285/2002 Sb.
LAW
of 30 March 2004. May 2002
for a donation, subscriptions and transplantation of tissues and organs and amending
Some laws
(the transplant law)
Change: 228/2005 Sb.
Modified: 296/2008 Sb.
Change: 129/2008 Sb.
Change: 41/2009 Sb.
Change: 281/2009 Sb.
Change: 375/2007 Sb.
Change: 44/Sb.
Parliament has passed the following Act of the United States:
PART THE FIRST
THE DONATION, SUBSCRIPTIONS AND THE TRANSPLANTATION OF TISSUES AND ORGANS
TITLE I OF THE
GENERAL PROVISIONS
§ 1
The subject of the edit
(1) this Act incorporates the relevant provisions of the European Union ^ 21) and
lays down rules to ensure the quality and safety of human organs
(hereinafter referred to as the "authority") intended for transplantation into the human body for the purpose of
ensure a high level of protection of human health, and that when their
the donation, testing, characterisation, sampling, preservation, transportation and
transplant.
(2) this Act also governs the terms of the donation, donations and transplantation
of tissues, cells and organs carried out solely for the purpose of providing
health services ^ 1). With regard to the quality and safety of tissues and cells,
proceed according to the law governing human tissues and cells ^ 7a).
§ 2
Basic concepts
For the purposes of this Act, means the
and a separate and viable) part of the human body, formed by
a structured arrangement of various tissues, which has zachovánu its
structure, blood supply and capacity to develop physiological functions with
an important level of autonomy; the authority shall also be considered as part of the authority,
where in the human body serve the same purpose as the entire organ, when
keeping the requirements on structure and blood supply,
b) tissues and cells of human body parts, including the remains of the
obtained for surgical operations, blood-forming cells derived from
bone marrow transplantation, peripheral and umbilical cord blood, with the exception of the organs, blood and
of its constituents, ^ 2) cells, embryonic and foetal tissues and
organs, hair, nails, the placenta and the waste products of any bodily
metabolism (hereinafter referred to as "tissue"),
(c) the possible donor patient) where, with regard to his health
death and assumes the possibility of tissue or organ, or the body of the deceased
of the person which has been demonstrated by the death and that foresees the possibility of subscription
tissue or organ,
d) donor, the person who donates body or tissue, whether to donate an
during the life of this person or after her death,
(e) the death of the irreversible loss of function) of the entire brain, including the brain stem,
or irreversible collateral blood circulation,
(f) a person registered in an expectant) National Register of persons waiting to
organ transplantation,
(g)) the recipient of the person receiving the transplanted organ or tissue
(h) the collection of all procedures required) for obtaining the tissues or organs intended
for a transplant including examination in order to assess health
eligibility of donors and its preparation for the collection,
I) the donation of the organ or tissue donation for transplantation,
j) process to restore transplant-specific functions
the human organism by transferring the organ or tissue from a donor into the body
the recipient,
donor characterisation Assembly) relevant information on the
the characteristics of the donor needed to assess its
medical certificate for donation organ or tissue for the purpose of
the implementation of proper assessment and minimisation of risks for the recipient and
optimization allocation of authority
l) characterizing the institution gathering relevant information about
the characteristics of the institution, which are needed to assess its
suitability for transplantation in order to assess and minimise the risk of
for the recipient and optimise the allocation of authority
m) preservation using chemical agents, alterations in environmental conditions or
other means in order to prevent biological or physical
damage to authority or a slowdown of such damage from the time of collection to the
transplantation,
n) serious adverse event any adverse and unexpected
events related to the donation, procurement, testing, characterisation,
preservation or transporting the body designated for transplantation and
Transplant authority, which could lead to the transmission of a portable
the disease, to death or life-threatening, damage to health or
restrictions for patients or which might result in, or
extend the period of hospitalization or illness,
o) serious adverse reaction an unexpected response of the living donor or
the recipient, including a portable diseases that could be related to
the donation, procurement, testing, characterisation, preservation or
transporting the body designated for transplantation and transplantation authority that
results in death, life-threatening, damage to health or restrictions
ability or will result in, or prolong, hospitalisation or his
disease,
p) workflows written instructions describing each stage of the
the process from donation after an organ transplant, including the materials and methods
to be used, and the expected overall result,
q) traceability option
1. determine the place where the institution is located, and identify it during each
stage of treatment with him, and find out whether or not the place of disposal,
2. identify a living or deceased donor,
3. identify the providers of health services, which carried out the subscription
authority,
4. key in the recipient's transplant center and
5. find and identify all the necessary data about products and
materials that come into contact with the body,
r) person a relative in the ascending line, the spouse, registered partner,
sibling, or the person sešvagřená.
TITLE II
COLLECTION OF TISSUES AND ORGANS
Part 1
Tissue and organs from living donors
§ 3
The admissibility of the collection of tissues and organs from a living donor
(1) subscription to the tissues or organs ("subscription") from a living donor, if
Additionally, unless otherwise specified, you can only do this if
and) is done solely in the interest of treatment benefit for recipients
(b)) at the time the subscription is not available suitable tissue or organ from a deceased
the donor and there is no other treatment method of equivalent effect,
(c) the person is an eligible donor) is put in the manner prescribed by this Act
a free, informed and specific consent (section 7), and this consent
actually said, and
(d)) this is a renewable tissue, or one of the paired organs function.
(2) the organ from a living donor, unless otherwise specified,
You can do this for the benefit of the recipient who
a) is close to the donor if the donor expressed a free, informed
and specific consent (section 7) in relation to that person,
(b) a person who is close to the donors), only under the conditions that
1. the donor expressly manifested a provable way will give your
authority of the recipient; the explicit expression of the will (hereinafter referred to as "observations") must
be made in writing and must have a certified signature of the donor; representation is
an integral part of the medical records of the donor,
2. with this donation in favour of the Ethics Committee pursuant to § 5 para. 5 (b). and)
consent.
(3) Subscription from living donors cannot be performed if the
a) can reasonably be expected that the subscription could serious
way to endanger the health or life of the donor,
(b)) is the donor a person located in the imprisonment or
in custody in the performance of security detention or in a protective treatment, with
the exception of organ donation among children and parents, siblings and spouses,
or
(c)) was established on the basis of an assessment of the medical fitness of the donor have reasonable
the suspicion that the donor is suffering from the disease or condition that might endanger
the health or life of the recipient. This does not apply if the health risk
the recipient is negligible compared to the life-saving
transplantation. Conditions for the prevention of human immunodeficiency virus infection
lays down specific legislation. ^ 4)
§ 4
Protection of minors, persons deprived of legal capacity
and persons with regard to their current health status, are not
able to consider all the consequences of the implementation of renewable tissue sampling for
your own health
(1) from the donors, who are minors, ^ 5) persons with reduced
competences the legal capacity or a person deprived of legal
capacity in full ^ 6) (hereinafter referred to as "detainee") or
persons who have expressed agreement with the collection, but with regard to their
the current state of health can reasonably be expected, despite the full
lessons to assess or not to consider all the consequences associated with
the collection of renewable tissue for own health (hereinafter referred to as "the person incapable
agree "), you can perform subscription-only renewable tissues, if it is not
unless provided otherwise below, and only if
and) there is no suitable donor who is able to give an express and
specific consent,
(b) the recipient is a sibling of the donor),
(c)) is the ability to life-saving donation recipient,
(d)) the legal representative of the donor, which is a minor or a person exempt from
competence, pursuant to § 7 para. 4 with this subscription agreement,
(e) the Ethics Committee voted, according to) § 5 para. 5 (b). (b)) with this collection
consent, and
(f)) this does not occur with a donation by the donor.
(2) the provisions of paragraph 1 (b). (b)), and (c)) shall not apply to cells,
If this subscription is only a minimal risk to health and life
the donor.
§ 5
The Ethics Committee
(1) the Ethics Committee is an independent Commission, which establishes and repealing
the statutory body of healthcare providers performing subscription
organ donors for the benefit of the recipient who is not his person [section 3
paragraph. 2 (a). (b))], or a renewable tissue minors, persons
deprived of their competence or persons unable to consent (section 4).
The Ethics Committee may be established as a fixed Commission or as needed to
the various cases.
