Circular 26/2013/tt-Byt: Blood Transfusion Activities Guide

Original Language Title: Thông tư 26/2013/TT-BYT: Hướng dẫn hoạt động truyền máu

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MINISTRY OF HEALTH
Number: 26 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, September 16, 2013

IT ' S SMART

Manual transfusion.

____________

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government Regulating the functions, duties, powers, and organizational structure of the Ministry of Health. ()

At the suggestion of the Director of the Bureau of Management, healing and the Chief of the Legal Affairs Department;

The Minister of Health has issued a blood transfusion manual.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

1. This information guides professional activity, blood transfusion techniques, including: selection of blood donors, blood clots, testing, preparation, preservation, transport, management, blood use, and blood processing in treatment; risk monitoring in blood transfusion; the Council of Nations. Blood transfusion on the basis of disease, healing, records and reporting mode.

2. This information does not regulate propaganda activities, blood donation; products are extracted from plasma, antibody antibodies, recombinated proteins; tissue grafting, human body parts and stem cells.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. The blood donor. is the person who is eligible to donate blood by regulation at this level and voluntarily donate the full blood or some of the blood components.

2. The blood component. is one or several types of blood cells and or blood plasma is taken directly from the blood donor with the separable and anticoagenated.

3. Full blood. The blood that is taken from the veins of the blood donor contains the blood cells, blood plasma, and the anticoagendas.

4. Aperesis is a part of the blood. is the technique for taking one or more direct blood components from the donor into the blood portion.

5. Blood preparations. is a product that is prepared at the blood transfusion facility, consisting of one or more types of blood cells, blood plasma derived from full blood or blood composition.

6. Blood bag. is a blood volume or blood product that is closed in a separate pocket.

7. Test Method is the self-making of tests with a specific combination of biomes that have been selected according to test purposes.

8. Regulation in closed system is the use of the technique to create blood preparations, in which the blood unit is contained in the pocket of multiple pockets attached to each other, uncut, or the cutting of blood bags made by sternable auto-cutting equipment.

9. Pool is the mixing of blood preparations of the same type from multiple blood units, in order to prepare the test sample or to ensure sufficient therapeutic doses.

What? 3. The principle of carrying out blood transfusion activity

1. For humanitarian purposes, not for profit purposes.

2. Make sure to voluntarily commit to the donor; not to force others to donate blood, into blood.

3. Only use blood and blood preparations for healing, training, scientific research.

4. Keep the secret of information relevant to the blood donor, the recipient of blood and blood preparations.

5. Secure the blood donors, blood transfusion, blood preparations, and related medical staff.

6. Make reasonable blood transfusion for the sick.

Chapter II

SELECTION OF BLOOD DONORS AND BLOOD.

Item 1

BLOOD DONATION.

What? 4. Blood donor standard

The blood donor is the one with enough standards of age, health and other conditions, namely the following:

1. Age: 18 to 60 years old.

2. Health:

a) The person who weighs at least 42 kg for women, 45 kg for men is allowed to donate all part; the weight of 42 kg to less than 45 kg is allowed to donate no more than 250 ml of blood every time; the weight of 45 kg of weight is allowed to donate blood. The total air is no more than 09 ml/kg of weight and no more than 500ml each time.

b) The person who weighs at least 50 kg is allowed to donate the blood components of the cup; the blood donor can donate one or more blood components in each cup, but the total volume of blood donation components is not more than 500 ml; people weigh less. At least 60 kg is allowed to donate the total body of the donor component per non-650 ml.

c) There is no chronic or acute neurological, mental, respiratory, cycas, urinary, digestive, liver, internal, blood, and blood-producing, systemic disease, disease, illness, disease, and severe allergic; no pregnancy at the time of the blood donation registration. (for women); there is no history to take, donate, grafted human body parts; non-drug addiction, alcohols; no severe disability and disability that is particularly severe in the Law of Persons with Disabilities; not using certain drugs prescribed at the Annex. 1 issued with this message; no transmission of the disease transmitted by the blood sugar, the sexually transmitted diseases at the time of registration. The blood.

d) Clinical:

-sober, good contact.

-The systolic blood pressure ranges from 100 mmHg to less than 160 mmHg and diastolic in about 60 mmHg to less than 100 mmHg;

-The heart rate is all about 60 times to 90 times.

-There is not one of the following expressions: ghaze, fast weight loss (over 10% of body weight in the six-month period); blue skin, pale mucosa; eye flowers, dizziness; big ganglia; fever; fever; badness; cough, shortness of breath; diarrhea; hemorrhagic; There are lesions, abnormal signs on the skin.

Test:

-For full blood donors and to donate the blood components of the cup: the hemoglobin concentration must be at least 120 g/l; if the total blood donation volume above 350 ml must be at least 125 g/l.

-For a donor plasma donor: the total serum protein concentration must be at least 60g/l and tested for no more than 1 month.

-For the donor platypus, county white blood cells, the stem cells separated: the number of platypus must be greater than or equal to 150 ' 10 9 /l.

3. In addition to the regulations stipulated at paragraph 1, Clause 2 This, the donation of blood by the doctor to determine the blood donor considers, decided.

What? 5.

1. Those who have to delay the blood donation in 12 months from the moment:

a) Fully Restored after foreign intervention;

b) From the disease after contracting one of the malaria, syphilis, tuberculosis, tetanus, encephalitis, meningitis;

c) The end of the rabies prevention vaccine after being bitten or injected, blood transfusion, blood preparations and biological preparations from the blood;

d) Birth or end of pregnancy.

2. Those who have to delay the blood donation for 06 months from time:

) The tattoo on the skin;

b) Press the earlobe, press the nose, press the umbilical cord or other positions of the body;

c) Phong infection with blood and body fluids from people at risk or have infected with infectious diseases through blood sugar;

d) From the disease after contracting one of typhoid, sepsis, a snake bite, vasculitis, vasculitis, osteomyelitis, pancreatitis.

3. Those who have to delay the blood donation in 04 weeks from time:

a) From the disease after contracting one of the gastroenteritis, urinary tract infections, dermatitis, bronchitis, pneumonia, measles, cough chicken, mumps, hemorrhagic fever, dysentery, rubella, cholera, mumps;

b) End of the rubella chamber vaccination, measles, typhoid, cholera, mumps, chickenpox, BCG.

4. Those who have to delay the blood donation in 7 days from the moment:

a) From the illness after contracting one of the flu, cold, throat allergy, throat, migraine migraine;

b) Vaccine vaccines, except for the types that have been specified at Point 1 and b Point 3 This.

5. Some regulations concerning the profession and activities of the blood donor: those who do some work and carry out the following special activities that only donate blood on the day off or only be done for work, this activity after the end of the day. A minimum donation of 12 hours:

a) People who work on high or below depth: pilot, crane driver, high working worker, mountaineer, miners, sailors, divers;

b) The operator of the public transport: driving a bus, driving a train, flying boat;

c) Other cases: professional athletes, heavy campaigners, heavy training.

6. For non-regulation cases at 1, 2, 3, 4 and 5 This, the delay of blood donation is due to a doctor who chooses a blood donor to consider and decide.

What? 6. The minimum amount of time between blood donations and blood components.

1. The minimum amount of time between the two full blood donation or the red blood sphere by the cup is 12 weeks.

2. The minimum amount of time between the two consecutive blood donation or the platamus by the cup is 2 weeks.

3. Charter of neutral grandiaries or a stem cell donor with a maximum peripheral blood separation no more than three times in 7 days.

4. The case of intercalation of the entire blood donation and the donation of different blood components to the same blood donor is the minimum amount of time between the constituts being considered in the form of the blood that was donated during the last time.

Item 2

DISCOVER THE DONOR REGISTRATION AND BLOOD DONATION, THE BLOOD COMPONENT.

What? 7. Register and manage blood donation information, blood composition.

1. The blood donor, the part of the blood that must be presented in one of the following types of papers: the identification of the people, passports, military proof paper, public safety, driver's license, a business card, student card, student card, a blood donation or a certificate of identity. The agency, the organization, the body, the local government.

2. The donor of the blood donation, the blood component must fill up enough information into the Donor Health Status Questioner that is prescribed at Annex 2 issued by this message.

3. Blood reception facilities must organize a blood donor information management according to a regulatory filing prescribed at Annex 3 issued by this message. Personal information about the donor must be classified, only to be used for the purpose of ensuring the health of the blood donor and the prevention of transmission of disease to the person who receives the blood.

What? 8. Selected Discovery Content Your blood donor

1. Make a medical inquiry, find health, and do the prescribed tests at Article 4 of this.

2. Do the HBsAg rapid test before the blood donation to the first blood donor registry.

3. Not obligated to perform an HBsAg quick test when the selection of a blood donor registered has resulted in the results of the latest pre-first donation HBsAg not to react or have negative HBsAg test results in the first time. The nearest health exam in the 12-month period to the date of the blood donation.

4. The case of someone with a history of doubt HBsAg positive wants to donate blood, must have negative results in two consecutive HBsAg tests 6 months apart by ELISA technique or radiography and simultaneously perform tests using biological engineering. I mean,

What? 9. The full blood work, the blood component

1. Before the blood is taken, the blood component must check, for example, the use of the strain, the integrity and the anticoagenal composition of the blood blood bag (the blood packaging).

2. The blood bag must be coded according to regulation at Section 3 Article 21 This message.

3. The donation of blood must ensure the sternation, safe for the blood donor.

4. The blood volume is prescribed at Point a and Point 2 Article 4 This message and must be consistent with the amount of anticoagenal solution available in the blood bag.

5. Make sure the prosecution is linked to the blood unit, the blood composition: code, actual blood volume, time, time, employee name for blood, the blood component.

6. The case of blood volume takes little or more than 10% more than the regulation for each type of blood that takes blood or has other abnormers in the process of taking blood, the blood worker must write warning on the blood bag with a durable pen or label to review and process. -Yeah.

What? 10. Request for experimental blood sampling

1. The blood samples used for tests must be taken from the blood donor at the same time as blood, into the blood composition or taken directly from the blood bag, the blood component bag.

2. The blood sample must be attached to the number of codes corresponding to the code of the blood bag, the blood component is taken as prescribed at Clause 2 This Article 9.

