Thông tư 26/2013/TT-BYT

Circular No. 26/2013/TT-BYT dated September 16, 2013, providing guidance on the blood transfusion

Nội dung toàn văn Circular No. 26/2013/TT-BYT guidance on the blood transfusion

THE MINISTRY OF HEALTH --------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 26/2013/TT-BYT	Hanoi, September 16, 2013

CIRCULAR

PROVIDING GUIDANCE ON THE BLOOD TRANSFUSION

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

At the request of the Director of Medical Examination and Treatment Administration and the Director of the Department of Legal Affairs;

The Minister of Health hereby promulgates the Circular on providing guidance on the blood transfusion.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of application

1. This Circular provides instructions on professional and technical operations concerning the blood transfusion, including the following processes like blood donor selection, blood collection, testing, processing and preparation, storage, transportation, management and use of blood and blood products in the medical treatment process; blood transfusion risk management; blood transfusion council of healthcare facilities; document or record filing and reporting policy.

2. This Circular shall not govern communication and promotion programs for blood donation; plasma, monoclonal antibody and recombinant protein products; human tissue, organ and stem cell transplantation.

Article 2. Interpretation of terms

Terms used herein shall be construed as follows:

1. Blood donor refers to the person eligible for blood donation under the provisions of this Circular and voluntarily donating the whole blood or several blood components.

2. Blood component refers to one or several of blood cell type(s) and/or plasma directly drawn from blood donors by apheresis and anticoagulation process.

3. Whole blood refers to the blood taken from a vein of the blood donor and composed of various blood cell types, plasma and supplemented with anti-coagulant solution.

4. Apheresis of blood components refers to the technical method for directly obtaining one or many blood component(s) from the blood component donor.

5. Blood product refers to the product prepared at a blood transfusion facility, inclusive of one or a wide range of blood cell(s), plasma separated from the whole blood or blood component(s).

6. Blood bag (blood unit) refers to a volume of donated blood or blood product packed in a separate bag.

7. Testing method refers to the process of performing tests supplemented with specific biologics selected for each testing purpose.

8. Blood preparation carried out in the closed system refers to the medical method employed to create blood products in which each unit of donated blood is contained in a set of bags attached together without being cut or sealed, or cut or sealed by means of the automatic sterile cutting or sealing equipment.

9. Pool refers to the mixture of blood components of the same kind collected from various blood units which used to prepare samples for the testing process or provide a sufficient amount of blood products for a medical treatment.

Article 3. Blood transfusion principles

1. Serve the humanitarian and not-for-profit purpose.

2. Ensure that the blood donor donates their blood or blood components on a voluntary manner; Do not force other persons to donate their blood or blood components.

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

4. Protect the confidentiality of all information about the blood donor, recipient and blood component.

5. Ensure the safety of the blood donor, recipient, blood component and the related medical staff.

6. Adhere to proper practices to give blood transfusion to patients.

Chapter II

BLOOD DONOR SELECTION AND BLOOD COLLECTION

Section 1. BLOOD DONATION REQUIREMENTS

Article 4. Blood donor eligibility

Blood donor must meet age and health requirements as well as others which are specified below:

1. Age: from enough 18 to 60 years.

2. Health:

a) Those who weigh at least 42 kg for female, 45 kg for male are eligible for whole blood donation; those who weigh from 42 kg to under 45 kg are permitted to donate less than 250 ml of whole blood per each donation; those who weigh 45 kg or more is permitted to donate their whole blood volume of 90 ml/ kg in weight and less than 500 ml per each donation.

b) Those who weigh at least 50 kg are eligible for blood donation apheresis; blood donors are able to donate one or a wide range of blood component(s) in each donation apheresis, but total volume of donated blood is restricted to less than 500 ml; those who weigh at least 60 kg are eligible to donate total whole-blood volume of less than 650 ml in each donation.

c) Do not suffer from acute or chronic diseases, including mental, nervous, respiratory, circulatory, genitourinary, digestive, hepatobiliary, endocrine, blood and hematopoietic, systemic, autoimmune and severe allergic diseases or symptoms; Do not have pregnancy at the day of blood donation registration (for female); Have the medical history of any human organ donation and transplantation surgery; Do not have addition to narcotics or alcohol; Do not have severe or extremely severe disability in accordance with regulations laid down in the Law on Disabled People; Do not take some medications stipulated by the Appendix 1 issued together with this Circular; Do not contract blood-borne or sexually transmitted diseases at the date of blood donation registration;

d) Clinical conditions:

- Have the normal state of consciousness and perception;

- Have the systolic pressure measured in the range from 100 mmHg to below 160 mmHg and diastolic pressure measured in the range from 60 mmHg to below 100 mmHg;

- Have the regular heart beat with the frequency ranging from 60 to 90 beats per minute;

- Do not show one of the following signs: light weight and fast weight loss (losing more than 10% of gross body weight within 6 months); pale skin or mucous membrane; dizziness or dazzle; night sweat; big nodes occurring throughout the body; fever; oedema; cough, dyspnea; diarrhea; hemorrhage of all types; injuries or abnormal skin conditions.

dd) Testing:

- With respect to the whole-blood donor and the donor who makes an apheresis donation of blood components, the hemoglobin concentration must equal at least 120 g/l; if the volume of whole blood donated is more than 350 ml, the minimum volume of whole blood drawn must be at least 125 g/l.

- With respect to the donor who makes an apheresis donation of plasma, the concentration of plasma protein separated from the whole blood must equal at least 60g/l and must be tested within a period of less than 01 month;

- With respect to the donor who makes an apheresis donation of platelets, granulocytes and stem cells, the number of platelets must be greater than or equal to 150x10⁹/l.

3. In addition to standards stipulated by Clause 1, 2 of this Article, the blood donation shall be considered and decided by blood donor selection practitioners.

Article 5. Blood donation postponement

1. Those required to postpone their blood donation for a period of 12 months from the date of:

a) Full recovery from surgical treatments;

b) Recovery from malaria, syphilis, tuberculosis, tetanus, encephalitis and meningitis;

c) End of a vaccination against rabies after being bitten by animals, or an injection or transfusion of blood, blood components and products;

d) Maternity or termination of pregnancy.

2. Those required to postpone their blood donation for a period of 06 months from the date of:

a) Tattoos;

b) Ear, nose, navel or other body-part piercing;

c) Exposure to the blood and body fluid of those who face the risk of being infected or have been infected with blood borne diseases;

d) Recovery from one of the following diseases or symptoms such as the typhoid, bacteremia, venomous snake bite, arterial and venous thrombosis, osteomyelitis and pancreatitis.

3. Those required to postpone their blood donation for a period of 04 weeks from the date of:

a) Recovery from one of the following diseases and symptoms such as gastritis, urinary tract infection, bacterial skin infection, bronchitis, pneumonia, measles, whooping cough, mumps, hemorrhagic fever, dysentery, rubella and cholera;

b) End of a vaccination against rubella, measles, typhoid, cholera, mumps, varicella and BCG.

4. Those required to postpone their blood donation for a period of 07 days from the date of:

a) Recovery from one of the following diseases or symptoms such as influenza, cold, nose and throat allergy, pharyngitis and Migraine headache;

b) Vaccination, except for vaccine types stipulated by Point C Clause 1 and Point b Clause 3 of this Article.

5. Several regulations on professions and particular activities of the blood donor: those who carry out the following work types and particular activities shall make their blood donation in days–off or are permitted to carry out the following work types or particular activities only after a minimum of 12 hours:

a) Those working at height or relational depth, including pilots, crane operators or construction workers working at height, mountain climbers, miners, sailors and divers;

b) Operator of public means of transport such as buses, trains, ships or vessels;

c) Others, such as professional athletes, and those who exercise and practice very intensely.

6. As for cases which are not governed by Clause 1, 2, 3, 4 and 5 of this Article, the blood donation postponement shall be considered and decided by blood donor selection practitioners.

Article 6. Minimum time between donations and blood components

1. The minimum time between two successive donations of the whole blood or the apheresis donation of erythrocyte count is 12 weeks.

2. The minimum time between two successive apheresis donations of plasma or platelets is 02 weeks.

3. The maximum donations of neutrophil granulocytes or stem cells by applying peripherical blood apheresis are made three times within a period of 07 days.

4. In case the same blood donor makes the donation of both whole blood and different blood components, the maximum time between blood donations must be considered depending on the blood component that has been collected at the latest donation.

Section 2. BLOOD DONOR SCREENING, SELECTION, BLOOD AND BLOOD COMPONENT COLLECTION

Article 7. Registration and management of information about blood and blood component donation

1. Blood and blood component donor must submit one of the following documentation: Identification card, passport, military and police identification card, driving license, work card, student card, blood donation card, blood donor certificate or personal status confirmation issued by local agencies, organizations, unions or authorities.

2. The blood or blood component donor must completely answer the questions about the blood donor's health stipulated by the Appendix 2 enclosed herewith.

3. Blood collecting facilities must manage blood donor information according to the file system stipulated by the Appendix 3 enclosed herewith. Personal information about the blood donor must be kept confidential and only used for the purpose of guaranteeing the normal health condition of the blood donor and preventing diseases from infecting the donated blood recipient.

Article 8. Procedure for blood donor screening and selection

1. Pose questions concerning heath condition and medical history as well as do medical tests as stipulated in Article 4 hereof.

2. Perform the rapid test for HBsAg applied to those who apply for the initial blood donation registration.

3. Do not require the frequent blood donor to undergo the rapid HBsAg test if (s)he has already kept the non-reactive result of the blood screening test for HBsAg performed in the preceding blood donation or the negative result of such test performed in the latest medical check within a period of 12 months prior to the date of blood donation registration.

4. If a person who has the medical history of a suspected positive result of test for HBsAG wishes to give the blood donation, (s)he must be tested negative for HBsAG in two successive tests with the time between two tests equal to 06 months by application of ELISA technique or chemiluminescence and molecular biology technique.

Article 9. Collection of whole blood and blood components

1. Before each draw of the whole blood or blood components, it is necessary to check and inspect the type, expiry date, integrity and anti-coagulation composition of blood bags (blood-containing articles).

2. The blood collecting bag must be coded under the provisions of Clause 3 Article 21 hereof.

3. The blood collection must be sterile and safe for the blood donor.

4. The volume of blood drawn shall be stipulated by Point a and b Clause 2 Article 4 hereof and proportionate to the volume of anti-coagulation solution available in the blood bag.

5. All of the data concerning the origin of each pint of blood and blood component must be traceable, including code, actual blood volume, date and time of blood or blood component donation, and blood or blood component drawing practitioner's name.

6. In case the volume of blood is collected at the rate of less than or greater than 10% compared with the regulated volume contained in each type of blood bag, or any abnormality may take place in the blood collection process, the blood collecting practitioner must write a warning on the blood bag of that kind in non-erasable ink pen or put a specific label on it for any consideration and solution.

Article 10. Requirements for the collection of blood samples for testing

1. Blood samples for medical tests must be collected on the date of blood or blood component donation or directly from blood or blood component bags.

2. The code of blood samples must be the same as that of bags of blood or blood components drawn under the provisions of Clause 2 Article 9 hereof.

Article 11. Processing of whole blood and blood components

Each pint of blood or blood component must be packed and shipped in conformity with the temperature requirement set out for each use purpose as stipulated by Article 20 hereof.

Section 3. GUARANTEE FOR BLOOD DONOR’S RIGHTS

Article 12. Blood donor's rights

1. Have access to the information about pathological signs or symptoms caused by hepatitis, HIV virus and some of blood borne diseases.

2. Be provided clear explanations about the blood collection and any accident that may unexpectedly occur, and pre- and post-transfusion tests.

3. Ensure that their clinical examination and test result will be kept confidential; Have an opportunity to consult with medical experts on any abnormal signs of their health in the health examination and donation process; Have access to advice on the abnormal test result stipulated by Clause 4 Article 17 hereof.

