Decree No. 114 / 2013 Coll.
Ordinance on the establishment of closer conditions for the assessment of medical fitness and the extent of the examination of a living or deceased organ donor for the purpose of transplantation (Ordinance on the medical fitness of an organ donor for the purpose of transplantation)
Valid
Order
Effective from 07.05.2013
114
DECLARATION
of 29 April 2013
laying down closer conditions for the assessment of medical fitness and the extent of the examination of a living or deceased organ donor for the purpose of transplantation (Organ donor medical certificate for transplantation)
The Ministry of Health provides, pursuant to § 6 (5), § 10 (7) and § 11 (3) of Act No. 285 / 2002 Coll., on Donation, Collection and Transplantation of Tissue and Organs and on the amendment of certain laws (Transplant Act), as amended by Act No. 296 / 2008 Coll. and Act No. 44 / 2013 Coll.:
Assessment of the medical fitness of a living organ donor
(1) The assessor shall base the assessment of the health status and medical fitness of the living 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 organ donor prior to collection shall include:
(a) a history with a targeted focus on identifying risk-related circumstances for the recipient of the institution, in particular:
1. the occurrence of infectious diseases, including those acquired in endemic risk areas;
2. the incidence of cancer,
3. risk behaviour, which means in particular intravenous application of addictive substances and risk sexual behaviour,
4. the occurrence or suspected occurrence of prion diseases, particularly in the treatment of natural growth hormone or in cases where the donor has been transplanted with a graft of brain, corneal or sclera denim,
5. the occurrence of chronic or other diseases which may endanger the health or life of the donor at the time of collection, the health or life of the recipient after transplantation or the quality of the organs intended for transplantation;
6. prior exposure to harmful substances or ionising radiation;
7. Information on current and previous use of medicinal products,
8. information on immunisation with live vaccines in the previous 6 months; and
9. Information on blood transfusion over the past 12 months,
(b) a comprehensive physical examination;
(c) laboratory tests, including baseline haematologic and biochemistry tests, blood group tests, pregnancy elimination tests in women of childbearing potential, and serological tests to rule out in particular viral hepatitis B and C and infections caused by human immunodeficiency virus; and
(d) another medical examination requested by the medical assessor in connection with the established state of health of the living organ donor, in order to exclude the diseases, defects or conditions listed in Annex 1 to this Decree; 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 Annex 1 to this Decree.
(3) In the case of living organ donors, the following procedures should be followed before collection:
(a) medical examination of psychiatric or psychological;
(b) comprehensive pre-operative examination;
(c) tests aimed at the size, condition and function of the authority to be collected.
(4) The assessor shall verify the data provided by the living donor of the organs referred to in paragraph 2 (a) according to the statement from the health file of the registrar of general medical practice or practical medicine for children and adolescents (hereinafter referred to as "the registrar ') of the donor or other treating physician, provided that such doctor has the donor in his custody.
(5) In assessing the medical fitness of a living organ donor, the physician shall take further account of:
(a) the age of that donor;
(b) specific requirements for the function of the authority designated for collection;
(c) the possibility of maintaining the viability of the organ if necessary for its use in the transplant; and
(d) the long-term expected development of the donor's state of health after organ collection.
(6) The conclusion on the medical fitness of a living organ donor cannot be drawn if, on the basis of a medical examination in the assessment of medical fitness, the living organ donor is found to be suffering from the disease, defect or condition listed in Annex 1 to this Decree.
(7) Information on the conclusion on the medical fitness of a living donor is provided by the provider of the health services that performed the procurement to the registry physician of the donor who bases it in the donor's medical documentation. If a registered practitioner discovers an organ donor disease when providing health care, which could cause additional health risks to the recipient, he shall forward information on this finding to the recipient health service provider that performed the procurement and to the health service provider who carried out the organ transplant.
(8) The medical examination of a living organ donor after collection shall include:
(a) monitoring of the health status of the living donor with regard to the organ collected; and
(b) further medical examination resulting from the health status of a living donor to identify possible additional health risks.
Assessment of medical fitness of the deceased organ donor
(1) When assessing the medical fitness of a deceased organ donor, the assessor is based on the findings of the deceased's medical condition at the time of his life and on the findings of further medical examination carried out after his death, which are:
(a) a survey of the deceased donor and the data set out in the death report;
(b) an autopsy, if any; the results of the post-organ transplant examination shall be assessed by the assessor retrospectively, taking into account the potential risks to the recipient, in order to ensure preventive measures to prevent the risk to the life or health of the recipient and, where appropriate, to ensure the provision of the necessary health care to the recipient,
(c) serological examination to exclude in particular viral hepatitis B and C and infection 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) another medical examination requested by the medical assessor to rule out the diseases, defects or conditions listed in Annex 1 to this Decree; 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 Annex 1 to this Decree.
