Rs 810.211 Order Of 16 March 2007 On The Transplantation Of Organs, Tissues And Cells Of Human Origin (Ordinance On Transplantation)

Original Language Title: RS 810.211 Ordonnance du 16 mars 2007 sur la transplantation d’organes, de tissus et de cellules d’origine humaine (Ordonnance sur la transplantation)

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810.211 order on the transplantation of organs, tissues and cells of human origin (the Transplant Ordinance) of March 16, 2007 (Status January 1, 2014) the Swiss federal Council, view the art. 2, al. 3, 8, al. 8, 9, al. 2, 10, al. 3, 14, al. 4, 15, 24, al. 2, 25, al. 4, 26, 29, al. 2, 30, al. 3, 31, al. 2 and 3, 36, al. 3, 42, 50, al. 2, 54, 59, al. 6, and 60, al. 1, of the Act of 8 October 2004 on transplantation (transplantation act), stop: Chapter 1 object, scope and definitions article 1 scope and field of application this rule order: a. the use of organs, tissues and cells of human origin, including: 1. their removal on deceased or living persons, 2... 3. transplantation of tissues or cells from embryos or fetuses;

b. tasks of the cantons in terms of organisation and coordination; c. the tasks related to the keeping of the register of stem cells.

The use of organs, tissues or cells for autogenous transplantation is governed: a. by the art. 2, 19, 26, 37-44, 48, 49 and 56; (b) in addition, by the art. 13, 14, al. 2 and 3, and by art. 15A when the organs, tissues or cells are prepared prior to the transplant.

This order does not apply to the use of transplant. The use of organs, tissues or cells used in the manufacture of Autogenous transplant is governed by art. 48 and 49; the use of organs, tissues or cells used in the manufacture of alien transplant is governed also by the art. 3 to 12.

Repealed by section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).
New content according to section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
New content according to section I of the Sept. 10 O. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Art. 2definitions in the sense of the Ordinance, means: a. use: any activity involving the use of organs, tissues or cells, including their collection, the fact of submitting them to a test, their preparation, their import, export, storage and their transplant; b. preparation: any activity to prepare organs, tissues or cells for subsequent transplantation without changing their physiological properties and their functions; preparation means including culture.

In addition, the definitions given in art. 2 the order of September 20, 2013, on clinical trials are applicable.

New content according to section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
RS 810.305 Chapter 2 of organs, tissues or cells on deceased individuals Section 1 Participation of relatives or people you trust in the decision-making process art. 3 relatives are deemed close according to art. 8, al. 8, of the law on transplantation: a. the spouse, partner or the person having conducted fact a married life with the deceased person; b. children, parents, brothers and sisters; c. the grandparents and the grandchildren; d. others who had close links with the deceased.

Art. 4 absence of documents certifying the consent or refusal in the absence of documents certifying the consent or the refusal of the deceased person, is asked at least one of the relatives if he has knowledge of a statement of gift made by the deceased person or he may designate another person having knowledge of such a statement.
If several family members are consulted and that the statements they know are divergent, the latest statement is considered to be crucial.
People under 16 years can also report of a statement of gift made by the deceased.

Art. 5 decision of the relatives is empowered to take the decision the more close to 16 years who had the closest connection with the deceased. The applicant establishes that by interviewing relatives.
The applicant can admit, provided no evidence to think otherwise, in the following order were most closely related to the deceased so they have had personal contact with her until his death: a. the spouse, partner or the person having conducted fact life as a couple with the deceased person; b. children; c. parents , the brothers and sisters; d. the grandparents and grandchildren; e. others who had close links with the deceased.

If there are several relatives within the meaning of para. 1, the levy is allowed if: a. all reachable within a reasonable people give their agreement; and sib. no opposition on the part of the close not reachable is known.

Art. 6 person any person over 16 years of age is entitled to appoint a person of confidence under art. 8, al. 6, of the law on transplantation.
If the deceased person has designated several trusted people, sampling is allowed if: a. all reachable within a reasonable people give their agreement; and sib. no opposition on the part of the people you trust not reachable is known.

Section 2 finding of death and preliminary medical measures art. 7 determination of death the death must be determined in accordance with the directives referred to in annex 1, Chapter 1.

Art. 8 duration of preliminary medical measures preliminary medical measures taken under art. 10, al. 3, of the law on transplantation should not last more than 72 hours after the death of the patient.