What? 11. Process the blood unit, the blood component right behind the blood.

Blood units, the component of the blood must be packaged, transported in temperature conditions in accordance with the purpose of use by regulation at this Article 20.

Section 3
TO ENSURE THE RIGHTS OF THE BLOOD DONORS

What? 12. Blood donor rights

1. Provided information about the signs, symptoms of pathology due to infection of hepatitis, HIV, and some other blood-borne infections.

2. To be explained in the process of taking blood, the undesirable accidents may occur, the tests will perform before and after the blood donation.

3. Secrets of the clinical examination of clinical findings, results of the test; advised on the abnormal findings of health care, blood donations; guided health care; advised on the abnormal test results by regulation at Clause 4 Articles 4. This is 17.

4. Be taken care of, treatment when there are undesirable accidents in and after the prescribed blood donation at Annex 4 issued by this message. Supported by the cost of care, treatment when there are undesirable accidents occur during and after the blood donation. Funding to support the treatment of blood donors by regulation at this paragraph is carried out by law.

5. Questioned By The Authority, the decision to honor, praise and secure other rights for the spirit, matter of the blood donor by the rule of law.

Chapter III

TESTING THE ENTIRE BLOOD UNITS AND THE BLOOD COMPOSITION.

What? 13. Principles of Test

1. Must perform screening tests for each blood unit, the blood component. No test results have been made from before or before the blood donation of the blood donor to the blood unit, the resulting blood component, except for the specified case at Article 3 of this Article 15.

2. Choose, use of the medications, the biopsy, the instrument, the test device that ensures the quality of the blood unit screening test is prescribed by the law. Performing quality control, testing quality tests.

3. Perform the test processes, test methods, analysis of outcomes in accordance with the product, equipment, equipment, and have been conducted by the unit leadership.

4. Make a screening of the screening agents transmitted through blood sugar to the blood unit, the blood component must ensure the following requirements:

a) The blood sample must be the same source as the blood unit, the prescribed blood component at this Article 10;

b) Can search for blood bags from blood samples and vice versa tracing blood samples from the blood bag;

c) Perform the test in the way of ensuring sensitivity, prevention of false negative risk and is approved by the unit leadership;

d) The test results screening agents transmitted through blood sugar to the blood unit, the blood component is only used for safety control for the blood unit, the blood component intended to prevent the infection of the infectious agent through blood sugar and not be used to prevent it. Answer, counselor to the blood donor.

5. When taking blood from the blood donor multiple times, it must be treated with the test results of the previous most recent blood donation unit. The case of the test results has different or mistaken suspicion of the test or error and the profile, which has to be retested with the sample taken directly from the blood unit, the blood component.

6. When doing an affirmable test of the infectious agent via blood sugar to the blood donor must ensure the following requirements:

a) Verification of the flesh of the blood that is made of blood;

b) Perform the test in order to ensure the specificness of the specification, prevention of the risk of false positive and granted authority approval;

c) The affirmable test results are only used for answers, health counseling for blood donors, and are not used to control the safety of blood units, the blood component.

What? 14. Blood unit screening tests

1. The mandatory tests must be done for all full blood units, the component blood component is:

a) blood group serum test: ABO, Rh (D) red blood cell group, abnormal antibodies screening;

b) test some infected agents: HIV screening tests, hepatitis B, hepatitis C, and syphilis.

2. In addition to the prescribed tests at Clause 1 Article, there must be an additional number of tests in the following cases:

a) The implementation of the Rh group (C, c, E, e) or the MNSs, Kidd, Duffy, P, Lewis when the treatment doctor specified the blood transfusion of the choice of red blood cells.

b) The malaria screening test for all-part blood units, the blood component taken from a living donor, worked in areas where malaria was published by the Ministry of Health or those who recently returned from the malaria epidemic during the 06-year period. Months or people with a history of malaria in the 12-month period since the treatment of malaria;

c) A CMV (Cytomegalovirus) test for blood processing units for the person with a tissue transplant, stem cell transplant or blood transfusion for the fetus or some other special cases at the request of the treatment doctor.

3. Additional testing: in some cases to ensure the safety of the person who receives blood, the blood transfusion facilities have sufficient technical condition to perform additional testing according to the treatment of the treatment doctor.

4. Technical requirements for mandatory tests:

a) The ABO blood group designation: must be done in two sample serum methods and sample red blood cells with equivalent minimum techniques or higher techniques performed in vitro. The blood group is only concluded when there is a consistent fitting of the two methods or is confirmed by additional tests;

b) Rh blood group theorem (D): must be done by a sample serum method with minimal technique performed in vitro. Only the blood unit conclusion has the negative Rh (D) group, after having performed tests confirmed by equivalent or higher testing of indirect globulin resistance;

c) The abnormal antibody screening test must carry out the test technique capable of detection of abnormal, minimous antibodies to the Rh, MNSs, Kell, Kidd, Duffy, Lutheran, according to the regulatory route at Article 70 of this.

d) HIV screening tests: must be performed with sensitivity, equivalent specificness or higher specification of the ELISA technique or radialization with the organism capable of simultaneously detection of antigen, HIV-1 and HIV-2 antibodies;

Test test for hepatitis B virus: must perform an HBsAg antigen detection test using sensitivity, equivalent specificness or higher than the ELISA technique or lumination;

e) A test for the screening of hepatitis C: must be performed with sensitivity, equivalent specification or higher specification of the ELISA technique or radiisome with a minimum possible organism to detect an inflammation of the hepatitis C;

g) HIV-1 and HIV-2 screening tests, hepatitis B virus, hepatitis C virus using NAT techniques applied to all blood units, the blood component according to regulatory route at Article 70;

h) A syphilis test: having to perform a syphilis detection test with sensitivity and equivalent specificness or higher than the RPR technique;

i) The malaria screening test: having to do a technical test with equivalent sensitivity or higher than the technique for malaria parasite.

And the droplets, the droplets, and the readings of the microscope with the microscope;

c) CMV test: must perform an IgM antibody detection test, the CMV resistance using equivalent sensitivity or higher sensitivity than the ELISA technique or lumination.

5. The order to carry out HIV screening tests, hepatitis B, hepatitis C, syphilis, and syphilis. The blood unit conclusion, the safe blood component with these agents must base the test results conducted by the ELISA technique and the NAT technique or the NAT optical and optical chemistry.

6. Must apply the measures to ensure the quality of the blood units, the blood component of the prescribed blood in Appendix 5, Annex 6 issued by this message.

What? 15. Test screening agents transmit disease via blood sugar in the special case.

1. HIV-1 and HIV-2 screening testing, hepatitis B, hepatitis C for the blood unit before transmission by a quick test method is only done when responding to the following conditions:

a) Only applies to the medical facilities in the mountains, deep regions, remote regions, borders and islands;

b) Only apply to all-part blood units; do not apply to blood component units;

c) The treatment doctor is blood transfusion and records in the medical records;

d) Have been associated with the nearest blood transfusion facility, but there is no integrated blood unit or blood-taking time from the nearest blood transfusion facility that does not respond to a request for emergency relief;

The sick person or the legal representative of the patient's patient confirmed to the medical records of the consent of the transmission of blood only by quick testing, after having been explained by paramedics on the risk of infection with the disease;

e) The confirmation of the person in charge of the department, the clinic, the cure or the authorized person on the non-unit of blood is stored at the clinic, curing or not enough compared to the need for treatment and patient records confirm the practice permit. Now, the quick test at the time needs to transmit the blood.

2. In the case of applying the regulations at paragraph 1 This is about the testing of the blood unit by the quick test method, the medical examination facilities, the treatment must be done as follows:

a) The delay is 24 hours from the time of the execution of the blood unit to be only screened by quick test methods, the medical examination facility, the treatment must continue to fully implement the prescribed tests at Article 14 of this and must save the test sample. regulation at this Article 16;

b) In the absence of the ability to carry out the prescribed tests at Article 14 and Point A 2 This, the examination facility, the treatment must be sent to the blood serum, the plasma of the blood unit transmitted to another facility is capable of performing tests. according to the regulations at Article 14 of this date in the slowest period, the following week is 7 days from the time the blood transfusion is only screened by rapid testing; the serum sample of the blood unit transmitted at the facility performing screening tests. regulation at this Article 16.

3. The facility for disease, mountain disease, depth, remote region, borders and islands are not likely to carry out the prescribed test at Article 14 of this and also cannot be sent to other facilities as a prescribed trial at Clause 2 This, which is expected. using the unit of blood that is screened by quick testing, when responding to the following conditions:

a) The blood donor was given a screening test under the regulation of Article 14 of this information in the period of no more than 12 months to the time of the blood donation with the results that answered the results of the test must be negative and stored at the donor basis;

b) The blood unit must be given a quick test of HIV screening, hepatitis B, hepatitis C with the results of the tests must be negative. .

What? 16. Save the Test template

1. Must save the serum sample or plasma used to test the screening of all the full blood units, the blood component. Save the blood bag by regulations at Appendix 6.

2. The test template must be preserved at temperatures from minus 18 o C (18) o C) get down, be encrypted and set up the management profile.

3. The test template must be kept at the facility performing a minimum test of 2 years from the date of the blood. For the blood unit, the blood diet has a shelf life of more than 2 years since the blood-taking, the duration of the sample retention period must last a minimum of 1 years from the expiration date of the use of blood units, the blood diet. The department (nest, group, department, room) is a serum that is independent of the laboratory.

What? 17. Manage Test results

1. After the test results, the test department must have the responsibility to inform the results by writing or transmitting electronic data in a manner that is approved by the unit leadership for relevant parts.

2. If the blood unit screening tests on the cause of the pathology of the disease have abnormal results, then the prescribed implementation at Annex 6 issued this message.

3. The case of a blood unit test, the blood component taken from a blood donor that repeated the abnormal results of blood-borne pathogens, the trial department screening the blood unit to reexamine blood samples from the blood unit, the blood component of the same. The blood donor at the previous donation; if the previous retrial of the previous constitution continues to reexamine the sample taken in the adjacent constitution, the test department has the responsibility to inform the department, the unit concerned to see it. It ' s on the same way that the Fourth Appendix is made available. The testing for the blood samples of previous donations must use the technique and the product with a high sensitivity of at least equal to or equivalent to the technique and the product performed last time.

