114/Sb.
DECREE
of 29 April 2004. April 2013
on the determination of the conditions detailed medical assessment and
scope of the examination of living or deceased donor tissues or organs for
the purpose of transplantation
(the Decree on the medical eligibility of donors of tissues and organs for the purposes of
transplant surgery)
Changed: 7/2014 Sb.
The Ministry of health shall, pursuant to section 6 (1). 5, section 10, paragraph 1. 7 and §
11 (1) 3 of law no 289/2002 Coll., on the donation, subscriptions and
transplantation of tissues and organs and on amendments to certain laws
(the Transplant Act), as amended by Act No. 297/2008 Coll. and Act No.
44/Coll.:
§ 1
Assessment of the medical fitness of a living donor tissues or organs
(1) the Examining physician is required to be based on the evaluation of the health
the State and health of a living donor tissues or organs (
"medical fitness") from all available medical findings
examination, including those requested.
(2) the medical examination of living tissues or organs from the donor
the collection is:
and history with the targeted) focusing on the findings:
1. the occurrence of infectious diseases "^ 1"), including the occurrence of the disease acquired
When you stay in endemic areas,
2. the occurrence of cancer,
3. risk behavior, which means in particular of intravenous administration
substance abuse and risky sexual behavior
4. the occurrence of disease or suspicion!, in particular when
the treatment of the natural growth hormone or in cases where the donor
transplanted graft Dura of the brain, cornea or skléra,
5. serious genetic disease; severe genetically
conditional disease for the purposes of this Ordinance, means such
genetically determined disease living donors of tissues or organs, which
may endanger the health or life of the donor, health or life
transplant recipient or the quality of tissues or organs intended for
transplantation,
6. systemic autoimmune, neurodegenerative or
neuropsychických disease or diseases of unknown origin,
7. previous exposure to harmful substances or ionising ^ 2)
radiation,
8. an overview of the current and the previous use of medicinal products,
9. an overview of immunization with live vaccines in the past 6 months,
10. review of the implementation of blood transfusion in the last 12 months, and
11. review of the implementation of body piercing or tattoos in the past 12
months,
(b)) a comprehensive physical examination,
c) laboratory examination, including the basic haematological and
biochemical examination, blood test, to the exclusion of groups
pregnancy in women of childbearing potential and further serological examination for the
the purpose of excluding, in particular, viral hepatitis B and C infections caused by
the human immunodeficiency virus, and
(d) additional medical examination requested) posuzujícím doctor in the context
with a known medical condition of a living donor of tissues or organs,
in order to avoid diseases, defects or conditions set out in annex 1 to the
This Decree; This medical examination shall be carried out in the case that
There is a medically justified suspicion that the donor is suffering from disease,
defect or condition referred to in annex 1 to this notice.
(3) in the case of living donors of organs is always executes before taking further
and) medical examination psychiatric or psychological,
(b)) medical examination, electrocardiography
c) medical examination of the function of the authority designated to receive the relevant
biochemical, haematological and molecular biological methods and
Imaging examinations of adequate methods, focusing on the size and shape of
authority and on the anatomy of the blood supply and
d) x-ray the heart and lungs.
(4) the Examining physician data referred to living donor tissues or organs
in accordance with paragraph 2 (a). and according to extract from) verifies medical
documentation of a registered provider in the field of general practical
medicine or in the field of practical medicine for children and adolescents (hereinafter referred to as
"registered general practitioner") by the donor or other health care professional,
If a doctor has a donor in their care.
(5) in assessing the medical fitness of a living donor tissue or
authorities examining the doctor also takes into account the
and the age of the donor)
(b) specific requirements on the function) of the tissue or the body designated to receive and
(c) maintaining the viability of options) or organ, if it is
for their use in the context of the need to transplant.
(6) conclusion on the health of a living donor to tissue procurement or
the authority cannot be issued if it was based on a medical examination when the
medical assessment found that living donors tissues or
authorities are suffering from disease, defect or condition that are listed in the annex.
1 to this notice.
