Decision of 17 January 2007, laying down new requirements for the safety and quality of body material (requirements decision body material 2006) we Beatrix, by the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the proposal of the Minister of health, welfare and Sport by 16 August 2006, characteristic GMT/MVG 2698800;
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (Oj L 102,), as well as on article 8 of the law safety and quality body material and article 18, paragraph 3, of the law on organ donation;
The State Council heard (opinion of 22 september 2006, number W 13.06.0351/III);
Having regard to the further report of our Minister of health, welfare and Sport of 11 January 2007, GMT/MVG attribute 2727986;
Have goedgevonden and mean: Chapter 1. General article 1.1 1 In this decision and the provisions based thereupon, the following definitions shall apply: a. law: the law safety and quality body material;
b. donation: donating body material or of organs for transplantation;
c. quarantine: the status of retrieved body material, or tissue that physically or by other effective means is isolated, pending a decision on the release or rejection;
d. serious adverse event: any untoward and as far as the donation of an organ are concerned unexpected occurrence associated with the procurement, testing, processing, storage and distribution of body material or that is located somewhere in the chain from donation to transplantation, and that for a patient transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for for patients or which might result in hospitalisation or morbidity, or as far as it concerns the transplantation of organs the duration of hospitalisation or morbidity;
e. serious adverse reaction: an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of body material or possibly somewhere in the chain from donation to transplantation in the donor or in the recipient associated with any living that is fatal, life-danger, disability or incapacity for work caused or might lead to may result in hospitalisation or prolongs the duration of hospitalization or leads to disease or morbidity;
f. donor characterisation: the collection of the relevant information on the characteristics of the donor needed to assess their suitability for organ donation, in order to undertake a proper risk assessment and the risks for the recipient and to optimise organ allocation;
g. characterization of the organ: the collection of the relevant information on the characteristics of the organ needed to evaluate the suitability of the organ, in order to undertake a proper risk assessment and the risks to the recipient in order to optimise organ allocation;
h. working procedures: written instructions describing the steps in a particular process are described, including the methods and materials to be used and the expected end result.
i. traceability: the ability to the organ at each stage of the chain from donation to transplantation or disposal to locate and identify, including the ability to: – identify the donor and the procurement organisation;
– to identify the recipient in the transplant center;
– all relevant non-personal information relating to the products and materials that come into contact with the organ, to detect and identify.
2 In Chapters 6, 7 and 8 shall be under body material also understood from tissue or cells manufactured products in which no human cells.
Article 1.2 1 an amendment under the EU tissues and cells directive technical requirements is laid down for the application of this decision shall apply with effect from the day on which must be given to the relevant amending Directive implementation.
2 the creation of the under the EU tissues and cells directive technical requirements laid down by the Minister is published in the Government Gazette.
Chapter 2. Organ Center Article 2.1 1 The within the organ Center to be performed and applicable responsibilities are written in job descriptions.
2 The employees are, including level of education, knowledge and experience, suitable for the work to be carried out by them.
Article 2.2 1 the organ Center maintains a quality system.
2 the quality system includes a documentation that in any case a description of the various processes and a record of its progress, including a description of the way in which safeguard measures.
3 at control of our Minister may be set with regard to the establishment of the quality system.
Article 2.3 1 the institution knows at every donation centre a unique identification code to the relevant body material.
2 the organ Centre focuses its administration so that physical material that is assigned through the Centre, using the identification code may be outdated: a. the for the use of the body material relevant personal data of the donor;
b. the institution where the material has come;
c. the date and time of the available of the material;
d., where appropriate, the destination for which the donor in accordance with the law on organ donation consent;
e. the characteristics and properties of the material and the purposes for which the, if appropriate taking into account the consent granted, suitable;
f. the necessary instructions for storage and use;
g. any side effects when using;
h. the substances and materials used in the transport, the supplier and the batch number;
i. the name and address of the institution to which the body material is delivered;
j. the personal data of the person at whose medical treatment the body material is used.
