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Standard Interpretation



Standard: 2016
Section: V1M1, Section 5.2


REQUEST:

Section 5.2.3 states that a study that does not meet the criteria of at least 7 days and no more than 7 months between the close of the previous study and open of the subsequent study is charged with a failed PT study.

Section 5.2.1.2 states that studies which are closer than 7 days from the closing date of the previous study are invalid for the purposes of compliance with this Standard and are not counted toward the laboratory's PT history of the most recent 3 attempts.

So is a study that fails the 7 days or greater criteria invalid or failed? For example, a lab has 3 PT studies; #1 opening 8/28 closing 9/21, #2 opening 9/26 closing 10/6, #3 opening 10/13 closing 10/24. Would study #2 be invalid and not counted as 2 of 3 or would it be a failure?

TNI FINAL RESPONSE:

Section 5.2.1.2 c) reads "any study that does not meet the 7-day wait time between the closing date of one study and the opening date of another is invalid and is not counted toward the laboratory's PT history of the most recent three attempts".

Using the examples provided with the question, Study 2 is invalid and is not counted toward the laboratory's PT history. Since it is not counted, it isn't judged as a failure.