Essential Quality Analysis Criteria in Forensic Genetics Identification: A Position Statement of Italian Society of Human Genetics
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2018, Vol 12, Issue 2
Abstract
The entry into force of DPR n. 87 of 7th April 2016 relating to the DNA Data Bank requires an implementation upgrade of the Forensic Genetics analysis to ensure the quality of results by the control of the pre-analytical and analytical processes. The decree provides the opportunity to define the operational guidance elements, shared by Italian laboratories in the Forensic Genetics field, aimed at ensuring the quality of data and at producing useful genetic profiles: for this reason, the laboratories who want to contribute to the Bank of DNA data need accreditation in accordance with ISO/IEC 17025. This document represents a brief technical document of the Italian Society of Human Genetics in the aim of supporting laboratories seeking accreditation as well as the Italian National Accreditation Body appointed by the State to perform accreditation activity (ACCREDIA).The entry into force of DPR n. 87 of 7th April 2016 relating to the DNA Data Bank requires an implementation upgrade of the Forensic Genetics analysis to ensure the quality of results by the control of the pre-analytical and analytical processes. The decree provides the opportunity to define the operational guidance elements, shared by Italian laboratories in the Forensic Genetics field, aimed at ensuring the quality of data and at producing useful genetic profiles: for this reason, the laboratories who want to contribute to the Bank of DNA data need accreditation in accordance with ISO/IEC 17025. In Italy few laboratories have been accredited so far. For this reason, the SIGU Working Group on Forensic Genetics perspective is to promote the accreditation path of Forensic Genetics laboratories. This document represents a brief technical document of the Italian Society of Human Genetics in the aim of supporting laboratories seeking accreditation as well as the Italian National Accreditation Body appointed by the State to perform accreditation activity (ACCREDIA).Acceptance and Management of Reference/Evidence Samples: a) Criteria 1: All pre-analytical procedures (sample collection methods, inspection methods and evidence conservation, etc.), analytical procedures (methods of extraction, quantification, typing etc.) and post-analytical procedures (data interpretation) must be documented. b) Criteria 2: All the files, worksheets, raw data, photographs, etc. related to a single procedure must be saved as directed by the judicial authorities. The DNA extracts must be available for the judicial authority, who are responsible for the authorization of their destruction, storage or return. c) Criteria 3: It is necessary that the laboratory ensures and maintains the integrity of the chain of custody of any evidence. The procedure is to write a record of acceptance documenting the origin of the reference/evidence samples together with the identity of the person who delivers those items to the laboratory [1]. d) Criteria 4: It is necessary that the laboratory establishes eligibility criteria with respect to conservation, storage and transport of reference/evidence samples.a) Criteria 5: Only authorized persons are permitted access to the sample conservation and analysis locations. b) Criteria 6: It is necessary to have a database containing the genetic profiles of people who have access to the lab for exclusion purposes. The database must be kept in accordance with any current regulations concerning the protection of privacy. c) Criteria 7: The laboratory has to document the competence, training and experience of its staff. The Quality Manual has to include the minimum requirements for the staff (Degree in Biology / Biotechnology / Medicine; Postgraduate courses in Forensic Genetics; professional experience gained in forensic genetics laboratories).
Authors and Affiliations
Giardina Emiliano, Piluso Giulio, Del Vecchio Blanco Francesca, Nutini Anna Lucia, Ragazzo Michele, Manzo Laura, Binni Francesco, Di Natale Manuela, Pietrangeli Ilenia, Piumelli Nunzia, Zampatti Stefania, Torrente Isabella, Mari Francesca, Bruttini Mirella, Amitrano Sara, Raso Barbara, Salvaderi Luca, Novelli Giuseppe, Grammatico Paola
Keywords
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- EP ID EP592754
- DOI 10.26717/BJSTR.2018.12.002213
- Views 164
- Downloads 0
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