Key Benefits:
Decision of 17 January 2007, laying down new requirements on the safety and quality of body material (Eisendecision physioplant 2006)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of Our Minister of Health, Welfare and Sport of 16 August 2006, attribute GMT/MVG 2698800;
Having regard to Directive 2004 /23/EC of the European Parliament and of the Council of 31 March 2004 setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells (PbEU L), 102), and Article 8 of the Law on Safety and Quality of Body Material and Article 18, third paragraph, of the Organ Donation Act ;
Heard the Council of State (opinion of 22 September 2006, number W13.06.0351/III);
Having regard to the further report by Our Minister for Health, Welfare and Sport of 11 January 2007, attribute GMT/MVG 2727986;
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. Act: the Law safety and quality body material ;
b. donation: the donation of body material or organs for transplantation;
c. Quarantine: the status of out-of-body material, or any tissue that is physically isolated or otherwise isolated, pending a decision on its release or disapproval;
ed. Serious adverse event: an unexpected and, in so far as it concerns the donation of a body, unexpected occurrence in connection with the acquisition, testing, processing, preservation and distribution of bodily material, or that occurs somewhere in the chain from donation to transplantation; and which may result in a patient being infected with a communicable disease, death, death, disability or incapacity, or may result in a hospital or prolongation of the duration of the disease, or if such a disease is the transplantation of organs involves the duration of hospitalisation or the disease lengthens;
e. serious adverse reaction: an unintended response, including a communicable disease, to the donor or recipient in connection with the acquisition or application to man of bodily material or who may be somewhere in the chain from donation to transplantation at the time of the donation. the living donor or the recipient presents death, life risk, disability or incapacity for work or may cause or lead to hospitalisation or the duration of hospital admission or until Disease leads to a prolongation of the disease;
f. Donor characterisation: the collection of the relevant information on the characteristics of the donor required to assess its suitability for organ donation, in order to carry out a proper risk assessment and minimise the risks to the recipient. To optimise the allocation of organs;
g. Characterisation of the body: the collection of the relevant information on the characteristics of the body needed to evaluate the suitability of the organ, in order to carry out a proper risk assessment and minimise the risks to the recipient; in order to optimise the allocation of organs;
h. Operating procedures: written instructions describing the steps of a particular process, including the materials and methods to be used and the expected end result.
i. Traceability: the ability to locate and identify the organ at any stage of the chain from donation to transplantation or disposal, including the ability to:
-identify the donor and the procurement organisation,
-identify the recipient in the transplantation centre;
-any relevant non-personal information relating to the products and materials coming into contact with the organ, to be identified and identified.
2 In the Chapter 6 , 7 and 8 materials derived from tissue or cells shall also be included in the body material, in which no more human cells are prevented.
1 An amendment to the technical rules laid down in the EU Directive shall apply to the application of this Decision as from the day on which the relevant amending Directive has to be implemented.
2 The establishment of the technical rules laid down by the EU Directive shall be published by Our Minister in the Official Gazette.
1 The work and responsibilities to be carried out within the organ system shall be documented in writing as a function of the functions.
2 Staff members are, inter alia, training levels, knowledge and experience, suitable for the work they are to carry out.
1 The organ system maintains a quality system.
2 The quality system shall comprise a documentation which shall, in any case, describe the various processes and record their progress, including a description of the manner in which safeguard measures are applied. ed.
3 The rules of our Minister may lay down detailed rules on the establishment of the quality system.
1 The organ centre assays a unique identification code for each donation to the body material concerned.
2 The system of organs shall address the administration so as to enable it to become obsolete using the identification code with respect to bodily material allocated through the centre of the Centre:
a. The donor ' s personal data relevant to the use of the body material;
b. the institution where the material has been made available;
(c) the date and time of the publication of the material;
d. where applicable, the destination for which the donor is to be used in accordance with Act on organ donation has been authorised;
e. the characteristics and characteristics of the material and the purposes for which, where applicable, it is appropriate to take account of the authorisation granted;
f. the necessary instructions for the storage and use;
g. any side effects when used;
h. The materials and materials used in the transport operation, the supplier and the batch number thereof;
the name and address of the institution to which the body material was delivered;
j. the personal data of the person in whose medical treatment the bodily material was used.
