Study on strategy to establish quality assurance/quality control system in Japanese forensic toxicology practices.

2004 Fiscal Year Final Research Report Summary

• Project/Area Number: 14370158
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Legal medicine
• Research Institution: Fukuoka University
• Principal Investigator: KAGEURA Mitsuyoshi Fukuoka University, School of Medicine, Professor, 医学部, 教授 (40037594)
• Co-Investigator(Kenkyū-buntansha): NIHIRA Makoto Nippon Medical School, Associate Professor, 医学部, 助教授 (40089636) ; KUDO Keiko Kyushu University, Graduate School of Medical Sciences, Lecturer, 大学院・医学研究院, 講師 (10186405) ; TERADA Masaru Toho University, Faculty of Mdedicine, Lecturer, 医学部, 講師 (30104649) ; GONMORI Kunio Hamamatsu University, School of Medicine, Research Assistant, 医学部, 助手 (10006744)
• Project Period (FY): 2002 – 2004
• Keywords: forensic toxicology laboratory guidelines / standard operating procedure manuals / qauality assurance / quality control / particular requirements / corrective action / UK / USA / Canada

Research Abstract

A study was made of possible strategies to establish quality assurance/quality control systems in Japanese forensic toxicology laboratories and` to address the particular requirements of their work. This was achieved by visiting forensic toxicology laboratories in the 'UK, USA and Canada, examining reference documents and literature obtained from Western forensic toxicologists, and then having discussions with our Japanese colleagues.
As a result of our research, we strongly recommend that :
1)Testing laboratories should :
・prepare standard operating procedure manuals which conform to international forensic toxicology laboratory guidelines,
・document all actions performed by the laboratory and its personnel,
・validate analytical methods and each analytical run,
・take corrective action for results which deviate from the specified acceptance criteria ;
2)Laboratories requesting tests to be performed by other laboratories should check on the nature, expertise and ability of the laboratory concerned, and should take full responsibility for the test samples (identification, integrity, chain-of-custody) ;
3)The Govemment should :
・carry out administrative reforms relating to forensic _toxicology,
・simplify the procedure for obtaining certified reference materials,
・defray adequate expenses for consultation and drug testing ;
4)All forensic pathologists, toxicologists and serologists should participate in discussions on how to reform their laboratories.