(7) information about the conclusion about the health of the living donor passes
provider of health services, which carried out the collection, registrujícímu
to the physician of the donor, which is based in the medical records
the donor. If a registered general practitioner in the provision of health
care detects disease living donors of tissues or organs, which could
bring additional health risks for the recipient, shall transmit the information about
the providers of health services, which carried out the collection, and
the providers of health services, which performed the transplant tissue
or authority of the recipient.
(8) the part of the medical examination of the donor's tissues or organs of a living after
the subscription is:
and) a serological examination for the purpose of exclusion, in particular of viral hepatitis
B and C and human immunodeficiency virus infection after 6 months after
tissue or organ,
(b) monitoring the health status of a living) donor with respect to the removed
tissue or organ and
(c)) the next medical examination arising out of the State of health of a living
the donor carried out in order to determine possible additional health risks.
§ 2
Assessment of the medical fitness of a deceased donor tissues or organs
(1) the Examining physician based in assessing medical fitness
deceased donor tissues or organs from the findings about the health
the deceased at the time of his life and the findings of the next medical examination
carried out after his death, which are
and a tour of the deceased donor) and the information referred to in the Protocol on the findings
death,
(b)), if it has been implemented; the results of the examination of the autopsy performed
tissue or organ transplant recipients will examine examining doctor
In addition, taking into account the risks to the recipient, with a view to
ensure preventive measures to prevent a threat to life or
the health of the recipient, where appropriate, ensure the supply of needed health care
the recipient,
(c)) a serological examination for the purpose of exclusion, in particular of viral hepatitis
(B) and (C) and infections caused by the human immunodeficiency virus,
d) medical examination in organ function, whose use for transplantation
It is intended,
(e) the medical examination of the brain) for deceased donors of the cornea, sclera and hard
mater on transmissible spongiform encephalopathy. This examination
shall be carried out at the national reference laboratory for the diagnosis of transmissible
spongiform encephalopathies and
(f)) for more on-demand medical examination by a doctor in order to posuzujícím
the exclusion of diseases, defects or conditions referred to in annex 1 to this
the Decree; This medical examination shall be carried out in the case that there is
medically justified suspicion that the deceased donor suffered disease, defect
or condition referred to in annex 1 to this notice.
(2) in assessing the medical fitness of a deceased donor tissues or
authorities examining the doctor also takes into account the
anamnestickým data) of a deceased donor,
(b)) cause of death,
c) age,
(d) the specific demands on function) of the tissue or the authority designated to receive,
(e)) the viability of tissue or organ, if it is for their clinical
the applicability of the necessary, and
(f)) makroskopickému evaluation of tissue or organ during collection; in the case of
doubts about the suitability of the removed tissue or organ for a transplant on the
the basis of the macroscopic evaluation is carried out to evaluate fast
a biopsy.
(3) the conclusion of the medical fitness of a deceased donor to donate tissue or
the authority cannot be issued if the
and) it was found that the authorities tested according to paragraph 1. (c)) are
broken,
(b)) it was established that the deceased had suffered from the disease, a defect in the donor, or a status,
which are listed in annex 1 to this notice,
(c)), the subscription of the tissue for more than
1.12 hours, if the body of the deceased was not saved at reduced temperature,
or
2. for 24 hours, if the deceased's body was kept at a reduced temperature (+ 4
degrees C), or
(d)) would perform the removed tissue or organ transplant meant
a greater threat to the health or life of the recipient than would be the contribution of
transplants.
(4) conclusion on the medical fitness of a deceased donor can be issued in
the event of the incapacity of the donor, if the risk
for the health of the recipient under this incapacity was
negligible in comparison with the life-saving transplant.
§ 3
Characterization of the donor and the characterization of authority in the assessment of health
eligibility of donors
(1) the characterization of the donor and the organ characterisation ^ 3) in assessing the
donor medical fitness shall be carried out on the basis of the assessment
minimum and additional data collected on donors and authority;
minimal data means information necessary for the characterization of the donor
and the authority, which is collected in the case of each donation; additional
data means information necessary for characterisation of the donor and organ,
that is collected to the minimum on the basis of a decision
medical team with regard to the availability of the information and the specific
circumstances of the case. The range of the minimum and additional information is provided in the
Annex No 2 to this Decree.