4. Only to be informed of the abnormal results for the blood donor when the test is confirmed according to Annex 6 issued this message. In the case of an assertion on HIV, it must be done according to the current Regulation of Health for the announcement of positive HIV test results.

Chapter IV

PREPARATION, PRESERVATION, BLOOD TRANSPORT AND BLOOD PREPARATIONS.

Item 1

GENERAL REQUIREMENTS

What? 18. Common Principles

1. Only use blood clots, a bag that separates the blood (blood packaging) that ensures the quality and has a clear origin.

2. Implementuation of blood preparations in the closed system or the preparation case in the open system must ensure the implementation of the steral process.

3. East cold and freezing cold blood plasma and precipitation preparations

a) The plasma unit must be frozen for a maximum duration of 8 hours from the time of the start of the freezing cold with the minus 25 temperature. o C (-25 o C) get down.

b) Preservation: must preserve at the maintenance temperature from minus 18 o C (-18) o C) get down.

c) To thaw, breeking the blood bag, the blood preparations must ensure the following conditions:

-Not to the surface of the blood, the blood transfusion sites are directly exposed to the solution.

-It melts in the heat from 30. o C to 37. o C in the time of no more than 15 minutes for cold precipitation and no more than 45 minutes for frozen plasma;

-The blood unit, the blood processed, is not frozen again.

4. Gamma refraction for blood bags and blood preparations

a) There must be gamma irradiation for blood bags and blood preparations to prevent leukemia leukaemia before transmission to patients with immunodepleation, with a radiation dose for each screening to reach at least 25 Gy (2,500 cGy);

b) The limitation of the red blood cell after the radiation is 28 days and it is required to comply with the restriction of the same type, the same time. The use of the platamus does not change after radiation;

c) It must be labeled a blood bag that has been irradiated with unmapped blood vesicles.

5. quarantine and destroy the blood unit:

a) The blood unit, the blood component, and the whole of the blood processing units that are not tested by regulation at Articles 14, Article 15 This Privacy must be isolated, preserved separately until the conditions are met. The method of handling the blood units, the blood component with an abnormal test results in accordance with the regulation at Annex 6 issued this message.

b) All blood units, unsafe or expired blood preparations must be isolated, managed separately, and destroyed by the current regulation of medical waste management.

What? 19. Cold equipment preservation of blood units and blood preparations.

1. Joint request for cold equipment preservation of blood unit and blood preparations.

a) The Chamber of Refrigeration Equipment protects the blood that must be secured with stable voltage and good ventilation;

b) The cold device has enough space in the preserved compartment to ensure the flow of gas flow, ease of inspection and observation;

c) The copper temperature is in every position inside the preserved cavity;

d) A cold device must have a temperature tracking system that meets the following requirements:

-It is possible to monitor temperature simultaneously by two independent, continuous, and circulate methods that are given the actual time by the automatic temperature recording system or manual recording at least four hours a time.

-The temperature monitoring system of the cold device must operate in case of power loss;

-There's an abnormal temperature warning system with sound, light.

The cold device protects the blood unit, the blood preparations are not used to preserve the trials, the food, the food, the food, the food.

e) There is a private reservation, which has a distinguished label for each type of blood, blood processing, as follows:

-The safety test is available.

-The untested.

-The kind of test and the abnormal results.

2. Demand for the freezer preservation of the blood unit, blood preparations

a) The temperature inside the preserved compartment is always 2 o C to 6. o C.

b) Ensure that the heat of the chamber is the heat of the conduit with the wind gusts;

c) Allow the observation to be stored by blood bags inside the preserved compartment, without opening the cabinet.

3. Required for the frozen counter to protect the blood unit, blood preparations

a) The temperature inside the preserved cavity always has temperatures from minus 18 o C (-18) o C) comes down depending on the preservation requirements of the type of blood preparations and the approved process;

b) There is a possibility to periodically self-break in the cold or to periodically destroy the frozen stone.

4. Required for the pendulum and the platamus maintenance cabinet

a) The temperature inside the preserved compartment is always 20 o C to 24 o C.

b) Make sure the field is temperature in the wind by the ventilation of the fan;

c) The observation is stored inside the storage compartment, without opening the cabinet;

d) The machine was horizontal.

There are alarm systems when the machine stops working or there are abnormties.

What? 20. Blood transport and blood preparations

1. The device, the transport vehicle must maintain the temperature consistent with the requirements for the preservation of each type of blood and blood preparations.

2. The transport of the unit of blood must ensure safety, control, monitor temperature and transport time according to the following requirements:

a) For the full blood and the red blood sphere: guarantee the maintenance of the temperature in the transport bay from 1 o C to 10 o C during the transport process; the full blood is used for the preparation of the preserved platomas, the prescribed transport at point b 2 Article 22 This message;

b) For the platypus and the white sphere: ensure the maintenance of the temperature in the transport bay from 20 o C to 24 o C.

c) For plasma and frozen blood preparations: ensure maintenance of the temperature in the transport compartment from minus 18. o C (-18) o C) get down.

d) The cold stone used for preservation is not directly placed in direct contact with the blood bag.

What? 21. The label of the blood unit and blood preparations

In addition to adhering to the current regulations on the label of goods, the label of the blood unit, the blood preparations must have the following information:

1. Name, address the basis of blood treatment and preparation.

2. Blood preparation name.

3. Code of blood unit, blood processing: only one code that allows access to donor information, blood clots, screening, preparation, storage, delivery, distribution and use of blood units, blood preparations.

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

5. Day, month, year of blood.

6. Name anti-freeze or preserve solution (for full blood or red blood).

7. expiration date.

8. The volume or weight of the blood preparation unit.

9. The preservation temperature.

10. Note on all the labels of blood bags, blood preparations: "The need to pass through the wire has a filter; it is not transmitted if there is a blood-soluble, abnormal color". With the blood, the blood preparations have been shown, the "radiated".

Item 2

STANDARD OF SOME BLOOD PREPARATIONS

What? 22. Full blood.

1. Standards: taken from a blood donor selected by regulation at Article 4 of this Notice and does not belong to the cases that must delay the blood donation by regulation at this Article 5. These all-blood units must have safe results with the tests prescribed at Article 14, Article 15 of this.

2. Terms of preservation and limitation of use:

a) When preserving at temperatures from 2ºC to 6ºC, the use of full blood is no more than 21 days with a phosphate-phosphate solution-phosphate-dextrose and no more than 35 days with Citrate solution-phosphate-dextrose-Adenin;

b) When preserving at temperatures from 20ºC to 24ºC, the use of full blood is no more than 24 hours.

3. Quality examination (which is done with a random sampling rate in proportion from 0.1% to 1% of total total blood units and no less than 05 units per month) on the following standards:

a) The volume difference is no more than 10% volume volume on the label (not including anti-freeze volume volume);

b) Check out the implementation of the prescribed tests at Article 14, Article 15 This Information;

c) minimum hemoglobin concentration of 10g in each volume of 100 ml of total blood;

What? 23.

1. The condensate red blood sphere is the rest of the entire blood that has separated the blood plasma after centrifugation or to listen and does not perform any other processing work.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 0.1 to 1% of total units being prepared and no less than 05 units per month) on the following standards:

a) The volume of the red blood sphere is 60% ± 15% of the original blood volume;

b) the minimum amount of hemoglobin is 10g from every 100ml of full blood prepared;

c) Hematocrit range from 0.65 to 0.75.

3. Terms of preservation and use of use: as the full blood rule stipulate at Point 2 Article 22 This message.

What? 24. The red block has a preserved solution

1. The dense red sphere with the addition of red blood cells to improve the quality of red blood cells.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 0.1% to 1% of total units processed and no less than 05 units per unit).

in the month of the following standards:

a) Use a preserved solution with Adenin in the composition;

b) The volume of the processing unit is 70% ± 15% of the original total blood unit volume;

c) The minimum amount of hemoglobin is 10g from each volume of 100ml of full blood processed;

d) Hematocrit from 0.50 to 0.70;

3. Terms of preservation and limitation of use:

a) For the sphere of red blood cells with a preserved solution prepared in the closed system: the use of implementation by the manufacturer's recommendation for blood clots and a blood protection solution, but does not last more than 42 days from the time of blood and protection at temperatures. from 2 o C to 6. o C.

b) For the sphere of red blood with a preserved solution prepared in the open system: only used for a period of no more than 24 hours if preserving at temperature from 2%. o C to 6. o C and no more than 6 hours if preservation at room temperature (from 18) o C to 24 o C) since the implementation of the system in the open system.

What? 25. The red block drops white blood cells

1. The red blood sphere of leukaemia is that the red blood cell is separated by a centrifugation method that removes over 70% of the white blood cells present in the original blood unit.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 0.1% to 1% of total units being prepared and no less than 05 units per month) on the following standards:

a) The volume of the red blood sphere is 70% ± 15% of the original blood volume;

b) the minimum amount of hemoglobin is 9.5g from every 100 ml of total blood;

c) Hematocrit from 0.50 to 0.70;

d) The remaining white count fewer than 1.2 ' 10 9 from every unit of red blood cells to reduce the white blood cells. At least 75% of the blood units tested must be reached this standard;

3. Terms of preservation and shelf life: The red blood cell reduction is preserved by regulation at paragraph 3 Article 24 This message.

4. The red blood sphere of leukaemia has a preserved solution: prescribed at paragraph 2 This and Article 24 of this.

What? 26.

1. The pink block of washing is the red blood sphere that is eliminated plasma by washing several times (minimum three times) with a caste solution and is diluted in an isotopal saline solution or in a preserved solution or in the plasma of the right.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 10% of total units being prepared) on the following standards:

a) The volume of this product is 65% ± 15% of the original total blood volume;

b) The concentration of protein in the last floating water is less than 0.5g/unit of red blood cells;

c) The minimum amount of hemoglobin is 9.0g from each of the original 100 ml of blood;

d) Hematocrit from 0.50 to 0.70;

3. Terms of preservation and shelf life: the pink block of washing in the open system, when preserving at temperature from 2 o C to 6. o Limit usage in 24 hours; when preserving at 20- o C to 24 o C has limited use within 6 hours of the end of the regulation. The red blood cells wash in the closed system, with the addition of a red blood cell preservation solution, preserving at a temperature of two. o C to 6. o C is limited to 14 days.

