Decree of the Ministry of Health No. 437 / 2002 Coll.
Ordinance of the Ministry of Health laying down detailed conditions for the assessment of medical fitness and the extent of examination of a living or deceased donor of tissues or organs for transplantation purposes (Ordinance on the medical fitness of a donor of tissues and organs for transplantation purposes)
Valid
Order
Effective from 11.10.2002
Text versions:
11.10.2002
437
DECLARATION
Ministry of Health
of 3 October 2002
laying down detailed conditions for the assessment of medical fitness and the extent of the examination of a living or deceased tissue or organ donor for the purpose of transplantation (Ordinance on the medical fitness of a tissue or organ donor for the purpose of transplantation)
According to Articles 6 (5) and 11 (3) of Act No. 285 / 2002 Coll., on donation, collection and transplantation of tissues and organs and on the amendment of certain laws (the Transplant Act), the Ministry of Health provides:
Assessment of the medical fitness of a living tissue or organ donor
(K § 6 of the Act)
(1) The assessor shall base his assessment of the health status and medical fitness of the living tissue or organ donor (hereinafter referred to as "medical fitness') on all available findings of medical examinations, including those requested.
(2) The medical examination of a living donor of tissues or organs prior to collection shall include:
(a) a history with a targeted focus on finding:
1. the occurrence of infectious diseases (1), including those acquired when travelling abroad or suspected,
2. the incidence of cancer,
3. risk behaviour, which means in particular the intravenous application of addictive substances and the risk sexual behaviour,
4. the occurrence or suspected occurrence of prion diseases, in particular in the treatment of natural growth hormone or in cases where the donor has been transplanted with a graft of a brain diaper, cornea or sclera,
5. serious genetically modified diseases; a serious genetically conditioned disease means, for the purposes of this decree, a genetically conditioned disease of a living tissue or organ donor that may endanger the health or life of the donor when the donor is taken, the health or the life of the recipient after a transplant or the quality of the tissues or organs intended for transplantation;
6. systemic autoimmune, neurodegenerative or neuropsychological diseases or diseases of unknown origin,
7. previous exposure to health of harmful substances or ionising radiation;
8. an overview of the current and previous use of medicinal products,
9. Summary of immunisation with live vaccines in the previous 6 months,
10. Summary of blood transfusion over the past 12 months,
11. overview of piercing or tattoo in the past 12 months,
(b) a comprehensive physical examination;
(c) laboratory tests, including basic haematologic and biochemical tests, blood group tests, pregnancy tests in women of childbearing potential, and serological tests to exclude in particular syphilis, viral hepatitis B and C and infections caused by human immunodeficiency virus; and
(d) any further medical examination requested by the medical assessor in connection with the established state of health of the living donor of tissues or organs in order to rule out the diseases, defects or conditions listed in the Annex; such medical examinations shall be carried out where there is a medically justified suspicion that the donor is suffering from the disease, defect or condition listed in the Annex.
(3) In the case of living organ donors, the following procedures should be followed before collection:
(a) medical examination of psychiatric or psychological;
(b) a medical examination of electrocardiographic;
(c) medical examination of echocardiographic;
(d) a medical examination of the function of the organ to be collected by appropriate biochemical, hematologic and molecular biological methods and a imaging examination by appropriate methods aimed at the size and shape of the organ and at the anatomy of its vascular supply; and
e) X-ray of the heart and lungs.
(4) The assessor shall verify the data provided by the living tissue or organ donor referred to in paragraph 2 (a) according to the statement from the medical file of the registering donor practitioner (3) or other treating physician, provided that such doctor has the donor in his custody.
(5) In assessing the medical fitness of a living tissue donor or organs assessed by a physician, further account shall be taken of:
(a) the age of that donor;
(b) specific requirements for the function of the tissue or organ to be collected; and
(c) the possibility of maintaining the viability of the tissue or organ, if necessary for their use in transplantation.
