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Requirements for Health Examination of Blood Donors (National Standard of the People's Republic of China GB 18467-2001)
1. Scope
The present standard specifies the items and requirements for the physical examination of blood donors and the blood test.
This standard applies to blood stations (blood banks) at all levels throughout the country, and is used for the management and evaluation of this organization.
2. Definitions
This standard adopts the following definitions.
2.1 Pre-tested donors
The blood donors who are required to donate blood after passing the physical examination and test.
2.2 Non-pre-tested Donors
Donors who only undergo a physical examination in advance and don't require a test to donate blood.
3. General Provisions
3.1 In order to ensure the health of blood donors and the safety of blood transfusion of blood recipients, pre-tested donors must undergo physical examination and blood test (initial test) before each blood donation, and the blood is collected after passing the test, and the collected blood must be qualified after re-examination before it can be used for clinical application.
3.2 Blood can be collected from non-pre-tested donors after they have passed the health enquiry and physical examination. The collected blood must be examined and re-examined, and can be used for clinical application only after passing the examination.
3.3 The reagents produced by the same reagent factory shall not be used for the initial and retesting of blood donors' blood, and the initial and retesting of the same specimen shall not be operated by the same person.
3.4 The health enquiry program for blood donation in this standard applies to the unpaid blood donation activities of blood collection vehicles and blood collection points that do not have the conditions for blood testing.
3.5 The physical examination and blood test of blood donors shall be based on the results of the blood station and be valid for two weeks.
3.6 This standard is an important basis for blood stations to implement the management of physical examination of blood donors and technical operation of testing and to conduct quality audits.
4. Requirements for Blood Donor Health Examination
4.1 Standards for Physical Examination of Blood Donors
4.1.1 Age: 18～55 years old.
4.1.2 Weight: male ≥50kg, female ≥45kg.
4.1.3 Blood pressure: 90mmHg～140mmHg/60mmHg～90mmHg, pulse pressure: ≥30mmHg
or: 12.0KPa～18.7KPa/8.0KPa～12.0KPa, pulse pressure: ≥4.0 KPa.
4.1.4 Pulse: regular rhythm, 60 to 100 beats/min, ≥50 beats/min in highly enduring athletes.
4.1.5 Normal temperature.
4.1.6 No yellowing of the skin, no traumatic infections, no extensive skin disease, and no obvious enlargement of the superficial lymph nodes.
4.1.7 No serious disease of the five senses, no yellowing of the sclera, and no enlargement of the thyroid gland.
4.1.8 No serious disability of the limbs, no serious functional disorders and no redness or swelling of the joints. There is no skin damage at the site of venous puncture of both arms and no traces of intravenous drug injection.
4.1.9 Chest: normal heart and lungs, no pathologic respiratory sounds and pathologic heart murmur, heart rate of 60 beats to 100 beats/min.
4.1.10 Abdomen: abdomen is flat and soft, no mass, no pressure pain, and liver and spleen are not enlarged.
4.2 Requirements for blood test of blood donors
4.2.1 Blood group test
4.2.1.1 ABO blood group (ortho- and trans-typing method).
4.2.1.2 Rh blood group (assayed in areas where it is available and where :;negative rates are high).
4.2.2 Hemoglobin: copper sulfate method: male ≥ 1.0520, female ≥ 1.0500; equivalent to male ≥ 120g / L, female ≥ 110g / L.
4.2.3 Alanine aminotransferase (ALT): ketone powder method (limited to the initial examination): negative; rate method: ≤ 40 units; Rai method: ≤ 25 units.
4.2.4 Hepatitis B virus surface antigen (HBsAg): negative (enzyme immunoassay, rapid diagnostic method is limited to the use of non-fixed blood collection points of the initial test).
4.2.5 Hepatitis C virus antibody (HCV antibody): negative (enzyme-linked immunoassay).
4.2.6 Antibodies to HIV: negative (enzyme-linked immunoassay).
4.2.7 Syphilis test: negative (RPR method, TRUST method or enzyme immunoassay).
4.2.8 Review 4.2.1, 4.2.3, 4.2.4, 4.2.5, 4.2.6, 4.2.7 (of which 4.2.3 must be by Rai or rate method).
4.2.9 One year after the clinical cure of hepatitis A, three consecutive tests with one-month intervals can be participated in blood donation (based on the clinical test report).
4.2.10 Malaria high incidence areas to detect Plasmodium.
4.3 Provisions on blood donation after immunization
4.3.1 Blood can be donated two weeks after the last immunization with live vaccines for measles, mumps, yellow fever, polio, etc., or four weeks after the last immunization with live rubella vaccine or rabies vaccine; and one year after the last immunization with rabies vaccine for a rabid dog bite.
4.3.2 Those who receive animal serum can donate blood four weeks after the last injection.
4.3.3 There is no need to postpone blood donation after immunization with Hepatitis B Vaccine and Hepatitis A Vaccine for healthy persons.
4.3.4 Blood can be donated only after one year after receiving hepatitis B immunoglobulin injection.
4.4 Those who have one of the following conditions are not allowed to donate blood for the time being
4.4.1 Those who have less than half a month after tooth extraction or other minor surgeries; those who have less than three months after appendectomy, hernia repair, and tonsil surgery; and those who have less than six months after a larger surgery.