(2) the Ethics Committee has at least 5 members; It is made up of doctors, one
clinical psychologist and lawyer. At least two-thirds of the members of the ethical
the Commission may not be in employment or similar relationship to the provider
health services referred to in paragraph 1. The Chairman and other members
ethical Commission appoints and dismisses the statutory authority of the provider
health services, in which the Commission was established. The Chairman and the
members of the Ethics Committee in the performance of the activities of the Ethics Committee are not bound by
instructions statutory authority providers of health services or instructions
other executive employees of providers of health services. The members of the
the Ethics Commission may be the only natural persons without a personal interest or
participation in the implementation of the subscription
and the authority for the benefit of the recipient), who is not close to the donors, or
on the transplantation of that authority,
b) renewable tissue, minor person devoid of distinctive character or
a person unable to consent or to transplant the tissue.
(3) the members of the Ethics Committee are required to maintain the confidentiality of all
the facts, which they learned in connection with the performance of their functions,
with the exception of cases when such fact shall be communicated with the consent of the donor,
the beneficiary or legal representative of a minor or a person deprived of
eligibility or on the basis of the exemptions required to maintain confidentiality.
The fact can be with the consent of the persons referred to in the first sentence to communicate so
It was not possible to obtain information about other people and that the
respected the anonymity between donor and recipient (section 20). For exemption
regarding members of the Commission shall apply specific legal
Regulation ^ 1) which sets out the rights and obligations of health care workers
in the provision of health services. Activity of the members of the Ethics Committee is
any other act in the general interest, which provides employees
time off work with wage compensation in the amount of average earnings in ^ 7) necessarily
extent necessary.
(4) the hearing of the Ethics Committee governed by the President. The Ethics Committee decides
a majority vote of its members. In case of equality of votes
of the President.
(5) the Ethics Committee grants on the basis of a written application submitted by the
the statutory body of providers of health services, which the Commission
established, the written approval or disapproval with the subscription
and donors for the benefit of) a beneficiary who is not the person,
b) renewable tissue, minor person devoid of distinctive character or
a person unable to consent.
Consent to or opt-out is part of the medical
documentation for anyone wishing to donate the organ or tissue donor,
minors, persons deprived of or persons unable to
agree to. The Ethics Committee shall within 7 days of the consent or
a copy of the Charter opt MRCC
transplantation.
(6) the request for consent shall contain the
and) health information provider, minors, persons deprived of
eligibility or persons unable to consent, that are applicable
for an assessment of potential renewable tissue sampling,
(b) a clinical psychologist) observations of the ability of the minor, the person
devoid of distinctive character or a person unable to consent to comment
Subscribe to pull doctor posuzujícím medical fitness of that person,
c) health information the recipient institution or renewable tissue,
(d) a copy of the full guidance and) informed consent of the donor of the authority or
the donor's legal representative (§ 7 para. 1 and 2), where expression
minors or persons devoid of competence (§ 7 para. 6),
(e) a copy of the full guidance and) the consent of a person unable to consent,
(f) a copy of the observations made by the donor) pursuant to § 3 (2). 2 (a). (b)), and
g) deadline by which the Ethics Committee is obliged to communicate consent or
opposition to the performing body donor or subscription renewable tissue
minors, persons deprived of the eligibility of a person unable to give or
consent.
(7) if necessary, the Ethics Committee may invite to the meetings on the granting of
affirmative or negative with the donor or of the legal representative
minors or persons devoid of competence, where appropriate, whether or not this
person. The Ethics Committee to act always invited
and) minor or person divested in the event that
a clinical psychologist has stated in its observations, that this person is able to
say you subscribe to,
(b) a person unable to consent),
(c)) the donor institution referred to in section 3, paragraph 3. 2 (a). (b)); in this case, in addition to
health aspects of the Ethics Committee ascertains and assesses whether or not the reasons
that led to the donation of the organ donor.
(8) the Ethics Committee in the case of consent referred to in paragraph 5 shall exercise
supervision over the course of the subscription and the maintenance of the rights of the donor, a minor,
a person deprived of or persons unable to consent.
(9) the Ethics Committee must keep essential records properly on its activities,
in particular, the written work procedures, list of members, together with their
professional competence, submitted by the application and the supporting documents, minutes of meetings,
reports and correspondence concerning its activities and the examination of applications
for at least 10 years, and that the providers of health services
which is established is established. In the case of the demise of the Ethics Commission shall ensure
proper storage of documentation of the statutory authority of the provider of health
services in which the Ethics Committee was established.
§ 6
Assessment of the medical fitness of a living donor
(1) prior to the collection from living donors must be evaluated by the health
eligibility for the donation of tissue or organ. For this purpose shall be carried out
such medical examinations and procedures to assess the health status of the
a living donor and the potential risks to health and life associated with donor
tissue or organ donation. At the same time, such procedures must be laid down,
that all available ways of limiting the risks to the health and life of the donor,
the removal of tissue or organ represents, without
compromised the quality and viability of removed tissues or organs.
An integral part of the assessment of the medical fitness of the donor is
characterization of the donor and the characterisation of the authority.
(2) for the assessment of medical fitness to the donor organ donation is
responsibility of the provider of health services, which performs the subscription. In
the case of the donation of tissues, an assessment of the medical fitness of the donor
proceed according to the law on human tissues and cells ^ 7a).
(3) the Examining doctor will carry out an assessment of the medical fitness record
the donor with the extent of the assessment and with the conclusion of the eligibility or
the incapacity of the donor. This entry stvrzený signature
assessing physician and date is an integral part of health care
documentation of the donor. Assessing physician passes within 7 days of the assessment
health donor listing from medical records in the
the extent of the record under the first sentence MRCC transplantation.
(4) the provider of health services, which carried out the collection, ensuring donors
provision of preventive health care.
(5) Further conditions of the medical assessment, the scope of the examination
a living organ donor, and the range of data for the characterization of this
the donor and to characterise organs from the same donor provides the Ministry of
health care (the "Ministry") by Decree.
(6) the donor or the legal representative of the minor, or the legal representative of the
persons deprived of the eligibility, if the donor of that person, may request
another doctor, who is not on a subscription or to other procedures the United
with the transplants involved, on the assessment of health risks of collection for the person
the donor. For this assessment does not apply the provisions of paragraphs 1 to 5.
§ 7
The full guidance and consent
(1) the doctor assessing the medical fitness of a living donor is obliged to
to provide donors a full lesson on the purpose, nature and consequences of the donation
tissue or organ, and about possible risks associated with it, including the risks
long-term. If the donor is a minor, or a person exempt from
competence, shall provide this information to her legal representative. Lessons
must be understood. The donor and the legal guardian of the minor or
the legal representative of a person deprived of competence has the right to ask questions,
to the extent provided in the first sentence, and the doctor is obliged to answer.
Part of the lesson is also the submission of information on the rights and protection of donor
laid down in this law.
(2) the donor and the legal representative of the minor, or the legal representative of the
persons deprived of the eligibility may require when instruction was present
Another witness. About this possibility shall inform in advance the physician providing the
complete the lesson. The doctor will perform a full record shall be drawn up lesson with his
concise content and this entry with an indication of the date when it was a lesson
done, signed by all interested parties. The record of the full lessons
the donor, or the legal guardian of the minor or of the legal representative
persons deprived of the eligibility is an integral part of the medical
documentation of the donor.
(3) the procurement by a doctor is obliged to immediately before performing the
subscription complete lessons, under the conditions laid down in paragraph 1.
(4) the consent of the donor or of the legal representative of the minor, or
the legal representative of a person deprived of the eligibility of the authorization on the basis of
full instruction referred to in paragraph 1 must be free, informed and
specific. Must be made in writing, confirmed by a signed and dated
and based on the medical documentation of the donor. Part of the consent of the
in connection with the collection of tissues is the definition of the purpose of its
the use of the.
(5) the donor or the legal representative of the minor, or the legal representative of the
persons deprived of competence may at any time withdraw your consent. Doctor
procurement is obliged to respect this appeal, unless they have been
made for the collection of irreversible acts whose interruption would mean
threat to the health or life of the donor.
(6) if they are minors or persons deprived of the eligibility of the capable
to an extent sufficient to understand the consequences of implementation or non-implementation of sampling
for themselves or for the recipient, it is necessary to provide them full lessons.
If the person referred to in the first sentence of the said opposition to the donation, it is
the opt-out must be respected.
(7) the provider of health care services, in the case of consent when I say in
connection with the collection of tissues, shall provide a copy of this consent, or
his amendment, a tissue establishment ^ 7a), which passes the tissue. The conformity of the copy
consent to the original provider of health confirms the relying
services.
§ 8
The making of the collection from a living donor
(1) a subscription to authority from a living donor can only be performed for the benefit of the person,
the donor has specified (section 3 (2)). If a living donor of tissue shall make the
their subscription donation to a person, this subscription can be done only in
the benefit of that person.
