E: Level II Laboratory Certification
Laboratories can obtain documentation from the manufacturer of their system's performance and traceability to the DCCT, i.e. documentation of NGSP certification. However, a manufacturer's demonstration of a product's traceability (NGSP certification) does not in itself guarantee the accuracy and precision of that product in the hands of every user (clinical laboratory). Laboratories using methods that are not certified must take primary responsibility for establishing that system's traceability to the DCCT. Therefore, laboratories may also participate with a Network laboratory (SRL) to document traceability through a laboratory certification process. The certification process and the certification criteria for Level II laboratory certification are the same as that for manufacturers as outlined in section C. Laboratories are awarded Certificates of Traceability for successfully completing fresh sample comparisons for the specific method, reagent lots, calibrator lots and instrumentation used. Traceability to the DCCT applies only to results from fresh or fresh frozen blood samples. Analysis of processed (e.g. lyophilized) material may be subject to matrix effects and any comparisons to the DCCT using results from processed specimens should be made with caution.