Medicalscientists in the clinical chemistry laboratory work predominantly with highlyautomated in vitro diagnostic methods to detect and measure any biochemicalchanges in the body. It is the detection and understanding of these changes thatis necessary in the evaluation of patient health and diagnosis of disease. Itis the role of the laboratory to provide accurate analytical results for theirpatients and are required for compliance with international regulations. The introductionof new instrumentation and analytical methods requires validation andverification studies to ensure they meet acceptable standards of performance foruse in the clinical chemistry laboratory. (Hartmann, 1983) Undoubtedly such automatedanalysers are vigorously validated by the manufacturers prior to use in theclinical settings.
However, these methods must be re-validated by a senior medicalscientist to verify that the data obtained from the manufacturer can be repeatedlyreproduced in a clinical setting. Validationand verification of methods can be approached several ways depending on thelaboratory. There is no general agreement regarding the extent of the evaluationprocedures needed, however, international organisations and regulatory authoritieshave published guidelines for the minimum verification requirements. It is imperativethat these guidelines are incorporated into method validation. INAB (The IrishNational Accreditation Board) is responsible for the accreditation of testing laboratoriesin Ireland, ensuring they are on par with testing laboratories in othercountries. The extent of validation required depends on whether the method inquestion is standard, modified or the laboratories own method and is incompliance with the International standardisation of organisations (ISO).
INABSverification and validation guidelines are based on ISO 15189 and ISO 17025. ISO15189 (Cl 220.127.116.11) for medical laboratories states, ‘Validation examinationprocedures used without modification shall be subject to independentverification by the laboratory before being introduced into routine use.’ And ISO17025 (Cl.5.4.2) for testing and calibration laboratories confirms verificationrequirements by stating, ‘The Laboratory shall confirm that it can operatestandard methods before introducing tests.’