Chapter 3 removal of organs, tissues or cells on living persons art. 9 information of the living donor responsible physicians of the removal of organs, tissues or cells must provide the potential donor of comprehensive and understandable information, orally and in writing, prior to the withdrawal.
They inform him including: a. purpose and conduct of preliminary examinations and intervention; (b) the fact that the donation must be voluntary and free and that it is punishable if it is made for consideration; c. short-term and long-term risk that the gift may be for the health of the donor; d. of the probable duration of hospitalization and the extent of the inability to work or other constraints which may be imposed; e. the need for the donor to undergo regular health screenings; f. the obligation, for the transplant center, to keep track of the State of health of the donor; g insurance under art. 11 and the reimbursement of expenses under art. 12; h. principles of treatment data; i. the right to oppose the gift without having to explain its refusal or revoke consent without any conditions to form; j. of the psychological consequences that the gift from a living donor may have on the latter and the possibility to benefit from psychological support; k. benefits of transplantation disadvantages that it can present and possible other options, therapies that are available to the recipient.

They give him time to consider reasonable to decide if it gives its consent or not.
They document the information process and retain the records for ten years.

Art. 10 audit of the voluntary character and free of the gift made by a living person of organs, tissues or cells can be taken from a living person unless an independent specialist with the experience necessary for such verification, ensured that the donor has freely consented to the gift and that this one is free.
The specialist must document verification and keep the records for ten years, separately from the medical record.
If a potential living donor is excluded from the don, he has the right to request a second opinion.

Art. 11 insurance anyone levies organs, tissues or cells from a living person must ensure that a contract of insurance within the meaning of the law of 2 April 1908 on insurance contract concluded for that person for death and disability risks associated with sampling and for a period of at least twelve months from the date of the withdrawal.
In case of death, the insurance amounts to 250 000 francs. The right to provide returns to the survivors.
The amount to be insured for a possible disability is 250 000 francs. The insurance benefit is calculated according to the provisions on the assessment of compensation for breach of integrity set out in Schedule 3 of the Ordinance of 20 December 1982 on accident insurance.

RS 221.229.1 RS 832.202 art. 12 compensation for costs are considered to be other costs to be repaid under art. 14, al. 2, let. b, of the law on transplantation all fees attested that the removal of organs, tissues or cells causes to the donor, in particular:

a. travel; b. expenses related to verification of the ability of the donor; c. the costs arising from the follow-up to life of the State of health of the donor in accordance with art. 16, let. e ch. 2; d. costs committed to paying officials to appeal, including the donor household aid or the aid necessary for the support of people.

Chapter 4 use of organs, tissues and cells Section 1 provisions general art. 13 quality assurance anyone using organs, tissues or cells must have a system for quality control in accordance with Annex 2, ch. 1.

Art. 14 international regulations all activities between the time the body is taken and the moment that precedes the transplant are governed by Annex 2, no. 2.
All activities in connection with the collection, preparation and storage of tissues or cells, with the exception of hematopoietic stem cells, are governed by Annex 2, Chapter 3, and by the rules of good manufacturing practices (GMP) referred to in annex 3.
The use of hematopoietic stem cells is governed by Schedule 4; the responsiveness to the testing procedure is governed by Annex 5, ch. 6.

Section 2 duty to report art. 15 removal of organs, tissues and cells the statement concerning the removal of organs, tissues or cells or transplantation of tissues or cells must be filed no later than the end of April for the past calendar year and indicate: a. the nature and the number of organs or tissue; (b) the nature of the sampled cells and the number of samples of cells c. nature and the number of transplanted tissue; d. la nature of the transplanted cells and the number of cell transplants.

Introduced by the I of O ch. 10 sept. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Art. 15aStockage of hematopoietic stem cells from cord blood for transplantation of Autogenous anyone who wants to store cells from hematopoietic stem of the cord for a transplantation of Autogenous blood, of must declare it to the federal Office of public health (FOPH) before the start of the activity.

Introduced by the I of O ch. 10 sept. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Section 3 plan and conditions for granting of the authorisation art. 16 organ transplantation the transplant organs is authorization if: a. the company has a technical manager with the knowledge and necessary experience, authorized to give instructions in its field of activity and the quality manager; b. medical specialties required in annex 6, point 1, are represented and that necessary medical personnel is available; c. premises, devices and technical equipment are suited to the intervention in question and the State of the science and technique (annex 6, ch. 2); (d) the quality assurance system meets the requirements laid down in annex 2, Chapter 1; e. the quality assurance system also includes a follow-up of the State of health of the living donor to ensure that: 1. the medical and psychosocial data collected before and after the operation will be captured and documented with the consent of the living donor 2. the living donor will be offered throughout his life, at appropriate intervals, 3 health screenings. the results of the reviews will be routinely subjected to a scientific assessment and that they will be made available to all transplant centers, 4. the living donor will be informed and advised if tests results show the need to take certain steps, 5. findings on the impact on health will be integrated in the information provided to the future living donors.

