Regulator's notification 06-2024: use of certified reference materials in the undertaking of forensic science activity of 'Toxicology: analysis for drugs in relation to s5A of the Road Traffic Act 1988' (FSA – DTN 102) (accessible)
Published 28 November 2024
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This publication is available at https://www.gov.uk/government/publications/regulators-notification-06-2024-use-of-certified-reference-materials-crms-in-analysis-for-drugs-in-relation-to-s5-of-the-road-traffic-act-1988/0141d8d4-5725-45da-976f-e249c09d15fa
Issue
The use of certified reference materials (CRMs) in the undertaking of forensic science activity (FSA) of “Toxicology: analysis for drugs in relation to s5A of the Road Traffic Act 1988” (FSA – DTN 102).
Background
The analysis for drugs in blood samples in relation to s5A of the Road Traffic Act 1988 is a FSA that is subject to the Code. Key Forensic Services reported to the Regulator that they had made a procedural error in the use of CRMs in the analysis of tetrahydrocannabinol (THC). The Key Forensic Services method required different manufacturer lot numbers of CRM to be used to prepare calibrants and internal quality control (QC) samples. Over the period 25th June to 27th September 2024 the same batch of CRMs was used in error. Key Forensic Services conducted an internal investigation and found that the QC stock used was made accurately and was stable over the period of use and concluded that all results can be considered to be accurate within the Forensic Science Regulator’s Expanded Uncertainty (FSREU) threshold for THC i.e. 30%.
Actions and outcomes
The Regulator commissioned an independent review to assess the significance of the procedural error.
The independent review concluded that the procedural error did not invalidate any of the case results reported over the period in question. This is partly due to procedures in place at Key Forensic Services, including the use of CRMs supplied by ISO 17034 accredited suppliers and the overlapping period between changing calibrants and QCs. The review also found that the unaccounted for variables associated with use of the same CRM for preparation of calibrants and QCs would not be expected to have any significant impact on the measured results and was within the FSREU. The review found Key Forensic Services to be compliant with the requirements of the Code, had identified the root cause and taken appropriate remedial action.
Mr Gary Pugh OBE
Forensic Science Regulator
November 2024