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

Section: 5.1-5.2

Question:  I am confused about the PT requirements for labs doing WET analysis.  The only 'true' PT is the DMRQA - but it runs longer than 45 days - which doesn't meet F.2.2 requirements.  I need to know will the DMRQA be allowed and counted as a PT until such a time as the PT providers have other PTs available?

TNI Response:  The 2009 standard extended the time period to 90 days. The 2016 standard removes all references to study dates for WET testing.  The SIR no longer applies to the 2009 or 2016 standards. Section 5.2.2 of 2016 V1M1 for WET testing: To maintain accreditation the laboratory shall participate in one (1) WET PT study per calendar year for each accreditation FoPT that correspond to the fields of accreditation for which the laboratory is accredited. a) This requirement can be met by annual participation in the EPA DMRQA studies for WET, or b) If the laboratory is not participating in an EPA DMRQA study for WET, the closing dates of subsequent PT study samples for WET testing PT studies must be no more than fourteen (14) months apart.

Question:  NELAC 2003 2.7.2 says, "For continuing accreditation, completion dates of successive proficiency rounds for a given field of proficiency testing shall be approximately six months apart.  Failure to meet the semiannual schedule is regarded as a failed study."   TNI V1M1 4.2.1 says, "The analysis dates of successive PT samples for the same accreditation FOPT shall be at least five months apart and no longer than seven months apart unless the PT sample is being used for corrective action to establish successful history …"  There is no language to describe what happens after 7 months have passed.   The sentence is missing from TNI that was in NELAC that directed or allowed the addition of a "failed study" when the semiannual requirement was not met.  Is it the intent of the standard for ABs to continue treating a failure to meet the semiannual schedule as a failed study?  This is a significant enforcement issue since a potential alternative seems to be in V2M2, 10.3:  "The Primary AB shall revoke the accreditation of a laboratory for a FoPT when: (a) the laboratory does not participate in the PT program as required by this Standard."  This penalty is too severe and problematic for what could be just a missed deadline.

TNI Response:  If a laboratory fails to report a single proficiency testing result it is evaluated as "not acceptable" per V2M2 7.3 part b. If the laboratory fails to report results for 2 out of 3 proficiency testing study time frames, then the laboratory's accreditation shall be suspended per V2M2 10.1 for failing to participate in the timeframes specified in the standard.The language has been clarified in the 2016 standard. Section 5.2.3 of V1M1 states a laboratory that fails to analyze and report PT studies for a particular field of accreditation with the frequency specified in Sections 5.2.1 or 5.2.2 for which it seeks to maintain accreditation is charged with a failed PT study. The SIR is likely obsolete.