Art. 17 storage of tissue or cells the authorization to store tissues or cells if: a. the company has a technical manager with the knowledge and experience needed, authorized to give instructions in its field of activity and the quality Manager; (b) the quality assurance system meets the requirements laid down in annex 2, Chapter 1.

Art. 18 import and export of tissues or cells and organs whose attribution is not defined according to the art. 16 to 23 of the law on transplantation the authorization to import or export of tissues or cells and bodies whose attribution is not defined according to the art. 16 to 23 of the law on transplantation is issued if: a. the company has a technical manager with the knowledge and experience needed, authorized to give instructions in its field of activity and the quality Manager; (b) the quality assurance system meets the requirements laid down in annex 2, Chapter 1.

Art. 19 use of organs, tissues or cells genetically modified anyone who wishes to deliver to third parties, or transplant, as part of a standard treatment, organs, tissue or genetically modified cells, must be licensed by the FOPH.
The authorization is granted if: a. the company has a technical manager with the knowledge and experience needed, authorized to give instructions in its field of activity and the quality Manager; (b) the quality and biological safety of organs, tissues or cells genetically modified are guaranteed for patients and, in general, for human beings, animals and the environment; c. the federal Office for the environment (FOEN) has consideration of protection of the environment and the indirect protection of human beings, agreed to the standard treatment.

New content according to section I of the Sept. 10 O. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Section 4 Obligations of holders of authorisation art. 20 obligations of transplant centers transplant centers must publish and submit to the FOPH, at the latest at the end of June, the results of the transplants carried out during the previous calendar year.
The results must indicate: a. the nature and the number of transplants and re-transplants so that the rates of re-transplants; b. the survival rate of recipients after one, six and twelve months, then annually; c. survival of the bodies after one, six and twelve months, then annually; d. important information about the effects and side effects of immunosuppressive therapy and the influence of the compatibility of the characteristics of the tissue on the functioning of the body; e. the number of patients who developed cancer after transplantation, the types of cancer involved and the time period between transplant and the appearance of cancer; f. any other given that transplant centers collect from studies or registers national and international as well as assessments are related.

The federal Department of the Interior may: a. set criteria for the reporting and assessment of the results of transplantation; b. provide transplant centers through the FOPH to other data if they are necessary to judge the quality of transplants.

Any transplant center that interrupt temporarily or permanently a transplant program must: a. immediately take the necessary steps so that transplants can be carried out in another centre if the patients concerned so desire; b. inform the patients concerned and the national service of assignments.

New content according to section I of the Sept. 10 O. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Art. 21 obligations of holders of a storage permit the holder of an authorization of storage of tissues or cells must keep a sufficient quantity of appropriate biological samples on donors, so that they can be subjected to the tests required for the two years following the transplant tissue or cells.
It is required to declare the FOPH, at the latest at the end of April, the data for the previous calendar year: a. the nature and number of the fabrics that it has stored; (b) the nature of the cells that he has stored and their dose unit; c. the number of inputs and outputs of fabrics as well as cells in unit doses.

Art. 22 obligations of holders of an authorization to import or export the holder of an authorization to import or export cannot import or export organs, tissues or cells in origin or destination of foreign services who have authorization for the use of cells, tissues or organs in accordance with the legislation of their countries.
It is required to declare the FOPH, at the latest at the end of April, the data for the previous calendar year: a. the nature and the number of tissues or organs that he imported or exported; (b) the nature of the cells he imported or exported and their number in unit doses; (c) the country of origin for imports , and the country of destination for exports.

Section 5 duties of care art. 23 ability to the gift, duty to perform tests and procedure for responsiveness to the tests


The gift ability is assessed by a doctor with the required experience or a person trained in this activity which is placed under the supervision of a doctor.
The assessment of the ability to the gift, the exclusion of the gift, the obligation to perform tests, the tests to be performed, the requirements that must meet tests on tissue or cells, as well as the procedure to follow in case of responsiveness to the tests, are governed by Annex 5.

Art. 24 communication to the donor of the responsiveness to the test reactivity to a test cannot be communicated to the dealer unless it has been previously confirmed by appropriate methods.
This communication must be accompanied by a proposal appropriate advice and follow-up.
The donor may not waive obtain communication of responsiveness to a test only if there is no risk of infection to others.

