| POCP_MT050200UV01 A_ProductCharacteristic |
Derived from RMIM: POCP_RM050200UV01 and HMD: POCP_HD050200UV01 |
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| Characteristics | |||||||||
| choice of Characteristic |
Design Comments: A code-value pair specifying descriptive properties of the medicine, such as color, shape, imprints, etc. The code has a data type of CE and the value has a data type of ANY, which allows codes or numeric values to be specified. This includes physical characteristics of the product, e.g., size, weight, as well as more abstract items such as whether the product is labeled for single use. A statement about a particular ingredient not being included within a product is also handled as a product characteristic. |
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| or ObservationGoal |
Design Comments: A desired characteristic of the product when it is reconstituted, i.e., a goal for the observation to be made for the reconstituted product. For example, allows stating the pH or osmolality of a powder for reconstitution. The "QS" null flavor is used with this goal to indicate the variable amount adjustable to meet the goal. |
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| or A_SubstanceSpecificationUniversal | |||||||||
| Characteristic |
Design Comments: A code-value pair specifying descriptive properties of the medicine, such as color, shape, imprints, etc. The code has a data type of CE and the value has a data type of ANY, which allows codes or numeric values to be specified. This includes physical characteristics of the product, e.g., size, weight, as well as more abstract items such as whether the product is labeled for single use. A statement about a particular ingredient not being included within a product is also handled as a product characteristic. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: The value provided, OBS, indicates that observation information is being passed. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [1..1] Observation (CD) {CWE:D:ObservationType} |
Design Comments: A code specifying which characteristic of the medicine is being described. The vocabulary domain is MedicationObservationType (a CWE domain which can be extended as necessary). For example, some values that are contained in the SPL Label Data value set within the MedicationObservationType vocabulary domain are listed below: * SPLIMPRINTCD - imprint code - Identifying marks on product * SPLSIZE - size - Description of size of the product as called for in regulations * SPLSHAPE - shape - Description of shape of the product as called for in regulations * SPLCOLOR - color - Description of color of the product as called for in regulations * SPLCOATING - coating - Description of the coating of the product as called for in regulations * SPLSCORING - scoring - Description of scoring of the product as called for in regulations * SPLSYMBOL - logo - Description of the logo on the product as called for in regulations [from SPL] |
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| text [0..1] Observation (ED) |
Design Comments: A text field that allows entry of free text description of the characteristics. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The value of the characteristic, e.g., a code for the specific shape or color, or a physical quantity specification for the size. |
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| methodCode [0..*] Observation (DSET<CD>) {CWE:D:ObservationMethod} |
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| analyte [0..1] (Analyte) | |||||||||
| participation [0..*] (Interactor) | |||||||||
| Analyte | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAnalyte, root= "ALY"} |
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| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||
| Interactor | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ReactionParticipant} |
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| functionCode [0..1] Participation (CD) {CWE:D:MolecularInteractionFunction} |
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| quantity [0..1] Participation (PQ) |
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| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||
| ObservationGoal |
Design Comments: A desired characteristic of the product when it is reconstituted, i.e., a goal for the observation to be made for the reconstituted product. For example, allows stating the pH or osmolality of a powder for reconstitution. The "QS" null flavor is used with this goal to indicate the variable amount adjustable to meet the goal. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodGoal, root= "GOL"} |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
Design Comments: A coded indication of the property which the goal specifies (e.g., pH). |
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| text [0..1] Observation (ED) |
Design Comments: A text description of the goal. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The constraint given for the observation goal, i.e., if an actual observation falls within that constraint (or meets the measurement within some reasonable margin of error) then the goal is considered met. |
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