Full text of health examination requirements for blood donors

Requirements for blood donors' health examination (20 12) The new national standard of People's Republic of China (PRC) * * * National standard GB18467-201replaces GB 18467-200 1, which is the health of blood donors. 20 12-07-0 1 implement the China people * * * and the preface II 1 scope 12 normative reference document issued by the Ministry of Health of China 13 terms and definitions 14 general rules 15 blood donation. 6 Blood donors' health consultation 37 Blood donors' general examination 58 Blood test before blood donation 59 Blood donation amount and blood donation interval 5 10 Blood test after blood donation 6 Appendix A. Blood donors' informed consent and health status inquiry 1 1 Preface 4, 5, 9, 10, 8.2 and 8.3 of this standard. This standard is drafted according to the rules given in GB/T 1. 1-2009. This standard replaces the requirements of GB 18467-200 1 blood donor health examination. Compared with GB 18467-200 1, the main technical changes are as follows:-adjusting the standard structure, adding contents, citing documents and informed consent of blood donors, and deleting the original appendix C; -adjusting the chapter structure of normative technical clauses; Adjust the relevant regulations on blood donation after immunization and manage it according to the vaccine production process; -Adjust the mandatory provisions, and add the content of informed consent of blood donors in addition to the original requirements of pre-blood donation testing, blood donation amount and interval, blood donation testing, etc. -Increase health consultation on blood donors' life experiences and travel experiences; —— Delete the related contents of blood test after blood donation, such as test methods and test marks; -Adjust the age, quantity, hemoglobin standard, platelet collection standard and blood donation interval of blood donation; -amending the provisions on eye diseases, homosexuality and blood donation after immunization; -Amend the relevant contents of Appendix A "Informed Consent Form and Health Inquiry Form for Blood Donors"; -Modify the relevant contents of blood test and blood donation record before blood donation in Appendix B. This standard is proposed by the Ministry of Health of the People's Republic of China. The main drafting unit of this standard: Beijing Red Cross Blood Center. Main drafters of this standard: Gao Dongying, Liu Jiang, Dai,,, Chen Xiao, Feng Jiang, Zhao Dongyan and Zhuang. The previous version replaced by this standard is: -GB 18467-200 1. Requirements for health examination of blood donors 1 scope This standard specifies the items and requirements for health examination of blood donors in general blood stations. This standard is applicable to the health examination of blood donors in general blood stations. This standard does not apply to hematopoietic stem cell donation, autologous blood storage and therapeutic apheresis. 2 normative reference documents The following documents are very important for the application of this document. For dated reference documents, only dated version is applicable to this document. For undated reference documents, the latest version (including all revisions) is applicable to this document. Terms and definitions for quality requirements of whole blood and blood components in GB 18469 The terms and definitions defined in GB18469 and the following terms and definitions are applicable to this document. 3. 1 Non-reloaded unpaid blood donors donate blood at least 3 times, and donate blood at least 1 time in the past 12 months. 3.2 Predicting the number of platelets after collection The lower limit of the number of platelets remaining in the blood donors after blood donation is used to verify the platelet collection scheme. 4 General provisions 4. 1 Informed consent of blood donors should be obtained before blood collection, and necessary health consultation, general examination and blood test should be carried out. See appendix a and appendix b for written records. 4.2 The whole body examination and blood test of blood donors before blood donation shall be subject to the blood station results, and the validity period is 14d. 4.3 The results of health examination before blood donation are only used to judge whether the blood donor is suitable for blood donation, and are not applicable to the diagnosis of the blood donor's health status or disease. 