Art. 25 designation of organs, tissues or organs, tissues or cells genetically modified cells genetically modified must be marked as "genetically modified".

Chapter clinical 5Essais art. 26. the order of September 20, 2013, on clinical trials is applicable to clinical trials for transplantation of organs, tissues or cells of human origin.

SR 810.305 art. 27 to 33 repealed Chapter 6 use of tissues or cells from embryos or fetuses art. 34 conditions of approval relating to the qualifications of staff and operating approval to transplant tissue or cells from embryos or fetuses is issued if: a. the company has a technical manager with the knowledge and experience needed, authorized to give instructions in its field of activity and the quality Manager; (b) the quality assurance system meets the requirements laid down in annex 2 c. 1.

Art. 35 information of the donor, the donor of tissues or embryonic cells or fetal obtained as a result of the termination of pregnancy or spontaneous abortion must receive a doctor specialized in comprehensive and understandable information, notably on: a. the purpose and nature of the use that will be made of tissue or cells; (b) diagnostic tests to which it will be submitted for the purpose of protecting the receiver.

She needs time to consider reasonable to decide if she consents or not.

Art. 36 information to the couple concerned the couple concerned referred to in art. 40 of the law on transplantation must receive a specialized doctor of comprehensive and understandable information, notably on: a. the purpose and nature of the use that will be made of tissue or some cells from supernumerary embryo; b. diagnostic tests that the couple or supernumerary embryo will be submitted for the purpose to protect the receiver.

He needs time to consider reasonable to decide if it gives its consent or not.

Chapter 7 authorization Procedure art. 37 application the application for permission should be addressed to the FOPH.

The application for authorization for the transplant, as part of a standard treatment of organs, tissues or cells genetically modified or for their release to third parties must include: a. a scientific literature outlining the results of clinical trials and pre-clinical tests; (b) data on the risks as organs, tissues or cells are for human beings , animals and the environment, including risk analysis conducted under the order of 25 August 1999 on contained use or under a procedure abroad for confined systems; c. an assessment of the risks associated with transplantation for humans, animals and the environment; d. a description of the security measures necessary for the protection of human beings the animal and the environment, particularly in order to prevent the release of microorganisms in the environment during and after the transplant, during transport, storage and treatment of waste.


The application for authorization for the transplant, as part of a standard treatment, tissue or cells from embryos or foetuses must include: a. a scientific literature outlining the results of clinical trials and pre-clinical reviews; (b) documents and forms making account information provided to the donor or to the couple concerned and their consent.

Repealed by section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).
SR 814.912 new content according to section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
Repealed by section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).

Art. 38 scientific assessment of the application for leave the FOPH can appeal to experts or independent bodies for the scientific assessment of the application for leave.
He informs the competent ethics commission expertise on applications for authorisation of clinical trials.

Art. 39 procedure of consultation the FOPH adjudicates applications for transplantation and delivery to third parties of organs, tissues or cells genetically modified, after collecting the opinion of the FOEN, of the Federal Commission of experts for biosafety (SECB) and the Federal Commission of ethics for biotechnology in the field not human (ECNH).
He shall communicate its decision to the FOEN, the SECB, to members and, in addition, at the competent ethics commission when it comes to clinical trials.

Art. 40 inspection the FOPH is conducting an inspection to determine whether the conditions for approval are met. He may waive an inspection if it is established in a different way that the conditions of the authorization are met.
He may, at any time, carry out additional inspections. It can load the cantons or third parties to carry out inspections.

Art. 41 scope and period of validity of the authorization the authorization is issued on behalf of the applicant; It is not transferable.
Validity period is up to five years.


Repealed by section 1 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).

Art. 42 suspension and withdrawal the FOPH may suspend or withdraw the authorization when: a. the conditions for approval are not or are no longer met; (b) the holder of the authorisation does not respect the obligations assigned; c. new information relating to the safety or scientific basis require it.

Art. 43 publication the FOPH publishes: a. once per year, the identity of the holders of an authorization and a description of the licensed activity; (b) within a period of 30 days, decisions to grant, withdrawal or suspension of a permit and the notice of expiry of authorization.

Art. 44 technical requirements for Federal authorization and reporting the Department of the Interior may issue technical requirements plan authorization and statement and records; It takes into account the relevant international standards.

Chapter 8 Execution Section 1 tasks of the cantons and local coordinators art. 45 definition and guarantee of the procedures the cantons ensure that hospitals with intensive care service including define the following procedures and ensure their running 24 hours a day: a. identification and support of potential donors of organs, tissues or cells and release of their names to the Coordinator local; b. determination of death; (c) information and support for loved ones , request for consent is understood.