(2) in the case where the removed tissue or organ will not be implanted
the designated person, it is necessary to ask, before you make a subscription for use
This tissue or organ donor consent for another person. The reasons that
led the doctor to decide that the removed tissue or authority could be
implant donor designated person shall be recorded in the medical
documentation of the donor and the persons designated by the donor.
§ 9
The transplantation of tissues or organs removed for any reason other than for
the purpose of transplantation
(1) if the tissue or organ of the patient are removed for any reason other than
for the purpose of transplantation, they can be implanted only recipients
If the patient has been on the consequences and possible risks of removal
instructed and before or after the removal of tissue or organ expressed with their
the use of consent for transplantation.
(2) the implementation of lessons learned and obtain the consent referred to in paragraph 1 shall
the provisions of § 7 shall apply mutatis mutandis.
Part 2
Subscription from deceased donors
§ 10
The admissibility of a subscription from a deceased donor and the findings of the death
(1) a subscription from a deceased donor can be done only if it was found to death.
If the subscription should be from a deceased donor is executed before the expiry of the 2
hours after death, can detect this subscription, execute first after signing
the Protocol referred to in paragraph 2. The doctors, who are discovering the death, shall not be
attend a subscription from a deceased donor transplantation and may not be
nurturing doctors considered the recipient.
(2) the findings of the death of a potential donor must always be carried out at least 2
doctors with the appropriate specialist qualifications, who have examined the donor
independently of each other. The findings of the death of a potential donor, in the case
prediction of the subscription before the end of 2 hours from this finding
be recorded in the log, which is an integral part of the medical
documentation of the donor. Protocol for the detection of death signed by doctors who
they found death.
(3) death [§ 2 (b), (e))] is determined by demonstrating
and a pledge of irreversible bloodstream), or
b) irreversible loss of function of the entire brain, including the brain stem in the
where are the functions of breathing or blood circulation maintained artificially
(hereinafter referred to as "brain death").
(4) in the event of death proof of irreversible collateral blood circulation
You can perform a subscription before the end of 2 hours from this finding,
and time if known) findings of death, and death was detected in
medical facility
1. at the intensive care unit,
2. the Department of Anaesthesiology and resuscitation Department
3. in the operating room,
4. on the Revenue Department or the ambulance to the hospital, income
(b)) if the death was determined on the basis of their unsuccessful resuscitation.
(5) the death of the brain may be established, if
and the patient) located in the State, on the basis of which can be considered
the diagnosis of brain death, and
(b)) can be demonstrated clinical signs of the death of the patient's brain, on the
can be used to make a diagnosis of brain death, supplemented by examination of the
confirming the irreversibility of death of the brain.
(6) status on the basis of the diagnosis may be considered the death of the brain
clinical signs of the death of the patient's brain, on the basis of which can be determined
the diagnosis of brain death examination is demonstrating and certifying examination
irreversibility of the death of the brain are listed in the annex to this Act.
(7) the Ministry shall determine the scope of data necessary to characterise the
deceased donor and to characterise organs from a deceased donor,
the elements and the presentation of the report on the findings of the death and the specialized
competence of doctors and physicians engaged in ensuring the death of examination
confirming the irreversibility of death by Decree. The Ministry may lay down
more detailed conditions about how to carry out the examination to demonstrate the death,
Tests confirming the irreversibility of the collateral blood circulation or death
the brain and the conditions for their implementation of the Decree.
section 10a
The admissibility of a subscription from a deceased donor, who is a stranger
(1) aliens ^ 9) in which it can be assumed according to the tissue or organs
This law, can be done in the case of subscription, if a holder of a
valid proof of positive expression of will to break up the donation of tissues
or authorities issued to the competent authority of the State of which the foreigner
citizen (hereinafter referred to as ' donor card ').
(2) in the case of an alien who is in possession of the donor card and for which
You can assume tissue or organs under this Act, shall take
Transplant coordination centre based on the complaint of the provider
health services, a written question to the competent authority of the State of which he is
the alien's nationality, whether the alien
and has not made a declaration of will) towards the expression of disagreement with the posthumous
the collection of tissues or organs, or
(b)) gave its assent to the donation tissues or organs, if the State
the stranger is a citizen of, applying the principle of the envisaged
disagreeing.
(3) when establishing contact to a person close to foreigners in order to meet
obligations under article 15, paragraph 2. 1 take the transplant coordination centre
on the initiative of the healthcare providers written for query
competent authority of the country of which the alien is a citizen.
(4) is received by the provider of health services to 72 hours information
the facts referred to in paragraph 2, or if you cannot inform a person close to
aliens under § 15 para. 1, it is considered that the conditions for the subscription are not
met.
§ 11
The inadmissibility of a subscription from a deceased donor
(1) a subscription from a deceased donor is excluded, if the
and) the deceased during his lifetime, or the legal representative of the deceased, who was
a minor or a person divested,
proven to be disagreement with the posthumous collection of tissues and organs (article 16),
(b)) cannot be based on the assessment of medical fitness to exclude that
the deceased had been suffering from the disease or condition that might endanger the health or
the life of the recipient; for the assessment of the medical fitness of a deceased donor
authorities responsible provider of health services procurement; in
the case of the donation of tissues, an assessment of medical fitness
deceased donor shall proceed according to the law governing human tissues and
the cell, or
(c)) of the deceased could not be identified.
(2) the Examining doctor will carry out an assessment of the medical fitness record
deceased donor with the delimitation of the scope of the assessment and with the conclusion of the
eligibility or ineligibility of a deceased donor. This entry with
the date of carrying out the assessment, assessing the signature of doctor stvrzený is
an integral part of the medical records of the deceased donor.
(3) Further conditions for medical assessment, and the scope of
examination of the deceased organ donor establishes a Ministry decree.
§ 12
The removed tissues and organs
(1) the doctor who performed the taking of tissue or organ, captures the enumeration
the removed tissues and organs and the expected purpose of their use in
the medical records of the donor.
(2) providers of health services, who are involved in the subscription
the organs or tissues from a deceased donor and transplant,
They shall inform each other without delay on delay detection of health
the incapacity of a deceased donor, and also without delay inform in the same
the scale and Coordination Center.
(3) the tissue removed under the law governing the management of human
tissues and cells that have not been used for a transplant, you can
further testing, processing, preservation, storage, preparation margin and
distribution pass only a tissue bank.
section 13 of the
The autopsy
(1) on the body of the deceased, which was done, is always done
autopsy under special legislation. ^ 10)
(2) an autopsy of the deceased, which was carried out the collection, shall be carried out at the time of what
short as possible so that in the case of the additional finding that the deceased
He suffered from illness or condition that might endanger the health or life
the recipient could be concluded about the incapacity of the deceased.
(3) in the event that the physician conducting an examination of the deceased suspects
that death occurred under unclear circumstances or violent deaths, including
suicide or murder, can be performed only on the condition that it will not
thwarted by the purpose of the autopsy ordered under special legislation. ^ 11)
At the same time, it is necessary for the purposes of the investigation, to inspect the
subscribed tissue or organ, and also the part of the body from which they were removed so
to the outcome of the inspections could become part of the autopsy protocol.
(4) if the doctor who performed the autopsy, on the basis of the results of the autopsy
It finds that the deceased suffered from a disease or condition that might endanger
the life or health of the recipient, shall notify this fact immediately
the providers of health services, which carried out the taking of tissue or
authority. If it was on the basis of the autopsy made additional findings
incapacity of the deceased donor and the organ or tissue collected from
This has already been a donor transplant recipients, the provider of health
the service, which carried out the transplant without delay precautionary measures to
the prevention of threats to the life or health of the recipient, where appropriate, ensure that
recipients to provide the necessary health care, and shall notify the
MRCC transplantation without delay.
§ 14
Respect for the human body
When you perform a subscription from the deceased and carrying out post-mortem examinations must be
to deal with the body of the deceased with respect and all tasks must be carried out
so that the body was adjusted as far as possible to its original form.
Part 3
The communication of the intended person and in opposition of the subscription with the posthumous
collection
§ 15
(1) the attending physician of the patient, in which tissue can be expected
or authorities under this Act, shall notify the persons close in an appropriate manner,
If the patient has not specified under § 19 (hereinafter referred to as the "designated person"),
estimated subscription option, provided that the designated person
interest of the patient and the patient during his lifetime, demonstrable
way mentioned the prohibition of disclosure of information about your health.
