Decision No. 937-BYT/QD Issuing the Blood Transfusion Regulations

Pursuant to …;

Issuing the Blood Donation Regulation

THE MINISTER OF HEALTH

At the proposal of the Director of the Health Management Department of the Ministry of Health,

DECISION:

Article 1: The "Blood Regulation" is hereby issued to be implemented at healthcare facilities (traditional medicine, military, state-owned, private) throughout the country.

Article 2: The "Blood Regulation" shall be used for quality assessment of treatment, as teaching material in medical schools, and for medical forensic examination.

Article 3: This Decision takes effect from the date of issuance, and all inconsistent documents are abolished.

Article 4: The Heads of the Office, Directors of Departments under the Ministry of Health, Provincial Health Departments, Institutes, hospitals, universities, and secondary health schools are responsible for implementing this Decision.

REGULATION

BLOOD DONATION
(Issued pursuant to Decision No. 937 BYT/QĐ dated September 4, 1992 of the Ministry of Health

I. SELECTION OF BLOOD DONORS:

A. GENERAL PRINCIPLES

1. Voluntary blood donors who are healthy individuals aged between 18 and 60 years (except special cases treated with blood withdrawal or with a doctor's prescription).

2. Each donor must undergo a thorough physical examination and testing before each donation.

3. Each donor must have a blood donation file and a blood donation card according to the unified model to monitor their health over time systematically.

B. CLINICAL STANDARDS: 

A medical examination must be conducted for each donor before each donation, including:

Weight: Male ³ 45 kg Female ³ 40 kg

Clinical examination to check general health status and blood pressure.

Maximum systolic blood pressure Ê 180 mmHg Ê Minimum systolic blood pressure

100 mmHg Ê Minimum diastolic blood pressure Ê 100 mmHg

Detailed questioning of the donor to detect blood-borne diseases and other contraindications.

For cases involving cell separation, particular attention should be paid to vascular conditions, digestive system, spleen, lymph nodes, and ideally, an electrocardiogram should be performed before each cell separation procedure.

C. BIOCHEMICAL STANDARDS:

For each donation, the following biochemical tests must be conducted:

1. Mandatory minimum tests.

Hemoglobin level measurement.

Over 120g/l for males.

Over 110g/l for females.

Blood group determination.

Glucose and proteinuria must be negative.

Detection of Hepatitis B surface antigen (HBsAg).

Detection of syphilis serology (minimum using the VDRL technique).

Detection of malaria parasites in blood (using direct microscopy).

Detection of anti-HIV antibodies in serum.

Detection of anti-HCV antibodies in serum.

2. Non-mandatory tests:

Hematocrit Male ³ 0.371/l

Female ³ 0.361/l

Red blood cell count, white blood cell count, and differential white blood cell count.

Transaminase

Abnormal antibody detection.

D. CHEST X-RAY AND LUNG FLUOROSCOPY.

II. BLOOD DRAWING PROVISIONS

1. Provisions for the blood drawing room: applicable to blood collection using bottles (open system).

The blood drawing room must be well-ventilated, enclosed, clean, and equipped with air conditioning to ensure adequate lighting.

Minimum dimensions: length 3m, width 2.5m, height 3m. In the blood drawing room, walls must be tiled with white ceramic tiles, the donor area and the blood collector area must be separated by glass, and the room must be designed with a one-way system.

The blood drawing room must be equipped with ultraviolet sterilization systems and chemical disinfection systems, monthly air bacterial cultures must be conducted, and sterility standards must be ensured.

Equipment in the room must be arranged conveniently for daily and weekly cleaning and movement.

There must be an emergency medicine cabinet to promptly handle complications during and after blood collection.

Near the blood drawing room, there must be a changing area for staff to shower and change clothes before entering the blood drawing room.

2. Blood Drawing Provisions:

a) Blood Drawing Room:

Must be disinfected with ultraviolet light for 30 minutes before blood collection.