4. Be offered medical care and treatment if any unexpected accident takes place within or after the blood donation as prescribed in Appendix 4 enclosed herewith. Be paid an amount of medical care and treatment costs incurred by unexpected accidents that may happen within and after the blood donation. Costs incurred from the medical care and treatment paid to the blood donor as stipulated by this Clause shall be governed by legal regulations.

5. Be honored or offered an award by competent authorities after their consideration and decision as well as guarantee other mental and material rights that a blood donor is granted as stipulated by laws.

Chapter III

TESTING OF WHOLE BLOOD AND BLOOD COMPONENTS

Article 13. Testing principles

1. Conduct the required screening of each pint of whole blood or blood component. As for the newly-drawn whole blood or blood component, the previous blood test result or the result of blood test performed in the previous blood donation shall not be accepted, except for cases stipulated by Clause 3 Article 15 hereof.

2. Select and use reagents, biological products, testing equipment or device in conformity with the blood screening requirements stipulated by laws. Control the quality of biological products and blood tests.

3. Ensure that the testing procedure, method and analysis of the test result must be made conformable to current biological products, testing equipment and device as well as approved by the leader of testing facilities.

4. The screening test of whole blood and blood components must conform to the following requirements:

a) The blood sample must have the origin which is the same as the origin of the whole blood and component blood in accordance with regulations laid down in Article 10 hereof;

b) It is likely to trace back a blood bag from a blood sample and vice versa;

c) The testing must be performed in the manner of guaranteeing that the test must prove its sensitivity and prevent the risk of false negative result as well as be approved by the leader of the blood collecting facility;

d) The result of the whole-blood or blood component screening test for any blood borne pathogens shall only be used for the purpose of controlling the safety of such whole blood and blood component in order to prevent such blood borne pathogens, and shall not be used for giving the response or advice to the blood donor.

5. When drawing each blood unit from the frequent blood donor, the blood test result must be compared with the preceding test. In case there is any change to the blood test result or any suspicion that the blood sample or blood test documentation is mistaken, the blood sample directly taken from the whole blood or blood component donated must be retested.

6. The confirmatory test for blood borne pathogens that a blood donor is required to undergo must conform to the following requirements:

a) Verifying the personal identity of the blood donor who gives the blood sample for testing;

b) Perform this test in the manner of guaranteeing the specificity, preventing the false positive result, and obtain the approval from the competent authority;

c) Use such confirmatory test result to serve the exclusive purpose of giving response and advice relating to health matters to the blood donor, but avoid using it as the method of controlling the safety of the whole blood or blood component.

Article 14. Types of blood screening test

1. Tests that the whole blood and blood components donated are required to undergo shall include:

a) Blood group serology test: determination of red blood cells ABO, Rh(D), and screening of abnormal antibodies;

b) Tests for several pathogens: screening test for HIV, hepatitis B, hepatitis C and syphilis.

2. In addition to tests stipulated by Clause 1 of this Article, several other tests are required under the following circumstances:

a) Determining the blood group systems like Rh(C, c, E, e) or MNSs, Kidd, Duffy, P and Lewis when a medical practitioner prescribing the blood transfusion medication selects compatible red cell antigens.

b) Performing the screening test for malaria that may be present in the whole blood or blood component collected from blood donors who are living or working in malaria-afflicted areas according to the declaration of the Ministry of Health, or those who have just returned from the malaria outbreak areas within a period of 06 months, or those who have the medical history of contracting the malaria disease within a period of 12 months prior to the date of recovery from such malaria;

c) Performing the CMV (Cytomegalovirus) test on blood products transfused into patients who have undergone tissue, stem cell transplantation or into the unborn baby or in some of other special cases upon the practitioner's request.

3. Supplementary blood tests: in certain cases, practitioners shall prescribe such tests in order to enhance the safety for blood recipients; any facility that meets the statutory technical standard shall be able to perform these tests.

4. Technical requirements that a compulsory blood test must adhere to shall include:

a) The ABO blood group system must be determined by performing 2 sample serum and red cell tests that conform to the minimum technical standard which is equivalent to or more advanced than the in-vitro test. The blood group shall be finally determined if two test results match or are confirmed by performing supplementary tests;

b) The Rh(D) blood group system must be determined by performing the sample serum test that conforms to the minimum technical standard of an in-vitro test. The Rh(D)-negative blood shall be confirmed only after the confirmatory blood test which is equivalent to or more advanced than the indirect antiglobulin test has been performed;

c) The abnormal antibody screening shall be carried out by performing tests which are likely to detect these abnormal antibodies, including those belonging to blood groups such as Rh, MNSs, Kell, Kidd, Duffy and Lutheran according to the plan stipulated by Article 70 hereof;

dd) The HIV screening test shall be performed by employing the test method which have the sensitivity and specificity equal to or greater than ELISA test, or chemiluminescence and biological reactivity test for concurrently detecting antigens and HIV-1 and HIV-2 antibodies;

dd) The Hepatitis B screening test shall be performed by employing the method for detecting HBsAg antigen which must have the sensitivity and specificity equal to or greater than the ELISA or chemiluminescence test;

e) The Hepatitis C screening test shall be performed by employing the method which must have the sensitivity and specificity equal to or greater than ELISA test, or chemiluminescence and biological reactivity test that has the minimum possibility of detecting Hepatitis C antibodies;

g) The screening test for HIV-1, HIV-2, Hepatitis B and C on all types of whole blood or blood components shall be performed by employing NAT method in accordance with the plan stipulated by Article 70 hereof;

h) The syphilis screening test shall be performed by employing the method for detecting syphilis which must have the sensitivity and specificity equal to or greater than the RPR test;

h) The malaria screening test shall be performed by employing the method which must have the sensitivity and specificity equal to or greater than the test for detecting malaria parasites in thick or thin blood films and the test result read by means of the optical microscope;

k) The CMV screening test shall be performed by employing the method for detecting IgM antigen and anti-CMV which must have the sensitivity and specificity equal to or greater than the ELISA or chemiluminescence test.

5. The sequence of blood screening tests for HIV, hepatitis B, C and syphilis shall be approved by the leader of blood collecting facility. The test result which shows that the whole blood or blood component is not infected with the abovementioned pathogens must be obtained by employing the combined method of ELISA and NAT, or chemiluminescence and NAT.

6. Necessary measures to control the quality of whole blood or blood component tests must be applied as stipulated by Appendix 5 and 6 enclosed herewith.

Article 15. Tests for screening pathogens that cause blood borne diseases in some special cases

1. The rapid screening test for HIV-1, HIV-2, Hepatitis B and C on each blood unit before transfusion shall be performed only when it conforms to the following conditions:

a) Such test is only performed at the medical facility located in mountainous, frontier, remote and island areas;

b) Such test is exclusively applicable to the whole blood but non-applicable to blood components;

c) The practitioner prescribes the blood transfusion medication and such test is recorded in the medical file;

d) The nearest blood transfusion facility has been contracted but there is none of compatible blood units, or the time of receiving the blood from the nearest blood transfusion facility does not meet the demand for the emergency treatment;

dd) A patient or patient’s legal representative has signed their name on the medical file to confirm their consent to the transfusion of blood screened by performing the rapid blood test after the medical staff has clearly explained any potential risk of being infected with diseases;

e) Leaders of a department or ward in a healthcare facility or their authorized persons shall confirm that none of compatible blood units is stored at the healthcare facility or an amount of compatible blood units are insufficient to meet the medical therapy demand as well as confirm by writing in the medical record that they approve the rapid test immediately at the moment the emergency blood transfusion is required.

2. In case regulations laid down in Clause 1 of this Article on testing of the blood unit by performing the rapid test is applied, healthcare facilities must implement the followings:

a) Within at least 24 hours from the date of transfusing the blood unit screened by performing the rapid test, healthcare facilities must proceed to perform all necessary tests stipulated by Article 14 hereof and store the blood sample in accordance with regulations laid down in Article 16 hereof;

b) In case a healthcare facility is unable to perform tests stipulated by Article 14 and Point a Clause 2 of this Article, that healthcare facility must send the sample of serum and plasma separated from the transfused blood unit to another healthcare facility capable of performing such tests under the provisions of Article 14 hereof within a maximum period of 07 days from the date of transfusing the blood unit screened by performing the rapid test; must store the sample of serum separated from the blood unit transfused at the blood screening facility in accordance with Article 16 hereof.

3. If a healthcare facility located in a mountainous, frontier, remote and island area is incapable of performing tests stipulated by Article 14 hereof and also unable to send the blood sample to other test facilities as stipulated by Clause 2 of this Article, such healthcare facility is permitted to use the blood unit screened by performing the rapid test after conforming to the following conditions:

a) The blood donor has undergone the screening test under the provisions of Article 14 hereof within a maximum period of 12 months prior to the blood donation date from which (s)he must obtain negative result sheets and be stored at the blood collecting facility;

b) The unit of blood donated must undergo the screening test for HIV, Hepatitis B, C and achieve the negative test result.

Article 16. Blood sample preservation

1. The serum or plasma sample must be preserved for use in order to test for screening all of whole blood or blood component units. A segment of the blood collection tube shall be stored in accordance with regulations laid down in the Appendix 6 hereof.

2. The blood sample used for the blood test must be stored at the temperature of minus 18^oC (-18^oC) or less, and coded and filed to serve the managerial purpose.

3. The blood sample used for the blood test must be stored at the testing facility within at least 02 years from the blood drawing date. As for the blood or blood product unit which has the shelf life of more than 02 years from the blood collection date, the expiry date of storing such sample shall be extended to at least 01 year from the expiry date of such blood or blood product unit. The medical group, team, department or ward in a healthcare facility who is assigned to store the serum or plasma sample must work independently of the blood testing department.

Article 17. Test result administration

1. After obtaining the test result, the blood testing department shall be responsible for notifying related departments in writing or by electronic data transfer which is approved by the leader of the healthcare facility of such test result.

2. If the blood screening test for pathogens causing blood borne diseases has the abnormal result, the regulations laid down in the Appendix 6 enclosed herewith shall be applied.

3. In case the test on the blood or blood component unit collected from the frequent blood donor has the abnormal result in terms of pathogens causing blood borne diseases, the blood testing department must retest the blood or blood component sample collected from that blood donor in the preceding blood donation; if the result achieved from such retest is abnormal, the blood sample collected in the preceding blood donation shall be examined. Meanwhile, such blood testing department shall be responsible for notifying related units or departments of this issue to collaborate in the blood testing process under the provisions of the Appendix 7 enclosed herewith. The testing of the blood sample collected from the preceding blood donation must be performed by employing the technical method and biological products which have the sensitivity at least equal to or identical to the technical method and biological products employed in the preceding blood donation.

4. The blood donor shall be notified of the abnormal result of such blood test only when the confirmatory test has been completed in accordance with the Appendix 6 enclosed herewith. In case of the confirmatory test for HIV, the notification of HIV-positive blood test result must be governed by applicable regulations introduced by the Ministry of Health.

Chapter IV

PREPARATION, STORAGE AND TRANSPORTATION OF BLOOD AND BLOOD PRODUCTS

Section 1. GENERAL REQUIREMENTS

Article 18. General principles

1. Only use blood bags or bags used for blood component apheresis (blood-containing articles) which conform to the accepted quality standard and have clear origin.

2. Separate blood components in the closed system or, if the open system is required, follow the sterile blood preparation process.

3. Freeze and thaw plasma and cryoprecipitate

a) A unit of plasma must be frozen within a maximum period of 8 hours from the start of the freezing process at the temperature of minus 25^oC (-25^oC) or less;

b) The freezing storage: the freezing temperature of minus 18^oC (-18^oC) or less must be maintained;

c) Thawing and warming blood or blood component bags must adhere to the following principles:

- Do not let the surface of the blood bag or areas where the needle for blood transfusion is inserted be in direct contact with the anticoagulation;

- Thaw the frozen cryoprecipitate at the temperature ranging from 30^oC to 37^oC within less than 15 minutes and the fresh frozen plasma within less than 45 minutes;

- Do not refreeze the unit of blood or blood components.

