Validation, quality control, and compliance practice for mass spectrometry assays in the clinical laboratory

Clinical laboratory assays using mass spectrometry are invariably developed in-house. Careful attention must therefore be given to both regulatory requirements and standards of professional practice regarding the validation, quality control, and competency/compliance aspects of offering, such assays. Here we review multiple guidelines and sources of information regarding this process: from federal requirements of the Clinical Laboratory Improvement Act (CLIA), accreditation requirements of the College of American Pathologists (CAP), Food and Drug Administration (FDA) guidance related to the pharmaceutical industry, and recommendations/reviews from the literature. We also discuss proposals for new FDA regulations regarding laboratory-developed tests (LDTs) that may have dramatic impact on clinical laboratories that utilize mass spectrometry. Only liquid and gas-chromatography mass spectrometry are discussed in this chapter.