For IHE LAW:
- The Laboratory Analytical Workflow (LAW) Profile is part of the Pathology and Laboratory Medicine (PaLM) domain and 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 is incorporated into the PaLM Volume 1 and Volume 2 Technical Framework (see link in Table above) and also can be found here.
- The LAW Profile defines the physical connection, message definitions (based on the HL7 Messaging Standard v2.5.1), and workflow definitions between instruments, middleware, and LIS systems in the laboratory. IICC collaborated with the IHE Pathology and Laboratory Medicine (PaLM) domain to develop the LAW Profile. See: http://ivdconnectivity.org/law-profile/
- This is a SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) standard.
For LIVD:
- The digital format for publication of LOINC® to Vendor IVD Test results (LIVD) includes vendor defined IVD tests associated with a set of pre-defined LOINC codes. LIVD helps assure that laboratory personnel select the appropriate LOINC codes for IVD tests used by their laboratory. LIVD also allows LIS systems to automatically map the correct in vitro diagnostic (IVD) vendor test result to a LOINC code. LIVD was developed by the IVD Industry Connectivity Consortium in collaboration with SHIELD.
- This is a SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) standard.
- For additional context, please refer to the Guidance for Industry and Food and Drug Administration Staff “Logical Observations Identifiers Names and Codes (LOINC) for In Vitro Diagnostics.”
- Note that the LIVD Implementation Specification (LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results) has not been vetted through a Voluntary Consensus Standards Body (VCSB) as defined in OMB Circular A-119.
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Submitted by jkegerize on 2022-08-18
ACLA ISA comment re: typo, header titles, harmonization status
Please clarify the term “harmonization status”. We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc. It is too nebulous as currently stated. For example, can it be measured and if so, how is it validated and how does it relate to the laboratory or provider’s EHR system Exchanging InVitro Diagnostics (IVD) Test Orders & Results?
Correct typo in last bullet. “OMB Circular A-1195” should be “OMB Circular A–119”.
The 2nd column ‘header’ is titled “Applicable Value Set(s) and Starter Set(s)” but the comments are not related to value sets; Suggest you retitle; these seem like general comments