Assigning Reject Reason Flags; Table 4.3 Reject Reason Flags - Procleix TIGRIS Operator's Manual

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Assigning Reject Reason Flags

A reject reason flag can be assigned to a specimen after a worklist has completed processing if
an issue with the specimen is discovered. Specimens with reject reason flags are considered
manually invalidated results. When using this feature, refer to the Interpretation of Results
section and the Quality Control Procedures section of the appropriate PROCLEIX
package insert.
Note: Calibrators and PROCLEIX
operator.
To manually invalidate a result:
1. In the Worklists grid, select the worklist with the specimen to be manually invalidated.
2. In the Worklist Detail grid, select the specimen.
3. Click Reject Result....
A Reject Result Reason window opens.
4. From the Reject Reason drop-down list, select the reason for manually invalidating the
test result.
Note: Reject reason flags are used in the event that specimen acceptability was
not properly assessed prior to testing or specimen acceptability limits were not met
during testing.
Flag Description
RO Other—specify reason
Sample* age beyond package
RSA
insert limits
RSB Sample icteric
RSBE Sample barcode entry incorrect
RSC Sample collection error
* All references to "samples" in this table indicate specimens.
** Not applicable to PROCLEIX
5. If RO – Other is selected, enter the reason for manually invalidating the specimen. Up to
47 characters can be entered.
Note: Only one reject reason flag is allowed per specimen. To assign more than
one reject reason flag, select RO - Other and enter the multiple reasons.
6. Click OK.
The System updates the specimen results in the database; the reject reason flag
appears in both the Worklist Detail grid and the Results Report.
Caution: The interpretation on the run report will not change for a specimen
flagged with a reject reason flag. The Flags column must be carefully reviewed to
identify specimens with reject reason flags.
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TIGRIS Controls cannot be manually invalidated by the
®
Assays.

Table 4.3 Reject Reason Flags

Flag Description
RSH Sample hemolyzed
RSI Incorrect sample used
RSM Sample mucoid**
RSS Sample storage error
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PROCLEIX TIGRIS System Operator's Manual
Volume I: Operating the Instrument
®
Assay