To optimize use of resources, IICC defines the scope of the technical work along four key dimensions.
- Geographic reach. An absolutely global perspective defines IICC’s vision and efforts.
- Labs may be country-oriented, but most IVD products are sold globally
- Differences among Europe, the US, Japan and others must be balanced
- National efforts should keep globalization in mind
- Data flow. The focus is on IVD test orders and IVD test results as they relate to patients and quality control. Currently, calibration data, operator information and process status monitoring are considered out of scope, but may be considered for future efforts.
- Types of IT systems. IICC will cover the transmission of orders and results between IT systems and IVD analyzers. In this context, IICC will not attempt to distinguish the roles of different types of IT systems (e.g., LIS, middleware, automation manager). IICC will not attempt to standardize the features of IT systems—only their external connectivity. And IICC is not specifically focused on middleware.
- Types of IVD testing. The priority by test area is as follows:
- Clinical chemistry
Point of care, anatomic pathology and imaging are out of scope.
Increased consistency and completeness of data through constrained message content and conformance criteria will yield:
- Reduced need for instrument driver development in IT systems
- Reduced need for interface mapping between IT systems and instruments
- Improved interoperability between lab products from different vendors
- Elimination of data errors related to differences in semantics
- Improved ability to audit historical lab operations
Use of HL7 2.x instead of ASTM 1394 and use of TCP/IP instead of serial cables will yield:
- Access to a larger software development community and more advanced development and troubleshooting tools
- Elimination of communication problems related to bandwidth
- Lower costs and shorter timelines for providers to acquire, install and connect lab analyzers and IT
- Improved reliability of laboratory systems, with faster issue resolution and lower maintenance costs
- Improved ability for providers to achieve accreditation and analyze lab operations
- Lower costs and shorter timelines for vendors to develop next generation laboratory analyzers and IT
- Fewer patient errors due to reduction of data semantics errors and human errors during system interfacing
- Higher-quality structured data upstream in the LIS and EHR