Ordinance On Safety Of Blood Donation

Original Language Title: Bekendtgørelse om sikkerhed i forbindelse med bloddonation

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Overview (Table of Contents)

Appendix 1

Appendix 2

Bekendtstatement on 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), set :

§ 1. The blood bank responsible for the blood bank must ensure that there are procedures for potential donors are informed of :

1) blog's basic properties,

2) the procedures for blood donation ; and hazards at this point

3) components made based on full-blood and trunks,

4) the advantages of receiving blood,

5) that personal data about the donor is protected,

6) The meaning of informed consent, including recall of the consent

7) to make a clinical estimate ; connection with donations and causes for this

8) to obtain information on health and medical history and the reasons for this,

9) that it is necessary to carry out testing of donated blood and its reasons. here,

10) that the donor will be informed about test results if they display an abnormal condition that is significant for donor health,

11) in the possibility of the possibility of a donor from giving blood,

12) that it is important that donor information on future conditions that can make previous taps unfit for transfusion,

13) in which situations a donor must remain from that give blood because it can either be harmful to the donor's own health or present a risk to the recipient,

14) the possibility that the blood and blood components of autolog donation cannot cover ; the need for a planned transfusion and

15) for the disposal of not used autologous blood and blood components, as well as the reasons for it.

Stk.  2. The Board of Health shall draw up information from the Board of Health to the potential donors of the information referred to in paragraph 1.  1, information referred to. The competent body of the blood bank shall ensure that there are procedures for the release of the pamphlet to potential donors.

§ 2. The person responsible for the blood bank responsible for the blood bank must ensure a unique identification ; by donor, and that prior to each tapping using a questionnaire and for a personal call, information on the donor's current and previous health and medical history.

Stk.  2. The responsibility for the application of those referred to in paragraph 1 shall be :  The tasks referred to in paragraph 1 shall be carried out by a qualified health-care person, the person responsible for the blood-bank manager.

Stk.  Paragraph 3. The provisions of paragraph 3.  1 the said questionnaire shall contain the questions and declarations referred to in Annex 1.

Stk.  4. The questionnaire must be signed by both the donor and the person responsible for obtaining the goods referred to 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).  

Section 3. The person responsible for the blood-bank responsible must ensure that there are procedures for the inclusion of an amnesty and investigation to decide whether or not the donor is suitable for donation. for blood or blood components according to the criteria listed in Annex 2.

Stk.  2. The person responsible for the blood bank shall ensure that there are procedures for the information of the donor, provided that the test results show abnormal status of donor health.

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

Stk.  2. All relevant information must be recorded in the donor journal, 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 form part of the donor file.

Stk.  3. Donor Journal must be kept for at least 30 years after completion.

section 5. Donor and information about the donor must be made anonymous for third parties.

section 6. The person responsible for the blood bank shall ensure that there are procedures for the following testing of thorns and of herds, including pre-deposited taps to autotransfusion :

1) ABO Type and

2) RhD Type.

Stk.  2. For testing of the following source of infection must be carried out by 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 tests with equivalent sensitivity for hepatitis C

6) ID NAT, or other test with similar sensitivity to the humane immunodeficiency virus (HIV).

Stk.  3. The following can be tested by the following source of infection with new donors and donors who can be equated to :

1) Anti-HTLV I/II.

Stk.  Paragraph 4. The first paragraph shall be :  1 that test must not be carried out if the taping alone results in plasma, intended for fraction.

Stk.  5. Investigation of the tests referred to in paragraph 1.  2 the type of contamination mentioned must be carried out on a blood sample, at the same time as the tapling.

Stk.  6. If in acute life-threatening situations it will be necessary to use blood or blood components where the results of the investigation of the markers are not yet available, the competent body of the blood bank shall ensure that there are procedures for : in writing, that the person responsible for handling it in writing is made aware that the results of the studies are not available to assess the use of the blood or blood components.

