Considering the LIS in the molecular diagnostics context

Laboratories have specific needs based on their size and testing types. Physician office laboratories, for example, typically perform fairly basic testing with straightforward setups. Larger laboratories, such as reference labs or hospital labs, require multiple work stations and analyzers to be set up, necessitating interfaces that can share and receive orders in real time to multiple offices and mobile applications. Specialized labs such as toxicology, pain management, and molecular diagnostic laboratories have unique workflows and specific customizable reports that require a streamlined process.

In the lab industry, the molecular diagnostic testing market is growing at a faster pace than routine testing.¹ In many cases, molecular-based diagnostics offer high sensitivity with shorter turnaround times than traditional laboratory techniques.

The molecular landscape

Complex molecular testing, generally conducted as laboratory developed tests (LDTs) under CLIA, require a laboratory that is certified for non-waived testing. Conducting LDTs requires sophisticated infrastructure. The onus is on the lab to provide for quality and assay performance, and there is often complex hands-on processing involved, including sample extraction, setup, and specialized equipment. Therefore, non-waived molecular testing is often conducted in core labs and reference labs.

For physicians and clinics not readily served by reference labs or a molecular core laboratory, molecular-based point-of-care instruments can have a positive impact on time to answer and outcomes. One commercially available alternative is a platform with an FDA CLIA Waiver for influenza and respiratory syncytial virus (RSV). It also supports detection of methicillin-resistant

Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) skin and soft tissue infections in less than one hour. Another system addresses acute respiratory infection, sepsis, or gastrointestinal distress, and a third has FDA-cleared tests that include influenza A and B and RSV, and work direct from a nasal swab to results in about an hour. These instruments can be operated by staff with less technical expertise than a molecular technologist. In general, they also require only a few minutes of hands-on time per specimen, without manual chemistries for extraction and processing.

The intention of referencing these instruments is not to endorse any one platform, but to illustrate that molecular diagnostics (MDx) is not always conducted in high complexity labs.

LIS functions

In both waived and non-waived testing, the laboratory information system (LIS) plays a key role. In either scenario, the order workflow can be streamlined with interfacing and rules.

Order interfaces reduce paper and manual transcription, while “Ask at Order Entry” questions can be designed to document information about an order or specimen. An LIS can also offer robust rules that can drive actions. Rules can combine or delete tests or orders, order additional tests, check for appropriateness of tests, or route orders based on patient insurance.

Waived or non-waived, support for molecular diagnostics requires resulting into an information system for quality control before posting to the patient record. This requires the input of manual results or the review and acceptance of online instrument results, depending on the application. Result entry, result review, and final acceptance can be accomplished via a workflow with an intuitive graphical user interface that can display previous patient results in tabular or graphical format.

Molecular instruments are evolving at a fast pace; some become virtually obsolete in as little as 18 months after launch. This fact, and the fact that many instrument vendors are not yet using a standardized output, make interfacing a challenge. The LIS can allow upload of data in Excel, ASCII, CSV, etc., when an ASTM or HL7 instrument interface is not available.

Molecular results can include images, such as those documenting results from a gel or other systems. During review and results reporting, images are needed to illustrate and document results. The LIS can accept and associate related attachments—such as pdf, image, graph, video—and store them in such a way that they can be retrieved by laboratorians in their workflow.

Molecular instruments vary in level of data analysis. Often, the laboratorian will need to perform calculations. Excel is a common format for the output from instruments, and, in some cases, lab personnel may utilize Excel for custom data manipulation. As a best practice, data manipulation is done at the instrument and/or in the LIS. Robust functionality for rules and calculations is a must to handle molecular data.

Laboratories conducting molecular diagnostic testing often employ a secondary review of results before releasing to the patient file. Given the technical nature of these results, users need the ability to verify that the results are correct and include the appropriate data. This involves sequential documentation in which one staff member enters or accepts results and a second staff member or supervisor completes a review before sending out the report. Since the specific review process will vary from lab to lab, users need the ability to customize the technical review process to accommodate their organization’s specific best practices.

Given the complexity from hands-on processing and interpretation, laboratories conducting LDTs require skilled staff and strong quality oversight. Laboratory information systems need to accommodate the complex multi-step workflows required for some LDTs. One must configure activities to be performed at each step and then confirm the quality and expected outcome before allowing the specimen to move on to the next step in the workflow. This can be accomplished through panels and reflex testing so that each step can have its own result, QC, and go-no go decision. QC features should also protect result quality: delta and normal range checking can highlight abnormal results, while QC failures can block resulting from filing.

Conducting complex multi-step workflows requires access to the lab’s standardized procedure documentation. Lab personnel need to access current policies and procedures, and supervisors need to ensure that the policies and procedures are up-to-date with scheduled reviews and sign offs. An embedded document management system allows users to upload documents and maintain revisions for each upload, allowing users to review or sign the versions.

There is an LIS to fit every unique laboratory and help maximize efficiency—and reimbursements. Lab leaders should look for an LIS that offers the latest technology and is streamlined and customizable for their laboratory’s specific needs.