4. Gamma irradiation of blood and blood component bags

a) The gamma irradiation of blood and blood component bags is required to abrogate the ability of lymphocytes with the aim of reducing the incidence of graft-versus-host disease before the blood or blood component transfusion into the patients with immune deficiency syndromes in which the dose of each irradiation delivered must be at least 25 Gy (2.500 cGy);

b) The shelf life of irradiated erythrocyte count shall be 28 days and must be aligned with the shelf life of unirradiated erythrocyte count of the same kind and time. The shelf life of platelet count shall not be changed after irradiation;

c) Irradiated and unirradiated must be labeled for distinction.

5. Donated blood quarantine and destruction:

a) Each unit of donated blood or blood component or all of blood products which have not been tested under the provisions of Article 14, 15 hereof must be quarantined and preserved in a particular manner until all of necessary conditions are met. Method for handling units of donated blood or blood components with the abnormal test result shall be governed under the provision of the Appendix 6 enclosed herewith.

b) All of units of donated blood or blood components which are not safe or end their shelf life must be quarantined and destroyed in on a specific basis in accordance with applicable regulations on the medical waste management.

Article 19. Refrigeration equipment for storage of blood and blood component units

1. General requirements of the refrigeration equipment for storage of blood and blood component units

a) The room used for installation of the refrigeration equipment for blood storage must have stable voltage source and must be well-ventilated;

b) The refrigeration equipment must be designed with the blood storage compartment which is spacious enough to keep the air circulated and must facilitate the examination and observation work;

c) The temperature at all corners of the storage compartment must be steady;

d) The refrigeration equipment must be mounted with the built-in temperature monitoring system which conforms to the following requirements:

- It can monitor the temperature by employing the independent or continuous temperature monitoring method, and record the real-time data by the automatic or manual temperature recoding system with the frequency of at least 4 hours per each;

- The operation of the temperature monitoring system is not interrupted in case the power failure occurs;

- It has the alarming system to alert any abnormal temperature change by emitting warning sound or light.

dd) The refrigeration equipment used for storage of blood or blood component units are not permitted to store other reagents or biological products used for medical tests, or foods;

e) It is stored in a separate space and specifically labeled for each blood and blood component type which includes:

- Blood or blood component units that have been tested safe for transfusion;

- Untested blood or blood component units;

- Those which have already tested and have the abnormal test results.

2. General requirements of the fridge for storage of blood and blood component units

a) The temperature inside of the storage compartment must always range from 2^oC to 6^oC;

b) It guarantees the steady temperature of the storage compartment by installing fans for forced air ventilation;

c) It can allow the observation of blood bags kept in the storage compartment without opening the door panel.

3. General requirements of the freezer for storage of blood and blood component units

a) The temperature inside of the storage compartment shall be minus 18^oC (-18^oC) or less, depending on the specific demand for storage of each blood component and the approved storage process;

b) It has an automatic defrost or requires a manual defrost so that the unit is free of ice.

4. Requirements of platelet shaker and storage cabinet

a) The temperature inside the storage compartment must steadily range from 20^oC to 24^oC;

b) It guarantees the steady temperature by installing fans for forced air ventilation;

c) It can allow the observation of blood bags kept in the storage compartment without opening the door panel;

d) It is designed with horizontal shaking function;

dd) It is combined with the alert system if it stops operating or any abnormal event occurs.

Article 20. Transportation of blood and blood components

1. Means of transportation must maintain the temperature suitable for storage of each blood or blood component type.

2. The transportation of blood or blood component unit must be safe, and control and monitor the temperature and time of transportation by conforming to the following requirements:

a) As for the whole blood and erythrocyte count, the temperature inside of the blood storage compartment shall range from 1^oC to 10^oC during the transportation process; the whole blood prepared for the platelet count shall be preserved and shipped under the provisions of Point b Clause 2 hereof;

b) As for platelet and leukocyte count, the temperature inside the storage compartment must steadily range from 20^oC to 24^oC;

c) As for plasma and frozen blood products, the temperature inside of the blood storage compartment shall be minus 18^oC (-18^oC) or less;

d) The ice used for storage process is not allowed to be in direct contact with blood bags.

Article 21. Blood and blood component label

In addition to adhering to applicable regulations on the commodity labeling, the blood and blood component label must consist of the following information:

1. Name and address of blood and blood component preparation facility.

2. Name of blood component.

3. Bar code of blood and blood component unit: only one bar code is made traceable back to the blood donor, blood collection, screening, processing, storage, transportation, distribution and transfusion of a unit of donated blood or blood component.

4. ABO and Rh(D) blood group; information about other blood groups (when applicable).

5. Blood draw date.

6. Name of anticoagulant or preservative solutions (applicable to the whole blood or erythrocyte count).

7. Expiry date.

8. Volume or weight of each unit of donated blood.

9. Storage temperature.

10. Remarks written on all of labels attached to donated blood or blood component bags: “The blood or blood component must be administered through a filter; the transfusion is not permitted if any haemolytic anemia or abnormal color is detected”. Especially for irradiated blood or blood component, the remark “Irradiated” must be additionally printed.

Section 2. STANDARD OF SEVERAL BLOOD COMPONENTS

Article 22. Whole blood

1. Standard: The whole blood must be collected from the screened blood donor under the provisions of Article 4 hereof and not fall into the cases in which the blood donation is postponed as prescribed in Article 5 hereof. All units of whole blood donated must be tested safe for transfusion by employing the blood tests stipulated by Article 14, 15 hereof.

2. Storage requirements and shelf life:

a) When being stored at the temperature varying from 2ºC to 6ºC, the whole blood should have the shelf life of less than 21 days by adding the anticoagulant solution Citrat-Phosphat-Dextrose and less than 35 days by adding the anticoagulant solution Citrat-Phosphat-Dextrose-Adenin;

b) When being stored at the temperature ranging from 20ºC to 24ºC, the shelf life of the whole blood shall be restricted to less than 24 hours.

3. The quality control (carried out by randomly collecting the number of samples from the whole blood at the rate ranging from 0.1% to 1% of total unit of whole blood and not fewer than 05 units per month) shall apply to the following standards:

a) The volume variation is not over 10% of the volume specified on labels (exclusive of the volume of the anticoagulant solution);

b) All medical tests stipulated by Article 14, 15 hereof must be inspected.

c) The hemoglobin content per each 100ml of the whole blood must be at least 10g;

Article 23. High-density erythrocyte count

1. The high-density erythrocyte count (residual red blood cell) refers to the remaining part of the whole blood which is centrifuged to separate the plasma, or settled as sediment without being gone through any therapy process.

2. Standards and quality control

The quality control (carried out by randomly collecting the number of samples at the rate ranging from 0.1% to 1% of total prepared unit and not fewer than 05 units per each month) shall apply to the following standards:

a) The unit volume of red blood cell count equals 60% ± 15% of the initial volume of the whole blood;

b) The hemoglobin content collected from each 100ml of the whole blood prepared shall equal at least 10g;

c) Hematocrit value ranges from 0.65 to 0.75.

3. Storage requirements and shelf life shall be governed by the regulations laid down in Point a Clause 2 Article 22 hereof as so applied to the whole blood.

Article 24. Preservative-added erythrocyte count

1. Preservative-added erythrocyte count refers to the high-density erythrocyte count supplemented with the erythrocyte preservative solution in order to improve the quality of erythrocyte.

2. Standards and quality control

a) The preservative solution with Adenine must be used;

b) The volume of the preservative-added erythrocyte unit equals 70% ± 15% of the initial volume of the whole blood;

c) The hemoglobin content collected from each 100ml of the whole blood prepared shall equal at least 10g;

d) Hematocrit value ranges from 0.50 to 0.70;

3. Storage requirements and shelf life:

a) As for the preservative-added erythrocyte count prepared in the closed system, the shelf life conforms to the instructions of the manufacturer of blood collecting and blood preservative solution bags, but does not exceed more than 42 days from the blood collection date and it is stored at the temperature ranging from 2^oC to 6^oC;

b) As for the preservative-added erythrocyte count prepared in the open system, the shelf life is restricted to less than 24 hours if it is stored at the temperature ranging from 2^oC to 6^oC, and does not exceed 6 hours if it is stored at the room temperature ranging from 18^oC to 24^oC from the date on which it is prepared in the open system.

Article 25. Erythrocyte count with a decreased number of leukocytes

1. The erythrocyte count with a decreased number of leukocytes refers to the red blood cells centrifuged to remove more than 70% of white blood cells contained in the initial unit of whole blood.

2. Standards and quality control

a) The unit volume of red blood cell count equals 70% ± 15% of the initial volume of the whole blood;

b) The hemoglobin content collected from each 100 ml of the whole blood shall equal at least 9.5g;

c) Hematocrit ranges from 0.50 to 0.70;

d) The remaining number of leukocytes shall be less than 1.2 x 10⁹ collected from each unit of erythrocyte count with a decreased number of leukocytes. At least 75% of this red blood cell unit after being tested must conform to this standard;

3. Storage requirements and shelf life of each unit of erythrocyte count with a decreased number of leukocytes shall be governed by the regulations laid down in Clause 3 Article 24 hereof.

4. Each unit of erythrocyte count with a decreased number of leukocytes supplemented with the preservative solution shall be governed by the regulations laid down in Clause 2 of this Article and Article 24 hereof.

Article 26. Washed erythrocyte count

1. The washed erythrocyte count refers to the red blood cell count which has plasma removed by using the isotonic saline to wash it multiple times (at least 3 times) and is diluted with the isotonic saline or preservative solution or compatible plasma.

2. Standards and quality control

The quality control (carried out by randomly collecting the number of samples at the rate of 10% of total prepared unit) shall apply to the following standards:

a) The volume of this blood component unit equals 65% ± 15% of the initial volume of the whole blood;

b) The residual protein concentrate left in the supernatant must be less than 0.5g/a unit of erythrocyte count;

c) The hemoglobin content collected from each 100ml of the initial whole blood shall equal at least 9.0g;

d) Hematocrit value ranges from 0.50 to 0.70;

3. Storage requirements and shelf life: as for the erythrocyte count washed in the open system, if being stored at the temperature ranging from 2^oC to 6^oC, its shelf life shall be within 24 hours; if being stored at the temperature ranging from 20^oC to 24^oC, its shelf life shall be within 6 hours after the preparation is completed. As for the erythrocyte count washed in the closed system and supplemented with the preservative solution, if being stored at the temperature ranging from 2^oC to 6^oC, its shelf life shall be within 14 days.

Article 27. Leukocyte-filtered erythrocyte count

1. The leukocyte-filtered erythrocyte count refers to the red blood cell count in which the white blood cell is removed by the leukocyte filter. The filtration of leukocytes must be carried out within 72 hours from the blood collection time.

2. Standards and quality control

The quality control (carried out by randomly collecting the number of samples at the rate of 5% of total prepared unit) shall apply to the following standards:

a) The volume of this red blood cell count equals 65% ± 15% of the initial volume of the whole blood;

b) The hemoglobin content collected from each 100ml of the initial whole blood shall equal at least 9.0g;

c) Hematocrit value ranges from 0.50 to 0.70;

d) The remaining number of leukocytes shall be less than 1.0 x 10⁶ collected from each unit of erythrocyte count. At least 90% of blood units after being tested must conform to this standard;

3. Storage requirements and shelf life of each unit of leukocyte-filtered erythrocyte shall be governed by the regulations laid down in Clause 3 Article 24 hereof.

Article 28. Frozen erythrocyte count

1. The frozen erythrocyte count refers to the red blood cell count preserved in the glycerol freezing solution and stored at the temperature ranging from minus 60^oC (-60^oC) or less. Before being transfused into patients, the frozen erythrocyte count must be defrosted, washed, glycerol-removed and diluted with the isotonic saline or supplemented with the erythrocyte preservative solution.