(2) information on the characterization of the donor and the authority identified in the assessment
medical fitness shall transmit without delay to the extent of minimum and
the additional data referred to in annex 2 to this Decree to the competent
transplantačnímu Centre by telephone or electronically. If it is to be
the exchange between the Member States of the authority, information on the characterization of the
donor and organ ^ 4) in the first sentence, electronically or by fax
passed through transplant coordination centre
the competent authority or to the designated body of the Member State with which it has
be made to the authority of the Exchange. If the information has not been
some information about donor and organ characterisation available are
Additionally other information immediately passed through to the
Transplant coordination centre to the competent authority or
a designated body of the Member State with which it has to be the exchange of authority
performed. Additional information can be passed through
Transplant Center directly transplantačnímu the Centre of the Member State,
to which authority should be replaced. In the case of a procedure under the fourth sentence of the
a copy of the additional information also passes to the MRCC
transplantation.
(3) when transmitting information about donor and organ characterisation of the transmitted
between the Member States apply workflows created pursuant to Section 4a
the decree governing the requirements for working procedures to ensure system
the quality and safety of human organs intended for transplantation ^ 5).
(4) laboratory tests required for the assessment of medical fitness
the donor can only be done in the lab, which has personnel with the appropriate
qualifications or training and facilities and equipment appropriate
carried out by the laboratory examination.
(5) in assessing the medical fitness of the donor it is possible to transplant
authority to consider the case even when there are all of the minimum
the necessary data for the characterization of the authorities and donors, if according to the analysis
risks and benefits in the particular case, including the threat to the life of the beneficiary,
outweigh the expected benefits to the recipient over the risks arising from
incomplete data.
§ 4
Protocol for the detection of death
(1) the Protocol on finding death contains the following elements:
and basic and secondary) diagnosis of the deceased,
(b)) carried examinations,
(c) a record of the findings) examination,
(d)) on the implementation of the time of the examination, where appropriate, the indication of the period of time
irreversible collateral blood circulation, and
e) identification data on physicians in ensuring death and doctors
carrying out the examination confirming the irreversibility of the death of the brain.
(2) presentation of the report on the findings of the death is given in Appendix 3 to this
the Decree.
(3) for the purposes of determining the moment of death essence
the findings of the death referred to in the Protocol by a doctor who is in annex 3 to the
This Decree marked as doctor B.
Assessment of medical competence in the other cases,
§ 5
Medically unfit are living or deceased donors, tissues or organs
under 18 years old
and if you grow up in an environment) associated with an increased risk of infection
the human immunodeficiency virus ("HIV"),
(b)) birth mothers with the HIV infection, if HIV infection cannot be with them
definitely ruled out, or
(c)) under the age of 18 months who are born to mothers with HIV infection or with
an increased risk of the disease.
§ 6
For additional assessment of the medical fitness of a living or deceased
the donor's tissues or organs, and in particular,
and when the recipient) develops a disease at the time of collection of the tissue or
authority of the unknown or the donor's tissues or organs undetected, or
(b) from the time of sampling) where the tissue or organ you are experiencing significant changes in
the methodology for the detection of communicable diseases
the serum donor intended for serological examination shall be kept in the laboratory,
who made the serological examination, at least 10 years after transplantation
the removed tissue or organ in the frozen state at a temperature of-40 ° C and
lower.
§ 7
Laboratory examination of blood living donors tissues or organs under section 1
paragraph. 2 (a). (c)) shall be made not more than 7 days prior to collection. In the case of
collection of hematopoietic cells from a living donor, this examination must not be
older than 30 days. A serological examination of a deceased donor tissues or
authorities pursuant to § 2 (2). 1 (b). (c)) shall be carried out immediately prior to collection
tissues or organs, or immediately after this subscription.
§ 8
Regulation (EEC)
Decree No. 437/2002 Coll., which sets conditions for further assessment
medical fitness and the scope of the examination of a living or deceased donor
tissues or organs for transplant purposes (the Decree on health
eligibility of donors of tissues and organs for transplantation purposes), is hereby repealed.
§ 9
The effectiveness of the
This Decree shall take effect on the date of its publication.
Minister:
doc. MUDr. Heger, CSc., r.