4.4.2 Women who have been menstruating for three days before or after their menstrual period, less than six months after pregnancy and abortion, and less than one year after childbirth and breastfeeding.
4.4.3 Those who have recovered from cold and flu, acute gastroenteritis for less than a week, acute urinary tract infection for less than a month, and pneumonia for less than three months.
4.4.4 Certain infectious diseases: such as dysentery disease has not completed six months, typhoid fever has not completed a year of recovery, Brucella disease has not completed two years of recovery, malaria has not completed three years of recovery.
4.4.5 Limited inflammation of the skin after the healing of less than a week, extensive inflammation after the healing of less than two weeks.
4.4.6 Oral inhibition or impairment of platelet function of drugs (such as aspirin or aspirin-like drugs) less than five days after the discontinuation of drugs.
4.4.7 Transfusion of whole blood and blood components within the last five years.
4.4.8 Injuries or contaminated wounds caused by devices contaminated with blood or tissue fluids and tattooing less than one year after the procedure.
4.4.9 Persons with a history of close contact with a person with an infectious disease from the date of contact to the longest incubation period of the disease.
4.5 People with one of the following conditions cannot donate blood:
4.5.1 People with viral hepatitis, positive surface antigen of hepatitis B, positive antibody to hepatitis C virus.
4.5.2 Acquired Immunodeficiency Syndrome (AIDS) patients and people infected with Human Immunodeficiency Virus (HIV).
4.5.3 People at high risk for human immunodeficiency virus infection, such as people with a history of drug use, homosexuals, and multiple sexual partners.
4.5.4 Persons with leprosy and sexually transmitted diseases, e.g. syphilis, gonorrhea.
4.5.5 Persons whose blood has caused transfusion-related infectious diseases in the recipient.
4.5.6 Patients with allergic diseases and recurrent allergies, such as frequent urticaria, bronchial asthma, drug allergies (simple urticaria can be donated if it is not during an acute attack).
4.5.7 Patients with various kinds of tuberculosis, such as pulmonary tuberculosis, renal tuberculosis, lymphatic tuberculosis and bone tuberculosis.
4.5.8 Patients with cardiovascular diseases, such as all kinds of heart disease, hypertension, hypotension, myocarditis and thrombophlebitis.
4.5.9 Patients with respiratory diseases, such as chronic bronchitis, emphysema, bronchodilatation and pulmonary insufficiency.
4.5.10 Patients with digestive system diseases, such as more severe gastric and duodenal ulcers, chronic gastroenteritis, and chronic pancreatitis.
4.5.11 Patients with diseases of the urinary system, such as acute and chronic nephritis, chronic urinary tract infections, nephrotic syndrome, and acute and chronic renal insufficiency.
4.5.12 Patients with blood diseases, such as anemia, leukemia, true erythrocytosis and various bleeding and clotting disorders.
4.5.13 Patients with endocrine diseases or metabolic disorders, such as pituitary and adrenal diseases, hyperthyroidism, acromegaly, uremia and diabetes mellitus.
4.5.14 Patients with organic neurological diseases or psychiatric disorders, such as encephalitis, sequelae of traumatic brain injury, epilepsy, schizophrenia, hysteria and severe neurasthenia.
4.5.15 Patients with parasites and endemic diseases, such as black fever, schistosomiasis, filariasis, hookworm disease, cysticercosis, schistosomiasis, and Crohn's disease and macrosomia.
4.5.16 Patients with various malignant tumors and benign tumors affecting health.
4.5.17 Those who have undergone surgery to remove important internal organs such as stomach, kidney, spleen and lungs.
4.5.18 Patients with chronic skin diseases, especially infectious, allergic and inflammatory systemic skin diseases, such as ringworm, generalized eczema and systemic psoriasis.
4.5.19 Patients with ophthalmic diseases, such as keratitis, optic neuritis and high myopia with changes in the fundus.
4.5.20 Autoimmune diseases and collagenous diseases, such as systemic lupus erythematosus, dermatomyositis and scleroderma.
4.5.21 Patients with Creutzfeldt-Jakob disease and those with a family history of the disease, or those who are treated with tissues or tissue derivatives (e.g., dura mater, cornea, human pituitary growth hormone, etc.) that may have originated from infection with the Creutzfeldt-Jakob pathogen.
4.5.22 Persons with certain occupational diseases, such as radiation sickness, pneumoconiosis, and acute and chronic poisoning due to harmful gases and toxic substances.
4.5.23 Patients with other diseases that the medical examiner thinks cannot donate blood.
4.6 Volume of Blood Donation and Interval of Blood Donation
4.6.1 Volume of Blood Donation: Any blood donor who complies with the "Health Examination Standards for Blood Donors" can donate 200 ml or 400 ml of blood at one time.
4.6.2 Interval of Blood Donation
4.6.2.1 Whole Blood Donation: more than six months.
4.6.2.2 Machine-recovered platelets: every four weeks. If the interval is less than 4 weeks, the platelet count should be ≥150×109/L or more before collection.
4.6.2.3 After machine-recovered platelets are collected, there should be an interval of more than 4 weeks before whole blood is donated, and subsequent whole blood donations should be made at the same intervals as whole blood donations.