If the patient is referred to in the first sentence of a minor or a person
stripped of eligibility, the possibility of attending physician shall communicate its subscription
legal representative and shall instruct him about the possibility of utter demonstrable
disagreement with the collection according to § 16 para. 1 (b). (c) in this case.)
do not apply the condition expression of interest of the patient. The attending physician at the same time
the designated persons, or legal representative will explain the scope and purpose of
the projected collection, respecting the anonymity of the recipient.
The designated person, or legal guardian have a right to ask questions,
the exception of the query to the recipient. If the specified person or legal
the representative of the fourth sentence explanation refuses, her treating physician
refusal to respect and this fact makes the record to the
the medical records of the patient.
(2) if the deceased, in which tissue can be expected
or authorities under this Act, it shall submit the information and if the deceased
a minor or a person stripped of eligibility whether or not lessons, according to the
paragraph 1, the doctor responsible for the statutory body of the providers of health
services, in which the deceased is located.
(3) the information submitted in accordance with paragraph 1 shall be a doctor writing in
medical documentation of the patient or of the deceased.
section 16 of the
(1) a subscription from the body of a deceased person may be made only if the
the deceased during his lifetime, or the legal guardian of the minor or
the legal representative of a person deprived of the eligibility of the mentioned the proven
the opposition. The opposition is considered a proven thing, if
and deceased) is a registered in the national register of persons who
the posthumous collection of tissues and organs, or
(b)) the deceased during his lifetime, yet right in the clinic before the
the treating physician and one witness States that he does not agree with the collection
in the event of their death, or
(c)) the legal representative of the minor, or the legal representative of a person deprived of
competence right in the clinic before the treating physician and
one witness States that he does not agree with the collection; This statement can be
make in case of death of a minor or a person deprived of the eligibility
even in her lifetime, or even after the death of that person.
(2) a disagreement with any collection referred to in paragraph 1 (b). b) or c)
writing without delay, which is part of the medical records. This
writing signed by the patient, the attending physician and the witness, and if the patient with
regard to their State of health could not sign, endorse the expression of his
will yet another witness. If it is a minor or a person
divested, sign and write her legal representative
the treating physician or a physician referred to in § 15 para. 2. The minutes shall
indicate also the date and hour when the Declaration was made. A copy of the minutes of the
the Declaration referred to in paragraph 1 (b). (b) a copy of the registration statement) or
made on death pursuant to paragraph 1. (c)) is a provider of
health services shall, within 3 days from his writing to send to the national
Register of persons who by the posthumous collection of tissues and organs.
(3) if it is not established that the deceased during his lifetime expressed
proven to be disagreement with the posthumous collection, with the collection
agrees.
TITLE III
The RECIPIENT
§ 17
(1) choosing the recipients of organs is based on the principle of
medical urgency, waiting and equality; When medical
the urgency of the account also of the overall time of the registration in the national
Register of persons waiting for an organ transplant.
(2) the provisions of paragraph 1 shall not apply to the taking of organs from living
donors.
(3) the beneficiary or his legal representative must give to the implementation of
the transplantation of the informed written consent of the authorization on the basis of the full
the lessons provided by the recipients of the doctor posuzujícím his health
capacity, or a doctor performing the transplant recipients; When
provide complete lessons and voicing the informed written consent of the
the provisions of § 7 shall apply mutatis mutandis. If it is not possible to request due
the State of health of the recipient's written consent or the consent of his
legal representative and, if the emergency power required transplantation
to save the life or health of the recipient, this consent is assumed. About
the reasons for that approval was not obtained pursuant to the preceding sentence,
does the record into the medical records of the recipient.
(4) the part of the beneficiary's medical records and data on the
State of health of the donor associated with the collection. Medical documentation
containing information on the State of health of the donor must be conducted so as to
anonymity of the donor.
TITLE IV
THE NATIONAL HEALTH REGISTRY RELATED TRANSPLANT
section 18
(1) part of the national health registries ^ 12) is a national register of persons
dissenting with the posthumous collection of tissues and organs, national register
organ donors, national registry of people waiting for an organ transplant, and
National registry of organ transplants carried out. These registers shall be established
the Ministry under special legislation. ^ 12)
(2) for the keeping of registers, data collection and handling
data applies a special law, ^ 12) ^ 13) If this law does not
otherwise.
(3) the tasks relating to the management of the national organ donation registry,
The national registry of people waiting for an organ transplant and the national
the registry carried out organ transplants fulfils coordination centre
Transplantation (section 25), which is under a special legal regulation ^ 1)
the processor of the personal data held in these registers. The tasks of the
related to the administration of the national register of persons who
the posthumous collection of the tissues and organs carries out the Coordination Centre for the
departmental health information systems. ^ 12) Centre referred to in the sentence
the second is for the purposes of keeping of registers personal data processor referred to in
special legislation. ^ 13)
(4) To the national registry of people complaining with the posthumous collection of the tissues
and authorities, compulsory lists the first and last name, social security number and address
residence of a person disagreeing with the posthumous collection of tissues and organs and
necessary information about the extent of the disagreement. The national registry of donors of tissues
and bodies and the national registry of people waiting for an organ transplant
It is mandatory to indicate the necessary identification data of the donor, the person pending
on organ transplant, persons who transplant was performed, and
the necessary information about the State of health of such persons. Details of the extent and
the content of the mandatory data to the national registry of persons who are
with the posthumous collection of tissues and organs, the national registry of organ donors,
The national registry of people waiting for an organ transplant and the national
the registry carried out organ transplants and the file data passed from the
These registers into the national health information system ^ 12)
the Ministry shall determine by Decree. The Ministry may also Decree
establish a set of data passed by the Centre to search for donors
stem cell registry of potential donors of hematopoietic cells to
The national health information system. ^ 12)
(5) for the purposes of carrying out the tasks
and) national register of organ donors, the donor also means the donor tissue,
(b)) the national registry of people waiting for an organ transplant, the person
waiting for transplant also means a person waiting for a transplant
tissue,
(c)) the national registry carried out organ transplants are carried out
transplantation of tissue transplants carried out also means.
TITLE V OF THE
OBLIGATIONS OF THE PROVIDERS OF HEALTH SERVICES IN THE PROVISION OF HEALTH
SERVICES IN CONNECTION WITH THE DONATION AND TRANSPLANTS OF TISSUES AND ORGANS
§ 19
Synergies in the provision of the data of the basic registers and other
information systems in public administration
(1) the Coordination Center and the Coordinating Centre for the
departmental health information systems make use of the basic
the population register for the performance of tasks in the management of national health
the registers kept under this Act, the following reference data:
and) surname,
(b) the name or names),
(c) the address of the place of stay), where appropriate, the address to which they are to be
documents can be delivered by a special legal regulation,
(d)) of the date, place and County of birth, for the data subject, who was born in
abroad, the date, place and the State where he was born,
(e)) of the date, place and County of death, in the case of the death of the data subject outside the territory
The United States, date of death, place and the State on whose territory the death
has occurred; If it is issued the Court's decision on the Declaration of death, day,
that is the decision, listed as the day of death, where appropriate, as the day on which
did not survive, and the date of the legal force of the decision.
(2) the Coordination Center and the Coordinating Centre for the
departmental health information systems make use of the information
system of population register for the performance of tasks in the management of the national
health registers kept under this Act, such a reference
details:
and the name or names), surname, maiden name,
(b)) date of birth,
c) gender,
d) place and County of birth and a citizen who was born abroad, instead of
and the State where he was born, citizen
(e)), social security number,
(f) the address of the place of residence), and the address to which they have
to be served documents according to a special legal regulation,
(g)) the beginning of permanent residence or cancellation date data on the place of
permanent residence or the date of their permanent residence in the territory of the United
Republic,
h) date, place and County of death; in the case of the death of a citizen outside the United
Republic, date of death, place and the State on whose territory the death occurred,
I) day, who was in the Court decision on the Declaration of death listed
as the day of death, or as a day that did not survive, and the date of acquisition
the decision of the Court on the Declaration of death.
(3) the Coordination Center and the Coordinating Centre for the
departmental health information systems make use of the information
of aliens for the performance of tasks in the management of national health
the registers kept under this Act, the following reference data:
and the name or names), surname, maiden name,
(b)) date of birth,
c) gender,
(d)) instead, and the State where the alien was born; in the case that he was born on
the territory of the United States, place and County of birth,
(e)), social security number,
(f)) the type and address of the place of residence on the territory of the Czech Republic, or
the address to which the documents are to be delivered by a special
legislation,
(g)) of the date, place and County of death; in the case of the death of foreigners outside the territory of the United
the Republic, the State in which the death occurred, or the date of death,
h) day, who was in the Court decision on the Declaration of death listed
as the day of death, where appropriate, as the day on which the stranger declared dead
did not survive.
