Key Benefits:
Completion of the safety of blood donation 1)
In accordance with section 7 and section 14 (4), Two, in Law No 295 of 27. April 2005 on the procurement of human blood for the purpose of processing (blood supply law), shall be determined as follows :
§ 1. The person responsible for the blood bank shall ensure that there are procedures for ensuring that potential donors are informed of :
1) the basic characteristics of the blog,
2) the procedures related to blood-taking and risks,
3) the components produced on the basis of thoroughbred and hertaps ;
4) the benefits of receiving blood,
5) the protection of personal data on the donor,
6) the meaning of informed consent, including revocation of the consent ;
7) it is necessary to make a clinical judgment in relation to donations and the reasons for it ;
8) it is necessary to obtain information on health and medical history and the reasons for it ;
9) it is necessary to carry out the testing of donor blood and the reasons for it ;
10) that the donor will be informed of the test results if they show an abnormal condition that is significant for the health of the donor ;
11) in which situations a donor may be excluded from giving blood,
12) that it is important that the donor be informed of a future relationship that may make previous taps unfit for transfusion ;
13) in which situations a donor must be refused from giving blood because it may be harmful to the donor's own health or present a risk to the recipient,
14) the possibility of the blood and blood components of an autolog donation unable to cover the need for a intended transfusion ;
15) on the disposal of the unused autologous blood and blood components, as well as the reasons for it.
Paragraph 2. The Board of Health shall prepare pamphlets for the use of potential donors of the information referred to in paragraph 1. 1, information referred to. The person responsible for the blood bank must ensure that there are procedures for the release of the leaflet to potential donors.
§ 2. The competent body of the blood bank shall ensure a unique identification of the donor and that, before each tapping using a questionnaire and a personal call, information on the donor's current and previous health and medical history shall be obtained.
Paragraph 2. The responsibility for the application of those referred to in paragraph 1. The duties referred to in paragraph 1 shall be carried out by a qualified health officer responsible for the competent blood bank.
Paragraph 3. The one in paragraph 1. 1 the questionnaire referred to in Annex 1 shall include the questions and declarations referred to in Annex 1.
Paragraph 4. The questionnaire must be signed by both donors and the health-care person responsible for obtaining them in paragraph 1. 1 mentioned information, cf. paragraph The signature of the health care staff confirms that the donor has received it in section 1 (1). 2, mentioned Pjece, and have had the opportunity to put questions to the end. Donor agrees with his signature, in the best of his opinion, to have provided correct information and received it in section 1 (1). 2, mentioned pjece.
§ 3. The competent body of the blood bank shall ensure that there are procedures for the inclusion of an amnesty and studies to determine whether or not the donor is suitable for donation of blood or blood components according to the criteria referred to in Annex 2.
Paragraph 2. The person responsible for the blood bank shall ensure that there are procedures for the donor being informed, provided that the test results show abnormal condition of the donor ' s health.
§ 4. For each potential donor, a journal (donor journal) must be created.
Paragraph 2. All relevant information must be recorded in the donor file, including f. Exes. cause of rejection or exclusion of the donor. The information referred to in sections 2 and 3 and the signed questionnaire and so on shall be included as part of the donor journal.
Paragraph 3. The donor journal must be kept for at least 30 years after the final tapping.
§ 5. Donor and information concerning the donor must be made anonymous to third parties.
§ 6. The competent body of the blood bank shall ensure that there are procedures for the testing of full blood and herds, including pre-deposited taps to autotransfusions :
1) ABO Type and
2) RhD type.
Paragraph 2. Test of the following contamination shall be carried out at the donor :
1) HBsAg,
2) Anti-HCV and
3) Anti-HIV 1/2
4) ID (individual donation) -NAT-(nucleic acid amplification test) or other test with corresponding sensitivity for hepatitis B
5) ID NAT or other test with corresponding sensitivity for hepatitis C
6) ID NAT or other test with similar sensitivity to the humane immunodeficiency virus (HIV).
Paragraph 3. The following are to be tested by the following source of infection with new donors and donors that may be placed on the side :
1) Anti-HTLV I/II.
Paragraph 4. The one in paragraph 1. 1 that test must not be carried out if the tapling alone results in plasma, intended for fractionation.
Paragraph 5. Investigation of the items referred to in paragraph 1 2 the said contamination must be carried out on a blood sample taken at the same time as the tapling.
Paragraph 6. Where, in acute life-threatening situations, blood or blood components, where the results of the examination of the markers are not yet available, the competent body of the blood bank shall ensure that there are procedures for : The competent medical examiner shall be aware in writing that the results of the studies are not available to assess the use of blood or blood components.
