Reviewing Lab Tests with Updated Results

Summary

A lab test review status is always set to either Reviewed or Unreviewed. The standard workflow for tests is that they are first set to an Unreviewed status once the order has been created and submitted to the lab. Once a test result is made available from the lab, and the associated panel order status is marked Complete, users are then able to perform reviews against the tests in the Study > Lab Data area. At that point, the status of a given test can change from Unreviewed to Reviewed.

Sometimes however, a lab test that was previously marked as Reviewed may have the results changed. This could happen one of two ways:

The lab sends over a new or updated set of results by way of the interface. This is the most common scenario.
The test result is manually updated by a qualified user in the ClinSpark user interface, via specimen result review areas. This is not common.

Updated Results via Lab Interface

Whenever a lab posts new or updated results via the interface, ClinSpark by default will always force a re-review of those tests. This is due to a conservative stance taken on test results reported by labs, to ensure that any new/changed results received are reviewed for potential safety concerns. Under this condition, and new/changed tests will have their status set back to Unreviewed and will also appears as such in various dashboard components.

The following screencast demonstrates the forced re-review process with a simple example.

https://www.loom.com/share/fc07850f73034ae8abd9114c114e0584

Updated Results via Manual Changes

Whenever lab test results are manually updated, ClinSpark does not force a re-review of those tests. This is by design. The changes where this can occur are within the Lab > Orders > Specimen > Panel Result > Lab Test Details area.

The need for a qualified user to make a modification to reported results from the lab is very rare. This typically is only necessary if/when a lab is unable to provide updated result files by way of interface, or, when it’s desired to make a change to a specific test result without the need for new/updated results to be sent by the lab (which would force a re-review of the panel).

Scenarios Where Labs Re-Submit Previously Reviewed Results

On rare occasion labs may re-submit results against previously reviewed tests long after reviews have taken place. We sometimes hear from our customers that labs will submit results in this manner without prior warning or explanation. This could happen at any time, and depending on when it occurs, it can create significant operational, data management, and reporting challenges.

This impact is already mitigated in locked studies, as locked studies will only accept results but not update the review status of tests. More about that is explained in this article: Database Locking | Lab Results in Locked Studies

If this situation were to occur, we strongly encourage our customers to reach out to their lab provider and discuss the topic to understand why results are re-submitted in this manner. Submission of results could be proactively avoided if communicated with the lab, and discussing that those results would have an undesirable impact in ClinSpark.

Our support team also has the ability to apply specific result transform logic a given lab interface to mitigate against this challenge. The logic will review inbound results and not reset the review status if the following attributes are left unchanged in the result file:

    'labTestName',
    'testId',
    'testNameId',
    'loincCode',
    'loincCodeListId',
    'additionalTestDescription',
    'testLevelComments',
    'reportedTextResult',
    'reportedTextResultCodeListId',
    'reportedNumericResult',
    'reportedNumericResultPrecision',
    'reportedReferenceRangeLow',
    'reportedReferenceRangeHigh',
    'reportedUnits',
    'reportResultType',
    'alertFlag',
    'limits',

Given that the result transform logic can be altered without a core-code change, the above requirements on acceptable changes against result file attributes can also be discussed and implemented based on customer needs.

If customers are interested in having the result transform logic updated, they should raise a service desk ticket and explain the circumstances of undesirable lab result submissions, and have our team investigate controlled changes against the result transform logic.