Requirements for molecular testing in a clinical laboratory:
(1) The selection of the test menu is appropriate for the level of expertise and resources available in the laboratory.
(2) Laboratory personnel have enough training to perform and interpret the testing appropriately and reliably.
(3) Technical requirements have been met (see below).
(4) The laboratory director or consultant is able to interpret and use the results so that they are clinically useful, including
(4a) understanding of legal and regulatory issues
(4b) recognition of technical pitfalls
(4c) able to recommend additional and/or confirmatory testing
(4d) able to explain the significance of findings to clinicians
(5) The cost of testing is justified.
Technical requirements include:
(1) Specification of appropriate and inappropriate specimens.
(2) A collection device has been selected that avoids false positive or negative results.
(3) Specimen collection and handling avoid conditions causing false positive or negative results.
(4) The laboratory testing locations have been selected to prevent false positive and negative results.
(5) Proficiency testing and controls are used to ensure reliable results.
(6) There is ongoing education and competency assessment.