Stk.  7. The blood bank responsible for the blood bank shall in the paragraphs of this Article.  6 in the case of such cases as far as possible ensure that there are procedures for the blood of the used blood obtained from a donor which has been checked and found negative for the markable marklet in the previous year.

section 7. The person responsible for the blood bank shall ensure that there are procedures to ensure that severe side effects observed during the donation of the donor are reported to the Board of Health in accordance with the rules laid down by the Minister for Health and Safety, Prevention.

Stk.  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 (3) is ensured.  2 and 3, mentioned the contamination of the virus and the number of positive following confirmed reports to Epidemiological Division, the Serum Institute.

§ 8 Intireate The provisions of the notice shall be punished by fine unless a higher penalty is owed under other legislation.

Stk.  2. Companies may be subject to the name of the company. (legal persons) punishable by the rules of the fifth chapter of the penal code,

section 9. The Bekendstatement shall enter into force on 1. January, 2009.

Stk.  2. At the same time, notification no. 24 of 19. January 2006 on the security of blood donation.

Health and Board of Health, 10. July 2008Jesper Fisker / Anne Mette Dons

Attachments 1


Appendix 2

Assessment of donor ' s fitness

questions for new donors
(The questions are answered with yes / no)
General Information :
Did you ever do ;
had any serious illnesses, or have you been operated?
had serious contagious diseases?
allergy (e.g. asthma, harvesting, mediate, medial sensitivity)?
had blackfit?
had blood shortage?
had too high or too low blood pressure?
have epileppsi (convulseizures) after puberty?
had cardio or circulatory disturbances?
had kidney diseases?
diabetic?
had a malignant disease (cancer)?
growth disorders treated with growth hormmon?
had any uncommon diseases?
sexual contact with another man (is replied to only by men)?
been a prostitute?
Smitterisiko :
Have you been in the last 6 months :
long prolonged feversessions?
had unintended weight loss?
had sexual contact with a bisexual man?
prostitutes in Denmark or abroad?
person from Africa, Asia, South or Mellemamerika?
person who is HIV positive?
index addict?
person who has been processed hemorrhage?
been pregnant (are replied to only by women)?
been out of Europe?
got blood transfusion?
pierced ears or elsewhere (piercing)?
successful acupuncture, tattoo or scarification (scratches on skin)?
Have you been in the last 2 months :
medication?
vaccinate vaccination occurred?
Other Information : :
Have you previously been a blood donor?
Do you have less than 50 kg?
Have you got that period from 1? 1 January 1980 to 31. December 1996 held you more than 12 months in everything in Britain (England, Northern Ireland, Scotland, Wales, Isle of Man, the Channel Islands, Gibraltar or Falklands)?
Have you been told that there is Creutzfeldt-Jakob disease in your family?
Have you ever fixated or shared syringe or syringe with others?
Have you been transplanted cornehinde or brain-inside?
Were you born or raised in an area that is malaria?
Is there anyone in your household that has contagious hepatitis?
Feeling perfectly well?
Have you had jaunseum, infectious hepatitis, malaria or syphilis?
Have you read the information materials for the Health Board for blood donors?
Could you have been exposed to HIV?
Do you want to talk to a doctor or a nurse in enroom?
Declining :
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 received satisfactory answers to my questions.
Date and donor signature :
Date and the person responsible for obtaining information responsible person's signature :
CodeDeclaration :
I agree that my blood may be used for quality assurance of routine analyses and for research purposes according to applicable rules.
Date and donor signature :
Calla for additional information :
Additional information may be obtained which may affect the blood or use of the blood to patients, from (own doctor / special doctor or hospital) ______________
concern to_________________
Date and donor signature :
Questions to Multisource donors
(The questions are answered with yes / no)
Last tapping page :
Have you been sick?
Have you left outside Europe?
Have you had blood transfusion?
Have you been vaccinated?
Have you had jaunseum, infectious hepatitis, malaria or syphilis?
Have you been medicated in the last 2 months
If so, which?
Have you ever been pregnant (are replied to only by women)?
If yes, please specify when you were born or aborted.
Smitterisiko (in the last 6 months) :
Have you got pierced ears or elsewhere (piercing)?
Have you been able to perform acupuncture, tattoo or scarification (scratches on skin)?
Have you been to the orthodontist in the last week?
Have you been exposed to exposure to blood donors in the Health Management Information Material for blood donors?
Is there anyone in your household that has contagious hepatitis?
Other Information : :
Have you ever fixated or shared syringe or syringe with others?
Have you ever had sexual contact with another man (replied to only by men)?
Feeling perfectly well?
Do you want to talk to a doctor or a nurse in enroom?
Declining :
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 received satisfactory answers to my questions.
Date and donor signature :
Date and the person responsible for obtaining information responsible person's signature :
CodeDeclaration :
I agree that my blood may be used for quality assurance of routine analyses and for research purposes in accordance with applicable rules.
Date and donor signature :
Additional information condensation :
Additional information may be obtained which may affect the blood or use of the blood to patients, from (own doctor / special doctor or hospital) ______________
concern to_________________
Date and donor signature :