(4) the Coordination Center and the Coordinating Centre for the
departmental health information systems use native from the registry
the numbers for the performance of the tasks in the management of the national health registries
conducted under this Act, the following reference data:
and social security number),
(b)) in the event of the original social security number, personal identification number,
(c) the name or names), surname, maiden name, where applicable, the bearer of the
social security number,
(d)) of the date, place and County of birth, and social security number for the bearer,
He was born in a foreign country, the place and the State in whose territory he was born.
(5) the data referred to in paragraphs 1 to 4 may be applied in a particular case always
only such data which are necessary for the performance of the task. Data,
that are kept as reference data in the base the population register,
to make use of the information system of the population register or an information
of foreigners only if they are in the shape of the preceding the current
status.
section 20
Respect for the anonymity of donors and recipients and information obligation
providers of health care services
(1) providers of health care services are required to maintain the anonymity of the
a) deceased donor tissues or organs to a recipient
b) living donor tissue or organ against the person referred to in § 3 (1). 2,
If the donor wishes,
(c) donor) of renewable tissues, if it is not a person referred to
in section 3, paragraph 3. 2.
(2) the provider of health services for conducting the subscriptions and transplantation
tissues, transplant centers and transplant coordination centre
record and maintain a social security number for identification purposes of the donor. For
to this end, the provider is entitled to require health care services
production of a document, in which the social security number. Social security number giver
shall be kept for the purposes of traceability.
(3) providers of health care services are required to immediately inform the
about the potential donors of organs transplantation centre concerned (section 22).
section 21
Provider of health services for conducting tissues and subscriptions
tissue transplantation
Provider of health services for conducting tissues and subscriptions
the transplantation of tissues, that is not a transplant Centre (section 22), it is
In addition to the obligations arising from a special legal regulation ^ 15)
shall be obliged to
and the persons to whom the report) was sampled in the national registry of donors
authorities,
(b) report to the transplantation) conducted the national registry
organ transplants,
c) in the case of tissues, provide data which will require coordination centre
transplantation,
d) receive information from the national registry of persons who
the posthumous collection of tissues and organs for the purposes of the implementation of the subscriptions from
deceased donors and respect as follows when I say disapproval with the collection,
e) verify the other ways of voicing disagreement with the demonstrable
the posthumous collection established by this Act and respect the following thing
disagreement,
(f) documentation of the performed) to keep subscriptions and transplantation and
waste taken from tissues or organs to log on
the final destination of tissues or organs, were removed.
g) to ensure the health of the living donors and recipients
h) have to import or export, import or export permit (sections 26a to
26 g).
section 22
Transplant Center
(1) the Transplantation Centre means a provider of health services,
who has been granted the status of highly specialized care center ^ 22) and that
on this basis, it can make donations and transplantation of hematopoietic
of cells, organs and tissues that have not been transmitted to the tissue bank in accordance with § 12
paragraph. 3. The transplant centre fulfils the obligations under section 21 and
obliged to
and to report to the indicated person) transplantation of tissues and organs to the national
Register of persons waiting for an organ transplant,
(b)) to carry out the transplantation of tissues and organs exclusively to recipients
registered in the national registry of persons waiting for a transplant
authorities,
(c)) work with transplant coordination centre in the selection
the most suitable recipients of organs,
d) on receipt of information pursuant to section 20 (2). 3 to determine whether they are fulfilled
the conditions for the subscription (10 to 11),
e) after finding that the conditions for the subscription to inform about possible donors
Transplant coordination centre,
(f)) to verify that it was done and recorded health assessment
eligibility of donors, including a complete characterisation of the organ and donor
(g)) to verify that the supplied authorities complies with the conditions of preservation and
transport,
(h)) to keep documentation on subscriptions and transplants carried out and
the management of the authorities taken to log on the final
the determination of the authorities, were removed.
I) report any serious adverse reactions and serious adverse reactions
MRCC of transplantation and medical providers
intercepting services subscriptions of tissues and tissue transplants or other
transplantačnímu Centre of performing subscription or transplant
j) report measures carried out for the solution of serious adverse reactions and
the reaction of MRCC transplantation.
(2) the transplant center is further obliged to
and to handle and maintain internal) system to ensure the quality and safety of
for all phases of the process from donation, transplant
(b)) for the purposes of traceability to use donor identification system and
of the beneficiaries, through which you can identify each donation, each
the associated authority and each recipient is associated with it; data needed
in order to ensure the traceability of the transplant center must keep at least
for 30 years,
(c)) apply workflows for the collection, preservation, packaging and
labelling authorities
(d)) apply the procedures for the reporting, investigation, registration and
the transmission of information about any serious adverse events that may have
effect on the quality and safety of organs, which can be caused by
the investigation, characterization, collection, preservation and transfer of organs, and
also information on any adverse reactions observed during
or after transplantation which may be associated with these activities,
(e)) ensure the application of working procedures to ensure the integrity
Authority during the transfer and an appropriate period of transport,
(f)) to ensure that healthcare professionals directly involved in the process
from donation after transplantation or disposal of organ or tissue should
the appropriate qualifications or training, they were technically eligible to
the profession and are adequately trained.
(3) the transplant center, performing the transplantation of hematopoietic cells
fulfils the obligations pursuant to article 21 (b). (c)), and (g)), it is required to cooperate
with the search for donors of hematopoietic cells (§ 24) when selecting
the most suitable unrelated donor hematopoietic cells and potential
performs the final selection of a suitable donor hematopoietic cells for a specific
of the recipient.
§ 22a
The Protocol for the handling of tissues and organs
Healthcare professionals who participated in the collection or transplantation
tissues and organs, any waste taken from tissues or organs
in the log, which is attached to the removed tissue or organ. Into this
the log is recorded, in particular, the date and place of sampling, and the final destination
the removed tissue or organ. If the removed tissue or body shall apply
for transplant, the log will record the date, the place and the person to whom
the transplant was performed. If it was decided that the removed tissue
and the authorities are not suitable for transplant, the log is recorded
the reason why they were found unfit, and way more load with them.
Provider of health services shall ensure that the send log
MRCC transplants within 7 days from the date when the
the final destination of the removed tissue or organ.
Article 23 of the
Tissue Bank
(1) the Tissue Bank is intended to provide donations, further processing,
the investigation, preservation, storage and distribution of tissues for
transplantation; in these activities it shall proceed according to the law of human
tissues and cells.
(2) the tissue banks are required to
and in the Organization of tissues), cooperate with the departments of Pathology
of forensic medicine, departments of obstetrics-porodnickými providers
health services, devices and services with the providers of blood transfusion
health services referred to in paragraph 21 and 22,
(b)) use the information the national registry of persons who
the posthumous collection of tissues and organs and the national registry of organ donors,
c) lead the documentation on the samples taken and received tissues, carried out
measurements taken of the tissue, the prepared transplantabilních
tissue štěpech that they have in stock, and štěpech issued by the
departments performing the transplant.
section 24
Centre for stem cell donation
(1) the Center for stem cell donor search is intended for
search for unrelated donor transplants of hematopoietic cells, investigation and
mediation of transplantation of hematopoietic cells from unrelated donors.
Centre for the search of hematopoietic cells can only be established with the
the consent of the Ministry. ^ 17)
(2) the Centre for stem cell donation in particular
and documentation of the performed) is conducting studies of the potential donors
hematopoietic cells and hematopoietic transplantation mediation
cells,
(b)) maintains a registry of potential donors of hematopoietic cells,
(c)) provides on request of providers of health services
information on potential donors of hematopoietic cells, and this in terms of
assessment of their suitability for a particular recipient,
(d)) provides and coordinates international cooperation in the implementation of the exchange of
hematopoietic cells for transplantation,
e) provides information to the public about the importance of and how to donate
hematopoietic cells in engaging new donors and ensures
the lessons of potential donors of hematopoietic cells of
the facts related to the voluntary donation,
(f) carrying out the assessment) ensures the health of potential
donors prior to their inclusion into the registry of potential donors
hematopoietic cells,
g) searches the registry of potential donors of hematopoietic cells suitable
an unrelated donor hematopoietic cells for a particular recipient,
h) provides health monitoring unrelated donor transplants after the collection,
I) ensures the release of unrelated donor for further examination.
