===Participation=== -Refer to LIS->tables->scope for interlaboratory comparison strategy used for individual examinations [[/cl_general|Login to LIS]] -In general one of the following is used - [[RIQAS]] - [[QAForum]] - [[exchange of samples with other laboratories]] ===Monitoring=== The laboratory monitors the results of the interlaboratory comparison programme(s) and participate in the implementation of corrective actions when predetermined performance criteria are not fulfilled. NOTE: The laboratory participates in interlaboratory comparison programmes that substantially fulfil the relevant requirements of ISO/IEC 17043. The procedure ensures that interlaboratory comparison participation includes defined responsibilities and instructions for participation, and any performance criteria that differ from the criteria used in the interlaboratory comparison programme. Interlaboratory comparison programme(s) chosen by the laboratory , as far as possible, provides clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre-examination procedures, and post-examination procedures, where possible. 5.6.3.2 Alternative approaches Whenever an interlaboratory comparison is not available, the laboratory develops other approaches and provides objective evidence for determining the acceptability of examination results. Whenever possible, this mechanism utilizes appropriate materials. NOTE: Examples of such materials may include: certified reference materials; samples previously examined; material from cell or tissue repositories; exchange of samples with other laboratories; control materials that are tested daily in interlaboratory comparison programmes. 5.6.3.3 Analysis of interlaboratory comparison samples The laboratory integrates interlaboratory comparison samples into the routine workflow in a manner that follows, as much as possible, the handling of patient samples. Interlaboratory comparison samples are examined by personnel who routinely examine patient samples using the same procedures as those used for patient samples. The laboratory does not communicate with other participants in the interlaboratory comparison programme about sample data until after the date for submission of the data. The laboratory does not refer interlaboratory comparison samples for confirmatory examinations before submission of the data, although this would routinely be done with patient samples. 5.6.3.4 Evaluation of laboratory performance The performance in interlaboratory comparisons are reviewed and discussed with relevant staff. When predetermined performance criteria are not fulfilled (i.e. nonconformities are present), staff participates in the implementation and recording of corrective action. The effectiveness of corrective action is monitored. The returned results are evaluated for trends that indicate potential nonconformities and preventive action are taken. 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: Replicate testing Examination of split samples (within the laboratory) Use of reference methods & materials, where available 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.