2. Standards and quality control

The quality control (carried out by randomly collecting the number of samples at the rate of at least 10% of total frozen erythrocyte count after being defrosted and glycerol-removed) shall apply to the following standards:

a) The volume of this red blood cell count equals 65% ± 15% of the initial volume of the whole blood;

b) The hemoglobin content collected from each 100 ml of the initial whole blood shall equal at least 8.0g;

c) Hematocrit value ranges from 0.50 to 0.75;

d) The absorbing peak is not higher than 340 mOsm/l at the maximum;

dd) The culture-based bacterial detection method must have the negative result.

3. Storage requirements and shelf life:

a) The shelf life shall be 10 years if it is preserved with the glycerol solution which has the content of 40% and at the temperature ranging from minus -80^oC (-80^oC) to minus 60^oC (-60^oC);

b) The shelf life shall be 10 years if it is preserved with the glycerol solution which has the content of 20% and at the temperature ranging from minus 150^oC (-150^oC) to minus 120^oC (-120^oC);

c) The shelf life shall be 14 days from the date on which the frozen erythrocyte is defrosted, glycerol-removed in the closed system and supplemented with the erythrocyte preservative solution;

d) The shelf life shall be restricted to 24 hours if it is stored at the temperature ranging from 2^oC to 6^oC, and 6 hours if it is stored at the room temperature from the date on which it is thawed and washed to remove the glycerol in the open system.

Article 29. Platelet count prepared from the unit of whole blood

1. The platelet count contains most of platelets fractionated from the unit of whole blood and stored at the temperature ranging from 20^oC to 24^oC within 24 hours from the blood collection time.

2. The standard and quality control of platelets prepared from a unit of whole blood.

The quality control (carried out by randomly collecting the number of samples at the rate ranging from 1% to 5% of total prepared unit and not fewer than 10 units per month) shall apply to the following standards:

a) The volume of such platelet unit ranges from 40 ml to 60 ml prepared from each unit of whole blood that has the volume of 250 ml or more;

b) The platelet count: there are at least 13×10⁹ of platelets contained in a unit of platelet count separated from each 100 ml of whole blood. At least 75% of this platelet unit after being tested must conform to this standard;

c) The count of platelets contained in each unit of platelet count:

- There is less than 0.05×10⁹ of white blood cells if such platelets are prepared by employing the method for separating the buffy coat. At least 75% of this platelet unit after being tested must conform to this standard;

- There is less than 0.2×10⁹ of white blood cells if such platelets are processed by employing the platelet-rich plasma preparation method. At least 75% of these platelet units after being tested must conform to this standard;

d) The pH level must range from 6.4 to 7.4 when it is measured at the temperature of 22^oC at the end of the storage time;

dd) The culture-based bacterial detection method must have the negative result.

3. The standard and quality control of platelet pool prepared from multiple units of whole blood.

a) The volume of such platelet unit ranges from 120 ml to 200 ml prepared from 1,000 ml of whole blood;

b) Platelet count: There are at least 140×10⁹ of platelets in a platelet unit prepared from 1,000 ml of whole blood. At least 75% of this platelet unit after being tested must conform to this standard;

c) The platelet count: there are less than 1.0×10⁹of white blood cells contained in each platelet unit;

d) The pH level and culture—based bacterial detection method shall be governed by regulations laid down at Point d, dd Clause 2 of this Article.

4. Storage requirements and shelf life

a) As for platelets prepared from the whole blood unit in the closed system, the shelf life shall conform to instructions of the blood bag manufacturer, but shall be restricted to 05 days from the date of blood collection if it is preserved at the temperature ranging from 20^oC to 24^oC along with continuous shakes;

b) As for platelets prepared from the whole blood unit in the open system: the shelf life is restricted to 06 hours from the date of preparation completion if it is stored at the temperature ranging from 20^oC to 24^oC along with continuous shakes.

Article 30. Apheresis platelets collected from blood donors

1. Apheresis platelet refers to platelets collected directly from blood donors by automated apheresis machine.

2. Standards and quality control

The quality control (carried out by randomly collecting the number of samples at the rate of 10% of total apheresis unit) shall apply to the following standards:

a) Variation in each unit volume does not exceed 15% of the volume specified on the label;

b) Each apheresis platelet unit (250 ml) has the number of platelets which equals at least 300×10⁹; if the apheresis platelet has the volume ranging from 120 ml to below 250 ml, the minimum number of platelets equals 150×10⁹;

c) The platelet concentrate must be less than 1.5×10⁹/ml;

d) The pH level must range from 6.4 to 7.4 and the culture-based bacterial detection method must have the negative result at the end of the storage time.

3. Storage requirements and shelf life must adhere to instructions of the platelet collection bag manufacturer, but be restricted to 5 days from the plateletpherisis if it is stored at the temperature ranging from 20^oC to 24^oC along with continuous shakes.

Article 31. Leukocyte-filtered platelet count

1. Leukocyte-filtered platelet count refers to platelets prepared from the whole blood or by employing the apheresis method and leukocyte-removed by using the leukocyte filter system.

2. Standards and quality control: the quality of leukocyte-filtered platelet unit is controlled

a) Variation in each unit volume does not exceed 15% (±15%) of the volume specified on the label;

b) Leukocyte-filtered platelets are prepared from the whole blood: there are at least 130×10⁹ of platelets in a platelet unit prepared from each 1,000 ml of whole blood;

c) Apheresis leukocyte-filtered platelets collected from blood donors: there is at least 300×10⁹ of platelets collected from each plateletpheresis;

d) There is less than 1×10⁶ of platelets collected from each platelet unit;

dd) The pH level must range from 6.4 to 7.4 measured at the end of storage time;

e) The culture-based bacterial detection method must have the negative result. The examination of this standard must apply to the minimum rate varying from 1% to 5% of prepared unit. This examination is not required for leukocyte-filtered platelets collected directly at medical beds.

3. Storage requirements and shelf life:

a) As for platelets prepared in the closed system, the shelf life shall conform to instructions of the blood bag manufacturer, but be restricted to 05 days from the date of blood collection if it is preserved at the temperature ranging from 20^oC to 24^oC along with continuous shakes;

b) As for platelets prepared in the open system: the shelf life is restricted to 06 hours from the date of preparation completion if it is stored at the temperature ranging from 20^oC to 24^oC along with continuous shakes.

Article 32. Plasma and frozen plasma

1. Plasma refers to the liquid suspension which does not hold the blood cells and is prepared from the unit of whole blood or directly collected from the apheresis plasma donor. The plasma can be used immediately after being prepared or frozen (also known as the frozen plasma) in accordance with regulations laid down in Clause 3 Article 18 hereof.

2. Standard and the quality control: the quality control (carried out by randomly collecting the number of samples at the rate ranging from 0.1% to 1% of total prepared unit and not fewer than 05 units per month) shall apply to the following standards:

a) The protein concentrate is lower than 50 g/l;

b) Variation in each plasma volume does not exceed 10% of the volume specified on the label.

3. Storage requirements and shelf life

a) The storage temperature ranging from 2^oC to 6^oC: the shelf life of the plasma is restricted to 14 days from the time of preparation in the closed system and 24 hours from the time of preparation in the open system;

b) The storage temperature ranging from minus 18^oC (-18^oC) to minus 25^oC (-25^oC): the shelf life of the plasma is restricted to 12 months from the time of blood collection or plasma apheresis;

c) The storage temperature ranging from minus 25^oC (-25^oC) or less: the shelf life of the plasma is restricted to 24 months from the time of blood collection or plasma apheresis.

d) Refreezing the thawed plasma is not permitted.

Article 33. Fresh plasma and fresh frozen plasma

1. Fresh plasma refers to the plasma which has the content of unstable blood coagulation factors is maintained at the physiological content level, and is prepared from the whole blood or directly collected from the blood donor by employing the apheresis method.

2. The fresh frozen plasma refers to the plasma stipulated by Clause 1 of this Article and the plasma freezing process takes place within 18 hours at the maximum from the time of blood collection or plasma apheresis. The plasma freezing process must be governed by Clause 3 Article 18 hereof.

3. Standard and the quality control for fresh plasma and fresh frozen plasma: the quality control (carried out by randomly collecting the number of samples at the rate ranging from 0.1% to 1% of total prepared unit and not fewer than 05 units per month) shall apply to the following standards:

a) Variation in each plasma volume does not exceed 15% of the volume specified on the label.

b) The concentrate of factor VIII is not lower than 0.7 IU (international unit)/ml. At least 75% of the sample after being tested must conform to this standard;

c) The number of residual cells: there is less than 1.0×10⁹ of red blood cells, 0.1×10⁹/l of white blood cells and 50×10⁹/l of platelets;

d) The total protein concentrate is not lower than 50 g/l;

dd) Abnormal color, muddy or clotty substance does not exist.

3. Storage requirements and shelf life:

a) The storage temperature ranging from minus 18^oC (-18oC) to minus 25^oC (-25oC): the shelf life of the plasma is restricted to 12 months from the time of blood collection or plasma apheresis;

c) The storage temperature ranging from minus 25^oC (-25^oC) or less: the shelf life of the plasma is restricted to 24 months from the time of blood collection or plasma apheresis;

c) As for fresh plasma product and thawed fresh frozen plasma:

- The storage temperature ranging from 2^oC to 6^oC: it must be immediately administered within 06 hours from the time when the thawing process begins; the label ‘plasma’ must be properly attached if it is stored more than 06 hours;

- Refreezing the thawed fresh frozen plasma is not permitted.

Article 34. Cryoprecipitate

1. Cryoprecipitate refers to the blood product separated from the precipitate collected from the defrostation of the fresh frozen plasma at the temperature of 10^oC or less. Cryoprecipitate can be further refined and virally inactivated by using chemicals or temperature.

a) The volume varying from 10 ml to 25 ml per each cryoprecipitate unit collected from each whole blood unit may have the volume greater than or equal to 250 ml. The volume varies from 80 ml to 120 ml per each pool of cryoprecipitate collected from 2,000 ml of whole blood. The actual variation in each cryoprecipitate volume does not exceed 15% of the volume specified on the label.

b) The concentrate of factor VIII is not less than 30 IU per each cryoprecipitate unit collected from a unit of whole blood which has the volume greater than or equal to 250 ml. At least 75% of the samples after being tested must conform to this standard;

c) The fibrinogen level is not less than 75mg in each cryoprecipitate unit which has not been virally inactivated and collected from a unit of whole blood with the volume greater than or equal to 250 ml. At least 75% of the samples after being tested must conform to this standard;

d) Abnormal color, muddy or clotty substance does not exist.

3. Storage requirements and shelf life:

a) The storage temperature of minus 18^oC (-18^oC) or less: the shelf life of the cryoprecipitate is restricted to 12 months;

b) Thawed cryoprecipitate:

- The storage temperature ranging from 2^oC to 6^oC: it must be administered immediately or within 06 hours from the time when the defrostation begins;

- Refreezing the thawed cryoprecipitate is not permitted.

Article 35. Neutrophil granulocyte count

1. Neutrophil granulocytes shall be collected directly from the blood donor by employing the apheresis or from units of whole blood stored at the temperature ranging from 20^oC to 24^oC within 24 hours from the blood collection time.

2. Standard and the quality control: the quality control (carried out by randomly collecting the number of samples at the rate of 10% of total prepared unit) shall apply to the following standards:

a) The volume of each unit of blood product ranges from 250 ml to 300 ml;

b) There is 10×10⁹of white blood cells in each blood product unit and at least 75% of blood products after being tested must conform to this standard.

3. The storage requirement and shelf life: it is stored at the temperature ranging from 20^oC to 24^oC without shakes within 06 hours from the time of preparation and 24 hours from the blood collection time.

Article 36. Blood products transfused into the unborn baby

1. Red blood cell transfused into the unborn baby refers to leukocyte-filtered erythrocytes stipulated by Article 27 hereof and conforms to the following requirements:

a) It must be stored at the temperature ranging from 2^oC to 6^oC within 05 days from the blood collection time;

b) Hematocrit value ranges from 0.70 to 0.85;

c) It can be irradiated under the provisions of Clause 4 Article 18 hereof.

