Is it necessary to perform method verification studies before using a non-waived instrument on loan from the manufacturer ('loaner' instrument)?

Any examples are for illustrative purposes only.

Although it is not necessary to repeat the extensive verification study performed when the method was originally evaluated, at a minimum, studies should be performed to determine the accuracy, reproducibility, and the reportable range of the "loaner" instrument. The accuracy can be verified by testing materials with known values for the analyte(s) such as quality control materials, calibration materials, or proficiency samples. The same materials, if properly selected, can be used to verify that the instrument is capable of accurate results across the reportable range(s) of the analyte(s). At least the low, middle, and high levels of the reportable range(s) should be checked. Reproducibility can be determined by replicate testing of quality control materials.

A sufficient number of replicates should be performed to determine the precision of the method. For those instruments with internal quality control capability, the reliability of the internal quality control must be evaluated. This can be accomplished concurrently with the reproducibility studies if external quality control materials are used for those studies in parallel with the internal quality control. The laboratory director or technical supervisor must approve the results of the abbreviated validation study before the instrument is used for patient testing and must determine the frequency of the external quality control requirements.

NOTE: This FAQ does not apply to waived instruments or methods. Verification of waived instruments or methods should be conducted to the extent determined by the laboratory director or technical supervisor.