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

Section: 4.2.8

Question: calls for "periodic in-depth data monitoring". What is TNI's interpretation of "periodic"? ELAP suggested "Each calendar quarter the QAO audits 5 % or 5 data packages, whichever is more" in the DI plan template we provide to labs. However, the monitoring should be dependent upon the lab's scope (chemistry, microbiology, asbestos) and workload (number of samples analyzed). Does TNI leave it up to the lab to decide at what frequency they perform the monitoring?

TNI Response:  There is no definition of periodic. The laboratory must clarify its intentions for complying with this requirement in the QAM or elsewhere. If the laboratory hasn't defined its requirements sufficiently, it could be cited for failure to comply with this section.  The 2009 and 2016 standards contain the identical language. The SIR is still valid.  Adding timeliness requirements may only further confuse the issue and cause unintended consequences. The Committee feels no further action need be taken.


Question:  If a lab's QAM defined "signature" on technical records, reports and chain of custodies as the hand-written signature or electronic equivalent, would this meet the signature requirement for each of these documents?  As we upgrade our LIMS and QC software, we have the ability to electronically sign off on chains and lab documents but want to know if this would be acceptable.

TNI Response:  Electronic signatures are acceptable provided that the signature is unique to the individual.  Some states may have regulatory requirements pertaining to the use of electronic signatures.  The laboratory should ensure that state requirements are met.
Question:  Are SOPs required for procedures not performed (e.g., “legal coc”? (f) says “if required”; or subcontracting)

TNI Response:  SOPs are not required for activities that the laboratory is not required to perform. The converse is obviously true, in that you must have an SOP if you perform, or are required to perform, these activities. The first paragraph of states that SOPs must "accurately reflect all phases of current laboratory activities". Where an activity is not performed, such as legal Chain of Custody, the laboratory should not be required to have an SOP for what it doesn't do. Compliance could be demonstrated if the lab's Quality Manual states “We do not perform legal CoC, and will refuse any samples requiring legal CoC”, although this is not mandatory.  This section was edited in 2009 but the SIR is still valid. There needs to be clarification that the Standard DOES NOT apply where it has not been requested or where it isn't the regulation of the land. As it relates to this SIR, a laboratory can't be expected to have a procedure for a process that it doesn't perform. This seems to be a question of clarity, so the use of a NOTE isn't exactly an issue.