Point-of-Care Device Implementation Guide
current - CI Build

Point-of-Care Device Implementation Guide, published by HL7 International - Devices Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/uv-pocd/ and changes regularly. See the Directory of published versions

Terminology

The ISO/IEEE 11073-10101 Nomenclature standard (MDC) provides a comprehensive terminology for device models according to the ISO/IEEE 11073-10201 Domain information model (DIM). It's the preferred code system for profiles in this implementation guide. Reference identifiers, terminology codes, and descriptions are available at the Rosetta Terminology Mapping Management System (RTMMS).

The PoCD profiles define rules for terminology usage:

  • Device.type shall have a coding from the MDC Device nomenclature if there is an appropriate code available. This ensures consistent coding using the ISO/IEEE 11073-10101 Nomenclature standard, which provides MDS, VMD, and Channel codes for device models according to the DIM. If there is no code available, proposed or private MDC codes or coding from an alternative code system may be used. As this element is of type CodeableConcept there can be additional coding from other code systems.
  • Same for the DeviceMetric.type, which shall have a coding from the MDC Metric nomenclature if there is an appropriate code available.
  • DeviceMetric.unit is an optional element of type CodeableConcept. If present, it shall have a coding from the MDC Units of measurement if there is an appropriate code available. Additional other coding is allowed as well. This element is the place for the MDC unit code, because the Observation resource has other constraints - see below.

The Vital Signs Profile, which is part of FHIR core specification, applies for some commonly used measurement observations (e.g., heart rate, blood pressure, respiratory rate, oxygen saturation, body temperature):

  • The PoCD profiles require an MDC coding in Observation.code and, for compound metrics, in Observation.component.code. Depending on the type of measurement, the Vital Signs profile may require LOINC codes as additional coding. Note that the MDC code can be more specific than the Vital Signs LOINC code.
  • The Quantity data type in Observation.value[x] and Observation.component.value[x] contains the units of measure. There is only a single coding that needs to be UCUM for all vital signs. Therefore the PoCD profiles require UCUM coding for all numerics.

Regenstrief, developers of LOINC, and IEEE, developers of the 11073 standards, are working together to support interoperable communications of medical and personal health devices. There is a LOINC/IEEE Medical Device Code Mapping Table available as product of this collaboration.

Code Systems

Operating mode code system

Operating mode definitions from the ISO/IEEE 11073-10207.

Safety classification code system

Safety classification definitions from the ISO/IEEE 11073-10207.

Kind of relation code system

Relation definitions from the ISO/IEEE 11073-10207.

Metric availability code system

Metric availability definitions from the ISO/IEEE 11073-10207.

Measurement status codes

Measurement status definitions from the ISO/IEEE 11073-10201 DIM.

Value Sets

MDC Object infrastructure and Device nomenclature

ValueSet for the ISO/IEEE 11073-10101 Nomenclature filtered by Object partition.

MDC Metric nomenclature

ValueSet for the ISO/IEEE 11073-10101 Nomenclature filtered by Metric (SCADA or Settings) partition.

MDC Unit of Measurement

ValueSet for the ISO/IEEE 11073-10101 Nomenclature filtered by Dimension partition.

Operating mode value set

ValueSet for IEEE 11073-10207 MdsState/OperatingMode.

Safety classification value set

ValueSet for IEEE 11073-10207 SafetyClassification.

Kind of relation value set

ValueSet for IEEE 11073-10207 Relation/Kind.

Metric availability value set

ValueSet for IEEE 11073-10207 MetricAvailability.

Observation interpretation codes

Observation interpretation codes including measurement status.