from the date of platelet separation when stored at a temperature between 20°C to 24°C, with continuous agitation.

Article 31. Leukocyte-Filtered Platelet Concentrate

1. Leukocyte-filtered platelet concentrate is a platelet concentrate prepared from whole blood or by centrifugation and filtered to remove leukocytes.

2. Quality standards and testing: quality testing of leukocyte-filtered platelet units

a) The volume of each unit varies not more than 15% (±15%) of the volume indicated on the label;

b) Leukocyte-filtered platelet concentrate prepared from whole blood: contains at least 130×10^9 platelets per unit prepared from each 1,000 ml of whole blood;

c) Leukocyte-filtered platelet concentrate separated from apheresis donors: contains at least 300×10^9 platelets per apheresis collection;

d) Contains fewer than 1×10^6 leukocytes per unit of platelet concentrate;

đ) pH must be between 6.4 and 7.4 at the end of storage time;

e) Negative bacterial culture test: this standard should be tested in at least 1% to 5% of the prepared units. This standard does not need to be tested for leukocyte-filtered platelet concentrates immediately at the bedside.

3. Storage conditions and shelf life:

a) For platelet concentrates prepared in a closed system: the shelf life is according to the manufacturer's recommendation for the blood bag, but not exceeding 05 days from the date of blood collection and platelet storage at a temperature of 20°C to 24°C with continuous agitation;

b) For platelet concentrates prepared in an open system: the shelf life does not exceed 06 hours from the end of preparation when stored at a temperature of 20°C to 24°C with continuous agitation.

Article 32. Plasma and Frozen Plasma

1. Plasma is the liquid portion without blood cells, prepared from whole blood units or directly collected from plasma donors by centrifugation. Plasma can be used immediately after preparation or frozen (called frozen plasma) in accordance with Clause 3, Article 18 of this Circular.

2. Quality standards and testing: quality testing (with a random sample size of 0.1% to 1% of the total number of prepared units and not less than 05 units per month) of the following standards shall be carried out:

a) Protein concentration not less than 50 g/l;

b) Plasma volume variation not more than 10% of the volume indicated on the label.

3. Storage conditions and shelf life

a) Stored at a temperature of 2°C to 6°C: the shelf life of plasma is not more than 14 days from the date of preparation in a closed system and not more than 24 hours from the date of preparation in an open system;

b) Stored at a temperature of -18°C to -25°C: the shelf life of plasma is not more than 12 months from the date of blood collection or plasma separation;

c) Stored at a temperature of -25°C or lower: the shelf life of plasma is not more than 24 months from the date of blood collection or plasma separation.

d) Plasma that has been thawed may not be refrozen.

Article 33. Fresh Plasma and Fresh Frozen Plasma

1. Fresh plasma is plasma with the concentration of unstable coagulation factors maintained at physiological levels, prepared from whole blood or directly collected from blood donors by centrifugation.

2. Fresh frozen plasma is plasma specified in Clause 1 of this Article and frozen within a maximum period of 18 hours from the time of blood collection or plasma separation. Freezing of plasma must be carried out in accordance with Clause 3, Article 18 of this Circular.

3. Quality standards and testing for fresh plasma and fresh frozen plasma: quality testing (with a random sample size of 0.1% to 1% of the total number of prepared units and not less than 05 units per month) of the following standards shall be carried out:

a) Plasma volume variation not more than 15% of the volume indicated on the label;

b) Factor VIII concentration not less than 0.7 IU/ml. At least 75% of the samples tested must meet this standard;

c) Residual cell count: red blood cells less than 6.0×10^9/l, white blood cells less than 0.1×10^9/l, platelets less than 50×10^9/l;

d) Total protein concentration not less than 50 g/l;

đ) No abnormal color, no sediment, no clot.

3. Storage conditions and shelf life:

a) Stored at a temperature of -18°C to -25°C: the shelf life of plasma is not more than 12 months from the date of blood collection or plasma separation;

b) Stored at a temperature of -25°C or lower: the shelf life of plasma is not more than 24 months from the date of blood collection or plasma separation;

c) For thawed fresh plasma and fresh frozen plasma products: - Stored at a temperature of 2°C to 6°C: must be used within 06 hours from the start of thawing; if stored longer than 06 hours, the label must be changed appropriately (plasma); - Fresh frozen plasma that has been thawed may not be refrozen.

Article 34. Cryoprecipitate

1. Cryoprecipitate is a product separated from the precipitate formed during the thawing of fresh frozen plasma at temperatures of 10°C or lower. Cryoprecipitate may be further refined and inactivated for viruses through chemical means or temperature.

2. Quality standards and testing: quality testing shall be conducted on random samples (with a quantity ranging from 0.1% to 1% of the total number of units prepared, but not less than five units per month) for the following standards:

a) Volume from 10 ml to 25 ml for each cryoprecipitate unit prepared from a whole blood unit with a volume of 250 ml or more. Volume from 80 ml to 120 ml for each pool of cryoprecipitate from 2,000 ml of whole blood. The measured volume of cryoprecipitate may differ by no more than 15% from the volume indicated on the label.

b) Factor VIII concentration of no less than 30 IU for each cryoprecipitate unit prepared from a whole blood unit with a volume of 250 ml or more, with at least 75% of the tested samples meeting this standard;

c) Fibrinogen content of no less than 75 mg for each unvirally-inactivated cryoprecipitate unit prepared from a whole blood unit with a volume of 250 ml or more, with at least 75% of the tested samples meeting this standard;

d) No abnormal coloration, no sediment, no clots.

3. Storage conditions and shelf life:

a) Storage at temperatures of -18°C or lower: the shelf life of cryoprecipitate does not exceed 12 months;

b) Thawed cryoprecipitate: - When stored at temperatures between 2°C and 6°C, it must be used immediately or within six hours from the start of thawing; - It must not be refrozen after thawing.

