The submission references "Ex. I, Tabs 2-6." We located these tabs, but found no documentation in Tabs 2, 5 and 6.
In Ex. I, the laboratory provided lists of patient specimen accession numbers for which the laboratory intended to issue corrected test reports. The laboratory provided no documentation to indicate corrected reports were issued. We also note that the Patient Impact Assessment (Ex. I, Tab 1) states that "remedial action was taken on 9/25/15," but "corrected reports were issued beginning on 11/10/15 and completed on 11/12/15." There was no explanation as to why there was such a long period of time between the remedial action and issuing corrected reports.
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.
D6076
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our review of D6083, D6085, D6086, D6093, D6094, D6098, and D6102.
D6079
Based on the laboratory's submission, this requirement is met.
D6083
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our review of D5413 and D5791.
D6085
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our review of D6115.
D6086
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