Observable and Investigation Model Project

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Overview

The following modeling and terming guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions will be documented separately.

A diagnostic product is a product with substance ingredients used in the diagnostic process, to aid the observation of phenomena which might otherwise be hard or impossible to observe. A typical example of a diagnostic product is the antibiotic product used in susceptibility testing, which is distinct from the pharmaceutical antibiotics products used for infection treatment of patients.

Example:

  • Product containing precisely amoxicillin and clavulanic acid, test disc (diagnostic product)
  • Product containing precisely amoxicillin 20 microgram and clavulanic acid 10 microgram, test disc (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, etest strip (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, 2 : 1 ratio, etest strip (diagnostic product)
  • Product containing precisely streptomycin 2 microgram/milliliter (diagnostic product)

Modeling

Diagnostic products concepts shall be modeled using the proximal primitive modeling pattern ("full modeling pattern"??)

Exceptions: none identified

Stated parent concept

xxx|Diagnostic product (product)|

Possibly also 63653004 | Biomedical device (physical object) | or xxx|Diagnostic product| is also a descendant of 63653004 | Biomedical device (physical object) |. Cf. <<411115002 | Drug-device combination product (product) |

E.g. 708548003 | Test strip (physical object) |

  • Exceptions: none identified
Semantic tag(diagnostic product)
Definition status

900000000000073002 | Sufficiently defined concept definition status (core metadata concept)

  • Exceptions: none identified

Attribute:

Has count of base of active ingredient

  • Range: <260299005 | Number (qualifier value) | - descendants only
  • Cardinality: 1..1 0 for groupers?

Attribute:

Has manufactured dose form

DO WE NEED TO REPRESENT THE PHYSICAL FORM, E.G. TEST DISC, STRIP, FLUID, ETC?? LOINC uses method axis for this information, e.g. Gradient strip.

Attribute:

Has unit of presentation


Relationship group

 One relationship group containing one instance of each of the following attributes is required for each precise active ingredient.

  • |Has precise active ingredient|
  • Range: <105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, roles, and combined substances
  • Cardinality: 1..1 per relationship group
  • |Has presentation strength numerator value|
  • Range: <260299005|Number (qualifier value)
  • Cardinality: 0..1 per relationship group

Product strength normalization for metric units:

  • Use picogram if value is <1000; if if > then convert to nanogram
  • Use nanogram if value is <1000; if > then convert to microgram
  • Use microgram if value is <1000; if > then convert to milligram
  • Use milligram if value is <1000; if > then convert to gram

Product strength normalization for units:

  • Use million unit if value is >1000000 unit

The following units are not allowed unless specifically noted as an exception:

  • 408165007 |Mega u (qualifier value)|
  • |Has presentation strength numerator unit|
  • Range: <258666001|Unit (qualifier value) - descendants only
  • Cardinality: 0..1 per relationship group. 0 to allow representation of ratios, if needed. Or use xxx | Unit one |?
  • |Has presentation strength denominator value|

Needed?

  • Range: <260299005|Number (qualifier value)
  • Cardinality: 0..1 per relationship group
  • denominator unit|
  • Range: <732935002|Unit of presentation (unit of presentation) - descendants only
    • Exceptions: none identified
  • Cardinality: 0..1 per relationship group

Terming

FSN

Use the following pattern for the FSN; align terming and case sensitivity with the FSN for the concepts that are selected as the attribute value. For multiple ingredient diangostic products, the ingredients must be in alphabetical order and separated by the word “and”.

Single ingredient:

  • Product containing precisely <Precise active ingredient FSN> [<Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>[/<Presentation strength denominator unit>]] each [<Manufactured dose form FSN>] (diagnostic product)

Example:

  • Product containing precisely streptomycin 2.0 microgram/milliliter (diagnostic product)

Multi ingredient:

  • Product containing precisely <Precise active ingredient FSN 1> [<Presentation strength numerator value FSN 1> <Presentation strength numerator unit FSN 1>[/<Presentation strength denominator unit 1>]] and ... <Precise active ingredient FSN n> [[<Presentation strength numerator value FSN n> <Presentation strength numerator unit FSN n>[/<Presentation strength denominator unit n>]], [<Manufactured dose form FSN>] (diagnostic product)

Example:

  • Product containing precisely amoxicillin and clavulanic acid, test disc (diagnostic product)
  • Product containing precisely amoxicillin 20 microgram and clavulanic acid 10 microgram, test disc (diagnostic product)
Preferred Term


Synonyms

Synonyms corresponding to the FSN are not allowed unless explicitly identified as an exception.

  • Exceptions: Existing instances of synonyms exactly matching the FSN will be retained until time and opportunity allows for their removal. Note that not all language reference set variations of the FSN were included as synonyms.

Additional synonyms are not allowed unless explicitly identified as an exception.

  • Exceptions: none identified

Exemplars

The following illustrates the stated view:

The following illustrates the inferred view:

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