College of American Pathologists
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  Middleware takes on molecular testing and more


CAP Today




March 2013
Feature Story

Brendan Dabkowski

Middleware vendors, who have long focused on chemistry and hematology applications, are turning their attention to molecular testing as a growing number of laboratories do the same.

“More laboratories and IVD vendors are turning to middleware for molecular testing, monitoring, and screening in anatomic pathology, microbiology, and blood banks,” says Data Innovations’ sales and marketing manager Hunter Bagwell. “The same challenges that chemistry and hematology work areas faced years ago with connectivity and workflow management are facing AP, microbiology, and blood banks with the adaptation of molecular testing in those areas.”

Technidata America Medical Software, too, recognizes the value of linking molecular and middleware, says North American sales manager Yves Charron. The company plans to release molecular and cytogenetics functionality for middleware in early 2014. The intent of the new middleware is to “address the requirements for clinical genetics as well as build a family-centric patient chart [and] store the data required for molecular pathology and cytogenetic testing,” Charron says.

Technidata recently introduced biobanking middleware, which addresses the needs of research-oriented labs that receive samples for which they don’t have patient demographics and for which they need to store result data. And the company has added postanalytical sample storage to its entire middleware product line.

New from Sysmex America is a management reports module for the company’s WAM version 4.1 database, says senior product manager Anne Tate. The module allows users to query the database directly for autoverification rates, as well as repeat, reflex, manual differential, and blood smear rates by test or profile; turnaround time statistics with discrete time points to identify gaps and delays within the automation system or across testing sites, or both; rule-utilization rates by specific rules or groups of rules; and data mining of patient results. Sysmex will release its WAM version 5.0 database by mid-year. The product, says Tate, includes an extended rule-checking module that will expand traditional delta checking by including previous results and coded comments and delta checks on flags received from an analyzer; coded or free-text results and/or order comments; and operator alerts within and across time intervals.

BioMérieux has been focusing on microbiology testing functionality for its middleware—specifically for managing and automating the processing of specimens from specimen receipt through media inoculation and incubation to testing and reporting the isolates recovered from the specimens, says Jacques Baudin, VP of commercial operations IT. “Culture plate management enhancements, such as virtual plate reading and workflow assistance, improve specimen traceability and standardize specimen processing,” Baudin notes. BioMérieux has also been working on simplifying the tracking and reporting of blood-culture contamination rates and providing real-time indicators for detecting multi-drug resistant organisms.

Beckman Coulter’s Sudhish Subhash says middleware has transformed into a system that manages workflow across multiple sites and provides traceability and quality control features. In the past year, Beckman has incorporated into its Remisol Advance solution a rules library, the functionality to integrate QC data into third-party systems, and Six Sigma QC features to help labs write customized rules to meet their workflow needs, says Subhash, who is global product manager, automation and informatics.

Pathagility recently added interface functionality to its AgilityEngine middleware. The new features allow users to create HL7 interfaces by selecting which type of HL7 communication they want to send and receive and later configuring that communication from a list of predefined/supported communication protocols. “It removes custom setup and configuration from the interface workflow,” says chief technologist Chad Files.

The most recent release of Dawning Technologies’ JResultNet middleware includes “‘into’ and ‘out of’ database actions,” which are applicable to smaller, customized databases used to execute rules, says Dawning president John Selmyer. These actions would be employed to retrieve or remove data elements from the custom database in order to save them until something else occurs, such as when matching or adding information to a patient record, Selmyer explains. “This has been very useful in managing connections to certain popular LIS products, as well as instrument connections to EMR systems,” he notes.

What more is in store for the middleware market? Data Innovations’ Bagwell foresees increasing demand to “integrate with one or more third-party vendors, such as quality control vendors” and automatic reporting to health care surveillance systems. Sysmex’s Tate, meanwhile, predicts that the middleware user base will expand beyond the laboratory bench to include, among others, pharmacists who must monitor key parameters to make dosage decisions. Also on the horizon, says Tate, are on-demand/real-time data dashboards that monitor, for example, hourly autoverification rates, turnaround time by site or location, and rule use by analyzers.

“The number of systems branding themselves as middleware has exploded in recent years,” Selmyer says, in the wake of the industry’s focus on middleware’s benefits. “The landscape includes a combination of third-party and homegrown systems”—among the offerings are rebranded LISs and systems provided by IVD companies, he explains. “Time will tell how these systems perform, evolve, are supported, and ultimately survive.”

CAP TODAY’s middleware systems product guide includes products from the aforementioned companies and from several other vendors. Readers interested in a particular system should confirm it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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