Redefining LIS Operations

The traditional reference to the laboratory information system (LIS) is a single, overreaching information system that controls laboratory operations. LIS is a misnomer, however, and needs to be plural to meet today's laboratory needs.

Gone are the days when one information system could provide the level of functionality and ease of use required to meet today's business demands; hence, we have seen a proliferation of middleware to drive increasing efficiency and improve workflow. Middleware does not replace the traditional LIS; rather, it becomes part of it.

The original application for middleware was trying to fill the gaps (the absence of functionality) in the LIS, instrumentation and automation systems. Labs that adopt middleware today find it is easier to configure than the system they already have, and provides better functionality for their workflow management. This is the outcome of an evolution in the development of both legacy LISs and middleware, which has been driven by their diverging priorities in response to today's rapidly changing healthcare environment.¹

Hospitals and health systems are shifting resources to development of electronic medical records (EMRs) and data repositories. This leads to health informatics companies shifting their resources toward meeting this need as well. Shortages of skilled labor and more sophisticated laboratory automation are forcing laboratories to look for information companies, such as middleware vendors, to help them improve laboratory operations.

Robust Options

Many LIS vendors offer limited support of autoverification; middleware can provide a more robust and user-friendly option. Labs that embark on an autoverification project may be tempted to just start writing rules, but documenting the parameters that are used to define the rules and creating algorithms that chart the workflow of the rules are important first steps. A middleware rules package can pull together all the pieces necessary to create a comprehensive solution.

And these packages go beyond just rules to include integrated testing engines to ease the validation of the system and reduce the regulatory burden of periodic retesting and validation. Many packages also include algorithms to visually document defined processes that easily translate into rules and provide a reference for maintenance and troubleshooting.

Finally, a predefined process assists in gaining approval from the medical director, which makes for a project that is both compliant with regulatory requirements and easy to maintain. A laboratory that can achieve even 80 percent autoverification does a better job of allowing scarce skilled resources to focus only on the most technically challenging tasks, such as manual differentials in hematology.

Quality Control

Along with autoverification, middleware provides an integrated quality control (QC) link that can allow users to monitor QC results in real-time via a bi-directional interface with the QC vendor's system- another example of how the LIS is no longer a single system, but rather plural, when this option is not available in the LIS. The same rules engine that supports autoverification can be used to evaluate QC results and alter results production immediately, as information is fed into it from the instrument and/or the QC vendor.

Most middleware is modular and can be made as sophisticated as a lab needs or can afford it to be.²Middleware can offer electronic scheduling and documentation management of the maintenance tasks performed in a lab, from instrumentation to refrigerator temperatures to linearity studies. This can include all the steps to take, embedded procedure documents, vendor instructions and links, providing guidance during the performance of tasks. It can also include notification when tasks are due (or overdue) or results are out of compliance, plus provide a way to document supervisor review electronically.

Bonus Features

Many LISs offer management of stored specimens, which can save valuable staff time in locating particular samples. Middleware provides this feature too, plus it can alert the user of pending tests before storing the sample. This can translate into much larger savings if the lab is now able to provide results of add-on testing within minutes rather than days, with no additional inconvenience to the patient. This is another example of how middleware can partner with the LIS to provide improved workflow in the laboratory that translates into reduced overall cost of healthcare and faster ROI when using it.

Data archiving can be an important feature of both the LIS and middleware for labs that retain paper records. Data can be moved to an archive database and even converted to .pdf for storage on any server. This can translate into significant cost reduction for labs storing instrument printouts to satisfy regulatory requirements. In hematology, newer instruments are now capable of sending images through the interface and middleware can now process, display and store images along with results long term. The volume of data stored is limited only by the storage capacity of your network. No more fees for offsite warehouse storage. And when you need to retrieve a record, it is a matter of a few clicks of the mouse. Purging is also simplified down to configuring it to occur automatically at regular intervals.

Report Generation

Middleware provides a rich source of information for departmental managers. This is of great value where reports generation from the LIS involves specialized programming on the part of IT staff. Middleware uses Open Database Connectivity (ODBC) to enable you to use applications with which you are familiar. As such, the user can query the database and extract user-defined sets of data to create reports like turnaround time, workload statistics or any number of ad hoc reports (e.g., a list of all positive HIV results for the past month). With ODBC and a minimum investment in training, a lab administrator can generate detailed reports in minutes.

Finally, disaster recovery can be enhanced by middleware that offers LIS backup capability. In the event of LIS downtime, instruments connected to middleware can continue producing results, utilizing the rules functionality, as normal. Some products allow for sample order entry, barcode label printing and report printing. Stat results production can proceed as if there were no interruption of LIS service. The middleware product can collect all data produced during the downtime and help ensure no records are lost until the LIS is returned to service. This also ensures no billing information is lost.

Grace Pfeiffer is implementation consultant, Data Innovations North America, South Burlington, VT.

References

1. 2007 Trends, The Dark Report.

2. Middleware Update: Not Just a Facilitator Anymore. Clinical Lab Products March 2009.