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.
D5024
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our reviews of D5403, D5437, D5447, D5469, D5481, D5779, and D5801.
D5217
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Some documents pertaining to this deficiency referenced in the submission were not included. Specifically, the submission references "Ex. A, Tab 4, § 7.1.2.2.d.2." We found no such reference contained in the materials provided to CMS. In addition, Ex. O, Tab 2 includes documentation stating: "The QC data are presented here: <Exhibit D Tab 7, Tab 8>." We found no "Tab 7" or "Tab 8" in "Exhibit D."
In the submission, the laboratory concludes:
- "Not enough patient data available for meaningful analysis"
- "No evidence of systemic errors"
- "No patient impact is expected"
However, no information as to how the laboratory came to these conclusions related to patient outcomes was submitted.
The laboratory states in Ex. O, Tab 1 that no peer data was available for the Siemens Immulite 2000. Based on lack of a peer group, the laboratory should compare its results to the "All Participants" values for troponin. Review of the laboratory's values versus the "All Participants" values shows that four of five of the laboratory's troponin values for the second proficiency testing event of 2014 were unacceptable when compared to the "All Participants" acceptable ranges. It appears the laboratory reviewed all of the mean values for all peer, instrument and method groups in order to determine an inappropriate acceptable range for its samples based on data not related to the "All Participants" values.
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.
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