Automated Quality Assurance Rules for Liquid Chromatography-Mass Spectrometry Testing in a Clinical Laboratory.

Gina Cassella-Mclane, Myles McGowan, Jillian Kodger, Thomas J S Durant

Journal: Clinics in laboratory medicine 2025;45(2):221-232

PMID: 40348434

Full Text on Elsevier Science View on PubMed

Abstract

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has seen an enormous increase in applications, such as toxicology, biochemical genetics, endocrinology, therapeutic drug monitoring, and dietary monitoring. Although LC-MS/MS has the potential to offer significant clinical benefit to patients and clinicians, these assays often require significant effort and complex quality-assurance data review processes to ensure accurate results. Manual LC-MS/MS data review is time consuming and susceptible to human error. Automation of data review can reduce time spent on manually reviewing each chromatogram, reduce human error, and improve practice and ensure regulatory compliance with the rules and guidelines established by the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), and Clinical and Laboratory Standards Institute (CLSI) C62-A.

Address: Department of Laboratory Medicine, Yale New Haven Hospital, New Haven, CT, USA.; Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA.; Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA; Biomedical Informatics, Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA. Electronic address: [email protected].

DOI: 10.1016/j.cll.2025.01.006

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MeSH Terms: Humans, Chromatography, Liquid, Tandem Mass Spectrometry, Laboratories, Clinical, Quality Assurance, Health Care, Quality Control, Mass Spectrometry, Liquid Chromatography-Mass Spectrometry