scope:

This standard specifies requirements for the data exchange associated with the analytical workflow between medical laboratory in vitro diagnostic (IVD) instruments and the systems managing their work. This data exchange includes test orders and test results for both patients and QC specimens. Additional guidance is also provided to aid in the standard's adoption and implementation. This standard applies to all medical laboratory specialties (including blood bank testing). The intended users of this standard are IVD instrument vendors, IVD software systems vendors (LIS and middleware), and medical laboratory information technology (IT) personnel. This standard:

• Does not apply to point-of-care information exchange, which is already standardized by CLSI document POCT01⁴

• Does not apply to imaging information exchange, which is already standardized by digital imaging and communications in medicine (DICOM)

• Is not intended to standardize the features of IVD instruments or IVD software systems, only their external connectivity

• Does not apply to communication between systems already covered by other Integrating the Healthcare Enterprise (IHE) profiles (ie, laboratory testing workflow [LTW] and laboratory device automation [LDA])

• Does not cover calibration data, configuration information, standardization of test or analyte nomenclature (eg, LOINC^®a [Logical Observation Identifiers Names and Codes]), or process status monitoring

• Does not discuss data privacy requirements

^a LOINC^® is a registered US trademark of Regenstrief Institute, Inc.