Article 35. Neutrophil Granulocyte Concentrate

1. Neutrophil granulocyte concentrate is directly centrifuged from a blood donor or prepared from whole blood units preserved at temperatures between 20°C and 24°C for no longer than 24 hours from the time of blood collection.

2. Quality standards and testing: quality testing shall be conducted on random samples (with a quantity representing 10% of the total number of units prepared) for the following standards:

a) Unit volume: from 250 ml to 300 ml;

b) Contains 10×10^9 neutrophil granulocytes per unit, with at least 75% of the tested units meeting this standard.

3. Storage conditions and shelf life: stored at temperatures between 20°C and 24°C without shaking, within six hours from the time of preparation and within 24 hours from the time of blood collection.

Article 36. Blood Products for Fetal Transfusion

1. Fetal red cell transfusion product is a leukoreduced red cell mass as specified in Article 27 of this Circular and must also meet the following requirements:

a) Stored at temperatures between 2°C and 6°C for up to five days from the time of blood collection;

b) Hematocrit from 0.70 to 0.85;

c) May be irradiated as specified in Clause 4, Article 18 of this Circular.

2. Fetal platelet transfusion product is a leukoreduced platelet mass as specified in Article 31 of this Circular, additionally it may be irradiated as specified in Clause 4, Article 18 of this Circular upon clinical physician's prescription.

Article 37. Blood Used for Neonatal Exchange Transfusion

1. Whole blood used for neonatal exchange transfusion: must meet the conditions as specified in Article 22 of this Circular and be stored for up to five days from the time of blood collection. Whole blood used for neonatal transfusion may be leukoreduced and irradiated according to the clinical physician's prescription.

2. Restored whole blood used for neonatal exchange transfusion: is a red cell mass prepared according to one of Articles 23, 24, 25, 26, 27, and 28 of this Circular and supplemented with fresh plasma or fresh frozen plasma as specified in Article 33 of this Circular to restore its characteristics similar to whole blood, in addition to meeting the following requirements:

a) Red cell mass stored for up to five days from the date of blood collection or the date of thawing of frozen red cells;

b) Removal of preservative solution after centrifugation;

c) Supplemented with Group AB or compatible fresh frozen plasma with the group of the red cell mass unit and the neonate's blood group;

d) Product stored at temperatures between 2°C and 6°C and used within four hours from the time of restoration;

đ) All restored whole blood units tested for quality according to Clause 3, Article 22 of this Circular and hematocrit reaching from 0.40 to 0.50;

e) Restored whole blood used for neonatal exchange transfusion, leukoreduced and irradiated when necessary according to the clinical physician's prescription.

Chapter V MANAGEMENT, USE OF BLOOD AND BLOOD PRODUCTS AT TREATMENT FACILITIES

Article 38. Principles for Distribution, Use, and Recovery of Blood and Blood Products

1. Blood units and blood products may only be distributed to patients when: no risk factors for blood-borne disease transmission are detected; complete results of ABO blood group system and Rh(D) typing tests are available; blood units and blood products meet corresponding standards and have not exceeded their respective expiration dates; there are no unusual signs upon external inspection; compatibility between blood units, blood products, and the recipient is ensured.

2. Blood units and blood products shall be recovered and isolated in the following cases:

a) Cases stipulated in Clause 2 and Clause 3 of Article 17 of this Circular;

b) Cases stipulated in Clause 2 of Article 41 of this Circular.

c) Whole blood units and plasma, platelet, and granulocyte concentrates derived from whole blood or blood components that test positive or suspected positive for abnormal antibodies as specified in Point c of Clause 4 of Article 14 of this Circular.

3. Rational blood transfusion should be based on each patient's medical condition.

4. The blood distribution department of the healthcare facility shall conduct blood compatibility testing and directly distribute blood to clinical departments within the healthcare facility for blood transfusions and blood product administration to patients.

Article 39. Transfer and Acceptance of Blood and Blood Products

The transfer and acceptance of blood and blood products between blood supply facilities and healthcare facilities or among healthcare facilities shall only be carried out if the following conditions are met:

1. The healthcare facility has been authorized by the competent authority to provide blood to other healthcare facilities;

2. There is a valid blood supply contract between the blood supply facility and the receiving healthcare facility;

3. There is a forecast and supply form for blood and blood products as prescribed in Appendix 8 attached to this Circular;

4. In the absence of a blood supply contract: the forecast form must be confirmed by the representative leader or authorized person of the healthcare facility;

5. There are healthcare personnel to carry out the transfer and acceptance of blood;

6. There are appropriate means for storing and transporting blood and blood products;

7. The blood transfer records must be kept and controlled as prescribed in Article 61 of this Circular.

Article 40. Inventory, Verification, and Storage of Blood at the Blood Distribution Unit of Healthcare Facilities

1. Before being stored, blood and blood products must be verified and inspected:

a) External appearance and packaging as prescribed in Article 41 of this Circular;

b) Information on labels as prescribed in Article 21 of this Circular;

c) Storage and transportation conditions suitable for each type of blood and blood product as prescribed in Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 of this Circular.

d) The inspector must report any abnormalities discovered during verification to the blood distribution unit supervisor for review and decision on handling.

2. Separate storage of blood bags and blood products according to blood groups A, B, O, AB, and Rh(D) negative in different compartments of refrigeration equipment or in separate refrigeration units.

Article 41. External inspection of blood bags and blood products

1. The external inspection of blood bags and blood products must be conducted in the following cases:

a) Transfer between departments within a blood transfusion facility;

b) Transfer between blood supply facilities and blood distribution units of medical examination and treatment facilities, or between blood distribution units of different medical examination and treatment facilities, or transfer between blood supply facilities.

c) Transfer between blood distribution units and treatment units within the same medical examination and treatment facility.

2. Blood units and blood products shall not be used if any of the following signs are detected:

a) Punctures, leaks, cracks, or breaks in the bag, tubing, or at the point of connection;

b) Abnormal layering or lack of layering among blood components after settling or centrifugation;

c) Abnormal color: - Pink or red color above the plasma-red blood cell interface or throughout the entire plasma; - Abnormal color in the plasma; - Red blood cells turning purple, dark black, or other abnormal colors.

d) Presence of clots, sediment, or precipitates;

đ) Presence of foam on the surface.

