All CLIA certified laboratories are required to "demonstrate that prior to reporting patient tests results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer. The laboratory must also verify that the manufacturer’s reference range is appropriate for the laboratory’s patient population."

Many laboratories perform a series of experiments designed to estimate certain types of analytical errors, e.g., a linearity experiment to determine reportable range, a replication experiment to estimate imprecision or random error, a comparison of methods experiment to estimate inaccuracy or systematic error, or interference and recovery experiments to specifically estimate constant and proportional systematic errors (analytical specificity), and a detection limit experiment to characterize analytical sensitivity.

MSCL assists hospital clients with their method validation studies by providing:

• routine, special and rare samples for testing
• advice and remote troubleshooting, when possible.

There is a nominal fee to cover retrieval, shipping and handling.