Ordinance On Safety Of Blood Donation

Original Language Title: Bekendtgørelse om sikkerhed i forbindelse med bloddonation

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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=120601

Overview (table of contents) Annex 1

Annex 2 the full text Announcement about safety of blood donation 1)

Pursuant to § 7 and § 14 (2) of law No. 295 of 27. April 2005 about obtaining human blood for therapeutic purposes (blood supply Act) shall be determined:

§ 1. The blood bank for competent doctor must ensure that there are procedures for that potential donors be informed of:





1) blood's basic properties,

2) procedures for blood collection and risks in doing so,

3) the components, which are manufactured on the basis of whole blood and Apheresis donations,

4) benefits to receive blood,

5) that personal data concerning the donor are protected,

6) the importance of informed consent, including revocation of consent,

7) that it is necessary to perform a clinical discretion in connection with donations and its causes,

8) that it is necessary to obtain information about health and medical history and its causes,

9) that it is necessary to carry out the testing of donor blood and its causes,

10) that the donor will be informed of the test results, if they show an abnormal condition that is of importance to the donor's health,

11) circumstances in which a donor can be excluded from giving blood,

12) that it is important that the donor informs about later events which can make the former donation unsuitable for transfusion

13) in which situations a donor must refrain from giving blood because it either can be harmful for the donor's own health or pose a risk to the recipient,

14) the possibility that blood and blood components by an autologous donation cannot cover the need in connection with a proposed trans-fusion and

15) on the disposal of unused autologous blood and blood components as well as the reasons for them.





(2). The National Board of health shall prepare informational pamphlets for use by potential donors about the information referred to in paragraph 1. The blood bank for competent doctor must ensure that there are procedures for that booklet handed out to potential donors.

§ 2. The blood bank for competent doctor must ensure a unique identification of the donor and that each donation by use of a questionnaire and by a personal interview collected information about the donor's current and past health and medical history.

(2). Responsible for the tasks referred to in paragraph 1 shall be carried out by a qualified healthcare practitioner, blood bank responsible for the doctor.

(3). The questionnaire referred to in paragraph 1 shall contain the questions and statements referred to in annex 1.

(4). The questionnaire must be signed by the donor, as well as by the health care professional who is responsible for obtaining the information referred to in paragraph 1, without prejudice to article. (2). Health the person's signature confirming that the donor has been provided with the article 1, paragraph 2 referred to in the leaflet and have had the opportunity to ask detailed questions. The donor confirms with his signature to the best of our knowledge and belief to have given proper information and have received it in § 1, paragraph 2 referred to in the booklet.

§ 3. The blood bank for competent doctor must ensure that there are procedures for that shooting anamnesis and carried out investigations to determine whether the donor is suitable for donation of blood or blood components in accordance with the criteria referred to in annex 2.

(2). The blood bank for competent doctor must ensure that there are procedures for that donor is informed, if test results show abnormality of significance to the donor's health.

§ 4. For each potential donor must create a journal (donor journal).

(2). All relevant information must appear on the donor register, including for example. reason for rejection or exclusion of the donor. In sections 2 and 3, the information referred to, and the signed questionnaire, etc. must be included as part of the donor register.

(3). Donor records must be kept for at least 30 years after the last collection.

§ 5. Donor and data concerning the donor must be made anonymous to third parties.

§ 6. The blood bank for competent doctor must ensure that there are procedures for carrying out the following testing of whole blood and Apheresis donations, including autologous predeposit donations to autologous transfusion:





1) ABO-type and

2) RhD-type.





(2). To be made to the testing of the following infectious markers in donors:





1) HBsAg,

2) Anti-HCV and

3) Anti-HIV 1/2

4) ID (individual donation)-NAT (nukelinsyre amplifikationstest) or other test with similar sensitivity for hepatitis B

5) ID-NAT or other testing with equivalent sensitivity for hepatitis C

6) ID-NAT or other testing with equivalent sensitivity for human immunodeficiency virus (HIV).





(3). To be made to the testing of the following infectious markers among new donors and donors who can be treated with this:





1) Anti-HTLV I/II.





(4). The testing referred to in paragraph 1 shall not be made if the donation alone results in plasma intended for fractionation.

(5). Investigation of the infection markers referred to in paragraph 2 shall be carried out on a blood sample taken at the same time with the donation.

(6). If it is in acute life-threatening situations will be necessary to apply the blood or blood components, where the result of the study of markers is not yet available, the blood bank for competent doctor ensure that there are procedures to ensure that the person responsible for examining physician in writing will be pointed out that the results of the studies are not available, so this can assess the use of blood or blood components.