Article 42. Requirements for Treatment Units Before Receiving Blood or Blood Products

1. Treating physicians need to assess the patient's condition and identify early the need for blood transfusion.

2. Treating physicians must prescribe tests for patients who are expected to require blood transfusions:

a) ABO and Rh(D) blood group typing;

b) Screening for abnormal antibodies for patients with: - History of blood transfusion; - Women with multiple pregnancies or miscarriages; - If during treatment, the patient requires multiple blood transfusions over several days, this test should be repeated every 7 days.

c) In cases where screening for abnormal antibodies yields a positive result, further testing to identify the specific abnormal antibodies should be prescribed;

d) For patients with identified abnormal antibodies, selecting compatible blood units that do not contain corresponding antigens should be prescribed;

đ) In cases where abnormal antibodies cannot be identified or suitable blood units cannot be found, the treating physician must collaborate with the blood distribution unit to consider and decide on appropriate treatment measures.

3. Blood transfusion should only be prescribed after considering the benefits and risks of transfusion for each patient when there are no alternative treatments available or when such alternatives are ineffective.

4. The treating physician or nurse must inform the patient or their family about the potential benefits and risks of blood transfusion. In urgent situations requiring immediate transfusion but where the patient is unconscious or has no family present, the physician must record this with the confirmation of a healthcare worker in the medical record. The patient or their family must confirm and sign the medical record if they refuse the blood transfusion or blood product.

5. Nurses must prepare a blood supply forecast form according to the model specified in Appendix 9 accompanying this Circular and collect venous blood samples from patients who have been prescribed blood transfusions, as follows:

a) When collecting blood samples, verify the transfusion prescription, the patient's name, age, patient code, department, and treatment bed number against the medical record;

b) Patient blood samples must be collected in two tubes, one containing 1 ml to 2 ml of anticoagulated blood and the other containing 4 ml to 5 ml of non-anticoagulated blood;

c) Record information on the tube labels: - Patient's full name or patient code; - Patient's year of birth; - Bed number, department.

d) Transfer the forecast form and blood samples to the blood distribution unit.

Article 43. Blood Compatibility Testing

Upon receiving the blood requisition form and patient's blood sample, the blood bank staff must perform the following tasks:

1. Verify and cross-check the information on the blood sample with the requisition form. If the information does not match, the blood sample shall not be used for blood typing and compatibility testing.

2. Determine the ABO blood group of the patient's blood sample and the blood unit:

a) Determine the ABO blood group using tube technique or other highly sensitive techniques;

b) Simultaneously determine the ABO blood group of the patient's blood sample, whole blood unit, and granulocyte mass using both serum and red cell methods. The serum method is used for red cell products, while the red cell method is used for plasma, cryoprecipitate, and platelet products;

c) The patient’s blood group determination must be performed twice on the same blood sample or two samples from the same patient. In case the results of the two ABO blood group determination methods within the same test or different tests do not match, additional tests must be conducted to confirm the blood group determination result;

d) Determine the ABO blood group of newborns and fetuses: Only use the serum method for blood group determination; do not use the red cell method. In cases where the blood group determination results are unclear, other supplementary tests may be used to confirm. If the blood group cannot be determined, blood compatibility selection should follow the provisions of Clause 1, Article 45 of this Circular;

3. Determine the Rh(D) blood group of the patient's blood sample:

a) When there is a requirement to transfuse whole blood units, red cell mass, platelet mass, and granulocyte mass;

b) Perform Rh(D) blood group determination using tube technique or other highly sensitive techniques.

4. Compare the results of previous screening and abnormal antibody identification tests according to Points b, c, d, and đ of Clause 2, Article 42 of this Circular.

5. Conduct blood compatibility testing: Perform compatibility testing in vitro or using more sensitive techniques in the following situations:

a) Transfusion of whole blood, red cell mass with significant plasma, granulocyte mass: - Compatibility testing in physiological saline solution at room temperature between 20°C and 24°C including: + Tube 1: Contains red cells of the blood unit, blood product mixed with recipient serum; + Tube 2: Contains plasma of the blood unit, blood product mixed with recipient red cells. - Compatibility testing at 37°C using anti-globulin serum (indirect Coombs test): Conduct compatibility testing between red cells of the blood unit, red cell mass, granulocyte mass, and recipient serum using tube method at 37°C and using anti-globulin serum or more sensitive techniques.

b) Transfusion of red cell mass with minimal or no plasma: - Compatibility testing in physiological saline solution at room temperature between 20°C and 24°C between red cells of the blood unit and recipient serum (Tube 1); - Compatibility testing at 37°C using anti-globulin serum (indirect Coombs test): Conduct compatibility testing between red cells of the blood unit, red cell mass, granulocyte mass, and recipient serum using tube method at 37°C and using anti-globulin serum or more sensitive techniques.

c) Transfusion of platelet and plasma products: Conduct compatibility testing between plasma of the blood product and recipient red cells in tube (Tube 2) in physiological saline solution at room temperature between 20°C and 24°C or using more sensitive techniques;

d) Compatibility test results are considered negative when there is no clotting or hemolysis. Blood units can only be released when the compatibility test results are negative, except for cryoprecipitate transfusion as stipulated in Clause 3, Article 44 of this Circular;

đ) When compatibility test results show clotting or hemolysis, review and cross-check relevant records and information, and coordinate with the treating physician to conduct further tests as required by Points b, c, d, and đ of Clause 2, Article 42 of this Circular.

6. After completing the tasks specified in Clauses 2, 3, 4, and 5 of this Article, the blood bank staff must prepare the blood release record as follows:

a) The blood transfusion form according to the model prescribed in Appendix 10 issued together with this Circular, to be sent to the treatment unit using the blood;

b) Record the blood group determination results and compatibility testing results, which are kept at the blood bank.