What? 27.

1. The white blood sphere filter is the red blood sphere removed by white blood cells. Leukaemia must be done in a 72-hour period, since taking blood from the blood donor.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 5% of total units to be prepared) on the following standards:

a) The volume of the red blood sphere is 65% ± 15% of the original blood volume;

b) the minimum amount of hemoglobin is 9.0g from each volume of 100 ml of the original portion;

c) Hematocrit from 0.50 to 0.70;

d) The remaining white count is less than 1.0 × 10 6 in every unit of red blood cells. There must be at least 90% of the blood units tested at this standard;

3. Terms of preservation and usage: as specified at Clause 3 Article 24 This message.

What? 28. The frozen red blood sphere.

1. The frozen red blood sphere is frozen red blood cells in frozen red-red red blood protection solution with glycerol and is preserved at temperatures from minus 60. o C (-60 o C) get down. Before being passed on to the sick person, the frozen red blood sphere must be melted, washed, and removed glycerol, which is dilated in an isotopic salt solution or the addition of a red blood cell preservation solution.

2. Quality and quality checks

Performing a quality check (with a minimum sample count of 10% of the total number of frozen red red blood mass units that dissipated and removed glycerol) on the following standards:

a) The volume of the red blood sphere is 65% ± 15% of the original blood volume;

b) the minimum amount of hemoglobin is 8,0g from every 100ml of the original blood;

c) Hematocrit from 0.50 to 0.75;

d) The maximum osmowork is not higher than 340 mosm/l;

It ' s a culture of negative bacteria.

3. Terms of preservation and limitation of use:

a) Limit usage is 10 years of preservation with a 40% glycerol solution at minus 80. o C (-80) o C) to minus 60 o C (-60 o C);

b) The restriction is 10 years of preservation with a 20% glycerol solution in liquid nitrogen at minus 150. o C (-150 o C) to minus 120 o C (-120 o C);

c) The restriction is 14 days from the date of the dissipation, the red blood cell removal of glycerol in the closed system and the addition of a red blood cell;

d) Use no more than 24 hours if preserving from 2 o C to 6. o C and no more than 6 hours if the protection at room temperature since dissolving and washing red blood cells removes glycerol in the open system.

What? 29. The plato block from the full blood unit

1. The platometer contains much of the platine prepared from the conservation total blood unit at temperatures from 20. o C to 24 o C in 24 hours from the blood.

2. Standards and test of the quality of the thromstone block from a full blood unit.

Perform a quality test (with a random sample count by 1% to 5% of total units being prepared and no less than 10 units per month) on the following standards:

a) Unit volume: volume from 40 ml to 60 ml of preparation from each of the total blood units that can be accumulated from 250ml or more;

b) Count the number of platos: a minimum of 13 × 10 9 The platamus in the subunit of the platamus from each volume of 100 ml of total blood. At least 75% of the blood units tested must be reached this standard;

c) Count the number of white blood cells per unit of platypus:

-Less than 0.05 × 10 9 Leukaemia for platypus by means of leukemia-leukaemia. At least 75% of the blood units tested must be reached this standard;

-Less than 0.2 × 10 9 The white blood cells are on the platypus of the platypus. At least 75% of the blood units tested must be reached this standard;

d) The pH must reach between 6.4 and 7.4 when measured at 22 temperature o C at the end of the preservation period;

The transplant test found the bacteria to have negative results.

3. Standards and test of unit quality pool unit quality from multiple partial blood units.

Perform a quality test (with a random sample count by 1% to 5% of total units being prepared and no less than 10 units per month) on the following standards:

a) Unit volume: volume from 120 ml to 200 ml of preparation of 1,000ml of total blood;

b) Count the number of platos: a minimum of 140 × 10 9 Platamus in a unit of platamus from 1,000ml of total blood. At least 75% of the units tested must be reached this standard;

c) Count the white count: less 1.0 × 10 9 the white blood cells in every subunit of the platypus;

d) The pH and cultured detection of bacteria: in accordance with the regulation of the point d, clause 2 This.

4. Terms of preservation and shelf life

a) For the regulatory mass of the course from the full blood unit in the closed system: the restriction used by the manufacturer's recommendation to collect blood, but not more than 5 days from the date of blood and urine protection at the temperature of 20. o C to 24 o It is accompanied by continuous shaking;

b) For the regulatory volume of the total blood unit in the open system unit in the open system: the use limit is not more than 06 hours, since the preparation of treatment at temperature from 20 o C to 24 o It is accompanied by continuous shaking.

What? 30. The plato block separates from the blood donor

1. The separable plato cube is the platamus that takes directly from the blood donor with the automatic cell separation machine.

2. Quality and quality checks

Perform a quality check (with a random sample count by a ratio of 10% of the total number of units separated) on the following standards:

a) The volume of each unit does not oscillate more than 15% of the volume on the label;

b) Each unit of separable subunit (250 ml) has a minimum number of 300 × 10. 9 ; in the case of the isolated platamus case volume of 120 ml to below 250 ml has a minimum platamus number 150 × 10 9 ()

c) The urine concentration must be less than 1.5 × 10 9 /ml;

d) The pH must reach between 6.4 and 7.4 and culture detection of bacteria must be negative at the end of the preservation period.

3. Conserved and shelf-use conditions: at the recommendation of the manufacturer pocket manufacturer, but not more than five days from the date of the platterus when preserving at temperatures from 20. o C to 24 o C, continuous shaking.

What? 31. White blood filter platypus

1. The platypus of leukaemia is a platypus that is prepared from the blood of the whole part or by a cup and is removed from the white blood cells by the white blood filter.

2. Standard and test quality: check out the quality of the white blood cell filter platypus units

a) The volume of each unit fluctuated no more than 15% (± 15%) volume on the label;

b) The white blood filter platypus is prepared from the full blood: there are at least 130 × 10 9 Platamus in the unit of platamus from every 1,000 ml of total blood;

c) The platypus of leukaemia diverts from blood donors: there are at least 300 × 10 9 The platterus with each turn of the platterus;

d) There is less than 1 × 10 6 the white blood cells in a unit of platypus;

The pH must reach between 6.4 and 7.4 at the end of the preservation period;

e) Cultured the detection of negative bacteria: check this standard in at least 1% to 5% of the processed units. There is no need to check this standard with the white blood filter platypus right at the hospital bed.

3. Terms of preservation and limitation of use:

a) For the regulatory subblock in the closed system: the restriction used by the recommendation of the manufacturer to take blood, but not more than 05 days from the date of the blood and urine protection at temperatures since 20 years. o C to 24 o It is accompanied by continuous shaking;

b) For the system of regulation in the open system: the usage limit is not more than 06 hours, since the preparation of the preparation when preserving at temperature from 20 o C to 24 o It is accompanied by continuous shaking.

What? 32. The plasma and blood are frozen.

1. The blood plasma is a liquid part that does not contain blood cells, which are prepared from the entire blood unit or taken directly from the donor plasma donor directly. The plasma can be used immediately after the preparation or the frozen (known as cold-eastern blood) in accordance with Article 3 Article 18 of this Information.

2. Standards and quality examination: perform the quality test (with a random sample count by a ratio of 0.1% to 1% of the total units being prepared and no less than 05 units per month) on the following standards:

a) protein concentration is no less than 50 g/l;

b) The volume of the plasma is not more than 10% volume on the label.

3. Terms of preservation and shelf life

a) o C to 6. o C: The restriction of blood plasma is no more than 14 days from the time of preparation in the closed system and no more than 24 hours from the time of preparation in the open system;

b) Preservation at minus 18 o C (-18) o C) to minus 25 o C (-25 o C): the restriction of blood plasma is not more than 12 months from the time of blood or blood separation;

c) Preservation at minus 25 o C (-25 o C) get down: the restriction of blood plasma is not more than 24 months from the time of blood or blood separation.

) Do not freeze the plasma of the same blood.

What? 33. The blood is fresh and the plasma is frozen.

1. The plasma is similar to the concentration of unsustainable blood clots maintained at physiological concentrations, which are prepared from the blood of the whole part or taken directly from the blood donor by the method of separation.

2. The frozen plasma frozen is the plasma that is prescribed at 1 This and is frozen in the plasma for a maximum duration of 18 hours from blood or blood separation. The cooling of the plasma is equivalent to regulation at the Article 3 Article 18.

3. Standards and quality tests for the plasma of fresh and frozen soy plasma: perform the quality test (with the random sample count by a ratio of 0.1% to 1% of total units being prepared and no less than 05 units per month) on the following standards:

a) The volume of the plasma is not more than 15% of the volume recorded on the label;

b) The concentration factor VIII is no less than 0.7 IU (international unit) /ml. At least 75% of the samples tested must be reached this standard;

c) The number of residual cells: red cells less than 6.0 × 10 9 /l, white blood cells less than 0.1 × 10 9 /l, plato less than 50 × 10 9 /l;

d) The total protein concentration is not less than 50g/l;

No, no, no, no, no, no, no, no.

3. Terms of preservation and limitation of use:

a) o C (-18) o C) to minus 25 o C (-25 o C): the restriction of blood plasma is not more than 12 months from the time of blood or blood separation;

b) Preservation at minus 25 o C (-25 o C) return: the use of blood

less than 24 months from the time of blood or blood separation;

c) For the plasma diet and the frozen plasma of the cold, it melts:

-Preservation at temperatures from 2. o C to 6. o C: must be used in the round of 06 hours from the time starting to thaw; the appropriate label must be changed (plasma) if preserved over 06 hours;

-It's not frozen. It's frozen. It's frozen.

What? 34. Cold

1. The cold is a diet from the precipitate that formed during the melting of the frozen plasma in the temperature of 10. o C get down. Cold precipitation can continue to be purified and inactivated by chemical or temperature.

