direct observation, was approved. It is also unclear why the training documentation is not consistent for all trainees.
We note that the updated procedure, "Training and Competency, Rev. C," includes the requirement for direct observation(§§ 6.9.4.1 and 6.9.4.4), but the Training and Competency Form (CL FRM03016-F2) does not reflect this procedural requirement. For the purpose of this review, item "(6)" on the Training and Competency Form would best indicate where the direct observation should be reflected. Review of the submitted training documentation (Ex. BB, Tab 9B) indicated that one of 13 testing personnel had not been trained, and that at "(6)," all training had been by VE (verbal explanation) or RR (record review), not direct observation.
The laboratory's April 1, 2016 portion of the submission states that competency records were included "for the tests [testing personnel] are performing" (page 90), but does not address the incomplete competency records for the instruments the testing personnel were using at the time of, or prior to the onsite survey.
The laboratory again failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information as set forth in our January 25, 2016 and March 18, 2016 letters. In addition, the laboratory again failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place, what systemic changes have been made to ensure the deficient practice does not recur, or how the corrective action is being monitored to ensure the deficient practice does not recur.
D6168
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our reviews of D6170 and D6171.
D6170
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
In its second submission, the laboratory states:
The "review" discussed in the submission was simply intended to refer to the analysis conducted to address the deficiency identified by CMS. The issue addressed by the "review"—i.e., failing to document corrective action for QC fails for the Fortessa and Canto—is the same issue identified by CMS in its deficiency, and thus did not constitute a new issue or occurrence.
As in the first submission to CMS, the laboratory again provided no documentation of investigation or corrective action for the "review" in the current submission.
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