3 the organ Center saves the information referred to in paragraphs 1 and 2 at least 30 years after the allocation.
Article 2.4 the organ Center may only outsource work to third parties by means of a written agreement.
Article 2.5 1 the organ Center points in accordance with the law on organ donation logged body material not then after it has satisfied itself that the donor as such medical qualify and is examined with a view to the factors, referred to in article 18, paragraph 3, of the law on organ donation, in particular that blood or body material of the donor is tested for the presence of infectious-pathogens and on other relevant aspects.
2 the organ Center shall satisfy itself, moreover, that the condition of the material concerned is in compliance with the applicable requirements according to the latest state of scientific knowledge, with particular attention to the necessary agreement between the characteristics of the material and the relevant characteristics for the implantation of the receiver, as well as to the prevention of diseases.
3 at control of our Minister can be made on the detailed rules for implementation of the first member criteria and perform laboratory tests.
Chapter 3. Procurement and testing § 1. Procurement and testing of body material article 3.1 this paragraph does not apply to organs.
Article 3.2 1 obtaining and testing body material is carried out by persons with appropriate training and experience.
2 obtaining and testing body material meets the under the EU tissues and cells directive asked technical rules on obtaining body material, the laboratory tests required for donors and the procedures for the procurement of body material and reception at the tissue establishment.
3 at control of our Minister can further rules concerning the acquisition and testing of body material.
Article 3.3 1 the work associated with the procurement of body material be carried out in such a way that donors evaluation and selection is carried out in accordance with the under the EU tissues and cells directive asked technical rules concerning selection criteria for donors of body material and relating to donors laboratorumtesten and required that the body material is procured, packaged and transported in accordance with the under the EU tissues and cells directive asked technical requirements relating to the purchase of the body material and reception at the tissue establishment.
2 In the case of an autologous donation, the suitability in accordance with the requirements under the EU tissues and cells directive asked technical rules concerning selection criteria for donors of body material.
3 the results of the donor evaluation and testing procedures shall be documented and any major anomalies shall be reported in accordance with the annex to the EU tissues and cells directive.
§ 2. Obtain organs Article 3.4
1 In a procurement organisation are medical activities including the selection and evaluation of donors carried out on the advice and under the direction of a physician.
2 living donors are selected on the basis of their health and fitness by a medical doctor who is trained.
Article 3.5 1 the organ Center maintains a list of living donors.
2 the doctor responsible for the medical management of the donor who has donated an organ in life, assume the following this donor after the donation has been made.
Chapter 4. Receive and store Article 4.1 1 tissue establishments shall ensure that each donation of body material in accordance with the under the EU tissues and cells directive asked technical rules on laboratory tests required for donors be tested and that the selection and acceptance of body material compliance under the EU tissues and cells directive asked technical requirements relating to the purchase of the body material and the receipt in a tissue establishment.
2 tissue establishments shall ensure that the body material and associated documentation comply with the under the EU tissues and cells directive asked technical requirements relating to the purchase of the body material and the receipt in a tissue establishment.
3 the tissue establishment verifies that the package of receiving human body material meets the under the EU tissues and cells directive asked technical requirements relating to the purchase of the body material and the receipt in a tissue establishment and make a note of this. Retrieved body material that does not meet those requirements is not used for medical human application, except if that body material so unique is that immediate application can be life-saving.
4 the acceptance or rejection of the body material is received in writing.
5 tissue establishments shall ensure that body material always correct is identified. Each delivery or batch of body material gets an identifying code, in accordance with article 4.2.
6 body material is held in quarantine until at least the requirements relating to donor research and information have been met in accordance with Chapter 3.
7 the tissue establishment receives only body material that is tested by a laboratory which is authorized to do so pursuant to article 12 of the law.
Article 4.2 1 knows The tissue establishment to each donation and to each related product a unique identification code.
(2) if the body material by mediation of the organ Center at the tissue establishment is offered, the tissue establishment by the institution from the Centre to the material identification code.
