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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard

Section: 5.10.11

Question:  Our question for TNI concerns the documentation of the laboratory’s scope of accreditation in the test report.  In this situation, our laboratory is licensed for a small number of tests in the State of Minnesota, which is adopting the NELAC Standard.  Our laboratory is licensed for a full scope of parameters in the State of Arizona, a non-NELAC state.  In Section 5.10, is there a requirement for qualifying data that is not included in the laboratory’s scope of accreditation?  If there is a requirement (either directly or implied), how should the laboratory indicate the lack of NELAC licensure on the Arizona-only parameters in order to comply with the NELAC Standard?  Is it sufficient to include a disclaimer on the cover page of the reports for Arizona-only work that indicates the data may only be used for compliance purposes in the State of Arizona and not in NELAC states?

TNI Response:  Based on the standards quoted above, if the laboratory is issuing a report and the report has results that are not accredited under NELAP, you must identify those methods that do not meet the NELAP requirements (i.e., methods certified by another accrediting body). The committee cannot comment on reports that are issued for Arizona compliance purposes.


Question:  In the analysis of samples for pH, our buffer range is 2 through 12.  Does that mean we need to flag any values outside this calibration range?  Is "J" appropriate?  or a flag identified as "outside calibration range"?   FYI - our analyst found a reference that states that negative values for pH are possible...and she actually got a sample like that last week from mine waste.

TNI Response:  The result must be qualified to indicate that it is outside the calibration range. The use of flags to qualify data is dependent on the client requirements and state regulatory requirements. The committee cannot comment on the specific qualifier that is appropriate to use, as the use of qualifiers varies.