Article 44. Selection of Compatible Blood Units

1. Whole blood and red cell concentrates compatible with the ABO blood group system shall be transfused to the recipient according to the following requirements: Recipient's Blood Group Donor Blood Unit Group Red Cell Concentrate Whole Blood A or O B or O AB AB or A or B or O AB

2. Plasma products compatible with the ABO blood group system shall be transfused to the recipient according to the following requirements: Recipient's Blood Group Donor Plasma Unit Group O or B or A or AB A or AB B or AB AB AB

3. Cold agglutinin-negative red cell concentrates may be transfused to the recipient with a dose not exceeding 10 ml/kg body weight within a period of 12 hours.

4. Selection of platelet and granulocyte units shall be made according to the following requirements: Recipient's Blood Group Blood Unit, Blood Product Group Blood Unit, Blood Product with Original Plasma Blood Unit, Blood Product without Original Plasma A or O B or O AB AB AB or A or B or O

5. Selection of whole blood, red cell concentrates, platelets, and granulocytes according to the Rh(D) blood group system shall be made according to the following requirements: Recipient's Blood Group Donor Blood Unit Group D(+) or D(-)

Article 45. Ensuring Compatibility in Certain Emergency Situations

1. In emergency situations, if it is not possible to complete all tests as required under Clause 2, Article 42 and Article 43 of this Circular, or if the recipient's blood group cannot be determined, or if compatible blood units or blood products cannot be selected, with the written consent of the treating physician, the following measures may be taken:

a) Transfuse blood of a different group to the recipient who has been prescribed whole blood or red cell concentrate transfusion as stipulated in Clause 1, Article 44 of this Circular.

b) Transfuse ABO and Rh(D)-compatible red cell concentrates to the recipient with Rh(D) negative blood group or undetermined Rh(D) group.

c) Transfuse blood of a different group to the recipient who has been prescribed plasma transfusion as stipulated in Clause 2, Article 44 of this Circular.

d) After emergency transfusion as provided for in Points a, b, and c of Clause 1 of this Article, all tests as required under Article 42 and Article 43 of this Circular must be completed.

2. Blood of Rh(D) positive group shall only be transfused to recipients with Rh(D) negative blood group in life-threatening situations and when the following conditions are met:

a) The recipient is male.

b) If the recipient is a female of childbearing age: consider the current treatment benefits and the risk of fetal complications if the recipient becomes pregnant in the future.

c) Cross-matching using anti-D serum at 37°C yields a negative result.

d) Written consent from the recipient or the recipient's family is obtained after consultation between the head or authorized representative of the blood issuing unit and the treating physician.

Article 46. Thawing and Warming Blood Bags and Blood Products

1. Thawing of blood product bags must meet the following conditions:

a) Thawing of blood products must comply with Point c, Clause 3, Article 18 of this Circular.

b) The time from the end of thawing to the completion of transfusion to the recipient must not exceed six hours.

c) After thawing, the condition of the blood bag and blood product must be checked as required under Clause 2, Article 41 of this Circular. If a blood bag does not meet quality standards, it must be discarded.

2. Warm the transfusion set when rapid and large-volume transfusions are necessary (more than 50 ml/kg/hour in adults and more than 15 ml/kg/hour in children). The warming temperature must not exceed 37°C.

Article 47. Blood and blood product handover between blood issuing units and treatment units

1. When handing over blood and blood products, staff from the treatment unit receiving blood and staff from the blood issuing unit must verify information on the blood requisition form, blood unit, and blood transfusion form.

2. Suitable means for storing and transporting blood and blood products must be available.

Article 48. Storage of blood unit samples and patient blood samples received

After distribution, patient blood samples and distributed blood unit samples must be retained for at least five days at a temperature between 2°C and 6°C at the blood issuing unit.

Article 49. Management of blood bags at treatment units

1. Blood bags transferred to the treatment unit must be administered to patients within six hours from the time of handover between the blood issuing unit and the treatment unit.

2. In cases where blood transfusion has not been initiated, blood bags or blood products must be stored appropriately in accordance with the provisions of Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 of this Circular.

Article 50. Implementation and monitoring of blood transfusions at treatment units

1. Treating doctors and nursing staff must conduct checks, verifications, blood grouping, monitor blood transfusions, promptly identify and address any abnormalities or unwanted adverse events occurring during and after blood transfusions.

2. Conduct checks and verifications of the following contents:

a) Verify patient information, blood unit information, and the blood transfusion form;

b) Check the expiration date and external appearance of the blood bag according to the provisions of Article 41 of this Circular.

3. Perform ABO blood grouping of the patient and the blood bag immediately at the bedside and compare with the information on the blood transfusion form.

a) When performing whole blood, red cell mass, or white cell mass transfusions: use serum samples for ABO blood grouping of the patient's blood taken just before the transfusion and of the blood sample from the blood unit to be transfused.

b) When performing platelet or plasma transfusions: - Use serum samples for ABO blood grouping of the patient's blood; - Mix two drops of the blood product with one drop of the patient's blood and check for clotting. Do not proceed with the transfusion if clotting occurs, except in cases of cold agglutinin transfusion as specified in Clause 3 of Article 44 of this Circular.

c) Collaborate with the blood issuing unit to investigate and clarify any discrepancies (if any) between medical records, blood transfusion forms, blood unit labels, and blood grouping results.

4. Implement blood transfusions, monitor developments, identify and address any abnormalities in the patient's health status:

a) Monitor and observe pulse rate, body temperature, blood pressure, and mental state of the patient at various points before and during the transfusion process, particularly paying attention to the first 15 minutes of the transfusion to promptly detect and address transfusion-related adverse events;

b) Must use a blood transfusion set with a filter to administer to the patient;

c) Record all pulse rate, body temperature, blood pressure, mental state, clinical developments, and any interventions (if any) of the patient on the blood transfusion form as prescribed in Appendix 10 issued together with this Circular;

d) Based on the patient's condition and developments during the transfusion process, the treating doctor shall prescribe post-transfusion monitoring.

