1) Documentation showing what corrective action(s) have been taken for patients found to have been affected by the deficient practice;
2) How the laboratory has identified other patients having the potential to be affected by the same deficient practice and what corrective action(s) have been taken;
3) What measure has been put into place or what systemic changes the laboratory has made to ensure that the deficient practice does not recur; and
4) How the corrective action(s) is being monitored to ensure the deficient practice does not recur.
The following explanation details why the laboratory's February 12, 2016 submission does not constitute a credible allegation of compliance and acceptable evidence of correction:
D2094
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, Exhibit (Ex.) O, Tab 2 states: "The QC data are presented here: <Exhibit D Tab 7, Tab 8>." We found no "Tab 7" or "Tab 8" in Ex. D.
Although the laboratory's submitted protocol indicates that ungraded proficiency testing (PT) results will be evaluated, the submitted protocol does not explain how an investigation is performed and who must sign an investigation of ungraded PT samples.
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. Documentation contained in Ex. O, Tab 2 also compares the "Range of Means" with no explanation as to what this refers to or how it correlates to the laboratory's ungraded PT results. The submission merely indicates that "the lab has investigated this ungraded PT event for ALP [alkaline phosphatase] and has documented its investigation and conclusion."
Furthermore, a Quality Monitoring and Process Improvement (QMPI) Program Meeting Agenda, CL FRM-00045-F1, was submitted as part of Ex A, Tab 13 and only includes PT for the Alternative Proficiency Assessment (APA). Based on information included in the submitted agenda, all PT issues were not addressed as required in CL QOP-00045, Revision A (Ex. A, Tab 12) in Sections 7.2.2.6 and 7.2.2.7.
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