Paragraph 7. The competent body of the blood bank shall be required in the first paragraph. The case, as far as possible, shall ensure that there are procedures for the fact that the blood used is derived from a donor which has been examined and found negative for the markable marklet in the last year.
§ 7. The competent body of the blood bank shall ensure that there are procedures for the reporting of serious adverse reactions during the donation of the donor to the Board of Health, by rules determined by the Minister for Health and Prevention.
Paragraph 2. The person responsible for the blood bank shall ensure that information on the number of studies carried out for the studies referred to in section 6 (2) shall be ensured. 2 and 3, mentioned the contamination of the virus and the number of positive following confirmation of confirmatory enquiries shall be reported to Epidemiological Division, the Serum Institute of the State.
§ 8. The violation of the provisions of the notice shall be punished by fine, unless a higher penalty is imposed on other legislation.
Paragraph 2. Companies can be imposed on companies. (legal persons) punishable by the rules of the penal code 5. Chapter.
§ 9. The announcement shall enter into force on 1. January, 2009.
Paragraph 2. At the same time, notice No 24 of 19. January 2006 on the safety of blood donation.
Appendix 1
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Questions to new donors
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(The questions are answered with yes / no)
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General information :
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Have you ever,
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Have you ever had any serious illness, or have you been operated on?
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had serious infectious diseases?
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allergies (e.g. asthma, harvesting, oversensitivity to medicine)?
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had blackouts?
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had blood loss?
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had too high or too low blood pressure?
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have epilepsy (seizure of convulges) after puberty?
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had heart or cardiac disturbances?
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had any kidney disease?
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had diabetes?
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had a malignant disease (cancer)?
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had growth disturbances treated with growth hormone?
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had any ill-gotten diseases?
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have sexual contact with another man (is replied to only by men)?
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were prostitutes?
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Smitterisiko :
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Have you been in the last six months?
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long-term fevered periods?
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has been unintentionally weighting?
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Sexual contact with a bisexual man?
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prostitutes in Denmark or abroad?
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African, Asia, South or Mellemamerika?
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Person who is HIV positive?
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-What?-What?
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Person treated for hemorrhaging disease?
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has been pregnant (are only answered by women)?
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been outside Europe?
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A blood transfusion?
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pierced ears or elsewhere (piercing)?
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have performed acupuncture, tattoo or scarification (scratches on skin)?
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Have you been in the last two months?
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Medication?
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had vaccination been carried out?
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Other information :
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Have you previously been a blood donor?
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You're less of a 50-pound weight?
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Have you got that period from 1? 1 January 1980 to 31. In December 1996, you stayed more than 12 months in Britain (England, Northern Ireland, Scotland, Wales, Isle of Man, the Channel Islands, Gibraltar or the Falklands)?
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Have you ever been told that there is Creutzfeldt-Jakob's disease in your family?
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Have you ever fixated or shared syringe or syringe with anyone else?
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Have you been transplanted cornholed or brain-hinde?
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Were you born or raised in an area where malaria is there?
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Is there anyone in your household that has contagious hepatitis?
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Are you feeling all right?
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Have you had jaunditis, infectious hepatitis, malaria or syphilis?
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Have you ever read the medical records of the Health Board for blood donors?
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Could you have been exposed to HIV infections?
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Do you want to talk to a doctor or a nurse in private?
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Declaration :
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The above questions have been answered in the best of conviction. I have read and understood the information provided by the Board of Health and services provided by the Board of Health. There has been an opportunity to ask questions, and I have been given satisfactory answers to my questions.
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Date and donor signature :
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Date and the person responsible for obtaining the person responsible for the information :
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Declaration of consent :
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I agree that my blood may be used for quality assurance of routine analyses and for research purposes in accordance with applicable rules.
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Date and donor signature :
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Condensation for further information :
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Additional information may be obtained which may affect the blood or use of the blood to patients, from (own doctor / special doctor or hospital) ______________
related to the _________________
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Date and donor signature :
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Multi-time donors questions
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(The questions are answered with yes / no)
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Since the final tapping :
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Have you been sick?
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Have you traveled outside Europe?
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Have you had a blood transfusion?
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Have you been vaccinated?
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Have you had jaunditis, infectious hepatitis, malaria or syphilis?
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Have you been medicated in the last two months?
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If so, which one?
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Have you ever been pregnant (are only answered by women)?
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If so, please specify when you were born or aborted.
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Smitterisiko (within the last 6 months) :
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Did you get your ears pierced or elsewhere (piercing)?
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Have you been able to perform acupuncture, tattoo or scarification (scratches on skin)?
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Have you been to the orthodontist in the last week?
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Have you ever been exposed to the risk of HIV infection, as listed in the health-related information material for blood donors?
