Additionally, in its second submission, the laboratory submitted a revised quality assessment mechanism, but submitted no documentation to indicate that the revised quality assessment mechanism has been effectuated. In addition, the laboratory stated that "training on the revised QMPI procedures has occurred. (Ex. BB, Tab 7 B-C)." We note that Ex. BB, Tab 7 B-C contains incomplete training documentation (one of training records did not include the same documents consistent with the other two records) for only three laboratory personnel, none of whom appear on the laboratory's Form CMS-209 dated February 8, 2016.
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. 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.
D6094
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #2:
See our reviews 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
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Based on the personnel list provided in Ex. HH, Tab 9A, the training documentation in Ex. HH, Tabs 98 and 14-16 is inconsistent or incomplete. This deficiency referred to personnel being untrained or incompletely trained prior to testing and reporting patient results. For CLIA purposes, training and competency are two different requirements.
In the second submission, the laboratory still did not address why personnel were allowed to test patient samples without being fully trained on the TPS and in the venipuncture lab. It is not clear to CMS if training was effective since the laboratory has stated that they have stopped testing and that they were unable to find some training documents (attestations as to training were submitted in lieu of training documentation). We also note that it is unclear if training, in fact, occurred prior to reporting patient test results. Instead, some new documentation has "pending [initials] [date]" indicating that the training is pending, which includes a date prior to or after the survey. When the date reflected on the training documents (Ex. HH, Tabs 98, 14-16) is prior to the survey, it appears
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