3 Organ centre shall retain the information referred to in paragraphs 1 and 2 at least 30 years after the allocation.
The Organ system may only subcontract work to third parties through a written agreement.
1 The organ centre designates according to the Act on organ donation notified body material not in place than after it has satisfied itself that the donor is considered to be medically eligible and has been examined for the factors mentioned in Article 18, third paragraph, of the Organ Donation Act , in particular, that blood or body material from the donor has been examined for the presence of overbearing pathogens and other relevant aspects.
2 The system of organs is further removed from the fact that the condition of the material in question is in accordance with the requirements of the last state of science, with particular reference to the necessary agreement. between the characteristics of the material and the characteristics of the recipient of the implantation, as well as to the prevention of diseases.
3 The rules of our Minister may lay down detailed rules on the criteria to be applied pursuant to paragraph 1 and the laboratory tests to be carried out.
This paragraph does not apply to organs.
1 The acquisition and testing of bodily material is carried out by persons with sound training and experience.
2 The acquisition and testing of bodily material complies with the technical requirements of the EU Directive on the acquisition of bodily material, laboratory tests required for donors and procedures for the use of human body material; for the acquisition of bodily material and reception in the tissue establishment.
3 The rules of our Minister may lay down detailed rules on the acquisition and testing of bodily material.
1 The work related to the acquisition of bodily material shall be conducted in such a way that donors are assessed and selected in accordance with the technical requirements of the EU Directive on tissues and cells. selection criteria for donors of body material and on laboratory tests required for donors and that the body material is obtained, packaged and transported in accordance with the technical requirements of the EU Directive requirements for the procurement of bodily material and reception in the tissue establishment.
2 In the case of autologous donation, compliance with the fitness requirements shall be determined in accordance with the technical requirements for selection criteria for donor to body material pursuant to the EU Directive on tissues and cells.
3 The results of the donor assessment and the tests carried out shall be recorded and any dissenting findings notified in accordance with the Annex to the EU Directive on tissues and cells.
1 In a procurement organisation, medical activities including the selection and evaluation of donors shall be made on the advice and under the guidance of a doctor.
2 Live donors are selected on the basis of their health and medical fitness by a doctor trained to do so.
1 The organ centre keeps a list of living donors.
2 The doctor responsible for the medical supervision of the donor who has donated a body upon life shall be responsible for following this donor after the donation has taken place.
The tissue establishment shall ensure that all donations of bodily material are tested for laboratory testing required for donors in accordance with the requirements of the EU Directive on tissues and cells and that The selection and acceptance of body material shall be complied with in the technical requirements laid down in the EU Directive on the procurement of bodily material and on reception in a tissue establishment.
2 The tissue establishment shall ensure that the body material and its associated documentation comply with the technical requirements laid down in the EU Directive on the procurement of bodily material and reception of bodily fluids; A tissue establishment.
3 The tissue establishment verifies that the packaging of the human body material received complies with the technical requirements laid down in the EU Directive on the procurement of bodily material and the reception of A tissue establishment and nots this. Any material material received that does not comply with those requirements shall not be used for medical purposes on humans, except where such material is so unique that the immediate application of the material may be life-saving.
4 The acceptance or disapproval of the received body material shall be recorded in writing.
5 The tissue establishment ensures that body material is always correctly identified. Each delivery or batch of body material will be given an identification code, according to Article 4.2 .
6 Body material shall be quarantined until at least the requirements for the examination and information of the donor are satisfied according to Chapter 3 .
7 The tissue establishment receives and only stores body material tested by a laboratory authorised to do so by reason of: Article 12 of the Act .
1 The tissue establishment shall assign a unique identification code to each donation and to each related product.
2 If the body material has been presented to the tissue establishment by the organ centre, the tissue establishment shall be taken from the identification code assigned to the material by the organ centre.