(3) the Centre for stem cell donors search for leadership
the registry referred to in paragraph 2 (a). (b)) implement and maintain an information system
Enabling trace the potential donors of hematopoietic cells. Data on the
potential donors will be kept for registration of donors in the registry,
However, a minimum period of 30 years from the date of collection of hematopoietic cells.
The consent of the potential donor with the management of the data concerning him in the register
must be written.
(4) the Centre for stem cell donor search processes to 1.
March of each year an annual report on the activities of the Centre for the search
stem cell donors for the previous calendar year. The annual
report no later than that date, shall be published in a manner allowing
remote access and submit it to the MRCC transplantation.
§ 25
Transplant coordination centre
(1) the Ministry of health establishes a coordination centre
transplants for the performance of the tasks referred to in paragraph 2. When you sign up
Ministry of transplant coordination centre shall proceed to
its independence has been maintained at transplant centers, from
the perspective for the 3-d, substantive and technical equipment and the location of the
of the Centre.
(2) the Coordination Center carries out the following tasks:
and the national registry of persons) waiting for an organ transplant,
(b)), national register of organ donors,
(c)) leads national registry carried out organ transplants,
d) coordinates sampling and transplant teams each
transplant center,
(e)) is choosing recipients for the removed organs; the selection is
carried out exclusively from the national registry of persons waiting for a transplant
authorities on the basis of a written allocation algorithm, defined in advance
f) methodically coordinates the activities of the Centre for the donor search
hematopoietic cells,
g) provides and coordinates international cooperation in the implementation of the exchange of
organs for transplantation (section 26),
h) works with the Ministry to ensure the quality and safety of
organ transplants,
I) performs tasks related to the exchange of organs between Member States
The European Union (hereinafter referred to as "Member State") and between the Member States and the
third countries,
j) enters into a written agreement with the European organisations for the exchange of organs,
If such organisations ensure compliance with the requirements laid down in this
by law,
to) processes for more workflows
l) performs other tasks specified by the Ministry.
(3) part of the transplant is the central coordination centre
monitoring unit that handles the summary data on the
subscriptions, transplants and their results for each calendar year, and
a report on how the Ministry no later than 31 passes. March
the following calendar year.
(4) the requirements for the establishment of working procedures to ensure
the system of quality and safety of organs, and for the collection, preservation,
packaging, labelling and transportation of organs, traceability and for Administration
accurate, rapid and verifiable reporting of serious adverse
the effects and reactions, and solution of serious adverse events and reactions,
the Ministry shall determine by Decree.
TITLE VI OF THE
INTERNATIONAL COOPERATION
section 26
(1) the international exchange of tissues and organs for transplantation is permissible
only, provided that its objective is to find the best
the recipient or transplant waiting rescue, whose life is
immediately at risk, and assuming that tissues and organs meet
quality and safety requirements and that it is their
traceability.
(2) authority to a foreign country in the framework of international exchange of organs according to the
paragraph 1 is only possible if the Czech Republic is not in the
The national registry of persons waiting for a transplant recorded suitable
candidate or a procedure within the membership of the international
Transplant organizations.
(3) tissues and organs for transplantation can be from abroad in the framework of the exchange of
tissues and organs referred to in paragraph 1 shall be taken only in the case that was
made to the eligible provider of health services and
in a way that is in accordance with the applicable legislation of the country of origin. Must
be demonstrated that prior to collection was evaluated by the medical fitness
the donor, and the donor's medical records associated with the collection must be
retrievable.
(4) the conditions for international cooperation in the transplantation of hematopoietic
cells may provide a Ministry decree.
Section 26a
(1) for importation of tissues in the United States or to their export from the United
Republic or the import or export of organs in the framework of international exchange
or offers in accordance with § 26 para. 1 and 2 (hereinafter referred to as "the import or export of tissues
or bodies ") are issued by the Ministry of an import or export permit. About
applications for import or export permit, the Ministry shall decide within 90 days
from the date of its submission.
(2) an application for an import or export permit shall, in addition
the General requirements under the administrative code include
and desetimístnou of subheading of the combined nomenclature) of the common customs
tariff and its name indicating the specified tissues or organs,
the import or export, import or export authorization requests
provided for by regulation of the Government,
(b) the proposed maximum amount) tissues or organs or cells
in millilitres,
(c) the proposed period of validity) of import or export permit
(d)) the purpose of the import or export of
(e) the name of the State or States) origin of tissues or organs in the case of imports,
the name of the State (s) of destination of tissues or organs in the case of exports.
(3) the application for an import or export authorisation, the applicant
connects
a) extract from the commercial register or a certified copy of the provisioning
of the Charter,
(b)) and the specifications of the species exported to enumerate or imported tissues or
authorities,
c) in the case of export document or its certified copy of the release
national authority confirming that this is a health provider
services authorized to carry out subscriptions to tissues or organs.
(4) in the event that the importation of authority within the United States or the export authority from
The Czech Republic is necessary because of the life-saving done in less
than 90 days, the Ministry of the import or export of approve additional
After its implementation. This additional approval request authority to import
The United States or export authority from the United States, the Ministry of
served immediately after its implementation.
section 26b
(1) the decision on the import or export permit, in addition to
the General requirements under the administrative code contains
and) registration number of the import or export permit
(b) subitem) the combined nomenclature of the customs tariff and its name
that indicates the tissue or authorities on the import and export of import or
the export authorisation is granted,
(c)) the period of validity of import or export permits, including the authorised
the maximum quantity of pieces of the organs or tissues or cells in millilitres,
You can import or export,
(d) the name of the State or States) origin of tissues or organs in the case of imports,
the name of the State (s) determine the tissues or organs in case of export, the
e) instruction on the obligation to return a copy of the written copy of the import
or export permit within 10 working days after it is exhausted or
its expiry (section 26e)
(f)) the purpose of the import or export of
g) annex to the decision; in each Annex is defined instead of for the record
the identification data of the providers of health services, which carried out the
taking of tissue or organ, and for the records of the Customs authorities on the use of
granted by the import or export permit (amount, date, imprint
stamp, signature); the number of attachments, the number of allowable maximum
imports or exports referred to in subparagraph (c)).
(2) the Ministry shall grant an import or export permit for a maximum period of 12
months.
section 26 c
(1) the Ministry shall authorise the import or export permit, if it
require the security interests of the United States (the possibility of threats
health and life of the population).
(2) the Ministry shall withdraw the import or export permit, if
and) import or export authorisation was granted on the basis of false
or incomplete information, the
(b)) have not been met or range of conditions laid down therein, or
(c)) required the security interests of the United States.
(3) an appeal against a decision to withdraw the import or export
the authorisation referred to in paragraph 2 does not have suspensory effect.
(4) the Ministry and the Directorate-General of Customs shall be provided between
data relating to the import or export permit, to the extent
the data referred to in the decision under section 26b. They shall immediately
informed of the facts relevant for the administrative procedure for granting,
refusal or withdrawal of an import or export authorisation under this
law, shall check compliance with the conditions laid down in the import or
export permits and impose sanctions.
section 26 d
(1) the import or export of tissue or organ under section 26a para. 1 in a particular
the case and the import or export of the authority under section 26a of the paragraph. 4 can be made
only with the consent of the transplant coordination centre that can
the consent of the
and export to a particular grant), if in the Czech Republic is not in the
National registry of people waiting for an organ transplant are registered
a suitable candidate,
(b)) to a specific importation, grant, if the organ or tissue intended for
a particular recipient.
(2) the Coordination Center works to
ensuring traceability with the Directorate-General of customs.
section 26e
Import or export permit cannot be transferred or is transferred to a legal
the successor. Provider of health services, which import or
the export authorisation, such authorisation to the Ministry is obliged to return the
within 10 working days after its exhaustion or termination of its validity, and
including the records of the Customs authorities about his use of, and the list of people in the
foreign countries approved by the State authority, to which the authorities or
tissue from the United States to be exported or from which organs or tissues
imported into the United States.
section 26f
cancelled
section 26 g
For the import or export of tissues or organs between the Czech Republic and
the Member States, the provisions of section 26a to 26 d shall apply mutatis mutandis.
