363.11 order of the FDJP on benefits and quality requirements for laboratories forensic for DNA testing (order of the FDJP on laboratories for DNA testing) of October 8, 2014 (State on January 1, 2015) the federal Department of justice and police (FDJP), view the art. 2, al. 3, and 20 of the Ordinance of December 3, 2004 on DNA profiles, stop: Section 1 DNA Art. forensic laboratories services 1 principles all laboratory must be accredited according to ISO 17025 standard, 2005.
It must be accredited for all of the benefits referred to in art. 2 to 8.
Unless otherwise provided in this order, the analysis is performed in accordance with the recommendations of the June 1, 2012, of the Swiss society of forensic medicine for the DNA of biological traces.
The internal steps of the process of the laboratory are designed for precise and correct treatment.
DNA (loci) markers to analyze are set in the annex.
Available against payment from the International Organization for Standardization, the ISO central Secretariat, ch. of the track - Creuse 1, CP 56, 1211 Geneva 20, or: HYPERLINK "http://www.iso.org" > Store > catalog of standards www.sgrm.ch > genetic forensics > Description in the section > Documents art. 2 basic benefits benefits to provide for each mandate analysis (basic services) include all stages of work related to the analysis of the material to be examined, receipt of the equipment on behalf of the authority on delivery of the result of the analysis.
Basic benefits include: a. the confirmation of receipt and registration of information related to the case; b. the double analysis of the result of the analysis; c. the conversion of data for profiles in the format of the file of the information system based on patterns of DNA (information system) and control of this file; (d) the transmission of data at the Service of coordination; e. in case of concordance , the verification of the data with the coordination Service; f. conservation and possible administration of the analyzed material or its delivery, or its destruction, in accordance with legal requirements; g. the conservation of documents of laboratory or their destruction, in accordance with the legal requirements; h. the documentation complete, and allowing to reconstruct them, of all stages of work.
Mandates must be treated within the following periods: a. sample of a person: six days; b. urgent sample of a person: two working days or according to agreement; c. simple path: 12 working days; d. urgent track: six days or according to agreement; e. after traces of a complex case: according to agreement; f. trace complex or difficult to treat: according to agreement; g. local comparison : according to agreement; h. confirmation of profiles: a business day, except for profiles complex or difficult to treat.
The instructions referred to in para. 3, let. a and c, must be observed for at least 96 percent of analyses of samples and tracks made for a year.
Processing time begins upon receipt of the material to be analyzed at the laboratory and ends the transmission of the results of the analysis to the recipients.
In particular case as major events or large-scale surveys, the laboratory implements the measures needed to be able to carry out its mandate within the time limits.
Art. 3 requirements for the analysis of samples of people any sample of people must be the subject of two independent analyses of the other; These two analyses are performed by different individuals or at different times.
Analysis includes: a. two independent DNA extractions from the other; b. a DNA profile for each retrieval establishment; (c) control of profiles and their transmission.
Art. 4 the trace analysis requirements all traces must be the subject of two independent analyses of the other; These two analyses are performed by different individuals or at different times.
Analysis includes: a. two independent extractions of DNA from another, depending on the amount of trace and its quality; b. a DNA profile for each extraction facility, or two institutions of the DNA profile independent one of the other in the presence of a single extraction; c. If quantification has given a negative result, at least a DNA analysis or a second quantification of extraction; d. control profiles and their transmission.
If a trace is located on a support, he agrees to do or indicate in the documentation: a. the description of trace support, including dimensions, color, material, brand and State; b. photography, photocopying or the sketch of the track support; c. the location of the trace and a close-up or a sketch of the track; d. description of the trace , including the size, color and the State; e. one or more sampling carried out on trace support.
Art. 5 further traces a further trace processing processing is carried out: a. in the case of tracks whose DNA is degraded; b. If traces contaminated; (c) in the case of traces from tissues such as bones or teeth or tissue fragments taken for histological examinations; d. after the separation of the mixed cells performed on a trail of sperm; e. to determine the type of the trace.
In-depth traces processing is done according to recognized scientific methods.
Art. 6 taking into account the differences in analysis of DNA if, during DNA analysis, a rare difference due to the use of different kits appears for a DNA marker, it is not taken into account in the comparison in the information system.
Art. 7 analysis of markers additional DNA analysis of additional DNA markers, which are not in annex, in order to increase the power of identification, to ensure that the interpretation of complex mixture profiles or make comparisons with profiles from abroad must be performed twice. It includes: a. other markers DNA autosomaux recognized at the international level; b. the DNA markers on chromosome Y; c. the DNA markers on the X chromosome.
Art. 8 confirmations of profiles in case of concordance in the information system, the laboratory checks the profiles at the request of the coordination Service and communicates the results. This task is included in the price of the profile.
Art. 9 conservation and destruction of the laboratory analysis data for profiles all lab retains 30 years profiles people and necessary trace data to track the analysis process, check a profile determined and a local comparison in accordance with art. 6 was of the order of 3 December 2004 on DNA profiles and then destroyed these data.