(7). The blood bank for competent doctor must in the circumstances referred to in paragraph 6 as far as possible, ensure that there are procedures for that it used blood from a donor who within the last year were examined and found to be negative for these markers.

§ 7. The blood bank for competent doctor must ensure that there are procedures for that serious adverse reactions observed during blood collection of donors will be reported to the health protection agency in accordance with the rules laid down by the Minister for health and prevention.

(2). The blood bank for competent doctor must ensure that there are procedures for that information on the number of examinations for those in article 6, paragraphs 2 and 3, said infection markers and the number of positive after confirmatory examinations thereof shall be reported for epidemiological Department, the Danish State Serum Institute.

§ 8. Violation of the provisions of the Executive order is punishable by a fine, unless a higher penalty is inflicted for other legislation.

(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

§ 9. The notice shall enter into force on the 1. January 2009.

(2). At the same time repealed Executive Order No. 24 by 19. January 2006 on the safety of blood donation.
The health protection agency, the 10. July 2008 Jesper Fisker/Anne Mette Dons Annex 1







 

 

 



 

 

 





Questions for new donors







(The questions are answered with Yes/No)





 

 

 





General information:







Have you ever;





 



had serious illnesses, or are you had surgery?





 



had serious infectious diseases?





 



had allergies (such as asthma, høsnue, hypersensitivity to medications)?





 



had fainting spells?





 



had anemia?





 



had too high or too low blood pressure?





 



had epilepsy (seizures) after puberty?





 



had heart or circulatory disorders?





 



had kidney disease?





 



had diabetes?





 



had a malignant disease (cancer)?





 



had growth disorders treated with growth hormone?





 



had uncommon diseases?





 



had sexual contact with another man (to be answered only by men)?





 



been a prostitute?





 

 

 





Infection risk:







Have you within the last 6 months:





 



had prolonged fever periods?





 



had the unintentional weight loss?





 



had sexual contact with a bisexual man?





 

 




prostitute in Denmark or abroad?





 

 



person from Africa, Asia, South or Central America?





 

 



person who is HIV positive?





 

 



slot addict?





 

 



person is treated for bleeding disorder?





 



been pregnant (to be answered only by women)?





 



been outside Europe?





 



got blood transfusion?





 



made holes in the ears or elsewhere (piercing)?





 



been carried out acupuncture, tattooing or scarification (scratches in the skin)?





 

 

 





Have you, within the last 2 months:





 



got medicine?





 



undergone vaccination?





 

 

 





Other information:







Have you previously been a blood donor?







You weigh less than 50 kg?







Do you have in the period from 1. January 1980 to 31. December 1996 stayed more than 12 months in total in the United Kingdom (England, Northern Ireland, Scotland, Wales, Isle of Man, Channel Islands, Gibraltar or Falkland Islands)?







Have you been told that Creutzfeldt-Jakob disease in your family?







Have you ever fixed or shared syringe or needle with others?







Have you got transplanted cornea or meninges?







Are you born or grew up in an area where there is malaria?







Does anyone in your household who have infectious hepatitis?







Do you feel full quickly?







Have you had jaundice, infectious hepatitis, malaria or syphilis?







Have you read the Board of Health's information material for blood donors?







You may have been exposed to infection with HIV?







Would you like to talk to a doctor or a nurse in private?





 

 

 





Statement:







The above questions are answered to the best of knowledge and belief. I have read and understood the information provided material prepared by the National Board of health. There has been the opportunity to ask questions, and I've got satisfactory answers to my questions.





 

 

 





Date and the donor's signature:



 



 

 

 





And the date of collection of the information responsible person's signature: consent form:







I agree that my blood may be used for quality assurance of the routine analyses and for research purposes, in accordance with the applicable rules.





 

 

 





Date and the donor's signature:



 



 

 

 



 

 

 



 

 

 





Consent to obtaining further information:







Who may obtain further information which may have significance for my donations of blood or the use of blood for patients, from (GP/specialist or hospital) ______________

vedrørende_________________





 

 

 





Date and the donor's signature:





 

 

 



 

 

 





Questions for multiple donors







(The questions are answered with Yes/No)





 

 

 





Since the last collection:







Have you been sick?







Have you traveled outside Europe?







Have you got a blood transfusion?







Have you been vaccinated?







Have you had jaundice, infectious hepatitis, malaria or syphilis?







Have you been given medication within the last 2 months





 



If yes which one?







Have you been pregnant (to be answered only by women)?





 



If Yes, please specify when, when you gave birth or aborted.





 

 

 






Infection risk (within the last 6 months):







Have you gotten made holes in the ears or elsewhere (piercing)?







Have you gotten carried out acupuncture, tattooing or scarification (scratches in the skin)?