4.4 For blood donors who are not suitable for blood donation after health examination, appropriate explanations should be given and attention should be paid to protecting their personal information. 5. Informed consent form of blood donors 5. 1 Staff of informed voluntary blood bank shall fulfill the obligation of informing blood donors in writing before donating blood and obtain the informed consent form signed by blood donors. 5.2 Informed content 5.2. 1 Motivation of blood donation The motivation of voluntary blood donation is altruism, and the purpose is to help patients who need blood transfusion. Please don't donate blood for the test. The state provides AIDS counseling and HIV antibody testing services free of charge. If necessary, please contact the local CDC (please contact the national public health hotline 12320). 5.2.2 Importance of Safe Blood Donors Unsafe blood will endanger the life and health of patients. Blood donors with high-risk behaviors should not donate blood, such as those who have a history of intravenous drug abuse, have sex with men or are at risk of blood-borne diseases (AIDS, hepatitis C, hepatitis B, syphilis, etc.). ) .5.2.3 Responsibility of high-risk actors to donate blood intentionally: Donating infectious blood will bring danger to the recipients, and they should bear moral responsibility to the recipients. According to Article 77 of the Law on the Prevention and Control of Infectious Diseases in People's Republic of China (PRC) and Articles 38 and 62 of the Regulations on the Prevention and Control of AIDS, high-risk blood donors who intentionally donate blood and cause the spread and prevalence of infectious diseases shall bear civil liability according to law; If a crime is constituted, criminal responsibility shall be investigated according to law. 5.2.4 Blood Donation in real-name registration system According to the Measures for the Administration of Blood Stations, blood donors should show their true and valid identity documents before donating blood, and blood stations should check and register. Whoever donates blood by using another person's identity shall bear the responsibility in accordance with relevant laws and regulations. 5.2.5 After donating blood, the blood donor shall report to the blood donor. If it is believed that the donated blood may have potential safety hazards, it shall inform the blood station as soon as possible. Blood stations should provide contact numbers. 5.2.6 Blood donation reaction In most cases, blood donation is safe. However, individuals may occasionally experience discomfort, such as dizziness, cold sweat, puncture site abrasion, hematoma, pain, etc. Very few people may experience more serious blood donation reactions, such as syncope. Medical staff should deal with blood donation reaction in time, and blood donors should follow the precautions before and after blood donation to reduce the probability of blood donation reaction. 5.2.7 Health Consultation and Examination According to the provisions of the People's Republic of China (PRC) Blood Donation Law, blood donors must be given health consultation and general examination, and blood donors should truthfully fill in the health status inquiry form. If it is not filled in truthfully, and the donated blood causes adverse consequences to the recipient, it shall be liable in accordance with the relevant laws and regulations. 5.2.8 Blood testing Blood stations will test the blood of blood donors for blood-borne diseases in accordance with state regulations. The qualified blood will be used in clinic, and the unqualified blood will be treated according to the national regulations. The unqualified blood test results only show that the donated blood does not meet the requirements of national blood standards, and it is not used as a diagnostic basis for infection or disease. 5.2.9 Epidemic Report According to the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases and other relevant regulations, the blood station reported the positive results of HIV infection and their personal data to the local disease prevention and control center. 5.3 Informed Consent of Blood Donors Blood donors should carefully read the relevant information of the informed consent form and sign it. 6. Health consultation for blood donors 6. 1 A blood donor cannot donate blood under any of the following circumstances 6. 1. 1 Patients with respiratory diseases, such as chronic bronchitis, bronchiectasis, bronchial asthma, emphysema, pulmonary insufficiency, etc. 6. 1.2 patients with circulatory diseases, such as various heart diseases, hypertension, hypotension, atherosclerosis of limbs, thrombophlebitis, etc. 6. 