2. Standards and quality checkup: perform the quality test (with a random sample count from 0.1% to 1% of the total units being prepared and no less than 05 units per month) on the following standards:

a) The volume from 10 ml to 25 ml per unit of cold precipitate from a single-blood unit has a volume greater than or equal to 250 ml. Volume from 80 ml to 120 ml per cold-precipitate pool from 2,000 ml of total blood. The cold precipitate of the food gradient is no more than 15% of the volume recorded on the label.

b) The factor of factor VIII is no less than 30 IU per unit of cold precipitation prepared from a full blood unit that can be more or equal to 250 ml and at least 75% of the samples tested at this standard;

c) The amount of fibrinogen is no less than 75mg for each unactivated cold precipitate order from a full-blood unit that can be more or equal to 250 ml and at least 75% of the samples tested at this standard;

d) No unusual color, no bullshit, clot.

3. Terms of preservation and limitation of use:

a) o C (-18) o C) return: the use of cold precipitation is no more than 12 months;

b)

-When it comes to the temperature of two. o C to 6. o C must use a cold precipitate or within 06 hours from time to start to thaw;

-It's not frozen after it melts.

What? 35. High-particle leukemia.

1. The neutral particle particle is directly separated from the blood donor or prepared from the all-preserved blood units preserved at the temperature of 20 years. o C to 24 o C is no more than 24 hours from the time of the blood.

2. Quality and quality examination: quality test execution (with a random sample count by a ratio of 10% of total units to be prepared) on the following standards:

a) product unit volume: from 250 ml to 300 ml;

b) There are 10 × 10 9 The white blood cell count in each of the food units and at least 75% of the number of food units are tested at this standard.

3. Terms of preservation and usage restrictions: preservation at temperatures from 20 o C to 24 o C, do not shake, within 6 hours from the time of the preparation and within 24 hours from the time of the blood.

What? 36. Blood preparations for children

1. The transmission of red blood cells to the fetus is the prescribed white blood filter by regulation at Article 27 and must meet the following requirements:

a) Be preserved at a temperature of 2 o C to 6. o C within 05 days from the time of the blood.

b) Hematocrit range from 0.70 to 0.85;

c) It is possible to be screened by regulation at paragraph 4, Article 18 of this Information.

2. The transmission volume for the fetus is the prescribed platypus of leukaemia at Article 31 of this, in addition to the prescribed radioactivity at Clause 4, Article 18 of this Information when the clinical treatment of the doctor is clinically treated.

What? 37. Blood used in blood transfusion for infants

1. The total blood is used to transmit blood on the newborn: it must meet the conditions prescribed in this Article 22 and be preserved within 5 days from the time of the blood. The full blood use is used to transmit the newborn to the white blood cells, radiated by the clinical physician's designation.

2. The full blood recovery is used to transpose blood for infants: being the prescribed red blood cell at one of the Articles 23, 24, 25, 26, 27 and 28, and the addition of a fresh plasma or frozen plasma of cold blood regulation. Article 33 This message to restore properties such as full blood, in addition must meet the following requirements:

a) The red sphere is preserved within 5 days of the date of the blood or day of the freezing of frozen red blood cells;

b) Are removed from the preservation solution after centrifugation;

c) The supplematuation of the AB group cold, or another group is immune to the group of the red blood cell unit and the blood group of the newborn;

d) The preservation product at temperatures from 2 o C to 6. o C and use within 4 hours of the time being restored;

Check out the quality of all the blood units restored by regulation at Section 3 Article 22 This message and hematocrit are between 0.40 and 0.50;

e) The total amount of recovery is used to transmit blood to infants, which are filtered by white blood cells, to be radiated in the case required by clinical treatment physicians.

Chapter V.

MANAGEMENT, BLOOD USE AND BLOOD WORK AT THE TREATMENT FACILITY

What? 38. The principle of urgency, use, blood recovery and blood food.

1. Only issued blood units and blood preparations for the sufferers when: no detection of the risk of infection of the infectious agent via blood sugar; there is full results of the ABO blood blood group test, Rh (D); blood unit, blood preparations to standard regulatory standards. corresponds and does not exceed the prescribed shelf life for each type; there are no unusual signs of external form examination; the guarantee of the immune harmony between blood units, blood preparations, and the transfusion of blood.

2. recall, quarantine of blood units, blood preparations in:

a) The specified cases at Clause 2, paragraph 3 Article 17 This Information;

b) The cases stipulate at Clause 2 Article 41 of this.

c) All-part blood units and plasma preparations, the platypus, the blood cell block from the blood unit, the blood component of an abnormal antibody test by regulation at Point 4 Article 14 This is positive or suspicious. Positive.

3. Simply use blood transfusion on the basis of the pathology of each person ' s pathology.

4. The blood department of the pathology facility, curing the treatment for a blood transfusion test and directly issuing blood to the clinical therapists of the clinic, treating the disease to perform blood transfusion, blood preparations for the sick.

What? 39. Delivery, blood receipt and blood preparations

The delivery, blood and blood delivery between the basis of blood supply with the facility of disease, disease, or between the facilities of the disease, is treated only when the following conditions are met:

1. The medical facility is authorized by the authority to allow the provision of blood supply to the facility of disease, healing other diseases;

2. There is a legal contract that provides blood between the supply base and the blood delivery facility, blood food;

3. There is a planned vote, supply of blood and blood preparations by regulation at Annex 8 issued this message;

4. The case does not have a blood supply contract: the expected vote must have the confirmation of the leadership representative or the authorized person of the facility, cure it;

5. There are health workers who perform the delivery and receive of blood;

6. There is a means of preservation, blood transport and suitable blood preparations;

7. Blood delivery records must be kept and controlled by regulation at Article 61 of this.

What? 40. Import, for reference, blood preservation at the blood transfusion unit of the medical examination facility, healing

1. Blood and blood preparations before entering the warehouse must be treated, examined:

a) The external form and the packaging under regulation at Article 41 This Information;

b) The information on the label pursues to Article 21 of this Information;

c) Preserving conditions, transporting blood in accordance with each type of blood, blood processing by regulations at Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35.

d) The test person, the passport must report the person in charge of the unit of blood on the abnormers detected when the reference to the review, decides how to handle it.

2. Private preservation of blood bags, blood-based blood products A, B, O, AB, Rh (D) negative in different compartments of cold equipment or in separate cold devices.

What? 41. Check the form outside the blood bag, blood preparations.

1. Must check the form outside the blood bag and blood preparations in the following cases:

a) The communication between the parts in the blood transfusion basis;

b) The communication between the basis of blood supply and the blood unit of the facility of disease, disease, or between the blood units of the disease facilities, the disease with each other, or the intersection of the blood supply facility.

c) The communication between the blood transfusion unit and the treatment unit of the same treatment facility, healing.

2. Do not use blood units and blood preparations, when the detection of the following signs:

a) Thbacking, opening, cracking, broken in bags, wire pipes, wire sockets;

b) The phenomenon of unsubclass or abnormal subclasses between the blood components when they were left to listen or centrifugate;

c) There is an unusual color:

-pink or red in the upper part of the blood plasma and red blood cells or all the plasma;

-The plasma is unusual in colour.

-The red blood exchange is red or dark black or other unusual color.

d) There is a clot, a thing, a precipitate;

There's a surface in the surface.

What? 42. Required for the treatment unit before the receipt of blood, blood preparations

1. The treatment doctor needs to assess the condition of pathology and early detection the need for blood transfusion in people.

2. The treatment doctor must specify the tests for the sick person who is expected to transmit blood:

a) ABO blood group, Rh (D);

b) Screening Abnormal Antibodies For The Sick:

-There's a history of blood transfusion.

Women have a history of pregnant, giving birth, and pregnant many times;

-If in the course of treatment, the person needs blood transfusion several times, many days to redo this test periodically no more than seven days.

c) The case of an abnormal antibody screening test for positive results, the need to specify an abnormal antibody definition test;

d) The case of an abnormal antibody has been named, requiring the designation of a suitable blood unit, without the antigens corresponding to the antibodies already present in the patient's serum;

The case cannot determine an abnormal body of antibodies or not find the appropriate blood unit, the treatment doctor must coordinate with the blood-based unit for consideration, the decision to apply the appropriate treatment.

3. Specify a blood transfusion after having considered the benefits and risks of blood transfusion to each person when there is no alternative treatment therapy, or alternative treatment therapies are not effective.

4. The treatment doctor or nursing nurse must inform the sick person or the family of the benefits and risks that may occur due to blood transfusion. In the event of an emergency, the patient cannot be notified, but it is not possible for the person to be in a coma, with no family, the doctor must clarify with the confirmation of a medical officer in the medical records.

People who are sick or sick people have to confirm and sign up to the hospital if they reject blood transfusion, blood preparations.

5. Nursing of the bill to provide blood on the prescribed pattern at Annex 9 issued by this message and take the venous blood sample of the patient with only the blood transfusion of the following requirements:

a) When a blood sample checks the blood transfusion, the name, the age, the number of people, the number of people, the number of cases of the treatment, the number of cases, the number of cases of the treatment.

b) The blood sample of the patient must take two tubes with a volume of 1 ml to 2 ml of blood with anticoagenemia and 4 ml to 5 ml of non-anticoagable blood;

c) The information on the test label:

-They and the names or codes of the sick.

-Year of the patient's birth;

-The bed number, the treatment department.

d) Project transfer and blood samples for the unit of blood;

What? 43.

Upon receiving the intended vote and the blood sample, the unit of blood transplants must perform the following work:

1. Check out the blood sample information with the expected vote. Where the information does not match, the blood sample is not used for blood clots and mixed tests.

2. The ABO blood group's definition of blood and blood units:

a) The group of ABO blood systems by engineering in vitro or other techniques with higher sensitivity;

b) The implementation of the blood group simultaneously equals two samples of sample serum and red blood cells for the blood type, the full blood unit, and the granal cell mass. Define the blood type by the blood serum method for the red blood cells. The blood group is defined by the blood method for plasma, cooling, and platoidal preparations;

c) The orientation of the human blood group is performed twice on the same blood sample or two blood samples of the same person. The case of the results of two ABO blood group definitions in the same one or of the blood group tests is not consistent with each other, having to perform additional tests to confirm the results of blood group orientation;

d) The ABO blood group of infants and children's ABO blood group: Only the blood group is done by the sample serum; the blood group is not defined by the pattern of red blood cells. In cases where the blood group is not clear, it is possible to use other additional tests to confirm. If you can't determine the blood group, you need to choose the same immune system as prescribed at Article 45 of this.