3 The tissue establishment shall address its administration so as to be able to become obsolete with respect to any bodily material presented to it, using the identification code:
a. The personal data relevant to the use of the body material of the person from whom the material originates;
b. the institution where the material has been made available;
(c) the date and time of the publication of the material;
d. the date on which the tissue establishment has received the material;
(e) where applicable, the destination for which the person from whom the material originates has granted or made available for the purposes of any legislation;
f. the characteristics and characteristics of the material and the purposes for which, where applicable, it is appropriate to take account of the authorisation or the provision of such equipment;
g. any operations that the material has undergone;
h. substances and materials used in the transport, storage or processing, the supplier and the batch number;
the necessary instructions for the storage and use;
(j) the period of durability;
k. any side effects when used;
l. the name and address of the institution to which the body material has been transferred.
4 The tissue establishment shall keep the data referred to in paragraphs 1 and 3 at least 30 years after the last use of the material in question.
1 Body material present in a tissue establishment is identifiable at all times.
2 During storage, any body material on the packaging or on a label attached to it shall, in any case, bear the identification code provided for in the chapeau of Article 4.2, first paragraph , as well as the technical data referred to in the EU Directive, or a reference to that information on the procedure for the acquisition of bodily material and its receipt in a tissue establishment and the processing, storage and distribution of bodily material.
1 The tissue establishment designates a person who in any case:
a. The holder of a diploma, certificate or other evidence of conclusion of a university course in the field of medicine or biology, or of a course of training recognised by our Minister as being of an equivalent degree;
b. has two years of practical experience in the relevant fields.
2 The person referred to in paragraph 1 shall be without prejudice Article 19 of the Act responsible for that:
a. Our Minister the for Article 9 of the Act receive the necessary information; and
b. The tissue establishment shall act in accordance with this Decision.
The tissue establishment inform our Minister of the name of the responsible person referred to in the first paragraph. In the case of permanent or temporary replacement of the person responsible, the tissue establishment inform our Minister immediately of the name of the new responsible person and the date of his entry into function.
1 The staff of the tissue establishment directly involved in the work for which the tissue establishment has been approved is, inter alia, knowledge and experience, suitable for the work to be carried out and has training which complies with the technical rules on training laid down in the EU Directive on tissues and cells.
2 The work and responsibilities to be carried out within the tissue establishment shall be documented in the form of written descriptions.
1 The tissue establishment shall maintain a quality system which shall in any case include the following documentation:
-standard practice rules;
-guidelines;
-handbooks and manuals;
-reporting forms;
-donor files,
-information on the final destination of the body material.
2 By way of derogation from the first paragraph, the quality system shall not be required to include any donor files, where use is made of donor files made available by the organ centre for consultation when applying to Article 18, 2nd paragraph, of the Organ Donation Act .
3 The tissue establishment shall keep the documentation available for the officials responsible for monitoring compliance with this Decision.
4 The quality system complies with the technical requirements laid down in the EU Directive on the quality system and specifications laid down in the EU Directive.
1 The tissue establishment shall ensure that all body material storage procedures are described in standard practice requirements and that the storage conditions comply with the technical requirements of the EU Directive on tissues and cells. requirements relating to the processing, preservation and distribution of bodily material.
2 The tissue establishment shall ensure that all storage procedures are controlled under controlled conditions.
3 The tissue establishment shall establish procedures for checking the packaging and storage spaces and apply those procedures in order to ensure that any condition adversely affecting the functionality or integrity of the body material is to prevent.
4 The tissue establishment shall have agreements and procedures which ensure that in the event of termination, whatever reason, the body material stored there is transferred in accordance with the relevant provisions permission, to one or more other tissue establishments that have been approved for that.
1 The tissue establishment shall include in its standard practice rules all operations that affect quality and safety and ensure that these are carried out under controlled conditions. The tissue establishment ensures that the equipment used, the environment, the process design, the validation and the control conditions are in accordance with the technical requirements of the EU Directive on tissues and cells. Preparation techniques for body material and the processing, preservation and distribution of body material.
2 Any amendments to the processes applied for processing the body material shall also comply with the criteria referred to in paragraph 1.
