PackagesCanonicalsLogsProblems
    Packages
    hl7.fhir.us.pq-cmc-fda@1.0.0-ballot
    http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7
{
  "description": null,
  "_filename": "example/PlanDefinition-aa514363-d43f-4052-b44e-b67aa4d6dee7.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2022-12-08",
  "meta": {
    "profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ]
  },
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "name": null,
  "goal": [ {
    "id": "32649771-1290-4386-9cf7-7a72274f22b4",
    "target": [ {
      "detailRange": {
        "low": {
          "code": "C45997",
          "unit": "pH",
          "value": 2,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "extension": [ {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
            "valueCodeableConcept": {
              "coding": [ {
                "code": "C61583",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "NLT (not less than)"
              } ]
            }
          } ]
        },
        "high": {
          "code": "C45997",
          "unit": "pH",
          "value": 3,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "extension": [ {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
            "valueCodeableConcept": {
              "coding": [ {
                "code": "C61585",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "LT (less than)"
              } ]
            }
          } ]
        }
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Average of 10 between 2-3 pH"
    }
  }, {
    "id": "59a4ca76-858e-4d58-8e5f-88e75f51ec33",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Conforms",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Maxima only at the same wavelengths compared to reference standard"
    }
  }, {
    "id": "c40aa176-e6aa-4fe4-869d-6550ee992903",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.5,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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            "coding": [ {
              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NMT (not more than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "<= 0.5 %"
    }
  }, {
    "id": "b122987d-586c-481b-951c-6202e660158d",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Conforms",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Color of solution is clear"
    }
  }, {
    "id": "929747ad-e83a-46f0-bbbc-133ee951e819",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.05,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NMT (not more than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "<= 0.05 %"
    }
  }, {
    "id": "8d7c85c2-7a4b-432e-ac94-226f296e4fca",
    "target": [ {
      "detailCodeableConcept": {
        "text": "pass",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "No Particulate Matter detected"
    }
  }, {
    "id": "de4f962a-d486-486d-8d84-f2d1635646b4",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.014,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NMT (not more than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "<= 0.014 %"
    }
  }, {
    "id": "b46dce64-a009-46cd-ab95-21d1d5b4df77",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.04,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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            } ]
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        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "<= 0.04 %"
    }
  }, {
    "id": "5566f501-37e1-49fb-8783-b20c074ec0c3",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.001,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NMT (not more than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "<= 0.001 %"
    }
  }, {
    "id": "db19e3ab-e28b-4477-8bd7-2409093ed5a3",
    "target": [ {
      "detailCodeableConcept": {
        "text": "pass",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution"
    }
  }, {
    "id": "82370588-7aae-4556-9262-a7f50dbd01aa",
    "target": [ {
      "measure": {
        "text": "Ethanol"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.2,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61585",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "LT (less than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Ethanol < 0.2%"
    }
  }, {
    "id": "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2",
    "target": [ {
      "measure": {
        "text": "Ethyl Ether"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.1,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61585",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "LT (less than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
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        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "Ethyl Ether < 0.1%"
    }
  }, {
    "id": "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279",
    "target": [ {
      "measure": {
        "text": "1—propanol"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.15,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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              "code": "C61585",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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          }
        } ]
      }
    } ],
    "addresses": [ {
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        "code": "C134029",
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        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "1—propanol < 0.15%"
    }
  }, {
    "id": "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3",
    "target": [ {
      "measure": {
        "text": "Total Residual Solvents"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.5,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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            "coding": [ {
              "code": "C61585",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "LT (less than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
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        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "Total < 0.5%"
    }
  }, {
    "id": "9100e938-42ff-4004-8473-ed5090d66f3a",
    "target": [ {
      "detailRange": {
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          "unit": "percent",
          "value": 99.5,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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                "code": "C61583",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "NLT (not less than)"
              } ]
            }
          } ]
        },
        "high": {
          "code": "C48570",
          "unit": "percent",
          "value": 100.5,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "extension": [ {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
            "valueCodeableConcept": {
              "coding": [ {
                "code": "C61586",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "NMT (not more than)"
              } ]
            }
          } ]
        }
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "99.5 - 100.5 %"
    }
  }, {
    "id": "af260128-f105-4692-ba40-49f21f12ad46",
    "target": [ {
      "detailInteger": 6
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "n=6"
    }
  }, {
    "id": "31d9dcac-bf72-420b-a415-c924155a83f4",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 85,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61583",
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              "display": "NLT (not less than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "Each unit is NLT Q + 5%"
    }
  }, {
    "id": "47c0d685-0b23-4637-9af8-a554e4fad7ec",
    "target": [ {
      "detailInteger": 6
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
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        "display": "Release"
      } ]
    } ],
    "description": {
      "text": "n=6"
    }
  }, {
    "id": "14d3dee8-e024-4367-b0a2-a2a809303ee0",
    "target": [ {
      "measure": {
        "text": "Average of 12 units"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 80,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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              "code": "C61583",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NLT (not less than)"
            } ]
          }
        } ]
      }
    }, {
      "measure": {
        "text": "unit"
      },
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
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