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Standard Interpretation



SIR #: 10009
Standard: 2003 NELAC
Section: 5.5.8.3.1
Link to relevant standard

REQUEST:

The test method specifies thermal preservation at a temperature of 4 C. The samples are hand delivered on ice to the lab on the same day as they are taken. They are received on ice, but the samples taken at the end of the sampling route may have only been chilling 15 - 30 mintues and may not be at or below 6 C as specified by the test method. The NELAC sample receipt protocol in 5.5.8.3.1 states that such samples may not meet the temperature criteria and that in such cases, the samples shall be considered acceptable. The question has arisen as to whether under these circumstances, documentation of receipt on ice is sufficient to meet the method and preservation documentation as the protocol implies, or does the actual sample receipt temperature still have to be recorded? What is the purpose of recording a temperature that is clearly acknowledged as likely to be outside the acceptance criteria if the sample is clearly deemed acceptable as described above. Would recording such temperature data actually make the data more susceptible to challenge by a third party?

TNI FINAL RESPONSE:

(Quality System Expert Committee/NELAP Board, 10-11-09)

The allowance for samples exceeding temperature requirements when delivered shortly after sampling does not alleviate the requirement to record a temperature, even in the presence of ice. No, documentation of receipt on ice is not sufficient to meet method requirements, since methods require the temperature upon receipt. Methods and regulations require that the temperature upon receipt be recorded, regardless of whether that information is in compliance or out of compliance. This should not make the data more susceptible to challenge, since it is clearly allowed as an exception.