In the submission, the laboratory states:
- "07/16/2015: Level 3 QC outside manufacturer's recommended range, and not repeated, therefore level 3 QC was out of control for the day"
- "09/01/2015 to 09/13/2015: all level 3 control results are outside the manufacturer's recommended range (negative bias)"
- "10/01/2015 - 10/31/2015: all level 3 control results are outside the manufacturer's recommended range (negative bias)"
- "All 3 levels of QC were not run on 11/04/2015, 11/05/2015, 11/07/2015, 11/08/2015, 11/09/2015, 11/10/2015, 11/12/2015, 11/14/2015, and 11/15/2015" [The laboratory provided no information as to whether patient HCG specimens were tested on the November dates listed.]
Yet, the laboratory concluded: "Results for urine HCG are quantitative with a cut off of 30 mUI/ml. Because of the nature of this assay no correct reports are required."
Since QC failures may indicate possible test system problems and it is unknown as to how the HCG (human chronic gonadotropin) test results were used and interpreted, we question the laboratory's conclusion and the accuracy and reliability of any patient HCG test results reported on the July, September, October, and November dates listed.
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 #4
In the submission, the laboratory states:
- "Anti-HBs is a qualitative assay with a positive cutoff of 11 so no corrected reports are required."
- "Qualitative assay will not require corrected reports to be issued"
We are unclear as to how the laboratory came to these conclusions and the submission does not contain any documentation to support these statements.
Nevertheless, 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
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