They ensure that hospitals with intensive care service communicate the name of the local coordinators to the national service of assignments.

Art. 46 tasks within transplant centers the local coordinator ensures that within the transplant centre the following procedures are correctly engaged and coordinated: communication at the national service of the powers of the name of the patients on the waiting list or remove from this list; b. identification and support of potential organ donors. tissues or cells; c. determination of death; d. information and support for loved ones, the consent request y understood; e. communication to the national service of the responsibilities of the donors name; f. communication to the national service of the powers of the organ transplants; g. notification to banks of tissue and cells of the existence of donors.

He is responsible for quality assurance and control procedures defined in para. 1. it works with the national service awards, other transplant centers, hospitals and banks of tissue and cells.

Art. 47 tasks within hospitals the local coordinator ensures that within the hospital the following procedures are correctly engaged and coordinated:

a. identification and support of potential donors of organs, tissues or cells; b. determination of death; (c) information and support for loved ones, the consent request there included; d. communication at the national service of the donors name assignments; e. notification to banks of tissue and cells of the existence of donors; f. levy.

He is responsible for quality assurance and control procedures defined in para. 1. it works with the national service awards, transplant centers and banks of tissue and cells.

Section 2 Protection of data art. 48 treatment of personal data the bodies responsible for the enforcement of legislation are authorized to process the personal data necessary for the performance of tasks assigned to them by the law on transplantation.
They can transmit non-confidential data to authorities or foreign institutions and international organizations.
The data processing and the rights of individuals who are subject to a processing of data are governed by the Federal law of June 19, 1992, on the protection of the data.

RS 235.1 art. 49 bodies of law enforcement data security take technical and organisational measures provided by legislation on the protection of the data to prevent personal data from being lost, processed or accessed without authorization, or even stolen by third parties. They notably establish the rules of treatment provided for by the Ordinance of June 14, 1993 the Federal data protection act.

SR 235.11 Section 3 registry Art. stem cells 50 maintaining the register of stem cells keeping the register of stem cells referred to in art. 62 of the law on transplantation is entrusted to Transfusion Switzerland its (Transfusion CRS) CRS.
For this purpose, the FOPH concludes with Transfusion CRS agreement which regulates such remuneration, by the Confederation, tasks delegated.

The name of the administrative unit has been adapted in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1). This mod has been taken throughout the text.

Art. 51 tasks Transfusion CRS treats all applications of stem cell research hematopoietic histocompatible with a given patient that emanate from the Switzerland or abroad.
She coordinates the picking, the tissue typing and transplantation of hematopoietic stem cells and keeps track of the State of health of the donor.
She fulfills the tasks assigned to him in accordance with the directives referred to in annex 1, point 3.

Art. 52 obligation to communicate data anyone who processes the data necessary for the establishment of the compatibility of tissues must communicate this data Transfusion CRS.
Communication is done in a pseudonymisee form, and includes: a. the dealer code; (b) his date of birth; c. sex; d. infectious status against cytomegalovirus; e. the tissue characteristics.

Chapter 9 provisions final art. 53 update of the annexes the federal Department of the Interior can update schedules 1 to 6 in order to adapt to international developments or technical progress. He proceeds to the updates which may constitute technical barriers to trade in accordance with the federal Department of the economy, training and research.

The name of the administrative unit has been adapted to 1 Jan. 2013 in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1).

Art. 54 repeal of the law in force the order of 26 June 1996 on the control of transplants is repealed.

[RO 1996 2309, 1999 1403 2001 1508 3294 ch. 10, 2002 82 II]

Art. 55 amendment of the law in force the change in the law in force is regulated in annex 7.

Art. 56 transitional provisions of transplantation of organs, tissues or cells clinical trials started before the entry into force of this order can be continued until the next change essential to the Protocol or until expiration of the authorization, but until July 1, 2012 at the latest, in accordance with the provisions of the Ordinance of 26 June 1996 on the control of transplants.


[RO 1996 2309, 1999 1403 2001 1508 3294 ch. 10, 2002 82 II]
Repealed by no I of O from 10 sept. 2008, with effect from Oct. 15. 2008 (RO 2008 4461).

Art. Transitional 56aDispositions relating to the amendment of September 10, 2008, anyone who stores already, at the time of the entry into force of the amendment of September 10, 2008, of this order, cells from hematopoietic stem of the cord for a transplantation of Autogenous blood, must inform the FOPH until April 15, 2009.

Introduced by the I of O ch. 10 sept. 2008, in effect since Oct. 15. 2008 (RO 2008 4461).