1.3 patients with digestive system diseases, such as chronic gastroenteritis, active or recurrent gastric and duodenal ulcers, chronic pancreatitis, nonspecific ulcerative colitis, etc. 6. 1.4 patients with urinary system diseases, such as acute and chronic glomerulonephritis, chronic pyelonephritis, nephrotic syndrome, chronic urinary tract infection and acute and chronic renal insufficiency. 6. 1.5 Patients with hematological diseases, such as anemia (except those cured by iron deficiency anemia and megaloblastic anemia), polycythemia vera, agranulocytosis, leukemia, lymphoma and various bleeding and coagulation diseases. 6. 1.6 patients with endocrine system diseases and metabolic disorders, such as pituitary and adrenal diseases, thyroid functional diseases, diabetes, acromegaly, diabetes insipidus, etc. 6. 1.7 patients with immune system diseases, such as systemic lupus erythematosus, dermatomyositis, scleroderma, rheumatoid arthritis, Takayasu arteritis, etc. 6. 1.8 patients with chronic skin diseases, especially infectious, allergic and inflammatory systemic skin diseases, such as chloasma, generalized eczema and systemic psoriasis. 6. 1.9 patients with allergic diseases and recurrent allergies, such as recurrent urticaria, bronchial asthma, drug allergy, etc. Blood donation is not allowed in acute attack of simple urticaria. 6. 1. 10 patients with nervous system diseases, such as cerebrovascular diseases, encephalitis, sequelae of brain injury, epilepsy, etc. And authors with a history of convulsions or repeated syncope. 6. 1. 1 1 patients with mental illness, such as depression, mania, psychosis, hysteria, etc. 6. 1. 1.2 patients with creutzfeldt-Jakob disease and those with family history, or those who have been treated with tissues or tissue derivatives (such as dura mater, cornea, human pituitary growth hormone, etc.). ) may be infected with the pathogen of creutzfeldt-Jakob disease. 6. 1. 13 Patients with various malignant tumors and benign tumors that affect their health. 6. 1. 14 patients with infectious diseases, such as patients with viral hepatitis and infected persons. Acquired immunodeficiency syndrome (AIDS) patients and human immunodeficiency virus (HIV) infected people. Leprosy and sexually transmitted diseases patients and infected persons, such as syphilis, treponema pallidum infection, gonorrhea, condyloma acuminatum, etc. 6. 1. 15 Various tuberculosis patients, such as tuberculosis, renal tuberculosis, lymphoid tuberculosis, bone tuberculosis, etc. 6. 1. 16 patients with parasites and endemic diseases such as schistosomiasis, filariasis, hookworm disease, paragonimiasis, cysticercosis, liver fluke disease, leishmaniasis, Keshan disease and Kaschin-Beck disease. 6. 1. 17 Some patients with occupational diseases, such as radiation diseases, pneumoconiosis, silicosis and acute and chronic poisoning caused by harmful gases and toxic substances. 6. 1. 18 Some drug addicts, such as patients who have been treated with adrenocortical hormones, immunosuppressants, sedation and hypnosis and psychotropic drugs for a long time; Past or present drug dependence, alcohol dependence or drug abuse, including smoking, eating or using steroids, hormones, sedatives, sleeping pills or narcotic drugs through intravenous, intramuscular and subcutaneous injections. 6. 1. 19 high-risk groups susceptible to blood-borne diseases, such as drug abuse history, men who have sex with men, and multiple sexual partners. 6. 1.20 allograft recipients: patients who have received allograft, including those who have received organ, skin, cornea, bone marrow, bone and dura mater transplantation. 6. 1.2 1 those with important organs such as stomach, kidney, spleen and lung removed. 6. 1.22 Blood donors who cause transfusion-related infectious diseases to the recipients. 6. 1.23 patients with other diseases that medical staff think are not suitable for blood donation. 6.2 A blood donor is temporarily unable to donate blood in any of the following circumstances. 6.2. 1 Less than three days after oral care (including tooth washing, etc. ); Less than half a month after tooth extraction or other minor surgery; Recovery after appendectomy, hernia repair and tonsillectomy was less than three months; Less than half a year after major surgery. 6.2.2 Benign tumor: gynecological benign tumor and body surface benign tumor less than one year after surgical treatment. 