5. No additional substances (including medications) may be added to the blood bag, except when diluting red cell mass is indicated, only isotonic saline solution (0.9% NaCl) for intravenous infusion may be used.

6. When adverse events related to blood transfusions occur, the treatment facility must immediately implement the following actions:

a) Depending on the severity of the adverse event, reduce or stop the transfusion. If the transfusion is stopped, maintain the intravenous route using isotonic saline solution;

b) Provide emergency treatment to the patient;

c) Do not continue to transfuse the blood unit or blood product related to the adverse event after stopping the transfusion for more than four hours.

Article 51. Returning, Receiving Back, and Using Returned Blood Units

1. When not using blood units that have been issued, the treatment facility (department, ward) must immediately return them to the blood issuing facility.

2. The blood issuing facility may only use returned blood units for transfusion to other patients when all of the following conditions are met:

a) Still within the expiry date;

b) No abnormal signs as prescribed in Article 41 of this Circular can be detected;

c) After receiving the blood unit, it has been stored and transported under the correct conditions as stipulated and confirmed in writing by the person responsible for the department or ward.

Article 52. Determining the Cause of Blood Transfusion-Related Complications

1. When complications occur during or after blood transfusion, to determine the cause, the treatment facility must immediately carry out the following actions:

a) Compare the patient's medical record information, the label of the transfused blood unit, and the transfusion report. The comparison results must be recorded in the medical record.

b) Collect samples of the patient's blood taken before the transfusion, and simultaneously collect blood and urine samples from the patient. In cases of severe complications threatening the patient's life, immediate ABO blood typing must be conducted at the patient's bedside by staff from the blood issuing facility within the healthcare institution. The blood typing results must be recorded in the medical record with confirmation from the treating physician, the treatment facility leader, and the person performing the blood typing technique;

c) Report blood transfusion-related complications to the blood issuing facility and the planning and coordination department according to the provisions set forth in Appendix 11 attached to this Circular;

d) Transfer related blood units and blood products back to the blood issuing facility to continue further work as prescribed in Clause 2 of this Article;

đ) The planning and coordination department prepares a report for the Blood Transfusion Council and the facility that provided the blood units and blood products according to the form specified in Appendix 11 attached to this Circular.

2. The blood issuing facility must recheck and compare relevant records, conduct tests to determine the cause of blood transfusion-related complications, and provide test results to the treatment facility and the planning and coordination department according to the form specified in Appendix 12 attached to this Circular.

3. The blood issuing facility must cooperate with the facility that provided the related blood units and blood products to determine the cause.

Chapter VI AUTOGRAFT BLOOD TRANSFUSION

Article 53. Principles for Implementing Autograft Blood Transfusion

1. There must be autograft blood transfusion procedures that comply with current regulations and the conditions of the healthcare institution. The selection, testing, collection, processing, storage, and transfusion procedures for autograft blood must be approved by the leadership of the healthcare institution.

2. Autograft blood transfusions should only be planned for preoperative cases where there is a forecasted risk of significant blood loss requiring transfusion, and the treating physician must carefully assess the patient's health condition to permit safe blood collection.

3. Blood collection for planned autograft blood transfusion and diluted autograft blood transfusion can only be carried out with the written consent of the patient or their legal representative.

4. In addition to complying with the labeling requirements for blood bags as stipulated in Article 21 of this Circular, the label of autograft blood bags must also include the phrase: "For autograft blood transfusion only."

5. Autograft blood bags must be stored separately from blood collected from donors.

6. Ensure that blood and blood products are transfused to the correct patient who had the blood collected. Blood collected for autograft transfusion purposes cannot be used for other patients.

Article 54. Planned Autologous Blood Transfusion

1. Selection criteria for patients

a) Age from 16 to 60 years old;

b) Body weight of at least 50 kg;

c) Clinical: as prescribed in Point d Clause 2 Article 4 of this Circular;

d) Hemoglobin concentration must be at least 120 g/L and Hematocrit must be at least 0.33;

2. Tests that must be conducted before blood collection include:

a) ABO blood group typing;

b) Testing to detect infectious agents transmitted through blood, including at minimum: HBsAg, antibodies against HIV-1 and HIV-2, antibodies against HCV, syphilis.

3. The volume of blood collected each time shall not exceed 7 ml/kg body weight; each blood collection session must be separated by at least 03 days, and the last blood collection session must be at least 72 hours prior to surgery.

4. The treating physician shall consider prescribing erythropoietin to stimulate red blood cell production.

5. Preparation, storage of blood units, and blood products must comply with the provisions set forth in Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 of this Circular.

6. Compatibility testing must be performed before autologous blood transfusion, and the transfusion and determination of causes related to autologous blood transfusion complications must be carried out according to the provisions set forth in Articles 40, 41, 43, 46, 47, 48, 49, 50, 51, and 52 of this Circular.

Article 55. Isovolemic Dilutional Autologous Blood Transfusion

1. Selection criteria for patients

a) Age from 16 to 60 years old;

b) Body weight of at least 50 kg;

c) Clinical: as prescribed in Point d Clause 2 Article 4 of this Circular;

d) Hemoglobin concentration must be at least 120 g/L and Hematocrit must be at least 0.33;

đ) Surgery using pre-anesthetic or general anesthesia techniques;

e) Isovolemic dilutional autologous blood transfusion should not be indicated for patients who poorly tolerate reduced oxygen supply conditions.

2. Pre-blood collection tests: to be conducted according to the provisions set forth in Clause 2 Article 54 of this Circular.

3. Requirements for performing isovolemic dilution and reinfusing the patient:

a) The volume of blood collected before surgery shall not exceed 7 ml/kg body weight;

b) The patient's hematocrit level must not fall below 0.25 after blood collection;

c) Volume balance between blood removed and fluid infused into the body must be maintained using isotonic solutions at a ratio of three times the volume of fluid infused compared to the volume of blood removed, or using high molecular weight solutions at a ratio of 1:1.