Have you been at dentist within the last week?







Have you been exposed to the risk of HIV infection, as indicated in the National Board of Health's information material for blood donors?







Does anyone in your household who have infectious hepatitis?





 

 

 





Other information:







Have you ever fixed or shared syringe or needle with others?







Have you ever had sexual contact with another man (to be answered only by men)?







Do you feel full quickly?







Would you like to talk to a doctor or a nurse in private?





 

 

 





Statement:







The above questions are answered to the best of knowledge and belief. I have read and understood the information material provided. There has been the opportunity to ask questions, and I've got satisfactory answers to my questions.





 

 

 





Date and the donor's signature:





 

 

 





And the date of collection of the information responsible person's signature:



 



 



 





Consent form:







I agree that my blood may be used for quality assurance of the routine analyses and for research purposes, in accordance with the applicable rules.





 





Date and the donor's signature:





 

 





Consent to obtaining further information:







Who may obtain further information which may have significance for my donations of blood or the use of blood for patients, from (GP/specialist or hospital) ______________

vedrørende_________________





 

 

 





Date and the donor's signature:





 

 

 



 

 

 



 

 

 





Annex 2

Assessment of donors







 



 





The blood bank for competent doctor must ensure that there are procedures for the assessment of donor suitability for donation of blood or blood components according to the following criteria.





 





1. Conditions of acceptance of whole blood and blood component donors





 






In exceptional circumstances, the blood bank for competent doctor allow individual donations from donors who do not meet the conditions below. All such cases should be documented clearly and in accordance with Decree No. 1230 by 8. December 2005 on the quality and safety requirements for blood establishment activity.







The following conditions do not apply to autologous donations.





 





1.1. Donorens alder og kropsvægt





 

















Alder





18-65 år



 



 



17-18 år





With written consent of custodian or legal guardian in accordance with applicable law.





 



New donors over 60 years of age on the basis of an estimate made by the blood bank's doctor.





 



Over 65 years are not normally Collected.

The blood bank for competent doctor may, however, grant permission after an annual individual assessment.







Kropsvægt





> 50 kg for fuldblods- og aferesedonorer

















 





1.2. Haemoglobin levels in donor's blood





 





In order to ensure donor toward the development of anemia by too frequent Phlebotomy must donor hemoglobin concentration is measured in connection to each collection.





 















Hemoglobin concentration Women

≥ 125 g/l

(7.8 mmol/l)





Men

≥ 135 g/l

(8.4 mmol/l)





Applicable to allogeneic whole blood or blood component donors.















 





There is a suspicion of anaemia haemoglobin concentration must be examined in the blood sample taken before the collection takes place.







For a donor who regularly donates blood, must be available as a starting point information about hemoglobin concentration in the last collection before the donation takes place.







If hemoglobin concentration differs from the foregoing, or if it falls more than 1.3 mmol/l (20 g/l) between two successive donations, the donor base must be further explored.





 



 



 



 





1.3. Protein levels in donor's blood Protein concentration ≥ 60 g/l Protein analysis for plasmaaferesedonorer must be made at least once a year.















 





1.4. Platelet levels in donor's blood Trombocyttkoncentration ≥ 150 x 109/l Level requirements for trombocytaferesedonorer.















 





2. Deferral criteria for donors of whole blood and blood component donors





 





Those with an asterisk (*) specified test and exclusion periods are not required, if the donation are used solely for plasma intended for fractionation.





 





2.1. permanent deferral criteria for donors of allogeneic donations cardiovascular disease Donors with active or past serious cardiovascular disease, except congenital abnormalities with complete cure.







Disease of the central nervous system a medical history with a serious disease of the central nervous system.







Abnormal bleeding tendency Donors, who suffers from a coagulation defect.







Repeated fainting spells (syncopation) or antecedents of seizures other than seizures as a child, or if the donor for at least three years have not taken the seizure medication and have not had a relapse.







Diseases of the gastrointestinal tract or of the genital and urinary organs, blood diseases, immune diseases, metabolic disorders, kidney diseases or diseases of the respiratory tract Donors with serious active or chronic illness or severe disease with relapse.







If insulin dependent diabetes.







Infectious diseases Hepatitis B, except for HBsAg-negative donors who are proven immune.





 



Hepatitis C HIV-1/2, HTLV I/II Babesiosis * Kala Azar (leishmaniasis) * Infection with Trypanosoma cruzi (Chagas ' disease) * Malignant disease Except in situ cancer with complete cure.







Transmissible spongiform encephalopathies (TSEs), (URf.eks. Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt-Jakob disease (vCDJ)) Donors, whose medical history implies that they are exposed to the risk of developing TSE, or persons who have undergone corneal or dura mater transplantation, or who have been treated with drugs made from human pituitary glands.

