Medical
scientists in the clinical chemistry laboratory work predominantly with highly
automated in vitro diagnostic methods to detect and measure any biochemical
changes in the body. It is the detection and understanding of these changes that
is necessary in the evaluation of patient health and diagnosis of disease. It
is the role of the laboratory to provide accurate analytical results for their
patients and are required for compliance with international regulations.

  The introduction
of new instrumentation and analytical methods requires validation and
verification studies to ensure they meet acceptable standards of performance for
use in the clinical chemistry laboratory. (Hartmann, 1983) Undoubtedly such automated
analysers are vigorously validated by the manufacturers prior to use in the
clinical settings. However, these methods must be re-validated by a senior medical
scientist to verify that the data obtained from the manufacturer can be repeatedly
reproduced in a clinical setting.  

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Validation
and verification of methods can be approached several ways depending on the
laboratory. There is no general agreement regarding the extent of the evaluation
procedures needed, however, international organisations and regulatory authorities
have published guidelines for the minimum verification requirements. It is imperative
that these guidelines are incorporated into method validation. INAB (The Irish
National Accreditation Board) is responsible for the accreditation of testing laboratories
in Ireland, ensuring they are on par with testing laboratories in other
countries. The extent of validation required depends on whether the method in
question is standard, modified or the laboratories own method and is in
compliance with the International standardisation of organisations (ISO).

INABS
verification and validation guidelines are based on ISO 15189 and ISO 17025. ISO
15189 (Cl 5.5.1.2) for medical laboratories states, ‘Validation examination
procedures used without modification shall be subject to independent
verification by the laboratory before being introduced into routine use.’ And ISO
17025 (Cl.5.4.2) for testing and calibration laboratories confirms verification
requirements by stating, ‘The Laboratory shall confirm that it can operate
standard methods before introducing tests.’