Art. 57 entry into force this order comes into force on July 1, 2007.

Annex 1 (art. 7, 27, 29, al. 1 let. a and 51, para. 3) guidelines 1. Ch. II, chapters 1 and 2, and ch. III, chap. A to C, guidelines medico-ethiques of the Swiss Academy of medical sciences for the diagnosis of death in the context of the transplantation of organs, in their version of May 24 2011.2. … 3. guidelines of the World Marrow Donor Association (World marrow donor association), in their version of November 1, 2008.

Update according to ch. I al. 1 o of the DFI of Jan. 12. 2010 (RO 2010 373), section I of the O of the DFI on 15 August 2011 (RO 2011 3797) and no 1 of annex 6 to the O on Sept. 20. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
This text can be consulted free of charge from the federal Office of public health, division of biomedicine, 3003 Bern. It can be obtained from the Swiss medical sciences, Petersplatz 13 Academy, 4051 Basel or downloaded on the Internet www.samw.ch > ethics > guidelines.
This text can be ordered against payment, consulted free of charge at the Office federal public health, biomedicine division, 3003 Bern, or downloaded on the Internet www.bag.admin.ch/transplantation/.

State on January 1, 2014, annex 2 (art. 13, 14, paras. 1 and 2: 16, let. d, 17, let. b, 18, let. b, and 34, let. b) international rules on safety and assurance quality applicable to the use of organs, tissues and cells the Guide on safety and quality of organs, tissues and cells of the Council of Europe in his version of 2009, is applicable in the following way: 1. QA referred to in art. 13 is governed by the provisions of Chapter 2; 2. activities ranging from the removal of organs at the time preceding their registry are governed by the provisions of Chapter 4; 3. the collection, preparation and storage of tissues and cells, with the exception of hematopoietic stem cells, are governed by the provisions of Chapter 5 (with the exception of point 7) and Chapter 6.

Update according to ch. I al. 1 o of the DFI of Jan. 12. 2010, in effect since Feb. 1. 2010 (2010 373 RO).
The Guide on safety and assurance of quality of organs, tissues and cells (3 edition and addendum 2009) can be ordered against payment or accessed for free from the federal Office of public health, division of biomedicine, 3003 Bern.

State on January 1, 2014, annex 3 (art. 14, para. 2) international rules of good manufacturing practices provisions in respect of the rules of good manufacturing practices (GMP) are the following: 1 Directive 2003/94 / CE of the Commission on October 8, 2003, establishing the principles and guidelines of good manufacturing practice for drugs for human use and investigational medicinal products for human; 2 use. Guide to good manufacturing practice laid down by the European Commission for drugs for human use and veterinary drugs, (EudraLex, volume 4). 3. Principles and guidelines of good manufacturing practices under the Convention of October 8, 1970, for the mutual recognition of inspections on manufacturing of pharmaceuticals, in their version of January 2009.

Update according to ch. II al. O 1 Sept. 10. 2008 (RO 2008 4461) and ch. I al. 1 o of the DFI of Jan. 12. 2010, in effect since Feb. 1. 2010 (2010 373 RO).
OJ L 262 of 14.10.2003, p. 22. This directive text can be ordered against payment, available free from the federal Office of public health, Department of biomedicine, 3003 Bern or downloaded on the Internet www.bag.admin.ch/transplantation/.
The text of the guide "Rules Governing Medicinal Products in the European Union, Volume 4: Medicinal Products for Human and Veterinary Use - Good Manufacturing Practices (2009) ' can be ordered against payment, available free from the federal Office of public health, Department of biomedicine, 3003 Bern or downloaded on the Internet www.bag.admin.ch/transplantation/.
RS 0.812.101. This text can be ordered against payment, consulted free of charge at the Office federal public health, biomedicine division, 3003 Bern, or downloaded on the Internet www.bag.admin.ch/transplantation.

State on January 1, 2014, annex 4 (art. 14, para. 3) international rules on the use of hematopoietic stem cells


The provisions applicable to the use of hematopoietic stem cells are the following: 1. international standards for the collection, preparation and transplantation of haematopoietic stem cell, fourth edition, in their October version 2008.2. International standards governing the sampling, preparation, submission to tests, the storage, the selection and the discount from umbilical cord blood, in their version of December 2008.

