D6093
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #1
See our review ofD5447, D5449, D5469, D5477, D5481, and D5779.
Finding #2
See our review of D5481.
The submission references "Ex. I, Tabs 2-6." We located these tabs, but found no documentation in Tabs 2, 5 and 6.
The laboratory's submission did not include an explanation or documentation of an investigation regarding the adjustment of QC ranges.
To ensure the deficient practice does not recur, the laboratory indicated that quarterly audits will be performed and suggested that the audits results would be reviewed within the laboratory's QMPI Program. However, the laboratory did not establish the procedure by which these quarterly audits are to be conducted. In its submission, the laboratory indicates that a "tracer audit may [emphasis added] be used," but did not provided a protocol for a "tracer audit," the means by which a "tracer audit" would be documented, and whether the results of a "tracer audit" would be the information reviewed by the QMPI Program.
The laboratory failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information set forth above and in our January 25, 2016 letter.
D6094
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #1
See our review of D5391, D5393, D5791, and D5793.
Finding #2
See our review of D5413, D5481, D5801, D5805, and D5821.
D6098
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our review of D5805.
D6102
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