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 The laboratory failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place or what systemic changes have been made to ensure the deficient practice does not recur; and, how the corrective action(s) is being monitored to ensure the deficient practice does not recur.

Finding #2 The submission references "Ex. A, Tab 18, § 3.7.1," and "Ex. A, Tab 23, §§ 7.14, 7.15, 8.6.1, 8.6.4, 8.6.5." We found no such references contained in the materials provided to CMS.

At the time of the onsite survey, the laboratory failed to establish a written protocol for the daily review of patient specimens referred to other laboratories for testing to ensure timely receipt and reporting of test results performed by other laboratories. The laboratory did not provide such a protocol with its submission.

In addition, it is unclear as to how the laboratory's QMPI Program would ensure the establishment of written protocols for all the laboratory's processes.

The laboratory failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place or what systemic changes have been made to ensure the deficient practice does not recur; and, how the corrective action(s) is being monitored to ensure the deficient practice does not recur.

D5393 The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.

The submission references "Ex. A, Tab 23, §§ 7.14, 7.15, 8.6.1, 8.6.4, and 8.6.5." We found no such references contained in the materials provided to CMS.

At the time of the onsite survey, the laboratory failed to document the daily review of patient specimens referred to other laboratories for testing to ensure the timely receipt and reporting of test results performed by other laboratories.

In the submission, we found no written protocol as to how the daily review would be documented and no evidence this quality assessment activity had been documented since the survey.

In addition, without daily written documentation, it is unclear as to how the laboratory's QMPI Program would ensure this quality assessment activity has been completed.

The laboratory failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place or what systemic changes have been made to ensure the deficient practice does not recur; and, how the corrective action(s) is being monitored to ensure the deficient practice does not recur.

D5400

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