New content according to chapter I al. 2 o of the DFI of Jan. 12. 2010, in effect since Feb. 1. 2010 (2010 373 RO).
The text titled "FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration" may be ordered against payment, consulted free of charge at the Office federal public health, biomedicine division, 3003 Bern or downloaded on the Internet www.bag.admin.ch/transplantation/.
The text titled "FACT NetCord International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release" can be ordered against payment, consulted free of charge at the Office federal public health, biomedicine division, 3003 Bern, or downloaded on the Internet www.bag.admin.ch/transplantation/.

State on January 1, 2014, annex 5 (art. 14, para. 3 and 23, para. 2) assessment of fitness to the don, exclusion from the gift, duty to perform tests, tests, requirements to satisfy the tests and procedure for reactivity to HIV, HBV and HCV 1 assessment tests the ability to donate in the assessment of the ability to the gift referred to in art. 23, al. 1, there is to be included: a. medical and social history; b. the clinical status; c. physical examination d. blood; e. querying of the donor or his relatives on: 1. the risk of infection by the virus IH (HIV) and hepatitis B (HBV) or hepatitis C (HCV) virus; 2. the presence of signs of other infections systemic incurable or of unknown origin, or signs of contamination by a prion disease.

2 exclusion from the gift are excluded from donation individuals: a. with a serious systemic infection incurable or of unknown origin; b. with prion illness, risk to be infected with such a disease, suspected to be infected with the rabies virus or another degenerative of unknown origin disease affecting the central nervous system; c. with a malignant neoplasm regardless of its location, with the exception of some primary central nervous system tumors do not metastasize, forming of primary Carcinoma of the basal cells of the skin or a carcinoma in situ of the cervix; However they are not excluded from the gift: 1. individuals who have not developed a tumor for at least five years; 2. people with a malignancy for cornea donations, with the exception of people with retinoblastoma, a hematologic neoplasm or a malignant tumor may affect the anterior pole of the eye.

3 duty tests 3.1 analysis adapted to the State of science and technology are made, through tests available, on organs, tissues, cells, or the person who donated it to detect the presence of pathogens or evidence to suggest the presence of such agents.3.2 the blood sample which will be covered by the tests must be taken as far as possible before a transfusion or a hemodilution. If the sample is taken at a later date, this element must be taken into account during the evaluation of the results of serologiques.3.3 tests if tests abroad, it is necessary to prove that they are adapted to the State of science and technology.

4 testing 4.1 must be made, in all cases, the following tests: HIV-1 and HIV-2, HBV and VHC.4.2 tests should focus on the detection of the following: a. antibodies anti-HIV-1 and anti-HIV-2 among donors of organs, tissues or cells; a. Antigen p24 of HIV-1 among donors of tissues or cells, except islet transplanted directly; b. viral genome HIV-1 using a technique of amplification of nucleic acids in the living organ donors; c. (Ag HBs) HBV surface antigen and antibody anti-HBc among donors of organs, tissues or cells; d. anti-HCV among donors of organs, tissues or cells; e. viral genome HCV through a technique of amplification of nucleic acids in donors of tissues and cells, except islet transplant directly , and among living donors of organs.

4.3 If the donor stayed in areas with high prevalence, the test must focus on the detection of the virus of the human leukemia (HTLV 1 and 2) T-cell.4.4 If transplantation may lead to infection, testing should focus on the detection of the following pathogens: a. cytomegalovirus; b. pale Treponema c. Epstein-Barr virus; d. Toxoplasma gondii; e. viruses Herpes simplex; f. virus Herpes Zoster.

5 requirements that must meet tests on tissue or cells 5.1 if the donor died, samples for testing must be collected immediately before or immediately after the collection of the tissue or the cellules.5.2 If the donor is alive, samples for testing must be collected at the time of the tissues or cells , or seven days before or after the prelevement.5.2.1 said a new sample must be collected 180 days after the first. It must be the object of the serological tests referred to in section 4.2, let's. a, c, and d. Tissues and cells may be transplanted if the result of the test on the second sample excludes not a transplantation.5.2.2 it is possible to waive a second test according to section 5.2.1 if: a. in addition to serological tests, the HIV-1, HBV and HCV viral genomes have been identified using a technique appropriate amplification of nucleic acids , or Frenchie. a procedure of extraction or inactivation of pathogens, validated for relevant viruses, could be applied.

