• Critical evaluation of testing devices which provide results appropriate to clinical requirements (i.e. is the chosen device fit for purpose ?)
• Pre-analytical considerations
o Instructions for patient preparation and sample collection
o Patient safety and risk management
o Operator training and on-going competency assessment
• Analytical considerations
o Frequency and type of quality control (QC)
o Recording of QC, action limits and procedures to be followed with QC failure
o External quality assessment (EQA) procedures
o Device maintenance and performance records
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