Exclusion criteria for blood donation

As exclusion criteria for blood donation refers to the criteria in which a blood donation is not possible. A distinction is made between permanent and temporary exclusion criteria. Different legal regulations apply in each country .

In addition, every carrier of a blood donation service can apply different criteria in detail, so this list only represents the most common criteria and does not have to apply in all cases and for all carriers.

On the one hand, these exclusion criteria serve to protect blood donors. A certain minimum weight is often required so that the donor is not weakened too much by donating blood. On the other hand, many infectious diseases can be transmitted through blood. So it came about B. in the 1980s to infections by HIV-contaminated blood products . To avoid this, certain risk groups are excluded from donating blood. Furthermore, the donated blood must not contain any undesirable drugs.

Germany

Donation eligibility

Before blood donations are taken, the suitability of the respective donor must be determined under medical responsibility, whereby the following criteria apply to the general suitability of people as blood donors according to the currently valid guidelines of the German Medical Association :

Donor Age:
- First-time donors: 18–60 years;
- Repeat donors: 18–68 years;
- Approval of older donors according to an individual medical decision;
Condition of the donor:
- at least 50 kg body weight;
- no recognizable symptoms;
- Hemoglobin or hematocrit in donor blood:
  - Women: Hb ≥ 125 g / l (7.75 mmol / l) or Hct ≥ 0.38 l / l,
  - Men: Hb ≥ 135 g / l (8.37 mmol / l) or Hct ≥ 0.40 l / l;
- Blood pressure :
  - systolic : 100–180 mm Hg,
  - diastolic : less than 100 mm Hg;
- Pulse :
  - inconspicuous,
  - Frequency 50-110 / min;
  - Donors who do intensive sport and have a pulse rate of less than 50 bpm can be admitted;
- Temperature: no fever;
- Skin at the puncture site free of lesions .

Temporary exclusion criteria

According to the currently valid guidelines of the German Medical Association, there are various criteria for the temporary exclusion ("deferral") of people as blood donors:

Infections :
- after the Q fever has definitely healed for 2 years;
- after the symptoms of toxoplasmosis have subsided for 6 months;
- after completing treatment for rheumatic fever for 2 years;
- after hepatitis A (HAV) or evidence of HAV infection (IgM-AK) for 4 months;
- after febrile illnesses and / or diarrheal illnesses of unknown cause for 4 weeks;
- after the symptoms of other infectious diseases than those mentioned above (with the exception of uncomplicated infections) have subsided for at least 4 weeks;
- after an uncomplicated infection for 1 week;
Exposure to the risk of acquiring a communicable infection:
- Sexual behavior with a significantly higher risk of transmission of serious infectious diseases that can be transmitted through blood, such as HBV, HCV or HIV, for 12 months compared to the general population:
  - heterosexual persons with sexual risk behavior, e.g. B. Sexual intercourse with frequently changing partners;
    - Have you had sexual intercourse with more than 3 partners in the past 12 months?
    - In the past 4 months, have you had sexual intercourse outside of a committed relationship?
  - People who offer sexual intercourse for accommodation, money or other services (e.g. drugs) (male and female sex workers);
  - Men who have sex with men (MSM) ;
  - transsexual persons with sexual risk behavior;
- after sexual intercourse with one of the aforementioned persons with an increased risk of infection for HBV, HCV and / or HIV for 4 months;
- who entered from an area in which they have stayed continuously for more than 6 months and in which HBV, HCV, HTLV-1, HTLV-2 or HIV infections have spread comparatively strongly, for 4 months after the last Residence (approval for donation in the case of shorter stays can be based on medical assessment);
- after sexual intercourse with a person who lives in an endemic area / high prevalence country for HBV, HCV or HIV or has entered from there for 4 months;
- during a detention and after release for 4 months;
- in the case of close contacts within a domestic community with the risk of infection with hepatitis viruses (HAV, HBV, HCV) for 4 months after the last contact;
- who were born or grew up in a malaria endemic area or who had continuously resided in a malaria endemic area for more than 6 months, for 4 years after leaving the endemic region (before starting donation activities, a specific anamnesis , clinical examination and a validated and quality-assured laboratory diagnostics determine that there is no evidence of infectivity);
- after visiting a malaria endemic area for at least 6 months;
- taking into account the respective epidemic situation in an area with continuous transmission of transfusion-relevant arboviruses , e.g. B. West Nile virus (WNV) , Zika virus (ZIKV) , Chikungunya virus (CHIKV) , for a period corresponding to the incubation period and viraemia , unless based on an order from the Paul Ehrlich Institute (PEI ) there is the possibility of testing;
- after allogeneic tissue transplants (for dura mater and cornea transplants, see section “ Permanent exclusion criteria ”) and after major operations for 4 months;
- after other operations at the discretion of the doctor;
- after endoscopies with flexible instruments and catheter applications (with the exception of single-use catheters) for 4 months;
- after receiving autologous and / or allogeneic cellular blood products and / or therapeutic plasma for 4 months;
- after invasive exposure (including contact with the mucous membrane) to foreign blood or injuries with injection needles or instruments contaminated by foreign blood for 4 months;
- after acupuncture (if this was not performed under aseptic conditions with disposable needles) for 4 months;
- after tattoos and other cosmetic interventions with skin or mucous membrane injuries (e.g. pierced ears , piercings , transdermal implants , cutting , branding , permanent make-up ) for 4 months;
- after a minor surgery or tooth extraction for 1 week and after the wound has healed;
- after dental treatment and professional teeth cleaning for 1 day;
Vaccinations :
- after administration of live vaccines (e.g. against yellow fever , rubella , measles , mumps , varicella , typhoid, cholera ) for 4 weeks;
- after vaccination against rabies if exposure is suspected for 12 months;
- after hepatitis B vaccination for 4 weeks.
- No deferral is required after application of dead or toxoid vaccines or genetically engineered vaccines (e.g. poliomyelitis inactivated, typhoid inactivated, diphtheria , influenza , cholera inactivated, tetanus , TBE , hepatitis A), provided the donor has no clinical symptoms and if Wellbeing is.
Other reasons for provision:
- after administration of sera of animal origin for 12 months;
- during and 6 months after pregnancy and while breastfeeding ;
- after taking medication depending on the pharmacokinetics and the indication of the drug used;
- Allergy symptoms at the time of donation that limit the general condition of the donor;
- Alcohol abuse; Alcoholics may be admitted after 12 months of abstinence;
- Anyone engaged in behavior or an activity that carries a high risk of bloodborne infectious diseases, e.g. B. in the event of occupational or other exposure to highly pathogenic pathogens, after the end of the behavior or activity for a period of time that is determined depending on the disease and the availability of suitable tests;
Deferred due to special epidemiological situations:
- if there is a risk of exposure in special epidemiological situations such as epidemics or outbreaks, adapted to the relevant situation.

Permanent exclusion criteria

According to the currently valid guidelines of the German Medical Association, there are various criteria for the permanent exclusion of people as blood donors:

people
- with severe heart and vascular diseases ;
- with severe diseases of the central nervous system ;
- with clinically relevant bleeding disorders ;
- with repeated fainting or convulsions ;
- with other serious active or chronic diseases of the gastrointestinal , urogenital , haematological , immunological , metabolic , renal or respiratory system , in which the donation of blood can endanger the donor or the recipient, or
- who suffer or have suffered from malignant neoplasms (exceptions: in situ carcinoma and basal cell carcinoma after complete removal);
- with diabetes mellitus , if treated with insulin ,
People who have been found to have any of the following infections:
- HIV-1 or HIV-2 ;
- Hepatitis B (HBV) , exception: Healed HBV infection (anti-HBc specifically reactive, negative result of a test for HBV genomes using NAT [minimum sensitivity ≤ 12 IU / ml]), and anti-HBs titre of ≥ 100 IU / l. If a donor is approved under the aforementioned conditions, a new anti-HBc screening can be omitted. The anti-HBs titer must be determined again every 2 years. If a titer <100 IU / l is detected, donations from this donor may no longer be used for the production of blood components.
- Hepatitis C (HCV) ;
- Human T-lymphotropic virus (HTLV), type 1 (HTLV 1) or type 2 (HTLV 2) ;
- Protozoonoses : babesiosis , trypanosomiasis (e.g. Chagas disease ), leishmaniasis ;
- Syphilis ;
- Malaria , osteomyelitis , tuberculosis and infections with Salmonella typhi and paratyphi (exception after confirmed healing according to a documented medical assessment);
- other chronically persistent bacterial infections, such as brucellosis , typhus and other rickettsioses , leprosy , relapsing fever , melioidosis or tularemia (exception after confirmed healing according to documented medical assessment);
People at risk of transmitting spongiform encephalopathies (TSEs) :
- after treatment with from human pituitary derived hormones ;
- after receiving dura mater or cornea transplants;
- with proven or suspected TSE ( Creutzfeldt-Jakob disease , variant of Creutzfeldt-Jakob disease or other TSE);
- because of a familial risk of developing TSE (known Creutzfeldt-Jakob disease or another TSE in one or more blood relatives );
- after a total of more than 6 months in the United Kingdom of Great Britain and Northern Ireland in the years 1980–1996;
- after surgery and / or transfusion ( cellular blood products , therapeutic plasma ) in the United Kingdom of Great Britain and Northern Ireland after January 1, 1980;
Recipients of xenografts , fresh cells of animal origin;
People who consume or abuse illegal drugs or who have a reasonable suspicion of doing so.