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Is there anyone in your household that has contagious hepatitis?
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Other information :
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Have you ever fixated or shared syringe or syringe with anyone else?
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Have you ever had sexual contact with another man (defensible by men only)?
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Are you feeling all right?
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Do you want to talk to a doctor or a nurse in private?
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Declaration :
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The above questions have been answered in the best of conviction. I have read and understood the information provided by the provided information. There has been an opportunity to ask questions, and I have been given satisfactory answers to my questions.
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Date and donor signature :
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Date and the person responsible for obtaining the person responsible for the information :
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Declaration of consent :
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I agree that my blood may be used for quality assurance of routine analyses and for research purposes in accordance with applicable rules.
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Date and donor signature :
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Condensation for further information :
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Additional information may be obtained which may affect the blood or use of the blood to patients, from (own doctor / special doctor or hospital) ______________
related to the _________________
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Date and donor signature :
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Appendix 2
Valuation of donors ' suitability
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The competent body of the blood bank shall ensure that there are procedures for the assessment of donor fitness for the donation of blood or blood components according to the criteria below.
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1. Conditions for acceptance of thoroughblood and blood components
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In exceptional circumstances, the competent body of the blood bank may authorise individual donations from donors who do not meet the following conditions. All such cases shall be clearly documented and in accordance with the notice. 1230 of 8. December 2005 on the quality and safety requirements of blood banking.
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The following conditions do not apply to autologous donations.
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1.1. age of the donor and body weight
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Age
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18-65 years
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17-18 years old
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By written consent from the custody or legal guardian of the custody under applicable law.
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New donors over 60 years
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On the basis of an estimate made by the doctor of the blood bank.
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Over 65 years
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Usually, it's not a regular thing.
However, the competent body of the blood bank may authorise an annual individual assessment to be authorised.
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Body weight
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> 50 kg for full-blood and replacement donors
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1.2. Hemoglobin levels in donor ' s blood
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In order to ensure the donor of the development of blood shortages by frequent tapping, the hemoglobin concentration of the donor must be measured in connection with each collection.
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Hemoglobin concentration
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Women.
125 grams per litre,
(7.8 mmol / l)
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Men.
135 grams per litre,
(8.4 mmol / l)
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Applies to allogeners full-blood or blood component donors.
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In the case of suspicion of anaemia the haemoglobin concentration must be tested in blood tests, taken before taking place.
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In the case of a donor who is regularly donating blood, the starting point shall be made as a starting point for the haemoglobin concentration at the last tapping before taking place.
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If the haemoglobin concentration differs from that or if it falls more than 1,3 mmol / l (20 g/l) between two successive tapses, the donor must be examined as a starting point.
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1.3. Protein levels in donor ' s blood
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Protein concentration
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60 grams per litre,
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The protein analysis for the plasma-derived donors must be carried out at least once a year.
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1.4. Trombocytlevels in donor ' s blood
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Trombocyed concentration
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150 x 10. 9 / l
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Level requirements for the thrombocytaferal donors.
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2. Criteria for the exclusion of thoroughbred and blood components
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The test and exclusions of an asterix (*) are not required if the taping is used exclusively for plasma intended for fractionation.
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2.1. Permanent deferral criteria for donors of allogenies
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Cardiovascular disease
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Donors with an active or previous serious cardiovascular disease, except for natural abnormalities, with complete recovery.
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Disease in the central nervous system
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A sickness story with a severe illness in the central nervous system.
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Abnormal molluscry
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Donors, who are suffering from a coagulation defect.
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Repeated blackouts (syncops) or in the case of seizures of seizures
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Except for cramping as a child, or if the donor for at least three years has not taken any convulcation and has not had relapse.
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Diseases in the bowels of the stomach-intestinal tract or in genitals, blood diseases, immune diseases, metabolic diseases, kidney diseases or diseases in the air routes ;
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Donors with a serious or chronic illness or severe illness with a relapse.
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Diabetes
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If insulin demanding.
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Infectious diseases
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Hepatitis B, except for HBsAg negative donors, which have been documented immunes.
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Hepatitis C
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HIV-1/2
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HTLV I/II
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Babesiose *
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Kala Azar (leishmaniasis) *
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Infection with Trypanosoma cruzi (Chagas ' disease) *
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Malignant diseases
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Except in situ cancer, with complete recovery.
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Transmissible spongiform encephalopathies (TSE), (e.g. : Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt-Jakob disease (vCDJ))
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Donors, whose medical history means that they are at risk of developing TSEs or persons who have been subjected to hornhinde or dura mater transplantation, or which have been treated with medicinal products derived from human pituitary.
Donors, as in the period of 1980-1996, have been in place for 12 months or more in Britain.