3 the tissue establishment shall address its administration so that physical material that is offered to her, using the identification code may be outdated: a. the for the use of the body material relevant personal data of the person from whom the material was derived;
b. the institution where the material has come;
c. the date and time of the available of the material;
(d) the date on which the institution has received the material tissue;
e., where appropriate, the destination for which the person from whom the material originates, has granted in accordance with any legislation or made it available;
f. the characteristics and properties of the material and the purposes for which the, if appropriate taking into account the granted permission or posting, suitable;
g. any operations that the material has undergone;
h. transport, store or edit the used substances and materials, the supplier and the batch number;
i. the necessary instructions for storage and use;
j. the term of shelf life;
k. any side effects when using;
l. the name and address of the institution to which the body material is transferred.
4 the tissue establishment shall keep the information referred to in the first and third paragraph at least 30 years after the last use of the relevant material.
Article 4.3 1 body material that is present in a tissue establishment, is identifiable at all times.
2 during storage is body material on the packaging or on a label inextricably bound up in any case with the identification code referred to in the chapeau of article 4, paragraph 1, as well as in the tissues and cells referred to EU directive technical specifications or a reference to that data on the procedure for the procurement of body material and the receipt in a tissue establishment and operation , storage and distribution of body material.
Article 4.4 1 the tissue establishment shall designate a person who in any case: a. holds a diploma, certificate or other evidence of completion of a university course of training in the field of medicine or biology, or a training course recognised as equivalent by the Minister;
b. two years of practical experience in the relevant fields.
2 The person referred to in the first paragraph is without prejudice to article 19 of the law responsible for: a. the Minister the required information for article 9 of the law, and (b). the tissue establishment shall act in accordance with this decision.
3 the Te shares our Minister the name of the responsible person referred to in the first paragraph. The responsible person is permanently or temporarily replaced, the tissue establishment shall notify the Minister immediately the name of the new responsible person and the date of the duties of that person commence.
Article 4.5 1 staff at the tissue establishment that is directly involved in the work for which the tissue establishment has received, including knowledge and experience, suitable for the work to be carried out and has received training that meets the under the EU tissues and cells directive asked technical rules on training.
2 The work to be carried out within the tissue establishment and applicable responsibilities are written in job descriptions.
Article 4.6 1 the tissue establishment maintains a quality system that includes at least the following documentation: – standard operating procedures;
– training and reference manuals;
– reporting forms;
– donor files;
-information on the final destination of the body material.
2 by way of derogation from the first paragraph needs no donor files to the quality system provided that use is made of donor files that are made available by the institution Centre for consultation in application of article 18, paragraph 2, of the law on organ donation.
3 the tissue establishment keeps the documentation available for the enforcement of this decision with officials.
4 the quality system meets the under the EU tissues and cells directive asked technical requirements relating to a quality system standards and specifications.
Article 4.7 1 tissue establishments shall ensure that all procedures associated with the storage of body material are documented in the standard operating procedures and that the storage conditions comply with the under the EU tissues and cells directive asked technical rules on the processing, storage and distribution of body material.
2 tissue establishments shall ensure that all storage processes are carried out under controlled conditions.
3 the tissue establishment shall establish procedures for the control of packaging and storage areas and applies those procedures, in order to prevent any circumstance that the functionality or integrity of the body material might adversely affect.
4 the tissue establishment has agreements and procedures that ensure that in the event of cessation, regardless of the reason for that, it there preserved body material is transferred in accordance with the relevant permission, to one or more other tissue establishments which have been recognized.
Chapter 5. Edit Article 5.1 1 tissue establishments shall include in their standard operating procedures all processes that affect quality and safety and ensures that these are carried out under controlled conditions. Tissue establishments shall ensure that the equipment used, the working environment, process design, validation and control conditions are in compliance with the requirements under the EU tissues and cells directive asked technical rules on the preparation processes for body material and the processing, storage and distribution of body material.
2 all changes to the processes used for operation of the body material meet also meet the criteria referred to in the first paragraph.
