Exchange InVitro Diagnostics (IVD) Orders and Results

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Federally required	Cost	Test Tool Availability
Standard	CLSI AUTO 16 - Next-Generation In Vitro Diagnostic Interface, 1st Edition	Final	Pilot	No	$	Yes
Standard	IVD Industry Connectivity Consortium: LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results V2.0	Final	Production	Yes	Free	No
Implementation Specification	IHE LAW – Laboratory Analytical Workflow Profile	Final	Production	No	Free	Yes
Implementation Specification	HL7® FHIR® Implementation Guide - LOINC/IVD Mapping (LIVD) R1 (STU 1)	Balloted Draft	Pilot	No	Free	No

Limitations, Dependencies, and Preconditions for Consideration	Applicable Value Set(s) and Starter Set(s)
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.	LIVD is only required for SARS-Cov-2 orders and results. See ISA section Units of Measure.

Limitations, Dependencies, and Preconditions for Consideration

Applicable Value Set(s) and Starter Set(s)

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.

LIVD is only required for SARS-Cov-2 orders and results.
See ISA section Units of Measure.

Comment

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

Submitted by dvreeman on 2018-09-27

Regenstrief - Comment

We are glad to see the addition of this new interoperability need. We recommend adding an emerging specification for the FHIR-based LIVD Implementation Guide that is currently in “Draft for Comment” status.