TITLE VII
OTHER ACTIVITIES RELATED TO THE DONATION, PROCUREMENT AND TRANSPLANT
section 27 of the
The Ministry of
The Ministry of
and provides information to the public) about the importance of and how to donate
tissues and organs, and especially stem cell donation, how
disagreeing with the posthumous collection and about the importance of transplantation;
in doing so, cooperate with other regulatory authorities and institutions of the territorial
Government, with health insurance companies, health care providers
services, professional organisations in health and other authorities and
institutions,
(b)) at the request of the European Commission or another Member State
informs you about the
1. the conditions that must be fulfilled in accordance with the legislation of the provider
health services, which intends to provide health services in accordance with
This law,
2. the activities of the health service providers engaged in the collection and
transplantation under this Act, the aggregate number of living and
deceased donors, the type and number of transplanted or destroyed
authorities, including the provision of a report pursuant to § 25 para. 3.
section 28
Prohibition of financial gain or other benefits, and dealing with tissues and
the authorities of the
(1) the human body and its parts shall not, as such a source of financial
benefits or other benefits; This is without prejudice to the provisions of section 28a-
28 d.
(2) the donor or any other person shall not make any claim against the recipient.
(3) for the purpose of advertisement and advertising demand or supply authorities are
disabled. For the advertisement and the advertisement does not constitute the procedure under section 27.
(4) Trading with tissues and organs collected for the purpose of transplantation
is prohibited.
section 28a
Contribution to the costs of the funeral
(1) the person who arranged the funeral of deceased donors, which was carried out
subscription to the authority belongs to the contribution to the costs associated with the dispatching
the funeral in the amount of CZK 5,000.
(2) a request for payment of the contribution to the costs of the funeral shall, in addition to the General
requirements under the administrative code include
and) proof of payment of funeral costs, donors
b) data relating to deceased donors, and that the name or names,
last name, date of birth and date of death,
(c) the name and address of the provider) of health services, in which it was
collection authority,
(d)) to determine the manner in which the amount is to be paid.
(3) if the request is submitted to the Ministry, 12 months from the date of dispatch of the
the funeral of the deceased donors are entitled to a contribution to the cost of the funeral shall cease to exist.
(4) the Transportation of the body from the place of the autopsy of the deceased donor to the place of burial shall be borne by
the recipient's health insurance company.
§ 28b
Compensation awarded to living organ donors
(1) the Donors body belongs to a replacement reasonably and demonstrably incurred
the expenditure (hereinafter referred to as "reimbursement of expenses"), and the difference between the loss of earnings and
received wage compensation, salary or remuneration, and received sickness from
health insurance, which was a temporary incapacity for work
in connection with the procurement authority and the provision of health services, which
This subscription's requested (hereinafter referred to as "loss of earnings").
(2) an application for the payment of compensation for expenses and loss of earnings, shall, in addition
the General requirements under the administrative code include
and the date of collection of the authority) and the period in which he has provided
health services associated with the procurement authority
(b)) name and address of transplant centers, which made the collection, and
address of the provider of health care services, in whose clinic
health services have been provided to donors associated with the procurement authority
(c) a document certifying the amount of usefully) and demonstrably incurred expenditure and
the amount of lost earnings, or a certified copy thereof,
(d) a certified copy of the document of) their temporary incapacity
associated with the collection; the person to whom it is issued, the proof of the temporary
incapacity for work, showing a written statement of the provider
health services for the period for which he could not carry on business, for which the
requires compensation for loss of earnings.
(3) the Ministry will ask the transplant center, which made the collection, and
providers of health services, which ensures the provision of
health services to donors, for confirmation of the facts referred to in paragraph 2
(a). (b)), and a statement whether the required expenses and loss of earnings
agrees with the period when it was done, and the donors of the institution when he was
provided with the collection of related health services. Transplant
Center and provider of health services are required to provide
the information you requested within 10 days from the date of receipt of the request.
(4) if the request for the payment of compensation for expenses or loss of earnings is submitted
within 24 months from the date of implementation of collection authority, entitled to a refund of their
ceases to exist.
(5) the donors will pay the expenses and loss of earnings in the amount of proven,
a maximum of twice the average wage in the national economy
the declared and published by the Ministry of labour and Social Affairs in the collection
for the purposes of employment laws ^ 23). To compensation for expenses is not counted
the refund of travel expenses to be paid by the donor under the law governing
public health insurance.
(6) the provider of health care services is required to ensure that the donor
prior to collection of the authority shall be informed of the possibility of requesting a refund of expenditure and
loss of earnings, and to that end submit a request referred to in paragraph 2. A record of the
This information, signed a medical professional, and the donor is
an integral part of the medical records kept by the donor.
section 28 c
The Ministry will decide on the contribution to the costs of the funeral, pursuant to section 28a or
compensation provided under section 28b. In the case of the procedure under section 28b of para. 3
the deadline for a decision is extended by 30 days.
section 28 d
The Ministry may delegate the performance of transplant coordination centre
scope according to § 28a to 28 c.
TITLE VIII
The FINE
section 29
(1) for failure to comply with or breach of obligations or prohibitions laid down
This Act (hereinafter referred to as "infringement") saves a penalty. Fine
stores,
a) in the case of an offence under section 10a, 22, § 24 para. 2 to 4 and §
26 d of paragraph 1. 1, Ministry,
(b)), unless the infringement referred to in subparagraph (a)),
1. the Regional Office of the provider of health services, which has granted pursuant to
special legal regulation the permission to the provision of health
Services ^ 1)
2. the Regional Office of legal persons with the address of the registered office in its territory, and
individuals doing business in its own name with the address of permanent residence
in its territory, not the providers of health services.
(2) a fine may be imposed
and providers of health care services)
1. to the amount of 100 000 EUR for non-compliance with or breach of the obligations laid down
in section 3, 4, § 6 (1). 1 and 4, § 8 para. 1, § 10 para. 1, 2 and 4, section 10a, 11,
13, § 16 para. 1 and 2, section 20 (2). 1 and 3, § 21, 22, § 23 para. 2, section 24
paragraph. 2 to 4, § 25 para. 2, § 26 para. 1 and 3, § 26 d of paragraph 1. 1 or § 28
paragraph. 1, 3 and 4,
2. the amount of $ 50,000 for failure to comply with or breach of the obligations laid down
in section 6 (1). 3, § 7 (2). 1 to 3, 6 and 7, § 8 para. 2, § 9 para. 1, § 12,
14, § 15 para. 1, § 16 para. 3, § 22a or § 25 para. 3,
3. that the imported or exported by the authorities without import or export
authorization to the above 5 000 000 CZK
4. which imported or exported contrary to authorities granted the import or
the export permit to the amount of $ 1 000 000
(b)) legal persons and natural persons operating on their own behalf to
the amount of 500 000 CZK for a violation of the prohibition in § 28 para. 3.
(3) the infringement referred to in paragraph 2 is repeated, if it
provider of health services, the legal person or natural person
doing business on their own behalf, committed at the time within 1 year after the previous
the offence, for which he was found guilty, fined by the
of paragraph 2.
(4) For repeated infringement to increase the upper limit of fines
referred to in paragraph 2 by half.
section 30
(1) the administrative authority, which imposed a fine of providers of health care services,
It shall send a copy of the decision imposing a fine under this Act health
the insurance company with which it has concluded a health care services provider
contract for the provision of health services.
(2) the procedure for the imposition of fines can be initiated within 1 year from the date of the
administrative authority empowered to imposition of a fine or a municipality entitled to save
fines for offences brought to their attention, but not later than within 3 years from the
the date on which the infringement occurred.
(3) when saving penalties and the determination of its amount takes into consideration the severity of the
the infringement caused by the effect, the degree of fault and
circumstances in which the infringement occurred.
(4) a fine collected and enforced by the administrative authority which it has saved, or municipality,
that it imposed. The fine imposed by the Ministry of State revenue
the budget, the fine imposed on the region, the regional budget income is fine
stored is income of the budget of the municipality.
(5) if the infringement referred to in § 29 para. 2 bases
merits of infringement under other legislation
and the competent administrative authority under another law proceedings
the imposition of fines has already started, the proceedings for the imposition of a fine under this Act
stops.
TITLE IX OF THE
COMMON AND TRANSITIONAL PROVISIONS
section 31
If this Act uses the term "donor" or "donation"
do not apply general legal regulations governing the donation and the formalities with the
related. ^ 20)
§ 32
(1) Medical collectors and transplantation,
transplant centers, tissue banks and the Centre for the donor search
hematopoietic cells and components of the national health registries (section 18)
must meet the conditions established by this Act not later than 2 years after the
the effective date of this Act.
(2) the Ministry shall publish the establishment of a national register of persons
dissenting with the posthumous collection of tissues and organs, and how to register
citizens in this registry, in a way which ensures that these
really fit in the widest possible audience. Until the establishment of the register
the disagreement with the posthumous collection follows the
the existing legislation, with the exception of cases, when a citizen of your
demonstrable opposition expressed according to § 16 para. 1 (b). (b)).
