This domain is the root domain to which all HL7-recognized value sets for the Observation.value attribute will be linked when Observation.value has a coded data type.

ISO 11073-10101 Health informatics - Point-of-care device codes, restricted to ECG Beat Types

ISO 11073-10101 Health informatics - Point-of-care device codes, restricted to ECG Observation Types

ISO 11073-10101 Health informatics - Point-of-care device codes, restricted to ECG Noise Types

ISO 11073-10101 Health informatics - Point-of-care device codes, restricted to ECG Rhythm Types

ISO 11073-10101 Health informatics - Point-of-care device codes, restricted to ECG Waveform Component Types

Diagnosis Value

This domain is established as a parent to a variety of value domains being defined to support the communication of Individual Case Safety Reports to regulatory bodies. Arguably, this aggregation is not taxonomically pure, but the grouping will facilitate the management of these domains.

A code that provides information on the overall effect or outcome of the adverse reaction/adverse event reported in the ICSR. Note the criterion applies to the case as a whole and not to an individual reaction.

Example concepts are: death, disability, hospitalization, congenital anomaly/ birth defect, and other medically important condition.

A code set that includes codes that are used to characterize the outcome of the device evaluation process. The code defines the manufacturer's conclusions following the evaluation.

Examples include: inadequate alarms, device maintenance contributed to event, device failed just prior to use, user error caused event

Code assigned to indicate a relevant fact within the context of the evaluation of a reported product. There are a number of concept types including the status of the evaluation, the type of evaluation findings, and the type of activity carried out as part of the evaluation process.

Examples include: Actual device involved in incident was evaluated, electrical tests performed, visual examination.

Code assigned to indicate an outcome of the manufacturer's investigation of a product for which a defect has been reported.

Examples include:.component/subassembly failure: air cleaner, computer-, imaging system-, microprocessor-controlled device problem: cache memory, design -- not fail safe.

A code to capture the reporter's assessment of the extent to which the reaction is related to the suspect product reported in the ICSR.

Example concepts include: related, not related, possibly related and unlikely related.

A code that characterizes the role that the primary reporter felt that the suspect intervention -- either a substance administration or a device related procedure - played in the incident being reported. This code will capture the primary reporter's assessment of the role that the suspect product played in the incident reported in the ICSR.

Examples include: Suspect, Concomitant, Interacting, Re-challenge.

Code used to indicate the action taken by practitioner in response to the problem (whether drug or device related) that is reported in the ICSR.

Examples include: failing device replaced, medication stopped, medication dose adjusted.

A code to capture the kind of reaction that was suffered by the investigated subject, and that is being reported in the ICSR. At this point, SNOMED or MedDRA have been suggested as code systems to be used for providing this information.

Example concepts include hives, swelling, rash, anaphylactic shock.

Code that captures the emphasis that the reporter placed on this reaction.

Examples include: highlighted by the reporter, NOT serious, Not highlighted by the reporter, NOT serious, Highlighted by the reporter, SERIOUS, Not highlighted by the reporter, SERIOUS.

Code that captures the type of outcome from an individual outcome of a reaction to the suspect product reported in the ICSR.

Examples include: Recovered/resolved. Recovering/resolving, Not recovered/not resolved, Recovered/resolved with sequelae, Fatal.

Values for observations of injuries.

Value for Act.partialCompletionCode attribute that implies 81-99% completion

Value for Act.partialCompletionCode attribute that implies 61-80% completion

Value for Act.partialCompletionCode attribute that implies 41-60% completion

Value for Act.partialCompletionCode attribute that implies 1-20% completion

Value for Act.partialCompletionCode attribute that implies 0% completion

Value for Act.partialCompletionCode attribute that implies 21-40% completion

Potential values for observations of severity.

Indicates the condition may be life-threatening or has the potential to cause permanent injury.

Indicates the condition may result in some adverse consequences but is unlikely to substantially affect the situation of the subject.

Indicates the condition may result in noticable adverse adverse consequences but is unlikely to be life-threatening or cause permanent injury.