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Intruvenous (IV) or intramusculary (IMs) of substance abuse
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Influence of intravenous or intramucous misuse of non-prescribed substances, including muscle-building steroids or hormones.
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Xenotransplantation
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Sexual behaviour
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Donors, who, because of their sexual behaviour, are at great risk of causing serious infectious diseases which can be transmitted in blood.
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2.2. Criteria for the temporary exclusion of alloc donors
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2.2.1 Infections
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After an infectious disease, donors are to be excluded for at least two weeks after the full clinical recovery.
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However, the following exclusions shall apply to the infected infections :
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Brucellosis *
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Two years after the date of full clinical recovery.
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Osteomyelitis
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Two years after the date of authenticating.
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Q fever *
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Two years after the date of authenticating.
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Syphilis *
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1 year after the date of confirmation of a recovery.
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Toxoplasmosis *
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6 months after the date of clinical recovery.
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Tuberculosis
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Two years after the date of authenticating.
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Married fever
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2 years after the date of termination of the symptoms, if there is no chronic heart condition.
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Feber > 38 ° C
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Two weeks after the date of termination of the symptoms.
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Influenza-like disease
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Two weeks after the date of termination of the symptoms.
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Malaria * :
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-donors who have lived during the first five years of life in a Malaria area
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3 years after the return of the last visit to endemic territory, provided that they continue to be symptomatic. The exclusion period may be reduced to 4 months if the immunological or molecular gene-genicity test is negative for each donation for three years after the return.
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-donors who have suffered from malaria.
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Three years without symptoms after the end of treatment. The donor is then accepted only if there is a negative immunological or molecular gene-genomical test.
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-asymptomatic donors who have visited a endemic region
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Six months after departure from endemic territory, unless there is a negative immunological or molecular gene-genomical test.
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-donors who have had the fever of unknown origin during a visit to a endemic region or within six months thermos;
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3 years after the termination of the symptoms ; the exclusion period may be reduced to 4 months if a negative immunological or molecular gene-genomical test is available.
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Vestnilvirus *
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28 days after leaving an area of the ongoing transfer of the Vestnilvirus to humans.
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2.2.2. exposure to the risk of infection which may be transmitted by transfusion
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Endoscopic investigation using bendable instruments
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Exclusion for six months or four months, if there is a negative NAT test for hepatitis C.
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Any path or slime contact with material containing blood or bodily fluke
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Blood transfusion
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Humant tissue or cell transplantation
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Greater surgical intervention
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Tattoo or body piercing
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Acupuncture, unless it is exercised by an authorized doctor and with sterile disposile needles
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Near contact (same household) to a person suffering from hepatitis B
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Exclusion for six months after the close contact has been discharged
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Behavior or activity at risk of infectious diseases which may be transmitted through the blood ;
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Exclusion of the risk movement for a period that depends on the disease in question and the existence of relevant tests.
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2.2.3. Vaccination
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Swoke viruses and bacteria
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Four weeks.
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Inatives / killed virua, germs or rickettsia
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No exclusion, if the donor is healthy.
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Toksoids
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No exclusion, if the donor is healthy.
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Hepatitis A-or hepatitis B vaccinations.
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No exclusion if the donor is healthy and if no exposure has been made.
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Rabies
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No exclusion if the donor is healthy and if no exposure has been made.
If the vaccination takes place after exposure, the donor shall be excluded for a period of 1 years.
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Vaccine for central European encephalitis
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No exclusion if the donor is healthy and if no exposure has been made.
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2.2.4. Other temporary exclusion
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Pregnancy
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6 months after maternity or pregnancy, except in exceptional circumstances and on the basis of a doctor's estimate.
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Minor surgical intervention
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One week.
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Dental
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Exclusion for 1 day in less treatment with dentistry or dental hygis. Dental extraction, root canal, and the like, are considered a minor surgical procedure.
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Medical treatment
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Depending on the nature of the medication prescribed, its operation and the disease being treated.
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2.2.5. Exclusion in particular epidemiological situations
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Special epidemiological situations
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Exclusion in accordance with the epidemiological situation.
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2.3. Criteria for the exclusion of autologous donors
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Severe heart disease
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Depending on the clinical parameters provided for the tapling,
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Donors, who have suffered from
-hepatitis B, except for HBsAg-negative people who have been documented immunes
-hepatitis C
-HIV-1/2
-HTLV I/II
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Active bacterial infection
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1) The announcement contains provisions which implement parts of Directive 2002 /98/EC of the European Parliament and of the Council of 27. In January 2003 establishing standards for the quality and safety of collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001 /83/EC, (EU-Official Journal of 2003), L 33, page 30-40).