2. Red blood cells transfused into the unborn baby may be leukocyte-filtered erythrocytes as stipulated by Article 31 hereof or may be irradiated under the provisions of Clause 4, Article 18 hereof if this is prescribed by the clinician.

Article 37. Blood for the exchange transfusion for newborn babies

1. The whole blood for the exchange transfusion for newborn babies must conform to requirements stipulated by Article 22 hereof and must be stored within 05 days from the blood collection time. The whole blood transfused into newborn babies may be leukocyte-filtered or irradiated according to the clinician’s prescription.

2. The salvaged whole blood for the exchange transfusion for newborn babies must be red blood cells prepared under the provisions of Article 23, 24, 25, 26, 27 and 28 hereof and supplemented with the fresh plasma or fresh frozen plasma stipulated by Article 33 hereof for the purpose of restoring the normal property of the whole blood, and must meet the following requirements:

a) Red blood cells must be stored within 05 days from the blood donation or frozen erythrocyte thawing date;

b) It must be centrifuged to remove the preservative solution;

c) It must be supplemented with the fresh frozen plasma collected from the blood group AB or others compatible with the immune system of the blood group containing red blood cell units and of the newborn baby's blood group;

d) It must be stored at the temperature ranging from 2^oC to 6^oC and administered within 04 hours from the blood salvage time;

dd) The quality of all whole blood units salvaged under the provision of Clause 3 Article 22 hereof must be controlled and the hematocrit value must range from 0.40 to 0.50;

e) The whole blood salvaged for the blood transfusion for newborn babies may be leukocyte-filtered or irradiated according to the clinician’s prescription.

Chapter V

MANAGEMENT, USE OF BLOOD AND BLOOD PRODUCTS AT HEALTHCARE FACILITIES

Article 38. Principle of blood or blood product dispensation, use and withholding

1. Blood and blood product unit shall be dispensed to patients only when there is no risk of infecting pathogens causing blood borne diseases; all necessary tests for determination of ABO, Rh(D) blood group system are performed; blood and blood product unit conforms to relevant statutory standards and does not exceed the regulated shelf life for each type; there is no abnormal signs detected by the examination of the outside of blood or blood product bags; these must ensure the immunological compatibility between the blood and blood product unit and the blood recipient.

2. The blood or blood product shall be withheld or quarantined if it falls into the following cases:

a) The cases stipulated by Clause 2 and 3 Article 17 hereof;

b) The cases stipulated by Clause 2 Article 41 hereof.

c) The whole blood and blood products such as plasma, platelets, leukocytes collected from the unit of blood or blood component when being tested for any abnormal antibody under the provision of Point c Clause 4 Article 14 hereof must have the positive or suspected positive result.

3. The blood transfusion medication must be based on the pathological state of each patient.

4. The blood dispensation department of healthcare facilities must perform medical tests to assess the immunological compatibility of transfused blood and directly dispense the donated blood or blood product unit transfused into patients to affiliated clinical wards.

Article 39. Delivery and receipt of blood and blood product

The delivery and receipt of blood and blood products between the blood supply facility and the healthcare facility or between healthcare facilities shall be allowed if the following requirements are met:

1. That healthcare facility is permitted by the competent authority to supply the blood or blood product to other healthcare facility;

2. There is a contract for blood and blood product supply between the blood, blood product supplier and the blood, blood product recipient;

3. The request form for blood and blood products supplied under the provisions of the Appendix 8 enclosed herewith;

4. If there is no contract for blood supply, this blood request form must be signed for confirmation from the leader's representative or authorized person of that healthcare facility;

5. There must be medical staff for blood delivery and receipt;

6. There must be proper equipment used for storage and shipping of blood and blood products;

7. The blood-received or dispatched documentation must be stored and monitored under the provision of Article 61 hereof.

Article 40. Warehousing, inspection and storage of blood at the blood dispensation department of the healthcare facility

1. Blood and blood product before being warehoused must be examined and inspected as follows:

a) The examination of the outside of blood products and packs according to regulations laid down in Article 41 hereof;

b) Information printed on the label according to regulations laid down in Article 21 hereof;

c) Blood storage, transportation conditions applied to specific blood or blood product types according to regulations laid down in Article 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35 hereof.

d) The person in charge of examination or inspection must report to the leader of the blood dispensation department on any abnormality detected for consideration and decision on measures to be taken to deal with this.

2. Blood or blood product bags must be stored by separately placing A, B, O, AB and Rh(D)-negative blood group in different compartments of the refrigeration equipment or purpose-made cooling system.

Article 41. Examination of the outside of blood or blood product bags

1. The examination of the outside of blood or blood product bags shall be required when:

a) These bags are delivered and received by internal departments of the blood transfusion facility;

b) These bags are delivered and received by the blood supply and blood dispensation department of the healthcare facility or by internal blood dispensation departments of the healthcare facility, or by blood supply facilities.

c) These bags are delivered and received by the blood dispensation and therapy department of the same healthcare facility.

2. Blood or blood product unit is prevented from being administered if there are several signs as follows:

a) The blood bag, tube or tube connection area is found damaged or broken;

b) There is no or abnormal fractionation of blood components after sedimentation or centrifugation;

c) Abnormal color is found as follows:

- Pink or red color appears at the upper fraction of buffy coat or all of the plasma;

- The plasma has abnormal colors;

- The erythrocyte fraction turns purplish or dark or any other abnormal color.

d) These bags remain muddy and clotty;

dd) These bags have a creamy layer on the surface.

Article 42. Requirements that a medical therapy department must meet prior to receipt of blood or blood products

1. The clinician must assess the pathological state and promptly detect the demand for blood transfusion of patients.

2. The clinician must prescribe patients for necessary tests who are intended to be transfused as follows:

a) ABO, Rh(D) blood typing;

b) Screening of abnormal antibodies at the following patients:

- Those who have the medical history of the blood transfusion;

- Female patients who have medical history of pregnancy, and maternity or abortion;

- In the course of curing process, the patient who needs to get the blood transfusion multiple times or in many days must perform these tests every 7 days at the maximum.

c) If the result of the screening test for abnormal antibodies is positive, patients should be prescribed to undergo another test for identification of such abnormal antibodies;

d) If these abnormal antibodies have been identified, the clinician must prescribe the proper medication of blood unit without antigens compatible with antibodies contained in the serum of patients;

dd) If it is impossible to identify such abnormal antibodies or selection of compatible blood unit is failed, the clinician must collaborate with the blood dispensation department in considering and deciding the appropriate therapy methods.

3. The blood transfusion shall be prescribed only after all blood transfusion benefits and risks have been weighed when realizing that there is no replacement therapy method or the replacement method is ineffective.

4. The clinician or nurse must notify patients or patient’s family relatives of blood transfusion benefits and risks. In the event that the emergency blood transfusion must be carried out right away without prior notification to patients who have lost their consciousness and no family relatives besides them, the clinician must specify this situation and a medical staff member also gives the confirmation in the medical record.

Patients or patient’s family relatives must give their confirmation and write their signature in the medical record if they refuse the blood or blood product transfusion.

5. The nurse must complete the blood request form for blood supply according to the form stipulated by the Appendix 9 enclosed herewith and collect the venous blood sample from patients prescribed for the blood transfusion, which must meet the following requirements:

a) When collecting the blood sample, the nurse must double-check the blood transfusion prescription, name, age and code of patients, departments and number of treatment bed with the medical record;

b) The blood sample collected from patients must be drained into 2 test tubes with the volume of anticoagulant-added blood varying from 1 ml to 2 ml and with the volume of anticoagulant-free blood from 4 ml to 5 ml;

c) The information below shall be printed on the blood test tube:

- Full name or code of the patient;

- Birth date of the patient;

- Number of the treatment bed and department.

d) The blood request form along with blood samples shall be handed over to the blood dispensation department;

Article 43. Test for guaranteeing the immunological compatibility of the transfused blood

When receiving the blood request form and blood samples from patients, the blood dispensation department must take the following steps:

1. Double check the blood sample date with the information provided in the blood request form. If the information is found inconsistent, such blood sample is not used for the blood typing and the immunological compatibility testing.

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

a) The in-vitro ABO typing or other techniques which have the greater sensitivity must be performed;

b) The blood typing by concurrently employing two methods for testing sample serum and erythrocyte shall be applied to the patient’s blood sample, unit of whole blood and granulocyte. The blood typing by employing the method for testing the sample serum shall be applied to erythrocyte components. The blood typing by employing the method for testing the sample erythrocyte shall be applied to serum, cryoprecipitate and platelet components.

c) The blood typing for patients shall be carried out two times on the same blood sample or two blood samples of the same patient. In case the results of two ABO typing methods achieved in one time or from other blood typing times do not match each other, the supplementary test must be performed to confirm the blood typing result;

d) As for the ABO typing for unborn and newborn babies, the method for testing the sample serum is exclusively used while the method for testing the sample erythrocyte is not applied. In case the blood typing result is not clear, it is likely that the supplementary test is performed to confirm the result. c) If it is likely that the blood group is not determined, the blood with the immunological compatibility as stipulated by Clause 1 Article 45 hereof must be selected.

3. Rh(D) typing of the patient's blood sample shall be performed as follows:

a) Whenever the transfusion of the whole blood, erythrocyte, platelet and leukocyte is indicated;

b) The in-vitro Rh(D) typing or other techniques which have the greater sensitivity must be performed;

4. The aforesaid double-checking of the result of the test for screening and identification of abnormal antibodies that has been previously performed shall adhere to regulations laid down at Point b, c, d and dd Clause 2 Article 42 hereof.

5. Test for the immunological compatibility of the transfused blood:

The test for the immunological compatibility by using test tubes or other techniques which have the greater sensitivity shall be performed in the following cases:

a) Transfusion of whole blood or erythrocytes containing a lot of plasma and leukocytes:

- The immunological compatibility test shall be performed in the physiological saline environment and at the room temperature ranging from 20^oC to 24^oC, including:

+ Tube 1: consisting of erythrocytes collected from the blood or blood component unit and the serum of the recipient;

+ Tube 2: consisting of plasma collected from the blood or blood component unit and the erythrocyte of the recipient;

- The immunological compatibility test shall be performed at the temperature of 37^oC and supplemented with the anti-globulin serum (indirect Coombs test): Performing the test for compatibility between erythrocytes collected from a unit of blood, red blood cell count, white blood cell count and the serum of the recipient by employing the in-vitro test method at the temperature of 37^oC and using the anti-globulin serum or other techniques which have the greater sensitivity.

b) Transfusion of erythrocytes containing a small amount of plasma or plasma-free erythrocytes:

- The immunological compatibility test shall be performed in the physiological saline environment and at the room temperature varying from 20^oC to 24^oC to test the reaction of erythrocytes collected from the donated blood unit with the serum of the recipient (tube 1);

c) Transfusion of platelet and plasma components: Performing the test for the immunological compatibility between the blood plasma component unit and erythrocytes of the recipient (tube 2) in the physiological saline environment and at the room temperature varying from 20^oC to 24^oC or using other techniques which have the greater sensitivity;

d) The result of the immunological compatibility test shall be considered negative if none of agglutination and haemolytic anemia is observed. Any blood unit with the negative result of the immunological compatibility test shall be dispensed, except for the transfusion of cryoprecipitate stipulated by Clause 3 Article 44 hereof;

dd) When the result of the immunological test shows that there is agglutination or haemolytic anemia, it is necessary to verify and double-check information provided in the documentation and collaborate with the clinician indicating the test in fulfilling requirements stipulated by Point b, Circular, d and dd Clause 2 Article 42 hereof.

