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Standard Interpretation



Standard: 2016
Section: V1M4, Section 1.5.2.1.2 and 1.5.2.2.2 (b)


REQUEST:

This question relates to failures of the ongoing verification of the DL and LOQ:

For the DL, the standard states: "In the event that verification fails, the laboratory shall perform a new DL study within thirty (30) calendar days". Is the laboratory allowed to perform analyses and report data according to the old DL and without qualification during this 30 calendar day period or must it cease analysis until the new DL study is performed?

Similarly for the LOQ one of the options for a failed verification is: "...raising the spiking level (and the quantitation limit if the spiking level is above it) and repeating the initial verification study within thirty (30) calendar days of the initial failure." Is the laboratory allowed to perform analyses and report data according to the old LOQ and without qualification during this 30 day calendar period or must it cease analysis until the LOQ study is performed?

Thank you.

TNI FINAL RESPONSE:

V1M4 does not preclude a laboratory from performing analyses and reporting data according to its old (current) DL during the 30-day calendar period after a DL verification failure in which it is performing a new DL study. Nor does V1M4 require qualification of data or cessation of analysis during this same period.

V1M4 does not preclude a laboratory from performing analyses and reporting data according to its old (current) LOQ during the 30-day calendar period after an LOQ verification failure in which it chooses to perform a new initial LOQ verification study at a higher spiking level. Nor does V1M4 require the cessation of analysis during this same period. V1M4 Section 1.5.2.2.2 b does, however, require the re-analysis of samples or the qualification of data reported for any samples analyzed in a batch associated with a failing LOQ verification.