Article 56. Intraoperative Blood Salvage

1. Intraoperative blood salvage shall only be performed when there is insufficient stored blood for emergency purposes and no alternative treatment can replace blood transfusion for the patient.

2. Blood for salvage is collected during surgery or from drainage tubes. For example, in cases of spleen rupture, post-operative mediastinal drainage following heart surgery.

3. Collected blood intended for salvage must be processed according to appropriate procedures to prevent bacterial infection, hemolysis, and removal of clots.

4. Salvaged blood must be transfused within four hours from the time of blood collection.

5. Records of intraoperative blood salvage must be kept in the patient's medical record.

6. Intraoperative blood salvage shall not be performed in the following situations:

a) Ruptured hollow organs;

b) Blood has been outside the body for more than six hours;

c) Blood poses a risk of infection;

d) There are signs of hemolysis.

Chapter VII MONITORING OF RISKS IN BLOOD TRANSFUSION

Article 57. Content of Risk Monitoring in Blood Transfusion

Risk monitoring in blood transfusion is an activity aimed at preventing, detecting, warning, recording, analyzing, and reporting risks causing blood transfusion safety issues, including:

1. Information about blood donors.

2. Information about processes, personnel, reagents, equipment, tools, consumables used in activities such as blood reception, screening, preparation, storage, transportation, allocation, prescription, and clinical use.

3. Information on results and abnormalities in blood transfusion activities.

4. Information on adverse events occurring in patients receiving blood transfusions.

5. Other information on risks and abnormalities affecting the community and society related to blood transfusion activities.

Article 58. Management, Supervision, and Reporting of Risks in Blood Transfusion

1. Any abnormalities occurring during blood transfusion activities must be detected, investigated, handled, summarized, and reported on a semi-annual basis.

2. When abnormalities occur that may affect patient safety or exceed the handling capacity of the medical examination and treatment facility:

a) The department or ward discovering such abnormalities must report to the leadership of the medical examination and treatment facility within two hours from the time of discovery.

b) Within twenty-four hours from receiving the report, the leadership of the medical examination and treatment facility must report to the superior management authority and related blood transfusion facilities.

3. Encouraging the reporting of risks and abnormalities related to blood donors, patients receiving blood, healthcare workers performing the work, and other individuals involved in blood transfusion activities:

a) Reports shall be conducted in accordance with the provisions set forth in Appendix 13 issued together with this Circular;

b) These reports shall be sent to the Blood Transfusion Council of the medical examination and treatment facility and the Central Institute of Hematology and Blood Transfusion.

4. Annually, facilities conducting blood transfusions must carry out the summarization, analysis, proposal of solutions to address and reduce abnormalities in blood transfusions, and report in accordance with the provisions of Article 62 of this Circular.

5. Based on the reports stipulated in Clause 3 and Clause 4 of this Article, the Central Institute of Hematology and Blood Transfusion will conduct summarization, analysis, propose solutions, and advise the Ministry of Health on measures to address, reduce, and prevent risks in blood transfusions.

Chapter VIII. BLOOD TRANSFUSION COUNCIL OF MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 59. Legal Status and Composition of the Blood Transfusion Council of Medical Examination and Treatment Facilities

1. The Blood Transfusion Council is a specialized council established by the director of the medical examination and treatment facility.

2. The Blood Transfusion Council (Council) consists of the following components:

a) Chairman of the Council: Director or Deputy Director responsible for professional matters;

b) Vice-Chairman of the Council: Deputy Director or Head of the Planning and Coordination Department;

c) Secretary of the Council: Head of the Planning and Coordination Department or person in charge of the blood distribution unit;

d) Members of the Council include representatives from departments and wards: Human Resources, Planning and Coordination, Nursing, Pharmacy, and clinical departments using blood.

3. The Council may combine with the Drug and Treatment Council based on actual conditions, supplementing members, functions, and tasks according to Clause 2 of this Article and Article 60 of this Circular.

Article 60. Functions and Tasks of the Blood Transfusion Council

1. Function: The Blood Transfusion Council has the function of advising the leadership of the medical examination and treatment facility on safe, reasonable, and effective blood transfusion.

2. Tasks:

a) Directing the development and review of specific principles, regulations, procedures, and guidelines for blood transfusion that are appropriate for the diagnostic and clinical treatment activities of the medical examination and treatment facility;

b) Directing the development of annual plans for blood and blood product usage;

c) Proposing solutions to improve the quality of blood transfusion activities; plans for developing blood transfusion activities, supplementing equipment, and applying new techniques;

d) Proposing the organization of training and instruction on professional procedures and regulations for blood transfusion;

đ) Monitoring, analyzing, summarizing, and reporting adverse events related to blood transfusion;

e) Evaluating the implementation of blood transfusion activity procedures and regulations in accordance with the conditions of the medical examination and treatment facility;

g) Conducting mid-term and annual reviews and reporting regularly every six months and twelve months.

3. Operations:

a) The Council operates under the principle of collective decision-making, deciding by majority on issues related to Council activities. In cases of differing opinions where the number of votes from Council members is equal, the Chairman of the Council is the final decision-maker. Dissenting opinions are recorded and kept in the Council's meeting minutes. Council members operate on a part-time basis;

b) The Council meets quarterly. In cases of emergency meetings, the Chairman decides;

c) Meeting minutes of the Council must fully record the opinions of each member who spoke at the session and must have signatures of the Chairman and Secretary of the Council;

d) The Chairman of the Council specifies the specific operations and assigns tasks to Council members

Chapter IX RECORD KEEPING AND REPORTING REGIME

Article 61. Record Keeping

The leaders of blood collection facilities, medical examination and treatment facilities, and blood distribution facilities must organize the implementation of record keeping according to the following requirements:

1. Record keeping at blood collection facilities:

a) Documents related to blood reception activities: - Health status questionnaire for blood donors as prescribed in Appendix 2 attached hereto; - Blood donor health records as prescribed in Appendix 3 attached hereto.

b) Documents related to testing, processing, storage, distribution, and blood product activities, including: - Code of blood units and blood products; - Type, batch, expiration date, quality control of test reagents; - Test results and conclusions; - Documentation on storage, inspection, and destruction of retained samples; - Documentation related to blood products from each donation round; - Information on the name of blood product types, preparation methods, equipment and tools used, code, blood group, preparation date, expiration date, name of blood collection, testing, and processing facility.