6. After following all required steps stipulated by Clause 2, 3, 4 and 5 of this Article, the medical staff of the blood dispensation department must file the documentation for the blood dispensation as follows:

a) Blood transfusion form by completing the form given in the Appendix 10 enclosed herewith. It shall be then sent to the blood-using therapy department;

b) Documents indicating the result of the blood typing, immunological compatibility test. These shall be stored at the blood dispensation department.

Article 44. Selection of immunologically compatible blood units

1. The transfusion of the whole blood and erythrocyte count compatible with the ABO blood group system of the recipient shall adhere to the following requirements:

The blood group of the patient	The transfused blood group
The blood group of the patient	Erythrocyte count	Whole blood
O	O	O
A	A or O	A
B	B or O	B
AB	AB or A or B or O	AB

2. Transfusing the plasma product compatible with the ABO blood group system of the recipient shall adhere to the following requirements:

The blood group of the patient	The blood group of transfused plasma unit
O	O or B or A or AB
A	A or AB
B	B or AB
AB	AB

3. It is possible to transfuse cryoprecipitate incompatible with the ABO blood group into the recipient with the transfused volume of less than 10 ml/kg of body weight within 12 hours.

4. Selection of platelets and granulocytes shall conform to the following requirements:

The blood group of the recipient	The blood group of transfused blood or blood product unit
The blood group of the recipient	Blood or blood product unit containing the primitive plasma	Blood or blood product unit of which the primitive plasma is removed
O	O	O
A	A	A or O
B	B	B or O
AB	AB	AB or A or B or O

5. Selection of whole blood units, red blood cells, platelets and granulocytes from the Rh(D) blood group shall conform to the following requirements:

The blood group of the recipient	The transfused blood group
D(-)	D(-)
D(+)	D(+) or D(-)

Article 45. Guarantee of the immunological compatibility for emergency blood transfusions

1. In the emergency case, if there is not enough time to perform all necessary tests stipulated by Clause 2 Article 42, 43 hereof or identification of the patient’s blood group or selection of appropriate blood or blood product unit is failed, and after obtaining the clinician’s prescription is received, the following blood or blood product units must be dispensed:

a) Giving the transfusion of blood group replacement to the patients who have been prescribed for whole blood and red blood cell transfusion as stipulated by Clause 1 Article 44 hereof.

b) Transfusing immunologically compatible ABO-group and Rh(D)-negative erythrocytes into the patients with Rh(D)-negative blood group or without Rh(D) blood group identified;

c) Transfusing the blood group replacement into the patients who have been indicated for blood plasma transfusion as stipulated by Clause 2 Article 44 hereof.

dd) After dispensing the blood or blood product unit in accordance with Point a, b and c Clause 1 of this Article, all necessary tests must be performed under the provision of Article 42 and 43 hereof.

2. The transfusion of Rh(D)-positive blood or blood product units for the patient with Rh(D)-negative blood group only if the patient’s life is threatened and such transfusion must conform to the following requirements:

a) Such patient is male.

b) If female patients are at the maternal age, benefits of the current therapy and risk of causing health accidents to future unborn babies must be weighed up;

c) The result of the immunological compatibility test by using the anti-globulin serum at the temperature of 37^oC must be negative;

d) After the medical consultation is held between the leader or authorized person of the blood dispensation department and the clinician, such blood or blood product transfusion is approved and the patient or patient family relative agrees to such transfusion as well.

Article 46. Thawing and warming of blood and blood product bags

1. Thawing of blood product bags must conform to the following requirements:

a) Thawing blood products in compliance with regulations laid down at Point c Clause 3 Article 18 hereof.

b) The time when the thawing process ends to the time when the blood transfusion for patients finishes does not exceed 06 hours;

c) After being thawed, blood or blood product bags must be checked in accordance with regulations laid down Clause 2 Article 41 hereof. Any bag that fails to meet the quality standards must be discarded.

2. The segment of blood transfusion tube is required to be warmed to get the rapid or massive transfusion (more than 50 ml/kg/hour for adults and more than 15 ml/kg/hour for children). The warming temperature does not exceed 37^oC.

Article 47. Blood and blood product delivery and receipt of the blood dispensation department and the therapy department

1. In the process of delivery and receipt of blood or blood product units, the medical staff of the therapy department shall be tasked with the receipt and the medical staff of the blood dispensation department shall be tasked with the double-checking of information provided in the blood request form as well as blood transfusion sheet.

2. Blood and blood products must be shipped by proper means of transport.

Article 48. Storage of transfused blood samples and blood samples of the patient receiving the blood transfusion

After the blood dispensation process, the blood sample of the patient receiving the blood transfusion and dispensed blood unit must be stored at the blood dispensation department for at least 05 days.

Article 49. Management of blood bags carried out at the therapy department

1. Blood bags that have been already delivered to the therapy department must be transfused into patients within 06 hours from the time when the delivery and receipt take place between the blood dispensation department and the therapy department.

2. In case the blood transfusion has yet to be performed, blood or blood product bags must be stored in a proper manner according to the regulations laid down in Article 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35 hereof.

Article 50. Blood transfusion practice and monitoring of blood transfusion at the therapy department

1. The clinician and nurse must examine, double check and determine the blood group, monitor the blood transfusion, promptly detect and deal with any abnormality and unexpected accidents that may happen during and after blood transfusion.

2. Examining and double-checking of the following data:

a) Double-checking of patient’s particulars, blood unit and blood transfusion sheet;

b) Checking of the expiry date and examination of the outside of the blood bag according to the regulations laid down in Article 41 hereof.

3. ABO typing of the patient's blood group and blood bags at the treatment bed and double-checking of information provided in the blood transfusion sheet

a) When the transfusion of whole blood, erythrocytes and leukocytes is performed, the sample serum used for ABO typing of the patient's blood group must be collected before transfusion and of the sample of the blood which is going to be transfused.

b) Transfusion of platelets and plasma:

- Using the sample serum used for ABO typing of the patient's blood sample;

- Mixing 02 drops of blood product with 01 drop of the patient’s blood and checking the agglutination. The blood transfusion is not permitted when agglutination occurs, except for the case in which the cryoprecipitate according to regulations laid down Clause 3 Article 44 hereof.

c) Collaborating with the blood dispensation department in clarifying any difference (if any) between information provided in the medical record, blood bag label and the blood typing result.

4. Performing the blood transfusion, monitoring any reaction, detect and deal with any abnormality affecting the health status of the patient as follows:

a) Checking and tracking indices relating to blood vein, temperature, blood pressure and mental change of patients during and before the blood transfusion with particular attention to monitoring such indices within 15 initial minutes of blood transfusion in order to promptly detect and deal with any health accident relating to the blood transfusion;

b) Using the blood transfusion tube set with a filter for the blood transfusion;

c) Write all of indices such as blood vein, temperature, blood pressure and mental health as well as clinical reaction of the patient, suggesting any solution in the blood transfusion sheet according to the regulations laid down in the Appendix 10 enclosed herewith;

d) Based on the health condition of the patient and any reaction occurring in the blood transfusion process, the clinician should indicate the post-transfusion care.

5. The addition of any unknown substance to blood bags (including medicines of all kinds) is not permitted. If the erythrocyte dilution is prescribe, only isotonic saline solution (NaCl 0.9%) used for intravenous infusion is acceptable.

6. When there is any accident that may happen in the blood transfusion process, the therapy department must take the following actions:

a) Depending on the severity of such accidents, the blood transfusion speed must be reduced or the blood transfusion is required to be halted. In case the blood transfusion is halted, the venous transfusion line must be sustained by using the isotonic saline solution;

b) Following emergency treatment methods;

c) Discontinuing the transfusion of blood or blood product units associated with such accidents after the blood transfusion is halted for over 4 hours.

Article 51. Return, return acceptance and use of returned blood units

1. When the dispensed blood is not administered, therapy department and ward must promptly return these blood bags to the blood dispensation facility.

2. The blood dispensation facility should only transfuse the returned blood into other patients when the following requirements are met:

a) The useful life of returned bags does not expire;

b) There is none of abnormal signs stipulated by Article 41 hereof;

c) The storage and transportation of blood unit after being received must conform to vigorous standards and approved in writing by the leader of the therapy department or ward.

Article 52. Identification of causes for transfusion-related accidents

1. Whenever any accident happens during and after the blood transfusion, in order to identify the cause, the therapy facility must take the following actions:

a) Double-check the information provided in the medical record of the patient, blood bag label and blood transfusion sheet. The result achieved after this double-checking must be written in the medical record.

b) Reclaim the blood sample of the patient before blood transfusion, concurrently collecting the blood and urine sample of the patient. In case there is any severe accident threatening the patient’s life, the ABO typing of the patient’s blood group must be carried out right at the treatment bed by the medical staff of the blood dispensation affiliated to the healthcare facility. The result of the blood typing must be written in the medical record with confirmatory signature of the clinician and the technician performing the blood typing;

c) Notify the blood dispensation facility and the general planning department of any accident relating to the blood transfusion as stipulated by the Appendix 11 enclosed herewith;

d) Send relevant blood or blood product units back to the blood dispensation facility in order to proceed to take further steps as stipulated by Clause 2 of this Article;

dd) The general planning department must report to the blood transfusion council and the facility that has provided units of blood and blood product by completing the form presented in the Appendix 11 enclosed herewith.

2. The blood dispensation facility must double-check the related documentation and perform necessary tests in order to identify the cause for transfusion-related accidents as well as respond with the test result to the therapy facility and the general planning department by completing the form stipulated by the Appendix 12 enclosed herewith.

3. The blood dispensation facility must collaborate with the blood and blood product supply facility concerned to identify such cause.

Chapter VI

AUTOTRANSFUSION

Article 53. Autotransfusion principles

1. The autotransfusion procedure must conform to applicable laws and conditions of healthcare facilities. Procedures such as selection, testing, blood collection, preparation, storage and autotransfusion practice must be approved by the leader of the healthcare facility.

2. The planned autotransfusion shall only be performed if the patient is preoperatively predicted to expose to the risk of losing the blood to an extent that the blood transfusion is needed. The clinician shall be responsible for carefully examining and assessing the health condition of the patient to check whether the patient is healthy enough for the blood collection.

3. The blood collection by employing the planned-operation autotransfusion and normovolemic hemodilutional autotransfusion shall be performed only when the patient or the patient’s legal representative gives their consent.

4. In addition to complying with regulations on blood bag labeling according to the regulations laid down in Article 21 hereof, the label attached to autologous blood bags must have the additional remark: "Only used for the autotransfusion”.

5. Autologous blood must be stored separately from the blood collected from the blood donor.

6. The right patients received the right transfusion of blood or blood products. The blood collected for the autotransfusion purpose shall not be transfused into other patients.

Article 54. Planned-operation autotransfusion

1. Selection criteria:

a) Age from 16 to 60 years;

b) Body weight from 50 kg or more;

c) Clinical condition stipulated by Point d Clause 2 Article 4 hereof;

d) Required hemoglobin concentrate must be at least 120g/l and hematocrit value must equal at least 0.33;

2. All necessary tests must be performed before the blood collection process, including:

a) ABO typing;

b) Test for pathogens causing blood borne diseases, at least including HBsAg, anti-HIV-1 and HIV-2 antibody, anti-HCV antibody and syphilis tests.

3. The volume of blood in each collection shall not exceed 7 ml/kg of body weight; time between two blood collections must be at least 03 days and the last blood collection must be at least 72 hours prior to the operation time.

4. The clinician shall consider prescribing the use of substance stimulating red blood cell production, called Erythropoietin.

5. The preparation and storage of blood and blood product unit shall be governed by regulations laid down in Article 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35 hereof.

6. The immunological compatibility test prior to the autotransfusion must be performed, the transfusion of autologous blood and identification of causes for any autotransfusion-associated accident must be governed by regulations laid down in Article 40, 41, 43, 46, 47, 48, 49, 50, 51 and 52 hereof.

