Addressing Molecular Diagnostic LIS Functionality Gaps: A JMD Response

In a 2018 article in The Journal of Molecular Diagnostics (JMD), the authors — Charles Myers, Matthew Swadley, and Alexis Carter — identified key gaps in functionality in laboratory information systems (LIS) for molecular labs. To continue the conversation, we collaborated with the Cleveland Clinic’s Molecular Pathology Section lab team on a response. In our article published on the JMD website on January 28, 2022, we describe the work we did together to customize a laboratory information management system (LIMS) in a way that addresses the issues identified by Myers et. al.

The main gaps in LIS and LIMS functionality

Myers et. al set out to analyze commercial LIS products and instrument software to determine if they fulfill basic functions for molecular laboratories. The authors conducted a survey of 80 representatives of various molecular societies and identified several major gaps in functionality:

  • Inability to track certain data unique to molecular assays, leading to people recording it separately on paper or in another unrelated field. This causes issues when someone attempts to retrieve the data for troubleshooting purposes.
  • Lack of support for barcode scanning. When information is manually transcribed, there’s a high potential for errors. A barcode can enable the information to be transferred easily and without error as samples proceed through analysis.
  • No interfacing between instrumentation and the LIS (also known as integration). This leads to the need to transcribe or copy and paste information from one system to another. For example, this can be necessary when someone needs to transfer raw result data into a report for review and sign out. The team also identified interoperability with external information systems as critically important.
  • Ineffective report generation. In addition to not being able to populate a report by pulling data from the LIS, many respondents said that their systems were not able to do basic report formatting.
  • Noncompliance with the Health Insurance Portability and Accountability Act (HIPAA). HIPAA requires that users log into a system with their own user account and password because results produced in molecular laboratories are considered protected health information. Many respondents reported that they did not do this. One reason why is that some molecular instruments simply do not provide the capability to create unique user accounts.
  • Lack of audit trails of user access. The inability to create user accounts leads to not being able to track user access, which is problematic if the lab needs to provide data for an audit or investigation.

The article also revealed that respondents who use a custom-built or molecular-specific commercial LIS were less likely to experience these issues. However, it’s important to note that these types of systems can come with a high price tag — an expense that can be difficult for some laboratories to justify.

If molecular professionals, software developers, and instrument manufacturers work together to address these challenges, labs could improve their ability to provide high-quality care for more patients.

The Cleveland Clinic’s project is an example of what can be done

At the Cleveland Clinic, the Molecular Pathology Section wanted to enhance its testing portfolio and processes. The team sought our help to replace its existing electronic- and paper-based data management system with a commercially available LIMS, a separate bioinformatics platform, customized test-interpretation applications, a dedicated sample-accessioning service, and a results-releasing software application.

We collaborated with the Cleveland Clinic team to develop a custom solution that addresses each of the gaps mentioned above. Specifically, we made sure the new system:

  • Tracks all relevant data. By selecting a molecular-specific LIMS and customizing each workflow, we were able to provide the lab with all the fields they need to capture relevant patient data.
  • Supports barcode scanning. We integrated the LIMS with a barcode printer and customized the LIMS to support barcode scanning across the entire specimen lifecycle.
  • Integrates instrumentation with the LIS/LIMS. We built integrations between all analytical instruments and the LIMS, and a custom interface to connect the LIS and the LIMS. This facilitated automatic specimen data transfer via HL7.
  • Provides effective report generation. We built a custom reporting application that pulls data from the LIMS into a carefully formatted report template, creating reports that are ready for review and sign out by a pathologist.
  • Complies with HIPAA. Each piece of software we customized and built requires unique logins and passwords for every user. This ensures that protected health information remains secure.
  • Supports audit trails. We made sure the LIMS tracks all the elements specified by the College of American Pathologists Laboratory General Accreditation Checklist. We also built custom elements, such as the reporting application, on top of the audit trail data layer. This facilitates auditing from report-building through to submission of the outbound HL7 message to the LIS.

If your lab is using a commercial LIS or LIMS, even if it’s heavily customized, we recommend you read these journal articles — the original article by Myers et. al and our response — to learn more about the limitations of commercially available solutions and how you might address them.

Or join the conversation yourself! We strongly believe that it’s through sharing knowledge that the entire sector can enhance levels of service and create innovative new solutions to improve patients’ lives.

Get in touch if your lab is currently facing these challenges. We’re here to help.