(2) In assessing the medical fitness of the deceased organ donor, the physician shall take further account of:
(a) the anamnistic data of the deceased donor;
(b) cause of death,
(c) age;
(d) specific requirements for the function of the authority designated for collection;
(e) the viability of the institution where necessary for its clinical applicability; and
(f) a macroscopic evaluation of the organ during collection; histological examination shall be carried out in case of doubt as to the suitability of the transplant organ taken on the basis of a macroscopic evaluation.
(3) The conclusion on the medical fitness of the deceased donor for organ procurement cannot be drawn if:
(a) it has been found that the authorities examined under paragraph 1 (a) are: (c) are inoperative;
(b) it has been found that the deceased donor has suffered from the disease, defect or condition listed in Annex 1 to this Decree; or
(c) carrying out a transplant of the organ taken would pose a greater risk to the health or life of the recipient than would be the benefit of the transplant.
(4) The conclusion on the medical fitness of the deceased donor may also be drawn when the medical incapacity of the donor is established if the risk to the health of the recipient resulting from that medical incapacity would be negligible compared to the overall benefit of the transplant.
Donor characterisation and organ characterisation in donor medical assessment
(1) Donor characterisation and organ characterisation (3) in the assessment of donor medical fitness are carried out on the basis of an assessment of the minimum and supplementary data collected on the donor and organ; minimum data means the information necessary to characterise the donor and the organ collected for each donation; additional data means the information necessary to characterise the donor and the body which are collected to the minimum data on the basis of the decision of the medical team with regard to the availability of this information and the specific circumstances of the case. The scope of the minimum and supplementary data is set out in Annex 2 to this Decree.
(2) Information on the characterisation of the donor and the body identified in the medical assessment shall be transmitted without delay to the minimum and supplementary data referred to in Annex 2 to this Decision by telephone or electronic means to the appropriate transplant centre. If an organ exchange is to take place between Member States, the information on the characterisation of the donor and the organ (4) shall be transmitted to the competent authority or to the delegated body of the Member State with which the organ exchange is to be carried out in accordance with the first sentence electronically or by fax via the Coordination Centre of Transplants. If, at the time of transmission of the information, some information on the characterisation of the donor and the organ was not available, the additional information found shall be transmitted without delay through the Coordination Centre by transplantation to the competent authority or to the delegated body of the Member State with which the organ is to be exchanged. Additional information may also be transmitted via the transplantation centre directly to the transplant centre of the Member State with which the organ is to be exchanged. In the case of the fourth sentence procedure, a copy of the additional information shall also be transmitted to the Coordination Centre by transplantation.
(3) In the transmission of information on the characterisation of the donor and of the organ transmitted between Member States, the working procedures established pursuant to Article 4a of the Decree governing the requirements for working procedures for ensuring the quality and safety of human organs intended for transplants (5) shall apply.
(4) Laboratory tests necessary for the assessment of donor medical fitness may only be carried out in a laboratory which has personnel with appropriate qualifications or training and premises and equipment corresponding to the laboratory tests carried out.
(5) In assessing donor medical fitness, an organ transplant may be considered even if all the minimum data necessary for the characterisation of organs and donors are not available, provided that, according to the risk-benefit analysis in a particular case, including the life of the recipient, the expected benefits to the recipient outweigh the risks arising from incomplete data.
Protocol on the detection of death
(1) The death report shall contain the following elements:
(a) the basic diagnosis of the deceased;
(b) a record of the examinations carried out;
(c) a record of the results of the clinical examination found,
(d) the time-limit for carrying out the examination and, where appropriate, the time-limit for the non-refundable arrest of blood circulation; and
(e) identification of the medical practitioners investigating death.
(2) The model of the death report is set out in Annex 3 to this Decree.
(3) For the purposes of determining the exact time of death, the relevant time of death as indicated in the Protocol shall be the date of death by the doctor designated as Doctor B in Annex 3 to this Decree.