Art. 10 obligation of communication all lab documents the following facts and communicate to the requesting authority: a. the faults of the samples sent as damages, the missing seals and incomplete directions; b. cost overruns expected processing times, with mention of the reasons and possible alternatives; c. errors or irregularities during the review of the results achieved in the implementation of the mandate.
Art. 11 availability of all lab laboratory is available to the requesting authorities, from Monday to Friday from 8 hours to 12 hours and from 2 p.m. to 5 p.m., except on national and regional holidays. If imperative invoked by the applicant authority, it must be also available outside these hours.
Art. 12 transmission of a mandate with the written agreement of the principal, the laboratory can transmit a mandate or a partial mandate to another laboratory recognized under art. 8, al. 1, of the Act of 20 June 2003 on the DNA profiles.
If none of the recognized Labs has the knowledge necessary to carry out a specific analysis, the term may, with the written agreement of the principal, be sent to a Swiss laboratory that is not recognized or to a foreign laboratory. This transmission is recorded in the report presenting the results of the analysis.
SR 363 art. 13 all quality control quality control should be performed according to the recommendations of the June 1, 2012, of the Swiss society of forensic medicine for the DNA of biological traces.
The results of the quality control must be documented.
Recognized laboratories for the criminal to the civil and administrative fields must, in one year, attend four quality controls external in the forensics field and a quality control external in the area of filiation, a matter of parentage to be resolved in one of four outside of the forensics field quality controls. If the four external quality controls of the forensics field does contain a question on filiation, the laboratory must participate in a second additional external quality control in the area of filiation in the meantime.
The federal Office of police (fedpol) recognizes participation in external quality control if it included control of all the markers referred to in annex and he succeeded.
If the external quality control has failed, the laboratory shall inform spontaneously fedpol in the quarterly report.
www.sgrm.ch > genetic forensics > Description in the section > Documents art. 14 working languages the working languages are German, the french, and Italian. Specific terms can also be given in English.
Section 2 operation of laboratories art. 15 qualification of personnel all lab again fedpol photocopies of the graduates of his laboratory staff.
It ensures that all employees have the specific knowledge needed to accomplish their task. As such, fedpol may at any time consult the continuous training and development plan.
Art. 16 conflict of interest any laboratory must immediately inform the requesting authority if he is faced with a conflict of interest related to a mandate of analysis accurate having been entrusted to him, either because he has a direct interest in a case, either because he has a relationship with a party or, more generally, cannot act independently.
Art. 17 billing all Lab directly address bills to the requesting authority. It sets the price.
Each analysis is charged, regardless of its outcome. The services provided must be clearly indicated on the invoice.
The coordination Service charges to the laboratory of the stages of work carried out in accordance with art. 9, art. 5, of the Ordinance of December 3, 2004 on the DNA profiles. The lab can then rebill these fees to the requesting authority.
Art. 18 measures to ensure data security and security of data only people who need to do their jobs have access to relevant data for the prosecution. These people must confirm in writing that they are aware of their duty of confidentiality to the senses of the art. 17, al. 3, of the Ordinance of December 3, 2004 on the DNA profiles.
Computer equipment containing the data must be in premises which access is controlled.
If external people access to devices or software to maintain them or repair them, adequate measures must be taken to ensure the protection of the information.
The laboratory shall immediately inform fedpol in writing: a. any suspicion of breach of the protection of the data or gaps in terms of data protection; b. any suspicion of a breach of the security of data or gaps in terms of data security; c. of any irregularities in the processing of the data.
Art. 19 communication platform all lab exclusively uses the platform of communication made available by fedpol.
If the communication platform is momentarily not available, samples must be still processed and later entered into this system.
Art. 20 communications to fedpol laboratory recovering spontaneously to fedpol the following documents: a. confirmation of the extension of accreditation by the Swiss Accreditation Service, accompanied by its scope of application; b. changes to registration in the trade register or any change of authority; c. confirmation of its participation in external quality controls, in accordance with art. 13, al. 3; d. information concerning changes in personnel involved in the process; (e) a quarterly report on the number of samples processed and reported irregularities, in accordance with art. 18, al. 4; f. an annual management report or an annual report.
Art. 21 administration of the results of the analyses laboratory administers results, sketching, derivatives and the remaining products of biological material in a fiduciary capacity.
Art. 22 measures in case of shutdown of operating a lab if a laboratory ended its operations, he puts all his biological material and laboratory documents to a recognized laboratory. If it is not possible to deliver this material and documents to another laboratory, they will be transmitted to the laboratory acting also as a coordination service.
The laboratory to which the material and documents are delivered takes over tasks which are related as well as the mandates given by the authorities concerning this material and these documents.
Section 3 provisions final art. 23 repeal of another act the order of Department of 29 June 2005 on laboratories for DNA testing is repealed.
[RO 2005 3341]
Art. 24 entry into force this order comes into force on January 1, 2015.
Annex (art. 1, para. 5) list of the loci to be analyzed D3S1358, vWA D16S539, D2S1338 D8S1179, D21S11, D18S51 D19S433 TH01 FGA D10S1248 D22S1045 D2S441 D1S1656 D12S391 Amelogenine State SE33 January 1, 2015