Annex 1
Diseases, defects and conditions excluding the medical requirements of the donor
Diseases, defects and conditions excluding the medical fitness of a living or
a deceased donor to donate tissues or organs are:
1. Disease or séropozitivita caused by HIV, or the behavior of the increasing
the risk of HIV infection,
2. the risk behavior of the donor (§ 2 para. 2 (a)), section 3),
3. a serious septic condition treatment, neovlivnitelný
4. active malignant growths of any location, except
some histological verified primary tumours of the Central
the nervous system, histologically verified locally marquee
basocelulárního skin cancer, in situ Carcinoma of the uterus; When
the donation of the cornea or sclera are a contraindication only malignant tumors
of the hematopoietic and lymphoid tissue and malignant tumors of the eye and its appendages,
5. systemic illness with serious effects on tissues and organs designed to
Transplant (e.g. kolagenózy, Vasculitis),
6. the Creutzfeld-Jakob disease or other human prion diseases, or
suspicion on them,
7. viral hepatitis B (HBsAg positivity); recipients with viral
hepatitis B can donate tissue or organ donor with viral hepatitis
(B),
8. viral hepatitis C; recipients with viral hepatitis C can donate
tissue or organ donor with viral hepatitis C
9. chronic hemodialysis,
10. lack of function of the authority designated for transplantation or pair
authority not intended for transplantation with living donors, if it is a
the subscription of the institutions,
11. intoxication (in the case of sampling of tissues); When corneal donation, or
the sclera are a contraindication only intoxication addictive substances or
intoxication with violent poisons that could harm the health of the recipient, or
endanger his life even in a completely minor, trace amounts, or
12. death by drowning, if it is a tissue.
Annex 2
Characterization of the institution and the donor
PART AND
The minimum data
1. the provider of health care services indicating the address of the medical
devices, in which it was done.
2. type of donor.
3. Blood group.
4. Sex.
5. Cause of death.
6. Date of death.
7. date of birth, or an estimated age.
8. Weight.
9. Height.
10. Earlier or contemporary history of intravenous abuse of narcotic drugs
substances.
11. Prior or current history of cancer.
12. Contemporary history of other communicable diseases.
13. Testing for HIV, viral hepatitis B and C viral hepatitis.
14. basic information on the evaluation of the functionality of the donated organ.
PART (B)
Additional data
1. General information
Contact details of the transplant centre, in which it was done,
necessary for coordination, allocation, and traceability of organs from donors to
recipients and vice versa.
2. the information about donors
Demographic and anthropometric data needed to guarantee the proper
compatibility between donor and recipient and between the authority and the beneficiary.
3. History of the donor
The medical history of the donor, in particular circumstances, which might affect the suitability of the
organs for transplantation, and give rise to the risk of transmission of the disease.
4. data from physical and clinical examination
Data obtained from clinical examinations, which are necessary for
reviews of physiological state of a potential donor, and any findings
revealing the circumstances that were not detected in the analysis of the donor's
history and which might affect the suitability of organs for transplantation
or give rise to the risk of transmission of the disease.
5. Laboratory parameters
The data needed to assess the functional characterisation of authorities and for
detection of any communicable diseases and potential contra-indications
the donation of the body.
6. Examination of using imaging methods
Examination using imaging techniques necessary for assessing the
of the State organs for transplantation.
7. treatment
Treatment prescribed donors relevant to an assessment of the functional State of organs
and their suitability for donation, in particular, the use of antibiotics, inotropic
support or transfusions.
Annex 3
Presentation of the report on the findings of the death
1) § 2 (2). 4 Act No. 258/2000 Coll., on the protection of public health and the
changes to some related laws, as amended by Act No. 274/2003 Coll.
2) § 5 para. 1 (b). h) Act No. 350/2007 Coll., on chemical substances and
chemical mixtures and amending some laws (legislation).
3) article 7 of European Parliament and Council directive 2010/53/EU of 7.
July 2010 about the quality and safety standards for human organs
intended for transplantation.
4) article 5 of Commission directive implementing 2012/25/EU of 9 June. October 2012,
laying down the procedures for the exchange of information of human organs
for transplantation between Member States.
5) Decree No 111/2013 Coll., laying down the requirements for the creation of a
working procedures to ensure the quality and safety of human
organs for transplantation, as amended by Decree No. 6/2014 Sb..
