Establishment of an ISO 17025:2005 accredited forensic genetics laboratory in Italy

Abstract

Forensic genetics is extremely useful for the resolution of criminal cases, identification of missing persons and in paternity/kinship testing. Each and every laboratory that works in the forensic genetics area has developed its own working method independently, however, generally in accordance with international guidelines. More than thirty institutional, public and private forensic laboratories that deal with the identification/paternity testing through DNA in Italy have been surveyed, but to this day, only five public laboratories (four of the police and one of a university hospital) and two private ones are accredited. There are, however, many other laboratories that perform occasional forensic genetics activities that have not been surveyed. The need to achieve the ISO 17025:2005 accreditation may represent for these laboratories an excellent opportunity to improve their activities. Although the DNA analysis for forensic investigation is used in Italy since the beginning of the technique, the quality of the results has been called into question more than once, as it appears by many court cases in which the results of genetic tests have been subject to strong criticisms. Obviously, the ISO 17025:2005 is not sufficient to guarantee the quality of the results. It is essential to show the laboratory working method to the scientific community in order to obtain reliable and robust analytical results that can be used in court to accuse/exonerate individuals accused of a crime or to assign a true biological father to a child. Here, we show a part of the workflow validation process of the internal method used in the Forensic Genetic Service (FGS) of the Diagnostic Genetics Unit (DG) of the Careggi University Hospital. This article outlines some relevant aspects of the methods adopted to ensure robustness, reliability and reproducibility of genetic profiles used for forensic identification.