Article 55. Normovolemic hemodilutional autotransfusion

1. Selection criteria:

a) Age: from enough 16 to 60 years;

b) Body weight from 50 kg or more;

c) Clinical condition stipulated by Point d Clause 2 Article 4 hereof;

d) Required hemoglobin concentrate must be at least 120g/l and hematocrit value must equal at least 0.33;

dd) Operations using the sedative premedication or general anesthesia;

e) The normovolemic hemodilutional autotransfusion shall not be indicated in case the patient has shown low tolerance to the hypoxemia.

2. All necessary tests performed prior to the blood collection process shall be governed by regulations laid down in Clause 2 Article 54 hereof.

3. Requirements of the homologous blood dilution and reinfusion of autologous blood into patients:

a) The volume of autologous blood collected prior to operations shall be restricted to less than 7 ml/kg of body weight;

b) Hematocrit value is not lower than 0.25 after the autologous blood collection;

c) The volume of collected blood and the volume of infused fluid must be balanced by supplementation of isotonic solutions in the ratio 3:1 of the fluid volume infused into the body to the blood volume collected from the body, or high molecular solution in the ratio of 1:1.

Article 56. Salvaged blood autotransfusion

1. Salvaged blood autotransfusion shall be required only if there is not sufficient blood amount for emergency transfusion and there is no other treatment options.

2. The blood shall be salvaged during operation or the drain tubing. Example: rupture of the spleen, mediastinal blood drainage in a cardiac surgery.

3. The salvaged blood used for autotransfusion must be processed according to the proper procedure in order to prevent the risk of bacterial infection, haemolytic anemia and must have blood clots removed.

4. The salvaged blood must be transfused within 04 hours of receipt of the savaged blood.

5. The salvaged blood transfusion must be documented in the medical record of the patient.

6. The salvaged transfusion shall be permitted in the following cases:

a) Rupture;

b) Blood has been drained over 06 hours;

c) Blood is exposed to the risk of bacterial infection;

d) There is a sign of haemolytic anemia.

Chapter VII

TRANSFUSION RISK MANAGEMENT

Article 57. Transfusion risk management activities

The transfusion risk management refer to actions to be taken to prevent, detect, alert, preserve, analyze and report any risk to the safety of blood transfusion, including:

1. The blood donor’s particulars.

2. Information about the processes, workforce, biologics, medical supplies, equipment, consumable supplies used for receipt, screening, preparation, storage, transportation, dispensation, indication and use of blood in the clinical treatment process.

3. Information about the result and any abnormality in the blood transfusion process.

4. Information about any accident that may happen to the blood recipient.

5. Other information about risks and any abnormality that residential and social communities may face in relation to blood transfusion activities.

Article 58. Control, monitoring and reporting of blood transfusion risks

1. All abnormal events that may occur in the blood transfusion must be detected, inspected, handled, aggregated and reported every 6 months.

2. If there is any abnormal event that can cause impact on the safety of patients or fall outside of the authority of the healthcare facility to deal with such event:

a) The department or ward must report to the leader of that healthcare facility within 02 hours as from the time it is detected;

b) Within a period of 24 hours of receipt of report, the leader must report to the superior management agency and the relevant blood transfusion facility.

3. It is advised that all risks and abnormal events relating to the blood donor, recipient and in-charge medical staff and other persons who get involved in the blood transfusion process are reported:

a) Report on implementation of regulations laid down in the Appendix 13 enclosed herewith;

b) Reports must be sent to the blood transfusion council of the healthcare facility and the Central Hematology - Blood Transfusion Institute.

4. Blood transfusion facilities must aggregate, analyze and propose solutions in order to deal with and restrict these abnormal events that may occur in the blood transfusion and carry out the reporting on yearly basis in accordance with regulations laid down in Article 62 hereof.

5. Based on the report stipulated by Clause 3 and 4 of this Article, the Central Hematology - Blood Transfusion Institute shall aggregate, analyze and propose solutions as well as advise the Ministry of Health on measures to be taken to deal with, restrict and prevent blood transfusion risks.

Chapter VIII

BLOOD TRANSFUSION COUNCIL OF THE HEALTHCARE FACILITY

Article 59. Legitimacy and composition of the blood transfusion council of the healthcare facility

1. The blood transfusion council is the professional council established under the decision of the director of the healthcare facility.

2. The blood transfusion council shall be composed of:

a) The council Chairperson: the Director or Deputy Director for professional tasks;

b) The council Vice Chairperson: the Deputy Director or the Head of the General Planning Department;

c) The council Secretary: the Head of the General Planning Department or the Head of the blood dispensation facility;

d) Commissioners shall include delegates of the department or ward: Staff Organization, General Planning, Nursery, Pharmacy and other clinical departments that use the blood.

3. The blood transfusion council can collaborate with the medicine and therapy council and, after considering actual conditions, shall be supplemented with more members, functions and tasks in accordance with Clause 2 of this Article and Article 60 hereof.

Article 60. Functions and tasks of the blood transfusion council

1. Functions:

The blood transfusion council shall perform its function to advise the leader of the healthcare facility about the safe, proper and effective blood transfusion.

2. Tasks:

a) Direct the formulation and assessment of specific principles, regulations, processes and guidelines concerning the blood transfusion in conformity with the testing and clinical treatment activities of the healthcare facility;

b) Direct the formulation of annual plans to use blood and blood product units;

c) Propose solutions to improving the blood transfusion efficiency; plans to develop blood transfusion activities and provide additional equipment as well as apply new techniques;

d) Propose organization of training classes on professional practices, processes and regulations on the blood transfusion;

dd) Manage, analyze, aggregate and report any accident involving the blood transfusion;

e) Make the evaluation report on implementation of processes and regulations on the blood transfusion in conformity with conditions of the healthcare facility;

g) Prepare the preliminary and final report every 6 months and 12 months.

3. Operations:

a) The blood transfusion council shall operate on the principle of collectives and under the majority rule in terms of matters pertaining to the council's operations. In case there is any conflicting opinions that may occur and the equal ballot cast by the council members, the Chairperson shall have the deciding vote. These conflicting opinions shall be preserved and written into the work record of the council. The council members shall work under the dual-employment arrangement;

b) The council shall hold its meeting every quarter. In some emergency cases, the Chairperson shall decide whether the meeting is convened;

c) The meeting minutes must record all of the members' opinions raised in each meeting session and must enclose all of required signatures of the council Chairperson and Secretary.

d) The Chairperson shall provide specific regulations on the council’s operations and assign tasks to the council members.

Chapter IX

FILING AND REPORTING SYSTEM

Article 61. Filing system

The leader of the blood transfusion, healthcare and blood dispensation facility must establish the filing system in which all records or documents are stored according to the following requirements:

1. Documents or records filed at the blood transfusion facility:

a) All relevant documents or records relating to the blood receipt:

- Blood donor health questionnaire according to the form enclosed in the Appendix 2 issued together with this Circular;

- Blood donor health assessment record according to the regulations laid down in the Appendix 3 issued together with this Circular.

b) Documents or records about the testing, preparation, storage and dispensation of blood and blood product units, including:

- Bar code of blood or blood product unit;

- Type, batch, shelf life, and control of the quality of biologics used in testing process;

- Result and conclusion of the blood test;

- Manuals on storage, inspection and destruction of preserved pathological specimens;

- Materials about blood components in each blood donation;

- Information about the name of blood component type, preparation method, used equipment and device, bar code, blood group, preparation date, expiry date, name of the blood collection, testing and preparation facility.

2. Documents or records filed at the blood-using healthcare facility:

a) Documents showing the receipt of blood from other blood supply facilities:

- Note of blood or blood product delivery or receipt;

- Note of blood or blood product return (if any).

b) Documents on the receipt of blood from departments or wards affiliated to the healthcare facility:

- Blood or blood product request form;

- Blood or blood product dispensation record.

c) Documents or records relating to the testing of blood for the immunological compatibility before dispensation:

- Type, batch, expiry date, control of the quality of biologics used in blood testing process;

- The result of the blood typing and immunological compatibility test;

- The result of the test for screening and identifying any abnormal antibodies (if any).

d) Documents relating to the use of blood at the healthcare facility: blood or blood product request and dispensation logbook and blood transfusion slip;

dd) Documents relating to the handling of transfusion-related accidents:

- At the blood dispensation facility: report on any transfusion-associated accident; record on the delivery and receipt of blood or blood product units associated with accidents; the result of tests for investigating transfusion-related accidents stipulated by Clause 2 Article 52 hereof;

- At the blood-using department or ward: document recording the patient state, applied solution or treatment; result of the testing of blood and urine sample before and after an accident associated with the blood transfusion happens.

3. Work processes, records, documents, templates and document control system shall be stored in the form of a normal written instrument or an electronic document system.

4. All documents or records shall be stored for 10 years from the date of the most recent update.

5. Any records or documents of which the storage term expires shall be destroyed in accordance with effective laws.

Article 62. Reporting policy

The leader of the blood transfusion, healthcare and blood dispensation facility must arrange their resources to prepare and send reports in conformity with the following requirements:

1. Annual report:

a) Report contents shall be governed by regulations laid down in the Appendix 14 enclosed herewith;

b) Before November 30 every year, blood-using healthcare facilities (including private healthcare service providers) must send an annual report stipulated by Point a Clause 1 of this Article to the health departments of centrally-affiliated cities or provinces, concurrently send another copy of that report to the Central Hematology – Blood Transfusion Institution;

c) Before January 15 of the following year, the Central Hematology – Blood Transfusion Institution shall prepare a general report on blood transfusion operations for submission to the Ministry of Health.

2. Spontaneous report shall conform to the request made by the management agency or the actual demand for submitting it to the superior management agency.

Chapter X

IMPLEMENTARY RESPONSIBILITY

Article 63. Responsibility of the Medical Examination and Treatment Administration affiliated to the Ministry of Health

1. Preside over or collaborate in formulation, modification or addition of legislative documents on the blood transfusion; set up the strategy, planning, proposal, program and project; introduce the national standard, technical regulation and professional instruction relating to the blood transfusion for submission to the Minister of Health or other competent authority for consideration or decision.

2. Direct, provide necessary resources for and guidance on and inspect the implementation of legislative documents, strategy, planning and professional rules, national technical and quality control regulations governing blood transfusion and blood-using healthcare facilities.

3. Preside over or collaborate in the assessment of eligibility for applying new techniques and high technology to the blood transfusion according to legal regulations.

4. Arrange necessary resources for the assessment of the licensing and suspension of the blood transfusion of healthcare facilities according to legal regulations.

5. Function as the focal point to organize professional councils for dealing with professional and technical issues, and direct and provide guidance on scientific and international cooperation activities in the blood transfusion field.

6. Direct, provide guidance on, enhance the capability of carrying out the state management and professional tasks at administrators in the blood transfusion field.

7. Direct and provide guidance on implementation of information technological application, data statistics and formulation of the database used in the blood transfusion administration.

Article 64. Responsibility of the Central Hematology – Blood Transfusion Institution

1. Function as the focal point to submit a proposal, advice or request in order for the Ministry of Health to carry out the formulation, modification or addition of legislative documents on the blood transfusion; set up the strategy, planning, proposal, program and project; introduce the national standard, technical regulation and professional instruction associated with the blood transfusion.

2. Provide training in, guidance on, and professional and technical support for blood transfusions across the nation.

3. Conduct study and assessment of the quality and method for using reagents, biologics, equipment and device used in the blood transfusion as stipulated by regulations adopted by the Ministry of Health.

4. Apply technological advances to, make a statistical report on and establish the database of the blood transfusion activities throughout the country.

5. Carry out transfusion risk management across the nation.

6. Examine and assess operations of blood transfusion facilities nationwide by completing the form presented in regulations laid down in the Appendix 15 enclosed herewith.

7. Conduct the technological research and application in the blood transfusion field.

8. Aggregate, analyze and report data about the activities of blood transfusion facilities in the national scope which shall be sent to the Ministry of Health.

Article 65. Responsibility of Health Departments of centrally-affiliated cities or provinces

1. Direct, implement, manage, examine and assess the blood transfusion of healthcare and blood transfusion facilities that fall within the remit of these health departments.