The responsible doctor shall ensure that there are procedures for the assessment of the donor ' s suitability for donation of blood or blood components according to the following criteria.
1. Conditions for acceptance of full-blood and blood component donors
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 for blood-banking.
The following conditions do not apply to autologous donations.
1.1. The age and body weight of the donor
Age
18-65 years
17-18 years
With written consent from custody or legal guardian under applicable law.
New donors over 60 years
Based on an estimate made by the doctor of the blood bank
Over 65 years
Not usually Tapped.
However, the competent doctor of the blood bank may authorise an annual individual assessment.
Body weight
> 50 kg for full-blods and dereresedonors

1.2. Hemoglobin levels in donor ' s blood
In order to ensure the development of blood shortages by frequent tapping, the haemoglobin concentration of the donor must be measured in connection to each collection.

Hemogloblobin-concentration
Women
25 125 grams per litre
(7.8 mmol / l)
Men
135 grams per litre
(8.4 mmol / l)
Applies to alloc full-blods or blood component donors.

In case of suspicion of anaemia the haemoglobin concentration must be tested in blood sample, extras taken before taking place.
In the case of a donor who is regularly donating blood, the following must be specified on the haemoglobin concentration at the last tapping before taking place.
If the haemoglobin concentration differs from that or if it falls more than 1,3 mmol / l (20 g/l) between two successive tapings, the donor must be examined as a starting point.
1.3. Protein levels in donor ' s blood

Protein concentration
60 g/l
The plasma recorder protein analysis must be made at least once an annual
1.4. Trombocytlevels in donor ' s blood

Trombocyttconcentrconcentration
150 x 109 / l
Level requirements for trombocytaferal donors.

2. Criteria for deferral of thoroughblood and blood component donors
The tests and exclusions specified with an asterix (*) are not required if the taping is used exclusively for plasma intended for fractionation.
2.1. Permanent deferral criteria for allogenous donors

Cardiovascular disease
Donors with an active or previous severe cardiovascular disease, except for full health abnormalities, with complete cure.
Disease in central nervous system
A sickness story with a severe disease in central nervous system.
Abstandard bleeding stone
Donors suffering from a decoding defective.
Repeated blackouts (syncops) or seizures of spasm
Except for cramping as a child or if the donor for at least three years has not taken a convulcation and has not been relapse.
Diseases in the bowels-intestinal tract or in genitals, blood diseases, immune diseases, metabolic diseases, metabolic diseases, kidney diseases or respiratory diseases
Diabetes
If insuindemanding.
Smydeme diseases
Hepatitis B, except for HBsAg negative donors, which have been documented Immunes.
Hepatitis C
HIV-1/2
HTLV I/II
Babesiose *
Kala Azar (leishmaniasis) *
Infection with Trypanosoma cruzi (Chagas ' disease) *
Ondarted diseases
Except in situ cancer with complete cure.
Transmissible spongiform encephalopathies (e.g. Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt-Jakob disease (vCDJ))
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 1980 to 1996, have been in 12 months or more in Great Britain.
Intravenous (IV) or intramusculously (IM) drug abuse
Influence of intravenous or intramuscular misuse of non-prescribed substances, including muscle-building steroids or hormones.
Xenotransplantation
Sexual behavior
Donors, which because of their sexual behaviour are at great risk of causing serious infectious diseases that can be transmitted with blood.