After blood collection, thorough cleaning must be done with antiseptic water containing chlorine (chloramine).

b) Blood Collection Staff:

Must shower, wear appropriate clothing, and wear sterile masks and hats when entering the blood drawing room.

c) Blood Drawing Equipment:

Including needles, tubes, bottles, cotton balls, alcohol, gauze... must be absolutely sterile.

d) Donors:

Must wash hands up to the elbow with soap, the venipuncture site must be disinfected with 70% alcohol iodine solution (iodine 5%).° e) Volume of Blood Drawn:

The maximum volume of blood drawn per session is limited to 7ml/kg body weight, not exceeding 400ml per draw (excluding samples taken for testing), with intervals of two and a half months. For plasma separation, it cannot exceed 10 times (twice a month) and not more than 500ml plasma per session.

f) Blood Bottle Provisions:

After blood collection, the bottle cap must be disinfected with 5% alcohol iodine, then sealed with sterile paper, nylon, or gauze if using a plastic bag. Before pressing and cutting the tube, it must be carefully disinfected. Blood bottles must be rechecked for blood type using the Beth-Vincent and Simonin methods, and only after confirmation can they be labeled and stored.

III. STORAGE OF BLOOD AND BLOOD PRODUCTS

A. ANTICOAGULANT SOLUTIONS: THERE ARE TWO TYPES ACD AND CPD

ACACD

Blood and blood products must be stored in specialized equipment with stable temperatures such as refrigerators at 2-6

C, cold counters below 18° C, platelet shakers. After collection or preparation, blood and blood products must be quickly transferred to storage.° At the storage location for blood or blood products, they must be neatly organized according to blood type and usage time. Records must be kept to manage, monitor, and report on storage, preservation, and distribution easily.

C. SOME QUALITY STANDARDS FOR WHOLE BLOOD AND BLOOD PRODUCTS:

1. Whole Blood:

Sterility:

Random samples of 2-5% of whole blood bottles must be cultured for sterility, and results must be negative.

Visual inspection to detect signs of contamination such as hemolysis, turbidity, or unusual color changes.

Tests for hepatitis B virus, hepatitis C virus, HIV antibodies, syphilis, and malaria must be negative.

Blood group ABO system determination. Additionally, Rh antigen determination is required for blood transfusion units for patients with blood group DC, those with multiple miscarriages, and foreigners.

Stored at +2

C to 6° C° C

Shelf life is 21 days with ACD and CPD anticoagulant solutions.

35 days with CPD anticoagulant solution supplemented with Adenine

2. Whole Blood Component (WBC): Similar to whole blood. Some additional standards

WBC Hematocrit Ê 60%, HT Ê 80%

2.3.1.1. Name of the production facility.

As for whole blood if prepared in a closed system within 24-48 hours at 2° C° C if prepared in an open system and supplemented with 0.9% sodium chloride hypertonic solution in the WBC component.

If other preservation solutions for WBC are used, permission from the quality control board of the blood transfusion sector must be obtained.

3. Rich Platelet Plasma (RPP):

Volume 150 ± 30 ml/unit or 300 ± 50 ml/pool

Prepared from whole blood within 24 hours from the time of blood collection

Platelet count: ³ 4 x 10¹⁰ platelets/unit

³ 8 x 10¹⁰ platelets/pool

Stored at 2° C - 6° C for 48 hours on a shaker

4. Plasma:

Volume 200 - 300 ml

Plasma protein ³ 50 g/l

Free hemoglobin in plasma Ê 50 ml/l

Storage:

1 month at 2° C - 6° C

24 hours at +2° C° C after thawing

Several months at Ê -18° C

5. Fresh Frozen Plasma (FFP):

As for plasma, some additional standards:

Separated from whole blood within 24 hours from the time of blood collection.

Factor V and VIII in plasma 0.6 international units/ml

Stored for 12 hours at +2° C° C

Stored for 3 months at Ê - 30° C

1 year at Ê - 50° C

12 hours at +2° C° C after thawing

6. Cryoprecipitate:

Volume 30-50 ml/unit, 150-250 ml/pool

Factor VIII ³ 2.5 international units/ml

Stored for 3 months at Ê - 18° C

six months Ê - 30° C

1 year at Ê - 50° C

3 hours at 2° C° C after thawing

IV. BLOOD PROCUREMENT AND ISSUE:

1. All blood bottles used in clinical facilities must be from blood banks within those facilities, which are responsible for ensuring the safety of blood transfusions for the bottles used (either collected and issued by their own blood bank or received from another blood bank).

2. All blood bottles intended for use must be tested for blood-borne infectious diseases such as Hepatitis B, Hepatitis C, AIDS, malaria, syphilis.