2. Based on the demand for blood used in healthcare facilities, aggregate, set up the annual plan to use the blood that falls within their jurisdiction; concurrently collaborate with relevant agencies in mobilizing people to donate their blood on a voluntary basis, ensure that the blood supply resource of healthcare facilities is sufficient for use.

3. Propose any amendment and supplementation to professional, administrative and managerial regulations, instructions in order to surmount any difficulty in the blood transfusion.

4. Aggregate, analyze and make a data report on the blood transfusion activities of healthcare facilities and blood transfusion facilities that fall within the area of their delegated authority for submission to the Medical Examination and Treatment Administration affiliated to the Ministry of Health.

Article 66. Responsibility of the blood transfusion facility

1. Raise people’s awareness of and participation in the voluntary blood donation. Provide information for the blood donor about the demand for the donated blood and about any risk of contracting blood borne diseases.

2. Provide clear explanations about the blood collection process, unexpected signs and accident that may occur, and pre- and post-transfusion tests; advise the blood donor on the self-care practice and healthcare services of specific department of a healthcare facility.

3. Ensure the clinical examination and test result shall be kept confidential. Notify the blood donor of the clinical examination and test result after receiving the request directly made by that blood donor.

4. Take care of and cure the blood donor whenever there is any unexpected event that may happen during and after the blood donation process.

5. Formulate, approve, implement and manage the professional process and instruction at blood transfusion facilities in order to ensure the safety for the blood donor and the quality of each unit of blood: making the registration of blood donation; writing medical documents or records; drawing the blood in a safe and sterile manner, reduce the infection risk; taking care of the blood donor; preventing and handling any accident that may happen to the blood donor; performing necessary tests for screening pathogens causing blood borne diseases and blood typing test; prepare, process, store and carry blood and blood product units.

6. Request competent authorities to honor and offer awards and guarantee other benefits granted to the blood donor in compliance with laws.

7. Arrange necessary resources for implementation of the management and control of risks associated with the blood transfusion as stipulated by Article 57 and 58 hereof.

8. Collaborate with other healthcare facilities in using the donated blood for:

a) Supplying, shipping and storing the blood or blood product unit in a safe manner and for the purpose of meeting the requirements for quantity and type of blood at blood-using facilities;

b) Providing information about the blood or blood product unit associated with any accident that may happen to the blood recipient;

c) Studying and investigating causes for transfusion-related accidents;

d) Creating materials, implementing training activities pertaining to the proper blood use in the clinical treatment procedure.

9. Carry out periodic or spontaneous examination and monitoring and assessment of blood transfusion activities that fall within the area of their responsibility by completing the form presented in the Appendix 15 enclosed herewith.

10. Aggregate, analyze and make a report on blood transfusion performance of healthcare facilities that fall within their delegated authority for submission to the Medical Examination and Treatment Administration and the Central Hematology – Blood Transfusion Institute.

11. Propose any amendment and supplementation in order to surmount any difficulty in the blood transfusion that may arise in the process of implementing regulations enshrined in this Circular.

Article 67. Responsibility of the blood-using healthcare facility

1. The Director of the blood-using healthcare facility shall be responsible for ensuring the safety of blood transfusion activities and efficiency in operations of the blood transfusion facility that fall within their remit, including the following tasks:

a) Organize a blood transfusion council as stipulated by Chapter VIII and arrange the work of testing, dispensing and using the donated blood; manage any transfusion-associated accident stipulated by Article 50 and 52 hereof; establish a blood dispensation agency at healthcare facilities or enter into the contract for professional support with other healthcare facilities eligible to perform the immunological compatibility test for blood transfusions;

b) Direct, arrange necessary resources for and approve regulations, procedures and manuals on the clinical blood transfusion at healthcare facilities; organize training sessions for relevant medical staff and take control of blood transfusions in accordance with approved regulations; arrange necessary resources for the compliance with regulations, processes and instructions within the delegated authority of healthcare facilities;

c) Consider, collaborate with blood transfusion facilities in and direct handling of any related issue in the course of implementing the work stipulated at Point b, c and d Clause 8 Article 66 hereof;

d) Arrange necessary resources for implementation of the management and control of risks associated with the blood transfusion as stipulated by Article 57 and 58 hereof;

e) Carry out the assessment of the blood transfusion quality and improve the blood transfusion quality in a healthcare facility in accordance with the Appendix 15 issued together with this Circular;

g) Propose any amendment and supplementation in order to surmount any difficulty in the blood transfusion that may arise in the process of implementing regulations enshrined in this Circular.

2. The blood dispensation facility affiliated to the healthcare facility which is entitled to perform the immunological blood test shall take on the following responsibilities:

a) Apply effective regulations and direction of the director of the healthcare facility to implementation of the related work stipulated by Clause 1 hereof;

b) Determine the demand for, set up the plan to use and collaborate in shipping and storing blood or blood products in a safe manner and in conformity with the demand for quantity and type of blood products;

c) Implement regulations relating to the responsibility of the blood dispensation facility as stipulated by this Circular.

3. Blood transfusion therapy departments or wards:

a) Apply effective regulations and direction of the director of the healthcare facility to implementation of the related work stipulated by Clause 1 hereof;

b) Provide equipment, device and medicine for emergency care unit in order to transfuse blood and promptly deal with any possible accident;

c) Clearly explain benefits and potential risks incurred from the blood transfusion to the patient or the patient's family relative. In case it is impossible to give such explanation, the reasons for this must be clearly stated in the medical record;

d) Implement regulations relating to the responsibility of these blood-transfusing departments and wards as stipulated by this Circular.

Article 68. Responsibility of the applicant for blood donation

1. Give honest answers to questions about the health condition and bear responsibility for these answers.

2. Confirm that (s)he has read information carefully and voluntarily donate their blood by appending his/her signature after being offered clear explanations and completing the questionnaire to collect information about the blood donor's health in accordance with regulations laid down in Clause 2 Article 7 hereof.

3. Do not pretend to donate blood to have access to free-of-charge health check or blood test.

4. Voluntarily refuse to donate blood if (s)he supposes that (s)he is not eligible for the blood donation in accordance with regulations laid down in Article 4, 5 and 6 hereof. Do not conceal the risk of contracting diseases when applying for the blood donation.

5. After each blood donation, immediately report to the blood receipt facility if (s)he think that (s)he can expose to any risk of contracting the hepatitis, HIV infection and other transmitted diseases.

Article 69. Responsibility of the recipient

Provide accurate information about the personal health condition in order to assist medical staff in giving indications, monitoring and dealing with any accident (if any).

Chapter XI

IMPLEMENTARY PROVISIONS

Article 70. Implementation plan

The screening test for HIV-1, HIV-2, Hepatitis B and C by employing NAT method in accordance with Point g Clause 4 Article 14 hereof and for determining abnormal antibodies in accordance with Point Circular Clause 4 Article 14 hereof shall be performed by implementing the following plan;

a) Blood transfusion facilities located in Hanoi, Thua Thien – Hue province, Ho Chi Minh city and Can Tho city shall implement this Circular before January 1, 2015;

b) Blood transfusion facilities located in Thai Nguyen, Hai Phong, Thanh Hoa, Nghe An, Da Nang, Khanh Hoa, Dac Lac, Binh Dinh shall implement this Circular before January 1, 2017;

c) Other nationwide blood transfusion facilities shall implement this Circular before January 1, 2018.

Article 71. Effect

This Circular shall come into force from November 15, 2013.

The Decision No. 06/2007/QĐ-BYT of the Ministry of Health dated January 19, 2007 on promulgating the blood transfusion regulation shall become invalid from the effective date of this Circular.

In the course of implementation, if there is any difficulty that may arise, relevant facilities and local authorities must notify the Medical Examination and Treatment Administration for research, consideration and solution./.

PP. THE MINISTER
THE DEPUTY MINISTER

Nguyen Thi Xuyen

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Thuộc tính Văn bản pháp luật 26/2013/TT-BYT
Loại văn bản	Thông tư
Số hiệu	26/2013/TT-BYT
Cơ quan ban hành	Bộ Y tế
Người ký	Nguyễn Thị Xuyên
Ngày ban hành	16/09/2013
Ngày hiệu lực	15/11/2013
Ngày công báo	...
Số công báo
Lĩnh vực	Văn hóa - Xã hội, Thể thao - Y tế
Tình trạng hiệu lực	Còn hiệu lực
Cập nhật	11 năm trước
Yêu cầu cập nhật văn bản này

Download Văn bản pháp luật 26/2013/TT-BYT

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File văn bản word (172KB)

Lược đồ Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Văn bản bị sửa đổi, bổ sung

Văn bản liên quan ngôn ngữ

Thông tư 26/2013/TT- BYT năm 2013 hướng dẫn hoạt động truyền máu

Văn bản sửa đổi, bổ sung

Văn bản bị đính chính

Văn bản được hướng dẫn

Văn bản đính chính

Văn bản bị thay thế

Văn bản hiện thời

Circular No. 26/2013/TT-BYT guidance on the blood transfusion
Loại văn bản	Thông tư
Số hiệu	26/2013/TT-BYT
Cơ quan ban hành	Bộ Y tế
Người ký	Nguyễn Thị Xuyên
Ngày ban hành	16/09/2013
Ngày hiệu lực	15/11/2013
Ngày công báo	...
Số công báo
Lĩnh vực	Văn hóa - Xã hội, Thể thao - Y tế
Tình trạng hiệu lực	Còn hiệu lực
Cập nhật	11 năm trước

Văn bản thay thế

Văn bản được dẫn chiếu

Law No. 51/2010/QH12 on persons with disabilities

Văn bản hướng dẫn

Văn bản được hợp nhất

Văn bản được căn cứ

Văn bản hợp nhất

Văn bản liên quan Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Luật 51/2010/QH12

Law No. 51/2010/QH12 of June 17, 2010, on persons with disabilities

Ban hành: 17/06/2010

Ngày hiệu lực: 01/01/2011

Hiệu lực: Còn hiệu lực

Cập nhật: 14 năm trước

Nội dung Lược đồ Lịch sử VB liên quan

Thông tư 26/2013/TT-BYT

Thông tư 26/2013/TT- BYT hướng dẫn hoạt động truyền máu do Bộ trưởng Bộ Y tế ban hành

Ban hành: 16/09/2013

Ngày hiệu lực: 15/11/2013

Hiệu lực: Còn hiệu lực

Cập nhật: 11 năm trước

Nội dung Lược đồ Bản PDF Lịch sử VB liên quan

Văn bản gốc Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Lịch sử hiệu lực Circular No. 26/2013/TT-BYT guidance on the blood transfusion

16/09/2013
Văn bản được ban hành
Trạng thái: Chưa có hiệu lực
15/11/2013
Văn bản có hiệu lực
Trạng thái: Có hiệu lực

Thông tư 26/2013/TT-BYT

Circular No. 26/2013/TT-BYT dated September 16, 2013, providing guidance on the blood transfusion

Nội dung toàn văn Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Thuộc tính Văn bản pháp luật 26/2013/TT-BYT

Download Văn bản pháp luật 26/2013/TT-BYT

Lược đồ Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Văn bản bị sửa đổi, bổ sung

Văn bản liên quan ngôn ngữ

Văn bản sửa đổi, bổ sung

Văn bản bị đính chính

Văn bản được hướng dẫn

Văn bản đính chính

Văn bản bị thay thế

Văn bản hiện thời

Văn bản thay thế

Văn bản được dẫn chiếu

Văn bản hướng dẫn

Văn bản được hợp nhất

Văn bản được căn cứ

Văn bản hợp nhất

Văn bản liên quan Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Luật 51/2010/QH12

Thông tư 26/2013/TT-BYT

Văn bản gốc Circular No. 26/2013/TT-BYT guidance on the blood transfusion

Lịch sử hiệu lực Circular No. 26/2013/TT-BYT guidance on the blood transfusion