18.07.14 IQC and validation of a new method

Question 1

What is IQC?

Answer 1

The activities undertaken to detect, reduce and correct deficiencies in a laboratory’s internal analytical process which gives confidence that the test if performing well. IQC provides a framework of control measures to enable deficiencies in quality to be identified prior to release of patient results

Question 2

Define validation.

Answer 2

Doing correct test
Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Question 3

Define verification

Answer 3

Doing the test correctly

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled’

Question 4

When should test validation be performed?

Answer 4

Shall be conducted prior to the introduction of new laboratory developed procedures, non-standard methods and for standard methods used outside their intended scope. Validation is also applicable where significant changes to existing methods or procedures are subsequently made that may affect the quality of outputs. Furthermore, the clinical utility of the new test should also be considered including implications of results, e.g. termination of pregnancy, inappropriate/no treatment, patient management for pre-symptomatic or late-onset disease.

Question 5

When should verification be performed?

Answer 5

applies to, for example, specific reagent kits, equipment, or commercial software applications/version updates and assesses whether the specified requirements of the kit or application have been met (BSI). Mattocks et al. (2010) and Berwouts et al. (2010) outline the implementation processes required to fulfil this requirement in detail, and present a generic framework to enable individual laboratories to systematically evaluate tests and procedures to a defined standard.