3 tissue establishments shall include in their standard operating procedures special rules for the use of body material to be discarded, in order to prevent the contamination of other body material, the processing environment or personnel.
Article 5.2 1 When an act outside the tissue establishment must takes place which influences the quality and safety of the body material, connect the tissue establishment a written agreement with a third party, in particular in the following circumstances: a. when the tissue establishment the responsibility for part of the operation of body material to a third party;
b. when a third party provides goods and services that affect quality and safety assurance of the body material, including the distribution;
c. where a tissue establishment provides services to a non-certified tissue establishment;
d where a tissue establishment distributes modified body material by third parties.
2 tissue establishments shall evaluate and select third parties on the basis of their ability to meet the requirements, laid down in or under this decision.
3 the tissue establishment shall keep a complete list of the agreements referred to in the first paragraph it has concluded with third parties.
4 agreements between tissue establishments and third parties shall specify the responsibilities of the third parties and detailed procedures.
5 the tissue establishment provides pursuant to article 19 of the law with supervising compliance with the law officer on request copies of agreements with third parties.
Article 5.3 1 the tissue establishment shall keep a register of its activities, including the type and quantity of body material that is procured, tested, preserved, processed, stored, distributed or otherwise used, as well as on the origin and destination of body material intended for human application. This register complies with the under the EU tissues and cells directive asked technical regulations on the procedure for the procurement of body material and reception at the tissue establishment.
2 the tissue establishment provides the Minister an annual report on the activities referred to in paragraph 1.
Chapter 6. Distribution Article 6.1 1 there will be no distribution of modified body material place as long as not all the requirements of this decision are met.
2 the tissue establishment carries body material do not have for human application after the end of the period during which according to the latest state of scientific knowledge the intended function of the material is maintained.
Article 6.2 1 the tissue establishment except if that body material so unique is that immediate application can be recognised lifesaving for the distribution of body material, takes care of transport and delivery conditions that the safety and quality of the body material.
2 to the transportation and delivery are the under the EU tissues and cells directive asked technical rules on the distribution of body material taken into account.
3 The tissue establishments shall include referred to in the first paragraph when transferring body material to third parties, where appropriate, the destination in eight for which permission has been granted in accordance with any legislation or it was made available.
Article 6.3 in case of exchange of an organ with a Member State of the European Union organ Center to this Member State consults for the traceability of organs required information included in accordance with the procedure laid down under the EU directive on organ transplantation implementing provisions on the exchange of information which is necessary in order to ensure the traceability of organs.
Article 6.4 in case of exchange of an organ with a Member State of the European Union bears the organ Center ensure that in the annex to the EU directive on organ transplantation information listed on the organ and donor characterisation on the other Member State to which the institution is exchanged, is passed in accordance with the procedure set out in under the EU directive on organ transplantation implementing provisions relating to the transfer of this information.
Chapter 6a. Transport Article 6.5 the transport of an organ takes place shall be in conformity with the EU directive organ transplant regulations regarding the transportation of organs.
Chapter 7. Use Article 7.1 the holding keeping body material awaiting use shall be carried out in such a way as to ensure the safety and quality of the material.
Article 7.2 setting can body material that is delivered with a view to human application but is not used, destroying under notification to the authority that issued it to her, or to return the body.
Article 7.2 (a) 1 obtained A body and the donor whose organ before transplant, be characterized by means of collecting the attached at the EU directive organ transplant information listed.
2 in part A of the annex referred to in paragraph 1 information includes the data collection that for every donation at least should be collected. In part B of the annex referred to in paragraph 1 concerns information additional information which in addition should be collected as far as that is necessary on medical grounds, taking into account the availability of such information and the particular circumstances of the case in question.
(3) without prejudice to the provisions of paragraphs 1 and 2, also an organ for transplant can qualify as not all in part A of the annex data referred to in the first paragraph that must at least be collected, available if in a particular case a risk-benefit analysis shows that the expected benefits for the recipient outweighs the risk of incomplete data.