6 procedure for reactivity to HIV, HBV and HCV 6.1 General tests a test result is reactive if, according to the State of science and technology, it can be established that there is an infection or presence of parameters indicating an infection. This may involve different tests are combined or that some test results are reactive way repetee.6.1.1 in the case of reactivity to HIV, HBV or HCV tests or tests for detection of other pathogens, the transplant is permitted if measures of reducing the risk of infection adapted to the State of science and technology are taken and that If necessary, prophylaxis of infection or of re-infection and one followed postoperative are effectues.6.1.2 the receiver must be informed in a comprehensive way on the risk that the transplant is for her. If he accepts that risk, he must confirm it in writing. If this information cannot be given to him before the transplant, she must be given after the Procedure to follow in case of reactivity of bodies intervention.6.2 and pancreatic islets to the tests.6.2.1 in the case of responsiveness to the test HIV, the organs and the islet can be transplanted if the receiver is also responsive to the test VIH.6.2.2 in the case of responsiveness to the HBV test , the organs and the islet can be transplanted if: a. the result of HBV (HBs Ag) surface antigen detection test is positive in the donor at the recipient; b. the anti-HBc antibody test result is positive in the donor, or sic. the result of the test for detection of anti-HBc antibody and the Antigen of HBV (HBs Ag) surface is positive in the donor and that the outcome of HBV (HBs Ag) surface antigen detection test is positive in the recipient.

6.2.3 in case of responsiveness to HCV, bodies and islet test may be transplanted if: a. the result of anti-HCV antibody test is positive in the donor died, positive or negative in the recipient and the presence of ribonucleique acid HCV has been highlighted in the recipient through a technique of amplification of nucleic acids; b. the anti-HCV antibody test result is positive or negative in the donor living at the receiver and that the presence of acid ribonucleique of HCV has been highlighted in the donor at the receiver, using a technique of amplification of nucleic acids; c. the detection of anti-HCV test result is positive in the donor living and that no trace of acid ribonucleique of HCV has been put highlight at the living donor through a technique of amplification of nucleic acids and that , in the recipient: 1. the detection of anti-HCV test result is positive, or que2. the detection of anti-HCV test result is negative and the presence of ribonucleique acid of HCV has been highlighted using appropriate technique of amplification of nucleic acids.


6.3 procedure for reactivity of tissues and cells in tests.

6.3.1 if reactivity to HIV testing, hematopoietic stem cells can be transplanted if the patient's life depends on it and that the receiver is also responsive to the test VIH.6.3.2 in case of responsiveness to HBV or HCV tests, hematopoietic stem cells may be transplanted if the life of the patient in depend.6.3.3 in case of reactivity to HIV tests HBV or HCV, it is forbidden to transplanting other tissues or cells, subject to section 6.3.4.6.3.4 If the result of the HBV (HBs Ag) surface antigen detection test is negative and anti-HBc antibody is positive, other tissue or cells may be transplanted if it can be guaranteed that a donor HBV infection is exclue.6.3.5 points 6.3.3 and 6.3.4 applies not to the islet.

Update according to ch. II al. O 1 Sept. 10. 2008 (RO 2008 4461) and ch. I al. 1 o of the DFI of Jan. 12. 2010, in effect since Feb. 1. 2010 (2010 373 RO).

State on January 1, 2014 annex 6 (art. 16, let. b and c) Organ Transplantation: medical specialties and required operating conditions 1 medical specialties required 1.1 transplants of the heart, liver, lung, kidney, small intestine, pancreas or islet: a. Anesthesiology (with experience of transplantation and circulatory assistance external); b. Angiology; c. the transplant surgery; d. diabetology (with experience of acute transplantation with islet isolation for the transplantation of pancreas or of such islets); e. Immunology; f. infectiology; g. intensive medicine h. Cardiology (with experience of the treatment of the most severe heart failure, transplantation and mechanical circulatory assistance); i. Nephrology including dialysis of emergency (with experience of emergency dialysis for kidney transplantation and acute transplant); j. pathology; k. Pulmonology , including possibility of Bronchoscopy of emergency (with acute transplantation and experience of emergency bronchoscopy, for lung transplantation); l. psychosomatic or psychology; Mr. Interventional Radiology.

1.2 transplants of the heart, lung, kidney, small intestine, pancreas or islet:-Gastroenterology, including emergency endoscopy.
1.3 liver transplant:-Hepatology (with experience of acute transplantation and of emergency endoscopy).

2 required operating conditions 2.1 requirements at the level of the company, with operating 24 hours on 24, 365 days a year: a. emergency emergency room; b. care intensive; c. operating rooms; d. coordination of transplantations; e. Laboratory of chemistry and Hematology with determination in emergency service; f. laboratory with typing system.

2.2 laboratory of microbiologie.2.3 laboratory for the determination of serum concentrations for immunosuppressive drugs.

State on January 1, 2014 annex 7 (art. 55) amendment of the law in force.

Mod. can be found at the RO 2007 1961.

State on January 1, 2014

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