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2.1 Assuming no resource or space limitations how would you set up a laboratory dedicated to PCR analysis?
The key point to address is the segregation of sample preparation and PCR analysis so as to avoid the possibility of cross contamination. To accomplish this, the laboratory should be designed around a one way work flow with the two areas being physically separate and self-contained in equipment that will include machines and manual handling equipment, such as pipettes, and computers.
2.2 How do the Quality Management Cycle and Quality Management System interact with each other?
The Quality Management Cycle (QMC) is dynamic and responsive to customer requirements and feedback, internal monitoring and external quality assessment and to changes required by accreditation standards. The Quality Management System will reflect all of the QMC inputs in the provision of an up to date document system covering the operation and organisation of the molecular laboratory.
2.3 What performance criteria must be addressed to validate a new diagnostic test?
The performance criteria are specificity, sensitivity and consistency. These must match specified standards that are available for the test. In instances where the equipment and reagents it uses are both new then the combination will require validation as a whole.
2.4 How should equipment, reagents and consumables be confirmed as suitable for use?
The unifying requirement is that complete and up to date records are available. For equipment this must include those for service and regular performance checks. For reagents and consumables records must show that they are in date, they have been stored correctly and have are being used with appropriate tests.
2.5 How can the published External Quality Assurance results for individual schemes assist in promoting the performance and development of a participating laboratory?
As part of the feedback provided to participating laboratories analysis is provided as to the ranking of methods used for External Quality Assessment (EQA) runs. Laboratories will be able to compare their method with others and in the instance where a protocol returns a higher score consider its adoption. In instances where superior results are associated with the use of different equipment the EQA result tables can be used as supportive evidence for new capital investment.