4 The testing required for the characterization referred to in the first paragraph shall take place in a laboratory that has the authorization referred to in article 12 of the law and that such work procedures which ensure that the information on the characterization referred to in the first paragraph the transplantation Centre in a timely manner.
Article 7.2 (b) 1 the doctor responsible for the medical supervision of a donor who donates an organ in life, is committed to the living donor to obtain all the necessary information that is important to understand the consequences of donation.
2 At donation after death, the doctor, who was responsible for the medical supervision of the person concerned for death, all information which is necessary to understand the effects of transplantation, from the relatives of the deceased or to other people.
3 The Member referred to in the first and second doctor makes the requested people attentive to the importance of rapid transfer of the requested information.
Article 7.3 1 the institution where body material is applied to the man, made the following information: a. the identification code referred to in the chapeau of article 4.2, paragraph 1;
(b) the kind of the material;
(c) the origin of the material;
d. the personal data of the person to whom the material is applied;
e. the date and time of the application.
2 the institution preserves the data referred to in the first paragraph at least 30 years.
3 at settlement of the Minister may be asked about the manner in which and the form in which the information is recorded.
Article 7.4 every one who uses body material, gives all the relevant information to the institution Centre or the tissue establishment, from which the material originates, in order to facilitate traceability and ensure quality and safety control.
Article 7.5 a transplant center to meet the requirements of the EU directive on organ transplantation.
Chapter 8. Serious adverse events and reactions Article 8.1 1 the organ Center, the tissue establishment and the doctor responsible for the medical supervision of a patient who has received an organ, responsible for systematically reporting, investigate, register and transmit relevant and necessary data on serious adverse events and reactions which may influence the quality and safety of body material or bodies that may be due to getting , testing, characterisation, processing, storage, preservation, distribution and transportation of body material or bodies, and about serious adverse side effects during or after clinical application or after transplantation be established and that the quality and safety of body material or with the transplant of organs or activities may be related.
2 The person referred to in article 4, paragraph 1, ensures that serious adverse events and reactions shall be reported to the pursuant to article 19 of the law with supervising compliance with that law officer, as well as that to this official an analytical report on the causes and consequences.
3. the tissue establishment shall ensure that an accurate, rapid and verifiable procedure on the basis of which it products with which serious adverse events or side effects related, from the distribution.
Article 8.2 the doctor responsible for the medical management of the donor who in life has donated an organ or of a patient who has received an organ and the organ Center shall ensure systematic identification, reporting and management of: a. events that may be related to the quality and safety of the donated organ in life and, consequently, the safety of the recipient; and b. serious adverse donor who has donated an organ in life and that may be the result of the donation.
In case of exchange of an organ with a Member State of the European Union bears the organ Center ensure that serious adverse events and reactions shall be reported according to the procedure that is included in under the EU directive on organ transplantation implementing provisions on the notification of serious adverse events and reactions.
Chapter 9. Data protection and confidentiality Article 9.1 1 the organ Center and tissue establishments shall ensure that in the framework of this decision and to which third parties have collected data, including genetic information, kept anonymous so that the donor and the recipient remain identifiable. To this end, they provide for: a. data security measures and safeguards against unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information;
b. procedures for resolving data discrepancies;
c. preventing unauthorised disclosure of information, which the traceability of donations.
2 the identity of the recipient of body material is not disclosed to the donor or his family and vice versa.
Chapter 10. Standards article 10.1 Our Minister may designate, in meeting standards to which the organ centers, tissue establishments or institutions referred to in chapters 7 be presumed to comply with the requirements laid down in this decision.
Chapter 11. Final provisions article 11.1 Requirements decision body material is hereby repealed.
Article 11.2 this decision shall enter into force at a time determined by Royal Decree.
Article 11.3 this decision is cited as: requirements decision body material 2006.
Charges and recommended that this decision with the corresponding note of explanation in the Official Gazette will be placed.
The Hague, January 17, 2007 Beatrix the Minister of health, welfare and Sport, j. f. Hamilton Published the 15th February 2007 the Minister of Justice e. m. h. Hirsch Ballin