SIR #: 204
Standard: 2009 TNI
Section: V1M4, Section 126.96.36.199
Section 188.8.131.52 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 184.108.40.206 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 220.127.116.11.