2. Record keeping at medical examination and treatment facilities using blood:

a) Documents related to receiving blood from external facilities: - Blood and blood product delivery receipt; - Blood and blood product return receipt (if applicable).

b) Documents related to receiving blood from internal departments within medical examination and treatment facilities: - Blood and blood product forecast form; - Blood and blood product distribution logbook.

c) Documents related to compatibility testing for blood transfusion: - Type, batch, expiration date, quality control of test reagents; - Blood grouping and compatibility testing results; - Screening and abnormal antibody identification testing results (if applicable).

d) Documents related to blood usage at medical examination and treatment facilities: forecast and distribution logs, transfusion forms;

đ) Documents related to handling adverse events associated with blood transfusions: - At blood distribution facilities: adverse event reports related to blood transfusions; handover documents for blood units and blood products related to adverse events; investigation test results related to blood transfusion adverse events as prescribed in Clause 2, Article 52 of this Circular; - In treatment departments using blood: patient condition records and applied treatment measures; test results of blood and urine samples before and after adverse events related to blood transfusions.

3. Work procedures, record-keeping forms, and document control systems are stored in both traditional paper format and electronic document systems.

4. Records are stored for ten years from the last update date.

5. Expired records are destroyed in accordance with current regulations.

Article 62. Reporting Regime

Leaders of blood collection facilities and medical examination and treatment facilities using blood must organize the implementation of report creation and submission according to the following requirements:

1. Annual periodic reports:

a) Report content as prescribed in Appendix 14 attached hereto;

b) Before November 30 each year, healthcare facilities using blood (including private medical examination and treatment facilities) submit reports as prescribed in Point a, Clause 1 of this Article to provincial/municipal health departments, simultaneously submitting to the Central Institute of Hematology and Blood Transfusion;

c) Before January 15 of the following year, the Central Institute of Hematology and Blood Transfusion submits a consolidated report on blood transfusion activities to the Ministry of Health.

2. Ad hoc reports: implemented according to the content requirements of management agencies or actual needs requiring reporting to higher authorities.

Chapter X OBLIGATIONS TO IMPLEMENT

Article 63. Obligations of the Department of Medical Examination and Treatment - Ministry of Health

1. To take the lead or coordinate in drafting, revising, and supplementing legal normative documents on blood transfusion activities; to develop strategies, plans, programs, projects; to establish national standards, technical regulations, and professional guidelines related to blood transfusion, and submit them for consideration and decision-making by the Minister of Health or competent authorities.

2. To direct, organize, guide, and inspect the implementation of legal normative documents, strategies, plans, professional regulations, national technical standards, and quality management for blood transfusion facilities and medical examination and treatment facilities using blood.

3. To take the lead or coordinate in reviewing conditions for applying new and advanced techniques in blood transfusion activities as prescribed by law.

4. To organize the review of permits for operating and suspending operations of medical examination and treatment facilities with blood transfusion activities as prescribed by law.

5. To serve as the focal point for organizing specialized councils to resolve professional and technical issues, directing and guiding scientific research and international cooperation in blood transfusion activities.

6. To direct, guide, and enhance the capacity of state management and professional skills for managers involved in blood transfusion activities.

7. To direct, guide, and implement the application of information technology, statistical data, and database construction in managing blood transfusion activities.

Article 64. Obligations of the Central Institute of Hematology and Blood Transfusion

1. To serve as the focal point for proposing, advising, and recommending to the Ministry of Health on drafting, revising, and supplementing legal normative documents on blood transfusion activities; developing strategies, plans, programs, projects; establishing national standards, technical regulations, and professional guidelines related to blood transfusion.

2. To implement training, guidance, and support for professional and technical matters related to blood transfusion activities nationwide.

3. To implement studies and evaluations of the quality and methods of using various types of reagents, biological products, equipment, and tools used in blood transfusion activities as prescribed by the Ministry of Health.

4. To implement the application of information technology, statistical data, and database construction for managing blood transfusion activities nationwide.

5. To carry out monitoring of blood transfusion risks nationwide.

6. To inspect and evaluate the activities of blood transfusion facilities nationwide according to the form specified in Appendix 15 attached hereto.

7. To conduct research and apply science and technology in blood transfusion.

8. To compile, analyze, and report statistical results of blood transfusion activities of blood transfusion facilities nationwide to the Ministry of Health.

Article 65. Obligations of Provincial Departments of Health under Central Cities

1. To direct, organize, manage, inspect, and evaluate blood transfusion activities of medical examination and treatment facilities and blood transfusion facilities within their jurisdiction.

2. Based on the demand for blood from medical examination and treatment facilities, to compile and develop annual blood usage plans for the locality; at the same time, to cooperate with relevant units in mobilizing voluntary blood donation to ensure a supply of blood for medical examination and treatment facilities.

3. To recommend revisions and supplements to professional and administrative regulations and guidelines aimed at addressing deficiencies related to blood transfusion activities.

4. To compile, analyze, and report statistical results of blood transfusion activities of medical examination and treatment facilities and blood transfusion facilities within their jurisdiction to the Department of Medical Examination and Treatment, Ministry of Health.

Article 66. Responsibilities of Blood Transfusion Facilities

1. Promote voluntary blood donation. Provide information to donors about the need for blood usage and the risks of blood-borne diseases.

2. Explain the blood collection process, unwanted reactions, possible complications, pre- and post-donation tests; advise donors on self-care and specialized medical services.

3. Ensure confidentiality of clinical examination and testing results. Inform donors of their clinical examination and testing results upon direct request from the donor.

