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In-Vitro Diagnostic (IVD) Data Integration


Despite investments in sophisticated equipment and expensive upgrades, every organization has a pool of legacy devices that capture critical data but still remain isolated for lack of a standardized approach to acquire, transform, transmit and store their data. In laboratories, these include specimen analyzers, which are major bottlenecks to completing data capture and analysis.

The quality of the analysis and the accuracy of the reports provided by a Laboratory Information System (LIS) is largely a function of the accuracy of the test result data generated by connected in-vitro diagnostic (IVD) analyzer devices; interoperability and standardized data capture between analyzers and LISs is crucial to this effort. While standards are being created and implemented on an ongoing basis, there are still large numbers of legacy systems deployed that use proprietary data formats and exchange protocols. The Infosys IVD Data Integration solution solves this problem.

By combining IVD domain knowledge with a structured, standards-based approach, Infosys integrates clinical devices with healthcare informatics systems, unlocking the data they capture. This facilitates interoperability and analytical workflow between legacy devices as well as makes new devices directly compliant to the latest Laboratory Analytical Workflow (LAW) profile from integrating the Healthcare Enterprise (IHE) Laboratory Technical Framework v3.0.

Our solution

The Infosys solution, residing in both the device manager and analyzer manager / LIS, implements an IHE LAW profile as an extensible and reusable platform for device connectivity and laboratory analytical workflow automation. It streamlines the scheduling, performance, and reporting of Analytical Work Order Steps (AWOS) between IVD testing systems and healthcare IT systems (LIS or middleware) by implementing analyzer and analyzer manager actors for the following transactions:

  • [LAB-27] AWOS Query
  • [LAB-28] AWOS Broadcast
  • [LAB-29] AWOS Status Change
In-Vitro Diagnostic Analyzer Data Integration

The solution helps automate laboratory analytical data flow between the LIS and analyzer, starting with patient order entry and specimen collection and barcoding. The barcoded sample reaches the analyzer where the test is carried out as per the respective work order with results transferred to the LIS for review and confirmation. The specialist / pathologist views the results using LIS user interface and confirms the results and transmits these to Hospital Information System (HIS) / Clinical Information System (CIS) / Electronic Medical Records (EMR) or prints the report for reporting to doctors.

  • Analytical workflow automation – The solution provides workflow standardization as per IHE-LAW Profile that supports queries for the Analytical Work Order Steps (AWOS) at specimen arrival at the analyzer and transfer of test results to the analyzer manager for further review, confirmation and reporting once the test is complete.
  • Support for legacy devices – Plug-in components convert proprietary data to Health Level Seven (HL7) and vice versa through smooth data transformation and provide a standardized interface between legacy analyzer devices and LISs.
  • Import and export – Import from and export to different data formats, e.g., XML, CSV, text and HL7 helps availability of analytical data for presentation, diagnosis, analytics and research.
  • Multiple communication options – Adapters for RS232, USB, socket, file and Web services allow multiple connectivity options for smooth and easy connectivity between analyzer and information systems.
  • Flexible, reliable, and secure data access – An abstract data access interface allows use of any existing database by implementing the data access interfaces to store and retrieve patient and test data and gives secure access to patient data through HIPAA compliance.
  • Support for Patient and Quality Control (QC) samples – The solution handles the data processing and reporting on patient and QC specimens.
  • WYSIWYG print – The solution has What You See is What You Get (WYSIWYG) printing facility so that doctors can get printed reports exactly the way they want to view them on screen.
  • Cost reduction – A reusable and extensible framework reduces the cost of integrating new analyzer devices with LISs.
  • Less time to market – The solution provides standardized IHE transactions and innovative HL7 data transformation components that support easy integration with analyzer and LISs, reducing the time needed to develop integration solutions from scratch.
  • Seamless connectivity with LIS / CIS / HIS / EMR – HL7 standardization allows seamless connectivity with information systems and reliable data availability.
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