6.2.3 Women with menstrual period and three days before and after, less than six months after pregnancy abortion, and less than one year after childbirth and lactation. 6.2.4 The recovery from active or progressive ophthalmic diseases is less than one week, and the recovery from ophthalmic surgery is less than three months. 6.2.5 Patients with upper respiratory tract infection recovered less than one week, and patients with pneumonia recovered less than three months. 6.2.6 Patients with acute gastroenteritis recovered less than one week. 6.2.7 Patients with acute urinary tract infection who recovered less than one month and patients with acute pyelonephritis who recovered less than three months are in the onset period of urinary calculi. 6.2.8 Wound healing or infection healing is less than one week, skin localized inflammation healing is less than one week, and skin extensive inflammation healing is less than two weeks. 6.2.9 Injury or wound caused by instruments contaminated by blood or tissue fluid, less than one year after tattoo operation. 6.2. 10 In case of close contact with patients with infectious diseases, the longest incubation period is from the date of contact to the date of onset. Less than one year after hepatitis A, less than half a year after dysentery, less than one year after typhoid fever and less than two years after brucellosis. Those who go to malaria endemic areas within one year or have recovered from malaria for less than three years, those who have recovered from toxoplasmosis for less than six months, and those who have fully recovered from Q fever for less than two years. 6.2. 1 1 If drugs that inhibit or damage platelet function (such as aspirin or aspirin) are taken orally for less than five days, whole blood for platelet apheresis and platelet preparation cannot be donated. 6.2. 12 Transfusion of whole blood and blood components within one year. 6.2. 13 Parasitic diseases: people who have not fully recovered from ascariasis and pinworm infection. 6.2. 14 acute rheumatic fever: less than two years after recovery. 6.2. 15 sexual behavior: those who have had sexual behavior with high-risk groups of blood-borne diseases for less than one year. 6.2. 16 Travel history: those who have a travel history in the epidemic areas of quarantine infectious diseases or monitored infectious diseases determined by the health administrative department of the State Council, and the entry time is less than the longest incubation period of the disease. 6.3 Provisions on Blood Donation after Immunization or Treatment of Biological Products 6.3. 1 Vaccination without Exposure 6.3. 1. 1 Those who have no symptoms or adverse reactions after vaccination with inactivated vaccine, recombinant DNA vaccine and toxoid injection will be suspended from donating blood 24 hours after vaccination, including typhoid vaccine, freeze-dried inactivated Japanese encephalitis vaccine and absorbed DTP combined vaccine. 6.3. 1.2 Those vaccinated with live attenuated vaccines can donate blood 2 weeks after the last immunization with live vaccines such as measles, mumps and poliomyelitis, or 4 weeks after the last immunization with live rubella vaccine, human rabies vaccine and live attenuated Japanese encephalitis vaccine. 6.3.2 Those who have been exposed to rabies vaccine and are bitten by animals can donate blood one year after the last immunization. 6.3.3 Those who receive biological products treatment receive antitoxin and immune serum injections: Blood donation, including tetanus antitoxin and rabies serum, can only be given four weeks after the last injection. People who receive hepatitis B immunoglobulin injections can donate blood one year later. 7 General examination of blood donors 7. 1. 1 age: the recommended age for blood donation by the state is 18 to 55 years old; If a number of blood donors who have no response to previous blood donation and meet the requirements of health examination voluntarily ask for blood donation again, their age can be extended to 60 years old. 7. 1.2 Weight: male ≥ 50, female ≥ 45. 7. 1.3 blood pressure:12.0kpa (90mmhg) ≤ systolic pressure <18.7kpa (140mmhg) ≤ diastolic pressure <12.0kpa (90mmhg) 7. 1.6 General health status: a) There are no yellow spots on the skin and sclera. The skin has no wound infection and extensive dermatosis. B) There is no severe or above disability of limbs, no serious dysfunction and no redness and swelling of joints. C) There is no skin injury at the venipuncture site of both arms. No trace of intravenous drugs. 8. Blood test before blood donation 8. 