Alternative approaches

For those tests where a formal EQA is not available, the laboratory shall adopt alternative approaches to validate performance. Such alternative approaches are:

  1. Replicate testing
  2. Examination of split samples (within the laboratory)
  3. Use of reference methods & materials, where available
  4. Exchange of samples with other accredited laboratories

When the laboratory exchanges samples with other laboratories as an alternative approach to EQA participation, following needs to be addressed:
In the case of comparison between 2 laboratories, one will function as the “reference laboratory” against which the other will be compared. This is to be documented as an MoU
When there are several laboratories, compare the result against the “reference laboratory”
The results obtained shall be compared statistically and for guidance, the laboratory may refer to the most current edition of CLSI document EP9 - Measurement Procedure Comparison and Bias Estimation Using Patient Samples.