Assessment of medical fitness in other cases
Health incapacitated are living or deceased organ donors under the age of 18
(a) the birth of HIV-infected mothers where HIV infection cannot be definitively ruled out; or
(b) 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 organ donor, in particular where:
(a) where the recipient has a disease at the time of collection of the body unknown or not detected by the donor; or
(b) if substantial changes in the method for detecting communicable disease have occurred since the date of collection of the authority;
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 frozen body at -40 ° C and below.
Laboratory examination of blood of a living organ donor as referred to in § 1 (2) (c) shall be carried out no more than 7 days before collection. A serological examination of the deceased organ donor as referred to in Article 2 (1) (c) shall be carried out immediately before or immediately after the organ collection.
Repeal
Decree 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), is hereby repealed.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Doc. MUDr. Heger, CSc., v. r.
Příloha č. 1
Annex No 1 to Decree No 114 / 2013 Coll.
Diseases, defects and conditions excluding the health status of the donor
Diseases, defects and conditions excluding the medical fitness of a living or deceased donor for the collection of tissues or organs are:
1. HIV-induced infection or seropositivity,
2. severe septic status not affected by treatment,
3. active malignant tumor growth of any localisation, except for some primary tumours of the central nervous system, histologically confirmed locally bounded basecellular carcinoma of the skin, in the site of uterine cancer; for donating corneal or sclera only malignant tumours of haematopoietic or lymphoid tissue and malignant tumours of the eye and its adnex are contraindicated,
4. systemic diseases with serious effects on organs for transplantation (e. g. collagenosis, vasculitis),
5. Creutzfeld-Jakob's disease or other prion diseases of man or suspect them,
6. insufficient function of the transplant or non-transplant pair organ in the living donor,
7. Other diseases, defects or conditions that, according to current knowledge of science and clinical medicine, could exclude donation.
Příloha č. 2
Annex No 2 to Decree No 114 / 2013 Coll.
Characterisation of organ and donor
Minimum data
1. The health service provider, indicating the address of the medical establishment where the collection took place.
2. Donor type.
3. Blood type.
4. Sex.
5. Cause of death.
6. Date of death.
7. Date of birth or estimated age.
8. Weight.
9. Height.
10. Early or current history of intravenous abuse of narcotic drugs.
11. Early or current history of cancer.
12. Current history of other communicable diseases.
13. Testing for HIV, viral hepatitis B and viral hepatitis C.
14. Basic information on the performance assessment of the donated body.
Additional data
1. General
The contact details of the transplant centre in which the collection was carried out are necessary for the coordination, allocation and traceability of organs from donors to recipients and vice versa.
2. Donor data
Demographic and anthropometric data needed to ensure appropriate compatibility between the donor and the recipient and between the authority and the recipient.
3. Anemesis of donor
Donor history, in particular circumstances that could affect the suitability of organs for transplantation and create a risk of disease transmission.
4. Data from physical and clinical examination
Data obtained in clinical investigations which are necessary for the evaluation of the physiological status of a potential donor and any findings revealing circumstances that were not detected in the donor's history analysis and which could affect the suitability of organs for transplantation or the risk of transmission of disease.
5. Laboratory Parameters
The data needed to assess the functional characterisation of the organs and to identify any communicable diseases and potential contraindications of organ donation.
6. Testing using imaging methods
Testing using imaging methods necessary to assess the anatomical state of the organs for transplantation.
7. Treatment
Treatment prescribed by donors relevant for the assessment of organ functioning and their suitability for donation, in particular the use of antibiotics, inotropic support or transfusions.
Příloha č. 3
Annex No 3 to Decree No 114 / 2013 Coll.
3) Article 7 of Directive 2010 / 53 / EU of the European Parliament and of the Council of 7 July 2010 on quality and safety standards for human organs intended for transplantation.
4) Article 5 of Commission Implementing Directive 2012 / 25 / EU of 9 October 2012 laying down information procedures for the exchange of human organs for transplantation between Member States.
5) Decree No. 111 / 2013 Coll., laying down requirements for the establishment of working procedures for ensuring the quality and safety of human organs intended for transplantation, as amended by Decree No. 6 / 2014 Coll.
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Regulation Information
| Citation | Decree No. 114 / 2013 Coll., on the establishment of closer conditions for medical assessment and extent of examination of a living or deceased organ donor for transplantation purposes (Organ donor medical certificate for transplantation purposes) (Organ donor medical certificate for transplantation purposes) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.05.2013 |
|---|---|
| Effective from | 07.05.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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