1 Blood group test: ABO blood group (positive type). 8.2 Hemoglobin (Hb) determination: male ≥120g/L; Female ≥ 1 15g/L If copper sulfate method is used, male ≥ 1.0520 and female ≥ 1.05 10. 8.3 Platelet donor: In addition to 8.2, the following requirements should be met: a) Red blood cell volume (HCT): ≥ 0.36b) Preharvest platelet count (PLT): ≥ 150× 109/L and < 450×109/L. 9 Blood donation amount and blood donation interval 9. 1 blood donation amount 9. 1. 1 whole blood donors can donate 400ml, 300ml or 200ml of whole blood at a time. 9. 1.2 Platelet donor: You can donate 1 to 2 treatment units or 1 treatment unit and no more than 200ml plasma each time. The total amount of platelets and plasma collected throughout the year shall not exceed 10L. Note 1: The above blood donation amount does not include the remaining blood after blood test and the amount of maintenance fluid or anticoagulant. 9.2 Blood donation interval 9.2. 1 whole blood donation interval: not less than 6 months. 9.2.2 Blood donation interval of apheresis platelets: not less than 2 weeks and not more than 24 times/year. Due to special matching needs, it must be approved by the doctor, and the shortest interval should not be less than 1 week. 9.2.3 The interval between platelet collection and whole blood donation: not less than 4 weeks. 9.2.4 The interval between whole blood donation and apheresis platelet donation: not less than 3 months. 10 blood test after blood donation 10. 1 blood type test: ABO and RhD blood types are correctly finalized. 10.2 alanine aminotransferase: it meets the relevant requirements. 10.3 hepatitis b virus (HBV) detection: it meets the relevant requirements. 10.4 hepatitis c virus detection: it meets the relevant requirements. 10.4 HIV test: it meets the relevant requirements. 10.5 Syphilis test: it meets the relevant requirements. The first part should know before donating blood 1. Safe blood can save lives, but unsafe blood can endanger lives. Safe blood can only come from blood donors with altruistic motives and a healthy lifestyle. High-risk actors (such as intravenous drug addiction, men who have sex with men, patients with AIDS or sexually transmitted diseases, etc.). Please don't donate blood. Knowing that it is a high-risk behavior and donating blood, resulting in the spread of infectious diseases, according to Article 77 of the Law on the Prevention and Control of Infectious Diseases in People's Republic of China (PRC), Article 38 and Article 62 of the Regulations on AIDS Prevention and Control, the corresponding civil liability shall be investigated. Please don't donate blood for testing. The state provides free AIDS counseling and testing services. If necessary, please contact the local CDC (please contact the national public health hotline 12320). 3. In order to evaluate your health status and whether it is suitable for blood donation, you need to fill in the health inquiry form truthfully. Please forgive me if the questions in the table involve your privacy or make you feel uncomfortable. 4. The "Measures for the Administration of Blood Stations" stipulates that blood donors should show their true identity documents before donating blood, and blood stations should check and register, so please support them. 5. If you think that the donated blood may have potential safety hazards, please tell us as soon as possible (tel: XXXXXXXX). 6. The blood donation process is safe. Use disposable sterile consumables for blood collection to ensure the safety of blood donors. Some people occasionally have discomfort such as blue puncture site, bleeding or pain, dizziness after blood donation. These discomforts are mild or temporary. I appeal to every blood donor to observe the precautions before and after blood donation to reduce the possibility of discomfort during blood donation. 7. Blood stations shall conduct blood tests in strict accordance with state regulations and use qualified blood for clinical use. Unqualified blood will be treated according to national regulations. The unqualified blood test results only show that your donated blood does not meet the requirements of national standards and cannot be used as the basis for diagnosis of infection or disease. 8. According to the provisions of the Law on the Prevention and Control of Infectious Diseases, blood stations report AIDS positive results and other personal data to the local CDC. We promise to keep your relevant information strictly confidential. Data on age and interval of blood donation in other countries and regions