3. Rh blood group designation (D) human blood type:

a) When you specify a full blood unit, the red blood, the platypus, and the white blood sphere;

b) The implementation of the Rh (D) blood group definition by engineering in vitro or other techniques has a higher sensitivity.

4. Reference to the screening test results and an abnormal identity of the antibody that has been previously prescribed at Points b, c, d, and Clause 2 Article 42 This message.

5. Make a blood transfusion test:

Perform the immune-immune test in vitro or by techniques with higher sensitivity in the following circumstances:

a) The full blood transfusion, the red blood cells, the plasma, the white blood cells.

-The immune compound test in the physiological salt water environment, the 20-year test room temperature o C to 24 o C:

+ Pipe 1: The red blood cell of the blood unit, the blood of the blood of the recipient's blood.

+ tube 2: The plasma of the blood unit, the blood of the recipient's blood.

-No, no, no, no, no. o C and the use of antiglobulin serum (indirect Coombs solution): Condone a fusion test between the blood cell of the blood unit, the red blood cell, the white blood cell with the serum of the recipient by the test method at 37. o C and have the use of serum globulin or higher sensitivity techniques.

b) The transfer of red blood cells is less or less blood:

-The immune fusion test in the physiological salt water environment, room temperature from 20 o C to 24 o C between the red blood cell of the blood unit with the recipient serum (tube 1);

-No, no, no, no, no. o C and the use of antiglobulin serum (indirect Coombs solution): performing a fusion test between the blood cell of the blood unit, the red blood cell, the white blood cell with the serum of the recipient by the test method at 37. o C and have the use of serum globulin or higher sensitivity techniques.

c) Traditional diuretic, plasma: perform a fusion test between the plasma of the blood processing unit with the recipient of the recipient ' s (tube 2) recipient in the physiological salt water environment, room temperature from 20%. o C to 24 o C or engineering has a higher sensitivity;

d) The combined test results are considered negative when there is no condensate, thaw. Only the blood unit issued when the combined test result is negative, except for the cold precipitation of regulation at paragraph 3 This Article 44;

When the result of a combination of security tests with a dissolving or dissolving of blood testing, the case projection, relevant information and coordination with the treatment doctor specifies the test to perform the regulation requirements at points b, c, d, and Clause 2. This is 42.

6. After completing the prescribed work at the 2, 3, 4, and 5 Articles, the unit worker emblood the blood-grade profile as follows:

a) A blood transfusion of blood transfusion in Annex 10 issued by this message, sent to the treatment unit for the use of blood;

b) The record records blood group results, the immune compound test, and the blood flow unit.

What? 44. Option of the immune system is immune to the immune system.

1. All-part blood and mass blood transfusion of ABO blood group merge with the recipient, according to the following request:

Blood type disease.

Blood unit blood.

The red blood sphere.

Full blood.

O.

O.

O.

A

A or O

A

B

B or O

B

AB

AB or A or B or O

AB

2. Transfusion of the units of the blood processing similar to the ABO blood group with the person who receives the blood according to the following requirements:

Blood type disease.

The blood unit's blood is similar.

O.

O or B or A or AB

A

A or AB

B

B or AB

AB

AB

3. It is possible that cold precipitation does not integrate the ABO group for the person who receives blood with a dose of not exceeding 10 ml/kg of body weight over a 12-hour period.

4. Select the selection of platypus and white blood cells at the following request:

Blood type disease.

Blood unit of the blood unit, the blood works.

Blood units, blood products, blood plasma.

Blood units, blood clots removed the blood plasma.

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 all-part blood units, red blood cells, platypus, county leukaemia according to the Rh (D) group at the following request:

Blood type disease.

The blood unit of the blood unit.

D (-)

D (-)

D (+)

D (+) or D (-)

What? 45. Secure the immune harmony in some emergency emergency cases.

1. In the event of an emergency, it is not timely to complete the prescribed trial at paragraph 2 Article 42 and Article 43 This is or not to determine whether the blood group is sick or not selected by the blood unit, the appropriate blood preparation, if written consent. of the treatment doctor who can be issued as follows:

a) Transfusion the blood group for the sick person with only partial blood transfusion, the prescribed red blood cell at the Clause of One Article 44.

b) The red blood cell transfusion of ABO and Rh (D) negative for Rh (D) blood type disease (D) negative or does not specify Rh (D) group;

c) Transfusion the blood group for the sick person with the prescribed blood transfusion of regulation at paragraph 2 Article 44 This message.

d) After the ER level, b, and c 1, it is necessary to fully execute on the provisions of Article 42 and Article 43 of this.

2. Only Rh (D) positive blood transfusion for the recipient of the negative Rh (D) group in the event of a threat to the patient ' s life and having sufficient conditions:

) The sick man is male.

b) In the case of the person the disease is a woman in the birth age: consider the current treatment benefits and the risk of the ear for the fetus if the person is pregnant in the future;

c) The immune resolution immunoglobulin serum in temperature 37 o C for negative results;

d) There is written consent in the outcome of the association between the person in charge or the authorized person of the blood transfusion unit, the physician treatment and the consent of the sick person or the family of the sick.

What? 46. To thaw, brewing blood bags, blood preparations

1. The melting of the blood diet must ensure the following conditions:

a) To dissolve blood preparations by regulation at Section 3 Article 18 of this Information;

b) The time from the end of the melting of the east until the end of the blood transfusion for the disease is not more than 06 hours;

c) After the break-up, we have to check the blood of blood, the blood work stipulated at Article 2 of this Article 41. If the blood bag doesn't guarantee the quality, you have to cancel that blood bag.

2. sleep the subunit of the blood processing unit when required fast and large volumes (above 50 ml/kg/hour in adults and above 15 ml/kg/hour in children). The warm incubation temperature does not exceed 37 o C.

What? 47. Blood delivery, blood preparations between the blood-based unit and the treatment unit

1. When blood delivery, blood processing, unit personnel treatment unit and employee of the blood flow unit must carry out information on a blood bill, blood unit, and blood transfer.

2. There is a means of preservation, blood transport, proper blood preparations.

What? 48. Save the sample of the blood unit and blood type disease.

After the issuer, the blood sample of the recipient ' s blood and the issued blood unit must be stored for at least 05 days at the temperature of 2 o C to 6. o C in the blood transfusion unit.

What? 49. Blood bag management in the treatment unit

1. The blood bag has moved back to the treatment unit which must transmit the sick to the patient within 6 hours from the time of the exchange between the blood-based unit and the treatment unit.

2. The case has not conducted blood transfusion, blood clots or blood preparations must be preserved in accordance with regulations at the terms 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35.

What? 50. execute and monitor blood transfusion at the treatment unit

1. The treatment doctor and nursing physician must perform the test, the reference, blood group orientation, blood transfusion, detection, timely execution of abnormtions, undesirable accidents occur during and after blood transfusion.

2. execute the test, which shows the following contents:

a) For the information of the sick person, the blood unit and the blood transfer;

b) Check out the use and form outside of the blood bag as prescribed at Article 41 This Information.

3. Make the patient ' s ABO blood group, of the blood bag right here

The bed and the information on the blood coupons.

a) When the full blood transfusion, the red blood cell, the white blood sphere: the use of the blood serum in the ABO blood sample of the human blood sample was taken just before the blood transfusion and of the blood samples taken from the blood unit that was about to transmit.

b) When you transmit the platyus, the plasma:

-Use the blood-samples of the patient's blood ABO.

-Mixing 2 drops of blood preparations with 1 drop of patient's blood and checkup. There is no blood transfusion when there is a condensate, except for the case of a cold precipitate on the Article 3 Article 44.

c) Coordinate with the blood transfusion unit that makes it clear all the difference (if any) between the hospital record, blood transfusion, blood unit label, and group definition results.

4. Practice of blood transfusion, acting tracking, detection, handling of the abnormability of the health status of the sick person:

a) Check, monitor the circuit, temperature, blood pressure, mental state of the patient at previous times and during the blood transfusion process, particularly noted for the first 15 minutes of blood transfusion to detect and timely execution of the border. related to blood transfusion;

b) Must use a selective blood transfusion wire to transmit to the sick;

c) The full profile of the circuit, temperature, blood pressure, mental state, clinical behavior of the sick, the action (if any) to the prescribed blood transfer at Annex 10 issued by this message;

d) The condition of the pathology of the sick and acting in the blood transfusion process, the treatment doctor indicated the tracking after the end of the blood transfusion.

5. No physical addition (including drugs) to the blood bag, except for the absence of a red-chain dilution solution, which is used only by an isotopal saline solution (NaCl 0.9%) of intravenous fluids.

6. When the accidents are associated with blood transfusion, the treatment facility must perform immediately following:

a) Depending on the severity of the accident that must reduce the speed or stop the blood transfusion. The case of a cessation of blood transfusion, it has to be maintained by using an open salt solution;

b)

c) Do not continue to transmit blood, blood preparations are associated with the ear after a four-hour transmission.

What? 51. Pay, return and use of the blood unit returned

1. Without the use of the issued blood unit, the treatment facility (faculties, chamber) must immediately return the blood-based facility.

2. The blood-based facility using only the blood unit has returned to transmit to other sufferers when there is full of the following conditions:

a) for use;

b) Do not detect the unusual signs prescribed at Article 41 This message;

c) The blood unit after the field, which is preserved, is transported in the correct condition and has a written confirmation of the curator, the treatment room.

What? 52. Define the cause of the accident associated with blood transfusion

1. When the occurrence of the calamus occurs during and after the blood transfusion, to determine the cause, the treatment facility must do some of the following:

a) The reference to the patient's medical records, the blood unit label that passed and the blood transfusion. The opposite result must record the case file.

b) Gather the blood of the infected person before the blood transfusion, and then sample the blood, the urine samples of the sick. The severe case of the accident threatens the human life of the disease, which is required to conduct an ABO blood group in the hospital bed by the staff of the blood-based facility. The results of the blood group determine the patient's condition with the confirmation of the treatment doctor, the head of the treatment facility and the execution of the blood group.

c) The ear notification is associated with blood transfusion for the blood-based facility and the combined planning room in Annex 11 issued by this message;

d) Transfer of blood units, blood-related blood preparations for taking over the prescribed work at Clause 2.

