Organisations such as FSNI who carry out the analysis of toxicology samples are working in a complex and evolving landscape. In recent years there have been advances in technology which have brought about changes to some traditional processes. There have also been questions raised over the integrity of reported toxicology data (none of which involved FSNI) which have, in some circumstances, led to the withdrawal of cases from the Criminal and Civil Justice Systems, and led to criminal investigations.
In response to these changes in methodology and concerns over data integrity, in 2018 UKAS undertook a review of all accredited laboratories within this sector. To this end UKAS consulted with the sector and produced a new publication, LAB 51 UKAS Accreditation of Laboratories Performing Analysis of Toxicology Samples. This UKAS publication is available from the UKAS website (UKAS, 2021).
Jane Bridges, a Higher Scientific Officer in the Analytical Services Team (AST), detailed what this meant for the Toxicology section. When AST received this news they first carried out a gap analysis which was a massive undertaking in itself. Lab 51 is concerned with all processes and procedures carried out from the moment the sample arrives at FSNI to when the finished report is issued. This includes things like who brought the sample, how it was stored, what temperature it was kept at etc. As FSNI receives samples from a number of stakeholders and customers, e.g. State Pathology and the PSNI, this was a complex exercise. It required input from many different sections and individuals throughout FSNI including both scientific and administrative staff. The completion of this gap analysis took several months of meticulous, hard work. Jane has provided an insight into what this entailed from the perspective of AST.
The alcohol and toxicology labs at FSNI already carry out extensive quality control tracking; when taking Lab 51 into consideration, this workload essentially doubled. Some of the work that goes into this includes the set up and management of complex spreadsheets and carrying out a variety of calculations. Jane explained that even the development of these spreadsheets was a time consuming and multifaceted task. Jane also went on to describe how the teams in AST have to recalculate the uncertainty of measurement for both alcohol and drugs. This is to make sure we can show that our methods are performing in the same way as they were when they were validated. In the screen that Toxicology runs, there are 106 drugs. To be able to recalculate the uncertainty of measurement you need 9 results for each of those drugs in blood and urine. Statistics are then carried out for those 106 drugs in blood and 106 drugs in urine. This is undoubtedly a vast amount of work.
Jane then went on to talk about system suitability, which involves assessing how the instruments and systems are working, and provided the following example. In Analytical Services chromatography is used. Chromatography is a technique for the separation of a mixture by passing it in solution or suspension through a medium in which the components move at different rates. For Lab 51, 3 months’ worth of results were taken and calculations carried out to provide demonstrable evidence of how the process was performing. Again, an onerous, but necessary task.
FSNI has already in place, extensive quality control measures; the Lab 51 accreditation provides another layer of checks and balances. However, the implications of Lab 51 of course mean that many processes carried out now take a little longer than before. However, this provides FSNI with certainty that the work we are carrying out and the results we provide can be relied upon and UKAS can be confident in the work we do. The results provided by FSNI can have very serious and wide ranging consequences; for example, they may help prove a person’s innocence or they may provide evidence which can lead to someone losing their driving licence, their job or even the custody of their children. It is for these very reasons that each and every piece of work carried out is so rigorously tested and controlled which in turn provides the Criminal Justice System with confidence in our results.
These examples don’t even begin to cover the huge amount of time and effort that went in to meeting the Lab 51 standards and the extensive work that was carried out. It’s important to highlight that meeting these standards required the knowledge and expertise of both scientific and administrative staff across the Agency.
FSNI first heard about the Lab 51 accreditation in June 2021 and were informed that we would be assessed against it at our next inspection; this was due in September 2021. This presented staff with an incredibly challenging timeline within which they had to carry out their gap analysis, address any gaps identified and prepare for the upcoming inspection. This was a mammoth task but all the staff involved rose to the challenge and gave it their all. We were informed by the UKAS assessor that FSNI was the first lab in the UK to sign an initial declaration confirming compliance with Lab 51. This is testament to the hard work and dedication of the staff at FSNI.