In its standard practice rules, the tissue establishment has special rules for handling body material to be discharged in order to prevent contamination of other bodily material, the operating environment and personnel.
1 When an action must take place outside the tissue establishment and that act affects the quality and safety of the body material, the tissue establishment shall conclude a written agreement with a third party, particularly in the following:
a. When the tissue establishment transfers responsibility to a third party for part of the operation of bodily material;
b. where a third party supplies goods and services which have an impact on the quality and safety of the body material, including its distribution;
c. When a tissue establishment provides services to an approved tissue establishment;
d. When a tissue establishment distributes body material processed by third parties.
2 The tissue establishment shall evaluate and select third parties on the basis of their ability to meet the requirements set out in or pursuant to this Decision.
The tissue establishment shall keep a complete list of the agreements referred to in paragraph 1 which it has concluded with third parties.
4 In the agreement between a tissue establishment and a third party, the responsibilities of the third party and the procedures to be followed are specified in detail.
5 The tissue establishment provides the following Article 19 of the Act Upon request, a copy of the agreements with third parties shall be made by means of supervision of compliance with the law.
1 The tissue establishment shall maintain a register of its activities, providing information on the type and amount of bodily material obtained, tested, preserved, processed, preserved, distributed or otherwise used, and on the basis of origin and the intended use of the body material intended for human use. This register shall comply with the technical requirements laid down in the EU Directive on the procedure for obtaining bodily material and receiving it in the tissue establishment.
2 The tissue establishment gives our Minister an annual report of the work referred to in the first paragraph.
1 No distribution of processed body material shall be carried out as long as all the requirements of this Decision are not met.
The tissue establishment does not transfer body material for the benefit of humans after the end of the period during which, according to the last state of scientific knowledge, the intended function of the material is retained.
1 The tissue establishment except where that body material is unique to the extent that the immediate application can be life-saving approved for the distribution of bodily material, shall ensure the transport and delivery conditions of the tissue establishment. ensure safety and the quality of the body material.
2 In the case of transport and delivery, the technical requirements laid down in the EU Directive on the distribution of bodily material shall be complied with.
3 The tissue establishment referred to in paragraph 1 shall, when transferring bodily material to third parties, comply, where appropriate, to the destination for which permission has been granted in accordance with any provisions of law or to be available. ed.
In the case of an exchange of a body with another Member State of the European Union, the system organ centre shall submit to that Member State the information required for the traceability of organs, in accordance with the procedure set out in, pursuant to the EU Directive. Organ Transplantation adopted implementing rules on the exchange of information necessary to ensure the traceability of organs.
In the case of an exchange of a body with another Member State of the European Union, the Agency shall ensure that the information on organ and donor characterisation, as set out in the Annex to the EU Directive on organ transplants, is addressed to: the other Member State with which the body is to be exchanged shall be transmitted in accordance with the procedure laid down in implementing rules for the transfer of this information adopted under the EU Organ Transplantation Directive.
The transport of an organ shall be carried out in accordance with the rules laid down in the EU Organ Transplantation Directive on the transport of organs.
The presence of body material in anticipation of use shall be carried out in such a way that the safety and quality of the material are preserved.
The institution may destroy the body material delivered to it for use in humans but not used for it, under notification to the authority which delivered it or to that authority. back.
1 An obtained organ and the donor to whom the organ originates shall be characterised before transplantation through the collection of the information set out in the Annex to the EU Organ Transplantation Directive.
2 The information set out in Section A of the Annex referred to in the first paragraph shall include the data set which must be collected for each donation at least. The information listed in Part B of the Annex referred to in the first paragraph shall cover additional data to be collected in addition to the necessary medical grounds, taking into account the availability of such information. and the particular circumstances of the case in question.
3 Without prejudice to the first and second paragraphs, an organ may also be eligible for transplantation if not all of the particulars listed in Part A of the Annex referred to in the first paragraph which must be collected at least, available if, in a particular case, a risk-benefit analysis indicates that the expected benefits for the recipient outweVed the risk of incomplete data.