3. Blood Procurement:

Medical facilities planning or procuring blood must have a blood procurement form clearly stating the patient's name, diagnosis, blood type, quantity of whole blood or component required, date and time of blood request.

The treating physician must sign and write their full name. When procuring blood, an empty bottle for the patient (without anticoagulant) must accompany the procurement.

The person procuring or planning to procure blood must be a specialist staff member of the facility where the patient is being treated, responsible for procuring and storing the blood during transportation. If the patient is from another hospital, it must be done by a staff member of that hospital’s blood bank who will procure or plan the blood and be responsible for transporting it.

Upon receiving blood, the recipient staff must carefully check the blood bottle for quantity, quality of whole blood or component without any suspicious signs (such as color change, no signs of red blood cell rupture, not cloudy, not thickened, clotted...), blood type, label, and blood release form must match the patient's name and blood type correctly, without any confusion before signing for receipt. Once the blood is taken out of the blood storage room, it cannot be returned.

4. Blood Issue: The blood issue department must strictly adhere to all safe blood issue regulations including:

a) Equipment:

Blood serum samples, purchased from state-designated facilities responsible for producing blood serum samples. If produced internally, they must meet color, label, solution color, national standard requirements, stored at 2° C° C (must be quality-checked by the industry).

Red blood cells of the blood as well as blood serum samples.

Must have complete equipment such as slides, tubes, microscopes, centrifuges meeting standards, blood issue forms, and monitoring records according to regulations.

b) Blood Typing:

The blood type of the blood bottle and the recipient must be thoroughly determined using two methods: serum sample (Beth-Vincent) and red blood cell sample (Simonin). If the blood type cannot be determined, the red blood cells must be washed three times with physiological saline and diluted according to technique before determining the blood type.

Each time determining the blood type, both serum sample and red blood cell sample methods must be conducted separately, then compared with results from two different serum sample sets and one confirmed red blood cell sample set. The head of the blood issue department must conclude the blood type determination, sign, and take responsibility for safety. It is important to maintain group controls (allo and auto) during blood typing. For recipients who are foreigners or suspected of having maternal-fetal blood type incompatibility, Rh blood type determination is mandatory.

c) Cross-matching Tests (Tube I and II): (Minimum at physiological stage and enzyme stage. If possible, Coombs stage should also be performed) simultaneously with blood type determination of the donor and recipient for any blood bottle issued.

d) Abnormal Antibody Screening

Conducted when necessary, especially for patients who have received multiple blood transfusions or multiple pregnancies.

e) Blood Issue:

Before issuing the blood bottle, the issuer must recheck the information on the blood bottle label, the patient's name, and the label must match the blood issue form and monitoring record, fully recording the completion time of the blood issue procedures, signing and writing their full name. The medical facility staff coming to procure blood must sign and record the procurement time on the blood procurement form and the blood issue monitoring record before receiving the blood bottle. Any suspicion or malfunction during the blood issue process must be immediately stopped and reported to the head of the blood bank for research and resolution.

VI. BLOOD TRANSFUSION

1. Prior to blood transfusion, the treating physician must conduct:

A final check of the information on the blood bottle label and ensure complete compatibility with the patient.

Re-determine the patient's blood type (directly from the patient's hand before transfusion) and the blood bottle's blood type using the serum sample method (Beth-Vincent) by the treating physician performing and reading the results.

The patient must be adequately prepared for blood transfusion, and all procedures during the transfusion must ensure sterility and perform cross-matching tests.

The treating physician must closely monitor the entire transfusion process. All manifestations before, during, and after the transfusion must be recorded in the transfusion monitoring form at specific intervals (every 15 minutes).

Any abnormal manifestations of the patient during blood transfusion must be immediately stopped, and reported to the treating doctor, who will collaborate with the blood transfusion room physician to handle the situation and take appropriate measures.

2. Blood Transfusion Principles

It is best to transfuse blood of the same group. In cases where different groups are transfused (such as group O to group A, B, and AB), the amount should not exceed 25% of the patient's blood volume. If more than this amount is required, type BO mass must be used.

A

O AB

B

Group O individuals can only receive group O blood.

Group A individuals can only receive group A or group O blood.

Group B individuals can only receive group B or group O blood.

Group AB individuals can only receive group AB, group A, or group B blood./.