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Safety Lab Validation Checklist

Summary

This page contains some of the checks customers should make sure are in place when validating their Laboratory Interface with ClinSpark.

HL7 content

  • Check if all the fields in the hl7 order file are completed as per expectations. The safety lab likely shared specifications for this.

  • Check if the data available in the Study > Lab data screen matches the data in the hl7 result file.

  • Ensure at least once, that all different tests have been exchanged with the laboratory and that results are returned for each test requested. This way you assure that there is full clarity on the test names/results that the laboratory returns for the specific test.

  • Ask the lab to perform at least one additional test in addition to the tests ordered. Check if the result of that additional test ends up successfully in ClinSpark.

  • Comments made by the lab technician need to end up (through the result file) in the Study > Lab data screen in ClinSpark.

  • Ensure the barcodes in the hl7 files correspond to the barcodes as available on the labels of the corresponding samples.

  • Do you need to transfer specific subject related information through the order file? Race, Sex, etc. Check if the information is transferred as per the requirements set out by the lab.

  • Are LOINC codes required in LB domain? Check if the lab provides the codes through the results file, and that these appear as expected in the ClinSpark UI

Requisition PDF

  • Check to see that the data about the order is accurately represented on the PDF

Barcodes

  • Ensure the barcode matches the expectations set by the Laboratory LIMS and/or the analyzers attached.

Things to take into account:

  • Length of the barcode

  • Can the barcode be read by the analyzers (if no relabeling is to be performed)

  • Does the barcode need to contain the specimen code?

Reporting

  • Check if the LB tab in the Transfer Data reports the laboratory data as per expectations.

Round Trip Flow

  • Send an order which has multiple samples for the same subject and same study event. ClinSpark uses unique barcodes for these samples, and it is critical to verify that the LIMS is configured to expect this

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