4. Care for and treat donors who experience unwanted complications during and immediately after donation.

5. Develop, approve, implement, and monitor procedures and professional guidelines at blood transfusion facilities to ensure safety for donors and quality of blood units: registration for donation; record keeping; safe and sterile blood collection, minimizing infection risk; donor care; prevention and safe handling of potential complications; screening for infectious agents and blood typing; blood processing, storage, transportation, and products.

6. Implement procedures to honor, reward, and ensure other rights of donors according to the law.

7. Organize management and monitoring of blood transfusion risks as stipulated in Articles 57 and 58 of this Circular.

8. Coordinate with healthcare facilities using blood in the following areas:

a) Supply, transport, and store blood and blood products safely and appropriately based on the quantity and type required by the facility.

b) Provide information about blood units and blood products related to complications occurring in patients receiving blood.

c) Investigate causes of complications related to blood transfusions.

d) Develop materials and conduct training on rational blood use in clinical treatment.

9. Regularly or urgently inspect, monitor, and evaluate blood transfusion activities within the assigned area according to the form specified in Appendix 15 issued along with this Circular.

10. Summarize, analyze, and report on the implementation of blood transfusion activities of healthcare facilities under their responsibility to the Department of Medical Examination and Treatment - Ministry of Health and the Central Institute of Hematology and Blood Transfusion.

11. Recommend amendments and supplements to address issues arising from the implementation of this Circular's regulations.

Article 67. Responsibilities of Healthcare Facilities Using Blood

1. The director of healthcare facilities using blood is responsible for ensuring safe and effective blood transfusion activities at their facility, including:

a) Establishing a Blood Transfusion Committee as prescribed in Chapter VIII and conducting blood compatibility testing, issuing, and using blood; managing complications related to blood transfusion as stipulated in Articles 50 and 52 of this Circular; organizing a blood distribution unit at the healthcare facility or contracting with another facility capable of performing blood compatibility testing.

b) Directing and organizing the development and approval of clinical blood transfusion regulations, procedures, and guidelines for the healthcare facility; training relevant staff and implementing blood transfusions according to approved regulations; supervising compliance with regulations, procedures, and guidelines within the healthcare facility.

c) Reviewing, coordinating, and directing resolution of issues when implementing tasks as stipulated in Points b, c, and d of Clause 8, Article 66 of this Circular with blood transfusion facilities.

d) Organizing the implementation of blood transfusion risk management and monitoring as stipulated in Articles 57 and 58 of this Circular.

e) Conducting evaluations of blood transfusion activity quality and improving quality within the unit according to Appendix 15 issued with this Circular.

g) Recommending amendments and supplements to address issues arising from the implementation of this Circular's regulations.

2. Blood distribution units within healthcare facilities that perform blood compatibility testing have the responsibility to:

a) Comply with current regulations and directives of the healthcare facility director regarding tasks as stipulated in Clause 1 of this Article.

b) Determine needs, plan usage, and organize coordination for safe and appropriate transportation and storage of blood and blood products based on quantity and type requirements.

c) Comply with regulations related to the responsibilities of blood distribution units as stipulated in this Circular.

3. Clinical departments performing blood transfusions:

a) Comply with current regulations and directives of the healthcare facility director regarding tasks as stipulated in Clause 1 of this Article.

b) Prepare equipment, tools, and emergency medications for blood transfusions and immediate handling of complications.

c) Explain to patients or their families about the benefits and potential risks of blood transfusions. If unable to explain to the patient and family, clearly state the reason in the medical record.

d) Comply with regulations related to the responsibilities of clinical departments with blood transfusions as stipulated in this Circular.

Article 68. Responsibilities of Blood Donors

1. Truthfully answer questions about their health status and be responsible for the content of their answers.

2. Sign to confirm understanding of all information and voluntary blood donation after being explained and completing the blood donor health status questionnaire as prescribed in Clause 2, Article 7 of this Circular.

3. Not to take advantage of blood donation for free health check-ups or tests.

4. Voluntarily refrain from donating blood if they consider themselves not meeting the blood donation conditions stipulated in Articles 4, 5, and 6 of this Circular. Do not conceal personal disease risks when registering or participating in blood donation.

5. Immediately report to the blood receiving facility if they discover they have a risk of contracting hepatitis, HIV, or other infectious diseases after donating blood.

Article 69. Responsibilities of Patients Receiving Blood Transfusions

Provide accurate information about their health status to assist healthcare staff in determining, monitoring, and handling any adverse reactions (if any).

Chapter XI IMPLEMENTATION PROVISIONS

Article 70. Implementation Schedule

The implementation of HIV-1, HIV-2, hepatitis B virus, and hepatitis C virus screening tests using NAT technology as prescribed in Point g, Clause 4, Article 14 of this Circular and abnormal antibody screening tests as prescribed in Point c, Clause 4, Article 14 of this Circular shall be carried out according to the following schedule:

a) Blood transfusion facilities in Hanoi City, Thua Thien Hue Province, Ho Chi Minh City, and Can Tho City must implement before January 1, 2015;

b) Blood transfusion facilities in Thai Nguyen Province, Hai Phong City, Thanh Hoa Province, Nghe An Province, Da Nang City, Khanh Hoa Province, Dak Lak Province, and Binh Dinh Province must implement before January 1, 2017;

c) Remaining blood transfusion facilities nationwide must implement before January 1, 2018.

Article 71. Effective Date

This Circular takes effect from November 15, 2013. Decree No. 06/2007/QĐ-BYT dated January 19, 2007 of the Minister of Health on the Blood Transfusion Regulation is abolished from the date this Circular takes effect. During implementation, if there are difficulties or obstacles, units and localities shall report to the Department of Medical Examination and Treatment, Ministry of Health for research, consideration, and resolution.

During implementation, if there are difficulties or obstacles, units and localities shall report to the Department of Medical Examination and Treatment, Ministry of Health for research, consideration, and resolution./.