(6) A conclusion on the medical fitness of a living tissue or organ donor may not be given if, on the basis of a medical examination when assessing medical fitness, the living tissue or organ donor has been found to suffer from the disease, defect or condition listed in the Annex.
(7) Information on the conclusion on the medical fitness of a living donor is provided by the medical establishment that has performed the procurement to the registry of the donor's physician who bases it in the donor's healthcare documents.4), 5) If a registered medical practitioner detects a disease of a living tissue donor or organ that could cause additional health risks to the recipient, he shall forward information on this finding to the medical establishment that has taken the sample and to the medical establishment that has carried out the tissue transplant or organ to the recipient.
(8) The medical examination of a living donor of tissues or organs after collection shall include:
(a) a serological examination to exclude in particular syphilis, viral hepatitis B and C and infections caused by human immunodeficiency virus after 6 months after collection of the tissue or organ;
(b) dispensarisation of a living donor with regard to the tissue or organ collected; and
(c) any further medical examination resulting from the health status of the living donor carried out to identify possible additional health risks.
Assessment of medical fitness of a deceased tissue or organ donor
(K § 11 of the Act)
(1) When assessing the medical fitness of a deceased tissue or organ donor, the assessor shall base his or her findings on the medical condition of the deceased at the time of his or her life and on any further medical examination carried out after his or her death, which shall be:
(a) inspection of the deceased;
(b) an autopsy, if any; the results of the autopsy (6) carried out after a tissue transplant or organ to the recipient shall be assessed retrospectively by the assessor, taking into account the potential risks to the recipient, with a view to ensuring preventive measures to prevent the risk to the life or health of the recipient, and, where appropriate, to providing the recipient with the necessary health care;
(c) serological examination to exclude in particular syphilis, viral hepatitis B and C and infections caused by human immunodeficiency virus;
(d) a medical examination of the function of the organs to be considered for transplantation,
(e) a medical examination of the brain in dead corneal donors, sclera and hard mena for transmissible spongiform encephalopathy; This examination shall be carried out at the national reference laboratory for the diagnosis of transmissible spongiform encephalopathy; and
(f) any further medical examination requested by the medical assessor to rule out the diseases, defects or conditions listed in the Annex; such medical examinations shall be carried out where there is a medically justified suspicion that the deceased donor has suffered from the disease, defect or condition listed in the Annex.
(2) In assessing the medical fitness of a deceased tissue donor or organs assessed by a physician, further account shall be taken of:
(a) the anamnistic data of the deceased donor;
(b) cause of death,
(c) age;
(d) specific requirements for the function of the tissue or the organ to be collected;
(e) the viability of the tissue or organ, if necessary for its clinical applicability; and
(f) a macroscopic evaluation of the tissue or organ during collection; in case of doubt as to the suitability of the tissue or organ to be collected on the basis of a macroscopic evaluation, a rapid biopsy shall be carried out and evaluated.
(3) The conclusion on the medical fitness of the deceased donor for the collection of tissue or organ cannot be drawn if:
(a) it has been found that the authorities examined under paragraph 1 (a) are: (c) are inoperative;
(b) the deceased donor has been found to have suffered from the disease, defect or condition listed in the Annex;
(c) the tissue collection would have taken place for more than:
1.12 hours if the body of the deceased has not been stored at a reduced temperature,
2.24 hours if the body of the deceased has been stored at a reduced temperature (+ 4 ° C); or
(d) carrying out a transplant of the tissue or organ collected would pose a greater threat to the health or life of the recipient than the benefit of the transplant.
(4) A conclusion on the medical fitness of a deceased donor may be made even if the medical incapacity of that donor is established if the risk to the health of the recipient resulting from that medical incapacity would be negligible compared to life saving transplantation.
