Clinical laboratories are required to comply with stringent regulations, which were introduced to ensure clinicians can obtain quality results on which to base diagnosis and treatment decisions. However, achieving regulatory compliance and obtaining the relevant accreditations can be a long, resource-intensive procedure. In order to understand the implications the accreditation process has for clinical laboratories, we spoke with Laura Owen, Principal Clinical Scientist at the University Hospital of South Manchester (UHSM) National Health Service (NHS) Foundation Trust. We also discussed how a fully automated liquid chromatography tandem mass spectrometry (LC-MS/MS) system, equipped with dedicated assays, could help address these challenges.
A Difficult, but Rewarding Process
To achieve compliance, laboratories must review all of their analytical processes, whether automated or manual, and make sure that the services they offer are of the highest quality. When it comes to manual processes in particular, establishing full regulatory control is important as these processes inherently incur a potential risk due to the possibility for human error. In general, ensuring compliance can be a very challenging and time consuming task, requiring laboratory staff to perform rigorous safety checks at every stage of the process.
Regulatory compliance plays a vital role in enabling labs to be established as the “go-to provider” of high-quality clinical results. “By being accredited by the United Kingdom Accreditation Service (UKAS), we are perceived as a trusted partner by NHS organizations and private medical providers alike, and are relied upon for the accurate analysis of patient samples,” says Ms Owen.
The Importance of Assay Compliance
It is crucial for clinical laboratories to ensure the LC-MS/MS assays they develop in-house conform to the highest quality standards. However, developing fully compliant assays in-house can be particularly challenging, requiring a high level of expertise. A full paper trail structure is necessary, not only to facilitate assay compliance, but to allow laboratory personnel to quickly detect and address problems in the process, as well as identify training needs.
What role could LC-MS/MS play?
“A system incorporating fully compliant assays could be beneficial to larger and smaller laboratories alike, particularly where the lack of LC-MS/MS expertise makes it challenging to develop inspection-ready assays,” comments Ms Owen.
In addition, Ms Owen believes a fully automated, integrated clinical LC-MS/MS system could eliminate the manual processes associated with current technology, reducing human error, saving time, and freeing more experienced staff to focus on developing and implementing specialist assays for the more demanding applications. Such a system could help laboratories maintain efficiencies and the high level of quality required by international standards.
In response, Thermo Fisher Scientific has developed the Thermo Scientific™ Cascadion™ SM Clinical Analyzer, a fully automated clinical analyzer with integrated LC-MS/MS technology. The Cascadion analyzer is designed specifically for the clinical laboratory with dedicated assay kits.