were needed. The submission also states: "There were no significant trends or bias in patient population data." The laboratory provided no explanations for these assertions.
In addition, the laboratory's submission states at Ex. B, Tab 6: "Matrix comparisons done by the manufacturer between serum and plasma showed correlation." The laboratory submitted no documentation supporting this statement.
The submission also states that "the lab has conducted training on these procedures to ensure that the practice is consistent with them," but did not include complete training documentation.
Because the laboratory has not shown whether it can follow its own validation protocols, it is uncertain whether the laboratory's quality assessment mechanisms could monitor the laboratory's corrective actions and ensure this deficient practice does not recur.
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.
D5429
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
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 address and provide acceptable evidence of correction consisting of: what measure has been put in place or what systemic changes have been made to ensure the deficient practice does not recur; and, how the corrective action(s) is being monitored to ensure the deficient practice does not recur.
D5437
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #1 & #2
At the time of the onsite survey, the laboratory failed to maintain calibration documentation for the complete blood count (CBC) instruments. In the submission, we found no evidence the laboratory has re-established its calibration documentation for the CBC instruments.
