In Ex. E of the submission, the laboratory provided the following "medical decision limits:"
| Deficiency: | <20.0 ng/mL |
| Insufficiency: | 20.0 - 29.0 ng/mL |
| Sufficiency: | 30.0 - 100.0 ng/mL |
| Possible Toxicity: | >100.0 ng/mL |
We were unclear as to the laboratory's definition of "medical decision limits." No definition of this phrase was found in Section 3—Definitions of the "Method Validation" protocol. In addition, no reference to CLSI EP28-A3 was found in the submitted protocol. We also note that the submitted protocol does not include a reference to "medical decision limits" as a criterion for determining reference range.
Since the laboratory provided no definition of "critical medical decision level," no information regarding the laboratory's disparity between the reference range (9.3 47.9 ng/mL) in the validation documentation and raw data reports, and no explanation as to how a Vitamin D level could be both normal and deficient or insufficient, it is unclear as to whether the laboratory has followed its own "Method Validation" protocol set forth at Section 8.4.
Throughout Ex. E, the laboratory provided a list of patient specimen accession numbers for which the laboratory "identified reports," but did not specify or submit documentation to indicate whether corrected reports were generated and issued.
Because the laboratory has not shown whether it could follow its own validation protocols, it is unclear whether the laboratory's quality assessment mechanisms can monitor the laboratory's corrective actions and ensure this deficient practice does not recur.
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.
D5801
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
The submission references "Ex. I, Tabs 2-6." We located these tabs, but found no documentation in Tabs 2, 5 and 6.
In the submission, the laboratory states:
Before PT/INR testing resumes, the lab will also prepare a revised assay-specific procedure for PT/INR to reinforce that the International Normalized Ratio (INR) must be calculated accurately prior to reporting patient test results. The relevant testing personnel will be required to demonstrate competency to ensure the practice is consistent with these procedures.
29
