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 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.
Findings #5
In the submission, the laboratory states: "Corrected [LH] reports to be sent for patient samples analyzed for the following time period: 7/1/2015-7/8/2015; all patient samples analyzed in 8/2015 and 9/2015." However, later in the submission, the laboratory concluded that "[b]ased on this review, 0 corrected reports are being issued." From these conflicting statements, it is unclear whether the laboratory addressed patient outcomes. The laboratory provided no documentation to indicate that corrected LH (luteinizing hormone) patient reports were issued.
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 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.
Finding #6
In the submission, the laboratory references "Ex. D, 1" and "Ex. D, 2-8." Ex. D, 1 and Ex. D, 2-8 relate to the laboratory's HCG testing, and not CA-125 testing, the analyte in the cited deficiency. However, the laboratory's CA-125 testing was found in Ex. C, Tabs 1 - 4. We considered those results in reaching the following conclusions.
In the submission, the laboratory states:
- "All patient results reported > 472 U/ml will need corrected reports."
- "Based on this review, 122 corrected [CA-125] reports are being issued to reflect the verified reportable range.”
The laboratory provided no documentation to indicate corrected reports were generated and issued. 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
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