What does validation of equipment or a method mean in practice? Explain using using the example of validating a semi-automated instrument to determine patient ABO groups.
From a practical perspective, validating equipment and methods means that laboratories must demonstrate and document that equipment and methods work as expected under real-world conditions before they are implemented.
To validate a semi-automated instrument to determine ABO groups, a sample protocol would be to test an appropriate number of samples to include
- the range of sample types encountered in the lab (e.g., clotted, EDTA)
- samples with
- normal ABO groups
- ABO discrepancies (as many types as possible)
- A2 and A2B groups
- weak subgroups (if available)