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As a member of the scientific team delivering a molecular based diagnostic laboratory service you have been asked to introduce a new test. How would approach this challenge in the context of meeting relevant standards?
The introduction of a new test will require the stepwise consideration of the following:
1. Understanding of the clinical requirement together with the expected specificity and sensitivity of the test.
2. Gather information as to available options to undertake the test and rank these against the expected specificity and sensitivity first. Consider ease of use (potentially indicating reliability) integration with existing systems within the laboratory and cost.
3 If the test requires new equipment then this must also be factored in. Assessment should be based on performance, cost, integration into LIMS, servicing and support and overall cost, inclusive of reagents, over a minimum five year period.
4. The introduction of new equipment may not only be expensive, but it could bring about a significant delay in offering the new test. At this stage the practicality of referring the test to another laboratory could be proposed as a temporary or alternative option to in house testing.
5. Assuming that steps 1 to 4 have been completed and reagents and suitable equipment are available then the validation process can commence. It may be possible to run more than one method. In this situation choice can be made as to which one best meets the test requirements.
6. Once validation has been successfully completed write the Standard Operating Procedure for the test and introduce or adapt record forms that are required. Gain approval for these and integrate them into the Quality Management System.
7. Train staff to undertake the new test and formally record that this has been done.
8. Introduce the new test to the clinical staff that had identified its need.
9. Begin to run the test in the laboratory and closely monitor performance using internal controls.
10. Participate in an External Quality Assessment scheme for the test and, if required, act on performance feedback without delay.