Considerations When Selecting an LIS for Gynecologic Cytology and Molecular Testing

Laboratories leaders investigating LIS solutions for Gynecologic Cytology and Molecular testing need dynamic solutions that meet all productivity and efficiency goals and regulatory requirements. Other essential factors include cytotech reporting, automated quality control review and reporting, pathology oversight and reporting, Bethesda reporting guidelines, management reporting, lookback reviews, and comprehensive cytology/molecular reports. Not all lab information systems are built to provide the full breadth and depth of these resources. Labs may need to upgrade their capabilities by replacing their LIS or supplementing their existing system by integrating a complementary LIS that can seamlessly provide these more sophisticated features. Let us review some of the unique LIS capability requirements for modern gynecologic cytology and molecular testing.

Specimen Management and Tracking

While speed and efficiency are essential, nothing is more important than ensuring patient safety by properly managing the specimen through a robust labeling and tracking program. A suitable LIS should provide for specimen and label printing at every step in the process. It should also let the user scan a specimen barcode (e.g., on a vial, slide, etc.) to ensure that the specimen is correct for the case being worked. The LIS specimen management should also provide for tracking of send-out cases and storage of specimens.

Initial Cytotech, QC Cytotech, and Pathologist Review and Reporting

Gynecologic cytology reporting is typically volume-based, so the LIS that manages this business needs to provide speed and efficiency while ensuring all safety guidelines. Cytotechs should be able to review all case information, client information, prior patient case history, concurrent cases (e.g., histology, molecular, etc.), and perform lookback reviews on previous cases. Cytotechs should be equipped with a Bethesda-compliant reporting system with hotkeys so they can easily report a case with the click of a single button.

These hotkeys can populate configured fields for Specimen Adequacy, Interpretation, Description, Comments, Additional Findings, and Recommendations. Hotkeys can be configured to the lab’s specifications. When a reflex condition is met, it should automatically notify the initial cytotech, QC cytotech, pathologist, and the lab that a test add-on has been recommended. If a case is pushed to the QC cytotech or flagged for a negative result QC review, it will be pushed to a QC cytotech review step. The QC cytotech can review the case, agree with the initial cytotech interpretation, provide their interpretation, or push the case to a pathologist for review. The pathologist can then review the initial cytotech and QC cytotech interpretations, agree with one or the other, or provide their own interpretation.

Quality Control

All gynecologic cytology labs require a robust quality control module. Labs should be able to set their own levels of QC review of negative cases. Although the standard setting is 10%, labs should be able to set their QC review of negative cases at a higher percentage if desired. Labs can also set QC levels higher for a specific cytotech. This feature will automatically flag a percentage of negative cases for review and document the QC cytotech’s diagnosis. The initial cytotech and the QC cytotech can also push the case to the pathologist for review if needed.

Molecular

Often when there is a positive pap result, a positive pap history, or other condition, the lab will want to order additional molecular testing. The LIS needs to recognize when these conditions are met and suggest the appropriate test add-ons. XiFin has a robust rules engine for users to create and manage these reflex testing rules. Once these molecular results are ready for review, the cytotech or pathologist should be notified so that they can review the results and create a comprehensive cytology/molecular report.

Management Reporting

Management reporting is another critical feature in any gynecologic cytology LIS offering. There are several standard reports that are required for monthly reporting, including:

• 10% Negative Review Reports
• Abnormal Reports
• ASC-US HPV Reports
• Cases by Client and Test Code
• Cyto/Histo Correlation
• Case Load Reports
• Cytotech Summary of Cases and Diagnosis
• Pathologist Summary of Cases and Diagnosis
• Discrepancy Reports
• Patient Retro Review
• Specimen Adequacy
• Accession Logs
• Completed Case Logs

Comprehensive Summary Report

The physician- and patient-facing lab report is, in many ways, a laboratory’s calling card. The LIS should provide highly configurable reports that enable pathologists to better support physicians by providing informative and clear diagnostic guidance. Ordering physicians need to be able to digest time-sensitive information quickly. Gynecology cytology and associated molecular results should be presented in a single comprehensive report to represent a complete diagnostic assessment that is easy for clinicians and patients to review and understand. The LIS should provide full automation of this process and include the option of placing cytology results on hold until the molecular results are completed.

Supplement Your Existing LIS

Replacing lab information systems can be time-consuming and costly. At XiFin, we recommend that if you have an LIS that works well for your lab but has capability gaps, you integrate a new system with the existing one to solve those deficiencies. Labs are not always in a position to change their LIS, but that does not mean they must live with systems that do not support their current and future needs. The expense of a supplemental LIS likely will more than pay for itself through efficiency and productivity improvements as well as physician satisfaction and patient experience.

Laboratory diagnostics can be complicated and require a pathologist to provide a comprehensive assessment to aid in the treatment planning of the patient. Labs need specific solutions for each case type they manage, and a means to review all the results and create a summary case report. The XiFin team believes in a configurable lab information system that allows the lab to define case types and workflows, integrate the data via an interface, and create a report representing those results. We believe in products that support the pathology team and further increase the value they provide to the care team.

Learn more about how XiFin LIS can augment your existing LIS to fill any capability gaps you suffer with in your cytology and molecular lab.

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