Assessment of medical fitness in other cases
Healthy incapacitated are living or deceased donors of tissues or organs under the age of 18,
(a) the behaviour of whose parents is associated with an increased risk of human immunodeficiency virus infection (HIV);
(b) the birth of HIV-infected mothers where HIV infection cannot be definitively ruled out; or
(c) under 18 months of age born to mothers with HIV infection or with an increased risk of this disease.
For an additional assessment of the medical fitness of a living or deceased donor of tissues or organs, in particular where:
(a) where the recipient has a disease at the time of collection of the tissue or organ unknown or undetected by the donor tissue or organs; or
(b) if substantial changes in the method for detecting communicable disease have occurred since the time of collection of the tissue or organ;
the donor serum intended for serological examination shall be kept in the laboratory which carried out the serological examination for at least 10 years after transplantation of the tissue or frozen organ at -40 ° C and below.
Laboratory examination of blood of a living donor of tissues or organs [§ 1 (2) (c)] shall be carried out no more than 7 days before collection. In case of collection of haematopoietic cells from a living donor, this examination must not be more than 30 days old. Serological examination of a deceased donor of tissues or organs [Paragraph 2 (1) (b)] shall be carried out immediately before or immediately after collection of the tissues or organs.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Dr. Součková v. r.
Annex to Decree No 437 / 2002 Coll.
Diseases, defects and conditions excluding the medical fitness of a living or deceased donor for the collection of tissues or organs
1. HIV-induced infection or seropositivity, or behaviour increasing the risk of HIV,
2. donor risk behaviour [§ 2 (2) (a) (3)];
3. severe septic status not affected by treatment,
4. active malignant tumor development of any localisation, except for some histologically proven primary tumours of the central nervous system, histologically confirmed locally bounded basecellular carcinoma of the skin, in-situ carcinoma of the uterus; for donating corneal or sclera only malignant tumours of haematopoietic or lymphoid tissue and malignant tumours of the eye and its adnex are contraindicated,
5. systemic diseases with severe effects on tissues and organs intended for transplantation (e. g. collagenosis, vasculitis),
6. Creutzfeld- Jakob's disease or other prion diseases of man or suspect them,
7. viral hepatitis B (HBsAg positivity); recipients with viral hepatitis B tissue or organ of the donor with viral hepatitis B can be donated,
8. viral hepatitis C; recipients with viral hepatitis C can be donated to tissue or organ donor with viral hepatitis C,
9. syphilis,
10. A history of chronic haemodialysis;
11. insufficient function of the transplant or non-transplant couples in the living donor as regards organ procurement;
12. intoxication (in case of tissue collection); in the case of donating corneal or sclera, only substance intoxication or intoxication with severe poisons are contra-indications which could harm the recipient's health or endanger his or her life even in a very small, trace amount; or
13. death by drowning when it comes to tissue collection.
1) Paragraph 2 (5) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws.
2) Paragraph 2 (8) (h) of Act No. 157 / 1998 Coll., on Chemicals and Chemical Products and amending certain other laws, as amended by Act No. 352 / 1999 Coll.
3) Paragraph 18 (3) (a) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws.
4) Article 21 (3) of Act No. 48 / 1997 Coll.
5) Paragraph 67b (10) (a) of Act No. 20 / 1966 Coll., on the Care of People, as amended by Act No. 260 / 2001 Coll., Act No. 285 / 2002 Coll. and Act No. 320 / 2002 Coll.
6) Government Decree No. 436 / 2002 Coll., implementing Act No. 285 / 2002 Coll., on Donation, Collection and Transplantation of Tissue and Organ and on the Amendment of Certain Laws (Transplant Act).
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Regulation Information
| Citation | Decree of the Ministry of Health No. 437 / 2002 Coll., laying down the detailed conditions for the assessment of medical fitness and the extent of examination of a living or deceased donor of tissues or organs for transplantation purposes (Ordinance on the medical fitness of a donor of tissues and organs for transplantation purposes) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.10.2002 |
|---|---|
| Effective from | 11.10.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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