When a laboratory report must be corrected, and the amended results are sent to the ordering physician, questions may be raised regarding the quality of the laboratory work; the proper operation of the instrumentation involved; the competency of the testing staff, and whether the laboratory director or technical consultant/supervisor were fulfilling their oversight responsibilities.
While the report is the end result of the testing process, the reasons for the release of an erroneous report must be investigated, and the investigation may need to go all the way back to the pre-analytical phase, from test ordering to specimen collection and handling, through the analytical phase (instruments/reagents/staff competency), to the post-analytic phase that includes verification of the LIS (lab information system) for automated and manual results transfer.
Of course, erroneous reports may be due simply to a manual transcription error, initial verbal reports that were misunderstood; or a manual patient mix up. But as simple (though serious) as these are, the reasons these occurred at all still indicates a problem that may involve the core issues of oversight , training, communication and documentation.
There needs to be a formal laboratory policy and procedure for the correction of erroneous laboratory reports (after the correct results are obtained), and for sending amended reports as soon as possible.
These should include the following policies:
1. Identify who to notify when the error is detected?
2. Document all steps taken to correct the error;
3. Provide the ordering physician with the corrected report;
4. Retain the original report and the corrected report for future reference
5. Perform a Root Cause Analysis if systemic issues are involved; if serious enough, perform an Incident Management study.
6. Alternative contact plans if the laboratory is unable to reach the ordering physician or provider in a timely manner.
7. Inclusion of this event as part of Quality Assessment; include follow up to ensure that the corrective actions taken were effective.
Following these policies and procedures will ensure a consistent quality laboratory response when erroneous reports are issued.