Term | Description | How does this help? | Comments |
Laboratory Quality Management System (LQMS) | A framework of practices, procedures and policies that support the quality of laboratory test results. | Enables quality monitoring of the end to end test process. Identifies gaps and issues to allow appropriate alerts and mitigations. | For the overarching principles of LQMS, see Laboratory quality management system: handbook.7 |
Validation | A process and practice to ensure the test (and test system) is performing as expected within a particular setting. | Provides confidence, locally that the test/test system is robust in the hands of a specific team and environment. | Please note that the terms validation andverification are sometimes used interchangeably. However, the principles are sound: ensure the test is working as expected in a particular environment and then continue to monitor its performance. International performance criteria on which HPV test performance is adjudicated exist. If the test is to be used for routine cervical screening. It is recommended that a test which is clinically validated according to these criteria is used.13 Regulatory claims for tests labeled as ‘diagnostic’ can help provide confidence in the assay. However, local validation is important to ensure that the test is performing as anticipated in a particular laboratory environment. Application of diagnostic test that is used ‘off label’ in a way that deviates from the instructions for use requires validation. |
Re-verification | A process to ensure the test continues to perform as anticipated in perpetuity. | Provides confidence that the test/test system is robust and working stably within a particular environment. | Re-verification schedule depends on local policy and real-time changes. Re-verification schedules may also depend on how frequently a test is performed and its complexity. Justification for the timing of a re-verification should be clear and reflect the demands and complexity of the specific test/process. |
Internal quality control (samples) | A practice to ensure day to day consistency of a test in its ability to meet anticipated and acceptable performance. | Provides confidence that the test/test system is robust on a day to day basis, provides insight into real-time issues. | Independently sourced internal quality control samples should be run in addition to those that may be prescribed by the manufacturer according to instructions for use. Internal quality control samples can be produced locally or sourced from independent providers and should reflect the sample being assessed routinely as closely as possible. If the HPV assay provides a quantitative or semiquantitative output this can be plotted and assessed to monitor assay drift. Tolerances should be defined, and deviations investigated. |
External quality assurance (external quality assessment) scheme | A scheme designed to confirm the accuracy of a test through provision of samples by an independent source, which is tested by the internal operators ‘blind’ to the expected result. | Independent assessment of assay performance. In addition to individual performance reports, the overall, international report generated by the scheme allows laboratories to assess and contextualize their performance relative to others. | For formal external quality assessment, the scheme provider controls the process of scheduling, dissemination, and scoring. For current examples of external quality assessment schemes see Table 2. Residual material from external quality assessment panels can support reagent-acceptance testing and re-verifications. |
Inter-laboratory schemes | A scheme operated by a network of laboratories to determine test accuracy and consistency; can involve reciprocal exchange of material(s) or rely on provision of material from a central source/laboratory. | Can build relationships and dialog with partner laboratories. Can complement external quality assessment or serve as a proxy for external quality assessment if participation in a formal scheme is not possible. Can be made bespoke (in terms of biospecimen) for a particular. test/application | Inter-laboratory schemes may be particularly beneficial at the ‘start’ of a new service supported by one or more laboratory within a particular setting. |