The IHE/IICC Laboratory Analytical Workflow (LAW) Profile defines plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory. It standardizes the data flow of IVD patient and QC test work order steps and results. LAW provides the following capabilities, some not currently supported by LIS2 (ASTM):
- Support for IA, CC, hematology, microbiology, and molecular testing
- Unique identification of each order request at the test or test panel level
- Improved query for orders
- Selection of query as the default mode
- Simplified order download
- Ability for an analyzer to accept or reject orders
- Improved device identification for test logging
- Contributing substance identification for test logging
- Basic and enhanced message interface to support IVD instrument rule evaluation
- LOINC identification of test requests and observations (LIVD format recommended)
- Unique identification of runs
- Support for hematology images, graphs, and plots
- Support for transmission of raw values
- Support for rerun and reflex testing
- HL7 2.5.1 based
- Supports LOINC® , JLAC10 , and UCUM
LAW is currently being implemented by all major IVD companies. It was also selected by the European Union to be part of the eHealth European Interoperability Framework (eEIF) and will be the basis for the upcoming Clinical and Laboratory Standards Institute (CLSI) AUTO16 standard for next generation In Vitro Diagnostic (IVD) instrument interfaces.
Download LAW Profile Specification (PDF – 191 pages)
Download LAW Profile Presentation – English (PDF)
Download LAW Profile Presentation – Simplified Chinese (PDF)
For IVD Companies Planning to Implement the LAW Profile
The LAW Profile specification is available for download and does not require any licensing permissions or fees for implementation. IHE provides extensive documentation and test resources to support your efforts.
IVD vendors interested in implementing and testing the LAW Profile should:
- Download the LAW Profile http://bit.ly/ihe_law_profile
Additional information can be found on the IHE Pathology and Laboratory Medicine (PaLM) domain http://bit.ly/ihe_palm
- Implement the LAW Profile on your instrument, middleware, or LIS
- Test your implementation online using the IHE Gazelle platform
- Participate to an IHE Connectathon event in North America, Europe, or Asia
- Assess the conformity of your LAW Profile implementation by an independent ISO17025 accredited laboratory
Why was HL7 2.x selected as the baseline?
Following the recommendation of the Technical Team, in March 2010, IICC announced the selection of HL7 2.x as the baseline standard for the technical work of IICC. The Technical Team went through rigorous evaluation of several options, including HL7 2.x, HL7 3 and ASTM 1394/CLSI LIS-2.
- HL7 2.x is established in the healthcare industry and continues to gain popularity, adoption and acceptance.
- HL7 2.x is continuously maintained and extended by a very active community within the HL7 organization.
- HL7 2.x covers very well the currently known and anticipated future use cases for laboratory workflow. The majority of messaging requirements and the most important low-level protocol requirements are fulfilled by HL7 2.x.
- The implementation and adoption of HL7 2.x are estimated to be fairly easy due to the low complexity of the message format and the existing wide base of tools and specialists.
The technical team will continue to monitor the use of HL7 2 and HL7 3 for communication in the healthcare industry. The recent versions of the HL7 2.x standard incorporate HL7 3 concepts in the message content, so the HL7 Orders & Observations Working Group is actively engaged in providing a migration path from HL7 2 to HL7 3. As the adoption of HL7 3 increases, the IICC Technical Team will evaluate also supporting HL7 3 as a baseline standard.