Key Benefits:
14 February 2007 (State on 1 April 2007)
The Swiss Federal Council,
See art. 8, para. 4, Federal Act of 8 October 2004 on Human Genetic Analysis (LAGH) 1 ,
Stops:
This order shall rule:
1 Laboratories that want to establish DNA profiles to determine a person's relationship or identity and who are not recognized as testing laboratories for forenics are recognized:
2 The European standard for accreditation under para. 1, let. A, is set out in the schedule. The department updates the Annex in order to adapt it to international developments and technical progress.
3 Recognition shall be granted for the field of application corresponding to that of accreditation.
4 The application for recognition must be filed with the Office.
Laboratories may be accredited in one of the following fields of application:
1 For laboratories that want to be accredited in the field of application according to Art. 5, let. A, the domain manager must have:
2 If the title provided for in para. 1, let. A, was acquired before 1 Er March 2003, it is necessary to add the "DNA/RNA diagnostic" complement;
3 The domain manager must also have a practical experience of at least two years in the field of relationship expertise and have assumed full responsibility for at least 100 cases of kinship ties.
4 For laboratories accredited under Art. 5, let. B, the domain manager must:
1 Laboratories not accredited under s. 4, para. 1, let. A, may file an application for provisional recognition with the Office, provided that they submit an application for accreditation to the SAS at the same time.
2 Provisional recognition is granted:
3 The Office can instruct the SAS to control the fulfilment of the conditions.
4 The Federal Data Protection and Transparency Préposed examines the concept for data protection and security.
5 Provisional recognition is subject to the burden on laboratories to obtain, within 18 months from the filing of the application for provisional recognition, accreditation by the SAS. The Office may, at the request of the SAS, extend the time limit of up to six months.
Recognition and provisional recognition may be subject to conditions or charges.
1 Recognized laboratories must successfully participate twice a year in an external quality control that relates to the scope of their recognition.
2 They must present the results of these checks to the Office until the end of February of the following year.
1 A laboratory may entrust the establishment of a DNA profile only to another laboratory recognized under this order and with the consent of the principal.
2 If a recognized laboratory does not have the necessary knowledge to perform a special analysis, it may, exceptionally, entrust the execution to an unrecognized laboratory outside Canada.
1 Each year, laboratories must, up to the end of February, report to the Office the number of reports of expertise carried out in the previous year to establish a relationship or to identify a person.
2 They must distinguish:
3 Laboratories must, on their own initiative, provide confirmation of the renewal of accreditation to the Office.
4 The laboratory shall immediately communicate to the Office any change in the person responsible for the domain.
1 The mandate for the establishment of a DNA profile should refer to the persons concerned by their surname, given name, date of birth, address and place of origin or nationality.
2 When taking the sample, the person concerned must justify his or her identity by means of a valid official photo identification. This part must be photocopied. The laboratory may waive the requirement to provide identification for an infant or infant.
3 When the sample is taken, the data subject must be photograted. The photo must be signed by the person concerned or by his or her legal representative.
4 The examination of the identity must be recorded and the documents relating thereto must be attached to the expert report provided for in Art. 16.
5 If the sample is taken by a physician contracted by the laboratory, the laboratory is responsible for the physician's investigation of the examination of the identity and the collection and retention of the sample.
1 The sample shall be marked in a sustainable manner so as not to be confused with other samples.
2 Bone marrow transplants and grooves should be reported.
3 The person conducting the identity examination and sample collection must confirm by signing the accuracy of the data.
4 The sample shall be retained and treated in such a way as to exclude any deterioration, exchange or loss.
1 The sample shall be subjected to two independent analyses.
2 The markers used must meet the scientifically proven criteria for transmissibility and stability.
The analysis report shall contain at least the following indications:
1 The mandate for the establishment of a DNA profile and the conclusions of the analysis report should be reported in the expert report.
2 If necessary, the conclusions should be subject to a proper biostatistical evaluation.
3 The Commission of Experts for Human Genetic Analysis may make recommendations on how to draw up the expert report.
1 The Office may make or order announced or unannounced inspections for the purpose of checking whether the requirements of the LAGH and this order are met.
2 It may entrust these inspections to the Commission of Experts for Human Genetic Analysis, other qualified experts or the SAS.
3 The laboratories must communicate to the persons responsible for carrying out the inspection all the information necessary to carry out their task and ensure that they have access to the premises and facilities used to establish the DNA profiles for the purpose of Determine the relationship or identity of a person. The persons responsible for the inspection have the right to inspect the files.
1 The department withdraws recognition if the laboratory:
2 In the case of minor infringements, the Office shall give a warning to the laboratory.
1 The SAS shall communicate to the Office the infringements of the obligations laid down in this order or by the LAGH which it finds in the course of its activity. It shall immediately inform the Office of the withdrawal or suspension of accreditation in the field of DNA profiles aimed at establishing the kinship or identity of a person.
2 The Board may consult the SAS file regarding the accreditation of a laboratory under this order.
3 It denounces the criminal law facts of the criminal prosecution authorities.
1 The collection of the fees for recognition and supervision is governed by the general order of 8 September 2004 on emoluments 1 .
2 The emoluments collected by the SAS for the tasks performed under this order shall be governed by the order of 10 March 2006 on the emoluments of the State Secretariat for the Economy in the field of accreditation 2 .
1 Laboratories not recognized in accordance with the order of 3 December 2004 on DNA profiles 1 And who have already established DNA profiles to determine the relationship or identity of a person under the former right must apply for certification under s. 4 or 7 before the Office within three months of the entry into force of this order.
2 They can continue their activity as long as their application has not been definitively rejected. Laboratories that do not submit their applications within the prescribed time limit must suspend their activity by the deadline.
3 The SAS accredited laboratory before 1 Er April 2007 in accordance with the order of 17 June 1996 on accreditation and designation 2 In the field of DNA profiles to determine the relationship or identity of a person may exceptionally be recognized under s. 5, let. A, even if the domain manager does not have the training required by s. 6, para. 1. In the event of a change in the domain manager, the new domain manager must meet the requirements of s. 6, para. 1 and 2.
This order shall enter into force on 1 Er April 2007.
(art. 4, para. 2)