The General Planning Board reports that the blood transfusion council and the facility have provided the blood unit, the blood preparations prescribed by the 11-issued Appendix to this message.

2. The blood-based facility must check, reissue the relevant case, perform tests aimed at determining the cause of the accident involving blood transfusion and answer results of the test results for the treatment facility, the prescribed composite planning room at the Annex. The 12 boards are accompanied by this message.

3. The blood-based facility coordinated with the facility has provided blood units, the relevant blood preparations for determining the cause.

Chapter VI

BLOOD TRANSFUSION

What? 53. The principle of execution of blood transfusion

1. There must be blood transfusion processes that are consistent with the existing regulations and conditions of the clinic, cure. The choice processes, testing, taking, regulating, preserving, and transfusion have to be led by the facility of the disease, healing the disease.

2. Only blood transfusion is planned for pre-surgical cases of the risk of loss of blood to the point of blood transfusion, and the treatment doctor has the responsibility to consider, assess the health condition that allows for safe blood. All right

3. The blood-based blood transfusion of blood-based self-transfusion and blood transfusion is only done when there is written consent of the sick person or the legal representative of the sick.

4. In addition to adhering to the prescribed blood bag labeling regulations at Article 21 This message, the label of the self-self blood bag must be added with the inscription: "Only for self-blood transfusion".

5. self-preservation blood pouts must be preserved separately from blood donors.

6. Make sure the blood transfusion, the blood of the disease, is blood. Blood transfusion with the purpose of blood transfusion is not used for other patients.

What? 54. Blood transfusion according to plan

1. Consumer Choice Standards

a) Age from 16 to 60;

b) The body weight from 50 kg or more;

c) Clinical: In accordance with the provisions at Point 2 Article 4 This message;

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

2. The tests must perform before taking blood, including:

a) the ABO blood group.

b) The test of the detection of the infectious agent through blood sugar, minimum including: HBsAg, HIV-1 antibody and HIV-2 resistant, antibody antibody HCV, syphilis.

3. The blood volume takes each time no more than 7 ml per kg of weight; each takes a minimum of 3 days apart and the last blood-taking before surgery at least 72 hours.

4. The treatment doctor considers the use of the erythropoietin erythropod.

5. The preparation, preservation of the blood unit, the appropriate blood preparations prescribed at the 22nd, 23rd, 24th, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35.

6. Do a pre-transfusion test before transfusion, execution of blood transfusion and determination of an ear-related cause of self-induced blood transfusion must follow regulations at article 40, 41, 43, 46, 47, 48, 49, 50, 51 and 52. Hey.

What? 55. The blood clot itself dilated by the blood thinner

1. Consumer Choice Standards

a) Age 16 to 60 years old;

b) The body weight from 50 kg or more;

c) Clinical: In accordance with the provisions at Point 2 Article 4 This message;

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

Surgery has a use of anaesthesia or anaesthesia.

e) Do not apply the blood transfusion of self-dilution in cases where the disease has poor tolerance to the decreased state of oxygen supply.

2. The tests must perform before the blood is taken: follow the regulation at the Article 2 of this Article 54.

3. Required for the implementation of the caste and transmission of blood to the sick:

a) The blood volume for surgery is no more than 7 milliliters of weight;

b) Hematocrit of the sick person is not lower than 0.25 after taking blood;

c) Must maintain the balance of blood volume and be able to integrate the transfusion of the body by means of a single-degree solution that translates to 3 times the amount of blood taken out of the body or by a high solution. molecule in a 1:1 ratio.

What? 56. reimbursable blood transfusion

1. Only execute the blood transfusion when there is not enough blood stored for the emergency and no other method of treatment replaces the blood transfusion for the sick.

2. The recovered blood is taken during surgery or from the ducal pipe. For example: in the case of a spleen, the lead from the middle of the center after a heart surgery.

3. The blood obtained to transmit the refund must be processed according to the right process to avoid the risk of infection, thaw blood, and the removal of the clot.

4. The recovery blood must be transmitted within 4 hours, since the time of the blood recovery.

5. The complete blood transfusion record must be saved in the patient ' s hospital.

6. No return of blood transfusion in the following cases:

a) The empty organ;

b) The blood flow is over 6;

c) Blood is at risk of infection;

d) There was a blood break.

Chapter VII.

RISK MONITORING IN BLOOD TRANSFUSION

What? 57. Content monitor risk in blood transfusion

Risk monitoring in blood transfusion is active in order to prevent, detect, alert, save, analyze, report the risk of blood transfusion, including:

1. Information about the blood donor.

2. Information on processes, manpower, products, equipment, tools, supplies of attriation to take on the activities of reception, screening, regulation, preservation, transport, delivery, designation, use of blood in clinical screening.

3. Information on the results and abnormus in the blood transfusion operation.

4. The accident information occurs in patients with blood transfusion.

5. Other information about the risks, unusual for the residential community, society is associated with blood transfusion activity.

What? 58. Manager, monitoring, risk reporting in blood transfusion

1. Every unusual occurring in transfusion activity must be detected, examined, processed, aggregated, and reported in a six-month period.

2. When the abnormers are at risk of affecting safety for the person who are sick or beyond the processing of the disease facility, cure the disease:

a) Faculty, the detection room must report to the head of the medical examination facility, cure the disease in the time of 2 hours, since the discovery;

b) During the 24-hour period, since receiving the report, the head of the medical examination, the treatment must report to the upper management authority and the relevant blood transfusion facility.

3. Encouragement to report the risks, irregularly related to the blood donor, the person who is in the blood, the health worker who performs the work and others are involved in the blood transfusion operation:

a) The following implementation reports at Annex 13 issued this message;

b) These reports are sent to the Blood Transfusion Council of the body of the disease, healing and the Central Blood Institute.

4. Annual periodic, the basis of transfusion activities must carry out the synthesis, analysis, proposal of solutions aimed at remediation, limiting abnormalization in transfusion and reporting by regulation at Article 62 of this.

5. The reporting base is prescribed at Clause 3 and Clause 4 This, the Central Blood Institute, which performs the synthesis, analysis, proposal of solutions, plots for the Ministry of Health on measures to overcome, restrict, prevarate the risks in the future. The blood.

Chapter VIII

THE BLOOD COUNCIL OF THE CLINIC, HEALING.

What? 59. Legal position and component of the blood transfusion board of the medical examination facility, healing

1. The blood transfer board is the board of expertise in the facility, which is located in the facility.

2. The blood transfusion (Council) includes the following components:

a) Chairman of the council: be the Director or Deputy Director in charge of expertise;

b) Vice President of the council: being the Deputy Director or General Planning Office;

c) The council clerk: The Summary Planning Office or the person in charge of the blood transfusion facility;

d) Council commissioners include faculty representatives, departments: Organization of cadres, Aggregate Planning, Nursing, And Clinical Sciences.

3. The Council may combine with the drug and treatment board on the basis of an actual condition that adds members, functions, and duties under Article 2 of this and this Article 60.

What? 60. Function, mission of the Blood Transmission Council

1. Function:

The blood transfusion council functions as the basis for the head of the medical examination, which is effective and effective and effective.

2. Mission:

a) The direction of the construction and the appraisal of principles, regulations, processes, specific guidelines on blood transfusion in accordance with the test activities, clinical treatment of the examination facility, healing;

b) Command planning to use blood and blood food every year;

c) Proposal to improve the quality of blood transfusion activity; successors

development of transfusion activity, the addition of equipment pages, the application of new techniques;

d) The organization of training, training of specialized processes and regulation of blood transfusion;

Monitoring, analysis, synthesis, and reporting of the calamus involved in blood transfusion;

e) Assessment of the implementation of processes, regulation of blood transfusion in accordance with the condition of the examination facility, healing;

g) execute the preliminary, sump, and report of 6 months and 12 months.

3. Activity:

a) The council works in accordance with the collective principle, which decides to follow a majority on matters related to the activities of the Council. In the case of a distinct opinion, the votes of the council members are equal, the Council Chairman is the final decision. The different opinions are preserved and write to the council's work margin. The members of the Council shall work in the service of the law.

b) The assembly meets every quarter once. The event of a breakaway meeting was decided by the President of the Council;

c) The Council of the Council meeting must be fully documented by each member who spoke at the session and must be fully signed by the President and the Secretary of the Council.

d) President of the Council for Specific Operations and Assignment Assignment to Council members of the Council.

Chapter IX

SAVE FILE AND REPORT MODE

What? 61.

The leader of the blood transfusion facility, the basis of the disease, the treatment, the basis of the blood transplants must organize the execution of the document, the records follow the following requirements:

1. Save the profile at the blood transfusion facility:

a) The document related to the operation of blood reception:

-The blood donor health questioner prescribed a prescribed pattern at Annex 2 issued by this message;

-Blood donor health records prescribed by Annex 3 issued by this message.

b) The document is related to the operation of testing, preparation, preservation, blood transfusion, blood preparations, including:

-The blood of the blood unit, the blood work.

-Type, batch, shelf life, test quality testing;

-Results and test conclusions;

-Document for preservation, examination and destruction of the sample of stored-food;

-Documents related to blood preparations from each blood donation;

-Information about the name of the type of blood product, modal modal, equipment, equipment, code, blood group, date of preparation, expiration date, blood base name, test and preparation.

2. Save the records at the facility of the disease, cure the disease of blood:

a) The document relates to the receiving of blood from external premises:

-Blood delivery, blood work.

-Blood bill, blood diet (if any).

b) The document involves taking blood from faculties, rooms in the internal affairs of the disease, healing:

-Blood bill, blood work.

-The blood flow, the blood work.

c) The document is related to the testing of the blood transfusion of blood transfusion.

-Type, batch, shelf life, test quality testing;

-The results of the blood group and the immune system test;

-A screening test results and an unusual antibody identifier (if any).

d) Document related to the use of blood at the basis of the disease, healing: predicate, blood transfusion, blood processing, and blood transfusion;

The document is related to the processing when there is an accident involving blood transfusion:

-On the basis of blood transfusion: the accident report involves blood transfusion; the receipt of blood units, blood-related blood preparations; the results of an accident investigation involving blood transfusion in accordance with Article 2 Article 52 of this.

-In the department, the treatment room uses blood: records show the condition of the patient and the treatment, the treatment applied; the results of the blood samples, the urine before and after the accident associated with blood transfusion.