In the event that there is such a contraindication , but the donor cannot freely admit it due to social pressure, the option of anonymous self-exclusion is provided, see also information on blood donors .

Exclusion of men who have sex with men if they have had sex within the last twelve months

The exclusion from blood donation of men who have sex with men (so-called MSM) is controversial at national and international level:

Men who have sex with men were generally excluded from donating blood in Germany until August 7, 2017. Since August 7, 2017, new guidelines from the German Medical Association apply, according to which men who have sex with men are excluded if they have had sex within the last twelve months. The guideline is regulated in Germany by the Transfusion Act (TFG) . It does not formulate the exclusion criteria for donors itself, but determines in § 5 Paragraph 1 Clause 2 TFG: "The donation withdrawal should not be granted if and as long as the person willing to donate is to be excluded from donation collection or postponed according to the guidelines of the German Medical Association." Binding regulations on the exclusion from blood donation are specified by the German Medical Association together with the Paul Ehrlich Institute in the form of haemotherapy guidelines. The European Court of Justice in Luxembourg decided on April 29, 2015 whether the general exclusion of MSM with the prohibition of discrimination on grounds of sexual orientation in Art. 21 Para. 1 and Art. 52 Para. 1 of the Charter of Fundamental Rights of the European Union is compatible, a judgment is made, according to which the general exclusion is inadmissible and a justified exclusion can only take place after individual questioning of the blood donor. The member states are requested to review the national regulations. The working group "Blood donation by persons with sexual risk behavior" - a joint working group made up of representatives of the "Working group blood according to § 24 TFG", the standing working group "Guidelines for hemotherapy according to §§ 12a and 18 TFG" of the Scientific Advisory Board of the German Medical Association (BÄK) , des The Robert Koch Institute (RKI) , the Paul Ehrlich Institute (PEI) and the Federal Ministry of Health (BMG) carried out such a review in 2016.

Internationally, such an exclusion is not provided in many countries (e.g. Italy ) or only temporarily (e.g. Spain , Czech Republic , Sweden , Great Britain, Netherlands , Ireland , France , Australia , Canada , South Africa , USA ).

Switzerland

Temporary exclusion criteria

5 years
- Stay for at least six months in countries with a high AIDS rate
12 months
- Ill with gonorrhea or other sexually transmitted diseases
- Sexual contact with changing partners
- Sexual contact with partners for which temporary or definitive exclusion criteria apply
- Sexual contact with partners who have received blood or blood products in the past five years in countries with high AIDS rates
6 months
- Sexual contact with a new partner
- Stay in a malaria area in the last six months without illness (longer embargo period in case of febrile illness)

Permanent exclusion criteria

Positive test for HIV , syphilis, hepatitis B and hepatitis C.
Protected or unprotected sexual contacts since 1977: professional sexual contact or sexual contact between men
Past or present injection of drugs
Blood clotting disorders that need to be treated with medicines made from blood
Stayed in the UK between 1980 and 1996 for at least 6 months because of increased BSE risk

literature

Ian M. Franklin: Is there a right to donate blood? Patient rights; donor responsibilities . In: Transfusion Medicine . Vol. 17, No. 3 , 2007, p. 161–168 , doi : 10.1111 / j.1365-3148.2007.00754.x (English).