Tuesday, August 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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1.1Medical and social evaluation

1. The evaluation of the donor should contain all the necessary medical and social information to assess the presences of the following aspects:

a) General contraindications concerning the safety of all donated tissue as stated in Directive 2004/23/EC Annex I;

b) Additional safety related contraindications that are the result of risk assessments that arise from health risks related to processing, donor population characteristics, emerging infectious diseases, or other relevant factors;

c) Tissue specific contraindications that involve the quality of the donated tissue.

2. The final determination of the criteria for exclusion for tissue donation is the responsibility of the responsible person, in consultation with a medical advisor or medical advisory committee, if needed. A list of mandatory and optional contraindications could be:

 

Medical evaluation

Weight and height

NTS (pre screening)

If no exact weight and height are known, an estimate will suffice.

Active systemic. infections and vaccinations

NTS (pre screening)

This includes all systemic infections (bacterial, viral, parasitical, prions).

Various circumstances are possible including:

1.     An infection at the time of death.

Please report:

§ the type of infection

§ lab results

§ whether cultures have been taken, including (provisional) results

§ antibiotic treatment, including duration and effectiveness of the treatment and if any, the results of the treatment (e.g. fever-free period).

2.     Suspicion of a systemic infection without supportive diagnostics. Please report the symptoms on which the suspicions are based.

3.     In case clinical signs are not highly suspect for an infection but infection cannot be ruled out, please report as such.

4.     Systemic infections of which the patient has been cured, but the cause is still (possibly latent) present (e.g. polio, hepatitis B-C, syphilis)

5.    Report vaccinations given with live attenuated virus, such as polio, mumps, measles, rubella and post exposure rabies vaccinations.

The criteria used to assess whether sepsis is present are in accordance with the internationally guidelines.

Clinical evidence or suspicion of neurodegenerative diseases with unknown aetiology, or other disorders possibly caused by prions

NTS (pre screening)

The following apply:

§  All non-vascular or unexplained forms of dementia, such as Alzheimer’s disease;

§  ALS, multiple sclerosis, Parkinson

§ variant CJD or risk factors for prion disease such as familial CJD, the use of growth hormone and stay in the UK during 1980-1996.

Haematological malignancies or other haematological disorders

NTS (pre screening)

All lymphoproliferative, myeloproliferative and other haemapoetic disorders, such as leukemia, Morbus Kahler, non-Hodgkin disease, polycythemia vera and aplastic anaemia.

Other malignancies.

Mind: Malignancies are no general CI

NTS (pre screening)

Present at time of death or in the medical history.

Infection or signs of infection

All, also local, infections or signs of infection such as lab results, positive cultures, infiltration on X-thorax. Treatment with antibiotics?

Infections can be a tissue specific contraindication.

Bone marrow suppression due to medication in the last 3 months

Medication administered within three months before death with a proven bone marrow depression. Mention which medication, indication, dose and last lab. results (Hb, leucocytes and platelets)

Chronic use of corticosteroids

Relevant in case of chronic use for more than 6 weeks. Provide details on indication, dosage and duration of use. Use of corticosteroids can be a tissue specific contra-indication.

Other medication

Please report all other medications that have been used.

Infusions and transfusions within the previous 48 hours

Only relevant if given for blood loss. Please report type and quantity of all infused fluids (blood products, colloids, crystalloids, plasma replacement, plasma expanders etc.), as well how much and time of the infusions/transfusions

Social evaluation

Presence of risk factors for HIV, HTLV, Hepatitis B or C

This group includes donors belonging to known risk groups

(either directly or through their sexual partners):

-  Persons who have used non-medical drugs intranasal in the last 5 years.

-  Persons who have ever injected non-medical drugs (intravenous, intramuscular or subcutaneous).

-  Persons with haemophilia or related clotting disorders who have received human-derived clotting factor concentrates before 1987.

-  Men who have had sex with another man in the preceding 5 years.

-  Men and women who have engaged in sex in exchange for money or drugs in the preceding 5 years.

-  Persons emigrated from countries where transfer of HIV infection through heterosexual contacts plays an important role in the spreading of the HIV virus, like countries in South East Asia, Caribbean and in countries in Africa below the Sahara.  Unless person has been in the Netherlands longer than 1 year and in that time has not been back to an endemic region.

-  Persons that, in the past 6 months, had sexual contact with persons of one of the above mentioned groups or were sexual partners of persons who are infected with HIV, HTLV or hepatitis C or B or who are suspected thereof.

-  Persons that, in the preced­ing 6 months, were exposed to (possibly) infected blood via accidental percutaneous puncture or through contact with an open wound and non-intact skin or mucous membrane.

-  Persons who are diagnosed or treated for SOA in past 6 months.

-  Children of 18 months or younger born to mothers with risk of HIV, or children from these mothers who were breastfed.

-  Tattoo: if the donor has had a tattoo, piercing or needle accident in the previous 6 months, there may be a reason for not accepting. Please contact the BIS doctor on duty for evaluation. We do not accept piercings made with the use of shared needles or genital piercings.

-  Persons of have jaundice of unknown but possibly infectious origin.

-  Persons who are in "Close contact" with another individual with infectious hepatitis, such as shared household (kitchen and toilet) or sexual partner during the last 6 months.

Intermittenthaemodialysis

Intoxications

Includes alcohol abuse, drug abuse and long term exposure to heavy metals such as lead, mercury, chromium, arsenic, pesticides. Nicotine abuse is not relevant.

Risk of tropical diseases, for example as a result of travel.

Report risk for emerging diseases contracted during travel to foreign countries, such as SARS, Avian Flu, Malaria, Yellow fever etc.

Mention: which country, duration and date period of stay, vaccinations.

If unknown report as such.

Travel / Visit to the United Kingdom

Report if known whether duration of stay was longer than 6 months and between January 1980 and December 1996.

If unknown report as such.

 

3. For every potential donor, anamnestic data must be obtained from the available relevant sources, such as the donor (living) treating physician, general practitioner, next of kin or other people who knew the donor well (deceased) and / or the donor's medical record included in the donor file.

4. When questioning donors or their relatives it must be established that the phrasing of the questions is understood by the answering person.

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