2.2. Criteria for the temporary exclusion of allogenous donors
2.2.1 Infections
After an infectious disease, donors are to be excluded for at least two weeks after full clinical recovery.
However, the following exclusions periods are applied to the listed infections :

Brucellosis *
2 years after the Full Clinical Clinical Date
Osteomyelitis
2 years after the date of authenticating.
Q fever *
2 years after the date of authenticating.
Syfilis *
1 year after the date of authenticate date.
Toxoplasmosis *
6 months after the date of a clinical recovery.
Tuberculosis
2 years after the date of authenticating.
Married fever
2 years after the date of termination of the symptoms, if there is no chronic heart condition.
Feber > 38 ° C
Influenza-like disease
Malaria * :
-donors who have lived during the first five years of life in a Malaria
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 genomics test is negative for each tapping in 3 years after the return.
-donors who have suffered from malaria
Three years without symptoms after the end of treatment. The donor is then accepted only if a negative immunological or molecular genomic test is available :
-asymptomatic donors who have visited a endemic area
6 months after departure from endemic territory, unless there is a negative immunological or molecular genomics test.
-donors who have had a fever of unknown reason during a visit to a endemic region or within six months therm=
3 years after termination of the symptoms ; the exclusion period may be reduced to 4 months if a negative immunological or molecular genomical test is available.
Vestnilviru* *
28 days after leaving an area of ongoing transfer of Vestnilvirus to people.

2.2.2. Exposure to risk of getting an infection that can be transmitted by transfusions

Endoscopic study using bendable instruments
Exclusion for 6 months or 4 months if there is a negative NAT test for hepatitis C.
Any path or slime contact with material containing blood or emblem
Blood transfusion
Humant tissue or cell transplantation
Greater surgical intervention
Tattoing or body piercing
acupuncture, unless it is exercised by an authorized doctor and with sterile dispossis : 0,123cm; padding-right : 0.123cm; padding-top : 0cm; padding-bottom : 0cm; border-left : 0.018cm solid #000000; border-right : 0.018cm solid #000000; border bottom : 0.018cm solid #000000; width : 444px; ">
Near contact (same household) to a person suffering from hepatitis B
Exclusion for 6 months after the close contact is disclosed
Behavior or activity causing infectious diseases that may be transmitted through the blood
Exclusion after the risk behavior end during a period that depends on the relevant disease and the existence of relevant tests.

2.2.3. Vaccination

Swoke viruses and bacteria
4 weeks.
Inatives / killed viruses, germs or rickettsia
No exclusion, if donor is healthy.
Toksoids
No exclusion, if donor is healthy.
Hepatitis A-or hepatitis B vaccinations.
No exclusion if the donor is healthy and if no exposure occurred.
Rabies
No exclusion if the donor is healthy and if no exposure has occurred.
If the vaccination takes place after exposure, the donor shall be excluded for 1 year.
Vaccination for central European encephalitis
No exclusion if the donor is healthy and if unexposure occurred.

2.2.4. Other temporary exclusion

Pregnancy
6 months after maternity or termination, except in exceptional circumstances and on the basis of a doctor's discretion.
Less surgical intervention
1 week.
Dentitreatment
Exclusion for 1 day in less treatment with dentistry or dental hygis. Dental tract, root processing and the like are considered a minor surgical intervention.
Medical Processing
Depending on the nature of the medication that is prescribed, its operation and the illness being treated.

2.2.5. Exclusion in particular epidemiological situations

Special epidemiological situations
Exclusion in accordance with the epidemiological situation.

2.3. Criteria for the exclusion of autologous donors

Severe Heart disease
Depending on the clinical parameters of the tapningen specified clinical parameters.
Donors who have a bit of
-hepatitis B, except for HBsAg-negative people who have been documented immunes
-hepatitis C
-HIV-1/2
-HTLV I/II
Active bacterial infection
Official notes

1) The Bekendtstatement contains provisions that 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).