3. The work processes, record forms records, stored document control systems include conventional text forms and electronic document systems.

4. The file is stored 10 years from the date of the last update.

5. The storage expiration profile is canceled under the current rules.

What? 62. Report Mode

The leader of the blood transfusion facility and the medical examination facility, cure the use of blood must organize the practice and send the report in accordance with the following requirements:

1. Annual Report:

a) Content reporting by regulations at Annex 14 issued by this message;

b) Before November 30, 11 years ago, medical facilities were using blood (including medical examination facilities, private treatment facilities) to submit reports as prescribed at Point A 1 This came to provincial health departments, the central city, and then sent the Institute of Blood Medicine. Central blood transfusion.

c) Before 15/01 of the next year, the Central Blood Institute reported aggregation of transfusion of blood transfusion to the Ministry of Health.

2. The report breaks out: perform according to the required content of the governing body or on the actual requirement that the unit needs to report to the upper level.

Chapter X

EXECUTE RESPONSIBILITY

What? 63. Accountability of the Bureau of Management, cure-Health Ministry

1. Host or co-ordination of construction, modification, addition of the legal code of law on blood transfusion; building strategies, planning, planning, programs, projects; building national standards, technical standards, relevant professional guidance, The blood transfusion, the Minister of Health or granting authority to review, decide.

2. Directed, organize, guide, test implementation of legal, strategic, planning, planning, expert regulations, national technical regulation, quality management for blood transfusion facilities, medical facilities, medical treatment facilities, medical treatment facilities, and more. The blood.

3. Host or coordinate the appraisal of conditions that allow the application of new, high-technical techniques in transfusion activities by law.

4. The organization for the appraisal of the licensing, suspension of the operation of the examination facilities, the treatment of transfusion activity under the rule of law.

5. As head of the organization of professional councils addressing the problems of the

Expertise, engineering, direction, guiding activities of scientific research and international cooperation in the field of blood transfusion.

6. Directed by, instruct, fostering raising the capacity of state management and professional expertise for management cadres in transfusion activity.

7. Directed, instructs the implementation of the implementation of the application of information technology, data statistics, database construction in the management of blood transfusion operations.

What? 64. The responsibility of the Blood Institute-Central Blood

1. Head of a proposal, staff, petition with the Ministry of Health in the construction, modification, addition of the legal code of law on blood transfusion; building strategies, planning, planning, programs, projects; building national standards, rules, and other issues. Engineering, expert guidance, transfusion of blood transfusion.

2. Deployment of training, guidance, professional support, techniques related to blood transfusion activities within the country.

3. Deploy the research, assessment of the quality, method of the use of drugs, products, equipment, tools used in the blood transfusion operation of the Ministry of Health.

4. Deploy the information technology, data statistics, building database management databases within the country.

5. Perform the operational deployment of the risk of blood transfusion in the nationwide range.

6. Test and evaluate the operation of blood transfusion facilities within the country according to the prescribed pattern at Annex 15 issued by this Information.

7. Do the study, apply the technology science in blood transfusion.

8. General, analysis, report the results of the blood transfusion of blood transfusion facilities in the entire country to the Ministry of Health.

What? 65. The responsibility of the provincial health department, the central city

1. Directed, execute, administer, test, evaluate the blood transfusion of the medical examination facilities, cure diseases and blood transfusion facilities on the site of management.

2. Based on the need to use the blood of the clinic, cure, synthesis, construction of the local ' s annual blood use plan; at the same time coordinating with the relevant units in the operation of the voluntary donation, ensuring the supply of blood to the public. Medical treatment facilities, healing facilities.

3. The revised petition, the addition of regulations, professional guidance, business, management, aims to rectify the inadequation related to the blood transfusion operation.

4. General, analysis, report on the results of the blood transfusion of medical treatment facilities, treatment and blood transfusion facilities on the management desk to the Department of Management, medical treatment, Ministry of Health.

What? 66. The responsibility of the blood transfusion facility

1. Propaganda of the volunteer blood donor. Provide information to the blood donor on the need for blood use, on the risk of transfusion diseases.

2. Explain the process of taking blood, the undesirable manifold, the calamus may occur, the tests will be done before and after the blood donation; the blood donor counseling of the health care and medical services.

3. Secret assurance of clinical findings and tests. Inform the donor of the results of the clinical trial, the test when you have a direct request from the blood donor.

4. Care for the blood donor when there are undesirable accidents in and immediately after the blood donation.

5. Construction, approval, deployment, monitoring of the procedure, specialized instruction applied at the blood transfusion facility to secure the safety of blood donors and the quality of the blood unit: registration of blood donations; record records; safe and sternable blood, decreased. The risk of bacterial infection; blood donors; prevention and safety treatment of possible accidents in blood donors; screening tests of infectious agents through blood sugar and blood unit orientation; treatment, preservation, blood transport, and processing. All right

6. Make the procedures for the granting of the authority to honour, commend and secure the other rights of the donor in accordance with the rule of law.

7. The organization performs management, the risk monitoring in blood transfusion is regulated at Article 57, Article 58 of this.

8. Coordinate with the medical examination facilities, healing the blood use in:

a) Supply, transport, blood preservation, safe blood preparations, in accordance with the need for quantity, strain of the basis of blood use;

b) Provide information about blood units, blood preparations associated with the accidents that occur in people with blood;

c) Find out, investigate the cause of the calamus associated with blood transfusion;

d) Build a document, perform training training on rational blood use in clinical treatment.

9. periodically or conduct tests, monitor and evaluate blood transfusion activities within the area of the area assigned by the prescribed pattern in Annex 15 issued by this message.

10. General, analysis, reporting results of the transfusion of medical treatment facilities, healing in the area assigned to the Department of Management, cure-the Ministry of Health and the Central Blood Institute.

11. The revised petition, additional to rectify the inadequate related to blood transfusion activities arise during the deployment of the provisions of this message.

What? 67. The responsibility of the examination facility, healing has blood use

1. The director of the medical examination, healing has the use of blood that is responsible for ensuring safe, effective blood transmissions at the unit due to its charge, including:

a) The organization established the Prescribed Blood Transfusion Council in Chapter VIII and the test, issuing, use; management of the blood transmuses prescribed at Article 50, Article 52 of this; the unit organization in the body of discovery. illness, healing or having a professional support contract with another facility is likely to perform a blood transfusion test;

b) Directed by, the organization builds and approx regulations, processes, clinical blood transmusing guidelines of the clinic, healing; training organizations for relevant employees and organizations that perform blood transfusion in accordance with approval; the organization. The monitoring of the compliance of regulations, processes, guidelines within the scope of the treatment facility;

c) Review, coordination and direction solving relevant issues when implementing regulatory work at point b, Point c, and Point 8 Article 66 This message with blood transfusion facilities;

d) The organization carried out the management, risk monitoring in blood transfusion prescribed at Article 57, Article 58 of this;

e) The organization reviews the quality of blood transfusion activity and improves the quality of blood transfusion in the unit range according to Annex 15 issued this message;

g) The revised, complementary initiative aims to rectify the inadequate related to blood transfusion activities that arise during the deployment of the provisions of this message.

2. The blood-based facility of the pathology of the disease, the treatment of a blood transfusion test, is responsible:

a) implementation of the existing regulations and direction of the director of the medical examination facility, to treat the disease in the implementation of the relevant work stipulated at this 1 Article;

b) Identilocate the need, planning of use and organization coordination of transportation, protection of blood, safe blood preparations, in accordance with the need for quantity, strain of blood preparations;

c) The implementation of the regulations regarding the responsibility of the blood-defined unit is regulated at this Smart.

3. Faculty, treatment room for clinical blood transfusion:

a) implementation of the existing regulations and direction of the director of the medical examination facility, to treat the disease in the implementation of the relevant work stipulated at this 1 Article;

b) Preparing the vehicle, the instrument, the emergency room medicine to carry out the blood transfusion and timely execution of the accident;

c) The explanation for the sick person or person of the sick person on the benefits and risks may occur due to blood transfusion. In the absence of an explanation for the sick and the family, it must be clear to the pathology of the disease.

d) Perform the regulations that are related to the responsibility of the department, the treatment room that has blood transfusion prescribed at this Smart.

What? 68. The responsibility of the donor register

1. Answer honesty about the health condition and take responsibility for your answering content.

2. Sign confirmation of the information and voluntary donation of blood, after being explained and filling in the blood donor health questionbook by regulation at paragraph 2 Article 7 This message.

3. Not to take advantage of the donation of blood to health care, free test.

4. Self-sacrifice without a blood donation if you find yourself not eligible for a blood donation by regulation at Article 4, Article 5, Article 6 This message. Do not conceal the risks of your own disease when you register, to join the blood donation.

5. After the blood donation, it is necessary to inform the facility to receive blood if it is found itself to be at risk for hepatitis, HIV infection, and other communicable diseases.

What? 69. The patient ' s responsibility is transmitted by blood.

Provide accurate information on the health of the individual to assist the medical staff in the designation, track and execute the headsets (if any).

Chapter XI

EXECUTION CLAUSE

What? 70.

The implementation of HIV-1 screening test, HIV-2, hepatitis B virus and hepatitis C virus by NAT technique prescribed at Point 4 Article 14 This message and an abnormal antibody screening test stipulated at Point 4 Article 14 This information is used. The following is the following:

a) The blood transfusion facilities on the site of Hanoi, the province of Hue, Ho Chi Minh City, and the city required Poems to perform before 1 January 2015;

b) The blood transfusion facilities on the site of the provinces, the cities of Taiyuan, Haiyuan, Puritization, Anhui, Da Nang, Khánh Thi, Dang Shing, Pacifcityt must be made before 1 January 2017;

c) The remaining blood transfusion facilities across the country must be made before 1 January 2018.

What? 71.

It has been in effect since 15 November 2013.

Number Decision Repeal 06 /2007/QĐ-BYT January 19, 2007, of the Minister of Health for the promulgation of the Blood Transfusion Statute since the date of this date is effective.

In the course of execution, if there is difficulty in the process, the units, the local report on the Bureau of Management, cure the disease, the Ministry of Health for study, review, and resolve.

KT. MINISTER.
Chief.

(signed)

Nguyen Thi