{
  "description": null,
  "_filename": "example/PlanDefinition-ab241f8c-d21e-4382-a70a-52190dbdf07e.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2023-11-28",
  "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": "e512320e-0ffb-47d9-922a-5415aaa4cb30",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Viscous upon cooling",
        "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": "Viscous upon cooling"
    }
  }, {
    "id": "2c6e465b-4dec-4a09-9dc5-58c480009d27",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Kappa, iota or Lambda",
        "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": "Kappa, iota or lambda"
    }
  }, {
    "id": "c233a5f7-37e2-4b2b-9f04-cf1b25534865",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Blue stringy precipitate forms",
        "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": "Blue, stringy precipitate forms"
    }
  }, {
    "id": "c759888d-1eac-4a12-aa9b-403f395f2c18",
    "target": [ {
      "detailCodeableConcept": {
        "text": "FTIR matches standard",
        "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": "FTIR matches standard"
    }
  }, {
    "id": "66d4035c-633a-49b1-b974-e3171911f44a",
    "target": [ {
      "detailQuantity": {
        "code": "C68742",
        "unit": "colony forming units",
        "value": 200,
        "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": "max 200 cfu/g"
    }
  }, {
    "id": "95bf9d43-f337-4905-9c50-788b69d00843",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Negative",
        "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": "Negative"
    }
  }, {
    "id": "4e475e2c-c235-4433-b1e4-201a17e45796",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Negative",
        "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": "Negative"
    }
  }, {
    "id": "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f",
    "target": [ {
      "detailCodeableConcept": {
        "text": "As Reported",
        "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": "As Reported"
    }
  }, {
    "id": "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73",
    "target": [ {
      "detailCodeableConcept": {
        "text": "As Reported",
        "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": "As Reported"
    }
  }, {
    "id": "464f3063-0a4b-4408-9f4a-d6c0b8170097",
    "target": [ {
      "detailQuantity": {
        "code": "C48523",
        "unit": "parts per million",
        "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": "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": "<= 3 ppm"
    }
  }, {
    "id": "03fbc16c-d4d4-40ac-8689-448bda831dac",
    "target": [ {
      "detailQuantity": {
        "code": "C48523",
        "unit": "parts per million",
        "value": 10,
        "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": "<= 10 ppm"
    }
  }, {
    "id": "28aba010-126e-4c47-8611-367cdacdd87e",
    "target": [ {
      "detailCodeableConcept": {
        "text": "As Reported",
        "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": "As Reported"
    }
  }, {
    "id": "4b3aa353-3bc7-463f-b4c2-defd041da2c7",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "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": "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": "<= 2.0%"
    }
  }, {
    "id": "8125f603-96e7-4f3e-8b13-c15c5870e6e6",
    "target": [ {
      "detailQuantity": {
        "code": "C28254",
        "unit": "mL",
        "value": 30,
        "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)"
            } ]
          }
        } ]
      }
    }, {
      "detailQuantity": {
        "code": "C42559",
        "unit": "degree Celsius",
        "value": 25,
        "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": "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": "<30ml H2O @ 25C"
    }
  } ],
  "type": "{:coding [{:system \\\"http://terminology.hl7.org/CodeSystem/plan-definition-type\\\", :code \\\"workflow-definition\\\", :display \\\"Workflow Definition\\\"} {:system \\\"http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy\\\", :code \\\"C48660\\\", :display \\\"Not Applicable\\\"}]}",
  "experimental": null,
  "resourceType": "PlanDefinition",
  "title": "Raw Material (Carrageenan) Specification Example",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension",
    "valueCodeableConcept": {
      "coding": [ {
        "code": "C133931",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Raw Materials/Excipients/Intermediates/Reagents"
      } ]
    }
  } ],
  "status": "active",
  "id": "486ef400-bec5-4e2d-b5c5-1ab605dcbeb3",
  "kind": null,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e",
  "identifier": [ {
    "value": "RawCitricacid"
  }, {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.34.5",
    "system": "urn:ietf:rfc:3986"
  } ],
  "action": [ {
    "id": "428fa917-a7d3-4515-9b48-c9366acd673a",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Identification",
    "action": [ {
      "title": "Identification A",
      "goalId": [ "e512320e-0ffb-47d9-922a-5415aaa4cb30" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 1.1
      } ]
    }, {
      "title": "Identification B",
      "goalId": [ "2c6e465b-4dec-4a09-9dc5-58c480009d27" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 1.2
      } ]
    }, {
      "title": "Identification C",
      "goalId": [ "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 1.3
      } ]
    }, {
      "title": "Identification D",
      "goalId": [ "c759888d-1eac-4a12-aa9b-403f395f2c18" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 1.4
      } ]
    } ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC7",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Identification"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 1
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "EX-TEST-001"
    } ]
  }, {
    "id": "f7cbb73f-4220-4987-b498-c049230091ea",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Microbial Limits",
    "action": [ {
      "title": "Total Bacterial Count",
      "goalId": [ "66d4035c-633a-49b1-b974-e3171911f44a" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 2.1
      } ]
    }, {
      "title": "Salmonella",
      "goalId": [ "95bf9d43-f337-4905-9c50-788b69d00843" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 2.2
      } ]
    }, {
      "title": "Escherichia Coli",
      "goalId": [ "4e475e2c-c235-4433-b1e4-201a17e45796" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 2.3
      } ]
    } ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC13",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Microbial Limits"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 2
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "EX-TEST-002"
    } ]
  }, {
    "id": "f5f8221c-f9ec-4b47-8ec7-90ff44f7388c",
    "code": {
      "text": "UV",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Elemental Impurities",
    "action": [ {
      "title": "Cadmium (Cd)",
      "goalId": [ "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 3.1
      } ]
    }, {
      "title": "Mercury (Hg)",
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