4 The tests required for the characterisation referred to in paragraph 1 shall be carried out at a labaratory which has the power to Article 12 of the Act permit the use of the said authorisation and operating procedures to ensure that the information on the characterisation referred to in the first paragraph reaches the transplantation centre in a timely manner.
1 The doctor responsible for the medical supervision of a donor who is a body donating to life shall endeavour to obtain from the living donor any necessary information relevant to understanding the consequences of a donor. donation.
2 In the case of donation after death, the doctor, who was responsible for the medical care of the person concerned, is working to obtain all the information necessary to understand the consequences of transplantation, in order to obtain information from the survivors of the deceased or of other persons.
3 The doctor referred to in paragraphs 1 and 2 shall make the information requested by information aware of the importance of the rapid transfer of the requested information.
1 The institution where body material has been applied to humans shall record the following:
a. The identification code specified in the First paragraph of Article 4.2 ;
b. The type of material;
c. the origin of the material;
d. the personal data of the person on whom the material has been applied;
e. the date and time of application.
2 The institution shall keep the information referred to in paragraph 1 at least 30 years.
3 The rules of our Minister may lay down detailed rules as to how and the form in which the data are to be recorded.
Any person using body material shall pass on all relevant information to the organ system or tissue establishment, from which the material comes, in order to facilitate traceability and improve the quality assurance and the quality of the material. to ensure safety.
A transplant centre complies with the requirements of the EU Organ Transplant Directive.
1 The organ centre, the tissue establishment and the physician responsible for the medical supervision of a patient who has received an organ shall ensure the systematic reporting, examination, registration and transmission of relevant, necessary data on serious adverse events and adverse reactions that may affect the quality and safety of body material or of organs and which may be due to the acquisition, testing, characterisation, Processing, storage, preservation, distribution and transport of body material, or -organs, and on serious adverse reactions identified during or after clinical application or after transplantation, with the quality and safety of bodily organs or organs or the transplantation activities May be related.
2 The in Article 4.4, first paragraph , the person referred to above shall ensure that serious adverse events and adverse reactions are reported to the following: Article 19 of the Act an official responsible for monitoring compliance with that law, and that an analytical report on the causes and effects of such an assessment shall be submitted to that official.
The tissue establishment shall provide an accurate, rapid and verifiable procedure for the distribution of products which may cause serious adverse events or adverse reactions to them.
The doctor responsible for the medical supervision of the donor who has donated to life an organ or a patient received an organ and the organ centre shall provide systematic identification, reporting and management of:
a. Occurrence likely to be related to the quality and safety of the organ of life and, therefore, to the safety of the recipient; and
b. Serious adverse reactions in the donor who has donated a body for life and who may be the result of the donation.
In the case of an exchange of a body with another Member State of the European Union, the system organ shall ensure that serious adverse events and adverse reactions are reported in accordance with the procedure laid down in Annex I to the EU Directive. Organ Transplantation adopted implementing rules on the notification of serious adverse events and adverse reactions.
1 Organ and tissue settings ensure that the data collected under this Decision that can be accessed by third parties, including genetic information, are anonymized so that the donor and the recipient can be identified. no longer to be identified. To that end, they shall:
a. Data security measures and guarantees against unauthorised addition, deletion or alteration of donor or exclusion registers, as well as against transmission of information;
b. Procedures for the resolution of discrepancies between the data;
c. The prevention of unauthorised disclosure of information, but the donations must remain traceable.
2 The identity of the recipient of bodily material shall not be disclosed to the donor or to his family, and vice versa.
Our Minister may designate standards, in fulfilment of which organ centres, tissue establishments, or in Chapter 7 the said institutions shall be presumed to comply with the requirements set out in this Decision.
The Body material Eisendecision shall be withdrawn.
This Decision shall enter into force on a date to be determined by Royal Decree.
This decision is cited as: Eisendecision of body material 2006.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 17 January 2007
Beatrix
The Minister for Health, Welfare and Sport
,J. F. Hoogervorst
Published the fifteenth of February 2007The Minister of Justice
E. M. H. Hirsch Ballin
