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Standard Interpretation



SIR #: 204
Standard: 2009 TNI
Section: V1M4, Section 1.5.2.1


REQUEST:

Section 1.5.2.1 Limit of Detection (LOD) in its opening sentence states: "If the laboratory is not reporting a value below the Limit of Quantitation, a Limit of Detection study is not required." Does this opening statement supercede, nullify, lessen and/or somehow impact on the requirments found in 1.5.2.1 d), e) and f)? To paraphrase, if you do not report a value below the Limit of Quantitation does a laboratory still have to initially determine the LOD, perform an LOD each time there is a change in the method or the instrument and/or verify the LOD annually. There is a need for clarity the standard and obtain an standards interpretation of this section of the standard as it pertains to the above question.

TNI FINAL RESPONSE:

(Quality Systems Expert Committee and NELAP AC, 1-20-14)

If the laboratory is not reporting a value below the Limit of Quantitation, a Limit of Detection study is not required, unless specified by the reference method. This statement supersedes any requirements that follow in Section 1.5.2.1.