PART TWO
cancelled
§ 33
cancelled
PART THREE
Amendment of the Act on public health insurance
§ 34
Act No. 48/1997 Coll., on public health insurance and amending and
certain related laws, as amended by Act No. 242/1997
Coll., Act No. 2/1998 Coll., Act No. 125/1998 Coll., Act No. 225/1999
Coll., Act No. 363/1999 Coll., Act No. 18/2000 Coll., Act No. 132/2000
Coll., Act No. 155/2000 Coll., Constitutional Court No. 167/2000 Coll.
Act No. 220/2000 Coll., Act No. 258/2000 Coll., Act No. 458/2000 Coll.,
Act No. 176/2002 Coll. and Act No. 198/2002 is amended as follows:
1. In section 13(2). 2 letter a) including footnote No. 23a):
"and out-patient treatment and) constitutional (including diagnostic care,
rehabilitation, care for the chronically ill and health care for the donor of tissues
or institutions related to their subscription), ^ 23a)
23A) Law No 289/2002 Coll., on donation and transplantation subscriptions
tissues and organs and on amendments to certain acts (the transplant law). ".
2. In § 13 para. 2, letter d) the following point (e)), which read as follows:
"e) tissue or organs for transplantation, and the necessary
waste management (storage, storage, processing and
examination), ^ 23a) ".
Subparagraph e) to (j)) shall become letters (f)) to).
3. In § 13 para. 2, the letter i) the following new letters j) to (l)),
are added:
"j) transport living donor to the sampling point and from there, to the point of
the provision of health care associated with the collection and from this place and
reimbursement of travel costs,
to transport a deceased donor) to the place of collection and from this place,
l) transport the removed tissues and organs (article 36, paragraph 4), the ".
Subparagraph (j)) and to) are known as letters m) and (n)).
4. under section 35, the following new section 35a, which including the title reads as follows:
"section 35a
The transplantation of tissues and organs
Health care for the living donor associated with the collection of tissues and organs,
collection of tissues and organs from living or deceased donors, necessary
waste taken from tissues and organs and transport living donor or
compensation for travel expenses and transport a deceased donor shall be borne by
health insurance, which the insured person is a living donor or the
insured person was deceased donor. ".
PART FOUR
cancelled
§ 35
cancelled
PART FIVE
cancelled
section 36
cancelled
PART SIX
cancelled
§ 37
cancelled
PART SEVEN
Amendment of the Act on the Czech Medical Chamber, the Czech dental Chamber and
Czech pharmacy Chamber
§ 38
In the Act No. 220/1991 Coll., on the Czech Medical Chamber, the Czech dental
the Chamber and the Czech Chamber of pharmacists, as amended by Act No. 160/1992 Coll., section
2 (2). 1 letter c) is added:
"(c)) shall consider and defend the rights and professional interests of its members".
PART EIGHT
The EFFECTIVENESS of the
§ 39
This Act shall take effect on 1 January 2000. September 2002, with the exception of part five
points 3 and 5, which will become effective on 1 January 2004. March 2003.
Klaus r.
Havel, v. r.
in the financial times in the r..
Annex
The discovery of death proof of death in the cases of the brain
And.
The State, on the basis of the diagnosis may be considered brain death
The State, on the basis of the diagnosis may be considered the death of the brain, is a condition
When
and the patient is not doubt) about the diagnosis of structural brain damage
or about his exploration, and
(b)) the patient is in a deep coma, on artificial pulmonary ventilation and is
excluded that the unconscious at the time of examination of the involved
1. intoxication,
2. buffer and relaxing effects of pharmaceuticals,
3. metabolic or endocrine disruption, or
4. primary hypothermia.
(B).
Clinical signs of brain death and the examination is proving
1. Clinical signs of brain death, on the basis of the proof can be
the diagnosis of brain death, are
areflexie, zornicová and)
(b)) were areflexie,
(c)) vestibulookulární areflexie,
(d)) the absence of any motor response to algický the initiative applied in
inervační area of the cranial nerves,
e) absence of kašlacího reflex or any immediate motor
responses to deep suction, tracheobronchial
f) perpetual arrest spontaneous breathing proven apnoickým test,
g) deep unconsciousness.
2. The examination to demonstrate clinical signs of brain death (
"the examination of the clinical signs of brain death") performs 2 wearing
independent doctors, and to the extent provided for in point 1.
3. In children under 1 year of age, the examination of the clinical signs of brain death in
extent specified in paragraph 1 shall carry out at least twice every 48 hours.
4. The reasons for which cannot be examination of the clinical signs of brain death
referred to in point 1, perform, record the doctor conducting the examination
the clinical signs of brain death in a log about the discovery of the death.
(C).
Tests confirming the irreversibility of the clinical signs of brain death
1. Examinations, confirming the irreversibility of the death of the brain are
and cerebral arteries, angiography)
(b) the brain and/or perfusion scintigraphy),
(c) a computerized tomography angiography),
Transcranial Doppler ultrasonography d), or
e) examination hearing stem evoked potentials (BAEP).
2. For deceased people with clearly objectively proven severe structural
infratentoriální lesions are performed only by clinical examination.
Annex 2
cancelled
Selected provisions of the novel
Article. (II) Act No. 44/Sb.
Transitional provisions
1. the data held in the registry made the transplantation of hematopoietic cells
before the date of entry into force of this Act shall transmit to the Czech haematological
Society of the Czech Medical Society of Jan Evangelista Purkyně in
cooperation with the coordination centre in the National Transplantation
the registry carried out organ transplants, within 12 months from the date of
entry into force of this Act.
2. providers of health services will begin to supply data on donors
tissues, people waiting for transplants of tissues and persons who have been
made of tissue transplants, including the necessary information about their
health in national health registers maintained under
Act No. 285/2002 Coll., in the version in force from the date of entry into force of
This Act, not later than 6 months from the date of entry into force of
of this Act.
3. compensation for expenses and loss of earnings under section 28b of the Act No 291/2002 Coll.,
in the version in force from the date of entry into force of this Act, is
living donors, if at the time of entry into force of this Act has already been
living donor in the incapacity to work. In this case, it is
replacement from the date of incapacity for work in full.
4. the Centre for stem cell donation processes annual
report pursuant to § 24 para. 4 of law no 289/2002 Coll., in the version in force from
the effective date of this Act, for the first time to the 1. March 2013.
5. The transplant centers are required to process internal system
ensure quality and safety for all phases of the process from donation after
pursuant to section 22(1) of the transplant. 2 (a). and Act No. 285)/2002 Coll., on
the version in force from the date of entry into force of this Act, and within 12 months
from the date of entry into force of this Act.
1) Law No. 372/2007 Coll., on health services and conditions of their
provision (law on health services).
2) Act No. 20/1966 Coll., as amended.
Act No. 79/1997 Coll., on pharmaceuticals and on amendments and additions to some
related laws, as amended.
4) Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended.
5) section 8 of the civil code.
6) § 10 of the civil code.
7) § 124 para. 2 and section 275 of the labor code.
7A) Act No. 297/2008 Coll., on ensuring the quality and safety of human
tissues and cells intended for human applications and amending related
laws (law on human tissues and cells).
9) Act No. 326/1999 SB. on residence of aliens in the territory of the Czech Republic and
amendments to certain laws, as amended.
10) section 28 of Act No. 20/1966 Coll., as amended.
Decree No 19/1988 Coll., on the procedure on the death and the funeral industry, as amended by
Act No. 257/2001 Coll.
11) § 105 and 115 criminal procedure.
12) section 70 of Act No. 372/2007 Sb.
13) Act No. 101/2000 Coll., on the protection of personal data and on amendments to certain
laws, as amended.
15) for example, law No. 372/2007 Coll., Act No. 297/2008 Coll., as amended by
amended, Act No. 48/1997 Coll., on public health
insurance and amending and supplementing certain related laws, as amended by
amended.
17) section 70 para. 2 of Act No. 20/1966 Coll., as amended.
20) for example, the civil code, Act No. 357/1992 Coll., on income tax, inheritance
the gift tax and real estate transfer tax, as amended
regulations.
21) directive of the European Parliament and of the Council 2010/53/EU of 7. July
2010 on the quality and safety standards for human organs intended for
transplant.
22) section 112 of the Act No. 372/2007 Sb.
23) Act No. 435/2004 Coll., on employment, as amended
regulations.