Donors, which in the period 1980-1996 have stayed for 12 months or more in the United Kingdom.







Intravenous (IV) or intramuscular (IM) substance abuse Antecedents of intravenously or intramuscularly abuse of non-prescribed substances, including muscle-building steroids or hormones.







Xenotransplantation sexual behavior donors who due to their sexual behavior is exposed to a high risk of inflicting serious infectious diseases that can be transmitted by blood.

















 





2.2. temporary deferral criteria for donors of allogeneic donations





 





2.2.1 Infections





 





After an infectious disease must be excluded as donors starting point for at least two weeks after the full clinical recovery.







However, the following exclusion periods apply for the listed infections:





 

















Brucellosis * 2 years from the date of full clinical recovery.







Osteomyelitis 2 years after the date of confirmed cured.







Q-fever * 2 years from the date of confirmed cured.







Syphilis * 1 year after the date of confirmed cured.







Toxoplasmosis * 6 months after the date of the clinical cure.







2 years after the date of confirmed tuberculosis cure.







Rheumatic fever






2 years after the date of cessation of symptoms, if there are no signs of a chronic heart condition.







Fever > 38 ° c 2 weeks after the date of cessation of symptoms.







Influenza-like illness 2 weeks after the date of cessation of symptoms.







Malaria *: – donors during the first five years of life have lived in a malarial area 3 years after returning from the recent visit in the endemic area, provided that they remain symptom-free. The exclusion period may be reduced to 4 months if the immunological or molecular genomic test is negative at each donation for 3 years after returning home.







– donors, who have suffered from malaria 3 years without symptoms after treatment cessation. After the donor is accepted only if there is an adverse immunological or molecular genomic test.







– asymptomatic donors who have visited an endemic area 6 months after departure from the endemic area, unless there is an adverse immunological or molecular genomic test.







– donors who have had fever of unknown cause during a visit to any endemic area or within six months then 3 years after cessation of symptoms; the exclusion period may be reduced to 4 months if an immunologic or molecular genomic test negative are available.







The West Nile virus * 28 days after leaving an area with ongoing transmission of the West Nile virus to humans.

















 



 



 



 



 





2.2.2. Exposure to the risk of getting an infection that can be transmitted by transfusion Endoscopic examination with the use of flexible instruments Exclusion in 6 months or at 4 months, if there is a negative NAT test for hepatitis C.







Jack accidentally or mucosal contact with material that contains blood or bodily fluid-blood transfusion Human tissue or cell transplant is Major surgery Tattoo body piercing or Acupuncture unless it is exercised by an authorized physician and with sterile disposable needles close contact (same household) for a person who suffers from hepatitis B Exclusion in 6 months after the close contact has ceased







Behaviour or activity that gives risk of inflicting themselves infectious diseases that can be transmitted through the blood Deferral after cessation of risk behaviour in a period that depends on the specific disease and the existence of the relevant test.

















 





2.2.3. Vaccination





 

















Svækkede vira og bakterier





4 uger.







Inactivated/killed viruses, bacteria or rickettsia No exclusion, if the donor is healthy.







Toksoider No exclusion, if the donor is healthy.







Hepatitis A or hepatitis B vaccinations.





No exclusion, if the donor is healthy, and if there is no exposure occurred.







Rabies No exclusion, if the donor is healthy, and if there is no exposure occurred.

If vaccination takes place after exposure, exclude the donor in 1 year.







Vaccinating against central European encephalitis No exclusion, if the donor is healthy, and if there is no exposure occurred.

















 





2.2.4. Other temporary exclusion





 

















Pregnancy 6 months after childbirth or abortion, except under exceptional circumstances and on the basis of a doctor's discretion.







Minor surgical intervention 1 week.







Dental treatment Exclusion in 1 day by minor treatment at the dentist or dental hygienist. Tooth extraction, root canal treatment and similar are considered a minor surgical operation.







Medical treatment depending on the type of medication that is prescribed, its functioning and the disease being treated.

















 





2.2.5. Deferral for particular epidemiological situations in particular epidemiological situations Exclusion in accordance with the epidemiological situation.















 





2.3. Deferral criteria for donors of autologous donations Serious heart disease depending on the for the donation provided clinical parameters.







Donors, who have suffered from

– hepatitis B, except for HBsAg-negative persons who are proven immune

– hepatitis C

– HIV-1/2

– HTLV I/II Active bacterial infection Official notes 1) Ordinance contains provisions implementing parts of a European Parliament and Council Directive 2002/98/EC of 27. January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (Official Journal of the European Union 2003 nr. L 33, page 29-40).